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From the 7/23/2021 release of VAERS data:

Found 506,830 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 280 out of 5,069

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VAERS ID: 1421683 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XD975 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Encephalitis
SMQs:, Noninfectious encephalitis (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? 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: ESJNJFOC20210640089

Write-up: ENCEPHALITIS; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, ES-AEMPS-903562] concerned a 58 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD975 expiry: unknown) dose was not reported, 1 total, administered on 24-MAY-2021 for covid-19 vaccination. No concomitant medications were reported. On 01-JUN-2021, the patient experienced encephalitis. On an unspecified date, the patient was hospitalized. The number of days of hospitalization was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of encephalitis was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: 20210640089-Covid-19 vaccine ad26.cov2.s-Encephalitis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1421966 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885/V1188 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Hyperhidrosis, Maternal exposure during pregnancy, Myalgia, Pyrexia, SARS-CoV-2 test, Scan, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID; LABETALOL
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (for 2.5 weeks); Hypertension; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210115; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test; Test Name: scan; Result Unstructured Data: Test Result:normal
CDC Split Type: GBPFIZER INC2021671416

Write-up: Generalized muscle aches; Headache; Sweating; Maternal exposure during pregnancy/exposed to the medicine second-trimester (13-28 weeks); Pain injection site; Fatigue; fever; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106070949227550-LJY8A. A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ET8885/V1188), via an unspecified route of administration on 05Jun2021 (at the age of 32 years old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included lactation decreased, ongoing pregnancy, hypertension, COVID-19 from Jan2021 to Jan2021 for 2.5 weeks. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not currently breastfeeding. Concomitant medications included folic acid taken for vitamin supplementation and pregnancy and labetalol taken for hypertension both from 01Feb2021. The mother reported she became pregnant while taking bnt162b2. The mother was 2 trimester pregnant at the onset of the event. The patient experienced fever on Jun2021; pain injection site and fatigue on 05Jun2021; generalized muscle aches, headache, and sweating on 06Jun2021. The events were medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test was yes - positive COVID-19 test on 15Jan2021 and scan was normal on an unspecified date. Therapeutic measures were taken as a result of generalized muscle aches and headache and included treatment with paracetamol. Outcome of fever, generalized muscle aches, and sweating was recovered on Jun2021; of the pain injection site and headache was recovering; and of the fatigue was not recovered. The clinical course was reported as follows: Took normal dose of paracetamol, helped with headache and muscle pain for a couple hours, symptoms returned. 2 days post-vaccine there is a less-intense but persistent headache and soreness of left arm (injection arm). All other symptoms have resolved. Did not check for fever during sweating episodes. Patient has not tested positive for COVID-19 since having the vaccine. Patient was exposed to the medicine Second-trimester (13-28 weeks). Details of scans or investigations: normal No follow-up attempts are possible. No further information is expected.


VAERS ID: 1422192 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

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

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

Write-up: High temperature; Muscle ache; Headache; Fatigue; Nausea; Joint ache; Injection site painful and swollen; Injection site painful and swollen; This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (High temperature), MYALGIA (Muscle ache), HEADACHE (Headache), FATIGUE (Fatigue), NAUSEA (Nausea), ARTHRALGIA (Joint ache) and VACCINATION SITE SWELLING (Injection site painful and swollen) in a 25-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. Concomitant products included PARACETAMOL from 11-Jun-2021 to an unknown date for Pain relief. On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and ARTHRALGIA (Joint ache) (seriousness criterion medically significant). In June 2021, the patient experienced VACCINATION SITE SWELLING (Injection site painful and swollen) (seriousness criterion medically significant) and VACCINATION SITE PAIN (Injection site painful and swollen). At the time of the report, PYREXIA (High temperature), MYALGIA (Muscle ache), HEADACHE (Headache), FATIGUE (Fatigue), NAUSEA (Nausea) and ARTHRALGIA (Joint ache) had not resolved and VACCINATION SITE SWELLING (Injection site painful and swollen) and VACCINATION SITE PAIN (Injection site painful and swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were provided. The patient reported that it was difficult to carry out daily tasks due to fatigue quickly and needed to sit and rest. The muscle aches began later than fatigue. Reportedly, the injection site was painful and swollen but not hot or discolored. No treatment information was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the reported 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 reported events, a causal relationship cannot be excluded.


VAERS ID: 1422482 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Loss of consciousness, Malaise
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: ITJNJFOC20210638611

Write-up: PARTIAL LOSS OF CONSIOUSNESS; GENERAL MALAISE WITH LYPOTHYMIC EPISODE; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, IT-MINISAL02-741424] concerned an 18 year old female. The patient''s weight was 60 kilograms, and height was 160 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: XD985 expiry: UNKNOWN) 0.5 ml, 1 total, administered on 01-JUN-2021 for covid-19 immunization. No concomitant medications were reported. On 01-JUN-2021, the patient experienced partial loss of consciousness and state of general malaise with lypothymic episode. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from partial loss of consciousness, and general malaise with lypothymic episode on 01-JUN-2021. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210638611 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- loss of consciousness-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). V0:20210638611 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- malaise-This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1423186 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Chills, Dizziness, Hypertension, Hypoaesthesia, Malaise, Nausea
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRITICUM
Current Illness:
Preexisting Conditions: Comments: Patient had no known allergies. No history of disease.
Allergies:
Diagnostic Lab Data: Test Date: 20210618; Test Name: Blood pressure; Result Unstructured Data: 160/110 mmHg; Test Date: 20210619; Test Name: Blood pressure; Result Unstructured Data: 100/90 mmHg
CDC Split Type: PTJNJFOC20210643807

Write-up: NUMBNESS IN LEFT HAND; NAUSEA; HYPERTENSION; FEELING GENERALLY UNWELL; CHILLS; DIZZINESS; This spontaneous report received from a patient concerned a 53 year old female. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included patient had no known allergies. no history of disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD974, and expiry: UNKNOWN) frequency 1 total, dose was not reported, administered on 18-JUN-2021 to left arm for prophylactic vaccination. Concomitant medications included trazodone hydrochloride. On 18-JUN-2021, the patient experienced hypertension, chills and was feeling generally unwell. On 18-JUN-2021, the laboratory data included: Blood pressure 160/110 mmHg. On 19-JUN-2021, the patient experienced numbness in left hand and nausea. On an unspecified date in Jun-2021, the patient experienced dizziness. On 19-JUN-2021, the laboratory data included: Blood pressure ) 100/90 mmHg. Treatment medications (dates unspecified) included: ethyl loflazepate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 18-JUN-2021, had not recovered from nausea, hypertension, numbness in left hand, and feeling generally unwell, and the outcome of dizziness was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: 20210643807-COVID-19 VACCINE AD26.COV2.-hypertension. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1424812 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5456 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Fatigue, Iron deficiency anaemia, Maternal exposure during pregnancy, Nausea, Pyrexia, Sinus headache, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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: FOLIC ACID
Current Illness: Pregnancy (Estimated due date: 05Nov2021)
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021677423

Write-up: Maternal exposure during pregnancy; Anaemia on iron supplements; Fever; Fever chills; Sinus headache; Nausea; Vomiting; Breathlessness; Tiredness This is a report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-YCVM-202106082057283700-8V3WA, Safety Report Unique Identifier GB-MHRA-ADR 25441112. A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Jun2021 (Lot Number: EY5456) as single dose for COVID-19 immunisation. Medical history included ongoing pregnancy Estimated due date: 05Nov2021, suspected covid-19 from an unknown date and unknown if ongoing (Unsure when symptoms started and stopped), vitamin supplementation from an unknown date and unknown if ongoing. Patient not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient is not currently breastfeeding.Concomitant medication included folic acid (FOLIC ACID) taken for vitamin supplementation, start and stop date were not reported. The patient experienced maternal exposure during pregnancy (medically significant) on an unspecified date with outcome of unknown, fever) (medically significant) on 02Jun2021 and stop date on 03Jun2021 with outcome of recovered, fever chills (medically significant) on 02Jun2021 and stop date on 03Jun2021 with outcome of recovered, sinus headache (medically significant) on 02Jun2021 and stop date on 02Jun2021 with outcome of recovered, nausea (medically significant) on 02Jun2021 and stop date on 03Jun2021 with outcome of recovered, vomiting (medically significant) on 02Jun2021 and stop date on 03Jun2021 with outcome of recovered, breathlessness (dyspnoea) (medically significant) on 02Jun2021 and stop date on 06Jun2021 with outcome of recovered, tiredness (medically significant) on 01Jun2021 and stop date on 03Jun2021 with outcome of recovered, anaemia on iron supplements (iron deficiency anaemia) (medically significant) on an unspecified date with outcome of unknown. The mother reported she became pregnant while taking bnt162b2. The mother was 17 Weeks pregnant at the onset of the event. The mother was due to deliver on 05Nov2021. The reporter''s assessment of the causal relationship of all 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, all the reported events except sinus headache, breathlessness, and anemia deficiency are related to the suspect product BNT162B due to the plausible drug-event temporal association. This case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer drug 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: 1425252 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0221 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Blood test, Blood thyroid stimulating hormone normal, Chest pain, Dizziness, Fatigue, Hyperhidrosis, Hypoaesthesia, Insomnia, Mobility decreased, Myalgia, Nausea, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Levothyroxine 100mcg daily Vitamin D 2000 UI daily Vitamin K 100mg daily Vitamin C 500mg daily
Current Illness: Total thyroidectomy due to thyroid cancer (2016), currently on levothyroxine 100mcg daily
Preexisting Conditions: Thyroid cancer
Allergies: Pollen, apples, plums
Diagnostic Lab Data: June 9 blood test from the ER
CDC Split Type:

Write-up: 10 minutes after the shot I developed extreme nausea and fatigue, I was sweating a lot like never before and felt dizzy. The staff at vaccination site gave me ice pack and water and asked to lie down until I feel better. After an hour there I didn''t feel much better but decided to go home. While walking every step made my knees hurt. At home I didn''t feel better and I was bedridden for about 3 days and had barely enough energy to go to move around. Then I felt fine for 2 days but shortly after the same side effects kicked back in, but stronger including burning sensation in my chest, pain in my chest and muscle aches. Every time I tried walking my knees were hurting again and I felt exhausted. I barely had any energy to speak or keep my eyes open. I called vaccination hotline and they said that sometimes side effects can be delayed. I couldn''t sleep the following night and had to go to the ER because I started to feel worse. At the ER they checked my TSH and it was much higher than 2 months before the shot. It went up from 2.0 to 9.0 and I''m positive didn?t adjust the dose of my daily Levothyroxine medication before vaccination. Currently I still don''t feel as good as I felt before taking the vaccine. My energy levels are low and I''m having randomised body aches, and my left leg goes numb often.


VAERS ID: 1431856 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Blood test, Dizziness, Heart rate increased, Loss of consciousness, Maternal exposure during pregnancy, Pain in extremity, Syncope
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), Retroperitoneal fibrosis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CYCLIZINE; FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Morning sickness
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: blood tests; Result Unstructured Data: Test Result:result not reported
CDC Split Type: GBPFIZER INC2021692904

Write-up: blacked out; Fainting; after an hour felt very light headed and had to sit down; tummy pains; Maternal exposure during pregnancy; heart did feel like it was bearing fast; achy arm; 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-202106111625590060-GXWU4. Safety Report Unique Identifier: GB-MHRA-ADR 25460094. A 33-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 10Jun2021 (Batch/Lot Number: EW3143) (age at vaccination: 33 years old) as single dose for COVID-19 immunization. The patient was pregnant. She had morning sickness. Concomitant medication(s) included cyclizine (CYCLIZINE) taken for morning sickness, start and stop date were not reported; folic acid (FOLIC ACID) taken for vitamin supplementation, start and stop date were not reported. This pregnant patient was exposed to the vaccine during second-trimester (13-28 weeks). The patient experienced achy arm during the night (date unspecified, on 10Jun2021 or 11Jun2021). On 11Jun2021, she woke up in the morning and had breakfast. After an hour she felt very light headed and had to sit down, had tummy pains. Her partner sat with her and then the patient blacked out for a few moments, fainting. She then came back around. They called general physician (GP). They spoke to GP and explained sequence of events. The patient also reported that heart did feel like it was bearing fast as well. Sitting up would cause her to feel light headed again so had to stay led down. GP said to come in for blood tests. Bloods taken at GP surgery, no results provided. Seriousness criterion of this report was provided as other medically important condition. The patient was recovering from events dizziness, blacked out and fainting. The outcome of the other events was unknown. The patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1431874 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Galactostasis, Mastitis, Maternal exposure during pregnancy, SARS-CoV-2 test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Functional lactation disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN [ACETYLSALICYLIC ACID]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Mastitis; Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021693033

Write-up: Mastitis; blocked milk ducts; Vaccinated at 37 weeks pregnant; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106111752395960-BNDPQ. Sender''s (Case) Safety Report Unique Identifier: GB-MHRA-ADR 25460659. A female patient of an unspecified age received BNT162B2, dose 1 via an unspecified route of administration on 01Jun2021 (Batch/Lot Number: Not known) as single dose for covid-19 immunisation. Medical history included mastitis. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medication included acetylsalicylic acid (ASPIRIN) taken for Pre-eclampsia toxemia from 03Dec2020 to an unspecified stop date. The patient experienced mastitis and blocked milk ducts on 02Jun2021 with outcome of recovered on 04Jun2021. Vaccinated at 37 weeks pregnant and not breastfeeding. Had mild mastitis/blocked milk ducts on vaccine side following day. Quickly resolved with massage and expression. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on an unspecified date. Patient had not tested positive for COVID-19 since having the vaccine. This is a non-serious case provided by Health Authority assessed by reporter. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1434660 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Impaired work ability, Maternal exposure during pregnancy, Pain, SARS-CoV-2 test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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: BECLOMETASONE DIPROPIONATE; FOLIC ACID; FORMOTEROL FUMARATE DIHYDRATE
Current Illness: Pregnancy (Patient was exposed to the medicine second trimester (13-28 weeks).)
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; Comments: Negative
CDC Split Type: GBPFIZER INC2021700839

Write-up: Headache; Maternal exposure during pregnancy; Affected my ability to work; pain; fatigue; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106131158079420-KULP3, Safety Report Unique Identifier GB-MHRA-ADR 25467281. A 34-years-old pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 05Jun2021 as dose 1, single dose for COVID-19 immunisation. The patient''s medical history included lactation decreased, ongoing pregnancy and asthma. Concomitant medication included beclometasone dipropionate taken for asthma; folic acid (400ug) taken for vitamin supplementation; formoterol fumarate dihydrate taken for an unspecified indication. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. On 05Jun2021, the patient was exposed to the vaccine in second trimester (13-28 weeks). On unspecified date in Jun2021, the patient experienced pain, fatigue and on 06Jun2021 experienced headache. The patient''s headache became worse on 08Jun2021. Has been occurring every day since with varying levels of pain. Fatigue was worse on 10Jun2021. Affected her ability to work. The patient underwent lab tests and procedures which included COVID-19 virus test: negative. The outcome of the event headache was not recovered, and 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: 1438524 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Maternal exposure during pregnancy, SARS-CoV-2 test, Vaccination site pain
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Date: 20210530; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021655396

Write-up: Maternal exposure during pregnancy/exposed to the medicine second trimester (13-28 weeks); Painful arm/Agonising pain in arm where injection received; This is a spontaneous report from a contactable consumer or other non-healthcare professional received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106030850050970-MZ1HZ. Safety Report Unique Identifier (GB-MHRA-ADR 25410409). A 35-years-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not known, expiration date was not reported), dose 1 via an unspecified route of administration, administered in arm on 01Jun2021 (at the age of 35-years-old) as 1st dose, single for COVID-19 immunization. Medical history included lactation decreased and ongoing pregnancy. Concomitant medications included folic acid supplementation. Patient had no symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient was not currently breastfeeding. Patient was not tested positive for COVID-19 since having the vaccine. On an unspecified date, the patient experienced maternal exposure during pregnancy. The patient was exposed to the medicine second trimester (13-28 weeks). She had painful arm on 01Jun2021. Agonising pain in arm where injection received. Constant through the night. Paracetamol was taken, ice applied for painful arm. The patient underwent lab tests and procedures which included COVID-19 virus test with result as no - negative covid-19 test on 30May2021. The outcome of event maternal exposure during pregnancy was unknown, while another event was recovering. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1438656 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (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: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Miscarriage; Pregnancy (Patient previously had pregnancy successful and had 1 child)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021715568

Write-up: Early miscarriage; Maternal exposure during pregnancy; miscarriage; wasn ? t aware of pregnancy prior to vaccine; 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-202106151156213550-BNLVJ. Safety Report Unique Identifier GB-MHRA-ADR 25476859. This consumer or other non hcp reported information for both mother and fetus/baby. This is a {enter maternal or fetus/baby} report. A 29-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 03Jun2021 (Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included abortion spontaneous and pregnancy (Patient previously had pregnancy successful and had 1 child). Patient no longer pregnant at the time of reporting. Concomitant medication included folic acid (Patient did not take folic acid supplement during pregnancy). Patient had 1 successful pregnancy with no issues previously. Patient has not had symptoms associated with COVID-19. Patient did not have a COVID-19 test. Patient was not enrolled in clinical trial. Patient was not currently breastfeeding. On an unspecified date in Jun2021, the patient had miscarriage and was not aware of pregnancy prior to vaccine. On 03Jun2021, the patient had maternal exposure during pregnancy (maternal exposure during pregnancy. On 11Jun2021, the patient had early miscarriage. On an unknown date in jun2021, the patient wasn''t aware of pregnancy prior to vaccine, had vaccine on the Thursday (03Jun2021), found out she was expecting the following Wednesday, thought to be around 4.5 weeks on the wednesday so would have been around 4 weeks at the time of the vaccine being administered. Patient was exposed to the medicine first-trimester (1-12 weeks). Patient miscarried on the Friday (11Jun2021). Details of scans or investigations: Miscarriage 1 week after covid jab. Wasn''t aware of pregnancy at the time but had positive test 2 days before miscarriage. Patient has not tested positive for COVID-19 since having the vaccine. Patient was unsure that the medicine had an adverse effect on any aspect of the pregnancy. Patient had another pregnancy test on Sunday (13Jun2021) and was negative. At the time of this report event early miscarriage was recovered on 12Jun2021 and other event outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be requested.


VAERS ID: 1439041 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: ITJNJFOC20210654945

Write-up: FAINTING AFTER ADMINISTRATION, PROMPTLY RESTORED. AFTER 10 DAYS THE APPEARANCE OF BRUISES ON LEGS BOTH SMALL AND MEDIUM BRUISES APPEARED ON THE LEGS CIRCUMFERENCE; This spontaneous report received from a physician via a Regulatory Authority [IT-MINISAL02-744831] concerned an 18-year-old female of unknown race and ethnicity. 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: 21C11-03 expiry: Unknown) 0.5 ml, 1 total, administered on 01-JUN-2021 for covid-19 immunisation. No concomitant medications were reported. On 01-JUN-2021, the patient experienced fainting after administration, promptly restored. After 10 days the appearance of bruises on legs both small and medium bruises appeared on the legs circumference. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fainting after administration, promptly restored. After 10 days the appearance of bruises on legs both small and medium bruises appeared on the legs circumference. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210654945-covid-19 vaccine ad26.cov2.s -fainting after administration, promptly restored. After 10 days the appearance of bruises on legs both small and medium bruises appeared on the legs circumference.. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1441141 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Abdominal pain upper, Chest pain, Cough, Decreased appetite, Dysphagia, Fatigue, Headache, Infectious mononucleosis, Investigation, Lip swelling, Lymphadenopathy, Nasal congestion, Nausea, Oropharyngeal pain, Pain, Pharyngeal disorder, Pyrexia, SARS-CoV-2 test, Streptococcus test
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: CONCERTA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: ADHD
Allergies:
Diagnostic Lab Data: Test Date: 20210617; Test Name: Mono test; Test Result: Positive ; Comments: Mono test (Unknown): Positive; Test Date: 20210610; Test Name: Covid test; Test Result: Negative ; Comments: Nasal Swab; Test Date: 202106; Test Name: strep tests; Test Result: Negative ; Comments: strep tests: Negative
CDC Split Type: CAPFIZER INC2021727797

Write-up: Mono test result back positive; fever on 7th day following the vaccine; Severe headache; body aches; fatigue; cough; stuffy nose; chest pains; throat pain; white patches on throat; difficulty swallowing; loss of appetite; swollen lymph nodes; upset stomach; Stomach pain; nausea; swollen lips; This is a spontaneous report from a contactable consumer (patient) and physician. A 15-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on the right arm on 03Jun2021 17:45 (at the age of 15-years-old) as dose 1, single for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD). The patient had no known allergies. Concomitant medication included ongoing methylphenidate hydrochloride (CONCERTA). The patient had no other vaccine in four weeks. The patient didn''t have COVID prior to vaccination. On 04Jun2021 12:00 PM, the patient experienced severe headache, body aches, fatigue for 3 days, cough, stuffy nose, chest pains, sore throat for 3 days, white patches on throat, difficulty swallowing along with a fever on the 7th day following the vaccine (on 10Jun2021). The patient had a COVID test (nasal swab) on 10Jun2021 and a Strep test in Jun2021; both were negative. The patient started antibiotics in Jun2021 as treatment. 4 days later (in Jun2021), the patient stated that the sore throat was worse along with loss of appetite, swollen lymph nodes and had an upset stomach. In Jun2021, the patient''s stomach pain, nausea, loss of appetite, fatigue, swollen lips, throat pain and fever continued, even with tramadol. In Jun2021, the patient had a mono test with a positive result 14 days after the vaccine (on 17Jun2021). The patient was going to an ultrasound on 18Jun2021 to check her spleen. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment of the events was done with antibiotics, ibuprophen, acetaminophen, and tramadol. It was reported that hospitalization was not prolonged (pending clarification). The outcome of the events was not recovered. Information on batch/lot number has been requested.


VAERS ID: 1448697 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Abscess limb, Maternal exposure during pregnancy, SARS-CoV-2 test, Scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? Yes
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: Pregnancy normal
Allergies:
Diagnostic Lab Data: Test Date: 20210618; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Date: 202106; Test Name: 12 weeks pregnancy scan; Result Unstructured Data: Test Result:revealed a missed miscarriage; Comments: revealed a missed miscarriage
CDC Split Type: GBPFIZER INC2021765614

Write-up: Maternal exposure during pregnancy first-trimester; Abscess leg; Miscarriage; This is a spontaneous report from a contactable consumer received from a regulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106221841103980-GXNB1, Safety Report Unique Identifier GB-MHRA-ADR 25521320. A 32-year-old female patient (pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05Jun2021 as a single dose for COVID-19 immunisation. The patient medical history included previous successful pregnancy. Patient had no symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medication included folic acid 400 microgram taken as Folic acid supplementation. The patient received first dose Pfizer covid vaccine on 05Jun2021, while approximately 8.5 weeks pregnant. Patient was exposed to the medicine first-trimester (1-12 weeks). No unexpected side effects experienced at the time and no pain or bleeding experienced in pregnancy, 12 weeks scan revealed a missed miscarriage, thought to have occurred at approximately 8.5 weeks, around the time of receiving the first Pfizer covid vaccine dose. On an unspecified date in Jun2021, the patient experienced abscess leg. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 test (sars-cov-2 test) on 18Jun2021, and result was negative. The reporter assessed the events as serious (medically significant, congenital anomaly). The outcome of the event abscess leg was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1448854 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-06
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, C-reactive protein, C-reactive protein increased, Chest X-ray, Chills, Decreased appetite, Echocardiogram, Electrocardiogram, Feeling abnormal, Headache, Magnetic resonance imaging heart, Myocarditis, Pericarditis, Pleural effusion, Pyrexia, SARS-CoV-2 test, Troponin, Troponin increased
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Dementia (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: SARS-CoV-2 infection (with mild symptoms)
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: Body temperature; Result Unstructured Data: Test Result:38-40 Centigrade; Comments: 5-6 days prior to her admission in the evenings she had fever reaching even 40 ?C; Test Date: 20210616; Test Name: chest X-ray; Test Result: Negative ; Comments: 09:58, Chest pa+right close-up shot: negative; Test Date: 202106; Test Name: crp; Result Unstructured Data: Test Result:increased; Test Date: 20210616; Test Name: echocardiography; Result Unstructured Data: Test Result:Heart cavities with normal width; Comments: 14:23, Opinion: Heart cavities with normal width and ventricular wall thickness. Good global systolic and diastolic left ventricular function. There is no segmental wall movement disorder. In the left ventricle there is sponatneous echocontrast. GLS reduced (-11,9), especially in the anterior and septal regions. Good right ventricular function. Vitium cannot be seen. On the diaphragmatic surface marked pericardial fluid.; Test Date: 20210618; Test Name: echocardiography; Result Unstructured Data: Test Result:GLS is still reduced; Comments: 13:54, Control echo: GLS is still reduced, same as before. Spontaneous echocontrast in the left ventricle cannot be seen. Maintained systolic left ventricular function.; Test Date: 20210616; Test Name: ecg; Result Unstructured Data: Test Result:in the III-aVF neg. Ts; Comments: in the III-aVF neg. Ts, otherwise no relevant deviation; Test Date: 20210617; Test Name: cardiac MRI; Result Unstructured Data: Test Result:Good left and right ventricular ejection fractions; Comments: 10:00, Opinion: Good left and right ventricular ejection fractions. Normal ventricular volumes. Clear MR sign indicating structural myocardial disease, acute myocarditis could not be identified.; Test Date: 20210614; Test Name: PCR; Test Result: Negative ; Test Date: 202106; Test Name: troponin; Result Unstructured Data: Test Result:increased
CDC Split Type: HUPFIZER INC2021753519

Write-up: acute peri-myocarditis; Pleural effusion; fever 38-40 degree C; her appetite is bad; feeling bad; mild pain in the region of the nape; chills; significantly increased CRP; high troponin; Acute pericarditis; This is a spontaneous report from a contactable physician. An 18-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 06Jun2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included COVID-19 from Mar2021 to Mar2021 with mild symptoms. The patient has no known internal medical disease, no surgery. The concomitant medications included contraceptive. The patient got her second Pfizer vaccination on 06Jun2021. A few days later in Jun2021, she developed fever, 38-40?C, she has dull headache in the region of the right nape. She was not coughing, there was no sputum discharge. There was no chest pain, shortness of breath, unconsciousness. Urine, stool normal. Her appetite and feeling are bad, there was no weight loss. PCR negative (14Jun2021) Referred to the hospital by the GP with suspected myocarditis. In the laboratory results CRP and Troponin were increased. In the ECG in the III-aVF neg. Ts, otherwise no relevant deviation. On 16Jun2021 09:58: Chest pa+right close-up shot: negative. On 16Jun2021 14:23: Echocardiography: Opinion: Heart cavities with normal width and ventricular wall thickness. Good global systolic and diastolic left ventricular function. There is no segmental wall movement disorder. In the left ventricle there is sponatneous echocontrast. GLS reduced (-11,9), especially in the anterior and septal regions. Good right ventricular function. Vitium cannot be seen. On the diaphragmatic surface marked pericardial fluid. On 17Jun2021 10:00. Cardiac MR: Opinion: Good left and right ventricular ejection fractions. Normal ventricular volumes. Clear MR sign indicating structural myocardial disease, acute myocarditis could not be identified. On 18Jun2021 13:54: Echocardiography control: Control echo: GLS is still reduced, same as before. Spontaneous echocontrast in the left ventricle cannot be seen. Maintained systolic left ventricular function. Applied therapy included ibuprofen, pantoprazole. The patient was admitted on 15Jun2021 20:37 and discharged on 18Jun2021 14:30. The events referring Emergency Care Unit. Diagnosis was myocarditis, fever, acute pericarditis, pleural effusion. Summary: In the medical history of the 18-year-old patient significant disease was not indicated. She received the 2nd Pfizer vaccination on 06Jun2021. A few days later she developed fever, 5-6 days prior to her admission in the evenings she had fever reaching even 40 ?C. It was accompanied by mild pain in the region of the nape and by chills, she had no other symptoms. At the time of admission significantly increased CRP and high troponin levels were discovered. The echocardiography showed reduced global longitudinal strain and spontaneous echocontrast in the ventricle with maintained left ventricular function. With urgent MR examination non-pathogenic contrast accumulation and marked bilateral pleural fluid were found. With non-steroid anti-inflammatory medication she became afebrile, her complaints stopped. Based on the medical history, the clinical condition, the laboratory results and the echocardiography image acute peri-myocarditis was opinionated, the treatment is continued accordingly. Possible relation with the drug is considered. She is discharged home in a good general condition, with recommended physical rest, regular fever measurement and 3x600 mg ibuprofen, and 40 mg pantoprazole in the evening. She was asked to return for a control visit at our outpatient care unit in two weeks. Seriousness for acute peri-myocarditis was hospitalization and medically significant, for other events was hospitalization. The outcome of fever 38-40 degree c, appetite and feeling are bad, mild pain in the region of the nape, chills was recovered, of other events was unknown. Information about batch/lot number were requested.; Sender''s Comments: The events of Myocarditis, Pleural effusion, Pyrexia, Decreased appetite, Feeling abnormal, Headache, Chills, C-reactive protein increased,Troponin increased and Pericarditis assessed as possibly related to the suspect drug bnt162b2 (COMIRNATY), based on temporal association, but consider also possible contributory effects from patient''s medical history. 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: 1456012 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Lower respiratory tract infection, Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthmatic
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021764750

Write-up: chest infection; palpitations; This is a spontaneous report from a Pfizer-sponsored program received by a contactable consumer (patient). A 17-year-old male patient received first dose of BNT162B2 (COMIRNATY), at same age, via an unspecified route of administration, administered in arm left on 02Jun2021 (Batch/Lot Number: EX6537) as dose 1, single for COVID-19 immunisation. Medical history included asthmatic. Patient received antibiotics within 2 weeks of vaccination. The patient experienced palpitations and chest pain post first dose diagnosed with a chest infection all in Jun2021 with outcome of not recovered. Events caused emergency room visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.


VAERS ID: 1462832 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-06-01
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001946 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, C-reactive protein, Cough, Pneumonia, Pyrexia, Rhinorrhoea, Seizure, White blood cell count, X-ray
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: body temperature; Test Result: Inconclusive ; Result Unstructured Data: 40 degree celsius; Test Date: 20210602; Test Name: C-reactive protein; Test Result: Inconclusive ; Result Unstructured Data: Test result: 146 mgL; Test Date: 20210602; Test Name: Leucocyte count; Test Result: Inconclusive ; Result Unstructured Data: Test result: 24.5 (+); Test Date: 20210602; Test Name: Lungs X-rays; Result Unstructured Data: Test result: pneumonia
CDC Split Type: LTMODERNATX, INC.MOD20212

Write-up: Cough; Runny nose; Pneumonia; Convulsions; Body temperature increased til 40 C; This regulatory authority case was reported by a consumer and describes the occurrence of SEIZURE (Convulsions) and PNEUMONIA (Pneumonia) in an 18-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001946) for Vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 29-Apr-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced SEIZURE (Convulsions) (seriousness criterion medically significant) and PYREXIA (Body temperature increased til 40 C). On 02-Jun-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). On an unknown date, the patient experienced COUGH (Cough) and RHINORRHOEA (Runny nose). On 01-Jun-2021, SEIZURE (Convulsions) had resolved. On 16-Jun-2021, PNEUMONIA (Pneumonia), COUGH (Cough) and PYREXIA (Body temperature increased til 40 C) had resolved. At the time of the report, RHINORRHOEA (Runny nose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jun-2021, Body temperature: 40 (Inconclusive) 40 degree celsius. On 02-Jun-2021, C-reactive protein: 146 (Inconclusive) Test result: 146 mgL. On 02-Jun-2021, White blood cell count: 24.5 (+) (Inconclusive) Test result: 24.5 (+). On 02-Jun-2021, X-ray: pneumonia (abnormal) Test result: pneumonia. Concomitant product use was not reported. Treatment information was not provided by the reporter. Very limited information regarding these events have been provided. No further information is expected.; Sender''s Comments: Very limited information regarding these events have been provided. No further information is expected.


VAERS ID: 1466310 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-06-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Vaccination site reaction
SMQs:, Termination of pregnancy and risk of abortion (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: BEPFIZER INC2021794701

Write-up: Miscarriage from Wednesday after; Injection site reaction; This is a spontaneous report from a contactable consumer downloaded from a regulatory authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-96122. A 39-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 29May2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced miscarriage from Wednesday after on 02Jun2021 and injection site reaction on Jun2021. The mother reported she became pregnant while taking bnt162b2. The mother was 1 trimester pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. Outcome of the events was unknown. No follow-up attempts are possible. Information on batch/lot number cannot be obtained.


VAERS ID: 1467556 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2473 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Fatigue, Morning sickness, SARS-CoV-2 test, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Factor V Leiden heterozygote
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: Nasal Swab; Test Result: Negative
CDC Split Type: ATPFIZER INC2021801270

Write-up: miscarriage; bleedings; normal symptoms of pregnancy: nausea, vomiting, fatigue,..; normal symptoms of pregnancy: nausea, vomiting, fatigue,..; This is a spontaneous report from a contactable consumer or other non hcp (patient). This consumer or other non hcp reported information for herself and her foetus. This is the maternal report. A 36-year-old pregnant female patient received BNT162B2 (COMIRNATY) (Batch/Lot Number: FC2473), dose 1, via an unspecified route of administration on 02Jun2021 (at the age of 36-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included factor v leiden mutation from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously took aspirin [acetylsalicylic acid] for an unknown indication with no adverse effects reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received D3 solarvit K2 within 2 weeks of vaccination. The patient reported at the time of the first vaccination, she was pregnant without knowing it (reported as early pregnancy, approximately 3-4 weeks pregnant). In the 5th week, the pregnancy was confirmed, but the fetus did not develop accordingly and ended in a miscarriage on 28Jun2021. No heartbeat of the baby when checked on 24Jun2021. Bleeding was noted from 25Jun2021, yolk sac and amniotic cavity developed well, unfortunately the foetus did not. The beta hCG level was consistently optimal. The patient experienced normal pregnancy symptoms (nausea, vomiting and tiredness). The adverse events results in a doctor or other hcp office/clinic visit. The event of miscarriage was assessed as serious (medically significant). The mother was 4 weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. The fetal outcome was intrauterine death. The patient underwent lab tests and procedures which included sars-cov-2 test (Jun2021): negative. Clinical outcome of the event miscarriage was not resolved. Clinical outcome of the remaining events was unknown.; Sender''s Comments: Linked Report(s) : AT-PFIZER INC-2021883011 foetus/mother case


VAERS ID: 1468512 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Anosmia, Feeling abnormal, Maternal exposure during pregnancy, Nasal congestion, Nasal obstruction, Nasopharyngitis, Nausea, SARS-CoV-2 test, Sinus congestion, Suspected COVID-19
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Taste and smell disorders (narrow), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Pregnancy (17+6 weeks pregnant); Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210624; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021797856

Write-up: Taste loss; Smell loss; Nauseous; have suffered complete nasal blockage until yesterday (Saturday) where I managed to do a nasal rinse.; Suspected COVID-19; Monday woke up with congested nose, not feeling well generally; Sinus congestion; Nasal congestion; Maternal exposure during pregnancy; congested nose; cold; 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-202106271745277920-KTRFM, Safety Report Unique Identifier is GB-MHRA-ADR 25552086. This consumer reported information for both mother and fetus/baby. This is a maternal report: A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Not known), dose 1 via an unspecified route of administration on 20Jun2021 at dose 1, single for COVID-19 immunisation. Medical history included suppressed lactation, ongoing pregnancy 17+6 weeks pregnant, suspected covid-19 from 22Jun2021 and ongoing, vitamin supplementation (Folic acid supplementation) from an unknown date and unknown if ongoing. Patient is not enrolled in clinical trial. Patient is not currently breastfeeding. Concomitant medication(s) included folic acid (FOLIC ACID) taken for vitamin supplementation, start and stop date were not reported. The patient experienced maternal exposure during pregnancy on 20Jun2021, congested nose, cold on Jun2021, taste loss, smell loss, nauseous, have suffered complete nasal blockage until yesterday (saturday) where i managed to do a nasal rinse, suspected covid-19 on 22Jun2021, sinus congestion, nasal congestion, monday woke up with congested nose, not feeling well generally on 21Jun2021. The mother reported she became pregnant while taking BNT162B2. The mother was 23 Weeks pregnant at the onset of the event. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24Jun2021 No - Negative COVID-19 test. Therapeutic measures were taken as a result of, have suffered complete nasal blockage until yesterday (saturday) where i managed to do a nasal rinse. (nasal obstruction). Pregnant at Time of Vaccination was Yes, Gestation Period: 23 Weeks. Vaccine received Sunday, Monday woke up with congested nose, not feeling well generally. By Tuesday I had no sense of taste or smell at all and have suffered complete nasal blockage until yesterday (Saturday) where I managed to do a nasal rinse. I''m not sure if I just happened to pick up a cold or if it is related to the vaccine. Also as I''m 17 weeks pregnant I wondered if my body is struggling to cope with a few things going on. But the main thing I am concerned about is no taste. I tried a teaspoon of English mustard and couldn''t taste it at all. Patient has not tested positive for COVID-19 since having the vaccine. Patient was exposed to the medicine Second-trimester (13-28 weeks). Suspect Reactions Please provide details of any relevant investigations or tests conducted: "Negative covid test". Outcome of event congested nose, cold, taste loss, smell loss, nauseous, sinus congestion, nasal congestion and suspected covid-19 was not recovered for maternal exposure during pregnancy, not feeling well generally it was unknown while for have suffered complete nasal blockage until yesterday (saturday) where i managed to do a nasal rinse, it was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1468525 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-27
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Dizziness, Epistaxis, Pallor, Syncope, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: drop blood pressure; Result Unstructured Data: Test Result:drop blood pressure
CDC Split Type: GBPFIZER INC2021797769

Write-up: Faint; felt faint; 10 minutes post vaccination Nose bleed; pale complexion; altered vision; drop blood pressure; This is a spontaneous report from a contactable other-HCP. This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202106271937007840-5IKTM, Safety Report Unique Identifier GB-MHRA-ADR 25552240. A 18-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: FC9001), via an unspecified route of administration on 27Jun2021 (at the age of 18-years) as dose 1, single for COVID-19 immunization. The patients medical history and concomitant medications were not reported. No needle phobia, no anxiety was reported. Patient was not tested positive for COVID-19 since having the vaccine. The patient experienced 10 minutes post vaccination 10 minutes post vaccination, nose bleed, pale complexion and felt faint with altered vision. Did not loose consciousness but did drop blood pressure on an unspecified date in Jun2021. On 27Jun2021, he had faint 10 minutes post vaccination. The patient underwent lab tests and procedures which included blood pressure measurement: drop blood pressure on Jun2021. This report was not related to possible blood clots or low platelets counts. The outcome of faint was recovered on 27Jun2021, while outcome of other events was unknown. Suspect Reactions: relevant investigations or tests conducted: Vital signs and fluids orally. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1468773 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-06
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Facial neuralgia, Insomnia, Maternal exposure during pregnancy, Neuritis, Oedema, Pain
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Immune-mediated/autoimmune 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:
Current Illness: Thrombophilia
Preexisting Conditions: Medical History/Concurrent Conditions: Caesarean section (Caesarean section for the delivery of a baby without problems); Facial paresis; Otitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC2021796065

Write-up: Facial neuralgia; Facial neuritis; Pregnant female was vaccinated with the first dose of BNT162B2 (COMIRNATY); Oedema of the left axe of the vaccinated arm; Pain was unbearable; Could not sleep; This is a spontaneous report from a contactable consumer downloaded from the WEB (Regulatory Authority report number: GR-GREOF-20215011). The patient, a 34-year-old pregnant female, was vaccinated with the first dose of BNT162B2 (COMIRNATY, Lot number and expiration date were not reported), intramuscular as dose 1, single on 06Jun2021 for COVID-19 immunization. The patient was 13-weeks pregnant at the time of the vaccination. Medical history included otitis in 2019 (not ongoing); ongoing thrombophilia; facial paresis in 2019 (not ongoing); and caesarian section for the delivery of a baby without problems in 2016. The patient''s concomitant medications were not reported. The patient was vaccinated upon the advice of her obstetrician. The next day after the vaccination, on 07Jun2021, the patient had presented with neuralgia facial and facial neuritis. The patient also presented with oedema of the left axe of the vaccinated arm in Jun2021. The next day after her vaccination, on 07Jun2021, the patient had felt initially numbness on the left side of the face that evolved into intense pain that extended from the center of the forehead till the left ear in the temporomandibular joint and in the cheek until the nose and the left ear. The patient had consulted an otorhinolaryngologist, a dentist, an oral surgeon and a neurologist. The otorhinolaryngologist prescribed her Zinadol for 7 days (as a prophylaxis, in case it was an infection that was not visible). The neurologist diagnosed neuritis based on the intensity of her symptoms and refused to prescribe her gabapentin (NEURONTIN) due to her pregnancy. On the next days, in Jun2021, the pain was unbearable (she could not sleep), and the obstetrician advised her to take gabapentin (NEURONTIN) for 20 days ( 1x1 for 3 days and 1x2 for the following) with the guideline to stop it in the first 10 days if the symptoms subside. The reported adverse events had resulted into physician''s office visit. The events, facial neuralgia, facial neuritis and oedema of the left axe of the vaccinated arm, were reported as serious (medically significant). The outcome of the events unknown for 13-week pregnant patient vaccinated with BNT162B2; and was not recovered for all the other events. No follow-up attempts are possible; information on batch number cannot be obtained.


VAERS ID: 1472100 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Chest pain, Electrocardiogram, Maternal exposure during pregnancy, Pain, SARS-CoV-2 test
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), 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: FOLIC ACID
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Irritable bowel syndrome; Lactation decreased; Suspected COVID-19 (Unsure when symptoms started. Unsure when symptoms stopped.)
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:normal; Test Name: ECG; Result Unstructured Data: Test Result:normal; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021735953

Write-up: Patient was exposed to the medicine Second-trimester (13-28 weeks).; pain; a stabbing chest pain on my left hand side where the heart is located.; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106161741088100-YVX58, Safety Report Unique Identifier GB-MHRA-ADR 25486743. A 31-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on unspecified date in Jun2021 (at the age of 31 years old) as DOSE 1, SINGLE for covid-19 immunisation. Patient was pregnant at time of vaccination. Patient was not currently breastfeeding. Medical history included lactation decreased, ongoing pregnancy, suspected covid-19, long term Irritable bowel syndrome and folic acid supplementation. No current medication and no medical issues, other than long term IBS which is managed through diet. Concomitant medications included folic acid taken for folic acid supplementation, start and stop date were not reported. patient was not enrolled in clinical trial. On unspecified date in Jun2021, the patient experienced a stabbing chest pain on my left hand side where the heart is located and pain. On unspecified date, the patient experienced patient was exposed to the medicine second- trimester (13-28 weeks) and this happened multiple times within 72 hours of the vaccine. Since having the vaccine, within 24 hours patient was in A&E with a stabbing chest pain on my left hand side where the heart is located. This happened multiple times within 72 hours of the vaccine, and is still happening almost 2 weeks later. The pain comes instantly, lasts for under 10 seconds then goes. It is debilitating. There was initially around 2 hours between the occurrence of pain. Now it has considerably decreased and may happen once or twice a day. Since the vaccination, the patient had not been tested for covid-19. The events was serious (medically significant). The patient underwent lab tests and procedures which included blood pressure normal, electrocardiogram normal and covid-19 virus test negative on unspecified date. Not had any scans/appointments since the vaccine; they are due imminently. Outcome of the events a stabbing chest pain on my left hand side where the heart is located, pain and this happened multiple times within 72 hours of the vaccine was recovering. Outcome of the event patient was exposed to the medicine Second- trimester (13-28 weeks) was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained


VAERS ID: 1472693 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Back pain, Chest pain, Neck pain, Pain, Pain in extremity
SMQs:, Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021784241

Write-up: pain; Then on the 25th I felt pain in my hips; chest pain; On the day I had it, it was just pain in the arm; Then my back and neck started hurting and then the pain spread to my chest; Then my back and neck started hurting and then the pain spread to my chest; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory ARA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106250100105650-ND6SR, Safety Report Unique Identifier GB-MHRA-ADR 25539808. An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 23Jun2021 (lot number not provided, at age of 18 years old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient experienced pain on an unspecified date, chest pain on 24Jun2021. Events were reported as medical significant. Additional information included: on the day the patient had it, it was just pain in the arm on 23Jun2021. Then on the 25th the patient felt pain in his hips, which he had never experienced before. Then in Jun2021 back and neck started hurting and then the pain spread to chest. Patient had not tested positive for COVID-19 since having the vaccine. The outcome of event chest pain was not recovered, the outcome of event pain was recovering, unknown for rest events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1473047 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-26
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210625; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021809296

Write-up: Swollen lymph nodes; Swollen lymph node on left side, same side of vaccine injection. Painful; This is a spontaneous report from a contactable consumer received from the Regulatory ARA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106282303166210-OGPRT. An 18-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Jun2021 (Lot number was not known) as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced swollen lymph nodes on 26Jun2021 with outcome of not recovered and swollen lymph node on left side, same side of vaccine injection. Painful on Jun2021 with outcome of unknown. The clinical information were as follows: Swollen lymph node on left side, same side of vaccine injection. Painful. The case was assessed as serious medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: negative (No - Negative COVID-19 test) on 25Jun2021. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1473800 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-06-01
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Dizziness, Hemiparesis, Muscular weakness, Pain, Pyrexia, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: only hair vitamin called ''Hairburst'' food supplement containing: vitamins, minerals, collagen, MSM & amino acids
Current Illness: no
Preexisting Conditions: no
Allergies: allergy to black henna and any containing pigmentation on skin like hair dyes.
Diagnostic Lab Data: after the day that I vomited alot i went to an ENT specialist to check on my ears. he prescribed me ''betaserc and draminex'' and told me to go to a ''balance specialist'' so i went to a ''balance specialist'' he told me maybe the crystals in my inner ear canals have moved and he made me some repositioning manoeuvres. after that day the off balance feeling was way better till it went away(as i mentioned obove) but dizziness is still there plus the new symptomes that appeared one day after which is the weakness of left limbs (also as mentioned above)
CDC Split Type:

Write-up: on the same day of the vaccination and the day after: fever and body ache (normal symptoms of vaccination not he ones I want to report) - after almost 4 days: dizziness and feeling off-balance all the time. - after almost 6 days: dizziness and off-balance feeling continues with severe dizziness and vomiting for almost 8 hours continuously. - after the vomiting day i started taking ''Betaserc 24mg'' and ''draminex'' -no vomiting occurred again but dizziness and off balance continued till almost one month. - after one month the off balance feeling went away but the dizziness continues with a new symptom which is weakness in left hand and leg. -till now (15/7/2021) i am still strugglin with dizziness and weakness in left limbs.


VAERS ID: 1478902 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0574 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Foetal placental thrombosis, Investigation, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (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 Name: placental analysis; Result Unstructured Data: Test Result:thrombus
CDC Split Type: BRPFIZER INC2021830714

Write-up: I felt very tired; I received the vaccine on 17Jun/ I was with 37 weeks and 4 days of gestation; The placental analysis signals thrombus; This consumer reported information for both mother and fetus. This is the mother report. This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and fetus/baby. This is a maternal report. A 41-year-old pregnant female patient received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: EY0574), via an unspecified route of administration on 17Jun2021 (at the age of 41-year-old) as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications were not reported. On an unspecified date in Jun2021, the patient experienced placental analysis signals thrombus. On 17Jun2021 the patient reported that she received the vaccine on 17Jun, she was with 37 weeks and 4 days of gestation. On 18Jun2021, the patient felt very tired. Clinical course was reported as: she received the vaccine in 17Jun, she was with 37 weeks and 4 days of gestation. On the day after the vaccination, she felt very tired and unfortunately on the day 20Jun (Day in which 38 weeks of gestation would be completed) she found out that her baby''s heart had stopped, probably from Friday to Saturday (as reported). She had a perfect gestation, her baby born without life with 3.3 kg. The placental analysis signals thrombus. She was waiting for the health plan to release the genetic exams of thrombophilia. She reported that the vaccine could have caused the reported issue. She was using anticoagulant, for her safety and due to the placental condition. She was insecure regarding receiving the second dose. The mother was 37 Weeks pregnant at the onset of the event. The mother was pregnant with 1 baby. The baby weighed 3300grams. The fetal outcome was intrauterine death. The patient underwent lab tests and procedures which included investigation: thrombus on an unknown date. The outcome of the events was unknown.; Sender''s Comments: Linked Report(s) : BR-PFIZER INC-2021840467 Mother-Baby Case


VAERS ID: 1479761 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (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: ITPFIZER INC2021654590

Write-up: miscarriage at week 7; got the vaccine she was about 4 weeks; This is a spontaneous report from a contactable consumer through the WEB. A female patient of an unspecified age received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 28May2021 as 1st dose, single for covid-19 immunisation. The patients medical history and concomitant medications were not reported. After 3 days of vaccination, she found out she was pregnant. Basically, by the time she got the vaccine she was about 4 weeks. The patient reported she became pregnant while taking bnt162b2. The patient was 1 trimester pregnant at the time of vaccination. The patient asked her family doctor and gynecologist, and no one can reassure her. She would like more info because, she could not live this moment with the joy she would like, she had so much anxiety. In Jun2021, unfortunately patient had a miscarriage at 7 weeks. It was reported that on 02Jul2021 she should have the second dose. The outcome of the event was unknown. Follow-up (03Jul2021): new information received from a contactable consumer includes: event: unfortunately I had a miscarriage at 7 weeks. Follow-up attempts completed. No further information expected.


VAERS ID: 1479998 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-06-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Lymph node pain, Lymphadenopathy, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: - swollen and painful lymph node in left arm pit, 2 days after vaccination and lasting for 3 weeks - intermittent tingling in bilateral medial scapula 3 weeks after vaccination and ongoing


VAERS ID: 1486748 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Termination of pregnancy and risk of abortion (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: BRPFIZER INC2021841264

Write-up: she began to have bleeding, where it was getting worse and, she suffered a spontaneous abortion; she began to have bleeding, where it was getting worse and, she suffered a spontaneous abortion; This is a spontaneous report from a contactable consumer (patient''s boyfriend) from Pfizer medical information team. This is a maternal report. A female patient of an unspecified age received BNT162B2 (COMIRNATY, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was 7-week pregnant and she took the first dose of Pfizer vaccine, on Thursday morning. On Friday night (Jun2021) she began to have bleeding, where it was getting worse and, on Tuesday, 15Jun2021, she suffered a spontaneous abortion. The outcome of the event was unknown. Information on the lot/batch number has been requested.


VAERS ID: 1496799 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2495 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Back pain, Body temperature, Chills, Cough, Dyspnoea, Fatigue, Headache, Maternal exposure during pregnancy, Myalgia, Pyrexia, Respiratory distress
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypersensitivity (broad), Arthritis (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: Body temperature; Result Unstructured Data: Test Result:greater than or equal to 38 Celsius degrees Centigrade; Comments: Fever
CDC Split Type: MXPFIZER INC2021868431

Write-up: Fever greater than or equal to 38 Celsius degrees; Headache; Asthenia; Fatigue; Chills; Cough; Dyspnea; Myalgia; Arthralgia; back pain; Respiratory distress; Pregnant: Yes 28 weeks; This is a Spontaneous report from a non-contactable Other Health Professional via a regulatory authority via email. Regulatory authority report number is 16070-7. A 21-year-old pregnant female (Gestation week: 28) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose intramuscularly, administered in Arm Left on 01Jun2021 (Lot Number: FC2495; Expiration Date: 30Sep2021) at age of 21 years old as a single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced respiratory distress, fever greater than or equal to 38 celsius degrees, headache, asthenia, fatigue, chills, cough, dyspnea, myalgia, arthralgia, back pain, all on 03Jun2021. The outcome of the events was not recovered. The patient underwent lab tests and procedures which included body temperature: greater than or equal to 38 celsius degrees centigrade (fever) on 03Jun2021. Therapeutic measures were taken as a result of all events except the event ''Maternal exposure during pregnancy, third trimester''. The patient was 28 Weeks pregnant at time of vaccination. Clinical course: started 2 days after vaccination with back pain, started with headache, fever quantified in 38 grades, chills, arthralgia, generalized fatigue, referred dyspnea at low effort (while speaking) accompanied by cough, currently all symptoms persist. Treatment received before receiving medical attention: yes, not reported. The patient had no infectious Disease in the last 15 Days prior to vaccination. The patient was healthy before vaccination. There had no allergies. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1496886 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2495 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Body temperature, Chest pain, Chills, Cough, Dysgeusia, Headache, Heart rate increased, Maternal exposure during pregnancy, Myalgia, Oxygen saturation, Pain assessment, Pharyngeal erythema, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: fever; Result Unstructured Data: Test Result:39; Test Date: 20210604; Test Name: fever; Result Unstructured Data: Test Result:greater than or equal to 38 Celsius degrees; Test Date: 20210604; Test Name: oxygen saturation; Test Result: 99 %; Test Date: 20210604; Test Name: opressive headache; Result Unstructured Data: Test Result:9/10
CDC Split Type: MXPFIZER INC2021887230

Write-up: Fever greater than or equal to 38 Celsius degrees/ fever of 39; adynamia; Chills; Cough; Myalgia; arthralgia; thoracic pain; dysgeusia; pharynx with erythema; opressive headache intensity 9/10; cardiac rhythms with increased intensity; patient is 28 weeks pregnant; This is a Spontaneous report from a non-contactable Other Health Professional. This is a report received from a regulatory authority via email. Regulatory authority report number is 16156-7. This other hcp reported information for both mother and fetus/baby. This is a maternal report. A 21-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in left arm on 01Jun2021 (Batch/Lot Number: FC2495; Expiration Date: 30Sep2021) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. No infectious disease in the last 15 Days prior to vaccination. Healthy before vaccination. No allergies. The patient experienced opressive headache intensity 9/10 (headache) (medically significant) on 04Jun2021 with outcome of unknown , cardiac rhythms with increased intensity (heart rate increased) (medically significant) on 04Jun2021 with outcome of unknown , patient is 28 weeks pregnant (maternal exposure during pregnancy) (non-serious) on 01Jun2021 with outcome of unknown, fever greater than or equal to 38 celsius degrees/ fever of 39 (pyrexia) (non-serious) on 04Jun2021 with outcome of unknown, adynamia (asthenia) (non-serious) on 04Jun2021 with outcome of unknown, chills (chills) (non-serious) on 04Jun2021 with outcome of unknown, cough (cough) (non-serious) on 04Jun2021 with outcome of unknown, myalgia (myalgia) (non-serious) on 04Jun2021 with outcome of unknown, arthralgia (arthralgia) (non-serious) on 04Jun2021 with outcome of unknown, thoracic pain (chest pain) (non-serious) on 04Jun2021 with outcome of unknown, dysgeusia (dysgeusia) (non-serious) on 04Jun2021 with outcome of unknown, pharynx with erythema (pharyngeal erythema) (non-serious) on 04Jun2021 with outcome of unknown. The mother reported she became pregnant while taking bnt162b2. The mother was 28 Weeks pregnant at the onset of the event. The patient underwent lab tests and procedures which included body temperature: 39 on 04Jun2021 , oxygen saturation: 99 % on 04Jun2021, pain assessment: 9/10 on 04Jun2021. The clinical course was reported as follows: Onset of symptoms on 04Jun21 with oppressive headache, intensity 9/10, and chills, fever of 39 intermittent, dry cough, myalgias, arthralgias, thoracic pain and dysgeusia. oxygen saturation 99 ay room air, oriented in 3 neurological spheres, hydrated oral mucosa, pharynx with erythema, cardiorespiratory: clear pulmonary vesicular murmur present. cr (cardiac rhythms) with increased intensity, no murmurs. Globose abdomen due to gestational uterus fhr (fetal heart rate) 178-188, dorsal right cephalic, negative giordano negative ureteral points. whole limbs no edema. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : 2021868411 Baby case


VAERS ID: 1497002 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Constipation, Exposure via breast milk, Nasopharyngitis, Pyrexia, Weight, Weight decreased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal exposures via breast milk (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: weight; Result Unstructured Data: Test Result:loss; Comments: deviated from the normal weight curve
CDC Split Type: NOPFIZER INC2021848265

Write-up: My 2 month old baby that I am full breastfeeding, developed a fever, cold, and constipation without other family members having the same symptoms.; My 2 month old baby that I am full breastfeeding, developed a fever, cold, and constipation without other family members having the same symptoms.; My 2 month old baby that I am full breastfeeding, developed a fever, cold, and constipation without other family members having the same symptoms.; DRUG EXPOSURE VIA BREAST MILK; Weight loss that deviated from the growth curve so that she had to be followed up at the health center.; This is a spontaneous report from a contactable other hcp downloaded from a regulatory authority-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-Udyye7. A 2-month-old female patient received bnt162b2 (COMIRNATY), transmammary when her mother received dose 1 intramuscular on 17Jun2021 13:10 (Lot Number: ET7205) as single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced drug exposure via breast milk on 17Jun2021; constipation, common cold and fever on 18Jun2021; weight loss in Jun2021. The events were described as follows: 2 month old baby that mother was full breastfeeding, developed a fever, cold, and constipation day after her mother (the reporter) received the first dose of Comirnaty vaccine without other family members having the same symptoms. The baby had weight loss, and her weight deviated from the normal weight curve. She had to be followed up at the public health center. Outcome of the events was recovering (also reported stop date 23Jun2021). Reporter comment: Reporter type: Psychologist Relatedness of drug to reaction(s)/event(s): Constipation, Common cold, Weight loss, Fever Source of assessment : a regulatory authority Result of Assessment: Possible No follow-up attempts possible. No further information expected.; Reporter''s Comments: Reporter type: Psychologist No further information available.


VAERS ID: 1362195 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Puerto Rico  
Vaccinated:2021-05-30
Onset:2021-05-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN IDK / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cognitive disorder, Malaise, Pyrexia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None I?m at home sick as a dog
CDC Split Type:

Write-up: Uncontrollable shaking. Fever, malaise, neurodeficit.


VAERS ID: 1362198 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 043B21A / 2 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Mobility decreased, Myalgia, Pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Started that night. Woke up about 1 am and had a fever, chills, and muscular soreness throughout my whole body. Spent the following day in bed as I couldn''t even get out of bed , my body was that sore. Did not feel better until 2 days later


VAERS ID: 1362200 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-05-28
Onset:2021-05-31
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0187 / UNK - / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Injection site swelling, Nausea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Sertraline NuvaRing Adderall
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Swelling of upper arm and shoulder on the night and day after vax. Second day after vax, chills, nausea/vomiting and fever of 100.6.


VAERS ID: 1362228 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: New York  
Vaccinated:2021-05-30
Onset:2021-05-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 176 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Dysphemia
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: Concerta
Current Illness: Bed bug bite
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Stuttering when talking, never had a stutter before.


VAERS ID: 1362234 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-05-24
Onset:2021-05-31
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site erythema, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (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: Gabapentin, pantoprazole, lisinopril, carvedilol, tizanidine, furosemide, amlodipine, Norco, metoclopramide, carafate
Current Illness: None
Preexisting Conditions: Patient reported no chronic conditions
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient called and reported redness at injection site that extended from the injection site down to close to the elbow. Patent reported it was a red band about 3 inches wide and possibly warm to the touch.


VAERS ID: 1362265 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821288 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Hypotonia, Presyncope
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (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: patient did not give name of vaccine
Other Medications: wellbutrin xl, metformin er, lexapro
Current Illness: none
Preexisting Conditions: diabetes, depression
Allergies: nkda
Diagnostic Lab Data:
CDC Split Type:

Write-up: injection given into left deltoid, within 5 minutes, patient complained of syncope, then became flaccid. He never lost consciousness and kept talking to immunizer. we applied a cold compress to neck and gave water and accompanied patient until he departed the store


VAERS ID: 1362280 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Musculoskeletal stiffness
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (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: UNKNOWN
Current Illness: UNKNOWN
Preexisting Conditions: UNKNOWN
Allergies: UNKNOWN
Diagnostic Lab Data: none
CDC Split Type:

Write-up: After the administration she felt tightness in her fingers in the same arm as the injection. It left a few minutes after the injection.


VAERS ID: 1362288 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: New York  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Dermatitis, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Topical hydrocortisone
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: total body rash/dermatitis


VAERS ID: 1362300 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011D21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Disorientation, Fall, Head injury, Pallor, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None Stated
Preexisting Conditions: None Stated
Allergies: NKDA
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Pt experienced syncope in his chair in the post-vaccine waiting area, fell out of his chair, and hit his head on the ground. Upon assessing the patient, he did not know where he was, but he did know his own name, pt appeared pale and was trembling. Paramedics were called for further assistance and took pt to hospital.


VAERS ID: 1362301 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Maine  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821281 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Cognitive disorder, Pallor, Seizure, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

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

Write-up: minutes after vaccine patient fainted. when i went over to check on her she had a very mild seizure like rxn. then cam to and said "where am I". we administered cold pack to fore head, checked pulse. she came around a bit more and we gave her cold water. then a glucose tablet. color started to come back into her face. gave her peanut butter crackers and a banana. she stayed for about 1 hr. called her sister to come get her.


VAERS ID: 1362304 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-05-26
Onset:2021-05-31
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0167 / 2 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Low dose aspirin, vitamins
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: Alpha galactose reaction, gluten Intolerant
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Extremely tired, and muscle pain in right shoulder + right arm. This is day 5 after vaccination, it started out mild tiredness now worse.


VAERS ID: 1362318 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-05-10
Onset:2021-05-31
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Hypertension, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amlodipine Losartan HCTZ Hydroxychloroquine Metoprolol Omeprazole
Current Illness: N/A
Preexisting Conditions: Polymyalgia rheumatica Hypertension CHronic anemia
Allergies: SUlfa, macrodantin, Bee sting, Methotrexate
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Tachycardia, Hypertension


VAERS ID: 1362323 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Feeling of body temperature change, Injection site pain, Musculoskeletal stiffness, Presyncope, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (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:

Write-up: Patient became extremely faint immediately after the injection. Patient began to shake, got really hot, then really cold and felt as if he were going to pass out. Also said that his arm hurt & felt stiff at the injection site. This feeling he described lasted about 15 minutes, then he began to start feeling a little bit better. We gave him some water and had him sit for as long as he needed. Patient sat for total of 30 minutes, then left of his on accord.


VAERS ID: 1362325 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0178 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anxiety, Cold sweat, Defaecation urgency, Diarrhoea, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No Known
Current Illness: NKDA
Preexisting Conditions: Anxiety
Allergies: NKDA
Diagnostic Lab Data: none
CDC Split Type:

Write-up: 5/31/21 10:50a vaccine administered. Pt anxious and feel like vomiting. Pt vomited. Pt didn''t eat breakfast. Pt reported felt clamish. Pt then felt like she will move her bowel. Pt escorted to washroom and had diarrhea. 11:07a pt had a bowel movement. Pt was monitored and after drinking orange juice felt better. 11:19a Pt felt better and left with Mom and Grandmother.


VAERS ID: 1362344 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0187 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Expired product administered, Product storage error
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: none known
Current Illness: None known
Preexisting Conditions: none known
Allergies: no known allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: A Pfizer COVID-19 vaccine that was past the 6-hour expiration time period was administered to patient. Error was realized immediately post-vaccination. Discussed with patient that dose could be subpotent and re-vaccination may be required. Advised patient that I would contact manufacturer regarding necessity/timing of re-vaccination and that she should contact pharmacy with any issues or concerns that come up.


VAERS ID: 1362347 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Rhode Island  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / 1 RA / IM

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

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

Write-up: fainted for a short period of time


VAERS ID: 1362355 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / UNK RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Dizziness, Hypotension, Nausea, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), 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: fluoxetine 10mg
Current Illness: no
Preexisting Conditions: no
Allergies: no
Diagnostic Lab Data:
CDC Split Type:

Write-up: The patient felt dizzy and weak then fainted while her mom was holding her . Her mom gradually led her to the floor from a sitting position. She felt nauseous and dizzy. I laid her on floor with her feet elevated on a chair with her head to the side so she would not aspirate if she vomitted.. She felt better after a while and wanted to sit. When she was sitting in the armchair she vomitted and said she felt worse, so I then called 911. They evaluated her and her blood pressure was very low and they gave her iv fluids and took her to the emergency room


VAERS ID: 1362371 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0178 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (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:

Write-up: Systemic: Chills-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild


VAERS ID: 1362374 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Rhode Island  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A` / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: none provided
Preexisting Conditions: none provided
Allergies: topiramate allergy
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Administered vaccine to patient . A few moments after patient reached the observation area they signaled they wanted some help. Once I arrived the patient stated they felt like fainting. Patient fainted for 3-5 seconds before regaining consciousness. Patient refused going with first responders.


VAERS ID: 1362380 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821288 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fatigue, Posture abnormal, Unresponsive to stimuli, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: pt mentioned taking zyrtec earlier in the day
Current Illness: none
Preexisting Conditions: anemia
Allergies: shellfish, peanut, red dye, iodine
Diagnostic Lab Data: none
CDC Split Type:

Write-up: patient sat on observation chair, slumped over some, said she felt tired, patient then would not respond to RPh questions, 911 called, patient woke up vomiting


VAERS ID: 1362408 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: New York  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: patient states she faint for all IMZ abd procedures as well
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: patient fainted within minutes of vaccine; recovered after being laid on floor and legs elevated


VAERS ID: 1362420 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Hyperhidrosis, Incontinence, Loss of consciousness, Nausea, Pallor
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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

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

Write-up: 18 y/o male received J&J vaccine. Five minutes after being vaccinated, pt complained of nausea. Patient presented with pale skin, diaphoretic, and incontinence of bladder in the observation area. Pt lost consciousness for 15 seconds in the car. After 15 sec, pt regained consciousness and was able to walk and talk. EMT brought the patient into the observation tent to lay on the cot. EMT obtained 4 sets of vitals and completed orthostatic vitals. Last set of vitals are: 10:15am: BP 103/60, Pulse: 74, Respiration 18 and O2 98% on room air. Blood Glucose level was 106. Pt returned back to normal state after 15 minutes in observation. Pt was no longer diaphoretic, pale, or nauseous. Pt is stable, alert, and oriented x4. Pt is walking and talking independently. No EMS services needed. Pt was instructed to follow up with the nearest ER, if symptoms return or worsen. Pt left with his mother, who is the driver.


VAERS ID: 1362430 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0182 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Hyperhidrosis, Malaise, Pallor, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), 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: Flu vaccine
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: No allergies
Diagnostic Lab Data: None
CDC Split Type:

Write-up: 01: 47 PM Pfizer Covid-19 Vaccine administered in left deltoid- mother and sister also in room. Patient left room ambulatory without any issues or distress to go sit in waiting room. 01: 52 PM Sister stated patient didnt feel well and alerted PCT . Mother present and witnessed patient have syncopal episode. He was lowered to floor but was arousable after 10-15 seconds. Patient sat upright and drank few sips of water. Patient was noted to be pale and sweating. He reports he has had similar episodes when receiving flu vaccine in the past. Mother and PCT remained with patient in lobby. 2:00 PM Patient did vomit x 1 in trash can and reports he is feeling some better 2:20 PM Patient remained in lobby with mother until feeling much better. He left ambulatory in no apparent distress.


VAERS ID: 1362435 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-05-30
Onset:2021-05-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0185 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product administered to patient of inappropriate age
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: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies: NONE
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Patient''s actual birthday is date but his mom lied to us and intentionally provided incorrect birth date in vaccine consent form to make patient''s age 12 just to get a vaccine for her son. When I asked for if he has insurance, she again lied and said no he does not have an insurance. I also overheard them that they were leaving town soon to visit may be location. So his mom had an intentional plan to provide wrong birthday and do not disclose insurance just to get vaccine. Patient will be 12 years soon. I called thrice to patient''s mom to verify DOB when found real DOB different with central patient search . First call she hung up on me, second call she did not answer and with third call, she said she was under impression of age limit is 9 for Pfizer vaccine, then why she need to provide wrong DOB in vaccine consent form? Also she asked me to make correction in a system of DOB and let it go. I refused it and told her I will use birthday you provided in vaccine consent form which is date


VAERS ID: 1362437 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: California  
Vaccinated:2021-05-30
Onset:2021-05-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal 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: Ibuprofen
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Blurred and cloudy vision with large halls around lihhts


VAERS ID: 1362439 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8736 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Ear disorder, Fall, Feeling hot, Headache, Hyperhidrosis, Hypoacusis, Loss of consciousness, Pallor, Photophobia, Vision blurred
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 (narrow), Accidents and injuries (narrow), Glaucoma (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none known
Current Illness: none known
Preexisting Conditions: none known
Allergies: none known
Diagnostic Lab Data: BP 116/82 , temp 97.1 degree f, pain 0/10, rr 18 / min, pulse 73 bpm.
CDC Split Type:

Write-up: Patient received the vaccine around 9:38 AM and was placed in a chair for observation. Within 3 minutes the patient had fallen onto the floor on his side out of the chair. The pharmacist on duty at the time myself ran over and asked patient if he was ok and touched his shoulder. The patient regained consciousness and was moved to the vaccination room and put feet up for evaluation. The patient loss consciousness for 10 more seconds. Vitals were taken immediately (see below) and patient was interviewed for adr''s. Patient had extreme diaphoresis, said he had no diplopia but did have blurred vision . Patient said his head hurt and was given 500 mg apap for one dose. He said his ears were hot. Patient said he had no pain other than his head hurting. Patient had no uticaria or redness . Patient appeared pale. He was given extensive amounts of water and a snack. He said that sounds were slightly muted. He said he had senstivity to lights.


VAERS ID: 1362441 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0185 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Citalopram
Current Illness: None
Preexisting Conditions: Anxiety Migraine headache
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Dizziness while sitting in observation room. Hx of Anxiety. Symptoms improved after eating snack and laying down. Left ambulatory in steady gait with husband


VAERS ID: 1362469 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Connecticut  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 025C21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
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:

Write-up: Patient experiencing redness, inflammation, and heat on the same arm as the injection. Redness is the size of the upper arm on the outside of the arm from the deltoid to the elbow.


VAERS ID: 1362470 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Presyncope
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: The patient became very dizzy after administration of the vaccine and appeared to almost faint.


VAERS ID: 1362473 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Utah  
Vaccinated:2021-05-28
Onset:2021-05-31
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / -

Administered by: Public       Purchased by: ?
Symptoms: Catheterisation cardiac normal, Chest pain, Dizziness, Echocardiogram, Ejection fraction decreased, Headache, Malaise, Myalgia, Myocarditis, Oropharyngeal pain, Pain in jaw, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Osteonecrosis (broad), Tendinopathies and ligament disorders (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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: acetaminophen, ibuprofen
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: 5/31 Cardiac cath- clean 5/31 TEE- EF 45% Will be getting an MRI tomorrow
CDC Split Type:

Write-up: It is thought to be vaccine-induced myocarditis. Myocardial infarction was ruled out. Patient does now have a reduced ejection fraction of 45%. Here is the note from the ED today: "He indicates that he was awakened from sleep with chest pain this morning around 2:50 AM. He ended up trying to sleep longer to see if it would improve and ended up going to his mother''s room. She recommended that he drink some orange juice and gave him some Tylenol. He states that the pain continued to increase since that time and he asked her to bring him to the emergency department. The patient states that the pain is on the left side of his chest radiates to his left shoulder and down his left arm. He denies that it radiates to his back. He has had lightheadedness. He does not feel short of breath. He does have some pain into his left jaw as well. He has not had any vomiting. He denies abdominal pain. He denies diarrhea. The patient did receive his second dose of the Moderna vaccine on Friday to his left arm. He has had fevers over the past 24 hours to 103 at home. His mother and he indicate that the go away with Tylenol though seem to come back when the Tylenol wears off. He did complain of some headache, myalgias, malaise and sore throat which she states were all worse when he would have a fever and seemed to dissipate when his fever resolved. He states he did not and has never had chest pain like this until this morning. The patient does not have a history of Covid infection. He is active and has run track in the past. He has not had any travel. He denies any pain or swelling to his legs or calves. He has had no sick contacts. His mother received her second dose of the vaccine on the same day that he did and has not had any similar symptoms. "


VAERS ID: 1362479 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0185 / 1 LA / ID

Administered by: Public       Purchased by: ?
Symptoms: Vertigo, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (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: None
Current Illness: None
Preexisting Conditions: Gestational Diabetes history
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Client stated, "My vision became blurred and I felt spinning." Client given water and crackers. Symptoms lasted less than 2 minutes and then went away completely. Had TDAP 5/26/21 without any reactions.


VAERS ID: 1362489 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 041C21A / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Hyperhidrosis, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: BP : 150/105 mm Hg
CDC Split Type:

Write-up: Patient was super anxious before getting shot. Patient felt dizziness and fainting after getting vaccine. Cold compress pouch was given patient was still sweating. Patient was also asked to lie down on floor and blood pressure was taken. Her BP was 150/105 mm Hg. Upon asking her for 911, she declined it. Patient was given water and food to eat as well after which she felt better and left store after 15 min.


VAERS ID: 1362495 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: New York  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821288 / 1 LA / IM

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

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

Write-up: patient fainted


VAERS ID: 1362496 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Vermont  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808986 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Nothing reported
Preexisting Conditions: History of Epilepsy
Allergies: Sulfa allergy
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: I administered the vaccine and asked patient to move to the waiting area for his 15 minute observation period. He moved out to the chair and sat down about 2 minutes later his abdomen started to move back and forth a few times and then he started to have what appeared to be a seizure. It was very short (20 seconds), he remained in the chair. His mom and I moved him to the floor with his help. He then mentioned that he forgot to take his seizure medication last night and was feeling very nervous about the vaccine.


VAERS ID: 1362499 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Iowa  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0178 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: tdap-just nausea
Other Medications: none
Current Illness: no
Preexisting Conditions: no
Allergies: no
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Nausea, and the fainted


VAERS ID: 1362521 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-05-30
Onset:2021-05-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 037B21A / 1 RA / IM

Administered by: Pharmacy       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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: PT received vaccine yesterday and this morning she was extremely dizzy and reported almost falling and passing out. I told pt she should call her PCP but she does not have one so I referred her to ER.


VAERS ID: 1362551 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER EW0177 / 2 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NA
Current Illness: None
Preexisting Conditions: None, according to husband.
Allergies: None
Diagnostic Lab Data: None.
CDC Split Type:

Write-up: Patient experiences 2 seizures in the span of 10 minutes.


VAERS ID: 1362554 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 035C21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Dehydration, Dizziness, Loss of consciousness, Nausea
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), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: After receiving the second dose of Moderna vaccine, patient felt nauseous, lightheaded and very weak then passed out. Patient was back in few seconds and declined 911 call. Patient was provided with Gatorade and Pedialyte to get some electrolytes. Patient was under pharmacist observation for 45 minutes. Her BP was checked 20 minutes after the shot was administered, which was 105/61. Patient confirmed history of dizziness but no history of low BP. Patient felt nauseous again and almost passed out and again declined 911. Her BP was checked again, it was 103/59. At this point pharmacist recommended her to take some more electrolytes to ensure she is hydrated and to see if her BP is due to dehydration. Final BP was checked 45 minutes after getting the shot. Patient was hydrated and alert and her BP when measured was 124/85. Patient was stable when left for home with her husband.


VAERS ID: 1362571 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-05-07
Onset:2021-05-31
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Angiogram cerebral abnormal, Anticoagulant therapy, Asthenia, Basilar artery thrombosis, Cardiovascular evaluation, Cerebellar infarction, Chest pain, Computerised tomogram head abnormal, Condition aggravated, Dizziness, Dysarthria, Dyspnoea, Electrocardiogram abnormal, Endotracheal intubation, Fatigue, Headache, Hyperhidrosis, Hypertension, Intensive care, Lethargy, Magnetic resonance imaging head abnormal, Palpitations, SARS-CoV-2 test negative, Syncope, Tinnitus, Unresponsive to stimuli, Vertebral artery occlusion, Vision blurred, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Hypertension (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Xanex, Norvasc, Cozaar, Metformin, Toprol XL, Klor-Con
Current Illness: Newly diagnosed Primary Hyperaldosteronism
Preexisting Conditions: HTN, Diabetes, Primary Hyperaldosteronism
Allergies: None
Diagnostic Lab Data: MRI as above COVID PCR from 0615 AM on May 31, 2021 negative (no COVID detected) Currently pending further interventional cardiology and neurology work up
CDC Split Type:

Write-up: Initially, the patient had dizziness, lightheadedness and a syncopal episode within 5 minutes of the vaccine. He returned to normal fairly quickly and went home by report. He presented to the ER shortly after with palpitations and shortness of breath and required a dose of IM epinephrine. Patient since had intermittent fatigue, dizziness, blurred and vision changes as well as tinnitus. On May 31, 2021, patient presented to the ER with headache, lethargy, weakness, diaphoresis and dizziness. Additionally, noted to have slurred speech by his wife. MRI of the brain done at 4 am on 5/31/21 showed the following "1. Acute bilateral cerebellar infarcts are seen with a right posterior 4.3 mm focus a left middle cerebellar peduncle 3.2 mm focus and a left superior cerebellar 7.9 mm linear focus. 2. Occlusion of the left vertebral artery extending into the basilar artery with reconstitution of the basilar artery via bilateral posterior communicating arteries. Findings are concerning for acute dissection occlusion. Consider further evaluation with MRA head and neck. 3. Question subtle area of restricted diffusion seen within the left dorsal medulla better appreciated on the maps measuring approximately 4.9 mm. Left lateral pontine 7.3 mm focus of restricted diffusion versus artifact. These infarcts are not definite and could be artifactual asymmetry.''. He required admission, heparin drip and neurology consult at that time, as well as permissive hypertension. shortly after 1 pm on May 31, he developed chest pain with ischemic changes on EKG requiring cardiology consult with possible intervention, though this was being coordinated with interventional neurology, as he also required basilar angiogram for his MRI findings. as cardiology and interventional neurology were coordinating taking patient for intervention, he became further unresponsive, though maintained his pulse, and required intubation and transfer to ICU, as well as repeat CT of the head to evaluate for continued thrombosis of his basilar system. Work up is still on going


VAERS ID: 1362572 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0180 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anxiety, Cold sweat, Dizziness, Immediate post-injection reaction, Malaise, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (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: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data:
CDC Split Type:

Write-up: Within 2-3 minutes she felt sick and dizzy, then became clammy and unresponsive. She was moved to the floor and regained consciousness within 1 minute. Was given water and a snack and felt better. She left happy and healthy, she does not like needles/vaccination - so she had anxiety from the vaccine.


VAERS ID: 1362579 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 UN / SYR

Administered by: Other       Purchased by: ?
Symptoms: Underdose
SMQs:, Medication errors (broad)

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

Write-up: Wrong Dose .3ml should have been .5ml


VAERS ID: 1362584 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Unknown  
Location: New York  
Vaccinated:2021-05-29
Onset:2021-05-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0185/EW0182 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dysmenorrhoea, Gait disturbance
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamin/daily 4,000iu vitamin D/daily
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: About 48 hours after both shots I had intense menstrual cramps, the worst cramps I have ever had in my life, it was hard to walk. It lasted with both shots about a few hours and subsided with Motrin


VAERS ID: 1362585 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0187 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blindness unilateral, Nausea, Syncope, Vision blurred, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Patient start having nausea and vomiting symptoms about 10 min after administration. She also mentioned blurry vision and loss of vision in one side. She was fainting too. Patient was positioned on her side in the waiting room Her blood pressure was 111/71 and pulse 60 when checked by the pharmacist. EMT was notified. They arrived and check her vitals, she was doing better. they didn''t consider that any future evaluation is needed.


VAERS ID: 1362594 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Puerto Rico  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0178 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Fall, Hyperhidrosis, Pallor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cannabis Medicinal
Current Illness: Sinusitis
Preexisting Conditions: None, ADHD on childhood.
Allergies: None
Diagnostic Lab Data: Not available
CDC Split Type:

Write-up: Patient falls to the floor, gets dizzy while sitting waiting 15 minutes after vaccination. He also presented sweating and pale face. Blood pressure taken by paramedic 110/80. Patient recovers and walked home with his mother who contacted him when the event began.


VAERS ID: 1362600 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011D21A / 2 - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Pain in jaw
SMQs:, Osteonecrosis (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: n/a
Current Illness: she had some unfilled cavities in mouth
Preexisting Conditions:
Allergies: n/a
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: pT WAS GIVEN VACCINE. sHE STAYED IN THE PHARMACY AREA 15 MINUTES. SHE WENT SHOPPING AND CAME BACK ABOUT 20-25 MUNITES LATES STATING SHE HAD A PAIN IN HER LEFT JAW RADIATING UP TO THE LEFT TEMPLE(EYE). i ASKED HER ALL THE WUESTIONS,. SHE DID NOT HAVE SWELLING OF FACE MOUTH OR TONGUE NO DIFFICULTY BREATHING. SHE DID NOT WANT BENADRYL. I GAVE HER ACETAMINOPHEN 500MG. SHE STAYED IN BOOTH FOR 15 MINUTES WITH TECHNICIAN WATCHING HER.I CHECKED OFTEN AND WAS=FEELING BETTER EACH TIME. WHILE IN THE BOOTH SHE SHARED ALL THIS INFORMATION WITH TECHNICIAN ABOUT UNFILLED CAVITIES IN HER MOUTH AND IT COULD HAVE BEEN FORM THAT. AFTER SHE LEFT ANOTHER TECHNICIAN MENITONED THAT SHE WAS VERY NEEDY ON HER FIRST VISIT. BOTH TECHNICIANS ON DUTY FELT SHE WAS MAKING IT UP FOR ATTENTION


VAERS ID: 1362606 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0202 / 2 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Patient stated that she fainted after receiving one of her HPV vaccinations
Other Medications:
Current Illness:
Preexisting Conditions: none
Allergies: nkda
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient fainted approximately 5-10 minutes after receiving her second Covid-19 vaccination


VAERS ID: 1362628 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-05-30
Onset:2021-05-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0178 / 2 - / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Feeling cold, Headache, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Daily muliti Vitamin, Tylenol p.m. for sleep, lexspro
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Started getting very achy about 18 hours after my second shot. I had no side effects with the first one. Cold chills and bad headache. Nauseous waves coming on and off.


VAERS ID: 1362630 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-05-30
Onset:2021-05-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Headache, Hyperacusis, Hyperhidrosis, Pain, Photophobia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Moderna vaccine #1, a month prior. And DTAPP in 2015
Other Medications: Ashwagandha, multi vitamin, turmeric
Current Illness:
Preexisting Conditions:
Allergies: Penicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever for more than 24hrs at 101.6F ,chills, sweating, very severe headache, sensitivity to light and sound, widespread body aches and pains.


VAERS ID: 1362631 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: California  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0187 / 2 - / IM

Administered by: Public       Purchased by: ?
Symptoms: Blood pressure increased, Dizziness, Hyperhidrosis, Immediate post-injection reaction, Nausea, Pallor, Vision blurred
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Hypertension (narrow), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

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

Write-up: client had reported effects after 1st dose and medical team had approved for client to receive 2nd dose today. Baseline vitals: blood pressure 162/90, pulse 94, oxygen 97%. Within 5 minutes of receiving vaccine client reported feeling dizzy, nausea, and blurry vision. Upon arrival client sitting in anti-gravity chair, pale, with mild diaphoresis. Client alert and oriented x4. RN took vitals at 1610: blood pressure 140/80, pulse 85, oxygen 97%. 1613 client reported blurry vision had resolved. Vitals at 1615: blood pressure 150/85, pulse 82, oxygen 97%. Per client dizziness and nausea had also resolved, skin color normal for ethnicity. Client denied chest pain, shortness of breath, headache, palpitations. Per client history of hypertension but provider had removed medication years ago as it resolved. No allergies. Client reported not following up with provider after first dose or for regular check-ups. Vitals at 1620: blood pressure 170/110, pulse 79, oxygen 97%. Retake blood pressure 172/110. Per client "feels fine". Vitals 1625: blood pressure 168/118, pulse 84, oxygen 95%. Per client no symptoms at this time. PHN advised client to follow up with provider regarding blood pressure. ER precautions given. Per client would make appointment with primary. Last vitals at 1653: blood pressure 160/110, pulse 80, oxygen 97%. Client able to stand with no complaints of dizziness, blurry vision, or nausea. Client denied chest pain, palpitations, headache, blurry vision at this time. Client stated drove alone and felt fine to drive. Client left facility with steady gait at 1640.


VAERS ID: 1362645 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: New York  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Decreased appetite, Dizziness, Fatigue, Feeling cold, Headache, Nausea, Pain, Pyrexia, Tenderness
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Morning 8:45am Prozac 30mg Vitamin B Vitamin D (Every Sunday) Has Mirena IUD since 09/2019
Current Illness: Adverse side effects to first shot - head ache -body ache -had some dizzy spells a week ago
Preexisting Conditions: Bipolar disorder
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: -Fever, dizziness, no appetite, nausea, fatigue, body aches, headache, whole body hurts to the touch., I''m freezing


VAERS ID: 1362658 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Nebraska  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature increased, Headache, Pain
SMQs:, Neuroleptic malignant 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: Venlafaxine XR 150mg once daily
Current Illness: No known illnesses
Preexisting Conditions: No chronic health conditions
Allergies: Beeswax, seasonal allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: Body aches, elevated temperature (100.8F), headache


VAERS ID: 1362830 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Nevada  
Vaccinated:2021-05-24
Onset:2021-05-31
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Erythema, Injection site swelling
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Redness/swelling around injection site. No pain at time of report submission.


VAERS ID: 1362836 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-05-23
Onset:2021-05-31
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 035C21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site rash, Injection site swelling, Oropharyngeal pain
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)

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

Write-up: Moderna COVID-19 Vaccine EUA Persistent sore throat rash/swelling around injection site , over a week after receiving.


VAERS ID: 1362839 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-05-27
Onset:2021-05-31
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0182 / UNK RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Purpura, Skin discolouration
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hypotonic-hyporesponsive episode (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: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: Medicine Allergies Name Such as: TraZODone; Baclofen 10gm; Gabapentin 100gm; etc.
Diagnostic Lab Data: I don''t have any Medical Tests yet. It''s just happened!
CDC Split Type:

Write-up: On the 4th day of my second COVID Vaccine, I got purpura. I got red or purple discolored spots on my left knee. I am so worried this symptom can cause a Cerebral hemorrhage. I never have a Cerebral hemorrhage Before! I need to contact the doctor.


VAERS ID: 1363704 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 004C21A / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Body chill, body soreness, headache, fatigue, nausea


VAERS ID: 1364286 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 009D21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Condition aggravated, Depressed level of consciousness, Dizziness, Feeling cold, Hyperhidrosis, Injection site erythema, Injection site swelling, Pruritus
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), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: 2nd Moderna shot given 5/31/21 at 12:49 pm. By 1:00 pharmacy tech saw that pt. had a large, red, swollen area surrounding inj site. Pt. complained of dizziness and extremely itchy upper arm. Pt reported no difficulty breathing. Had pt lower her head while staying seated. 1:00 pm bp 131/92 pulse 76. Pt then reported increasing dizziness. Had pt. lie on floor with lower legs up resting on chair. 1:05 pm bp 142/102 pulse73. Pt''s alertness was decreased compared to before shot. Called 911 around this time. 1:10 pm bp 148/101 pulse 76. Still no difficulty breathing when asked. Then at 1:12 pm pt. complained of being cold throughout whole body. 1:14 pm pt. started to perspire. Pt. was brought a light blanket and covered. 1:15 pm pt. started to shiver. Ambulance personnel arrived, assessed pt. and transported her to e.d. shortly thereafter.


VAERS ID: 1364473 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: California  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 049C21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Fall, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

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

Write-up: Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Additional Details: Patient fell down but did not hit his head. He was advised to lay down at which point he was able to cool down and relax. Drank some water too.


VAERS ID: 1364497 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: New York  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0172 / 1 RA / IM

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

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

Write-up: Pt experienced syncopal episode at vaccine table. According to vaccinator, episode lasted only "a few seconds". Pt was assisted to wheelchair and was taken to medical evaluation room for observation. Vitals were regularly obtained and Pt was observed for 15 minutes; during this time, Pt was administered water. After observation, Pt was assisted to observation area, where family was met, and Pt left without further incident.


VAERS ID: 1364571 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808986 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
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:

Write-up: After administering the vaccination, I realized that the vaccine was given after the recommended beyond use time. The vial was punctured at 9:15AM on 5/31 and the beyond use time was 3:15 PM. The vaccine was administered to the patient at 3:45 PM, 30 minutes after the beyond use time of 6 hours. I attempted to reach the patient several times to inform him of this error, but I was unable to reach the patient.


VAERS ID: 1364586 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 009D21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anxiety, Dyskinesia, Dyspnoea, Lacrimation increased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Lacrimal disorders (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: hydrochlorothiazide 25 mg q day clotrimazole-betamethasone 1%-0.05% cream bid albuterol hfa prn (hasn''t used recently)
Current Illness: none
Preexisting Conditions: asthma, high blood pressure
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt. received 2nd Moderna shot at 3:23 pm on 5/31/21. At about 3:45 pm pt. brought to our attention that she was having difficulty breathing. She said it started as soon as she got the shot but she waited thinking it would be going away. She was anxious, upset, eyes teary, looked afraid, and was raising her shoulders as she breathed. 911 was called. Pt. agreed to receive epi-pen. Time given was 3:47 pm. Pt. reported that breathing felt a little easier. BP taken at 3:51 pm was 182/121 pulse 93. Ambulance personnel arrived at about 3:52 pm. Pt told emt that the difficulty breathing was not like when she needs to use her inhaler. Ambulance personnel assessed and left with pt.


VAERS ID: 1364599 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-05-28
Onset:2021-05-31
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin c , turmeric, probiotic
Current Illness: No
Preexisting Conditions: No
Allergies: Pennicilynn
Diagnostic Lab Data:
CDC Split Type:

Write-up: 101,Fever after 8 hours of receiving the vaccine, nausea fist few hours. fever lasted for 24 Hours. Heavy period started 60 hours after receiving second dose.


VAERS ID: 1364647 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-05-25
Onset:2021-05-31
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema, Injection site warmth, Lymphadenopathy, Pain, Peripheral swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (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: Nifedipine Cerazette
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 6+ days after and my armpit started to feel swollen. Day 8 morning my arm is swollen Popeye style, with red patch, heat where injection was. Very clearly large swelling and soreness using arm . Armpit glands swollen onto chest area. Paracetamol and ibuprofen taken.


VAERS ID: 1364655 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1820095 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product administered to patient of inappropriate age
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: no
Current Illness: no
Preexisting Conditions: no
Allergies: no
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient (came in with father) did not give proper age because they wanted to get the 1 dose J&J. It was not until after vaccinating the patient and we were processing the vaccine that we learned that she was not 18. We spoke with patient and her parent, and they apologized for giving us the wrong DOB.


VAERS ID: 1364657 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: New York  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0172 / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Asthma, Heart rate increased, Respiratory tract congestion
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Dehydration (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: 30 armor thyroid, multivitamin, vitamin c, b12, magnesium, elderberry, fiber gummies
Current Illness:
Preexisting Conditions: Hashimotos thyrioditis, RA, fibromyalgia, ptsd, Sicca syndrome, IBS, degenerative and osteo arthritis, obesity
Allergies: Lactose intolerant, gluten sensitivity
Diagnostic Lab Data: Use of asthma treatments, waiting on call back from pulmonologist, waiting on advice, if in person visit is necessary. So far ER is not. I do not plan on getting second shot. I?m going to click on dr. Visit just in case, so far it has been a call.
CDC Split Type:

Write-up: Congestion started soon aftrerward, by evening needed emergency inhaler, rapid heartbeat overnight for a few hours, asthma symptoms continue


VAERS ID: 1364660 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: New York  
Vaccinated:2021-05-18
Onset:2021-05-31
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 016CZ1A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fatigue, Headache, Hyperhidrosis, Injection site erythema, Injection site reaction, Nausea, Pain in extremity, Peripheral swelling, Rash, Skin lesion
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin
Current Illness: Swollen glands on neck
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: I felt nauseated within 5-10 minutes after the covid vaccine shot. For 2-3 days I suffered from nausea, I broke out in a sweat, headache, fatigue and rashes all over my body. My left arm was painful and swelling for more than a week. On May 31, 2021 I noticed my left arm was very itchy and saw a huge red lesion on the injection site.


VAERS ID: 1364684 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-05-28
Onset:2021-05-31
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 003C21A / 2 - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Decreased appetite, Headache, Injection site nodule, Injection site pain, Lethargy, Lymphatic disorder, Neck pain, Pain, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (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: Vitamin E, 400 units, Vitamin D, 4000 units, Eye Promise Supplement
Current Illness: None
Preexisting Conditions: None
Allergies: Sulfa
Diagnostic Lab Data:
CDC Split Type:

Write-up: The second Moderna vaccine produced an angry red knot at the left arm injection sight that grew into intermittent stabbing pain. I became lethargic then grew weak to the point I could not sit up straight and slept almost all day. I developed a massive headache that radiated down to the top of my neck and loss of appetite. My lymphatic system was in overdrive.


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