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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 345 out of 6,867

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VAERS ID: 1516903 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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: Fatigue, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy; Seizure (Used to have seizures and was under a neurologist.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100909385

Write-up: felt tired; Seizure; 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-202107172218499750-MBC6F. Safety Report Unique identifier GB-MHRA-ADR 25669322 . A 49-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 17Jul2021 (Batch/Lot Number: FD8813) as single dose (at the age of 49-year-old) for COVID-19 immunisation. Medical history included seizure (Used to have seizures and was under a neurologist), and pregnancy. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant. The patient''s concomitant medications were not reported. On 17Jul2021, the patient came home from having vaccination felt tired. She slept for about 2 hours woke up and had a seizure. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of both events was resolved on 17Jul2021. Both events were serious with medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516910 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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: Dizziness, Malaise
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100909429

Write-up: dizzy; Light-headed; Feeling sick; This is a spontaneous report from a contactable consumer received from the regulatory authority. The Regulatory Authority report number is GB-MHRA-WEBCOVID-202107172258370300-BSLPD, Safety Report Unique Identifier GB-MHRA-ADR 25669354. A 36-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 17Jul2021, as single dose, for COVID-19 immunisation. Medical history included pregnancy from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19, did not have a COVID-19 test. Patient was not enrolled in clinical trial. Concomitant medications were not reported. The patient experienced dizzy (medically significant) on 17Jul2021 with outcome of not recovered, light-headed (medically significant) on 17Jul2021 with outcome of not recovered, feeling sick (medically significant) on 17Jul2021 with outcome of not recovered. it was reported that the patient felt very light headed and dizzy, bit quite with it and feeling quite sick. Started feeling like this about 6 hours post vaccination. Patient did not test positive for COVID-19 since having the vaccine. Adverse reaction did not occur as a result of an exposure during pregnancy. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1516944 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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: Heart rate
SMQs:

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: Test Date: 20210717; Test Name: Heart rate; Result Unstructured Data: Test Result:Heart rate
CDC Split Type: GBPFIZER INC202100916695

Write-up: Heart rate; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The Regulatory Authority report number is GB-MHRA-WEBCOVID-202107181511039250-S5DJH, Safety Report Unique Identifier GB-MHRA-ADR 25669782. A 41-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 17Jul2021 (Batch/Lot Number: Fd8813), as single dose, for COVID-19 immunisation. Medical history included suppressed lactation from an unknown date and unknown if ongoing. Patient was not pregnant and was not pregnant at time of vaccination. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test, was not currently breastfeeding, was not enrolled in clinical trial. Concomitant medications were not reported. The patient experienced heart rate (medically significant) on 17Jul2021 with outcome of recovered on 18Jul2021. The patient underwent lab tests and procedures which included heart rate: heart rate on 17Jul2021. 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: 1516954 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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: Arthralgia, Breast pain, Hyperhidrosis, Nausea, Nipple pain, Off label use, Product use issue, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Lipodystrophy (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Medication errors (broad), Hypoglycaemia (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100916407

Write-up: Fainting; Aching joints; Nipple pain; Nauseous; Heavy sweating; Breast pain; maternal exposure during breast feeding; maternal exposure during breast feeding; This is a spontaneous report from a contactable consumer received from The regulatory authority report number is GB-MHRA-WEBCOVID-202107182208339720-D1LKH. Safety Report Unique Identifier GB-MHRA-ADR 25670090. The consumer reported for the mother and the baby. This is the mother case. A 31-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Jul2021 as single dose for COVID-19 immunisation. Medical history included ongoing breast feeding. She has not had symptoms associated with COVID-19, not pregnant, and not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced maternal exposure during breast feeding on 17Jul2021; fainting, aching joints, nipple pain, nauseous, heavy sweating, breast pain on an unspecified date. Case narrative: All breast and nipple pain on the side that the vaccine was given. She has not tested positive for COVID-19 since having the vaccine. She underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on an unspecified date. The patient recovered from fainting and nauseous on an unspecified date, while outcome of other events was recovering. Case was reported as medically significant by health authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202100924301 Baby case


VAERS ID: 1516962 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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: Arthralgia, Asthenia, Vaccination site erythema
SMQs:, Guillain-Barre syndrome (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100916776

Write-up: low energy; Red marks around injection side; Aching joints; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107182259348030-F307Z, Safety Report Unique Identifier GB-MHRA-ADR 25670158. A 40-year-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 17Jul2021 (at the age of 40-years-old) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Unsure if patient has had symptoms associated with COVID-19 Not had a COVID-19 test. The patient experienced low energy on an unspecified date, aching joints on 17Jul2021 and red marks around injection side on an unspecified date. The events were serious (disability). The events were described as: red marks around injection side, all lims aching, low energy. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Aching joints was not resolved, the outcome of the 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: 1516970 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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: Asthenia, Axillary pain, Chest pain, Chills, Fatigue, Headache, Hyperhidrosis, Inappropriate schedule of product administration, Limb discomfort, Lymphadenopathy, Malaise, Nausea, Pyrexia, Skin sensitisation
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Inflammation; Lactation decreased; Pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100916823

Write-up: tiredness; weakness; sweating; Inappropriate schedule of vaccination administered; Headache; Fever; Shivering; Swollen lymph nodes; Arm discomfort; Fatigue; Skin sensitisation; Swollen glands; Chest aching; Malaise; Weakness generalised; Nausea; Armpit pain; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107190712100030-T7BLV, safety report unique identifier is GB-MHRA-ADR 25670774. A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 17Jul2021 (Lot Number: FF3319) at age og 28 years as single for COVID-19 immunisation. The patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15May2021 (Lot Number: ET8885) as single for COVID-19 immunisation. Medical history included suppressed lactation from an unknown date and unknown if ongoing, inflammation from 17Jul2021 to an unknown date , pain from 17Jul2021 to an unknown date. Concomitant medication(s) included ibuprofen (IBUPROFEN) taken for inflammation from 17Jul2021 to an unspecified stop date; paracetamol (PARACETAMOL) taken for pain from 17Jul2021 to an unspecified stop date. The patient experienced tiredness (fatigue) (medically significant) on an unspecified date with outcome of recovering , weakness (asthenia) (medically significant) on an unspecified date with outcome of recovering , sweating (hyperhidrosis) (medically significant) on an unspecified date with outcome of recovering , headache (headache) (medically significant) on 17Jul2021 with outcome of not recovered , fever (pyrexia) (medically significant) on 17Jul2021 with outcome of not recovered , shivering (chills) (medically significant) on 17Jul2021 with outcome of not recovered , swollen lymph nodes (lymphadenopathy) (medically significant) on 17Jul2021 with outcome of not recovered , arm discomfort (limb discomfort) (medically significant) on 17Jul2021 with outcome of not recovered , fatigue (fatigue) (medically significant) on 17Jul2021 with outcome of not recovered , skin sensitisation (skin sensitisation) (medically significant) on 17Jul2021 with outcome of not recovered , swollen glands (lymphadenopathy) (medically significant) on 17Jul2021 with outcome of not recovered , chest aching (chest pain) (medically significant) on 17Jul2021 with outcome of recovered on 18-JUL-2021 00:00 , malaise (malaise) (medically significant) on 17Jul2021 with outcome of not recovered , weakness generalised (asthenia) (medically significant) on 17Jul2021 with outcome of not recovered , nausea (nausea) (medically significant) on 17Jul2021 with outcome of not recovered , armpit pain (axillary pain) (medically significant) on 17Jul2021 with outcome of not recovered , inappropriate schedule of vaccination administered (inappropriate schedule of product administration) (medically significant) on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of tiredness (fatigue), headache (headache) , fatigue (fatigue).Clinical course was :Had vaccine in the afternoon and had onset of symptoms about 3-4hrs later, mild at first mainly headache and tiredness but gradually got worse. By following day could barely move out of bed, severe fatigue and severe headache that was not eased with paracetamol. Shivering one minute and then sweating and high temp the next. Severe weakness all over and skin very sensitive, could barely stand to have a sheet over me. Severe arm pain, especially under the arm pit, lymph nodes swollen (feels like a golf ball is under my arm). For part of the day my chest was aching, not severe but felt like malaise and just a general unwellness, not severe enough for medical attention. Currently day 3 following vaccine and still having symptoms, had to call in sick to work.Additonal information: 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: 1516971 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   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 FO8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Breast pain, Lymphadenopathy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Lipodystrophy (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: PARACETAMOL
Current Illness: Fertility decreased (Ongoing referral due to fertility issues)
Preexisting Conditions: Medical History/Concurrent Conditions: Fever; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: Body temperature; Result Unstructured Data: Test Result:37.8
CDC Split Type: GBPFIZER INC202100916786

Write-up: breast pain; Swollen lymph nodes; fever (37.8); This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The Regulatory Authority report number is GB-MHRA-WEBCOVID-202107190718318840-3BVPI, Safety Report Unique Identifier GB-MHRA-ADR 25670747. A 32-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 16Jul2021 (Batch/Lot Number: FO8813), as single dose, for COVID-19 immunisation. Medical history included suppressed lactation from an unknown date and unknown if ongoing, pyrexia from an unknown date and unknown if ongoing, ongoing infertility (ongoing referral due to fertility issues). Patient has not had symptoms associated with COVID-19, did not have a COVID-19 test, was not pregnant, was not currently breastfeeding, did not test positive for COVID-19 since having the vaccine, was not enrolled in clinical trial. Concomitant medication included paracetamol (unknown manufacturer) taken for an unspecified indication from 17Jul2021 to 17Jul2021. The patient experienced fever (37.8) (medically significant) on 17Jul2021 with outcome of recovered on 18Jul2021, breast pain (medically significant) on 19Jul2021 with outcome of recovering, swollen lymph nodes (medically significant) on 18Jul2021 with outcome of not recovered. It was reported that lymph nodes in armpit where vaccine was given swell up and become painful. The patient underwent lab tests and procedures which included body temperature: 37.8 on 17Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1517016 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
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: COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100941525

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; This is a spontaneous report from a contactable pharmacist received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107220841466860-0YGLW. Safety Report Unique Identifier GB-MHRA-ADR 25691078. A 81-year-old male patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), (Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single, and dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not have symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient tested positive after both vaccines. On 17Jul2021, the patient experienced SARS-CoV-2 infection (COVID-19, (hospitalization, medically significant)). The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 17Jul2021. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1517030 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Dizziness postural, Dyspnoea, Fatigue, Hypoaesthesia, Hypokinesia, Impaired work ability, Insomnia, Joint lock, Maternal exposure during pregnancy, Morning sickness, Muscle spasms, Myalgia, Nausea, Neuralgia, Pain, Paraesthesia, Pruritus, Rash, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NAPROXEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Date: 20210608; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Do painful have not been able to sleep; affecting my daily living; In my left arm where injection was administed arm unable to lift arm properly; nausea; Severe pain in my hands, fingers, lower leg and sole, of feet in both sides of my body; Muscle pain; Nausea gravidarum; Dizziness postural; Labored breathing; Nerve pain; Numbness in hand; Pins and needles; Weakness; Spasm muscle; Joint lock; Joint pain; Fatigue extreme; Rash; Itching all over; maternal exposure during pregnancy; This regulatory authority pregnancy case was reported by a consumer and describes the occurrence of DIZZINESS POSTURAL (Dizziness postural), DYSPNOEA (Labored breathing), NEURALGIA (Nerve pain), HYPOAESTHESIA (Numbness in hand), PARAESTHESIA (Pins and needles), ASTHENIA (Weakness), MUSCLE SPASMS (Spasm muscle), PRURITUS (Itching all over), JOINT LOCK (Joint lock), MORNING SICKNESS (Nausea gravidarum), INSOMNIA (Do painful have not been able to sleep), IMPAIRED WORK ABILITY (affecting my daily living), HYPOKINESIA (In my left arm where injection was administed arm unable to lift arm properly), RASH (Rash), ARTHRALGIA (Joint pain), FATIGUE (Fatigue extreme), NAUSEA (nausea), PAIN (Severe pain in my hands, fingers, lower leg and sole, of feet in both sides of my body) and MYALGIA (Muscle pain) in a 47-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Clinical trial participant. Concomitant products included NAPROXEN from 04-Jun-2018 to an unknown date for Arthritis. On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 17-Jul-2021, the patient experienced PRURITUS (Itching all over) (seriousness criteria disability and medically significant), RASH (Rash) (seriousness criteria disability and medically significant) and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). On 18-Jul-2021, the patient experienced DYSPNOEA (Labored breathing) (seriousness criteria disability and medically significant), NEURALGIA (Nerve pain) (seriousness criteria disability and medically significant), HYPOAESTHESIA (Numbness in hand) (seriousness criteria disability and medically significant), PARAESTHESIA (Pins and needles) (seriousness criteria disability and medically significant), ASTHENIA (Weakness) (seriousness criteria disability and medically significant), MUSCLE SPASMS (Spasm muscle) (seriousness criteria disability and medically significant), JOINT LOCK (Joint lock) (seriousness criteria disability and medically significant), ARTHRALGIA (Joint pain) (seriousness criteria disability and medically significant) and FATIGUE (Fatigue extreme) (seriousness criteria disability and medically significant). On 19-Jul-2021, the patient experienced DIZZINESS POSTURAL (Dizziness postural) (seriousness criteria disability and medically significant). On 20-Jul-2021, the patient experienced MORNING SICKNESS (Nausea gravidarum) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced INSOMNIA (Do painful have not been able to sleep) (seriousness criteria disability and medically significant), IMPAIRED WORK ABILITY (affecting my daily living) (seriousness criteria disability and medically significant), HYPOKINESIA (In my left arm where injection was administed arm unable to lift arm properly) (seriousness criteria disability and medically significant), NAUSEA (nausea) (seriousness criteria disability and medically significant), PAIN (Severe pain in my hands, fingers, lower leg and sole, of feet in both sides of my body) (seriousness criteria disability and medically significant) and MYALGIA (Muscle pain) (seriousness criteria disability and medically significant). At the time of the report, DIZZINESS POSTURAL (Dizziness postural), DYSPNOEA (Labored breathing), NEURALGIA (Nerve pain), HYPOAESTHESIA (Numbness in hand), PARAESTHESIA (Pins and needles), ASTHENIA (Weakness), MUSCLE SPASMS (Spasm muscle), PRURITUS (Itching all over), JOINT LOCK (Joint lock), MORNING SICKNESS (Nausea gravidarum), INSOMNIA (Do painful have not been able to sleep), IMPAIRED WORK ABILITY (affecting my daily living), HYPOKINESIA (In my left arm where injection was administed arm unable to lift arm properly), RASH (Rash), ARTHRALGIA (Joint pain), FATIGUE (Fatigue extreme), NAUSEA (nausea), PAIN (Severe pain in my hands, fingers, lower leg and sole, of feet in both sides of my body) and MYALGIA (Muscle pain) had not resolved and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jun-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient states that Adverse reaction did not occur as a result of an exposure during pregnancy. Treatment medication was not provided. Patient reported that she was very sensitive as well and ambulance attended on 22 Jul 2021. Concerning the event of maternal exposure during pregnancy, this female has no associated AE and based on the reporter''s report the vaccination has not had an adverse effect on any aspect of the pregnancy. Concerning the events, Dizziness postural, Dyspnoea, Neuralgia, Hypoaesthesia, Paraesthesia, Asthenia, Muscle spasms, Pruritus, Joint lock, Morning sickness, insomnia, Impaired work ability, Hypokinesia, Rash, Arthralgia, Fatigue, Fatigue, Nausea, Pain and Myalgia, 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: Concerning the event of maternal exposure during pregnancy, this female has no associated AE and based on the reporter''s report the vaccination has not had an adverse effect on any aspect of the pregnancy. Concerning the events, Dizziness postural, Dyspnoea, Neuralgia, Hypoaesthesia, Paraesthesia, Asthenia, Muscle spasms, Pruritus, Joint lock, Morning sickness, insomnia, Impaired work ability, Hypokinesia, Rash, Arthralgia, Fatigue, Fatigue, Nausea, Pain and Myalgia, 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: 1517063 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Inappropriate schedule of product administration, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), 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: Asthma (very mild, not even a monthly problem); Eczema (hay fever eczema (mild)); Faint; Hay fever (hay fever eczema (mild))
Allergies:
Diagnostic Lab Data: Test Date: 20201227; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100926614

Write-up: feeling faint; Light-headed; the patient received the first dose on 22May2021 and the second dose on 17Jul2021; This is a spontaneous report from a contactable consumer. This is the second of two reports. The first report is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107181505221560-Q3WTA, Safety Report Unique Identifier GB-MHRA-ADR 25669785. A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Jul2021 (Lot Number: FE1510), at the age of 35 years, as the second single dose, for COVID-19 immunization. Medical history included eczema, asthma, hay fever, fainted twice in adulthood. Asthma (very mild, not even a monthly problem) hay fever eczema (mild), had fainted twice in adulthood, checked over by GP, ER to no conclusion. Patient has not had symptoms associated with COVID-19 Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) received on 22May2021 (Lot Number: ET8885), at the age of 35 years, for COVID-19 immunization, experiencing light-headed and feeling faint. The patient''s concomitant medications were not reported. The patient experienced feeling faint on an unspecified date with outcome of not recovered and light-headed on 17Jul2021 with outcome of recovering. The case was reported serious per other medically important condition. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 27Dec2020. Additional information: both doses resulted in minor light-headedness on the day of the jab. The following day was more severe, felt the need to sit down as the feeling was close to feeling faint. Adequate water and food taken before and after each dose as apart of normal meal times. Sitting down but not necessarily sleeping helped, first occasion was at work but did not feel comfortable being away from home. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202100916699 same patient/same product, different dose/events


VAERS ID: 1517476 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure diastolic decreased, Blood pressure measurement, Depressed level of consciousness, Heart rate, Heart rate decreased, Nausea, Oxygen saturation, Pallor
SMQs:, 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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma bronchial
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: Blood pressure; Result Unstructured Data: Test Result:92/50 mmHg; Comments: 26 minutes after the vaccination; Test Date: 20210717; Test Name: Blood pressure; Result Unstructured Data: Test Result:94/60 mmHg; Comments: 49 minutes after the vaccination; Test Date: 20210717; Test Name: Blood pressure; Result Unstructured Data: Test Result:136/60 mmHg; Comments: 53 minutes after the vaccination; Test Date: 20210717; Test Name: Pulse; Result Unstructured Data: Test Result:53; Comments: 49 minutes after the vaccination; Test Date: 20210717; Test Name: SpO2; Test Result: 100 %; Comments: 49 minutes after the vaccination.
CDC Split Type: JPPFIZER INC2021908153

Write-up: Pulse 53; pallor facial; Consciousness clouding; Feeling queasy; blood pressure 92/50 mmHg; This is a spontaneous report from a contactable physician received via the Regulatory Authority. The patient was a 44-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Flutiform within 2 weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included Asthma bronchial. On 17Jul2021 at 10:30 (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EW0203, Expiration date 30Sep2021) intramuscular in the left arm for COVID-19 immunization. On 17Jul2021 at 11:00 (30 min after the vaccination), the patient experienced adverse events. The course of the event was as follows: 26 minutes after the vaccination, the patient experienced feeling queasy, blood pressure 92/50 mmHg. 39 minutes after the vaccination, intravenous administration of Soldem 1 200ml plus Primperan A started. 44 minutes after the vaccination, pallor facial and consciousness clouding developed. 49 minutes after the vaccination, the blood pressure 94/60 mmHg, SpO2 100%, Pulse 53, Bosmin 0.3 ml intramuscular performed. 53 minutes after the vaccination, blood pressure 136/60 mmHg. The patient was sent to emergency at 59 minutes after the vaccination. The reporter stated the events result in doctor or other healthcare professional office/ emergency room. The outcome of the events was resolved with treatment including Intravenous drip and Bosmin 0.3 ml intramuscular. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1517492 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Chills, Cyanosis, Heart rate, Hypoaesthesia, Incontinence, Oxygen saturation, Peripheral coldness, Syncope, Vital signs measurement
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Blood Pressure; Result Unstructured Data: blood pressure fell to an unmeasurable level; Test Date: 20210717; Test Name: Blood Pressure; Result Unstructured Data: 110; Test Date: 20210717; Test Name: Heart rate; Result Unstructured Data: 40 s; Test Date: 20210717; Test Name: Heart rate; Result Unstructured Data: 60; Test Date: 20210717; Test Name: percutaneous oxygen saturation; Result Unstructured Data: 99 %; Test Name: Vital sign; Result Unstructured Data: stable
CDC Split Type: JPTAKEDA2021TJP064276

Write-up: Syncope; Incontinence; Cyanosis of lip; Numbness; Peripheral coldness; Shivering; This case was received via Takeda Pharmaceuticals (Reference number: 2021TJP064276) on 21-Jul-2021 and was forwarded to Moderna on 29-Jul-2021. This regulatory authority case was reported by a physician and describes the occurrence of SYNCOPE (Syncope), INCONTINENCE (Incontinence), CYANOSIS (Cyanosis of lip), HYPOAESTHESIA (Numbness), PERIPHERAL COLDNESS (Peripheral coldness) and CHILLS (Shivering) in an 18-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 17-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant), INCONTINENCE (Incontinence) (seriousness criterion medically significant), CYANOSIS (Cyanosis of lip) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness) (seriousness criterion medically significant), PERIPHERAL COLDNESS (Peripheral coldness) (seriousness criterion medically significant) and CHILLS (Shivering) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Syncope), INCONTINENCE (Incontinence), CYANOSIS (Cyanosis of lip), HYPOAESTHESIA (Numbness), PERIPHERAL COLDNESS (Peripheral coldness) and CHILLS (Shivering) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jul-2021, Blood pressure measurement: 110 (normal) 110. On 17-Jul-2021, Heart rate: 40 (Low) 40 s and 60 (normal) 60. On 17-Jul-2021, Oxygen saturation: 99 (normal) 99 %. On an unknown date, Blood pressure measurement: low (Low) blood pressure fell to an unmeasurable level. On an unknown date, Vital signs measurement: stable (normal) stable. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. On 17-Jul-2021, at 10:31, patient received first dose of vaccine and at 10:33, few minutes after vaccination, experienced syncope and incontinence, consciousness immediately improved and patient was able to talk. Vital signs were kept stable, but patient had symptoms of shivering and numbness and was examined in bed. Heart rate (HR) became 40s and blood pressure fell to an unmeasurable level, and thus the patient received extracellular fluid at a full rate of infusion. The level of consciousness was Japan Coma Scale (JCS) I-1 to I-2. The patient experienced cyanosis of lip and peripheral coldness. The patient had shivering and marked sweating with no rash or enanthema. Normal sound was not heard by auscultation. The final vital signs were kept stable of blood pressure (BP) 110s, HR 60, and percutaneous oxygen saturation (SpO2) of 99%. As there was no improvement in shivering or numbness, the patient was transported by ambulance. No concomitant medication details was provided. The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1517514 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Diarrhoea, Dyspnoea, Hallucination, Headache, Heart rate increased, Nausea, Pain, Pyrexia, Vision blurred
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MTJNJFOC20210760091

Write-up: FEVER; DIARRHOEA; NAUSEA; CHILLS; HALLUCINATIONS; SHORTNESS OF BREATH; HIGH HEART RATE; BLURRED VISION; PAIN; HEADACHE; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, MT-ADM-2072021] concerned a 22 year old female of unknown race and ethnicity. The patient''s weight was 48 kilograms, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 17-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 01-JAN-2021, the patient experienced fever. On 17-JUL-2021, the patient experienced shortness of breath, high heart rate , hallucinations , blurred vision , pain , headache and chills. On 18-JUL-2021, the patient experienced nausea. On 19-JUL-2021, the patient experienced diarrhoea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 01-JAN-2021, and chills on 19-JUL-2021, and had not recovered from diarrhoea, nausea, high heart rate, headache, hallucinations, blurred vision, pain, and shortness of breath. This report was serious (Other Medically Important Condition, Life Threatening, and Disability Or Permanent Damage).; Sender''s Comments: V0: 20210760091-COVID-19 VACCINE AD26.COV2.S-hallucinations, shortness of breath, high heart rate, blurred vision, pain, headache, fever, diarrhoea, chills, nausea. 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: 1517629 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-07-17
   Days after vaccination:43
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002616 / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Echocardiogram, Electrocardiogram, Pericarditis, Physical examination
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: Cardiac ultrasound; Result Unstructured Data: Findings on clinical examination, EKG and ultrasound scan of the heart were compatible with pericarditis.; Test Date: 20210717; Test Name: EKG; Result Unstructured Data: Findings on clinical examination, EKG and ultrasound scan of the heart were compatible with pericarditis.; Test Date: 20210717; Test Name: Physical examination; Result Unstructured Data: Findings on clinical examination, EKG and ultrasound scan of the heart were compatible with pericarditis.
CDC Split Type: NOMODERNATX, INC.MOD20212

Write-up: Perikarditt; This regulatory authority case was reported by a physician and describes the occurrence of PERICARDITIS (Perikarditt) in a 50-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002616) for COVID-19 vaccination. No Medical History information was reported. On 04-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced PERICARDITIS (Perikarditt) (seriousness criteria hospitalization and medically significant). At the time of the report, PERICARDITIS (Perikarditt) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jul-2021, Echocardiogram: abnormal (abnormal) Findings on clinical examination, EKG and ultrasound scan of the heart were compatible with pericarditis.. On 17-Jul-2021, Electrocardiogram: abnormal (abnormal) Findings on clinical examination, EKG and ultrasound scan of the heart were compatible with pericarditis.. On 17-Jul-2021, Physical examination: abnormal (abnormal) Findings on clinical examination, EKG and ultrasound scan of the heart were compatible with pericarditis.. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered PERICARDITIS (Perikarditt) to be possibly related. 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 this event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.


VAERS ID: 1517700 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Presyncope
SMQs:, Anticholinergic syndrome (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: PTJNJFOC20210758553

Write-up: SWEATING REACTION AS IF VASOVAGAL HYPOTENSION PALLOR; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-B202107-3376] concerned a 37year 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: XE393 expiry: UNKNOWN) 0.5 ml, 1 total, administered on 17-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 17-JUL-2021, the patient experienced sweating reaction as if vasovagal hypotension pallor for 30 minutes. The dose of covid-19 vaccine ad26.cov2.s was not changed. The patient recovered from sweating reaction as if vasovagal hypotension pallor on 17-JUL-2021 within 30 minutes of onset. This report was serious (Other Medically Important Condition).; Reporter''s Comments: Other information- A young 37 years-old with dizziness, fainting sensation but no lipothymia, sweating in the moments immediately following administration of Janssen vaccine. Capillary glycemia 81 mg/dl, AT 110/75, CF 72, Sat (aa) 97%, Tredelenburg maneuver, hydration and stabilization of AT and vital parameters.; Sender''s Comments: V0: 20210758553-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Sweating reaction as if vasovagal hypotension pallor. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1517739 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-17
   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 - / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210719; Test Name: sars-cov-2 PCR test; Result Unstructured Data: Test Result:Positive; Comments: Nasal Swab
CDC Split Type: PTPFIZER INC202100927929

Write-up: Covid-19; Covid-19; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received BNT162B2 (COMIRNATY; Formulation: Solution for injection, Lot Number: Unknown), via intramuscular route of administration, on 05Jul2021 at 13:00 (at the age of 62-year-old), as dose 2, single in left arm; and received BNT162B2 (COMIRNATY; Formulation: Solution for injection, Lot Number: Unknown), via intramuscular route of administration, on 14Jun2021 at 13:00 (at the age of 62-year-old), as dose 1, single in left arm for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Prior to vaccination, the patient had not been diagnosed with COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 17Jul2021, 11 days and 11 hours after the vaccine, the patient experienced vaccination failure and COVID-19. The patient underwent lab tests and procedures which included SARS-CoV-2 test (nasal swab): positive on 19Jul2021. The clinical outcome of the events was recovered. Information on batch number has been requested.


VAERS ID: 1519190 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214004 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angioedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SIFROL; COSENTYX; IZALGI
Current Illness: Fibromyalgia; Restless legs syndrome; Spondylitis ankylosing
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Urticaria giant; This regulatory authority case was reported by a physician and describes the occurrence of ANGIOEDEMA in a 47-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 214004) for COVID-19 vaccination. Concurrent medical conditions included Fibromyalgia, Restless legs syndrome and Spondylitis ankylosing. Concomitant products included SIFROL and COSENTYX for Product used for unknown indication, PAPAVER SOMNIFERUM, IZALGI for an unknown indication. On 16-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced ANGIOEDEMA (seriousness criterion medically significant). At the time of the report, ANGIOEDEMA was resolving. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided by the reporter. Sender''s Case Report Number: FR-AFSSAPS-LM20211947 Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1520351 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 72076 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiovascular disorder, Chest pain, Fatigue, Headache, Heart rate, Heart rate increased, Oxygen saturation, Oxygen saturation decreased, Pain in extremity, Syncope, Vaccination site pain
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Headache; Pericarditis (at 21 years old)
Allergies:
Diagnostic Lab Data: Test Name: pulse; Result Unstructured Data: Test Result:increased heart rate; Comments: Sometimes a strong pulse when resting; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:Oxygen saturation decreased; Comments: sometimes 5% lower than normal even when resting
CDC Split Type: DEPFIZER INC202100921319

Write-up: headache; pain in limb; arm pain at the injection site/ vaccination site pain; circulatory weakness; severe tiredness/ increased need for sleep; chest pain/ slight pain in the chest; increased heart rate/ a strong pulse when resting; oxygen saturation decreased/ sometimes 5% lower than normal even when resting; syncope; This is a spontaneous report received from a contactable nurse (patient) reporting for himself. A 29-year-old male patient received the first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (batch/lot number: 72076) at 29 years old as DOSE 1, SINGLE for COVID-19 immunization. The patient''s medical history included pericarditis experienced at 21 years old and acute headache from an unknown date. Patient had no known previous illnesses or allergies. Concomitant medications included ibuprofen (IBUPROFEN) 400mg taken for acute headache, start and stop date were not reported. The patient reported that during the first two days , he experienced the usual symptoms such as headache and pain in limb, arm pain at the injection site (vaccination site pain), and general circulatory weakness (circulatory instability) with severe tiredness (onset dates not reported). The patient also experienced chest pain from day 3 similar to pericarditis which he had already experienced when he was 21 years old. The circulatory weakness with tiredness and increased need for sleep has lasted since 28Jun2021 and was sometimes accompanied by slight pain in the chest. Sometimes increased heart rate reported as a strong pulse when resting as well as oxygen saturation decreased described as oxygen saturation which was sometimes 5% lower than normal even when resting. Yesterday, 17Jul2021, patient suffered from syncope after consuming alcohol the day before. Medical clarification has not yet taken place but will be made up soon. The outcome of the events was unknown.; Sender''s Comments: The association between the event syncope with COMIRNATY use can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1520558 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-17
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003602 / 1 - / OT

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

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

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS in a 27-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003602) for COVID-19 vaccination. No Medical History information was reported. On 12-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 17-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced MYOCARDITIS (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS was resolving. mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was withdrawn on 12-Jul-2021. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment information was provided. No laboratory data was provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time


VAERS ID: 1520687 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 FF0680 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Erythema, Heart rate, Investigation, Loss of consciousness, Malaise
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (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: Nerve pain (vagal discomfort)
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:maintained; Test Name: HR; Result Unstructured Data: Test Result:70; Comments: bpm; Test Name: staining; Result Unstructured Data: Test Result:good
CDC Split Type: FRPFIZER INC202100948886

Write-up: Consciousness loss; Feeling sick/malaise; redness of the trunk; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-PO20213687. A 40-year-old male patient received BNT162B2 (COMIRNATY, lot number: FF0680), intramuscular, administered in Left Arm on 17Jul2021 (at 40-year-old) as dose 1, 0.3 ml single for COVID-19 immunisation. Medical history included a history of vagal discomfort. The patient has no history of Covid-19 infection and has not been tested. The patient''s concomitant medications were not reported. On 17Jul2021 the patient experienced consciousness loss (hospitalization, life threatening), feeling sick (hospitalization, life threatening), redness of the trunk (hospitalization). Clinical details: 17Jul2021: First injection of COMIRNATY vaccine lot FF0680 in intramuscular in the left arm. 1 minute after the injection, onset of malaise with loss of consciousness, redness of the trunk, no pharyngeal edema. Blood pressure maintained, HR 70bpm, good staining. Consciousness recovery after injection of ANAPEN in the left thigh. The patient was hospitalized for surveillance. The outcome of event consciousness loss was recovered on 17Jul2021, outcome of event feeling sick was not recovered, outcome of event redness of the trunk was unknown.


VAERS ID: 1520697 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-07-17
   Days after vaccination:197
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALPRAZOLAM
Current Illness: Depression; Obesity; Smoker; Tabaquism
Preexisting Conditions: Medical History/Concurrent Conditions: Hormonal contraception
Allergies:
Diagnostic Lab Data: Test Name: thrombophilia assessment; Result Unstructured Data: Test Result:unknown results
CDC Split Type: FRPFIZER INC202100948852

Write-up: Pulmonary embolism; pulmonary infarction; This is as spontaneous report received from a contactable physician downloaded from the . The regulatory authority report number FR-AFSSAPS-ST20212894. A 37-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 05Jul2021 (Batch/Lot Number: unknown) as 0.3 ml single for covid-19 immunisation; olanzapine (manufacturer unknown), orally from Jan2021 (Batch/Lot Number: Unknown) to an unspecified date at 20 mg, daily for depression; cyproterone acetate, ethinylestradiol orally from an unspecified date (Batch/Lot Number: Unknown) to 17Jul2021 at 35 ug for hormonal contraception. Medical history included ongoing tabaquism, ongoing depression, ongoing obesity, ongoing smoking, and hormonal contraception. Concomitant medication at the time of the reaction included alprazolam. The patient experienced pulmonary embolism and pulmonary infarction on 17Jul2021 with outcome of recovering. The patient experienced life-threatening events. The action taken in response to the events for olanzapine was permanently withdrawn on an unspecified date in 2021, for cyproterone acetate, ethinylestradiol was permanently withdrawn on 17Jul2021. Reporter''s Comments: on day 12 of comirnaty and olanzapine in a context of obesity and active smoking: pulmonary embolism at high intermediate risk complicated by pulmonary infarction. Smoking cessation; CO [Carbon monoxide] stop; thrombophilia assessment started, awaiting further information. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: on day 12 of comirnaty and under olanzapine in a context of obesity and active smoking: pulmonary embolism at high intermediate risk complicated by pulmonary infarction. Smoking cessation; CO [Carbon monoxide] stop; thrombophilia assessment started, awaiting further information.


VAERS ID: 1520769 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100916681

Write-up: Chills; Maternal exposure during pregnancy/Patient was exposed to the medicine Third-trimester (29-40 weeks); This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-APPCOVID-20210718111318, Safety Report Unique Identifier is GB-MHRA-ADR 25669648. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 17Jul2021 (at the age of 37 years old) as dose number unknown, single for COVID-19 immunisation. Medical history was not reported. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not currently breastfeeding. Concomitant medication included folic acid taken for vitamin supplementation. The patient experienced chills on 18Jul2021 and maternal exposure during pregnancy/patient was exposed to the medicine third-trimester (29-40 weeks) on 17Jul2021. The mother reported she became pregnant while taking bnt162b2. The mother was 3 trimester pregnant at the onset of the event. The event chills was medically significant. Patient is not enrolled in clinical trial. Outcome of the chills was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1520772 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Malaise, Muscle spasms, Nausea, Paraesthesia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Pseudomembranous colitis (broad), Dystonia (broad), Guillain-Barre syndrome (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: TEVA MIRTAZAPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100916455

Write-up: cramps; felt tired; Stomach cramps; tingling skin/tingling; Diarrhea; felt really sick and unwell; felt really sick and unwell, as though going to vomit; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority. The regulatory authority report number, Safety Report Unique Identifier. A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jul2021 as single dose for COVID-19 immunisation. Medical history included lactation decreased and anxiety. Generally fit and healthy. She has not had symptoms associated with COVID-19, not had a COVID-19 test, not pregnant, not currently breastfeeding, and not enrolled in clinical trial. Concomitant medication included TEVA mirtazapine taken for anxiety from 24May2021. The patient experienced cramps, unwell on an unspecified date; stomach cramps, tingling skin/tingling, and diarrhea on 17Jul2021. Case narrative: Symptom started on Saturday morning, felt really sick and unwell, as though going to vomit. She didn''t vomit, and the sick feeling went away in about 5 minutes, but have had cramps and tingling, and felt tired ever since. Cramps were worse today. She has not tested positive for COVID-19 since having the vaccine. The patient recovered from felt really sick and unwell, as though going to vomit on an unspecified date, while not recovered from other events. Case was reported as medically significant by health authority. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1520774 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 - / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Axillary pain, Breast pain, Erythema, Fatigue, Joint stiffness, Migraine, Pain, Pruritus, SARS-CoV-2 test, Swelling, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Lipodystrophy (broad), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Migraine; Tiredness
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100916590

Write-up: pain; migraine; swelling; itchy; red; tiredness; pain and stiffness in the elbow and armpit; pain and stiffness in the elbow and armpit; pain in left breast; Low energy; Left arm progressively became raised/swollen, red and itchy around injection site; Left arm progressively became raised/swollen, red and itchy around injection site; Left arm progressively became raised/swollen, red and itchy around injection site; This is a spontaneous report from a contactable consumer. This is a report received from the The regulatory authority report number is GB-MHRA-APPCOVID-202107182137244370-0MZRF, Safety Report Unique Identifier GB-MHRA-ADR 25670052. A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# was not reported), via an unspecified route of administration in left arm on 17Jul2021 at 26-year-old as dose 2, single for COVID-19 immunization. Medical history included fatigue, migraine, and 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. On an unknown date, the patient experienced pain, migraine, swelling, itchy, red, tiredness, pain and stiffness of elbow and armpit, pain in left breast and low energy. On 17Jul2021, the patient experienced left arm progressively became raised/swollen, red and itchy around injection site. The outcome of the events pain, migraine, swelling, itchy, red, tiredness was recovering; The outcome of the events in and stiffness of elbow and armpit, pain in left breast and low energy was unknown and the outcome of vaccination site swelling, redness and itch was not recovered. The events were medically significant. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on an unknown date. It was reported as left arm progressively became raised/swollen, red and itchy around injection site and then another red itchy swollen area near injection site appeared, over the past 24h the swelling and itchiness has spread into one large area on upper arm. tightness and shooting pains from top of arm to top of hand, pain and stiffness in the elbow and armpit and pain in left breast. Low energy/tiredness and woke up with severe migraine. 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.


VAERS ID: 1520782 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 FF3319 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Headache, Muscle spasms, Nausea
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Dystonia (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 INC202100923277

Write-up: painful cramps; nausea; headache; Watery diarrhoea; Watery diarrhoea; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Authority. The regulatory authority report number. Safety Report Unique Identifier. A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE) via parenteral on 17Jul2021, at patient age of 39-year-old, as single dose (Batch/Lot Number: FF3319) for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced watery diarrhoea on 17Jul2021 and on 19Jul2021. The patient reported painful cramps with diarrhoea that was very watery. She was unable to make it to bathroom in time. She had nausea and headache. The outcome of the event watery diarrhoea was not resolved. The outcome of the other events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1520820 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ear pain, Fatigue, Headache, Oropharyngeal pain, Pain, Pyrexia, Skin sensitisation, Suspected COVID-19
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100916600

Write-up: Skin sensitisation; Headache; Earache; Sore throat; Fatigue; Generalised aching; Feverish/Fever chills/High temperature; Suspected COVID-19; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107180732188520-HU9GA. Safety Report Unique Identifier GB-MHRA-ADR 25669515. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jul2021 (Batch/Lot number was not reported) as DOSE 2 , SINGLE for covid-19 immunisation. Medical history included lactation decreased. 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 paracetamol. The patient experienced feverish/fever chills/high temperature and suspected covid-19 on 17Jul2021. The patient also experienced skin sensitization, headache, earache, sore throat, fatigue and generalised aching on an unspecified date. The events were assessed as serious (medically significant). The outcome of the event earache was recovered with sequel; suspected COVID-19 was unknown; while not recovered for the rest of the events. No follow-up attempts are possible, information about the batch number cannot be obtained.


VAERS ID: 1520834 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   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 FE/510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Headache, Hypoaesthesia, Paraesthesia, Pyrexia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Temperature; Result Unstructured Data: Test Result:37.2; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100916444

Write-up: temperature/High temperature; headache; Scalp numbness/numbness; tingling; This is a spontaneous report from a contactable consumer received from a regulatory authority. A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot FE/510), via an unspecified route of administration on 16Jul2021 as dose 2, single for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 17Jul2021, the patient''s back of head on right side was feeling numbness/scalp numbness and had tingling. He also had temperature/high temperature and headache on an unspecified date. The events were reported as serious medically significant. The patient underwent laboratory test which included Sars-cov-2 test: negative and body temperature: 37.2, both on an unspecified date. The outcome of numbness was not recovered; for other events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1520842 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 NOT KNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Discomfort, Eye swelling, Fatigue, Joint swelling, Pain, Peripheral swelling, Pruritus, Rash, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100916393

Write-up: Eye swelling/eyes swollen; hand swelling/feet, hands swollen; Fatigue; wrists swollen; rash/rash starting as small spots on arms slowly spreading over whole body and then joining up; Itchy scalp; achy; heavy feeling throughout body; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107181327273480-CGFCF, Safety Report Unique Identifier is GB-MHRA-ADR 25669743. A 37-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number not known; expiration date not provided), via an unspecified route of administration on 17Jul2021 (at the age of 37-years-old) at DOSE 2, SINGLE for COVID-19 immunisation. Patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient experienced ''rash/rash starting as small spots on arms slowly spreading over whole body and then joining up'' and itchy scalp on 17Jul2021; ''eye swelling/eyes swollen'', ''hand swelling/feet, hands swollen'', ''wrists swollen'', and fatigue on 18Jul2021; ''achy'' and ''heavy feeling throughout body'' on unspecified dates in 2021. Patient''s clinical course is as follows: It was reported that it started with very itchy scalp all day very soon after jab. Led into rash starting as small spots on arms slowly spreading over whole body and then joining up. Early hours of following day wrists feet hands and eyes swollen. Feel achy and heavy feeling throughout body. The events were assessed as serious (medically significant). The 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 with result of ''negative; No - Negative COVID-19 test'' on an unknown date. Outcome of the events ''rash/rash starting as small spots on arms slowly spreading over whole body and then joining up'' and ''eye swelling/eyes swollen'' was recovering; outcome of the events ''hand swelling/feet, hands swollen'' and ''fatigue'' was not recovered; outcome of the event ''itchy scalp was recovered on an unspecified date; outcome of the events ''wrists swollen'', ''achy'' and ''heavy feeling throughout body'' was unknown. No follow-up attempts are possible. information about lot/batch number cannot be obtained.


VAERS ID: 1520857 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Myalgia, Pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), 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? 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: Fever; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100916542

Write-up: muscle pain; Fever; Pain; weak; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number: GB-MHRA-WEBCOVID-202107181703355510-UBMKK, Safety Report Unique Identifier: GB-MHRA-ADR 25669840. A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Jul2021 (Lot Number: FD8813) as single dose for COVID-19 immunisation. Medical history included pyrexia, and lactation decreased. Unsure if patient has had symptoms associated with COVID-19. Patient has not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient had muscle pain all over the body all night on an unspecified date. She took paracetamol and aspirin, but pain continued. On 17Jul2021, she had fever at 38.5, pain and weak. She had compresses (towels wet in room temperature water) on lymphatic nodes which managed to lower it to 37.4. Paracetamol did not help. For 20 hours, patient still have pains, weak, stay in bed. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of muscle pain was recovering while other events had not recovered. No follow-up attempts are Possible. No further information is expected.


VAERS ID: 1520862 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Abdominal pain lower, Deep vein thrombosis, Headache, Pain in extremity, Rash, Rash macular, SARS-CoV-2 test, Upper gastrointestinal haemorrhage
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, venous (narrow), Gastrointestinal haemorrhage (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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:
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 INC202100916426

Write-up: left; upper; arms; plus; lower; blotchy rash; Headache; Rash; This is a spontaneous report from a contactable consumer or other non-health care professional. This is a report received from the Regulatory Authority. The Regulatory authority report number is (GB-MHRA-WEBCOVID-202107181737024850-NSEUX) and the Safety Report Unique Identifier is (GB-MHRA-ADR 25669860). A male patient of an unspecified age received 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 16Jul2021 as dose 2, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unspecified date, the patient experienced arms (pain in arm), plus (swelling abdomen), lower (lower abdominal pain), Blotchy rash on both upper arms plus left lower arm, left (left deep vein thrombosis), upper (upper gastrointestinal bleeding) and on 17Jul2021, the patient had headache and rash. The patient underwent lab tests and procedures which included COVID-19 virus test results Negative for SARS-CoV-2. The outcome of the event headache was recovering, rash was not recovered, and the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1520869 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Dizziness, Fatigue, Headache, Insomnia, Lymphadenopathy, Nausea, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), 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: 20210710; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100916350

Write-up: Fever chills; Dizziness; Swollen lymph nodes; Appetite lost; Headache; Tiredness; Nausea; Insomnia; Painful arm; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107181901435660-GPNT7. A 31-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Jul2021 (lot number: FD8813) as single dose for COVID-19 immunisation. Medical history included lactation decreased. She has not had symptoms associated with COVID-19, not pregnant, not currently breastfeeding, and not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced insomnia and painful arm on 17Jul2021; fever chills, dizziness, swollen lymph nodes, appetite lost, headache, tiredness, and nausea on 18Jul2021. 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 10Jul2021. The patient was recovering from insomnia and painful arm, while not recovered 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: 1520875 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Diarrhoea, Hyperhidrosis
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (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? 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 INC202100916623

Write-up: Acute diarrhea; Pain abdominal; sweating; This is a spontaneous report from a contactable consumer (patient). This report is received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107182004340870-WXFTM and Safety Report Unique Identifier is GB-MHRA-ADR 25669966. A 54-year-old patient of an unspecified gender received the second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Batch/Lot Number: FF3319), via an unspecified route of administration on 17Jul2021, at the age of 54 years, dose 2, single for COVID-19 immunization. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient''s concomitant medications were not reported. On 17Jul2021, the patient had acute diarrhea, pain abdominal and sweating. The clinical course was reported as follows: Symptoms started almost as soon as patient emerged from the vaccination center. After 10 car journey home, went to toilet immediately and acute diarrhea commenced followed by acute cramps/abdominal pain. Heavy sweating followed. After about 30 minutes had a shower, went to bed and slept about 90 min say. When patient woke up the symptoms had disappeared altogether, had normal evening including a meal. No symptoms since. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The case is serious (medically significant). The outcome of the events acute diarrhea, pain abdominal and sweating was recovered on 17Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1520878 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Deafness, Ear pain, Facial pain, Headache, Heart rate, Heart rate abnormal, Hypoaesthesia, Respiratory rate
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Hearing impairment (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Headache; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:didn''t indicate any general poor health; Test Name: heart rate; Result Unstructured Data: Test Result:unknown result; Test Name: heart rate; Result Unstructured Data: Test Result:stable; Test Name: breathing; Result Unstructured Data: Test Result:stable
CDC Split Type: GBPFIZER INC202100916550

Write-up: hearing loss; numbness of half of her face and scalp, then this progressed into tongue, throat, and neck numbness; right arm and leg were not as badly affected; heart rate; headache; Numbness of the face and hearing loss persisted, however she also started developing mild pains in these regions; Facial pain; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Authority. The regulatory authority report number. Safety Report Unique Identifier. A 26-year-old female patient received first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration in the right arm on 14Jul2021 (lot number: FD8813) as single dose for COVID-19 immunisation. Medical history included lactation decreased and headache. She has not had symptoms associated with COVID-19, 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 hearing loss, neck numbness, heart rate, and headache on an unspecified date; facial pain on 17Jul2021. Case narrative: She started experiencing hearing loss on her right ear. Within 45 minutes, it progressed onto numbness of half of her face and scalp, then this progressed into tongue, throat, and neck numbness. Her right arm and leg were not as badly affected. She had her jab on her right arm. Emergency blood tests didn''t indicate any general poor health. Heart rate and breathing were stable. Numbness of the face and hearing loss persisted, however she also started developing mild pains in these regions as well as a headache. She has not tested positive for COVID-19 since having the vaccine. The outcome of facial pain was not recovered, unknown for ear pain, and 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: 1520887 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cold sweat, Fatigue, Headache, Lymphadenopathy, SARS-CoV-2 test
SMQs:, 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: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100916653

Write-up: fatigue; Swollen glands, swollen neck glands; Headache; cold sweat; This is a spontaneous report from a contactable consumer, received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202107182104449080-ALJIA, Safety Report Unique Identifier GB-MHRA-ADR 25670015. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Jul2021 as single dose for COVID-19 immunisation. Medical history included suspected COVID-19 from 17Jul2021 and ongoing. She was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced cold sweat on 17Jul2021; swollen glands and headache on 18Jul2021; fatigue on an unspecified date. Case narrative: Headache, swollen neck glands, cold sweats, and general fatigue. She has not tested positive for COVID-19 since having the vaccine. Relevant investigations or tests conducted: negative COVID test. She underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on 18Jul2021. The patient recovered from cold sweat on 18Jul2021, not recovered from swollen glands and headache, while outcome of fatigue was unknown. Case was reported as medically significant by health authority. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1520898 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Axillary pain, Hyperaesthesia, Joint range of motion decreased, Pain in extremity
SMQs:, Guillain-Barre syndrome (broad), Arthritis (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 INC202100916352

Write-up: Pain in arm; Armpit pain; weak; Sensitive to touch; inability to lift arm; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number. Safety Report Unique Identifier. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 17Jul2021 as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test. On 17Jul2021, the patient experienced pain in arm, armpit pain, weak, sensitive to touch and inability to lift arm. The events were reported as serious per other medically important condition. The clinical course was reported as follows: Very painful arm, inability to lift arm and very sore under armpit. Sensitive to touch and weak. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the events pain in arm and armpit pain was not recovered, while outcome of the remaining events was unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.


VAERS ID: 1520903 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 FD8813 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Disturbance in attention, Fatigue, Glossodynia, Headache, Impaired driving ability, Insomnia, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (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: AMOXICILLIN; CEFALEXIN; CO-AMOXICLAV [AMOXICILLIN;CLAVULANATE POTASSIUM]; CO-CODAMOL; CODEINE PHOSPHATE; CYCLIZINE; DESOGESTREL; FEXOFENADINE HYDROCHLORIDE; IOMERON; NASEPTIN; NITROFURANTOIN; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy; Endometriosis; Hay fever; Hydronephrosis (recently recovered); Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response); Lactation decreased; Nausea; Nosebleed; Pain; UTI (recurring UTIs)
Allergies:
Diagnostic Lab Data: Test Name: CT scan; Result Unstructured Data: Test Result:unknown result; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100916506

Write-up: points; Unable to drive; lack of concentration; Insomnia; Headache; Fatigue; Nausea; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107190019578200-QIMLV. Safety Report Unique Identifier is GB-MHRA-ADR 25670230. A 19-year-old female patient received first dose BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: FD8813), via an unspecified route of administration on 17Jul2021 as single dose for COVID-19 immunisation. Medical history included hydronephrosis, endometriosis, lactation decreased, immunodeficiency (taking other treatments or medicines, not listed above, known to lower the immune response), UTI, pain, nausea, hay fever, and nosebleed. Additional information: Hydronephrosis recently recovered, recurring UTIs, appendectomy earlier in year (unknown year), endometriosis. She has not had symptoms associated with COVID-19, not pregnant, not currently breastfeeding, and not enrolled in clinical trial. Concomitant medication included amoxicillin taken for UTI, cefalexin taken for UTI, amoxicillin, clavulanate potassium (CO-AMOXICLAV) taken for UTI, codeine phosphate, paracetamol (CO-CODAMOL) taken for pain, codeine phosphate taken for pain, cyclizine taken for nausea, desogestrel taken for endometriosis, fexofenadine hydrochloride taken for hay fever, iomeprol taken for CT scan, chlorhexidine hydrochloride, neomycin sulfate (NASEPTIN) taken for nosebleed, nitrofurantoin taken for UTI, and paracetamol taken for pain. The patient experienced headache, fatigue, and nausea on 17Jul2021; insomnia on 18Jul2021; pain tongue (reported as points) on an unspecified date. Case narrative: Headache reduced after rest - same with fatigue. Painkillers made headache more manageable. Insomnia didn''t seem to be reduced by any measures. Nausea minor at most points and manageable with ''sea bands'' and plain foods. Cyclizine anti-nausea medication also useful. Unable to drive while suffering from headache due to lack of concentration. Same for nausea. 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 and CT scan: unknown result, both on an unknown date. The patient was recovering from headache, points, and fatigue; not recovered from nausea and insomnia; while outcome of other events was unknown. Case was reported as medically significant by health authority. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1520912 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Asthenia, Asthenopia, Body temperature, Body temperature increased, Contusion, Headache, Insomnia, Irritability, Lymph node pain, Myalgia, Pain in extremity, SARS-CoV-2 test, Somnolence, Stress, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Corneal disorders (broad), Eosinophilic pneumonia (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: Appetite absent; Cold; Fatigue; Fever; Flu; Headache; Illness; Immunodeficiency; Lactation decreased; Migraine (started getting migraines this year.); Nose congestion; Sore throat; Thick nasal mucus
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: body temperature; Result Unstructured Data: Test Result:elevation; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Inconclusive test; Comments: Inconclusive test
CDC Split Type: GBPFIZER INC202100923283

Write-up: Lymph node pain; Temperature elevation; Headache; Bruising of arm/Few areas of discolouration on lower arm (near elbow) of jabbed arm. Doesn''t disappear when pressed, slightly painful, looked like bruising under the skin; Irritable; Stress; Weakness; Drowsiness; Tired eyes; Muscle pain; Stomach cramps; pain in arm around injection site; resting arm was painful and uncomfortable; Difficulty sleeping; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107190744242060-KSQ3W. Safety Report Unique Identifier GB-MHRA-ADR 25671143. A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Jul2021 (Lot Number: FD8813) as single dose for COVID-19 immunisation. Patient age at vaccination was 33-year-old. Medical history included immunodeficiency, lactation decreased, thick nasal mucus, sore throat, headache, fatigue, pyrexia, nasopharyngitis, influenza, illness, blocked nose, no appetite and migraine (suffered severe illness on holiday a few years ago and two episodes in one month. The 2nd took 4-6 months to get better. Persistent fever, headache, sore throat, thick mucus, blocked nose, fatigue, only got out of bed for essentials (eating, drinking, toilet), no appetite, never experienced any cold/flu as bad as that before. Thought it''s weakened her immune system. Started getting migraines this year). Unsure if patient had symptoms associated with COVID-19. Inconclusive test. Patient was not pregnant. Patient was not currently breastfeeding. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number was not reported) as single dose for COVID-19 immunisation. The patient''s concomitant medications were not reported. The patient experienced pain in arm around injection site and difficulty sleeping, both on 17Jul2021 with outcome of recovering, lymph node pain, temperature elevation, headache, bruising of arm and irritable, all on 18Jul2021 with outcome of recovered on 19Jul2021; stress, weakness, drowsiness, tired eyes, muscle pain, all on 18Jul2021 with outcome of recovering, stomach cramps on 18Jul2021 with outcome of recovered on 18Jul2021. Clinical course was reported as pain in arm around injection site. Patient didn''t notice much else on the day. Got worse at night and resting arm was painful and uncomfortable, prevented a good night sleep. More noticeable next morning. Had to support with a sling. Symptoms starting developing and patient had to lie down, close eyes, and try to rest. Headache was quite bad. Usually how patient felt when she was ill. Slept better and felt much better the 2nd morning (19th). Few areas of discolouration on lower arm (near elbow) of jabbed arm. Doesn''t disappear when pressed, slightly painful, looked like bruising under the skin. The patient underwent lab tests and procedures which included COVID-19 virus test: inconclusive test. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This case was reported as serious with seriousness criteria-other medically important condition. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1520915 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-17
   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 NOT KNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Pain
SMQs:, Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100923018

Write-up: shooting pain; Wrist pain; 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-202107190820128180-IBQUY, Safety Report Unique Identifier GB-MHRA-ADR 25671007. A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Jul2021 (Batch/Lot Number: Not known) as dose 1, single for COVID-19 immunization. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Patient is not pregnant, Patient is not currently breastfeeding. Medical history included lactation decreased. The patient''s concomitant medications were not reported. The patient experienced shooting pain on an unspecified date, wrist pain on 17Jul2021. Additional information included: Shooting pain in both wrists. The patient was taking ibuprofen to ease but not taking pain away. 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. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1520923 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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: Body temperature, Body temperature increased, Cardiac flutter, Illness, Migraine, Pain, SARS-CoV-2 test, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Tachyarrhythmia terms, nonspecific (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: Decreased lactation; palpitations.
Allergies:
Diagnostic Lab Data: Test Date: 07/17/2021; Test Name: temperature; Result Unstructured Data: Test Result: Elevation; Comments: Elevation; Test Date: 07/18/2021; Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202100923290

Write-up: This is a spontaneous report from a contactable consumer, received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202107190840251560-DELWP; safety report unique identifier: GB-MHRA-ADR 25671120). A 55-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot# FD5613), at age of 55, via an unspecified route of administration, on Jul 17, 2021, single dose, for COVID-19 immunization. Medical history included palpitations and decreased lactation. Also reported: No illnesses and not any medication. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. Historical vaccine include first dose of BNT162B2 for COVID-19 immunisation. After having both vaccines have experienced lots of heart flutterings. The patient experienced migraine, temperature elevation, general body pain, sickness and sleepiness on Jul 17, 2021, heart fluttering in Jul 2021. Events were reported as medical significant. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 18Jul2021. Patient had not tested positive for COVID-19 since the vaccination. Patient was not enrolled in a clinical trial. The outcome of event sickness was recovered Jul 2021. The outcome of heart fluttering unknown, recovering for rest events. No follow-up attempts needed. No further information expected.


VAERS ID: 1520930 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 FE15KD / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Eyelid ptosis, Headache, Hyperhidrosis, Retching, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100923362

Write-up: Ptosis; Retching; Shivering; Sweating; Headache fullness; 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-202107190911071040-7HJQ1, Safety Report Unique Identification Number: GB-MHRA-ADR 25671499. A 37-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 17Jul2021 (Batch/Lot Number: FE15KD) (at the age of 37-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. The patient experienced ptosis on 19Jul2021, headache fullness on 17Jul2021, retching, shivering and sweating on 18Jul2021. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on 17Jul2021. The outcome of the events ptosis and headache fullness was not resolved, of the events retching and shivering was resolved on 18Jul2021, of the event sweating was resolving. The events were reported as serious due to medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1520934 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Oropharyngeal pain
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: IBUPROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Period pains
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100923201

Write-up: Sore throat; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107190924405510-CEDHG. Safety Report Unique Identifier GB-MHRA-ADR 25671516. A 20-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 17Jul2021 (Batch/Lot number was not reported) (at the age of 20-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Period pains from an unknown date. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Concomitant medication included ibuprofen taken for Period pains, start and stop date were not reported. The patient experienced sore throat on 17Jul2021 with outcome of not recovered. The event was reported as serious due to medically significant. 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: 1520990 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cold sweat, Maternal exposure during pregnancy, SARS-CoV-2 test, Syncope, Vision blurred, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN (E.C.); FOLIC ACID
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Lactation decreased; Pregnancy induced hypertension
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100923000

Write-up: I felt like I was going to faint; sudden blurring and intense white light to vision; cold sweats; sudden blurring and intense white light to vision/Abnormal vision; Patient was exposed to the medicine Third-trimester (29-40 weeks).; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107191156450030-XSGN3, Safety Report Unique Identifier GB-MHRA-ADR 25672223. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 17Jul2021 at 40-year-old (Batch/Lot Number: FD8813) as DOSE 2, SINGLE for covid-19 immunization. Medical history included Lactation decreased, ongoing pregnancy, pregnancy induced hypertension, folic acid supplementation. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)) taken for pregnancy induced hypertension; folic acid taken for Folic acid supplementation. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Approx 10 minutes after having vaccine, the patient experienced sudden blurring and intense white light to vision. This was accompanied by sudden cold sweats. This lasted for approx. 30 seconds. These symptoms repeated approx 30 minutes later while walking - this time she felt like she was going to faint. Again, symptoms subsided after about 30 seconds. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient was exposed to the medicine Third trimester (29-40 weeks). The patient underwent lab tests and procedures which included No - Negative COVID-19 test. Outcome of the event was exposed to the medicine Third trimester (29-40 weeks) was unknown, of other events was recovered on 17Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1521020 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bedridden, Fatigue, Insomnia, Pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100923067

Write-up: This is a spontaneous report from a contactable consumer, received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202107191409433330-PXRFH; safety report unique identifier: GB-MHRA-ADR 25673557). A 35-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not reported), via an unspecified route of administration on Jul 17, 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 is not enrolled in a clinical trial. Patient has not tested positive for COVID-19 since the vaccination. After the dose, patient started to ache 8 hours on Jul 17, 2021. Could not sleep that night on Jul 17, 2021. Following day, tired-out and could not get out of bed. The outcome of ache recovered on Jul 18, 2021; tired-out recovering; and of others unknown. No follow-up attempts possible. information about lot/batch number cannot be obtained.


VAERS ID: 1521027 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Hyperhidrosis, Influenza
SMQs:, Neuroleptic malignant syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100923420

Write-up: Headache; Flu symptoms; Sweating; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107191505377440-OWISN. Safety Report Unique Identifier GB-MHRA-ADR 25673704. A 29-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Jul2021 (Lot number was not reported) as single dose (at age of 29-years-old) for COVID-19 immunisation. Medical history was not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medications were not reported. On 17Jul2021 patient experienced sweating and on 18Jul2021 she experienced headache and flu symptoms. Events considered serious as medically significant. Patient had not recovered from sweating and flu symptoms, while she was recovering from the other event. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1521033 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Limb discomfort, Lymph node pain, Lymphadenopathy, Pruritus, SARS-CoV-2 test, Vaccination site mass, Vaccination site pain, Vaccination site pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100923423

Write-up: Injection site: large red lump, itching and soreness; Injection site: large red lump, itching and soreness; Injection site: large red lump, itching and soreness; Multiple enlarged lymph nodes (3) causing severe pain; Heavy legs-legs feel too heavy to move; itching; Supraclavicular lymph nodes enlarged; Swollen lymph nodes; 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-202107191541401930-1NYYR, Safety Report Unique Identifier GB-MHRA-ADR 25673912. A 28-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: FD8813), via an unspecified route of administration on 17Jul2021 (at the age of 28-yers-old) as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Patient was not pregnant; patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced itching on an unspecified date, swollen lymph nodes on 17Jul2021, supraclavicular lymph nodes enlarged on 18Jul2021, injection site: large red lump, itching and soreness on an unspecified date, multiple enlarged lymph nodes (3) causing severe pain on an unspecified date and heavy legs-legs felt too heavy to move on an unspecified date. The events were described as: Injection site: large red lump, itching and soreness. Multiple enlarged lymph nodes (3) causing severe pain. Collar bone around lymph nodes sore/painful. Heavy legs-legs felt too heavy to move. 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 an unspecified date. Itching, Swollen lymph nodes and supraclavicular lymph nodes enlarged were not resolved, the outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1521053 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   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 ET8885 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Heart rate increased, Pain, Palpitations, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), 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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100923367

Write-up: achey; headache; Very tired; Heart racing / heart felt like it was quivering / palpitating and pounding; heart would feel like it was beating really hard and fast; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107191743322300-1FZL3. Safety Report Unique Identifier GB-MHRA-ADR 25674732. A 29-year-old female patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 16Jul2021 (Lot Number: ET8885) as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. On an unspecified date, the patient experienced very tired, achey and headache. On 17Jul2021, patient experienced the most alarming symptoms. Her heart felt like it was quivering and woke her up first night and continued to feel like it was palpitating and pounding for two days after on and off. Even if she just turned over in bed heart would feel like it was beating really hard and fast. The patient underwent SARS-CoV-2 test and was negative (No - Negative COVID-19 test). The events were reported as serious, medically significant. The outcome of the events was recovering at the time of report. . No follow-up attempts are possible. No further information is expected.


VAERS ID: 1521072 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100923242

Write-up: Pain in armpit; Swelling of limb; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107191900151530-4VCLD, Safety Report Unique Identifier GB-MHRA-ADR 25675445. A 40-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 16Jul2021 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No illnesses. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient''s body weight was 84 kg and height was 170 cm. The patient was previously taken first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date for COVID-19 immunisation. Pain in armpit and swelling from armpit to pectoral. Ache in upper arm. The patient experienced swelling of limb on 17Jul2021. Seen local GP. Events were medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on an unspecified dated (No - Negative COVID-19 test). Patient has not tested positive for COVID-19 since having the vaccine. Outcome of the event swelling of limb was not recovered. Outcome of other event Pain in armpit was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1521092 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 FO8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Eye swelling, Fatigue, Headache, Influenza, Malaise, Myalgia, SARS-CoV-2 test, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (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; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100923236

Write-up: weakness; muscle ache; flu; fatigue; headache; swollen eyes; After around 10 hours of having the vaccine I felt ill; Vomiting; This is a spontaneous report from a contactable consumer. This is a report, received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107192039578820-CKO7G, Safety Report Unique Identifier GB-MHRA-ADR 25676282. A 19-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 17Jul2021 (Lot Number: FO8813) as dose 2, single for COVID-19 immunisation. Medical history included suppressed lactation. The patient''s concomitant medications were not reported. The patient experienced weakness (medically significant) on an unspecified date with outcome of not recovered, muscle ache (medically significant) on an unspecified date with outcome of not recovered, flu (medically significant) on an unspecified date with outcome of not recovered, fatigue(medically significant) on an unspecified date with outcome of not recovered, headache (medically significant) on an unspecified date with outcome of not recovered, swollen eyes (medically significant) on an unspecified date with outcome of not recovered, vomiting (medically significant) on 17Jul2021 with outcome of recovered, around 10 hours of having the vaccine I felt ill (medically significant)on unspecified date with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: No - Negative COVID-19 test on 14Jul2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The clinical course was reported as follows: After around 10 hours of having the vaccine I felt ill. I felt like I had the flu x3. The next morning I woke up needing to vomit and this was around 7:30am, this proceeded til around 10:30am. I felt muscle ache, fatigue, headache and swollen eyes. This only lasted the day but I''m not sure if this reaction is normal? I needed to call off work due to the vomiting and weakness I felt. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1521100 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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: Body temperature, Chills, Fatigue, Headache, Nausea, Pain, Pyrexia, Rash, Rectal haemorrhage
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (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:
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: Body temperature; Result Unstructured Data: Test Result:High
CDC Split Type: GBPFIZER INC202100922988

Write-up: pink blotches; Skin rash; High temperature; Shivering; Headache; Nausea; Fatigue; aches and pains; 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-202107192127251320-VJL4I, Safety Report Unique Identifier GB-MHRA-ADR 25676365. A 35-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE/ Comirnaty), (lot number: FE1510), via an unspecified route of administration at single dose on 17Jul2021 for COVID-19 immunization at the age of 35-year-old. The patient medical history was not reported. 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 previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE/ Comirnaty) via an unspecified route of administration at single dose on an unknown date for COVID-19 immunisation. The patient experienced pink blotches on an unspecified date, skin rash on 18Jul2021, high temperature, shivering, headache, nausea, fatigue on 17Jul2021. The clinical course was as follows: Received vaccine on morning of 17Jul2021, developed high temp, nausea, aches and pains, headache and shivering overnight. Fatigue and headache continued following day (18Jul2021). Developed skin rash (pink blotches) on chest back and stomach later that day. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the event skin rash was not recovered, was unknown for Rectal bleeding and the rest events were recovered on 18Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1521105 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 NOT KNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Ear pain, Insomnia, Memory impairment, Nausea, Pyrexia, Rash erythematous, SARS-CoV-2 test, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (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: BUSCOPAN; CANDESARTAN; DULOXETINE; MEBEVERINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Irritable bowel syndrome; Lactation decreased; Migraine; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100923009

Write-up: Ear pain; Nausea; Feverish; Forgetfulness; Injection site pain; Insomnia; Chills; Red rash; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107192201320980-V2ZZP, Safety Report Unique Identifier GB-MHRA-ADR 25676610. A 34-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 17Jul2021 (Batch/Lot number was Not Known) at the age of 34-years-old as SINGLE DOSE for covid-19 immunisation. Medical history included Lactation decreased, suspected covid-19 from 12Aug2020 to an unknown date Unsure when symptoms stopped, Irritable colon/irritable bowel, migraine. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medications included hyoscine butylbromide (BUSCOPAN) taken for Irritable colon, start and stop date were not reported; candesartan taken for migraine from 02Jul2021 to an unspecified stop date; duloxetine taken for migraine, start and stop date were not reported; mebeverine taken for irritable bowel, start and stop date were not reported. The patient experienced ear pain on 18Jul2021, red rash on 17Jul2021, nausea on 18Jul2021, chills on 17Jul2021, feverish on 18Jul2021, insomnia on 17Jul2021, forgetfulness on 18Jul2021, injection site pain on 17Jul2021. The case was reported as serious medically important condition. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unknown date. The outcome of the event chills was recovered, and the outcome of the other events was not recovered. 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. No further information is expected.


VAERS ID: 1521123 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abnormal sensation in eye, Eye pain, Headache, Influenza like illness, Malaise, Pruritus, Pyrexia, Skin reaction, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Corneal disorders (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: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100922960

Write-up: headache; flu like symptoms; itchy; feverish; sore eyes; hot sore eyes; generally unwell; ''Covid arm''/ Large red swelling, hard, hot, itchy; ''Covid arm''/ Large red swelling, hard, hot, itchy; ''Covid arm''/ Large red swelling, hard, hot, itchy; ''Covid arm''/ Large red swelling, hard, hot, itchy; ''Covid arm''/ Large red swelling, hard, hot, itchy; Skin reaction; This is a spontaneous report from a contactable consumer received from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107192311541880-ASZNN, Safety Report Unique Identifier GB-MHRA-ADR 25677047. A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Jul2021 as dose 2, single for COVID-19 immunisation. Medical history included suppressed lactation. The patient''s concomitant medications were not reported. 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. The patient experienced headache, covid arm, flu like symptoms, itchy, feverish, sore eyes, generally unwell on unspecified date and skin reaction on 17Jul2021. Large red swelling, hard, hot, itchy and growing in size. Search showed something called ''Covid arm'' which matches her symptoms. Feeling generally unwell, feverish, headache, hot sore eyes. Flu like symptoms. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of Skin reaction was not recovered and other events was unknown. The report was considered as serious as medically significant from regulatory authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1521146 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Headache, Illness, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100923111

Write-up: Headache; Sickness; Diarrhea; Nausea; 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-202107200727093200-ZCCUA, safety report unique identifier is GB-MHRA-ADR 25678190. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 14Jul2021 (Lot Number: FD8813) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced sickness, diarrhea, nausea on 17Jul2021, headache on 18Jul2021 with outcome of not recovered. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on unknown date. Outcome of events sickness, diarrhea was recovered on 19Jul2021, of nausea was recovering, of headache was not recovered. 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: 1521152 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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: Axillary pain, 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100928995

Write-up: Swelling of lymph nodes under armpit on the side the vaccine was administered; Armpit pain; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107200857071420-C1JWF, Safety Report Unique Identifier is GB-MHRA-ADR 25678873. A 33-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Jul2021 (Lot Number: FC9001), at the age of 33-years, as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on unspecified date (Lot number and expiry date were not reported) for COVID-19 immunisation. Patient is not enrolled in clinical trial. The patient experienced armpit pain on 17Jul2021. The patient also experienced swelling of lymph nodes under armpit on the side the vaccine was administered on unspecified date. It has lasted for 3 days so far. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of armpit pain was not recovered, while for the other event was unknown. The case has been considered serious due to seriousness criterion of other medically important condition. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1521159 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   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 FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Eye pain, Headache, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Date: 20210720; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100928879

Write-up: fever; nausea; headaches; eye pain; Dizziness; This is a spontaneous report from a contactable consumer received from The regulatory authority report number is GB-MHRA-WEBCOVID-202107201339506890-Q34CU, Safety Report Unique Identifier GB-MHRA-ADR 25680489. A 28-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jul2021 (Lot Number: FD8813) as single dose for COVID-19 immunisation. Medical history included Clinical trial participant Patient has not tested positive for COVID-19 since having the vaccine. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on unspecified date for COVID-19 immunisation. The patient experienced worst fever, nausea, and headaches (all on unspecified date) including dizziness (on 17Jul2021) and eye pain (on unspecified date). The patient still is having headaches three days later. The patient had negative COVID-19 virus test on 20Jul2021. The outcome of dizziness was recovered with sequel on 18Jul2021, while for the other events was recovering. The events were considered serious, medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1521164 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8B13 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, SARS-CoV-2 test
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100928705

Write-up: Diarrhoea; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107201534195470-PSUON Safety Report Unique Identifier GB-MHRA-ADR 25681330. A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jul2021 (Lot Number: Fd8b13) as dose 2, single for COVID-19 immunization. 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 diarrhoea (assessed as medically significant) on 17Jul2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 18Jul2021. 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: 1521165 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Menstruation delayed, Scan
SMQs:, Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: scan; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC202100929144

Write-up: Menstruation delayed; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency. Regulatory authority report number is GB-MHRA-WEBCOVID-202107201600127480-PSZRK, Safety Report Unique Identifier is GB-MHRA-ADR 25681422. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiry date not reported), via an unspecified route of administration on 17Jul2021 (age at vaccination was 32 years) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included suppressed lactation (lactation decreased). 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 immunisation. The patient experienced menstruation delayed on 17Jul2021 with outcome of not recovered. The patient underwent lab tests and procedures which included scan: unknown results on an unspecified date. The event was assessed as serious, medically significant by the health authority. Additional information: Prepping for ivf transfer so was having scans every other day. Had both vaccines this cycle and since Friday scan the lining has been getting thinner and follicles disappeared which is unknown as to why as I''ve not ovulated. Only change was the vaccine the following day. Now had to abandon my IVF as a result. Patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. Information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1521236 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Maternal exposure during pregnancy, Pain in extremity, SARS-CoV-2 test, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), 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: FOLIC ACID; ASPIRIN [ACETYLSALICYLIC ACID]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: COVID-19 virus test negative; Test Name: Ultrsound scan; Result Unstructured Data: screening showed Low PAPP A
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Maternal exposure during pregnancy; Pain in arm; This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and PAIN IN EXTREMITY (Pain in arm) in a 24-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concomitant products included FOLIC ACID for Folic acid supplementation, ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 17-Jul-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. The patient''s last menstrual period was on 30-Mar-2021 and the estimated date of delivery was 07-Jan-2022. On 17-Jul-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna CoviD-19 Vaccine) beginning around the fifteenth week of the pregnancy. On 22-Jul-2021, PAIN IN EXTREMITY (Pain in arm) had resolved. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jul-2021, SARS-CoV-2 test: negative (Negative) COVID-19 virus test negative. On an unknown date, Ultrasound scan: normal (normal) screening showed Low PAPP A. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The treatment information was not provided. Patient reported that she was exposed to the vaccine in second trimester 13-28 weeks.Post vaccination patient not tested positive for COVID-19.Also patient was not enrolled in any clinical trials. Patient was not breastfeeding at the time of reporting. It was reported that patient had no symptoms associated with COVID-19. Company comment: This is a case of product exposure during pregnancy with associated AE of Pain in extremity and other AEs for this 24-year-old female. No further information is expected.; Sender''s Comments: This is a case of product exposure during pregnancy with associated AE of Pain in extremityand other AEs for this 24-year-old female. No further information is expected.


VAERS ID: 1521418 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Diarrhoea, Erythema, Faeces soft, General physical condition
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Meat allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: Body temperature; Result Unstructured Data: Test Result: 35.9 Centigrade; Comments: before vaccination; Test Date: 20210717; Test Name: vital; Result Unstructured Data: Test Result: stable.
CDC Split Type: JPPFIZER INC202100917993

Write-up: the possibility of anaphylaxis; diarrhoea; Generalised erythema/ erythema appeared on both limbs; soft diarrheal stool; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The Regulatory authority report number is v21120221. A 63-year 3-month old female patient received the first dose of bnt162b2 (COMIRNATY) (Lot number EW0201, Expiration date 30Sep2021) on 17Jul2021 at 13:08 (at the age of 63-years-old) via unknown route of administration at single dose for COVID-19 immunisation. Medical history included allergy to beef. Concomitant medications were not reported. Body temperature before vaccination was 35.9 centigrade. Patient experienced the possibility of anaphylaxis on 17Jul2021 at 13:35; soft diarrheal stool on 17Jul2021 at 13:35; Generalised erythema/ erythema appeared on both limbs on 17Jul2021 at 13:35. On an 17Jul2021 at 13:08 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Lot number EW0201, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 17Jul2021 at 13:35 (27 minutes after the vaccination), the patient experienced generalised erythema and diarrhoea. Clinical course was reported as follows: About 30 minutes after the inoculation, erythema appeared on both limbs without itching, and soft diarrheal stool appeared once. Symptoms tended to improve 60 minutes after vaccination. Vitals were also stable and no respiratory or cardiovascular symptoms appeared during the course. It was a symptom several tens of minutes after the vaccination, and we were considering the possibility of anaphylaxis. The patient decided to go home and urge the family doctor to decide on a second vaccination. On 17Jul2021 (the day of vaccination), the outcome of the events was recovering. The reporting physician classified the events as non-serious that the events was unrelated to bnt162b2. There was no other possible cause of the events such as any other diseases. The reporting physician commented as follows: Symptoms appeared several tens of minutes after the vaccination. Considering the possibility of anaphylaxis. No follow up attempts are possible. No further information is expected. Reporter''s Comments: Symptoms appeared several tens of minutes after the vaccination. Considering the possibility of anaphylaxis. Sender''s Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the event Anaphylactic reaction cannot be completely excluded.


VAERS ID: 1521423 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 FD0348 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Heart rate, Oxygen saturation, Throat irritation, Vital signs measurement
SMQs:, Neuroleptic malignant syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypertension (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: Drug allergy; Food allergy; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: BP; Result Unstructured Data: Test Result:197/89; Comments: Originally high; Test Date: 20210717; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210717; Test Name: HR; Result Unstructured Data: Test Result:95; Comments: originally high; Test Date: 20210717; Test Name: SpO2; Test Result: 97 %; Test Date: 20210717; Test Name: vital signs; Result Unstructured Data: Test Result:no abnormal vital signs, no symptoms other than it; Comments: no abnormal vital signs, no symptoms other than itching.
CDC Split Type: JPPFIZER INC202100918053

Write-up: BP 197/89; Itchy throat; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21120230. The patient was a 62-year old female. Body temperature before vaccination was 36.4 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 Allergic to garlic and pilin. Hypertension. Itching after the first dose vaccination of the COMIRNATY. On 17Jul2021 at 16:03 (the day of vaccination), the patient previously received the second dose of bnt162b2 (COMIRNATY, Lot number FD0348, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 17Jul2021 at around 16:15 (12 minutes after the vaccination), the patient experienced the following events. Clinical course was reported as follows: On 19Jun2021 (the day of the first dose vaccination), the patient received the first dose vaccination. At that time, itching in the throat and itching in the arm occurred within 15 minutes. FEXOFENADINE was taken orally, and it was improved in about 1 hour. On 17Jul2021(the day of vaccination), the second dose vaccination of the COMIRNATY performed. Also reported as 10 minutes after the vaccination, Itchy throat again. No decrease in blood pressure, SpO2 97%, no abnormal vital signs, no symptoms other than itching. (BP 197/89 HR95) originally high. FEXOFENADINE was taken orally, and it was improved. Observe for 40 minutes after vaccination and return home. On 17Jul2021(the day of the second dose vaccination), the outcome of the events was recovering. The reporting physician classified the events as non-serious and assessed that the events was related to bnt162b2. There was no other possible cause of the event such as any other diseases. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1521424 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 FC3661 / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure increased, Blood pressure measurement, Body temperature, Dyspnoea, Heart rate, Hyperhidrosis, Oxygen saturation, Somnolence, Tachycardia
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Cardiomyopathy (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: 20210717; Test Name: blood pressure; Result Unstructured Data: Test Result:162/110; Test Date: 20210717; Test Name: blood pressure; Result Unstructured Data: Test Result: mildly increased; Test Date: 20210717; Test Name: BODY TEMPERATURE; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination.; Test Date: 20210717; Test Name: pulse rate; Result Unstructured Data: Test Result:122; Comments: 14:25; Test Date: 20210717; Test Name: pulse rate; Result Unstructured Data: Test Result:108; Test Date: 20210717; Test Name: pulse rate; Result Unstructured Data: Test Result:83; Comments: decreased; Test Date: 20210717; Test Name: SpO2; Test Result: 98 %.
CDC Split Type: JPPFIZER INC202100918054

Write-up: Anaphylaxis; Tachycardia; difficulty of breath; sweaty; increased blood pressure/blood pressure was 162/100; Sleepiness; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120292. The patient was a 48-year-old male. Body temperature before vaccination was 36.6 degrees Centigrade. Medical history was none. Concomitant drugs ere not reported. On 17Jul2021 at 14:15 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) via an unspecified route of administration on arm right as 0.3 ml single dose for COVID-19 immunization at age of 48-year-old. On 17Jul2021 at 14:25 (10 minutes after the vaccination), the patient experienced blood pressure increased. On 17Jul2021 (the day of vaccination), the outcome of the event was recovering. The course of the event was as follows: On 17Jul2021 at 14:15 (the day of vaccination), the patient received the 0.3ml Comirnaty from triceps brachii on the right upper arm for the first dose. After the vaccination, the patient was under observation. On 17Jul2021 at 14:25 (10 minutes after the vaccination), the patient felt strong chest beating and difficult of breath. The patient complained that he was sweaty. The pulse rate was 122. The patient had a clear consciousness and was able to walk and talk. He moved to the bed and lay on the bed. The blood pressure was 162/100, the SpO2 was 98%, the pulse rate was 108. No headache, no chest pain. Then the patient had a rest and the symptom of dyspnoea disappeared. The pulse rate was improved and decreased down to 83. There was a mildly increased blood pressure, but it increased usually. The patient was under observation for 30 minutes. The patient got permission to go home since the feeling of sweaty was improved. But the patient was prohibited to use motorcycle because he had a feeling of sleepiness. The patient was asked to have a good rest. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. here was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: It was tachycardia caused by anaphylaxis symptom, and the symptom was improved after a rest (the blood pressure increased [illegible characters]).


VAERS ID: 1521425 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 EY5420 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100918056

Write-up: Anaphylaxis; This is a spontaneous report from a contactable other hcp received from the Regulatory Authority. Regulatory authority report number is v21120703. A 46-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 17Jul2021 11:00 (Batch/Lot Number: EY5420; Expiration Date: 31Aug2021) as dose 2 single for covid-19 immunisation. The patient has no medical history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient''s concomitant medications were not reported. On 17Jul2021 at 11:10 (10 minutes after the vaccination also reported as 40 minutes), the patient experienced anaphylaxis. On 17Jul2021 (the day of vaccination), the patient was admitted to the hospital and discharged on 18Jul2021. The course of the event was as follows: At about 11:10 (40minutes after the vaccination as reported), cough and queasy appeared. At 11:25 moved to emergency. The patient was given fluid replacement and oxygen. Wheezing, shivering, vomiting. RINDERON, Gaster, Adrenaline was administered. At 11:40 Adrenaline was re-administered. At 12:45 the patient was admitted to hospital at emergency ward. Body temperature before vaccination was 36.2 degrees Centigrade. On 18Jul2021, the outcome of the event was recovered. The reporting other hcp classified the event as serious (hospitalization from 17Jul to 18Jul) 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: 1521437 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 EW0207 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Dyspnoea, Fall, Heart rate, Hyperventilation, Oxygen saturation, Pallor, Respiratory rate
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (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: Dyspnoea; Egg allergy (allergy to raw crab, raw shrimp(dyspnoea and larynx itching)); Larynx itching; Seafood allergy (allergy to raw crab, raw shrimp(dyspnoea and larynx itching))
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: blood pressure; Result Unstructured Data: Test Result:131/78; Comments: 15minutes after vaccination.; Test Date: 20210717; Test Name: pulse; Result Unstructured Data: Test Result:80; Comments: 15minutes after vaccination.; Test Date: 20210717; Test Name: SpO2; Test Result: 99 %; Comments: 15minutes after vaccination.; Test Date: 20210717; Test Name: respiration; Result Unstructured Data: Test Result:about 30 times; Comments: 15minutes after vaccination.
CDC Split Type: JPPFIZER INC202100918218

Write-up: Hyperpnoea; dyspnoea/difficulty in breathing; felt that face turned pale; fall down from chair; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21120217. A 49-year-old (reported as 49-year and 6-month-old) female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 17Jul2021 14:00 (Batch/Lot Number: EW0207; Expiration Date: 30Sep2021) as dose1, single at the age of 49-year-old for covid-19 immunisation. Medical history included allergy to raw egg, raw crab, raw shrimp (dyspnoea and larynx itching). The patient''s concomitant medications were not reported. On 17Jul2021 at 14:00 (the day of vaccination), the patient received the first dose of bnt162b2 (Solution for injection, Lot number EW0207, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 17Jul2021 at about 14:00, the patient experienced hyperpnoea and dyspnoea. The outcome of the event was not reported. The course of the event was as follows: 15 minutes after vaccination, the patient complained that difficulty in breathing and felt that face turned pale. The patient was fall down from chair and was transported to bed (at about 14:20). Blood pressure 131/78, pulse 80, respiration was about 30 times, SpO2 99%, had no wheezing when tested by auscultation. The patient could response when talk to. Route was kept, the patient was emergency transported to hospital. At 14:30 the ambulance departed. The patient could conversationable when in ambulance. (From the symptoms appeared and before emergency transported, the epinephrine was not used.) The event outcome was unknown. The reporting physician classified the event as non-serious and assessed that the causality between the event and bnt162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: it is suspected that the event was unrelated to bnt162b2, it might be he stress because of vaccination. No follow-up attempts possible. No further information expected.


VAERS ID: 1521443 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 FA5765 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Erythema, Malaise, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Eosinophilic pneumonia (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: Allergic reaction; General anesthesia
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: blood pressure; Result Unstructured Data: Test Result: normal; Test Date: 20210717; Test Name: Body temperature; Result Unstructured Data: Test Result: 36.6 Centigrade.
CDC Split Type: JPPFIZER INC202100918301

Write-up: redness of face; Wheezes; Anaphylaxis; malaise; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The Regulatory authority report number is v21120379. A 43-year-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Lot number: FA5765; Expiration Date: 30Sep2021), via an unspecified route of administration at the age of 43-year-old on 17Jul2021 08:59 at single dose for covid-19 immunisation. Medical history included allergies due to general anesthesia. The patient family history was unknown. The patient''s concomitant medications were not reported. On 17Jul2021 at 09:30 (31 minutes after the vaccination), the patient experienced anaphylaxis. On 17Jul2021 (the day of vaccination), the outcome of the event was recovering. The course of the event was as follows: On 17Jul2021 at 08:59(the day of the vaccination), received vaccination. On 17Jul2021 at around 09:30 (31 minutes after the vaccination), although patient complained of malaise, judged to be mild symptom and the follow-up observation was extended .On 17Jul2021 at around 09:45 (46 minutes after the vaccination), malaise became stronger and redness of face was noted. At the same time, wheezes was heard. Blood pressure was normal, no gastrointestinal symptoms. On 17Jul2021 at 10:00 (61 minutes after the vaccination), 5 ml of adrenaline was injected intramuscularly and wheezes disappeared. The patient underwent lab tests included blood pressure: normal on 17Jul2021, body temperature: 36.6 centigrade on 17Jul2021. The outcome of event wheezes was recovered and other events was recovering. The reporting physician classified the event as non-serious 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 physician commented as follows: Patient has a history of allergies and is considered to be a reaction due to the vaccine from the course of recovering after administration of adrenaline. No follow-up attempts possible. No further information expected.


VAERS ID: 1521445 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 FA5765 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Depressed level of consciousness, Dyspnoea, Heart rate, Oxygen saturation decreased, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (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: FLUTIFORM; SPIRIVA
Current Illness: Asthma; Emphysema
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: Blood pressure; Result Unstructured Data: Test Result: 143/100; Test Date: 20210717; Test Name: body temperature; Result Unstructured Data: Test Result: 36.8 Centigrade; Comments: Before vaccination; Test Date: 20210717; Test Name: Pulse; Result Unstructured Data: Test Result: 122.
CDC Split Type: JPPFIZER INC202100918322

Write-up: depressed level of consciousness; SpO2 92%; wheezes; feeling of dyspnea; Anaphylaxis; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The Regulatory authority report number is v21120222. The patient was a 59-year and 6-month-old female. Body temperature before vaccination was 36.8 degrees Centigrade. The patient had no family history. The patient had a history of ongoing refractory asthma and ongoing emphysema. The patient was ongoing taking FLUTIFORM at 8 inhalation/day and using SPIRIVA to treat refractory asthma and emphysema. There was no drug allergies. Recently (3 months), asthma control was stable. The patient also had a history of pyrexia due to influenza vaccination. On 17Jul2021 at 15:20 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization at age of 59-year-old. On 17Jul2021 at 15:26 (6minutes after the vaccination), the patient experienced Anaphylaxis. On 17Jul2021 (the day of vaccination), the outcome of the event was recovered. The course of the event was as follows: Vaccination was carried out at 15:20. There was a complaint of feeling of dyspnea at 15:26. On the way to the wheelchair, the patient experienced depressed level of consciousness, SpO2 92% and wheezes at 15:28. BOSMIN 0.3 ml was injected to right shoulder at 15:30 and consciousness was restored at 15:32. Venous route was secured with Lactec at 15:33. BP143/100, P122. After that, wheezes gradually disappeared. After taking PSL 30 mg orally and observing the patient by intravenous drip, the patient returned home at 17:45. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: It might be anaphylaxis due to the vaccination.


VAERS ID: 1521448 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 FD0889 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Hot flush, Pruritus, Somnolence
SMQs:, Anaphylactic reaction (narrow), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: MONTELUKAST; TRICHLORMETHIAZIDE; LAFUTIDINE; TOFISOPAM; CANDESARTAN; AMLODIPINE; CLARITHROMYCIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchitis; Hyperlipidaemia; Hypertensive angiopathy; Lumbago; Osteoarthrosis; Reflux oesophagitis; Rhinitis allergic; Thyroiditis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100918345

Write-up: Anaphylaxis-like symptoms; forehead and feet itching/body itching; Groggy; Hot flushes of trunk; This is a spontaneous report received from a contactable physician via Pfizer sales Representative. The patient was a 53-year-old female. Other medical history included hypertensive, reflux oesophagitis, lumbago, thyroiditis, Rhinitis allergic, OA (osteoarthrosis), bronchitis, hyperlipaemia. Concomitant drug included montelukast, trichlormethiazide 1mg, lafutidine 10mg, tofisopam 50mg, candesartan 4mg, amlodipine 2.5mg, clarithromycin 200mg. On 17Jun2021 11:10, the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FD0889, Expiration date 30Sep2021) intramuscular for COVID-19 immunization. Patient age at vaccination was 53-year-old. On 17Jul2021 (the day of vaccination), the patient experienced anaphylaxis-like symptoms. The details of clinical course as following: On 17Jul2021 at 11:40 (30 minutes after the vacciantion), the patient experienced forehead and feet itching, body itching, groggy, hot flushes of trunk. The symptoms disappeared about 12:20. The patient hoped to receive a second dose of the vaccine. The outcome of the event was recovered on 17Jul2021 at 12:20. The reporter classified the event as non-serious and the causality between the suspect drug and event was probably related.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event anaphylactic reaction and suspect drug BNT162B2 cannot be excluded.


VAERS ID: 1521450 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 EY0583 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Feeling abnormal, Headache, Pallor, Radial pulse, Shock
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Dementia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210717; Test Name: the pulse of radial artery; Result Unstructured Data: Test Result:could not detect
CDC Split Type: JPPFIZER INC202100918406

Write-up: shock state; pallor facial; feels poorly; headache; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21120178. A 15-year and 6-month-old male patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: EY0583, Expiration date: 31Oct2021), at the age of 15 years old, on 17Jul2021 at 09:35 at single dose for COVID-19 immunization. Body temperature before vaccination was 36.7 degrees Centigrade. Medical history was none. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire. The patient''s concomitant medications were not reported. On 17Jul2021 at 09:35 (the day of vaccination), the patient received the first dose of BNT162B2. On 17Jul2021 at 09:45 (10 minutes after the vaccination), the patient experienced some events. On 17Jul2021 (the same day of the vaccination), the outcome of the event was recovered. The course of the event was as follows: 10 minutes after the vaccination, the patient became pallor facial and claimed that he experienced feels poorly and headache. Onset began. The reporter could not detect the pulse of radial artery, so the reporter diagnosed it as shock state. The patient was conducted intravenous administration with hydrocortisone sodium succinate (SOLU-CORTEF) at 500mg, intramuscular injection with epinephrine at 0.3mg, and intravenous administration with potassium chloride; sodium chloride; sodium lactate (SOLITA-T NO.3) at 200ml. After several minutes, the patient recovered from shock state. About one hour after the vaccination, the reporter permitted the patient to go home. The reporting physician classified the event as serious (likely lead to disability) and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Nothing special. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Nothing special.


VAERS ID: 1521453 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 FC9880 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Pallor, Presyncope
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased; Test Date: 20210717; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before the vaccination
CDC Split Type: JPPFIZER INC202100918439

Write-up: vagus nerve reflex; complexion ill; blood pressure decreased; This is a spontaneous report from a contactable physician (vaccinator) received from the regulatory authority. Regulatory authority report number is v21120233. A 19-year-old female patient received (COMIRNATY, Solution for injection, Lot number FC9880, Expiration date 30Sep2021) via an unspecified route of administration on 17Jul2021 12:24 as dose 1, single (at the age of 19 years old) for COVID-19 immunisation. Medical history was reported as none. The patient''s concomitant medications were not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 17Jul2021 at 12:30 (6 minutes after the vaccination), the patient experienced vagus nerve reflex, complexion ill and blood pressure decreased. On 17Jul2021 (the day of vaccination), the outcome of the event was recovering. The course of the event was as follows: On the above date and time, complexion ill and blood pressure decreased were observed during follow-up after vaccination. It was considered to be a vagus nerve reflex, fluid replacement was given, the patient was stayed calm, and had an emergency request. The reporting physician classified the event as non-serious and assessed that the event was unrelated to bnt162b2. There was no other possible cause of the event such as any other diseases. The patient underwent lab tests and procedures on 17Jul2021 which included body temperature: 36.4 degrees Centigrade before the vaccination and blood pressure: decreased. Therapeutic measures were taken as result of all the events. The outcome of the events was recovering. The reporting physician commented as follows: The symptoms was considered as due to vagus nerve reflex.; Reporter''s Comments: The symptoms was considered as due to vagus nerve reflex.; Sender''s Comments: Based on temporal association and known safety profile theevents vagus nerve reflex,complexion ill,blood pressure decreased were assessed related to suspect product 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: 1521462 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 EY0573 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Laryngeal discomfort, Laryngeal oedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: body temperature; Result Unstructured Data: Test Result: 36.0 Centigrade; Comments: before vaccination.
CDC Split Type: JPPFIZER INC202100918656

Write-up: mild Laryngeal oedema; Feeling of stuffiness due to mild Laryngeal oedema; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The Regulatory authority report number is v21120176. A 75-year-old female patient received BNT162B2 (COMIRNATY, Batch/Lot Number: EY0573; Expiration Date: 30Sep2021), intramuscular on 17Jul2021 11:00 (at the age of 75 years old) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Body temperature before vaccination was 36.0 degrees Centigrade on 17Jul2021. The patient previously took ASTOMIN and experienced allergy. On 17Jul2021 at 11:30 (30 minutes after the vaccination), the patient experienced feeling of stuffiness due to mild laryngeal oedema. 30 minutes later, Bosmin 0.3 mg administration was given and recovered. The outcome of the events was recovered on an unspecified date. The reporting physician classified the events as non-serious and assessed that the event was related to bnt162b2. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1521480 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 EY0572 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Coma scale, Depressed level of consciousness, Dizziness, Gait disturbance, Heart rate, Heart rate increased, Nausea, Oxygen saturation, Presyncope, Respiratory rate increased
SMQs:, 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), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INSULIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer; Contrast media allergy; Diabetes mellitus; Hypertension; Vagal reaction
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: BP; Result Unstructured Data: Test Result:180/100; Comments: at 14:35; Test Date: 20210717; Test Name: BP; Result Unstructured Data: Test Result:170/100; Comments: at 15:15; Test Date: 20210717; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before the vaccination; Test Date: 20210717; Test Name: JCS; Result Unstructured Data: Test Result:II-20; Comments: at 14::35; Test Date: 20210717; Test Name: JCS; Result Unstructured Data: Test Result:I-1; Comments: at 14:45; Test Date: 20210717; Test Name: PR; Result Unstructured Data: Test Result:120; Comments: at 14:35; Test Date: 20210717; Test Name: SpO2; Result Unstructured Data: Test Result:98; Comments: at 14:35; Test Date: 20210717; Test Name: SpO2; Result Unstructured Data: Test Result:98; Comments: at 15:15
CDC Split Type: JPPFIZER INC202100919119

Write-up: light feeling queasy; PR 120; RR 24; transient depressed level of consciousness/JCSII-20/JCSI-1; BP180/100 / BP170/100; Difficulty in walking; Vasovagal reflex; light-headed feeling; This is a spontaneous report from a contactable physician (vaccinator) received from the regulatory authority report number is v21120370. A 55-year and 10-month-old female patient received the first dose of BNT162B2 (COMIRNATY, Lot#: EY0572, Expiration Date: 31Oct2021) via an unspecified route of administration at single dose on 17Jul2021 at 14:35 at the age of 55-year-old for COVID-19 immunization. Body temperature before vaccination was 36.3 degrees Centigrade on 17Jul2021. 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 diabetes mellitus (insulin injection), hypertension, breast cancer, vagus nerve reflex due to blood sampling and allergy to contrast media when taking MRI. Concomitant medication included insulin for diabetes mellitus. On 17Jul2021 at 14:35 (time at the vaccination), the patient experienced difficulty in walking and vasovagal reflex. The course of the event was as follows: Symptom: transient depressed level of consciousness, difficulty in walking. On 17Jul2021 at 14:35 (the day of vaccination), the patient received the vaccination, since the patient experienced light-headed feeling when she wanted to stand up from the chair after vaccination, she laid on the examination table with assistance. BP 180/100, SpO2 98, PR 120, RR 24, JCS II-20. No skin or mucosal symptoms. No respiratory symptom. Since the patient had a history of vagus nerve reflex, she laid on the bed for observation. On 17Jul2021 at 14:45 (the date of vaccination), the patient was able to answer the question (JCS I-1), but complained about light feeling queasy. On 17Jul2021 at 15:15 (the date of vaccination), the patient was able to have a normal conversation on the seat (BP 170/100, SpO2 98), but still had difficulty to stand up due to the light-headed feeling. No quadriplegia, no dysarthria, light reflex was normal. Although the patient could walk to the toilet with assistance, she was taken to the hospital for detailed examination and treatment because of the light-headed feeling and difficulty in walking. The outcome of events was unknown. The reporting physician classified the event as non-serious and assessed that the causality between the event and BNT162B2 as unassessable. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1521483 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 EY0572 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure fluctuation, Blood pressure measurement, Body temperature, Bradycardia, Heart rate, Nausea, Oxygen saturation, Presyncope
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: Blood pressure; Result Unstructured Data: Test Result:85/40 mmHg; Comments: at 15:25; Test Date: 20210717; Test Name: Blood pressure; Result Unstructured Data: Test Result:132/55 mmHg; Comments: at 15:28; Test Date: 20210717; Test Name: Blood pressure; Result Unstructured Data: Test Result:132/52 mmHg; Comments: at 15:31; Test Date: 20210717; Test Name: Blood pressure; Result Unstructured Data: Test Result:116/54 mmHg; Comments: at 15:45; Test Date: 20210717; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccination; Test Date: 20210717; Test Name: Heart rate; Result Unstructured Data: Test Result:71/min; Comments: at 15:25; Test Date: 20210717; Test Name: Heart rate; Result Unstructured Data: Test Result:49/min; Comments: at 15:28; Test Date: 20210717; Test Name: Heart rate; Result Unstructured Data: Test Result:46/min; Comments: at 15:31; Test Date: 20210717; Test Name: Heart rate; Result Unstructured Data: Test Result:47/min; Comments: at 15:45; Test Date: 20210717; Test Name: sat; Test Result: 99 %; Comments: at 15:45
CDC Split Type: JPPFIZER INC202100919180

Write-up: 49/min, 46/min, 47/min; 85/40mmHg; 85/40mmHg, 132/55, 132/52, 116/54; queasy; Vasovagal reflex; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21120191. A 17-year-old male patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EY0572, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization on 17Jul2021 at 15:07. Body temperature before vaccination was 36.8 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, etc.). The event onset date as reported was 17Jul2021 at 15:23 (16 minutes after vaccination). The course of the event was as follows: At 15:23 (16 minutes after the vaccination), queasy appeared, consciousness clear, able to walk. At 15:25 (18 minutes after the vaccination), 85/40 mmhg, 71/min. queasy disappeared immediately. At 15:28 (21 minutes after the vaccination), 132/55, 49/min. in a general good condition. At 15:31 (24 minutes after the vaccination), 132/52. 46/min. At 15:45 (38 minutes after the vaccination), 116/54, 47/min. sat: 99%. Went home. On 17Jul2021 (the day of vaccination), the outcome of the events was recovered. The reporting physician classified the event as non-serious and assessed that the causality between the event and bnt162b2 as related. There was no other possible cause of the event such as any other diseases. The reporter commented as follows: It was considered vasovagal reflex.


VAERS ID: 1521510 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Electrocardiogram, Palpitations, Vital signs measurement
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? 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: 20210617; Test Name: body temperature; Result Unstructured Data: Test Result:35.6 Centigrade; Comments: before the vaccination; Test Date: 20210617; Test Name: EKG; Result Unstructured Data: Test Result:no problem; Test Date: 20210617; Test Name: vital cheak; Result Unstructured Data: Test Result:no problem
CDC Split Type: JPPFIZER INC202100921594

Write-up: Palpitations; This is a spontaneous report from a contactable physician (vaccinator) received from the Agency Regulatory Authority. Regulatory authority report number is v21120180. A 49-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 17Jul2021 10:48 (Batch/Lot Number: EY5423; Expiration Date: 31Aug2021) (at age 49-years-old) as dose 1, single for covid-19 immunisation. The patient''s concomitant medications were not reported. Body temperature before vaccination was 35.6 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 17Jul2021 at 10:48 (the day of vaccination), the patient received the first dose of bnt162b2. The event onset date was reported as on 17Jul2021 at 10:58 (10 minutes after the vaccination). On 17Jul2021 (the day of vaccination), the outcome of the event was recovered. The course of the event was as follows: After the vaccination, the patient experienced palpitations. There was no problem on EKG and vital check. Intravenous drip of normal saline 100ml was performed, and then the symptom was recovering. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2.


VAERS ID: 1521518 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 FC9880 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Depressed level of consciousness, Feeling abnormal, Nausea, Oxygen saturation, Somnolence
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? 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: 20210717; Test Name: blood pressure; Result Unstructured Data: Test Result:87-105 mmHg; Test Date: 20210717; Test Name: Body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: before vaccination; Test Date: 20210717; Test Name: oxygen saturation; Result Unstructured Data: Test Result: 98-96%.
CDC Split Type: JPPFIZER INC202100923740

Write-up: Depressed level of consciousness; blood pressure decreased; nausea; feels poorly; Tendency to drowsy; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120502. An 84-year and 4-month-old male patient received the first dose of bnt162b2 (COMIRNATY), On 17Jul2021 at 16:05 at the age of 84-year-old (Lot#FC9880, Expiration date 30SEP2021) as single dose for covid-19 immunisation. 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 17Jul2021 at 16:25 (20 minutes after the vaccination), the patient experienced blood pressure decreased, depressed level of consciousness and nausea. On 17JUL2021 (the day of the vaccination), the patient was admitted to the hospital. The course of the event was as follows, 15 minutes after the vaccination and the observation finished, the patient left the venue and immediately complained of feels poorly. Tendency to drowsy, the blood pressure was 87-105, oxygen saturation was 98-96. Suspicion even in observation, after adrenaline was injected by intramuscular injection, the emergency was requested. The reporting physician classified the event as serious (hospitalization from 17Jul2021 to 19Jul2021) and the causality between the event and bnt162b2 as unassessable. On 19JUL2021 (2 days after the vaccination), the outcome of the event was recovered.


VAERS ID: 1521531 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-17
   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 EW0207 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction, Magnetic resonance imaging head
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BICALUTAMIDE; AZOPT; TAPROS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Glaucoma (treated with Tapros and Azopt); Prostatic pain (treated with bicalutamide)
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: MRI brain; Result Unstructured Data: Test Result:cerebral infarction on the right of corona radiata
CDC Split Type: JPPFIZER INC202100923795

Write-up: Cerebral infarction/cerebral infarction on the right of corona radiata; This is a spontaneous report from a contactable physician (attending physician) received from the Regulatory authority report number is v21120517. The patient was an 84-year and 2-month-old male. 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 prostatic pain treated with bicalutamide and glaucoma treated with Tapros and Azopt ophthalmic solution. Concomitant medications included bicalutamide for prostatic pain; tafluprost (TAPROS) and brinzolamide (AZOPT), both for glaucoma. On 09Jul2021 (the day of vaccination), at the age of 84-year-old the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EW0207, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 17Jul2021 at about 14:00 (8 days 14 hours after the vaccination), the patient experienced cerebral infarction. On 17Jul2021 (8 days after the vaccination), the patient was admitted to the hospital. On 19Jul2021 (10 days after the vaccination), the outcome of the event was not recovered. The course of the event was as follows: On 17Jul2021 (8 days after vaccination), the patient experienced paralysis on the left of upper and lower limbs. Since cerebral infarction on the right of corona radiata was observed by MRI brain, the patient was admitted to the hospital for treatment. Outcome of the event was not recovered. The reporting physician classified the event as serious (hospitalized, start from 17Jul2021) and assessed that the event was related to bnt162b2. Other possible cause of the event such as any other diseases was advanced age. The reporting physician commented as follows: Since the patient experienced cerebral infarction after the vaccination of COVID-19 for the first time in his life, the causality between the symptom and vaccine cannot be denied.


VAERS ID: 1521554 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 FC3661 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Bradycardia, Feeling abnormal, Heart rate, Oxygen saturation, Presyncope, Tension
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: BP; Result Unstructured Data: Test Result:80/47 mmHg; Comments: 14:20; Test Date: 20210717; Test Name: BP; Result Unstructured Data: Test Result:44/67 mmHg; Comments: 14:28; Test Date: 20210717; Test Name: BP; Result Unstructured Data: Test Result:123/76 mmHg; Comments: 14:42; Test Date: 20210717; Test Name: BP; Result Unstructured Data: Test Result:129/51 mmHg; Comments: 14:54; Test Date: 20210717; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination.; Test Date: 20210717; Test Name: body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: 14:54; Test Date: 20210717; Test Name: pulse; Result Unstructured Data: Test Result:47; Comments: 14:20; Test Date: 20210717; Test Name: pulse; Result Unstructured Data: Test Result:82; Comments: 14:42; Test Date: 20210717; Test Name: pulse; Result Unstructured Data: Test Result:72; Comments: 14:54; Test Date: 20210717; Test Name: SpO2; Test Result: 99 %; Comments: 14:20; Test Date: 20210717; Test Name: SpO2; Test Result: 98 %; Comments: 14:42; Test Date: 20210717; Test Name: SpO2; Test Result: 99 %; Comments: 14:54
CDC Split Type: JPPFIZER INC202100924292

Write-up: Pulse 47/min; Feels poorly; BP 80/47mmHg/BP 44/67 mmHg; Vagal reflex; over Tension; This is a spontaneous report from a contactable other HCP received from the regulatory authority. Regulatory authority report number is v21120351. A 21-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration at the age of 21-year-old on 17Jul2021 14:14 (Lot Number: FC3661; Expiration Date: 30Sep2021) as single dose for COVID-19 immunisation. Medical history included none. There were no concomitant medications. The patient was a 21-year and 4-month-old male. Body temperature before vaccination was 36.4 degrees centigrade on 17Jul2021. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The event onset date was reported as 17Jul2021 at 14:20 (same day at the vaccination). The course of the event was as follows: At 14:14, vaccination of first dose. The patient was planned to observed till 14:29. At 14:20, Feels poorly appeared told by patient, BP 80/47mmHg. Pulse 47/min SpO2 99%.Rested in bed. Carried to the bed, raised up the lower limbs. Bosmin intramuscular injection administered on outside of right thigh center. At 14:28 BP 44/67 mmHg, the patient felt better.At 14:42 BP 123/76. Pulse 82/min, SpO2 98%.At 14:54 BP 129/51. Pulse 72/min, SpO2 99%, BT 36.9 centigrade. On 17Jul2021(same day at the vaccination), The outcome of the event was reported as recovered. The reporter classified the event as non-serious and the causality between the event and bnt162b2 was not provided. There was no other possible cause of the event such as any other diseases. The reporter commented as follow: For Blood pressure decreased, Bradycardia were appeared, consider as the Vagal reflex due to the over Tension not the side effect by the vaccine. (2-W). Therapeutic measures were taken as a result of events. The outcome of events was recovered on 17Jul2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1521570 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 FD0348 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cellulitis, Dermatitis allergic, Erythema, Feeling hot, Peripheral swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Iodine contrast media allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100927269

Write-up: cellulitis likely; Skin eruption/allergic rash; the back of the right hand swelling, redness and warmth; the back of the right hand swelling, redness and warmth; the back of the right hand swelling, redness and warmth; This is a spontaneous report from a contactable physician(Emergency response doctor) received from Medical Devices Agency. A 72-years-old female patient received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration on 17Jul2021 at age of 72-years-old (Batch/Lot Number: FD0348; Expiration Date: 31Oct2021) as DOSE 2, SINGLE for covid-19 immunization. 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.) included: Iodine contrast media allergy. The patient''s concomitant medications were not reported. On 17Jul2021 at 17:30 (the same day of vaccination) Skin eruption occurred. The reporter classified the event non-serious and assessed the causality between the event and the vaccines as unassessable. Other possible cause of the event was cellulitis. The course of the event was as follows: After vaccination the patient experienced the back of the right hand swelling, redness and warmth. Yesterday (19Jul2021), the patient said she planted trees in the garden (with gloves). Symptoms was cellulitis likely, but it also could be skin eruption. Oral antiallergic agent. The reporter concluded as follows: Compare with allergic rash, it was cellulitis likely. Observation at home, if not relieved, visit dermatologist. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1521714 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-07-17
   Days after vaccination:35
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: Arthralgia, Body temperature, Chills, Fatigue, Headache, Hyperpyrexia, Malaise, Myalgia
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: MOMETASON
Current Illness:
Preexisting Conditions: Comments: No medical reported history provided by the reporter.
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: Body temperature; Result Unstructured Data: hyperpyrexia): 40.5 Celcius.
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of HYPERPYREXIA in a 46-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003652) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical reported history provided by the reporter. Concomitant products included MOMETASONE FUROATE (MOMETASON) for an unknown indication. On 12-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 17-Jul-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 17-Jul-2021, the patient experienced HYPERPYREXIA (seriousness criterion medically significant). 17-Jul-2021, the patient experienced MALAISE, ARTHRALGIA, HEADACHE, MYALGIA and CHILLS. On 18-Jul-2021, the patient experienced FATIGUE. On 18-Jul-2021, MALAISE, ARTHRALGIA, HEADACHE, MYALGIA and CHILLS had resolved. At the time of the report, HYPERPYREXIA and FATIGUE was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jul-2021, Body temperature: increased (High) : 40.5 Celcius. Treatment information was not reported. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1522340 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214006 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary pain, Chest pain, Nausea, Vaccination site inflammation
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of CHEST PAIN , VACCINATION SITE INFLAMMATION (Vaccination site inflammation), NAUSEA and AXILLARY PAIN in a 26-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 214006) for COVID-19 vaccination. The patient''s past medical history included COVID-19 in September 2020. On 17-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced CHEST PAIN (seriousness criterion medically significant), VACCINATION SITE INFLAMMATION (Vaccination site inflammation) (seriousness criterion medically significant), NAUSEA (seriousness criterion medically significant) and AXILLARY PAIN(seriousness criterion medically significant). On 18-Jul-2021, NAUSEA had resolved. At the time of the report, CHEST PAIN , VACCINATION SITE INFLAMMATION (Vaccination site inflammation) and AXILLARY PAIN was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. 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: 1522418 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Administration site pain, Aphthous ulcer, Body temperature, Ear pain, Fatigue, Headache, Myalgia, Nausea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (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? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: Body temperature; Result Unstructured Data: 40 C
CDC Split Type: ROJNJFOC20210800317

Write-up: ADMINISTRATION SITE PAIN; NAUSEA; PAIN IN EAR; HEADACHE; FEVER; FATIGABILITY; CANKER SORES ORAL; MYALGIA; This spontaneous report received from a health care professional via a Regulatory Authority [EMEA EVHUMAN NLP, RO-NMA-2021-SPCOV12033] concerned a 30 year old female. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C13-01 expiry: UNKNOWN) 1 dosage forms, 1 total, administered on 17-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 17-JUL-2021, the patient experienced pain in ear, canker sores oral, administration site pain, nausea, headache, fever, fatigability, myalgia. Laboratory data included: Body temperature (NR: not provided) 40 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from administration site pain, nausea, pain in ear, headache, fever, fatigability, canker sores oral, and myalgia. This report was serious (Life Threatening).; Sender''s Comments: V0: 20210800317- covid-19 vaccine ad26.cov2.s-PAIN IN EAR,CANKER SORES ORAL, ADMINISTRATION SITE PAIN,NAUSEA,HEADACHE,FEVER,FATIGABILITY,MYALGIA. 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: 1523773 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Accidental underdose, Atrial fibrillation, Chest discomfort, Incorrect route of product administration
SMQs:, Anaphylactic reaction (broad), Supraventricular tachyarrhythmias (narrow), Drug abuse and dependence (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PLAVIX; HYDROCHLOROTHIAZIDE; OMEPRAZOLE ALMUS; PRAVASTATINE A; LOSARTAN [LOSARTAN POTASSIUM]; SOTALOL HYDROCHLORIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary artery atheroma; Hypercholesteraemia; Tobacco user
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: AFib; Chest tightness; Patient received COVID 19 Vaccine Moderna via oral route; accidental underdose; This regulatory authority case was reported by a physician and describes the occurrence of ATRIAL FIBRILLATION (AFib) and CHEST DISCOMFORT (Chest tightness) in a 68-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Coronary artery atheroma, Tobacco user and Hypercholesteraemia. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), HYDROCHLOROTHIAZIDE, OMEPRAZOLE (OMEPRAZOLE ALMUS), PRAVASTATIN SODIUM (PRAVASTATINE A), LOSARTAN POTASSIUM (LOSARTAN [LOSARTAN POTASSIUM]) and SOTALOL HYDROCHLORIDE for an unknown indication. On 17-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Oral) .3 milliliter. On 17-Jul-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient received COVID 19 Vaccine Moderna via oral route) and ACCIDENTAL UNDERDOSE (accidental underdose). On 19-Jul-2021, the patient experienced ATRIAL FIBRILLATION (AFib) (seriousness criteria hospitalization and medically significant) and CHEST DISCOMFORT (Chest tightness) (seriousness criterion hospitalization). On 17-Jul-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient received COVID 19 Vaccine Moderna via oral route) and ACCIDENTAL UNDERDOSE (accidental underdose) had resolved. On 19-Jul-2021, CHEST DISCOMFORT (Chest tightness) had resolved. On 20-Jul-2021, ATRIAL FIBRILLATION (AFib) had resolved. For mRNA-1273 (COVID 19 Vaccine Moderna) (Oral), the reporter did not provide any causality assessments. Concomitant medications also included chlorhydrate de sotalol and losartan potassique. The Sender''s (Case) Safety Report Unique Identifier was FR-AFSSAPS-ST20212896. This report refers to a case of Inappropriate schedule of vaccine administered and Accidental underdose for mRNA-1273 (lot # unknown) with associated AEs reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient?s medical history could be a confounding risk factor to the events.; Sender''s Comments: This report refers to a case of Inappropriate schedule of vaccine administered and Accidental underdose for mRNA-1273 (lot # unknown) with associated AEs reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient?s medical history could be a confounding risk factor to the events.


VAERS ID: 1523794 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diplegia, Eyelid disorder, Fatigue, Nasopharyngitis, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Periorbital and eyelid disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100927348

Write-up: Fatigue; intermittent paralysis in her legs; rhinopharyngitis; tingling; the left eyelid which jumped a lot and got stuck; This is a spontaneous report from a contactable consumer via medical information. A 34-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, Batch/Lot number and expiration date: was not reported), via an unspecified route of administration on 16Jul2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 17Jul2021, the patient experienced, In the morning she had a runny nose, sore throat. In the evening she experienced in a random way intermittent paralysis in her legs and tingling which is still ongoing. She also had her left eyelid jumping a lot and getting stuck. This lasted for 1 day. She saw her physician who diagnosed nasopharyngitis and prescribed vitamins. He told her that the other adverse effects were due to fatigue. Test was negative. Therapeutic measures were taken as a result of nasopharyngitis included vitamins. The outcome of the event eyelid jumping a lot and getting stuck was recovered on 18Jul2021 and the outcome intermittent paralysis in her legs and tingling were not recovered and outcome of the event fatigue was unknown.


VAERS ID: 1523804 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   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 FD8813 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy, Oropharyngeal pain, SARS-CoV-2 test
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Caesarean section; Lactation decreased; Pre-eclampsia (Blood thinners for 6 weeks and blood pressure medication.)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No-Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100916664

Write-up: Swollen glands; Sore throat; This is a spontaneous study report from a contactable consumer. This is a report received from the Regulatory authority report number is GB-MHRA-APPCOVID-20210718144430, Safety Report Unique Identifier is GB-MHRA-ADR 25669775. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Jul2021 (Lot Number: FD8813) as an unknown dose number at a single dose for COVID-19 immunisation. Medical history included C- section, pre-eclampsia and lactation decreased both from an unknown date. It was reported that patient had a recent C-section. Pre-eclampsia. Blood thinners for 6 weeks. Blood pressure medication. Patient has not had symptoms associated with COVID-19. Patient is not pregnant; is not currently breastfeeding. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced swollen glands and sore throat both on 17Jul2021. The events were reported as serious (medically significant). The patient underwent lab tests and procedures which included SARS-COV-2 test with No-Negative COVID-19 test result on an unknown date. The patient had not recovered from swollen glands and sore throat. No follow up attempts are possible. No further information is expected.


VAERS ID: 1523843 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 FD8813 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Heart rate, Heart rate abnormal, Hypoaesthesia, Myocarditis, Nausea
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pain (Pain relief Active Drug substance names: Paracetamol Date of start of drug: 17Jul2021)
Allergies:
Diagnostic Lab Data: Test Name: Heart rate; Result Unstructured Data: Test Result:Unknown Result
CDC Split Type: GBPFIZER INC202100916394

Write-up: myocarditis; Nausea; Heart rate; Chest pain; Numbness of limbs; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107181344586630-YXYXT, Safety Report Unique Identifier: GB-MHRA-ADR 25669749. A 36-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection,Batch/Lot Number: Fd8813), via an unspecified route of administration on 17Jul2021 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included pain, pain relief Active Drug substance names: Paracetamol Date of start of drug: 17Jul2021. Concomitant medication(s) included paracetamol (PARACETAMOL) taken for analgesic therapy from 17Jul2021 to an unspecified stop date. On an unspecified date, the patient experienced myocarditis, On 17Jul2021, nausea, heart rate, chest pain, numbness of limbs.The patient underwent lab tests and procedures which included heart rate: unknown result on. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. He was concerned about these symptoms lining up with myocarditis. Patient was not enrolled in clinical trial. The outcome of event myocarditis was unknown, events (chest pain, numbness of limbs) were recovered on 18Jul2021 and other events were recovering. No follow-up attempts are possible; No information is expected.


VAERS ID: 1523846 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 FD8813 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100916512

Write-up: Toothache; Headache; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107181716467480-PESWL, Safety Report Unique Identifier GB-MHRA-ADR 25669846. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Jul2021 (Lot Number: Fd8813) as 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. The patient experienced toothache and headache both on 17Jul2021. The events were reported as serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included SARS-COV-2 test with No - Negative COVID-19 test on an unknown date. The patient had not recovered from the events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1523854 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Vaccination site swelling
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: AMITRIPTYLINE; CITALOPRAM; RIGEVIDON [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Premenstrual tension; Tension headache
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100928670

Write-up: Armpit pain; Injection site swelling; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The Regulatory authority report number is GB-MHRA-WEBCOVID-202107191137178890-SVH3W and the Safety Report Unique Identifier is GB-MHRA-ADR 25672122. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FD8813), via an unspecified route of administration on 17Jul2021 (at the age of 37 years old) as dose 2, single for COVID-19 immunization. Medical history included tension headache, depression, and premenstrual tension. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test. Patient was not pregnant and not currently breastfeeding. Historical vaccine included first dose of BNT162B2, received on an unspecified date for COVID-19 immunization. Concomitant medications included amitriptyline taken for tension headache from Mar2019; citalopram taken for depression from Dec2018; and ethinylestradiol, levonorgestrel (RIGEVIDON) taken for premenstrual tension from Oct2018. The patient experienced armpit pain and injection site swelling on 17Jul2021. The events were reported as serious per other medically important condition. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1523859 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood glucose increased, Blood pressure measurement, Dizziness, Dyskinesia, Heart rate, Hyperventilation, Malaise, Pain, Presyncope, Vision blurred
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dyskinesia (narrow), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vestibular disorders (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: 20210717; Test Name: BP; Result Unstructured Data: Test Result:stable; Test Date: 20210717; Test Name: pulse; Result Unstructured Data: Test Result:stable; Test Date: 20210717; Test Name: glucose blood; Result Unstructured Data: Test Result:increased
CDC Split Type: GBPFIZER INC202100923425

Write-up: eyes felt "fuzzy"; Glucose blood increased; unwell; dizzy; Vasovagal reaction; pain all over body; hyperventilating; legs and arms jerking; This is a spontaneous report from a contactable pharmacist received from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107191553246880-KTGWA, Safety Report Unique Identifier GB-MHRA-ADR 25674055. A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Jul2021 (Lot Number: FF3319) as Dose 2, single at 38-year-old for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. On 17Jul2021, the patient experienced eyes were fuzzy, glucose blood increased, felt unwell, dizzy, vasovagal reaction, pain all over body, hyperventilating and legs and arms were jerking. The outcome of the events was recovered on an unknown date. It was reported that eyes felt "fuzzy" at end of 15 minute observation, taken to lie down, bp, heart rate and pulse stable, apyrexial; observed for 15 minutes, given water and felt better; called partner to move car closer to entrance, walked out of the centre with her and then became dizzy again; wheelchair obtained and transferred using wheelchair back to resus area; called partner to come in to support. The patient laid back down again flat, slowly sat up over 30 minutes bp and obs stable. She went to toilet with assistance of partner then agreed to use wheelchair to go to car. She felt unwell in wheelchair again. She was brought back inside for a second time, laid flat again then started to complain of pain all over body, hyperventilating, legs and arms jerking and shouting with pain. Unsure if patient is enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1523860 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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: Axillary mass, Breast pain, Inappropriate schedule of product administration, Off label use, Pain in extremity, Peripheral swelling, Product use issue, Swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Lipodystrophy (broad), Tendinopathies and ligament 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (Asthma 4 months postpartum); Uterine contraction strong excessively
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100923258

Write-up: arm was swollen/sore; arm was swollen/sore; first dose on 22May2021, second dose on 17Jul2021; breast feeding infant; breast feeding infant; Breast pain; Swelling/ lump in armpit; Swelling/ lump in armpit; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107191707013430-WGVDX, Safety Report Unique Identifier: GB-MHRA-ADR 25674523. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot# FD5613), via an unspecified route of administration on 17Jul2021 at dose 2, single for COVID-19 immunization. The patient''s medical history included uterine hypertonus, Asthma 4 months postpartum. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. The patient''s concomitant medications were not reported. Patient is not enrolled in clinical trial. Patient received first dose of BNT162B2 on 22May2021 with Batch/lot number: EW4109 for COVID-19 immunization. The patient experienced swelling /lump in armpit on 17Jul2021, breast pain on 18Jul2021, arm was swollen/sore on an unspecified date. Clinical course was reported as follows: Day after vaccine arm was swollen/sore, followed by swelling/lump in armpit. Then pain began in breast (left side) same side as vaccine was given pain was severe and caused a lot of pain especially while breast feeding infant. The outcome of swelling/ lump in armpit, breast pain was not recovered, outcome of arm swollen/sore was unknown. Case reported as serious due to Other medically important condition. 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: 1523922 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Lymphadenopathy, Myalgia, Pain in extremity, Pruritus, SARS-CoV-2 test, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100928560

Write-up: Muscle soreness; Soreness at injection site; Redness/Injection sight is red; injection sight is red, hot; itchy; Swollen lymph nodes; Sore arm; tightness of chest; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107192324462830-MZ87X, Safety Report Unique Identifier is GB-MHRA-ADR 25679578. A 33-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- Fd8813) via an unspecified route of administration on 17Jul2021 at 18:20 in arm as dose 2 single (at the age of 33-year-old) for COVID-19 immunization. Medical history included lactation decreased. No to both questions above. Had no medical conditions. Patient has not had symptoms associated with COVID-19. Patient was not pregnant at the time of vaccination, Patient was not currently breastfeeding. Concomitant medications were not reported. On 17Jul2021, patient experienced tightness of chest, sore arm. On 19Jul2021, patient experienced itchy, swollen lymph nodes, soreness at injection site/muscle soreness, redness/injection sight is red, hot. Clinical course included vaccine at 18:20. Sore arm straight after. Tightness of chest immediately after. Soreness at injection site. Swollen lumph nodes in injection arm. So far has lasted 2 continuous days with no dullness. Injection sight is red and hot, often itchy. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unknown date No - Negative COVID-19 test. The outcome of the events tightness of chest, itchy was recovered, outcome of the event soreness at injection site/muscle soreness was recovering, outcome of the event sore arm was unknown and outcome of the other events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1523945 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-17
   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 FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy, SARS-CoV-2 test
SMQs:, Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: COVID-19 virus test; Test Result: Negative; Comments: Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202100928575

Write-up: Patient received: dose 1 on 29Apr2021 & dose 2 on 15Jul2021; Swollen lymph nodes; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107200934088890-ON1GU, Safety Report Unique Identifier GB-MHRA-ADR 25678968. A 21-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: FF3319) via an unspecified route of administration on 15Jul2021 (at the age of 21-years-old) as dose 2, single for COVID-19 immunization. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EW4109), via an unspecified route of administration on 29Apr2021 as dose 1, single for COVID-19 immunization. Concomitant medications were not reported. The patient received dose 1 on 29Apr2021 & dose 2 on 15Jul2021. On 17Jul2021, the patient experienced swollen lymph nodes on 17Jul2021. It was reported that the swollen painful lymph nodes in opposite armpit to vaccination. The event was serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests which included SARS-CoV-2 test: Negative COVID-19 test on 19Jul2021. The outcome of event swollen lymph nodes was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1523951 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 FA1027 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Limb discomfort, Malaise, Myalgia, Pyrexia, SARS-CoV-2 test, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210717; Test Name: temperature; Result Unstructured Data: Test Result:37.5; Comments: temperature up to 37.5, Slight temperature; Test Date: 20210716; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100928627

Write-up: Feeling unwell; Pain injection site; Slight temperature/temperature up to 37.5; feeling my legs heavy; Muscle ache; This is a spontaneous report from a contactable consumer received from the The regulatory authority report number is GB-MHRA-WEBCOVID-202107201021549150-CHZ8N, Safety Report Unique Identifier: GB-MHRA-ADR 25679287. A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot# FA1027), dose 2 via an unspecified route of administration on 17Jul2021 at dose 2, single at 33-year-old for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. On 17Jul2021, the patient experienced usual pain on the arm where vaccine injected (pain injection site), slight temperature/ temperature up to 37.5, feeling unwell, feeling my legs heavy and muscle ach. Got some paracetamol. The outcome of the events pain injection site, slight temperature, feeling unwell, feeling my legs heavy was recovered on 19Jul2021 while muscle ache recovered on 18Jul2021. The events were medically significant. The patient underwent lab tests and procedures which included COVID-19 test: Negative on 16Jul2021. 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 information is expected.


VAERS ID: 1523952 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-17
   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 FD8813 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative
CDC Split Type: GBPFIZER INC202100928943

Write-up: Fatigue; Nausea; Anxiety state; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107201029141350-KG3SP. A female patient of an unspecified age received bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, lot FD8813), via an unspecified route of administration on 15Jul2021 as dose 2, single for Covid-19 immunisation. The patient''s medical history included anxiety. Concomitant medication included sertraline for anxiety, start and stop date were not reported. The patient experienced anxiety state on 17Jul2021. She also had fatigue and nausea on an unspecified date. The events were reported as serious medically significant. The patient underwent laboratory test which included Sars-cov-2 test: negative on unspecified date. The outcome of events was not recovered. No follow-up attempts are possible. No further information was expected.


VAERS ID: 1523965 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bruxism, Rash, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), 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: Pregnancy.
Allergies:
Diagnostic Lab Data: Test Date: 07/19/2021; Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202100929177

Write-up: This is a spontaneous report from a contactable consumer, received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202107201137029900-36WRG; safety report unique identifier: GB-MHRA-ADR 25679686). A 42-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot# FE1510), at the age of 42, via an unspecified route of administration, on Jul 17, 2021, single dose, for COVID-19 immunization. Medical history included pregnancy. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced fainting on Jul 17, 2021, with outcome of recovered with sequelae; skin rash on Jul 18, 2021, with outcome of not recovered; and teeth clenching on Jul 18, 2021, with outcome of not recovered. The patient underwent lab tests and procedures, which included COVID-19 virus test: No - Negative COVID-19 test on Jul 19, 2021. Patient has not tested positive for COVID-19 since the vaccination. Patient is not enrolled in clinical a trial. No follow-up attempts possible. No further information expected.


VAERS ID: 1523992 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-17
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Computerised tomogram, Ear discomfort, Hypoacusis, Hypoaesthesia, SARS-CoV-2 test, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hearing impairment (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cold sores (it happened that she had a cold sore at the time she had the vaccine and at the time she developed the symptoms of blocked ear and facial numbness.); Lactation decreased; Swelling of tongue
Allergies:
Diagnostic Lab Data: Test Name: Blood Test; Result Unstructured Data: Test Result:normal; Test Name: CT scan; Result Unstructured Data: Test Result:normal; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100929009

Write-up: forhead; I could not hear with that year; Numbness in face/umbness on the right side of head (including face, chin, ear, head, forehead); right ear was blocked; This is a spontaneous report from a contactable consumer (patient). This report is received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107201356186160-MMIZM. Safety Report Unique Identifier is GB-MHRA-ADR 25680565. A 46-year-old female patient received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), (Lot number was not reported), via an unspecified route of administration on 15Jul2021 at single dose for COVID-19 immunisation. Medical history included swollen tongue, Lactation decreased, oral herpes from unspecified date. She usually got cold sores (on lips) quite often and it happened that she had a cold sore at the time she had the vaccine and at the time she developed the symptoms of blocked ear and facial numbness. 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 forhead on an unspecified date with outcome of recovered, numbness in face on 17Jul2021 with outcome of recovered on 19Jul2021, felt that her right ear was blocked on 17Jul2021 with outcome of unknown, could not hear with that year on an unspecified date with outcome of unknown. Events were serious as medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on unspecified date. The clinical course was reported as follows: Approximately 46 hours following the vaccine, she felt that her right ear was blocked and started developing numbness on the right side of head (including face, chin, ear, head, forehead). She could not hear with that year. She called emergency services and was sent to A&E. She had a blood test and a CT scan, which were normal. 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. No further information is expected.


VAERS ID: 1523996 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Influenza, Nausea, Pain, Pain in extremity, Poor quality sleep, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (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? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL; IBUPROFEN
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 INC202100928551

Write-up: Flu symptoms; Painful arm; nauseous; Didn''t sleep very well and woke up extremely tired but as the morning went on starting feeling achy, very tired and nauseous.; Didn''t sleep very well and woke up extremely tired but as the morning went on starting feeling achy, very tired and nauseous.; Didn''t sleep very well and woke up extremely tired but as the morning went on starting feeling achy, very tired and nauseous.; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency. The regulatory authority report number is [GB-MHRA-WEBCOVID-202107201415353540-HALZ6], Safety Report Unique Identifier: [GB-MHRA-ADR 25680836]. A male patient of an unspecified age, received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration on 17Jul2021 (Lot Number: fe1510) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Concomitant medications included paracetamol was taken for an unspecified indication, start and stop date were not reported; ibuprofen was taken for an unspecified indication, start and stop date were not reported. Historical condition included the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Lot Number: not reported) as dose 1, single for COVID-19 immunisation. On an unspecified date in 2021, the patient experienced nauseous and did not sleep very well and woke up extremely tired but as the morning went on starting feeling achy, very tired and nauseous. On 17Jul2021 the patient experienced painful arm. On 20Jul2021, the patient experienced flu symptoms. The patient reported that he did not sleep very well and woke up extremely tired but as the morning went on starting feeling achy, very tired and nauseous. Paracetamol and ibubrofen. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Therapeutic measures (treatment) were taken as a result of nauseous, painful arm, flu symptoms, did not sleep very well and woke up extremely tired but as the morning went on starting feeling achy, very tired and nauseous including treatment with paracetamol and Ibuprofen. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date No - Negative COVID-19 test. The outcome of the events nauseous and did not sleep very well and woke up extremely tired but as the morning went on starting feeling achy, very tired and nauseous were unknown. The outcome of the event painful arm was recovering. The outcome of the event flu symptoms was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1524009 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lower respiratory tract infection, SARS-CoV-2 test
SMQs:, Infective pneumonia (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:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100929103

Write-up: Chest infection; This is a spontaneous report from a contactable consumer received from the Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107201524032310-LIPHZ, Safety Report Unique Identifier GB-MHRA-ADR 25681296. A 31-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jul2021 (Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Unsure if patient has had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient experienced chest infection on 17Jul2021. The event was reported as disabling and medically significant. The patient underwent lab tests and procedures which included covid-19 virus test: negative on an unspecified date (No - Negative COVID-19 test). 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 about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1524011 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-17
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Oropharyngeal pain, Pain, Pruritus, SARS-CoV-2 test, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: 20210719; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100929149

Write-up: itchy/itchy skin; pain; Sore throat; Swelling face; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107201530100710-WSXL2, safety report unique identifier is GB-MHRA-ADR 25681323. A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), dose 2 via an unspecified route of administration on 15Jul2021 as single dose 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 itchy/ itchy skin on an unspecified date with outcome of recovering, pain on an unspecified date with outcome of unknown, swelling face on 17Jul2021 with outcome of recovering, sore throat on an unspecified date with outcome of recovering. The events were serious as medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 19Jul2021. Clinical course: 2 days after receiving her second dose, her whole face swelled up and was incredibly itchy. She had to get prescribed steriods to get rid of the pain. 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. No further information is expected.


VAERS ID: 1524019 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   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 - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: COVID-19 virus test; Test Result: Negative; Comments: Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202100929168

Write-up: Headache; nausea; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107201607019580-T0JX6, Safety Report Unique Identifier GB-MHRA-ADR 25681432. A non-pregnant 25-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration on 16Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. Relevant medical history included lactation decreased on an unspecified date. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. Patient got an initial headache the day after her second dose on 17Jul2021 which lasted 2 days. This continued and progressed into nausea on an unspecified date in 2021. The patient underwent lab tests and procedures which included COVID-19 virus test on 17Jul2021 Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event headache was recovered on 19Jul2021 duration of 2 days, while for nausea, it was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1524035 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-07-17
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Menopausal
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100928701

Write-up: bleeding; Vaginal bleeding; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number: GB-RA-WEBCOVID-202107201801405640-UPYX1, Safety Report Unique Identifier: GB-RA-ADR 25682349. A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Jun2021 (Lot Number: EW3143) as single dose for COVID-19 immunisation. Medical history included menopause wherein patient had not had a period for over 10 years. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient previously took levonorgestrel (MIRENA) for intrauterine contraception. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19May2021 (Lot Number: ET8885) as single dose for COVID-19 immunisation. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. The patient experienced vaginal bleeding on 17Jul2021. Patient experienced unusual bleeding on an unspecified date and reported that there was still spotting. This is the first time this has occurred. Patient has not tested positive for COVID-19 since having the vaccine. The events were considered non-serious. The outcome of bleeding and vaginal bleeding was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1524046 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   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 FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Migraine, Nausea, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100928682

Write-up: Nausea; Migraine; Fever; Ache; Chronic fatigue; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-RA-WEBCOVID-202107201937348730-Z65QU. Sender''s (Case) Safety Report Unique Identifier is GB-RA-ADR 25682902 A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FF3319), via an unspecified route of administration on 17Jul2021 as dose2, single for Covid-19 immunization. Patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: not reported), dose 1 via an unspecified route of administration on an unspecified date as a single dose for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with Covid-19. Patient has not tested positive for Covid-19 since having the vaccine Patient is not enrolled in clinical trial. On 17Jul2021, the patient experienced chronic fatigue, ache, fever. On 18Jul2021, she had migraine. On 19Jul2021, she had nausea. The patient underwent lab tests and procedures which included Covid-19 test: negative on 20Jul2021 No - Negative Covid-19 test. Outcome of the event migraine, fever was resolving; nausea, chronic fatigue was not recovered; while ache was resolved on 19Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1524063 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-17
   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 FC9001 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Varicose vein
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100929154

Write-up: Varicose veins; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-RA-WEBCOVID-202107202137576690-WIKAD, Safety Report Unique Identifier GB-RA-ADR 25683585. A 35-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on 13Jul2021 (Lot Number: Fc9001) as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient previously received first dose of BNT162B2 on 13Jun2021 (lot# Fc8289) for COVID-19 immunization. The patient experienced varicose veins (hospitalization) on 17Jul2021. Varicose veins appeared on patient''s left leg. The outcome of event was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1524073 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-17
   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: Menstrual disorder, Menstruation delayed, 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
Allergies:
Diagnostic Lab Data: Test Name: pregnancy test; Test Result: Negative ; Test Date: 20210719; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100928895

Write-up: never late on my period/However, I am now 4 days late and no sign of coming on; Menstrual cycle abnormal; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107202247578830-JASKV, Safety Report Unique Identifier: GB-MHRA-ADR 25683691. A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 04Jul2021 (Lot number was not known) as dose 1, single 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 menstrual cycle abnormal on 17Jul2021. Clinical course reported: she was never late on her period. However, she was now 4 days late and no sign of coming on. The only reason she could think of was the Pfizer vaccine. She had a negative pregnancy test (unspecified date). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on 19Jul2021. The outcome of the events menstrual cycle abnormal was not recovered and for ''late period'' was unknown. Regulatory authority assessed the events as serious: medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


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