VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1004453
Sex: F
Age:
State: NY

Vax Date: 01/14/2021
Onset Date: 01/20/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: she was useless; diarrhea; vomiting; low grade fever; sore arm; Stomach cramps; didn't feel good; This is a spontaneous report from a contactable consumer (patient). The 54-years-old female patient (weight: 150lb-160lb) received first dose of bnt162b2 (BNT162B2, lot number: EL0142), via an unspecified route of administration in left arm on 14Jan2021 15:40 at SINGLE DOSE for covid-19 immunisation. Medical history included none. No Prior Vaccinations (within 4 weeks). Concomitant medication included levothyroxine sodium (SYNTHROID), omeprazole, calcium. On 20Jan2021 weds: "bad diarrhea", vomiting, low grade fever, sore arm (only the day after) and bad stomach cramps. Caller says, "if that's going to happen after 2nd dose- I wont take it". Caller referred to HCP for treatment of post vaccination side effects. She notes that at work on Wednesday she didn't feel good on 20Jan2021 and yesterday she was useless on 21Jan2021. She does feel better today thank goodness. No AE(s) require a visit to Emergency Room or Physician Office. The outcome of the events didn't feel good, she was useless, sore arm was unknown and was recovering for the rest events. No follow-up attempts possible. No further information expected.

Other Meds: SYNTHROID; OMEPRAZOLE; CALCIUM

Current Illness:

ID: 1004454
Sex: M
Age:
State: OK

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: It was hurting really bad this morning about where your heart is; felt like my chest was caving in for 5-6 hours; felt like a mule had kicked him in the chest; both sides of my ribs was hurting like I had been rodeoing/they were real sore/rib cage on both sides hurt real bad; felt drugged; dizzy feeling/lightheaded; headache; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date in Jan2021 at single dose for COVID-19 immunization. The patient medical history included blood pressure (abnormal). Concomitant medications included 5 mg of a blood pressure pill and male enhancement stuff. The patient stated he went to the health department and they sent him somewhere else to get the shot on Wednesday (Jan2021). It was the first dose of the vaccine and he had a little headache that night (Wednesday) at about 20:00 and he took a couple of aspirin. Got up on 21Jan2021 morning both sides of his ribs was hurting like he had been rodeoing, they were real sore, also reported as his rib cage on both sides hurt real bad and about 6 hours later it wore off. Thursday (Jan2021) he felt drugged, dizzy feeling and lightheaded, around 11:00 it dissipated. On 22Jan2021 morning when he got up he felt like his chest was caving in for 5-6 hours (also reported as he felt like a mule had kicked him in the chest) but he went on out and did his thing and it was 5 hours like that. It was hurting really bad on 22Jan2021 morning about where his heart was. He didn't know if he was having a heart attack. His symptoms were gone he was 98-99% better than he was. It wore itself down through the morning hours. By 10:30-11:00 it was about 50% gone and by 13:00 it was gone. He didn't think it went away, it was kind of hiding back there. It made his wonder if he should take the second shot. He had never had no Corona. The problems came when he had the shot. He took 5 mg of a blood pressure pill and male enhancement stuff that his doctor did warn him to tell them he was on it if he ever go to the ER. His second shot was scheduled for 10Feb2021. Wanted to know if this was a side effect that made him feel bad and hurt half the day and by the afternoon it's gone. Wanted to be sure since he was to get the booster. Wanted to know is this normal and what to do. The outcome of the events of the event rib pain was recovered on 21Jan2021, of the events felt drugged & dizzy feeling/lightheaded was recovered in Jan2021, of the other events was recovering. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1004455
Sex: F
Age:
State: MO

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: Passed out; Pulseless for 30 seconds; Feel dizzy and nauseous; Feel dizzy and nauseous; This is a spontaneous report from a contactable Other Health Professional (patient). A 25-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown since not available/provided to reporter at the time of report completion), via an unspecified route of administration at left arm on 22Jan2021 11:45 at single dose for COVID-19 immunization at a Nursing Home/Senior Living Facility. The patient's medical history included known allergies: Sulfa and poppy seed. No other known medical history/conditions. For concomitant medications, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took amoxicillin, clarithromycin (BIAXIN) and cefaclor (CECLOR), and experienced drug allergy. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for COVID-19 since the vaccination. After receiving the vaccine, the patient was sitting in the observation area for about 10 minutes when she started to feel dizzy and nauseous. She raised her hand up and called for the nurse to come over. She passed out. She was pulseless for 30 seconds and they had to begin giving her CPR chest compressions. She woke up lying on the ground and was taken to the emergency room (ER) where they ran tests to see how she was doing and for observation for several hours. The patient was "discharged" this afternoon and was doing better. The events result in emergency room/department or urgent care. Treatment was received for the events, ER observation and care, and CPR chest compressions. The patient underwent lab tests and procedures which included test on 22Jan2021: unknown results. The outcome of events at the time of last observation was recovering. The reporter's assessment of the events was non-serious, no results in death, no life threatening, not causing/prolonging hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. Information on the lot/batch number has been requested.; Sender's Comments: The reported passed out and pulseless for 30 seconds were likely related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. However, considering the clinical course and medical history, other cause(s)/confounding factors cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1004456
Sex: F
Age:
State:

Vax Date: 01/15/2021
Onset Date: 01/01/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: her blood pressure which was 208/189; really bad shakes a fever of 102 degrees; really bad shakes a fever of 102 degrees; This is a spontaneous report from a contactable other HCP(patient). A 46-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunization. Medical history included COVID-19 in Nov2020/Dec2020. The patient's concomitant medications were not reported. 12 hours later the patient had really bad shakes a fever of 102 degrees and she checked her blood pressure which was 208/189. She went to the Emergency Room to get checked out and she was told that it was probably due to the vaccine. Patient wanted to know if she should receive the second dose of the vaccine since she had this type of reaction after the first dose. She had COVID-19 in Nov2020/Dec2020. She was told in the Emergency Room that since she had a previous COVID-19 infection that she would experience worse side effects from the first dose of the COVID-19 dose than the second dose. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported blood pressure increased. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1004457
Sex: M
Age:
State: NY

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Headache; Fever; Fatigue; Nausea; This is a spontaneous report from a contactable physician (patient). A 41-year-old male patient received second dose of bnt162b2 (reported as: product=COVID 19, brand=Pfizer), batch/lot no. and expiration date not provided, via an unspecified route of administration (vaccination location: left arm) on 21Jan2021 09:30 at a single dose for covid-19 immunization. Medical history included sinus tachycardia and Pvc (premature ventricular contractions). He had no allergies to medications, food, or other products. Concomitant medication included atenolol. Historical vaccine included first dose of bnt162b2 (reported as: product=COVID 19, brand=Pfizer) for covid-19 immunization on 31Dec2020 09:15 AM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The most recent COVID-19 vaccine was administered at a hospital. The patient experienced headache 24-36 hours, fever at 36 hours, fatigue, and nausea on 21Jan2021 05:00 PM. No treatment received for the adverse events. All events were assessed as non-serious (did not result to death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, and no congenital anomaly/birth defect). Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. Information on the lot/batch number has been requested.

Other Meds: ATENOLOL

Current Illness:

ID: 1004458
Sex: F
Age:
State: FL

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: Injection site very sore; arm swollen; Feverish; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL8982), via an unspecified route of administration in the left arm, on 21Jan2021 at 10:15 (at the age of 65-years-old) at a single dose for COVID-19 immunization. Medical history included atrial fibrillation (AFIB), shellfish allergy, allergy to pain medications, cancer, diabetes, high blood pressure, and COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications, taken within two weeks of vaccination, included amlodipine (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), and esomeprazole magnesium (ESOMEPRA). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced arm swollen and feverish on 21Jan2021 at 19:30 and injection site very sore on 23Jan2021. The events were reported as non-serious. It was reported that the injection site was very sore on the third day. Therapeutic measures were taken as a result of the events, which included paracetamol (TYLENOL) and icing arm. The clinical outcome of injection site very sore, arm swollen, and feverish was not recovered.

Other Meds: AMLODIPINE; SPIRONOLACTONE; LEVOTHYROXINE; ESOMEPRA

Current Illness:

ID: 1004459
Sex: F
Age:
State: WI

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Moderate to Extreme headaches daily since injection; Extreme fatigue/tiredness/Overall feel vary tired; Moderate to Extreme body temperate changes throughout the day; This is a spontaneous report from a contactable healthcare professional (patient). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose via an unspecified route of administration in the right arm on 12Jan2021 at 08:30 at single dose for covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient had no medical history and no concomitant medications. The patient had no allergies to medications, food, or other products. The most recent COVID-19 vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not been tested for COVID-19 since the vaccination. The patient experienced moderate to extreme headaches daily since injection, extreme fatigue/tiredness and moderate to extreme body temperate changes throughout the day on 12Jan2021 at 20:30. Overall feel vary tired along with headaches since the injections. No treatment was received for the adverse events. The events were considered as non-serious as did not results in death, non-Life threatening, did not cause/prolong hospitalization, non-disabling/incapacitating and no congenital anomaly/birth defect. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1004460
Sex: F
Age:
State: MT

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Sore at injection site; Severe nausea; vomiting; diarrhea starting 6 hours after injection; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Pfizer brand; lot number: Ek3246), via an unspecified route of administration on 13Jan2021 10:15 on left arm at a single dose for COVID-19 immunization. Medical history included psoriasis, lymphocytic colitis and allergies to pistachios (anaphylaxis). The patient's concomitant medications were not reported. The patient experienced sore at injection site, severe nausea, vomiting and diarrhea starting 6 hours after injection (pending clarification); all on 13Jan2021 14:30 (as reported). Then the same symptoms starting 22Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was at the hospital. The report was non-serious. The outcome of the events was recovered with sequelae.

Other Meds:

Current Illness:

ID: 1004461
Sex: F
Age:
State: CO

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: By 10am the day after vaccine the fever broke and I was just left with fatigue; 10 hours after vaccine I started with a fever that climbed to 103.3F overnight; This was joined by chills; This was joined by chills and body/joint discomfort as well as headache; body/joint discomfort; headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection lot number: EL8982), intramuscular at left arm on 21Jan2021, 08:15 at single dose for COVID-19 immunization. The patient's medical history included hypothyroidism, penicillins allergy and COVID-19 diagnosed on an unspecified date prior to vaccination. The patient's concomitant medications included levothyroxine, minerals nos, vitamins nos (PRENATAL VITAMIN), and riboflavin. The patient was not pregnant at the time of vaccination. The patient previously received the first dose of BNT162B2 (lot number: EK9231) on 30Dec2020, 12:30 PM at left arm for COVID-19 immunization. The patient has not been tested for COVID-19 since vaccination. On 21Jan2021 18:00 (10 hours after vaccine), the patient started with a fever that climbed to 103.3F overnight. This was joined by chills and body/joint discomfort as well as headache. By 10am the day after vaccine (22Jan2021), the fever broke and she was just left with fatigue. No treatment was given for the events. Facility where the most recent COVID-19 vaccine was administered was at the hospital. The outcome of the events were recovering. The events were non-serious.

Other Meds: LEVOTHYROXINE; PRENATAL VITAMIN; RIBOFLAVIN

Current Illness:

ID: 1004462
Sex: F
Age:
State: SC

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Pain in the arm of the injection; muscle pain; fatigue; This is a spontaneous report from a contactable nurse reporting for herself. A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3249), via an unspecified route of administration on the right arm on 22Jan2021 08:45 am at single dose for COVID-19 immunisation. Medical history included hyperthyroidism, BP elevation, hyperlipidaemia and allergies to chocolate, coconuts, pineapple, and red dye from an unknown date. Patient previously took codeine, statins, Diflucan, and experienced allergies. Concomitant medication included methimazole, dexlansoprazole (DEXILANT), amlodipine, ezetimibe (ZETIA), evolocumab (REPATHA) from unspecified date and indication. On 22Jan2021 at 08:45 pm, it was reported that the patient experienced pain in the arm of the injection, muscle pain, and fatigue. No treatment was received. The events were considered as non-serious and did not resulted in death, life threatening condition, prolonged hospitalization, disability, and congenital anomaly or birth defect. The patient was not diagnosed with COVID-19 prior to the vaccination and has not been tested for COVID-19 since vaccination. No other vaccines were received within the last 4 weeks prior to receiving the COVID-19 vaccination. The patient was reported to be not pregnant at the time of vaccination. The outcome of the events were not recovered.

Other Meds: METHIMAZOLE; DEXILANT; AMLODIPINE; ZETIA; REPATHA

Current Illness:

ID: 1004463
Sex: F
Age:
State: FL

Vax Date: 01/17/2021
Onset Date: 01/17/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: Area of injection site has become very large, swollen, hot to touch, and firm in the middle; Area of injection site has become very large, swollen, hot to touch, and firm in the middle; Area of injection site has become very large, swollen, hot to touch, and firm in the middle; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 53-year-old female patient received second dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on her left arm on 17Jan2021 12:45 at single dose for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included piroxicam (PAXIL), thyroid (ARMOUR THYROID), both from an unspecified date for unspecified indication. The patient previously took the first dose of bnt162b2 on 27Dec2020 at 01:00 PM on her left arm for covid-19 immunisation. On 17Jan2021 at 14:00, the patient experienced that the area of injection site has become very large, swollen, hot to touch, and firm in the middle. The events were reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Other Meds: PAXIL; ARMOUR THYROID

Current Illness:

ID: 1004464
Sex: F
Age:
State: OH

Vax Date: 01/23/2021
Onset Date: 01/23/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Pain at injection site; muscle pain; fatigue; dizziness; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old female patient (unknown if pregnant at the time of vaccination) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on left arm on 23Jan2021 13:15 at single dose for covid-19 immunisation. Medical history included Migraines with aura, vasovagal syncope, PCOS, environmental allergies/hay fever, eczema. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included cefixime (FLEXERIL), ibuprofen (ADVIL), montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC), inositol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pain at injection site, muscle pain, fatigue, dizziness, all on 23Jan2021 1400. The events were assessed as non-serious. Since the vaccination, the patient has not been tested for COVID-19. No treatment was given for the events. The outcome of the events was recovering.

Other Meds: FLEXERIL [CEFIXIME]; ADVIL [IBUPROFEN]; SINGULAIR; ZYRTEC; INOSITOL

Current Illness:

ID: 1004465
Sex: F
Age:
State: UT

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: Body aches; chills; SOB; fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 20-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date were not reported), via an unspecified route of administration in left arm on 22Jan2021 17:00 (reported as 05:00 PM) at SINGLE DOSE for COVID-19 immunisation. The patient was administered COVID-19 vaccine at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Medical history included endometriosis, interstitial cystitis, depression, anxiety, post-traumatic stress disorder (PTSD), pelvic pain, migraines, and diagnosis of COVID-19 prior to vaccination. Concomitant medications included etonogestrel (NEXPLANON), duloxetine hydrochloride (CYMBALTA), buspirone hydrochloride (BUSPAR), pantoprazole, and others (unspecified). The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date were not reported) on 31Dec2020 at 11:45 AM at the right arm for COVID-19 immunization and patient was 20-year-old at the time of the vaccination. On 22Jan2021 at 20:30 (reported as 08:30 PM), the patient experienced body aches, chills, shortness of breath (SOB), and fatigue. The reporter considered the events as non-serious. There was no treatment received for the events. It was also reported that since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events body aches, chills, SOB, and fatigue. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: NEXPLANON; CYMBALTA; BUSPAR; PANTOPRAZOLE

Current Illness:

ID: 1004466
Sex: F
Age:
State: MN

Vax Date: 01/21/2021
Onset Date: 01/23/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: Supraclavicular and axillary lymphadema; tenderness only in side where shot was given; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (vaccine location: left arm) on 21Jan2021 10:15 for COVID-19 immunization. Age at vaccination: 31-year-old. Facility where the most recent COVID-19 vaccine was administered: Hospital. Medical history included asthma. The patient had no known allergies. The patient was not pregnant at the time of vaccination and was not pregnant at the time of reporting. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications within 2 weeks of vaccination. On 23Jan2021 07:00, the patient experienced supraclavicular and axillary lymphedema; and tenderness only in side where shot was given. No treatment was given for the events. The events were considered non-serious by the reporter. Since the vaccination, the patient had not been tested for COVID-19. The patient was recovering from the events at the time of reporting. Information on the lot/batch number has been requested

Other Meds:

Current Illness:

ID: 1004467
Sex: F
Age:
State:

Vax Date: 01/20/2021
Onset Date: 01/01/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: extremely nauseated; my eyes kind of crossed; Well after the shot I could barely even walk from the first tent to the second tent; UTI; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reported stated she receive the first dose of the COVID-19 vaccine on Wednesday 20Jan2021 and she had a "strange" reaction on 20Jan2021. Specifically, she states, "as soon as she pushed it in, I became extremely nauseated, my eyes kind of crossed and I had to sit in my car for 4 hours afterwards because I couldn't drive. They had 2 tents set up. Tent 2 was for people who had previous reactions or allergies and tent 1 was for people who had no reactions. Well after the shot I could barely even walk from the first tent to the second tent I stayed there for 45 minutes and then I could barely even walk to my car." Caller wants to know if she should get the second dose of the vaccine. She was started on the antibiotic sulfamethoxazole;trimethoprim (BACTRIM) on 22Jan2021 for a UTI which started after receiving first dose of COVID-19 vaccine in Jan2021. She would like to know if it is okay to use this medication since she just received the vaccine. She reported that she submitted her urinalysis the same day that she received the vaccine on 20Jan2021. The patient underwent lab tests and procedures which included urinalysis: with unknown results on 20Jan2021. Therapeutic measures were taken as a result of UTI. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1004468
Sex: F
Age:
State: FL

Vax Date: 01/07/2021
Onset Date: 01/01/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: Sore arm first evening then it went away, it did wake me up that night; Sore arm first evening then it went away, it did wake me up that night; The caller's friend then tested positive for Covid 19 on 24Jan2021./The caller has had a rapid Covid test and xray in the ER and both were neg for Covid 19; This is a spontaneous report from a contactable consumer. A 78-year-old female consumer reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), at single dose on 07Jan2021 for COVID-19 immunization. She is due for her 2nd dose 30Jan2021. Medical history and concomitant drugs were unknown. Following the 1st vaccine dose she had a sore arm first evening then it went away, it did wake her up that night. In addition she reported that has friend she took to the ER with rectal bleeding on 23Jan2021. and the caller spent the whole day with ''in a couple feet" of her friend. The caller's friend then tested positive for Covid 19 on 24Jan2021. The caller has had a rapid Covid test and xray in the ER and both were neg for Covid 19. She is wondering if this can effect her getting her 2nd shot. Further the caller is "suppose to take someone in for a hip replacement tomorrow am and then pick up 1-3 days and she was supposed to stay at her house following surgery. She wondered if it is safe to take care of her. The friend having surgery received her first vaccine shot 07Jan2021. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1004469
Sex: F
Age:
State: GA

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: Facial filler swelling in cheeks and lips; Facial filler swelling in cheeks and lips; fever; chills; coughing; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (also age at vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number Not available/provided to reporter at the time of report completion, dose number: 1), via an unspecified route of administration in left arm on 21Jan2021 09:30 at SINGLE DOSE for covid-19 immunisation. The patient is not pregnant at the time of vaccination. Medical history included prior to vaccination the patient was diagnosed with covid-19 on unspecified date. However, since the vaccination the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products and no other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. The patient's concomitant medications were not reported. The patient experienced Facial filler swelling in cheeks and lips, fever, chills and coughing on 21Jan2021 at 12:00 AM. No treatment was received for the events. The case was reported to be non-serious (not resulting to death, Caused/prolonged hospitalization, Congenital anomaly/birth defect, Disabling/Incapacitating or Life threatening). The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1004470
Sex: M
Age:
State: DC

Vax Date: 01/16/2021
Onset Date: 01/17/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: nausea; headache; lip fever blisters; severe body aches (as bad as when I had Covid 8 months ago); chills; fevers up to 101.9 (baseline 96); fatigue; This is a spontaneous report from a contactable physician (patient). A 58-year-old male receive first single dose of BNT162B2 (Solution for injection, lot number= EL1283, exp date not reported), via an unspecified route of administration on 16Jan2021 10:45 for Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Hospital. Age at vaccination reported as 58-years-old. Medical history included autoimmune thyroiditis, and 'Covid Pneumonia' on Jun2020. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medication/ other medications the patient received within 2 weeks of vaccination included levothyroxine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Jan2021 01:30, 15 hours after dose 1, the patient developed severe body aches (as bad as when he had Covid 8 months ago), chills, fevers up to 101.9 (baseline 96), and fatigue. This lasted for 46 hours. On 21Jan2021 (day 4), patient had nausea, headache, and lip fever blisters. The events were considered as non-serious by the reporter. The events required doctor or other healthcare professional office/clinic visit. The patient received treatment: ibuprofen, and oral fluids for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on an unspecified date in Jan2021.

Other Meds: LEVOTHYROXINE

Current Illness:

ID: 1004471
Sex: F
Age:
State: GA

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: a few hours after injection my arm was unusually sore past; my elbow chills that lasted for about 6 hrs; temp of 100.6; body aches; nausea; This is a spontaneous report from a contactable consumer. A 65-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3302), via an unspecified route of administration in the left arm on 21Jan2021, at 08:00 a single dose for covid-19 immunization. Medical history included breast cancer stage one from Oct2019. There were no allergies to medications, food, or other products. Concomitant medication included rosuvastatin (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), benazepril (MANUFACTURER UNKNOWN). The patient experienced the following event on 21Jan2021, at 03:00: a few hours after injection my arm was unusually sore past, my elbow chills that lasted for about 6 hrs, temp of 100.6, body aches and nausea. The patient underwent lab tests and procedures which included body temperature: 100.6 Fahrenheit on 21Jan2021. Details were as follows: a few hours after injection, the patient noted that her arm was unusually sore past elbow chills that lasted for about six hours. Temp of 100.6 body aches nausea. It was reported that treatment was not received for the events; however she used a heating pad to relieve the pain. The events were non-serious. No diagnosis of COVID-19 prior to vaccination was noted. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events, a few hours after injection my arm was unusually sore past, my elbow chills that lasted for about 6 hrs, temp of 100.6, body aches and nausea was recovered in Jan2021.

Other Meds: ROSUVASTATIN; AMLODIPINE; BENAZEPRIL

Current Illness:

ID: 1004472
Sex: M
Age:
State: WA

Vax Date: 01/20/2021
Onset Date:
Rec V Date: 02/05/2021
Hospital:

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: Sagging left lip; rash under arms; This is a spontaneous report from a contactable other hcp (patient). A 68-years-old male patient received bnt162b2 (BNT162B2, brand: Pfizer) first dose, via an unspecified route of administration at arm left on 20Jan2021 10:30 AM at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Patient had no allergies to medications, food, or other products. Concomitant medication included atorvastatin, vitamin d3, alpha lipoic acid received within 2 weeks of vaccination. The patient experienced sagging left lip on an unspecified date with outcome of unknown, rash under arms on an unspecified date with outcome of unknown. No treatment was received. Prior to vaccination, the patient was not diagnosed with COVID-19. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, the possible contribution of suspect vaccine BNT162B2 to the event facial droop cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: ATORVASTATIN; VITAMIN D3; ALPHA LIPOIC ACID

Current Illness:

ID: 1004473
Sex: F
Age:
State: WI

Vax Date: 01/18/2021
Onset Date: 01/18/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: chest soreness/pain; pain with breathing/hurt to breathe; severe fatigue; soreness at injection site; This is a spontaneous report from a contactable other healthcare professional (hcp), reporting for herself. A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot ELO142) , on 18Jan2021 at 09:00 intramuscular in Right arm at single dose for COVID-19 immunization.Medical history included allergy to Shellfish. Patient was not pregnant. Concomitant medication included ibuprofen (ADVIL) prophylactically, at 2DF daily on 18Jan2021 and at 2 DF each day through on 19Jan2021; vitamin D3; fish oil; ascorbic acid (VITAMIN C) and cyanocobalamin (VITAMIN B12). The patient experienced chest soreness/pain, pain with breathing/hurt to breathe, severe fatigue, soreness at injection site, on 14Jan2021 (as reported). Events were also described as follows: patient prophylactically took 2 ibuprofen 30 minutes before vaccine on 18Jan2021 at 08:30 am and got the vaccine on 18Jan2021 at 9am. She just had soreness at injection site that evening. She kept up with the ibuprofen (only 2 doses each day) through on 19Jan2021. On 21Jan2021 she felt severe fatigue and later in the evening she started to feel chest soreness/pain and pain with breathing. It felt muscular but she went to emergency department (ED) because it hurt to breathe. They did a cardiac and PE work up which was negative. The pain was relieved by Toradol IV. She was discharged from emergency department (ED) . She took more ibuprofen on 22Jan2021 when she started to feel the same, but lesser, symptoms and the pain went away. On 23Jan2021, so far patient felt okay. The final outcome of the events was reported as recovering.; Sender's Comments: Based on the temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the events "chest soreness/pain, pain with breathing/hurt to breathe". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: ADVIL [IBUPROFEN]; VITAMIN D3; FISH OIL; VITAMIN C [ASCORBIC ACID]; VITAMIN B12 [CYANOCOBALAMIN]

Current Illness:

ID: 1004474
Sex: F
Age:
State:

Vax Date: 12/26/2020
Onset Date:
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: patient tested positive for COVID; patient tested positive for COVID; Had the 1st dose of COVID 19 vaccine last 26Dec20 - Due for 2nd dose on 27Jan21; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 26Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was tested positive for COVID and quarantined on an unspecified date. The patient had the 1st dose of COVID 19 vaccine last 26Dec2020, will be due for 2nd dose on 27Jan2021. The patient asked if it is safe to have the 2nd dose of the vaccine. The patient underwent lab tests and procedures which included COVID test: positive on an unspecified date. The outcome of events was unknown. Information about lot/batch has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 virus test positive cannot be totally excluded. The case will be reassessed if additional information becomes available.

Other Meds:

Current Illness:

ID: 1004475
Sex: F
Age:
State:

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: received the first dose of the vaccine/have pre-existing conditions having floaters and headaches. but there's an increase in frequency.; received the first dose of the vaccine/have pre-existing conditions having floaters and headaches. but there's an increase in frequency.; received the first dose of the vaccine/have pre-existing conditions having floaters and headaches. but there's an increase in frequency.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (Age: 67; Unit: Unknown) received her first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 (on the 07 or 08 of this month) at single dose for covid-19 immunisation. Medical history included she had pre-existing conditions having floaters and headaches. The patient's concomitant medications were not reported. The patient received the first dose of the vaccine on the 07 or 08 of this month. She stated she had pre-existing conditions having floaters and headaches. This could be coincidental, but there was an increase in frequency. She asked if it was ok to get the second vaccine. She asked if there was any information on floater or blindness. She wanted to know if it was okay to take Benadryl. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1004476
Sex: M
Age:
State: MI

Vax Date: 12/28/2020
Onset Date:
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Following day, bloody stool-diarrhea.; Nausea wanting to vomit; Nausea wanting to vomit; massive diarrhea; severe fatigue; chills; diaphoresis; This is a spontaneous report from a contactable nurse (patient). A 50-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 3248), via Intramuscular on left arm on 28Dec2020 at 10:00 AM at single dose for COVID-19 immunization. The relevant medical history included hypertension. Concomitant medications included acetaminophen. The patient experienced nausea wanting to vomit, massive diarrhea, severe fatigue, with chills and diaphoresis. Following day, bloody stool-diarrhea. No treatment received for the events. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. The outcome of the events was recovering.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on bloody stool-diarrhea reported cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: ACETAMINOPHEN

Current Illness:

ID: 1004477
Sex: F
Age:
State: NC

Vax Date:
Onset Date:
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: tachycardia; This is a spontaneous report from a contactable physician via a sales representative. An adult female patient (cardiac nurse) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first COVID vaccine and had tachycardia for several hours immediately following the injection on an unspecified date. Patient planned to get second injection. Outcome of event was unknown. No follow-up attempts are possible. Information about Lot/Batch could not be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1004479
Sex: M
Age:
State: KY

Vax Date: 01/18/2021
Onset Date: 01/01/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: his left arm entire bicep there's giant hematoma, a bruised yellowish green blue; his left arm entire bicep there's giant hematoma, a bruised yellowish green blue; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported for himself. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 18Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient said that in his left arm entire bicep there's giant hematoma, a bruised yellowish green blue in Jan2021. It was around 2 inches wide by 5 inches long and didn't know if it was from the COVID-19 Vaccine since he didn't do anything last week after taking the vaccine. The outcome of events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1004480
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: had little bit sore; This is a spontaneous report from a contactable female consumer via Pfizer-sponsored program. A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number/Exp. date unknown) on unknown date at single dose for covid-19 immunisation. Medical history included high level of potassium. Concomitant medication was not provided. The patient stated that she received her first dose of the Covid-19 vaccine last Tuesday and had little sore and had no other reactions. The patient inquired what ingredients were in the injection as she was concern if there was potassium content in the vaccine. The outcome of event "had little sore" was unknown. The lot number/expiration date for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1004481
Sex: F
Age:
State: AZ

Vax Date: 01/11/2021
Onset Date: 01/13/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: tested positive for Covid19; tested positive for Covid19; chills; nausea; headache; Loss of smell; This is a spontaneous report from a Pfizer Sponsored Program Pfizer. A contactable female consumer of an unspecified age reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive for covid-19 on unspecified date, chills, nausea, headache, loss of smell on 13Jan2021 with outcome of unknown. Patient second dose of Covid will be on 02Feb2021. Information on Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1004482
Sex: F
Age:
State: AR

Vax Date:
Onset Date:
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer, the patient, reported a female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), first dose, via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a headache. The clinical outcome of the headache was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1004483
Sex: F
Age:
State: TX

Vax Date: 01/15/2021
Onset Date: 01/01/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: COVID-19 virus test positive (swab test); COVID-19 virus test positive (swab test); bad allergies; feeling not so good; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting for herself. A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 15Jan2021, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 15Jan2021/16Jan2021 the patient started feeling not so good, she had bad allergies. She went to an urgent care and they did a COVID-19 virus test (swab test) and she tested positive. The information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1004484
Sex: U
Age:
State: NY

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: running fever; tiredness, and fatigue; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced running fever, tiredness, and fatigue after taking the vaccine on 19Jan2021. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1004485
Sex: F
Age:
State: CO

Vax Date:
Onset Date:
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: sore throat; body aches; This is a spontaneous report from a contactable nurse received from a Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced a sore throat and body aches. The patient outcome of the events was unknown. Information on the batch number has been requested.

Other Meds:

Current Illness:

ID: 1004486
Sex: F
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: hives from neck to bottom of feet/ Hives or nettle rash, also urticaria from the neck to the foot; This is a spontaneous report from a contactable Other health care professional (HCP) (patient). A female patient not pregnant of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on unknown date as a single dose for COVID-19 immunisation, lot number: unknown. Medical history and concomitant medications were not provided. Patient stated that four days after first dose had hives from neck to bottom of feet. Resolved after diphenhydramine hydrochloride (BENADRYL) 100 mg per day for 3 days. It was also reported hives or nettle rash, also urticaria from the neck to the foot, patient wanted to know whether she could take the second dose. Patient recovered from the event on unknown date. No follow-up attempts are possible, information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1004487
Sex: F
Age:
State: CA

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: small joint pain; This is a spontaneous report from a contactable consumer reporting for a patient. A 42-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown and expiration date not provided), via an unspecified route of administration (anatomical location: arm left) on 31Dec2020 at SINGLE DOSE for covid-19 immunisation. Medical history included was reported as none. The patient's concomitant medications were not reported. Patient was not pregnant at the time of vaccination. It was reported that patient experienced small joint pain on 31Dec2020. Outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1004488
Sex: F
Age:
State:

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: had her first dose this morning/She received a notification that her second dose was today as well at 4 p.m.. She mentioned that her last name was misspelled/wanted to reschedule the second dose; She doesn't feel good; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2, via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had her first dose this morning (21Jan2021). She received a notification that her second dose was today as well at 4 p.m.. She mentioned that her last name was misspelled. She wanted to reschedule the second dose. She asked if she could take a second dose at a later time. She said she didn't have time and she didn't feel good. Outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1004489
Sex: F
Age:
State: LA

Vax Date: 01/20/2021
Onset Date: 01/01/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: experienced running fever; tired; chills; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 20Jan2021 as a single dose for COVID-19 immunisation, lot number: unknown. Medical history and concomitant medications were not provided. On unknown date in Jan2021 patient experienced running fever, tired and chills and wanted to know if she could take paracetamol (TYLENOL). Outcome of the events was unknown. Information on lot number/batch number was requested.

Other Meds:

Current Illness:

ID: 1004490
Sex: M
Age:
State: TX

Vax Date: 01/02/2021
Onset Date: 01/08/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: developed Covid symptoms/diagnosed positive in Covid19; developed Covid symptoms/diagnosed positive in Covid19; This is a spontaneous report from a contactable nurse (patient's wife). This nurse reported same event for two patients, this is the second of two reports. A 70-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0142), via an unspecified route of administration in arm (reported as deltoid) on 02Jan2021 at single dose for COVID. Medical history included hypertension and bad cholesterol. Concomitant medication included levothyroxine (low dose of it), amlodipine besilate (EMADINE) for hypertension, losartan for hypertension, levothyroxine sodium (SYNTHROID) for bad cholesterol, lovastatin (LOVASTIN) for bad cholesterol. The patient got his first dose on 02Jan2021, and on 08Jan2021 developed Covid symptoms. On 11Jan2021, he tested positive for Covid19/diagnosed positive in Covid19. The reporter nurse think they were exposed sometime at that pharmacy, she mean there was a lot of people in the line. Tomorrow (unspecified) was supposed to be second dose and his family physician didn't know if he should get that second dose. The outcome of events was unknown.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-2021061825 Same reporter/drug/event, different patient

Other Meds: LEVOTHYROXINE; EMADINE [AMLODIPINE BESILATE]; LOSARTAN; SYNTHROID; LOVASTIN

Current Illness:

ID: 1004491
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: felt a lot of aching; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (patient). A female patient of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unknown date as a single dose for COVID-19 immunisation, lot number: unknown. Medical history and concomitant medications were not provided. Patient received the first vaccine at 1oclock and did not feel anything, however after an hour she felt a lot of aching and wanted to know if she could take paracetamol (TYLENOL). Patient was experiencing some reactions that they think were normal after taking the vaccine. They just wanted to know if she could take TYLENOL after taking the vaccine. Outcome of the event was unknown. Information about Lot/Batch has been requested.

Other Meds:

Current Illness:

ID: 1004492
Sex: F
Age:
State: NC

Vax Date: 01/09/2021
Onset Date: 01/01/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: severe chills; Fever; Dizziness; not feeling quite right; heart pains; Nauseated; threw up; Tiredness; muscle aches; a little swelling in her face; weakness; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EK5730) intramuscularly on arm left on 09Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included heart problems from May1966 and ongoing (heart problems/She had open heart surgery at that time and had stents put in a couple of times since then), bone spurs and arthritis in her feet. Concomitant medications were none. Patient used to receive unspecified injections in her feet because she has bone spurs and arthritis in her feet. Patient experienced heart pains in Jan2021, dizziness on 10Jan2021, not feeling quite right on 10Jan2021, severe chills on 11Jan2021, fever on 11Jan2021, nauseated in Jan2021, threw up in Jan2021, tiredness in Jan2021, muscle aches in Jan2021, a little swelling in her face in Jan2021, weakness in Jan2021. The outcome of the events was unknown. Patient received her first Pfizer vaccine on 09Jan2021. Patient explains she has had adverse reactions to the vaccine ever since she received it. Patient confirms she took the vaccine on Saturday, 09Jan2021. On Sunday, 10Jan2021, she started having a little bit of dizziness and feeling just not quite right. Sunday night, she went to bed and woke up at around 3:30 a.m. with severe chills and a fever. Her fever was a little over a 100. She states it took about 2 hours to get her chills under control. She took 2 Tylenol at that time. That day (11Jan2021) she ran fever off and on all day. The next day (12Jan2021), she seemed to be better. She had a low-grade fever, but she was better. She was just kind of tired from the day before. But then, that night, she ended up with the same thing again- she woke up at 4am with chills. Her fever had gone up 101.7, and she ended up taking 2 Tylenol and so forth. She got up that morning around 10 am, and was nauseated. She threw up that morning. She felt really bad. She was experiencing tiredness, muscle aches. (At this point it was about Tuesday (12 Jan) or Wednesday (13 Jan). There was one day during the day, she felt better, but a day went by and she ended up having the chills and fever again. Every time her fever kept going up. Her fever this particular night was 102 something. About Wednesday night, when she had the chills and fever, her fever went up to 103.8. That next morning, she called her doctor's office and tried to get an appointment. She could not get an appointment with the office. Her office ended up doing a televist and sending her a Prednisone pack to take for the reaction that it seemed she was having. She started the prednisone pack which seemed to take the fever down and the chills ended up stopping. Caller clarifies further she believes she has recovered from the fever and chills. The Prednisone pack seemed to kind of make those symptoms go away. However, she still felt really bad. This went on all weekend again. Tuesday of this week, (19Jan2021), she still felt really bad. She called her doctor again and her doctor wouldn't see her because of the symptoms she is having after receiving the COVID-19 vaccine are the same symptoms of the actual COVID-19 virus. She clarifies further the adverse effects of the shot are also same ones as the COVID-19 virus. Her doctor suggested she either go to the Emergency Room or to an Urgent Care. Patient called the Urgent Care and they were able to do a COVID test on her to check and see if she did have COVID-19. She confirms this test was on Tuesday, 19Jan2021. The results came back negative. However, they did another swab test. The patient is unsure what the second swab test was for but was told it would be a couple days before they would have the results of this test. At this point, they put her on a Z-pak. Patient mentions she has heart problems. She has nitroglycerin for any problems that she has. She started having some heart pains when she was down to about 3 tablets of that Prednisone pack she was taking. When she took one of the Prednisone tablets, within 30 minutes of taking it, she started having chest pains. She clarifies it started in her throat and went down to her chest. She took 2 nitroglycerin's to get her feeling back to normal/better. Caller doesn't provide NDC, Lot number or expiration date for the Nitroglycerin she took when probed. Patient mentions her cheeks had been pink. She doesn't really know but she may have a little swelling in her face. She can't figure that out herself. She was experiencing dizziness and weakness. Today is the first day which is the 13th day after receiving the vaccine, she has felt like trying to get this stuff together and her thoughts together to try and figure out what is going on with her. She tried calling her primary doctor and this urgent care and she couldn't get anybody to see her. Patient got her Prednisone pack filled at (Pharmacy name), (Address details) The prescription was issued to her on Thursday, 14Jan2021, but she didn't start taking the pack until Saturday. On Saturday, that's when her fever had went up to 103 and she knew she needed to take the Prednisone pack. They are 4mg tablets and she started out taking 6 tablets the first day and then her dose decreased every day. NDC: 164793723369, Lot: 20K0041P, she believes the second digit is a zero and not a "D", Expiry date: Aug2022. Z-pak: patient states she no longer has the box, therefore she is not sure of the dose and how it was prescribed. She makes the comment she believes the first day it was 2 tablets. NDC: Unknown, Lot: 7996030, Expiry: Feb2022. She clarifies she did not take Tylenol as stated earlier. She took Kirkland's brand, Acetaminophen. They are 500mg tablets. She provides the following product information: Lot: 2GE1779B. The last digit is either a "B" or an 8/, Expiry date: May2015; patient clarifies she knows they just bought this bottle, but she thinks her husband put his extra pills in the wrong bottle. No further details were provided or obtained in regard to this statement. The patient wants to find out about this and what is going on with her. To her understanding and her reading information, she is scheduled to take her next shot 27Jan2021. She is not supposed to take it then, correct? Investigations: patient confirms she had a COVID-19 test done (she is not sure what type of test- PCR, Antibody, etc), they swabbed her nose and the results came back negative. She had a second test done, where they swabbed her nose again, but she hasn't got the results back. She isn't sure what that test is for. Vaccination Facility Type was Hospital. Additional Vaccines Administered on Same Date of the Pfizer Suspect was no. Did any AE(s) require a visit to: Emergency Room was No, she is trying to keep herself out of the hospital. Physician Office? Her doctor would not see her but offered a virtual visit. She did go to the Urgent Care. Prior Vaccinations (within 4 weeks): Caller states she went to the foot doctor on 22Dec2021 (pending clarification). She was given injections in her feet because she has bone spurs and arthritis in her feet. Patient does not know exactly what kind of injection it was. She confirms she has no name, ndc, lot and expiry date for the injections she received. Patient asks the call handler, what should she have done on this? She was lost. She read the information that was provided to her and she doesn't feel there was sufficient information on what to do if you had a reaction. She guesses the best thing she can be told is to call #. She didn't know it was a # emergency. She didn't know what she was supposed to do. It was hard for her to get any information out of anybody as to what to do. The outcome of the events was unknown.

Other Meds:

Current Illness: Heart disorder (She had open heart surgery at that time and had stents put in a couple of times since then)

ID: 1004493
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Unbareable Headache that pain relievers will not help; Continues eye twitching; Exteremly tired; This is a spontaneous report from a non-contactable nurse (patient). This female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unknown date, the patient experienced knot, swollen and heat at the injection site, unbearable headache that pain relievers will not help, continues eye twitching, and extremely tired. The outcome of the events was unknown. No follow-up attempts are possible. No further information expected. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1004494
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Unbareable Headache that pain relievers will not help; Continues eye twitching; Exteremly tired; 102.5 Fever that doesn't want to come down; Body Aches; This is a spontaneous report from a non-contactable nurse (patient). This female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose BNT162B for COVID-19 immunization and experienced knot, swollen and heat at the injection site, unbearable headache that pain relievers will not help, continues eye twitching, extremely tired. After second shot, on an unspecified date the patient also experienced knot, swollen and heat at the injection site, unbearable headache that pain relievers will not help, continues eye twitching, extremely tired, 102.5 fever that doesn't want to come down and body aches. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1004495
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: was not able to get out of bed or have lights on; Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Unbearable Headache; Continues eye twitching; Extremely tired; had a hard time walk due to the body aches; had a hard time walk due to the body aches; This is a spontaneous report from a non-contactable nurse (patient). A female patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced Knot, Swollen and heat at the injection site, unbearable Headache that pain relievers would not help, Continues eye twitching, Extremely tired, and was not able to get out of bed or have lights on. She had a hard time walk due to the body aches. Outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Mobility decreased cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1004496
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: not able to get out of bed or have lights on; Unbareable Headache; Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Continues eye twitching; Exteremly tired; 102.5 fever; Body Aches; had a hard time walk due to the body aches; This is a spontaneous report from a non-contactable nurse (patient). A female patient of an unspecified age received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose BNT162B for COVID-19 immunization and experienced knot, swollen and heat at the injection site, unbearable headache that pain relievers would not help, continues eye twitching, extremely tired, and was not able to get out of bed or have lights on. she had a hard time walk due to the body aches. After second shot, she also experienced knot, swollen and heat at the injection site, unbearable headache that pain relievers would not help, continues eye twitching, extremely tired, and was not able to get out of bed or have lights on, she had a hard time walk due to the body aches, and 102.5 fever that didn't want to come down. Outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Considering a vaccine-event chronological association, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1004497
Sex: F
Age:
State:

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: significant arm pain at site; This is a spontaneous report from a contactable Other HCP. An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 at single dose in arm for COVID-19 immunisation at the age of 82-year-old. Medical history and concomitant medications were unknown. The patient complained of significant arm pain at site the at evening on 20Jan2021. Thus far, no other notable symptoms. The outcome of the event was unknown. Information on Lot/bath number has been requested.

Other Meds:

Current Illness:

ID: 1004498
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/05/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: encephalitis; has stopped walking; diarrhea; getting sick/He is not doing well; This is a spontaneous report from a Pfizer Sponsored program. A non-contactable consumer reported for her brother that a male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EE8492), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Her brother was hospitalized after the COVID vaccine and has stopped walking. He was not doing well. He also had diarrhea. Her brother did get the vaccine and now he has encephalitis. He was in the hospital but he is out now. He got the vaccine and then started getting sick. And he is not the only one. She could send in evidence of all of this. The consumer was on the Internet and (social media name) reading about the COVID Vaccine. She has complaints about it not being FDA approved, and not being approved to prevent COVID-19. She just saw in another location that 30 people in a nursing home died. 30 people have died in nursing homes. There are 32 side effects and she has all 32 of them. She wanted to speak with the scientists or manufacturers of the COVID vaccine. Someone in development. She is really concerned about the vaccine. It has many side effects. It is not FDA approved. It is also not approved to prevent COVID-19. Even if you get the vaccine you could still get COVID. It is not studied long term. Even doctors have said that. There have been many deaths. You don't know what will come of it. She does not know why Pfizer does not pull this back. She has seen videos that have been taken down because Pfizer does not want people to see the real news. They need to show these on the real news. Consumer clarified that she did not have any side effects. She did not take the vaccine. She does not take any vaccines. People need to learn about their nutrition. They need to tell people to take Zinc, Vitamin C, stop eating animal products and meat. She is vegan and she has never gotten sick. No flu or anything. Meat lowers your immune system. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1004499
Sex: F
Age:
State:

Vax Date: 01/20/2021
Onset Date: 01/21/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: it hurt more than her first vaccination and much sooner; arm was sore; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2, via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced it hurt more than her first vaccination and much sooner; arm was sore on 21Jan2021 with outcome of unknown. Yesterday afternoon at approximately 1 p.m. EST, she saw a post on (Social media name) from a friend who received her 2nd Pfizer COVID-19 vaccine. She stated she received it the day before (20Jan2021) and it hurt more than her first vaccination and much sooner. She stated that her arm was sore that day (21Jan2021) but no other side effects. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1004500
Sex: M
Age:
State: CA

Vax Date: 12/28/2020
Onset Date: 01/08/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: 11 days after he tested positive for Covid; 11 days after he tested positive for Covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a male patient (consumer's husband) of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The patient got his 1st dose of vaccine and 11 days after he tested positive for Covid on 08Jan2021. He wanted to know if he could take the second dose of the Covid vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1004501
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Have a soreness on her arm where injection occurred; Being achy, tired; Being achy, tired; This is a spontaneous report from a contactable consumer, the patient. A female patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that after receiving the 2nd dose of the Covid 19 vaccine she report being achy, tired and have a soreness on her arm where injection occurred. The symptoms subsided after 24 hours. The clinical outcome of the events achy, tired and have a soreness on her arm where injection occurred was recovering. No follow-up attempts are possible; information about lot number cannot be obtained.

Other Meds:

Current Illness:

ID: 1004502
Sex: M
Age:
State:

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 02/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: dry cough; This is a spontaneous report via a Pfizer-sponsored program from a contactable consumer (patient) reported for self. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced dry cough on 16Jan2021. He was supposed to get his second on 06Feb2021, but they didn't give him a time. He was given the COVID vaccine by his local health department. Relayed to reach out to them, and they should be able to give him a time. While he was talking, he was coughing and stated he had a dry cough this morning. The outcome of event was unknown. Information on the lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 1004503
Sex: F
Age:
State: MA

Vax Date: 01/04/2021
Onset Date: 01/05/2021
Rec V Date: 02/05/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: severe back and leg pain and paresthesias bilaterally; severe back and leg pain and paresthesias bilaterally; severe back and leg pain and paresthesias bilaterally; This is a spontaneous report from a contactable other hcp. A 81-years-old female patient (not pregnant) received bnt162b2 (BNT162B2, manufacture: Pfizer), via an unspecified route of administration on 04Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included Known allergies: sulfa. No covid prior vaccination. No covid tested post vaccination. The patient's concomitant medications were not reported. The patient experienced severe back and leg pain and paresthesias bilaterally on 05Jan2021. The events resulted in hospitalization. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on a drug-event chronological association, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events severe back and leg pain and paresthesias cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm