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From the 9/17/2021 release of VAERS data:

Found 711,579 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 334 out of 7,116

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VAERS ID: 1584839 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004672 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Oedema peripheral, Tongue oedema, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), 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? 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: ESMODERNATX, INC.MOD20212

Write-up: Edema tongue; Urticaria; This case was received via regulatory authority (Reference number: ES-AEMPS-963913) on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of TONGUE OEDEMA (Edema tongue), URTICARIA and OEDEMA PERIPHERAL in a 29-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004672) for COVID-19 vaccination. No Medical History information was reported. On 30-Jul-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced TONGUE OEDEMA (Edema tongue) (seriousness criterion medically significant), URTICARIA (seriousness criterion medically significant) and OEDEMA PERIPHERAL (seriousness criterion medically significant). On 30-Jul-2021, TONGUE OEDEMA (Edema tongue), URTICARIA and OEDEMA PERIPHERAL had resolved. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 30-Jul-2021. No concomitant medications provided by the reporter. No treatment medications provided by the reporter. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1584863 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 21C18-05 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, Body temperature, Dysphagia, Electrocardiogram, Guillain-Barre syndrome, Hypertension, Muscular weakness, Nervousness, Pyrexia, Scan, Sensory loss
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Demyelination (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (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: EVRA; IBUPROFEN
Current Illness: Blood pressure high
Preexisting Conditions: Medical History/Concurrent Conditions: Inflammatory bowel disease; Comments: medicated for crisis
Allergies:
Diagnostic Lab Data: Test Date: 20210812; Test Name: Body temperature; Result Unstructured Data: 37.8 C; Test Date: 20210812; Test Name: Blood pressure; Result Unstructured Data: 150/120 mmHg; Test Date: 20210812; Test Name: Scan; Result Unstructured Data: Normal; Comments: Normal; Test Date: 20210812; Test Name: Blood test; Result Unstructured Data: Normal; Comments: Normal; Test Date: 20210812; Test Name: Electrocardiogram; Result Unstructured Data: Normal; Comments: Normal
CDC Split Type: ESJNJFOC20210826832

Write-up: DIFFICULTY EATING AND SWALLOWING; WALK WORSE AND FEELS THAT HER LEGS ARE VERY WEAK; FEVER; HIGH BLOOD PRESSURE; GUILLAIN-BARRE SYNDROME; GENERAL LOSS OF SENSITIVITY; NERVOUS; This spontaneous report received from a patient concerned a 27 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included: inflammatory bowel syndrome, and concurrent conditions included: high blood pressure, and other pre-existing medical conditions included: medicated for crisis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C18-05, and batch number: 21C18-05 expiry: 30-SEP-2021) dose was not reported, administered on 28-JUL-2021 for prophylactic vaccination. Concomitant medications included ethinylestradiol/norelgestromin for contraceptive, and ibuprofen for walk worse and feeling of weakness in her legs, nervous, general loss of sensitivity, and difficulty eating and swallowing. On 30-JUL-2021, the patient experienced general loss of sensitivity. On 30-JUL-2021, the patient experienced nervous. On 11-AUG-2021, the patient experienced guillain-barre syndrome. On 11-AUG-2021, the patient experienced high blood pressure. On 11-AUG-2021, the patient experienced fever. On 12-AUG-2021, Laboratory data included: Blood pressure (NR: not provided) 150/120 mmHg, Blood test (NR: not provided) Normal, Body temperature (NR: not provided) 37.8 degrees celsius, Electrocardiogram (NR: not provided) Normal, and Scan (NR: not provided) Normal. On an unspecified date, the patient experienced difficulty eating and swallowing, and walk worse and feels that her legs are very weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from guillain-barre syndrome, general loss of sensitivity, high blood pressure, difficulty eating and swallowing, nervous, and walk worse and feels that her legs are very weak on AUG-2021, and fever on 12-AUG-2021. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:This spontaneous report received from a patient and concerns a 27 year old female who experienced Guillain-Barre syndrome 12 days post vaccination. The patient''s past medical history includes inflammatory bowel syndrome, and concurrent conditions included: high blood pressure, and other pre-existing medical conditions included: medicated for crisis. Concomitant medications included Ethinylestradiol/norelgestromin for contraceptive, and ibuprofen .The patient experienced general loss of sensitivity 2 days post vaccination. Guillain-Barre syndrome, high blood pressure and fever 12 days post vaccination. On an unspecified date, the patient had trouble swallowing, inability to walk and leg weakness .Laboratory data included: Blood pressure -150/120 mmHg, Blood test -Normal, Body temperature (NR: not provided) 37.8 degrees Celsius, Electrocardiogram -Normal, and Scan -Normal. At the time of the report the patient had recovered from all the events. The information available precludes a complete and meaningful assessment. Information to support the diagnosis and potential etiologies of GBS was insufficient. The occurrence of the events could represent background incidence of such events in the general population. Considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.


VAERS ID: 1585243 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-07-30
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dehydration, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hiatus hernia
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100992397

Write-up: Nauseated; Dehydrated; Persistent vomiting; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-EYC 00257568., Safety Report Unique Identifier GB-MHRA-ADR 25737839. A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), parenteral on 24Jul2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included hiatus hernia from an unspecified date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced persistent vomiting on 30Jul2021, nauseated and dehydrated on an unspecified date. Clinical course was as below: Seek Advice Details: Vomiting despite taking regular medication for nausea that I was prescribed for my hiatus hernia. Given new medication which has stopped me vomiting although still extremely nauseated. Told I am dehydrated. Therapeutic measures were taken as the result of vomiting. The outcome of event persistent vomiting was recovered on 01Aug2021, of nauseated and dehydrated was not recovered. Serious criteria for the case was reported as medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1585284 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Heart rate, Heart rate irregular, Inappropriate schedule of product administration, Palpitations, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LYMECYCLINE; MARVELON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acne
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: heartbeats; Result Unstructured Data: Test Result:irregular; Test Date: 20210715; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100992272

Write-up: Chest pain; Shortness of breath; Heart pounding; Heartbeats irregular; dose 1 on 04Jun2021/dose 2 on 30Jul2021; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202108010715493770-PR4NZ, Safety Report Unique Identifier GB-MHRA-ADR 25737800. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FD8813), dose 2 via an unspecified route of administration on 30Jul2021 (at the age of 25 years old) as dose 2, single for COVID-19 immunization. Medical history included acne. Patient has not had symptoms associated with COVID-19. Patient is not pregnant and is not currently breastfeeding. Concomitant medications included lymecycline taken for acne from 01Mar2021; desogestrel, ethinylestradiol (MARVELON) taken for contraception from 01Jul2018. The patient previously took the dose 1 of bnt162b2 (lot number: EW3143) on 04Jun2021 for COVID-19 immunisation. On 31Jul2021, the patient experienced chest pain, shortness of breath, heart pounding, and heartbeats irregular. The events were medically significant. The patient underwent other lab tests and procedures which included COVID-19 virus test was no - negative COVID-19 test on 15Jul2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the events chest pain, shortness of breath, heart pounding, and heartbeats irregular was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585288 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Diarrhoea, Gastrointestinal pain, Inappropriate schedule of product administration, Insomnia, Loss of personal independence in daily activities, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Obsessive-compulsive disorder (managed with mediation and therapy)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100984751

Write-up: unable to sit; muscle pain; difficulty sleeping; loose stools; GI pain; Chills; Diarrhea; Fever; Muscle ache; Inappropriate schedule of vaccine administered; 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-202108012310094750-SD9FD, Safety Report Unique Identifier is GB-MHRA-ADR 25738488. A 29-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) on 30Jul2021 (at the age 29 years old) as single dose for COVID-19 immunisation. Medical history included obsessive-compulsive disorder on an unknown date managed with mediation and therapy. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Concomitant medication included citalopram (CITALOPRAM) taken for an unspecified indication from 30Nov2018 to an unspecified stop date. The patient previously received the first dose of BNT162B2 on 04Jun2021 (lot number unknown) for COVID-19 immunisation. The patient experienced unable to sit, muscle pain, difficulty sleeping and loose stools all on an unspecified date; muscle ache on 30Jul2021, fever, chills and diarrhea all on 31Jul2021; GI pain on 01Aug2021. The patient received second dose of BNT162B2 on 30Jul2021 which was an inappropriate schedule of vaccine administered. The event was reported as serious (disabling). Clinical course was reported as follows: Muscle pain started the evening of vaccine administration. Fever and chills began the following day, 24hours after vaccine. This has continued for a further 24hours. Now experiencing GI pain, stabbing sensation with episodes loose stools throughout the day roughly 48hours following vaccination. Taking regular paracetamol to control fever. However, experiencing difficulty sleeping due to chills and pain waking me up overnight, not feeling rested. Unsure if I will be able to go to work tomorrow due to side effects, unable to sit and work for periods of time without requiring the toilet or to rest due to fever abs chills. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient was recovering from unable to sit, muscle pain, difficulty sleeping, loose stools while patient has not recovered from fever, GI pain, chills, diarrhea, muscle ache. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1585290 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cold sweat, Cough, Decreased appetite, Eye pain, Headache, Hyperhidrosis, Lymph node pain, Lymphadenopathy, Myalgia, Nausea, Poor quality sleep, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (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: ACICLOVIR; LYMECYCLINE
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 INC202100984780

Write-up: eating/ no appetite; eyes; Nausea; Headache; Sleep restless; Muscle ache; hot and cold sweats; Fever; Lymph node pain; Very swollen and painful lymph node; cough; cold sweats; 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-202108012329399360-EF5EQ, Safety Report Unique Identifier is GB-MHRA-ADR 25738497. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FE1510) via an unspecified route of administration on 30Jul2021 as single dose for COVID-19 immunisation. The patient''s medical history was not reported. Patient has not had symptoms associated with COVID-19. Concomitant medications included aciclovir (ACICLOVIR) taken for an unspecified indication, start and stop date were not reported; lymecycline (LYMECYCLINE) taken for an unspecified indication, start and stop date were not reported. The patient experienced eating/ no appetite on an unspecified date; fever, lymph node pain, very swollen lymph node, sleep restless and muscle ache, hot and cold sweats, cough, eyes all on 30Jul2021; nausea and headache both on 31Jul2021. The events were reported as serious (medically significant). Clinical course was reported as follows: very swollen and painful lymph node, random pain in muscles. Incredibly broken sleep first night following with a fever and hot and cold sweats, a cough, no appetite and nausea whenever eating, muscle aching to the point I could not move. Headache behind eyes. 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 result on an unspecified date. The patient was recovering from fever, nausea, headache, sleep restless and muscle ache while patient had not recovered from lymph node pain and very swollen and painful lymph node. The outcome of other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585300 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100992257

Write-up: sickness; Diarrhea; Vomited; Fatigue; 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-202108020937102600-G2RDJ, Safety Report Unique Identifier is GB-MHRA-ADR 25739729. A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Jul2021 as single dose for COVID-19 immunisation. Medical history included lactation decreased. 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 sickness on an unspecified date, fatigue on 30Jul2021, diarrhea and vomited on 01Aug2021. Case narrative: Fatigue from the day following. Then sickness and diarrhoea during which extreme fatigue. Diarrhoea continuing with fatigue although sickness stopped. She has not tested positive for COVID-19 since having the vaccine. The patient recovered from sickness on an unspecified date and from vomited on 01Aug2021; recovering from diarrhea; not recovered from fatigue. Case reported as medically significant by health authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1585304 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC202100992504

Write-up: COVID-19; COVID-19; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108021002057190-YLXCZ, Safety Report Unique Identifier GB-MHRA-ADR 25739801. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot er7934) via an unspecified route of administration 18Apr2021 as dose 2, single; BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot unknown), via an unspecified route of administration on unspecified date as dose 1, single;, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. It was unsure if patient has had symptoms associated with COVID-19. The patient experienced COVID-19 on 30Jul2021. The patient underwent laboratory test which included Sars-cov-2 test: positive on 30Jul2021. The outcome of event was not recovered. No follow-up attempts are possible. No further information is expected. Information on the lot number cannot be obtained.


VAERS ID: 1585321 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Diarrhoea, Dizziness, Fatigue, Malaise, Pain in extremity, Vaccination site pain
SMQs:, Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN [ACETYLSALICYLIC ACID]; PARACETAMOL; PROGESTERONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood progesterone low; Lactation decreased; Pain menstrual (severe menstrual pain)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100992301

Write-up: Fatigue; Malaise; Diarrhea; Dizzy; arm was very sore to touch and was sore even without touch; Shoulder soreness; site of injection was a bit sore; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108021135217260-SYOAO. Safety Report Unique Identifier: GB-MHRA-ADR 25741350 A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, in arm left, on 30Jul2021 16:00 (Lot number was not reported) at the age of 32 years old, as second dose, single for COVID-19 immunization. Medical history included lactation decreased, pain menstrual (severe menstrual pain) and low progesterone production. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not pregnant and not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Concomitant medications included acetylsalicylic acid (ASPIRIN) for pain menstrual; paracetamol for pain menstrual, and progesterone for hormone therapy. On 30Jul2021, the patient experienced shoulder soreness, site of injection was a bit sore. On 31Jul2021, the patient experienced dizzy and arm was very sore to touch and was sore even without touch. On 01Aug2021, the patient experienced diarrhea, fatigue, malaise. "I received my jab at 4pm. Within a few hours, the site of injection was a bit sore. The following day (31Jul2021), the arm was very sore to touch, and was sore even without touch. Paracetemol did not help the pain, but aspirin did. I am an athlete and was able to train normally. The following day (01Aug2021), I woke up fine, but about 2pm through the day became very dizzy. The feeling was if I''d stood up from a chair too quickly, but this feeling didn''t pass with rest, and continued throughout the following day (02Aug2021). I had to cancel all plans (including desk work and sports) due to malaise. I had to rest in bed." Therapeutic measure was taken as a result of the events site of injection was a bit sore and arm was very sore to touch and was sore even without touch which included paracetamol and aspirin. Outcome of the events diarrhea, dizzy, malaise was recovering. Outcome of the event fatigue was recovered on unspecified date in Aug2021; event shoulder soreness was recovered on 01Aug2021. Outcome of all the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1585340 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Malaise
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: FEXOFENADINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Asthmatic; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100992344

Write-up: Headache; Feeling sick; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108021259045020-AU44U. Safety Report Unique Identifier GB-MHRA-ADR 25740859. A 29-year-old female patient received second dose of BNT162B2(COVID-19 MRNA VACCINE BIONTECH, Solution for injection, lot number: Fd8813), via an unspecified route of administration on 30Jul2021 (At the age of 29-year-old) as single dose for COVID-19 immunisation. Medical history included lactation decreased, allergy, asthmatic. Patient had no symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant, Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. Concomitant medications included fexofenadine taken for allergy from May2020 to an unspecified stop date. The patient previously received BNT162B2 (lot number: Fd8813) on 21May2021 for COVID-19 immunisation and experienced swelling face, tingling lips. The patient experienced headache, feeling sick on 30Jul2021. The events were reported as medical significant. Patient had not tested positive for COVID-19 since having the vaccine. The outcome of event headache was not recovered, the outcome of event feeling sick was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585356 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse, Hypotension, Influenza like illness, Muscular weakness, Nausea, Syncope, Tinnitus, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hearing impairment (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (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: 20210730; Test Name: Blood pressure low; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC202100992258

Write-up: nausea; flu like symptoms; ringing in ears; vomiting; faint; collapsing on the floor; weak leg; Low blood pressure; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202108021417308770-0TXMP, Safety Report Unique Identifier GB-MHRA-ADR 25741422. A 32-year-old male patient (age at vaccination: 32-year-old) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot FF3319), via an unspecified route of administration on 30Jul2021 as dose 2, single for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test. The patient experienced low blood pressure on 30Jul2021. He also reported of faint and weak leg feeling, ringing in ears then collapsing on floor, vomiting, feeling nausea with flu like symptoms on unspecified date. The events were reported as serious medically significant. The outcome of low BP was recovered on 02Aug2021; for other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585364 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-25
Onset:2021-07-30
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Dyspnoea, SARS-CoV-2 test, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Lactation decreased.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100992490

Write-up: wheezing; shortness of breath; Asthma/asthma flared up worse; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Authority. Regulatory authority report number: GB-MHRA-WEBCOVID-202108021459062080-P4GQ6; Safety Report Unique Identifier: GB-MHRA-ADR 25741639. A 17-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 25Jul2021 (Batch/Lot Number: FD8813) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included Lactation decreased and asthma from an unknown date. Patient had 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 wheezing and shortness of breath on an unspecified date, asthma/asthma flared up worse on 30Jul2021. A few days after receiving second vaccine, patient stated asthma flared up worse then usual whilst routinely exercising which caused significant shortness of breath and wheezing. Following this, she went back onto a preventer inhaler, which she didn''t normally need during the summer. 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 an unspecified date. Therapeutic measures were taken as a result of wheezing, shortness of breath and asthma/asthma flared up worse included she went back onto a preventer inhaler. The outcome of the event asthma/asthma flared up worse was resolving and of the other events was unknown. The events were reported as serious due to medically significant. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1585367 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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 INC202100992013

Write-up: Shivers; Itching; Tiredness; Headache; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108021512089540-N2NNY. Safety Report Unique Identifier GB-MHRA-ADR 25741719. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 29Jul2021 as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not enrolled in clinical trial. On 30Jul2021, the patient experienced itching, tiredness, and headache. On 31Jul2021, the patient experienced shivers. The events were medically significant. Outcome of the itching was not recovered, of the tiredness was recovered on 01Aug2021, while of the remaining events was recovered on 31Jul2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1585394 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac flutter, Chest pain, Dyspnoea, Myocarditis, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100991944

Write-up: Chest pain; Breathing difficult; Myocarditis; Heart fluttering; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108021625286130-CJNHJ. Safety Report Unique Identifier-GB-MHRA-ADR 25742141. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jul2021 (Batch/Lot Number: FE1510) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. Patient is not enrolled in clinical trial. The patient experienced chest pain, breathing difficult, myocarditis and heart fluttering on 30Jul2021. The events were reported as serious (other medically important condition). Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1585400 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy, Lymphoedema, Mobility decreased, Pain, SARS-CoV-2 test
SMQs:, Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Haemodynamic oedema, effusions and fluid overload (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: IBUPROFEN; MICROGYNON [ETHINYLESTRADIOL;LEVONORGESTREL.]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Menstrual cramp.
Allergies:
Diagnostic Lab Data: Test Date: 20210709; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100992063

Write-up: Moderate to severe swelling of the axillary lymph node; causing pain and reduced mobility; causing pain and reduced mobility; Lymphedema; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108021718470240-WLXEZ, Safety Report Unique Identifier GB-MHRA-ADR 25742453. A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Jul2021 (Lot Number: FD8813), (at the age of 24 year old) as second dose, single for COVID-19 immunisation. Medical history included lactation decreased and menstrual cramp. Patient has not had symptoms associated with COVID-19. Patient is not pregnant and not currently breastfeeding. Concomitant medications included ibuprofen for menstrual cramp; and ethinylestradiol, levonorgestrel (MICROGYNON [ETHINYLESTRADIOL;LEVONORGESTREL]) for contraception. On 30Jul2021, the patient experienced lymphedema. The patient further reported moderate to severe swelling of the axillary lymph node (right armpit) causing pain and reduced mobility on 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 09Jul2021. Outcome of the event lymphedema was recovering. Outcome of all the other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585407 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Lymph node pain, Lymphadenopathy, Pain in extremity, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (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: LORATADINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic urticaria (due to histaminosis); Histaminosis; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100992452

Write-up: Mild face angioedema; inflammation of lymph node in the underarm area with pain; Swollen lymph nodes; Painful arm; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202108021832423220-VKNTP. Safety Report Unique Identifier GB-MHRA-ADR 25742839. A 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 30Jul2021 (Lot number was not reported) as single dose (at the age of 33-years-old) for COVID-19 immunisation. Medical history included Chronic urticaria due to histaminosis, Lactation decreased. Patient had not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Concomitant medication included loratadine taken for histamine intolerance, start and stop date were not reported. On 30Jul2021, the patient experienced Mild face angioedema starting 2 hours after the vaccine treated with 30mg of loratadine and getting better on day 3. The patient also experienced Inflammation of lymph node in the underarm area with pain, still on-going on day 3. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on an unspecified date. The outcome of Mild face angioedema and Painful arm was resolving. The outcome of other events was not resolved. All events were serious with medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1585413 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Insomnia, Nausea, Pruritus
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMITRIPTYLINE.
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Nerve compression.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100992050

Write-up: tiredness; itch/intense itch (upper body); prevented sleep; Itchy skin; Nausea; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108021931353820-8UVYP. [Safety Report Unique Identifier: GB-MHRA-ADR 25743217]. A 49-year-old male patient received first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection batch/lot number not known; expiration date not provided), via an unspecified route of administration on 30Jul2021 (at the age of 49-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. Patient''s medical history included nerve compression from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient has not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medication included amitriptyline from an unspecified date and unknown if ongoing for nerve compression. The patient experienced nausea on 30Jul2021; itchy skin on 31Jul2021; tiredness, ''itch/intense itch (upper body)'', ''prevented sleep'' on unspecified dates. Patient''s clinical course is as follows: It was reported that patient had intense itch (upper body), worsening, no control, and nothing seems to help. Additionally, patient had tiredness and nausea for about 2 days. It was further reported that the itch was uncontrollable and prevented all activities and sleep. The events were assessed as serious (medically significant and disability). Patient has not tested positive for COVID-19 since having the vaccine. Outcome of the event ''itchy skin'' was not recovered; outcome of the event nausea was recovering; outcome of the events ''itch/intense itch'', ''tiredness'', and ''prevented sleep'' was unknown. No follow-up attempts are possible, information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1585419 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

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

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

Write-up: Cold; Shivering; Chills; Fever; This case was received via RA (Reference number: 25743481) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of Cold, Shivering, Chills, and Fever in a 33-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. No Medical History information was reported. On 30-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced Chills (seriousness criterion medically significant) and Fever (seriousness criterion medically significant). On an unknown date, the patient experienced Cold (seriousness criterion medically significant) and Shivering (seriousness criterion medically significant). On 31-Jul-2021, Chills and Fever had resolved. At the time of the report, Cold and Shivering was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) was unknown. Concomitant product was not provided by the reporter. Patient reported that he experienced cold, shivering uncontrollably, after few hours flipped to fever. 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. 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: 1585420 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Pain, Rash papular, SARS-CoV-2 test, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100992341

Write-up: Facial swelling; Generalised raised red spots trunk; Pretty painful and spot like.; Dose 1 on 28May2021; dose 2 on 30Jul2021; This is a spontaneous report from a contactable consumer received from the regulatory authority, report number is GB-MHRA-WEBCOVID-202108022024174980-23MGY, Safety Report Unique Identifier GB-MHRA-ADR 25743547. A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 30Jul2021 (Lot Number: FF3380) at the age of 36-year-old as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient previously took first dose of BNT162B2 (lot# EW4109) via an unspecified route of administration received on 28May2021 for COVID-19 immunisation. The patient experienced facial swelling and generalised raised red spots trunk on 01Aug2021 with outcome of not recovered, pretty painful and spot like in Aug2021 with outcome of unknown. Clinical course: patient had hard lumps all over arms, legs and a few around the face and very close/inside lymph nodes. New lumps were appearing each day. He had pretty painful and spot like. Events were reported as serious (medically significant). The patient underwent lab tests and procedures which included covid-19 virus test: no - negative covid-19 test on 30Jul2021. Patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585435 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Burning sensation, Carpal tunnel syndrome, Decreased appetite, Dizziness, Fatigue, Headache, Insomnia, Lymphadenopathy, Malaise, Neck pain, Nightmare, Oropharyngeal pain, Pain in extremity, Peripheral swelling, Vision blurred
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ESCITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Joint pain; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100991959

Write-up: carpal tunnel syndrome; Appetite lost; Neck pain; burning sensation; Fatigue; Joint pain/Shoulder pain; dizzy/light headed; swelling under arm has caused a lot of pain; Feeling sick; Swelling arm; Sore throat; Swollen lymph nodes; Headache; Blurry vision; Sleep loss; Nightmares; This is a spontaneous report from a contactable consumer (patient) received from the Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108022227019490-TOR1S, Safety Report Unique Identifier: GB-MHRA-ADR 25744089. A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ff3319), via an unspecified route of administration, administered in arm on 30Jul2021 (at the age of 41 years old) as dose 2, single for COVID-19 immunisation. Medical history included joint pain, lactation decreased, and anxiety. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not pregnant and is not currently breastfeeding. Concomitant medication included escitalopram taken for anxiety. The patient experienced carpal tunnel syndrome on an unspecified date; dizzy/light headed, swelling under arm has caused a lot of pain, feeling sick, swelling arm, sore throat, swollen lymph nodes, headache, blurry vision, sleep loss, nightmares all on 30Jul2021; fatigue and joint pain/shoulder pain on 31Jul2021; appetite lost, neck pain, and burning sensation all on 01Aug2021. The events were medically significant. Outcome of the carpal tunnel syndrome and burning sensation was recovering, of the dizziness was unknown, and of the remaining events was not recovered. The clinical course was reported as follows: After having my second jab I started feeling sick then dizzy, light headed, a dull headache started, by the evening swelling had started to form under my arm (same arm I had the vaccine). I hardly slept the first night due to a lot of joint pain and the swelling has caused a lot of pain. I felt very sick and still do. By the second evening the swelling under my arm was really big, and very uncomfortable with a lot of pain, I have been having a lot of nightmares when I do sleep and having blurry vision. Neck pain has started with burning sensation. I do suffer with various pains but they have definitely become worse since having the vaccine on Friday. I do suffer with carpal tunnel syndrome and this has made the arm I had the injection a lot more painful. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1585436 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy, 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? 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: 20210729; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100991968

Write-up: Swollen glands; Generalised muscle aches; Fever; Pain injection site; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108022243269770-SHJYH, Safety Report Unique Identifier is GB-MHRA-ADR 25744085. A 34-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FF3319), via an unspecified route of administration, administered in the arm, on 30Jul2021 (at the age of 34 years old) as dose 2, single for COVID-19 immunization. Medical history was not reported, nothing relevant so far as patient was aware, unsure if they had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced swollen glands on 31Jul2021; generalised muscle aches, fever and pain injection site, all on 30Jul2021. The events were reported as serious per other medically important condition. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 29Jul2021. The clinical course was reported as follows: Fever came first, together with or slightly before pain at the injection site (which affected the entire arm on that side). Then fever within six hours of injection, followed by generalised muscles aches. Swollen glands may have started during the generalised aches phase, but it was the side effect which persisted. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the event swollen glands was not recovered. The outcome of the event fever was recovered on 31Jul2021, while outcome of the events generalised muscle aches and pain injection site was recovered on 01Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585453 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Lymph node pain
SMQs:, Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100998643

Write-up: Lymph node pain; Inappropriate schedule of vaccine administration; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202108030547484600-SCEDI, Safety Report Unique Identifier is GB-MHRA-ADR 25746173. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jul2021 (Lot number and expiry date not reported) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (lot number and expiry date not known), via an unspecified route of administration on an 16Jun2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient experienced lymph node pain on 02Aug2021 with outcome of recovering, and inappropriate schedule of vaccine administration on 30Jul2021. The event lymph node pain was reported as serious, medically significant by the health authority. Additional Information: Patient had not had symptoms associated with COVID-19. Patient had not had a COVID-19 test. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1585455 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Blood test, Blood test abnormal, Chest X-ray, Chest pain, Electrocardiogram, Myocarditis
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Pericarditis
Allergies:
Diagnostic Lab Data: Test Name: blood tests; Result Unstructured Data: Test Result:Normal; Comments: normal and pain stopped after a few hours.; Test Name: blood tests; Result Unstructured Data: Test Result:abnormal; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Normal; Comments: normal and pain stopped after a few hours.; Test Name: ECG; Result Unstructured Data: Test Result:unknown results
CDC Split Type: GBPFIZER INC202100992148

Write-up: heart pain; blood tests; myocarditis; Chest pain; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202108030613071750-NBLLI. Safety Report Unique Identifier GB-MHRA-ADR 25744651 A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Jul2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased and pericarditis, all from an unknown date and unknown if ongoing. Reported that patient was perfectly healthy with no health conditions. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced heart pain on an unspecified date with outcome of recovered on an unspecified date, blood tests (abnormal) on an unspecified date with outcome of recovered on an unspecified date, myocarditis on an unspecified date with outcome of recovered on an unspecified date, chest pain on 30Jul2021 with outcome of recovered on 30Jul2021. The patient underwent lab tests and procedures which included blood test: normal and abnormal, chest x-ray: normal, ECG with unknown results, on unspecified dates. Patient has not tested positive for COVID-19 since having the vaccine. The events were assessed as serious and medically significant by regulatory authority. The clinical course was reported as follows: Suffered heart pain which has previously never happened in my life. Took myself to A&E to be checked out. Had chest X-ray, blood tests and chest X-ray. Everything returned normal and pain stopped after a few hours. I assume it was myocarditis or pericarditis since I have since discovered these are rare side effects following second Pfizer jab. I was disappointed that staff at the hospital seemed not to be aware of this side effect. Relevant investigations or tests conducted: "ECG, Chest X-ray and blood test" No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1585482 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Influenza like illness, Lethargy, Lymphadenopathy, Musculoskeletal stiffness, Pain, SARS-CoV-2 test
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CETIRIZINE HYDROCHLORIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hay fever (good health experience seasonal hay fever, controlled by antihistamines); Lethargy; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20201128; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101005797

Write-up: Headaches are dull behind eyes and at back of head and into the top of my neck; Still some lethargy and aches; Stiff neck; Flu-like aching; Headache; Lethargy; Swollen glands; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. The Regulatory authority report number is (GB-MHRA-WEBCOVID-202108040934386810-KSIF1) and the Safety Report Unique Identifier is (GB-MHRA-ADR 25751961). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number FA3319), dose 2 via an unspecified route of administration on 29Jul2021 as DOSE 2, SINGLE for covid-19 immunization. Medical history included lethargy, hay fever and suspected COVID-19 from 28Nov2020. Concomitant medications included cetirizine hydrochloride taken for seasonal allergy from 01Apr2021 to an unspecified stop date. Patient was not enrolled in clinical trial. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on unspecified date for covid-19 immunization. On 30Jul2021, the patient experienced headache, lethargy, swollen glands and flu-like aching. On 03Aug2021, the patient experienced stiff neck. On unspecified date, the patient experienced headaches are dull behind eyes and at back of head and into the top of my neck and still some lethargy and aches. It was stated that swollen glands we in neck and under arm on side vaccine administered Friday to Monday, noticed an improvement on Tuesday. Headaches are dull behind eyes and at back of head and into the top of my neck- still present despite paracetamol being taken. Patient will continue to monitor as aware this may last a week. Still some lethargy and aches- they were most noticeable 30-31Jul. Patient working but feeling under the weather. Patient has not tested positive for covid-19 since having the vaccine. The events were serious (medically significant). The patient underwent lab tests and procedures which included covid-19 virus test positive on 28Nov2020. Details of any relevant investigations or tests conducted none. Treatment included paracetamol. Outcome of the event swollen glands was recovered on 03Aug2021. Outcome of the events lethargy and flu-like aching was recovering. Outcome of the event headache and stiff neck was not recovered. Outcome of the other events was unknown. No follow-up attempts are possible; No further information expected.


VAERS ID: 1585516 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ear swelling, Pain of skin
SMQs:, Angioedema (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Varicella-like rash (I had chicken pox as a kid)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101005820

Write-up: Scalp pain; Ear swelling; This is a spontaneous report from a contactable consumer from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108042220332420-2GYCM, Safety Report Unique Identifier GB-MHRA-ADR 25756882. A 32-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: FD8813, Expiry date: not reported), dose 2 via an unspecified route of administration on 29Jul2021 as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included varicella like rash (I had chicken pox as a kid). Patient had not had symptoms associated with COVID-19, not had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. On 30Jul2021, the patient experienced ear swelling and scalp pain on 31Jul2021. The patient was hospitalized for the events. Additional information as reported: My doctor had prescribed Ramsay Hunt syndrome and I was medicating against this. This had come as a result of the vaccine. I was being treated against Ramsay Hunt Syndrome with acyclovir and prednisolone, after two doctors signed this off. The outcome of events was reported as not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1585553 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Illness, Pain, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

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

Write-up: pain; Sickness; Diarrhea; Rash; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (pain), ILLNESS (Sickness), DIARRHEA (Diarrhea) and RASH (Rash) in a 27-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant). On 04-Aug-2021, the patient experienced ILLNESS (Sickness) (seriousness criterion medically significant) and DIARRHEA (Diarrhea) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (pain) (seriousness criterion medically significant). At the time of the report, PAIN (pain), ILLNESS (Sickness) and DIARRHEA (Diarrhea) was resolving and RASH (Rash) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. Treatment information was not provided. It was reported that adverse events experienced was not linked to any food or stomach bug. Rash with intense pain on first day. On day 5 I had severe sickness lasting 6 hours and bad stomach lasting 12 hours. Not linked to any food or stomach bug. Rash appeared larger on day 6 and then tripled in size ongoing from here. Currently a week and 2 days after vaccine and rash is large and still a lump. No signs of rash reducing." 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: 1585563 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Pyrexia, SARS-CoV-2 test, Throat irritation
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), COVID-19 (broad)

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

Write-up: Itchy throat; Fever; Frontal headache; This case was received via RA (Reference number: 25772863) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Itchy throat), PYREXIA (Fever) and HEADACHE (Frontal headache) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 30-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced THROAT IRRITATION (Itchy throat) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and HEADACHE (Frontal headache) (seriousness criterion medically significant). On 01-Aug-2021, PYREXIA (Fever) and HEADACHE (Frontal headache) had resolved. On 03-Aug-2021, THROAT IRRITATION (Itchy throat) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The concomitant medications were not provided. The Treatment information was not provided. 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. Very limited information regarding these events has been provided at this time. No further information is expected 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 events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time.


VAERS ID: 1585573 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Pain; Fever; Chills; This case was received via on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Pain), PYREXIA (Fever) and CHILLS (Chills) in a 33-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 30-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced PAIN (Pain) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). The patient was treated with PARACETAMOL at a dose of xUNK, qh,''Two paracetamol every few hours. On 02-Aug-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. On 05-Aug-2021, PAIN (Pain) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient was not enrolled in clinical trial. No concomitant medication details was provided. Treatment medication included two paracetamol every few hours (or as instructed on the box) were enough to help reduce the side effects a little. 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. Very limited information regarding these events has been provided at this time. No further information is expected 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 events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time.


VAERS ID: 1585619 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, SARS-CoV-2 test, Vaccination site pain
SMQs:, 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 Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100992043

Write-up: Tiredness; Pain injection site; This is a solicited report from the RA Regulatory Vaccine Monitor program from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-YCVM-202108021917217270-9P8YV, Safety Report Unique Identifier GB-MHRA-ADR 25743109. A 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jul2021 (at the age of 27 year old) (Lot Number: ff3319) as single dose for COVID-19 vaccination. The patient medical history was not reported. Patient last period date is 05Jul2021. Patient had no symptoms associated with COVID-19. Patient was not pregnant, Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced pain injection site on 30Jul2021, tiredness on 31Jul2021. Events were reported as medical significant. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on an unspecified date. Patient was not enrolled in clinical trial. The outcome of events was recovered on 01Aug2021. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on temporal association and profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the events vaccination site pain and fatique cannot be completely excluded.The case will be reassessed if additional information becomes available.


VAERS ID: 1585633 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101006447

Write-up: Dosage text: Dose 1, Date of start of drug: 28May2021 / Dosage text: Dose 2, Date of start of drug: 30Jul2021; 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-202108032114145030-FPDFY, Safety Report Unique Identifier GB-MHRA-ADR 25750188. A female patient of an unspecified age received second dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number and Expiration date was not reported) via an unspecified route of administration on 30Jul2021 as DOSE 2, SINGLE for covid-19 immunization. Patient had historical vaccine of first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number and Expiration date was unknown), via an unspecified route of administration on 28May2021 as DOSE 1, SINGLE for COVID-19 immunization and experienced sinus headache, sinusitis non infective. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient medical history was not reported. The patient''s concomitant medications were not reported. On an 30Jul2021 the patient received dose 2, 63 days after the first dose. No follow-up attempts are possible, information about lot/batch number cannot be obtained. Linked Report(s): GB-PFIZER INC-202100998316 Dose 1.


VAERS ID: 1586093 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004669 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cold sweat, Depressed level of consciousness, Fatigue, Hypotension, Presyncope
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

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

Write-up: This case was received via Regulatory Authority(Reference number: 765600) on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEPRESSED LEVEL OF CONSCIOUSNESS in a 29-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004669) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. On 30-Jul-2021, the patient experienced DEPRESSED LEVEL OF CONSCIOUSNESS (seriousness criterion medically significant), COLD SWEAT , PRESYNCOPE , HYPOTENSION and FATIGUE. At the time of the report, DEPRESSED LEVEL OF CONSCIOUSNESS , COLD SWEAT , PRESYNCOPE , HYPOTENSION and FATIGUE was resolving. Concomitant medication was not provided. 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. The translation of the source document has been requested.; Reporter''s Comments: dose moderna: 30/07/2021-15.17-moderna-3004669(12/01/2022)-spalla sx; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The translation of the source document has been requested.


VAERS ID: 1586094 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004499 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hyperhidrosis, Laryngospasm
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Dystonia (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

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

Write-up: This case was received via Agency (Reference number: 765636) on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LARYNGOSPASM and HYPERHIDROSIS in a 55-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004499) for COVID-19 vaccination. No Medical History information was reported. On 30-Jul-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter in total. On 30-Jul-2021, the patient experienced LARYNGOSPASM (seriousness criterion medically significant) and HYPERHIDROSIS (seriousness criterion medically significant). At the time of the report, LARYNGOSPASM and HYPERHIDROSIS was resolving. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Company''s comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter''s Comments: Treatment - Oui; 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: 1586142 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure increased, Blood pressure measurement, Body temperature, Cardiac failure acute, Chest X-ray, Heart rate, Hypoxia, Oxygen saturation, Pulmonary congestion, Respiratory failure, Slow speech
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: blood pressure; Result Unstructured Data: Test Result:149/65 mmHg; Test Date: 20210730; Test Name: body temperature; Result Unstructured Data: Test Result:Unknown results Centigrade; Test Date: 20210730; Test Name: simple photo of the chest; Result Unstructured Data: Test Result:cardiac expansion and pulmonary congestion; Test Date: 20210730; Test Name: heart rate; Result Unstructured Data: Test Result:105; Test Date: 20210730; Test Name: SpO2; Test Result: 84 %; Test Date: 20210730; Test Name: SpO2; Test Result: 80 %; Test Date: 20210730; Test Name: SpO2; Result Unstructured Data: Test Result:under 90 %
CDC Split Type: JPPFIZER INC202100987027

Write-up: Cardiac failure acute; poor response (slow speech); 149/65mmHg; respiratory failure; anaphylaxis; Pulmonary congestion; Hypoxaemia; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21122087. A 73-year-old (also reported as 73-year and 4-month-old) male patient received BNT162B2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 30Jul2021 at 16:22 (Batch/Lot number was not reported) (at the age of 73-years-old) as dose 1, single for COVID-19 immunisation. Medical history included hypertension. The patient''s concomitant medications were not reported. Body temperature before vaccination was unknown. Information on the patient''s family history was unknown. On 30Jul2021 at 16:40 (18 minutes after the vaccination), the patient experienced cardiac failure acute. On 30Jul2021 (the same day of the vaccination), the patient was admitted to the hospital. On 02Aug2021 (3 days after the vaccination), the outcome of the event was recovering. The course of the event was as follows: On 30Jul2021 at 16:22, the patient received COVID-19 vaccination. During 15-minute course observation, no problem occurred. But after leaving the clinic, on the way home, poor response (slow speech) developed, and the patient was back to the clinic. SpO2 decreased to 80%, nasal oxygen 2L was administered, but SpO2 was still under 90%. So, ambulance was called. During transportation, blood pressure 149/65 mmHg, heart rate 105, SpO2 84%. No apparent skin eruption. Due to respiratory failure, anaphylaxis cannot be denied. Adrenaline 0.3mg was injected via intramuscular immediately. Oxygen was added to Reservoir mask 6L. Solu-Medrol 125mg intravenous injection was administered. Oxygenation was improved, so scanning was conducted. From the simple photo of the chest, images of cardiac expansion and pulmonary congestion could be seen. Cardiac failure acute was considered, and the patient was transported to hospital on the same day. Diuretic was administered and the symptoms were on improvement tendency. The reporting physician classified the event as serious (hospitalization from 30Jul2021) and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases. The outcome of the events was recovering. The reporting physician commented as follows: When the patient came to the hospital, blood pressure remained, no shock. Although the patient was visiting other hospitals due to hypertension, the patient did not have treatment history due to cardiac failure. After vaccination, the condition worsened suddenly, so the cause of cardiac failure acute had to be considered as vaccine. Pulmonary congestion caused by cardiac failure acute was considered to be the reason of hypoxaemia. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reporter''s Comments: When the patient came to the hospital, blood pressure remained, no shock. Although the patient was visiting other hospitals due to hypertension, the patient did not have treatment history due to cardiac failure. After vaccination, the condition worsened suddenly, so the cause of cardiac failure acute had to be considered as vaccine. Pulmonary congestion caused by cardiac failure acute was considered to be the reason of hypoxaemia.


VAERS ID: 1586149 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Muscle spasms, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Dystonia (broad), 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: Fahr''s disease; Rehabilitation therapy; Symptomatic epilepsy (Anti-epilepsy drugs were taken orally)
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100987522

Write-up: tetanic spasm in his four limbs; Convulsion; This is a spontaneous report from a contactable physician received from the Agency . Regulatory authority report number is v21122117. A 45-year-old female patient received bnt162b2 (COMIRNATY; Batch/Lot Number: EY5423; Expiration Date: 31Aug2021), via an unspecified route of administration, on 30Jul2021 at 14:20 (at the age of 45 years old) as dose 2, single for COVID-19 Immunization. Medical history included symptomatic epilepsy due to congenital basal ganglia calcification wherein the patient was undergoing rehabilitation and took oral anti-epilepsy drugs. Body temperature before vaccination was 36.8 degrees Centigrade. The patient''s concomitant medications were not reported. On 30Jul2021 at 16:40 (2 hours 20 minutes after the vaccination), the patient experienced convulsion. On 30Jul2021 (the same day of the vaccination), the outcome of the event was recovered. The course of the event was as follows: Anti-epilepsy drugs were taken orally for symptomatic epilepsy due to congenital basal ganglia calcification. The patient was hospitalized in our hospital for rehabilitation of congenital basal ganglia calcification. After vaccination on 30Jul2021 at 16:20, the patient experienced tetanic spasm in his four limbs at 16:40 and within a few minutes the convulsion naturally stopped. After that, the convulsion passed without recurrence. The outcome of the events was recovered on 30Jul2021. The reporting physician classified the event as serious (medically significant) and the causality between the event and bnt162b2 as unassessable. Other possible cause of the event such as any other diseases was symptomatic epilepsy.


VAERS ID: 1586184 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0572 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Erythema, Face oedema, Rash
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Dermatitis; Eczema
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: BT; Result Unstructured Data: Test Result: 37.0.
CDC Split Type: JPPFIZER INC202100994434

Write-up: redness all over the body; Face oedema; rash on the body/rash all over the body; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. The Regulatory authority report number is v21122184. A 64-year and 4-month-old male patient received BNT162B2 (COMIRNATY; lot number: EY0572, expiration date: 31Oct2021), via an unspecified route of administration on 29Jul2021 at the age of 64-year and 4-month-old, dose 2, single for COVID-19 immunisation. Medical history included asthma, dermatitis, eczema. The patient''s concomitant medications were not reported. Historical vaccine included BNT162B2 (COMIRNATY; lot number: EW0203 and expiration date: 30Sep2021) administered via an unspecified route of administration on an unspecified date, dose 1, single for COVID-19 immunisation. The clinical course of the event was as follows On 30Jul2021, there was a rash on the body as well as face oedema. On 02Aug2021, the patient visited hospital, had rash and redness all over the body. The patient''s body temperature was 37.0 and the general condition was good. The patient received stronger Neo-Minophagen intravenous drip and Bilanoa was prescribed. The outcome of the events was recovering. The reporting physician classified the event as non-serious and assessed that the event was related to BNT162B2. The reporting physician commented as follows:Considered that it was adverse reaction of Comirnaty. Mild-moderate disease. No follow-up attempts are possible, No further information is expected.


VAERS ID: 1586187 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure increased, Blood pressure measurement, Cough, Dyspnoea, Oxygen saturation, Throat irritation
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), 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: Medical History/Concurrent Conditions: Drug allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: blood pressure; Result Unstructured Data: Test Result:126/72; Comments: Immediately after vaccination; Test Date: 20210730; Test Name: blood pressure; Result Unstructured Data: Test Result:198/90; Comments: Immediately after intramuscular Bosmin injection (within 1 minute); Test Date: 20210730; Test Name: SPO2; Result Unstructured Data: Test Result:93-95 %; Test Date: 20210730; Test Name: SPO2; Test Result: 97 %; Comments: At 15:28
CDC Split Type: JPPFIZER INC202100994488

Write-up: Anaphylaxis; throat irritation; slight dyspnoea; blood pressure 198/90; Mild cough; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21122292. A 67-year-old female (age at vaccination) patient received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot Number: EW0201; Expiration Date: 30Sep2021), via an unspecified route of administration, on 30Jul2021 14:35 (the day of vaccination), as Dose 1 single, for COVID-19 immunisation. Medical history included allergies to other medicines from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 30Jul2021 at 14:45 (10 minutes after the vaccination), the patient experienced anaphylaxis. The course of the event was as follows: Immediately after vaccination, blood pressure was 126/72. On 30Jul2021 at 14:45, the patient complained of throat irritation and slight dyspnoea. Oxygen saturation (SPO2) 93-95%. On the same day, suspected anaphylaxis with unmeasured blood pressure and Bosmin 0.3 ml intramuscular injection was given. Immediately after intramuscular injection (within 1 minute), blood pressure was 198/90, on 30Jul2021. The patient had clear consciousness, no wheezing, no cutaneous symptom, and no gastrointestinal symptom. On the same day, the patient had mild cough and was started to receive fluid replacement with normal saline and oxygen at 3 L/min. Then, subjective symptom was disappeared. At 15:28, After oxygen administration finished, SPO2 recovered with 97%. After that, until 17:20, it ended without exacerbation of symptoms. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. On 31Jul2021 (1 day after the vaccination), the outcome of the event was recovered. The reporting physician commented as follows: The patient had no delayed symptom, and the patient''s condition improved with the treatment for acute phase reactions. As the patient had a past history of allergies to other medicines, and the mucosal and respiratory symptoms developed, the patient was judged to have anaphylaxis. It remained doubtful whether blood pressure increased symptoms was a reaction to Bosmin administration or not. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1586271 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-07-30
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004669 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blister, Burns second degree, Erythema, Skin reaction
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Accidents and injuries (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: This case was received via Agency (Reference number: 766473) on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of BURNS SECOND DEGREE, BLISTER, SKIN REACTION and ERYTHEMA in a 51-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004669) for Vaccination. Concomitant products included HYDROCHLOROTHIAZIDE, NEBIVOLOL HYDROCHLORIDE for Hypertension. On 27-Jul-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced BURNS SECOND DEGREE (seriousness criterion hospitalization), BLISTER (seriousness criterion hospitalization), SKIN REACTION (seriousness criterion hospitalization) and ERYTHEMA (seriousness criterion hospitalization). At the time of the report, BURNS SECOND DEGREE, BLISTER, SKIN REACTION and ERYTHEMA had not resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No relevant medical history was reported. No treatment information was provided by the reporter. Company comment: Very limited information regarding this event has been provided at this time. Further information will not be requested. Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Significant Follow up including vaccination details and new events.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information will not be requested.


VAERS ID: 1588678 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-15
Onset:2021-07-30
   Days after vaccination:165
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: DEPFIZER INC202101003371

Write-up: Patient: PRIVACY.: 1st Comirnaty vaccination 21Jan2021 (EJ6795)/myocarditis; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority, regulatory authority number DE-PEI-202100155238. An 82-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 15Feb2021 (Batch/Lot Number: EJ6788) as dose 2, single for covid-19 immunisation. The patient''s medical and concomitant medications were not reported. The patient received the first dose of COMIRNATY (batch/lot: EJ6795) on 21Jan2021 for Covid-19 immunisation. The patient experienced "patient: privacy.: 1st comirnaty vaccination 21jan2021 (ej6795) (as reported, pending clarification)/myocarditis" on 30Jul2021. It was reported that the event caused hospitalization. The outcome of the event was not recovered. Sender''s comments: Exclusion of viral causes Relatedness of drug to reactions/events Source of assessment: Result of Assessment: D. Unclassifiable No follow-up attempts are possible; information about batch number already obtained.


VAERS ID: 1588951 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-07-30
   Days after vaccination:51
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4632 / 2 - / 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? 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: 20210730; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Positive
CDC Split Type: ESPFIZER INC202101010240

Write-up: COVID-19; PCR + on 30Jul2021 due to close contact; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number ES-AEMPS-963237. A 55-years-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number FA4632), unknown on 09Jun2021 as DOSE 2, SINGLE for covid-19 immunization. Previously the patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number FA4598), unknown on 19May2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 30Jul2021, the patient was diagnosed for covid-19. The patient informed that this happened because patient was in close contact with an infected person who she lives with. The patient had lab test for covid-19 via PCR and results were positive for covid-19 infection. The outcome of the event was reported as recovering. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1589153 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness
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: AMITRIPTYLINE HYDROCHLORIDE; CITALOPRAM; CLENIL MODULITE; DESUNIN; LACTULOSE; LEVOTHYROXINE; LYMECYCLINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depressed mood; Ill-defined disorder; White blood cell count abnormal
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101012862

Write-up: Severe dizziness; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Agency (RA). Regulatory authority report number: GB-MHRA-TPP24910888C7514742YC1627654924743, Safety Report Unique Identifier: GB-MHRA-ADR 25757776. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 30Jul2021 (at the age of 40-year-old) as dose number unknown, single for COVID-19 immunisation. Medical history included depressed mood from an unknown date and unknown if ongoing, white blood cell count abnormal from an unknown date and unknown if ongoing and Ill-defined disorder. Concomitant medications included amitriptyline hydrochloride was taken for ill-defined disorder from 08Mar2021 to an unspecified stop date; citalopram was taken for ill-defined disorder from 05Oct2020 to an unspecified stop date; beclometasone dipropionate (CLENIL MODULITE) was taken for ill-defined disorder from 09Jun2021 to 29Jul2021; colecalciferol (DESUNIN) was taken for ill-defined disorder from 17Aug2020 to an unspecified stop date; lactulose was taken for ill-defined disorder from 05Oct2020 to an unspecified stop date; levothyroxine was taken for ill-defined disorder from 24Nov2020 to an unspecified stop date and lymecycline was taken for ill-defined disorder from 24Nov2020 to an unspecified stop date. On 30Jul2021, the patient experienced severe dizziness. The outcome of the event was unknown. Reporter''s comments: Severe dizziness No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Severe dizziness


VAERS ID: 1589179 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymph node pain, Lymphadenopathy, Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (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: CITALOPRAM; HYDROXOCOBALAMIN; RIGEVIDON [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: B12 deficiency anemia; Contraception; Depression
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101005753

Write-up: pain; Swelling; Lymphadenopathy; Lymph node pain; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number (GB-MHRA-WEBCOVID-202108031020059400-UD1RM), Safety Report Unique Identifier (GB-MHRA-ADR 25745740). A 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot Number: FD8813) via an unspecified route of administration at single dose on 28Jul2021 for COVID-19 immunization. Medical history included contraception, depression, anaemia vitamin b12 deficiency. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medication(s) included citalopram taken for depression; hydroxocobalamin taken for anaemia vitamin b12 deficiency; ethinylestradiol/levonorgestrel (RIGEVIDON) taken for contraception. The patient experienced lymph node pain (medically significant) on 30Jul2021 with outcome of not recovered, lymphadenopathy (medically significant) on 31Jul2021 with outcome of not recovered, pain (medically significant) on an unspecified date with outcome of unknown, swelling (medically significant) on an unspecified date with outcome of unknown. Patient has not tested positive for COVID-19 since having the vaccine. The clinical course was reported as follows: Lymphadenopathy. Sharp pain and swelling of lymph node on collarbone identified 36 hours after vaccination. Appointment made with general practitioner on 2/8/21 for a check-up and confirmed to most likely be a reaction to the second vaccination. Swelling occurred on the same side that the injection was given. Told to monitor for 4-5 weeks and if no improvement, return to general practitioner. No follow-up attempts are possible. No further information is expected


VAERS ID: 1589183 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Fatigue, Headache, SARS-CoV-2 test, Vaccination site pain, Vaccination site swelling
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: ESCITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Social anxiety disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No-Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100998380

Write-up: Headache; Injection site pain; arm started hurting the day after the injection and has since swollen; armpit is also very sore; Exhaustion/ feeling tired; 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-202108031031534210-IV9BP, Safety report unique identifier is GB-MHRA-ADR 25745799. A 31-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the arm on 30Jul2021 at the age of 31 years old (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included lactation decreased from an unknown date and social anxiety disorder both from an unknown date. Concomitant medication included escitalopram (ESCITALOPRAM) taken for social anxiety disorder, start and stop date were not reported. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. The patient experienced tired on 30Jul2021; headache, exhaustion and injection site pain all on 31Jul2021. The events were reported as serious (medically significant). Clinical course was reported as follows: I started feeling tired a few hours after the vaccination. The following day I had a terrible headache and was too exhausted to get out of bed. My arm started hurting the day after the injection and has since swollen. My armpit is also very sore. My headache has still not gone away and I''m too tired to do anything yet. 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 negative result on 01Aug2021. The patient was recovering from headache while patient has not recovered from the other events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1589206 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210520; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100998647

Write-up: cramps; bleeding; fatigue; Vaginal bleeding; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202108031232314110-8XGHA, Safety Report Unique Identifier is GB-MHRA-ADR 25746504. A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jul2021 (Lot Number: FF3319, Expiry date not reported) as dose 2, single for COVID-19 immunization. Medical history included suppressed lactation, and suspected COVID-19 from 09May2021 (Unsure when symptoms stopped). Patient was not pregnant. Patient was not currently breastfeeding. Concomitant medications were not reported. Historical vaccine included BNT162B2 (lot number and expiry date not known), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient experienced fatigue on an unspecified date with outcome of not recovered, cramps on an unspecified date with outcome of not recovered, bleeding on an unspecified date with outcome of not recovered, and vaginal bleeding on 30Jul2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: yes - positive COVID-19 test on 20May2021. The events were reported as serious, medically significant by the health authority. Additional information: Increasingly heavy vaginal bleeding starting on Day 12 of menstrual cycle. Periods usually regular (exactly 28 days). No breast tenderness or swelling suggesting this bleeding is not an early period. Mild cramps also accompanying bleeding. Bleeding started off thick, dark brown with heavy clots, now continuing with thinner, red blood. Bleeding has not yet stopped. Extreme fatigue also reported, making it hard to perform daily tasks. 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. No further information is expected.


VAERS ID: 1589219 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-07-30
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Anembryonic gestation, SARS-CoV-2 test, Scan
SMQs:, Termination of pregnancy and risk of abortion (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: FOLIC ACID
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; Test Name: scan; Result Unstructured Data: Test Result:blighted ovum
CDC Split Type: GBPFIZER INC202100998466

Write-up: blighted ovum; Miscarriage of pregnancy; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number (GB-MHRA-WEBCOVID-202108031351093360-EUYYR), Safety Report Unique Identifier (GB-MHRA-ADR 25746988). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot Number: EW3143), via an unspecified route of administration at dose 1, single on 01Jun2021 for COVID-19 immunization. Medical history included suppressed lactation. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Concomitant medication included folic acid taken for vitamin supplementation, start and stop date were not reported. The patient experienced miscarriage of pregnancy on 30Jul2021 with outcome of recovering. Patient was exposed to the medicine during first trimester (1-12 weeks). Details of scans or investigations revealed blighted ovum (outcome was unknown). The patient underwent lab tests and procedures which included Negative COVID-19 test. Patient was no longer pregnant at the time of reporting. 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: 1589275 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-07-30
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest X-ray, Dyspnoea, Electrocardiogram, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: bloods taken; Result Unstructured Data: Test Result:unknown result; Test Name: chest X-ray; Result Unstructured Data: Test Result:unknown result; Test Name: ECG; Result Unstructured Data: Test Result:unknown result; Test Date: 20210801; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100998307

Write-up: Breath shortness; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108032041224930-2BV08 and Safety Report Unique Identifier GB-MHRA-ADR 25749941. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Jul2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included lactation decreased from an unknown date and unknown if ongoing and suspected covid-19 from 30Jul2021 to 01Aug2021. Patient is not pregnant at time of vaccination. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced breath shortness on 30Jul2021. Constantly trying to catch by breath, difficult to get a yawn out. The event was reported as medically significant. The patient underwent lab tests and procedures which included covid-19 virus test: negative on 01Aug2021, ECG, chest X-ray, and bloods taken on unknown date with unknown result. 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 lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1589292 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Feeling cold, Headache, Pyrexia, Restlessness, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OMEPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acid indigestion; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210108; Test Name: COVID-19 virus test (Lateral flow test); Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100998608

Write-up: Fatigue; Feeling cold; Shivers/Shivering; Feverish; Restless; Headache; Aching joints; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108032226074080-IILZA. Safety Report Unique Identifier GB-MHRA-ADR 25750389. A 48-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 30Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included suspected COVID-19 (Unsure when symptoms stopped) and acid indigestion. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Concomitant medications included omeprazole taken for acid indigestion from 17Feb2021 to an unspecified stop date. It was reported that after going to bed on Friday evening (30Jul2021), the patient woke-up feeling cold and shivering, although he was hot to the touch (Feverish), he had a restless night that evening. The patient also experienced headache and aching joints on 30Jul2021. It was reported that on 31Jul2021, the patient continued to feel fatigued. The events were assessed as serious (medically significant). Lab data includes COVID-19 virus test (Lateral flow test): No - Negative COVID-19 test on 08Jan2021. The outcome of the events restless, headache, fatigue was not recovered; events shivers, feverish, aching joints was recovered on 01Aug2021; event feeling cold was recovering. No follow-up attempts are possible, information about the batch number cannot be obtained.


VAERS ID: 1589295 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Heavy menstrual bleeding, Peripheral swelling, Pruritus, Vaccination site pain, Vaccination site swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
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: Dizziness; Irritable bowel syndrome; Skin rash.
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100998210

Write-up: fatigue; Medium sized painful swelling around the injection site; Swelling was decreasing after 5 days but still hard and tender to touch; Heavy periods; Swollen arm; Itchy skin; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108032306102480-QLTXO, Safety Report Unique Identifier GB-MHRA-ADR 25750414. A 30-year-old female non pregnant patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry date: not reported) via an unspecified route of administration on 29Jul2021 as single dose for COVID-19 immunisation. Medical history included suppressed lactation, dizziness. The patient previously took histamine. Currently suffering from believed at histamine intolerance low level allergy reactions (ibs, skin rashes, dizziness). Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. On an unspecified date, the patient experienced fatigue, swelling. On 30Jul2021, the patient experienced swollen arm and itchy skin. On 31Jul2021, the patient experienced heavy periods. Additional information as reported: Medium sized painful swelling around the injection site accompanied by fatigue and a temperature for a few days. Swelling was decreasing after 5 days but still hard and tender to touch. The events were reported as medically significant. The outcome of the event heavy periods was unknown. The outcome of the event itchy skin was not recovered. The outcome of other events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1589307 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Discomfort, Fatigue, Lymph node pain, Lymphadenopathy, Myalgia, Pyrexia, SARS-CoV-2 test, Tremor, Urine output, Urine output decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: temperature; Result Unstructured Data: Test Result:fever of up to 38 Centigrade; Comments: about 12-14 hours; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 20210731; Test Name: urine output; Result Unstructured Data: Test Result:decreased
CDC Split Type: GBPFIZER INC202100998517

Write-up: tiredness; discomfort; Fever/fever of up to 38 degrees Celsius; Shaking/whole-body shaking; Swollen lymph nodes/swelling of the lymph nodes in the armpit developed; Lymph node pain/lymph nodes are painful to the touch of pressure and are causing a lot of discomfort; Urine output decreased; Muscle soreness/Muscle pain; This is a spontaneous report from a contactable consumer (patient). This is the first of two reports. The first report is a report downloaded from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108040246493430-LFXFF, Safety Report Unique Identifier: GB-MHRA-ADR 25750508. A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 30Jul2021 (Lot Number: FE3380) as dose 2, single for COVID-19 immunisation. The patient''s medical history was not reported. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Lot Number: not known) as dose 1, single for COVID-19 immunisation and experienced tiredness and soreness in the shoulder. The patient experienced urine output decreased (approximately 20 hours after the vaccine administration - 31Jul2021); tiredness, discomfort on an unspecified date; muscle soreness on 30Jul2021; and fever, shaking, swollen lymph nodes, lymph node pain, and muscle pain on 31Jul2021. Clinical course reported: the first vaccine dose caused only mild common side effects such as tiredness and soreness in the shoulder. The second dose caused much more pronounced side effects. The vaccine was administered at around noon. He was about 12-14 hours (Jul2021), a fever of up to 38 degrees Celsius developed together with whole-body shaking. The latter lasted for 3-4 hours. Fever persisted for another couple of days. Two doses of paracetamol 500 mg were taken to manage fever. Approximately 20 hours after the vaccine administration (31Jul2021), a significant swelling of the lymph nodes in the armpit developed. The lymph nodes were painful to the touch of pressure and were causing a lot of discomfort. As of now, 5 days after the vaccination, the lymph nodes remained swollen and painful, although there was a mild relief of the symptoms. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on an unspecified date. The outcome of the events urine output decreased, tiredness, discomfort was recovered on an unspecified date; shaking was recovered on 31Jul2021; fever and muscle soreness/muscle pain was recovered on 01Aug2021; swollen lymph nodes and lymph node pain was recovering. Regulatory authority assessed the events as serious: medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589319 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-07-30
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Feeling abnormal, Herpes zoster, Lethargy, SARS-CoV-2 test
SMQs:, Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (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:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100998234

Write-up: shingles across her right-hand side shoulder blade; I was tired; lethargic; Hours/felt abnormal for about 4 weeks; This is a spontaneous report from a contactable consumer or other non-health care professional received from the Regulatory authority report number GB-MHRA-WEBCOVID-202108040748187070-YYKAB, Safety Report Unique Identifier GB-MHRA-ADR 25751173. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Jun2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. After having the vaccine, on an unspecified date the patient was tired and lethargic for about 48 hours. Following this she felt hours/ felt abnormal for about 4 weeks and then on 30Jul2021, patient developed shingles across her right-hand side shoulder blade. Events were considered as medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test results no negative for covid-19 test on unspecified date. Relevant investigations or tests conducted for Suspect Reactions as Doctor diagnosed. outcome of shingles was recovering, and hours/ felt abnormal, tired and lethargic was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1589320 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-30
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Diarrhoea, Muscle spasms, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Dystonia (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 Date: 20210723; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101006092

Write-up: spasms; cramps; abdominal pain; Diarrhea; Abdominal cramp; This is a spontaneous report from a contactable consumer received from the Regulatory Authority.The regulatory authority report number is GB-MHRA-WEBCOVID-202108040754305970-CBIZ9 Safety Report Unique Identifier GB-MHRA-ADR 25751188. A 34-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FE1510) via an unspecified route of administration on 17Jul2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history was not reported. Unsure if patient has 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. The patient''s concomitant medications were not reported. Historical vaccine includes patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) dose 1, via an unspecified route of administration on unspecified as DOSE 1, SINGLE for COVID-19 immunization. On 30Jul2021 patient experienced diarrhea, abdominal cramp and on unspecified date spasms, cramps and abdominal pain. Persistent abdominal pain, cramps, spasms that have persisted for 5 days. Pain has abated slightly but is not going away yet. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 23Jul2021 No - Negative COVID-19 test. The clinical outcome of diarrhea was recovering and not recovered for abdominal cramp. For rest other events was unknown. No follow-up attempts are possible, No further information is expected.


VAERS ID: 1589348 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Asthenia, Faeces discoloured, Fatigue, Headache, Loss of personal independence in daily activities, Malaise, Nausea, Somnolence
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101005907

Write-up: Stomach upset; Faeces discoloured; Tired all the time; Weakness/constantly feel weak; Throbbing headache/horrid headaches; Nausea; Drowsiness; she needed assistance around the house to do her usual activities; feeling unwell; nauseous; This is a spontaneous report from a contactable consumer or other non healthcare professional received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108041051264190-WWOWZ, Safety Report Unique Identifier GB-MHRA-ADR 25752537. A 32-year-old non-pregnant female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 Vaccine, Solution for injection, Lot Number: FD8813), via an unspecified route of administration on 30Jul2021 (at the age of 32-years), as dose 2, single for COVID-19 immunisation. Medical history included suppressed lactation, and asthma, were from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19, and not had a COVID-19 test. Patient was not currently breastfeeding. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW3143), via an unspecified route of administration on 03Jun2021, as dose 1, single for COVID-19 immunisation. On 30Jul2021, she had drowsiness. On 31Jul2021, she got Throbbing headache/horrid headaches, constantly feel weak/weakness and nauseous, tired all the time. On 01Aug2021, had stomach upset and faeces discoloured. On an unknown date in 2021, she needed assistance around the house to do her usual activities and also help to look after her children whilst she was feeling unwell. On an unknown date in 2021, had nauseous. She had taken paracetamol regularly which has not helped the symptoms. The outcome of the event feeling unwell and nauseous was recovering, and the other events was not recovered. No follow-up attempts are possible. No further information is expected


VAERS ID: 1589362 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Pain in extremity, Paraesthesia, Pyrexia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (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: 20210804; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101005783

Write-up: Headache; Fever; Pins and needles; Painful arm; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority report number GB-MHRA-WEBCOVID-202108041224102970-KCQFL, Safety Report Unique Identifier GB-MHRA-ADR 25753042. A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number was not reported) via an unspecified route of administration on 30Jul2021 (at the age of 32 years old) at single dose 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 headache (medically significant) on 03Aug2021, pins and needles (medically significant) on 01Aug2021, painful arm (medically significant) on 30Jul2021, fever (medically significant) on 02Aug2021. The patient underwent lab tests and procedures which included COVID-19 virus test: negative (No - Negative COVID-19 test) on 04Aug2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the event painful arm was recovered on 04Aug2021, of the other 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: 1589414 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Myalgia, Nausea, Paraesthesia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101005740

Write-up: Pins and needles; Nausea; Muscle ache; Fatigue; Headache; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202108041820517020-BDPZT. Sender''s (Case) Safety Report Unique Identifier: GB-MHRA-ADR 25755726 A male patient of an unspecified age received bnt162b2 (BNT162B2)(PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 29Jul2021 (Batch/Lot Number: FF3319) as DOSE 2, SINGLE for covid-19 immunisation. Patient has not had symptoms associated with COVID-19. The patient medical history was not reported. The patient''s concomitant medications were not reported. Patient is not enrolled in clinical trial. The patient experienced fatigue (fatigue) (medically significant) on 30Jul2021 with outcome of not recovered , headache (headache) (medically significant) on 30Jul2021 with outcome of not recovered , nausea (nausea) (medically significant) on 31Jul2021 with outcome of not recovered , muscle ache (myalgia) (medically significant) on 30Jul2021 with outcome of not recovered , pins and needles (paraesthesia) (medically significant) on 02Aug2021 with outcome of not recovered. The patient underwent COVID-19 virus test with negative result on 03Aug2021. 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: 1589461 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Dizziness, Fatigue, Headache
SMQs:, Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), 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: AMLODIPINE; CYMBALTA; FOSTAIR; ROSUVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101005660

Write-up: Dizzy spells; Fatigue; Diarrhoea; Headache; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108050615144730-W0UHF, Safety Report Unique Identifier GB-MHRA-ADR 25757267. A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Jul2021 (Lot Number: FF3319) as single dose for COVID-19 immunisation. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medications included amlodipine; duloxetine hydrochloride (CYMBALTA); beclometasone dipropionate / formoterol fumarate (FOSTAIR); rosuvastatin. The patient experienced diarrhoea and headache on 30Jul2021, fatigue on 31Jul2021, dizzy spells on 02Aug2021. All of the events were considered as serious medically significant. The outcome of the event 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. No further information is expected.


VAERS ID: 1589483 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
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, Pain, Pain in extremity, Pyrexia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hay fever; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101012758

Write-up: pain; swelling in my armpit; sore aching bones and body; Inappropriate schedule of vaccine administered; Swollen lymph nodes; Fever; This is a spontaneous report from a contactable consumer (patient) or other non HCP. This is a report received from the Agency Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202108051130214960-Z0S7V, Safety Report Unique Identifier GB-MHRA-ADR 25758811. A 31-year-old (non-pregnant) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: FF3319, Expiration date was not reported), via an unspecified route of administration on 29Jul2021 as dose 2, single for COVID-19 immunization. Medical history included lactation decreased from an unknown date and unknown if ongoing, Seasonal allergy from an unknown date and unknown if ongoing. The patient''s 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 took beclomethasone. patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: ET8885), via unspecified route on 21May2021 as dose 1 single for COVID-19 immunization. The patient experienced pain, swelling in my armpit, sore aching bones and body, inappropriate schedule of vaccine administered on an unspecified date. On 30Jul2021 the patient had experienced swollen lymph nodes, fever. Upper arm or vaccination site was very sore within 15 minutes of receiving the vaccination (much more so than the experience with her first dose where the arm pain did not start until 24-48 hours later). Within 12 hours, strong pain and extreme swelling in my armpit and surrounding areas (on the side on which the vaccine was administered). Coupled with fever, sore aching bones and body etc - typical flu symptoms. The events seriousness was assessed as medically significant. The outcome of the events pain, swollen lymph nodes was recovering, and outcome of fever was recovered on 02Aug2021 and outcome of event swelling in my armpit, sore aching bones and body, inappropriate schedule of vaccine administered was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589585 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Nausea, Pain, Pain in extremity
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)

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

Write-up: Sore arm; Nauseous; Nausea; Fatigue; Pain; This case was received via RA (Reference number: 25780755) on 11-Aug-2021 and was forwarded to Moderna on 11-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), NAUSEA (Nauseous), PAIN (Pain), NAUSEA (Nausea) and FATIGUE (Fatigue) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 30-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced PAIN (Pain) (seriousness criterion medically significant). On 31-Jul-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) (seriousness criterion medically significant) and NAUSEA (Nauseous) (seriousness criterion medically significant). On 31-Jul-2021, NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved. On 02-Aug-2021, PAIN (Pain) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) and NAUSEA (Nauseous) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. Treatment information were not provided. Company''s 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: 1589766 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-30
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4213 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Investigation, Lymphadenopathy, Migraine, Psoriatic arthropathy
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune 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: Medical History/Concurrent Conditions: Psoriatic arthritis
Allergies:
Diagnostic Lab Data: Test Name: Cardiological visit; Result Unstructured Data: Test Result:nothing abnormal; Test Name: senologist visit; Result Unstructured Data: Test Result:nothing abnormal was found; Comments: (the patient goes to the breast specialist for swelling of the axillary lymph node of the same arm in which the vaccine was inoculated) and the swelling is regressing.
CDC Split Type: ITPFIZER INC202101009432

Write-up: 13 days after the second dose: sudden aggravation of previous arthritis, swelling of the left armpit nodule (vaccine side), chest pain and shortness of breath, daily migraine.; 13 days after the second dose: sudden aggravation of previous arthritis, swelling of the left armpit nodule (vaccine side), chest pain and shortness of breath, daily migraine.; 13 days after the second dose: sudden aggravation of previous arthritis, swelling of the left armpit nodule (vaccine side), chest pain and shortness of breath, daily migraine.; 13 days after the second dose: sudden aggravation of previous arthritis, swelling of the left armpit nodule (vaccine side), chest pain and shortness of breath, daily migraine.; 13 days after the second dose: ofsudden aggravation previous arthritis, swelling of the left armpit nodule (vaccine side), chest pain and shortness of breath, daily migraine.; This is a spontaneous report received from a contactable consumer downloaded from the Regulatory Authority. This consumer reported events for the same patient after 2 doses of the vaccine. This is the first of two reports for the second dose. A 47-year-old female patient received second dose of BNT162B2 (Comirnaty; Solution for injection; Lot number: FF4213), via intramuscular route of administration on 17Jul2021 as dose 2, single for COVID-19 immunization. The patient medical history INCLUDED Psoriatic arthritis. Past Drug Event included allergies to Zerinol, Zeppeli. Past drug included Aspirin. The patient Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration on 08Jun2021 as dose 1, single for COVID-19 immunization and experienced Blurring of vision. On 30Jul2021, 13 days after the second dose, the patient experienced sudden aggravation of previous arthritis, swelling of the left armpit nodule (vaccine side), chest pain and shortness of breath, daily migraine. It was reported that In addition to the description of the adverse reaction at the second dose of the vaccine, the patient reports: ''Vision deterioration after first dose Pfizer. Waiting for investigations by the cardiologist and the ophthalmologist. Verification carried out by the senologist. Follow-up information (04Aug2021): following the cardiological visit, nothing abnormal emerged. The patient still has shortness of breath, while her chest pain is no longer present. Following the breast examination, nothing abnormal was found (the patient goes to the senologist for swelling of the axillary lymph node of the same arm in which the vaccine was inoculated) and the swelling is regressing. Examination carried out by the senologist; Cardiological visit performed. The lab tests included Investigation(Cardiological visit): nothing abnormal, Investigation(senologist visit): nothing abnormal was found (the patient goes to the breast specialist for swelling of the axillary lymph node of the same arm in which the vaccine was inoculated) and the swelling is regressing)on unknown dates. The outcome of events was unknown. Sender''s comment: Although it has been indicated that the adverse events that have occurred are not serious, the ''sudden aggravation of previous arthritis'' is included in the IME list and therefore among the events of serious type - another clinically relevant condition.


VAERS ID: 1589820 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cold sweat, Dysstasia, Feeling abnormal, Heart rate, Neurogenic shock, Presyncope, Respiratory rate
SMQs:, Anticholinergic syndrome (broad), Hypoglycaemic and neurogenic shock conditions (narrow), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: BP; Result Unstructured Data: Test Result:108/69; Test Date: 20210730; Test Name: BP; Result Unstructured Data: Test Result:125/75; Test Date: 20210730; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20210730; Test Name: HR; Result Unstructured Data: Test Result:61; Test Date: 20210730; Test Name: HR; Result Unstructured Data: Test Result:55; Test Date: 20210730; Test Name: RR; Result Unstructured Data: Test Result:15-20; Comments: times
CDC Split Type: JPPFIZER INC202100999661

Write-up: Neurogenic shock; vasovagal reflex; feels poorly; cold sweat; a slight difficulty in standing; This is a spontaneous report from a contactable physician, received from the Pharmaceuticals and Medical Devices Agency (PMDA). Regulatory authority report number: v21122297. A 42-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 30Jul2021 14:30 (Batch/Lot Number: FA4597; Expiration Date: 31Aug2021) as dose 1, single (at the age of 42-years-old) for Covid-19 immunisation. Medical history was reported as none. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.6 degrees Centigrade. On 30Jul2021 at 14:40 (10 minutes after vaccination), the patient experienced vasovagal reflex. The course of the events was as follows: The patient had chief complaints of feels poorly and cold sweat. The patient had a slight difficulty in standing and was examined. The vital signs at the time of the perception were blood pressure (BP) 108/69, heart rate (HR) 61, respiratory rate (RR) 15-20 times. The patient got rehydration in a sitting position, and the event feels poorly has improved. The patient was observed in a supine position. Fifteen minutes later, the patient stated that the symptoms had improved. As more than 30 minutes had passed since the vaccination, the patient was allowed to return home. At the time of returning home, BP 125/75, HR 55. On 30Jul2021 (the same day of the vaccination), the events resolved. The reporting physician classified the events 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 reporting physician commented as follows: considered to be feels poorly due to neurogenic shock. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the close temporal relationship, the association between the reported events 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: 1589991 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure increased, Blood pressure measurement, Oxygen saturation, Vaccination site pain
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypertension (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (found before 1999, but no more medical treatments after 26March2019.); Drug ineffective.
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: blood pressure; Result Unstructured Data: Test Result:126/72; Comments: 14:35; Test Date: 20210730; Test Name: blood pressure; Result Unstructured Data: Test Result:198/90; Comments: immediately after BOSMIN 0.3mL intramuscularly injected; Test Date: 20210730; Test Name: SPO2; Result Unstructured Data: Test Result:93-95 %; Comments: 14:45; Test Date: 20210730; Test Name: SPO2; Test Result: 97 %; Comments: 15:28
CDC Split Type: JPPFIZER INC2021586533

Write-up: Vaccination site pain; Anaphylaxis; blood pressure 198/90; This is a spontaneous report from a contactable physician via a Pfizer colleague. A female patient of unspecified age received the second dose of BNT162B2 (COMIRNATY; solution for injection; Lot Number: EW0201; Expiration Date: 30Sep2021) intramuscularly on 30Jul2021 at 14:35 (the day of vaccination) as a single dose in the left upper arm for COVID-19 immunisation. Medical history included asthma from 1999 to 26Mar2019 (found before 1999, but no more medical treatments after 26March2019) and local anesthesia and analgesics were used, but still felt painful from an unspecified date and unspecified if ongoing. Concomitant medications were not reported; however, it was reported that the patient did not receive any other concomitant drug within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received pengood for an unspecified indication on an unspecified date and experienced cough and difficult to breath. On 30Jul2021 at 14:45 (10 minutes after the vaccination), the patient experienced anaphylaxis, on 30Jul2021 at an unspecified time the patient experienced blood pressure 198/90 and on an unspecified date the patient experienced vaccination site pain. The course of the events was reported as follows: At 14:35, COMIRNATY was intramuscularly injected. Immediately after that, blood pressure was 126/72. At 14:45, there was a complaint that "the throat feels prick pain and difficult to breath." SPO2 was 93-95%. Suspected anaphylaxis, BOSMIN 0.3mL intramuscularly injected. No blood pressure was recorded immediately before intramuscular injection. Immediately after was 198/90. Clear consciousness, no wheezing, no skin symptoms, no gastrointestinal symptoms, and mild cough were noted. Saline replacement fluid and oxygen 3 L / min administration were started. Subjective symptoms disappeared quickly. At 15:28, after the end of oxygen administration, improvement was confirmed with SPO2 97%. At 17:20 "Follow-up" and return home. After that, there was no delayed symptom, and the situation was confirmed on the morning of 03Aug2021, but there was no abnormality. The patient also confessed that she had vaccination site pain during the second vaccine. Relevant tests were reported as none. The clinical outcome of the event anaphylaxis was recovered on an unspecified date in 2021 with treatment including BOSMIN intramuscular, saline drip and the clinical outcomes of the events blood pressure 198/90 and vaccination site pain were recovered/resolved on an unspecified date in 2021. The reporter classified the event anaphylaxis as non-serious and stated the events resulted in physician office/clinic visit. The reporting physician assessed that the event was related to vaccination. The reporter considered that the event vaccination site pain was non-serious and the causality between the suspect drug and event was definitely related. Reporter Comment: At 14:35, COMIRNATY was intramuscularly injected. Immediately after that, blood pressure was 126/72. At 14:45, there was a complaint that "the throat feels prick pain and difficult to breath." SPO2 was 93-95%. Suspected anaphylaxis, BOSMIN 0.3mL intramuscularly injected. No blood pressure record immediately before intramuscular injection. Immediately after was 198/90. Clear consciousness, no wheezing, no skin symptoms, no gastrointestinal symptoms, and mild cough were noted. Saline replacement fluid and oxygen 3 L / min administration were started. Subjective symptoms disappeared quickly. At 15:28, after the end of oxygen administration, improvement was confirmed with SPO2 97%. At 17:20 "Follow-up" and return home. After that, there was no delayed symptom, and the situation was confirmed on the morning of 03Aug2021, but there was no abnormality. No follow up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information available and considering temporal relationship a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Anaphylaxis. The case will be reassessed further upon receipt of additional information.


VAERS ID: 1590005 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-07-30
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Post procedural pneumonia
SMQs:, Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP069199

Write-up: Postoperative pneumonia; This case was received via agency (Reference number: 2021TJP069199) on 04-Aug-2021 and was forwarded to Moderna on 17-Aug-2021. This case was reported by a vaccine recipient via the Drug Information Center. Postoperative pneumonia was assessed as serious by the MAH. On 11-Jul-2021, around 10:30, the patient received the 1st dose of this vaccine. On 30-Jul-2021, the patient underwent surgery. Thereafter, pneumonia developed. The outcome of postoperative pneumonia was unknown. No follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. on all applicable RSis. Company comment- Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.


VAERS ID: 1590019 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004495 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP071817

Write-up: Seizure; Chest pain; This case was received via the RA (Reference number: 2021TJP071817) on 02-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This case, initially reported to the RA by a (physician), was received via the RA (Ref, v21122692). Fibromyalgia, Sjogren''s syndrome, Under ambulant follow-up after the diagnosis of epilepsy. On 30-Jul-2021, at 15:35, the patient received the 1st dose of the vaccine. At 15:45, the patient complained of chest pain. Although the patient was awake and alert, the patient experienced seizure in the upper half of the body, which was considered as partial seizure. As the symptom did not improve after observation, the patient was transported by ambulance. Other skin, gastrointestinal, and respiratory symptoms did not develop. A history of epilepsy may have been another possible contributing factor. The outcome of chest pain and seizure was unknown. follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: It is thought that seizure was induced by the drug or stress.; 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: 1590022 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003657 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Bradycardia, Photopsia, Presyncope
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retinal disorders (narrow), 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 Name: Body temperature; Result Unstructured Data: 36.6 degree celsius
CDC Split Type: JPTAKEDA2021TJP071833

Write-up: Bradycardia; Vasovagal reaction; flash vision; This case was received via regulatory authority(Reference number: 2021TJP071833) on 02-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This case, reported by a physician, was received by regulatory authority via Moderna''s adverse reaction reporting site (TASK0020658). Bradycardia was assessed as serious by the MAH. On an unknown date, body temperature before vaccination: 36.6 degrees Celsius. On 30-Jul-2021, at 10:40, the patient received the 1st dose of this vaccine. At 10:45, the patient developed flash vision symptoms several minutes after vaccination. Bradycardia was noted. It is thought to be a vasovagal reaction. The patient recovered in bed rest recumbency. The outcome of vasovagal reaction, Bradycardia was recovered. Inability to follow up. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1590023 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-07-30
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Inappropriate schedule of product administration, Oxygen saturation
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: House dust allergy; Shellfish allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Oxygen saturation; Result Unstructured Data: did not decrease.
CDC Split Type: JPTAKEDA2021TJP071838

Write-up: Anaphylaxis; Inapropiate schedule of vaccine administered; This case was received via regulatory authority (Reference number: 2021TJP071838) on 02-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This case, reported by a vaccine recipient/a reporter other than physician, was received by regulatory aukthority Company Limited via Modernas adverse reaction reporting site (TASK0020667). A patient with allergy (shellfish, house dust). On 22-Jun-2021, the patient received the 1st dose of the vaccine. The patient experienced itching of skin, which was considered as mild allergic symptom. On an unknown date, body temperature before the vaccination: 35.9 degrees Celsius. On 30-Jul-2021, at 12:02, the patient received the 2nd dose of the vaccine. At 12:14, while under observation at the venue after the vaccination, the patient experienced respiratory discomfort, malaise, and itching of skin. The symptoms were considered as anaphylaxis. Although SpO2 did not decrease, a physician in charge of pre-examination determined that there was a risk of acute exacerbation as the allergic symptom also developed after the 1st dose of the vaccine. Therefore, the patient was transported to a hospital by ambulance and was hospitalized overnight. The outcome of allergy was unknown. The outcome of anaphylaxis was reported as resolving. Follow-up investigation will be impossible. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Company Comment: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273 (lot # 3003658) with the associated serious listed adverse event of Anaphylaxis. 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: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273 (lot # 3003658) with the associated serious listed adverse event of Anaphylaxis. 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: 1590041 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004221 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP072010AA

Write-up: Loss of consciousness; Feeling cold in both fingers; This case was received via regulatory authority (Reference number: JP-TAKEDA-2021TJP072010AA) on 06-Aug-2021 and was forwarded to Moderna on 17-Aug-2021. This case was reported by a physician via a medical representative. Loss of consciousness was assessed as serious by the regulatory authority On an unknown date, the patient received the 1st dose of this vaccine. After the vaccination, the patient lost consciousness for a few seconds. On 30-Jul-2021, the patient received the 2nd dose of this vaccine. The patient felt cold in both fingers after the vaccination. The patient recovered after the follow up at rest. Th outcome of loss of consciousness after the 1st dose of vaccine was unknown. The outcome of feeling cold in both fingers after the 2nd dose of vaccine was reported as recovered. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Not reported.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1592407 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: es zeigte sich eine deutliche Troponin?mie
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: This case was received via European Medicines Agency (Reference number: 202100159111) on 17-Aug-2021 and was forwarded to Moderna on 17-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myokarditis, 2-3 Tage nach der Impfung tratten Thoraxschmerzen bei der Patientin auf, es zeigte sich eine deutliche Troponin?mie) and CHEST PAIN (Thoraxschmerzen) in a 24-year-old female patient who received mRNA-1273 (Spikevax) for Prophylactic vaccination. No Medical History information was reported. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced MYOCARDITIS (Myokarditis, 2-3 Tage nach der Impfung tratten Thoraxschmerzen bei der Patientin auf, es zeigte sich eine deutliche Troponin?mie) (seriousness criteria hospitalization and medically significant) and CHEST PAIN (Thoraxschmerzen) (seriousness criterion hospitalization). At the time of the report, MYOCARDITIS (Myokarditis, 2-3 Tage nach der Impfung tratten Thoraxschmerzen bei der Patientin auf, es zeigte sich eine deutliche Troponin?mie) and CHEST PAIN (Thoraxschmerzen) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, Troponin: increased High. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant products were reported. No treatment information provided. 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. Translation pending for completing the assessment.; 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. Translation pending for completing the assessment.


VAERS ID: 1592477 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-07-30
   Days after vaccination:137
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result: Positive.
CDC Split Type: ESPFIZER INC202101010238

Write-up: PCR + on 30Jul2021 due to close contact; Vaccination failure; This is a spontaneous report from a contactable physician from the Regulatory Authority. The regulatory authority number ES-AEMPS-963241. A 96-year-old non-pregnant female patient received bnt162b2 (COMIRNATY), dose 1 on 22Feb2021 (Batch/Lot Number: EP9598) as dose 1, single, and dose 2 on 15Mar2021 (Batch/Lot Number: ET1831) as dose 2, single, both given via unspecified route of administration for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 30Jul2021, the patient experienced vaccination failure as the patient was PCR+ on 30Jul2021 due to close contact. The patient underwent lab tests and procedures which included Covid-19 PCR test positive on 30Jul2021. The outcome of the events was recovering. No follow-up attempts are possible, information about batch number already obtained.


VAERS ID: 1592479 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2752 / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101010319

Write-up: This is a spontaneous report from a contactable consumer, downloaded via the regulatory authority (ES-AEMPS-963343). A 31-year-old female patient received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# FF2752), intramuscularly, left arm, on Jul 29, 2021, single dose, for COVID-19 immunization. The patient''s medical history and concomitant medications not reported. The patient was not pregnant. The patient has not been previously diagnosed with COVID-19. The patient previously received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), on an unspecified date, single dose, for COVID-19 immunization. The patient experienced dyspnea, chest pain and shortness of breath on Jul 30, 2021. The outcome of the events: not recovered. The events considered serious (medically significant). No follow-up attempts possible. No further information expected.


VAERS ID: 1592485 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8405 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? 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: Neurological examination; Result Unstructured Data: Test Result:No motor deficit.; Comments: not facial or speech disorder. No motor deficit. No dysmetria, nausea and vomiting, sweating
CDC Split Type: ESPFIZER INC202101010244

Write-up: Tonic-clonic convulsion; This is a spontaneous report from a contactable physician downloaded from EudraVigilance WEB ES-AEMPS-964142. A 17-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 29Jul2021 (Batch/Lot Number: FE8405) as DOSE 1, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On an unspecified date, it was reported that While standing, the patient disconnects from the environment and loses muscle tone. The patient was held in time to be put on the floor and he begins tonic-clonic movement/Tonic-clonic convulsion of 10 seconds, fixed gaze, not hypersalivation. He was kept in a lateral safety position. Recovery ad integrum instantly. He remembers everything that happened, recognizes that he can listen to the voices and noticed that he cannot react. EPISODE LESS THAN 24 HOURS AFTER FIRST DOSE OF PFIZER. After crisis, not post-critical. Isochoric and normoreactive pupils, not facial or speech disturbance. No motor deficit. No dysmetria, Nausea and vomiting, sweating. Recovered after 15-20 minutes. The patient underwent lab tests and procedures which included neurological examination: no motor deficit. on an unspecified date not facial or speech disorder. No motor deficit. No dysmetria, nausea and vomiting, sweating. The patient was prescribed stesolid. The patient received treatment for the event. The outcome of the event was recovered on 30Jul2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1592489 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8405 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Electrocardiogram, Hyperhidrosis, Loss of consciousness, Malaise, Neurological examination, Sinus bradycardia, Syncope, Vision blurred, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Disorders of sinus node function (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: ECG; Result Unstructured Data: Test Result:Sinus bradycardia at 55bpm; Test Date: 2021; Test Name: Neurological Examination; Result Unstructured Data: Test Result:Normal
CDC Split Type: ESPFIZER INC202101010287

Write-up: This is a spontaneous report from a contactable healthcare professional downloaded from the Agency. A 21-year-old female patient received BNT162B2 (COMIRNATY, Batch/Lot Number: FE8405), intramuscular on 30Jul2021 as dose 1, 0.3 ml, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 30Jul2021, the patient was translated to the Regional Hospital with syncope. After getting up from the chair receiving the first dose of the Pfizer vaccine, she reported blurred vision with profuse sweating with subsequent loss of consciousness of 5 seconds duration. Subsequent general malaise with sweating and vomiting in the ambulance. She denied centrothoracic pain prior to syncope, no breathlessness or pruritus. After arrival at the hospital, she stated she is better, without feeling dizzy or pain. During her stay the patient shows an evolution, without feeling dizzy, so it was decided to discharge at home with observation and instructions. Diagnostic impression was syncope of vasovagal features. The patient underwent electrocardiogram (ECG): sinus bradycardia at 55bpm, and Neurological Examination: normal, both on an unknown date in 2021. The patient recovered from the events on 30Jul2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1592493 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-30
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD9309 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis, Fibrin D dimer, Platelet count
SMQs:, Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: D-dimer; Result Unstructured Data: Test Result:3769 ng/ml; Test Date: 20210709; Test Name: Platelets; Result Unstructured Data: Test Result:254000 /mm3; Test Date: 20210730; Test Name: Platelets; Result Unstructured Data: Test Result:361000 /mm3; Test Date: 20210731; Test Name: Platelets; Result Unstructured Data: Test Result:254000 /mm3; Test Date: 20210802; Test Name: Platelets; Result Unstructured Data: Test Result:255000 /mm3
CDC Split Type: ESPFIZER INC202101017248

Write-up: Cerebral venous sinus thrombosis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number ES-AEMPS-965464. A 33-years-old female patient (non-pregnant at the administration of the vaccine) received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FD9309), dose 1 via an unspecified route of administration, administered in Arm on 17Jul2021 as Dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced cerebral venous sinus thrombosis on 30Jul2021. Patient was hospitalised for the event. The patient underwent lab tests and procedures which included fibrin d dimer: 3769 ng/ml on 30Jul2021, platelet count: 254000 /mm3 on 09Jul2021, platelet count: 361000 /mm3 on 30Jul2021, platelet count: 254000 /mm3 on 31Jul2021, platelet count: 255000 /mm3 on 02Aug2021. Image diagnostic method used was CT, pending confirmation MRI. Determination of anti-PF4 antibodies and technique used: Request to external laboratory on 31Jul, pending submission of results. The outcome of the event cerebral venous sinus thrombosis was recovering. No follow-up attempts possible. No further information expected.


VAERS ID: 1592505 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-07-30
   Days after vaccination:91
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3014 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Alanine aminotransferase, Aspartate aminotransferase, Auscultation, Basophil count, Blood chloride, Blood creatinine, Blood glucose, Blood lactate dehydrogenase, Blood osmolarity, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, Body temperature, C-reactive protein, COVID-19 pneumonia, Chest X-ray, Drug ineffective, Electrocardiogram, Eosinophil count, Erythroblast count, Fibrin D dimer, Gamma-glutamyltransferase, Haematocrit, Haemoglobin, Heart rate, International normalised ratio, Investigation, Lymphocyte count, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Monocyte count, Neutrophil count, Odynophagia, Oxygen saturation, Platelet count, Prothrombin level, Prothrombin time, Red blood cell count, Red cell distribution width, SARS-CoV-2 test, White blood cell count
SMQs:, Lack of efficacy/effect (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PANTOPRAZOLE; CANDESARTAN; EMCONCOR; AAS 100; ATORVASTATIN; TAMSULOSIN; ESCITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cholecystectomy; Dyslipidemia; Hypertension arterial; Myocardial infarction; Pancreatitis; Prostate cancer; Stent placement
Allergies:
Diagnostic Lab Data: Test Name: APTT and APTT RATIO; Result Unstructured Data: Test Result: in notes; Comments: APTT (T. Cephalin) was 31.2 sec (23.0 - 36.0), APTT RATIO (T. Cephalin) was 1.06 (0.8 - 1.25); Test Name: ALT; Result Unstructured Data: Test Result:12 IU/l; Test Name: AST; Result Unstructured Data: Test Result: 41 IU/l; Test Name: Heart and pulmonary auscultation; Result Unstructured Data: Test Result: in notes; Comments: heart auscultation shows rhythmic without murmurs or extratons, pulmonary auscultation shows crackles predominantly in the left lung field; Test Name: basophils; Result Unstructured Data: Test Result: 0.0 x10 3/mm3; Comments: and Basophils% 0.4%; Test Name: chloride; Result Unstructured Data: Test Result: 107 mmol/L; Test Name: creatinine; Test Result: 0.91 mg/dl; Test Name: glucose; Test Result: 123 mg/dl; Test Name: LDH; Result Unstructured Data: Test Result: 465 IU/l; Test Name: Calculated osmolality; Result Unstructured Data: Test Result:303 mosm/kg; Test Name: potassium; Result Unstructured Data: Test Result: 4.7 mmol/L; Test Name: blood pressure; Result Unstructured Data: Test Result: 134/55 mmHg; Test Name: sodium; Result Unstructured Data: Test Result: 143 mmol/L; Test Name: urea; Test Result: 59 mg/dl; Test Name: temperature; Result Unstructured Data: Test Result: 40 Centigrade; Test Date: 20210807; Test Name: Chest x-ray; Result Unstructured Data: Test Result: infiltrates; Comments: bilbar infiltrates in Upper left lobe and Lower left lobe (similar to previous ones of yesterday 06Aug2021/similar to prior to 24 hours ago); Test Name: protein c-reactive; Result Unstructured Data: Test Result: 79.7 mg/l; Test Name: ECG; Result Unstructured Data: Test Result: sinus rhythm at 52 bpm; Comments: sinus rhythm at 52 bpm Normal axis. PR 0.15 sec. Narrow QRS. Without repolarization disturbances; Test Name: eosinophils; Result Unstructured Data: Test Result:0.0 x10 3/mm3; Comments: and Eosinophils% 0.7%; Test Name: Erythroblasts; Result Unstructured Data: Test Result:0.0 x10 3/mm3; Comments: (Erythroblasts was 0.0/ 100WBC (0.0 - 1.0)); Test Name: D-dimer; Result Unstructured Data: Test Result:751 ng/ml; Comments: (immunoturbidimetry); Test Name: gamma-glutamyltransferase; Result Unstructured Data: Test Result:26 IU/l; Test Name: hematocrit; Test Result: 35.6 %; Test Name: hemoglobin; Result Unstructured Data: Test Result:12.2 g/dl; Test Name: heart rate; Result Unstructured Data: Test Result:55; Comments: bpm; Test Name: INR; Result Unstructured Data: Test Result:1.28; Comments: 1.28 R.N.; Test Name: Great Alarm. Immature, Brescia, LUC; Result Unstructured Data: Test Result:in notes; Comments: Great Alarm. Immature +; LUC was 1.6%, and Brescia was 0. SEIMC-SCORE was 16.; Test Name: lymphocyte count; Result Unstructured Data: Test Result:0.7 x10 3/mm3; Comments: lymphopenia and Lymphocytes% 14.3%; Test Name: MCH; Test Result: 30.5 pg; Test Name: MCHC; Result Unstructured Data: Test Result:34.3 g/dl; Test Name: mcv; Result Unstructured Data: Test Result:88.9; Comments: fl; Test Name: monocytes; Result Unstructured Data: Test Result:0.3 x10 3/mm3; Comments: and Monocytes% 6.1%; Test Name: neutrophil count; Result Unstructured Data: Test Result: 3.8 x10 3/mm3; Comments: and Neutrophils% 76.9%; Test Name: oxygen saturation; Test Result: 94 %; Comments: baseline; Test Name: platelet count; Result Unstructured Data: Test Result:127 x10 3/mm3; Test Name: Activity of prothrombin; Test Result: 67%; Test Name: prothrombin time; Test Result: 15 s; Test Name: red blood cell count; Result Unstructured Data: Test Result:4 x10 6/mm3; Test Name: RDW; Test Result: 14.1 %; Test Date: 20210804; Test Name: COVID-19 antigenic test; Test Result: Positive; Test Name: leukocyte count; Result Unstructured Data: Test Result: 5.0 x10 3/mm3.
CDC Split Type: ESPFIZER INC202101055802

Write-up: Drug ineffective; COVID-19 pneumonia; odynophagia; This is a spontaneous report from a contactable physician from the Regulatory Authority. The regulatory authority number ES-AEMPS-970785. An 81-years-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number EY3014), intramuscularly on 30Apr2021 as DOSE 2, SINGLE; also, first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EW2243), intramuscularly on 08Apr2021 as DOSE 1, SINGLE; both for covid-19 immunization. Medical history included hypertension arterial (HTA) from an unknown date, dyslipidaemia (DL) from an unknown date, posterior acute myocardial infarction (AMI) from an unknown date in 2010 to an unknown date with stent placement on an unknown date in 2010 to an unknown date, prostate cancer from an unknown date, pancreatitis from an unknown date, cholecystectomy on an unknown date. Concomitant medication(s) included PANTOPRAZOLE 40 mg, CANDESARTAN 8mg, EMCONCOR 2.5 mg, AAS 100mg, ATORVASTATIN 20 mg, TAMSULOSIN 0.4mg, ESCITALOPRAM 10 mg, all taken for an unspecified indication, from an unknown start date. The patient was not pregnant at the time of vaccination. On day plus 8 days after, he had fever of up to 40 C on unspecified date in 2021 (tonight), had cough with expectoration (cough with whitish expectoration mixed with blood strands that target, not hemoptysis), odynophagia, and anosmia and appeared dyspnea at rest. No chest pain, no dyspnoea, no headache, no myalgia, no nausea, vomiting or diarrhoea, no ageusia, no orthopnea, no PND, no urine retention, no abdominal pain, no arthromyalgia, no medical voiding. He reported nasal congestion that causes anosmia, not ageusia. The patient went to emergency room due to worsening of his general condition. Reason for consultation was fever, cough, and odynophagia in covid-19 on 07Aug2021. The patient went to hospital for the same reason. On unspecified date, the patient underwent some lab test which included temperature was 40 C, blood pressure was 134/55 mmHg, heart rate was 55 BPM, Oxygen Saturation (SatO2) was 94% baseline, heart auscultation shows rhythmic without murmurs or extratons, pulmonary auscultation shows crackles predominantly in the left lung field, Glucose was 123.00 mg/dl (60.0-100.0), Urea was 59.00 mg/dl (21.0-50.0), creatinine 0.91 mg/dl (0.6-1.2), Sodium was 143.00 mmol/L (135.0-145.0), Potassium was 4.70 mmol/L (3.5-5.0), chloride was 107.00 mmol/L (101.0-111.0), LDH was 465.00 U/L (120.0-246.0), ALT (GPT) 12.00 U/L (6.0-40.0), AST was 41.00 U/L (6.0-40.0), gamma-glutamyltransferase was 26.00 U/L (8.0-61.0), Calculated osmolality 303 mOsm/KG, C-reactive protein 79.70 mg/L (0.1-10.0), Hemogram had Leukocytes 5.00 x10E3 / microL (4.0 - 11.5), Neutrophils was 3.8 10E3 / microL (1.5 - 7.5), Lymphocytes was 0.7 10E3/microL (1.2 - 4.0), Monocytes was 0.3 10E3 /microL (0.2 - 1.0), Eosinophils was 0.0 10E3/microL (0.0 - 0.4), Basophils was 0.0 10E3/microL (0.0 - 0.2), Neutrophils% was 76.9%, Lymphocytes% was 14.3%, Monocytes% was 6.1%, Eosinophils% was 0.7%, Basophils% was 0.4%, LUC was 1.6%, Great Alarm. Immature plus, Red blood cells was 4.00 10E6/microL (4.0 - 5.4), hemoglobin was 12.2 g/dL (12.0 - 17.0), hematocrit was 35.6% (41.0 - 53.0), MCV was 88.9 fL (82.0 - 97.0), MCH was 30.5 pg (26.0 - 31.0), MCHC was 34.3 g / dL (32.0 - 36.0), Erythroblasts was 0.00 10E3/microL (Erythroblasts was 0.0/ 100WBC (0.0 - 1.0)), RDW was 14.10% (8.0 - 14.8), Platelets was 127 10E3/microL (150.0- 400.0), Prothrombin time was 15.0 sec (9.5-14.0), Activity of prothrombin was 67.0% (70.0 - 120.0), I.N.R. was 1.28 R.N. (0.8 - 1.2), APTT (T. Cephalin) was 31.2 sec (23.0 - 36.0), APTT RATIO (T. Cephalin) was 1.06 (0.8 - 1.25), D-Dimer (immunoturbidimetry) was 751.0 ng / ml (0.0 - 500.0), ECG results showed sinus rhythm at 52 bpm. Normal axis. PR 0.15 sec. Narrow QRS. Without repolarization disturbances. Brescia was 0. SEIMC-SCORE was 16. The patient was in good general condition. Well hydrated, perfused, and colored. Eupneic at rest. On 30Jul2021, plus 10 days after, the patient was diagnosed with covid-19 infection and covid pneumonia (drug ineffective) on unspecified date in 2021 (yesterday) at the hospital. The patient had covid-19 antigenic test on 04Aug2021, and results were positive. On unspecified date in 2019 (today), start of depositions diarrhea without blood or other pathological products. Referred losses of urine and feces spontaneously that was not related to Valsalva maneuvers. He referred to what happen to him when he was extremely relaxed since he suffered Covid. No other associated symptoms. Blood tests performed with lymphopenia, elevated CRP (79), and D-dimer 751 were concluded for lab tests. Clinical assessment concluded Covid-19 pneumonia (Left bilobar covid-19 pneumonia). Given the analytical and radiological alterations, and the age of the patient, the medical history, admission was decided. On 07Aug2021 the patient was hospitalized due to the events. On 07Aug2021, chest X-ray showed: bilbar infiltrates in upper left lobe and lower left lobe similar to previous ones of yesterday 06Aug2021/similar to prior to 24 hours ago. Objectifying pneumonia of left predominance so levofloxacin, dexamethasone 4 mg and bemiparin 3500IU given. The patient was discharged from the hospital. The patient was treated with treatment at discharge BEMIPARIN 3500 IU/24h, levofloxacin 500 mg, dexamethasone, and paracetamol. The outcome of the event Covid-19 pneumonia and odynophagia was reported as recovering. No follow-up attempts possible. No further information expected. Information about batch number has been obtained


VAERS ID: 1592741 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7010 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Ultrasound Doppler
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adenomyosis; Cervical conisation; Femoral neck fracture (at the age of 1 1/2 years); Pregnancy; Thrombosis venous deep (Left fibular)
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Doppler ultrasound; Result Unstructured Data: Test Result:deep vein thrombosis of 3.5 mm without dilatation
CDC Split Type: FRPFIZER INC202101010384

Write-up: Thrombosis venous deep; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number FR-AFSSAPS-TO20216115. A 47-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, lot number: FE7010), intramuscularly administered in the left arm on 29Jul2021 as dose 1, single for c COVID-19 immunization. Medical history included thrombosis venous deep (left fibular) from 2021 to an unknown date, cervical conisation from 2000 to an unknown date, femoral neck fracture (at the age of 1 1/2 years) from an unknown date and unknown if ongoing, adenomyosis from an unknown date and unknown if ongoing, pregnancy on 2003 and on 2006. The patient''s concomitant medications were not reported. The patient experienced thrombosis venous deep on 30Jul2021. It was reported that on 30Jul2021, the patient experienced onset of left internal twin deep vein thrombosis. The Doppler ultrasound performed that day revealed a deep vein thrombosis of 3.5 mm without dilatation of the vein, but obstructive on one of the medial gastrocnemius veins (clinical history of fibular vein). Starting Xarelto 15 mg x2 for 12 days with constraints. The patient underwent lab tests and procedures which included Doppler ultrasound: deep vein thrombosis of 3.5 mm without dilatation on 30Jul2021. The outcome of the event was not recovered. No follow up attempts are needed. No further information is expected.


VAERS ID: 1592815 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Herpes zoster, Nausea, Rash, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fatigue.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101014846

Write-up: This is a spontaneous report from a contactable consumer, received via the regulatory authority (report number: GB-MHRA-APPCOVID-202108071618260090-7LT1O; safety report unique identifier: GB-MHRA-ADR 25770665). A female patient, of an unspecified age, received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not reported), via an unspecified route of administration, on Jul 29, 2021, single dose, for COVID-19 immunisation. Medical history included fatigue. Patient has not had symptoms associated with COVID-19, nor had a COVID-19 test. Patient not enrolled in a clinical trial. The patient''s concomitant medications not reported. The patient experienced vomiting in 2021, fatigue (Jul 30, 2021), skin rash in 2021, shingles (Aug 3, 2021) and nausea (Aug 2, 2021). All events reported serious (medically significant). Clinical course: Following day, patient had fatigue and it continued two days. Then patient had nausea for three days, followed by vomiting. Skin rash identified as shingles by GP (general practitioner). Outcome of shingles and nausea: not recovered; of other events: unknown. Patient has not tested positive for COVID-19 since the vaccination. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1592854 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Muscle spasms, Pain, Pregnancy test, Vaginal haemorrhage, Vulvovaginal pain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (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: CERELLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Irritable bowel syndrome; Lactation decreased; Period pains
Allergies:
Diagnostic Lab Data: Test Name: Pregnancy test; Result Unstructured Data: Test Result:negative result
CDC Split Type: GBPFIZER INC202101012762

Write-up: cramping; pain; Vaginal bleeding; Vaginal pain; This is a spontaneous report from a contactable consumer(patient) received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108050915338220-ME9NL. Safety Report Unique Identifier GB-MHRA-ADR 25758178. A 23-year-old female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FE1510, expiry date: not reported) dose 2 via an unspecified route of administration on 29Jul2021 as single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome, lactation decreased, period pains. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiry date: not reported) dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Concomitant medication included desogestrel (CERELLE) taken for period pains from 27Feb2019 to an unspecified stop date and contraceptive pill. On 30Jul2021, the patient experienced pain, vaginal bleeding, vaginal pain. On an unspecified date, the patient experienced cramping. Case narrative as reported: Vaginal bleeding and pain occurred the day after the second dose and persisted for 2 days. I believe this is unusual and related to the vaccine as I am currently on the contraceptive pill (I have no periods or any bleeding/pain usually) and not pregnant. The bleeding was not heavy however the cramping was quite painful and mimicked regular period pain. On an unspecified date, the patient underwent lab tests and procedures which included pregnancy test: negative. The outcome of cramping was not recovered. The outcome of pain was recovered on an unspecified date. The outcome of vaginal bleeding and vaginal pain was recovered on 31Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1592884 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Fatigue, Headache, Nasopharyngitis, Nausea, Oropharyngeal pain, Skin mass
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101012963

Write-up: cold; Skin nodule; Abdominal pain; Tiredness; Headache; Nausea; Sore throat; This is a spontaneous report from a contactable consumer received from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108051137201850-JZIRO, Safety Report Unique Identifier GB-MHRA-ADR 25758913. A 21-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 30Jul2021 (at the age of 21-year-old) (Lot Number: FD8813) as single dose for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The concomitant medications were not reported. The patient experienced cold, skin nodule and abdominal pain on an unspecified date, tiredness, headache, nausea and sore throat on 30Jul2021. Clinical course as follow: Nausea set in fairly quickly after having the vaccine (whilst in the waiting area) and lasted about an hour. Headache began a few hours after the vaccine, but was minor and resolvable with paracetamol (500mg) and was not present the next day. Tiredness began around the same time as the headache, and was so extreme on the first day that multiple naps were needed that day. The tiredness was still present the next day, but was less extreme. Sore throat began on the evening after having the vaccine, and was similar to the feeling one experiences just prior to a cold. The sore throat was still present the next day, but less severe, and was fully resolved by the third day. The events were considered as medically significant. The outcome of the event tiredness and sore throat was recovered on 01Aug2021, of headache was recovered on 31Jul2021, of nausea was recovered on 30Jul2021. The outcome of other events was recovered on unknown date. 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: 1592909 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Headache, Myalgia, Neck pain, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CODEINE PHOSPHATE; NAPROXEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Knee pain
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101012928

Write-up: muscular pain; Headache; Dizzy spells; Neck pain; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-RA-WEBCOVID-202108051326313830-D0Z1Y. Sender''s (Case) Safety Report Unique Identifier: GB-RA-ADR 25759396. A 26-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on 30Jul2021 (Batch/Lot number was not reported) as dose 2, single (at age of 26-years-old) for covid-19 immunisation. Medical history included knee pain. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Concomitant medications included codeine phosphate taken for knee pain from an unspecified date to 14Jul2021; naproxen taken for knee pain. The patient experienced muscular pain on 02Aug2021, headache on 02Aug2021, neck pain on 30Jul2021, dizzy spells on 02Aug2021. Headaches, muscular pain and dizzy spells began 3 days after vaccine and confined for 4-5 days. Negative COVID test so suspected to be vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: negative. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the events muscular pain was unknown, of the event headache was recovering, of the events neck pain and dizzy spells was not recovered. The report was serious with seriousness criteria of medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1592923 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Electrocardiogram, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOSTAIR
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:Unknown resutls
CDC Split Type: GBPFIZER INC202101012957

Write-up: Pericarditis; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-RA-WEBCOVID-202108051509356180-ZUBNX. Safety Report Unique Identifier GB-RA-ADR 25760137. A 29-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 29Jul2021 (Lot Number: FD8813) as single dose 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. Concomitant medication included beclometasone dipropionate, formoterol fumarate (FOSTAIR) taken for asthma. The patient experienced pericarditis on 30Jul2021 with outcome of recovering. Lab test included ECG. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1592926 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Feeling abnormal, Loss of consciousness, Oropharyngeal blistering, Pyrexia, SARS-CoV-2 test, Vertigo
SMQs:, Torsade de pointes/QT prolongation (broad), Severe cutaneous adverse reactions (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
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; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210701; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: passing; chills; lasted; hours; day; Vertigo; Fever chills; High temperature; This case was received via regulatory authority RA (Reference number: 25760323) on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of OROPHARYNGEAL BLISTERING (lasted), PYREXIA (High temperature), LOSS OF CONSCIOUSNESS (passing), CHILLS (chills), VERTIGO (Vertigo), PYREXIA (Fever chills), FEELING ABNORMAL (hours) and PYREXIA (day) in a 42-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased and Suspected COVID-19 (Unsure when symptoms stopped) on 21-Jun-2021. Concomitant products included PARACETAMOL from 29-Jul-2021 to an unknown date for an unknown indication. On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant) and PYREXIA (Fever chills) (seriousness criterion medically significant). On 05-Aug-2021, the patient experienced VERTIGO (Vertigo) (seriousness criterion medically significant). On an unknown date, the patient experienced OROPHARYNGEAL BLISTERING (lasted) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (passing) (seriousness criterion medically significant), CHILLS (chills) (seriousness criterion medically significant), FEELING ABNORMAL (hours) (seriousness criterion medically significant) and PYREXIA (day) (seriousness criterion medically significant). On 30-Jul-2021, PYREXIA (High temperature) and PYREXIA (Fever chills) had resolved. At the time of the report, OROPHARYNGEAL BLISTERING (lasted), LOSS OF CONSCIOUSNESS (passing), CHILLS (chills), FEELING ABNORMAL (hours) and PYREXIA (day) was resolving and VERTIGO (Vertigo) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medications were reported. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 1592954 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DULOXETINE; OMEPRAZOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Esophageal reflux; Fibromyalgia; Lactation decreased; Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101012742

Write-up: Heavy period clots; Prolonged heavy periods; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202108051812174650-U94XX, Safety Report Unique Identifier GB-MHRA-ADR 25761293. A 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: not reported), dose 2 via an unspecified route of administration on 30Jul2021 as 2nd dose, single for COVID-19 immunization (at the age of 38-years). Patient''s medical history included suppressed lactation, fibromyalgia, and gastrooesophageal reflux disease from an unknown date and unknown if ongoing. Patient''s concomitant medications included duloxetine taken for fibromyalgia from 03May2021 to an unspecified stop date, omeprazole taken for gastrooesophageal reflux disease from 28Apr2016 to an unspecified stop date. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: not reported), via an unspecified route on an unknown date for covid-19 immunization. Neither the patient had symptoms associated with COVID-19 nor had a COVID-19 test. Patient is not currently breastfeeding. Patient was not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient experienced prolonged heavy periods on 30Jul2021 and heavy period clots on an unspecified date. Heavy period clots bigger than a grape and changing pad every hour even at night. Both the events were reported as medically significant. The outcome of events was not recovered. Patient will have a blood test anemia tomorrow. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1592963 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMITRIPTYLINE; DESOGESTREL; IBUPROFEN; MEBEVERINE; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Armpit pain; Contraception; Irritable bowel syndrome; Lactation decreased; Tension headache
Allergies:
Diagnostic Lab Data: Test Date: 20210706; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101012978

Write-up: pain; discomfort; inflammation; inflamed lymph node; Armpit pain; This is a spontaneous report from a contactable consumer. This is a report received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108051909379680-FZMDG. Safety Report Unique Identifier is GB-MHRA-ADR 25761475 . A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 30Jul2021 (age at vaccination is 32 year) (Lot Number: FD8813) as single dose for COVID-19 immunisation. Medical history included lactation decreased, tension headache, contraception, armpit pain, irritable bowel syndrome. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medications included amitriptyline taken for tension headache; desogestrel taken for contraception; ibuprofen taken for tension headache and armpit pain; mebeverine taken for irritable bowel syndrome; paracetamol taken for tension headache. The patient experienced pain, discomfort and inflammation on an unspecified date, armpit pain on 30Jul2021. Clinical course as follow: Stabbing pain upon movement and constant ache/inflammation began a few hours after vaccine given, assumed to be inflamed lymph node, lasted for about 72 hours, over the counter painkillers (ibuprofen and paracetamol) taken to relieve discomfort. The events was considered as medically significant. COVID-19 virus test on 06Jul2021 was No - Negative COVID-19 test. The outcome of the event armpit pain was recovered on 02Aug2021, of other events was recovered on unknown date. 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: 1593025 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-07-30
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Comments: Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101013036

Write-up: Headache; 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-202108052319435930-JPZJP, Safety Report Unique Identifier (GB-MHRA-ADR 25762694). A 22-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 27Jul2021 (Lot number was not reported) as Dose 2, Single for COVID-19 immunisation. Medical history included Lactation decreased. Historical Vaccine included BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 01May2021 (Lot number was not reported) at single dose for COVID-19 immunisation. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 Patient is not pregnant, Patient is not currently breastfeeding. The patient experienced headache (medically significant) on 30Jul2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test negative on unspecified date. Clinical course as reported, Taken painkillers not helping, Patient has not tested positive for COVID-19 since having the vaccine, Patient is not enrolled in clinical trial. Suspect Reactions Please provide details of any relevant investigations or tests conducted, None. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1593064 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Heavy menstrual bleeding, Inappropriate schedule of product administration, Menstrual disorder, Postmenopausal haemorrhage, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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: FOLIC ACID; IBUPROFEN; MYO INOSITOL; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Headache; Lactation decreased; Menstrual cramps; Polycystic ovarian syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210728; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101014421

Write-up: menstrual bleeding; felt faint; menorrhagia; light-headed; Passed very large clots; Very heavy bleed started again; Menstrual flooding; vaccine is administered outside of the range 19 - 42 days after the first dose; This is a spontaneous report from a contactable consumer (patient). This is the first of two reports. The first report is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108060906440750-QHL8B Safety Report Unique Identifier GB-MHRA-ADR 25763900. A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: FF3319 and expiry date was not reported), via an unspecified route of administration, on 30Jul2021 (age at vaccination: 33 years) , as a single dose for COVID-19 immunization. The patient''s medical history included lactation decreased from an unknown date and unknown if ongoing, polycystic ovarian syndrome from an unknown date and unknown if ongoing, headache from an unknown date and unknown if ongoing, and menstrual cramps from an unknown date and unknown if ongoing (PCOS). The Patient has not had symptoms associated with COVID-19. The patient was not pregnant and was not currently breastfeeding. Concomitant medications included folic acid taken for polycystic ovaries from 01May2020 to an unspecified stop date; ibuprofen taken for dysmenorrhea, start and stop date were not reported; inositol (MYO INOSITOL) taken for polycystic ovaries from 01May2020 to an unspecified stop date; and paracetamol taken for headache, start and stop date were not reported. Historical vaccine included received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ET8885 and expiry date was not reported), via an unspecified route of administration, on 26May2021, as a single dose for COVID-19 immunization and had passing a lot of large clots and menorrhagia (outcome of reaction/event recovered). The patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. On an unspecified date, the patient experienced felt faint, menorrhagia, light-headed, and menstrual bleeding. On 30Jul2021, the patient had vaccine is administered outside of the range 19 - 42 days after the first dose. On 01Aug2021, the patient experienced menstrual flooding. On 02Aug2021, the patient experienced very heavy bleed started again. On 05Aug2021, the patient experienced passed very large clots. On 02Aug2021, very heavy bleed started again for 6 days and had to take tranexamic acid. Next menstrual cycle was normal. On 01Aug2021, Menstrual bleeding started unexpectedly but ''normal'' flow. On 05Aug2021, passed very large clots & heaving bleeding. Emptying menstrual cup every 15 minutes. Became very light-headed and felt faint. Took tranexamic acid to stop the heavy bleeding. On 06Aug2021, still passing some smaller clots and heavy flow but continuing to take tranexamic acid. Menorrhagia used to be normal for me but through supplements & diet changes she had regulated her period for the past 12 months and have only suffered with very heavy bleeding once since May/June 2020 prior to her Covid vaccinations and it has rarely been as bad as it has been post vaccinations. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 28Jul2021 No - Negative COVID-19 test. Therapeutic measures were taken as a result of the events. Outcome of the event menstrual bleeding, felt faint, and menorrhagia was recovered on an unspecified date, menstrual flooding was not recovered and for all other events, it was unknown. No follow-up attempts are possible, No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101022292 same patient same product different dosage and different event.


VAERS ID: 1593083 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Cough, Dyspnoea, Fatigue
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101014766

Write-up: Coughing; Chest tightness; Exhaustion; Breathing difficult; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108061011403330-AFA7U. Safety Report Unique Identifier GB-MHRA-ADR 25764191. A 20-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 30Jul2021 at age of 20-year-old (Lot Number: FD8813) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Breathing becomes difficult, even if he just go up the stairs. Patient is not enrolled in clinical trial. The patient experienced breathing difficult on 30Jul2021 with outcome of not recovered, coughing on 05Aug2021 with outcome of not recovered, chest tightness on 31Jul2021 with outcome of not recovered, exhaustion on 31Jul2021 with outcome of not recovered. Events were medically significant. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1593142 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-27
Onset:2021-07-30
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chest scan, Crohn's disease, Endoscopy, Fatigue, Heart rate, Heart rate increased, Inflammatory bowel disease, Lymphadenopathy, Mouth ulceration, Ocular hyperaemia, Pyrexia, SARS-CoV-2 test, Stomach scan
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal premalignant disorders (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Ischaemic colitis (broad), Glaucoma (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Dehydration (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Inflammatory bowel disease
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: Chest scan; Result Unstructured Data: Test Result:Unknown results; Test Name: endoscopy; Result Unstructured Data: Test Result:Unknown results; Test Name: high heart rate; Result Unstructured Data: Test Result:high; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: stomach scan; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC202101014729

Write-up: inflammatory bowel disease; fever; swollen glands; bowel urgencies; red eyes; exhaustion; mouth ulcers; high heart rate; Crohn''s; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108061630462070-G6E1X, Safety Report Unique Identifier GB-MHRA-ADR 25766453. A 22-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 27Jun2021 at dose 1, single for COVID-19 immunisation. Medical history included ongoing inflammatory bowel disease, 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 swollen glands, bowel urgencies, exhaustion, fever, high heart rate, mouth ulcers, red eyes. Treated in hospital and later diagnosed with inflammatory bowel disease (Crohns) on 30Jul2021. 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 chest scan, stomach scan, endoscopy was unknown results, sars-cov-2 test was negative (No - Negative COVID-19 test), heart rate was high. The outcome of the event Crohn''s was resolving, the outcome of the other events was unknown. No follow-up at tempts are possible, information about Lot/Batch number cannot be obtained. No further information is expected.


VAERS ID: 1593238 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Chills, Fatigue, Lymphadenopathy, Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (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: ALLOPURINOL; FLUCONAZOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abscess; Gout; Rheumatoid arthritis (Taking regular medicines for RA (or other types of arthritis except osteoarthritis))
Allergies:
Diagnostic Lab Data: Test Date: 20210805; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101014489

Write-up: shaking; fever; fatigue; aching back and arms; aching back and arms; chills/shivering; Ache; Swollen glands/tender; This is a spontaneous report from a contactable Consumer (patient). This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202108062237253510-IQUO4, Safety Report Unique Identifier GB-MHRA-ADR 25768857. A 40-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EY5456), via an unspecified route of administration at single dose on 30May2021 and the second dose (lot number unknown) at single dose on an unspecified date for COVID-19 immunization. Medical history included rheumatoid arthritis, taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthritis), gout, abscess. Patient has not had symptoms associated with COVID-19. Concomitant medications included allopurinol taken for gout, low dose (100 mg day) for several years; fluconazole taken for abscess from 16Jul2021 to 23Jul2021; taking regular medicines for rheumatoid arthritis. The patient experienced shaking, fever, fatigue, aching back and arms on an unspecified date; ache, chills/shivering and swollen glands/tender on 30Jul2021. Clinical course: 5 days after having the second dose I had severe fatigue and aching back and arms, followed by shaking and chills as though coming down with a fever. This only lasted a night and a day after which I felt better, but my armpit glands have remained swollen and tender since. It has now been 12 days since my second dose and I still have swollen armpit glands. 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: negative on 05Aug2021 No - Negative COVID-19 test. The outcome of shaking, fever, fatigue and aching back and arms was recovered on an unspecified date, of chills/shivering and ache was recovered on 01Aug2021, of swollen glands/tender was not recovered. Serious criteria for the case was reported as medical significant. No follow-up attempts are possible, information about lot/batch number of the second dose cannot be obtained. No further information is expected.


VAERS ID: 1593307 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Disturbance in attention, Dizziness, Fatigue, Hangover, Headache, Loss of personal independence in daily activities, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant (The ONS study on Covid); Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:I had no covid marker; Test Date: 20210720; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 20210802; Test Name: Rapid Antifen tests; Result Unstructured Data: Test Result:unknown result; Test Date: 20210805; Test Name: Rapid Antifen tests; Result Unstructured Data: Test Result:unknown result
CDC Split Type: GBPFIZER INC202101014891

Write-up: nauseous; feel it is harder to focus; Headache; Nausea; Dizziness; hangover; could do my usual activities; Tiredness; This is a spontaneous report from a contactable consumer (patient). The regulatory authority report number is GB-MHRA-WEBCOVID-202108071301062540-WBEO7. Safety Report Unique Identifier GB-MHRA-ADR 25770460. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 30Jul2021 (Batch/Lot Number: FD8813) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included suppressed lactation, clinical trial participant. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Patient received the first dose of BNT162B2 on unknown date. The patient''s concomitant medications were not reported. I felt very tired in the following hours (Friday 30) on 30Jul2021. On Sunday (01Aug2021), I felt as if I had a slight hangover but could do my usual activities. On Monday I felt as if I had a huge hangover. I was tired, nauseous, I had a terrible headache. It had then improved but I''m constantly feeling tired and have moderate headaches (which I do NEVER have usually). I also feel it is harder to focus (which is quite problematic as my job is to think). Patient also experienced nauseous on unknown date and dizziness on 02Aug2021. Events were reported as serious with criteria of other medically significant and disability. Patient has not tested positive for COVID-19 since having the vaccine. I always had negative results since November and the blood test said I had no covid markers before I had the vaccine. "Rapid Antifen tests on Monday 2 August and Thursday 5." Patient had COVID-19 virus test on 20Jul2021 with negative result. Outcome of event tiredness was not recovered, of nausea (happened on 02Aug2021) was recovered on 03Aug2021, of headache was recovering, of Hangover and nauseous on unknown date was recovered on unknown date, of dizziness was recovered with sequel, of others was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1593341 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-30
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210725; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101014732

Write-up: agony; Late period; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108071843370580-O6XHX, Safety Report Unique Identifier GB-MHRA-ADR 25770853. A 35-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ff3319), via an unspecified route of administration on 21Jul2021 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 previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 Immunization. The patient was a week late on her period (30Jul2021), she was in agony, there''s no chance of pregnancy, she was bloated and ready to come on her period but it''s not happening. She spotted for a few days after her vaccine but have had no period since being due. 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 was negative on 25Jul2021 (No - Negative COVID-19 test). The outcome of the event Late period was not resolved, the outcome the other event was unknown. No follow up attempts are possible. No further information is expected.


VAERS ID: 1593358 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Amenorrhoea, Menstrual disorder, Postmenopausal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101014701

Write-up: menstrual bleeding; all periods; Menstruation abnormal; 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-202108072116116940-37JZJ, Safety Report Unique Identifier GB-MHRA-ADR 25770983. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration on 28Jul2021 as dose 2, single for COVID-19 immunisation. Medical history included pregnancy. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test. The patient''s concomitant medications were not reported. Reporter stated that, ongoing menstrual bleeding. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 1 single for COVID-19 immunization. On an unspecified date, the patient experienced all periods, menstrual bleeding. on 30Jul2021 patient experienced menstruation abnormal. ongoing menstrual bleeding. That was uncommon as the Implant was used for contraception and all periods have stopped previously. Adverse reaction did not occur as a result of an exposure during pregnancy. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of event Menstruation abnormal was recovered on 07Aug2021 and outcome of other events was recovered on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1593478 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Cold sweat, Diarrhoea, Dizziness, Dizziness postural, Headache, Nausea, SARS-CoV-2 test, Sensory loss, Tenderness, Visual impairment
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DESOGESTREL; SUMATRIPTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine
Allergies:
Diagnostic Lab Data: Test Date: 20210705; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101012745

Write-up: Stomach upset; Dizziness on standing up; Vision abnormal; Felt faint; Cold sweat; Sensation loss; Nausea; Headache; Tenderness; Diarrhoea; This is a solicited report from the RA Yellow Card Vaccine Monitor program from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-YCVM-202107141349343680-6UG45, Safety Report Unique Identifier GB-MHRA-ADR 25757778. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot Number: FF3319), via an unspecified route of administration at single dose on 30Jul2021 (at age of 17 year old) for COVID-19 vaccination. Medical history included migraine. Patient had no symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Patient last menstrual period date is 03Jul2021. Concomitant medications included desogestrel taken for contraception from 17Feb2021 to an unspecified stop date; sumatriptan taken for migraine from 31Jan2021 to an unspecified stop date. The patient experienced diarrhoea and, tenderness on 30Jul2021, stomach upset, nausea, dizziness on standing up, vision abnormal, felt faint, cold sweat, sensation loss and headache on 01Aug2021. Events were reported as medical significant. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 05Jul2021. Patient was not enrolled in clinical trial. The outcome of events nausea, vision abnormal, felt faint, cold sweat and sensation loss was recovered on 01Aug2021, the outcome of rest events was not recovered. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the current available information and the strong drug event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events tenderness, abdominal discomfort, dizziness postural, vision impairment, cold sweat, sensory loss, diarrhoea, nausea and headache cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1593551 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004492 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Burning sensation, Feeling hot, Hypoaesthesia oral, Loss of consciousness, Pain in extremity, Peripheral swelling, Skin discolouration, Vaccination site joint movement impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

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

Write-up: This case was received via European Medicines Agency (Reference number: 765875) on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS , PERIPHERAL SWELLING, BURNING SENSATION , HYPOAESTHESIA ORAL , PAIN IN EXTREMITY , SKIN DISCOLOURATION , FEELING HOT and ARTHRALGIA in a 23-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004492) for COVID-19 vaccination. No Medical History information was reported. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. On 30-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS, PERIPHERAL SWELLING , BURNING SENSATION (seriousness criterion medically significant), HYPOAESTHESIA ORAL(seriousness criterion medically significant), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (seriousness criterion medically significant), PAIN IN EXTREMITY (seriousness criterion medically significant), SKIN DISCOLOURATION , FEELING HOT (seriousness criterion medically significant) and ARTHRALGIA (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS , PERIPHERAL SWELLING , BURNING SENSATION, HYPOAESTHESIA ORAL , VACCINATION SITE JOINT MOVEMENT IMPAIRMENT, PAIN IN EXTREMITY, SKIN DISCOLOURATION FEELING HOT and ARTHRALGIA had not resolved. Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Seriousness criteria for all the events were updated from hospitalization to medically significant; 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: 1593553 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF7481 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101016470

Write-up: Post-dose anaphylactic shock 1 dose Comirnaty Pfizer-Biontech vaccine right arm. Upper limb skin erythema cyanosis and dyspnoea; This is a spontaneous report from a contactable physician from the Regulatory Authority. The regulatory authority number IT-MINISAL02-766210. A 22-years-old female patient received bnt162b2 (COMIRNATY; Solution for injection, Lot Number: FF7481), intramuscular, administered in arm right on 30Jul2021 (at the age of 22-years-old) as dose 1, single for Covid-19 Immunisation. The patient medical history and concomitant medications were not reported. It was reported that post-dose anaphylactic shock 1 dose Comirnaty Pfizer BioNTech and upper limb skin erythema cyanosis and dyspnea on 30Jul2021. The event caused hospitalization. The outcome of event was recovered in 2021.


VAERS ID: 1593564 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004492 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Accidental underdose, Arthralgia, Dysentery, Headache, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Accidental under dose; This case was received via Medicines Agency (Reference number: 767763) on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE, PYREXIA, DYSENTERY, VOMITING and ARTHRALGIA in a 12-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004492) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 29-Jul-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .3 milliliter in total. On 30-Jul-2021, the patient experienced HEADACHE (seriousness criterion disability), DYSENTERY (seriousness criteria disability and medically significant), VOMITING (seriousness criterion disability) and ARTHRALGIA (seriousness criterion disability). On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Accidental under dose). At the time of the report, HEADACHE PYREXIA DYSENTERY VOMITING ARTHRALGIA and ACCIDENTAL UNDERDOSE (Accidental under dose) had resolved. Concomitant product use was not provided. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the events other than accidental underdosage, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per SD Authority reporting. Events seriousness per assessment by Authority. Event of underdosage added. Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Additional information received on 12-Aug-2021: Non Significant follow-up; Reporter''s Comments: Nessuna; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the events other than accidental underdosage, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per SD Authority reporting. Events seriousness per assessment by Authority. Event of underdosage added.


VAERS ID: 1593600 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2625 / 1 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLEXANE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clostridium difficile infection; Muscle atrophy; Renal insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101061885

Write-up: Pulmonary embolism; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [-MINISAL02-770435]. A 63-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 29Jul2021 (Lot Number: FE2625) as dose 1, single for covid-19 immunisation. Medical history included Clostridium difficile infection, muscular hypotrophy, and renal insufficiency. Concomitant medication included enoxaparin sodium (CLEXANE) taken for an unspecified indication, start and stop date were not reported. The patient previously took vancomicina [vancomycin]. Approximately 1 day after vaccine inoculation (30Jul2021), the patient experienced pulmonary embolism. The event was assessed as life threatening. Timely resuscitation maneuvers were undertaken with consequent transfer to the resuscitation center. The referring doctor informs us that on 10Aug2021, the patient is improving. No follow-up at tempts are possible. No further information is expected. Batch/Lot numbers has been obtained. ; Reporter''s Comments: RLFV 12Aug2021 Suspect vaccine Comirnaty (PFIZER). Booster dose number 1.


VAERS ID: 1593612 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Feeling hot, Joint range of motion decreased, Paralysis, Swelling, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: KIPRES; SYMBICORT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchial asthma; Deafness; Mutism
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101007562

Write-up: the upper limbs could not be moved; vaccination site pain; local feeling hot; swelling; prominent shoulder joint range of motion limitation Grade III; This is a spontaneous report from a contactable physician. A non-pregnant 33-year-old female patient received the second single dose of BNT162b2 (COMIRNATY, solution for injection, lot number unknown as not available/provided to reporter at the time of report completion) intramuscularly in the left arm on 30Jul2021 at 11:30 (the day of vaccination, at the age of 33-years-old) at dose 2, single for COVID-19 immunization. Other medical history included asthma bronchial and the patient was deaf and mute. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient concomitant medications included montelukast sodium (KIPRES) and budesonide, formoterol fumarate (SYMBICORT), reported as drugs received within 2 weeks of vaccination. On 09Jul2021 (the day of the first vaccination, at the age of 33-years-old), the patient previously received the first single dose of BNT162b2 intramuscularly in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jul2021 at 13:00 (1 hour and 30 minutes after the vaccination), the patient experienced vaccination site pain and the upper limbs could not be moved. On 30Jul2021, the patient experienced local feeling hot, swelling, prominent shoulder joint range of motion limitation Grade III. The clinical course of the adverse events was as follows: from 13:00 on 30Jul2021, the patient experienced vaccination site pain and the upper limbs could not be moved. Around 14:30 on 30Jul2021, the patient visited the hospital. The patient experienced local feeling hot, swelling, prominent shoulder joint range of motion limitation Grade III. The patient had no redness. The patient was prescribed acetaminophen 300 mg for 10 doses. After that, the patient did not need to come to the hospital. The reporter stated the events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender''s Comments: Based on the current available information and the strong drug event temporal association,a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1593738 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 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: JPTAKEDA2021TJP072368

Write-up: This case was received. This case, initially reported On an unknown date, body temperature before the vaccination: Unknown. On 28-Jul-2021, in the afternoon, the patient received the 1st dose of this vaccine. On 30-Jul-2021, around 03:00, since precordial pain developed, and pain worsened; thus, the patient was urgently taken to the hospital after an emergency call was made. Although there was no problem in the patient''s blood pressure, ST elevation was seen widely in the upper limb and chest leads of electrocardiogram, and CPR 4.96 were noted. The patient was diagnosed with acute myocarditis and was hospitalized. On an unknown date, the patient remained in the hospital for rest and follow-up, but the myocarditis resolved spontaneously, chest pain improved, and hemodynamics stabilized. On 08-Aug-2021, the patient was discharged from the hospital. The outcome of acute myocarditis (total chest pain) was reported as resolving. Follow-up investigation will be made. Company Comment:The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. 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.; Reporter''s Comments: The patient was a young person with no underlying disease and experienced new episode of acute myocarditis approximately 2 days after the vaccination. Acute myocarditis is highly likely to have been induced by the vaccination. The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1593838 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dysarthria, Dyspnoea, Hypoaesthesia, SARS-CoV-2 test, Vital signs measurement
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: COVID-19 antigen test; Result Unstructured Data: negative; Test Date: 202107300316; Test Name: Vital signs measurement; Result Unstructured Data: normal; Test Date: 202107301330; Test Name: Vital signs measurement; Result Unstructured Data: stable
CDC Split Type: PHJNJFOC20210838916

Write-up: CHILLS AND DIFFICULTY OF BREATHING; SLURRING SPEECH; CHILLS AND DIFFICULTY OF BREATHING; NUMBNESS; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300099076] concerned a 32 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A) 0.5 ml, 1 total, administered on right deltoid on 30-JUL-2021 at 14:40 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, at 01:30 PM, the patient arrived at vaccination site (physically well, no complaints, vital signs were normal and ambulatory. She was examined/ screened and approved for vaccination. At 03:00 PM, at the encoding area, patient had no signs of adverse effect. At 03:15 PM, the patient experienced chills and difficulty of breathing, slurring speech and numbness and was hospitalized. At 03:16 PM, at the observation area, vital signs were normal. The physician was notified and assessment was done. The patient was brought to the hospital and was then admitted complaining of numbness of Left part of the body and slurring speech in addition to recent complaints. The rapid antigen test was negative. The lab request was given for blood urea nitrogen, creatinine, sodium, potassium, and urine analysis and computerized tomogram scan. There were still ongoing investigation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and difficulty of breathing, numbness and slurring speech was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210838916-covid-19 vaccine ad26.cov2.s-difficulty of breathing, slurring speech . 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). 20210838916-covid-19 vaccine ad26.cov2.s- chills, numbness. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1593907 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Headache, Pain, Pyrexia, Visual impairment
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210837860

Write-up: MUSCLE ACHES THROUGHOUT THE BODY; BLURRED VISION; SHORTNESS OF BREATH; FEVER 38.3C; HEADACHE; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-T202107-5695] concerned an 18 year old male. The patient''s weight was 66 kilograms, and height was 189 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: EC0898 expiry: UNKNOWN) 0.5 ml, administered 1 total on 30-JUL-2021 for covid-19 immunization. No concomitant medications were reported. On 30-JUL-2021, the patient experienced muscle aches throughout the body, blurred vision, shortness of breath, fever 38.3 degree Celsius and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision, shortness of breath, fever 38.3 C, and headache on 31-JUL-2021, and the outcome of muscle aches throughout the body was not reported. This report was serious (Disability Or Permanent Damage).; Sender''s Comments: V0: 20210837860- COVID-19 VACCINE AD26.COV2.S- muscle aches throughout the body, blurred vision, shortness of breath. 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). 20210837860-COVID-19 VACCINE AD26.COV2.S- fever 38.3 degree Celsius, headache. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1593981 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 30046701 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Fatigue, Palpitations, Presyncope, Pyrexia, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: This case was received via RA (Reference number: 068238) on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PRESYNCOPE, TREMOR, FATIGUE, PALPITATIONS, DYSPNOEA, PYREXIA and CHEST PAIN in a 22-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 30046701) for COVID-19 vaccination. The patient''s past medical history included No adverse event. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced PRESYNCOPE (seriousness criterion hospitalization), TREMOR (seriousness criterion hospitalization), FATIGUE (seriousness criterion hospitalization), PALPITATIONS (seriousness criterion hospitalization), DYSPNOEA (seriousness criterion hospitalization), PYREXIA (seriousness criterion hospitalization) and CHEST PAIN (seriousness criterion hospitalization). On 31-Jul-2021, PYREXIA had resolved. On 01-Aug-2021, CHEST PAIN had resolved. At the time of the report, PRESYNCOPE and TREMOR outcome was unknown and FATIGUE, PALPITATIONS and DYSPNOEA was resolving. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant products were reported. No treatment information provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of 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 events, a causal relationship cannot be excluded.


VAERS ID: 1594025 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Pulmonary embolism, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Medication errors (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: ADHD; Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101039354

Write-up: Got clots in the leg which later spread to the lungs, several pulmonary emboli; Got clots in the leg which later spread to the lungs, several pulmonary emboli; First dose on 16Jun2021 and second dose on 30Jul2021; This is a spontaneous report from a contactable other hcp. A 24-year-old male patient received second dose of bnt162b2 (COMIRNATY, Batch/Lot Number: FD6840), intramuscularly administered in Arm Left on 30Jul2021 at 01:00 at age of 24-year-old as single dose for covid-19 immunisation. The patient received first dose of bnt162b2 (COMIRNATY, Batch/Lot Number: FA4632), intramuscularly administered in Arm right on 16Jun2021 at 01:00 AM at age of 23-year-old as single dose for covid-19 immunisation. Patient had no known allergies. The patient had not received any other vaccine within 4 weeks. Medical history included attention deficit hyperactivity disorder (ADHD), obesity. Patient had unspecified concomitant medications. The patient experienced Got clots in the leg which later spread to the lungs, several pulmonary emboli on 31Jul2021 at 01:00, seriousness criteria were reported as hospitalization and life threatening. The events lead emergency room visit and physician office visit. The patient was hospitalized for Got clots in the leg which later spread to the lungs, several pulmonary emboli (thrombosis) for 7 days. Patient received treatment Blood thinning for the events. First dose on 16Jun2021 and second dose on 30Jul2021 was inappropriate schedule of product administration. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of event Got clots in the leg which later spread to the lungs, several pulmonary emboli was recovering, of First dose on 16Jun2021 and second dose on 30Jul2021 (inappropriate schedule of product administration) was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1622871 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Malaise, Nausea, Pyrexia
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)

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: BEMODERNATX, INC.MOD20212

Write-up: This case was received via RA (Reference number: 103694) on 13-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE, HEADACHE, PYREXIA, CHILLS , NAUSEA and MALAISE in a 24-year-old female patient who received mRNA-1273 for COVID-19 vaccination. No Medical History information was reported. On 30-Jul-2021, the patient received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced FATIGUE (seriousness criterion disability), HEADACHE (seriousness criterion disability), PYREXIA (seriousness criterion disability), CHILLS (seriousness criterion disability), NAUSEA (seriousness criterion disability) and MALAISE criterion disability). On 02-Aug-2021, FATIGUE, HEADACHE , NAUSEA and MALAISE was resolving. Concomitant medication was not provided. Treatment medication was not provided. 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.; Reporter''s Comments: Treatment ibuprofen. Evolution of the ADR 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.


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