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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 224 out of 8,010

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VAERS ID: 1732974 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, SARS-CoV-2 test, Vaccination site pain
SMQs:, 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; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101196485

Write-up: Headache; Vaccination site pain; This is a spontaneous report from a contactable consumer received from the regulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109121822371100-7NOJ0, Safety Report Unique Identifier GB-MHRA-ADR 25929298. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported and Expiration date was unknown), via an unspecified route of administration on 10Sep2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 for COVID-19 immunization. On 11Sep2021 the patient experienced headache and vaccination site pain on 10Sep2021. All the events were medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on an unspecified date. Therapeutic measures were taken as a result of headache with unspecified medication. Patient was not enrolled in clinical trial. The clinical outcome of headache was not recovered and vaccination site pain was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1733011 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101196376

Write-up: hives all over body and face; Severe itching; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109122203360300-NOZRW, Safety Report Unique Identifier GB-MHRA-ADR 25929447. A male patient of an unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 09Sep2021, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial. On 10Sep2021, the patient experienced severe itching; on 11Sep2021, the patient experienced hives all over body and face; both the events were reported as serious for being medically significant. Patient had not tested positive for COVID-19 since the vaccination. The clinical outcome of the events severe itching and hives all over body and face was not resolved 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: 1733047 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Headache; Immune system disorder (Possible mild auto immune that has been dormant, I was nervous that the vaccine would trigger it.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101205595

Write-up: Just feeling generally sick, a little weaker, a little less resilient; Headache; Fatigue; This is a spontaneous report from a contactable consumer or other non-health care professional received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109131109538080-OGHFD. Sender''s (Case) Safety Report Unique Identifier: GB-MHRA-ADR 25933827. An unspecified age female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 09Sep2021, as dose 2, single for COVID-19 immunization. The patient medical history included immune system disorder (Possible mild auto immune that has been dormant, I was nervous that the vaccine would trigger it) and headache. Historical vaccine included that the patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on an unspecified date as dose 1, single for COVID-19 immunization. Concomitant medication included ibuprofen (IBUPROFEN) taken for headache (from 10Sep2021 to an unspecified stop date). 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 Not had a COVID-19 test. On an unspecified date, just feeling generally sick, a little weaker, a little less resilient. On 10Sep2021, the patient experienced headache and fatigue. All the events were serious (medically significant). The patient stated that she was on day four, she expected the reaction to only last one or two days. Just feeling generally sick, a little weaker, a little less resilient, sudden onset of headaches. Hoping it is still temporary, but she was just not finding a lot of information about side effects that last more than two days. Therapeutic measures were taken as a result of headache. The outcome of the event just feeling generally sick, a little weaker, a little less resilient was unknown and the events headache and fatigue was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1733049 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Axillary pain, Breast pain, Breast swelling, Fatigue, Headache, Paraesthesia, Peripheral swelling, SARS-CoV-2 test, Vaccination site mass, Vaccination site rash, Vaccination site swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Lipodystrophy (broad), Hypersensitivity (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: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101205475

Write-up: This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109131210192360-PADVZ, Safety Report Unique Identifier is GB-MHRA-ADR 25931565. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FE8087), via an unspecified route of administration on 10Sep2021 as dose 2, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient had not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. Historical vaccine included that patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. On an unspecified date, the patient experienced tingling sensation, tiredness, swelling around injection site as well as a red rash, swelling turned into a fluid like lump which was painful and very hot to the touch, swelling under the arm pit which on the third day has spread into her left boob, no energy. On 10Sep2021, experienced swelling arm, armpit pain, headache, fatigue and on 13Sep2021, had breast pain. Swelling around injection site as well as a red rash. This grew from a 50p size into the size of the base of a large mug. Swelling turned into a fluid like lump which was painful and very hot to the touch. There was swelling under the arm pit which on the third day has spread into her left boob, again painful to the touch. There was an occasional tingling sensation in her left hand and forearm which she feel the need to shake away. She had a constant mild headache and was extremely fatigued. On the Friday she slept for 12 hours and stayed in bed due to no energy. She continued to dose for throughout Saturday going to bed at 8.30pm and again sleeping through till 7. She feel extremely tired but this tiredness has eased a little on her third day. Though she feel wiped out if she do too much. She had gone to the doctor and received antibiotics. She had to keep an eye to ensure it does not get any larger or turn into a hard lump. The patient underwent lab tests and procedures which included Covid-19 test: negative (No - Negative COVID-19 test) on an unspecified date. The reporter considered the events as serious (medically significant). The outcome of events Tingling sensation, tiredness, fatigue was recovering, swelling arm, armpit pain, headache, breast pain was not recovered and unknown for other events. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1733101 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acne, SARS-CoV-2 test
SMQs:, 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 started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Acne; This case was received via RA (Reference number: GB-MHRA-ADR 25948278) on 16-Sep-2021 and was forwarded to Moderna on 16-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ACNE (Acne) in a 27-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped). On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced ACNE (Acne) (seriousness criterion medically significant). At the time of the report, ACNE (Acne) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment: This case concerns a 27-year-old, female patient with no relevant medical history, who experienced the unexpected event of acne. The event occurred approximately 1 day after the first dose of mRNA-1273. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.; Sender''s Comments: This case concerns a 27-year-old, female patient with no relevant medical history, who experienced the unexpected event of acne. The event occurred approximately 1 day after the first dose of mRNA-1273. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.


VAERS ID: 1733125 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-29
Onset:2021-09-10
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, Chest X-ray, Chest pain, Heart rate irregular, Hypoaesthesia, Insomnia, Investigation, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), COVID-19 (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? 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 Name: blood pressure; Result Unstructured Data: Test Result:nothing shown; Test Name: blood test; Result Unstructured Data: Test Result:nothing shown; Test Name: chest x-ray; Result Unstructured Data: Test Result:nothing shown; Test Name: heart monitor; Result Unstructured Data: Test Result:nothing shown; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative
CDC Split Type: GBPFIZER INC202101227094

Write-up: nausea; pain still continuing and numbness in left arm where i had the vaccine; Chest pain; Heartbeats irregular; Numbness in hand; Numbness; Insomnia; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109171831018700-8VVDN, Safety Report Unique Identifier is GB-MHRA-ADR 25960826. A 26-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FE8087) at single dose in left arm on 29Aug2021 for COVID-19 immunisation. Relevant medical history and concurrent conditions were none. Concomitant medication was not reported. The patient previously took ibuprofen. Patient had not had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient experienced nausea on an unspecified date with outcome of recovered, pain still continuing and numbness in left arm where patient had the vaccine on an unspecified date with outcome of recovered, chest pain on 10Sep2021 with outcome of not recovered, heartbeats irregular on 10Sep2021 with outcome of not recovered, numbness in hand on 10Sep2021 with outcome of not recovered, numbness on 10Sep2021 with outcome of not recovered, insomnia on 10Sep2021 with outcome of not recovered. 10Sep2021 10pm - pounding heartbeat, nausea, chest pain, insomnia. 11Sep2021 10am- pounding heartbeat, chest pain, went to hospital a and e. Patient was put on heart monitor, blood pressure checked, ECG, chest x-ray, blood test, nothing shown. Patient was discharged. COVID-19 virus test was no - negative. Chest pain, pounding heartbeat, insomnia on 12Sep and 13Sep, went back to was all manor hospital a and e. Completed blood tests, ECG. Completed health check by doctor. Senior doctor explained he had a reaction to the vaccine, told him to take ibuprofen. Pain was still continuing and numbness in left arm where he had the vaccine, was unable to make a fist with his hand. This report was assessed as serious as life threatening and other medically important condition. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1733153 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Inappropriate schedule of product administration, Pain, 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), 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: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201217; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101216952

Write-up: body aches; head ache; swollen; inappropriate schedule of vaccination administered; This is a spontaneous report from a contactable consumer. This is the second of 2 reports. The first report received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109121213273020-WVH0Z, Safety Report Unique Identifier(GB-MHRA-ADR 25929059). A 39-year-old female patient received bnt162b2 (BNT162B2, Batch/Lot Number were not reported, Batch/Lot Number: FF2153), dose 2 via an unspecified route of administration, administered in Arm Right on 10Sep2021 (at the age of 39 years old) as Dose 2, Single for COVID-19 immunisation. Medical history included covid-19 from 17Dec2020 to an unknown date. Historical vaccine included bnt162b2 (BNT162B2) dose 1, Lot Number: FD5613 via on an unspecified route of administration on 11Jul2021 for COVID-19 immunization and the patient experienced swelling and pain in extremity. The patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced body aches, headache, swollen on an unspecified date, inappropriate schedule of vaccination administered on an 10Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test was positive (Yes - Positive COVID-19 test) on 17Dec2020. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101196412 Same patient, different events/doses


VAERS ID: 1733380 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-09-10
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0680 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Intra-abdominal haematoma, Physical examination, Platelet count, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Name: Platelets count; Result Unstructured Data: Test Result:56000; Test Name: Impact on quality of life; Result Unstructured Data: Test Result:3/10
CDC Split Type: ITPFIZER INC202101223043

Write-up: thrombocytopenia; Abdominal hematomas; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-785070. A 46-year-old male patient received second dose of bnt162b2 (COMIRNATY) (Lot Number: FF0680) intramuscular in deltoid left single dose for COVID-19 immunisation on 15Jul2021 14:12. Medical history included: hypertension. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY) (Lot Number: FC3098) in left deltoid for covid-19 immunisation on 11Jun2021 at 15:02. The patient experienced thrombocytopenia and abdominal hematomas (life threatening) on 10Sep2021 with outcome of not recovered. Haematological check to be carried out. Lab data included platelet count: 56000, Impact on quality of life: 3/10. Reporter Comment: Hypertension No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Hypertension


VAERS ID: 1733433 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG0978 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Dyspnoea, Oropharyngeal discomfort, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101191344

Write-up: anaphylaxis; Urticaria; Pharynx strange sensation of; Dyspnoea; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution . The patient was a 40-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient had no other medical history. On 20Aug2021 (the day of vaccination), the patient previously received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot numberFE8162, Expiration date 30Nov2021) intramuscular in the arm left for COVID-19 immunization. On 10Sep2021 at 12:45 (the day of vaccination), the patient received the second single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FG0978, Expiration date 30Nov2021) intramuscular in the arm left for COVID-19 immunization. On 10Sep2021 at 13:00 (15 minutes after the vaccination), the patient experienced Urticaria, Pharynx strange sensation of, dyspnoea and anaphylaxis. The clinical course was reported as follows: Urticaria appeared a few minutes after vaccination. Even with intravenous injection of Antihistamine, the urticaria did not get better. Pharynx strange sensation of and dyspnoea appeared, which was judged to be anaphylaxis. No decrease in blood pressure and oxygenation was observed. After the administration of BOSMIN, the patient was taken to the emergency department by ambulance. the patient recovered after treatment and went home. The events resulted in Emergency room/department or urgent care. The outcome of the events was recovered with treatment including BOSMIN intramuscular injection. Since the vaccination, the patient had not been tested for COVID-19.; Sender''s Comments: Based on the information in the case report, a possible causal relationship between reported events Urticaria, Oropharyngeal discomfort, Dyspnoea and suspect drug BNT162B2 cannot be completely 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: 1733440 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0843 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Heart rate, Oxygen saturation
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: Medical History/Concurrent Conditions: Hypotension
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: BP; Result Unstructured Data: Test Result:92/56; Test Date: 20210910; Test Name: body temperature; Result Unstructured Data: Test Result:36.7; Comments: before vaccination; Test Date: 20210910; Test Name: Pulse; Result Unstructured Data: Test Result:90; Test Date: 20210910; Test Name: SpO2; Test Result: 93 %; Test Date: 20210910; Test Name: SpO2; Test Result: 99 %
CDC Split Type: JPPFIZER INC202101192306

Write-up: Anaphylaxis; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21126468. A 37-year and 3-month-old non-pregannt female received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF0843, Expiration date 31Oct2021) via an unspecified route of administration on 10Sep2021 at 11:10 (the day of vaccination) at the age of 37-year and 3-month-old, as 0.3mL, single dose for COVID-19 immunization. Medical history included hypotension. Body temperature before vaccination was 36.7 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). Prevaccination Screening Questionnaire for COVID-19 vaccine was reported as follows: It was the first time for the patient to receive COVID-19 vaccine. The patient currently did not treat (with medications, etc.) for any disease (Concomitant medication was none). The patient never been sick or had a fever in the past month. The patient was not feel sick the day of vaccination. The patient never been convulsions (seizures). The patient not have severe allergic reactions (anaphylaxis, etc.) to a medication or food, causative medication/food. The patient never been sick after receiving vaccination. The patient was not possibly pregnant (e.g. late period) or currently breast-feeding. The patient was not received any other vaccines in the past two weeks. The patient had been told by treating physician of the above disease that it was OK for the patient to receive this vaccination. Event onset date was reported as on 10Sep2021 at 11:15 (5 minutes after vaccination), event was reported as Anaphylaxis. The course of the event was as follows: Approximately 5 minutes after the vaccination, the patient felt dyspnoea, While the patient remained sitting, Rash appeared on left forearm. SpO2 was measured at the patient''s request and it showed that SpO2 was 93%. The patient had no wheezing, but Rash (Red rash)on left forearm was confirmed. BP 92/56, P 90. The patient said she had hypotension originally. Later, the patient stay quietly and Skin eruption disappeared after 30 minutes, Respiratory symptom disappeared. On 10Sep2021 ( the day of the vaccination), the outcome of the event Anaphylaxis was recovering. 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: After vaccination, Skin eruption, dyspnoea , SpO2 decreased and hypotension occurred quickly, and the skin eruption disappeared and SpO2 was restored to 99 after a while, the events were considered to be attributable to anaphylaxis (due to the vaccine). Follow up attempts are completed. Further information is not expected.


VAERS ID: 1733443 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF5357 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Cold sweat, Feeling abnormal, Heart rate, Hypoacusis, Loss of consciousness, Presyncope, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: BP; Result Unstructured Data: Test Result:71/40; Test Date: 20210910; Test Name: BP; Result Unstructured Data: Test Result:100/69; Test Date: 20210910; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 degrees Centigrade; Comments: Before vaccination; Test Date: 20210910; Test Name: P/ HR; Result Unstructured Data: Test Result:50; Test Date: 20210910; Test Name: P/ HR; Result Unstructured Data: Test Result:67
CDC Split Type: JPPFIZER INC202101192765

Write-up: The patient''s vision went black; The patient''s vision went black; Vasovagal reaction; feels poorly; BP 71/40; cold sweat; Hearing reduced; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21126552. A 29-year and 0-month-old female patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 10Sep2021 at 16:16 (the day of vaccination) at the age of 29 years old (Batch/Lot Number: FF5357; Expiration Date: 30Nov2021) as dose 2, single 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). The patient had no medical history. The patient''s concomitant medications were not reported. The patient''s body temperature before vaccination on 10Sep2021 was 36.2 degrees Centigrade. On 10Sep2021 at 16:20 (4 minutes after the vaccination), the patient experienced vasovagal reaction. On 10Sep2021 (the day of vaccination), the outcome of the event was recovered. The course of the events was reported as follows: On 10Sep2021 at 16:16, took vaccination. At 16:20, feels poorly occurred, blood pressure (BP) 71/40, pulse (P) 50, the patient''s vision went black, cold sweat and hearing reduced appeared. At 17:00, the patient recovered from the symptoms after resting. Consciousness clear, BP: 100/69, heart rate (HR): 67, and the patient went home. 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: recovered and went home. The patient had recovered from all the events on 10Sep2021 at 17:00.


VAERS ID: 1733447 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF5357 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Epilepsy, Fall, Head injury, Magnetic resonance imaging head, Seizure, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), 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 (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: body temperature; Result Unstructured Data: Test Result:35.7 Centigrade; Comments: before vaccination; Test Date: 20210910; Test Name: Head MRI; Result Unstructured Data: Test Result:showed no abnormality; Comments: and there was no finding of which could be the cause
CDC Split Type: JPPFIZER INC202101192871

Write-up: Convulsion; Syncope; loss of posture; hit the right top of the head; epileptic seizure; This is a spontaneous report from a contactable physician received from a regulatory authority. The regulatory authority report number is v21126531. A 16-year-old (also reported as 16-year and 9-month-old) female patient received BNT162B2 (COMIRNATY, solution for injection, lot number: FF5357, expiration date: 30Nov2021), via an unspecified route of administration on 09Sep2021 at 14:00 (at the age of 16-years-old- as reported) at dose 1, single for COVID-19 immunisation. Body temperature before vaccination on 09Sep2021 was 35.7 Centigrade. The patient''s family history included his father having childhood epilepsy. Medical history and concomitant medications were reported as none. 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 10Sep2021 at 10:00 (reported as 1 day after vaccination), the patient experienced convulsion. The course of the event was as follows: On 10Sep2021 at 10:00, the patient was in the school classroom sitting at the desk, when she suddenly experienced syncope and loss of posture. The patient, at that time, hit the right top of her head. According to a witness, the patient experienced convulsion for about 15 seconds after the syncope and her eyes were moving. The patient did not remember the episode, but immediately recovered her consciousness. At 14:00, the patient visited the clinic. Head CT showed no abnormality and there was no finding of which could be the cause. The events required physician office visit. On 10Sep2021 (reported as 1 day after vaccination), the outcome of the events was reported as recovering. The reporter classified the events as non-serious and assessed that the events were related to BNT162B2. Other possible cause of the event such as any other diseases was: first episode of epileptic seizure. The reporting physician commented as follows: This was the first time of epileptic seizure. As it occurred one day after vaccination, could not deny the causality between the event and the vaccine.; Reporter''s Comments: This was the first time of epileptic seizure. As it occurred one day after vaccination, could not deny the causality between the event and the vaccine.


VAERS ID: 1733449 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4204 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cough, Pruritus, Throat irritation, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Bronchial asthma; Food allergy (corn); Rhinitis allergic
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: body temperature; Result Unstructured Data: Test Result:37.2 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101192900

Write-up: Dry cough; the patient experienced Pharyngolaryngeal Itching; localized Itchy skin/ Itchy skin of upper limbs; Early after the vaccination, the impression of urticaria appeared; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21126540. An 18-year-old female patient received bnt162b2 (COMIRNATY) (at the age of 18-year-old), dose 1 via an unspecified route of administration on 10Sep2021 16:00 (Batch/Lot Number: FF4204; Expiration Date: 31Oct2021) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included asthma bronchial, rhinitis allergic, food allergy (corn) and several basic diseases of allergy. The patient''s concomitant medications were not reported. The patient was a 18-year-old female. Body temperature before vaccination was 37.2 degrees Centigrade. The patient had Asthma bronchial, Rhinitis allergic and food allergy(corn). On 10Sep2021 at 16:00 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF4204, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 10Sep2021 at 16:20 (20 minutes after the vaccination), the patient experienced localized Itchy skin and Dry cough. On 10Sep2021 (the day of vaccination), the outcome of the event was recovering. The course of the event was as follows: On 10Sep2021 at 16:10 (10 minutes after the vaccination), 10 minutes after the vaccination, the patient experienced Itchy skin of upper limbs. On 10Sep2021 at 16:20 (20 minutes after the vaccination),20 minutes after the vaccination, the patient experienced Pharyngolaryngeal Itching and it was confirmed to be Dry cough. Normal saline 100 ml and Solu-Medrol 250ml, intravenous drip infusion within 30 minutes. Itching disappeared and cough frequency decreased. The patient went home. 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. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The patient had several basic diseases of allergy. Early after the vaccination, the impression of urticaria appeared. There existed possibility of suppression of anaphylaxis by early response. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1733453 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0349 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Panniculitis, 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? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before the vaccination
CDC Split Type: JPPFIZER INC202101193103

Write-up: Panniculitis; Itching; This is a spontaneous report received from the Regulatory Authority. The regulatory authority report number is v21126534. A contactable physician reported that a 44-year-old male patient received BNT162B2 (Solution for injection), via an unspecified route of administration, on 10Sep2021 at 10:10 (Lot Number: FD0349; Expiration Date: 31Oct2021) (at the age of 44 years old) as dose 2, single for COVID-19 immunization. The patient has no relevant medical history. There were no concomitant medications. 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 was previously administered the first dose of BNT162B2 (Solution for injection), via an unspecified route of administration, on 20Aug2021 (Lot number and expiration date were unknown) as dose 1, single for COVID-19 immunization. On 10Sep2021 about 21:00 (the day of the vaccination), the patient experienced panniculitis and itching. The events resulted to physician office visit. The regulatory authority assessed the events as non-serious. The course of the events was as follows. On 20Aug2021, the patient was vaccinated with the first dose of Covid19 Vaccine (Pfizer). On 10Sep2021, shortly after 10:00, the patient was vaccinated with the second dose. Body temperature before vaccination was 36.3 centigrade. On the same night, several tip-of-thumb-sized erythema with a bump (raised erythema) appeared on the back, buttock, and trunk. Itching and dull pain were present. On the morning of 11Sep2021, the patient visited the reporter''s clinic. The bump disappeared from the erythema area. The pink color of erythema got lighter. There was an impression that it was close to so-called Moderna arm. Fexofenadine (60) 2 tablets to be taken after breakfast and dinner and Voalla ointment were prescribed as treatment for the events. The patient underwent lab tests and procedures which included body temperature: 36.3 centigrade on 10Sep2021 (before the vaccination). On 11Sep2021 (1 day after the vaccination), the outcome of the events panniculitis and itching was recovering. The reporter classified the event as non-serious and assessed that the events were related to BNT162B2. There was no other possible cause of the event such as any other diseases. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1736094 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-10
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Pulmonary embolism, SARS-CoV-2 test
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic heart failure; Chronic obstructive bronchopneumopathy; Cognitive disorders; Deep venous thrombosis prophylaxis; Hypothyroidism; Parkinson''s disease
Preexisting Conditions: Medical History/Concurrent Conditions: Adnexectomy; COVID-19; Hysterectomy; Comments: Extrapyramidal symptoms, introduction of modopar in 2020-SARS Cov 2, hospitalized in 11.20 (picture of febrile diarrhea). complicated by multisensitive Kblesiella bacteremia, urinary starting point and bilateral peroneal DVT, treated with eliqus for 3 months-11.2020: decision of SAD facing high post-voiding residuals and repeated urinary tract infection-heart failure-cognitive disorders hypothyroidism-severe swallowing issues: speech therapy care in 11.20: need for thickened fluids-COPD under seretidecure of bilateral inguinal hernia-hysterectomy and annexectomy-cystopexy twice
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: SARS-CoV-2 test; Result Unstructured Data: Positive
CDC Split Type: FRJNJFOC20210945962

Write-up: Deep vein thrombosis leg; Pulmonary embolism; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, FR-AFSSAPS-GR20214170) on 23-SEP-2021 concerned an 87 year old female of an unspecified race and ethnic origin. The patient''s weight was 75 kilograms, and height was 160 centimeters. The patient''s past medical history included: covid-19, adnexectomy, and hysterectomy, and concurrent conditions included: cognitive disorders, chronic heart failure, parkinson''s disease, chronic obstructive bronchopneumopathy, deep venous thrombosis prophylaxis, and hypothyroidism, and other pre-existing medical conditions included: Extrapyramidal symptoms, introduction of modopar in 2020-SARS Cov 2, hospitalized in 11.20 (picture of febrile diarrhea). complicated by multisensitive Kblesiella bacteremia, urinary starting point and bilateral peroneal DVT (deep venous thrombosis), treated with eliqus for 3 months NOV-2020 decision of SAD facing high post-voiding residuals and repeated urinary tract infection-heart failure-cognitive disorders hypothyroidism-severe swallowing issues: speech therapy care in NOV-2020 need for thickened fluids-COPD (chronic obstructive bronchopneumopathy) under seretidecure of bilateral inguinal hernia-hysterectomy and annexectomy-cystopexy twice. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) .5 ml with frequency 1 total administered on 22-AUG-2021 for covid-19 vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 10-SEP-2021, the patient experienced deep vein thrombosis leg, pulmonary embolism and was hospitalized (date and days unspecified). On the same day, the patient went for laboratory tests included SARS-CoV-2 test (NR: not provided) Positive (units unspecified). Treatment with Covid-19 vaccine ad26.cov2.s was withdrawn on 22-AUG-2021. The patient recovered with sequelae from deep vein thrombosis leg, and pulmonary embolism. This report was serious (Hospitalization Caused / Prolonged).; Reporter''s Comments: Bilateral pulmonary embolism with lesions at the level of the two lower lobes as well as at the level of the apices in particular at the level of the upper right lobar artery. With right common femoral venous thrombosis potentially being the starting point of the embolism.


VAERS ID: 1736230 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Menstrual disorder, SARS-CoV-2 test, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210914; 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: regular periods; Menstruation abnormal; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25945542) on 16-Sep-2021 and was forwarded to Moderna on 16-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (regular periods) and MENSTRUAL DISORDER (Menstruation abnormal) 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 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced MENSTRUAL DISORDER (Menstruation abnormal) (seriousness criterion medically significant). On an unknown date, the patient experienced VAGINAL HAEMORRHAGE (regular periods) (seriousness criterion medically significant). At the time of the report, VAGINAL HAEMORRHAGE (regular periods) had not resolved and MENSTRUAL DISORDER (Menstruation abnormal) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment was reported. Company Comment: This case concerns a female subject with no reported relevant history, who experienced the unexpected events of Vaginal haemorrhage and Menstrual disorder. The events occurred next day after the second dose of the study drug administration. The rechallenge was unknown since there?s no information about the first dose. The reporter did not provide causality assessment. The benefit-risk relationship of the study drug in not affected by this report.; Sender''s Comments: This case concerns a female subject with no reported relevant history, who experienced the unexpected events of Vaginal haemorrhage and Menstrual disorder. The events occurred next day after the second dose of the study drug administration. The rechallenge was unknown since there?s no information about the first dose. The reporter did not provide causality assessment. The benefit-risk relationship of the study drug in not affected by this report.


VAERS ID: 1736339 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Low density lipoprotein increased, Lymphadenopathy, Pain in extremity, Peripheral swelling, SARS-CoV-2 test, Somnolence, Type IV hypersensitivity reaction
SMQs:, Cardiac failure (broad), Angioedema (broad), Dyslipidaemia (narrow), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Delayed type hypersensitivity; Large arm swelling; Swollen lymph nodes; Dizziness; LDL cholesterol increased; Pain in arm; Sleepiness; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 25949925) on 16-Sep-2021 and was forwarded to Moderna on 16-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (Delayed type hypersensitivity), SOMNOLENCE (Sleepiness), PERIPHERAL SWELLING (Large arm swelling), PAIN IN EXTREMITY (Pain in arm), LYMPHADENOPATHY (Swollen lymph nodes), LOW DENSITY LIPOPROTEIN INCREASED (LDL cholesterol increased) and DIZZINESS (Dizziness) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. No Medical History information was reported. On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced SOMNOLENCE (Sleepiness) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant) and LOW DENSITY LIPOPROTEIN INCREASED (LDL cholesterol increased) (seriousness criterion medically significant). On 11-Sep-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Delayed type hypersensitivity) (seriousness criterion medically significant), PERIPHERAL SWELLING (Large arm swelling) (seriousness criterion medically significant), LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (Delayed type hypersensitivity), PERIPHERAL SWELLING (Large arm swelling), PAIN IN EXTREMITY (Pain in arm), LYMPHADENOPATHY (Swollen lymph nodes), LOW DENSITY LIPOPROTEIN INCREASED (LDL cholesterol increased) and DIZZINESS (Dizziness) had not resolved and SOMNOLENCE (Sleepiness) was resolving. 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. No treatment information was provided. No relevant concomitant medications were reported. Company Comment : This case concerns a 37-year-old, female patient with no relevant medical history, who experienced the unexpected events of sleepiness, pain in arm, delayed type IV hypersensitivity reaction, pheripheral swelling, lymphadenopathy and dizziness. The events occurred approximately 1 day after the second dose of Moderna covid -19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a 37-year-old, female patient with no relevant medical history, who experienced the unexpected events of sleepiness, pain in arm, delayed type IV hypersensitivity reaction, pheripheral swelling, lymphadenopathy and dizziness. The events occurred approximately 1 day after the second dose of Moderna covid -19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1737978 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-10
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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? 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: DEJNJFOC20210947351

Write-up: MYOCARDITIS; This spontaneous report received from a consumer via Regulatory authority (EVHUMAN Vaccines, DE-PEI-CADR2021179459) on 24-SEP-2021 and concerned a 25-year-old male of unspecified race and ethnic origin. The patient''s weight was 65 kilograms, and height was 172 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: XE395 expiry: unknown) dose was not reported, 1 total administered on 10-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-SEP-2021, the patient experienced myocarditis. On an unspecified date, he was hospitalized. 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 myocarditis. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1738850 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PFIZER FE3592 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Rash, Syncope, Testicular pain
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101211542

Write-up: Rash; Fainting; Testicular pain; Dizziness; This is a spontaneous report from a contactable consumer, received from the products Regulatory Agency. The regulatory authority re-port number is GB-MHRA-WEBCOVID-202109142118155400-NX1MB, Safety Report Unique Identifier GB-MHRA-ADR 25942241. A 25-years-old male patient received first dose of BNT162B2 (COMRINATY, Formulation: Solution for injection, Lot Number: Pfizer fe3592) via an unspecified route of administration on 10Sep2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient not had symptoms associated with COVID-19 and did not have a COVID-19 test. On 10Sep2021, the patient experienced testicular pain, fainting and dizziness; On 14Sep2021, had rash. Reportedly, the side effects began 30 minutes after the first dose was given. The seriousness criteria of the events was medically significant. The patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1738871 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chest pain, Diarrhoea, Ear infection, Insomnia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101217589

Write-up: Diarrhea; Vomiting; Shoulder pain; Ear infection; Chest pain; Insomnia; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109150752174970-32ZX7 with Safety Report Unique Identifier GB-MHRA-ADR 25943895. A 25-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2153) via an unspecified route of administration on 10Sep2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have symptoms associated with COVID-19, and was not enrolled in clinical trial. On 07Sep2021, the patient underwent COVID-19 virus test and the result was negative. On 10Sep2021, the patient experienced chest pain and insomnia; on 11Sep2021,1 day after the vaccination, the patient experienced diarrhea, vomiting, shoulder pain and ear infection; all the events were reported as serious for being medically significant. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event chest pain was resolved on 12Sep2021, after the duration of 2 days; diarrhea were resolved on 12Sep2021, after the duration on 1 day; vomiting was resolved on 13Sep2021, after the duration of 2 days; shoulder pain was resolved on 14Sep2021, after the duration of 3 days; insomnia was resolved on 14Sep2021, after the duration of 4 days; while that of ear infection was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1738899 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE33803 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Oedema, Rash, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101217574

Write-up: Edema; Rash; DOSE 1: 16Jul2021, DOSE 2: 10Sep2021; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202109151421108820-MBB3M, Safety Report Unique Identifier GB-MHRA-ADR 25945668. A 19-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE33803) via an unspecified route of administration on 10Sep2021 as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and suspected COVID-19 from 10Sep2020 to 15May2021. The patient was not pregnant and was not breastfeeding at the time of this report. It was unsure whether the patient was enrolled in a clinical trial. The patient previously took levothyroxine (MANUFACTURER UNKNOWN) for hypothyroidism. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 16Jul2021 as a single dose for COVID-19 immunisation. On 11Sep2021, 1 day after the vaccination, the patient experienced rash and oedema; both were reported as serious for being medically significant. On an unknown date, the patient underwent COVID-19 virus test and the result was negative. The patient had not tested positive for COVID-19 since having the vaccine. Therapeutic measure was taken as a result of rash and oedema which included one antihistamine tablet 24hrs after the side effects developed. The clinical outcome of the events rash and oedema was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1738961 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-09-10
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dysmenorrhoea, SARS-CoV-2 test
SMQs:, 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 COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Menses painful; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25951515) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSMENORRHOEA (Menses painful) in a 26-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced DYSMENORRHOEA (Menses painful) (seriousness criterion medically significant). At the time of the report, DYSMENORRHOEA (Menses painful) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative covid-19 test (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications reported by reporter. No treatment medications provided by the reporter. The patient''s first period after receiving her first vaccine was very painful to the point of vommiting and no over the counter medication helped. This lasted the entire duration of her period from the 10-SEP-2021 and was still ongoing. Company Comment: This case concerns a 26-year-old, female patient with no relevant medical history, who experienced the unexpected event of dysmenorrhea. The events occurred approximately 14 days after the second dose of Moderna CoviD-19 Vaccine. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a 26-year-old, female patient with no relevant medical history, who experienced the unexpected event of dysmenorrhea. The events occurred approximately 14 days after the second dose of Moderna CoviD-19 Vaccine. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1738979 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-10
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004223 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dermatitis, SARS-CoV-2 test
SMQs:, Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Dermatitis; This case was received via regulatory authority (Reference number: 25958169) on 19-Sep-2021 and was forwarded to Moderna on 19-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DERMATITIS (Dermatitis) in a 22-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. No Medical History information was reported. On 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced DERMATITIS (Dermatitis) (seriousness criterion medically significant). At the time of the report, DERMATITIS (Dermatitis) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided. Treatment information was not reported. Company Comment: This case concerns a 22-year-old, female patient with no relevant medical history, who experienced the unexpected events of dermatitis. The events occurred approximately 3 days after the second dose of Moderna Covid-19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The event was considered related to the study drug, per the reporter''s assessment was not known. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a 22-year-old, female patient with no relevant medical history, who experienced the unexpected events of dermatitis. The events occurred approximately 3 days after the second dose of Moderna Covid-19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The event was considered related to the study drug, per the reporter''s assessment was not known. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1738993 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Feeling cold, Headache, Hot flush, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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

Write-up: Vomiting; Feeling cold; Nauseous; Headache; Hot flush; This case was received via Regulatory Authority RA (Reference number: GB-MHRA-ADR 25960970) on 19-Sep-2021 and was forwarded to Moderna on 19-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous), VOMITING (Vomiting), HEADACHE (Headache), HOT FLUSH (Hot flush) and FEELING COLD (Feeling cold) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. No Medical History information was reported. On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and HOT FLUSH (Hot flush) (seriousness criterion medically significant). On 11-Sep-2021, the patient experienced NAUSEA (Nauseous) (seriousness criterion medically significant). On 13-Sep-2021, the patient experienced FEELING COLD (Feeling cold) (seriousness criterion medically significant). On 14-Sep-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant). On 16-Sep-2021, VOMITING (Vomiting) had resolved. At the time of the report, NAUSEA (Nauseous), HEADACHE (Headache), HOT FLUSH (Hot flush) and FEELING COLD (Feeling cold) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant products were not provided. Treatment medication were not reported. Patient''s medical history was that the patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Company Comment: This case concerns a female patient with no relevant medical history, who experienced the unexpected events of nausea, vomiting, headache, hot flush and feeling cold. The events headache and hot flush occurred on the same day after first dose of Spikevax. The event nauseous occurred 1 day after first dose of Spikevax. The event feeling cold occurred 3 days after the first dose of Spikevax. The event vomiting occurred 4 days after the first dose of Spikevax. The rechallenge was not applicable, as the events happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a female patient with no relevant medical history, who experienced the unexpected events of nausea, vomiting, headache, hot flush and feeling cold. The events headache and hot flush occurred on the same day after first dose of Spikevax. The event nauseous occurred 1 day after first dose of Spikevax. The event feeling cold occurred 3 days after the first dose of Spikevax. The event vomiting occurred 4 days after the first dose of Spikevax. The rechallenge was not applicable, as the events happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1739046 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Back pain, Blood test, Chest pain, Dizziness, Dyskinesia, Electrocardiogram, Feeling abnormal, Heart rate, Heart rate increased, Movement disorder, Muscle twitching, Myocardial infarction, Nervous system disorder, Seizure, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Akathisia (broad), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210913; Test Name: blood tests; Result Unstructured Data: Test Result:Normal; Test Name: ECG; Result Unstructured Data: Test Result:still stable; Test Date: 20210913; Test Name: ECG; Result Unstructured Data: Test Result:Normal; Test Name: Pulse rate; Result Unstructured Data: Test Result:high pulse; Test Name: Pulse rate; Result Unstructured Data: Test Result:90 beats/minute; Comments: after given diazepam; Test Date: 20210913; Test Name: Pulse rate; Result Unstructured Data: Test Result:48 to 118 beats/minute
CDC Split Type: GBPFIZER INC202101205690

Write-up: seizures; body twitching uncontrollably; couldn''t talk; mouth moving open without control; could not lift her head/cant get up unaided, body like in Parkinson''s disease; nervous system was attacked; dizziness; still has the feeling of water in her ear and head; heart attack; high pulse; worsening during the weekend across her back and chest; worsening during the weekend across her back and chest; pain in the left hand; This is a spontaneous report from a contactable consumer (patient herself). A 31-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FF8222) via an unspecified route of administration on 10Sep2021 (at the age of 31-years) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated that on the evening after vaccination on 10Sep2021, she had felt pain in the left hand where vaccine was administered. The pain had worsened during the weekend across her back and chest. On Sunday, she had called 911 and they had not called her back. On Monday 13Sep2021, she was taken to A&E with seizures where when lab tests performed showed ECG and blood tests normal. She had some kind (form) of heart attack, some issue with her heart, high pulse with heartbeat from 48 to 118 beats/minute for about 6 hours. She had body twitching uncontrollably, could not talk so was taken to A&E again. Back in the hospital, seizures were going back constantly, could not lift her head, mouth moving open without control. The reported also stated that the patient was usually healthy before and the doctor had told that was reaction to vaccination. They also believed that her nervous system was attacked. She was given diazepam to calm her down and heartbeat came down to normal at 90 beats/minute however, she still could not get up unaided with body like in Parkinson''s disease. She had felt better then but with a feeling of water in her ear and head, had dizziness. She was then discharged from the hospital. On an unspecified date, ECG was still stable, but her body twitching continued. Therapeutic measures were taken as a result of high pulse (heart rate increased), seizures (seizure), nervous system was attacked (nervous system disorder). The outcome of the event high pulse was recovered on an unknown date and rest other events was unknown.


VAERS ID: 1739427 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF5357 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure decreased, Blood pressure measurement, Body temperature, Dizziness, Dyspnoea, Heart rate, Oxygen saturation, Oxygen saturation decreased, Vision blurred
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (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? Yes, 1 days
   Extended hospital stay? 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: 20210910; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before the vaccination; Test Date: 20210910; Test Name: HR; Result Unstructured Data: Test Result:78; Comments: 17:50; Test Date: 20210910; Test Name: HR; Result Unstructured Data: Test Result:70; Comments: 18:10; Test Date: 20210910; Test Name: HR; Result Unstructured Data: Test Result:70; Comments: 18:50; Test Date: 20210910; Test Name: HR; Result Unstructured Data: Test Result:76; Comments: 19:15; Test Date: 20210910; Test Name: SpO2; Test Result: 98 %; Comments: 17:50; Test Date: 20210910; Test Name: SpO2; Result Unstructured Data: Test Result:decreased to 92 %; Comments: 19:10; Test Date: 20210910; Test Name: SpO2; Result Unstructured Data: Test Result:recovered to 99 %; Test Date: 20210910; Test Name: SpO2; Test Result: 92 %; Comments: 19:15; Test Date: 20210910; Test Name: BP; Result Unstructured Data: Test Result:112/72; Comments: 17:50; Test Date: 20210910; Test Name: BP; Result Unstructured Data: Test Result:120/83; Comments: 18:10; Test Date: 20210910; Test Name: BP; Result Unstructured Data: Test Result:120/70; Comments: 18:50; Test Date: 20210910; Test Name: BP; Result Unstructured Data: Test Result:98/80; Comments: 19:15
CDC Split Type: JPPFIZER INC202101201120

Write-up: BP 98/80; Dyspnoea; SpO2 decreased to 92%; Anaphylaxis; Swaying feeling; Vision blurred; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126662. The patient was a 14-year and 5-month-old female. (age at second dose of vaccination) Body temperature before vaccination was 36.2 degrees Centigrade. 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 10Sep2021 at 17:30 (the day of vaccination), the patient received the second dose of bnt162b2 (comirnaty, solution for injection, Lot number FF5357, Expiration date 30Nov2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 10Sep2021 at 17:50 (the day of the vaccination), the patient experienced Anaphylaxis. On 10Sep2021 (the day of vaccination), the patient was admitted to the hospital. On Sep2021, the outcome of the events was not provided.(as reported) The course of the event was as follows: At 17:50 the patient experienced Swaying feeling. Vision blurred. (BP 112/72, HR 78, SpO2 98%) The patient was rested in bed. No rash nor gastrointestinal symptoms developed. At 18:10 the symptom slightly improved. The patient sat down and was followed-up. (BP 120/83, HR 70) . At 18:50 BP 120/70, HR 70. At 19:10 Dyspnoea developed. Swaying feeling in front of the eyes. SpO2 decreased to 92. Dyspnoea persisted. BOSMIN 1A was intramuscular injected. O2 3e was started to be administered. SpO2 recovered to 99%. At 19:15 Dyspnoea worsened, BP 98/80 HR 76 SpO2 92%. At 19:25 additional BOSMIN 1A was administered. The reporter classified the events as serious (hospitalized from 10Sep2021 to 11Sep2021) and assessed that the events was related to bnt162b2. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1739433 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-09-10
   Days after vaccination:70
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Gastric perforation, Gastrointestinal perforation, Peritonitis
SMQs:, Gastrointestinal perforation (narrow), Ischaemic colitis (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: JPPFIZER INC202101206456

Write-up: Gastrointestinal perforation; Peritonitis/ Panperitonitis; Gastric perforation; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21126665. A 77-year-old female patient received the second dose of COVID-19 vaccine (manufacturer unknown) via an unspecified route of administration on 02Jul2021 (at the age of 77-year-old ) as a single dose for COVID-19 immunization. Primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status were unknown. On 02Jul2021(the day of vaccination), the patient received the second dose of COVID-19 vaccine (manufacturer unknown). On 10Sep2021 in the evening ( 2 months after the vaccination), the patient experienced Gastrointestinal perforation and Peritonitis. On 13Sep2021, the patient was admitted to the hospital. The course of the event was as follows: On 10Sep2021, from evening, abdominal pain occurred. On 12Sep2021, due to abdominal pain continued, went to hospital and had a visit. Panperitonitis occurred. It was confirmed as gastrointestinal perforation. Introduction to this hospital. On 12Sep2021, Emergency surgery was done and it was confirmed as gastric perforation. Hospitalization. The outcome was unknown. The reporting physician classified the event as serious (Hospitalized from 13Sep2021) and assessed that the causality between the event and bnt162b2 as un-assessable. The lot number for the vaccine was not provided and will be requested during follow up.


VAERS ID: 1739437 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-09-10
   Days after vaccination:85
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Endoscopy upper gastrointestinal tract, Gastric haemorrhage, Haematemesis, Haematochezia, Haemoglobin, Haemoglobin decreased, Upper gastrointestinal haemorrhage
SMQs:, Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (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: 20210910; Test Name: upper gastrointestinal endoscopy; Result Unstructured Data: Test Result:There was a large amount of Clot in the stomach; Comments: and the source of bleeding was unknown. there was a decrease in Hb; Test Date: 2021; Test Name: hemoglobin; Result Unstructured Data: Test Result:decreased
CDC Split Type: JPPFIZER INC202101206576

Write-up: Upper gastrointestinal haemorrhage; Haematemesis; Bloody stool; There was a large amount of Clot in the stomach; there was a decrease in Hb; This is a spontaneous report from a contactable physician received from the Agency (A). Regulatory authority report number is v21126664. The patient was a 68-year and 7-month-old male received the second dose of BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown, solution for injection, Lot number unknown), via an unknown route, on 17Jun2021 (at the of 68-year and 7-month) at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On 10Sep2021 (85 days after the vaccination), the patient experienced haematemesis and bloody stool. On 11Sep2021 (86 days after the vaccination), the patient was admitted to the hospital. The course of the event was as follows: The patient was transported to hospital due to Haematemesis and Bloody stool. Gastric lavage and upper gastrointestinal endoscopy were performed. There was a large amount of clot in the stomach, and the source of bleeding was unknown. As there was a decrease in Hb, the patient was hospitalized after administration of 4U Transfusion. The outcome of the events was unknown. The reporting physician classified the event ''upper gastrointestinal haemorrhage'' serious because caused hospitalization from 11Sep2021 and assessed that the causality between the event and BNT162B2 as unassessable. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1739471 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-09-10
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bradycardia, Presyncope
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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: JPMODERNATX, INC.MOD20213

Write-up: Tendency of bradycardia; Vasovagal reflex; This case was received (Reference number: 2021TJP093879) on 13-Sep-2021 and was forwarded to Moderna on 25-Sep-2021. This case, reported by a physician, was received by Moderna''s adverse reaction reporting site (TASK0021714), and reported to the Pharmaceuticals and Medical Devices Agency (PMDA) by a physician, was received via the PMDA (Ref, v21126675). Tendency of bradycardia was assessed as serious by the MAH. On 06-Aug-2021, the patient received the 1st dose of this vaccine. On an unknown date, body temperature before vaccination: 36.4 degrees Celsius. On 10-Sep-2021, the patient received the 2nd dose of this vaccine. At 11:39, vasovagal reflex developed. The patient also had a symptom of low visibility. BP was 105/55 with P 54 which showed tendency of bradycardia. The patient was placed on follow-up in bed, and BP returned to 114/64, and P to 70. The symptoms also disappeared. The outcome of vasovagal reflex and tendency of bradycardia was reported as recovered. Follow-up investigation will be made. Company Comment: This case concerns a 22-year-old, male patient with no relevant medical history, who experienced the unexpected events of bradycardia and presyncope. The events occurred following the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as events occurred after second dose and no further dosing was reported or planned, based on information provided. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; 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 22-year-old, male patient with no relevant medical history, who experienced the unexpected events of bradycardia and presyncope. The events occurred following the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as events occurred after second dose and no further dosing was reported or planned, based on information provided. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1740495 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-08
Onset:2021-09-10
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Status epilepticus
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? 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: Convulsive status epilepticus; This case was received via Regulatory Authority (Reference number: JP-TAKEDA-2021TJP094349) on 14-Sep-2021 and was forwarded to Moderna on 27-Sep-2021. This case, initially reported to the Agency by a (physician), was received via the RA (Ref, v21126677). On an unknown date, the patient received 1st dose of the vaccine. On 08-Aug-2021, the patient received 2nd dose of the vaccine. On 10-Sep-2021, at 20:00, the patient was taken to the hospital due to convulsive status epilepticus. Head CT showed no obvious haemorrhage. Diazepam 3A was administered. The outcome of convulsive status epilepticus was unknown. 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.; Reporter''s Comments: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Another factor could be Hashimoto''s disease or epilepsy.; Sender''s Comments: This case concerns a 49 year-old male patient with no relevant medical history, who experienced the unexpected event of Status epilepticus. The event occurred 2 days after the most recent dose of mRNA-1273 vaccine. It is unclear whether the most recent dose was the first or second dose based on the conflicting information provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1742571 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dizziness, Dyspnoea, Migraine, Nausea, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acid reflux (esophageal); Endometriosis; Fibromyalgia; Folate deficiency; Irritable bowel syndrome; Polycystic ovarian syndrome; Vitamin D deficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210913; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101217929

Write-up: Nausea; Chest pain; Breathing difficult; Dizziness; Migraine; difficulty breathing; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109152119257490-6ITEG. Safety Report Unique Identifier GB-MHRA-ADR 25948286. A 39-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 10Sep2021 (at the age of 39-years) (Batch/Lot Number: Fe8087) as dose 1, single for COVID-19 immunisation. Medical history included vitamin d deficiency, endometriosis, fibromyalgia, folate deficiency, polycystic ovaries, irritable bowel syndrome and acid reflux. Patient not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. On an unspecified date in 2021 the patient experienced difficulty breathing, migraine on 10Sep2021, dizziness on 10Sep2021, chest pain on 11Sep2021, breathing difficult on 11Sep2021 and nausea on 13Sep2021. The patient Spoke to doctor, referred to migraines clinic nothing said regarding tightness/ pain of chest and difficulty breathing/ hurts when breathing. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 13Sep2021. The clinical outcome of difficulty breathing was unknown and rest of the events were not recovered. No Follow-up attempts are needed. No further information is expected.


VAERS ID: 1742767 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac flutter
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Tachyarrhythmia terms, nonspecific (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: GBPFIZER INC202101204818

Write-up: on the left breast, my chest is constantly fluttering; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 10Sep2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date for COVID-19 immunisation without any adverse event. The patient experienced "on the left breast, my chest is constantly fluttering on 10Sep2021 with outcome of unknown. The patient reported as follows: "I have a question, I don''t know whether I should call 911, I want to check with you before if any advice. I had my 2nd jab this Friday and since Friday - on the left breast, my chest is constantly fluttering. It is not painful. Can t be a side effect? I read PIL on uncommon side effect so can it be connected with heart?" The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.


VAERS ID: 1742780 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Migraine, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperthyroidism (Past hyperthyroid diagnosis 2017 - 2020); Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20200518; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101256518

Write-up: Joint ache; Migraine; Nausea; Tiredness; This is a solicited report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-YCVM-202106121502465930-UNQE3; Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25636268. A 27-year-old female patient received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on 10Sep2021 as single dose for COVID-19 immunization. The patient previously received the first dose on 07Jul2021 (lot number: FE151) and experienced nausea, headache, joint ache, tiredness, and injection site muscle pain. Medical history included suspected COVID-19 from 16May2020 to an unknown date (unsure when symptoms stopped). Past hyperthyroid diagnosis 2017 - 2020. She was not pregnant, not currently breastfeeding, and not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced nausea and tiredness on 10Sep2021; joint ache and migraine on 11Sep2021. Events were reported as medically significant by health authority. She patient underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on 18May2020. The patient recovered from nausea on 12Sep2021 and from joint ache and migraine on 13Sep2021 while not recovered from joint ache. The reporter''s assessment of the causal relationship of the events with the suspect products 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; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on plausible temporal relationship, a possible causal association between nausea, fatigue, arthralgia and migraine and the suspect drug BNT162B2 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: 1742921 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood pressure measurement, Body temperature, Loss of consciousness, Pain in extremity, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Glucose; Result Unstructured Data: Test Result:unknown; Test Name: blood pressure; Result Unstructured Data: Test Result:low; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Test Name: body temperature; Result Unstructured Data: Test Result:37.4 Centigrade
CDC Split Type: ITPFIZER INC202101208438

Write-up: Loss of consciousness, fainting. I had been given the second dose of Pfizer Covid vaccine the previous day; Loss of consciousness, fainting. I had been given the second dose of Pfizer Covid vaccine the previous day; Fever; pain in my arm; This is a spontaneous report from a contactable consumer or non health professional downloaded from a regulatory authority-WEB IT-MINISAL02-783992. A 27-year-old female patient received bnt162b2 (COMIRNATY, formulation: Solution for injection, Lot number: FG6273, Expiration Date: 30Nov2021), via intramuscular, administered in arm left on 09Sep2021 as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 10Sep2021, the patient experienced loss of consciousness, fainting, had been given the second dose of pfizer COVID vaccine the previous day, fever and pain in my arm. Seriousness of the event loss of consciousness reported as medically significant. The Intervention of paramedics who measured my blood pressure, found to be low, body temperature found to be 36.8, but before fainting it was 37.4, and blood glucose checked. On an unspecified date, the patient underwent lab tests and procedures which included glucose: unknown, blood pressure: low, body temperature: 36.8 centigrade and 37.4 centigrade. The outcome of the events was recovering. Health authority comments: The day after the Pfizer vaccination second dose I woke up with fever and pain in my arm. Shortly afterwards I lost consciousness for a couple of minutes. I came to my senses after a family member intervened and lifted my legs. After half an hour, the ambulance company 118 was called. They measured my fever, blood pressure, which was low, and my blood sugar, but nothing serious was found. I refused transport to the emergency room. No follow-up attempts possible. No further information expected.; Reporter''s comments: The day after the Pfizer vaccination second dose I woke up with fever and pain in my arm. Shortly afterwards I lost consciousness for a couple of minutes. I came to my senses after a family member intervened and lifted my legs. After half an hour, the ambulance company 118 was called. They measured my fever, blood pressure, which was low, and my blood sugar, but nothing serious was found. I refused transport to the emergency room.


VAERS ID: 1742930 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101208531

Write-up: 3 minutes after inoculation of the vaccine (Pfizer), the boy fainted and seizures occurred on the left side of the body (where the injection was given); and seizures occurred on the left side of the body (where the injection was given) and then extended to the right.; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-784221. A 15-year-old male patient received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection), via intramuscular route of administration in arm left on 10Sep2021 (Lot Number: FG7387, Expiry date was not reported, at the age of 15-year-old) as 0.3 ML single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On 10Sep2021, the patient experienced 3 minutes after inoculation of the vaccine (Pfizer), the boy fainted and seizures occurred on the left side of the body (where the injection was given) and seizures occurred on the left side of the body (where the injection was given) and then extended to the right, Impact on quality of life (1/10). The outcome for the events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1742945 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005687 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hyperhidrosis, Paraesthesia, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

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

Write-up: This case was received via regulatory authority (Reference number: IT-MINISAL02-785085) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of HYPERHIDROSIS and VOMITING in an 18-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005687) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy. On 10-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter in total. On 10-Sep-2021, the patient experienced HYPERHIDROSIS (seriousness criterion medically significant), PARAESTHESIA (seriousness criterion medically significant) and VOMITING (seriousness criterion medically significant). At the time of the report, HYPERHIDROSIS, PARAESTHESIA and VOMITING was resolving. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Laboratory investigation performed on 10 Sep 2021 included Heart rate, O2 saturation and Blood pressure all whose results are not reported. Treatment information was not provided. Patient had history of allergy to Anauran (skin reaction). No pathologies or therapy to report. Lab test COVID-19 test conducted on last 06-Sept-2021. Result was Negative. Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Translation document received on 24-Sep-2021. Event verbatim updated. Reporter''s comment added in i-narrative supplement.; Sender''s Comments: This case concerns an 18-year-old male with a serious unexpected event of paraesthesia, hyperhidrosis, and vomiting. Latency within 1 day after dose mRNA-1273. Events resolving. Rechallenge not reported. Reporter causality not provided. Causality possible based on temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1743193 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       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? 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: Anaphylactic reaction (grade1); This case was received via Takeda Pharmaceuticals (Reference number: JP-TAKEDA-2021TJP090000) on 14-Sep-2021 and was forwarded to Moderna on 27-Sep-2021. This case was reported by a physician via a medical representative. The patient had medical history of high fever due to influenza vaccine and adverse reaction of pharynx strange sensation due to OTC ibuprofen (Ringle Ivy). On 10-Sep-2021, around 16:18, the patient received the 1st dose of this vaccine. After 15 minutes of follow-up, strange feeling in the mouth developed. The route was secured, and d-chlorpheniramine maleate 5s and saline 20 mL was administered intravenously, but facial flushing and facial itching occurred. The symptoms were determined to be grade 1 anaphylactic reaction. Vital signs did not change during the follow-up. The patient was urgently transported to the hospital. Recovery of the symptoms was confirmed. The patient went home without any additional treatment. The outcome of anaphylactic reaction (grade 1) was reported as recovered. 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.; Reporter''s Comments: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 39-year-old, male patient with relevant medical history of adverse reaction of pharynx strange sensation to Ibuprofen, who experienced the expected event of anaphylactic reaction. The event anaphylactic reaction occurred approximately 15 minutes after the first dose of mRNA-1273 vaccine administration. The rechallenge was not applicable, as the event occurred after the first dose. The event were considered possibly related to the product per the reporter''s assessment. The event is consistent with the current understanding of the mechanism of action of the vaccine. The medical history of adverse reaction of pharynx strange sensation to Ibuprofen remain confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1743208 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-10
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       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? 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: Myocarditis; This case was received via Pharmaceutical Company (Reference number: JP-TAKEDA-2021TJP094155) on 14-Sep-2021 and was forwarded to Moderna on 27-Sep-2021. This case, initially reported to the Regulatory Authority by a (physician), was received via the Regulatory Authority (Ref, v21127811). The patient was under treatment with oral medications for hyperuricaemia. On an unknown date, the patient received the 1st dose of the vaccine. On 07-Sep-2021, the patient received the 2nd dose of the vaccine. On 08-Sep-2021, body temperature went up to 38.5 degrees Celsius. On 09-Sep-2021, body temperature went down to 37.0 degrees Celsius. On 10-Sep-2021, at 05:00, chest pain suddenly developed. Although the patient saw the course of the symptom, there was few improvements and thus the patient called an ambulance. The patient was transported to the reporting hospital. On arrival at the hospital, chest pain was persisting. A blood test found increases in CK, CK-MB, troponin T, and CRP level while no increase in D-dimer level was found. Echocardiography showed hypokinesis of the inferior wall. Coronary angiography was performed to show no stenosis in the coronary arteries. In addition, left ventriculography was performed to show hypokinesis of the inferior wall. The patient was hospitalized with a diagnosis of myocarditis. Chest pain improved over time. On 11-Sep-2021, a blood test and an echocardiography were performed. On 12-Sep-2021, a blood test and an echocardiography were performed. The blood test found decreases in CK, CK-MB, troponin T, and CRP level. The echocardiography showed no pericardial fluid and no further hypokinesis of the wall. As chest pain disappeared, it was considered that the patients condition was improving. Based on the course of the disease, it was considered highly possible that the patient experienced myocarditis. On 13-Sep-2021, relief of the symptom was confirmed. The outcome of myocarditis was reported as resolving. Follow-up investigation will be made. Reporter comments continuation: The patient had no significant stenoses in the coronary arteries and had wall hypokinesis limited to the inferior wall, which was one of characteristics of myocarditis associated with the vaccine reported to date. In addition, the patient was a young man who received the 2nd dose, had localized hypokinesis of the wall, and experienced increases in CK, CK-MB, troponin T, and CRP level. Based on the above, it was considered as highly possible that the patient experienced myocarditis. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 25-year-old, male patient with no relevant medical history, who experienced the serious expected event of Myocarditis. The event occurred approximately 4 days after the second dose of Spikevax. The rechallenge was not applicable since no events were reported after the first dose. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1743235 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005693 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Altered state of consciousness, Loss of consciousness, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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? 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: JPMODERNATX, INC.MOD20213

Write-up: Disturbed consciousness; Convulsion; Loss of consciousness; This case was received via Pharmaceutical company (Reference number: JP-TAKEDA-2021TJP096021) on 17-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This case, initially reported to the regulatory authority by a physician, was received via the regulatory authority(Ref, v21127059). On 09-Sep-2021, the patient received the 1st dose of this vaccine. On 10-Sep-2021, the patient experienced convulsion and was able to move the body, and loss of consciousness developed. The patient regained naturally. On 11-Sep-2021, the patient felt sick. On 12-Sep-2021, at 08:25, disturbed consciousness developed. There was no symptom in the daytime. On 13-Sep-2021, there was no symptom in the daytime. On 14-Sep-2021, at 08:25, the patient was found lying down and urgently transported to the reporting hospital. Coma Scale (CS) was 2-10. There were no other symptoms of cardiovascular or respiratory other than disturbed consciousness. The patient was hospitalized because of unknown cause despite the detailed examination. Cerebral hemorrhage and cerebral infarction were not observed. Disturbed consciousness gradually improved in the midnight. On 15-Sep-2021, the patient became awake and alert, and recovery of the symptoms was confirmed. The outcome of convulsion, loss of consciousness, and disturbed consciousness was reported as recovered. 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.; Sender''s Comments: This case concerns a 35 year old male patient with no relevant medical history, who experienced the unexpected events of altered state of consciousness, seizures and loss of consciousness. The events occurred approximately 1 day after the first dose of the Moderna COVID-19 vaccine. The rechallenge was not applicable as this is the first dose. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1743337 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-09-10
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8871 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: 20210911; Test Name: RT-PCR; Test Result: Positive
CDC Split Type: PHPFIZER INC202101219824

Write-up: COVID-19 PCR test positive; COVID-19 PCR test positive; sore throat; cold; headache; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the regulatory authority. Regulatory authority report number PH-PHFDA-300105356. A 30-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number: FF8871) via intramuscularly at an unspecified anatomical location on 20Aug2021 (at the age of 30-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 11Sep2021, the patient experienced COVID-19 PCR test positive. This report was serious (medically significant). On 10Sep2021 12:00, the patient had sore throat, cold and headache. On 11Sep2021, the patient underwent lab tests and procedures which included polymerase chain reaction: positive. Outcome of the events were recovering and for sore throat and headache was recovered in Sep2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1746604 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-10
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Cardiac discomfort, Chest pain, Congenital cystic kidney disease, Feeling abnormal, Heart rate increased, Hypertension, Liver function test, Myalgia, Palpitations, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Congenital, familial and genetic disorders (narrow), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cortisol; Flu; Hypertension
Allergies:
Diagnostic Lab Data: Test Name: benign polyps on kidneys.; Result Unstructured Data: Test Result:unknown result; Test Name: hypertension; Result Unstructured Data: Test Result:140/90 mmHg; Comments: regular 140/90 before medicine; Test Name: derranged liver functions; Result Unstructured Data: Test Result:possibly NAFLD
CDC Split Type: GBPFIZER INC202101217818

Write-up: two days after vaccine; palpitations; after 1 hour of having vaccine; fine before vaccine; heart pain; hypertension; occurred again an hour later; heart rate was raised; Heart pressure sensation of; Chest pain; Heart pounding; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109152258141440-XIGMZ. Safety Report Unique Identifier: B-MHRA-ADR 25948815. A 34-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: FE8087), dose 2 via an unspecified route of administration in 2021 as dose 2, single for covid-19 immunization. Medical history included hypertension, blood cortisol, influenza. Concomitant medication(s) included amlodipine (AMLODIPINE) taken for hypertension; atorvastatin (ATORVASTATIN) taken for hypertension; ramipril (RAMIPRIL) taken for hypertension. The patient previously took cortisol [hydrocortisone]. The patiently previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), as dose 1, single for COVID-19 immunization. Only mild hypertension (regular 140/90 before medicine). Previously high cortisol levels. Slightly deranged liver functions (possibly NAFLD) and benign polyps on kidneys. No other previous reactions to medicines or vaccines. Only other side effect was a short period of flu like symptoms in the night immediately after vaccine. Patient has not had symptoms associated with COVID-19, Not had a COVID-19 test. On an unspecified date, the patient experienced two days after vaccine (myalgia), palpitations, after 1 hour of having vaccine (syncope), fine before vaccine (tremor), heart pain (angina pectoris), hypertension, occurred again an hour later (feeling abnormal). The patient experienced heart pounding, chest pain on 10Sep2021, heart pressure sensation of (cardiac discomfort) on 13Sep2021. It was reported that the patient was fine before vaccine, fine immediately after. After 1 hour of having vaccine, started to get slight heart pain - a minor stabbing pain like an injection in the heart area. Went away after 5 minutes. Occurred again an hour later, and went away again after 5 minutes. Occurred several more times through the evening after vaccine, particularly when heart rate was raised i.e. climbing up stairs. Next day woke up fine, within an hour, same chest pain only slightly more intense. Phones 111 for advice, reported online, never received a call back. Two days after vaccine, woke up in night with heart palpitations, took an hour to get back to sleep. Phoned GP in the morning, suffered heart pressure sensation throughout the day with waves of previous dull stabbing pain approximately every hour. GP checked over, no blood clots. Advised to take pain killers and ibuprofen. Chest pain and occasional palpitation continues. Still taking ibuprofen and previous medication for hypertension. 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 congenital cystic kidney disease: unknown result, hypertension: 140/90 mmhg on regular 140/90 before medicine, liver function test: possibly nafld. Therapeutic measures were taken as a result of two days after vaccine (myalgia), palpitations (palpitations), after 1 hour of having vaccine (syncope), fine before vaccine (tremor), heart pain (angina pectoris), hypertension (hypertension), occurred again an hour later (feeling abnormal), heart pounding (palpitations), heart pressure sensation of (cardiac discomfort), chest pain (chest pain). The outcome of the events heart pounding, chest pain, heart pressure sensation of (cardiac discomfort) was reported as not recovered and outcome of all the other events was reported as recovering. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1746613 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-09-10
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Fatigue, Heavy menstrual bleeding, Menstrual disorder, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (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: COVID-19 virus test; Result Unstructured Data: Test Result:Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101224677

Write-up: Abnormal bleeding/ Menstruation abnormal; heavy and bleeding longer than usual; very painful; exhausting; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109160814186980-OQOTF with Safety Report Unique Identifier GB-MHRA-ADR 25950571. A patient of unspecified age and gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 24Aug2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have symptoms associated with COVID-19 and was not enrolled in the clinical trial. On 10Sep2021, 17 days after vaccination, the patient experienced abnormal bleeding/ menstruation abnormal reported as serious for being medically significant. On an unknown date in 2021, the patient experienced heavy and bleeding longer than usual, very painful and exhausting. On an unknown date, the patient underwent a COVID-19 virus test and the result was negative. The patient had not been tested positive for COVID-19 since having the vaccine. The clinical outcome of the event abnormal bleeding/ menstruation abnormal was recovering while that of the events heavy and bleeding longer than usual, very painful and exhausting was unknown 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: 1746706 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Fatigue, Limb discomfort, Lymphadenopathy, Mobility decreased, Pain in extremity, SARS-CoV-2 test
SMQs:, Parkinson-like events (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: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Shingles
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101225240

Write-up: moving very slowly, everything seemed much more effort; increasing arm pain; pain in the corresponding armpit section; Swollen lymph nodes, noticeable swelling under armpit which she understood to be lymph nodes; Arm discomfort; Tiredness; This is a spontaneous report from a contactable consumer (patient) received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109161224412310-JHK2E. Safety Report Unique Identifier is GB-MHRA-ADR 25952363. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Sep2021 (lot number: FE8087) as single dose for COVID-19 immunisation. The patient previously received the first dose on Jun2021 and experienced shingles. Medical history included shingles from Aug2021. She had shingles the previous month, not sure if this meant her immune system was worse than usual. She has not had symptoms associated with COVID-19 and not enrolled in clinical trial. Concomitant medications included acyclovir and codeine phosphate, paracetamol (CO-CODAMOL), both taken for shingles from Aug2021 to Aug2021. The patient experienced extreme tiredness and increasing arm pain and pain in the corresponding armpit section from 24 hours afterwards, swollen lymph nodes, arm discomfort, and tiredness on 10Sep2021. Case narrative: Extreme tiredness and increasing arm pain and pain in the corresponding armpit section from 24 hours afterwards, followed slightly later on the same day by noticeable swelling under armpit which she understood to be lymph nodes. Next day (11Sep2021) extremely tired and moving very slowly, everything seemed much more effort, arm and armpit still painful and swollen, took ibuprofen. Tiredness had mostly gone by following day but still pain and swelling for another couple of days. She has not tested positive for COVID-19 since having the vaccine. She underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on an unspecified date. The patient recovered from tiredness on 12Sep2021 and from axillary lymph nodes enlarged and arm discomfort on 14Sep2021; recovering from pain in arm and armpit pain; while outcome of mobility decreased was unknown. Case was reported as medically significant by health authority. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1746710 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-09-10
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Haemorrhage, Heavy menstrual bleeding, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (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: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101224709

Write-up: Heavy periods/ heavier bleeding with more clots; Increased period pain; Bleeding; This is a spontaneous report from a contactable consumer, the patient. This is a report received from a regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109161233009700-9KN19, Safety Report Unique Identifier GB-MHRA-ADR 25952359. A 24-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3380), via an unspecified route of administration on 16Aug2021 at single dose for COVID-19 immunisation. Medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medication included ethinylestradiol, gestodene (MILLINETTE) from 01Nov2020 as oral contraceptive. The patient experienced bleeding in 2021; heavy periods on 10Sep2021. The events bleeding and heavy periods were reported as serious for being medically significant. On an unknown date in 2021, the patient experienced increased period pain. The clinical course was as follows: patient had heavier bleeding with more clots and increased period pain. The usual dose of tranxenamic acid she took did not make a difference. The patient''s bleeding was so heavy from 10Sep2021 to 13Sep2021 that she could not leave the house. The patient underwent lab test which included COVID-19 virus test: No - Negative COVID-19 test on an unknown date. Patient has not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event heavy periods was resolving; while that of the events bleeding and increased period pain was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1746840 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-09-10
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101233511

Write-up: Heavy periods; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202109190845437450-ZFS2N, Safety Report Unique Identifier GB-MHRA-ADR 25965926. A 31-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; batch/Lot Number: not known), via an unspecified route of administration on 27Aug2021, at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. On 10Sep2021, 14 days after vaccination, the patient experienced heavy periods; reported as serious for being medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event heavy periods was recovered on 15Sep2021, after the duration of 5 days. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1746857 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Mobility decreased, SARS-CoV-2 test
SMQs:, Parkinson-like events (broad), Tendinopathies and ligament 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:
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: Mobility decreased; This case was received (Reference number: GB-MHRA-ADR 25967323) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Mobility decreased) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced MOBILITY DECREASED (Mobility decreased) (seriousness criterion medically significant). At the time of the report, MOBILITY DECREASED (Mobility decreased) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No- negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient not had symptoms associated with COVID-19. Patient was not pregnant, Patient was not currently breastfeeding. Concomitant product was not provided. The patient had inflammation of injection site leading to loss of full movement of arm and hand in side of injection. Still 11 days after return of full movement to hand has still not happened slight concern given the length of time it''s still as it is. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Treatment medication was not reported. Company comment This case concerns a 32-year-old female patient with no relevant medical history reported, who experienced serious unexpected event of Mobility decreased. The event occurred approximately 1 day after the second dose of mRNA-1273. The rechallenge was not applicable as no additional dosing is expected. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however, there was no information in the source document of seriousness from a clinical or regulatory standpoint.; Sender''s Comments: This case concerns a 32-year-old female patient with no relevant medical history reported, who experienced serious unexpected event of Mobility decreased. The event occurred approximately 1 day after the second dose of mRNA-1273. The rechallenge was not applicable as no additional dosing is expected. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however, there was no information in the source document of seriousness from a clinical or regulatory standpoint.


VAERS ID: 1746888 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dyspnoea, Heavy menstrual bleeding, Menstruation delayed, Palpitations, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Fertility disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic pain (that was worsened significantly after the vaccination.); Concentration impaired
Allergies:
Diagnostic Lab Data: Test Date: 20200710; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: NEGATIVE
CDC Split Type: GBPFIZER INC202101223600

Write-up: Menstruation delayed; Menstruation increased; Fever; Shortness of breath; Cough; Palpitations; This is a spontaneous report from a contactable consumer or other non hcp received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109151507372010-OOHRV, Safety Report Unique Identifier GB-MHRA-ADR 25946097. A 33-year-old non-pregnant nor breastfeeding female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number FE8087, expiration date unspecified, at the age of 33 years), via an unspecified route of administration on 10Sep2021 as dose 2, single for covid-19 immunization. Patient is not enrolled in clinical trial. Previously the patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number FD8813, expiration date unspecified), via an unspecified route of administration on 19Jul2021 as dose 1, single for covid-19 immunization (33 year when vaccinated) and experienced low-grade fever and pain. Medical history included disturbance in attention, chronic neurological pain (that was worsened significantly after the vaccination). Patient has not had symptoms associated with COVID-19. Patient is not pregnant, and is not currently breastfeeding. The concomitant medications were not reported. The patient experienced pain on 19Jul2021, which is still persisting. On 10Sep2021, post vaccination, the patient experienced cough, palpitations, shortness of breath and fever. On 14Sep2021, the patient reported that her menstruation delayed and menstruation increased. On 10Jul2020, the patient underwent lab tests which included sars-cov-2 test and results was negative. The outcome of the events fever, Menstruation increased, and cough was not recovered; for palpitations and shortness of breath was recovering and for menstruation delayed was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101217863 Same patient and product, different event/dose.


VAERS ID: 1747109 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF5357 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Muscular weakness, Oropharyngeal discomfort, Presyncope
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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: Medical History/Concurrent Conditions: Fruit allergy; Oral allergy syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101213230

Write-up: vasovagal reflex/vasovagal symptoms; pharynx strange sensation of; no strength in hands; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority number is v21126814. The patient was a 20-year and 4-month-old female (age at vaccination). Body temperature before vaccination was 36.8 centigrade. The patient had a history of oral allergy due to pineapple. On 10Sep2021 at 11:00 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number FF5357, Expiration date 30Nov2021) via an unspecified route of administration for COVID-19 immunization. On 10Sep2021 at 11:29 (the same day of the vaccination), the patient experienced vasovagal reflex. On 10Sep2021 (the same day of the vaccination), outcome of the events was recovered. The clinical course was reported as follows: 30 minutes after the vaccination, the patient experienced floating sensation. Blood pressure and oxygen saturation were normal; no rash. The patient had pharynx strange sensation of and no strength in hands. It was difficult to diagnosed as anaphylaxis; examination was conducted. The patient said that she had oral symptoms. IV treatment with vascular route secured was conducted just in case; observation continued. It was considered as one of the vasovagal symptoms due to vaccination. The reporting physician classified the event as non-serious and assessed that the event was unrelated to the bnt162b2.; Sender''s Comments: Considering a temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported events Presyncope Oropharyngeal discomfort and Muscular weakness cannot be completely 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: 1747319 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA FE9174 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, C-reactive protein, COVID-19 immunisation, Cardiac telemetry, Cold sweat, Electrocardiogram, Influenza like illness, Myocarditis, Nausea, Troponin I, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: Cardiac telemetry; Result Unstructured Data: VT-complexes; Test Date: 20210910; Test Name: C-reactive protein; Result Unstructured Data: Slightly elevated (not specified); Test Date: 20210910; Test Name: EKG; Result Unstructured Data: Global ST-elevations and PR-depressions.; Test Date: 20210910; Test Name: Troponin I; Result Unstructured Data: 25000 Fluctuating troponins on day 2 in hospital
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: REVACCINATION WITH DIFFERENT COVID-19 VACCINE; EPIGASTRIC PAIN; COLD SWEAT; INFLUENZA-LIKE SYMPTOMS; NAUSEA; VOMITING; This case was received via Regulatory Authority(Reference number: NO-NOMAADVRE-E2B_00050418) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS in a 22-year-old male patient who received mRNA-1273 (batch no. FE9174) for Vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Vaccination: Comirnaty. On 08-Sep-2021, the patient received second dose of mRNA-1273 (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced MYOCARDITIS (seriousness criteria hospitalization and medically significant), ABDOMINAL PAIN UPPER (EPIGASTRIC PAIN), COLD SWEAT (COLD SWEAT), INFLUENZA LIKE ILLNESS (INFLUENZA-LIKE SYMPTOMS), NAUSEA (NAUSEA) and VOMITING (VOMITING). On an unknown date, the patient experienced COVID-19 IMMUNISATION (REVACCINATION WITH DIFFERENT COVID-19 VACCINE). At the time of the report, MYOCARDITIS, ABDOMINAL PAIN UPPER (EPIGASTRIC PAIN), COLD SWEAT (COLD SWEAT), INFLUENZA LIKE ILLNESS (INFLUENZA-LIKE SYMPTOMS), NAUSEA (NAUSEA) and VOMITING (VOMITING) was resolving and COVID-19 IMMUNISATION (REVACCINATION WITH DIFFERENT COVID-19 VACCINE) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2021, C-reactive protein: slightly elevated (High) Slightly elevated (not specified). On 10-Sep-2021, Cardiac telemetry: abnormal (abnormal) VT-complexes. On 10-Sep-2021, Electrocardiogram: abnormal (abnormal) Global ST-elevations and PR-depressions.. On 10-Sep-2021, Troponin I: abnormal (abnormal) 25000 Fluctuating troponins on day 2 in hospital. For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments. Patient was hospitalized 2 days after vaccination . First dose was Comirnaty. No concomitant medications were reported. Patient exhibited clinical improvement on the 2nd day of hospitalization. No treatment medications were reported. Company comment: This case concerns a 22-year-old male patient with no relevant medical history, who experienced serious, listed event of myocarditis. The serious event occurred after 3 days of 2nd dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the event occurred after 2nd dose of Moderna COVID-19 Vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Previously well Hospitalized 2 days after COVID-19 vaccination. 1st dose Comirnaty Severe epigastric pain, nausea, vomiting, cold sweats and prodromal influenza-like symptoms Clinically and biochemically diagnosed with perimyocarditis, considered vaccination related. Clinical improvement on the 2nd day of hospitalization. Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Translation received on 24-Sep-21 contains no significant information. Sender''s comments were updated.; Sender''s Comments: This case concerns a 22-year-old male patient with no relevant medical history, who experienced serious, listed event of myocarditis. The serious event occurred after 3 days of 2nd dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the event occurred after 2nd dose of Moderna COVID-19 Vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1749110 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Diarrhoea, Heart rate, Heart rate increased, Hypertension
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Noninfectious diarrhoea (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: Medical History/Concurrent Conditions: Allergy (the day before of vaccination date so I took Zertec.); Breast cancer; Foramen ovale patent; Hypertension (normally controlled between 120 to 130 with medication)
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: Blood pressure; Result Unstructured Data: Test Result:200/105; Test Date: 20210920; Test Name: Blood pressure; Result Unstructured Data: Test Result:152; Test Date: 20210910; Test Name: Heart rate; Result Unstructured Data: Test Result:Increased but stable
CDC Split Type: AUPFIZER INC202101227374

Write-up: high bP the day after her first dose, was really high 200/105.; Heart rate was increased; diarrhea; This is a spontaneous report from a contactable other health care professional (Patient). A 79-years-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number and expiry date were not reported) via an unspecified route of administration on 09Sep2021 as dose 1, single for covid-19 immunisation. Medical history included breast cancer, PFO/hole in the heart, Hypertension normally controlled between 120 to 130 with medication, Allergy the day before of vaccination date so took Zertec. Patient previously took tamoxifen (I had a breast cancer and was on tamoxifen) and Norvasc for Blood pressure, stop because I have peripheral circulation problem and took midazolam when patient had an endoscopy and was sleeping for 2 days. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for allergy and valsartan (VALSARTAN) for blood pressure, start and stop date not reported. On 10Sep2021 patient experienced high blood pressure the day after her first dose, was really high 200/105 which, heart rate was increased, diarrhea. She took extra blood pressure medication to try and rectify this, nitrolingual spray and norvasc extra tablets. Likely that it should have been brought down but it wasn''t. The patient used her wrist blood pressure machine, went to her doctor to check were her readings valid. The patient wanted to know information on the second dose after such a side effect, and if it was still recommended. She wants to take the second dose but was she doing the right thing. What was the latest advice as she was very uncertain and the doctors she has spoken to does not really know about it this. The patient also inquired that her reaction be due to the ingredients and how long will this type of side effect persist. The patient was on blood pressure medication valsartan and tried to take one more tablet on the day and used nitro sublingual spray but it did not bring my BP down which was scary. The patient heart rate was increased (not too high) but stable on10Sep2021. The patient had diarrhea too on the day on 10Sep2021. The patient was normally sensitive to any drugs ( had midazolam when the patient had an endoscopy and was sleeping for 2 days and for Nurofen and took child dose which was enough for the patient) The lab test which included Blood pressure, resulted 200/105 on 10Sep2021 and 152 on 20Sep2021 another lab test done which included Heart rate: Increased but stable on 10Sep2021.The outcome of all 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 available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events 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: 1749312 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-09-10
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2832 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Menstruation delayed
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101228732

Write-up: Menstruation increased; Menses delayed; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Agency WEB, regulatory authority number ES-AEMPS-999566. A 39-years-old nonpregnant female patient received bnt162b2 Second dose of (COMIRNATY Solution for injection, (Lot Number: FF2832) ),via an unspecified route of administration on 13Aug2021 as ,Single for covid-19 immunisation . The patient medical history and concomitant medications were not reported. Historical vaccine, The patient received First dose of (COMIRNATY Solution for injection, (Lot Number: FE8405)), via an unspecified route of administration right arm on 23July2021 as, Single for covid-19 immunisation. Patient has not COVID-19 passed. On 10Sep2021, the patient experienced menstruation increased with, menses delayed. treatment medication Iron orally were taken as a result of menstruation increased. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1749316 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-10
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       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? 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: ESMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: ES-AEMPS-999694) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS in a 19-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. In 2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced MYOCARDITIS (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provider by the reporter. Treatment information was not provided. Company Comment: This case concerns a 19-year-old, male patient with no relevant medical history, who experienced the expected event of myocarditis. The event myocarditis occurrence unknown with respect to mRNA-1273 vaccine administration. The rechallenge was unknown as there''s no information available about the dose number and the occurrence of the event with respect to mRNA-1273 vaccine administration. The No product report assessment was given from the reporter. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Translation document received on 26-Sep-2021. Dosage text is translated.; Sender''s Comments: This case concerns a 19-year-old, male patient with no relevant medical history, who experienced the expected event of myocarditis. The event myocarditis occurrence unknown with respect to mRNA-1273 vaccine administration. The rechallenge was unknown as there''s no information available about the dose number and the occurrence of the event with respect to mRNA-1273 vaccine administration. The No product report assessment was given from the reporter. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1751037 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Back pain, Dysmenorrhoea, Pain in extremity, SARS-CoV-2 test, Vaginal discharge
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament 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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: None
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101226561

Write-up: Low back pain; Menstrual cramp; Leg pain; Vaginal discharge; Pain stomach; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is -MHRA-WEBCOVID-202109171646530440-TU0AM, Safety Report Unique Identifier -MHRA-ADR 25960217. A female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on 09Sep2021 (Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history was none and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. The patient experienced low back pain, menstrual cramp, leg pain, vaginal discharge and pain stomach on 10Sep2021. Patient had not tested positive for COVID-19 since having the vaccine. 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 unspecified date. The case was assessed as serious- medically significant. The outcome of all the events was not resolved 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: 1751047 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-09-10
   Days after vaccination:129
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7934 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Heavy menstrual bleeding, Polymenorrhoea, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (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: COVID-19 virus test; Test Result: Negative ; Comments: Negative COVID-19 test; Test Name: blood tests; Result Unstructured Data: Test Result:all clear
CDC Split Type: GBPFIZER INC202101226969

Write-up: It is also my 2nd period in 2 weeks; Heavy periods; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202109171744050690-Y1AOD, Safety Report Unique Identifier GB-MHRA-ADR 25960489. A 41-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine), DOSE 2 via an unspecified route of administration on 04May2021 (Batch/Lot Number: ER7934) as DOSE 2, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. On 10Sep2021, the patient experienced heavy periods. The patient experienced heavy period which has gone from blood red in colour to clear & watery - it is not stopping. "It is also my 2nd period in 2 weeks" on unknown date. Seriousness criteria was reported as medically significant. Relevant investigations or tests conducted: "Had blood tests - all clear " on unknown date. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on an unspecified date. Outcome of the event heavy period was not recovered. Outcome of the event It is also my 2nd period in 2 weeks was unknown. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1751102 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-09-10
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Menstruation delayed, Premenstrual pain, SARS-CoV-2 test
SMQs:, Fertility 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:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101226654

Write-up: Menstruation delayed; Premenstrual abdominal pain; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109180039544980-IWNGE and Safety Report Unique Identifier is GB-MHRA-ADR 25962925. A 22-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Aug2021 (lot number unknown) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient experienced premenstrual abdominal pain on 10Sep2021, and menstruation delayed on 14Sep2021. Events were reported as serious, medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test on unspecified date with result of negative (No - Negative COVID-19 test). Patient has not tested positive for COVID-19 since having the vaccine. Outcome of events menstruation delayed, and premenstrual abdominal pain was not recovered. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1751130 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-09-10
   Days after vaccination:199
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8713 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Tinnitus
SMQs:, Hearing impairment (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210501; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101226656

Write-up: Tinnitus; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109180920448860-RNHGZ. Safety Report Unique Identifier GB-MHRA-ADR 25964827. A 53-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/ Lot Number: EL8713) via an unspecified route of administration on 23Feb2021, as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. On 10Sep2021 (after 6 months of vaccination), patient experienced tinnitus (medically significant). Patient had a pulsing in her left ear and was very loud almost like heartbeat in her ear. Patient was waiting for a doctor''s appointment. Lab test on 01May2021, included COVID-19 virus test: No - Negative. The outcome of event was not resolved. No Follow-up attempts are needed. No further information is expected.


VAERS ID: 1751218 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-09-10
   Days after vaccination:148
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM 4965 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: heart examination; 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 INC202101233501

Write-up: Stroke; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority; report number is GB-MHRA-WEBCOVID-202109190753467060-TGQYW with Safety Report Unique Identifier of GB-MHRA-ADR 25965914. A female patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Em 4965), via an unspecified route of administration on 15Apr2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: not known) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. On 10Sep2021, patient experienced stroke which was reported as serious for being hospitalization. Patient was now on going heart examination. The patient underwent lab test and procedure which included COVID-19 virus test: No - Negative COVID-19 test, heart examination with unknown results, both on unknown dates. Patient has not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event stroke was resolved with sequelae in Sep2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1751240 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Lethargy, Lymph node pain, Lymphadenopathy, Neck pain, Oropharyngeal pain
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Sore throat; Neck pain; Shortness of breath; Lethargy; Swollen lymph nodes; Lymph node pain; This case was received via a Regulatory Authority (Reference number: GB-MHRA-ADR 25973939) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes), LYMPH NODE PAIN (Lymph node pain), OROPHARYNGEAL PAIN (Sore throat), NECK PAIN (Neck pain), DYSPNOEA (Shortness of breath) and LETHARGY (Lethargy) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 10-Sep-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced LYMPH NODE PAIN (Lymph node pain) (seriousness criterion disability). On 11-Sep-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion disability), NECK PAIN (Neck pain) (seriousness criterion disability), DYSPNOEA (Shortness of breath) (seriousness criterion disability) and LETHARGY (Lethargy) (seriousness criterion disability). On 20-Sep-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion disability). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes), LYMPH NODE PAIN (Lymph node pain), OROPHARYNGEAL PAIN (Sore throat), NECK PAIN (Neck pain), DYSPNOEA (Shortness of breath) and LETHARGY (Lethargy) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product was not provided by the reporter. Patient reported that he experienced long term side effects, particularly the pain caused from swollen lymph nodes. Treatment information was not provided. Company comment: This case concerns a 33-year old patient, gender unknown with no relevant medical history, who experienced the unexpected events of Lymphadenopathy, Lymph node pain, Oropharyngeal pain, Neck pain, and Dyspnoea. The event Lymph node pain occurred 1 day after a dose of MODERNA COVID-19 VACCINE, dose number unknown; the events Lymphadenopathy, Neck pain, and Dyspnoea occurred 2 days after the vaccine; while Oropharyngeal pain occurred approximately 11 days after the vaccine. The benefit-risk relationship of MODERNA COVID-19 VACCINE is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however, there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity/disability.; Sender''s Comments: This case concerns a 33-year old patient, gender unknown with no relevant medical history, who experienced the unexpected events of Lymphadenopathy, Lymph node pain, Oropharyngeal pain, Neck pain, and Dyspnoea. The event Lymph node pain occurred 1 day after a dose of MODERNA COVID-19 VACCINE, dose number unknown; the events Lymphadenopathy, Neck pain, and Dyspnoea occurred 2 days after the vaccine; while Oropharyngeal pain occurred approximately 11 days after the vaccine. The benefit-risk relationship of MODERNA COVID-19 VACCINE is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however, there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity/disability.


VAERS ID: 1751353 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005687 / 1 - / OT

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

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

Write-up: This case was received via Regulatory Authority (Reference number: IT-MINISAL02-785429) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005687) for COVID-19 immunisation. No Medical History information was reported. On 10-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. On 10-Sep-2021, the patient experienced LOSS OF CONSCIOUSNESS (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS had resolved. The concomitant medications on use were not provided. No treatment information was provided. Patient had experienced lost of consciousness. On 14 SEP 2021 batch number was corrected 3005687 instead of 3004492 upon reporter correction. Company Comment: This case concerns a 30-year-old, female patient with no relevant medical history, who experienced the unexpected event of loss of consciousness. The event occurred the same day after the first dose of Spikevax. The rechallenge was unknown, since no information about the second dose was disclosed. The benefit-risk relationship of Spikevax in not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Follow up received on 22-SEP-2021 contain information about vaccination date and lot number. On 22-Sep-2021: Translation received on 28 SEP 2021 contains: Event verbatim and Sender''s Comment updated in narrative.; Sender''s Comments: This case concerns a 30-year-old, female patient with no relevant medical history, who experienced the unexpected event of loss of consciousness. The event occurred the same day after the first dose of Spikevax. The rechallenge was unknown, since no information about the second dose was disclosed. The benefit-risk relationship of Spikevax in not affected by this report.


VAERS ID: 1751356 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005687 / 1 - / OT

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

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

Write-up: his case was received via regulatory authority (Reference number: IT-MINISAL02-785627) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS. In a 24-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005687) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. On 10-Sep-2021, the patient experienced LOSS OF CONSCIOUSNESS (DYSMENORRHOEA, NASAL CONGESTION, RASH ERYTHEMATOUS and HEADACHE). At the time of the report, LOSS OF CONSCIOUSNESS, DYSMENORRHOEA, NASAL CONGESTION, RASH ERYTHEMATOUS (sinistra.) and HEADACHE was resolving. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Patient was fainting, feeling hot, foggy and had bowel blockage, congested nose, headache. The day after, only a red rash on the left shoulder. No treatment information was provided. Company comment: This case concerns a 24-year-old, female patient with no relevant medical history, who experienced the unexpected event of loss of consciousness. The event occurred approximately 2 days after the first dose of Spikevax. The rechallenge was not applicable as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Translated document received on 24-Sep-2021 included event description.; Sender''s Comments: This case concerns a 24-year-old, female patient with no relevant medical history, who experienced the unexpected event of loss of consciousness. The event occurred approximately 2 days after the first dose of Spikevax. The rechallenge was not applicable as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1751480 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005288 / 1 - / OT

Administered by: Unknown       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? 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; This case was received via Pharmaceutical Company (Reference number: 2021TJP096901) on 21-Sep-2021 and was forwarded to Moderna on 29-Sep-2021. This case, initially reported to the Regulatory Authority by a (physician), was received via the Regulatory Authority (Ref, v21127387). The patient has a history of transient unexplained high fever after influenza vaccination. On an unknown date, body temperature before vaccination: 36.4 degrees Celsius. On 10-Sep-2021, at 16:18, the patient received the 1st dose of this vaccine. Around 16:28, there was pharynx discomfort with the pruritus. There was some discomfort near the back teeth. Blood pressure 140/102, pulse 75, respiration 16, Sat.O2 97. Previously, the patient reported that she had once had a pharyngeal discomfort when taking the over-the-counter drug ibuprofen, which resolved spontaneously. The patient then took another over-the-counter drug, ibuprofen, with no onset of symptoms. At 16:35, route secured. Flushed face and itching of the face were observed. At 16:38, the patient received intravenous injection of d-chlorpheniramine malate + saline 20 ml. Blood pressure 138/100, pulse 60, Sat.O2 96. At 17:00, the patient''s symptoms tended to improve, but he could not be followed up and was urgently transported. The patient was diagnosed with anaphylaxis by the emergency physician. No specific treatment was added. The patient''s symptoms subsequently recovered. The outcome of anaphylaxis was reported as recovered. 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.; Reporter''s Comments: The patient was diagnosed with anaphylaxis due to the vaccination.; Sender''s Comments: This case concerns a 39-year-old, female patient with previous relevant medical history of transient unexplained high fever after influenza vaccination, who experienced the expected event of Anaphylactic reaction. The event occurred on the same day after the first dose of Spikevax. The rechallenge was not applicable since only information about the first dose was disclosed. The reporter assessed the events as possible. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1752928 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005244 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Disorientation, Dizziness, Fatigue, Hyperhidrosis, Injection site pain, Loss of consciousness, Malaise, Myalgia, Nausea
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: After vaccine: sweating, dizziness, nausea, feeling of disorientation, faintness, stupefaction, general malaise, muscle pain, severe fatigue, localized pain at the injection site; After vaccine: sweating, dizziness, nausea, feeling of disorientation, faintness, stupefaction, general malaise, muscle pain, severe fatigue, localized pain at the injection site; After vaccine: sweating, dizziness, nausea, feeling of disorientation, faintness, stupefaction, general malaise, muscle pain, severe fatigue, localized pain at the injection site; After vaccine: sweating, dizziness, nausea, feeling of disorientation, faintness, stupefaction, general malaise, muscle pain, severe fatigue, localized pain at the injection site; After vaccine: sweating, dizziness, nausea, feeling of disorientation, faintness, stupefaction, general malaise, muscle pain, severe fatigue, localized pain at the injection site; After vaccine: sweating, dizziness, nausea, feeling of disorientation, faintness, stupefaction, general malaise, muscle pain, severe fatigue, localized pain at the injection site; After vaccine: sweating, dizziness, nausea, feeling of disorientation, faintness, stupefaction, general malaise, muscle pain, severe fatigue, localized pain at the injection site; After vaccine: sweating, dizziness, nausea, feeling of disorientation, faintness, stupefaction, general malaise, muscle pain, severe fatigue, localized pain at the injection site; After vaccine: sweating, dizziness, nausea, feeling of disorientation, faintness, stupefaction, general malaise, muscle pain, severe fatigue, localized pain at the injection site; This case was received via Regulatory Authority (Reference number: IT-MINISAL02-784894) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (After vaccine: sweating, dizziness, nausea, feeling of disorientation, faintness, stupefaction, general malaise, muscle pain, severe fatigue, localized pain at the injection site) in a 22-year-old female 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 10-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 ml. On 10-Sep-2021, the patient experienced LOSS OF CONSCIOUSNESS (After vaccine: sweating, dizziness, nausea, feeling of disorientation, faintness, stupefaction, general malaise, muscle pain, severe fatigue, localized pain at the injection site) (seriousness criterion medically significant), DISORIENTATION (After vaccine: sweating, dizziness, nausea, feeling of disorientation, faintness, stupefaction, general malaise, muscle pain, severe fatigue, localized pain at the injection site), DIZZINESS (After vaccine: sweating, dizziness, nausea, feeling of disorientation, faintness, stupefaction, general malaise, muscle pain, severe fatigue, localized pain at the injection site), MALAISE (After vaccine: sweating, dizziness, nausea, feeling of disorientation, faintness, stupefaction, general malaise, muscle pain, severe fatigue, localized pain at the injection site), HYPERHIDROSIS (After vaccine: sweating, dizziness, nausea, feeling of disorientation, faintness, stupefaction, general malaise, muscle pain, severe fatigue, localized pain at the injection site), NAUSEA (After vaccine: sweating, dizziness, nausea, feeling of disorientation, faintness, stupefaction, general malaise, muscle pain, severe fatigue, localized pain at the injection site), MYALGIA (After vaccine: sweating, dizziness, nausea, feeling of disorientation, faintness, stupefaction, general malaise, muscle pain, severe fatigue, localized pain at the injection site), INJECTION SITE PAIN (After vaccine: sweating, dizziness, nausea, feeling of disorientation, faintness, stupefaction, general malaise, muscle pain, severe fatigue, localized pain at the injection site) and FATIGUE (After vaccine: sweating, dizziness, nausea, feeling of disorientation, faintness, stupefaction, general malaise, muscle pain, severe fatigue, localized pain at the injection site). At the time of the report, LOSS OF CONSCIOUSNESS (After vaccine: sweating, dizziness, nausea, feeling of disorientation, faintness, stupefaction, general malaise, muscle pain, severe fatigue, localized pain at the injection site), DISORIENTATION (After vaccine: sweating, dizziness, nausea, feeling of disorientation, faintness, stupefaction, general malaise, muscle pain, severe fatigue, localized pain at the injection site), DIZZINESS (After vaccine: sweating, dizziness, nausea, feeling of disorientation, faintness, stupefaction, general malaise, muscle pain, severe fatigue, localized pain at the injection site), MALAISE (After vaccine: sweating, dizziness, nausea, feeling of disorientation, faintness, stupefaction, general malaise, muscle pain, severe fatigue, localized pain at the injection site), HYPERHIDROSIS (After vaccine: sweating, dizziness, nausea, feeling of disorientation, faintness, stupefaction, general malaise, muscle pain, severe fatigue, localized pain at the injection site), NAUSEA (After vaccine: sweating, dizziness, nausea, feeling of disorientation, faintness, stupefaction, general malaise, muscle pain, severe fatigue, localized pain at the injection site) and MYALGIA (After vaccine: sweating, dizziness, nausea, feeling of disorientation, faintness, stupefaction, general malaise, muscle pain, severe fatigue, localized pain at the injection site) had not resolved and INJECTION SITE PAIN (After vaccine: sweating, dizziness, nausea, feeling of disorientation, faintness, stupefaction, general malaise, muscle pain, severe fatigue, localized pain at the injection site) and FATIGUE (After vaccine: sweating, dizziness, nausea, feeling of disorientation, faintness, stupefaction, general malaise, muscle pain, severe fatigue, localized pain at the injection site) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medications were reported. Treatment information was not provided. This case concerns a 22-year-old, female patient with no relevant medical history, who experienced the unexpected event of loss of consciousness and altered state of consciousness along with other non serious events. The event occurred on the same day after the first dose of Moderna COVID-19 Vaccine. As reported after vaccine the patient experienced sweating, dizziness, nausea, feeling of disorientation, faintness, stupefaction, general malaise, muscle pain, severe fatigue and localized pain at the injection site. The events were not resolved, as reported. The rechallenge was unknown since no information about the second dose was disclosed and events were still ongoing. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Translation was received on 26-Sep2021. Verbatim event terms updated due to translation. On 24-Sep-2021: Events updated: Needle fatigue updated to fatigue; pain localized updated to injection site pain.; Sender''s Comments: This case concerns a 22-year-old, female patient with no relevant medical history, who experienced the unexpected event of loss of consciousness and altered state of consciousness along with other non serious events. The event occurred on the same day after the first dose of Moderna COVID-19 Vaccine. As reported after vaccine the patient experienced sweating, dizziness, nausea, feeling of disorientation, faintness, stupefaction, general malaise, muscle pain, severe fatigue and localized pain at the injection site. The events were not resolved, as reported. The rechallenge was unknown since no information about the second dose was disclosed and events were still ongoing. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1754877 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-09-10
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Alanine aminotransferase, Aspartate aminotransferase, Blood alkaline phosphatase, Blood bilirubin, Cytomegalovirus test, Epstein-Barr virus test, Full blood count, Gamma-glutamyltransferase, HIV test, Hepatitis B virus test, Hepatitis C virus test, Hepatocellular injury, Lipase, Pain, Prothrombin time, Ultrasound scan, Vomiting
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Functional bowel syndrome; Goiter; Polycystic ovarian syndrome
Allergies:
Diagnostic Lab Data: Test Name: Alanine transaminase; Result Unstructured Data: Test Result:559 (10N); Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result:757 (20N); Comments: Cytolysis predominantly, decreasing compared to previous assessments; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:73; Test Name: Bilirubin; Result Unstructured Data: Test Result:Normal; Test Name: Cytomegalovirus; Test Result: Negative ; Test Name: Epstein-Barr virus; Test Result: Negative ; Test Name: Complete blood count; Result Unstructured Data: Test Result:Normal; Test Name: gamma GT; Result Unstructured Data: Test Result:111; Test Name: Hepatitis B Virus serology; Test Result: Negative ; Test Name: Hepatitis C Virus serology; Test Result: Negative ; Test Name: Human Immunodeficiency Virus serology; Test Result: Negative ; Test Name: Lipase; Result Unstructured Data: Test Result:19; Test Name: prothrombin time; Test Result: 110 %; Comments: Normal; Test Name: Ultrasound; Result Unstructured Data: Test Result:Normal liver size; Comments: no biliary tract abnormalities, no explanation for current symptomatology
CDC Split Type: FRPFIZER INC202101228937

Write-up: Post-vaccination pain; Hepatocellular injury; Belly ache; Vomiting; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number FR-AFSSAPS-NT20214022. A 34-years-old female patient received BNT162B2 (COMIRNATY, solution for injection), dose 2 intramuscular, administered in Arm Left on 15Aug2021 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included goitre, Polycystic ovarian syndrome, Functional bowel syndrome. The patient''s concomitant medications were not reported. On an unspecified date, It was reported patient had Post-vaccination pain prompted a work stoppage and the initiation of treatment by amitriptyline for a few days (dates of administration not known but administration at the end of Aug2021). On 10Sep2021, patient experienced Hepatocellular injury, Belly ache and vomiting. On 10Sep2021 (26 days after the vaccination), there was sudden onset of a hyperalgesic pain attack localised in the epigastrium transfixing to between the scapula and the right shoulder with favourable evolution in 30 minutes. Recurrence of two other hyperalgesic pain attacks in the evening, one of which with episodes of vomiting. The blood test found Aspartate aminotransferase 757 (20N), Alanine transaminase 559 (10N), gamma GT 111, alkaline phosphatase 73. Lipase at 19. Patient was admitted to the Emergency Room. Blood test was performed which showed Cytolysis predominantly at the Aspartate aminotransferase, decreasing compared to previous assessments, normal prothrombin time 101%, normal bilirubin. Normal complete blood count. Ultrasound showed Normal liver size, no biliary tract abnormalities, no explanation for current symptomatology. Viral serologies negative (Human Immunodeficiency Virus, Hepatitis B Virus, Hepatitis C Virus, Human Immunodeficiency Virus, Cytomegalovirus, Epstein-Barr virus). No autoimmune assessment performed. In summary, hepatocellular damage occurred 26 days after the 2nd dose of COMIRNATY. Incomplete aetiological assessment. At the time of this report the outcome of Vomiting and Post-vaccination pain was unknown, Belly ache recovered on an unknown date in 2021 and Hepatocellular injury was recovering. No follow-up attempts are possible. No further information expected. Information about batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101195781


VAERS ID: 1754917 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214017 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Epilepsy, Pain in extremity, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), Tendinopathies and ligament 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: Ehlers-Danlos syndrome
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Epileptic fit; Pain in arm; Asthenia; Emesis; This case was received via Regulatory Authority(Reference number: FR-AFSSAPS-RE20212567) on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of EPILEPSY (Epileptic fit) in a 32-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214017) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Ehlers-Danlos syndrome. On 09-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced EPILEPSY (Epileptic fit) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in arm), ASTHENIA (Asthenia) and VOMITING (Emesis). At the time of the report, EPILEPSY (Epileptic fit) had resolved and PAIN IN EXTREMITY (Pain in arm), ASTHENIA (Asthenia) and VOMITING (Emesis) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 09-Sep-2021. Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter. No re-challenge was done, recurrence was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Translation received on 27-Sep-2021 contain no new information.; Sender''s Comments: This case concerns a 32 year female with a history of Ehler-Danlos Syndrome who experienced the serious unlisted event of Epilepsy one day after the first dose of Spikevax. Rechallenge is not applicable as this was the first dose. The medical history of Ehlers-Danlos Syndrome remains a confounder as it may have exacerbated the events. Benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1754988 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-10
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NOT KNOWN / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dysmenorrhoea, Muscle spasms
SMQs:, Dystonia (broad)

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

Write-up: Sore cramps; Painful periods; This case was received via RA (Reference number: GB-MHRA-ADR 25949565) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSMENORRHOEA (Painful periods) and MUSCLE SPASMS (Sore cramps) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Not known) for COVID-19 vaccination. No Medical History information was reported. On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced DYSMENORRHOEA (Painful periods) (seriousness criterion medically significant). On an unknown date, the patient experienced MUSCLE SPASMS (Sore cramps) (seriousness criterion medically significant). At the time of the report, DYSMENORRHOEA (Painful periods) had not resolved and MUSCLE SPASMS (Sore cramps) had resolved. 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: This case concerns a female patient of unknown age with no relevant medical history, who experienced the serious unexpected events of Dysmenorrhoea and Muscle spasms. The events occurred around 9 days after first dose of Spikevax. The rechallenge was unknown as there''s no information available about the second dose. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a female patient of unknown age with no relevant medical history, who experienced the serious unexpected events of Dysmenorrhoea and Muscle spasms. The events occurred around 9 days after first dose of Spikevax. The rechallenge was unknown as there''s no information available about the second dose. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1755086 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Constipation, Heavy menstrual bleeding
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101233718

Write-up: Constipation; Heavy periods; This is a spontaneous report from a contactable consumer or other non HCP received from the regulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109192105449610-W8OIX, Safety Report Unique Identifier GB-MHRA-ADR 25966326. A 23-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 09Sep2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was unsure if she has had symptoms associated with covid-19, not had a covid-19 test. Patient was not currently breastfeeding. On 10Sep2021, 1 day after first dose the patient experienced heavy periods. on 15Sep2021, 6 days after first dose the patient experienced constipation. The case was assessed as serious (medically significant) by the health authority. Patient had not tested positive for covid-19 since having the vaccine. Patient was not enrolled in clinical trial. 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: 1755283 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-09-10
   Days after vaccination:68
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7010 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dysstasia, Tachycardia, Vomiting
SMQs:, Acute pancreatitis (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101229734

Write-up: Tachycardia; Difficulty in standing; Vomiting; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-785010. A 60-year-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection) intramuscular, administered in Arm Left on 04Jul2021 (Lot Number: FE7010) as single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously received BNT162B2 (COMIRNATY, Solution for injection) via unspecified route of administration (Batch/Lot Number was unknown) as single dose for COVID-19 immunization. On 10Sep2021 the patient experienced tachycardia, vomiting, difficulty in standing. The events were serious (hospitalization). Outcome of the event was unknown. Sender comment: 14Sep2021 follow-up information requests to the reporter regarding medical records, outcome. Awaiting. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Any other diseases of the patient (allergies, chronic diseases) None.


VAERS ID: 1755532 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004670 / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: C-reactive protein, Chest pain, Myocarditis, Troponin, White blood cell count
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202109; Test Name: C-reactive protein; Result Unstructured Data: 66; Test Date: 202109; Test Name: Troponin NOS; Result Unstructured Data: 109; Test Date: 202109; Test Name: Leucocyte count; Result Unstructured Data: 11.05
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: This case was received (Reference number: NO-NOMAADVRE-E2B_00050677) on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of CHEST PAIN (Brystsmerte) and MYOCARDITIS in a 29-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004670) for COVID-19 vaccination. No Medical History information was reported. On 09-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced CHEST PAIN (Brystsmerte) (seriousness criterion medically significant) and MYOCARDITIS (myokarditt) (seriousness criterion medically significant). At the time of the report, CHEST PAIN (Brystsmerte) and MYOCARDITIS (myokarditt) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, C-reactive protein: 66 (High) 66. In September 2021, Troponin: 109 (High) 109. In September 2021, White blood cell count: 11.05 (High) 11.05. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered CHEST PAIN (Brystsmerte) and MYOCARDITIS (myokarditt) to be possibly related. No concomitant medications reported by reporter. No treatment medications provided by the reporter. Follow-up received on 23-SEP-2021 included no new information Company comment - This case concerns a 29-year-old, male patient with no relevant medical history, who experienced the unexpected event of chest pain and the expected event of myocarditis. The events occurred 2 days after the second dose of Spikevax. The rechallenge was not applicable, as no additional dosing will be given. The event myocarditis is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Translation Document received on 27-SEP-2021 and does not contain any new information.; Sender''s Comments: This case concerns a 29-year-old, male patient with no relevant medical history, who experienced the unexpected event of chest pain and the expected event of myocarditis. The events occurred 2 days after the second dose of Spikevax. The rechallenge was not applicable, as no additional dosing will be given. The event myocarditis is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1755562 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-10
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004729 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bell's palsy
SMQs:, Hearing impairment (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: PHMODERNATX, INC.MOD20213

Write-up: Bell''s palsy; This regulatory authority case was reported by an other health care professional and describes the occurrence of BELL''S PALSY (Bell''s palsy) in a 49-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3004729) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 10-Sep-2021 at 3:00 PM, the patient experienced BELL''S PALSY (Bell''s palsy) (seriousness criteria disability and medically significant). At the time of the report, BELL''S PALSY (Bell''s palsy) outcome was unknown. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. Treatment medications were not reported. Company Comment : This case concerns a 49 year old female patient with no relevant medical history ,who experienced the serious expected event of Bell''s palsy . The event occurred on 10-sep-2021 after administration of unknown dose of Spikevax ,the date of administration was not reported . The rechallenge was unknown as there''s no information available about the dose number.The benefit-risk relationship of Spikevax is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity .; Sender''s Comments: This case concerns a 49 year old female patient with no relevant medical history ,who experienced the serious expected event of Bell''s palsy . The event occurred on 10-sep-2021 after administration of unknown dose of Spikevax ,the date of administration was not reported . The rechallenge was unknown as there''s no information available about the dose number.The benefit-risk relationship of Spikevax is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity .


VAERS ID: 1757791 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-09-10
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TRANEXAMIC ACID
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Bleeding; Heavy menstruation period; Excessive menstruation; This case was received via the RA (Reference number: GB-MHRA-ADR 25995280) on 26-Sep-2021 and was forwarded to Moderna on 26-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding), HEAVY MENSTRUAL BLEEDING (Heavy menstruation period) and HEAVY MENSTRUAL BLEEDING (Excessive menstruation) in a 48-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. No medical history was provided by the reporter. Previously administered products included for Product used for unknown indication: Norethisterone. Concomitant products included TRANEXAMIC ACID for an unknown indication. On 20-Jul-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Excessive menstruation) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced HAEMORRHAGE (Bleeding) (seriousness criteria hospitalization and medically significant). an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (Heavy menstruation period) (seriousness criteria hospitalization and medically significant). At the time of the report, HAEMORRHAGE (Bleeding), HEAVY MENSTRUAL BLEEDING (Heavy menstruation period) and HEAVY MENSTRUAL BLEEDING (Excessive menstruation) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient was having heavy menstruation period, over 2 weeks. On an unknown date, the patient had relevant investigations or tests conducted to check ovaries and uterus. The patient had already taken the Tranexamic Acid, bleeding still persists. The patient had the new prescription, Norethisterone from hospital, the 2nd day on trial, still having menstrual bleeding on and off, but the volume was less compared to Tranexamic Acid. The event was not resolved. But she can''t progress to the next step if she dont fill in this part. Company Comment: This case concerns a 48-year-old, female patient with no relevant medical history, who experienced the unexpected events of heavy menstrual bleeding and haemorrhage. The events occurred approximately 1 month after the dose of Spikevax. The rechallenge was unknown. The benefit-risk relationship of Spikevax is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting. Rechallenge was captured as per RA assessment provided in SD.; Sender''s Comments: This case concerns a 48-year-old, female patient with no relevant medical history, who experienced the unexpected events of heavy menstrual bleeding and haemorrhage. The events occurred approximately 1 month after the dose of Spikevax. The rechallenge was unknown. The benefit-risk relationship of Spikevax is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting. Rechallenge was captured as per RA assessment provided in SD.


VAERS ID: 1757806 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       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? 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 European Medicines Agency (Reference number: IT-MINISAL02-788293) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS in a 28-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation. No Medical History information was reported. On 10-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milligram. On 10-Sep-2021, the patient experienced MYOCARDITIS (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Medical history also includes allergic asthma. It was reported On 14-Sep-2021 , C-reactive protein and troponin I laboratory tests were conducted and results were not provided. No concomitant medication was reported. Treatment information was not provided by reporter. Company Comment: This case concerns a 28-year-old, male patient with no relevant medical history, who experienced the expected event of Myocarditis. The event occurred the same day after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Translation received on 29-Sep-2021 contains medical history added in I narrative.; Sender''s Comments: This case concerns a 28-year-old, male patient with no relevant medical history, who experienced the expected event of Myocarditis. The event occurred the same day after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1757808 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005687 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Hyperthermia
SMQs:, Accidents and injuries (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: ITMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: IT-MINISAL02-788410) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERTHERMIA and HEADACHE in a 12-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005687) for COVID-19 immunization. No Medical History information was reported. On 10-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter in total. On 10-Sep-2021, the patient experienced HYPERTHERMIA (seriousness criterion disability) and HEADACHE (seriousness criterion disability). At the time of the report, HYPERTHERMIA and HEADACHE was resolving. No concomitant medication were provided. No treatment medication were provided Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity. Company Comment: This case concerns a 12-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of hyperthermia and headache. The events occurred 5 hours after the second dose of Spikevax. The rechallenge was not applicable, as the event occurred after the second dose and no additional dosing will be given. The benefit-risk relationship of Spikevax in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Translation document received on 29-Sep-2021 and included no new information.; Sender''s Comments: This case concerns a 12-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of hyperthermia and headache. The events occurred 5 hours after the second dose of Spikevax. The rechallenge was not applicable, as the event occurred after the second dose and no additional dosing will be given. The benefit-risk relationship of Spikevax in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1757838 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pain in extremity, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

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

Write-up: SYNKOPE; SM?RTA ?VERARM; This case was received via Regulatory Authority (Reference number: -MPA-2021-083058) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of SYNCOPE (SYNKOPE) and PAIN IN EXTREMITY (SM?RTA ?VERARM) in a 22-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Concurrent medical conditions included ADD. Concomitant products included LISDEXAMFETAMINE MESILATE (ELVANSE) for an unknown indication. On 09-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced SYNCOPE (SYNKOPE) (seriousness criterion medically significant) and PAIN IN EXTREMITY (SM?RTA ?VERARM) (seriousness criterion medically significant). On 10-Sep-2021, SYNCOPE (SYNKOPE) had resolved. At the time of the report, PAIN IN EXTREMITY (SM?RTA ?VERARM) was resolving. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No treatment medication information was mentioned by reporter. Company Comment: This case concerns a 22-year-old female with serious unexpected events of syncope and pain in extremity. Event onset the day after second dose mRNA-1273. Syncope resolved, and pain in extremity reported as resolving. Rechallenge not applicable. Reporter causality not provided. Causality possible based on temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Translation received on 29-SEP-2021. Dosage form of concomitant drug updated.; Sender''s Comments: This case concerns a 22-year-old female with serious unexpected events of syncope and pain in extremity. Event onset the day after second dose mRNA-1273. Syncope resolved, and pain in extremity reported as resolving. Rechallenge not applicable. Reporter causality not provided. Causality possible based on temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1758210 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005288 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dysaesthesia, Neuropathy peripheral
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre 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: JPMODERNATX, INC.MOD20213

Write-up: Peripheral nerve disorder; Paresthesia; This case was received via Regulatory Authority (Reference number: 2021TJP098706) on 24-Sep-2021 and was forwarded to Moderna on 30-Sep-2021. This case, reported by a physician, was received by Regulatory Authority via Moderna''s adverse reaction reporting site (TASK0021884). Peripheral nerve disorder was assessed as serious by the MAH. On 10-Sep-2021, at 12:10, the patient received the 1st dose of this vaccine. At 12:20, peripheral nerve disorder and paresthesia developed, and numbness in the left upper limb was observed. The patient''s symptoms improved after 15 minutes of resting and lying in bed. The symptom was improved, and the patient returned home. The outcome of peripheral nerve disorder and paresthesia 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.; 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 21-year-old, female patient with no known medical history, who experienced the unexpected event of peripheral neuropathy and dysaesthesia. The events occurred the same day after the first dose of Moderna vaccine. The events were considered related to the product per the reporter''s assessment. The benefit-risk relationship of Moderna vaccine is not affected by this report. Event seriousness of event peripheral neuropathy was assessed as per Regulatory Authority reporting, however based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, it is considered non-serious.


VAERS ID: 1758234 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD9309 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Lymph node pain, Lymphadenopathy, Pain in extremity, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101229351

Write-up: Lymph node pain; Syncope; Fever; Swelling of the axillary node of the arm in which the vaccine was received (left arm); general pain in left arm; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number ES-AEMPS-999707. A 13-year-old male patient received BNT162B2 (COMIRNATY), intramuscular, administered in left arm on 10Sep2021 (at the age of 13-year-old) (Lot Number: FD9309) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (COMIRNATY), intramuscular, administered on 20Aug021 (Lot Number: FF2832) as dose 1, single for COVID-19 immunization. The patient experienced fever on 10Sep2021, syncope on 11Sep2021, lymph node pain on 12Sep2021, swelling of the axillary node of the arm in which the vaccine was received and general pain in left arm on an unspecified date. The patient was hospitalized for all the events except pain in extremity on an unspecified date. The patient received treatment for all the events except pain in left arm with unspecified analgesics. The outcome of syncope, pyrexia was recovered. The outcome of pain in extremity was unknown and outcome of other events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1758295 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: General physical health deterioration, Headache, Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: RITALIN; PARACET [PARACETAMOL]
Current Illness: ADHD
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: This case was received via a regulatory authority (Reference number: 00050911) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPOAESTHESIA, HEADACHE and GENERAL PHYSICAL HEALTH DETERIORATION in a 35-year-old female patient who received mRNA-1273 (Spikevax) for Vaccination. The patient''s past medical history included Migraine. Concurrent medical conditions included ADHD. Concomitant products included METHYLPHENIDATE HYDROCHLORIDE (RITALIN) for ADHD, PARACETAMOL (PARACET [PARACETAMOL]) for an unknown indication. On 10-Sep-2021 at 8:24 AM, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced HYPOAESTHESIA (seriousness criterion hospitalization), HEADACHE (seriousness criterion hospitalization) and GENERAL PHYSICAL HEALTH DETERIORATION (seriousness criterion hospitalization). On 12-Sep-2021, GENERAL PHYSICAL HEALTH DETERIORATION had resolved. At the time of the report, HYPOAESTHESIA and HEADACHE had not resolved. No treatment medication use was reported. The event reported by primary source as weakness for the event of General physical health deterioration. Patient reported latency for all reported side effects as 3-4 hours. company comment: This case concerns a 35 year-old, female subject, with medical history of migraine, who experienced the unexpected events of Hypoaesthesia, Headache and General physical health deterioration. The event of Headache is unexpected as it is retained as serious per the source document Authority reporting. The events occurred the same day after second dose of Spikevax. The rechallenge was unknown since no information about the first dose was disclosed. The medical history of migraine remains confounder. The benefit-risk relationship of Spikevax is not affected by this report. Seriousness was assessed as per Regulatory Authority report. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Translation document received on 29-Sep-2021 and included no new information.; Sender''s Comments: This case concerns a 35 year-old, female subject, with medical history of migraine, who experienced the unexpected events of Hypoaesthesia, Headache and General physical health deterioration. The event of Headache is unexpected as it is retained as serious per the source document Authority reporting. The events occurred the same day after second dose of Spikevax. The rechallenge was unknown since no information about the first dose was disclosed. The medical history of migraine remains confounder. The benefit-risk relationship of Spikevax is not affected by this report. Seriousness was assessed as per Regulatory Authority report.


VAERS ID: 1758402 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-10
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy
SMQs:, Hearing impairment (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 INC202101242576

Write-up: Bell''s palsy; This is a spontaneous report from a contactable other health professional via the regulatory authority report number is 622883. A 27-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced Bell''s palsy on 10Sep2021, onset time in days was 11 days. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1758421 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angioedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic 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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic reaction (to environmental stimuli and after infectious conditions); Infection; Urticaria (to environmental stimuli and after infectious conditions)
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202101242373

Write-up: angioedema; This is a spontaneous report from a contactable physician (unspecified relationship with the patient), who is also a Pfizer colleague reporting through RA portal. A 13-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on 10Sep2021 (Batch/Lot Number: Unknown) as dose 1, single at the age of 13-years-old for covid-19 immunisation. Medical history included urticaria and allergic reactions to environmental stimuli and after infectious conditions. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient''s concomitant medications were not reported. The patient was not taking any other medications/products within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced angioedema (medically significant) on 10Sep2021. The patient with a history of sporadic allergic conditions, including to infectious stimuli, having presented episodes of urticaria and hypersensitivity on some occasions, received the Pfizer vaccine on 10Sep2021 and evolved with edema of the lips and limbs around 6 hours after vaccination. She went to the health service, diagnosed with angioedema with complete reversal of the case after antihistamine and corticosteroids. The events result in doctor or other healthcare professional office/clinic visit; emergency room/department or urgent care. Outcome of the event was recovered. Information on the lot/batch number has been requested.; Sender''s Comments: A possibly contributory role of bnt162b2 (COMIRNATY) in triggering the onset of angioedema cannot be fully excluded, considering the close time association and known adverse event profile of the suspect vaccine. 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: 1760060 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chills, Cold sweat, Dizziness, Fatigue, Influenza like illness, Malaise, Myalgia, Nausea, Pain in extremity, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coagulation disorder; COVID-19; Fibromyalgia
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101239779

Write-up: Influenza like illness; Nausea; Pain in arm; Giddiness; fever; chills; cold sweats; malaise; fatigue; muscle pain; This is a spontaneous report from a contactable other hcp (patient) downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-ST20213456. A 40-year-old female patient received the first dose of bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 10Sep2021 (Lot Number: FG7387) at the age of 40-year-old as DOSE 1, 0.3 ML, SINGLE for covid-19 immunisation. Medical history included coagulation disorder, fibromyalgia, covid-19. The patient''s concomitant medications were not reported. The patient experienced influenza like illness, nausea, pain in arm/internal arm pain, giddiness, fever, chills, cold sweats, malaise, fatigue, muscle pain, all on 10Sep2021 with outcome of not recovered. Event influenza like illness reported as serious with medically significant. Events were occurred 6 hours after injection. It is reported the patient notes as consequences: obstruction of concentration harmful professionally, forced rest, inability to manage household and children.


VAERS ID: 1760063 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2834 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MABTHERA.
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatoid arthritis.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101239759

Write-up: Dyspnea; Other back pain with radiating symptoms; This is a spontaneous report from a contactable consumer and an Other Health Professional downloaded from the Regulatory Authority, regulatory authority number FR-AFSSAPS-TO20217932. A 59-year-old female patient received the second dose of bnt162b2 (COMIRNATY), intramuscular on 09Sep2021 (Lot Number: FF2834) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included rheumatoid arthritis. Concomitant medication included rituximab (MABTHERA) taken for rheumatoid arthritis, start and stop date were not reported. The patient experienced dyspnea, other back pain with radiating symptoms both on 10Sep2021 with outcome of recovered on 10Sep2021. Events were considered as serious with hospitalization. Therapeutic measures were taken as a result of dyspnea, other back pain with radiating symptoms. Events caused patient visit emergency room, and disappearance of the symptoms under PERFALGAN. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1760117 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-09-10
   Days after vaccination:115
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anti-thyroid antibody, Blood thyroid stimulating hormone, Thyroiditis, Thyroxine, Tri-iodothyronine
SMQs:, Hypothyroidism (broad), Hyperthyroidism (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: anti TPO; Result Unstructured Data: Test Result:940; Test Name: anti-TG; Result Unstructured Data: Test Result:127.2; Test Name: TSH; Result Unstructured Data: Test Result:<0.0025; Test Name: T4; Result Unstructured Data: Test Result:24.87; Test Name: T3; Result Unstructured Data: Test Result:11.86
CDC Split Type: BEPFIZER INC202101272457

Write-up: Thyroiditis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number BE-FAMHP-DHH-N2021-106675. A 49-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 18May2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced thyroiditis on 10Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included on an unspecified date anti-thyroid antibody: 940; anti-thyroid antibody: 127.2; blood thyroid stimulating hormone: <0.0025; thyroxine: 24.87; tri-iodothyronine: 11.86. Therapeutic measures were taken as a result of thyroiditis. Seriousness criteria of the event was reported as life threatening. Reporter Comment: Treatment - Yes Evolution of the ADR - Examinations - T4 24.87 T3 11.86 TSH <0.0025 anti-TG 127.2 anti TPO 940 ADR description - Thyroiditis No follow-up attempts are possible, information on batch number cannot be obtained. ; Reporter''s Comments: Treatment - Yes Evolution of the ADR - Examinations - T4 24.87 T3 11.86 TSH <0.0025 anti-TG 127.2 anti TPO 940 ADR description - Thyroiditis


VAERS ID: 1760185 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-09-10
   Days after vaccination:87
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram thorax, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Chest CT; Result Unstructured Data: Test Result:Bilateral pulmonary embolism; Comments: Heart attack was excluded
CDC Split Type: DEPFIZER INC202101272832

Write-up: Lung embolism; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Agency-WEB [Regulatory Authority number DE-PEI-202100196633]. A 45-year-old male patient received the 2nd dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 15Jun2021 (Batch/Lot Number: FD5996) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. Previously the patient received the 1st dose of bnt162b2 (COMIRNATY, Lot/Batch# EX3510) on 04May2021 at 45 years for COVID-19 immunisation. The patient experienced lung embolism (caused hospitalization, life threatening) on 10Sep2021 with outcome of not recovered. The patient underwent lab tests and procedures which included computerised tomogram thorax: bilateral pulmonary embolism on unspecified date (heart attack was excluded). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1760420 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Cerebrovascular accident, Vaccination site pain, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Heart attack (40 years ago, taking blood thinners)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101239476

Write-up: Accident cerebrovascular; Balance difficulty; Visual disturbance; Pain in vaccinated arm; This is a spontaneous report from a non-contactable consumer downloaded from the Agency WEB, Regulatory authority report number DE-PEI-CADR2021179134. A 90-years-old male patient received BNT162B2 (COMIRNATY), intramuscular on 09Sep2021 (Batch/Lot Number: Unknown) as 0.3 ML, SINGLE for COVID-19 immunization. Medical history included Heart attack from an unknown date 40 years ago, taking blood thinners. The patient''s concomitant medications were not reported. The patient experienced Balance difficulty on 13Sep2021, Visual disturbance on 13Sep2021, Accident cerebrovascular on 13Sep2021, Pain in vaccinated arm on 10Sep2021. The patient was hospitalized from 13Sep2021 to an unknown date for Balance difficulty, Visual disturbance, Accident cerebrovascular. Outcome of Pain in vaccinated arm was recovered on 10Sep2021, outcome of other events was unknown. Sender''s comments Do you or the person concerned have any known allergies? If so, which ones? No. Details of risk factors or previous illnesses Heart attack 40 years ago, taking blood thinners vaccination initially well tolerated, complained of about 2 hours of serious pain in vaccinated arm, about 24 hours afterwards. Otherwise no reaction. Woke up today 4 days after vaccination with visual and balance problems and was admitted to hospital with a suspected stroke. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1760805 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Paraesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre 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 ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101242849

Write-up: Pins and needles; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency (RA).The regulatory authority report number is GB-MHRA-WEBCOVID-202109201928151170-K16JX. Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25970172. A 38-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FE3380) via an unspecified route of administration on 10Sep2021 as DOSE 2, SINGLE (age at vaccination: 38-year-old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. On 10Sep2021, the patient experienced pins and needles. Seriousness criteria reported as other medically important condition. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date (No - Negative COVID-19 test). Outcome of the event was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1760815 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Dizziness, Dizziness postural, Nausea, Neuralgia, Paraesthesia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210920; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101242959

Write-up: Nausea; dizzy spells; Dizziness postural; Nerve pain; Tingling feet/hands; Made anxiety worse; This is a spontaneous report from a contactable consumer (patient). This is the first of two reports. The first report is a report downloaded from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109202044241680-WTNGE. Safety Report Unique Identifier GB-MHRA-ADR 25970765. A 44-year-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number FE8087), via an unspecified route of administration on 10Sep2021 (at the age of 44 years old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not pregnant; Patient was not currently breastfeeding. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization and experienced dizzy spells (dizziness). On 10Sep2021 made anxiety worse, tingling feet/hands and on 11Sep2021 patient experienced dizzy spells, dizziness postural, nerve pain and on 12Sep2021 nausea. Started having dizzy spells a couple of weeks after first jab. It settled then started again the day after her second jab accompanied with other symptoms. The patient underwent lab tests which included sars-cov-2 test: negative on 20Sep2021 No - Negative COVID-19 test. Therapeutic measures were taken as a result of made anxiety worse (anxiety), doctors gave anxiety tablets. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome for dizzy spells and tingling feet/hands, nerve pain was recovering and for dizziness postural, nausea, made anxiety worse it was not recovered. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101254371 same patient, different dose/event


VAERS ID: 1760991 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Haematoma
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diverticulitis (diverticulitis therapy with Normix)
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ITPFIZER INC202101239571

Write-up: hematomas on the inside of the thigh; This is a spontaneous report from a contactable consumer (patient) downloaded from the -WEB:IT-MINISAL02-786746. A 39-year-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FG6273; Expiration Date: 30Nov2021), intramuscular, administered in Arm Left on 09Sep2021 17:19 (at unknown age) as single dose for COVID-19 immunisation. Medical history included diverticulitis therapy with Normix. The patient''s concomitant medications were not reported. The patient previously took amoxicillin sodium;clavulanate potassium (AUGMENTIN) and had allergy. The patient experienced hematomas on the inside of the thigh on 10Sep2021 and was hospitalized. Patient went to the emergency room where they did blood tests to rule out thrombosis, and today patient was going for an angiological visit. The outcome of the event was not recovered. No follow-up attempts possible. No further information expected.


VAERS ID: 1761101 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-10
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis, Paraesthesia, Paraesthesia oral, Throat irritation
SMQs:, Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (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 INC202101242603

Write-up: Facial paralysis; Paraesthesia; Paraesthesia oral; throat irritation; This is a spontaneous report from a contactable other health care professional received from the Regulatory Authority. Regulatory authority report number 623256. A 59-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Batch/lot number: not reported) via an unspecified route of administration on an unknown date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 10Sep2021, the patient experienced facial paralysis, paraesthesia, paraesthesia oral and throat irritation. The outcome of the events was reported as recovered on an unknown date. No follow-up attempts were possible, information about lot/batch number could not be obtained. No further information was expected.


VAERS ID: 1762655 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214005 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Fever; Pain in limb; This case was received via Regulatory Agency (Reference number: FR-AFSSAPS-LY202111101) on 28-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of PYREXIA (Fever) and PAIN IN EXTREMITY (Pain in limb) in an 18-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214005) for Revaccination with different COVID-19 vaccine. Previously administered products included for Product used for unknown indication: Pfizer/BioNTech vaccine - COMIRNATY (Patient had his 1st dose of Pfizer/BioNTech vaccine - COMIRNATY on left arm, Intramuscular and Batch no : FE8244) on 17-Aug-2021. Past adverse reactions to the above products included No adverse event with Pfizer/BioNTech vaccine - COMIRNATY. On 09-Sep-2021 at 8:00 PM, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 10-Sep-2021 at 8:00 AM, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Pain in limb) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever) and PAIN IN EXTREMITY (Pain in limb) had not resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications was not reported. Treatment history was not reported. This case concerns an 18 year old male who a history of vaccination with Pfizer/BioNTech vaccine on 17 Jul 2021 who experienced the unlisted, serious event of Pyrexia and Pain in extremity 12 hours after the first dose of Spikevax. Re-challenge not applicable as this is the first dose. The use of the Pfizer previously remains A confounder as the interchange may have affected the response. Benefit-risk relationship is not affected by this report. The events are assessed as serious by the RA; however, there is no information in the source documents that support the events as medically significant and serious. Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Translation received on 30-sep-21 included significant information. Medical history was updated.; Sender''s Comments: This case concerns an 18 year old male who a history of vaccination with Pfizer/BioNTech vaccine on 17 Jul 2021 who experienced the unlisted, serious event of Pyrexia and Pain in extremity 12 hours after the first dose of Spikevax. Re-challenge not applicable as this is the first dose. The use of the Pfizer previously remains A confounder as the interchange may have affected the response. Benefit-risk relationship is not affected by this report. The events are assessed as serious by the RA; however, there is no information in the source documents that support the events as medically significant and serious.


VAERS ID: 1763264 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2834 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood creatine phosphokinase, Blood lactate dehydrogenase, Muscle swelling, Myalgia, Rhabdomyolysis
SMQs:, Rhabdomyolysis/myopathy (narrow), Neuroleptic malignant syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:1439 IU/l; Test Date: 20210910; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result:479 IU/l; Test Date: 20210910; Test Name: Creatine phosphokinase; Result Unstructured Data: Test Result:2945 IU/l; Test Date: 20210910; Test Name: Lactate dehydrogenase; Result Unstructured Data: Test Result:124.260 IU/l
CDC Split Type: ITPFIZER INC202101239509

Write-up: major rhabdomyolysis; Lower limb myalgia with bilateral quadriceps swelling; bilateral quadriceps swelling; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-787946. A 28-year-old female patient received the first dose of bnt162b2 (COMIRNATY) via intramuscular and administered in right arm on 09Sep2021 15:05 (Lot Number: FF2834) as DOSE 1, 0.3ML SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took Heparin for anticoagulation. The patient experienced lower limb myalgia with bilateral quadriceps swelling and major rhabdomyolysis (hospitalization) on 10Sep2021. The patient was hospitalized for this from 10Sep2021 to an unknown date. The patient underwent lab tests and procedures which included alanine aminotransferase: 1439 IU/L on 10Sep2021 (normal range: 8-43 IU/L); aspartate aminotransferase: 479 IU/L on 10Sep2021 (normal range: 7-45 IU/L); blood creatine phosphokinase: 2945 IU/L on 10Sep2021 (normal range: 80-300 IU/L); blood lactate dehydrogenase: 124.260 IU/L on 10Sep2021 (normal range: 38-176 IU/L). Therapeutic measures were taken. Events outcome was not recovered. The clinical course was reported as follows: Hospitalised for major rhabdomyolysis on 10Sep2021, she started intravenous hydration with progressive improvement of hematochemical tests. At the time of discharge, clear improvement of the clinical picture, but no full recovery yet. No follow-up attempts are possible. No further information expected.


VAERS ID: 1766509 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

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

Write-up: This case was initially received via regulatory authority (Reference number: IT-MINISAL02-789522) on 28-Sep-2021. The most recent information was received on 28-Sep-2021 and was forwarded to Moderna on 30-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEPRESSED LEVEL OF CONSCIOUSNESS and LOSS OF CONSCIOUSNESS in a 13-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Concurrent medical conditions included Pollen allergy and Mite allergy. On 09-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced DEPRESSED LEVEL OF CONSCIOUSNESS (seriousness criterion medically significant) and LOSS OF CONSCIOUSNESS (seriousness criterion medically significant). At the time of the report, DEPRESSED LEVEL OF CONSCIOUSNESS and LOSS OF CONSCIOUSNESS had resolved with sequelae. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. This case concerns a 13 year-old female patient with no relevant medical history, who experienced the unexpected serious events of depressed level of consciousness and loss of consciousness. The events approximately 2 days after the dose of mRNA 1273 vaccine. The rechallenge was unknown since only one dose has been given and no information about the second dose is available. The benefit-risk relationship of the vaccine in not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Translation document received on 30-Sep-2021 added medical history- allergy to mites.; Sender''s Comments: This case concerns a 13 year-old female patient with no relevant medical history, who experienced the unexpected serious events of depressed level of consciousness and loss of consciousness. The events approximately 2 days after the dose of mRNA 1273 vaccine. The rechallenge was unknown since only one dose has been given and no information about the second dose is available. The benefit-risk relationship of the vaccine in not affected by this report.


VAERS ID: 1768389 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7206 / 2 LA / IM

Administered by: School       Purchased by: ?
Symptoms: Influenza like illness, Intermenstrual bleeding, Joint swelling, Pain, Skin exfoliation
SMQs:, Severe cutaneous adverse reactions (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Sept 9- Received 2nd dose Sept 10- Expected flue like symptoms. Started menstrual period for first time in 7 months since having IUD placed. Sept 12- Both feet started to peel EXCESSIVLEY, primarily on the toes and soles of the feet. Sept 21-26- Swelling in both ankles. Extreme pain when walking. No pain relief with rest. Sept 26-29- Pain and swelling subsided.


VAERS ID: 1769152 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-10
Submitted: 0000-00-00
Entered: 2021-10-07
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? 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: DEJNJFOC20211011272

Write-up: VACCINATION FAILURE; COVID-19; This spontaneous report received from a consumer via a regulatory authority (DE-PEI-202100201609) on 06-OCT-2021 and concerned a 27 year old male 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 admin not reported, batch number: XE395 expiry: UNKNOWN) 1 dosage forms, 1 total administered on 19-AUG-2021 for an unspecified indication. No concomitant medications were reported. On 10-SEP-2021, the patient experienced vaccination failure, covid-19 and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccination failure, and covid-19. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint.


VAERS ID: 1772470 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-09-10
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8236 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood test normal, Chest pain, Electrocardiogram, Fatigue, Heart rate increased, Myalgia, Palpitations
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (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? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: excessive blood pressure (upper value above 130); Result Unstructured Data: Test Result:upper value $g130; Test Date: 202109; Test Name: Blood values; Result Unstructured Data: Test Result:all in order; Comments: Blood values; Test Date: 202109; Test Name: ECG; Result Unstructured Data: Test Result:conspicuous; Test Date: 20210910; Test Name: Very high pulse; Result Unstructured Data: Test Result:Very high pulse: resting pulse 100 to 110, at lowe; Comments: resting pulse 100 to 110, at lowest load 130 - 160
CDC Split Type: DEPFIZER INC202101274469

Write-up: exhaustion; increased heart rate / Very high pulse (resting pulse 100 to 110, at lowest load 130 - 160); blood pressure increased; palpitations; Stabbing in the Chest; Pain like sore muscles in legs; This is a spontaneous report from a contactable consumer (patient''s mother). A 16-year-old female patient of an unspecified gender received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 19Aug2021 (at the age of 16-year-old) (Batch/Lot Number: FE8236) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain like sore muscles in legs (hospitalization) in 2021 (before 10Sept201) with outcome of unknown, exhaustion (hospitalization) on 10Sep2021 with outcome of unknown, increased heart rate (hospitalization) on 10Sep2021 with outcome of unknown, blood pressure increased (hospitalization) on 10Sep2021 with outcome of unknown, palpitations (hospitalization) on 10Sep2021 with outcome of unknown, stabbing in the chest (hospitalization) on 10Sep20201 with outcome of unknown. The course of events was as follows: On 10Sep2021 the 2nd vaccination should have taken place. The day she went to school by bike and came back completely exhausted. Before the vaccination the patient was in top shape and very sporty. A 20 km bike ride was no effort for her... She rode only 6 km to school. Since 10Sep2021 her body has not regenerated. Very high pulse (resting pulse 100 to 110, at lowest load 130 - 160), excessive blood pressure (upper value above 130), palpitations and heart stuttering. The last few days she also felt a stabbing in the chest. Before 10Sept201 she had a pain like sore muscles in her legs for several days, without having put any weight on her legs. In the meantime she has being treated in a university hospital. In Sep2021 Blood values were all in order, ECG conspicuous, no one can explain what exactly was going on in her body. Next week a cardioligical MRI will be done. An inpatient hospitalization has taken place from 14 - 16Sep2021. There it was decided that a cardioligical MRI has to be done. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1773100 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-09-10
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004492 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Constipation, Headache, Loss of consciousness, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: ITMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: IT-MINISAL02-790690) on 30-Sep-2021 and was forwarded to Moderna on 30-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS in an 18-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 3005687 and 3004492) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form in total. On 10-Sep-2021, the patient experienced LOSS OF CONSCIOUSNESS (seriousness criterion medically significant), CONSTIPATION, PYREXIA and HEADACHE. At the time of the report, LOSS OF CONSCIOUSNESS, CONSTIPATION, PYREXIA and HEADACHE was resolving. The action taken with mRNA-1273 (Spikevax) (Intramuscular) and mRNA-1273 (Spikevax) (Unknown) was unknown. Patient took first dose of vaccine on 30 July 2021 and lot no. was 3004492. Concomitant product use was not provided by reporter. Treatment information was not provided. Company Comment: This case concerns a 18-year-old male patient with no reported medical history, who experienced the serious unexpected event Loss of consciousness. The events occurred one day after the second dose of mRNA-1273 Moderna vaccine. The event Loss of consciousness was classified as non-serious by RA, however, as per IME is upgraded to serious. Rechallenge is not applicable as no additional dosing is expected. Inappropriate schedule of product administered was also captured as an event. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Translation received on 04-Oct-2021 and sender''s comment translated and added 1st dose information; Reporter''s Comments: 1? DOSE 30/07/2021 LOTTO 3004492; Sender''s Comments: This case concerns a 18-year-old male patient with no reported medical history, who experienced the serious unexpected event Loss of consciousness. The events occurred one day after the second dose of mRNA-1273 Moderna vaccine. The event Loss of consciousness was classified as non-serious by RA, however, as per IME is upgraded to serious. Rechallenge is not applicable as no additional dosing is expected. Inappropriate schedule of product administered was also captured as an event. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.


VAERS ID: 1773313 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-10
Submitted: 0000-00-00
Entered: 2021-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Chills, Dizziness, Headache
SMQs:, Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Concomitant elements: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20211011241

Write-up: DIZZINESS; CHEST PAIN; SHIVERING; HEADACHE; This spontaneous report received from a consumer via a Regulatory Authority (PT-INFARMED-T202109-1921) on 06-OCT-2021 concerned a 19 year old male. The patient''s weight was 85 kilograms, and height was 185 centimeters. The patient''s pre-existing medical conditions included: Concomitant elements: None. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD985 expiry: unknown) 0.5 ml, 1 total, administered on 23-AUG-2021 for covid-19 immunisation. No concomitant medications were reported. On 10-SEP-2021, the patient experienced dizziness, chest pain, shivering (cold sweats) and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 12-SEP-2021 and shivering on 15-SEP-2021 and the outcome of chest pain and headache was not reported. This report was serious (Disability Or Permanent Damage).


VAERS ID: 1777200 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2832 / 1 - / 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: CZPFIZER INC202101278210

Write-up: Collapse; This is a spontaneous report from a contactable physician downloaded from the , regulatory authority number CZ-CZSUKL-21010697. A 14-year-old female patient received first dose of bnt162b2 (COMIRNATY,Solution for injection,Batch/Lot Number: FF2832), intramuscular on 10Sep2021 as DOSE 1, SINGLE for COVID-19 immunisation.The patient medical history and concomitant medications not reported. On 10Sep2021,the patient experienced collapse 10 minutes after vaccination.The outcome of event was recovered on 10Sep2021. No follow up attempts possible. No further information is expected.


VAERS ID: 1777840 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE4721 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea at rest, Heart rate, Laboratory test, Maternal exposure during pregnancy, Palpitations, Supraventricular tachycardia
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rhinitis allergic
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: Heart rate; Result Unstructured Data: Test Result:180-200; Comments: between 180-200; Test Date: 2021; Test Name: Analytical; Result Unstructured Data: Test Result:normal; Comments: rules out anemia (physiological in pregnancy)
CDC Split Type: ESPFIZER INC202101273426

Write-up: Supraventricular tachycardia; onset being at rest of dyspnea sensation; palpitations/heart rate between 180-200; 30 weeks pregnant; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number ES-AEMPS-1010349. A 43-year-old pregnant female patient received bnt162b2 (COMIRNATY, Lot Number: FE4721), dose 2 intramuscular on 10Sep2021 (at the age of 43-year-old) as dose 2, 0.3 ml single for COVID-19 immunization. Medical history included mild allergic rhinitis. There were no concomitant medications. No toxic habits, no usual medication. The patient previously received the first dose of bnt162b2 (COMIRNATY, Lot Number: FF2832) intramuscular on 20Aug2021 as single dose for COVID-19 immunization. She has no history of having suffered from COVID19. The patient experienced supraventricular tachycardia on 13Sep2021; onset being at rest of dyspnea sensation and palpitations/heart rate between 180-200 on 10Sep2021; and 30 weeks pregnant on an unspecified date in 2021. This mother reported her last menstrual period was on 15Feb2021. The mother was 30 Weeks pregnant at the onset of the event. The mother was due to deliver on 22Nov2021. Course of events: After receiving the second dose of bnt162b2, the same day she arrives at the consultation around 2 p.m. with a heart rate between 180-200, and reports sudden onset being at rest of dyspnea sensation and palpitations. TPSV (Supraventricular tachycardia) is objective, and at 3 p.m. 6mg of adenosine intravenous (IV) is administered, which reverts to sinus rhythm. She is transferred to the hospital by medicalized ambulance to assess the condition of the fetus. In the emergency room of the hospital, she presented a new episode of TPSV, but he reverted without treatment to sinus rhythm (RS). Assessed by gynecology, they rule out fetal alteration. During his stay in the emergency room, a patient was monitored without warning signs. Hemodynamically stable, eupneic and asymptomatic. Normal analysis on an unspecified date in 2021, rules out anemia (physiological in pregnancy). Discharge at home. The events supraventricular tachycardia, onset being at rest of dyspnea sensation, palpitations resulted in Emergency room visit and physician office visit. Therapeutic measure was taken as a result of the events supraventricular tachycardia, onset being at rest of dyspnea sensation, palpitations which included 6mg of adenosine intravenous (IV). The outcome of the event 30 weeks pregnant was unknown. The patient recovered from the remaining events on 13Sep2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1778126 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Blood test, Computerised tomogram, Coordination abnormal, Diplopia, Hypoaesthesia, Inappropriate schedule of product administration, Lumbar puncture, Magnetic resonance imaging, Miller Fisher syndrome, Paraesthesia, SARS-CoV-2 test, Speech disorder
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Medication errors (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood tests; Result Unstructured Data: Test Result:Unknown; Comments: Unknown; Test Name: CT; Result Unstructured Data: Test Result:Unknown; Comments: Unknown; Test Name: Lumber puncture; Result Unstructured Data: Test Result:Unknown; Comments: Unknown; Test Name: MRI; Result Unstructured Data: Test Result:Unknown; Comments: Unknown; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101325462

Write-up: double vision; pins and needles; numbness; Initially problems with balance and coordination; problems with speech (slurred and nasally); Initially problems with balance and coordination; Miller Fisher Syndrome; inappropriate schedule of vaccine administered; 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-202110051245539220-36TMR.Safety Report Unique Identifier GB-MHRA-ADR 26038079. A 17-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Sep2021 (Batch/Lot Number: FE8087) as single dose (at the age of 17-year-old) for COVID-19 immunisation. The patient medical history was not reported. Has always been very healthy. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. Historical vaccine includes BNT162B2 Dose 1 on 14Jul2021 for COVID-19 immunisation. The patient experienced initially problems with balance and coordination, then blurred/ double vision, numbness, pins and needles and then problems with speech (slurred and nasally) Immunoglobulin treatment. Events were reported as serious with criteria hospitalized, medically significant and life-threatening. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Lab data included Lumber puncture, CT & MRI scan, blood tests on unknown date with unknown result and COVID-19 virus test negative on unknown date. Outcome of event Miller Fisher syndrome was not recovered, of others was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1779759 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3318 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Aspartate aminotransferase, Blood creatine phosphokinase, Echocardiogram, Electrocardiogram, Fatigue, Headache, Laboratory test, Magnetic resonance imaging, Myocardial necrosis marker, Myocarditis, Troponin T
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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Name: glutamate oxalate transaminase; Result Unstructured Data: Test Result:increasing; Test Name: CK; Result Unstructured Data: Test Result:1267 U / 1; Test Name: echocardiography; Result Unstructured Data: Test Result:unknown result; Test Name: ECG; Result Unstructured Data: Test Result:ST segment changes as part of myocarditis.; Test Name: laboratory test; Result Unstructured Data: Test Result:exclusion of cardiological viruses; Test Name: cardio-MRI; Result Unstructured Data: Test Result:unknown result; Test Name: cardiac enzymes; Result Unstructured Data: Test Result:increasing; Test Name: troponin T; Result Unstructured Data: Test Result:1402 pg/mL
CDC Split Type: DEPFIZER INC202101273450

Write-up: Myocarditis; headache; tiredness; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-202100196605. A 14-years-old patient of an unspecified gender received bnt162b2 (COMIRNATY) at the age of 14-years-old, via an unspecified route of administration on 09Sep2021 (Batch/Lot Number: FF3318) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included covid-19 from Apr2021 to Apr2021. The patient''s concomitant medications were not reported. The patient experienced myocarditis on 11Sep2021, headache and tiredness on 10Sep2021. The patient was hospitalized for myocarditis from 11Sep2021 to 17Sep2021. The patient underwent lab tests and procedures which included aspartate aminotransferase: increasing, blood creatine phosphokinase: 1267 u/l, echocardiogram: unknown result, electrocardiogram: st segment changes as part of myocarditis, laboratory test: exclusion of cardiological viruses, magnetic resonance imaging: unknown result, myocardial necrosis marker: increasing, troponin t: 1402 pg/ml on unspecified dates. The outcome of the events was unknown.vent assessment : Comirnaty/ event /regulatory authority /Result of Assessment : B. Indeterminate Sender Comment: Initials: PRIVACY Inpatient admission on September 11th with thoracic pain, increasing cardiac enzymes (increase in CK (1267 U / 1), troponin T 1402 pg / ml, LOH and glutamate oxalate transaminase) and ST segment changes in the ECG as part of myocarditis. The pain is burning, stabbing and independent of breath. No dyspnea, no other symptoms. In April of this year, a corona infection with loss of taste appeared as the leading symptomatology. On the day after the vaccination, headache and tiredness appeared. On 11Sep in the early morning the patient woke up with angina pectoris symptoms in the sense of a stinging in the chest and radiating back pain and a feeling of weakness. Slightly restricted LV function. Structurally inconspicuous heart. Strict bed rest, cardio-MRI, exclusion of cardiological viruses, echocardiography, electrocardiology, monitoring. Discharge on 17Sep with recommendation of behavior and sports ban. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1784248 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG0978 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, 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? 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: 20210909; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101283190

Write-up: Syncope; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21127740. A 15-year and 5-month-old female patient received the second dose of bnt162b2 (COMIRNATY) intramuscular on 09Sep2021 09:30 (at the age of 15-year and 5-month-old) (Lot Number: FG0978; Expiration Date: 30Nov2021) as single dose for COVID-19 immunisation. Medical history was none. 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. Body temperature before vaccination was 36.1 degrees centigrade. The event onset date was reported as 10Sep2021 (1 day after the vaccination), the patient experienced Syncope. The course of the event was as follows: On 09Sep2021, the patient received Comirnaty intramuscular injection. The next day on 10Sep2021, the patient transported to first-aid hospital for Syncope. On 18Sep2021 (9 days after the vaccination), the outcome of the event was recovered. The reporter classified the event as non-serious and assessed that the causality between the event and bnt162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The outcome of the event was recovered on 18Sep2021. No follow-up attempts are possible. No further information is expected.


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