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From the 10/15/2021 release of VAERS data:

Found 800,916 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 243 out of 8,010

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VAERS ID: 1765284 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: New Mexico  
Vaccinated:2021-08-20
Onset:2021-09-08
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 3 AR / SYR

Administered by: Public       Purchased by: ?
Symptoms: Nasopharyngitis, Productive cough, Sinus disorder, Sneezing, Throat irritation
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (broad), Infective pneumonia (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: Omeprazole; Famotidine; Hydroxychloroquine; Orencia; Venlafaxine.
Current Illness: No.
Preexisting Conditions: Rheumatoid arthritis; GERD/Reflux; Environmental allergies; Sleep Apnea.
Allergies: Demerol (IV reaction); Environmental Allergies (Tree Pollen, etc.).
Diagnostic Lab Data: No.
CDC Split Type: vsafe

Write-up: I noticed a little bit of irritation around my left side of my face and throat which suggests eustachian tube and it progressed into my throat and then into my upper respiratory. I had coughing and I had mucus that I coughed up. I felt irritation in my sinuses. I think I had sneezing. I felt like it was a common cold. I haven''t had one in a very long time since I have been diagnosed with RA in 2013. The next year, I got flu vaccines every year since 2014, I don''t believe I have had any kind of flu or cold since that time. I had called my doctor''s office and asked about getting the COVID test, and because I had symptoms they said I needed to see the provider. He concluded that it was the common cold and said it has been going around. He said I shouldn''t get a COVID test. Guaifenesin (expectorant to help); Nasal sinus rinse and he said to gargle. I had the symptoms a little bit less than a month, about three weeks.


VAERS ID: 1765290 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-09-05
Onset:2021-09-08
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 048F21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Joint stiffness
SMQs:, 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: multivitamin
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: reports joint stiffness in knees, shoulders, neck and hands. comes and goes, feels especially after getting up from sitting and when using the joint such as when turns neck


VAERS ID: 1765291 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3184 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest discomfort, Palpitations
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (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: Wellbutrin
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: The day after I got the vaccine my chest started to feel heavy and my heart was having many palpitations. It''s a month later and the symptoms have not let up at all. It''s actually getting worse.


VAERS ID: 1765321 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-03-29
Onset:2021-09-08
   Days after vaccination:163
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 008B21-2A / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: COVID POSTIVE


VAERS ID: 1766450 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-06-26
Onset:2021-09-08
   Days after vaccination:74
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 204A21A / 1 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Chest X-ray abnormal, Chills, Cough, Dyspnoea, Hypoxia, Pyrexia
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: DM2 and HLD
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: Acute respiratory failure with hypoxia Pneumonia due to COVID-19 COVID 19 virus infection Symptom onset ~ 9/8 (chills, cough, fever, shortness of breath) Detected 9/13 Vaccination status: vaccinated J&J 6/26 CXR Patchy multifocal bilateral pulmonary infiltrates Oxygen requirements on admission: 2L NC Current oxygen requirements: 96% RA Medical therapy: remdesivir and steroids Stable for DC to home with Dexamethasone to complete 10 day course and PRN Albuterol inhaler


VAERS ID: 1767302 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Chest discomfort, Feeling abnormal, Malaise, Pyrexia, Sluggishness, Somnolence
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: Body temperature; Result Unstructured Data: low grade temperature
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: Heart felt like it was coming out of her chest all day then it went away; felt as if she was about to die; Had a fever of 99.8?F/Keeping a low grade temperature; Felt odd; little sluggish; Slept from 12:00 noon-10:30 pm; Really didn''t feel well; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt odd), SLUGGISHNESS (little sluggish), SOMNOLENCE (Slept from 12:00 noon-10:30 pm), MALAISE (Really didn''t feel well) and CHEST DISCOMFORT (Heart felt like it was coming out of her chest all day then it went away) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Sep-2021, the patient experienced FEELING ABNORMAL (Felt odd), SLUGGISHNESS (little sluggish), SOMNOLENCE (Slept from 12:00 noon-10:30 pm), MALAISE (Really didn''t feel well) and PYREXIA (Had a fever of 99.8?F/Keeping a low grade temperature). On 10-Sep-2021, the patient experienced CHEST DISCOMFORT (Heart felt like it was coming out of her chest all day then it went away) and FEELING ABNORMAL (felt as if she was about to die). At the time of the report, FEELING ABNORMAL (Felt odd), SLUGGISHNESS (little sluggish), SOMNOLENCE (Slept from 12:00 noon-10:30 pm), MALAISE (Really didn''t feel well), FEELING ABNORMAL (felt as if she was about to die) and PYREXIA (Had a fever of 99.8?F/Keeping a low grade temperature) was resolving and CHEST DISCOMFORT (Heart felt like it was coming out of her chest all day then it went away) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Sep-2021, Body temperature: 99.8?f (High) low grade temperature. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided.


VAERS ID: 1767355 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Blood cholesterol, Blood pressure measurement, Body temperature, Chills, Headache, Immunisation, Off label use, Platelet count, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Autoimmune disorder; Blood pressure high; High cholesterol; Platelet count low; Thrombocytopenia
Allergies:
Diagnostic Lab Data: Test Name: Cholesterol; Result Unstructured Data: Test Result:High; Test Name: blood pressure; Result Unstructured Data: Test Result:High; Test Name: temperature; Result Unstructured Data: Test Result:97 Fahrenheit; Comments: normal; Test Name: temperature; Result Unstructured Data: Test Result:99 Fahrenheit; Test Name: temperature; Result Unstructured Data: Test Result:100, 100 point something Fahrenheit; Test Name: temperature; Result Unstructured Data: Test Result:101 Fahrenheit; Test Name: temperature; Result Unstructured Data: Test Result:99.2 Fahrenheit; Test Name: platelet count; Result Unstructured Data: Test Result:low
CDC Split Type: USPFIZER INC202101176498

Write-up: chills; fever; received a third dose/booster today; received a third dose/booster today; headache; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received third dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration on 08Sep2021 as dose 3, single (age at vaccination: 69-year-old) for COVID-19 immunisation. Medical history included thrombocytopenia, High cholesterol, High blood pressure, Low platelet count from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously took first dose (on an unspecified date) and second dose of BNT162B2 on an unspecified date in Feb2021, both for COVID-19 immunisation. On 08Sep2021, the patient received a third dose/booster today (off label use, extra dose administered). Additional information included patient received both doses of database, second in Feb2021, just received a third dose/booster today and was told the booster will be made of a different component that she received today. Caller states that she has thrombocytopenia, and her hematologist told her a month ago that she could get the booster any time, so she went to the pharmacy today and asking if booster is the same as a third shot and if they are of the same formulation. Did not probe as to any other medical conditions that would have deemed her immunocompromised and did not realize until after call ended that she may not have qualified for the third dose. Consumer stated, Yes. I have high blood pressure, high Cholesterol. I have low platelet count and that''s the reason, I went for the third shot, because my immunologist told me, Because I am very sick and because my immune system is stimulated. I don''t know, doesn''t make any sense and I have a reaction to it after the second shot. I was having the same symptoms, A headache, Fever, Chills and then fever the next day, on a way came back at night on a way, the next day was fine. I have been fine all day today, Except I had a little fever. That''s why I called. I don''t know. It it''s normal for Pfizer, A normal reaction after taking Pfizer and having it for 2 days. Consumer stated, "That''s all I take. So, The day after the shot yesterday. No. Wednesday after the shot, I got a headache so, I took some Aceterin you know after they works. So, In mid of the night, yesterday. 2''o clock in the morning, I got the chills so, I took my temperature so, it was normal like 97 and okay so, I took Tylenol to get rid of the chills, that worked, and I went back to sleep and then in the morning, I find my blood pressure, Tired and I sat on the couch for all other day. My temperature was like 99. Is that a 100, 100 point something, then it went up to 101 and I was like okay so, I took 2 Tylenol. It did nothing. It didn''t take the fever gone. It didn''t take away the headache. I said okay and I took two Ibuprofen and then that seems to help. So, if you want to know, I was fine. I was fine all day. All last evening, No headache, No fever, Nothing. I get up this morning and I took temperature just for fun. It was 99.2 and I was like, how that''s so, I just, it took a couple kind of day and it stays around 99 and then it went up to 100 and I am like, why is this going up. Or why is it up. This is just 2 days since the shot so, that''s why I was calling to find out, If that''s the normal reaction to Pfizer. Caller states I got a third shot that I needed because I have an autoimmune disease. I got it Wednesday (08Sep) in the morning and by the evening I had a headache. I took an Excedrin and went to bed then at 2 in the morning I had chills. The scanner thermometer said I didn''t have a fever, but I think I did. I took 2 Tylenol then and then at 10 in the morning, still feeling like garbage I took 2 more Tylenol and then at 12:30 in the afternoon I still got a fever of 101F and a headache then the Tylenol never touched it. So, I took 2 ibuprofen and that seemed to bring it right down I was good the rest of the day, all day yesterday I was good even into the evening. With my second shot I had the same exact symptoms I ended up with a fever later that night which would have been last night, but last night I did not but today I got up and had a 99.2F which I know is technically not a fever but that''s not normal for me and this afternoon it''s been up around 100F so I don''t understand, that''s 2 days now. I went out and I ran some errands. Ibuprofen seemed to help and like I said I ran some errands, and I was okay most of the night I checked my temperature it was back to normal 97 something I went yeah okay I''m over this. My hematologist told me because I have a low platelet count that when I get my third dose, I could be sicker than I was with the second and I said oh delightful, so I don''t know if that''s maybe why it''s taken me 2 days to recover. I just wanted to make sure this is normal. I tried calling her, but she''s on vacation and she never calls me back, so I figured I''d call you to see if this is normal. The patient received treatment with Tylenol, Aceterin, Ibuprofen. The patient underwent lab tests and procedures which included blood cholesterol: high, blood pressure measurement: high, body temperature: 97 fahrenheit normal, body temperature: 99 fahrenheit, body temperature: 100, 100 point something fahrenheit, body temperature: 101 fahrenheit, body temperature: 99.2 fahrenheit, platelet count: low on an unspecified date. Therapeutic measures were taken as a result of headache (headache), chills (chills), fever (pyrexia). The outcome of the events Chills, headache, Fever was recovered and outcome for other events was unknown. The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up. Follow-up (10Sep2021): New information received from a contactable consumer. This consumer (patient) reported that: Relevant medical history and Lab test (High cholesterol, High blood pressure, Low platelet count, body temperature), New events (Booster, Chills, headache, Fever). The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.


VAERS ID: 1767470 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Texas  
Vaccinated:0000-00-00
Onset:2021-09-08
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 3 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anxiety, Depression, Diarrhoea, Malaise, Nausea, Suicidal ideation
SMQs:, Acute pancreatitis (broad), Suicide/self-injury (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Primary immunodeficiency syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101252432

Write-up: almost to the point of suicidal thoughts; sick; horrible nausea; on and off bad diarrhea; terrible depression; anxiety; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on an unspecified date (Lot Number: FC3183, unknown expiration) as dose 3 (booster), single for COVID-19 immunisation. Medical history primary immunodeficiency (CVID). There were no concomitant medications. The patient previously took hydrocodone and had known allergies to it. The patient previously received first dose of BNT162B2 (Lot number: EN6205) on 22Mar2021 at 01:30 pm in left arm and experienced period even though she was on continuous birth control and sick at the age of 29 years old and second dose of BNT162B2 (lot number: EN6955) on unspecified date in left arm for COVID-19 immunization. On 08Sep2021, the patient experienced sick, horrible nausea, and on and off bad diarrhea. She is 15 days out and still getting on and off bad diarrhea. Also, on 08Sep2021, the patient is having terrible depression and anxiety, her depression is much worse than normal almost to the point of suicidal thoughts. The patient did not receive treatment for the events. No COVID prior to vaccination and has not been tested for COVID post vaccination. No other vaccine in four weeks. The patient has not yet recovered from the events. No follow-up attempts are possible; information about batch number was already obtained.


VAERS ID: 1767613 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-02-26
Onset:2021-09-08
   Days after vaccination:194
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL9266 / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cholesterol
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: body temperature; Result Unstructured Data: Test Result:slight fever; Test Date: 20210910; Test Name: covid/COVID swab; Test Result: Positive
CDC Split Type: USPFIZER INC202101294617

Write-up: she had the Delta variant; she had the Delta variant; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9266), via an unspecified route of administration, administered in left arm on 26Feb2021 at around 7:30 in the morning or 8:00 in the morning (at the age of 68-year-old) as DOSE 2, SINGLE and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9266), via an unspecified route of administration, administered in left arm on 05Feb2021 (at the age of 68-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient''s medical history included cholesterol from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient''s historical vaccine included flu shot in Sep2020. Prior to vaccinations (within 4 weeks), the patient had received no other vaccines. The patient had a breakthrough case in Sep2021. On 08Sep2021, the patient started to have COVID symptoms which further clarified as stuffy nose/stuffiness in nose, stuffy ears, slight fever, drainage, and sore throat. The patient also had tiredness, loose stools, and headache, stuffiness, stuffiness in nose and ears really bad. At first, the patient thought it was just sinus issue, went to the doctor and was tested for COVID. The test came back positive on 10Sep2021. The doctor informed the patient that they have been seeing breakthrough cases. The patient was assuming she had the delta variant. The patient was unsure what was happening, at first thinking it''s a sinus infection. The adverse events resulted in physician office visit. The doctor was concerned that the patient was at the end of her shot period. The patient does not know how long the shot period was. The patient wanted to know if the booster shot will against the delta variant. The patient underwent lab tests and procedures which included body temperature: slight fever on 08Sep2021, covid/COVID swab: positive on 10Sep2021. The clinical outcome for the events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1767621 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Iowa  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 2 LA / OT

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest pain, Gait disturbance, Headache, Mental impairment, Pain
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: WARFARINE
Current Illness: Clot blood (Needing 5 stent surgery Pertinent details: Taking warfarin blood thinners)
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Also has needed antibodies, 1 hour long infusion of Bamlavinivimad.); Stent placement
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101309811

Write-up: heavy chest pain; headache; inhabilities to barely walk; Very sore; Not able to function mentally; This is a spontaneous report received from a contactable consumer (patient). This is the second of two reports with events experienced under the second dose. A 60-year-old female patient received second dose of bnt162b2 (BNT162B2), intramuscular, administered in Arm Left on 07Sep2021 16:00 (Lot Number: EW0191) as single dose for covid-19 immunisation. Medical history included blood clot in pelvis from 26Jan2015 and ongoing needing 5 stent surgery (Pertinent details: Taking warfarin blood thinners), covid-19 from Jan2021 to an unknown date (also had needed antibodies, 1 hour long infusion of Bamlavinivimad). Vaccination Facility Site: Pharmacy or Drug Store. Prior vaccinations were reported as no. Concomitant medications included warfarine (WARFARINE) taken for blood clots in pelvis, and blood thinners. First dose of bnt162b2 (BNT162B2) was administered on 18Aug2021 at 10:00 AM intramuscular in Upper left arm, Lot: EW0181, for COVID-19 immunisation and patient from 19Aug2021 to 20Aug2021 experienced walking difficulty, very sore, headache, not able to function mentally, muscle pain, pain in hip, severe leg pain and lower back pain. On 08Sep2021 patient experienced heavy chest pain, inhabilities to barely walk, very sore, headache, not able to function mentally. Events considered serious due to Persistent/significant disability/Incapacity. No treatment received for the events. Patient stated that both shots of vaccine resulted in total body inabilities to barely walk, very sore, headache, not able to function mentally, second shot has same but also included severe chest pain. Patient almost went to hospital, she had covid in Jan2021 and also has needed to antibodies 1 (hr) hour long infusion of Bamlavinivimad(?). On 09Sep2021 patient recovered from the events. No follow-up attempts are needed. No further information expected.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202101075436 Same reporter, patient and product / different events and dose


VAERS ID: 1767955 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Mississippi  
Vaccinated:2021-08-18
Onset:2021-09-08
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3181 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Aura, Diarrhoea haemorrhagic, Haematochezia, Micturition urgency, Pain in extremity, Urine analysis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Convulsions (broad), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad), Generalised convulsive seizures following immunisation (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamins c, d, zinc
Current Illness: None
Preexisting Conditions: Exercise induced asthma
Allergies: Dairy
Diagnostic Lab Data: No uti
CDC Split Type:

Write-up: Moderate-severe Bladder Urgency. Treatment otc AZO standard, vitamins. No uti. Three weeks. Also, not reported to provider yet: random bloody diarrhea, bloody stool: onset October 25, 2021, 4 occurrences to date, random left arm pain since day 1; increased vision aura with and without migraine onset 2 weeks post dose.


VAERS ID: 1768018 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-05-15
Onset:2021-09-08
   Days after vaccination:116
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 037A21B / 1 - / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / -

Administered by: Public       Purchased by: ?
Symptoms: COVID-19, Chest pain, Cough, Fatigue, Headache, Pyrexia, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None Reported
Allergies:
Diagnostic Lab Data: SARS CoV2 NAA Positive on 9/14/2021
CDC Split Type:

Write-up: Breakthrough case after Covid vaccination. Dose #1 4/17/21 Dose #2 5/15/21. C/O fever, headache, fatigue, cough , and chest pain


VAERS ID: 1768058 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-08-18
Onset:2021-09-08
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 033C21A / 1 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Menometrorrhagia, Polymenorrhoea
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: zoloft, 50 mg daily
Current Illness: none
Preexisting Conditions: none
Allergies: penicillin
Diagnostic Lab Data: not yet
CDC Split Type:

Write-up: So far both menstrual periods since receiving the vaccine have been highly irregular. Periods began on 9/8/21 and 10/3/21. Both were a few days early when my cycle is usually 28 days like clockwork. More importantly, both period have been EXTREMELY heavy and have lasted twice as long as typical. The bleeding has been excessive and I''ve yet to receive my second dose because of how concerning this is. have an appointment to discuss with my doctor coming up, but as far as I know I am 100% healthy otherwise.


VAERS ID: 1768111 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017E21A / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Heart rate increased, Pain in extremity, Pruritus, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypersensitivity (narrow), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: N/A
Preexisting Conditions: History of auto immune issues
Allergies: N/A
Diagnostic Lab Data: On 9/10/21 Urgent care PA said not to worry about symptoms
CDC Split Type:

Write-up: Fever, arm pain, spreading rash on left arm (continued to spread for 5 days), itching, rapid heart rate on day 3 (150 beats per minute resting pulse). One month later, heart rate continues to be higher than previous rate although rarely over 130 bpm. Rash and arm pain/itching has gone away.


VAERS ID: 1768474 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-28
Onset:2021-09-08
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Back pain, Chills, Dysmenorrhoea, Fatigue, Menstrual disorder, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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

Write-up: Chills, fatigue and body aches after the shot . An extreme change in menstrual period and symptoms . Nausea, lower back pain and really really bad cramps.


VAERS ID: 1770485 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006B21A / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: Received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine). On 08-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment medication were reported.


VAERS ID: 1770495 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006B21A / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: Received expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were mentioned. No treatment details were reported.


VAERS ID: 1771089 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
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: USMODERNATX, INC.MOD20213

Write-up: This spontaneous case reported by a nurse, describes the occurrence of administered expired product (received expired vaccine) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 006B21A) for COVID-19 immunization. No medical history reported. In 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 8, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 8, 2021, patient administered expired product (received expired vaccine). At the time of the report, administered expired product (received expired vaccine) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.


VAERS ID: 1771171 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 058E21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Circumstance or information capable of leading to medication error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Wrong patient (documentation in EMR).


VAERS ID: 1771398 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-03-25
Onset:2021-09-08
   Days after vaccination:167
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8733 / 2 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Electroencephalogram, Headache, Hemiparesis, Magnetic resonance imaging normal, Paraesthesia, Sensory loss, Tremor, Vertigo
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Vestibular disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: EEG - 10/05/2021 - Results pending MRI - 10/07/2021 - Results are clear (no signs of damage)
CDC Split Type:

Write-up: Tingling headaches, tremors on left side of body (including face, shoulder, arm, leg, foot). Loss of sensation and muscle weakness on left side of body. Vertigo.


VAERS ID: 1771399 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Unknown  
Location: Georgia  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Expired product administered
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: Vaccine error - Vaccine was administered past its beyond use date. The vaccine had been stored in the freezer beyond the time frame recommended by the manufacturer.


VAERS ID: 1771413 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Unknown  
Location: Georgia  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: Vaccine error - Vaccine was administered past its beyond use date. The vaccine had been stored in the freezer beyond the time frame recommended by the manufacturer.


VAERS ID: 1771638 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-08-29
Onset:2021-09-08
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2587 / 3 UN / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain, Bell's palsy, Colitis, Diplopia, Ear pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hearing impairment (broad), Ocular motility disorders (broad), Noninfectious diarrhoea (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Baclofen 10mg Calcum/vit D 5/500 celecoxib 200mg cholecalciferol 2000 units ciprofloxacin 500mg metronidazole 500mg diclofenac gel duloxetine 30mg fish oil 1000mg folic acid 1mg gabapentin 300mg lactobacillus lidocaine 5% patch losartan 50m
Current Illness: interventional pain surgery done on 08/26/2021
Preexisting Conditions: chronic low back pain, hyperlipidemia, GERD, morbid obseity, hypertension, T2DM, sleep apnea, asthma, recurrent major depression
Allergies: NKA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient after a week of receiving the vaccine, was admitted through the emergency room for abdominal pain and admitted for colitis. Patient was treated and discharged with ciprofloxacin and metronidazole. While on antibiotics patient developed diplopia that remained unresolved until 10/7/2021. Patient returned to ER 9/28/2021 for left sided Otalgia leading to Bells palsy of the left side of face. Symptoms of bells palsy has improved but has not resolved.


VAERS ID: 1772322 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Expired product administered
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: Vaccine error: Vaccine administered past its beyond use date. The vaccine stored in the freezer beyond the timeframe recommended by the manufacturer.


VAERS ID: 1772336 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: Vaccine error - Vaccine was administered past its beyond use date. The vaccine had been stored in the freezer beyond the time frame recommended by the manufacturer.


VAERS ID: 1772373 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Unknown  
Location: Georgia  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: Vaccine error - Vaccine was administered past its beyond use date. The vaccine had been stored in the freezer beyond the time frame recommended by the manufacturer.


VAERS ID: 1772389 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: Vaccine error - Vaccine was administered past its beyond use date. The vaccine had been stored in the freezer beyond the time frame recommended by the manufacturer.


VAERS ID: 1773464 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 AR / IM

Administered by: Military       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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none reported
Preexisting Conditions: active smoker, active vaper
Allergies:
Diagnostic Lab Data: vision screening: 20/20 OD, 20/16 OS, 20/16 b/l IOP''s: 12 b/l
CDC Split Type:

Write-up: reported blurry vision, intermittent x 1 month starting day of vaccination. Currently monitoring, awaiting further workup


VAERS ID: 1775015 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-05-20
Onset:2021-09-08
   Days after vaccination:111
Submitted: 0000-00-00
Entered: 2021-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 004C21A / 1 LA / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 053C21A / 2 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Exposure during pregnancy, Foetal heart rate abnormal, Labour induction, Stillbirth, Ultrasound antenatal screen abnormal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (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? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: In April, I became pregnant with my second child. After heavy advising, I recieved the first dose of the covid vaccine in May, my first month of being pregnant. I received the second dose in June, my second month of pregnancy. On Sept 8th, during a routine scheduled ultrasound, the fetus was found to have no heartbeat. Which resulted in an emergency induction of labor. I had a stillbirth delivery the next day, Sept 9th.


VAERS ID: 1775199 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-07-26
Onset:2021-09-08
   Days after vaccination:44
Submitted: 0000-00-00
Entered: 2021-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EWO196 / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Dysmenorrhoea, Influenza like illness
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: Xyzal 5mg
Current Illness:
Preexisting Conditions: Ear tube dysfunction, cholinergic urticaria
Allergies: Penicillin, sulfas, latex, shellfish, dairy, eggs
Diagnostic Lab Data:
CDC Split Type:

Write-up: Flu-like symptoms for 2 days. This started a few hours after vaccine. Long-term side effects started 9/08/2021 with extreme menstrual cramping before, during, and after menstruation. This never happened beforehand, and I think it?s related. I went to an obgyn and they didn?t have much of any information or help.


VAERS ID: 1776755 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-09-01
Onset:2021-09-08
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Hypoaesthesia, Joint swelling, Pain in extremity, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

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

Write-up: Day 8: right knee joint pain, slight swelling, and slight numbness. Left and right hand joint pain. Day 9: same as day 8 Day 10: knee no longer in pain. Hand less but still joint pain. Left foot joint pain, slight numbness and swelling, and left ankle joint pain and swelling. Day 11: only left foot and ankle remain painful. Day 12: same as day 11.


VAERS ID: 1776779 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-03-01
Onset:2021-09-08
   Days after vaccination:191
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Acute coronary syndrome, Acute myocardial infarction, COVID-19, Dyspnoea, SARS-CoV-2 test positive, Troponin increased
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Troponin (9/8/21): 292 COVID PCR (9/9/21): positive
CDC Split Type:

Write-up: The patient was admitted on 9/8/21 with suspected acute coronary syndrome. She was seen by cardiology and felt to have type II NSTEMI likely secondary to dyspnea and recent Covid infection. She


VAERS ID: 1776886 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Montana  
Vaccinated:2021-08-18
Onset:2021-09-08
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 049E21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blister, Burning sensation, COVID-19, Erythema, Headache, Herpes zoster, Swelling
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Escitalopram
Current Illness: None
Preexisting Conditions: None
Allergies: Peanuts
Diagnostic Lab Data: September 11: Urgent Care visit (given antibiotics) September 13: Urgent Care visit (given Valacyclovir) September 13: Urgent Care visit (later filled a prescription for Acyclovir when the Shingles persisted) October 3: Positive COVID test October 4: Antibody Infusion
CDC Split Type:

Write-up: I initially woke up with intense burning/pain on my forehead. Over the next few days, the site of the pain became red, swollen, and blistered. I went to the urgent care at Hospital on September 11. They thought I had a skin infection (but could possibly be Shingles) and prescribed antibiotics. The antibiotics were not helping and the blisters were spreading (across my face, around my eye, under my hair--all on the right side) so I went to a different urgent care location on September 13. They told me that it looked like I had Shingles and prescribed Valacyclovir 1000 mg twice/day. That started helping, but the Shingles persisted for quite a while. I also had to visit an eye doctor because the Shingles were around my eye. He prescribed additional medication for me, which I am still taking now (Acyclovir). Two out of the three doctors I saw said that this could have definitely been triggered by the vaccine. Consequently I was not able to get the second dose, and I''m not sure that I want to. While my immune system was down because of the Shingles, I ended up contracting COVID. I am currently fighting that as well.


VAERS ID: 1778831 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Kansas  
Vaccinated:2021-09-06
Onset:2021-09-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 301308A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Gait disturbance, Movement disorder, Muscle spasms, Muscular weakness, Pain in jaw, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Osteonecrosis (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: NA
Preexisting Conditions: NA
Allergies: NKA
Diagnostic Lab Data: NA
CDC Split Type:

Write-up: First Covid Vaccine: Aug 15 Second Covid Vaccine: Sept 6 2-3 days after second dose couldn''t walk because of leg fatigue. Dragging legs because he felt like he could not move. Muscle cramps. Leg tingling in the morning and throughout the day. Bilateral jaw pain. Tylenol given. Running and jogging helps alleviate the pain. He is not having difficulty breathing. I advised the following: Ibuprofen as needed for pain. Take a daily multivitamin. Continue to exercise as tolerated. Report his symptoms to the vaccine adverse effects hotline. Seek medical attention if he is having difficulty breathing. Mother aware and in agreement with this plan.


VAERS ID: 1779112 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Iowa  
Vaccinated:2021-08-30
Onset:2021-09-08
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 020F21A / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest discomfort, Dissociation, Dizziness, Feeling abnormal, Laboratory test, Panic attack, Presyncope, Suicidal ideation, Syncope, Tremor, Vibratory sense increased
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Suicide/self-injury (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Lab tests Sept 30
CDC Split Type:

Write-up: Dizziness, fainting, brain fog, hands shaking, internal vibration, tinnitus right ear, pressure in chest, feeling disconnected from self to such a degree felt suicidal (one day only). On all days to date, doing smallest things like writing a simple email for 10 minutes, or any kind of focus-- talking on phone, etc , will suddenly make me feel panic and I feel lightheaded and start to pass out (note this side effect is ongoing in week 6 but to lesser degree). Feel very rundown--this is ongoing. All side effects are ongoing in week six except chest tightness.


VAERS ID: 1779151 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Alabama  
Vaccinated:2021-08-16
Onset:2021-09-08
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0171 / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Vaccine positive rechallenge
SMQs:

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: COVID19 (Pfizer) dose 1, Staring on day 4 from injection and lasting 7 days - Severe nausea, abdominal pain, diarrhea and consti
Other Medications: Amlodopine, Protonix, Flowmax, Nasacort
Current Illness:
Preexisting Conditions: Vasculitis
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Severe abdominal pain, Severe nausea, Diarrhea and Constipation, lasting 33 days


VAERS ID: 1779353 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 035C21A / 1 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Exposure during pregnancy, No adverse event, Product administered to patient of inappropriate age
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Medication errors (narrow)

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

Write-up: A 17-year-old patient who is pregnant was given COVID-19 Moderna vaccine series. Patient did not report any adverse reaction.


VAERS ID: 1779523 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 1 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Bell's palsy, Blood test normal, Computerised tomogram normal, Electrocardiogram normal, Facial paralysis, Hypoaesthesia oral, Movement disorder, Pregnancy test negative, SARS-CoV-2 test negative
SMQs:, Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Duloxetine 60 mg, Amphet/dextr 10 mg 3x day.
Current Illness: None
Preexisting Conditions: None
Allergies: Nickle
Diagnostic Lab Data: 9/13/21: EKG- negative for any heart issues. CAT scan- negative for stroke or heart issues. COVID test- negative. Pregnancy test- negative. Blood work- normal ranges.
CDC Split Type:

Write-up: Approximately 5 min after injection my lips became numb. Three days later tongue was numb. By Monday there was noticeable droopiness of the face and lack of movement on the right side of my face. I went to the emergency room and was diagnosed with having Bell''s Palsy,


VAERS ID: 1780451 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-17
Onset:2021-09-08
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Hospitalization after First MMR vaccine as a baby
Other Medications:
Current Illness:
Preexisting Conditions: Hashimoto?s Thyroiditis, hypertension, anxiety, depression
Allergies: MMR vaccine
Diagnostic Lab Data:
CDC Split Type:

Write-up: Itchiness/rash on random areas of body at random times of the day after second Pfizer vaccine dose on 09/07/2021


VAERS ID: 1780474 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / UNK - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test, Burning sensation, Chills, Diarrhoea, Dizziness, Fatigue, Heart rate increased, Hypertension, Influenza like illness, Muscle spasms, Muscle twitching, Nausea, Paraesthesia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), 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: Synthroid .175 mg
Current Illness: None
Preexisting Conditions: Thyroid Disease (hypo), but normal levels
Allergies: Allergic to sulfa
Diagnostic Lab Data: Blood test done on 10/6/2021. Results not known yet.
CDC Split Type:

Write-up: Elevated heart rate - 157 resting heart rate, chills, fatigue, high blood pressure, nauseous, flu-like symptoms, diarrhea, tingling, sharp burning sensation (like glass in eyes) and sensation through forehead and in spine, twitching in hands, cramps in calves/toes, dizziness. Did not feel right or good at all. Symptoms minimized over three weeks, but still have issues to date (sensation in spine and through forehead and elevated heart rate at least 10 beats higher that normal as of 10/12/21.


VAERS ID: 1782752 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-04-06
Onset:2021-09-08
   Days after vaccination:155
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: COVID 19


VAERS ID: 1783029 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: South Dakota  
Vaccinated:2021-05-17
Onset:2021-09-08
   Days after vaccination:114
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 041B21A / 2 LA / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: Anticoagulant therapy, Deep vein thrombosis, Embolism venous, Oedema peripheral, Ultrasound Doppler abnormal, Weight increased
SMQs:, Cardiac failure (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, UNSPECIFIED TYPE 2 DIABETES MELLITUS WITHOUT COMPLICATIONS TYPE 2 DIABETES MELLITUS WITH DIABETIC NEUROPATHIC ARTHROPATHY MORBID (SEVERE) OBESITY DUE TO EXCESS CALORIES
Allergies: Keflex, Cephalosporins
Diagnostic Lab Data: Doppler to left leg 9/14/2021
CDC Split Type:

Write-up: ACUTE EMBOLISM AND THROMBOSIS OF LEFT FEMORAL VEIN Orders from PAC received as resident has partial thrombus distal superficial femoral vein, nonocclusive. Start Eliquis for DVT. Stop Naproxen and Pepto-bismal d/t possible interaction with Eliquis. Resident weight has been increasing and legs are significantly edematous. Increase Lasix to 40 mg daily and f/u in 1 week for recheck.


VAERS ID: 1783048 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-04-10
Onset:2021-09-08
   Days after vaccination:151
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0151 / 2 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Eye irritation, Headache, Nasal discomfort, SARS-CoV-2 test positive, Sneezing, Throat clearing
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Corneal disorders (broad), Hypersensitivity (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Atorvastatin; olmesartan
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: COVID test, positive results on the 13th and that was positive result.
CDC Split Type: vsafe

Write-up: Starting on Wednesday, Sept 8, I started having burning eyes and nose started burning, too. On the Sunday before, I had sneezing, about three times. I had a light headache that felt like a sinus headache but when I took my allergy pill it didn''t go away when I took it at onset (this was Wednesday). Thursday-Friday, no headache but still had burning eyes and burning nose. On Sunday, I began to had to keep clearing my throat, not a cough but just had to keep clearing my throat. On the following Monday, 13th, I went to the doctor. They gave me a steroid shot and they prescribed some antibiotics and then they told me to get some OTC medications for coughs that wouldn''t affect my high blood pressure because I was draining a lot. After doing the steroid shot, I started to feel good but that lasted for only a short period. Through that whole week, I would start feeling better but the cough wouldn''t go away. But I found out that the medication I was taking for coughing would just quiet it down for a break for the cough and so I needed to take it for every four hours the moment I could take it otherwise I was coughing every few minutes. I had it all for a week and a half.


VAERS ID: 1783611 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-08-20
Onset:2021-09-08
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Heart attack


VAERS ID: 1784811 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-01-28
Onset:2021-09-08
   Days after vaccination:223
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8982 / 1 UN / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6201 / 2 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Dyspnoea, Hypoxia, Infection, Laboratory test abnormal, Nasopharyngitis
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad)

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

Write-up: 74-y/o female patient with a history of hypertension colon cancer thalassemia hyperlipidemia brought to the emergency room with complaints of generalized weakness for the last few days which is been getting worse and she also has developed cold symptoms on September 2 and tested positive on September 3 and since then patient was short of breath and mildly hypoxic about 86% and she took the more dose of the core with vaccine on February 2021 and nobody is sick in the home Patient denies any fever or chills chest pain vomiting diarrhea constipation body aches change in taste or smell.The patient began the hospital with positive infection ID consultation steroids nebulizer treatment andAntiviral medications per ID.


VAERS ID: 1785455 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: California  
Vaccinated:2021-09-01
Onset:2021-09-08
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / 1 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Blood test, Cardiac stress test, Chest X-ray, Chest discomfort, Chest pain, Dizziness, Dyspnoea, Electrocardiogram
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Nothing
Current Illness: I had COVID.
Preexisting Conditions: None
Allergies: Nothing
Diagnostic Lab Data: So far I''ve had blood work, chest x ray, ekg and cardiac stress test.
CDC Split Type: vsafe

Write-up: I felt light headed, weak, shortness of breath and chest pain. Discomfort in my chest area.


VAERS ID: 1785769 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cough, Fatigue, Hot flush, Respiratory tract congestion
SMQs:, Anaphylactic reaction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Had flu vaccine, second shingles vaccine and covid vaccine same time
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Hot Flashes still having them bad Tired Cough Congested


VAERS ID: 1785811 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-04-13
Onset:2021-09-08
   Days after vaccination:148
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2613 / 2 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Anticoagulant therapy, Blood test, COVID-19, Chest X-ray, Computerised tomogram, Cough, Dyspnoea, Hypoaesthesia, Pollakiuria, Pyrexia, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Losartan; Omeprazole
Current Illness: no
Preexisting Conditions: elevated blood pressure
Allergies: no
Diagnostic Lab Data: CT scan and X-ray for lungs; bloodwork
CDC Split Type: vsafe

Write-up: I tested positive for COVID in mid September. I had a high fever and a lot of coughing and a hard time breathing. I went to ER and they admitted me to hospital for five days. I received Steroid injection: anti-viral - Remdisiver - had that every day. They put me on blood thinners, too. My breathing is better now but I am still having a cough - but it''s much reduced. They sent me home with prescription for these: I took Benzonatate - for a cough and Prednisone. Side issues now - I cannot feel the top of my left foot or shin - I noticed that when I left the hospital - happened during the hospital stay. I am waiting to see a specialist for this. I now have frequent urination - almost like a prostrate issue that started with the event. Follow up with NP. I probably had the flu vaccine six months prior to the first COVID vaccine.


VAERS ID: 1785953 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2589 / UNK LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain upper, Cough, Dizziness, Dyspnoea, Feeling of body temperature change, Mobility decreased, Muscular weakness, Pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: I was taking Centrumine 37.5mg half a tab daily I also Prenazone 5mg alternating days, topiramate 50mg every day and 25mg at night Lomperazole and it take that in the morning at 20mg and its time released. Flonaze spray 4 a day, I usu
Current Illness: none
Preexisting Conditions: Chronic lung disease, and i''m going thru transplant qualifications.
Allergies: I''m allergic to Bactrim clindamycin and anything with sulfa in it and codeine. I''m allergic to scallops
Diagnostic Lab Data: No test or lab results.
CDC Split Type: vsafe

Write-up: I had to call my boyfriend because I couldn''t get up. I had pain in stomach, a shooting pain to my neck and towards to my leg. I had an intense fever, and I was really hot and dizzy. I didn''t have the ability to stand up and that made me nervous, and I couldn''t get up the stairs. I had weakness in my muscles, but not how I experience it on that day. I went from hot and cold and it surprised and scared me. I had breathing issues, more coughing and labor breathing. I haven''t heard from my doctor. I was given tips to try some home remedies that helped me. It felt like I had covid again.


VAERS ID: 1786364 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Burning sensation, Chest pain
SMQs:, Peripheral neuropathy (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

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

Write-up: Burning chest pain around one hour after injection and continued intermittently for 24 hours


VAERS ID: 1699566 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-09-08
   Days after vaccination:63
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC-6208 / 2 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Headache, Menstruation irregular, Vertigo, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Fertility disorders (broad)

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

Write-up: Halted and then irregular menstruation, vomiting, vertigo and headaches.


VAERS ID: 1707931 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-08
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004668 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Feeling abnormal, Immunisation, Myocarditis, SARS-CoV-2 test, Troponin
SMQs:, Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test; Test Name: Troponin; Result Unstructured Data: high
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: vaccination; hours; chest pain; Myocarditis; This case was received via the RA (Reference number: GB-MHRA-ADR 25913259) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of IMMUNISATION (vaccination), FEELING ABNORMAL (hours), CHEST PAIN (chest pain) and MYOCARDITIS (Myocarditis) in a 19-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004668) for COVID-19 vaccination. No Medical History information was reported. On 05-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). On an unknown date, the patient experienced IMMUNISATION (vaccination) (seriousness criterion medically significant), FEELING ABNORMAL (hours) (seriousness criterion medically significant) and CHEST PAIN (chest pain) (seriousness criterion medically significant). At the time of the report, IMMUNISATION (vaccination), FEELING ABNORMAL (hours) and CHEST PAIN (chest pain) outcome was unknown and MYOCARDITIS (Myocarditis) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) No - Negative COVID-19 test. On an unknown date, Troponin: 200 (High) high. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were provided. No treatment medication were provided. Company Comment: This case concerns a 19 year-old, male subject with no relevant medical history, who experienced the unexpected event of Myocarditis. The event occurred approximately 3 days after the second dose of Moderna Covid -19 Vaccine and had a AESI. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of Moderna Covid-19 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 19 year-old, male subject with no relevant medical history, who experienced the unexpected event of Myocarditis. The event occurred approximately 3 days after the second dose of Moderna Covid -19 Vaccine and had a AESI. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of Moderna Covid-19 Vaccine is not affected by this report.


VAERS ID: 1707940 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-08
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NOT KNOWN / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Influenza, Pyrexia, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Flu symptoms; Fever; Menstrual flow excessive; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25917323) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Menstrual flow excessive), INFLUENZA (Flu symptoms) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. Not Known and Unknown) for COVID-19 vaccination. No Medical History information was reported. On 04-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1. On 08-Sep-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Menstrual flow excessive) (seriousness criterion medically significant). On an unknown date, the patient experienced INFLUENZA (Flu symptoms) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). At the time of the report, HEAVY MENSTRUAL BLEEDING (Menstrual flow excessive) had not resolved and INFLUENZA (Flu symptoms) and PYREXIA (Fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had a delivery in April. Patient received first dose of vaccine on 10 Jul a2021 nd had her first period on 06 Aug 2021 for 5 days as normal. Then the patient received second dose of vaccine on 04 Sep 2021 and experienced fever and flu symptoms for 24 hours and on 08 Sep 2021 had extremely heavy bleeding. Patient reported that she had not experienced this since she got her first period. Patient was not under any stress and didn''t have any other health issues. Concomitant medications were not reported. No treatment details were provided. Company Comment: This case concerns a female patient with no relevant medical history, who experienced serious unlisted events of Heavy menstrual bleeding, influenza, and pyrexia. The event (Heavy menstrual bleeding) occurred 4 days and the rest on an unknown date after 2nd dose of Spikevax. The rechallenge was not applicable as the event was after 2nd dose. The reporter causality was not provided. The benefit-risk relationship of drug Spikevax in not affected by this report.; Sender''s Comments: Company Comment: This case concerns a female patient with no relevant medical history, who experienced serious unlisted events of Heavy menstrual bleeding, influenza, and pyrexia. The event (Heavy menstrual bleeding) occurred 4 days and the rest on an unknown date after 2nd dose of Spikevax. The rechallenge was not applicable as the event was after 2nd dose. The reporter causality was not provided. The benefit-risk relationship of drug Spikevax in not affected by this report.


VAERS ID: 1707946 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Feeling hot, Headache, Renal pain, SARS-CoV-2 test
SMQs:, Guillain-Barre syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Feeling hot; Kidney pain; Headache; Weakness; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25920363) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FEELING HOT (Feeling hot), RENAL PAIN (Kidney pain), HEADACHE (Headache) and ASTHENIA (Weakness) in a 29-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced FEELING HOT (Feeling hot) (seriousness criterion medically significant), RENAL PAIN (Kidney pain) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and ASTHENIA (Weakness) (seriousness criterion medically significant). At the time of the report, FEELING HOT (Feeling hot), RENAL PAIN (Kidney pain) and ASTHENIA (Weakness) was resolving and HEADACHE (Headache) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time


VAERS ID: 1707947 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004222 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Lymphadenopathy, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: fatigue; Fever; Chills; Headache; Swollen lymph nodes; Tiredness; Generalised muscle aches; This case was received via Regulatory Authority MHRA (Reference number: GB-MHRA-ADR 25920611) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), LYMPHADENOPATHY (Swollen lymph nodes), FATIGUE (Tiredness) and MYALGIA (Generalised muscle aches) in a 27-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004222) for COVID-19 vaccination. No Medical History information was reported. On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and MYALGIA (Generalised muscle aches) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (fatigue) (seriousness criterion medically significant). On 09-Sep-2021, CHILLS (Chills) had resolved. At the time of the report, FATIGUE (fatigue) and LYMPHADENOPATHY (Swollen lymph nodes) had not resolved and PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Tiredness) and MYALGIA (Generalised muscle aches) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was given. Patient had a swollen node under armpit which was quite painful. No treatment medication was given. Company comment: Based on current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1709956 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, SARS-CoV-2 test
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Myocarditis (suffered from myocarditis in may and was admitted to hospital for 3 nights)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Acute chest pain; This case was received via RA (Reference number: GB-MHRA-ADR 25913658) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHEST PAIN (Acute chest pain) in an 18-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Myocarditis (suffered from myocarditis in may and was admitted to hospital for 3 nights). On 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced CHEST PAIN (Acute chest pain) (seriousness criterion medically significant). At the time of the report, CHEST PAIN (Acute chest pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication details was reported. No treatment medication details was reported. Company Comment: This case concerns a 18 year-old, female subject with a history of myocarditis who experienced the unexpected event of CHEST PAIN. The event occurred approximately 1 day after the second dose of Spikevax. The rechallenge was not applicable as there is no information about dose 1. The medical history of myocarditis remains a confounder. The benefit-risk relationship of Spikevax is not affected by this report. Event term, onset date, outcome and seriousness captured per SD from Regulatory Authority reporting.; Sender''s Comments: This case concerns a 18 year-old, female subject with a history of myocarditis who experienced the unexpected event of CHEST PAIN . The event occurred approximately 1 day after the second dose of Spikevax. The rechallenge was not applicable as there is no information about dose 1. The medical history of myocarditis remains a confounder. The benefit-risk relationship of Spikevax is not affected by this report. Event term, onset date, outcome and seriousness captured per SD from Regulatory Authority reporting.


VAERS ID: 1709957 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Maternal exposure during breast feeding, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal exposures via breast milk (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: LACTULOSE; SERTRALINE.
Current Illness: Breast feeding.
Preexisting Conditions: Comments: No medical history information was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Maternal exposure during breast feeding; Vomiting; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25913871) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and VOMITING (Vomiting) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No medical history information was reported. Concurrent medical conditions included Breast feeding. Concomitant products included SERTRALINE for Anxiety, LACTULOSE for Constipation. On 06-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) (seriousness criterion medically significant). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown and VOMITING (Vomiting) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient was not enrolled in clinical trial. No treatment medication details was provided. Company Comment: This case concerns a 32-year-old, female patient with no relevant medical history, who experienced the unexpected events of maternal exposure during breastfeeding and vomiting. The events occurred approximately 1 and 2 days after the second dose of the Moderna vaccine. The rechallenge was unknown since there''s no information about the first dose. Events assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious. The benefit-risk relationship of Moderna vaccine is not affected by this report. Sender''s Comments: This case concerns a 32-year-old, female patient with no relevant medical history, who experienced the unexpected events of maternal exposure during breastfeeding and vomiting. The events occurred approximately 1 and 2 days after the second dose of the Moderna vaccine. The rechallenge was unknown since there''s no information about the first dose. Events assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious. The benefit-risk relationship of Moderna vaccine is not affected by this report.


VAERS ID: 1709958 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Dizziness, Feeling abnormal, Headache, Paraesthesia, Pyrexia, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (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? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CO-CODAMOL; NAPROXEN; PARACETAMOL
Current Illness: Suspected COVID-19 (Unsure when symptoms started)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210831; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fever; Tingling; Headache; Dizziness; Back pain; Faint; Spaced out; This case was received via the regulatory authority (Reference number: GB-MHRA-ADR 25915890) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), PARAESTHESIA (Tingling), HEADACHE (Headache), DIZZINESS (Dizziness), BACK PAIN (Back pain), SYNCOPE (Faint) and FEELING ABNORMAL (Spaced out) in a 27-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Suspected COVID-19 (Unsure when symptoms started). Concomitant products included CODEINE PHOSPHATE, PARACETAMOL (CO-CODAMOL) from 09-Jan-2021 to an unknown date and PARACETAMOL from 01-Sep-2021 to an unknown date for Chest infection, NAPROXEN from 08-Sep-2021 to an unknown date for Throat infection. On 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criterion disability), PARAESTHESIA (Tingling) (seriousness criterion disability), HEADACHE (Headache) (seriousness criterion disability), DIZZINESS (Dizziness) (seriousness criterion disability), BACK PAIN (Back pain) (seriousness criterion disability), SYNCOPE (Faint) (seriousness criteria disability and medically significant) and FEELING ABNORMAL (Spaced out) (seriousness criterion disability). At the time of the report, PYREXIA (Fever), PARAESTHESIA (Tingling), HEADACHE (Headache), DIZZINESS (Dizziness), BACK PAIN (Back pain), SYNCOPE (Faint) and FEELING ABNORMAL (Spaced out) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Aug-2021, SARS-CoV-2 test: negative (Negative) negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No Treatment medication were provided. Company comment: This case concerns a 27-year-old, female patient with no relevant medical history, who experienced the unexpected events of Pyrexia, Paraesthesia, Headache, Dizziness, Back Pain, Syncope, and Feeling abnormal. The events occurred approximately 1 day after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna CoviD-19 Vaccine in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a 27-year-old, female patient with no relevant medical history, who experienced the unexpected events of Pyrexia, Paraesthesia, Headache, Dizziness, Back Pain, Syncope, and Feeling abnormal. The events occurred approximately 1 day after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna CoviD-19 Vaccine in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1709962 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004223 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: COVID-19 virus test negative.
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Ache; Dizzy; Lightheadedness; Fever; Nausea; Headache; This case was received via RA (Reference number: GB-MHRA-ADR 25916949) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Ache), DIZZINESS (Dizzy), DIZZINESS (Lightheadedness), PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Headache) in a 22-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. No Medical History information was reported. On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced PAIN (Ache) (seriousness criterion medically significant), DIZZINESS (Dizzy) (seriousness criterion medically significant), DIZZINESS (Lightheadedness) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, PAIN (Ache), DIZZINESS (Dizzy), DIZZINESS (Lightheadedness), PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, SARS-CoV-2 test: negative (Negative) COVID-19 virus test negative.. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided by the reporter. Treatment information was not provided. Company comment: This case concerns a 22-year-old, male patient who experienced the unexpected events of Pain, Dizziness, Headache, Pyrexia, Nausea. The events occurred the same day after the second dose vaccination. The rechallenge is unknown since no information about the first dose was disclosed. The events were considered related to the vaccine per the reporter''s assessment. The benefit-risk relationship of Spikevax (mRNA-1273 - Moderna COVID-19 Vaccine) is not affected by this report. Events assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious.; Sender''s Comments: This case concerns a 22-year-old, male patient who experienced the unexpected events of Pain, Dizziness, Headache, Pyrexia, Nausea. The events occurred the same day after the second dose vaccination. The rechallenge is unknown since no information about the first dose was disclosed. The events were considered related to the vaccine per the reporter''s assessment. The benefit-risk relationship of Spikevax (mRNA-1273 - Moderna COVID-19 Vaccine) is not affected by this report. Events assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious.


VAERS ID: 1709963 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Headache; Muscle ache; Fever; This case was received via RA (Reference number: GB-MHRA-ADR 25917336) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MYALGIA (Muscle ache) and PYREXIA (Fever) in a 21-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. No medical history was provided. Concurrent medical conditions included Suspected COVID-19 since 08-Sep-2021. On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache), MYALGIA (Muscle ache) and PYREXIA (Fever) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product was not provided by the reporter. Treatment product was not provided by the reporter. Absolutely worst illness patient have ever had. Covid was a walk in the park compared to this. Never felt more ill in her life. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial Company Comment: This case concerns a 21-year-old, female patient with no relevant medical history, who experienced the unexpected events of headache, myalgia and pyrexia. The events occurred the same day after the second dose of Spikevax. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Spikevax in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a 21-year-old, female patient with no relevant medical history, who experienced the unexpected events of headache, myalgia and pyrexia. The events occurred the same day after the second dose of Spikevax. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Spikevax in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1709965 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA BN3004223 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Cough, Eye swelling, Headache, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BECLOMETHASONE; SALBUTAMOL
Current Illness: Asthma; Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: Negative COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Chills; Eye soreness; Cough; Fever; Headache; This case was received via the RA (Reference number GB-MHRA-ADR 25917675) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of Cough, Fever, Headache, Eye soreness, and Chills in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. BN3004223) for COVID-19 vaccination. Concurrent medical conditions included Asthma and Suspected COVID-19 since 08-Sep-2021. Concomitant products included BECLOMETHASONE and SALBUTAMOL for Asthma. On 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced Fever (seriousness criterion medically significant) and Headache (seriousness criterion medically significant). On 09-Sep-2021, the patient experienced Cough (seriousness criterion medically significant). On an unknown date, the patient experienced Eye soreness (seriousness criterion medically significant) and Chills (seriousness criterion medically significant). At the time of the report, Cough, and Fever had not resolved, Headache had resolved with sequelae and Eye soreness, and Chills had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) was unknown. The concomitant medications on use were not provided. No treatment information was provided. Patient woke up 16 hours after the second dose of Moderna with complete body chills and fever. Patient have had covid-19, and the chills and fever were worse than when she caught COVID-19 itself. These lasted 12 hours and have since continued. Patient have had a persistent headache and eye soreness since the vaccine. On the second night after the vaccine, throughout the night of the 08 Sep 2021 through the morning of the 09 Sep 2021, patient have had a severe cough. Again this cough has been worse than when she caught COVID-19. Patient was not enrolled in clinical trial. This case concerns a 28 year-old, female subject with a history of Asthma and Suspected Covid-19, who experienced the unexpected event of eye swelling, headache, pyrexia, and chills. The events occurred approximately 2 days after the first dose of Moderna Covid-19 vaccine. The event was considered related to the study drug per the reporter''s assessment is not provided. The medical history, of Asthma, concurrent event of cough and use of concomitant medication Beclomethasone and Salbutamol may be a confounding factor. The benefit-risk relationship of drug mRNA-1273 in not affected by this report. This case concerns a 28 year-old, female subject with a history of Asthma and Suspected Covid-19, who experienced the unexpected event of eye swelling, headache, pyrexia, and chills. The events occurred approximately 2 days after the first dose of Moderna Covid-19 vaccine. The event was considered related to the study drug per the reporter''s assessment is not provided. The medical history, of Asthma, concurrent event of cough and use of concomitant medication Beclomethasone and Salbutamol may be a confounding factor. The benefit-risk relationship of drug mRNA-1273 in not affected by this report.


VAERS ID: 1709966 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004223 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Chills, Hyperhidrosis, Peripheral swelling, Pyrexia, Renal pain, SARS-CoV-2 test, Tremor
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19 (Unsure when symptoms started)
Preexisting Conditions: Medical History/Concurrent Conditions: Acne
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Swollen arm; Sweating; Weakness; High temperature; Chills; Shaking; Kidney pain; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 25917964) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RENAL PAIN (Kidney pain), PERIPHERAL SWELLING (Swollen arm), HYPERHIDROSIS (Sweating), ASTHENIA (Weakness), PYREXIA (High temperature), CHILLS (Chills) and TREMOR (Shaking) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. The patient''s past medical history included Acne. Previously administered products included for Acne: LYMECYCLINE. Concurrent medical conditions included Suspected COVID-19 (Unsure when symptoms started). On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced RENAL PAIN (Kidney pain) (seriousness criterion medically significant) and TREMOR (Shaking) (seriousness criterion medically significant). On 09-Sep-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant), HYPERHIDROSIS (Sweating) (seriousness criterion medically significant), ASTHENIA (Weakness) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On 09-Sep-2021, TREMOR (Shaking) had resolved. At the time of the report, RENAL PAIN (Kidney pain), PERIPHERAL SWELLING (Swollen arm), HYPERHIDROSIS (Sweating), ASTHENIA (Weakness) and PYREXIA (High temperature) had not resolved and CHILLS (Chills) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment medications was reported. Company Comment: This case concerns a male patient with no relevant medical history, who experienced the unexpected events of renal pain, peripheral swelling, asthenia, pyrexia, tremor, chills, and hyperhidrosis. The events renal pain and tremor occurred 1 day after the second dose of Spikevax. The events peripheral swelling, hyperhidrosis, asthenia, pyrexia, and chills occurred 2 days after the second dose of Spikevax. The rechallenge was unknown as there''s no information available about the first dose. The benefit-risk relationship of Spikevax is not affected by this report. Event term, onset date, outcome and seriousness captured per SD from Regulatory Authority reporting.; Sender''s Comments: This case concerns a male patient with no relevant medical history, who experienced the unexpected events of renal pain, peripheral swelling, asthenia, pyrexia, tremor, chills, and hyperhidrosis. The events renal pain and tremor occurred 1 day after the second dose of Spikevax. The events peripheral swelling, hyperhidrosis, asthenia, pyrexia, and chills occurred 2 days after the second dose of Spikevax. The rechallenge was unknown as there''s no information available about the first dose. The benefit-risk relationship of Spikevax is not affected by this report. Event term, onset date, outcome and seriousness captured per SD from Regulatory Authority reporting.


VAERS ID: 1709969 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002622 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210109; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Temperature elevation; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 25917606) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Temperature elevation) in a 59-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002622) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 from 06-Jan-2021 to 13-Jan-2021. On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced BODY TEMPERATURE INCREASED (Temperature elevation) (seriousness criterion medically significant). On 09-Sep-2021, BODY TEMPERATURE INCREASED (Temperature elevation) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jan-2021, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company Comment: This case concerns a 59 year old female patient with a history of suspected COVID-19, who experienced the unexpected event of Body Temperature Increased. The event Body Temperature Increased occured approximately one day after the first dose of Moderna CoviD-19 Vaccine. The rechallenge was not applicable, as the event happened after the first dose. The event is considered related to the product per the reporter''s assessment. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report; Sender''s Comments: This case concerns a 59 year old female patient with a history of suspected COVID-19, who experienced the unexpected event of Body Temperature Increased. The event Body Temperature Increased occured approximately one day after the first dose of Moderna CoviD-19 Vaccine. The rechallenge was not applicable, as the event happened after the first dose. The event is considered related to the product per the reporter''s assessment. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report


VAERS ID: 1710173 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-09-08
   Days after vaccination:210
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: COVID-19 virus test; Test Result: Positive.
CDC Split Type: IEPFIZER INC202101197005

Write-up: Vaccination Failure; I tested positive for Covid on the 08Sep2021; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: EK9788) via an unspecified route of administration on 10Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced vaccination failure and tested positive for covid on the 08Sep2021. The patient underwent lab tests which included COVID-19 test (SARS-CoV-2 test) Positive on 08Sep2021. The outcome of the events was unknown.


VAERS ID: 1716052 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, B-cell lymphoma stage III, Dyspnoea, Fatigue, Feeling hot, Lymphadenopathy, Malaise, Pyrexia, Vaccination site pain, Vision blurred
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Malignant lymphomas (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Haematological malignant tumours (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: Co-Codamol
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: feeling sick; shortness of breath; blurred vision; abdominal pain; feel hot; lymph nodes (on the axilla and breast); 40 temperature; feeling tired; sore arm from the injection; Nodular lymphoma involving lymph nodes of multiple sites; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25926909) on 12-Sep-2021 and was forwarded to Moderna on 12-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of B-CELL LYMPHOMA STAGE III (Nodular lymphoma involving lymph nodes of multiple sites), MALAISE (feeling sick), DYSPNOEA (shortness of breath), VISION BLURRED (blurred vision) and ABDOMINAL PAIN (abdominal pain) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included CODEINE PHOSPHATE, PARACETAMOL (CO-CODAMOL) from 16-Jul-2020 to an unknown date for an unknown indication. On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced B-CELL LYMPHOMA STAGE III (Nodular lymphoma involving lymph nodes of multiple sites) (seriousness criterion medically significant), FATIGUE (feeling tired) and VACCINATION SITE PAIN (sore arm from the injection). On 10-Sep-2021, the patient experienced FEELING HOT (feel hot), LYMPHADENOPATHY (lymph nodes (on the axilla and breast)) and PYREXIA (40 temperature). On an unknown date, the patient experienced MALAISE (feeling sick) (seriousness criterion medically significant), DYSPNOEA (shortness of breath) (seriousness criterion medically significant), VISION BLURRED (blurred vision) (seriousness criterion medically significant) and ABDOMINAL PAIN (abdominal pain) (seriousness criterion medically significant). On 10-Sep-2021, B-CELL LYMPHOMA STAGE III (Nodular lymphoma involving lymph nodes of multiple sites) had not resolved. At the time of the report, MALAISE (feeling sick), DYSPNOEA (shortness of breath), VISION BLURRED (blurred vision) and ABDOMINAL PAIN (abdominal pain) was resolving and FEELING HOT (feel hot), LYMPHADENOPATHY (lymph nodes (on the axilla and breast)), PYREXIA (40 temperature), FATIGUE (feeling tired) and VACCINATION SITE PAIN (sore arm from the injection) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. On First day, the patient started experiencing sore arm from the injection, felling tired, on Second day feeling hot (40 temperature), feeling sick, blurred vision, shortness of breath, abdominal pain, on Third day, the patient had lymph nodes (on the axilla and breast). company comment This case concerns a 36-year-old, female patient with no relevant medical history, who experienced the unexpected events of B-cell lymphoma stage III, malaise, dysponea, vision blurred, abdominal pain and feeling hot and the expected events of pyrexia, vaccination site pain and fatigue. The events occurred approximately 1 day after the second dose of Spikevax. The rechallenge was unknown as there''s no information available about the first dose. The benefit-risk relationship of Spikevax is not affected by this report. The reported RA event coded as LLT/PT [Nodular lymphoma involving lymph nodes of multiple sites/B-cell lymphoma stage III ] does not match the verbatim [lymph nodes (on the axilla and breast). Events seriousness captured as per Regulatory Authority assessment in the Source Document.; Sender''s Comments: This case concerns a 36-year-old, female patient with no relevant medical history, who experienced the unexpected events of B-cell lymphoma stage III, malaise, dysponea, vision blurred, abdominal pain and feeling hot and the expected events of pyrexia, vaccination site pain and fatigue. The events occurred approximately 1 day after the second dose of Spikevax. The rechallenge was unknown as there''s no information available about the first dose. The benefit-risk relationship of Spikevax is not affected by this report. The reported RA event coded as LLT/PT [Nodular lymphoma involving lymph nodes of multiple sites/B-cell lymphoma stage III ] does not match the verbatim [lymph nodes (on the axilla and breast). Events seriousness captured as per Regulatory Authority assessment in the Source Document.


VAERS ID: 1716055 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Hyperhidrosis, Limb discomfort, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210119; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: sweaty; Arm discomfort; Chronic headaches; Fever; This case was received via Agency Regulatory Authority (Reference number: GB-MHRA-ADR 25927600) on 12-Sep-2021 and was forwarded to Moderna on 12-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweaty), LIMB DISCOMFORT (Arm discomfort), HEADACHE (Chronic headaches) and PYREXIA (Fever) in a 27-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 17-Jan-2021. On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced LIMB DISCOMFORT (Arm discomfort) (seriousness criterion medically significant), HEADACHE (Chronic headaches) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERHIDROSIS (sweaty) (seriousness criterion medically significant). At the time of the report, HYPERHIDROSIS (sweaty) and LIMB DISCOMFORT (Arm discomfort) was resolving and HEADACHE (Chronic headaches) and PYREXIA (Fever) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. It was reported that patient barely move entire arm. Painful headaches, don''t know which medical term is correct, but painful and lasted two days constantly so far, and patient still feel hot and sweaty due to fever Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No concomitant medication information was provided. No treatment medication information was provided. Company Comment: This case concerns a 27 years-old, male subject with a history of Suspected Covid-19, who experienced the unexpected events Limb Discomfort, Headache, Pyrexia. The event occurred approximately after the first dose of Moderna Covid-19 Vaccine. The event was considered related to the study drug per the reporter''s assessment it was not provided. The benefit-risk relationship of Moderna Covid-19 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 27 years-old, male subject with a history of Suspected Covid-19, who experienced the unexpected events Limb Discomfort, Headache, Pyrexia. The event occurred approximately after the first dose of Moderna Covid-19 Vaccine. The event was considered related to the study drug per the reporter''s assessment it was not provided.The benefit-risk relationship of Moderna Covid-19 Vaccine is not affected by this report.


VAERS ID: 1716066 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-09-08
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Menstruation delayed, Oral herpes
SMQs:, Oropharyngeal infections (narrow), Fertility disorders (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Late period; Herpes on lip; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25928704) on 12-Sep-2021 and was forwarded to Moderna on 12-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ORAL HERPES (Herpes on lip) and MENSTRUATION DELAYED (Late period) in a 29-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 from 10-Feb-2020 to 01-May-2020. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage form. On 08-Sep-2021, the patient experienced ORAL HERPES (Herpes on lip) (seriousness criterion medically significant). On 09-Sep-2021, the patient experienced MENSTRUATION DELAYED (Late period) (seriousness criterion medically significant). At the time of the report, ORAL HERPES (Herpes on lip) and MENSTRUATION DELAYED (Late period) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Period has been late, scatty flow, and brown. Before the start of patient''s cycle I had a cold sore outbreak on her mouth and felt very unwell which was highly unusual for patient. Patient has not tested positive for COVID-19 since having the vaccine Not had a COVID-19 test Patient was not pregnant, Patient was not currently breastfeeding. No concomitant medications were provided. Treatment medications was not provided. Company Comment; This case concerns a 29-year-old, female patient with relevant medical history of suspected Covid-19, who experienced the unexpected events of oral herpes and menstruation delayed. The events occurred approximately 40 days after the first dose of Moderna CoviD-19 Vaccine. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a 29-year-old, female patient with relevant medical history of suspected Covid-19, who experienced the unexpected events of oral herpes and menstruation delayed. The events occurred approximately 40 days after the first dose of Moderna CoviD-19 Vaccine. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1717110 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-08
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Disturbance in attention, Generalised tonic-clonic seizure, Seizure, Thermal burn
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Depression (excl suicide and self injury) (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: FLUOXETINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101217089

Write-up: difficulty in focussing; grand mal seizure; burn; Seizure; This is a spontaneous report from a contactable consumer (patient). This is the second of 2 reports. The first report is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109091515583730-XAVND, safety report unique identifier is GB-MHRA-ADR 25918560. A female patient in her 20''s received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number not provided), dose 2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient''s medical history was not reported. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medication included fluoxetine from 01Jun2016. The patient previously received the first dose of BNT162B2 on 22Jun2021 (at the age of 21 years old) (lot number: FC9001) for COVID-19 immunisation and experienced faint, Swollen tongue, Small hemorrhages in the tongue, Felt very odd, unable to focus, Diarrhoea. The patient experienced difficulty in focussing (life threatening) on an unspecified date, grand mal seizure (life threatening) on an unspecified date, burn (life threatening) on an unspecified date, Seizure (life threatening) on 08Sep2021. The clinical course provided as follows: the patient''s second vaccination, the following day she was finding difficulty in focussing again and in the afternoon, less than 24 hours after having the vaccination, she had a grand mal seizure, lasting approximately 3 minutes. Ambulance was called and she went to A & E suffering burns from the scalding hot milk that she was holding when the seizure occurred. Accident and emergency are referring re the seizure. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of Seizure was recovering. The outcome of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1717501 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-08
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cellulitis
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: KRJNJFOC20210933409

Write-up: CELLULITIS; This spontaneous report received from a health care professional via a Regulatory Authority concerned a 4 decade old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 212A21A, expiry: 21-DEC-2021) dose was not reported, 1 total administered on 04-SEP-2021 at deltoid for prophylactic vaccination. No concomitant medications were reported. On 08-SEP-2021, the patient experienced cellulitis and received outpatient treatment (unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cellulitis was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210933409-Covid-19 vaccine ad26.cov2.s -Cellulitis. 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: 1718522 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-09-08
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: covid-19 virus test; Test Result: Positive
CDC Split Type: ZAPFIZER INC202101179536

Write-up: received her first dose of the vaccine about 5 weeks ago and has tested positive yesterday.; received her first dose of the vaccine about 5 weeks ago and has tested positive yesterday.; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown and expiration date: Not reported) via an unspecified route of administration on an unknown date in Aug2021 as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 08Sep 2021, after vaccination the patient underwent sars-cov-2 test for which result was positive, received her first dose of the vaccine about 5 weeks ago and has tested positive yesterday. The event outcome was unknown. No further information was available at the time of this report. ; Sender''s Comments: Linked Report(s) : 202101181120 same reporter, same product, similar event, different patient;202101181119 same reporter, same product, similar event, different patient


VAERS ID: 1718862 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-08
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: DEJNJFOC20210937711

Write-up: COVID-19; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via a Regulatory Authority (DE-PEI-202100189681) was received on 20-SEP-2021 and concerned a 43 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, route of admin not reported, batch number: 21C11-01 expiry: UNKNOWN) 1 dosage forms, 1 total administered on 31-MAY-2021 for an unspecified indication. No concomitant medications were reported. On 08-SEP-2021, the patient experienced covid-19 (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint


VAERS ID: 1720774 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101176215

Write-up: Dizziness aggravated; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109080743341570-LG6ZY. Safety Report Unique Identifier GB-MHRA-ADR 25910484. A 35-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: FF2153), dose 1 via an unspecified route of administration on 07Sep2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Unsure if patient has had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. On 08Sep2021, the patient experienced dizziness aggravated (medically significant). The patient feeling dizzy with every sudden move, everything was spinning around. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (No - Negative COVID-19 test) on an unspecified date. The outcome of event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1720821 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004225 / 2 - / OT

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

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

Write-up: Fever; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 25916873) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 20-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004225) for COVID-19 vaccination. No Medical History information was reported. On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On 09-Sep-2021, PYREXIA (Fever) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment: This case concerns a 20-year-old, female subject with no relevant medical history, who experienced the unexpected event of pyrexia. The event occurred on the day of administration of the second dose. The rechallenge was unknown since no information about the first dose was provided. The event was considered possibly related to the product per the reporter''s assessment. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Of note, the event was assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, the event is not considered serious.; Sender''s Comments: This case concerns a 20-year-old, female subject with no relevant medical history, who experienced the unexpected event of pyrexia. The event occurred on the day of administration of the second dose. The rechallenge was unknown since no information about the first dose was provided. The event was considered possibly related to the product per the reporter''s assessment. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Of note, the event was assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, the event is not considered serious.


VAERS ID: 1720838 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Nausea, Pyrexia, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19.
Allergies:
Diagnostic Lab Data: Test Date: 08/08/2021; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: Yes - Positive COVID-19 test.
CDC Split Type: GBPFIZER INC202101190790

Write-up: This is a spontaneous report from a contactable consumer, received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202109091754151550-9GCA9; safety report unique identifier GB-MHRA-ADR 25919416). A female patient, of an unspecified age, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported, expiry date: unknown), via an unspecified route of administration, on Sep 8, 2021, single dose, for COVID-19 immunisation. Medical history included suspected COVID-19 from Aug 8, 2021 to Aug 16, 2021. The patient''s concomitant medications not reported. The patient experienced fever and temporal headache on Sep 8, 2021. Fainting and aggravated nausea on Sep 9, 2021. The events reported medically significant. Patient has not tested positive for COVID-19 since the vaccination. Patient not enrolled in a clinical trial. The patient underwent lab tests and procedures, which included SARS-CoV-2 test: Yes - Positive COVID-19 test on Aug 8, 2021. The outcome of events: recovering. No follow-up attempts possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1720843 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101190696

Write-up: Headache; Fatigue; Pain injection site; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202109091856237540-WGOQO, Safety Report Unique Identifier GB-MHRA-ADR 25919722. A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 08Sep2021 (at the age of 32-years-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as single dose for COVID-19 immunization. On 09Sep2021 the patient experienced headache. On 08Sep2021 the patient experienced fatigue, pain injection site. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on No-Negative COVID-19 test. Outcome of events was recovering for Pain injection site and rest all not recovered. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1720861 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Hot flush, Photopsia, SARS-CoV-2 test, Seasonal allergy, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Retinal disorders (narrow), Vestibular disorders (broad), Conjunctival disorders (narrow), Hypersensitivity (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101190795

Write-up: Dizziness; Hot flush; Vomiting; Flash vision; Hay 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-202109100106537450-7EIWU and Safety Report Unique Identifier GB-MHRA-ADR 25921314. A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported) via an unspecified route of administration on 08Sep2021 as dose 1, single for COVID-19 immunization (41-year-old at time of vaccination). Medical history included suspected covid-19 from 08Sep2021 and ongoing. The patient''s concomitant medications were not reported. On 08Sep2021 patient experienced dizziness, hot flush, vomiting, flash vision, hay fever. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 09Sep2021. The outcome of Events for hot flush was not resolved, Hay fever resolved on 09Sep2021 and other events were resolved on 08Sep2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1720870 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Bleeding; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25929103) on 13-Sep-2021 and was forwarded to Moderna on 13-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding) in a 51-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Suspected COVID-19 since 07-Sep-2021. On 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced HAEMORRHAGE (Bleeding) (seriousness criterion medically significant). At the time of the report, HAEMORRHAGE (Bleeding) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication were provided. No treatment medication were provided Adverse reaction did not occur as a result of an exposure during pregnancy Company comment: This case concerns a 51-year-old, female patient with no relevant medical history, who experienced the unexpected event of bleeding. The event occurred approximately 2 days after the second dose of Spikevax. The rechallenge was not applicable, as the event happened after the second dose. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 51-year-old, female patient with no relevant medical history, who experienced the unexpected event of bleeding. The event occurred approximately 2 days after the second dose of Spikevax. The rechallenge was not applicable, as the event happened after the second dose. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1721231 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005691 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Altered state of consciousness, Contusion, Post-traumatic pain, Presyncope
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Transient disturbance of consciousness; Bruise on the right side of the head; Vasovagal reflex; headache; This case was received via Regulatory Authority (Reference number: JP-TAKEDA-2021TJP092470) on 10-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This case, initially reported to the Agency by a physician (Ref, v21126276). On an unknown date, body temperature before the vaccination: 36.7 degrees Celsius. On 08-Sep-2021, the patient received the 1st dose of this vaccination. At 17:30, vasovagal reflex developed. The patient fell from the chair due to transient disturbance of consciousness. The patient bruised on the right side of the head. The patient requested an ambulance and was transported the hospital. The patient was awake and alert and no vital deviation noted. Traumatic scar is not clear. The patient complained of pain in the temporal region and right temporal region of the injured site. Head CT and neck XP showed no traumatic changes, and the patient returned home. The symptom was recovered. The outcome of transient disturbance of consciousness, bruise on the right side of the head, vasovagal reflex, headache was reported as recovered. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 21-year-old, female patient with no relevant medical history, who experienced the unexpected events of altered state of consciousness, presyncope, contusion and post traumatic pain. The events occurred on the same day after the first dose of Spikevax. The rechallenge was not applicable, as the events happened after the first dose. The reporter assessed the events as related to the product. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1721235 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-08
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: KRJNJFOC20210933316

Write-up: DIZZINESS; NAUSEA; This spontaneous report received from a health care professional via a Regulatory Authority concerned a 6 decade old female of unspecified race and ethnic origin. 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: 211A21A expiry: 14-DEC-2021) dose was not reported, 01 total, administered at deltoid on 07-SEP-2021 for drug used for unknown indication. No concomitant medications were reported. On 08-SEP-2021, the patient experienced dizziness and nausea, and was hospitalized (date unspecified). The patient received inpatient treatment. The number of days the patient was hospitalized was unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea and dizziness was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0:20210933316-covid-19 vaccine ad26.cov2.s-Dizziness.This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210933316-covid-19 vaccine ad26.cov2.s-Nausea.This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1722121 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Headache, Pyrexia, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Chest pain; Rash; Headache; Fever; This case was received via Agency (Reference number: GB-MHRA-ADR 25932709) on 14-Sep-2021 and was forwarded to Moderna on 14-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHEST PAIN (Chest pain), PYREXIA (Fever) and RASH (Rash) in a 23-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concomitant products included PARACETAMOL from 08-Sep-2021 to an unknown date for Headache. On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 09-Sep-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion medically significant) and RASH (Rash) (seriousness criterion medically significant). On 11-Sep-2021, RASH (Rash) had resolved. At the time of the report, HEADACHE (Headache) and CHEST PAIN (Chest pain) had not resolved and PYREXIA (Fever) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment medication was not provided. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. Company Comment: This case concerns a 23-year-old, male patient with no relevant medical history, who experienced the unexpected events of HEADACHE (Headache), CHEST PAIN (Chest pain), PYREXIA (Fever) and RASH (Rash). The events occurred on the same day after the second dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 23-year-old, male patient with no relevant medical history, who experienced the unexpected events of HEADACHE (Headache), CHEST PAIN (Chest pain), PYREXIA (Fever) and RASH (Rash). The events occurred on the same day after the second dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1724561 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101182313

Write-up: Vomiting; extreme dizziness (swirling head); This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory Authority report number GB-MHRA-WEBCOVID-202109081027136650-VMRKP, Safety Report Unique Identifier GB-MHRA-ADR 25911227. A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2153) via an unspecified route of administration on 07Sep2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was unsure that he had symptoms associated with COVID-19 and was not enrolled in clinical trial. On 08Sep2021, 1 day after vaccination, the patient experienced vomiting: reported as serious for being medically significant and on unknown date in 2021, the patient felt extreme dizziness (swirling head). The patient had not tested positive for COVID-19 since having the vaccine. On 08Sep2021, the patient underwent COVID-19 virus test and the result was negative. The clinical outcome of the event vomiting was not recovered and extreme dizziness (swirling head) was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1724568 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

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? 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 INC202101182315

Write-up: Seizure; This is a spontaneous report from a contactable pharmacist. This is a report received from the Agency Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109081214087690-O1BQY with Safety Report Unique Identifier GB-MHRA-ADR 25911648. A 35-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: FE3380) via an unspecified route of administration on 08Sep2021 (at the age of 35-years-old) as a dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have symptoms associated with COVID-19. It was unsure if the patient was enrolled in a clinical trial. On 08Sep2021, the patient experienced seizure. The patient reacted to the Pfizer vaccination, few minutes after getting vaccinated. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event seizure was recovering (also reported with a stop date of 08Sep2021) at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1724592 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test; Comments: Positive COVID-19 test.
CDC Split Type: GBPFIZER INC202101182452

Write-up: Fever; Dizziness; Backache; Chest ache; Headache; Vomiting; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109090708065720-MQX1N. Safety Report Unique Identifier GB-MHRA-ADR 25916027. A 21-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 08Sep2021 as DOSE 2, SINGLE (age at vaccination: 21-year-old) for covid-19 immunisation. Medical history included suspected covid-19 from an unknown date to 14Jun2021 Unsure when symptoms started. Patient has not had symptoms associated with COVID-19. 19. Patient was not pregnant, Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. Historical Vaccine received as bnt162b2 (BNT162B2, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. On 08Sep2021, The patient experienced headache, vomiting, dizziness, backache and chest ache. On 09Sep2021, The patient experienced fever. The events were reported as medically significant. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: yes - positive covid-19 test on Positive COVID-19 test on an unspecified date. The outcome of the events (headache, vomiting, dizziness, backache, chest ache and fever) was not recovered. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1724631 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: NITROFURANTOIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101190543

Write-up: Fever; Shivers; Tiredness; Headache; Pain in arm; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202109100151094050-1TWBM, Safety Report Unique Identifier GB-MHRA-ADR 25921324. A 27-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2153) via an unspecified route of administration on 08Sep2021 (at the age of 27-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Patient was not enrolled in clinical trial. Concomitant medications included nitrofurantoin (MANUFACTURER UNKNOWN) for cystitis from 04Sep2021 to 06Sept2021. The patient had no symptoms associated with COVID-19 and not had a COVID-19 test. The patient was not enrolled in clinical trial. The patient was not pregnant and was not breastfeeding at the time of this report. On 08Sep2021, the patient experienced pain in arm which started a few hours after vaccination and next morning after waking up on 09Sep2021, 1 day after vaccination she experienced fever, tiredness, shivers and headache; all events were reported as serious for being medically significant. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the events fever and shivers was resolved on 09Sep2021, after the duration of 1 day; while that of pain in arm, tiredness and headache was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1724650 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Nausea, Restlessness, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101191695

Write-up: Vomiting; restless; nauseous; headache; fatigue; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109101248466180-ZK9JU, Safety Report Unique Identifier GB-MHRA-ADR 25923755. A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number was not reported), via an unspecified route of administration on 07Sep2021 as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number was not reported) on an unspecified date for COVID-19 immunization. The patient not had symptoms associated with COVID-19. The patient was not pregnant. The patient was not currently breastfeeding. The patient experienced nauseous, headache, fatigue, restless on an unspecified date in 2021 and vomiting on 08Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test was negative covid-19 test. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The events were serious (medically significant). The outcome of the events was recovering for vomiting, unknown for restless, fatigue, headache, nauseous. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1724718 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blindness transient, Dizziness, Fatigue, Headache, Inappropriate schedule of product administration, Paraesthesia, SARS-CoV-2 test, Syncope, Tinnitus
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Retinal disorders (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Medication errors (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cough; Gastroenteritis
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101191731

Write-up: pins and needles; headache; dizzy; very tired and heavy; vision disappeared (seeing black and white shapes); heard a ringing noise; Fainting; inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109111212014780-EQU8O, Safety Report Unique Identifier GB-MHRA-ADR 25928142. This is the first of 2 reports. A 20-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 08Sep2021 (at the age of 20-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included cough from 28Aug2021 to 01Sep2021, gastroenteritis from 25Aug2021 to 28Aug2021. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not pregnant at the time of vaccination, Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on Jun2021 as single dose for COVID-19 immunization and experienced pins and needles, dizzy, Fainting, No vision. On 08Sep2021 the patient experienced inappropriate schedule of vaccine administered. On an unspecified date patient experienced pins and needles, headache, dizzy, dizziness, very tired and heavy, vision disappeared, heard a ringing noise. On 09Sep2021 the patient experienced fainting. The events were assessed as medically significant. The clinical course was reported as follows, I have never fainted before in my life and regularly drink plenty of water so I know that it wasn''t dehydration. The patient reported after my second vaccine (Evening of 08Sep2021) I felt completely fine. The next day I had eaten breakfast and a morning snack. As I felt very tired and heavy, I slept from around 11:45am - 2:15. After sitting up in bed for 10 minutes, I went downstairs to make food and felt pins and needles in one of my feet. In the kitchen I felt dizzy and sat down for a minute and when I stood up again, I felt myself fainting and my vision disappeared (seeing black and white shapes). I lay on the floor and tried to breathe. In this time, I felt pins and needles along both my hands and arms and heard a ringing noise. Afterwards I had a headache but recovered over a few hours. I didn''t lose consciousness in either circumstance, but I felt very close to it and think that I would have fainted had I not prepared myself. Again, I have never fainted before, so I do feel that this is related to the vaccine as both cases happened within 24 hours of it. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on No - Negative COVID-19 test. The outcome of event Fainting was recovered on 10Sep2021, outcome of pins and needles, headache, dizzy was recovered on an unspecified date and for rest event was unknown. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected. .; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101198095 same patient,different dose, different event


VAERS ID: 1724725 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Influenza, Pain, SARS-CoV-2 test, Suspected COVID-19
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101191720

Write-up: my whole body aching; Suspected COVID-19; Flu; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109111321117900-VWCDS.Safety Report Unique Identifier GB-MHRA-ADR 25928221. A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: not reported), dose 2 via an unspecified route of administration on 07Sep2021 as 2nd dose, single for COVID-19 immunization. Patient''s medical history included suspected covid-19 from 08Sep2021 and ongoing. The patient''s concomitant medications were not reported. Patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: not reported), via an unknown route on an unspecified date for covid-9 immunization. Patient was not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient experienced flu and suspected covid-19 on 08Sep2021, and my whole body aching on an unspecified date. Patient went to bed Tuesday felt fine, woke up early Wednesday morning with his whole body aching and feeling pretty bunged up. As the week went on, he started to worse and worse. All the events were reported as medically significant. The patient underwent lab tests and procedures which included negative sars-cov-2 test on 09Sep2021 no-negative COVID-19 test. The outcome of flu was not recovered, while outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1724729 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Date: 20210908; Test Name: temperature; Result Unstructured Data: Test Result:high
CDC Split Type: GBPFIZER INC202101191652

Write-up: Shivering; High temperature; Sweating; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109111505225270-EPPNX. Safety Report Unique Identifier GB-MHRA-ADR 25928336. A 56-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration, administered on 07Sep2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not had symptoms associated with covid-19. It was reported that on 08Sep2021 the patient experienced shivering, high temperature, sweating. Patient was not enrolled in clinical trial. On an unspecified date the patient underwent lab tests and procedures which included covid-19 virus test which was resulted as negative (No - Negative COVID-19 test). The patient was not recovered from the event of shivering. The patient was recovering from the event of sweating. The patient was recovered/resolved with Sequel from the event of high temperature. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1724744 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-08
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, SARS-CoV-2 test
SMQs:, Hearing impairment (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210114; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101191482

Write-up: Palsy Bells; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109112229310010-6FV5F and Safety Report Unique Identifier is GB-MHRA-ADR 25928750. A 23-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: unknown), dose 2 via an unspecified route of administration on 01Sep2021 as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included suspected covid-19 from 13Jan2021 to 22Jan2021. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: unknown), dose 1 via an unspecified route of administration on an unknown date as DOSE 1, SINGLE for COVID-19 immunisation.The patient''s concomitant medications were not reported. On 08Sep2021, the patient experienced palsy bells. Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 14Jan2021 Yes - Positive COVID-19 test. No follow-up attempts are possible, information about lot/batch number cannot be obtained, No further information is expected.


VAERS ID: 1724806 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Hypoaesthesia, Nausea, Panic attack, Paralysis, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: GRPFIZER INC202101175595

Write-up: fainted; my body paralysed and my fingers ''turned''; nausea; dizziness; body was numb; i had a panic attack; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 39-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 08Sep2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. 2 minutes after vaccination (08Sep2021) the patient experienced nausea, dizziness and she fainted. Her body was numb, paralysed and her fingers ''turned'' (paralysis). She also experienced panic attack. Therapeutic interventions included IV saline treatment with adrenaline, cortisone and Fenistil. She was told that she did not experience an allergic reaction. She was not given any instructions. The outcome of the events was unknown. The lot number for [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1725016 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005691 / 1 - / OT

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

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

Write-up: Anaphylaxis; This case was received via the regulatory authority (Reference number: JP-TAKEDA-2021TJP092061) on 11-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This case, initially reported to the regulatory authority by a physician, was received via theRA (Ref, v21127795). Anaphylaxis was assessed as serious by the RA. On an unknown date, the patient received the 1st dose of the vaccine. On 08-Sep-2021, at 17:39, the patient received the 2nd dose of the vaccine. At 17:50, while waiting, redness developed around the neck and on the face. Anaphylactic symptom was noted. The patient became aware that the redness was more severe than usual while being treated for atopy. No respiratory discomfort developed. No abdominal symptom developed. Thereafter, it was confirmed that the symptom subsided. The outcome of anaphylaxis was reported as resolving. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case refers to a 55-year-old male patient with a medical history of Atopy who experienced the expected event of Anaphylaxis on the same day the second dose of COVID-19 Vaccine Moderna was administered. The reporter assessed the event as possibly related to COVID-19 Vaccine Moderna. The past medical history of atopy remains a confounder. The benefit-risk relationship of COVID-19 Vaccine Moderna is not affected by this report.


VAERS ID: 1725019 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005293 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Heart rate, Loss of consciousness, Oxygen saturation, Presyncope
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: Test Name: BP; Result Unstructured Data: normal; Test Name: Pulse rate; Result Unstructured Data: low; Test Name: SpO2; Result Unstructured Data: 99%
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Transient loss of consciousness; Vasovagal reflex; This case was received via Pharmaceuticals (Reference number: 2021TJP093013) on 11-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This case, initially reported to the Agency (A) by a physician, was received via the A (Ref, v21126425). Transient loss of consciousness was assessed as serious. On 08-Sep-2021, the patient received the 1st dose of the vaccine. 20 minutes after the vaccination, vasovagal reflex developed. The patient experienced dizziness followed by transient loss of consciousness. Subsequently, the patient quickly recovered with follow-up. BP: 120/63, P: 52, and SpO2: 99%. There was no change in the condition as the patient rested on bed. The outcome of transient loss of consciousness and vasovagal reflex was reported as recovered. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Not reported. The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 47-year-old, male patient with no relevant medical history, who experienced the unexpected events of Loss of consciousness and Presyncope. The events occurred 20 minutes after the first dose of COVID 19 Vaccine Moderna. The rechallenge was not applicable since only information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of COVID 19 Vaccine Moderna is not affected by this report.


VAERS ID: 1725839 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-08
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210943219

Write-up: DEEP VEIN THROMBOSIS LEG; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, DE-PEI-202100192066) was received on 22-SEP-2021 and concerned a 56 year old male of unspecified 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, route of admin not reported, batch number: 21C-1801 expiry: UNKNOWN) dose was not reported, 1 total administered on 23-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-SEP-2021, the patient experienced deep vein thrombosis leg, and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from deep vein thrombosis leg. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1728653 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Back pain, Chills, Decreased appetite, Fatigue, Headache, Inappropriate schedule of product administration, Maternal exposure during pregnancy, Myalgia, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FERROUS SULPHATE [FERROUS SULFATE]; FOLIC ACID; PREGNACARE ORIGINAL [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM PANTOTHENATE;COLECALCIFEROL;COPPER;CY
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Folic acid supplementation
Allergies:
Diagnostic Lab Data: Test Date: 20210901; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101191582

Write-up: pain; Maternal exposure during pregnancy; Fever; Generalised muscle aches; Backache; Headache; Chills; Weakness; Decreased appetite; Tiredness; inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-APPCOVID-202109102133074250-PYHVF, safety report unique identifier is GB-MHRA-ADR 25926588. A 32-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number: not reported), dose 2 via an unspecified route of administration on 08Sep2021 (age at time of vaccination 32-years-old) as DOSE 2, SINGLE for covid-19 immunization. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 14Jul2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing pregnancy, anaemia and folic acid supplementation from an unknown date and unknown if ongoing. Concomitant medications included ferrous sulphate for anaemia from 09Sep2021 to an unspecified stop date; folic acid taken for folic acid supplementation, start and stop date were not reported; ascorbic acid, betacarotene, biotin, calcium pantothenate, colecalciferol, copper, cyanocobalamin, folic acid, iodine, iron, magnesium, nicotinamide, phytomenadione, pyridoxine hydrochloride, riboflavin, selenium, thiamine mononitrate, tocopheryl acid succinate, zinc (PREGNACARE ORIGINAL [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM PANTOTHENATE;COLECALCIFEROL;COPPER;CYANOCOBALAMIN;FOLIC ACID;IODINE;IRON;MAGNESIUM;NICOTINAMIDE;PHYTOMENADIONE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;SELENIUM;THIAMINE MONONITRATE;TOCOPHERYL) taken for pregnancy from 12Apr2021 to an unspecified stop date. Patient had not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unspecified date, the patient experienced pain, maternal exposure during pregnancy. On 09Sep2021, fever, chills, weakness, decreased appetite, tiredness, generalised muscle aches, backache and headache. On 08Sep2021, inappropriate schedule of vaccine administered. Events were consider as medical significant except inappropriate schedule of vaccine. Approximately 12 hours after my vaccination, early in the morning on the 9th, I awoke with a fever, chills, and full body aches and pains. I took 2 paracetamol several hours later, as the symptoms grew more intense. The symptoms persisted with only slight relief from the paracetamol. I tried to had a late breakfast but only managed a small meal as my appetite had decreased. By the afternoon I began to develop a headache, which was concentrated at the front of my head and around my eyes/sinuses. I also began to develop a constant ache in my lower back. I took 2 more paracetamol in the evening, which had much more success at relieving most of my symptoms. My appetite by this time was nearly non existent and I only managed to eat a small snack before bed. When I awoke on the 10th my fever had gone as well as the general aches and pains, headache and lower back ache. Instead I felt very weak and tired and sensitive to pain and temperature. These symptoms gradually disappeared throughout the day and no further treatment was deemed necessary. I still had a decreased appetite but it was slowly returning and I was also still tired but was now able to get up and around without difficulty. Patient was exposed to the medicine second-trimester (13-28 weeks). Therapeutic measures were taken as a result of pain, generalised muscle aches, backache, headache and chills. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Sep2021 (No - Negative COVID-19 test). The outcome of the events generalised muscle aches, backache, weakness were recovered on 10Sep2021, fever, chills, headache were recovered on 09Sep2021. Pain, decreased appetite, tiredness were resolving and rest all were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1728668 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NORIDAY [NORETHISTERONE]; TRANEXAMIC ACID
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101191615

Write-up: Vomiting; This is a spontaneous report from a contactable consumer or other non-healthcare professional. This is a report received from the Regulatory Agency (RA).The regulatory authority report number is GB-MHRA-WEBCOVID-202109090812107470-F5VKN,Safety Report Unique Identifier(GB-MHRA-ADR 25916348). A 20-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 07Sep2021 as Dose 2, Single for COVID-19 vaccination. Medical history included suspected covid-19 from 06Jun2021 and ongoing. Patient was not currently breastfeeding. Patient did not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Concomitant medications included norethisterone (Manufacture Unknown) taken for an unspecified indication from an unspecified start date to Jul2021; tranexamic acid (Manufacture Unknown) taken for an unspecified indication from Jul2021 to an unspecified stop date. The patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 vaccination. The patient experienced vomiting on 08Sep2021. The events were reported as medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on unknown date. (Yes - Positive COVID-19 test). The outcome of event was recovered on 08Sep2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1728879 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-08
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Infection, Vaccination site rash, Vaccination site swelling
SMQs:, 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: FEC; PREGABALIN; NALTREXONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101183278

Write-up: confirmed as infection at ED; Swelling and rash on right arm at site of injection; Swelling and rash on right arm at site of injection; This is a spontaneous report received from a contactable patient via regulatory authority. A 52-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration, administered in arm right on 04Sep2021 09:45 (at the age of 52-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation, administered at clinic. Medical history included breast cancer. No known allergies. Concomitant medication(s) within 2 weeks of vaccination included cyclophosphamide, epirubicin hydrochloride, fluorouracil (FEC) for chemotherapy; pregabalin (PREGABALIN); naltrexone (NALTREXONE), all taken for an unspecified indication, start and stop date were not reported. Patient was not pregnant at time of vaccination. The patient has not received other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in arm right on 14Aug2021 13:45 (at the age of 52-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient experienced confirmed as infection at ED (medically significant) on 08Sep2021 12:00 with outcome of recovering, swelling and rash on right arm at site of injection (medically significant) on 08Sep2021 12:00 with outcome of recovering. The course of events was as follows: Swelling and rash on right arm at site of injection, confirmed as infection at ED. The adverse events resulted in any Emergency room/department or urgent care. The treatment received for the adverse event was Flucloxacillin 500mg. Since the vaccination, the patient has not been tested for COVID-19.


VAERS ID: 1728993 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-09-08
   Days after vaccination:58
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Morbid obesity
Preexisting Conditions: Medical History/Concurrent Conditions: Thrombophlebitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101215997

Write-up: Vaccination failure; COVID-19 aggravated; Sars cov 2 pneumonia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-ST20213401. A 39-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 12Jul2021 (Batch/Lot Number: Unknown) as DOSE 2, 0.3ML SINGLE, dose 1 intramuscular on 17Jun2021 (Batch/Lot Number: unknown) as DOSE 1, 0.3ML SINGLE for covid-19 immunisation. Medical history included thrombophlebitis and ongoing obesity. The patient''s concomitant medications were not reported. Patient having had a complete vaccination schedule with the Comirnaty. On 08Sep2021, the patient experienced vaccination failure and covid-19 aggravated. The patient experienced a life-threatening event. The patient had not yet recovered from vaccination failure and covid-19 aggravated. The patient was hospitalized in intensive care on 08Sep2021 for hypoxemic Sars cov 2 pneumonia; under 15 L O2 for the moment evolution to follow. The outcome of events was not recovered. According to the Clinical decision support. According to the Summary of Product Characteristics. Based on the information currently available, the company assessed the relationship of COMIRNATY to the events. Information on the lot/batch number has been requested.


VAERS ID: 1729006 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Mammary duct ectasia, Mastitis, Maternal exposure during breast feeding, Nausea, Off label use, Product use issue
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Functional lactation disorders (narrow), Neonatal exposures via breast milk (narrow), 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:
Current Illness: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101190726

Write-up: Maternal exposure during breast feeding; blocked ducts in breasts but baby still feeding as normal; Drug use in unapproved population; Off label use; Mastitis; Chills; Shivering; Nausea; Headache; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109090822398390-WYGDX. Safety Report Unique Identifier GB-MHRA-ADR 25916374. This is the first of 2 reports. This is a maternal case. A 28-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/ Lot Number: FF2153), via an unspecified route of administration on 07Sep2021 as dose 2, single for COVID-19 immunisation. Medical history included ongoing breast feeding. Concomitant medication was not reported. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/ Lot Number: not reported) via an unspecified route of administration on unspecified date as dose 1, single for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient experienced maternal exposure during breast feeding. On 08Sep2021 (one day after vaccination), patient experienced mastitis, chills, shivering, nausea and headache. On an unspecified date, the patient had blocked ducts in breasts but baby still feeding as normal. The events were serious (medically significant). The outcome of event blocked ducts in breasts but baby still feeding as normal was unknown, and events mastitis, chills, shivering were recovering, while nausea, and headache were not recovered. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101198267 Baby case


VAERS ID: 1729096 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-08
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101190607

Write-up: Heavy periods; Much heavier and more painful period than usual; nausea; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109091007162870-HRBKK with Safety Report Unique Identifier of GB-MHRA-ADR 25916950. A 26-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no symptoms associated with COVID-19. The patient was not enrolled in clinical trial. The patient was not pregnant and was not breastfeeding at the time of this report. Concomitant medications were not reported. On 08Sep2021, the patient experienced heavy periods and on an unknown date in 2021, the patient experienced nausea; both reported as serious for being medically significant. On an unknown date in 2021, the patient experienced much heavier and more painful period than usual which was reported as the first period since having the second vaccination. On an unknown date, the patient underwent COVID-19 virus test and the result was negative. The clinical outcome of the event heavy period was not recovered while that of nausea and much heavier; more painful period was unknown at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1729105 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DESOGESTREL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101190648

Write-up: Armpit pain; chills; Headache; fever/fever chills; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109100751234560-DBEUS, Safety Report Unique Identifier GB-MHRA-ADR 25922293. A 20-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2153), via an unspecified route of administration on 08Sep2021 (at the age of 20-year-old) at single dose for COVID-19 immunisation. Medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medications included desogestrel from 13Sep2018. The patient previously took nitrofurantoin (MACROBID) for urinary tract infection (UTI) from 26Jul2021 to 30Jul2021. The patient experienced fever, fever chills and headache on 08Sep2021; armpit pain on 09Sep2021; all events were reported as serious for being medically significant. It was reported that fever and chills started about 10 hours after vaccine given on 08Sep2021, pain in armpit same side as vaccine given started the next day and had intensified, not resolved. Headaches had been consistent since fever started, eased with paracetamol. The patient underwent lab test which included COVID-19 virus test: No - Negative COVID-19 test on an unknown date. Patient has not tested positive for COVID-19 since having the vaccine. Therapeutic measures were taken as result of headache and fever included paracetamol. The clinical outcome of the event chills was recovering; outcome of fever, headache and armpit pain was not recovered. No follow-up attempts are needed. No further information is expected.


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