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From the 11/12/2021 release of VAERS data:

Found 875,292 cases where Vaccine is COVID19 and Patient Did Not Die

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

This is page 179 out of 8,753

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VAERS ID: 1794516 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3712 / UNK - / -
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebrovascular accident, Facial paresis, 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), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Transient ischemic attack (2 previous TIA''s with the last one in March 2021); Comments: Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test
Allergies:
Diagnostic Lab Data: Test Name: Covid 19 virus test; Result Unstructured Data: (Test Result:negative,Unit:unknown,Normal Low:,Normal High:)
CDC Split Type: GBGLAXOSMITHKLINEGB202121

Write-up: facial weakness; Stroke; Case received by GSK via MHRA on 15th October 2021. This case was reported by a physician via regulatory authority and described the occurrence of stroke in a 87-year-old female patient who received Hepatitis A vaccine for prophylaxis. Co-suspect products included BIONTECH COVID 19 VACCINE (batch number FG3712, expiry date unknown) for prophylaxis. The patient''s past medical history included transient ischemic attack (2 previous TIA''s with the last one in March 2021). Additional patient notes included Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. On an unknown date, the patient received Hepatitis A vaccine (unknown). On 14th October 2021, the patient received BIONTECH COVID 19 VACCINE (unknown). On 14th October 2021, unknown after receiving Hepatitis A vaccine, the patient experienced stroke (serious criteria GSK medically significant and life threatening). On an unknown date, the patient experienced facial weakness (serious criteria life threatening). On an unknown date, the outcome of the stroke was not recovered/not resolved and the outcome of the facial weakness was recovered/resolved. It was unknown if the reporter considered the stroke and facial weakness to be related to Hepatitis A vaccine. Additional details were reported as follows: The age at vaccination was not reported. On an unknown date, the patient had COVID-19 virus test which was negative. In the medical history and concurrent conditions section it was reported that patient not had a COVID-19 test but covid-19 lab test was captured based on the statement patient has not tested positive for COVID-19 since having the vaccine as reported in the narrative. On 14th October 2021, less than a day after receiving BIONTECH COVID 19 VACCINE, the patient experienced stroke and facial weakness. It was unknown if the reporter considered the stroke and facial weakness to be related to BIONTECH COVID 19 VACCINE. The TTO was reported as 1 day but was captured as less than a day with respect to BIONTECH COVID 19 VACCINE and unknown with respect to Hepatitis A vaccine as reported by RA. Initial information was reported by physician via regulatory authority on 15th Oct 2021: stroke, facial weakness Case narrative: Patient had Pfzier Covid Booster Vaccine today. She developed right sided weakness affecting upper and lower limbs with right facial weakness. Ambulance was called and she was transferred to A&E. She has a history of 2 previous TIA''s with the last one in March 2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Reaction Does your report relate to possible blood clots or low platelet counts? If yes, we will ask you additional questions at the end of this report: "No"


VAERS ID: 1800067 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-14
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN ABZ5320 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Chest pain, Heart rate, Heart rate increased, Hypertension, Injection site pain, Malaise
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (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: Medical History/Concurrent Conditions: COVID-19 (treated with antibiotics at the time)
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: Blood pressure; Result Unstructured Data: 158 mmHg, high; Test Date: 20211015; Test Name: Heart rate; Result Unstructured Data: 126 (high); Test Date: 20211016; Test Name: Blood pressure; Result Unstructured Data: 158 mmHg; Test Date: 20211016; Test Name: Heart rate; Result Unstructured Data: 110 (high)
CDC Split Type: PLJNJFOC20211031005

Write-up: CHEST PAIN; HIGH BLOOD PRESSURE; HIGH HEART RATE; PAIN IN THE INJECTION SITE; WAS NOT FEELING WELL; This spontaneous report received from a patient concerned a 25 year old female of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient''s past medical history included: ill with covid-19 six months ago (APR-2021) and was being treated with antibiotics at the time. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: ABZ5320, and expiry: unknown) dose was not reported, 1 total was administered in right arm on 14-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-OCT-2021 (after she had been vaccinated), the patient was not feeling well. On 15-OCT-2021 (next day after vaccination) at around 5 pm, the patient experienced chest pain, high blood pressure, high heart rate, and pain in the injection site. Laboratory data included: Blood pressure was (high) 158 mmHg (millimeters of mercury), and Heart rate was126 (high). On the day of report (16-OCT-2021), patient had similar blood pressure (158 mmHg), high heart rate (110), chest pain and still had pain in the injection site. The patient wanted to get information about the side effects. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, pain in the injection site, high blood pressure, high heart rate, and was not feeling well. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0; 20211031005; covid-19 vaccine ad26.cov2.s- chest pain-This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1802892 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-01
Onset:2021-10-14
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haematemesis, Upper gastrointestinal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (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: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101380746

Write-up: coffee ground vomit; Upper gastrointestinal hemorrhage; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110142332569290-B7QIZ, Safety Report Unique Identifier GB-MHRA-ADR 26080123. A 93-year-old female patient received third dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE; Batch/Lot number not known), via an unspecified route of administration on 01Oct2021 as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Patient''s medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient has not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medication included influenza vaccine (INFLUENZA VIRUS) on an unspecified date for immunisation. The patient experienced upper gastrointestinal hemorrhage on 14Oct2021 and ''coffee ground vomit'' on an unspecified date. Patient''s clinical course was as follows: It was reported that vaccination date was approximate (had between 10 and 14 days previous). It was reported that the patient resides in a nursing home. The patient had several episodes of coffee ground vomit today (unspecified date), one witnessed by reporter - looks like altered blood. The events were assessed as serious (medically significant, life-threatening, and hospitalization). The patient has not tested positive for COVID-19 since having the vaccine. The report does not relate to possible blood clots or low platelet counts. Outcome of the event upper gastrointestinal hemorrhage was not recovered; outcome of the event ''coffee ground vomit'' was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1809323 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-14
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20211041309

Write-up: COVID-19 PNEUMONITIS; VACCINATION FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority (regulatory authority, FR-AFSSAPS-NY20214745) on 21-OCT-2021 and concerned a 42 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) 1 dosage forms, frequency time 1 total administered on 15-SEP-2021 for covid-19 vaccination. The drug start period and last period was 29 days and duration of drug was 1 day. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 14-OCT-2021, the patient experienced covid-19 pneumonitis and vaccination failure and was hospitalized (date and days unspecified). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid-19 pneumonitis, and vaccination failure. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint.; Reporter''s Comments: Vaccination failure with COVID-19 pneumonia in a 42 year old man 29 days after the first injection of the JANSSEN vaccine (lot not provided) probably in (country). Hospitalisation and resuscitation due to COVID-19 DELTA variant pneumonia. Not resuscitated.


VAERS ID: 1809619 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF 8222 / 3 - / -
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Chills, Feeling cold, Headache, Malaise, Nausea, Pain, Pyrexia, SARS-CoV-2 test, Tremor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (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: EDOXABAN; EVOREL; GABAPENTIN; INFLUENZA VIRUS VACCINE; OXYCODONE; SILDENAFIL
Current Illness: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Myeloma (Myeloma - Plasmacytoma in right pelvis. ICP/Hydrocephalus - VP Shunt, Saddle Pulmonary Embolism, POEMS Syndrome,Polycythemia Vera,Meningitis")
Preexisting Conditions: Medical History/Concurrent Conditions: Hydrocephalus; Meningitis; Myeloma; POEMS syndrome; Polycythemia vera; Pulmonary embolism (Myeloma - Plasmacytoma in right pelvis. ICP/Hydrocephalus - VP Shunt, Saddle Pulmonary Embolism, POEMS Syndrome,Polycythemia Vera,Meningitis); Comments: I have been very unwell for 7 years; Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Date: 202110; Test Name: Body temperature; Result Unstructured Data: (Test Result:38.9,Unit:degree C,Normal Low:,Normal High:); Test Name: COVID-19 virus test; Result Unstructured Data: (Test Result:No - Negative COVID-19 test,Unit:unknown,Normal Low:,Normal High:)
CDC Split Type: GBGLAXOSMITHKLINEGB202121

Write-up: pain; unwell; shaking; Fever; Joint ache; Nausea; Throbbing headache; Generally unwell; Shakiness; Feeling cold; Shivering; Case received by Regulatory Authority on 21st October 2021. This case was reported by a consumer via regulatory authority and described the occurrence of pain in a 46-year-old female patient who received Hepatitis A vaccine for prophylaxis. Co-suspect products included COVID-19 MRNA VACCINE BNT162B2 (batch number FF 8222, expiry date unknown) for prophylaxis. The patient''s past medical history included pulmonary embolism (Myeloma - Plasmacytoma in right pelvis. ICP/Hydrocephalus - VP Shunt, Saddle Pulmonary Embolism, POEMS Syndrome,Polycythemia Vera,Meningitis), hydrocephalus, myeloma, poems syndrome, polycythemia vera and meningitis. Concurrent medical conditions included immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...) and myeloma (Myeloma - Plasmacytoma in right pelvis. ICP/Hydrocephalus - VP Shunt, Saddle Pulmonary Embolism, POEMS Syndrome,Polycythemia Vera,Meningitis"). Additional patient notes included I have been very unwell for 7 years; Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding. Concomitant products included edoxaban, estradiol (Evorel), gabapentin, INFLUENZA VACCINE (INFLUENZA VIRUS VACCINE), oxycodone and sildenafil. On an unknown date, the patient received Hepatitis A vaccine (unknown). On 13th October 2021, the patient received the 3rd dose of COVID-19 MRNA VACCINE BNT162B2 (unknown). On 14th October 2021, unknown after receiving Hepatitis A vaccine, the patient experienced feeling cold (serious criteria other: Serious as per reporter) and shivering (serious criteria other: Serious as per reporter). On an unknown date, the patient experienced pain (serious criteria other: Serious as per reporter), unwell (serious criteria other: Serious as per reporter), shaking (serious criteria other: Serious as per reporter), fever (serious criteria other: Serious as per reporter), joint ache (serious criteria other: Serious as per reporter), nausea (serious criteria other: Serious as per reporter), throbbing headache (serious criteria other: Serious as per reporter), generally unwell (serious criteria other: Serious as per reporter) and shakiness (serious criteria other: Serious as per reporter). The patient was treated with paracetamol and cyclizine. Rechallenge with COVID-19 MRNA VACCINE BNT162B2 was unknown. On an unknown date, the outcome of the pain, unwell and shaking were recovered/resolved and the outcome of the feeling cold, shivering, fever, joint ache, nausea, throbbing headache, generally unwell and shakiness were recovering/resolving. It was unknown if the reporter considered the pain, unwell, shaking, feeling cold, shivering, fever, joint ache, nausea, throbbing headache, generally unwell and shakiness to be related to Hepatitis A vaccine. Additional details was reported as follows: The age at vaccination was unknown. On an unknown date, patient was tested with Covid 19 with result No - Negative COVID-19 test . In October 2021, patient''s body temperature was 38.9 degree C. The time to onset for pain, unwell, shaking,fever, joint ache, nausea, throbbing headache, generally unwell and shakiness was less than a week with respect to COVID-19 MRNA VACCINE BNT162B2. The time to onset for feeling cold and shivering was 1 day with respect to COVID-19 MRNA VACCINE BNT162B2 It was unknown if the reporter considered the pain, unwell, shaking, feeling cold, shivering, fever, joint ache, nausea, throbbing headache, generally unwell and shakiness to COVID-19 MRNA VACCINE BNT162B2. Note- The Suspect vaccine COVID-19 MRNA VACCINE BIONTECH was coded to the nearest possible match as COVID-19 MRNA VACCINE BNT162B2 available in product coding dictionary. The patient had received booster dose of COVID-19 MRNA VACCINE BNT162B2. Initial information was received from consumer via regulatory authority on 15th October 2021 pain, unwell, shaking, feeling cold, shivering, fever, joint ache, nausea, throbbing headache, generally unwell and shakiness Case narrative All the side effects came on very quickly & out of the blue. It was approximately 24 hours after I had the booster vaccine. I have felt extremely unwell in a short period of time. I was shaking fiercely & in pain & then my temperature rose to 38.9. Thankfully I took some paracetamol & Cyclizine for the nausea, and fell asleep for a couple of hours, when I woke up I still felt very unwell & still had a temperature of 38.9. I had the usual things to help bring my temperature down; 2 fans, ice & wet flannels. At 4 hours I repeated the painkillers & took my usual evening medications. Eventually the pain & shaking improved and my temperature began to improve. All the symptoms lasted approximately 8 hours. I''m just beginning to feel better now. It''s 23:30 now & it started at 15:00. Patient has not tested positive for COVID-19 since having the vaccine.Patient is not enrolled in clinical trial


VAERS ID: 1809625 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Computerised tomogram, Fibrin D dimer, Interchange of vaccine products, Off label use
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), Medication errors (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 Date: 20211015; Test Name: CT scan; Result Unstructured Data: Test Result:has been successfully thrombolysed; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:D-dimer was not $g4000
CDC Split Type: GBPFIZER INC202101393040

Write-up: Stroke; Had AZ for first two doses then Pfizer for booster; Had AZ for first two doses then Pfizer for booster; This is a spontaneous report from a contactable pharmacist. This is a report received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202110151605346040-ZPYE2, Safety Report Unique Identifier GB-MHRA-ADR 26082713. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 14Oct2021 as dose 3 (booster), 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 and did not had a COVID-19 test. The patient previously received the dose 1 and dose 2 of COVID-19 vaccine Astrazeneca for COVID-19 immunisation. The patient experienced stroke on 14Oct2021. She was positive for facial drooping, arm weakness, speech difficulties and time (FAST) around 12-14 hrs. after the COVID booster. Computerised tomogram (CT) scan showed she has been successfully thrombolysed on 15Oct2021. The patient underwent other lab tests and procedures which included fibrin d dimer that showed d-dimer was not $g4000 on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the stroke was not recovered. The event caused hospitalization and was life threatening and medically significant. No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1809898 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-10-14
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005692 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood creatine phosphokinase, 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: Test Date: 20211014; Test Name: CPK; Result Unstructured Data: Test Result: 2400
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Myocarditis; This case was received via regulatory authority (Reference number: JP-TAKEDA-2021TJP108862) on 15-Oct-2021 and was forwarded to Moderna on 21-Oct-2021. This case, initially reported to the regulatory authority by a physician, was received via the regulatory authority (Ref, v21129411). On 15-Sep-2021, the patient received the 1st dose of this vaccine. On 13-Oct-2021, the patient received the 2nd dose of this vaccine. On 14-Oct-2021, around 02:00, the patient was aware of precordial tightness. At 16:30, CPK increased to 2,400 in the reporting hospital. The patient was hospitalized for myocarditis. The outcome of myocarditis 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.; Sender''s Comments: The case concerns a 18-year-old-male patient with no previous relevant medical history, who experienced the unexpected event of myocarditis. The event occurred one day after the second dose of Spikevax. The rechallenge was unknown since there''s no information about the first dose. The reporter assessed the event as possible. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1810016 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-14
Submitted: 0000-00-00
Entered: 2021-10-23
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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20211040999

Write-up: SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 INFECTION; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA:PH-PHFDA-300111860] concerned a 33 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose was not reported,1 total, administered on AUG-2021 for an unspecified indication. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 14-OCT-2021,at 8.40 the patient experienced covid-19 infection (CAP-LR). On an unspecified date, the patient experienced suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 infection on 14-OCT-2021 at 11:00, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender''s Comments: V0: 20211040999-Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1814310 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004674 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Fatigue, Headache, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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: COVID-19 VACCINE MODERNA
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: Headache; Low back pain; Aches & pains in legs; Tiredness; Fever chills; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26078919) on 15-Oct-2021 and was forwarded to Moderna on 15-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), BACK PAIN (Low back pain), PAIN IN EXTREMITY (Aches & pains in legs), FATIGUE (Tiredness) and PYREXIA (Fever chills) in a 24-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004674) for COVID-19 vaccination. Concomitant products included COVID-19 VACCINE MRNA (MRNA 1273) (COVID-19 VACCINE MODERNA) from 12-Aug-2021 to an unknown date for Vaccination. On 13-Oct-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), BACK PAIN (Low back pain) (seriousness criterion medically significant), PAIN IN EXTREMITY (Aches & pains in legs) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and PYREXIA (Fever chills) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache), BACK PAIN (Low back pain), PAIN IN EXTREMITY (Aches & pains in legs), FATIGUE (Tiredness) and PYREXIA (Fever chills) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medications provided. Unsure if patient has had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. Company Comment: This case concerns a 24-year-old, female patient with no relevant medical history, who experienced the unexpected events of headache, back pain, pain in extremity, fatigue and pyrexia. 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 benefit-risk relationship of the 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 24-year-old, female patient with no relevant medical history, who experienced the unexpected events of headache, back pain, pain in extremity, fatigue and pyrexia. 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 benefit-risk relationship of the 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: 1816736 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NOT KNOWN / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test Patient is not pregnant. Patient is not currently breastfeeding.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Nausea; Headache; Chills; Vomited; Felt faint; Pain; This case was received via Agency Regulatory Authority (Reference number: GB-MHRA-ADR 26081354) on 18-Oct-2021 and was forwarded to Moderna on 18-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Felt faint), PAIN (Pain), NAUSEA (Nausea), HEADACHE (Headache), CHILLS (Chills) and VOMITING (Vomited) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Not known) for COVID-19 vaccination. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test Patient is not pregnant. Patient is not currently breastfeeding. On 14-Oct-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced PAIN (Pain) (seriousness criterion medically significant). On 15-Oct-2021, the patient experienced DIZZINESS (Felt faint) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and VOMITING (Vomited) (seriousness criterion medically significant). On 15-Oct-2021, VOMITING (Vomited) had resolved. At the time of the report, DIZZINESS (Felt faint), PAIN (Pain), NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (Chills) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown Route) was unknown. The patient received jab at approximately 6.15 pm on 14-Oct-2021. No side effects other than mild pain around injection site until approximately 4 am on 15-Oct-2021. Experienced chills, nausea and headache. At approximately 8.30 am, almost fainted when standing for a brief period of time to put in contact lenses. Had to sit down quickly on bathroom floor and then vomited approximately 1 minute later. Nausea, headache, chills and feeling faint persist at approximately 10am. Patient had not tested positive for COVID-19 since having the vaccine. Patient not enrolled in clinical trial. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company Comment: This case concerns a 31-year-old, female with no reported medical history, who experienced the serious, unexpected events of nausea, dizziness, headache, pain, chills and vomiting. The event pain occurred on the same day after second dose of Spikevax. The events nausea, dizziness, headache, chills and vomiting occurred 1 day after second dose of Spikevax. The rechallenge was not applicable, as no additional dosing will be given. The benefit-risk relationship of Spikevax is not affected by this report. Event terms, onset dates, outcomes and seriousness captured per RA from Regulatory Authority reporting.; Sender''s Comments: This case concerns a 31-year-old, female with no reported medical history, who experienced the serious, unexpected events of nausea, dizziness, headache, pain, chills and vomiting. The event pain occurred on the same day after second dose of Spikevax. The events nausea, dizziness, headache, chills and vomiting occurred 1 day after second dose of Spikevax. The rechallenge was not applicable, as no additional dosing will be given. The benefit-risk relationship of Spikevax is not affected by this report. Event terms, onset dates, outcomes and seriousness captured per RA from Regulatory Authority reporting.


VAERS ID: 1816740 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Cold sweat, Mental impairment, Migraine, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), 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 Date: 20211003; 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: Difficulty thinking; Painful arm; Cold sweat; Chest pain; Migraine; Fever; This case was received via RA (Reference number: GB-MHRA-ADR 26083071) on 18-Oct-2021 and was forwarded to Moderna on 18-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (Difficulty thinking), PAIN IN EXTREMITY (Painful arm), COLD SWEAT (Cold sweat), CHEST PAIN (Chest pain), MIGRAINE (Migraine) and PYREXIA (Fever) in a 28-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Oct-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced MENTAL IMPAIRMENT (Difficulty thinking) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), COLD SWEAT (Cold sweat) (seriousness criterion medically significant), CHEST PAIN (Chest pain) (seriousness criterion medically significant), MIGRAINE (Migraine) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). At the time of the report, MENTAL IMPAIRMENT (Difficulty thinking), PAIN IN EXTREMITY (Painful arm), COLD SWEAT (Cold sweat), CHEST PAIN (Chest pain), MIGRAINE (Migraine) and PYREXIA (Fever) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Oct-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 relevant concomitant medications were reported. Patient has not tested positive for COVID-19 since having the vaccine. No treatment information was provided. This case concerns a 28-year-old male patient with no relevant medical history, who experienced the unexpected events of mental impairment, pain in extremity, cold sweat, chest pain, migraine, and pyrexia. The events occurred approximately the same day after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (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 were serious; Sender''s Comments: This case concerns a 28-year-old male patient with no relevant medical history, who experienced the unexpected events of mental impairment, pain in extremity, cold sweat, chest pain, migraine, and pyrexia. The events occurred approximately the same day after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (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 were serious


VAERS ID: 1817802 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-14
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia, Nausea, Paraesthesia, Pyrexia, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20211048355

Write-up: JOINT PAIN; FATIGUE; CHILLS; HEADACHE; MUSCLE PAIN; TINGLING IN THE FINGERTIPS FOR 30 MINUTES; VOMITING; FEVER; NAUSEA; This spontaneous report received from a consumer via a Regulatory Authority (EVHUMAN Vaccines, BE-FAMHP-DHH-N2021-107840) on 25-OCT-2021 and concerned a 27 year old female of unspecified race and ethnicity. The patient''s weight was 67 kilograms, and height was 170 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: JJ-XE393 expiry: UNKNOWN) dose was not reported, 1 total, administered on 14-OCT-2021 for covid-19 immunisation. No concomitant medications were reported. On 14-OCT-2021, the patient experienced joint pain, fatigue, chills, headache, muscle pain, tingling in the fingertips for 30 minutes, vomiting, fever and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from joint pain, fatigue, chills, headache, muscle pain, tingling in the fingertips for 30 minutes, vomiting, fever, and nausea. This report was serious (Disability Or Permanent Damage).; Reporter''s Comments: Treatment: Yes Daflagan Evolution of the ADR-Improving ADR description: Tingling in the fingertips for 30 minutes, accompanied by chills. Vomiting Information on the temporal link (ADR): 24 hours from 8 pm on 14-OCT-2021


VAERS ID: 1819486 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-14
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: 20211014; Test Name: SARS-CoV-2 rapid test; Test Result: Positive
CDC Split Type: GRPFIZER INC202101373040

Write-up: covid-19; covid-19; This is a spontaneous report from a contactable physician. A 16-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 12Aug2021 as dose 2, single and bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced cough, headache, loss of taste and low grade fever since 11Oct2021. On 14Oct2021 the patient experienced covid-19. Event was medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test (reported as SARS-CoV-2 rapid test): positive on 14Oct2021. Outcome of the events were unknown. Information about batch number was not available and is going to be requested upon FU.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the Lack of efficacy, Covid-19 Positive and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)


VAERS ID: 1819980 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-10-14
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis, Troponin
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: Troponin; Result Unstructured Data: troponin increased.
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Myocarditis; This case was received via Regulatory Authority (Reference number: JP-TAKEDA-2021TJP109784) on 19-Oct-2021 and was forwarded to Moderna on 21-Oct-2021. This case, initially reported to the Regulatory Agency (RA) by a physician, was received via the RA (Ref, v21129545). Myocarditis was assessed as serious by the health authority. On 11-Sep-2021, the patient received the 1st dose of this vaccination. There was no problem especially. On 09-Oct-2021, the patient received the 2nd dose of this vaccination. On 12-Oct-2021, chest pain developed. On 13-Oct-2021, the patient had a chest pain. On 14-Oct-2021, the patient visited the hospital in the morning. There were no particular findings in echo or electrocardiogram, but troponin increased. The patient was diagnosed with myocarditis. On 18-Oct-2021, the recovery of symptom was confirmed. The outcome of myocarditis 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 developed mild myocarditis, and the improvement in the symptom was confirmed only by the bed rest. 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 15-year-old, male subject with no relevant medical history reported, who experienced the unexpected event of myocarditis. The event occurred 33 days after the first dose of Spikevax. The rechallenge was not applicable, as no information about additional dosing was disclosed. The benefit-risk relationship of Spikevax is not affected by this report .


VAERS ID: 1822381 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-14
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Balance disorder, Diarrhoea, Dizziness, Fatigue, Joint swelling, Malaise, Nausea, Pain in extremity, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20211051072

Write-up: Dizzy spells; General malaise; Diarrhea; Swelling of R knee; Churning of stomach; Fever; Knee pain; Unsteadiness; Tiredness; Pain in arm; This spontaneous report received from a consumer via Regulatory Authority (regulatory authority, ES-AEMPS-1028741) on 25-OCT-2021 and concerned an adult female of an unspecified age. The patient''s weight was 65 kilograms, and height was 162 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 dosage forms, frequency 1 total, administered on 13-OCT-2021 for covid-19 vaccination. The drug start and end period was 2 days. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 14-OCT-2021, the patient experienced dizzy spells, general malaise, diarrhea, swelling of r knee, churning of stomach, fever, knee pain, unsteadiness, tiredness and pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizzy spells, general malaise, diarrhea, swelling of r knee, churning of stomach, fever, knee pain, unsteadiness, tiredness, and pain in arm. This report was serious (Other Medically Important Condition).


VAERS ID: 1822684 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Feeling cold, Headache, Influenza like illness, Insomnia, Interchange of vaccine products, Lymph node pain, Night sweats, Off label use, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Medication errors (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: AMLODIPINE; TAMSULOSINE [TAMSULOSIN]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high; COVID-19 (Unsure when symptoms stopped); Prostate adenoma
Allergies:
Diagnostic Lab Data: Test Date: 20210103; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101400454

Write-up: sweating/soaked the bed with sweat in sleep; Lymph node pain/ the (mildly) sore lymph nodes; Chilliness; patient received third dose of BNT162b2 while first two vaccinations was of Astra Zeneca; patient received third dose of BNT162b2 while first two vaccinations was of Astra Zeneca; Headache; Flu-like aching; Dry cough; difficulty sleeping the first night after being vaccinated; 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-202110161725512290-4WOTV, Safety Report Unique Identifier GB-MHRA-ADR 26085062. A 73-year-old male patient received third dose of BNT162b2 (COMIRNATY; Lot Number: FF8288) via an unspecified route of administration on 14Oct2021 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. Medical history included prostate adenoma, blood pressure high and suspected covid-19 from 28Dec2020 and unsure when symptoms stopped. The patient underwent COVID-19 virus test on 03Jan2021 and the result was positive. Concomitant medications included influenza vaccine (INFLUENZA VIRUS) for immunisation on 05Oct2021; amlodipine (Manufacturer Unknown) for blood pressure high and tamsulosin (TAMSULOSINE) for prostate adenoma; both started from an unknown date and unknown if ongoing. The patient was not enrolled in clinical trial. On 14Oct2021, the patient experienced headache, flu-like aching, dry cough and difficulty sleeping the first night after being vaccinated. On 15Oct2021 the patient experienced chilliness. On 16Oct2021 the patient experienced sweating and lymph node pain/ the (mildly) sore lymph nodes. The events headache, chilliness, flu-like aching, sweating, dry cough and lymph node pain were reported as serious for being medically significant. The clinical course was as follow: On the second night the patient soaked the bed with sweat in sleep. After that incident, the patient began to feel better, but the (mildly) sore lymph nodes were a new symptom. The patient had no significant reaction to first two vaccinations (Astra Zeneca) other than a slightly sore arm, but patient had not alarmed by the reactions. The patient was reporting that he understood that they were more likely after a booster jab and all the reactions were quite common. The patient was reporting them in the hope that it would be helpful. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event chilliness was recovered on an unknown date on Oct2021. The clinical outcome of the events headache, sweating, flu-like aching, dry cough were recovering. The clinical outcome of the event lymph node pain/ the (mildly) sore lymph nodes was not recovered, while difficulty sleeping the first night after being vaccinated was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1822686 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 30004674 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Axillary pain, Chills, Fatigue, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Joint pain; Armpit pain; Nausea; Fatigue; Fever; Chills; This case was received via regulatory authority RA (Reference number: -MHRA-ADR 26085172) on 19-Oct-2021 and was forwarded to Moderna on 19-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain), AXILLARY PAIN (Armpit pain), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 30004674) for COVID-19 vaccination. No Medical History information was reported. On 14-Oct-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On 15-Oct-2021, the patient experienced ARTHRALGIA (Joint pain) (seriousness criterion medically significant), AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). At the time of the report, ARTHRALGIA (Joint pain), AXILLARY PAIN (Armpit pain) and FATIGUE (Fatigue) had not resolved, PYREXIA (Fever) and CHILLS (Chills) was resolving and NAUSEA (Nausea) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not had symptoms associated with COVID-19. Joint pain was worse in hands, whilst it''s all over the hands are the worst and patient felt fine prior to vaccine. Fever was lasting longer than the 48 hours mentioned in the leaflets hence why she thought worth recording. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter. This case concerns a 31-year-old, female patient with no relevant medical history, who experienced the unexpected events of Arthralgia, Axillary pain, Fatigue, Pyrexia, Chills, Nausea. The events occurred approximately on the same day after the unknown dose of Moderna CoviD-19 Vaccine. The rechallenge was not applicable, as the events happened after the unknown dose. 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 31-year-old, female patient with no relevant medical history, who experienced the unexpected events of Arthralgia, Axillary pain, Fatigue, Pyrexia, Chills, Nausea. The events occurred approximately on the same day after the unknown dose of Moderna CoviD-19 Vaccine. The rechallenge was not applicable, as the events happened after the unknown dose. 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: 1822949 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF5357 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Hyperhidrosis, Pallor, Shock
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:90 mmHg; Test Name: blood pressure; Result Unstructured Data: Test Result:110 mmHg
CDC Split Type: JPPFIZER INC202101404891

Write-up: Shock; Diaphoresis; Pallor facial; This is a spontaneous report from a contactable other health care professional and from the different physician communicated to a Pfizer sales representative. A 30-year-old male patient received BNT162B2 (COMIRANTY; Solution for injection; Batch/Lot Number: FF5357; Expiration Date: 30Nov2021), dose 1 via an unspecified route of administration on 14Oct2021 (the day of vaccination), (Age at vaccination: 30-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. The patient did not had other allergy history before. The event was found after using the product. On an unspecified date (after vaccination), the patient experienced shock and received Epipen. Later, patient was taken to the hospital. On 14Oct2021, 10 mins after the vaccination, the patient experienced Pallor facial and Diaphoresis. The blood pressure was 90 and received EpiPen. Then went to hospital, blood pressure was about 110. Seriousness and causality of the event were not provided. The patient underwent lab tests and procedures which included blood pressure measurement: 90 mmhg and blood pressure measurement: 110 mmhg. The event was recovered with treatment including Epipen and IV drip. The outcome of the event was recovered on an unspecified date in 2021.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, the causal relationship between the event shock and 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: 1823028 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache, Hyperpyrexia, Malaise, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: hyperpyrexia; Result Unstructured Data: Test Result:Fever: 40.5 to 42 degree Celsius Centigrade
CDC Split Type: NLPFIZER INC202101403944

Write-up: Fever: 40.5 to 42 degree Celsius; Not feeling well; Pain in the joints; Headache; Nausea; muscle pain; Chills; Fatigue; This is a spontaneous report received from a contactable consumer or other non-health care professional (Patient) downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number NL-LRB-00699739. A 16-years-old female patient received second dose of bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Batch no: not reported; Lot number/ Expiry date Unknown) via an unspecified route of administration on 14Oct2021 (Age at vaccination: 16 years) as dose 2, single for covid-19 immunization. Medical history included suspected covid-19 from 20Aug2021 to an unknown date. The patient''s concomitant medications were not reported. Historical vaccine included patient previously first dose of bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Batch no: not reported; Lot number/ Expiry date Unknown) via an unspecified route of administration on 22Sep2021 as dose 1, 0.3 ML single for covid-19 immunization and she was tired and had muscle pain everywhere (especially her legs and arms and abdomen, the arm into which vaccine was injected hurt the most. She had there a bruise). On 14Oct 2021 within one day of vaccination patient experienced chills, headache, nausea, myalgia, Pain in the joints, fatigue, not feeling well, Fever: 40.5-to-42-degree Celsius centigrade following administration of covid-19 vaccine Pfizer injection. On 14Oct2021, Patient underwent lab tests and procedure which included Body temperature results 40.5-to-42-degree Celsius centigrade fever (Hyperpyrexia). Treatment included for hyperpyrexia was treated with 500mg paracetamol once a day. Outcome of the events fatigue, headache, not feeling well, myalgia was not recovered and chills, Pain in the joints, Fever: 40.5-to-42-degree Celsius was recovering and nausea recovered on 14Oct2021. No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101437855 same patient, different vaccine doses and events


VAERS ID: 1823204 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-10-14
   Days after vaccination:101
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: 20211014; Test Name: sars-cov-2 test; Test Result: Positive
CDC Split Type: PTPFIZER INC202101379561

Write-up: positive test for COVID-19; positive test for COVID-19; This is a spontaneous report from a contactable consumer, the patient''s mother. A male patient of an unspecified age received bnt162b2 (COMIRNATY, formulation: solution for injection, Lot number: FA5831), dose 1 via intramuscularly on 14Jun2021 as DOSE 1, SINGLE, dose 2 via intramuscularly on 05Jul2021 (Lot number: FA5831) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 14Oct2021, the patient had a positive test for covid-19. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 14Oct2021. At the time of the report, the outcome of the event was unknown. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up. Follow-up (19Oct2021): New Information received form Agency included that dose 1 and dose 2 vaccination start date and lot numbers were added. Follow-up attempts completed. No further information expected.


VAERS ID: 1824966 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-14
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Injection site pain, Injection site reaction, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (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: BEJNJFOC20211051403

Write-up: INJECTION SITE PAIN; SHIVERING; INJECTION SITE REACTION; FEVER; This spontaneous report received from a consumer by a Regulatory Authority (BE-FAMHP-DHH-N2021-107856) on 25-OCT-2021 and concerned a 29 year old female of unspecified race and ethnic origin. The patient''s weight was 65 kilograms, and height was 170 centimeters. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 124535J1, expiry: unknown) dose was not reported, 1 total, administered on 14-OCT-2021 for covid-19 immunisation. No concomitant medications were reported. On 14-OCT-2021, the patient experienced injection site pain (severe), shivering (cold chills), injection site reaction, and fever. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain, shivering, injection site reaction, and fever. This report was serious (Disability or Permanent Damage).; Reporter''s Comments: Treatment - No Evolution of the ADR - No ADR description improvement - I have been suffering high fever ($g38) ever since the injection of the vaccine. It started from 6 hours after the injection. Besides, I got severe pain at the injection site. I have got no other symptoms. More information about the time relationship (ADR) - Start from 6 hours after the injection.


VAERS ID: 1825903 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0810 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PLAQUENIL S; PROBIOTICS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adiposis dolorosa; Bartonella test positive; Celiac disease; Drug allergy (Past drug allergy: yes); EBV infection; Lupus erythematosus; Polycystic ovarian syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101389059

Write-up: excruciating upper gastric burning pain; could barely swallow; This is a spontaneous report from a contactable nurse (patient) received via Regulatory Authority. A 38-year-old female patient received 0.3 ml of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FD0810), via an unspecified route of administration, administered in Left arm (left deltoid) on 14Oct2021 13:00 (at the age of 38 year old) as dose 1, single for COVID-19 immunization. Medical history included systemic Lupus, celiac, dercums disease, bartonella, EBV (Epstein-Barr virus), PCOS (polycystic ovary syndrome) from an unknown date. Patient had past drug allergy. Concomitant medications included hydroxychloroquine sulfate (PLAQUENIL S); Pontotoc and probiotics all for an unspecified indication. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks. On 14Oct2021, within 30 mins of receiving the vaccine, at 13:30, patient started experiencing excruciating upper gastric burning pain to the point that she could barely swallow. At the time of report (8 hours later from vaccination) it was still present. Since the vaccination, the patient has not been tested for COVID-19. No prolonged hospitalization for the event. The outcome of the events was not recovered.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Dyspepsia and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1826402 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-10-14
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
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:
CDC Split Type: GBPFIZER INC202101380631

Write-up: Vaginal bleeding; This is a spontaneous report from a contactable consumer (patient). This is a report received from the regulatory authority report number is GB-MHRA-WEBCOVID-202110140039435380-QIVJR. Safety Report Unique Identifier GB-MHRA-ADR 26077699. A 29-year-old female patient received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Formulation: Solution for injection, Batch/Lot Number was not reported), via an unspecified route of administration on 24Sep2021 as dose 2, single for COVID-19 immunization. The patient medical history included suspected covid-19 from an unknown date and unknown if ongoing unsure when symptoms started, unsure when symptoms stopped. The patient concomitant medications were not reported. The patient was received BNT162B2 via an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced vaginal bleeding on 14Oct2021. Third-day of the period patient experienced heavy vaginal bleeding which was abnormal and required going to the emergency. The patient was not enrolled in clinical trial. The patient was not had a COVID-19 test. The outcome of the event was not recovered. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1826405 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: 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:
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 INC202101380644

Write-up: Heavy periods; Bleeding; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110140630525450-X9BME.Sender''s (Case) Safety Report Unique Identifier: GB-MHRA-ADR 26077733. A 38-year-old non-pregnant female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 13Oct2021 as dose number unknown, 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 enrolled in clinical trial. The patient experienced bleeding on an unknown date in 2021, heavy periods on 14Oct2021. Just had period now have heavy bleeding after jab. Not pregnant. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an un specified date. The outcome of the event heavy periods was reported as not recovered and bleeding was unknown. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1826413 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: 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: FIASP
Current Illness: Type 1 diabetes mellitus (Type 1 diabetic takes fiasp on omnipod)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101380678

Write-up: Vomiting; This is a spontaneous report from a contactable consumer. This is the report received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202110140819364090-UTY1N, Safety Report Unique Identifier GB-MHRA-ADR 26077825. A 14-years-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 Vaccine, Solution for injection, Batch/ Lot number: not known) via an unspecified route of administration on 13Oct2021 as dose 1, single for COVID-19 immunisation. Medical history included ongoing type 1 diabetes mellitus Type 1 diabetic (takes fiasp on omnipod). Concomitant medication included insulin aspart (FIASP) for type 1 diabetes mellitus from 31Jan2019. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 14Oct2021 (after 1 day of vaccination), patient experienced vomiting. Adverse reaction did not occur as a result of an exposure during pregnancy. The case was reported as serious. The outcome of event was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1826499 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (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: GEDAREL; METHOTREXATE; NAPROXEN; SULPHASALAZINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthritis)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101380689

Write-up: Shivers; Headache; Vomiting; Fatigue; Off label use; Interchange of vaccine products; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110141505379600-IFUAJ. Safety Report Unique Identifier GB-MHRA-ADR 26079211. A female patient of an unspecified age received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/ Lot number was not reported) via an unspecified route of administration on 14Oct2021 as dose 3 (booster), single for COVID-19 immunization. Medical history included rheumatoid arthritis (taking regular medicines for rheumatoid arthritis or other types of arthritis except osteoarthritis). Patient had previously received bnt162b2 (COVID-19 VACCINE ASTRAZENECA) on an unspecified date for COVID-19 immunization and influenza vaccine (INFLUENZA VIRUS) on 29Sep2021 for influenza immunization. Concomitant medications included sulphasalazine and methotrexate; both for rheumatoid arthritis; desogestrel, ethinylestradiol (GEDAREL) and naproxen both for an unspecified indication; all start and stop date were not reported. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unspecified date, patient experienced shivers, headache, vomiting. On 14Oct2021, patient had interchange of vaccine products and off label use. Events were medically significant. Lab test included COVID-19 virus test: negative on an unspecified date. The outcome of event shivers, headache was not resolved, vomiting was resolved and fatigue was resolving. No follow-up attempts are possible; information about lot/batch number cannot be requested. No further information is expected.


VAERS ID: 1826522 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Discomfort, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Allergy to antibiotic
Allergies:
Diagnostic Lab Data: Test Date: 20211012; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101380675

Write-up: discomfort; Abdominal pain; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110141821019450-LLQ5H. Safety Report Unique Identifier is GB-MHRA-ADR 26079670. A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 (at the age of 15 years old) via an unspecified route of administration on 14Oct2021 as dose 1, single for COVID-19 immunisation. Medical history included allergic to many antibiotics. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. On an unspecified date, the patient experienced discomfort. On 14Oct2021, abdominal pain. About 3 hours after having the vaccine he started to have abdominal pains. It came in waves which cause discomfort. Patient has 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: negative on 12Oct2021 (No - Negative COVID-19 test). Outcome of event discomfort was recovered on an unspecified date; 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: 1826526 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: Body temp; Result Unstructured Data: Test Result:40 degs C; Test Date: 20201220; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test; Comments: POSITIVE
CDC Split Type: GBPFIZER INC202101380878

Write-up: High temperature/ 40 degs C; This is a spontaneous report from a contactable consumer, received from the Regulatory Authority; report number is GB-MHRA-WEBCOVID-202110141912325960-VDOA5, Safety Report Unique Identifier GB-MHRA-ADR 26079757. A 47-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Not known) via an unspecified route of administration on 13Oct2021 as dose 3B (booster), single for COVID-19 immunization. Medical history included suspected COVID-19 from 18Dec2020 to 10Feb2021. Patient was not currently breastfeeding. The patient previously received first and second dose of bnt162b2 (Batch/Lot Number: Unknown) via an unspecified route of administration on unspecified dates for COVID-19 immunization. Concomitant medications were not reported. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. On 14Oct2021, the patient experienced high temperature (medically significant). The patient underwent lab tests and procedures which included SARS-CoV-2 test: yes- positive COVID-19 test on 20Dec2020; body temperature: 40 degs C on an unspecified date. The outcome of the event high temperature was not resolved. No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.


VAERS ID: 1826530 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, SARS-CoV-2 test, Vertigo
SMQs:, Vestibular disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101380628

Write-up: Vertigo; Chills; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202110142039184170-5XLXY, Safety Report Unique Identifier GB-MHRA-ADR 26079811. A 30-year-old patient of an unspecified gender received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch/lot number was not known, and expiration date was unknown), via an unspecified route of administration, on 13Oct2021, as dose 3 (booster), single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient experienced vertigo and chills on 14Oct2021 (1 day after the third dose). All the events were medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test was negative (no - negative COVID-19 test) on an unspecified date. Outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1826534 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-14
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Bell's palsy, Facial paralysis, Hypoaesthesia, Immunisation, Lethargy, Nausea, Off label use, Paralysis, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Taste and smell disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (broad), Hypoglycaemia (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101380762

Write-up: loss of taste; lethargic; nauseous; odd numb sensation to left armpit, across abdo and right thigh; Off label use; Booster; facial palsy; bells palsy; Nerve paralysis; This is a spontaneous report from a contactable physician. This is a report received from The regulatory authority report number is GB-MHRA-WEBCOVID-202110142130460930-URHCJ. Safety Report Unique Identifier GB-MHRA-ADR 26079851. A male patient of an unspecified age received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history included suspected COVID-19 from 30Aug2021 to an unknown date (Unsure when symptoms stopped). Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced facial palsy, bells palsy, loss of taste, lethargic, nauseous, odd numb sensation to left armpit, across abdo and right thigh, off label use and booster on an unspecified date, nerve paralysis on 14Oct2021. It was reported that felt unwell since covid pfizer booster 10 days ago, lethargic, nauseous, odd numb sensation to left armpit, across abdo and right thigh. Clinically normal sensation. Today left facial palsy and loss of taste (LMN lesions). Diagnosis bells palsy. Discharged with prednisolone. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date (Yes - Positive COVID-19 test). The outcome of the events was facial palsy, bells palsy, nerve paralysis, loss of taste, lethargic was not recovered and other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be requested. No further information is expected.


VAERS ID: 1826540 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5782 / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Chest pain, Myalgia, Myocarditis, Pain in extremity, Pericarditis, SARS-CoV-2 antibody test
SMQs:, Rhabdomyolysis/myopathy (broad), Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GEDAREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 ELISA test; Result Unstructured Data: Test Result:unknown result
CDC Split Type: GBPFIZER INC202101380691

Write-up: chest pain; arm pain; covid in left; Armpit pain; Muscle pain; Myocarditis; Pericarditis; This is a spontaneous report from a contactable consumer. This is the first of two reports. The first report is received from the regulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110142235575880-GBY5H, Safety Report Unique Identifier GB-MHRA-ADR 26080105. A 32-year-old non-pregnant patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FJ5782), via an unspecified route of administration, administered in Arm Left on 14Oct2021 (at the age of 32-years-old) as Dose 3 (Booster), Single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included contraception. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not currently breastfeeding. Concomitant medication included desogestrel, ethinylestradiol (GEDAREL) taken for contraception from 01Jan2016 to an unspecified stop date. Patient received historical vaccine first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on 26Jan2021 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), on 13Apr2021 for COVID-19 immunisation. Historical vaccine was received as flu vaccine (flu vaccine in another arm. (Covid in left, flu in right)) on an unspecified date for immunisation. On 14Oct2021, the patient experienced myocarditis, pericarditis, armpit pain, muscle pain. On an unspecified date, chest pain, arm pain, covid in left. Arm pain, under arm pain, sharp chest pain. Also had flu vaccine in other arm. (Covid in left, flu in right). Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient underwent lab test and procedures included COVID-19 ELISA test: unknown result. Outcome of myocarditis, pericarditis, armpit pain, muscle pain was not recovered, chest pain, arm pain, COVID-19 ELISA test was unknown. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101392189 same patient, same product, different dose/event


VAERS ID: 1826548 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Erythema, Muscle strain, Neck pain, Pain, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Accidents and injuries (narrow), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101380774

Write-up: My left arm is extremely sore; Area around my left shoulder and back is extremely red; painful to turn his head to the right; neck pain; Muscle strain; sudden onset of back/neck pain that went down the left side of the body (same side as injection); sudden onset of back/neck pain that went down the left side of the body (same side as injection); This is a spontaneous report from a contactable consumer (patient), received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110150410436970-PSUZM, Safety Report Unique Identifier GB-MHRA-ADR 26080176. A 42-years-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: Not known), via an unspecified route of administration on 13Oct2021 as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Medical history included rheumatoid arthritis from an unknown date (Patient is taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthritis)). Patient has not had symptoms associated with COVID-19 and did not have a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient previously took ramipril, Ventolin inhaler, clinil inhaler, amlodipine, naproxen and lansoprazole. The patient previously took historical vaccine which included dose 1 and dose 2 of BNT162B2 vaccine (Batch/Lot Number: Unknown) via an unspecified route of administration on unspecified dates for COVID-19 immunization. On an unspecified date, the patient experienced neck pain, left arm was extremely sore and the area around left shoulder and back was extremely red when looked in the mirror before showing, painful to turn his head to the right. On 14Oct2021, the patient experienced muscle strain and sudden onset of back/neck pain that went down the left side of the body (same side as injection) while driving to work on 14Oct2021. The events were considered serious (medically significant). Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.


VAERS ID: 1826576 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-09
Onset:2021-10-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Chills, Myocarditis, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: CLENIL MODULITE; OMEPRAZOLE; PREDNISOLONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acid indigestion; Asthma; Pemphigus (pemphigus sufferer since 2006); Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: Body temperature; Result Unstructured Data: Test Result:High
CDC Split Type: GBPFIZER INC202101417667

Write-up: myocarditis; Feeling of total lack of energy; Chills; Nausea; High temperature; 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-202110201458166500-KOTVR. Safety Report Unique Identifier GB-MHRA-ADR 26099021. A 75-year-old female patient received third dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number was not reported), via an unspecified route of administration on 09Oct2021 as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Medical history included steroid therapy (taking regular steroid treatment (e.g. orally or rectally), pemphigus sufferer since 2006, Acid indigestion, asthma. Concomitant medications included beclometasone dipropionate (CLENIL MODULITE) taken for asthma,; influenza vaccine taken for an unspecified indication in 2021; Omeprazole taken for acid indigestion, start and stop date were not reported; Prednisolone taken for pemphigus. Patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 31Jan2021 as DOSE 1, SINGLE and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 17Apr2021 as DOSE 2, SINGLE for covid-19 immunization. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Patient was not enrolled in clinical trial. On an unspecified date the patient experienced myocarditis. On 14Oct2021 the patient experienced feeling of total lack of energy, chills, nausea, high temperature. The patient underwent lab tests and procedures which included body temperature: high on 14Oct2021. The events were reported as serious (medically significant). The outcome of event myocarditis was not recovered while outcome of event feeling of total lack of energy, chills was recovering. The outcome of event nausea, high temperature was recovered on 18Oct2021. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1826583 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-10-14
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial tachycardia, Blood pressure measurement, Blood test, Chest pain, Cyanosis, Dizziness, Dyspnoea, Electrocardiogram, Heart rate, Hypertension, Lip swelling, Palpitations, SARS-CoV-2 test, Skin discolouration
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Blood pressure; Result Unstructured Data: Test Result:150/105; Test Date: 2021; Test Name: Blood test to exclude a heart attack; Result Unstructured Data: Test Result:Unknown results; Test Date: 2021; Test Name: ECG; Result Unstructured Data: Test Result:atrial tachycardia; Test Date: 2021; Test Name: Heart rate; Result Unstructured Data: Test Result:140 per minute; Test Date: 20211014; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101426280

Write-up: Chest pain with radiation to left arm; Heart palpitation/heart rate was 140 per minute; lips turned blue; hands and feet turned blue; dizzy when performing normal day to day activities; blood pressure was 150/105; atrial tachycardia; chest pain; shortness of breath; Swelling of lips; This is a spontaneous report from a contactable healthcare professional (patient). This is a report received from the Regulatory authority report number is GB-MHRA-WEBCOVID-202110211717402230-NNSFJ with Safety Report Unique Identifier of GB-MHRA-ADR 26104938. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (COMIRNATY; Lot Number: FF8222) via an unspecified route of administration on 24Sep2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no symptoms associated with COVID-19 and was not enrolled in clinical trial. The patient was not currently breastfeeding. On 14Oct2021, the patient experienced chest pain with radiation to left arm; on an unknown date in 2021, the patient experienced chest pain, swelling of lips, atrial tachycardia and shortness of breath; all the events were reported as serious for being medically significant and hospitalisation. On an unknown date in 2021, the patient experienced heart palpitation, lips, hands and feet turned blue and dizzy when performing normal day to day activities. The clinical course was reported as follows: The patient had started to feel pain in chest and heart palpitation and shortness of breath. The patient lips, hands and feet turned blue. The patient called 999. Paramedics checked her vital signs and heart rate was 140 per minute and blood pressure was 150/105. The patient was transferred to hospital. The patient was given intravenous medication to lower heart rate. ECG showed atrial tachycardia. The patient had taken oral medication every day to control heart. After 1 week post this incident, the patient still getting short of breath when walking and dizzy when performing normal day to day activities. The patient feels chest pain and heart palpitation at times even after taking medication. On 14Oct2021, the patient underwent COVID-19 virus test and the result was negative. On an unknown date in 2021, the patient underwent lab test for blood test to exclude a heart attack and the results was unknown. The patient had not tested positive for COVID-19, since having the vaccine. The report was related to possible blood clots or low platelet counts. The report was not related to possible myocarditis or pericarditis. The clinical outcome of the event chest pain with radiation to left arm was recovered with sequelae on 15Oct2021, after the duration of 1 day. The clinical outcome for the events chest pain, swelling of lips, atrial tachycardia and shortness of breath were recovering at the time of this report. The clinical outcome for the events heart palpitation, lips, hands and feet turned blue and dizzy when performing normal day to day activities, and blood pressure was 150/105 were unknown at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1826821 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5790 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Heart rate, Heart rate decreased, Oxygen saturation, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? 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: 20211014; Test Name: BP; Result Unstructured Data: Test Result:80; Comments: at 13:20 (13 minutes after the vaccination); Test Date: 20211014; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before the vaccination; Test Date: 20211014; Test Name: P; Result Unstructured Data: Test Result:54; Comments: at 13:20 (13 minutes after the vaccination); Test Date: 2021; Test Name: O2sar; Test Result: 80 %; Test Date: 2021; Test Name: O2sar; Test Result: 98 %
CDC Split Type: JPPFIZER INC202101376648

Write-up: Syncope; blood pressure decreased/Bp was 80; P was 54; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). Regulatory authority report number is v21129380. A 17-year-old female patient received the first dose of BNT162b2 (COMIRNATY, Formulation: solution for injection, Lot Number: FJ5790, Expiration date: 31Dec2021), via an unspecified route of administration, on 14Oct2021 at 13:07 (the day of vaccination) (at the age of 17-year-old), as dose 1, single for COVID-19 immunisation. Body temperature before vaccination was 36.3 degrees Centigrade on 14Oct2021. 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). Medical history was none and concomitant medications were not reported. On 14Oct2021 at 13:20 (13 minutes after the vaccination), the patient experienced the following event. The event course was reported as follows: The patient experienced Syncope, blood pressure decreased (illegible characters) (BP was 80, P was 54), 2.6 (as reported), O2Sar was 80%, O2 was 98%. The outcome of all the events was unknown. The reporter classified the event as non-serious and the causality between the event and bn162b2 as un assessable. There was no other possible cause of the event such as any other diseases. Follow up attempts are completed. Further information is not expected.


VAERS ID: 1826825 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0151 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Hypoaesthesia, Muscular weakness, Paralysis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: Medical History/Concurrent Conditions: Asthma bronchial; Seafood allergy
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101377096

Write-up: Paralysis flaccid/Paralysis flaccid, expanded to the upper limbs; Numbness of limbs/Numbness of lower extremities/numbness of extremities; Weakness of the lower limbs; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21129407. A 48-year and 5-month-old female patient received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: FH0151, Expiration date: 31Dec2021), via an unspecified route of administration, on 14Oct2021 at 11:30 (the day of vaccination) (at the age of 48-year and 5-month-old), as dose 1, single for COVID-19 immunization. Body temperature before vaccination was 36.8 degrees Centigrade on 14Oct2021. The family history was none in particular. There were points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) as follows: Asthma bronchial, Allergic to raw shrimp and raw squid. Concomitant medications were not reported. On 14Oct2021 at 11:40 (10 minutes after the vaccination), the patient experienced numbness of extremities and paralysis flaccid (as reported). On an unspecified date, the outcome of the event was not provided. The course of the event was as follows: About 10 minutes after vaccination, Numbness of lower extremities appeared. The patient experienced Weakness of the lower limbs, Paralysis flaccid, expanded to the upper limbs. Consciousness level, breathing stabled. After 1 hour, the symptoms improved, the patient was able to move upper and lower limbs, about 4 hours, standing up and walking became possible. The reporting physician classified the event as serious (risk of disability) and assessed the causality between the event and the vaccines as related. There was no other possible cause of the event such as any other diseases. Follow up attempts are completed. Further information is not expected.


VAERS ID: 1826826 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ7489 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure increased, Blood pressure measurement, Body temperature, Conversion disorder, Dizziness, Dizziness postural, Dry mouth, Dyspnoea, Expired product administered, Heart rate, Oxygen saturation, Swelling face
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylaxis
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: BP; Result Unstructured Data: Test Result:168/113; Test Date: 20211014; Test Name: Body temperature; Result Unstructured Data: Test Result:35.6 degrees Centigrade; Comments: before vaccination; Test Date: 20211014; Test Name: HR; Result Unstructured Data: Test Result:76; Test Date: 20211014; Test Name: SPO2; Test Result: 98 %
CDC Split Type: JPPFIZER INC202101377479

Write-up: Cheek swelling; Dry mouth; Dyspnoea; Possibility of Psychogenic hysteria; Giddiness; Dizziness on standing up; Suspicion of anaphylaxis; BP was 168/113; Drug taken beyond expiry date; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21129413. A 52-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: FJ7489, Expiration date 31Jan2021), via an unspecified route of administration, on 14Oct2021 at 15:15 (the day of vaccination) (at the age of 52-year-old) as dose 1, single for COVID-19 immunization. There were points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations, and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) as follows: medical history of anaphylaxis. Body temperature before vaccination was 35.6 degrees Centigrade on 14Oct2021. The patient''s concomitant medications were not reported. On 14Oct2021, the patient received the first dose of vaccine with expiration date 31Jan2021 and the drug was taken beyond expiry date. On 14Oct2021 at 15:18 (3 minutes after the vaccination), the patient experienced anaphylaxis, Giddiness, Dizziness on standing up, Cheek swelling, Dry mouth, Dyspnoea and possibility of Psychogenic hysteria. On 14Oct2021 (the same day of the vaccination), the outcome of the event was recovered. The course of the event was as follows: At 15:15, vaccine was performed. At 15:18, the patient experienced giddiness, dizziness on standing up. At 15:22, the patient experienced cheek swelling, dry mouth, after that dyspnoea appeared. On 14Oct2021, BP (blood pressure) was 168/113, HR (heart rate) was 76, SPO2 (oxygen saturation) was 98%. Vitals cannot be objectively judged to be anaphylaxis, but subjective symptoms, history of anaphylaxis, BOSMIN 0.3 ml intramuscular injection, hospitalized with suspicion of anaphylaxis. The reporting physician classified all the events as serious (hospitalized from 14Oct2021 to an unknown date) and assessed the causality between the event and the vaccines as related. Other possible cause of the event such as any other diseases was psychogenic hysteria. The reporting physician commented as follows that after hospitalized, the patient was emotionally restless, the possibility of Psychogenic hysteria was high, and it cannot be denied anaphylaxis. Follow up attempts are completed. Further information is not expected.


VAERS ID: 1826860 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5790 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Bradycardia, Dysphoria, Heart rate, Oxygen saturation, Presyncope
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Depression (excl suicide and self injury) (narrow), Hypotonic-hyporesponsive episode (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: Dysphoria
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: BP; Result Unstructured Data: Test Result:104/60; Comments: at 16:38; Test Date: 20211014; Test Name: BP; Result Unstructured Data: Test Result:106/71; Comments: at 16:00 in lying position; Test Date: 20211014; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before the vaccination; Test Date: 20211014; Test Name: HR; Result Unstructured Data: Test Result:66; Comments: at 16:38; Test Date: 20211014; Test Name: HR; Result Unstructured Data: Test Result:42; Comments: at 16:00 in lying position; Test Date: 20211014; Test Name: SpO2; Test Result: 97 %; Comments: at 16:38; Test Date: 20211014; Test Name: SpO2; Test Result: 99 %; Comments: at 16:00 in lying position
CDC Split Type: JPPFIZER INC202101383493

Write-up: Dysphoria; Vagal reflex; Bradycardia; This is a spontaneous report from a contactable physician received through the regulatory authority: Regulatory authority report number is v21129416. A 22-year-old adult female received the first dose of BNT162B2 (COMIRNATY, solution for injection; Lot FJ5790 expiry 31Dec2021) as a single dose via an unspecified route on 14Oct2021 at 15:38 (at 22-years-old; the day of vaccination) for COVID-19 immunisation. Body temperature before vaccination was 36.2 degrees Centigrade. It was unknown if the patient had any Family History. Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) included that dysphoria due to Blood sampling. On 14Oct2021 at 16:00 (22 minutes after the vaccination), the patient experienced Bradycardia, Dysphoria, and Vagal reflex. The clinical course was reported as follows: The patient experienced Dysphoria in 22 minutes after the vaccination. At 16:00 The patient was in lying position. BP was 106/71, HR was 42, SpO2 was 99 (as reported). At 16:38 BP was 104/60, HR was 66, SpO2 was 97%; There was Bradycardia temporarily, it was considered Vagal reflex. The outcome of the events Vagal reflex, Bradycardia, and Dysphoria was recovering. The reporter has assessed the causality between the events and BNT162B2 as related; There was no other possible cause of the event such as any other diseases. Follow up attempts are completed, no further information expected.


VAERS ID: 1826863 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3023 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Epistaxis, Fall, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before the vaccination
CDC Split Type: JPPFIZER INC202101383592

Write-up: Anaphylaxis; loss of consciousness; fall from chair; bleeding nose; This is a spontaneous report from a contactable other health professional received from the Pharmaceuticals and Medical Devices Agency (PMDA). Regulatory authority report number is v21129473. This patient was a 46-year and 8-month-old male (age at vaccination). Body temperature before vaccination on 14Oct2021 was 36.5 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 14Oct2021 at 15:55 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, solution for injection, lot number: FH3023, expiration date: 31Dec2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. Event onset date was reported as 14Oct2021 at 16:05 (10 minutes after the vaccination) the patient experienced Anaphylaxis. The outcome of the event was not provided. The event course was reported as follows: the patient experienced loss of consciousness then fell from chair during observation after the vaccination. The patient hit hard on the face, then had bleeding nose. The floor was made of artificial lawn, therefore the injury was mild. The patient received epinephrine (BOSMIN) injection and IV of calcium chloride dihydrate/potassium chloride/sodium chloride/sodium lactate (LACTEC), then the patient was transferred to emergency room. The reporter did not provided seriousness. The reporter classified the causality between the event and bn162b2 as related. Other possible cause of the event such as any other diseases was not provided. Outcome of the events was unknown. Follow up attempts are completed. No further information is expected.


VAERS ID: 1829982 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymph node pain, SARS-CoV-2 test
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210922; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101392971

Write-up: Lymph node pain; This is a spontaneous report received from a contactable consumer via regulatory authority. The regulatory authority report number is GB-MHRA-APPCOVID-20211015091914. Sender''s (Case) Safety Report Unique Identifier -GB-MHRA-ADR 26081219. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration on 13Oct2021 as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. On 14Oct2021 (after 1 day of vaccination), patient experienced lymph node pain. Underarm lymph nodes very painful at side of jab. The patient underwent lab test included COVID-19 virus test: negative on 22Sep2021. The outcome of 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: 1829984 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3712 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: body temperature; Result Unstructured Data: Test Result:high; Test Date: 20211013; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101393158

Write-up: Headache; Shivering; Ache; High temperature; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-APPCOVID-202110151333359310-420KR. Safety Report Unique Identifier is GB-MHRA-ADR 26082406. A 54-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration on 14Oct2021 (at the age of 54-years-old) (Lot Number: FG3712) as dose 3 (Booster), 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 is not pregnant,Patient is not currently breastfeeding. On 14Oct2021 the patient experienced headache, shivering, ache, high temperature. Treated with paracetamol. 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 sars-cov-2 test: negative on 13Oct2021, No - Negative COVID-19 test, body temperature: high on 14Oct2021. Therapeutic measures were taken as a result of headache, shivering, ache, high temperature. The outcome of the event shivering was recovered on 15Oct2021 and recovering for other events. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1829990 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101380893

Write-up: Adverse drug reaction NOS/Fever headache chills; Fever; headache; chills; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority report number is GB-MHRA-EYC 00263480, Safety Report Unique Identifier GB-MHRA-ADR 26079766. A 57-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, solution for injection, Batch/Lot number was not reported), via parenteral on 13Oct2021 (at the age of 57 years) as dose 3, (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 13Oct2021, the patient received a third/booster dose and experienced adverse drug reaction NOS/ fever headache and chills on 14Oct2021. The patient was taking Pfizer Covid 19 vaccine for COVID-19 immunisation. The outcome of all the events was recovered on 14Oct2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.


VAERS ID: 1830073 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cold sweat, Ear pain, Erectile dysfunction, Eye pain, Fatigue, Feeling abnormal, Headache, Hyperhidrosis, Interchange of vaccine products, Migraine, Off label use, Pain in jaw, Pyrexia, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Glaucoma (broad), Osteonecrosis (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sexual dysfunction (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: Asthma; Chronic headaches; Sinus disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101392859

Write-up: Pain injection site; Feverish; Migraine; Foggy feeling in head; Jaw pain; Fatigue; off label use; Interchange of vaccine products; couldn''t get comfy; headache; clammy; sweaty; Ear pain; Eye pain; This is a spontaneous report from a contactable other hcp received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110151010543680-CGLAH, Safety Report Unique Identifier GB-MHRA-ADR 26081447. A 27-year-old female patient received the third dose of BNT162B2 (COMIRNATY, solution for injection, bath/lot number was not known), via an unspecified route of administration, on 14Oct2021 (at the age of 27-year-old), as DOSE 3 (BOOSTER), single for COVID-19 immunization. Medical history included chronic headaches, asthma, sinus issues (asthma - take daily inhalers, sinus issues and chronic headaches). Concomitant medications were not reported. Historical vaccine included the first dose of COVID-19 VACCINE ASTRAZENECA (solution for injection, batch/lot number was unknown), via an unspecified route of administration, on an unspecified date in Jan2021, as dose 1, single and second dose of COVID-19 VACCINE ASTRAZENECA (solution for injection, batch/lot number was unknown), via an unspecified route of administration, on an unspecified date in Apr2021, as dose 2, single, both the doses for COVID-19 immunization. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient report did not relate to possible blood clots or low platelet counts. On an unspecified date in 2021, the patient could not get comfy, headache, clammy, sweaty, ear pain, eye pain. On 15Oct2021 (1 day after the third dose), had pain injection site, feverish, migraine, foggy feeling in head, jaw pain, fatigue. On 14Oct2021, had off label use and interchange of vaccine products. Clinical information included patient woke up about 6am very hot and sweaty, then cold and clammy which kept repeating. Headache started before waking up (strong pain around ears/eyes/nose/jaw). Could not get comfy, felt fidgety and injection site and muscles around it extremely painful when moving. Symptoms have continued since about 6am. Events off label use and interchange of vaccine products were reported as non-serious whereas all other events were reported as medically significant. Outcome of the events could not get comfy, headache, clammy, sweaty, pain injection site, migraine, foggy feeling in head, jaw pain, fatigue was not recovered, event feverish was recovering and outcome of the events ear pain, eye pain was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1830104 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5782 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Fatigue, Malaise, Pain in extremity
SMQs:, Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101393175

Write-up: Tiredness; Ill feeling; Weakness; Painful arm; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority(MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110151340143380-UKVG1, Safety Report Unique Identifier GB-MHRA-ADR 26082410. An 84-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: FJ5782) via an unspecified route of administration on 13Oct2021 as dose 3 (booster), single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient had no symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. On 14Oct2021, the patient experienced tiredness, ill feeling, weakness and painful arm. The events were assessed as medically significant. The outcome of the events was not resolved. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1830115 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-08
Onset:2021-10-14
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial flutter, Cardiac flutter, Cough, Dizziness, Fatigue, Heart rate irregular, Loss of consciousness, SARS-CoV-2 test
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), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiac arrhythmia terms, nonspecific (narrow), Tachyarrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Long covid after covid infection Jan 2020, and re-infection Jan 2021); Palpitations
Allergies:
Diagnostic Lab Data: Test Date: 20210112; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101393139

Write-up: Cardiac flutter; increased dizziness; almost blacking out; no heart beats for about 15 seconds; cough; heart flutter; fatigue; This is a spontaneous report from a contactable pharmacist. This is the report received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202110151505405210-BTPDF, Safety Report Unique Identifier GB-MHRA-ADR 26082649. A 45-year-old non-pregnant female patient received third dose of bnt162b2 (COMIRNATY, Solution for Injection, Lot Number: Ff8222), via an unspecified route of administration on 08Oct2021 as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Medical history included palpitations from an unknown date and unknown if ongoing, suspected covid-19 from 01Feb2020 and ongoing, covid-19 from Jan2020 to an unknown date Long covid after covid infection Jan 2020, and re-infection Jan 2021, covid-19 from Jan2021 to an unknown date Long covid after covid infection Jan 2020, and re-infection Jan 2021. Patient previously received bnt162b2 (PFIZER BIONTECH COVID-19 Vaccine, Solution for Injection) via unspecified route of administration on unknown date for COVID-19 immunization. The patient''s concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient is not pregnant, Patient is not currently breastfeeding. On an unspecified date in 2021, the patient experienced cough, heart flutter, fatigue, increased dizziness, almost blacking out, and no heart beats for about 15 seconds. On 14Oct2021, she had cardiac flutter. It was reported that patient had heart flutter for about 15 seconds followed by a period of no heart beats for about 15 seconds with increased dizziness and almost blacking out. A cough started up the heart beating again, with normal output resuming plus fatigue. Some palpitations previously but described as strong fast beats that self-corrected after a few seconds and not like the fluttering (or heart stopping) experienced in this episode. Patient any possible blood clots or low platelet counts: No. Patient relevant investigations or tests conducted: Going for ECG and blood test next weem. Long covid after covid infection Jan 2020, and re-infection Jan 2021. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 12Jan2021 Yes - Positive COVID-19 test. Outcome was not resolved for cardiac flutter, was resolving for cough, heart flutter, and fatigue, and was unknown for rest of the events. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1830122 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: 20211012; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101393046

Write-up: Headache; Vomiting NOS; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority (RA).The regulatory authority report number is GB-MHRA-WEBCOVID-202110151627245780-5TGHT,Safety Report Unique Identifier(GB-MHRA-ADR 26082836). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FF8222), dose 3 via an unspecified route of administration on 14Oct2021 (at the age of 66-year-old) as Dose 3 (Booster), Single for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. The patient medical history and concomitant medications were not reported. On 14Oct2021, the patient experienced headache, vomiting NOS. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 12Oct2021 (No - Negative COVID-19 test). Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Outcome of event headache was recovering, and vomiting NOS was recovered on 15Oct2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1830146 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Interchange of vaccine products, Off label use, Pain in extremity, SARS-CoV-2 test
SMQs:, Tendinopathies and ligament disorders (broad), Medication errors (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: Clinical trial participant (received 2 doses of the Novavax vaccine under the clinical trial earlier this year (April/May))
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101392962

Write-up: Chills; received 2 doses of the Novavax vaccine under the clinical trial earlier this year; received 2 doses of the Novavax vaccine under the clinical trial earlier this year; Painful arm; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110152030466450-FRF78. Senders (Case) Safety Report Unique Identifier-GB-MHRA-ADR 26083668. A 25-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 3 via an unspecified route of administration on 14Oct2021 (Batch/Lot Number: Ff8288, age at the time of vaccination: 25-year-old) as DOSE 3, (BOOSTER) SINGLE for covid-19 immunisation.Medical history included clinical trial participant (received 2 doses of the Novavax vaccine under the clinical trial earlier this year (April/May)). The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19, Patient is not pregnant at the time of vaccination, Patient is not currently breastfeeding. Previously the patient received Novavax (lot number not reported) as Dose 1 and dose 2 on an unknown date in Apr/May 2021 for covid-19 immunization. It was reported that patient already received 2 doses of the novavax vaccine under the clinical trial earlier this year (Off- label use, interchange of vaccine products). The patient experienced painful arm on 14Oct2021, chills on 15Oct2021. The patient underwent lab tests and procedures which included Covid-19 virus test: negative on an unknown date (No - Negative COVID-19 test). The outcome of events was reported as not recovered. No follow-up attempts are Needed. No further information is expected.


VAERS ID: 1830171 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Feeling abnormal, Headache, Interchange of vaccine products, Off label use, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; BICALUTAMIDE; FAMOTIDINE; SIMVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood cholesterol; Blood pressure; Gastritis; Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy)); Prostate cancer (Treated for prostate cancer. Hormone treatment)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101392818

Write-up: Fever; Headache; Aches & pains in legs; off label use; interchange of vaccine products; feeling absolutely awful; This is a spontaneous report from a contactable consumer or other non hcp received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110160917462410-D37YB. Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 26084656. A 77-year-old male patient received the third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, lot number: FF8288), via an unspecified route of administration, on 14Oct2021 (at the age of 77-year-old), as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included prostate cancer (treated for prostate cancer, hormone treatment), neoplasm (recently had treatment for cancer, leukemia or lymphoma (radiotherapy or chemotherapy)), gastritis, blood cholesterol and blood pressure. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. Concomitant medications included amlodipine taken for blood pressure from 01Jan1996, bicalutamide taken for prostate cancer from 01Oct2021, famotidine taken for gastritis from 01Jan1990 and simvastatin taken for blood cholesterol from 01Jan1996. The patient''s historical vaccine included both the doses (dose 1 and dose 2) of COVID-19 VACCINE ASTRAZENECA (solution for injection, batch/lot number was unknown) via an unspecified route of administration, on an unspecified date, as single dose for COVID-19 immunization. The patient experienced feeling absolutely awful on an unspecified date in 2021, fever, headache, aches & pains in legs on 15Oct2021 (1 day after the third dose), off label use and interchange of vaccine products on 14Oct2021. Clinical information included feeling absolutely awful, did not have these symptoms with AZ vaccines. Symptoms came on 12hrs later. Taking paracetamol. Have cancelled flu vaccine as will probably finish me off. Patient has not tested positive for COVID-19 since having the vaccine. The seriousness criteria of the events feeling absolutely awful, fever, headache, aches & pains in legs were reported as medically significant. The patient received the treatment for the events fever, headache, aches & pains in legs. Outcome of the event Feels awful was unknown and outcome of the events fever, headache, aches & pains in legs was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1830177 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMOXICILLIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Splenectomy (Spleen removed 1982 following motorbike accident.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101392914

Write-up: Shivering; Pain muscle; Tiredness; 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-202110161113278010-OGIGS, Safety Report Unique Identifier GB-MHRA-ADR 26084743. A 57-year-old male patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 14Oct2021 as dose 3 (booster), single (Age at vaccination: 57-year-old) for covid-19 immunization. Medical history included splenectomy from 1982 to an unknown date Spleen has been removed, Spleen removed 1982 following motorbike accident. Patient has not had symptoms associated with COVID-19. Not had a COVID-19. Concomitant medication included amoxicillin taken for splenectomy from 01Jun1990 to an unspecified stop date. On 14Oct2021, The patient experienced shivering, pain muscle and tiredness. Intense shivering approximately 8 hrs following vaccine lasting 24 hrs Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. The outcome of the event (shivering) was recovered on 16Oct2021 and events (pain muscle and tiredness) was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected


VAERS ID: 1830185 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211011; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101393242

Write-up: itchy; Itchy rash; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110161336070580-TFTQP Safety Report Unique Identifier GB-MHRA-ADR 26084862. A 59-year-old male patient received bnt162b2 (COMIRNATY), Solution for injection, (Lot Number: FF8288), via an unspecified route of administration on 13Oct2021 as dose 3 (booster), single for COVID-19 immunization. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. The patient concomitant medications were not reported. The patient had experienced itchy on an unspecified date and itchy rash on 14Oct2021. The events seriousness was assessed as medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test (SARS-CoV-2 test): negative on 11Oct2021 No - Negative COVID-19 test. Itchy red rash under the armpits and trunk of the body, no other side effects and generally felt well. Treated with camomile lotion and piriton. Therapeutic measures were taken as a result of itchy, itchy rash. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of events itchy was unknown and itchy rash was recovering. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1830190 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Inflammation, Interchange of vaccine products, Peripheral swelling, Pruritus, SARS-CoV-2 test, Skin warm, Vaccination site erythema, Vaccination site rash, Vaccination site warmth
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALIN 1 A PHARMA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101392944

Write-up: redness/injection site redness; rash/Injection site rash; injection site is hot to touch; Itching; Large arm swelling; Skin warm; Numbness; Inflammation; the patient received a third/booster dose; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202110161421481800-94SKI, Safety Report Unique Identifier GB-MHRA-ADR 26084904. A 30-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, Lot number was not reported), via an unspecified route of administration on 14Oct2021 (at the age of 30 years), as dose 3 (booster), single for COVID-19 immunization. Medical history included suspected COVID-19 from 27Mar2020 to an unknown date (unsure when symptoms stopped), and depression. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Concomitant medication included sertraline hydrochloride (SERTRALIN 1 A PHARMA) taken for depression, start and stop date were not reported. The patient previously received two doses of COVID-19 VACCINE ASTRAZENECA, dose 1 via an unspecified route of administration on an unspecified date and experienced a swollen arm, redness, warm to touch, some numbness and rash around the injection and dose 2 via an unspecified route of administration on an unspecified date and had no adverse reactions, both for COVID-19 immunization. After first dose, Sought GP advice and believed it may be affected but went down after a week. She had the second AstraZeneca jab and it was fine. On 14Oct2021, the patient received a third/booster dose and on 15Oct2021, inflammation, large arm swelling, skin warm and numbness, on 16Oct2021, had itching and on an unspecified date, experienced redness/ injection site redness, rash/ injection site rash and injection site was hot to touch. It was reported that patient went for her Phizer booster two days ago and have started to develop a rash, the injection site was hot to touch and numb. Appears to be developing the same as the AstraZeneca jab. The patient underwent lab tests and procedures which included SARS-CoV-2 test: Positive (Yes - Positive COVID-19 test) on an unspecified date. The outcome of rash/ injection site rash and redness/ injection site redness was recovering, outcome of injection site is hot to touch was unknown while rest all the events were not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1830208 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema, Pruritus, Rash, Rash pruritic, SARS-CoV-2 test, Skin swelling, Vaccination site pain, Vaccination site warmth
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210628; 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: full red large teardrop shape mark on skin; Rash; itching; itchy; Itchy rash; Vaccination site warmth; Skin swelling of; Vaccination site tenderness; This case was received via Agency Regulatory Authority (Reference number: GB-MHRA-ADR 26094998) on 21-Oct-2021 and was forwarded to Moderna on 21-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ERYTHEMA (full red large teardrop shape mark on skin), RASH (Rash), PRURITUS (itching), PRURITUS (itchy), RASH PRURITIC (Itchy rash), VACCINATION SITE WARMTH (Vaccination site warmth), SKIN SWELLING (Skin swelling of) and VACCINATION SITE PAIN (Vaccination site tenderness) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 from 26-Jun-2021 to 06-Jul-2021. On 14-Oct-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth) (seriousness criterion medically significant), SKIN SWELLING (Skin swelling of) (seriousness criterion medically significant) and VACCINATION SITE PAIN (Vaccination site tenderness) (seriousness criterion medically significant). On 16-Oct-2021, the patient experienced RASH PRURITIC (Itchy rash) (seriousness criterion medically significant). On an unknown date, the patient experienced ERYTHEMA (full red large teardrop shape mark on skin) (seriousness criterion medically significant), RASH (Rash) (seriousness criterion medically significant), PRURITUS (itching) (seriousness criterion medically significant) and PRURITUS (itchy) (seriousness criterion medically significant). At the time of the report, ERYTHEMA (full red large teardrop shape mark on skin), RASH (Rash), PRURITUS (itching) and PRURITUS (itchy) was resolving and RASH PRURITIC (Itchy rash), VACCINATION SITE WARMTH (Vaccination site warmth), SKIN SWELLING (Skin swelling of) and VACCINATION SITE PAIN (Vaccination site tenderness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jun-2021, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment information was reported. Full red large teardrop shape mark on skin, covering whole of deltoid muscle for 3 days after vaccination. Since first 3 days, teardrop is now round and more of a rash. Clearly visible and very itchy. Itching moved down the arm. Vacc site still warm almost 6 full days after Vacc site still tender, so much so that sleep was disturbed as well as carrying backpack to work. Company Comment: This case concerns a 30-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Vaccination site warmth, skin swelling, Vaccination site pain, rash pruritic, erythema, rash, and pruritus (reported as "itching" and "itchy"). The events of rash and vaccination site pain are unexpected as they are retained as serious per the source document Authority reporting. The event Vaccination site warmth, skin swelling, and vaccination site pain occurred on the same day after the first dose of Spikevax. The event rash pruritic occurred 2 days after the first dose of Spikevax. For the events erythema, rash, and pruritus, the time to onset from vaccination was not reported. The rechallenge was unknown as per RA reporting. The benefit-risk relationship of Spikevax is not affected by this report. Events term, onset date, outcome and seriousness captured per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 30-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Vaccination site warmth, skin swelling, Vaccination site pain, rash pruritic, erythema, rash, and pruritus (reported as "itching" and "itchy"). The events of rash and vaccination site pain are unexpected as they are retained as serious per the source document Authority reporting. The event Vaccination site warmth, skin swelling, and vaccination site pain occurred on the same day after the first dose of Spikevax. The event rash pruritic occurred 2 days after the first dose of Spikevax. For the events erythema, rash, and pruritus, the time to onset from vaccination was not reported. The rechallenge was unknown as per RA reporting. The benefit-risk relationship of Spikevax is not affected by this report. Events term, onset date, outcome and seriousness captured per Regulatory Authority reporting.


VAERS ID: 1830239 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Peripheral swelling, Pruritus, SARS-CoV-2 test, Sleep disorder
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Date: 20210921; 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: itchy; swollen; Swollen arm; Sleep disturbed; Tiredness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26105891) on 22-Oct-2021 and was forwarded to Moderna on 22-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PRURITUS (itchy), PERIPHERAL SWELLING (swollen), PERIPHERAL SWELLING (Swollen arm), SLEEP DISORDER (Sleep disturbed) and FATIGUE (Tiredness) in a 70-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Clinical trial participant. On 13-Oct-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant). On 15-Oct-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant) and SLEEP DISORDER (Sleep disturbed) (seriousness criterion medically significant). On an unknown date, the patient experienced PRURITUS (itchy) (seriousness criterion medically significant) and PERIPHERAL SWELLING (swollen) (seriousness criterion medically significant). At the time of the report, PRURITUS (itchy) and PERIPHERAL SWELLING (swollen) had not resolved and PERIPHERAL SWELLING (Swollen arm), SLEEP DISORDER (Sleep disturbed) and FATIGUE (Tiredness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Sep-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had swollen hard red itchy arm. No treatment information was provided. Concomitant active drug substance name reported included SARS-COV-2 virus. Company comment: This case concerns 70-year-old female patient with no relevant medical history, who experienced the unexpected events fatigue, peripheral swelling, sleep disorder, pruritus, peripheral swelling. The events occurred approximately 1-2 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown since no information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 (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 were serious.; Sender''s Comments: This case concerns 70-year-old female patient with no relevant medical history, who experienced the unexpected events fatigue, peripheral swelling, sleep disorder, pruritus, peripheral swelling. The events occurred approximately 1-2 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown since no information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 (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 were serious.


VAERS ID: 1830257 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3712 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Interchange of vaccine products, Nausea, Off label use, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (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: ATORVASTATIN; CO-AMILOFRUSE; COD LIVER OIL [COD-LIVER OIL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high; High cholesterol; Pre-diabetic; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101393229

Write-up: Feverish; Nauseous; received the full primary immunization series of COVID-19 VACCINE ASTRAZENECA/received bnt162b2 as dose 3 (booster); received the full primary immunization series of COVID-19 VACCINE ASTRAZENECA/received bnt162b2 as dose 3 (booster); Tiredness; This is a solicited report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-YCVM-202110152054244210-9XNLC, Safety Report Unique Identifier GB-MHRA-ADR 26084035. A 72-year-old female patient received BNT162B2 (COMIRNATY, Lot Number: FG3712), via an unspecified route of administration on 14Oct2021 (at the age of 72 years old) as dose 3 (booster), single for COVID-19 immunisation. Medical history included type 2 diabetes, pre-diabetic, high blood pressure, and high cholesterol. Patient has not had symptoms associated with COVID-19. Concomitant medications included atorvastatin taken for high cholesterol; amiloride hydrochloride, furosemide (CO-AMILOFRUSE) taken for blood pressure high; cod-liver oil; influenza vaccine (INFLUENZA VIRUS) taken for immunisation on 18Sep2021. The patient previously received first dose of COVID-19 vaccine Astrazeneca (Lot number: AB0005) on 04Feb2021 for COVID-19 immunisation and experienced tiredness, sleeplessness, feeling hot, nauseous then second dose of COVID-19 vaccine Astrazeneca (Lot number: PW40009) on 08Apr2021 for COVID-19 immunisation. On 14Oct2021, the patient experienced tiredness. On 15Oct2021, the patient experienced feverish and nauseous. The events were medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test was no - negative COVID-19 test on an unspecified date. Thyroid function blood test to be repeated. Patient is not enrolled in clinical trial. Outcome of the events tiredness, feverish, and nauseous was recovering. The reporter''s assessment of the causal relationship of the events tiredness, feverish, and nauseous with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events tiredness, feverish and nauseous cannot be excluded.


VAERS ID: 1830265 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (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: TOLTERODINE; LEVOTHYROXINE SODIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism; Polyuria
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101447978

Write-up: Muscle soreness; This is a solicited report from the RA from a contactable consumer. This is the 3rd of 3 reports. The first report was received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-YCVM-202110071434557890-J911J. A 60-year-old female patient received BNT162B2 (COMIRNATY), dose 3 via an unspecified route of administration on 14Oct2021, a the age of 60 year, (Batch/Lot Number: FF8222) as dose 3 (booster), single for COVID-19 vaccination. Medical history included polyuria, hypothyroidism. Concomitant medications included tolterodine taken for polyuria and levothyroxine sodium taken for hypothyroidism. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 13Jan2021 as dose 1, single (Batch/Lot number: EK1768) for COVID-19 vaccination for which the patient experienced fatigue and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 02Apr2021 as dose 2, single (Batch/Lot number: ER1749) for COVID-19 vaccination which was considered as Inappropriate schedule of vaccine administered. The patient experienced muscle soreness on 14Oct2021. The case is serious (medically significant). The patient had COVID-19 virus test (Unknown date): No - Negative COVID-19 test. The outcome for muscle soreness was not recovered. The reporter''s assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event myalgia cannot be excluded. The case will be reassessed if additional information becomes available.


VAERS ID: 1830397 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0151 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Confusional state, Depressed level of consciousness, Investigation, Muscle tightness, Nausea, Presyncope, Tension, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (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), 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: Psychiatric disorder NOS
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20211014; Test Name: depressed level of consciousness (II-10 ~ III-100); Result Unstructured Data: Test Result:depressed level of consciousness (II-10 - III-100)
CDC Split Type: JPPFIZER INC202101382527

Write-up: Vasovagal reflex; It was reported that tightness in the shoulder remained.; too much Tension; It is considered that the patient was in a state of confusion; Thereafter, about 20 minutes later, since depressed level of consciousness (II-10 - III-100) was observed; Vomiting; Queasy; This is a spontaneous report from a contactable Physician received from the regulatory authority report number is v21129461. A 47-year and 4-month-old female (age at the 1st vaccination) on 14Oct2021 at 09:30 (the day of the 1st vaccination), the patient received the 1st dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FH0151, Expiration date 31Dec2021) via an unspecified route of administration as a single dose for COVID-19 immunization. Body temperature before vaccination was 36.6 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). However it was also reported that the patient had an underlying disease for which the patient visits a psychiatric clinic. On 14Oct2021 at 10:30 (the day of the 1st vaccination), Vasovagal reflex occurred. The patient experienced also the following events: vomiting and queasy on 14Oct2021 09:40, depressed level of consciousness (II-10 - III-100) on 14Oct2021 10:00, tightness in the shoulder on 14Oct2021 10:30, too much tension on 14Oct2021 10:30, state of confusion on 14Oct2021 10:30. The course of the event was as follows: 10 minutes after receiving the 1st dose of the vaccine (COVID-19), the patient experienced vomiting, queasy. Thereafter, about 20 minutes later, since depressed level of consciousness (II-10; III-100) was observed, an ambulance was requested. After a while of the transfer by ambulance, the patient''s consciousness was regained, and the patient went home. It was reported that tightness in the shoulder remained. On 15Oct2021 (1 day after the 1st vaccination), the outcome of the events was recovered. The reporting physician classified the event as non-serious (as reported) and assessed that the causality between the event and bnt162b2 as unassessable. The reporting physician commented as follows: The patient has an underlying disease for which the patient visits a psychiatric clinic. It is considered that the patient was in a state of confusion due to too much Tension.


VAERS ID: 1830399 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5790 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asterixis, Blood pressure decreased, Blood pressure measurement, Dizziness, Fall, Feeling cold, Heart rate, Heart rate decreased, Hypoaesthesia
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Vestibular disorders (broad), Dehydration (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: Test Date: 20211014; Test Name: Blood pressure (BP); Result Unstructured Data: Test Result:110/66 mmHg; Comments: 15 minutes after the vaccination; Test Date: 20211014; Test Name: Blood pressure (BP); Result Unstructured Data: Test Result:92/64 mmHg; Comments: 38 minutes after the vaccination; Test Date: 20211014; Test Name: Heart rate (P); Result Unstructured Data: Test Result:82; Comments: 15 minutes after the vaccination; Test Date: 20211014; Test Name: Heart rate (P); Result Unstructured Data: Test Result:57; Comments: 38 minutes after the vaccination
CDC Split Type: JPPFIZER INC202101383060

Write-up: Asterixis; Feeling cold; DIZZY; Numbness in hand; Heart rate decreased from 82 to 57; Blood pressure decreased from 110/66 mmHg to 92/64 mmHg; collapsed from the waiting chair; This is a spontaneous report from a non-contactable pharmacist. An adult female patient received bnt162b2 (COMIRNATY), dose 1 intramuscularly on 14Oct2021 (Batch/Lot Number: FJ5790; Expiration Date: 31Dec2021) as DOSE 1, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 14Oct2021, the patient experienced asterixis (medically significant), feeling cold (non-serious), dizzy (non-serious), numbness in hand (non-serious), heart rate decreased from 82 to 57 (non-serious), blood pressure decreased from 110/66 mmHg to 92/64 mmHg (non-serious), collapsed from the waiting chair (non-serious). The clinical course was reported as follows: It was unknown whether the patient was pregnant or not. It was unknown whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine or not. It was unknown prior to vaccination, whether the patient was diagnosed with COVID-19 or not. On 14Oct2021, the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number FJ5790, Expiration Date 31Dec2021) intramuscularly for COVID-19 immunization. On 14Oct2021 (after the vaccination), the patient experienced asterixis, feeling cold, dizzy, numbness in hand, heart rate decreased from 82 to 57 and blood pressure decreased from 110/66 mmHg to 92/64 mmHg. The course of the event was as follows: 15 minutes after the vaccination, the patient collapsed from the waiting chair and said she was experiencing dizzy. The heart rate of the patient was 82, and the blood pressure was 110/66 mmHg. The patient experienced feeling cold. The patient said she was experiencing numbness in hand. 38 minutes after the vaccination, the heart rate of the patient became 57, and the blood pressure became 92/64 mmHg. The patient said, it was almost good but there was numbness in her hands, and she wanted to take a little more rest. She returned home 55 minutes after the vaccination. The outcome of the events was recovering without treatment. It was unknown since the vaccination, whether the patient has been tested for COVID-19 or not. The patient underwent lab tests and procedures which included blood pressure (BP): 110/66 mmHg on 14Oct2021 (15 minutes after the vaccination), blood pressure (BP): 92/64 mmHg on 14Oct2021 (38 minutes after the vaccination), heart rate (P): 82 on 14Oct2021 (15 minutes after the vaccination), heart rate (P): 57 on 14Oct2021 (38 minutes after the vaccination). The clinical outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on possible dose- event relationship post-vaccination the causal role of BNT162B2 vaccine cannot be excluded for the reported events 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: 1830442 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-14
Submitted: 0000-00-00
Entered: 2021-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Body temperature, Body temperature increased, Disturbance in attention, Heart rate increased, Sleep disorder, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalopathy/delirium (broad), Hypertension (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: Body temperature; Result Unstructured Data: less than or equal to 37 Cel
CDC Split Type: LVJNJFOC20211057668

Write-up: BODY TEMPERATURE INCREASED; HEART RATE INCREASED; SLEEP DISTURBANCE; BLOOD PRESSURE INCREASED; SYNCOPE; ATTENTION CONCENTRATION DIFFICULTY; This spontaneous report received from a consumer via a Regulatory Authority (LV-SAM-2021106788) on 28-OCT-2021 and concerned a 34 year old male. The patient''s weight was 87 kilograms, and height was not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: ACA5778 expiry: unknown) 0.5 ml, 1 total, administered on 14-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-OCT-2021, the patient experienced body temperature increased, heart rate increased, sleep disturbance, blood pressure increased, syncope, and attention concentration difficulty. Laboratory data included: Body temperature (NR: not provided) less than or equal to 37 celcius. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body temperature increased, heart rate increased, sleep disturbance, blood pressure increased, and attention concentration difficulty, and syncope on 14-OCT-2021. This report was serious (Other Medically Important Condition).


VAERS ID: 1834591 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenopia, Chest discomfort, Chest pain, Dizziness, Dry eye, Dyspnoea, Feeling abnormal, Head discomfort, Headache, Musculoskeletal chest pain, Pain in extremity, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Corneal disorders (broad), Vestibular disorders (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20201015; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101400593

Write-up: Chest ache; Chest pressure; Breathlessness; Shortness of breath; Calf pain; Rib pain; Dry eye; Tired eyes; Faint; Headache; Fuzzy head; Light-headed; Head pressure; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-APPCOVID-20211017173910, Safety Report Unique Identifier GB-MHRA-ADR 26085572. A 24-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: unknown) via unspecified route of administration on 14Oct2021 (at the age of 24-year-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Patient Medical history included suspected covid-19 from 14Oct2020 to an unknown date Unsure when symptoms stopped. Concomitant medications were not reported. Patient was not pregnant. Patient was not breastfeeding. Patient is not enrolled in clinical trial. On 14Oct2021 the patient experienced headache, fuzzy head, light-headed and head pressure. On 15Oct2021 patient experienced chest ache, chest pressure, breathlessness, shortness of breath, calf pain, rib pain, dry eye, tired eyes and faint. Events were considered serious (medically significant). The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 15Oct2020 Yes - Positive COVID-19 test. Outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1834652 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-08
Onset:2021-10-14
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3461 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Brain scan normal, Cerebrovascular accident, Chills, Dysarthria, Fatigue, Headache, Hypoaesthesia, Illness, Pain, SARS-CoV-2 test, Transient ischaemic attack, Tremor
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chest cold
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:normal; Comments: blood tests were fine; Test Name: brain scan; Result Unstructured Data: Test Result:Unknown results; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101393044

Write-up: stroke; shivering; headache; shaking; felt very ill; Ached; Felt very tired; my right side face went numb; speech started slurring; Ministroke; This is a spontaneous report from a contactable consumer or other non hcp received from a Regulatory Authority). The regulatory authority report number is GB-MHRA-WEBCOVID-202110161141141290-DEIT4. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: FG3461), dose 3 via an unspecified route of administration on 08Oct2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included chest cold from an unknown date and unknown if ongoing. Concomitant medication(s) included paracetamol (PARACETAMOL) taken for lower respiratory tract infection, start and stop date were not reported. Patient has not had symptoms associated with COVID-19. On an unspecified date patient experienced stroke, shivering, headache, shaking, felt very ill, ached, Felt very tired, my right side face went numb, speech started slurring and on 14Oct2021 experienced ministroke. Patient had a booster jab on Friday 8th. Friday night patient was shivering and shaking all night. On Saturday patient could not get off the sofa all day, felt very ill and surreal. My fingers felt like sausages and ached all over. Felt a bit better Sunday morning but by the evening had a thumping headache. Felt very tired Monday, Tuesday and Wednesday and had a thumping headache. Thursday morning about 9am my speech started slurring then my right side face went numb, I took an aspirin and phoned doctor who told me to go straight to a&e. Went to (name) Hospital. They blue lighted me to (name) where I was in resus for 4 hours but my speech came back during that time. The conclusion was a mini stroke but the hospital could find no reason for it. They kept asking if patient had taken any different medication during the past week but the only thing I had done differently was to have the booster jab and hadn''t felt well since. All my blood tests were fine, my heart lungs liver and kidneys fine. Blood sugar and cholesterol fine. Heart and blood flow monitor. Events were consider as hospitalization, medically significant. 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 blood test: normal on blood tests were fine, brain scan normal: unknown results on, sars-cov-2 test: negative on No - Negative COVID-19 test. On an unspecified date the outcome of event stroke, shivering, headache, shaking, speech started slurring were resolved, ministroke was resolving and rest all were unknown. No follow-up attempts are Needed. No further information is expected.


VAERS ID: 1834654 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Headache, Immunisation, Off label use, SARS-CoV-2 test, Vaccination site pain
SMQs:, Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101393184

Write-up: Pain joint; Tiredness; Headache; Vaccination site pain; Off label use; BOOSTER; This is a spontaneous report from a contactable consumer received from a Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110161310075710-RLJXI. Safety Report Unique Identifier GB-MHRA-ADR 26084842 A 37-year-old non pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection,Batch/Lot Number: FF8288), via an unspecified route of administration on 14Oct2021 (age at vaccination 37-year-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation.The patient medical history and concomitant medications were not reported. On 14Oct2021, the patient experienced headache, vaccination site pain, off label use, booster, On 15Oct2021, tiredness, On 16Oct2021, pain joint.The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on No - Negative COVID-19 test. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial.The outcome of event Headache was recovered on 16Oct2021, tiredness was recovering, pain joint, vaccination site pain were not recovered and other events were unknown. No Follow-up attempts are needed. No further information is expected.


VAERS ID: 1834689 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain lower, Bedridden, Body temperature, Chest pain, Fatigue, Headache, Lymphadenopathy, Pain, Periorbital swelling, Pyrexia, SARS-CoV-2 test, Swelling, Vaccination site pain, Vaccination site swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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: 20211016; Test Name: Temperature; Result Unstructured Data: Test Result:38 degrees; Comments: Fluctuating fever; Test Date: 20211017; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test, lateral flow tests negative
CDC Split Type: GBPFIZER INC202101400809

Write-up: Chest pain; Lower abdominal pain; Swollen glands; Fluctuating fever; Headache/ headache got worse/ worsening headache; Stayed in bed all day; Puffy eyelids; Slight body aching; Swelling; Fatigue; Large swelling and pain on vaccine injection site; Large swelling and pain on vaccine injection site; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110171038088660-QRX6I, Safety Report Unique Identifier GB-MHRA-ADR 26085341. A 13-year-old non-pregnant female patient received first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number was not reported), via an unspecified route of administration on 14Oct2021 (at the age of 13-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not pregnant and was not currently breastfeeding at the time of vaccination. The patient experienced large swelling and pain on vaccine injection site on 14Oct2021 also experienced swelling, fatigue, slight body aching on 15Oct2021, swollen glands, fluctuating fever, headache/ headache got worse/ worsening headache, stayed in bed all day, puffy eyelids on 16Oct2021 and experienced chest pain, lower abdominal pain on 17Oct2021. The events were assessed as serious- medically significant. The clinical course was reported as: Received vaccine on 14Oct2021 and had large swelling and pain on vaccine injection site. Started with fatigue on Friday and slight body aching. Saturday 16Oct2021 stayed in bed all day with headache, swollen glands and puffy eyelids. Headache got worse in the evening so had one dose of ibuprofen. Woke up very early Sunday morning 17Oct2021 with very painful lower abdomen and left sided chest pain and worsening headache. Dose of ibuprofen given again and plenty of fluids. Also had temperature of 38 degrees and lateral flow tests negative. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Therapeutic measures were taken as a result of headache/ headache got worse/ worsening headache with ibuprofen. Patient would call advice number if gets worse. The patient underwent lab tests and procedures which included body temperature: 38 degrees on 16Oct2021 Fluctuating fever , sars-cov-2 test: negative on 17Oct2021 No - Negative COVID-19 test, lateral flow tests negative. The outcome of the events swollen glands was resolving, events swelling, fluctuating fever, headache/ headache got worse/ worsening headache, chest pain, lower abdominal pain, fatigue was not resolved, whereas rest other events were unknown at the time of this report. No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1834695 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Erythema, Fatigue, Interchange of vaccine products, Lymphadenopathy, Myalgia, Nausea, Off label use, Pyrexia, Swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: Temperature; Result Unstructured Data: Test Result:High
CDC Split Type: GBPFIZER INC202101400781

Write-up: Redness; Swollen glands; Swelling; High temperature; Muscle ache; Fatigue; Nausea; Off label use; Interchange of vaccine products; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110171117074870-UUT8K, Safety Report Unique Identifier GB-MHRA-ADR 26085363. A patient of an unspecified age and gender received bnt162b2 (COMIRNATY, solution for injection), via an unspecified route of administration on 14Oct2021 (Lot number: not reported) as dose 3 (booster), single for COVID-19 immunization. Medical history included clinical trial participant. Concomitant medications were not reported. The patient previously received INFANRIX IPV HIB via an unspecified route of administration on an unspecified date for immunization, received both first dose and second dose of COVID-19 VACCINE NOVAVAX via an unspecified route of administration on an unspecified date in Nov2020 for COVID-19 Immunization and experienced reaction was so much milder (Novavax reaction was so much milder no idea why it hasn''t been approved yet). Patient had no symptoms associated with COVID-19. Not had a COVID-19 test. The patient experienced high temperature, muscle ache, fatigue, nausea on 15Oct2021, experienced swelling, swollen glands on 16Oct2021 and experienced redness on 17Oct2021. The events high temperature, muscle ache, fatigue, nausea, swelling, swollen glands and redness were assessed as serious- medically significant. The clinical course was reported as: Patient had 2 Novavax vaccines in November last year, this was patient''s first Pfizer. Novavax reaction was so much milder no idea why it hadn''t been approved yet. Now had to have a Pfizer due to unapproved of patient''s vaccine and felt awful. The system did not let patient put Novavax in for previous vaccines. Patient had not tested positive for COVID-19 since having the vaccine. Clinical trial participant. Study details: NOVAVAX. The patient underwent lab tests and procedures which included temperature: high on 15Oct2021. The outcome of the events swelling, redness was not resolved, events high temperature, fatigue, swollen glands was resolving and events muscle ache, nausea resolved on unspecified date in Oct2021 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: 1834703 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster, Immunisation, Off label use
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101400488

Write-up: Shingles; Off label use; Booster; This is a spontaneous report from a contactable healthcare professional received from the regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202110171200585150-FOAVH, and Safety Report Unique Identifier is GB-MHRA-ADR 26085385. A 29-year-old female patient received BNT162B2 (Comirnaty, Batch/Lot number and expiry date were not reported), via an unspecified route of administration on 14Oct2021 as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient experienced shingles on 16Oct2021 with outcome of not recovered; off label use and booster on 14Oct2021 with outcome of unknown. The event shingles was reported as serious, medically significant by the health authority, while the other events were non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1834716 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Erythema, Lymphadenopathy, Oedema, Pruritus, Rash, Swelling, Vaccination site erythema, Vaccination site pain
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Allergy to animals; Pollen allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101400979

Write-up: larger red area next day; Rash; enlarged lymph nodes in the neck; Lymphadenopathy; Swelling; Oedema; Itching; Redness; Pain at injection site; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110171426086480-T40UE. Safety Report Unique Identifier GB-MHRA-ADR 26085480. A 49-year-old non-pregnant female patient received a dose of BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 14Oct2021 (Age at vaccination 49-years-old) as dose 3 (booster), single for COVID-19 immunization. Medical history included hypersensitivity, seasonal allergy, and allergy to the animal. The patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. The patient was not pregnant at the time of vaccination. The patient was not currently breastfeeding. The patient has not tested positive for COVID-19 since had the vaccine. The patient has enrolled in a clinical trial was unsure. Study details include Novavax vaccination. The patient concomitant medications were not reported. On an unspecified date, the patient experienced the larger red area the next day, rash, enlarged lymph nodes in the neck, on 14Oct2021, she had redness, pain at the injection site on 15Oct2021, she had swelling, oedema, itching and on 16Oct2021 she had lymphadenopathy. The clinical course included she received anti-histamines for allergies to dust or grass or pollen and animals. The pain at the injection site on the day of injection. A larger red area the next day progressed to swelling over the shoulder and down to the elbow. Rash or redness developed around 36 hours, local heat and swelling, itchiness, and enlarged lymph nodes in the neck. The outcome of the events pain at the injection site, rash, and enlarged lymph nodes in the neck was unknown, swelling, redness, oedema, itching, lymphadenopathy was not resolved and the larger red area the next day was resolving. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1834723 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pain in extremity, Peripheral swelling, SARS-CoV-2 test, Vaccination site erythema
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: Medical History/Concurrent Conditions: COVID-19 (sars-cov-2 test positive on 03Dec2020 (Yes-Positive COVID-19 test).)
Allergies:
Diagnostic Lab Data: Test Date: 20201203; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101400536

Write-up: swelling under arm pit; painful arm; Swelling arm; This is a spontaneous report from a contactable consumer received from The regulatory authority report number is GB-MHRA-WEBCOVID-202110171723128040-KUGQK, Safety Report Unique Identifier GB-MHRA-ADR 26085560. A 13-year-old male patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot Number: FF8288), dose 1 via an unspecified route of administration on 13Oct2021 as dose 1, single for Covid-19 immunisation. Medical history included covid-19 from on 03Dec2020 to unknown date. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 03Dec2020 (Yes-Positive COVID-19 test). The patient experienced swelling under arm pit and painful arm on an unspecified date, swelling arm on 14Oct2021. Swelling under arm pit, painful arm, side of injection. Took paracetamol. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Therapeutic measures were taken as a result of swelling under arm pit, swelling arm, painful arm. Events seriousness was reported as medically significant. The outcome of the events swelling under arm pit and painful arm was unknown, swelling arm was resolving. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1834744 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Dizziness, Headache, Hypoaesthesia, Myalgia, Pain in extremity, Paraesthesia, SARS-CoV-2 test, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? 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 Date: 20210607; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101400508

Write-up: Had pain from the site of injection; tingling; Generalised muscle aches; Pain in arm; Giddiness; Numbness in hand; Numbness in face; Pain in joint involving shoulder region; Headache; This is a spontaneous report from a contactable consumer. received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110172336287040-LMIBH. Sender''s (Case) Safety Report Unique Identifier-GB-MHRA-ADR 26085796. A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 3 via an unspecified route of administration on 14Oct2021 (at the age of 54-years-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included suspected covid-19 from an unknown date and unknown if ongoing (Unsure when symptoms started Unsure when symptoms stopped). Patient was not pregnant; Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 07Jun2021 (No - Negative COVID-19 test). The patient experienced headache on 14Oct2021, generalised muscle aches, pain in arm, giddiness, numbness in hand, numbness in face and pain in joint involving shoulder region on 15Oct2021, had pain from the site of injection and tingling on an unspecified date. Had pain from the site of injection up through shoulder into neck and lower jaw was numb and tingling. The events seriousness reported as medically significant. Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. The outcome of the events headache was resolved with sequelae, generalised muscle aches, giddiness, numbness in face was resolved on 17Oct2021, pain in arm, numbness in hand, pain in joint involving shoulder region was resolving, had pain from the site of injection and tingling was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1834751 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster, Intraocular pressure test, Ophthalmological examination
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Partial sight; Retinitis pigmentosa; Shingles
Allergies:
Diagnostic Lab Data: Test Name: Occular pressure; Result Unstructured Data: Test Result:Unknown results; Test Name: eye tests; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC202101400567

Write-up: shingles on left hand side of face from scalp to the eye lid; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110180623489420-DI8BL, Safety Report Unique Identifier GB-MHRA-ADR 26085855. The 81-year-old female patient received dose 3a of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) (Lot number was not reported and Expiration date was unknown) via an unspecified route of administration on 14Oct2021 (at the age of 81-year-old) as dose 3a (booster), single for COVID-19 immunisation. The medical history included herpes zoster, retinitis pigmentosa and visual impairment. The patient concomitant medications were not reported. Patient did not have symptoms associated with COVID-19 and was not tested for COVID-19. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 14Oct2021 the patient experienced shingles. It was reported that shingles on left hand side of face from scalp to the eye lid. Patient was prescribed antiviral and eye drops. The event seriousness was reported as medically significant. The patient underwent lab tests and procedures which included intraocular pressure test: unknown results, ophthalmological examination: unknown results, full suite of eye tests. Therapeutic measures were taken as a result of shingles. The outcome of the event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1834755 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Interchange of vaccine products, Myalgia, Nausea, Off label use, Retching, SARS-CoV-2 test, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (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: HUMIRA; INFLUENZA VIRUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Crohns disease aggravated; Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis)); Ulcerative colitis
Allergies:
Diagnostic Lab Data: Test Date: 20210706; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101400665

Write-up: Nausea; Vomiting; Stomach ache; Muscle ache; Off label use; Interchange of vaccine products; dry heaving; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110180806439390-5JH4H, Safety Report Unique Identifier GB-MHRA-ADR 26085876. A 36-year-old non-pregnant female patient received the third dose of BNT162B2 (COMIRNATY, solution for injection, Lot number was not known), via an unspecified route of administration, on 14Oct2021 (at the age of 36-year-old), as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Medical history included inflammatory bowel disease (taking medicines for inflammatory bowel disease) crohn''s disease, ulcerative colitis and covid-19 from 06Jul2021. Patient has not had symptoms associated with COVID-19. Patient was not pregnant at the time of vaccination. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not currently breastfeeding. Concomitant medications included adalimumab (HUMIRA) taken for crohn''s disease and influenza vaccine (INFLUENZA VIRUS) taken for immunization from 01Oct2021. The historical vaccine included the first dose of COVID-19 VACCINE ASTRAZENECA (solution for injection, batch/lot number was not reported) via an unspecified route of administration, on 27Jan2021, as dose 1, single and second dose of COVID-19 VACCINE ASTRAZENECA (solution for injection, batch/lot number was not reported) via an unspecified route of administration, on 15Apr2021, as dose 2, single, both doses for COVID-19 immunization. The patient experienced dry heaving on an unspecified date in 2021, nausea, vomiting, stomach ache, muscle ache on 15Oct2021 (1 day after the third dose), off label use and interchange of vaccine products on 14Oct2021. Clinical information included unable to keep food down, so nauseous patient can''t get out of bed, dry heaving all night as nothing left to vomit. Can even keep water down. The seriousness criteria of the events dry heaving, nausea, vomiting, stomach ache and muscle ache were reported as disability. The patient underwent lab tests and procedures which included COVID-19 virus test was positive (yes - positive covid-19 test) on 06Jul2021. Outcome of the event dry heaving was unknown, event nausea, vomiting, stomach ache was not recovered and event muscle ache was recovering. Patient was not enrolled in clinical trial. No Follow-up attempts are needed. No further information is expected.


VAERS ID: 1834795 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Antibody test, Blood fibrinogen, Computerised tomogram thorax, Confusional state, Fibrin D dimer, Fracture, Hypoxia, Platelet count, Prothrombin time, Pulmonary embolism, Pyrexia, SARS-CoV-2 test
SMQs:, Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Eosinophilic pneumonia (broad), Osteoporosis/osteopenia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (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:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Dementia; Fracture; Gastritis; Hypertension; Mobility decreased; Non-smoker
Allergies:
Diagnostic Lab Data: Test Name: aPTT; Result Unstructured Data: Test Result:23.8; Test Name: anti-PF4 antibodies; Result Unstructured Data: Test Result:Unknown results; Test Name: Fibrinogen; Result Unstructured Data: Test Result:5.2; Test Date: 20211015; Test Name: CTPA scan; Result Unstructured Data: Test Result:acute bilateral PEs; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:D-dimer was not $g4000; Test Name: platelet count; Result Unstructured Data: Test Result:233; Comments: lowest platelet count after vaccine; Test Name: platelet count; Result Unstructured Data: Test Result:195; Comments: last platelet count before vaccine; Test Date: 20211013; Test Name: platelet count; Result Unstructured Data: Test Result:No; Test Name: PT; Result Unstructured Data: Test Result:10.5; Test Date: 20211014; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101400664

Write-up: Pulmonary embolus; fractured ankle and fibula; fever; hypoxia; confusion; This is a spontaneous report from a contactable physician receive by regulatory authority report number is GB-MHRA-WEBCOVID-202110181330466380-2K0NI, Safety Report Unique Identifier is GB-MHRA-ADR 26086459. An 83-years-old female patient received bnt162b2 (COMIRNATY, Solution for Injection), via an unspecified route of administration on 13Oct2021 (Batch/Lot number: not reported) as dose 3 (booster), single for COVID-19 immunisation. Medical history included gastritis, fracture, Alzheimer''s dementia, non-tobacco user, dementia, hypertension (HTN), and reduced mobility. The patient did not have history of, or current, malignancy and intracranial malignancy. The patient did not have concurrent or recent intracranial infections. Patient had no symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Concomitant medications were not reported. On an unspecified date in 2021, the patient experienced fractured ankle and fibula, fever, hypoxia, and confusion. On 14Oct2021, pulmonary embolus. The patient underwent lab tests and procedures which included activated partial thromboplastin time (aPTTT): 23.8 on an unknown date, anti-PF4 antibodies: unknown results on an unknown date, fibrinogen: 5.2 on an unknown date, computerised tomogram thorax (CTPA scan): acute bilateral PEs on 15Oct2021, fibrin D dimer: D-dimer was not more than 4000 on an unknown date, platelet count: 233 on an unknown date (lowest platelet count after vaccine), was 195 on an unknown date (last platelet count before vaccine), and no platelet count on 13Oct2021, prothrombin time (PT): 10.5 on an unknown date, and SARS-COV-2 test: negative on 14Oct2021. It was reported that patient was admitted to hospital with hypoxia, acute confusion and fever following COVID vaccine booster prior day. During admission found to have fractured ankle and fibula. New oxygen requirement in hospital. CTPA found acute bilateral PEs most likely secondary to fractures however could be due to COVID vaccine as had previous day and symptoms started. Report did not relate to possible myocarditis or pericarditis. The patient was not reviewed by a haematologist. Haemorrhage was not identified. The patient had no recent surgical or medical interventions to the central nervous system (including lumbar puncture. The patient had no recent trauma/head injury. Outcome was resolving for pulmonary embolus and was not resolved for all other events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1834803 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Dyspepsia, Fatigue, Headache, Illness, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Behcet''s syndrome; Blood pressure high; Diverticulitis; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Irritable bowel syndrome
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101400684

Write-up: Tiredness; Diarrhea; Heartburn; Headache; Sickness; Feverish; This is a spontaneous report from a contactable consumer. This is a report received from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110181435113220-ZMDDN. Safety Report Unique Identifier GB-MHRA-ADR 26086594. A 61-year-old female patient received third/ booster dose of BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 13Oct2021 at 09:00 (Lot Number: FF8222, Expiration date: Not reported) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Medical history included diverticulitis, immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef), behcet''s syndrome, high blood pressure, IBS (Irritable Bowel Syndrome): All from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. The patient experienced tiredness, diarrhea, heartburn, headache, sickness and feverish on 14Oct2021 at 01:00. The events were assessed as serious- medically significant. The clinical course was reported as: Feverish, headache, sickness, diarrhoea, heartburn and tiredness, had injection at 09:00 on 13Oct2021 and symptoms started at 01:00 on 14Oct2021 until 15Oct2021 after a night''s sleep. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: negative (No - Negative COVID-19 test) on an unspecified date. The outcome of the events was resolved on 15Oct2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1834810 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6431 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Axillary pain, Immunisation, Lymphadenopathy, Off label use, Pruritus, Rash, Rash macular, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101401005

Write-up: Off label use; Booster; itchy; Enlarged lymph nodes (excl infective); Armpit pain; Rash trunk; Blotchy rash; Shoulder pain; This is a spontaneous report from a contactable consumer or other non hcp received from a Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110181612526530-VAGLZ. Safety Report Unique Identification Number: GB-MHRA-ADR 26086736. A 35-years-old non-pregnant female patient received third dose bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FG6431) via an unspecified route of administration on 14Oct2021 as DOSE 3 (BOOSTER), SINGLE (age at vaccination: 35-years) for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included suspected covid-19 from 02Dec2020 to 16Dec2020. The patients concomitant medications were not reported. The patient experienced, shoulder pain on 14Oct2021, blotchy rash, rash trunk on 15Oct2021, enlarged lymph nodes (excl infective), armpit pain on 16Oct2021, off label use, booster, itchy, on an unspecified date. Events were serious and medically significant. Patient is not pregnant. Patient is not currently breastfeeding. The patient last menstrual period date was 09Oct2021. Patient has 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 sars-cov-2 test: no - negative covid-19 test on unspecified date. The outcome of the events itchy was not recovered, the outcome of the events blotchy rash, enlarged lymph nodes (excl infective), armpit pain, shoulder pain, rash trunk was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1834822 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0112 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Dyspnoea, Nervousness, Palpitations, Presyncope, SARS-CoV-2 test, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (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: 20211015; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101400663

Write-up: Heart racing; Tachycardia; Dizzy spells; Breath shortness; Near fainting; Shaky feelings; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110181858118080-FMYJ5, Safety Report Unique Identifier GB-MHRA-ADR 26087610. This case is for COMIRNATY booster dose. A 35-year-old non-pregnant female patient received third/ booster dose of bnt162b2 (COMIRNATY, solution for injection), via an unspecified route of administration on 13Oct2021 (Lot Number: FK0112, Expiration date: Not reported) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history was none (fit and well). Patient has not had symptoms associated with COVID-19. Patient was not pregnant and was not currently breastfeeding at the time of vaccination. Patient last menstrual period date was 28Sep2021. Concomitant medication included received single dose of influenza vaccine (INFLUENZA VIRUS) via an unspecified route of administration on 13Oct2021 for immunization. Historical vaccine included previously received first dose of bnt162b2 (COMIRNATY, solution for injection), via an unspecified route of administration on 15Jan2021 (Lot Number: unknown, Expiration date: Not reported) as DOSE 1, SINGLE and received second dose of bnt162b2 (COMIRNATY, solution for injection), via an unspecified route of administration on 15Mar2021 (Lot Number: unknown, Expiration date: Not reported) as DOSE 2, SINGLE for COVID-19 immunization. The patient experienced heart racing, tachycardia, dizzy spells, breath shortness, near fainting, shaky feelings on 14Oct2021. The events were assessed as serious- medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: negative (No - Negative COVID-19 test) on 15Oct2021. Patient had not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. The outcome of the event shaky feelings resolved on an unspecified date in Oct2021, events dizzy spells, breath shortness was not resolved, whereas rest other events were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101483881 Same patient and product, different event/dose.


VAERS ID: 1835846 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Influenza like illness, Syncope, Vaccination site reaction
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (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: DEMODERNATX, INC.MOD20213

Write-up: Reaction at the injection site; Feeling of dizziness; She collapsed tonight and we went to the hospital by ambulance...; Fever, chills, malaise, headache; This case was received via regulatory authority (Reference number: DE-PEI-202100208366) on 25-Oct-2021 and was forwarded to Moderna on 25-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (She collapsed tonight and we went to the hospital by ambulance...), INFLUENZA LIKE ILLNESS (Fever, chills, malaise, headache), VACCINATION SITE REACTION (Reaction at the injection site) and DIZZINESS (Feeling of dizziness) in a 14-year-old female patient who received mRNA-1273 (Spikevax) for Prophylactic vaccination. No Medical History information was reported. On 13-Oct-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced SYNCOPE (She collapsed tonight and we went to the hospital by ambulance...) (seriousness criteria hospitalization and medically significant), INFLUENZA LIKE ILLNESS (Fever, chills, malaise, headache) (seriousness criterion hospitalization) and DIZZINESS (Feeling of dizziness) (seriousness criterion hospitalization). On an unknown date, the patient experienced VACCINATION SITE REACTION (Reaction at the injection site) (seriousness criterion hospitalization). At the time of the report, SYNCOPE (She collapsed tonight and we went to the hospital by ambulance..) was resolving, INFLUENZA LIKE ILLNESS (Fever, chills, malaise, headache) and VACCINATION SITE REACTION (Reaction at the injection site) had not resolved and DIZZINESS (Feeling of dizziness) outcome was unknown. No Concomitant medication was reported. The patient has allergies included Hay fever, cats Insulin resistance is reported as risk factors or previous diseases. The patient even before falling asleep slight dizziness, nausea at night, fever, went to toilet, then collapsed in bathroom. No treatment medications were reported. Company Comment: This case concerns a 14-year-old female patient with no relevant medical history reported, who experienced the serious unexpected events of Syncope, Influenza like illness, Vaccination site reaction and Dizziness. The events occurred 1 day after the second dose of COVID-19 Vaccine Moderna (mRNA-1273). The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Translation received on 27-OCT-2021 included updated medical history and updated narrative; Reporter''s Comments: Do you or the person concerned have any allergies? If yes, which? Hay fever, cats Information on risk factors or previous diseases Insulin resistance / Even before falling asleep slight dizziness, nausea at night, fever, went to toilet, then collapsed in bathroom; Sender''s Comments: This case concerns a 14-year-old female patient with no relevant medical history reported, who experienced the serious unexpected events of Syncope, Influenza like illness, Vaccination site reaction and Dizziness. The events occurred 1 day after the second dose of COVID-19 Vaccine Moderna (mRNA-1273). The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.


VAERS ID: 1837253 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-14
Submitted: 0000-00-00
Entered: 2021-11-02
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 INC202101402994

Write-up: Bell''s palsy; This is a spontaneous report from a contactable other health professional via the Agency Regulatory Authority. Regulatory authority report number is 643762. A 41-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced Bell''s palsy on 14Oct2021. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1837336 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Fatigue, Limb discomfort, Swelling face, Vision blurred
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101408694

Write-up: pain in my chest from the side of the heart; general fatigue; swelling in the face; heaviness in the left hand; lose focus; This is a spontaneous report received from a contactable Consumer (patient). This 36-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Lot number unknown) at left arm at single dose for COVID-19 immunisation on 13Oct2021 at 11:45 (36-year-old at the time of vaccination). Relevant history and concomitant drugs were unknown. The patient previously received the first dose of BNT162B2 (COMIRNATY) at single dose for COVID-19 immunisation on 17Sep2021. In the second day after taking the vaccine at 07:00, the patient woke up to a pain in his chest from the side of the heart, and he felt general fatigue, swelling in the face and heaviness in the left hand and started to lose focus on 14Oct2021. No treatment therapy was not received. No hospitalization involved. The outcome of event was resolving. The event pain in his chest reported as serious (medically important). The events resulted in Emergency room/department or urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The lot number for [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1838039 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Steroid therapy (I am being treated with high dose systemic steroids); Comments: .
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101401171

Write-up: Back pain; Red rash; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-APPCOVID-20211017130507, Safety Report Unique Identifier GB-MHRA-ADR 26085433. A 31-year-old non-pregnant female patient received BNT162B2 (COMIRNATY, solution for injection, batch/lot number: unknown), via an unspecified route of administration on 14Oct2021 (at the age of 31-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included steroid therapy (patient was being treated with high dose systemic steroids) from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant. Patient was not breastfeeding. Patient was not enrolled in clinical trial. Concomitant medications were not reported. On 14Oct2021, same day of vaccination, the patient experienced back pain and red rash. Events were considered serious (medically significant). The outcome of the event red rash was recovered on 15Oct2021, and back pain was recovered on 17Oct2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1838105 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Interchange of vaccine products, Neck pain, Off label use, SARS-CoV-2 test
SMQs:, Arthritis (broad), Medication errors (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: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Liver disorder; Portal hypertension; Spleen enlarged; Varices oesophageal
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101400867

Write-up: Neck pain; previous vaccines were Astra Zeneca 1 dose and Astra Zeneca 2nd dose. Yesterday was a Third dose but it was Pfizer; previous vaccines were Astra Zeneca 1 dose and Astra Zeneca 2nd dose. Yesterday was a Third dose but it was Pfizer; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110151551038800-YROPE. Safety Report Unique Identifier GB-MHRA-ADR 26086220. A female patient of an unspecified age received BNT162B2 (COMIRNATY), via an unspecified route of administration, administered in Arm Left on 14Oct2021 (Lot Number: FF8222) as third booster dose, single for COVID-19 immunization. Medical history included portal hypertension, varices oesophageal, immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef), fibropolycystic liver disease, enlarge spleen. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient previously took COVID-19 VACCINE ASTRAZENECA on unspecified date as first dose and on unspecified date as second dose for covid-19 immunization. The patient experienced neck pain on 14Oct2021 with outcome of recovering. "I had the injection in my left arm, but later the pain travelled up into my neck on the left side, like a sort of burning pain, neck ache. This was I was told a third jab as I have a low immune system, I am due to have a booster in 6 months. My previous vaccines were Astra Zeneca 1 dose and Astra Zeneca 2nd dose. Yesterday was a Third dose but it was Pfizer." Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included covid-19 virus test: No - Negative COVID-19 test on unspecified date. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1838113 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH F66431 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Body temperature, Eye pain, Headache, Immunisation, Off label use, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: Body temperature; Result Unstructured Data: Test Result:High; Comments: High temperature
CDC Split Type: GBPFIZER INC202101401128

Write-up: Eye pain; Headache; High temperature; Booster; Off-label use; Stomach ache; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110162036537850-BBXI0, Safety Report Unique Identifier GB-MHRA-ADR 26085135. The 43-year-old (non-pregnant) female patient received DOSE 3a of bnt162b2 (COMIRNATY, solution for injection) (Lot Number: F66431) via an unspecified route of administration on 14Oct2021 (at the age of 43-years-old) as DOSE 3a (BOOSTER), SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previous took BNT162b2 as dose 1 single and dose 2 single on an unspecified date for COVID-19 immunization. Patient did not have symptoms associated with COVID-19 and was not tested for COVID-19. Patient was not currently breastfeeding. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 14Oct2021, the patient experienced stomach-ache, on 15Oct2021 headache and high temperature, on 16Oct2021 eye pain. The event seriousness was reported as medically significant. The patient underwent lab tests and procedures which included body temperature: high on an unspecified date. The outcome of the event stomach-ache, headache, high temperature was recovering, eye pain was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1838122 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Breast mass, Breast pain, Chills, Malaise, Mastitis, Off label use, Product use issue, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Lipodystrophy (broad), Functional lactation disorders (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
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; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101401076

Write-up: fever; chills; general malaise; Breast lump; painful breast; Acute mastitis; Off label use; Drug use in unapproved population; This is a spontaneous report from a contactable consumer. The first report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110170744270860-T8MLK, Safety Report Unique Identifier GB-MHRA-ADR 26085243. This is the first of two reports. This is the maternal case. A 32-years-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 14Oct2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Medical history included ongoing breast feeding, suspected COVID-19 (Unsure when symptoms started, Unsure when symptoms stopped) from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 14Jan2021 and second dose on 03Apr2021, both for COVID-19 immunisation; and influenza vaccine (INFLUENZA VIRUS) taken for immunisation on 05Oct2021. The patient experienced off label use and drug use in unapproved population on 14Oct2021; acute mastitis on 15Oct2021; and fever, chills, general malaise, breast lump and painful breast on an unspecified date. The case was assessed as serious (medically significant). The patient underwent lab tests and procedures which included COVID-19 virus test: no-negative COVID-19 test on an unspecified date. The outcome of the event ''acute mastitis'' was not recovered and outcome of the other events was unknown. The clinical course was reported as follows: Chills the evening of the vaccine 24 hours later a painful breast lump noted, general malaise 24 hours after this developed fever. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101410363 Baby case


VAERS ID: 1838134 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Chills, Erythema, Feeling hot, Insomnia, Lymphadenopathy, Malaise, Nausea, Pain, Pain in extremity, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: HRT
Allergies:
Diagnostic Lab Data: Test Date: 20211013; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101400850

Write-up: nauseous; restricted arm/her arm was very painful/She felt like she''s been punched in the arm; my arm was very painful, red and hot; her arm was hot; pain reached right into her armpit; pain reached right into her armpit which continues to be very sore and she thinks is swollen; Swollen lymph nodes; Nausea; Feeling unwell; Pain; Chills; Insomnia; This is a spontaneous report from a contactable consumer (patient). This is a report received from the regulatory authority report number [GB-MHRA-WEBCOVID-202110171010100740-2IMUE], Safety Report Unique Identifier [GB-MHRA-ADR 26085322]. This is the first of two reports; the report for the third dose of Comirnaty. A 52-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 14Oct2021 (Batch/Lot Number: FF8288), at the age of 52-year-old, as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history included hormone replacement therapy (HRT) from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162B2 on 22Jan2021 for COVID-19 immunisation and second dose of BNT162B2 on 03Apr2021 for COVID-19 immunisation. The patient''s concomitant medications were not reported. The patient experienced nauseous, restricted arm/her arm was very painful/She felt like she''s been punched in the arm, her arm was very painful, red and hot, ''her arm was hot'', ''pain reached right into her armpit'', ''pain reached right into her armpit which continues to be very sore and she thinks is swollen'' on an unspecified date; swollen lymph nodes on 17Oct2021; insomnia on 14Oct2021; feeling unwell, pain and chills on 15Oct2021; and nausea on 16Oct2021. The events were assessed as serious (medically significant). The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 13Oct2021. The outcome of the events ''swollen lymph nodes'', ''insomnia'' and ''pain'' was not recovered; events ''feeling unwell'', ''chills'' was recovering; event ''nausea'' was recovered on an unspecified date; and outcome of the other events was unknown. The clinical course was reported as follows: HRT. Unsure if patient has had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. No treatment. Patient felt unwell the day after and her arm was very painful, red and hot. She felt like she''s been punched in the arm. She had restricted arm movement. Yesterday the pain reached right into her armpit which continues to be very sore and she thinks is swollen. Yesterday she felt very unwell and nauseous. She has had insomnia since the injection. She sleep well for a few hours. Then she''s wide awake. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101417578 same patient, different dose /different event.


VAERS ID: 1838152 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 3 - / -
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Eye contusion, Immunisation, Loss of consciousness, Off label use, Pain in extremity
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101400954

Write-up: felt unsteady; bruising on eye; Passed out; sore arm and leg; 3rd dose is administered and the patient previously received the full primary immunization series of BNT162b2; 3rd dose is administered and the patient previously received the full primary immunization series of BNT162b2; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Authority (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202110171938490780-QZTZX, Safety Report Unique Identifier GB-MHRA-ADR 26085653. A female patient of an unspecified age received BNT162B2 (COMIRNATY, Lot Number: Ff8222), via an unspecified route of administration on 14Oct2021 as dose 3 (booster), single for COVID-19 immunisation and influenza vaccine (manufacturer unknown), route of administration, start and stop date, batch/lot number and dose were not reported for immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and did not had a COVID-19 test. The patient previously took the dose 1 and dose 2 of bnt162b2 on an unspecified date for COVID-19 immunisation. On 14Oct2021, the patient had sore arm and leg after receiving the flu and COVID booster vaccines. The following morning (15Oct2021), the patient felt unsteady and passed out on the floor. She was not sure for how long for but received bruising on her eye. She have never experienced this before. The events were medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the passed out was recovered on 15Oct2021 while of the remaining events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1838192 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Irritable bowel syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101417456

Write-up: dizzy; unwell; Dizziness; This is a spontaneous report from a contactable consumer (Patient). This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110190727282170-YAJHV, Safety Report Unique Identifier GB-MHRA-ADR 26090494. A 28-year-old non-pregnant female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FF8288) via an unspecified route of administration on 14Oct2021 (at the age of 28-years-old) as booster single dose for COVID-19 immunisation. The patient''s medical history included irritable bowel syndrome from an unknown date and unknown if ongoing, IBS. Patient had no symptoms associated with COVID-19, not had a COVID-19 test. Patient was not pregnant; patient was not currently breastfeeding. The patient''s concomitant medications were not reported. On 14Oct2021 in evening of receiving the vaccine (approx 11hrs), the patient was sitting down then dizziness came over her. On unspecified date had to go to bed due to feeling dizzy and unwell. Woke up next morning dizziness still there. No treatment received. Resolving now only occasionally dizziness, Patient had not tested positive for COVID-19 since having the vaccine, patient was not enrolled in clinical trial, The report does not relate to possible inflammation of the heart. The clinical outcome of event dizzy was not recovered, dizziness was recovering, and unwell outcome was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1838208 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Headache, Immunisation, Lethargy, Lymphadenopathy, Neck pain, Off label use, Pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (broad), 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: NAPROXEN; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Back pain; Depression
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101417533

Write-up: Headache; Joint pain; Swollen glands; Lethargy; very tender underarm (armpit) pain; inside elbow pain; neck pain; off label use; Booster; This is a spontaneous report from a contactable consumer. This is the first of two reports. The first report is a report received from the Regulatory Authority. The Regulatory authority report number GB-MHRA-WEBCOVID-202110191416580120-WENGA, Safety Report Unique Identifier GB-MHRA-ADR 26092617. A 48-year-old female patient received the third dose of BNT162B2 (COMIRNATY), (Lot number was not reported), via an unspecified route of administration on 14Oct2021 (at the age of 48 years), as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Medical history included back pain from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing. Concomitant medication(s) included NAPROXEN taken for back pain, start and stop date were not reported; SERTRALINE taken for depression, start and stop date were not reported. The patient previously received bnt162b2 (COMIRNATY), 26Feb2021 as dose 1 (Batch/Lot Number: ER1741) for covid-19 immunization. The patient previously received bnt162b2 (COMIRNATY), 21Apr2021 as dose 2 (Batch/Lot Number: ER1749) for covid-19 immunization. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. On 14Oct2021 patient experienced off label use, booster, on 15Oct2021 headache, joint pain, swollen glands, lethargy, very tender underarm pain, inside elbow pain, neck pain. The patient underwent lab tests and procedures which included sars-cov-2 test Negative COVID-19 test. It was reported that Patient had very bad headache on waking up the next morning, along with very tender underarm (armpit) pain, neck pain, and inside elbow pain. Patient was also very tired. 5 days on the joint pain is nearly gone but the lethargy hasn''t. The outcome of headache was recovered on 16Oct2021, joint pain, swollen glands, lethargy was recovering, very tender underarm pain, inside elbow pain, neck pain, off label use, and booster was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained. Sender''s Comments: Linked Report(s): GB-PFIZER INC-202101427457 same patient, different dose and events.


VAERS ID: 1838213 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Lethargy, Malaise, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), 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: 20211019; Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101417520

Write-up: Diarrhea; feeling sick for a couple of days; lethargy; stomach ache; fatigue; Nausea; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110191534550490-MEU33. Safety Report Unique Identifier GB-MHRA-ADR 26092993. A 72-year-old (age at vaccination) male patient received BNT162B2 (COMIRNATY, solution for injection), (Batch/Lot number was not reported) dose 3 via an unspecified route of administration on 13Oct2021 as dose 3 (booster), 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. The patient experienced on 14Oct2021, feeling sick for a couple of days, lethargy, stomach ache, fatigue, nausea, and diarrhea on 15Oct2021. The patient underwent lab tests and procedures which included COVID-19 virus test negative on 19Oct2021. Therapeutic measures were taken as a result of stomach ache and diarrhea and treatment included with took Pepto bismal until monday 18Oct2021 and didn''t eat at all yesterday. Patient stated that Feeling sick for a couple of days, then stomach ache, and diarrhoea. Only drank water and stayed in bed with fatigue/lethargy. Today he feel a bit better and he thought it was resolving. The symptoms started the day after booster jab. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient''s report did not relate to possible inflammation of the heart (myocarditis or pericarditis). The outcome of events was recovering. No follow-up attempts are possible, information about lot/batch number cannot be obtained.


VAERS ID: 1838268 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-06
Onset:2021-10-14
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Disorientation, Dizziness, Headache, Hypoaesthesia, Ischaemic stroke, Magnetic resonance imaging, Pruritus, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: MRI; Result Unstructured Data: Test Result:Results Unknown; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101428986

Write-up: Disorientated; dizzy; numbness on my head on the left side; headache; itching scalp on the left also; Ischemic stroke; This is a spontaneous report from a contactable consumer (patient) or other non hcp received from the regulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110220946356720-ZQHMH, Safety Report Unique Identifier number is (GB-MHRA-ADR 26108216). A 52-year-old non-pregnant female patient received BNT162B2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 06Oct2021 (Batch/Lot number was not known) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Up until now, patient had enjoyed good health. Patient did not take any regular medication. Patient has not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. The patient experienced dizzy, headache on an unspecified date, ischemic stroke on 14Oct2021. It was reported that mini-stroke began with an intense headache and numbness on my head on the left side as well as an itching scalp on the left also. Patient was a little dizzy and disorientated. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (no - negative COVID-19 test), magnetic resonance imaging: results unknown on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The clinical outcome of dizzy, headache was not recovered. The clinical outcome of ischemic stroke was recovering. The clinical outcome of numbness on my head on the left side, itching scalp on the left also, disorientated was unknown. Reaction: Does your report relate to possible inflammation of the heart (myocarditis or pericarditis). If yes, we will ask you some additional questions at the end of this report: "No". Suspect Reactions: Please provide details of any relevant investigations or tests conducted: "Had some neurological tests as well as an MRI scan". No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1838297 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Dysgeusia, Fatigue, Hot flush, Interchange of vaccine products, Off label use, Pain in extremity, Upper-airway cough syndrome
SMQs:, Taste and smell disorders (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BENDROFLUAZIDE; RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101428916

Write-up: Taste metallic; Chronic post nasal drip; Tiredness; Off label use; Interchange of vaccine products; Painful arm; Chills; Hot flush; Joint ache; This is a solilcited report from the RA program from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-YCVM-202110061843516370-VKDST, Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 26111270. A 61-year-old female patient received third dose of BNT162B2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 14Oct2021 (at the age of 61 years old) (Lot number was not reported) as dose 3 (booster), single for COVID-19 vaccination. Medical history included steroid therapy from an unknown date and unknown if ongoing Taking regular steroid treatment (e.g. orally or rectally). Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Concomitant medications included bendroflumethiazide (BENDROFLUAZIDE) taken for an unspecified indication; ramipril (RAMIPRIL) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included COVID-19 VACCINE ASTRAZENECA, Dose 1 (Lot number: AZ0003) on 21Jan2021 and Dose 2 (Lot number: PW40009) on 08Apr2021 for COVID-19 vaccination. The patient experienced painful arm (medically significant) on 14Oct2021, chills (medically significant) on 14Oct2021, hot flush (medically significant) on 14Oct2021, joint ache (medically significant) on 14Oct2021, tiredness (medically significant) on 15Oct2021, taste metallic (medically significant) on 16Oct2021, chronic post nasal drip (medically significant) on 16Oct2021, off label use on 14Oct2021, interchange of vaccine products on 14Oct2021. Unsure if patient was enrolled in clinical trial. The outcome of the events painful arm was recovered on 19Oct2021, Chills was recovered on 15Oct2021, hot flush and tiredness was recovered on 16Oct2021, joint ache and taste metallic was recovered on 17Oct2021, chronic post nasal drip was recovered on 21Oct2021 and for other events it was unknown. No causality was provided for painful arm, chills, hot flush, joint ache, tiredness, taste metallic, chronic post nasal drip, off label use, interchange of vaccine products. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on available information and the drug temporal relationship, the causality between the all reported events Painful arm,chills,hot flushes,fatigue,metallic taste, Chronic post nasal drip,off label use, interchange of vaccine products and the 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: 1838463 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0108 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Epilepsy, Feeling abnormal, Insomnia, Loss of consciousness, Vital signs measurement
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), 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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: Body temperature; Result Unstructured Data: Test Result:35.6 Centigrade; Comments: Before vaccination.; Test Date: 20211014; Test Name: Vital sign; Result Unstructured Data: Test Result:No abnormalities; Comments: checked every 5 minutes from 11:15 to 11:40
CDC Split Type: JPPFIZER INC202101404052

Write-up: had not slept after night shift; Loss of consciousness (Dozens of seconds)/Epileptic seizure-like Loss of consciousnes; Epileptic seizure-like Loss of consciousnes; feels poorly; This is a spontaneous report from a contactable physician received from the Regulatory authority (RA). Regulatory authority report number is v21129654. A 26-year and 4-month-old male patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FK0108, Expiration date 31Jan2022), via an unspecified route of administration on 14Oct2021 at 11:00 (the day of first vaccination, at the age of first vaccination 26-year and 4-month-old), as dose 1, single COVID-19 immunization. Medical history was none. The patient had no family history. Body temperature before vaccination was 35.6 degrees Centigrade on 14Oct2021. 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. On 14Oct2021 (the same time with first vaccination), the patient experienced epileptic seizure-like loss of consciousness (dozens of seconds), feels poorly, and had not slept after night shift on an unspecified date. The course of the event was as follows: Few minutes after the vaccination, the patient experienced feels poorly. Immediately after that, the patient experienced Epileptic seizure-like Loss of consciousness. After Dozens of seconds, the patient regained consciousness and became able to walk. But the patient complained of feels poorly, and the follow-up was operated with the patient rest on bed. Vital signs were checked every 5 minutes from 11:15 to 11:40, but no abnormalities were observed. The patient was transported by Emergency since he complained of Feels poorly. The outcome of the events was unknown. The reporting physician 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 reporting physician commented as follows: The patient told the reporter that he had not slept after night shift, and there were no abnormalities before the vaccination.


VAERS ID: 1838536 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004498 / 3 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Anaphylactic reaction, Blood pressure measurement, Dyspnoea, Heart rate, Hypoaesthesia oral, Oxygen saturation, Pruritus, Rash, Restlessness, Throat irritation
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Akathisia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: Blood pressure; Result Unstructured Data: 170/100 mmHg; Test Date: 20211014; Test Name: Pulse rate; Result Unstructured Data: 72 heart beats per minute; Test Date: 20211014; Test Name: Oxygen saturation; Result Unstructured Data: 99 percent
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: Possible anaphylactic reaction; Possible anaphylactic reaction; Possible anaphylactic reaction; Possible anaphylactic reaction; Possible anaphylactic reaction; Possible anaphylactic reaction; Possible anaphylactic reaction; Possible anaphylactic reaction; This case was received via regulatory authority (Reference number: NO-NOMAADVRE-E2B_00056113) on 25-Oct-2021 and was forwarded to Moderna on 25-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of PRURITUS (Possible anaphylactic reaction), HYPOAESTHESIA ORAL (Possible anaphylactic reaction), RESTLESSNESS (Possible anaphylactic reaction), DYSPNOEA (Possible anaphylactic reaction), ABDOMINAL PAIN UPPER (Possible anaphylactic reaction), THROAT IRRITATION (Possible anaphylactic reaction), RASH (Possible anaphylactic reaction) and ANAPHYLACTIC REACTION (Possible anaphylactic reaction) in a 51-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004498) for Vaccination. No Medical History information was reported. On 14-Oct-2021 at 2:10 PM, the patient received third dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 14-Oct-2021, the patient experienced PRURITUS (Possible anaphylactic reaction) (seriousness criterion hospitalization), HYPOAESTHESIA ORAL (Possible anaphylactic reaction) (seriousness criterion hospitalization), RESTLESSNESS (Possible anaphylactic reaction) (seriousness criterion hospitalization), DYSPNOEA (Possible anaphylactic reaction) (seriousness criterion hospitalization), ABDOMINAL PAIN UPPER (Possible anaphylactic reaction) (seriousness criterion hospitalization), THROAT IRRITATION (Possible anaphylactic reaction) (seriousness criterion hospitalization), RASH (Possible anaphylactic reaction) (seriousness criterion hospitalization) and ANAPHYLACTIC REACTION (Possible anaphylactic reaction) (seriousness criteria hospitalization and medically significant). At the time of the report, PRURITUS (Possible anaphylactic reaction), HYPOAESTHESIA ORAL (Possible anaphylactic reaction), RESTLESSNESS (Possible anaphylactic reaction), DYSPNOEA (Possible anaphylactic reaction), ABDOMINAL PAIN UPPER (Possible anaphylactic reaction), THROAT IRRITATION (Possible anaphylactic reaction), RASH (Possible anaphylactic reaction) and ANAPHYLACTIC REACTION (Possible anaphylactic reaction) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Oct-2021, Blood pressure measurement: 170/100 mmHg (High) 170/100 mmHg. On 14-Oct-2021, Heart rate: normal (normal) 72 heart beats per minute. On 14-Oct-2021, Oxygen saturation: 99 percent (normal) 99 percent. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered PRURITUS (Possible anaphylactic reaction), HYPOAESTHESIA ORAL (Possible anaphylactic reaction), RESTLESSNESS (Possible anaphylactic reaction), DYSPNOEA (Possible anaphylactic reaction), ABDOMINAL PAIN UPPER (Possible anaphylactic reaction), THROAT IRRITATION (Possible anaphylactic reaction), RASH (Possible anaphylactic reaction) and ANAPHYLACTIC REACTION (Possible anaphylactic reaction) to be possibly related. Concomitant medication was not provided. On suspicion of incipient anaphylaxis, the patient was given adrenaline 0.5 mg i.m, hydrocortisone 250 mg i.v and polaramine 5 mg i.m which brought a significant improvement with the result that patient was almost symptom-free. Later she was taken by ambulance to hospital for observation. The reporter stated that the events described may be consistent with a severe immediate allergic or anaphylactic reaction. The patient experienced numbness of the tongue, itchiness on throat, rash on the cheek, was anxious and had labored breathing especially when breathing in 2-3 minutes post third dose of vaccination. She was also gradually developing abdominal pain, was extremely anxious and had itchiness all over the body. Investigation of the heart, lungs and throat were NAD. No signs on inspection of throat, heart or lungs were there. Company comment; This case concerns a 51-year-old female patient with no relevant medical history reported, who experienced the expected serious events of Anaphylactic reaction and the serious unexpected events of Throat irritation, Rash, Pruritus, Hypoaesthesia oral, Restlessness, Dyspnoea and Abdominal pain upper. The events occurred on the same day of the third dose of Spikevax. The rechallenge was not applicable as no information about additional dosing was disclosed. The benefit-risk relationship of Spikevax vaccine is not affected by this report. Clinical manifestations of the Anaphylactic reaction included throat irritation, rash, pruritus, hypoaesthesia oral, restlessness, dyspnoea and abdominal pain, hence these events are also considered expected. Treatment with adrenaline, hydrocortisone and antihistamines was given, with resolution of the event. Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Translated document received on 27 Oct 2021, Event verbatim and narrative was updated.; Sender''s Comments: This case concerns a 51-year-old female patient with no relevant medical history reported, who experienced the expected serious events of Anaphylactic reaction and the serious unexpected events of Throat irritation, Rash, Pruritus, Hypoaesthesia oral, Restlessness, Dyspnoea and Abdominal pain upper. The events occurred on the same day of the third dose of Spikevax. The rechallenge was not applicable as no information about additional dosing was disclosed. The benefit-risk relationship of Spikevax vaccine is not affected by this report. Clinical manifestations of the Anaphylactic reaction included throat irritation, rash, pruritus, hypoaesthesia oral, restlessness, dyspnoea and abdominal pain, hence these events are also considered expected. Treatment with adrenaline, hydrocortisone and antihistamines was given, with resolution of the event.


VAERS ID: 1840833 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-14
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pericardial effusion, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101402976

Write-up: Pericardial effusion; Pericarditis; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 643843. A 20-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced pericardial effusion and Pericarditis, both on 14Oct2021. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1840854 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-14
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Eye haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Retinal disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101403193

Write-up: Eye haemorrhage; This is a spontaneous report from a contactable health professional via the TRegulatory Authority. Regulatory authority report number is 644439. A 46-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (lot number was not reported), dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced eye haemorrhage on 14Oct2021 with outcome of recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1840862 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-14
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101403287

Write-up: Appendicitis; Pyrexia; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 644742. A 14-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 14Oct2021, the patient experienced appendicitis and pyrexia. The outcome of events was recovered with sequel on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1840910 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-01
Onset:2021-10-14
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dizziness, Fatigue, Foetal death, Nausea, Pyrexia, Stillbirth
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Termination of pregnancy and risk of abortion (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: Crohn''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC202101415350

Write-up: still birth; Detection death fetus; Dizziness; Nausea; Fever attacks; Shivering; Tiredness/Exhaustion; This is a spontaneous report from a contactable consumer (patient). A pregnant female patient of an unspecified age received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 01Oct2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient previously received the first dose of bnt162b2 (COMIRNATY) on 03Sep2021 as single dose for COVID-19 immunization and experienced maternal exposure during pregnancy, second trimester. Medical history included Crohn''s disease. The patient''s concomitant medications were not reported. After the 2nd vaccination on an unspecified date in 2021, the patient experienced dizziness, nausea, fever attacks, shivering and tiredness/exhaustion. Determination of fetal death on 14Oct2021 and stillbirth on 16Oct2021. She was 22 Weeks pregnant at the onset of the event. The pregnancy resulted in still birth. The fetal outcome is intrauterine death. The outcome of the events was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.


VAERS ID: 1841465 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6931 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Discomfort, Immunisation, Off label use, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LOSARTAN; INDAPAMIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101426463

Write-up: pins an needles in my right leg from my knee to my foot and this got worse; experienced discomfort; Paraesthesia; Off label use; Booster; This is a spontaneous report from a contactable consumer. This is the report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-EYC 00264062, Safety Report Unique Identifier GB-MHRA-ADR 26101206. A 68-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FG6931), via parenteral on 14Oct2021 as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The patient medical history included hypertension. Concomitant medication(s) included losartan taken for hypertension, indapamide taken for hypertension. On 18Oct2021, the patient experienced paraesthesia, discomfort. On an unspecified date, pins and needles in my right leg from my knee to my foot and this got worse. On 14Oct2021, off label use, booster. It was reported that, Extreme pins and needles in might leg extending from his knee to his foot. 4 days after covid booster she experienced discomfort from pins and needles in his right leg from his knee to his foot and this got worse overnight prompting him to seek urgent medical advice. After examination by general practitioner (GP) told to await outcome of neurology referral. Subsequently over the course of the next 3 days his symptoms had eased a little but was continuing and had not yet gone away. The outcome of events off label use, booster were unknown and other events were not recovered. Seek Advice Details: Obtained emergency appointment with his GP and after examination they referred his symptoms to neurology for urgent assessment. Awaiting outcome of referral. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1841491 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5782 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Fatigue, Limb discomfort, Pain in extremity, Respiratory disorder, SARS-CoV-2 test, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211016; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101400476

Write-up: short breathing; Tachycardia/heart was accelerated; Chest pain; arm was sore and feeling very heavy; Fatigue; Arm discomfort/arm was sore and feeling very heavy; This is a spontaneous report from a contactable consumer (patient). This report received from the Regulatory Authority (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110171820004180-P9JHS, Safety Report Unique Identifier (GB-MHRA-ADR 26085605). A 42-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Oct2021 (Batch/Lot Number: FJ5782) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No relevant medical history. Patient had not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. The patient experienced tachycardia, chest pain, arm was sore and feeling very heavy, fatigue, and arm discomfort all on 14Oct2021. After patient had the vaccine, she started feeling a discomfort in her left arm. Her arm was sore and feeling very heavy. That evening even though she was not moving (just watching Netflix) her heart was accelerated and she had short breathing. Later on she experienced some sharp chest pain that would come and go. That went on the following day. The patient took some paracetamol as advised by the nurse that give she the vaccine. 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 sars-cov-2 test: negative on 16Oct2021 (No - Negative COVID-19 test). The outcome of events Tachycardia/heart was accelerated, Chest pain and Fatigue was not recovered, outcome of short breathing was unknown, outcome of other events was recovering. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1841493 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5782 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Ultrasound scan
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Medication errors (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: AZATHIOPRINE; EVOREL SEQUI
Current Illness: Crohn''s disease (treated with Azathioprine over the last 2 years, with a couple of short term courses of steriods)
Preexisting Conditions: Medical History/Concurrent Conditions: HRT; Perimenopausal symptoms; Ulcerative colitis
Allergies:
Diagnostic Lab Data: Test Date: 20211017; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: Ultrasound scan; Result Unstructured Data: Test Result:cervical polyp
CDC Split Type: GBPFIZER INC202101417875

Write-up: heavy cycle; off label use; Booster; Interchange of vaccine products; This is a spontaneous report from a contactable consumer. This report is received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110180909198680-K5FAK. Safety Report Unique Identifier GB-MHRA-ADR 26085912. A 52-year-old female patient received third dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot Number: FJ5782), via an unspecified route of administration on 14Oct2021 (at the age of 52-year-old) as dose 3 (booster), single for COVID-19 immunisation. Medical history included ongoing Crohns disease (treated with Azathioprine over the last 2 years, with a couple of short-term courses of steroids), colitis ulcerative, menopausal symptoms and hormone replacement therapy from an unknown date. Concomitant medications included influenza vaccine (INFLUENZA VIRUS) taken for influenza immunisation from 19Sep2021 to 19Sep2021; azathioprine taken for Crohns disease, start and stop date were not reported; estradiol, norethisterone acetate (EVOREL SEQUI) taken for hormone replacement therapy, start and stop date were not reported. The patient previously took COVID-19 VACCINE ASTRAZENECA (Lot number: unknown) dose 1, via an unspecified route of administration on 03Mar2021 as dose 1, single and dose 2 via an unspecified route of administration on 20May2021 as dose 2, single for COVID-19 immunisation. After second dose of COVID-19 VACCINE ASTRAZENECA patient experienced heavy cycle and menstruation abnormal. Patient has not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient had off label use, interchange of vaccine products and booster dose administration on 14Oct2021. The patient experienced heavy cycle on 15Oct2021. Clinical course: Two weeks after her second Astrazeneca vaccine a menstrual cycle started that was heavy and lasted for 7 weeks. Patient was perimenopausal/menopausal and had not had a cycle for many months before. Since the previous extended cycle her periods stopped again and then patient had the Pfizer Vaccine which was followed the very next day by the onset of a heavy cycle which was still continuing. The case was assessed as serious (medically significant) by the health authority. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative COVID-19 test on 17Oct2021, ultrasound scan: cervical polyp on an unspecified date. The outcome of event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1841556 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-12
Onset:2021-10-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Body temperature increased, Chest pain, Electrocardiogram, Palpitations, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: blood test; Result Unstructured Data: Test Result:No blood markers; Comments: No blood markers for pericarditis, nor myocarditis have been found in the blood samples; Test Date: 2021; Test Name: Body temperature; Result Unstructured Data: Test Result:Elevated temperature; Test Date: 2021; Test Name: ECG; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210710; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101417801

Write-up: elevated temperature; Palpitations; chest pain; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202110192034120470-CTFCH, Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 26094667. A 13-year-old male patient received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 12Oct2021 as dose 1, single for COVID-19 immunisation. Medical history included suspected covid-19 from 09Jul2021 to 15Jul2021, covid-19 from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Patient is not enrolled in clinical trial The patient experienced chest pain and elevated temperature on an unspecified date, and palpitations on 14Oct2021. GHPD had an elevated temperature for the first two days following vaccination and started to experience palpitations and mild chest pain on day two. He consequently attended A&E on day 2 and again on day 5 due to these symptoms and had ECG and blood tests. Patient has not tested positive for COVID-19 since having the vaccine. relevant investigations or tests conducted included No blood markers for pericarditis, nor myocarditis have been found in the blood samples. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 10Jul2021 Yes - Positive COVID-19 test, body temperature: elevated temperature on an unspecified date, electrocardiogram: unknown results on an unspecified date, blood test: no blood markers on an unspecified date No blood markers for pericarditis, nor myocarditis have been found in the blood samples. Outcome of chest pain was not recovered, palpitations was recovering; whereas the elevated temperature outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1841565 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-10-14
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Electrocardiogram, Magnetic resonance imaging, 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: ECGs; Result Unstructured Data: Test Result:Unknown results; Test Name: MRI; Result Unstructured Data: Test Result:Unknown results; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101417848

Write-up: Stroke; This is a spontaneous report from a contactable consumer (Patient) received from the regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202110200241548970-EI6O3, Safety Report Unique Identifier GB-MHRA-ADR 26095494. A 16-year-old non-pregnant female patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 24Sep2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at time of vaccination.The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19, Patient was not currently breastfeeding. On 14Oct2021, the patient experienced stroke.The patient underwent lab tests and procedures which included electrocardiogram: unknown results on, magnetic resonance imaging: unknown results on, sars-cov-2 test: negative on No - Negative COVID-19 test. Patient reported that patient ended up in hospital because patient had a stroke, at 16 years old not long after patient had the vaccine. No one ever in a my family has had a stroke at such a young age Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient did not report related to possible inflammation of the heart (myocarditis or pericarditis). Suspect Reactions as details of any relevant investigations or tests conducted as MRI ECGs. The outcome of the reported event (stroke) was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected


VAERS ID: 1841604 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PK0112 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Retroperitoneal fibrosis (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? Yes, ? days
   Extended hospital stay? 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; Comments: Yes - Positive COVID-19 test.
CDC Split Type: GBPFIZER INC202101426443

Write-up: pain; Leg pain; pain in my arm; pain in lower back; This is a spontaneous report from a contactable consumer or other non hcp (patient) received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202110210937234810-T0Q7U. Safety Report Unique Identifier GB-MHRA-ADR 26103105. A 38-year-old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: Pk0112) via an unspecified route of administration on 14Oct2021 (At the age of 38-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included suspected covid-19 from an unknown date and unknown if ongoing (Unsure when symptoms started, Unsure when symptoms stopped). The patient''s concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 14Oct2021 patient experienced leg pain, on an unspecified date in 2021 pain in my arm, pain in lower back and on an unspecified date pain. Reported as, the day patient had the vaccine he had severe pain in arm, lower back and left leg. The pain has reduced on arm but still continues in the other part of the body. Patient reportedly rang the doctor and spoke with nurse. The nurse advised to speak with doctor, and he was waiting for an appointment. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). The patient underwent lab tests and procedures which included sars-cov-2 test positive on an unspecified date, Yes - Positive COVID-19 test. The outcome of pain was recovering, leg pain was not recovered, pain in my arm, pain in lower back was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1841622 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-01
Onset:2021-10-14
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ear pain, Headache, Pain in jaw, SARS-CoV-2 test, Teething
SMQs:, Osteonecrosis (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: Asthma; Insulin pump therapy; Type 1 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20211020; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101426419

Write-up: pain in teeth; ear pain; Headache; Pain in jaw; 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-202110211512507000-UFA64, Safety Report Unique Identifier GB-MHRA-ADR 26104245. A 46-year-old non pregnant female patient received first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number and Expiry date was not reported), via an unspecified route of administration on 01Oct2021 as single dose for COVID-19 immunisation. Patient last menstrual period date was 28Sep2021. The patient''s medical history included asthma, type 1 diabetes mellitus, insulin therapy, from an unknown date and unknown if ongoing. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced pain in jaw on right side of face. Starting in teeth then radiating up to the ear and side of head. On an unspecified date, the patient experienced pain in teeth, ear pain, headache and on 14Oct2021, the patient experienced pain in jaw. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No dental infections detected. The patient underwent lab tests and procedures which included SARS-COV-2 test no - negative COVID-19 test on 20Oct2021. Outcome of the event pain in jaw was not recovered and rest of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


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