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From the 9/10/2021 release of VAERS data:

Found 686,636 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 372 out of 6,867

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VAERS ID: 1516425 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fatigue, Headache, Muscular weakness, Nausea, Pain in extremity, Pyrexia, Rash, SARS-CoV-2 test, Skin warm
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BUDESONIDE; FEXOFENADINE; LAMOTRIGINE; PREGABALIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Petit mal epilepsy; Seasonal allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021907102

Write-up: Dizziness; Weakness of arms; Fever; Nausea; headache; arm pain; Leg pain; Fatigue/Tiredness; Skin rash/rash; Skin warm; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is [GB-MHRA-WEBCOVID-202107150920529810-ZFDE1], Safety Report Unique Identifier [GB-MHRA-ADR 25654921]. A 37-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 14Jul2021 (at the age of 37-year-old) (Lot Number: FE1510) as dose 2, single for COVID-19 immunisation. Medical history included, seasonal allergy, petit mal epilepsy. Concomitant medication(s) included budesonide (BUDESONIDE) taken for seasonal allergy, start and stop date were not reported; fexofenadine (FEXOFENADINE) taken for an unspecified indication, start and stop date were not reported; lamotrigine (LAMOTRIGINE) taken for absence seizure (petit mal epilepsy), start and stop date were not reported; pregabalin (PREGABALIN) taken for absence seizure (petit mal epilepsy), start and stop date were not reported. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient experienced nausea (medically significant) on 14Jul2021 with outcome of recovering, headache (medically significant) on 14Jul2021 with outcome of not recovered, arm pain (same side as injection) (medically significant) on 14Jul2021 with outcome of recovering, leg pain (same side as injection) (medically significant) on 14Jul2021 with outcome of recovering, fatigue/tiredness (medically significant) on 14Jul2021 with outcome of not recovered, skin rash/rash (medically significant) on 14Jul2021 with outcome of recovered on 15Jul20021, skin warm (medically significant) on 14Jul2021 with outcome of recovering, dizziness (medically significant) on 15Jul2021 (also reported as on 14Jul2021 in the afternoon) with outcome of recovering, weakness of arms (medically significant) on 15Jul2021 (also reported as on 14Jul2021 in the afternoon) with outcome of not recovered, fever (medically significant) on 14Jul2021 with outcome of not recovered (also reported as recovering). The course of events was as follows: Nausea, headache, arm pain and leg pain (same side as injection) later in day after vaccine. Dizziness, Rash, Weakness in the afternoon. Rash gone next day. Tiredness, Headache, Fever, present. Weakness of right arm (worse than yesterday) still hot around injection site. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 13Jul2021 No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516428 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210629; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021907132

Write-up: Pain localized; 1st dose on 07May2021 and 2nd dose on 14Jul2021; This is a spontaneous report from a contactable consumer received from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is [GB-MHRA-WEBCOVID-202107150932072880-WYIP2], Safety Report Unique Identifier [GB-MHRA-ADR 25654933]. This consumer reported information for both dose. This is the second dose case. A 42-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 14Jul2021 (Lot number was not reported) as dose 2, single for COVID-19 immunisation. Patient received the first dose of bnt162b2 on 07May2021 and experienced fatigue and Pain localized. Medical history included suspected covid-19 from 28Jun2021 to 04Jul2021. The patient''s concomitant medications were not reported. The patient experienced pain localized (medically significant) on 14Jul2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 29Jun2021 No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202100916194 Same patient/ different dose, different event


VAERS ID: 1516434 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Eye pain, Fatigue, Headache, Myalgia, Nausea, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Eosinophilic pneumonia (broad), Vestibular disorders (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: VENLAFAXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021907280

Write-up: dizziness; fatigue; muscle aches; Eye ache; Dizzy spells; Nauseous; Headache; Chronic fatigue; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency. Regulatory authority report number is GB-MHRA-WEBCOVID-202107151039290800-BDRPG, Safety Report Unique Identifier GB-MHRA-ADR 25655313. A 22-year-old male patient received 2nd dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot Number: FF3319), at single dose on 14Jul2021 08:45 for COVID-19 immunization. Medical history included anxiety. Patient has not had symptoms associated with COVID-19. Concomitant medication included venlafaxine (Manufacturer unknown) taken for anxiety from 15Mar2021. The patient had vaccine at 8:45, then sat for 15 minutes and felt fine. Then walked 10 minutes to work. Sat at his desk and within 15 minutes he ran to the toilet to throw up. He then felt a strong headache, dizziness and nauseous as he walked back home from work. He spent the whole day in bed feeling extremely fatigued, had achy muscles and a headache that wouldn''t go away. He took some ibuprofen and paracetamol but they haven''t helped. He was now on his 2nd day and am still off work with head and muscle aches and the fatigue. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient experienced dizziness with outcome of unknown, fatigue with outcome of unknown, muscle aches with outcome of unknown, nauseous on 14Jul2021 with outcome of recovering, headache on 14Jul2021 with outcome of not recovered, chronic fatigue on 14Jul2021 with outcome of not recovered, eye ache on 15Jul2021 with outcome of not recovered, dizzy spells on 14Jul2021 with outcome of not recovered. The lab tests included No - Negative COVID-19 test on 14Jul2021. All the events were assessed serious as Medically Significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516445 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Feeling hot, Head injury, Hyperhidrosis, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021906951

Write-up: Fainting; head injure/ head just read and sore; sweaty; feeling very hot; This is a spontaneous report from a contactable other healthcare professional received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107151201453620-SSHMZ. Safety Report Unique Identifier GB-MHRA-ADR 25655748. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jul2021 (Lot Number: FD8813) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient experienced fainting, head injure feeling very hot and sweaty on 14Jul2021 with outcome of recovered on an unspecified date. The clinical course included: immediately after the vaccination the patient sat in the chair in the resting area. The patient fainted on the chair but dropped to the floor before staff members could reach them. When the staff member arrived we put them in the recovery position and they came back round. The patient had a small head injure which was a graze. No bleeding on the head just read and sore. A cold compress was applied to the patients head. They asked for a bottle of water as they were feeling very hot and sweaty. The patient then sat up right when they felt ready to. They answered all the questions correctly and told staff member that he hadn''t eaten since the night before at 21:00 on the 13Jul2021. They felt ready to leave after 20 minutes in the resting area. The Staff member advised them to have a lift home but he refused to do so. Patient did not leave a contact telephone number for me to contact them. They were advised if the head injure got worst to go and speak to the GP. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow up attempts are possible. No further information is expected.


VAERS ID: 1516458 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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 INC2021907241

Write-up: Diarrhea; Fever; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202107151359341140-UHGJI, Safety Report Unique Identifier GB-MHRA-ADR 25656599. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot was not provided), via an unspecified route of administration on 14Jul2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced fever on 14Jul2021, diarrhea on 15Jul2021. The events were serious for being medical significant. The patient underwent lab tests included COVID-19 virus test: negative on unspecified date (reported as No - Negative COVID-19 test). Patient was not enrolled in clinical trial. The outcome of event fever was recovered on 15Jul2021, of event diarrhea was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1516462 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Neuralgia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021907317

Write-up: Headache; Nerve pain; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107151418151210-JV6GS. A 25-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 14Jul2021 as dose 2, single (at age of 25-years-old) for COVID-19 immunisation. Medical history included Lactation decreased. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced headache on 14Jul2021, nerve pain on 14Jul2021. The patient underwent lab tests and procedures which included COVID-19 virus test: negative 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 events was not recovered. This report was serious with seriousness criteria of medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1516470 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Contraceptive implant (have not had a period not once in all that time)
Preexisting Conditions: Medical History/Concurrent Conditions: Hidradenitis suppurativa (prescribed with doxycycline 100 mg twice a day); Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021906888

Write-up: bleeding; cramping; Vaginal bleeding; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. Regulatory authority report number is GB-MHRA-WEBCOVID-202107151501354850-QM1WR, Safety Report Unique Identifier is GB-MHRA-ADR 25658164. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jul2021 (Lot Number: FF3319, Expiry date not reported) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included hidradenitis suppurativa (prescribed with doxycycline 100 mg twice a day), suppressed lactation (lactation decrease), and ongoing implants in arm as contraception since 2013 (have not had a period not once in all that time). Patient had not had symptoms associated with COVID-19. Patient had not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. Concomitant medications were not reported. Historical vaccine included BNT162B2 on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced bleeding on an unspecified date with outcome of not recovered, cramping on an unspecified date with outcome of not recovered, and vaginal bleeding on 14Jul2021 with outcome of not recovered. The event haemorrhage was assessed as serious, medically significant, while the other events were non-serious. Case narrative: I suffer with hidradenitis suppurativa but I have not actually been taking my medication for the last few months. I was prescribed doxycycline 100mg twice a day. But again this hasn''t actually been taken in over 2 months. I have been having implants in my arm as contraception since 2013 and I have not had a period not once in all that time but within 2 days of getting my 2nd vaccine I am experiencing some bleeding, and cramping. This is unusual for me as I''ve not bled in over 6 years until having this 2nd dose online suggest there are similar cases. Patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516492 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Migraine with aura, Nausea, Paraesthesia, Photophobia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), 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: GBPFIZER INC2021907324

Write-up: headache; nausea; aversion to light; Pins and needles; Migraine with aura; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107151722249950-QA8S2, Safety Report Unique Identifier GB-MHRA-ADR 25658158. A 38-years-old female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 Vaccine) via an unspecified route of administration on 14Jul2021 (Batch/Lot number was not reported) as dose 2, single (at age of 38-years-old) for COVID-19 Immunisation. Th patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient experienced headache on an unspecified date, nausea on an unspecified date, aversion to light on an unspecified date, migraine with aura on 14Jul2021, pins and needles on left side on 15Jul2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the events headache, nausea and aversion to light was unknown, migraine with aura and pins and needles was recovering. This report was serious with seriousness criteria of medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1516512 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-07-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Fatigue, Malaise, Myalgia, Nausea, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021906948

Write-up: exhausted/felt drained; vomited; felt sick; little appetite; Vomiting; Fatigue; Nausea; Muscle ache; This is a spontaneous report from a contactable consumer (patient). This is a report received from the United Kingdom''s Medicines Healthcare products Regulatory Agency (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-202107152008232100-ADSE6, Safety Report Unique Identifier GB-MHRA-ADR 25659308. A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jul2021 as single dose for COVID-19 immunisation. Medical history included lactation decreased. 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. The patient experienced nausea and muscle ache on 14Jul2021, fatigue and vomiting on 15Jul2021, exhausted and vomited on an unspecified date. Additional clinical course was reported as follows: By 6 pm the third day after receiving the vaccine the patient suddenly felt drained and sick. This lasted until going to be and at 2 am she woke and vomited. The patient''s muscles were very sore and she could not get comfortable. The next morning the patient was exhausted and still had muscle ache. No more vomiting but still slight feeling of nausea and a very little appetite. Events were reported as medical significant. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of events muscle ache was not recovered, event vomiting (occurred on 15Jul2021) was recovered on 15Jul2021. The outcome of events feeling sick and decreased appetite was unknown. The outcome of rest events was recovering.


VAERS ID: 1516517 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chest pain, Cough, Headache, Heart rate, Heart rate increased, Pain, Pollakiuria, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic 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), 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: CERAZETTE [DESOGESTREL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception; COVID-19; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Fever; Result Unstructured Data: Test Result:above 38; Test Date: 20210714; Test Name: Fever; Result Unstructured Data: Test Result:37.6; Test Name: Heart rate; Result Unstructured Data: Test Result:60; Comments: usually 60; Test Date: 20210714; Test Name: Heart rate; Result Unstructured Data: Test Result:81; Test Date: 20201227; Test Name: Lateral flow test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021906881

Write-up: keeping temperature; Ache; Fever/ increases above 38; Cough; Headache; Chest ache; Heart rate high; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107152026598470-ACWM0, Safety Report Unique Identifier is GB-MHRA-ADR 25659431. A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jul2021 (Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included lactation decreased, contraception both from an unknown date and COVID-19 on 27Dec2020. Concomitant medication included desogestrel (CERAZETTE) taken for contraception from Jun2008 to an unspecified stop date. Patient has not had symptoms associated with COVID-19 Patient is not pregnant; patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient experienced keeping temperature (also reported as Urination frequency of) on an unspecified date; ache, fever, cough, headache, chest ache, heart rate high all on 14Jul2021. It was reported that lateral flow test undertaken and negative. Resting heart rate is at 81 when usually 60. Paracetamol is keeping temperature at 37.6 but if not kept up every 4 hours increases above 38. The events were reported as serious (medically significant). The patient underwent lab tests and procedures which SARS-COV-2 test with Yes - Positive COVID-19 test result on 27Dec2020. The patient was recovering from fever, headache and heart rate high while patient has not recovered from ache, cough and chest ache. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1516518 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021907275

Write-up: Enlarged lymph nodes (excl infective); This is a spontaneous report from a contactable consumer received from the Regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107152030480790-WFC0W. A 32-year-old no pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jul2021 (Lot Number: FD8813) as dose 2, single for COVID-19 immunization. Medical history included lactation decreased. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. On 14Jul2021 patient experienced enlarged lymph nodes (excl infective). The outcome of event was recovered. Patient has not tested positive for COVID-19 since having the vaccine. Case reported as serious due to medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516558 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021906827

Write-up: Ache; Patient received BNT162B2 Vaccine Dose 1 on 18May2021, Dose 2 on 14Jul2021; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107152139028680-T0R05. Safety Report Unique Identifier GB-MHRA-ADR 25659980. A 31-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 14Jul2021 (at age of 31 years old) as single dose for COVID-19 immunisation. The patient medical history was not reported. Patient had no symptoms associated with COVID-19 and not had a COVID-19 test. He previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 18May2021 as single dose for COVID-19 Immunisation. Patient has not tested positive for COVID-19 since had the vaccine. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. On set c.12hrs after second dose of Pfizer vaccine, ongoing at 36hrs after vaccine. On 14Jul2021, the patient experienced ache and patient received BNT162B2 vaccine dose 1 on 18May2021, dose 2 on 14Jul2021. The case classified as serious (medically significant). The outcome of event ache was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be requested. No further information is expected.


VAERS ID: 1516559 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Fatigue, Headache, Lymphadenopathy, Oropharyngeal pain, Rhinorrhoea
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021906868

Write-up: sore throat; Swollen glands; fatigue; cough; headache; runny nose; 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-202107152139579270-LLRKE. Safety Report Unique Identifier is GB-MHRA-ADR 25659975. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 13Jul2021 as dose 2, single for COVID-19 immunization. Medical history included lactation decreased and anxiety. Patient has not had symptoms associated with COVID-19, has not had a COVID-19 test, was not pregnant, and was not currently breastfeeding. Concomitant medication included sertraline taken for anxiety from 01Jan2020. The patient experienced fatigue, cough, headache, and runny nose on 14Jul2021; and experienced sore throat and swollen glands on 15Jul2021. The events were reported as serious per other medically important condition. The clinical course was reported as follows: Next day, headache, fatigue, cough, runny nose. Second day sore throat and swollen glands on one side. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the event swollen glands was not recovered, while outcome of the remaining events was recovering. No follow-up attempts are possible. Information about lot/batch no cannot be obtained. No further information is expected.


VAERS ID: 1516568 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Disease recurrence, Rotator cuff syndrome, SARS-CoV-2 test
SMQs:, Arthritis (broad), Tendinopathies and ligament 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: Medical History/Concurrent Conditions: Rotator cuff tendinitis; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC2021907199

Write-up: previous rotator cuff injury on his right shoulder which flared up within a few hours; previous rotator cuff injury on his right shoulder which flared up within a few hours; Joint pain; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107152316132520-Safety Report Unique Identifier GB-MHRA-ADR 25660420. A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Dose 2 via an unspecified route of administration on 14Jul2021 (Batch/Lot Number: FD8813) at age of 36 years old as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included suspected covid-19 from 01May2020 to 01Jun2020, Rotator cuff tendinitis. Concomitant medications were unknown. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19May2021 for covid-19 immunisation. The patient had a previous rotator cuff injury on his right shoulder which flared up within a few hours of having second vaccine. The patient experienced joint pain on 14Jul2021. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on an unspecified date. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Outcome of the event joint pain was not recovered, of the event previous rotator cuff injury on his right shoulder which flared up within a few hours was unknown. This is a serious report. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516575 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Insomnia, Lymphadenopathy, Malaise, Maternal exposure during pregnancy, Myalgia, Nausea, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210709; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No-Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021907247

Write-up: Maternal exposure during pregnancy; Insomnia; Diarrhoea; Swollen lymph nodes; Unwell; Pain; Muscle pain; Tiredness; Headache; Nausea; Fever; Chills; This is a spontaneous study report from a contactable consumer or other non hcp. This is a report received from the Regulatory Agency (RA). Regulatory authority report number [GB-MHRA-WEBCOVID-202107160303441280-VSMC8], Safety Report Unique Identifier [GB-MHRA-ADR 25660500]. This consumer or other non hcp reported information for both mother and fetus. This is a maternal exposure during pregnancy report. A 21-years-old pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: unknown) via an unspecified route of administration on 14Jul2021 (at the age of 21-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Patient was not currently breastfeeding. Medical history included lactation decreased, Folic acid supplementation from an unknown date and unknown if ongoing and ongoing pregnancy. Concomitant medications included folic acid taken for Folic acid supplementation, start and stop date were not reported. Patient had not had symptoms associated with covid-19. Patient was not enrolled in clinical trial. Since the vaccination, the patient had not been tested positive for covid-19. On 14Jul2021, the patient experienced nausea, fever, chills, muscle pain, tiredness, headache, unwell and pain. On 15Jul2021, the patient experienced insomnia, diarrhoea and swollen lymph nodes. On unspecified date, the patient experienced maternal exposure during pregnancy. It was stated that patient was exposed to the medicine first-trimester (1-12 weeks). The mother reported she became pregnant while taking bnt162b2. The mother was 12 weeks pregnant at the onset of the event. The patient underwent lab tests and procedures which included covid-19 virus test was negative on 09Jul2021. Outcome of the event maternal exposure during pregnancy was unknown. Outcome of the other events was not recovered. The events was serious (medically significant). No follow up attempts are possible; Information about lot/batch number cannot be obtained.


VAERS ID: 1516585 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Joint pain
Allergies:
Diagnostic Lab Data: Test Date: 20210629; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100908996

Write-up: pain; Joint pain/severe pain in left shoulder, elbow and wrist; This is a spontaneous report from a contactable consumer. This is a report received from the United Kingdom Medicines and Healthcare products Regulatory Agency (UK-MHRA). Regulatory authority report number [GB-MHRA-WEBCOVID-202107160821237190-LRYGQ], Safety Report Unique Identifier [GB-MHRA-ADR 25661666]. A 48-year-old male patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on 13Jul2021 (Batch/Lot number: FD5613) at dose 2, single for COVID-19 immunisation. Medical history included joint pain on an unknown date. Concomitant medications included Ibuprofen taken for arthralgia from 14Jul2021 to an unspecified stop date; paracetamol taken for arthralgia from 14Jul2021 to an unspecified stop date. The patient experienced pain on an unspecified date and joint pain/severe pain in left shoulder, elbow and wrist on 14Jul2021. The events were assessed as serious (medically significant). The patient underwent lab tests and procedures which included COVID-19 virus test: Negative COVID-19 test on 29Jun2021. The outcome of the event ''pain'' was recovering and event ''joint pain/severe pain in left shoulder, elbow and wrist'' was not recovered. The clinical course was reported as follows: Started off on 14Jul2021 with severe pain in left shoulder, elbow and wrist. Pain eased in wrist by the morning of 15Jul2021 but the pain continued in shoulder and elbow until this time 08:25am 16Jul2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Additional information: Patient has not had symptoms associated with COVID-19. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516596 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Myalgia, Nausea, Peripheral swelling, Vaccination site erythema, Vaccination site swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROXINE SODIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism; Lactation decreased; Vertigo
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100909423

Write-up: swollen jab site on arm on day of second vaccine; red swollen patch around "hav site"; Headache; Muscle pain; Swollen arm; Fatigue; Nausea; This is a spontaneous report from a contactable consumer. This consumer reported for two reports. This is the first of two reports. This was received from the Regulatory Agency (RA). The regulatory authority report number: GB-MHRA-WEBCOVID-202107160944159060-QSV2X, Safety Report Unique Identifier: GB-MHRA-ADR 25662307. A 34-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), dose 2 via an unspecified route of administration in arm on an unspecified date (Lot Number: FA1027) as single dose for COVID-19 immunisation. Medical history included lactation decreased, preexisting vertigo condition, and hypothyroidism. Patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medication included levothyroxine sodium taken for hypothyroidism. The patient previously received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), dose 1 via an unspecified route of administration on an unspecified date (Lot Number: EW4109) as single dose for COVID-19 immunisation. It was reported that the first dose only triggered a preexisting vertigo condition, and nausea which lasted one day. The patient experienced headache, muscle pain, swollen arm, fatigue and nausea on 14Jul2021. It was further reported that the patient only had swollen jab site on arm on day of second vaccine (date not reported). Since then, they have had continued muscle pain from head to toe, headache that come and goes and red swollen patch around "site", these symptoms have not left since the jab. The events were considered serious: medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of swollen jab site on arm was unknown while the other events had not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516612 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Nausea, Off label use, Pain, Pain in extremity, Product use issue, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (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: PARACETAMOL
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Cold
Allergies:
Diagnostic Lab Data: Test Date: 20210709; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100909357

Write-up: Fever; Nausea; ongoing breast feeding; ongoing breast feeding; Ache; Painful arm; This is a spontaneous report from a contactable consumer received from the Regulatory Authority Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107161106175210-S3O45. Safety Report Unique Identifier GB-MHRA-ADR 25662741. The consumer reported for both mother and baby. This is the mother case, only this case is serious. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on 14Jul2021 (at age of 35-year-old, Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included ongoing breast feeding, cold. Unsure if patient has had symptoms associated with COVID-19 Patient is not pregnant. Concomitant medication included paracetamol taken for cold. Historical vaccine included first dose of BNT162B2 on unspecified date for COVID-19 immunisation. The patient experienced maternal fever and nausea (medically significant) on 15Jul2021 with outcome of recovered on 16Jul2021, ache (medically significant) on 14Jul2021 with outcome of recovering, painful arm (medically significant) on 14Jul2021 with outcome of recovering. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on 09Jul2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202100927316 baby case


VAERS ID: 1516614 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Anaphylactic shock, Confusional state, Dizziness, Hyperacusis, Migraine, Pyrexia, Tinnitus
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hearing impairment (narrow), Vestibular 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? 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: Hyperacusis; Migraine; Tinnitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100909297

Write-up: hyperacusis; tinnitus; anaphylaxis; anaphylaxis shock; dizziness; high temperature; migraine; confusion; This is a spontaneous report from a contactable consumer. This is a report received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107161111322380-9BO7Z, Safety Report Unique Identifier GB-MHRA-ADR 25663018. A 27-year-old male patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 14Jul2021 (Lot Number: FA1027) at the age of 27 years as single dose for covid-19 immunisation. Medical history included tinnitus, migraine, hyperacusis. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient''s concomitant medications were not reported. The patient experienced hyperacusis on an unspecified date, tinnitus on an unspecified date, dizziness on 14Jul2021, high temperature on 14Jul2021, anaphylaxis on an unspecified date, adverse reaction on 14Jul2021, migraine on 14Jul2021, confusion on 14Jul2021. 2 minutes after vaccine, high temperature followed by dizziness confusion and migraine like symptoms. Suspected anaphylaxis shock. Recovered in about 20 minutes. Temporary exasperation of pre-existing tinnitus. Appears to have made pre-existing hyperacusis slightly worse. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No relevant investigations or tests conducted. Outcome of migraine was unknown, high temperature, dizziness, anaphylaxis shock and confusion were recovered on 14Jul2021 and the other events were recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516618 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100908974

Write-up: Fainting; This is a spontaneous report from a contactable pharmacist. This is a report received from theregulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107161135204820-KKISH. Safety Report Unique Identifier GB-MHRA-ADR 25663083. A 30-year-old female patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection),(Lot Number: FC9001) via an unspecified route of administration on 14Jul2021 as dose 1, single for COVID-19 immunisation. The patient medical history included suppressed lactation from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Patient had no symptoms associated with COVID-19 and did not do a COVID-19 test. Patient was not pregnant and was not currently breastfeeding. Patient did not test positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 14Jul2021,the patient experienced fainting.This event was considered as medically significant. The outcome of the event was resolved. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516619 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-07-14
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypomenorrhoea, Menstruation delayed, SARS-CoV-2 test
SMQs:, Fertility disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ESCITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression (Taking antidepressants for 4 years which have never affected my periods); Heavy periods; Lactation decreased; Menstruation normal
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100909238

Write-up: Light periods; Delayed period; This is a spontaneous report from a contactable consumer (patient) received from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107161140305750-ZT0KI. Safety Report Unique Identifier GB-MHRA-ADR 25662893. A 24-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jun2021 as single dose for COVID-19 immunisation. Medical history included lactation decreased, depression, and her period has always been like clockwork and never more than a day late and was usually heavy. Taking antidepressants for 4 years which have never affected her periods. She has not had symptoms associated with COVID-19, not pregnant, not currently breastfeeding, and not enrolled in clinical trial. Concomitant medication included escitalopram taken for depression from 20Jun2017. The patient experienced light periods and delayed period on 14Jul2021. Case narrative: Her period was a week late and significantly lighter than usual. Her period has always been like clockwork and never more than a day late and was usually heavy. No relevant investigations or tests conducted. She has not tested positive for COVID-19 since having the vaccine. She underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on 13Jul2021. The outcome of the events was not recovered. Case was reported as medically significant by health authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1516629 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, 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? 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: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210219; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100909396

Write-up: Headache; Muscle pain; Chills; This is a spontaneous report from a contactable consumer. This is a report received from the Agency Regulatory Authority.The regulatory authority report number is GB-MHRA-WEBCOVID-202107161214129430-RJN0B,Safety Report Unique Identifier GB-MHRA-ADR 25663271. A female patient of an unspecified age received second dose BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jul2021 as single dose for COVID-19 immunisation. Medical history included suspected covid-19 from 16Feb2021 and unsure when symptoms stopped. The patient''s concomitant medications were not reported. The patient experienced chills on 14Jul2021, headache on 15Jul2021, muscle pain on 14Jul2021. The outcome of the events was recovered on 16Jul2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 19Feb2021. Patient was not enrolled in clinical trial. The case was reported as serious with seriousness criteria of medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1516633 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Headache, Heart rate increased, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (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 Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100908746

Write-up: increased heart rate; Headache; Nausea; Chest pain; 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-202107161242325730-CLF9P, safety report unique identifier is GB-MHRA-ADR 25663613. A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FD8813), via an unspecified route of administration on 14Jul2021 (at the age of 22-years-old) as dose 1, single for COVID-19 immunisation. No medical history and concomitant medications were reported. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. On 14Jul2021, headache, nausea, chest pain, and on an unspecified date, the patient experienced increased heart rate. The events were assessed as serious (medically significant). It was reported that the patient had chest pain, was a shooting pain that was happening regularly and increased heart rate. The patient underwent lab test which included SARS-CoV-2 test: Negative (No - Negative COVID-19 test) on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the events increased heart rate was unknown, nausea and chest pain not recovered, while the event headache was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516646 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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 INC202100909123

Write-up: This is a spontaneous report from a contactable consumer, received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202107161448565890-NRYNO; safety report unique identifier: GB-MHRA-ADR 25664459). A 39-year-old patient, of an unspecified gender, received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, lot# FD8813), via an unspecified route of administration on Jul 13, 2021, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19, nor had a COVID-19 test. Patient has not tested positive for COVID-19 since the vaccination. Patient is not enrolled in a clinical trial. On Jul 14, 2021, patient experienced headache and muscle pain. On Jul 15, 2021, patient experienced armpit pain. Outcome of the armpit pain and headache: recovering. Outcome of the event muscle pain was recovered on Jul 16, 2021. No follow-up attempts possible. No further information expected.


VAERS ID: 1516656 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Myocarditis, Pleuritic pain, SARS-CoV-2 test, Troponin, Troponin increased
SMQs:, Myocardial infarction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hay fever
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: troponin; Result Unstructured Data: Test Result:rising; Comments: "+ve troponin and rising"
CDC Split Type: GBPFIZER INC202100909353

Write-up: chest pain; central pleuritic; High Troponin result; Myocarditis; This is a spontaneous report from a contactable physician received from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107161545172610-BXWWM. Safety Report Unique Identifier GB-MHRA-ADR 25664861. A 34-years-old female patient received BNT162B2, dose 2, via an unspecified route of administration on 12Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. Medical history included Hay fever. Hay fever nil else. Unsure if patient is enrolled in clinical trial. Not on any regular medications. Unsure if patient has had symptoms associated with COVID-19. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced chest pain on an unspecified date with outcome of unknown, myocarditis on 14Jul2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on No - Negative COVID-19 test. Relevant investigations or tests conducted: "+ve troponin and rising". Attended ED following vaccination with 2 day hx of central pleuritic chest pain. High Troponin result. Patient last menstrual period date was 30Jun2021. Report was not related to possible blood clots or low platelet counts. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1516666 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100909059

Write-up: Swollen lymph nodes; This is a spontaneous report from a contactable consumer received from the United Kingdom''s Medicines Healthcare Products Regulatory Agency (MHRA). Regulatory authority report number is GB-MHRA-WEBCOVID-202107161643355420-NV0IK, Safety Report Unique Identifier is GB-MHRA-ADR 25665025. A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number and expiry date were not reported), via an unspecified route of administration on 14Jul2021 (age at vaccination was 36 years) as DOSE 2, SINGLE for COVID-19 immunization. Patient had not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. Medical history included suppressed lactation. Concomitant medications were not reported. Historical vaccine included BNT162B2 on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced swollen lymph nodes on 14Jul2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date, Yes - Positive COVID-19 test. The event was reported as serious, medically significant by the health authority. Case narrative: Patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1516698 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Mass, Pain of skin, Pruritus, Rash, Rash erythematous, 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: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100909412

Write-up: raised lump; itchy; red circle rash spreading daily, hot; very sore; Rash; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number [GB-MHRA-WEBCOVID-202107162010276280-QAMWC], Safety Report Unique Identifier [GB-MHRA-ADR 25666554]. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 13Jul2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. Medical history included pregnancy from an unknown date and unknown if ongoing and suspected covid-19 from 14Jul2021 and ongoing. The patient''s concomitant medications were not reported. The patient experienced raised lump, itchy, red circle rash spreading daily, hot and very sore on an unspecified date; rash on 14Jul2021. 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 an unspecified date. The outcome of the event ''rash'' was recovering and the other events was unknown. The clinical course was reported as follows Raised lump, red circle rash, spreading daily, itchy, hot and very sore. Patient was not enrolled in clinical trial. No follow-up attempts are needed; information about lot/batch number cannot be obtained.


VAERS ID: 1516736 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Headache, Heavy menstrual bleeding, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100908753

Write-up: headache; dizzy; Heavy periods; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107162116253750-SFDU4. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection,Batch/Lot Number: Not known), dose 2 via an unspecified route of administration on 13Jul2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection) for covid-19 immunization. The patient medical history, concomitant medications were not reported. 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 No - Negative COVID-19 test. On an unspecified date The patient experienced headache, dizzy, On 14Jul2021 heavy periods. Events were consider as medical significant. The outcome of event heavy periods was not resolved and rest of all were unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516757 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-07-14
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Haemorrhage, Intermenstrual bleeding, SARS-CoV-2 test, Sexually transmitted disease 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: LEVEST [ETHINYLESTRADIOL;LEVONORGESTREL]; LYMECYCLINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acne; Contraception; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20201001; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Name: regular STI tests; Test Result: Negative
CDC Split Type: GBPFIZER INC202100909408

Write-up: Intermenstrual bleeding; cramps; bleeding; 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-202107162211015420-YFCXO. Safety Report Unique Identifier is GB-MHRA-ADR 25667405. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 29May2021 as dose 1, single for COVID-19 immunization. Medical history included lactation decreased, acne and contraception. They were unsure if patient has had symptoms associated with COVID-19. Patient was not pregnant and was not currently breastfeeding. Concomitant medications included ethinylestradiol, levonorgestrel (LEVEST) taken for contraception from 01Feb2019; and lymecycline taken for acne from 20Feb2021. The patient experienced bleeding and cramps on an unspecified date in 2021, and intermenstrual bleeding on 14Jul2021. The events were reported as non-serious. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 01Oct2020; and regular STI tests: negative on an unspecified date. The clinical course was reported as follows: The patient has never had any concerns before with intermenstrual bleeding. She was on the Levest Contraceptive pill and in the middle of her pill packet so should not be having cramps and bleeding. The patient had regular STI tests that have all been negative. If she continued bleeding, then she would be reporting this to her GP for further investigation. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the event bleeding was recovering, the outcome of the event cramps was unknown, while the outcome of the event intermenstrual bleeding was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1516758 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Computerised tomogram, SARS-CoV-2 test, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: IRON; MICROGYNON 21
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: blood test; Result Unstructured Data: Test Result:not reported; Test Date: 202107; Test Name: CT; Result Unstructured Data: Test Result:not reported; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100909410

Write-up: Clot blood; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority re-port number GB-MHRA-WEBCOVID-202107162219326110-1LGF3, Safety Report Unique Identifier GB-MHRA-ADR 25667401 A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of ad-ministration on 13Jul2021, as single dose for covid-19 immunization. Medical history was not re-ported. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medications included iron and ethinylestradiol, levonorgestrel (MI-CROGYNON 21); both taken for an unspecified indication, start and stop date were not reported. On 14Jul2021, the patient experienced clot blood. The clinical course was reported as follows: anti-clotting medication. Therapeutic measures were taken as a result of event. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included blood test and computerised tomogram (CT); both results not reported on an un-specified date in Jul2021 and sars-cov-2 test: no - negative covid-19 test on an unspecified date. The outcome of event was reported as resolving. No follow-up attempts were possible; information about lot/batch number could not be obtained.


VAERS ID: 1516761 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Axillary pain, SARS-CoV-2 test
SMQs:, Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OXYBUTYNIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Frequency urinary; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100908830

Write-up: Aching joints; Armpit pain; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107162233089210-F5AUE, Safety Report Unique Identifier GB-MHRA-ADR 25667472. A 34-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: FF3319), via an unspecified route of administration on 14Jul2021 (at the age of 34-year-old), as dose 2, single for COVID-19 immunisation. The patient''s medical history included suppressed lactation and pollakiuria (from an unknown date and unknown if ongoing). Concomitant medication(s) included oxybutynin (OXYBUTYNIN) taken for pollakiuria (from 2019 to an unspecified stop date). Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. Unsure if patient had had symptoms associated with COVID-19, Patient was not pregnant, Patient was not currently breastfeeding. On 14Jul2021, the patient experienced aching joints and armpit pain. The outcome of the event armpit pain was not recovered. The outcome of the event aching joints was recovered on 15Jul2021. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on an unspecified date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516766 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Body temperature increased, Conjunctival haemorrhage, Head discomfort, Headache, Sinus pain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Conjunctival disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Body temperature; Result Unstructured Data: Test Result:Increased
CDC Split Type: GBPFIZER INC202100908792

Write-up: Subconjunctival hemorrhage; Headache; Head pressure; Sinus pain; Body temperature increased; This is a spontaneous report from a contactable consumer received from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107162312508330-7DA65, Safety Report Unique Identifier GB-MHRA-ADR 25667696. A 39-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/ Lot Number: FA1027 and Expiration date was unknown), via an unspecified route of administration on 13Jul2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. 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, and not had a COVID-19 test. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/ Lot Number and Expiration date was unknown), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 14Jul2021, the patient experienced subconjunctival hemorrhage, headache, head pressure, sinus pain, and body temperature increased. The patient underwent lab tests and procedures which included body temperature: increased on 14Jul2021. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516791 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, 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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210704; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: Lateral flow test; Result Unstructured Data: Test Result:unknown
CDC Split Type: GBPFIZER INC202100909053

Write-up: shivers; body aches; Fever; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. The regulatory authority report number: GB-MHRA-WEBCOVID-202107170752390200-0JBQ3; Safety Report Unique Identifier: GB-MHRA-ADR 25667961. A 50-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), dose 1 via an unspecified route of administration on 09Jul2021 (Lot Number: FD8813) as single dose for COVID-19 immunisation. Medical history included lactation decreased. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. On the night from 14Jul2021 to 15Jul2021, patient had a high fever that was brought down by paracetamol. She also had shivers and body aches on an unspecified date. At the time of reporting, she was a bit better regarding shivers and body aches, but fever was still going up during the day and night. The events were considered serious: medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 04Jul2021. Patient has not tested positive for COVID-19 since having the vaccine. Other relevant investigations or tests conducted on an unspecified date included lateral flow rests (results unknown). The outcome of fever was not recovered while other events were recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516830 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Chills, Confusional state, Cough, Decreased appetite, Disorientation, Electric shock sensation, Headache, Paraesthesia, SARS-CoV-2 test, Sensitive skin, Somnolence
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suppressed lactation
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100908855

Write-up: cough; confusion; disorientated; brain zaps; tingling nerves; SARS-CoV-2 infection; COVID-19; Shivering; Headache; Sensitive skin; Appetite lost; Confused; Drowsiness; This is a spontaneous report from a contactable consumer or other non-healthcare professional received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107171143473640-H3BM1. Safety Report Unique Identifier GB-MHRA-ADR 25668509. A 27-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an route of administration on 14Jul2021 as first dose, single for COVID-19 immunization. Medical history included suppressed lactation. Patient had no symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. On an unspecified date, the patient experienced cough, confusion and disorientated. On 14Jul2021, patient was confused and drowsiness. On 15Jul2021, patient had sars-cov-2 infection, COVID-19, shivering, headache, sensitive skin and appetite lost. Clinical course was felt slow and disorientated after the first vaccine, had a continuous cough before the vaccine that continued. The day after she tested positive for COVID-19 and continue to test positive. Continue to have a cough, sensitive skin, achey, headaches, brain zaps, tingly nerves, loss of appetite and confusion. On 15Jul2021, the patient underwent lab tests and procedures which included sars-cov-2 test: negative (No-Negative COVID-19 test). The outcome of the events sars-cov-2 infection, appetite lost and drowsiness was not resolved on an unspecified date and remaining events was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1516866 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhage, Hypomenorrhoea, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100908946

Write-up: bleeding; Light periods; This is a spontaneous report from a contactable consumer received from the Regulatory Authority; report number is GB-MHRA-WEBCOVID-202107171555430460-UBDDU, Safety Report Unique Identifier GB-MHRA-ADR 25668933. A 21-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FD8813), on 13Jul2021 as dose 1, single for COVID-19 immunisation. Medical history included suppressed lactation. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Patient had period already this month and had completely finished the day after my vaccine I then began to have light bleeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. On an unspecified date, the patient experienced bleeding, and on 14Jul2021, the patient had light periods. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 14Jul2021 No - Negative COVID-19 test. The outcome of event bleeding was recovered on an unspecified date and event light periods was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516898 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fatigue, Headache, Illness, 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: Medical History/Concurrent Conditions: Anaemia vitamin B12 deficiency; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100908918

Write-up: Sickness; Began throwing up; Fatigue; Dizziness; Headache; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Authority; report number GB-MHRA-WEBCOVID-202107172123328880-Y0YGT. A 20-years-old non pregnant female patient received bnt162b2 (COVID-19 MRNA VACCINE BIONTECH; Solution for injection; Batch/Lot Number: FD5613) via an unspecified route of administration on 14Jul2021 as dose 2, single for covid-19 immunisation. Medical history included anaemia vitamin b12 deficiency and suppressed lactation.The patient concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant and patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine and patient was not enrolled in clinical trial. The patient previously received first dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH; Solution for injection; Batch/Lot Number: unknown) via an unspecified route of administration on an unknown date as dose 1, single for covid-19 immunisation. The patient experienced headache and dizziness on 14Jul2021, fatigue on 15Jul2021 and sickness on 16Jul2021. Headache began first the evening after the vaccine, got very painful early in the morning. Dizziness began the morning after. 2 days after the vaccine began throwing up around 5 times during the day and dizziness and headache got worse along with fatigue. Headache, dizziness and fatigue still ongoing (3 days after vaccine) with everything but the headache easing. The events were assessed as medically significant. The outcome of the event sickness was recovered on 16Jul2021. Outcome for headache was not recovered. Outcome of dizziness and fatigue was recovering. No follow-up attempts are Possible. No further information is expected.


VAERS ID: 1516916 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Ear infection, Eye discharge, Lacrimation increased, Pyrexia, SARS-CoV-2 test, Tinnitus
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hearing impairment (narrow), Lacrimal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ear infection
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: Negative
CDC Split Type: GBPFIZER INC202100909068

Write-up: fever; chills; ear infection; Watery sticky eyes; Watery sticky eyes; Tinnitus; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107180017234970-KV8C4. Safety Report Unique Identifier (GB-MHRA-ADR 25669394). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot unknown), via an unspecified route of administration on 13Jul2021 as dose 1, single for Covid-19 immunization. Medical history included ear infection. The patient''s concomitant medications were not reported. The patient experienced tinnitus on 14Jul2021 and on unspecified date, he had fever, chills, ear infection and watery sticky eye. The events were reported as serious medically significant, disability. The patient underwent laboratory test which included Sars-cov-2 test: negative covid-19 test on unknown date. The outcome of tinnitus was not recovered; for other events was unknown. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1516931 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-14
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Dizziness postural, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (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: Benign paroxysmal positional vertigo
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100916711

Write-up: brain disease; Positional 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-202107180913431670-BIT48, Safety Report Unique Identifier GB-MHRA-ADR 25669595. A 25-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 02Jul2021 (Batch/Lot Number: FD5613) as dose 1, single for covid-19 immunisation. Medical history included benign paroxysmal positional vertigo (BPPV). Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced brain disease (reported as cerebral haemorrhage) on an unspecified date and positional dizziness on 14Jul2021. The events were reported as serious (medically significant). It was reported that patient was not sure if this symptom was caused by the vaccination. He thought that one of the possibilities is BPPV (Benign paroxysmal positional vertigo) caused by his sleeping posture. On the other hand, he suspected the possibility of some brain disease caused by vaccination. He didn''t guess this was a side effect because it started 12 days after vaccinating. He reported just in case. 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 (No - Negative COVID-19 test) on 16Jul2021. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1517131 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XD986 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Computerised tomogram, Disorientation, Dizziness, Fibrin D dimer, Generalised tonic-clonic seizure, International normalised ratio, Laboratory test, Platelet count, Prothrombin time ratio
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: The patient did not have any past medical history according to the doctor.
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: CT scan; Result Unstructured Data: Normal; Test Date: 20210726; Test Name: Prothrombin ratio; Result Unstructured Data: 14.11; Test Date: 20210726; Test Name: Fibrin D dimer; Result Unstructured Data: still waiting for the result; Test Date: 20210726; Test Name: INR; Result Unstructured Data: 1.1; Test Date: 20210726; Test Name: Platelet count; Result Unstructured Data: 344,000; Test Date: 20210726; Test Name: Lab test; Result Unstructured Data: normal; Test Date: 20210726; Test Name: APTT; Result Unstructured Data: 33.7
CDC Split Type: IEJNJFOC20210758591

Write-up: EPISODE OF DISORIENTATION; EPISODE OF DIZZINESS/FELT LIKE GOING TO FAINT; GENERAL CLONIC-TONIC SEIZURE; This spontaneous report received from a physician concerned a 21 year old female. The patient''s height, and weight were not reported. The patient did not have any past medical history according to the doctor. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD986) dose was not reported, 1 total, administered on 14-JUL-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 14-JUL-2021, three minutes later after vaccination she had a general clonic-tonic seizure. She was advised to go to her local hospital, but she refused to go. On 16-JUL-2021, after two days she had an episode of disorientation, dizziness and felt that she was going to faint. She recovered and went to a coffee shop where she had another episode. There were some paramedical staff who took her to her local hospital. On an unspecified date in JUL-2021, she had her brain scan performed and the result was normal so she was discharged to home. On 26-JUL-2021, she had similar episodes of (disorientation, dizziness, felt she was going to faint) and she denied loss of consciousness. She was admitted to emergency room where she was at present. Laboratory data included: routine laboratory test (NR: not provided) normal, PMH-nil, activated partial thromboplastin time (NR: not provided) 33.7, Fibrin D dimer (NR: not provided) still waiting for the result, international normalized ratio (NR: not provided) 1.1, Platelet count (NR: not provided) 344, 000, and Prothrombin ratio (NR: not provided) 14.11. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had recovered from clonic-tonic seizure and and the outcome of episode of disorientation and episode of dizziness/felt like going to faint was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210758591-Covid-19 vaccine ad26.cov2.s -GENERAL CLONIC-TONIC SEIZURE, EPISODE OF DISORIENTATION, EPISODE OF DIZZINESS. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1517209 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003605 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Hyperpyrexia
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: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of HYPERPYREXIA and HEADACHE in a 55-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003605) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form in total. On 14-Jul-2021, the patient experienced HYPERPYREXIA (seriousness criterion medically significant) and HEADACHE (seriousness criterion medically significant). At the time of the report, HYPERPYREXIA and HEADACHE was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1517257 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0572 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, C-reactive protein, Neutrophil count, Neutrophil count increased, Pyrexia, Tonic convulsion
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bacterial infection; Subarachnoid haemorrhage
Allergies:
Diagnostic Lab Data: Test Date: 20210712; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination; Test Date: 20210714; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210714; Test Name: CRP; Result Unstructured Data: Test Result:within normal range; Test Date: 20210715; Test Name: CRP; Result Unstructured Data: Test Result:not increased; Test Date: 20210714; Test Name: Neutrophils; Result Unstructured Data: Test Result:increased; Test Date: 20210715; Test Name: Neutrophils; Result Unstructured Data: Test Result:increased
CDC Split Type: JPPFIZER INC202100909765

Write-up: Tonic convulsion attack; Pyrexia with 38s centigrade; Neutrophils increased; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120129. A 65-year-old female patient received BNT162B2 (COMIRNATY, Solution for Injection; lot number: EY0572 and expiration date: 31Oct2021), via an unspecified route of administration on 12Jul2021 at 14:09 (the day of vaccination), at the age of 65 years old as dose 2, single for COVID-19 immunization. Medical history included sequelae of subarachnoid hemorrhage and was still under medical treatment and also had bacterial infection. She had no medical history of seizure attack. The patient had no family history. The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.7 degrees centigrade on 12Jul2021. The event onset date was reported as 14Jul2021 at 03:20 (2 days after vaccination). In Jul2021, the patient was admitted to the hospital. The course of the event was as follows: The patient experienced tonic convulsion attack on 14Jul2021 at 03:00 AM. After diazepam (CERCINE) intravenous injection, the patient''s event was subsided. Almost around the same time, the patient experienced pyrexia with 38 centigrade on 14Jul2021 at 03:20. The blood test showed that neutrophils increased and C-reactive protein (CRP) was within normal range on 14Jul2021. The patient began to take sodium valproate, after that the patient experienced intermittent pyrexia and short seizures which were continued. The examination on the next day still showed that neutrophils were persistently increased and CRP was not increased on 15Jul2021. For treatment, the patient was transferred to other hospital. On 15Jul2021 (3 days after the vaccination), the outcome of the events was unknown. The reporting physician classified the event as serious (can lead to disability and hospitalization) and assessed that the events was related to BNT162B2. Other possible cause of the event such as any other diseases was suspect of bacterial infection. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: The reporting physician commented as follows: For sequelae of Subarachnoid hemorrhage, the patient prone to Symptomatic epilepsy. Antibiotics did not work for pyrexia with neutrophilia and almost normal range CRP. Therefore, it was considered that the event had causal relationship with vaccination.


VAERS ID: 1517278 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9880 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Hyperventilation, Seizure
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contrast media allergy; Panic disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202100910077

Write-up: Hyperventilation syndrome; Convulsion; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21119975. A 66-year and 10-month-old female patient received BNT162B2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 14Jul2021 at 14:20 (Batch/Lot Number: FC9880; Expiration Date: 30Sep2021) (at the age of 66-years-old) as dose 1, single for COVID-19 immunisation. Body temperature before vaccination was 36.9 degrees Centigrade. The patient had a history of allergy caused by examination using contrast media and panic disorder. The patient''s concomitant medications were not reported. On 14Jul2021 at 14:30 (the day of vaccination), the patient experienced Convulsion. On 14Jul2021 (the day of vaccination), the patient was admitted to the hospital. On 15Jul2021 (1 day after the vaccination), the outcome of the event was recovered. The course of the event was as follows: The patient was worried about adverse event (AE) of the vaccine. About 13 minutes after the vaccination, the palpitations and hyperpnoea occurred. Gradually the numbness of limbs and fingers'' stiffness appeared. It was diagnosed as hyperventilation syndrome and was recovering by breathing technique and drip of Anxiolytic. The patient had underlying disease of panic disorder and was very worried about vaccination AE, that could be a possible factor. The reporting physician classified the event as serious (caused hospitalization from 14Jul2021 to 15Jul2021) and assessed that the event was unrelated to BNT162B2. Other possible cause of the events such as any other diseases was panic disorder. The reporting physician commented as follows: The patient was alone (the patient''s sister was on night duty) and anxious about the transit of a long-distance route bus. So, the patient was hospitalized overnight just in case. The hospital took a follow-up observed. The patient was discharged without any problem. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: The patient was alone (the patient''s sister was on night duty) and anxious about the transit of a long-distance route bus. So, the patient was hospitalized overnight just in case. The hospital took a follow-up observed. The patient was discharged without any problem.; Sender''s Comments: The events seizure and Hyperventilation are considered intercurrent conditions and unrelated to suspect product BNT162B2 (COMIRNATY, Solution for injection).


VAERS ID: 1517296 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0843 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Dyspnoea, Hypersensitivity, Hypertension, Oxygen saturation, Palpitations
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Urticaria (The patient is being treated for urticaria.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Blood pressure; Result Unstructured Data: Test Result:185/105 mmHg; Comments: high; Test Date: 20210714; Test Name: Body temperature; Result Unstructured Data: Test Result:35.5 Centigrade; Comments: before vaccination; Test Date: 20210714; Test Name: SpO2; Test Result: 98 %
CDC Split Type: JPPFIZER INC202100910824

Write-up: allergic reaction; Shortness of breath; Palpitations; Blood pressure 185/105 mmHg, high; This is a spontaneous report from a contactable physician received from the Agency Regulatory authority report number is v21120161. A 65-year-old female patient received the first dose bnt162b2 (COMIRNATY), via an unspecified route of administration on 14Jul2021 12:00 (at the age of 65 years) (Batch/Lot Number: FF0843; Expiration Date: 31Oct2021) as a single dose for COVID-19 immunization. Medical history included ongoing urticaria and patient is being treated for it. The patient had no family history. Concomitant medication included an unspecified antiallergic medication for urticaria. Body temperature before vaccination was 35.5 degrees Centigrade. Urticaria appeared occasionally from before, and this time, the patient had urticaria from 4 days before the vaccination and antiallergic medication was administered and was under observation. On 14Jul2021 at 12:00 (same day of the vaccination), there was no urticaria symptoms, Comirnaty was given. The patient went home after 15 minutes of observation in the hospital. At 12:30 (30 minutes after the vaccination), when the patient arrived home, shortness of breath and palpitations appeared, and visited the hospital. Blood pressure 185/105 mm/Hg high, SpO2 98%. For physical findings, no other observation was found. Diagnosed as an allergic reaction caused by Comirnaty injection, Solu-Cortef 250mg was given by IV drip. Symptom was recovering about 1 hour. Then the patient went home. When the patient arrived home, the symptoms appeared again and the patient visited the hospital again. On 14Jul2021 (same days of the vaccination), the outcome of the event was recovering. The reporting physician classified the event as non-serious and assessed that that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1517303 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-14
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis, Magnetic resonance imaging head
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Infarction (Through head MRI)
Allergies:
Diagnostic Lab Data: Test Name: Head MRI; Result Unstructured Data: Test Result:Little old infarction
CDC Split Type: JPPFIZER INC202100911178

Write-up: Facial palsy; This is a spontaneous report from a contactable pharmacist received from the regulatory authority. The regulatory authority report number is v21120020. A 69-year-old female patient received BNT162B2 (COMIRNATY; solution for injection; lot number was not reported), via an unspecified route of administration on 03Jul2021 (at the age of 69-years-old) as dose 2, single for COVID-19 immunisation. Medical history included little old infarction (through head MRI). The patient''s concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY) on 12Jun2021 (lot number was not reported) as dose 1, single for COVID-19 immunisation. The clinical course of the event was as follows: On 03Jul2021 (the day of vaccination), the patient received the second dose of BNT162B2. In the morning of 14Jul2021 (11 days after the vaccination), the patient experienced facial palsy. The patient felt that water was leaking from the left corner of mouth, and mouth tilted to the right, so the patient received a check-up showed that the patient''s left eye could be closed. Through head MRI, only could be her little old infarction was found. The patient was treated with drug and rehabilitation. As of 16Jul2021 (13 days after the vaccination), the outcome of the event was not recovered. The reporting pharmacist 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. Information on the lot/batch number has been requested.


VAERS ID: 1517385 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1945 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Extensor plantar response, Intention tremor, Magnetic resonance imaging, Thirst, Tremor
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (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? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Flour sensitivity; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: MRI; Result Unstructured Data: Test Result:NO organic lesions
CDC Split Type: JPPFIZER INC2021894622

Write-up: Tremor limb; Thirst; Intention tremor; Reflex Babinski positive; This is a spontaneous report from a contactable Physician received via COVID-19 Regulatory Authority. The patient was a 70-year-old male. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and received antidiabetic drug and antihypertensive agent. The patient received BNT162B2 (COMIRNATY; Lot Number: FD1945), intramuscular in left arm on 14Jul2021 14:15 (at the age of 70-years-old) as dose 2, single for COVID-19 immunization. Medical history included diabetes mellitus, hypertension, and allergy to flour. Historical vaccine included BNT162B2 (COMIRNATY; Solution for injection; Lot Number: EW201), intramuscular on 23Jun2021 (at the age of 70-years-old) as dose 1, single for COVID-19 immunization. The patient experienced tremor limb and thirst on 14Jul2021 14:45 and later had intention tremor and Reflex Babinski positive on 14Jul2021. Tremor limb and thirst appeared 30 minutes after vaccination. After securing the route, Bosmin and Solu-Cortef were administered. The symptom was recovering once, but after that, the patient was transferred to the emergency hospital because of Intention tremor and Reflex Babinski positive. The patient was admitted to reporting physician''s hospital and followed up because the symptoms disappeared with no organic lesions on Magnetic resonance imaging (MRI). Outcome of events was resolved on 14Jul2021 with treatment including Bosmin and Solu-Cortef. The patient was discharged the next day, on 15Jul2021. Since the vaccination, the patient has not been tested for COVID-19. The reporter classified the events as serious (Hospitalization) and stated the events result in Hospitalization.; Sender''s Comments: Based on temporal association, the causal relationship between BNT162B2 and the events tremor, thirst, intention tremor and extensor plantar response cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1517388 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure decreased, Blood pressure measurement, Body temperature, Discomfort, Presyncope
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Blood pressure; Result Unstructured Data: Test Result: decreased; Test Date: 20210714; Test Name: Body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021896291

Write-up: Anaphylaxis; Parasympathetic reflex/vagal reflex; blood pressure decreased; feeling of discomfort; This is a spontaneous report from a contactable physician received from the Medical Agency (MA). Regulatory authority report number is v21119682. The patient was a 61-year and 9-month-old male (age at vaccination). Body temperature before vaccination was 36.1 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 14Jul2021 at 14:47 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EY0779, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 14Jul2021 at 15:00 (13 minutes after the vaccination), the patient experienced anaphylaxis. On 14Jul2021 (the day of the vaccination), the outcome of the event was recovering. The course of the event was as follows: 10 minutes after the vaccination, feeling of discomfort and blood pressure decreased. There were no other symptoms. It was suspected as Parasympathetic reflex. The reporting physician classified the event as non-serious and assessed that the event was unrelated to bnt162b2. The reporting physician commented as follows: It was very likely the vagal reflex was caused by the vaccination.


VAERS ID: 1517389 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8736 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Dyspnoea, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)

Life 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.
Allergies:
Diagnostic Lab Data: Test Date: 07/14/2021; Test Name: Body temperature; Result Unstructured Data: Test Result: 36.4?C.
CDC Split Type: JPPFIZER INC2021896507

Write-up: This is a spontaneous report from a contactable physician, received via the regulatory authority (report number: v21119747). A 51-year(8-month)-old male received the first dose of BNT162B2 (Comirnaty, solution for injection, lot# FC8736, expiration date: Sep 30, 2021), via unspecified route of administration, on Jul 14, 2021, at 17:00 (the day of vaccination), single dose, for COVID-19 immunization. Body temperature on Jul 14, 2021 (before vaccination) was 36.4?C. According to the vaccine screening questionnaire, patient had asthma. The event onset date was reported as Jul 14, 2021, at 17:30. On Jul 14, 2021 (the same day of the vaccination), the outcome of the event was recovering. The course of the event as follows: Mild dyspnea and the feeling of the pharynx being tightened occurred. The onset was 30-40 minutes after the vaccination. The symptoms were recovering after treatment with steroid and Neophyllin DIV. The patient was permitted to go home. The reporting physician classified the event as serious and related to BNT162B2. The reporting physician commented as follows: mild anaphylaxis. Follow-up attempts have been completed. No further information expected.


VAERS ID: 1517394 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9880 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Dyspnoea, Heart rate, Oxygen saturation, Pharyngeal swelling, Throat irritation
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: blood pressure; Result Unstructured Data: Test Result:117/70; Test Date: 20210714; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before the vaccination; Test Date: 20210714; Test Name: pulse; Result Unstructured Data: Test Result:98/min; Test Date: 20210714; Test Name: SpO2; Test Result: 99 %
CDC Split Type: JPPFIZER INC2021898071

Write-up: Anaphylaxis; the patient complains of itching, swelling in his throat; the patient complains of itching, swelling in his throat; Dyspnea; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. Regulatory authority report number is v21119704. A 39-years-old (reported as 39-year and 5-month-old) female patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: FC9880; Expiration Date: 30Sep2021), intramuscular on 14Jul2021 14:58 (at the age of 39 years old) as dose 1, single for covid-19 immunisation. The patient had no medical history (none). There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.5 degrees Centigrade (14Jul2021). On 14Jul2021 at 15:08 (10 mins after vaccination), the patient experienced anaphylaxis. On 14Jul2021 (the day of vaccination), the patient was admitted to the hospital. The course of the event was as follows: Approximately 10 minutes after intramuscular injection of COMIRNATY (14Jul2021 15:08), the patient complained of itching, swelling in his throat, dyspnea. Blood pressure 117/70, SpO2 99%, pulse 98 / min. Although the patient was normal consciousness, she was transferred to the hospital for observation and hospitalized from 14Jul2021. The outcome of the events reported was unknown. The reporting physician classified the event as serious (hospitalized from 14Jul2021) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1517420 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Muscular weakness, Rash
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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: Urticaria
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021903017

Write-up: Weakness of left upper extremities; rash on upper extremities; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21119744. A 46-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 14Jul2021 14:48 (Batch/Lot Number: EY0573; Expiration Date: 30Sep2021) as DOSE 1, SINGLE (age at vaccination 46 years old) for covid-19 immunisation. Medical history included urticaria from an unknown date and unknown if ongoing. The patient had history of in the evening, there was urticaria reason unknown. The patient''s concomitant medications were not reported. The patient experienced weakness of left upper extremities on 14Jul2021 15:13 and rash on upper extremities on 14Jul2021 15:13. The course of the event was as follows: Originally, the patient had urticaria in the evening every day. Follow-up was observed for 30 minutes. 25 minutes after vaccination, the patient experienced weakness of left upper extremities and rash on upper extremities. It was judged as early adverse effect, Atarax-P was injected, no obvious vital change. As it could not be predicted for the progress situation in the future, requested for an ambulance. The reporting physician classified the event as serious (likely disability) and assessed that the causality between the event and bnt162b2 as unassessable. The reporting physician commented as follows: Would like to collect data on weakness of upper extremities after vaccination.The patient underwent lab tests and procedures which included body temperature: 36.3 centigrade on 14Jul2021 before vaccination. Outcome of the events was unknown.


VAERS ID: 1517435 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1945 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asterixis, Asthenia, Blood pressure measurement, Body temperature, Depressed level of consciousness, Feeling abnormal, Oxygen saturation, Presyncope, Respiratory rate, Slow response to stimuli, Urinary incontinence
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Endometriosis (Receiving medical treatment in hospital.(details was unknown).)
Allergies:
Diagnostic Lab Data: Test Date: 20210614; Test Name: blood pressure; Result Unstructured Data: Test Result:104-110/70-80 mmHg; Comments: after vaccination; Test Date: 20210614; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination.; Test Date: 20210614; Test Name: SpO2; Result Unstructured Data: Test Result:97-98 %; Comments: after vaccination; Test Date: 20210614; Test Name: Respiratory rate; Result Unstructured Data: Test Result:17-18; Comments: after vaccination 17-18/min
CDC Split Type: JPPFIZER INC2021903339

Write-up: Consciousness clouding rapidly; Asterixis; Vasovagal reflex; Foggy feeling in head; No response to calling name; Urinary incontinence; Feelings of weakness; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21119815. The patient was a 42-year and 5-month-old female. Body temperature before vaccination was 36.4 degrees centigrade. 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) as follows: Endometriosis, receiving medical treatment in hospital (details was unknown). On 14Jul2021 at 12:00 (the day of the vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Lot number: FD1945, Expiration date: 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization. The event onset date was reported as 14Jul2021 at 12: 05 (5 mins after the vaccination), the patient experienced Vasovagal reflex. The course of the event was as follows: Body temperature before vaccination was 36.4 degrees centigrade, no subjective symptoms. No abnormal in pharyngolarynx, heart sound, breath sound. Consciousness was clear. After the intramuscular injection of 0.3 ml FD1945 of Pfizer company. The patient told the counter that Foggy feeling in head appeared in several minutes. After that, consciousness clouding rapidly, no response to calling name, Urinary incontinence. Instantly moved to bed, brought down the head posture, raised up lower limbs. After several minutes, regained consciousness, had response to calling name. Movement of limbs could follow the instruction normally. Feelings of weakness, meantime SpO2 97-98%, blood pressure 104-110/70-80 mmHg, Respiratory rate 17-18/min, after about 10 minutes, still could not keep the posture, ambulance requested, transferred to hospital. Strongly doubted as serious Vasovagal reflex for the vaccination. It was also reported that the patient experienced asterixis. The outcome of the events was reported as unknown. The reporter classified of the events as serious (Medically significant) and assessed that the causality between the event and bnt162b2 as unassessable. Other possible cause of the event such as any other diseases: Unable to comment. The reporter commented as follow: Strongly doubted as serious Vasovagal reflex for the vaccination. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1517458 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-07-14
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0203 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cold sweat, Feeling cold, Heart rate, Hyperhidrosis, Oxygen saturation
SMQs:, Neuroleptic malignant syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Bp; Result Unstructured Data: Test Result:135/88 mmHg; Test Date: 20210615; Test Name: Body temperature; Result Unstructured Data: Test Result:35.4 Centigrade; Comments: before vaccination; Test Date: 20210714; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Test Date: 20210714; Test Name: pulse rate; Result Unstructured Data: Test Result:69; Comments: p:69 times/minutes; Test Date: 20210714; Test Name: SpO2; Test Result: 97 %
CDC Split Type: JPPFIZER INC2021905177

Write-up: Feeling cold; cold sweat; sweaty; This is a spontaneous report from a contactable office work received from the Agency Regulatory authority report number is v21120066. A 73-year 1-month old male patient received the first dose of BNT162b2 (COMIRNATY, Lot number EW0203, Expiration date 30Sep2021) via an unspecified route of administration on 15Jun2021 at 13:40 (the day of vaccination) (at the age of 73-year 1-month old) for COVID-19 immunisation. Body temperature before vaccination was 35.4 centigrade. Patient''s history according to 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) included that there was rash 2-3 days after influenza vaccination last year, and there were no other allergies. Concomitant medications were not reported. On 14Jul2021 (29 days after the vaccination), the patient experienced the following events. Clinical course was reported as follows. After the first dose vaccination of Comirnaty, feeling cold was obvious with cold sweat. Body temperature: 36.4 centigrade. Bp: 135/88mmHg. p: 69 times/minutes. SpO2: 97%. Obvious sweating, under observation with fluid replacement. After the drip, the patient returned home without feeling poorly. On 14Jul2021 (29 days after the vaccination), the outcome of the event was recovering. It was also reported that the events resolved on 14Jul2021. The reporting physician classified the event as non-serious and the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1517469 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0203 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Seafood allergy
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:37.0 degrees Centigrade
CDC Split Type: JPPFIZER INC2021905876

Write-up: bleeding spot; allergic reactions; urticaria appeared on the right forearm; This is a spontaneous report from a contactable physician received via COVID-19 and received from the Agency Regulatory authority report number is v21120160. A 58-year-old female patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EW0203, Expiration date 30Sep2021) via intramuscular route of administration in the right deltoid muscle on 14Jul2021 at 11:30 at age of 58 years old as single dose for COVID-19 immunization. Medical history included allergy to abalone and hypertension. Body temperature before the vaccinations was 37.0 degrees Centigrade. The patient was non-pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received prescription drugs within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient family history was unknown. Patient''s history according to 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, etc.) was allergy to abalone. After vaccination, at around 13:00, urticaria appeared on the right forearm. At around 15:00, the patient visited reporting hospital, although urticaria disappeared, bleeding spots were seen at 15:15 on 14Jul2021. The event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event was unknown with treatment including Anti-allergic agent administration. Since the vaccination, the patient had not been tested for COVID-19. Clinical course of the event was reported as follows: On 14Jul2021, at 11:30, intramuscular injection was performed on the right deltoid muscle. On the same day, at around 13:00, wheals was noted on the right forearm. At 15:15, the patient had a medical examination. Welts disappeared and bleeding spots was noted. The systemic condition was well. On 14Jul2021 (the day of vaccination), the outcome of event was not recovered. The reporter classified the event as non-serious and assessed the causality between the event and the vaccines as related. Other possible cause of the event such as any other diseases was none. The reporter concluded as follows: The symptoms were considered allergic reactions (urticaria) due to the vaccination.


VAERS ID: 1517473 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-14
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021908097

Write-up: the patient was admitted to the hospital as infected with COVID-19; the patient was admitted to the hospital as infected with COVID-19; This is a spontaneous report received from a contactable consumer (patient) communicated to medical information team. A 68-year-old patient of an unspecified gender received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number not confirmed, Expiration date not confirmed), via an unspecified route of administration, on 30Jun2021 (the day of vaccination), as Dose 1 single, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 14Jul2021, at the daytime, the patient was admitted to the hospital as infected with COVID-19. The patient may be discharged on 28Jul2021. The scheduled second dose, which was on 21Jul2021, was cancelled once, and was rescheduled on 30Jul2021, on the premise of discharge from the hospital on 28Jul2021. The patient was asking if it was okay to perform vaccination on this schedule; also, would antibody be produced if infected. The outcome of the event COVID-19 was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1517683 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Chest discomfort, Heart rate increased, Myalgia, Palpitations, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210714; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade
CDC Split Type: PLPFIZER INC202100913534

Write-up: Palpitation; muscle pain; weakness; fever; tightness of the chest; fast heartbeat; This is a spontaneous report from a non-contactable consumer received by phone. A female patient of an unspecified age received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 14Jul2021 09:30 (Batch/Lot number was not reported) as 2 DOSE, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 an unknown date. The patient experienced palpitation (medically significant) on 14Jul2021 with outcome of unknown , muscle pain (non-serious) on 14Jul2021 with outcome of unknown, weakness (non-serious) on 14Jul2021 with outcome of unknown, fever (non-serious) on 14Jul2021 with outcome of unknown, tightness of the chest (non-serious) on 14Jul2021 with outcome of unknown, fast heartbeat (non-serious) on 14Jul2021 with outcome of unknown. The patient took Ibuprofen. The patient underwent lab tests and procedures which included body temperature: 39 centigrade on 14Jul2021. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1519166 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002920 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Dizziness, Gait deviation, Headache, Physical examination, Syncope
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: Test Date: 20210714; Test Name: RR; Result Unstructured Data: 155/110; Test Date: 20210714; Test Name: FAST; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: ATMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of GAIT DEVIATION, DIZZINESS, SYNCOPE and HEADACHE in a 56-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002920) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 14-Jul-2021 at 3:00 PM, the patient experienced GAIT DEVIATION (seriousness criterion hospitalization), DIZZINESS (seriousness criterion hospitalization), SYNCOPE (seriousness criteria hospitalization and medically significant) and HEADACHE (seriousness criterion hospitalization). At the time of the report, GAIT DEVIATION, DIZZINESS, SYNCOPE and HEADACHE had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jul-2021, Blood pressure measurement: 155/110 (High) 155/110. On 14-Jul-2021, Physical examination: negative (Negative) Negative. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter considered GAIT DEVIATION, DIZZINESS, SYNCOPE and HEADACHE to be possibly related. No concomitant medications were reported. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1519215 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1820095 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse event, Paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: KRJNJFOC20210763499

Write-up: ACUTE PARALYSIS; OTHER EVENTS; This spontaneous report received from a health care professional via a Regulatory Authority concerned a 7 decade 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: 1820095, expiry: 4-JUL-2021) dose was not reported, 1 total, administered on deltoid on 12-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUL-2021, the patient experienced acute paralysis and other events. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the acute paralysis and other events was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210763499- covid-19 vaccine ad26.cov2.s-Acute paralysis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1519350 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202100925352

Write-up: Anaphylactic reaction; Pain; This is a spontaneous report from a contactable other health professional received via the Regulatory Authority, Regulatory authority report number is 586903. A 46-year-old female patient received second dose of BNT162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 14Jul2021, the patient experienced anaphylactic reaction and pain, both 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: 1520481 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chills, Feeling cold, Gait inability, Muscle tightness, Nervousness, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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: Back disorder; Osteoarthritis of cervical spine
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202100915635

Write-up: Inability to walk; Cold; Extreme muscle tension; Nervousness; Tremor; Chills/shivering; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory Agency WEB ES-AEMPS-944276. A 47-year-old male patient received the second dose of bnt162b2 (COMIRNATY), intramuscular, administered in arm left on 13Jul2021 (Batch/Lot Number: FE6208) as a single dose for COVID-19 immunization. Medical history included spinal osteoarthritis and back problems. Patient has not been infected with COVID-19. The patient''s concomitant medications were not reported. Patient previously received the first dose of bnt162b2 (COMIRNATY) on an unspecified date. The patient experienced inability to walk, cold, extreme muscle tension, nervousness, and tremor on 14Jul2021. Treatment followed for the adverse drug reaction included paracetamol. Clinical course was reported as follows: Everything that happened was at 3 in the morning. It took the patient a lot to walk because of the tension, chills, and shivering. Patient have a lot of back problems but he can walk without problem and play sports. Patient had a good time getting down the stairs, trying to lean on the railing and walls. When he got to the medicine drawer, he could not bend down to get a paracetamol, due to the generalized huge tension throughout his body. He managed to put two blankets on the bed with his house at 24?C inside temperature. At the time of report, patient has nervousness, but no longer had tremors, and no longer disabled, as he was a few hours ago. The patient states that "It was a savage experience last night. Nothing like this had ever happened to me." Outcome of the events inability to walk and tremor was recovered on 14Jul2021; of the events cold, extreme muscle tension, and chills/shivering was recovering; and of the event nervousness was not recovered. Therapeutic measures were taken as a result of all events. This case was reported as serious with seriousness criteria: medically significant. No follow-up attempts possible. No further information expected.


VAERS ID: 1520775 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-07-14
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Fatigue, Illness, Menstruation irregular, Nasopharyngitis, Polymenorrhoea, SARS-CoV-2 test
SMQs:, Fertility disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20201214; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100923043

Write-up: period 2 weeks early; loss of appetite; feel run down; ill/sick; cold; Frequent periods; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-APPCOVID-202107191959453480-4IDQS, Safety Report Unique Identifier GB-MHRA-ADR 25675771. A 27-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 23Jun2021 (Batch/Lot Number: fc9001) as SINGLE DOSE for covid-19 immunisation. Medical history included Lactation decreased, suspected covid-19 from 14Dec2020 to 22Dec2020. The patient''s concomitant medications were not reported. Patient is not pregnant. Patient is not currently breastfeeding. The patient experienced cold on an unspecified date, frequent periods on 14Jul2021, loss of appetite on an unspecified date, period 2 weeks early on an unspecified date, feel run down on an unspecified date, ill/sick on an unspecified date. The case was reported as serious due to medically important condition. The patient underwent lab tests and procedures which included COVID-19 virus test: Yes - Positive COVID-19 test on 14Dec2020, COVID-19 virus test: negative on an unknown date. The outcome of the event Cold was recovering, the outcome of the event Frequent periods was not recovered, and the outcome of the other events was unknown. The clinical course was reported as follows: "Since having the vacine I have started my period 2 weeks early, its not like a normal period for me its almost like it stops but then the next day I bleed again. My period are always every 4 weeks, I am not on birth control, I am definitely not pregnant. Since this has started I have become ill, I feel run down, with a cold, loss of appetite, sick. I have taken a covid test to check and it is negative". Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1520818 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Body temperature fluctuation, Headache, Hyperacusis, Hyperaesthesia, Influenza, Joint stiffness, Myalgia, Photophobia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Hearing impairment (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19 (Unsure when symptoms started and when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: temperature; Result Unstructured Data: Test Result:fluctuation; Test Date: 20210714; Test Name: temperature; Result Unstructured Data: Test Result:dip; Test Date: 20210208; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100916432

Write-up: flu; headache; Generalised joint pain; Joint stiffness; Muscle ache; Body temperature fluctuation; sensitive to light, noise; sensitive to light, noise; increase in muscle and skin sensitivity/ sensitive to touch; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number, and Safety Report Unique Identifier. A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jul2021 (lot number: FC9001) as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased, and suspected COVID-19 from an unknown date and unknown if ongoing (unsure when symptoms started and when symptoms stopped). Patient is not pregnant and not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medications were not reported. The patient experienced increase in muscle and skin sensitivity/ sensitive to touch on 14Jul2021 with outcome of recovering, flu on an unspecified date with outcome of recovering, headache on an unspecified date with outcome of recovering, generalised joint pain on 16Jul2021 with outcome of recovered with sequelae on 16Jul2021, joint stiffness on 15Jul2021 with outcome of recovered on 17Jul2021, muscle ache on 14Jul2021 with outcome of recovering, body temperature fluctuation on 14Jul2021 with outcome of recovered on 16Jul2021, and sensitive to light, noise on 14Jul2021 with outcome of recovering. The events were assessed as serious as other medically important condition and disability. Additional Information: Sensitive to touch, light, noise. Sensitive and tender in gland areas, headache and muscle ache as though getting flu. Then after temperature dip (exposed to change in temperature), rapid (within 20 minutes) increase in muscle and skin sensitivity, stiffness of joints and pain to the point was afraid to move. Paracetamol taken. Wore off over couple of hours but left with heightened but milder sensitivity and still aching, though mild. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 08Feb2021, body temperature: dip on 14Jul2021, body temperature: fluctuation on 14Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1520823 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-14
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest X-ray, Dyspnoea, Electrocardiogram, Heart rate, Palpitations, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: GAVISCON [ALGINIC ACID;ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM TRISILICATE;SODIUM BICARBONATE]; LACTOBACILLUS ACIDOPHILUS; VITAMIN D [VITAMIN D NOS]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Belching; Irritable bowel
Allergies:
Diagnostic Lab Data: Test Name: blood tests; Result Unstructured Data: Test Result:unknown results; Test Name: chest X-ray; Result Unstructured Data: Test Result:unknown results; Test Name: ECG; Result Unstructured Data: Test Result:unknown results; Test Date: 20210717; Test Name: heart; Result Unstructured Data: Test Result:pounding; Test Date: 20210716; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100916611

Write-up: Heart pounding; Shortness of breath; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107180951590190-KQ0QE and Safety Report Unique Identifier is GB-MHRA-ADR 25669619 A 31-year-old male patient received first dose of BNT162B2 (BNT162B2), via an unspecified route of administration on 07Jul2021 (lot number: FE1510) as single dose for COVID-19 immunisation. The patient medical history included belching and irritable bowel. He has not had symptoms associated with COVID-19 and not enrolled in clinical trial. Concomitant medications included alginic acid, aluminium hydroxide gel, dried, magnesium trisilicate, sodium bicarbonate (GAVISCON) taken for belching from 01May2020; lactobacillus acidophilus taken for irritable bowel from 13Apr2021; Vitamin D taken for irritable bowel from 01Aug2020. He previously took penicillin and experienced allergic to penicillin. The patient experienced shortness of breath on 14Jul2021 and heart pounding on 17Jul2021. Case narrative: Went to emergency department after calling 111 on 17/07 after suffering multiple episodes of shortness of breath throughout the day without doing anything physical. Relevant investigations or tests conducted: ECG, chest X-ray, blood tests on an unknown date with unknown results. He has not tested positive for COVID-19 since having the vaccine. He underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on 16Jul2021. The outcome of the events was not recovered. Case was reported as serious by health authority (hospitalization and medically significant). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1520866 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Ear pain, Lymphadenopathy, Migraine, Muscle spasms, Nasal congestion, Neck pain, Parosmia
SMQs:, Taste and smell disorders (narrow), Dystonia (broad), 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: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100916424

Write-up: Altered smell sensation; Nose congestion; Swollen lymph nodes; Neck pain (with radiation); Ear pain; Joint pain; Migraine headache; Leg cramps; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107181829225390-DHM4X, Safety Report Unique Identifier is GB-MHRA-ADR 25669859. A 30-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (lot number: FE1510) as single dose for COVID-19 immunisation. Medical history included lactation decreased and suspected COVID-19 from 30Mar2021 to 18Apr2021. She has not had a COVID-19 test, not pregnant, not currently breastfeeding, and not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced leg cramps on 14Jul2021; joint pain and migraine headache on 15Jul2021; altered smell sensation, nose congestion, swollen lymph nodes, neck pain (with radiation), and ear pain on 16Jul2021. She has not tested positive for COVID-19 since having the vaccine. The patient recovered from joint pain and migraine headache on 17Jul2021, while recovering from other events. Case was reported as medically significant by health authority. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1520893 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-14
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Migraine, Neck pain, SARS-CoV-2 test
SMQs:, Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LISDEXAMFETAMINE DIMESYLATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Attention deficit disorder; Lactation decreased; Neck pain
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100916573

Write-up: neck pain; Migraine; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number, Safety Report Unique Identifier. A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Jul2021 (Batch/Lot Number: FD8813) as dose number unknown, single for COVID-19 immunization. Medical history included neck pain, lactation decreased and attention deficit disorder. Patient has not had symptoms associated with COVID-19. Patient is not pregnant; Patient is not currently breastfeeding. Concomitant medication included lisdexamfetamine mesilate (LISDEXAMFETAMINE DIMESYLATE) taken for attention deficit disorder from 10Jun2013. On an unspecified date, the patient experienced neck pain. On 14Jul2021, the patient experienced migraines. The patient had COVID-19 Virus Test (16Jul2021): No- Negative COVID-19 test. The patient has been experiencing very painful migraines and neck pain. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The case is serious (medically confirmed). The outcome of the neck pain was recovering; outcome for the migraine was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1520904 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Catarrh, Cough, Dyspnoea, Feeling abnormal, Influenza like illness, Lacrimation increased, Nasal congestion, Productive cough, Pyrexia, Rhinorrhoea, Sneezing
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Lacrimal disorders (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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: BENADRYL ALLERGY RELIEF; IBUPROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hay fever; Pain menstrual
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: Fever; Result Unstructured Data: Test Result:37.5 Centigrade
CDC Split Type: GBPFIZER INC202100923295

Write-up: watery eyes; phlegm; catarrh; Flu like symptoms; weak; Coughing; Difficulty breathing; Feeling dazed; Fever/mild fever of 37.5C; Nose congestion; Sneezing; Runny nose; This is a spontaneous report from a contactable consumer (patient) received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107190023218630-RTMDY. Safety Report Unique Identifier GB-MHRA-ADR 25670198. A 41-year-old female patient received the second dose of BNT162B2 via an unspecified route of administration on 12Jul2021 (Lot Number: FE1510) as single dose for covid-19 immunization. Medical history included Pain menstrual and Hay fever. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medications included acrivastine (BENADRYL ALLERGY RELIEF) taken for Hay fever from 25May2021 to 02Jul2021; ibuprofen (IBUPROFEN) taken for Pain menstrual from 01Jan2000 to an unspecified stop date. The patient experienced watery eyes on an unspecified date with outcome of recovering, phlegm on an unspecified date with outcome of recovering, catarrh on an unspecified date with outcome of recovering, feeling dazed on 16Jul2021 with outcome of recovered on 18Jul2021, fever on 16Jul2021 with outcome of recovered on 18Jul2021, sneezing on 14Jul2021 with outcome of recovered on 18Jul2021, runny nose on 14Jul2021 with outcome of not recovered, nose congestion on 15Jul2021 with outcome of not recovered, coughing on 17Jul2021 with outcome of not recovered, difficulty breathing on 16Jul2021 with outcome of not recovered, Flu like symptoms on an unspecified date with outcome of unknown, weak on an unspecified date with outcome of unknown. The events were serious as medically significant. Clinical course: Started with sneezing and intensive catarrh after less than 2 days since taking the second jab. Then had flu like symtoms, mild fever of 37.5C, feeling dazed, weak, watery eyes, not feeling fit to work, with mild breathing difficulties developing towards more breathing difficulties, feeling like her bronchial tubes are narrowed, cough changing into more dry, more intensive, few times have felt she had a phlegm in her mouth. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1520938 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Diarrhoea, Fatigue, Headache, Hyperhidrosis, Nausea, Nightmare, Tension headache
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100923307

Write-up: Diarrhea; Nausea; Armpit pain; headache; Nightmares; Fatigue; Drenching sweats; Tension headache; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107190956492880-1TWS4. Safety Report Unique Identifier GB-MHRA-ADR 25671661. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 14Jul2021 (Lot Number: FD5613), at the age of 34-year-old, as dose 2, single, for COVID-19 immunisation. Medical history included lactation decreased. No existing conditions or medication. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced headache on 14Jul2021 with outcome of not recovered , nightmares on 14Jul2021 with outcome of recovered on 16Jul2021, fatigue on 14Jul2021 with outcome of recovering diarrhea on 19Jul2021 with outcome of not recovered, armpit pain on 16Jul2021 with outcome of recovering, nausea on 19Jul2021 with outcome of not recovered, drenching sweats on 14Jul2021 with outcome of recovering, tension headache on 14Jul2021 with outcome of recovered on an unknown date. The events were reported as serious (medically significant). The clinical course included: Approx 12 hours after vaccine developed headache, sweats, fatigue and nightmares. All persisted for 48 hours. Armpit pain developed after 48 hours and persisted for 48 hours. Digestive issues developed on 5th day, ongoing. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No Follow-up attempts are needed. No further information is expected.


VAERS ID: 1521028 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysphonia, Hangover, Pain, SARS-CoV-2 test, Speech disorder
SMQs:, Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (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: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression mental; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100923414

Write-up: hungover; Hoarse voice; I have struggled speaking; it goes on the more painful it is/It''s painful to talk; This is a spontaneous report from a contactable consumer (patient) received from The regulatory authority report number is GB-MHRA-WEBCOVID-202107191513446040-JMKVJ, Safety Report Unique Identifier is GB-MHRA-ADR 25673715 A 37-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jul2021 (Lot Number: FD5613) as single dose for COVID-19 immunisation. The patient was not pregnant and not currently breastfeeding. Medical history included suppressed lactation and depression mental, both from an unknown date and unknown if ongoing. Concomitant medication included sertraline taken for depression mental, start and stop date were not reported. On 14Jul2021, the patient experienced hungover and hoarse voice. The clinical course was reported as follows: the day after my jab I felt hungover and like I''d been hit by a bus but that only lasted 24hrs but it''s a week tomorrow that I have struggled speaking. Sometimes my voice comes back to normal but the longer it goes on the more painful it is/It''s painful to talk, painkillers barely touch it. The events were serious, medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on an unspecified date. The patient outcome of hungover was recovered and the outcome of the other events was not recovered. Additional information: the patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1521044 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Abdominal pain upper, Foetal monitoring, Gynaecological examination, Inappropriate schedule of product administration, Maternal exposure during pregnancy, Muscle contractions involuntary, Uterine contractions during pregnancy
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation
Allergies:
Diagnostic Lab Data: Test Name: Foetal monitoring; Result Unstructured Data: Test Result:Normal; Test Name: internal vaginal/cervix assessment; Result Unstructured Data: Test Result:Normal
CDC Split Type: GBPFIZER INC202100923208

Write-up: pain in abdomen; contractions lessoned/back and hips like contractions; contracted stomach area; Uterine contractions during pregnancy; Maternal exposure during pregnancy/Patient was exposed to the medicine Third-trimester (29-40 weeks).; received dose1 on 20May2021, dose 2 on 14Jul2021; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107191656318910-96OUL. Safety Report Unique Identifier GB-MHRA-ADR 25674316. A 35-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 14Jul2021 (Batch/Lot Number: FE1510) (at the age of 35-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing pregnancy, folic acid supplementation from an unknown date. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not currently breastfeeding. Concomitant medication included folic acid taken for folic acid supplementation, start and stop date were not reported. Historical vaccine includes BNT162B2 dose 1 via an unspecified route of administration on 20May2021 (lot number EW4109) for COVID-19 immunisation and experienced increased pain/contraction pains and tightening reduced over the next few days, Braxton Hicks type contractions at 27 weeks, maternal exposure during pregnancy, Premature uterine contractions. The patient experienced pain in abdomen on an unspecified date, contractions lessoned/back and hips like contractions on an unspecified date, uterine contractions during pregnancy on 15Jul2021, contracted stomach area on an unspecified date, maternal exposure during pregnancy/patient was exposed to the medicine third-trimester (29-40 weeks) on 14Jul2021, received dose1 on 20may2021, dose 2 on 14jul2021. Following day of vaccine 1, Braxton Hicks type contractions at 27 weeks, increased pain and regularity throughout day, reduced baby movement. Went to hospital for monitoring found baby movement ok but signs of cervix moving and preterm labour. Reduced and contraction pains and tightening reduced over the next few days. Following 2nd vaccine, 1 am the next morning contraction type pains. Both very contracted stomach area and pain in abdomen, back and hips like contractions. Came and went for 5 hours until it settled down and contractions lessoned and resolved themselves. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Details of previous pregnancies: No other issues whilst pregnant. Patient was exposed to the medicine Third-trimester (29-40 weeks). Details of scans or investigations: All on track. The patient underwent lab tests and procedures which included foetal monitoring: normal on an unspecified date, internal vaginal/cervix assessment: normal on an unspecified date. The outcome of the event pain in abdomen and contractions lessoned/back and hips like contractions was not resolved, of the event uterine contractions during pregnancy was resolved on 15Jul2021 and of the other events was unknown. The events were reported as serious due to hospitalization, medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1521207 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-07-14
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Diarrhoea, Headache, Hot flush, Inappropriate schedule of product administration, Maternal exposure during pregnancy, Myalgia, Pyrexia, SARS-CoV-2 test, Scan
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CYCLIZINE; IRON; ONDANSETRON
Current Illness: Pregnancy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative; Test Name: Scan; Result Unstructured Data: Expected growth, suffering from hyperemisis gravdarum since 5 weeks pregnant.
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Maternal exposure during pregnancy; Inappropriate schedule of product administration; Chills; Muscle ache; Stools loose; Hot flush; Headache; Fever; This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flush), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle ache) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3003608 and 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Supplementation therapy: FOLIC ACID (Patient did not take folic acid supplement during pregnancy.). Past adverse reactions to the above products included No adverse event with FOLIC ACID. Concurrent medical conditions included Pregnancy. Concomitant products included CYCLIZINE, IRON and ONDANSETRON for an unknown indication. On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 14-Jul-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On 15-Jul-2021, the patient experienced DIARRHOEA (Stools loose), HOT FLUSH (Hot flush) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and MYALGIA (Muscle ache) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration). On 16-Jul-2021, HOT FLUSH (Hot flush), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle ache) had resolved. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration) outcome was unknown and DIARRHOEA (Stools loose) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Scan: abnormal (abnormal) Expected growth, suffering from hyperemisis gravdarum since 5 weeks pregnant.. No treatment information were provided by the reporter. This is a case of Maternal exposure during pregnancy with associated AEs (Diarrhea, Hot, flush, Headache, Pyrexia, Chills, Myalgia) for this 31-year-old female. This is also a case of Inappropriate schedule of product administration. No further information is expected.; Sender''s Comments: This is a case of Maternal exposure during pregnancy with associated AEs (Diarrhea, Hot, flush, Headache, Pyrexia, Chills, Myalgia) for this 31-year-old female. This is also a case of Inappropriate schedule of product administration. No further information is expected.


VAERS ID: 1521369 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2707 / 2 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Haemorrhagic pneumonia, Hypoxia, Myocardial ischaemia, Overdose, Pneumopericardium, Respiratory failure, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Drug abuse and dependence (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Medication errors (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Hypokalaemia (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:
CDC Split Type: ITPFIZER INC202100948625

Write-up: Asthenia; Pneumopericardium; Myocardial ischemia; Respiratory failure; Hemorrhagic pneumonia; Syncope the next morning; Vomiting; Hypoxia; as dose 2, 0.5 ml single for covid-19 immunisation.; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-759324. A 49-year-old male patient received the second dose of bnt162b2 (COMIRNATY; solution for injection; Lot Number: FE2707; Expiration Date: 31Oct2021) via an unspecified route of administration, administered in right arm on 14Jul2021 15:26, 0.5 ml single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced asthenia about 2 hours later, vomiting at night, in the morning after syncope and later hospitalization for respiratory failure in right lung (suspected hemorrhagic bacterial lung), with pneumopericardium, myocardial ischemia due to hypoxia, ins, acute prerenal) on 14Jul2021 at 17:26. Therapeutic measures were taken as a result of the events with antibiotic therapy with Levofloxacin and Piperacillin / Tazobactam and continuous positive airway pressure. No improvement and transfer from Intensive therapy to the medical ward on 19Jul2021. The clinical outcome of the events was recovering. Regulatory authority comment: 20Jul2021 Pharmacovigilance Regional Center: requests for follow-up information from the reporter regarding the medical documentation of the case. Pending. Reporter Comment: Reaction time: 17:26 - Posted by VigiCovid19-tab.


VAERS ID: 1521384 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100909889

Write-up: Headache; Malaise; Giddiness; Micturition frequency increased; This is a spontaneous report from a non-contactable Consumer received via COVID-19 Vaccine Adverse Event Self-Reporting Solution. A 44-year-old male patient received BNT162B2 (COMIRNATY; Lot Number: EW0207; Expiration Date: 30Sep2021), via an unspecified route of administration on 13Jul2021 13:15 (at the age of 44-years-old) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 13Jul2021 at 13:15 (the day of vaccination), the patient was vaccinated. On 14Jul2021 (1 day after the vaccination), the patient experienced Headache, Malaise, Giddiness and Micturition frequency increased. The outcome of the events was recovered in Jul2021 with treatment including Intravenous ST3: 200 ml. The reporter did not provide seriousness assessment. No follow up attempts are possible. No further information is expected.


VAERS ID: 1521391 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Depressed level of consciousness, Dyspnoea, Feeling cold, Heart rate, Heart rate increased, Oropharyngeal discomfort, Oxygen saturation, Oxygen saturation decreased
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (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: MARVELON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Endometriosis
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Blood pressure; Result Unstructured Data: Test Result:118/60; Test Date: 20210714; Test Name: Blood pressure; Result Unstructured Data: Test Result:122/80; Test Date: 20210714; Test Name: HR; Result Unstructured Data: Test Result:102; Test Date: 20210714; Test Name: HR; Result Unstructured Data: Test Result:88; Test Date: 20210714; Test Name: SPO2; Result Unstructured Data: Test Result:89; Test Date: 20210714; Test Name: SPO2; Result Unstructured Data: Test Result:98
CDC Split Type: JPPFIZER INC202100911416

Write-up: consciousness clouding; SpO2 89; Feeling cold; Difficulty in breathing; Oropharyngeal discomfort; Heart rate (HR) was 102; This is a spontaneous report from a contactable physician received via COVID-19 Vaccine Adverse Event Self-Reporting Solution (COVAES). A 44-year-old non-pregnant female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 14Jul2021 12:15 (Batch/Lot Number: EW0201; Expiration Date: 30Sep2021) (at the age of 44 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included endometriosis from an unknown date and unknown if ongoing. Concomitant medication included desogestrel, ethinylestradiol (MARVELON) taken for an unspecified indication, start and stop date were not reported. The patient previously took PL and experienced drug hypersensitivity. Historical vaccine included bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 23Jun2021 12:15 (Batch/Lot Number: FC3661; Expiration Date: 30Sep2021) (at the age of 44 years) for covid-19 immunisation. The patient experienced consciousness clouding, feeling cold, difficulty in breathing, oropharyngeal discomfort, spo2 89, Heart rate (HR) was 102 all on 14Jul2021 12:45 with outcome of recovered. Therapeutic measures were taken as a result of events. On 14Jul2021 at 12:45 (30 minutes after the vaccination), the patient experienced adverse events. The patient experienced feeling cold and feeling like leaning back in the chair 12 minutes after the vaccination. Dyspnoea and oropharyngeal discomfort also developed. Blood pressure was 118/60. Heart rate (HR) was 102. SpO2 was 89. The patient was lying on bed at rest and feeling better after intravenous drip of Lactec 250ml. Blood pressure was 122/80. HR was 88. SpO2 was 98. Consciousness clouding also recovered. The reporter classified the events as non-serious. The outcome of the events was recovered with treatment including intravenous drip (fluid replacement). Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on temporal association, the reported events are probably related to the 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 RAs, Ethics Committees, and investigators, as appropriate.


VAERS ID: 1521399 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Feeling abnormal, Hyperhidrosis, Vital signs measurement
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Dementia (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PRAVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidaemia
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: blood pressure decreased; Result Unstructured Data: Test Result:70 mmHg; Comments: 14:30; Test Date: 20210714; Test Name: blood pressure decreased; Result Unstructured Data: Test Result:100 mmHg; Comments: after lying down; Test Date: 20210714; Test Name: Vital measurement; Result Unstructured Data: Test Result:unknown results
CDC Split Type: JPPFIZER INC202100911735

Write-up: blood pressure decreased to 70 mmHg; feels poorly; sweating moistly; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. A 65-year-old non-pregnant female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number EY5423, Expiration date 31Aug2021), intramuscular, administered in arm left on 14Jul2021 14:15 as dose 2, single (at the age of 65 years old) for COVID-19 immunisation. Medical history included errors of lipid metabolism from an unknown date. Concomitant medication included pravastatin taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (COMIRNATY, Solution for injection, Lot Number: FA5829, Expiration date:31Aug2021), via intramuscular in the arm left on 23Jun2021 at 14:15 as dose 1, single for COVID-19 immunization. On 14Jul2021 at 14:30 (15 minutes after the vaccination), the patient experienced feels poorly, and blood pressure decreased to 70 mmHg, and sweating moistly. The patient lay down and the blood pressure increased to 100 mmHg, and the patient was being observed in the Lifesaving center. The patient underwent lab tests and procedures on 14Jul2021 which included blood pressure decreased: 70 mmhg on 14:30, blood pressure decreased: 100 mmhg after lying down and vital measurement: unknown results on 14Jul2021. Therapeutic measures were taken as result of the events. The outcome of the event was recovered with treatment including vital measurement and the patient was being observed until 15:57 (unspecified date). The reporter stated the events resulted in Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event blood pressure decreased and the suspect drug 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: 1521535 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-14
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9880 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction, Computerised tomogram, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: CT; Result Unstructured Data: Test Result:suspected for cerebral infarction
CDC Split Type: JPPFIZER INC202100923817

Write-up: suspected for Cerebral infarction; weakness of right upper and lower extremities; This is a spontaneous report from a contactable nurse received from the Regulatory Authority report number is v21120459. The patient was a 91-year-old female. Body temperature before vaccination was not reported. Relevant medical history was not reported. Concomitant medications were not reported. Previously the patient received the 1st dose of bnt162b2 (COMIRNATY, Lot number EY5422, Expiration date 31Aug2021) on an unspecified date, via an unspecified route of administration, as single dose, for COVID-19 immunisation. On 08Jul2021, the patient received the second dose of bnt162b2 (COMIRNATY, Lot number FC9880, Expiration date 30Sep2021) via an unspecified route of administration, as single dose, for COVID-19 immunisation. On 14Jul2021 in the afternoon (6 days after the vaccination), the patient experienced the following events: suspected for cerebral infarction and weakness of right upper and lower extremities. Clinical course of the events was reported as follows: on 14Jul2021 in the afternoon (6 days after the vaccination), the patient experienced weakness of right upper and lower extremities. On the next day, went to the hospital for examination. The patient was introduced to reporter''s hospital due to the event. With heart pace maker inserting, the patient was suspected for cerebral infarction according to computerised tomogram (CT) and was hospitalized. Treatment was initiated based on cerebral infarction. On an unspecified date, the outcome of the events was not reported. The reporter classified the events as non-serious and assessed the causality between them and bnt162b2 as unassessable. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1521711 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3143 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210715; Test Name: hyperpyrexia; Result Unstructured Data: Test Result:40.5 - 42 Centigrade; Comments: Fever: 40.5 to 42 degrees Celcius
CDC Split Type: NLPFIZER INC202100914271

Write-up: Headache; Cold chills; Myalgia; Not feeling well; Inflammatory reaction at the reaction site: pain, swelling, arising within one week of vaccination, heat; Pain in the joints; Injection site swelling; Fatigue; Reaction at or around the injection site: heat; Fever: 40.5 to 42 degrees Celcius; Injection site pain; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number -LRB-00626054. A 39-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 14Jul2021 (Batch/Lot Number: FC3143) (at age 39-years-old) as dose 2, single for covid-19 immunisation. The first dose was received on 09Jun2021 and experienced sensitive arm. The patient''s medical history and concomitant medications were not reported. The patient experienced fever: 40.5 to 42 degrees Celsius, injection site pain, headache , cold chills, myalgia, not feeling well, inflammatory reaction at the reaction site: pain, swelling, arising within one week of vaccination, pain in the joints, injection site swelling, fatigue, reaction at or around the injection site: heat on 14Jul2021. Outcome of the event of fatigue and cold chills was recovering while for the remaining events was not recovered. Paracetamol was given as treatment for all events. Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes. ADRs: No only sensitive arm Date: 09Jun2021 Extensive swelling of vaccinated limb: no. Previous COVID-19 infection: No No follow-up attempts possible. No further information expected.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: No only sensitive arm Date: 09Jun2021 Extensive swelling of vaccinated limb: no Previous COVID-19 infection: No; Sender''s Comments: Linked Report(s) : PFIZER INC-202100955856 same patient, different dose;-PFIZER INC-202100955856 same patient/reporter, different dose/events


VAERS ID: 1522345 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Influenza like illness, Loss of consciousness, Migraine, Nausea, Paraesthesia, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

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

Write-up: Consciousness loss of; Migraine headache; Influenza like illness; Blurry vision; Localised tingling; Nausea; This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Consciousness loss of) in a 54-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arterial hypertension. On 13-Jul-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (Consciousness loss of) (seriousness criterion medically significant), MIGRAINE (Migraine headache), INFLUENZA LIKE ILLNESS (Influenza like illness), VISION BLURRED (Blurry vision), PARAESTHESIA (Localised tingling) and NAUSEA (Nausea). At the time of the report, LOSS OF CONSCIOUSNESS (Consciousness loss of), INFLUENZA LIKE ILLNESS (Influenza like illness), VISION BLURRED (Blurry vision), PARAESTHESIA (Localised tingling) and NAUSEA (Nausea) had resolved and MIGRAINE (Migraine headache) was resolving. No concomitant medication information was provided. No treatment medication information was provided. The batch number of the suspect product is unknown. Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The translation of the source document has been requested.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The translation of the source document has been requested.


VAERS ID: 1522346 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214004 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dermo-hypodermitis
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy to antibiotic; Hypertension arterial; Insufficiency renal
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Dermo-hypodermitis; This regulatory authority case was reported by a physician and describes the occurrence of DERMO-HYPODERMITIS (Dermo-hypodermitis) in an 84-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 214004) for COVID-19 vaccination. Concurrent medical conditions included Hypertension arterial, Allergy to antibiotic and Insufficiency renal. On 12-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 14-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced DERMO-HYPODERMITIS (Dermo-hypodermitis) (seriousness criterion medically significant). At the time of the report, DERMO-HYPODERMITIS (Dermo-hypodermitis) had not resolved. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was reported. Action taken with mRNA-1273 in response to the drug was not applicable. Very limited information regarding this event has been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further information is expected.


VAERS ID: 1522360 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Pain, Pulmonary pain, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210430; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Pain; Headache; Lung pain; Headache NOS; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Pain), PULMONARY PAIN (Lung pain), HEADACHE (Headache) and HEADACHE (Headache NOS) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced HEADACHE (Headache NOS) (seriousness criterion medically significant). On 17-Jul-2021, the patient experienced PULMONARY PAIN (Lung pain) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (Pain) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, PAIN (Pain) and HEADACHE (Headache) outcome was unknown and PULMONARY PAIN (Lung pain) and HEADACHE (Headache NOS) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant products were not provided. Treatment medication were not reported. Patient reported that Headache is from the top and middle of the head downwards and a "thin" feeling pain,Pain in the chest is in 2 or 3 spots on the left side and varies in intensity, can be left feeling out of breath at random. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1522526 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Bradycardia, Heart rate, Hyperhidrosis, Pallor, Pulse abnormal, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Pulse; Result Unstructured Data: Test Result:abnormal
CDC Split Type: AUPFIZER INC202100925470

Write-up: Bradycardia; Syncope; Hyperhidrosis; Pallor; Pulse abnormal; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 587451. A 78-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose (dose number unknown) for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced bradycardia, syncope, hyperhidrosis, pallor, and pulse abnormal on 14Jul2021 with outcome of recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1523539 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Condition aggravated
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (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: Allergic rhinitis; Asthma (MILD BRONCHIAL ASTHMA, SOME EXACERBATIONS); Pollen allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202100927062

Write-up: Asthma bronchial; Condition aggravated; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number ES-AEMPS-944928. A 29-year-old non-pregnant female patient received bnt162b2 (COMIRNAT solution for injection, (Batch/Lot Number: FE6208)), dose 1 intramuscular, administered in the left arm on 14Jul2021 (age at vaccination 29-year-old) as dose 1, single for covid-19 immunization. The patient''s medical history included asthma from 15Jan2019 to an unknown date mild bronchial asthma, some exacerbations, seasonal allergy from 15Jan2019 to an unknown date, rhinitis allergic from 15Jan2019 to an unknown date. The patient''s concomitant medications were not reported. On 14Jul2021 the patient experienced asthma bronchial, and condition aggravated. The outcome of events was unknown. No follow-up attempts are possible. No further information expected.


VAERS ID: 1523543 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7959 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Basophil count, Blood creatine phosphokinase, Blood creatine phosphokinase MB, Blood creatinine, Blood glucose, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, C-reactive protein, Chest X-ray, Electrocardiogram, Eosinophil count, Glomerular filtration rate, Haematocrit, Haemoglobin, Heart rate, Investigation, Lymphocyte count, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Mean platelet volume, Monocyte count, Neutrophil count, Oxygen saturation, Pericarditis, Platelet count, Prothrombin time, Red blood cell count, Red cell distribution width, Troponin I, White blood cell count
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SALAZOPYRINA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol use; Mastitis (Surgery: Mastitis); Smoker; Uveitis
Allergies:
Diagnostic Lab Data: Test Name: basophils; Test Result: 0.3 %; Test Name: Basophils (Absolute V.); Result Unstructured Data: Test Result:0.0 x 10? uL; Test Name: CK (Creatine Kinase); Result Unstructured Data: Test Result:65 IU/l; Test Name: CK-MB; Result Unstructured Data: Test Result:mass ng/ml; Comments: The determination of CK-MB mass is not applicable when the CK concentration is 190 IU / L; Test Name: Creatinine; Test Result: 0.70 mg/dl; Test Name: Glucose; Test Result: 80 mg/dl; Test Name: Potassium; Result Unstructured Data: Test Result:4.4 mmol/L; Test Name: Blood pressure; Result Unstructured Data: Test Result:181/82; Test Name: Sodium; Result Unstructured Data: Test Result:137 mmol/L; Test Name: BUN (Urea Nitrogen); Test Result: 17 mg/dl; Test Name: Urea; Test Result: 36 mg/dl; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Centered, inspired. Normal CTI, without condensation; Comments: Centered, inspired. Normal cardiothoracic index (CTI), without condensation or infiltrates, free sinuses, preserved bone framework; Test Name: C-reactive protein; Test Result: 0.70 mg/dl; Test Name: ECG; Result Unstructured Data: Test Result:Sinus rhythm at 55 bpm, normal narrow axis QRS, mi; Comments: Sinus rhythm at 55 bpm, normal narrow axis QRS, millimeter ST elevation over the entire lower face and doubtfully in V2, V3, V4 without other repolarization alterations.; Test Name: eosinophils; Test Result: 2.5 %; Test Name: Eosinophils (Absolute V.); Result Unstructured Data: Test Result:0.2 x 10? uL; Test Name: Estimated glomerular filtration rate (CKD); Result Unstructured Data: Test Result:117.84; Comments: ml / min / 1.73m ^ 2; Test Name: Hematocrit; Test Result: 41.9 %; Test Name: Hemoglobin; Result Unstructured Data: Test Result:14.1 g/dl; Test Name: Heart rate; Result Unstructured Data: Test Result:69; Test Name: Hemolysis index; Result Unstructured Data: Test Result:77; Test Name: % lymphocytes; Test Result: 22.9 %; Test Name: Lymphocytes; Result Unstructured Data: Test Result:1.6 x 10? uL; Test Name: Mean corpuscular hemoglobin; Test Result: 31.4 pg; Test Name: MCHC; Result Unstructured Data: Test Result:33.7 g/dl; Test Name: Mean corpuscular volume blood; Result Unstructured Data: Test Result:93.3; Comments: fl; Test Name: Mean platelet volume; Result Unstructured Data: Test Result:10.2; Comments: fl; Test Name: monocytes; Test Result: 9.4 %; Test Name: Monocytes (Absolute V.); Result Unstructured Data: Test Result:0.7 x 10? uL; Test Name: Neutrophils (Absolute V.); Result Unstructured Data: Test Result:4.5 x 10? uL; Test Name: segmented; Test Result: 64.9 %; Test Name: Sat O2; Result Unstructured Data: Test Result:98; Test Name: Platelets; Result Unstructured Data: Test Result:216 x 10? uL; Test Name: Prothrombin time; Result Unstructured Data: Test Result:Hemolyzed sample seconds; Test Name: Red blood cells; Result Unstructured Data: Test Result:4.5 x 10^6 uL; Test Name: RDW; Test Result: 12.2 %; Test Name: Troponin I; Result Unstructured Data: Test Result:0.012 ng/ml; Comments: Cut-off value for AMI: 0.12; Test Name: Leukocytes; Result Unstructured Data: Test Result:6.89 x 10^3 uL
CDC Split Type: ESPFIZER INC202100926169

Write-up: Pericarditis; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number ES-AEMPS-946205. A 27-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 12Jul2021 (Batch/Lot Number: FD7959) as DOSE 1, SINGLE for covid-19 immunization. Medical history included uveitis from an unknown date and unknown if ongoing, tobacco user from an unknown date and unknown if ongoing, alcohol use from an unknown date and unknown if ongoing, mastitis from an unknown date and unknown if ongoing Surgery: Mastitis. The patient was not pregnant at the administration of the vaccine. Comes with a history of stabbing pain in the thoracic center, since this morning, which worsens when he takes a deep breath, in sternal region, not irradiated. She refers that it worsens when sitting or leaning forward. Denies dyspnea. No deterioration of functional class., No edema in inferior extremities (MMII). No orthopnea, no paroxysmal nocturnal dyspnea (DPN). Denies respiratory or other infections in recent weeks. Last menstrual period (LMP) now. Concomitant medication included sulfasalazine (SALAZOPYRINA) taken for an unspecified indication from 01Sep2018 to an unspecified stop date. The patient experienced pericarditis (medically significant) on 14Jul2021. The patient underwent lab tests and procedures on 14Jul2021 which included basophil count: 0.3 %, basophil count: 0.0 x 10^3 ul, blood creatine phosphokinase: 65 iu/l, blood creatine phosphokinase mb: mass ng/ml . The determination of CK-MB mass is not applicable when the CK concentration is 190 IU / L , blood creatinine: 0.70 mg/dl, blood glucose: 80 mg/dl, blood potassium: 4.4 mmol/l , blood pressure measurement: 181/82, blood sodium: 137 mmol/l , blood urea: 17 mg/dl, blood urea: 36 mg/dl, chest x-ray: Centered, inspired. Normal cardiothoracic index (CTI), without condensation or infiltrates, free sinuses, preserved bone framework , c-reactive protein: 0.70 mg/dl, electrocardiogram: Sinus rhythm at 55 bpm, normal narrow axis QRS, millimeter ST elevation over the entire lower face and doubtfully in V2, V3, V4 without other repolarization alterations , eosinophil count: 2.5 % . PHYSICAL EXAMINATION: Blood pressure 121/82, Heart rate (HR): 69, Oxygen saturation (Sat O2): 98. Good general condition, conscious and oriented, Eupneic and Normally colored. Symmetric and normo expansible chest, without increased work of breathing. Cardiac auscultation: rhythmic, I do not hear murmurs or pericardial friction. Lung auscultation: vesicular murmur preserved, no auscultation of pathological sounds added. Abdomen: Anodyne, MMII: no edema or signs of deep vein thrombosis (DVT). SUPPLEMENTARY TESTS: Electrocardiogram (ECG): sinus rhythm at 55 bpm, narrow QRS normal axis, millimeter ST elevation over the entire lower face and doubtfully in V2, V3, V4 without other repolarization alterations. Analytic: Extraction Date: 14Jul2021 16:39:05. Count: Leukocytes 6.89 x 10? ul (3.5 - 12.0) Red blood cells 4.5 x 10 ^ 6 ul (3.5 - 5.8) Hemoglobin 14.1 g / dl (12 - 15) Hematocrit 41.9% (36 - 43) Mean corpuscular volume blood 93.3 fl (80 - 100 ) Mean corpuscular hemoglobin 31.4 pg (27 - 32) MCHC 33.7 g / dl (31.5 - 34.5) RDW 12.2% (11.2 - 15.2) Platelets 216 x 10? ul (150 - 450) Mean platelet volume 10.2 fl (9 - 13) Formula % lymphocytes 22.9% (20 - 45)% monocytes 9.4% (2 - 10)% segmented 64.9% (40 - 75)% eosinophils 2.5% (1 - 5)% basophils 0.3% (0 - 2) Lymphocytes (Absolute V. ) 1.6 x 10? ul (1.2 - 5.0) Monocytes (Absolute V.) 0.7 x 10? ul (0.1 - 1.0) Neutrophils (Absolute V.) 4.5 x 10? ul (1.7 - 8.0) Eosinophils (Absolute V.) 0.2 x 10? ul (0.0 - 0.5) Basophils (Absolute V.) 0.0 x 10? ul (0.0 - 0.3) Profiles and basic tests Prothrombin time sg (10 - 14) Hemolyzed sample. Biochemistry Glucose 80 mg / dl (74 - 109) Urea 36 mg / dl (17 - 49) BUN (Urea Nitrogen) 17 mg / dl (8 - 23) Creatinine 0.70 mg / dl (0.51 - 0.95) Estimated glomerular filtration rate (CKD) -EPI) 117.84 ml / min / 1.73m ^ 2 Enzymes. CK (Creatine Kinase) 65 IU / l (Inf. 170) CK-MB mass ng / ml (Inf. 3.6) The determination of CK-MB mass is not applicable when the CK concentration is 190 IU / L. Ion, Sodium 137 mmol / L (136 - 145) Potassium 4.4 mmol / L (3.5 - 5.1) Hemolysis index 77 Proteins C-reactive protein * 0.70 mg / dl (Inf. 0.5). Cardiac markers: Troponin I 0.012 ng / ml Upper reference limit: 0.08 (Inf. 0.12) Cut-off value for AMI: 0.12 - Imaging tests: Chest X-ray. Centered, inspired. Normal CTI, without condensation or infiltrates, free sinuses, preserved bone framework. DIAGNOSTIC TRIAL: Acute uncomplicated pericarditis. TREATMENT: Colchicine 0.5 mg in the morning. Ibuprofen 600 mg every 8 hours at least 3 weeks or until consultation with the Autoinumnes Team. Omeprazole 20 mg in the morning while taking daily ibuprofen. Therapeutic measures were taken as a result of pericarditis (pericarditis). The outcome of event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1523549 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD9309 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Laboratory test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: lab test; Result Unstructured Data: Test Result:confirm that the syncope is not due to any health; Comments: problem of the patient
CDC Split Type: ESPFIZER INC202100926981

Write-up: Syncope; This is a spontaneous report from a contactable consumer downloaded from the Medicines Agency (MA) regulatory authority-WEB, regulatory authority number ES-AEMPS-946740. A 38-year-old male patient received bnt162b2 (COMIRNATY, Lot Number: FD9309), via an unspecified route of administration, administered in Arm Left on 14Jul2021 as dose 1, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced syncope considered life threatening on 14Jul2021 and required an emergency room visit. The patient underwent lab tests and procedures which included laboratory test: confirm that the syncope is not due to any health problem of the patient on a unspecified date. The outcome of the event was recovering. No follow-up attempts possible. No further information expected.


VAERS ID: 1523627 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2707 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100932211

Write-up: Influenza like illness; Diarrhea; This is a spontaneous report from a contactable consumer downloaded from the , regulatory authority number FR-AFSSAPS-LY20218036. A 45-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 13Jul2021 (Batch/Lot Number: FE2707) as DOSE 2, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced influenza like illness and diarrhea on 14Jul2021. Further ADR description stated that the 45-year-old patient had an influenza like illness and a 24-hour diarrhea with no reported history. Symptomatic management; evolution was unknown and severity criterion was work stoppage. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1523760 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-14
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Ischaemic stroke, Magnetic resonance imaging, Neurological examination, Platelet count
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (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: ATORVASTATIN; PERINDOPRIL; LERCANIDIPINE; KARDEGIC; ULTIBRO BREEZHALER [GLYCOPYRRONIUM BROMIDE;INDACATEROL MALEATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol use; Angina attack (2 years ago); Blindness (operated on several times (blindness right eye)); Blood pressure high; Carotid artery stenosis (right internal carotid stenosis of around 50% in 2020); Chronic venous insufficiency; Deafness (right ear); Diaphragmatic hernia NOS (right diaphragmatic hernia); Dyslipidaemia; Gastrooesophageal reflux; Hypertension arterial; Leg ulcer; Neovascular glaucoma; Phlebitis; Prethrombosis retinal (thrombosis of the central vein of the right retina); Recovered smoker (chronic tobacco intoxication quit 50 years ago); Renal microlithiasis (right calyceal renal lithiasis); Vesicle (multi-lithiasis vesicle)
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: Magnetic resonance imaging; Result Unstructured Data: Test Result:Recent ischaemic attack in the territory; Comments: Recent ischaemic attack in the territory concordant with the clinical picture: superficial and deep right middle cerebral. Also punctiform damage to the left anterior cerebral territory. Significant irregularity of the right bulbar internal carotid artery, in favour of atheromatous infiltration, without tight stenosis.; Test Date: 20210714; Test Name: Neurological examination; Result Unstructured Data: Test Result:upper left limb ataxia; Test Date: 20210714; Test Name: Platelets; Result Unstructured Data: Test Result:251 x10 9/l; Test Date: 20210716; Test Name: Platelets; Result Unstructured Data: Test Result:260 x10 9/l
CDC Split Type: FRPFIZER INC202100932215

Write-up: Ischemic stroke/ischaemic multifocal sylvian stroke; This is a spontaneous report received from a contactable physician downloaded from the The regulatory authority report number is FR-AFSSAPS-RS20212330, Safety report unique identifier FR-AFSSAPS-2021094602. Source verbatim: 78-year-old patient. Medical history: Occasional alcohol, high blood pressure, dyslipidaemia, right internal carotid stenosis of around 50% in 2020, angina 2 years ago, thrombosis of the central vein of the right retina, complicated by neovascular glaucoma, operated on several times (blindness right eye), chronic venous insufficiency with history of phlebitis and leg ulcers, gastroesophageal reflux disease, right calyceal renal lithiasis, multi-lithiasis vesicle, right diaphragmatic hernia, right ear deafness, chronic tobacco intoxication quit 50 years ago. Usual treatment: ATORVASTATIN 10 mg: 1 in the evening, PERINDOPRIL 4 mg: 1 in the morning, LERCANIDIPINE 20 mg: 1 in the evening, KARDEGIC 75 mg: 1 in the morning, ULTIBRO BREEZHALER 85 ug/43 ug: 1 in the evening. History of the disease: Date of 1st dose of Comirnaty vaccine not known (lot number: unknown). 06Jul2021: 2nd dose of the Comirnaty vaccine (lot number: unknown) intramuscular for COVID-19 immunisation. 07Jul2021-10Jul2021: evidence of atheromatous lesions on non-stenosing coronaries, without indication for revascularisation. Switch perindopril to Esidrex? in view of hypokalaemia. 8 days after Dose 2 of Comirnaty, i.e. 14Jul2021: the patient presents with paresthesia and numbness in the left hand of sudden onset, associated with bilateral frontal headaches, weakness of the lower left limb and discreet left central facial paralysis. Urgent hospitalisation: Neurological examination reported: upper left limb ataxia. 15Jul2021: Magnetic resonance imaging: Recent ischaemic attack in the territory concordant with the clinical picture: superficial and deep right middle cerebral. Also punctiform damage to the left anterior cerebral territory. Significant irregularity of the right bulbar internal carotid artery, in favour of atheromatous infiltration, without tight stenosis. Treatment included: Aspegic 250 mg intravenous bolus. Platelets on 14Jul2021: 251 G/l [150-400 G/L], Platelets on 16Jul2021: 260 G/l [150-400 G/L]. At the therapeutic level: - No reinfusion treatment. - Switch from anti-platelet aggregation with Kardegic to clopidogrel. Outcome: Not recovered/not resolved. Overall: 78-year-old patient with a cardiovascular history who presented with a right ischaemic multifocal sylvian stroke (ischemic stroke) 8 days after the 2nd dose of the Comiraty vaccine. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1523788 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-14
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1573 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Face oedema, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Drug allergy (Allergy to Clamoxyl.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210510; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202100932354

Write-up: Urticaria giant; Oedema face; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority number FR-AFSSAPS-TS20213076. A 34-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 10Jul2021 (Batch/Lot Number: FE1573) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included ongoing drug hypersensitivity, Allergy to Clamoxyl. The patient''s concomitant medications were not reported. Information contained in the statement: "Generalized urticaria, swollen eyelids and lips. No respiratory discomfort. The patient experienced urticaria giant and swelling of the face on 14Jul2021. Consultation at emergency medical services following a call to the urgent medical aid service during the night from 14Jul2021 to 15Jul2021. Prescription of Prednisolone (3 in the morning/3 days) and Desloratadine (1 in the evening/7 days)". The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 10May2021. Therapeutic measures were taken as a result of the events. The outcome of the event was recovering. No follow-up attempts are possible, no further information is expected.


VAERS ID: 1523943 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-14
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Amenorrhoea, Pregnancy test, SARS-CoV-2 test
SMQs:, Fertility disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: pregnancy test; Test Result: Negative ; Test Date: 20210609; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100928937

Write-up: Menses lack of; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is-MHRA-WEBCOVID-202107200932194280-BYFJK, Safety Report Unique Identifier: -MHRA-ADR 25678771. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Not known), via an unspecified route of administration on 01Jul2021 as dose 1, single for COVID-19 immunisation. Medical history included lactation decreased and suspected covid-19 from an unknown date and unknown if ongoing, unsure when symptoms started , unsure when symptoms stopped. Patient is not pregnant at time of vaccination. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced menses lack of on 14Jul2021. The event was reported as medically significant. The patient underwent lab tests and procedures which included covid-19 virus test: negative on 09Jun2021 (No - Negative COVID-19 test), patient also took a pregnancy test on an unknown date and it was negative. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event was not recovered. No follow-up attempts are possible, information on the batch/lot number was unknown. No further information is expected.


VAERS ID: 1524001 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Inappropriate schedule of product administration, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMITRIPTYLINE; MICROGYNON [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception; Irritable bowel syndrome; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100929085

Write-up: dizzy; vomited; Woozy; First dose: 19May2021/ Second dose: 14Jul2021; This is a spontaneous report from a contactable consumer. This report is received from. The regulatory authority report number is GB-MHRA-WEBCOVID-202107201435052760-H18ZM. Safety Report Unique Identifier is GB-MHRA-ADR 25680924. A 27-year-old female patient received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), (Lot Number: fd5613), via an unspecified route of administration at single dose on 14Jul2021 (at age of 27 years old) for COVID-19 immunisation. Medical history included lactation decreased, irritable bowel syndrome, contraception. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. Concomitant medications included amitriptyline taken for irritable bowel syndrome; ethinylestradiol, levonorgestrel (MICROGYNON) taken for contraception. Historical vaccine included: first dose of BNT162B2 (Batch/lot number: ew4109) on 19May2021 for COVID-19 immunisation. The patient experienced woozy on 16Jul2021, dizzy and vomited on an unspecified date. Events were reported as medical significant. The patient received first dose: 19May2021/ second dose: 14Jul2021. Feeling dizzy/woozy and then vomited once. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of event woozy was not recovered, unknown for rest events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1524002 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Dyspnoea, Fatigue, Feeling abnormal, Loss of consciousness, Malaise, Nausea, Pain, Pain in extremity, Photophobia, Pyrexia, SARS-CoV-2 test, Tinnitus, Vision blurred, Visual impairment, Yellow skin
SMQs:, Torsade de pointes/QT prolongation (broad), Cholestasis and jaundice of hepatic origin (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), 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: Breathlessness; Fatigue
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100928870

Write-up: dizzy; nausea; bright lights; Fatigue/tired; Yellow skin; Blackout spell/lose consciousness; Ache; Fever; Foggy feeling in head; Breathlessness; feeling very unwell; field of vision clouded; could see blackness; Loud whooshing in ears; Painful arm; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202107201438379260-SHW1W, Safety Report Unique Identifier is GB-MHRA-ADR 25681201. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jul2021 as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included dyspnoea and fatigue. Concomitant medications were not reported. Historical vaccine included bnt162b2, dose 1 single on an unspecified date for COVID-19 immunisation. Patient had not had symptoms associated with COVID-19. Patient had no recent illnesses and no medicines taken in past 3 months. The patient experienced dizzy on 15Jul2021 with outcome of recovering , nausea on 15Jul2021 with outcome of recovering, bright lights on 15Jul2021 with outcome of recovering, fatigue/tired on 15Jul2021 with outcome of not recovered, yellow skin on 15Jul2021 with outcome of recovered on 15Jul2021, blackout spell/lose consciousness on 15Jul2021 with outcome of recovered on 15Jul2021, ache on 15Jul2021 with outcome of recovered on 19Jul2021, fever on 15Jul2021 with outcome of recovered on 18Jul2021, foggy feeling in head on 15Jul2021 with outcome of not recovered, painful arm on 14Jul2021 with outcome of recovered on 16Jul2021, breathlessness on 15Jul2021 with outcome of recovering, feeling very unwell on 15Jul2021 with outcome of recovering, field of vision clouded on 15Jul2021 with outcome of recovered on 15Jul2021, could see blackness on 15Jul2021 with outcome of recovered on 15Jul2021, and tinnitus on 15Jul2021 with outcome of recovered on 15Jul2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 16Jul2021 No - Negative COVID-19 test. The events were reported as serious, medically significant. Additional information: Received the second dose of vaccine around 11am on 14th July 2021 - felt fine for the rest of the day. Woke up as usual the next morning - feeling slightly achy and tired but generally ok. Went to the kitchen to drink some water and had a sudden onset of feeling very unwell - felt nausea and dizzy and started to lose consciousness. Field of vision clouded and could see blackness and some small bright lights. Loud whooshing in ears which continued for around 10 minutes. Unsure whether consciousness was lost briefly. Skin was yellow in appearance which resolved later that day. Returned to bed and have been resting since 15th July 2021. Fatigue, breathlessness and brain fog are still ongoing. Walking was limited heavily by fatigue and breathlessness, but was trying to build up activity (previously was able to walk long distances). Patient had 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.


VAERS ID: 1524013 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100928760

Write-up: Diarrhea; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107201540351750-CSQFB. Safety Report Unique Identifier GB-MHRA-ADR 25681338. A female patient of an unspecified age received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 VACCINE), via an unspecified route of administration on 14Jul2021 (Batch/Lot Number: FD5613) 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. Not had a COVID-19 test. On 14Jul2021, the patient experienced diarrhea. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The event was reported as serious, medically significant. The outcome for the event diarrhea was not recovered. No follow up attempts are possible. No further information is expected.


VAERS ID: 1524072 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-14
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CETIRIZINE; LORATADINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pollen allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100928477

Write-up: Headache; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202107202235486910-LHA3X, Safety Report Unique Identifier GB-MHRA-ADR 25683684. A 28-year-old male patient received first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Formulation: Solution for injection, Batch/Lot Number was not reported), via an unspecified route of administration as single dose on 29Jun2021 for COVID-19 immunization. The patient medical history included seasonal allergy. The patient Concomitant medication included cetirizine taken for seasonal allergy; loratadine taken for seasonal allergy. The patient had not had symptoms associated with COVID-19. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. On 14Jul2021 the patient experienced headache. On 19Jul2021 the patient underwent lab tests and procedures which included COVID-19 virus test was negative. The event was reported as eventually medically significant. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1524076 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cellulitis, Chills, Feeling cold, Hypersensitivity, Inhibiting antibodies positive, Nausea, Peripheral swelling, Pyrexia, Rash erythematous, Rash pruritic, SARS-CoV-2 test, Somnolence
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), 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: Medical History/Concurrent Conditions: Cellulitis; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: body temperature; Result Unstructured Data: Test Result:fever; Test Name: IgG antibody; Result Unstructured Data: Test Result:40.8; Comments: 40.8 AU/mL Tested IgG antibody processed on Abbott Architect analyser platform in a laboratory and the result was negative.; Test Date: 20210704; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100929105

Write-up: rash/red rash; cellulitis; hypersensitivity; Swollen arm; Itchy rash; Shivers; feeling cold; Drowsy on awakening; Nausea; Body temperature/fever; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107202329433250-YYH2W. Safety Report Unique Identifier GB-MHRA-ADR 25683736. A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 14Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included suppressed lactation, cellulitis. 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 previously took flucloxacillin. The patient had two doses of COVID vaccines in Nov2020. But before she took this dose of Pfizer vaccine, she had tested her IgG antibody processed on Abbott Architect analyser platform in a laboratory and the result was negative (40.8 AU/mL). The patient experienced feeling cold, drowsy on awakening, nausea, body temperature/fever on 14Jul2021, rash/red rash, cellulitis, hypersensitivity on an unspecified date, swollen arm, itchy rash, shivers on 16Jul2021. The case was serious per medically significant. Clinical course: Feeling cold, drowsy and nauseous every day from the first vaccination day till now. Developing red rash on the vaccinated arm on the third day. The rash was getting wider every day. The first doctor said it''s cellulitis. However, taking flucloxacillin did not work. The second doctor said it''s hypersensitivity. She applied prescribed betamethasone dipropionate (DIPROSONE) and also took 15mg oral prednisone for once. The rash area disappeared very soon. However, the rash totally came back the next morning. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 04Jul2021. Therapeutic measures were taken as a result of rash/red rash, cellulitis, hypersensitivity, itchy rash. The outcome of event body temperature/fever was resolved on 16Jul2021, outcome of events feeling cold, rash/red rash, cellulitis, hypersensitivity was resolving, outcome of other events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1524416 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction, Dysarthria, Magnetic resonance imaging head, Malaise
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: Medical History/Concurrent Conditions: Hyperlipidaemia
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: MRI brain; Result Unstructured Data: Test Result:Cerebral infarction
CDC Split Type: JPPFIZER INC202100910268

Write-up: Cerebral infarction; articulation problem; malaise; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21120124. A 67-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 13Jul2021 (Batch/Lot Number: FD0889; Expiration Date: 30Sep2021) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hyperlipidaemia from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 14Jul2021 at 10:00(1 day after the vaccination), the patient experienced cerebral infarction.On 16Jul2021 (3 days after the vaccination), the patient was admitted to the hospital. The course of the event was as follows: On 13Jul2021 (the day of vaccination), the patient received the second dose of vaccination. On 14Jul2021 at about 10:00 (1 day after the vaccination), the patient experienced articulation problem and malaise. On 16Jul2021 (3 days after the vaccination), the patient visited our hospital. Cerebral infarction was found by brain MRI. The reporting physician classified the event as serious (hospitalized, started from 16Jul2021) and assessed that the event was related to bnt162b2. Other possible cause of the event such as any other diseases was hyperlipidaemia.


VAERS ID: 1524426 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-14
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, C-reactive protein, Investigation, Pneumonia, X-ray
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210720; Test Name: blood test; Result Unstructured Data: Test Result:the inflammatory reaction has improved at all; Comments: the inflammatory reaction has improved at all; Test Date: 20210714; Test Name: CRP; Result Unstructured Data: Test Result:high; Test Date: 20210714; Test Name: an image of pneumonia with no symptoms; Result Unstructured Data: Test Result:an image of pneumonia with no symptoms; Comments: an image of pneumonia with no symptoms; Test Date: 20210720; Test Name: X-ray; Result Unstructured Data: Test Result:a faint image of pneumonia; Comments: a faint image of pneumonia
CDC Split Type: JPPFIZER INC202100924135

Write-up: there was an image of pneumonia with no symptoms; This is a spontaneous report from a contactable physician received via Medical Information Team. A patient of unspecified age and gender (were not provided) received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 02Jul2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Details: On 02Jul2021(the day of vaccination), the patient received first dose of vaccination. At that time, there was no problem with vaccine (no adverse reaction). On 14Jul2021 (12 days after the vaccination), there was an image of pneumonia with no symptoms. The patient was treated for pneumonia because CRP and inflammatory response were so high. On 20Jul2021 (18 days after the vaccination), as a result of a blood test, the inflammatory reaction has improved at all. The reporting physician wondered if there is a faint image of pneumonia on an X-ray, but thought it would probably heal naturally. The second of vaccination for the patient who had a pneumonia image was scheduled for 27Jul2021, the physician wondered when the patient should receive. The patient underwent lab tests and procedures which included blood test: the inflammatory reaction has improved at all on 20Jul2021, c-reactive protein: high on 14Jul2021, investigation: an image of pneumonia with no symptoms on 14Jul2021, x-ray: a faint image of pneumonia on 20Jul2021. Therapeutic measures were taken as a result of there was an image of pneumonia with no symptoms. The outcome of the event was unknown. The event was considered as serious (medically significant). No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the event Pneumonia cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.


VAERS ID: 1524428 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood pressure measurement, Blood pressure systolic increased, Body temperature, Cerebral infarction, Decreased appetite, Heart rate, Oxygen saturation, Pyrexia, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: Medical History/Concurrent Conditions: Atrial fibrillation; Dialysis; Haemorrhagic cerebral infarction; Renal failure (regularly received dialysis on Tuesday, Thursday, and Saturday.)
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Blood sugar; Test Result: 103 mg/dl; Test Date: 20210714; Test Name: Blood pressure; Result Unstructured Data: Test Result:150/87 mmHg; Test Date: 20210715; Test Name: Blood pressure; Result Unstructured Data: Test Result:162/88 mmHg; Test Date: 20210714; Test Name: Body temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Comments: Before vaccination; Test Date: 20210714; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: In the evening; Test Date: 20210715; Test Name: Body temperature; Result Unstructured Data: Test Result:37.6 Centigrade; Test Date: 20210714; Test Name: Pulse; Result Unstructured Data: Test Result:56; Test Date: 20210715; Test Name: Pulse; Result Unstructured Data: Test Result:70; Test Date: 20210714; Test Name: SpO2; Test Result: 98 %
CDC Split Type: JPPFIZER INC202100924244

Write-up: Cerebral infarction; body temperature of 36.9/body temperature of 37.6; blood pressure of 150/87/blood pressure of 162/88; did not eat meals and did not respond to verbal stimulation; did not eat meals and did not respond to verbal stimulation; This is a spontaneous report from a contactable physician received from the regulatory authority report number is v21120568. An 82-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 14Jul2021 14:15 (Batch/Lot Number: FD0889; Expiration Date: 30Sep2021) as dose 2, single dose (at the age of 82-years-old) for COVID-19 immunisation. Medical history included renal failure from 10May2021: after the occurrence of renal failure, the patient regularly received dialysis on Tuesday, Thursday, and Saturday, haemorrhagic cerebral infarctionfrom 07Dec2020 and atrial fibrillation. Family history was not reported. Concomitant medications were not reported. Body temperature before vaccination was 37.1 degrees centigrade.On 15Jul2021 at 08:25 (1 day after the vaccination), loss of consciousness was noted. On 15Jul2021 (1 day after the vaccination), the patient was admitted to the hospital. The course of the event was as follows: On 14Jul2021 at 17:45, after the second dose of vaccination, the patient did not eat meals and did not respond to verbal stimulation. No vomiting and queasy were noted. The patient nodded to verbal stimulation. Laboratory data included body temperature of 36.9, blood pressure of 150/87, and SpO2 of 98%, and a wait-and-see attitude was adopted; pulse was also reported as 56. At 18:20, the patient''s conditions did not change. Measurement of blood sugar was instructed, and the results showed 103 mg/dL. The patient was placed on observation. On 15Jul2021 at 07:00, vital signs included pulse of 70, blood pressure of 162/88, and body temperature of 37.6. Cooling was instructed and performed. Medical examination by physician A was also instructed. At 08:25, information was received that the patient''s level of consciousness decreased and transferring the patient to hospital A was instructed. At 09:30, the patient was urgently transferred to hospital A, where cerebral infarction was diagnosed after examination. A physician of hospital A recommended the patient''s family to hospitalize the patient in clinic A, and the patient was admitted to clinic A. The reporting physician classified the event as serious (life-threatening) and considered that the causality between the event and BNT162b2 was unassessable. The reporting physician did not mention other possible causes of the event such as any other diseases. The patient did not receive treatment for cerebral infarction and was hospitalized from 15Jul2021 to an unspecified date. Cerebral infarction was considered serious by the regulatory authority as life-threatening and requiring hospitalization. The outcome of the events was unknown.


VAERS ID: 1524429 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Anxiety, Blood pressure measurement, Body temperature, Depressed level of consciousness, Dyspnoea, Headache, Heart rate, Malaise, Oxygen saturation, Vaccination site warmth
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: blood pressure (BP); Result Unstructured Data: Test Result:not serious; Test Date: 20210714; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Test Date: 20210714; Test Name: pulse (P); Result Unstructured Data: Test Result:not serious; Test Date: 20210714; Test Name: SPO2; Result Unstructured Data: Test Result:not serious
CDC Split Type: JPPFIZER INC202100924251

Write-up: headache; vaccination site(left upper arm) warmth; mild consciousness decreased; malaise; Dyspnoea(mild); Consciousness disturbed(mild); anxiety; This is a spontaneous report from a contactable physician (vaccinator) received from the Regulatory authority. Regulatory authority report number. A 27-year and 6-month old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration, administered in left arm on 14Jul2021 at 14:13 (Batch/Lot Number: FD0889; Expiration Date: 30Sep2021) (at the age of 27-years-old) as dose 1, single for COVID-19 immunisation. Medical history was reported as none. The patient''s concomitant medications were not reported. There were no points provided 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, etc.). On 14Jul2021 at 14:30 (17 minutes after the vaccination), the patient experienced Dyspnoea (mild) and Consciousness disturbed (mild). On 15Jul2021 at 10:00 (the next day of vaccination), the outcome of the events was recovered. The reporter classified the event as non-serious and assessed the causality between the event and the vaccines as unassessable and no possible cause of the event such as any other diseases. The course of the events was as follows: After 30 minutes of vaccination, mild dyspnoea, mild consciousness decreased, and malaise occurred. After around 1hr, symptoms disappeared but dyspnoea, headache and vaccination site (left upper arm) warmth occurred. Blood pressure (BP), SpO2, Pulse (P) not serious. On 16Jul2021, all symptoms disappeared. The reporter concluded as follows: The patient was hospitalized for observation. There was a strong psychological effect. The patient couldn''t understand the language in a foreign country, and she had strong anxiety about the environment. The outcome of the event anxiety was unknown, while for the rest of events was recovered on 15Jul2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1524430 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Body temperature, Cardiac arrest, Computerised tomogram, Echocardiogram, Electrocardiogram, Foaming at mouth, Heart rate, Malaise, Oxygen saturation, Oxygen saturation decreased, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hospitalization; Pancreatic carcinoma (required hospitalization)
Allergies:
Diagnostic Lab Data: Test Name: coronary CT angiography; Result Unstructured Data: Test Result:definite cause has not been found; Test Date: 20210713; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination; Test Date: 20210714; Test Name: Body temperature; Result Unstructured Data: Test Result:36 Centigrade; Comments: at around 00:00 (mid night); Test Name: CT scan; Result Unstructured Data: Test Result:definite cause has not been found; Test Name: echocardiography; Result Unstructured Data: Test Result:definite cause has not been found; Test Name: electrocardiogram; Result Unstructured Data: Test Result:definite cause has not been found; Test Date: 20210714; Test Name: Pulse rate; Result Unstructured Data: Test Result:not palpable; Comments: at 01:42; Test Date: 20210714; Test Name: SpO2; Test Result: 86 %; Comments: at around 01:30
CDC Split Type: JPPFIZER INC202100924257

Write-up: cardiac arrest occurred, pulse was not palpable; SpO2 was 86%; ventricular fibrillation; foaming at the mouth; feeling sick/malaise; This is a spontaneous report from a contactable pharmacist received from the Agency Regulatory authority report number is v21120528. The patient was a 79-year and 3-month-old male. Body temperature before vaccination was 36.6 degrees Centigrade. Medical history included pancreatic body cancer (required hospitalization). Concomitant medications and family history were not provided. On an unspecified date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On 13Jul2021 at 15:40 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EW0201, Expiration date 30Sep2021) at 79 years old an unspecified route of administration as a single dose for COVID-19 immunization. On 14Jul2021 at 01:30 (9 hours 50 minutes after the vaccination), the patient experienced ventricular fibrillation. The course of the events was as follows: On 13Jul2021, while the patient was being observed for 20 minutes after the second dose of the vaccination, there were no problems in particular. On 14Jul2021 at midnight (around 8 hours after the vaccination), the patient complained of feeling sick. The body temperature was in the range of 36 degrees Centigrade. Malaise was noted. At around 01:30 (around 10 hours after the vaccination), he was found foaming at the mouth. VF (ventricular fibrillation) waveform was present and SpO2 (oxygen saturation percutaneous) was 86%. Intubation was performed. At 1:42, pulse was not palpable. As cardiac arrest occurred, CPR (cardio pulmonary resuscitation) was performed. At 01:49, spontaneous circulation was returned. The reporting pharmacist classified the event ventricular fibrillation and cardiac arrest as serious (life-threatening condition) and assessed 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 pharmacist commented as follows: There was a low possibility that his underlying disease (pancreatic body cancer) was the cause of ventricular fibrillation and cardiac arrest occurred at midnight on 14Jul2021. Although CT scan, electrocardiogram, echocardiography and coronary CT angiography were performed on an unspecified date after 14Jul2021, a definite cause has not been found at present stage. Since ventricular fibrillation and cardiac arrest occurred 10 hours after the second dose of BNT162b2, the causal relationship with BNT162b2 could not be denied. The outcome of the event cardiac arrest was recovered on 14Jul2021 at 01:49 while for the other events was recovered on 15Jul2021 (2 days after the vaccination - as reported). Follow up attempts are completed. No further information is expected.


VAERS ID: 1524454 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Hypoaesthesia, Neuropathy peripheral
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Immune-mediated/autoimmune disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100925507

Write-up: Numbness in the left hand (peripheral nerve disorder); Numbness in the left hand (peripheral nerve disorder); Chest pain; This is a spontaneous report from the contactable physician received from the Regulatory authority. Regulatory authority report number. A 51-year and 9-month-old male patient received bnt162b2 (COMIRNATY, Lot number was not reported), via an unspecified route of administration on 14Jul2021 (the day of vaccination, at the age of 51-year-old) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The date and time of onset was provided on 14Jul2021 (the day of the vaccination). The event term was reported as numbness in the left hand (peripheral nerve disorder). Clinical course of the event was reported as follows: Numbness in the left hand appeared and chest pain from the moment of the first dose of bnt162b2. The patient complained of the same symptomatism but was on the observation. From 5 days after the execution, chest pain and numbness in the left hand increased. The patient requested an emergency and visited a hospital. Chest pain was slightly reduced when carrying in. The events resulted in emergency room visit. The outcome of the events was not recovered on 20Jul2021. The reporter classified the event as non-serious and the causality between the event and bnt162b2 as unassessable. No other possible cause of the event such as any other diseases. The reporting physician commented as follows: Numbness from the moment the injection was performed, which might be an omission factor. Information on the lot/batch number has been requested.


VAERS ID: 1524455 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Hyperhidrosis, Quadriplegia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100925695

Write-up: Left upper and lower limb paralysis; Tremor finger; Sweaty; Chills; This is a spontaneous report from the contactable physician received from the Agency. Regulatory authority report number is v21120579. The patient was 79-year-old female. The body temperature before the vaccination was 36.4 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 13Jul2021 at 14:50 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY Intramuscular injection, Lot number: EY5423, 0.3ml; expiration date: 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. The date and time of onset was provided on 14Jul2021 at 12:00 (the day of the vaccination). The event term was reported as Left upper and lower limb paralysis, Tremor finger, Sweaty, Chills. Clinical course of the event was reported as follows: On 13Jul2021 at 2:50 pm (the day of the vaccination), the second dose of bnt162b2 (no illness before vaccination) was performed. On 14Jul2021 around 12:00 (1 day after the vaccination), there was a tilt to the left and weakness of the left upper lower extremities, and it gradually worsened, and from around 16:00, chills and sweaty became apparent. The patient was hospitalized for observation. Symptom improved and discharged on 16July2021. The outcome of the events was recovered on 16Jul2021. The reporter classified the event as serious (hospitalization, from 14Jul2021 to 16Jul2021) and the causality between the event and bnt162b2 as unassessable. No other possible cause of the event such as any other diseases. The reporting physician commented as follows: Numbness from the moment the injection was performed, which might be an omission factor. Also reported as this is not the first time that patient received Coronavirus Disease vaccine. The "1st dose" of vaccinations was "22Jul2021". This is the name of patient''s present local municipal government (who issues a Certificate of Residence for you) correctly printed on the coupon ticket. The patient read "Coronavirus Disease 2019 Vaccination Guide" and understood its effect and potential side effects. The patient fell under priority vaccination groups of 65 years or older. No follow-up attempts are possible. No further information is expected


VAERS ID: 1524456 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Body temperature, Nausea, Rash
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: NONE
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Body temperature; Result Unstructured Data: Test Result:35.8 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100925823

Write-up: Abdominal pain; Queasy; Skin eruption; This is a spontaneous report from the contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21120588. A 16-year and 3-month-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 14Jul2021 15:41 (Batch/Lot Number: FC5947; Expiration Date: 30Sep2021) as dose 1, single for COVID-19 immunization. There was no medical history. The patient''s concomitant medications were not reported. The body temperature before the vaccination was 35.8 degrees centigrade. The date and time of onset was provided on 14Jul2021 at 15:50 (the day of the vaccination). The event term was reported as abdominal pain, queasy, skin eruption. Clinical course of the event was reported as follows: On 14Jul2021 in 10 minutes after the vaccination, queasy appeared. Abdominal pain was followed after that. Several minutes later, the abdominal pain was worsen. On 14Jul2021 at 16:15 (the day of the vaccination), Epipen was taken for 0.3. At 16:20, the symptom was recovering.The outcome of the events was unknown. Therapeutic measures were taken as a result of events. The reporter classified the event as serious (Medically Significant, transported to hospital after frequent pain) and assessed that the event was related to bnt162b2. No other possible cause of the event such as any other diseases. No follow-up attempts are possible. No further information expected.


VAERS ID: 1524483 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction, Dysarthria, Magnetic resonance imaging, Malaise
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: EZETIMIBE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypercholesterolaemia
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: MRI; Result Unstructured Data: Test Result:Cerebral infarction confirmed; Comments: Magnetic Resonance Imaging for head
CDC Split Type: JPPFIZER INC202100927191

Write-up: Cerebral infarction; Inarticulateness; malaise; This is a spontaneous report from a non-contactable other HCP received via COVID-19 Adverse Event Self-Reporting Solution The patient was a non-pregnant 67-year-old female. It was unknown whether the patient received any other vaccines within 4 weeks before vaccination. The patient received Ezetimibe within 2 weeks of vaccination. It was unknown prior to vaccination, whether the patient was diagnosed with COVID-19 or not. Other medical history included Hypercholesterolaemia. On 22Jun2021, the patient previously received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) for COVID-19 immunization. On 13Jul2021, the patient received the second single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FD0889, Expiration date 30Sep2021) for COVID-19 immunization. On 16Jul2021(as reported), the patient experienced adverse events. On 14Jul2021 around 10:00, the patient experienced Inarticulateness, malaise (as reported). On 16Jul2021, Cerebral infarction confirmed by head MRI. The events result in hospitalized. It was unknown whether there was any treatment performed to the patient or not. Since the vaccination, it is unknown whether the patient has been tested for COVID-19. No follow up attempts are possible. No further information is expected.


VAERS ID: 1524490 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Liver tumour
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100927331

Write-up: Nausea; Pyrexia; Right side muscle pain; This is a spontaneous report from a contactable pharmacist received via COVID-19 Self-Reporting. A 79-year-old male patient received BNT162B2 (COMIRNATY), intramuscular in right arm on 13Jul2021 (Lot Number: FA5765; Expiration Date: 30Sep2021; at the age of 79 years old) as dose 1, single for COVID-19 immunisation. Other medical history included Cerebral infarction and Liver tumour. The patient had no allergies to medications, food, or other products. The patient has unspecified concomitant medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received drugs within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 13Jul2021 (the day of vaccination), the patient received the first dose (as reported) of BNT162B2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration date 30Sep2021) intramuscular in the Arm Right for COVID-19 immunization. On 14Jul2021 at 02:00 (1 day after the vaccination), the patient experienced Nausea, Pyrexia, and Right side muscle pain. The course of the event was as follows: On 13Jul2021, inoculation of COMIRNATY in the arm right (second dose) (as reported). Nausea, Pyrexia, and Right side muscle pain started late at night. The patient was hospitalized, and duration of hospitalization was 6 days. The outcome of the event was recovered without treatment. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible; information about batch number was already obtained. Sender''s Comments: Based on temporal association, the causal relationship between BNT162B2 and the events nausea, pyrexia, and myalgia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the product is evaluated as part of 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, as appropriate.


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