VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
46,870MODERNA
532GLAXOSMITHKLINE BIOLOGICALS
353PFIZER\BIONTECH
231MERCK & CO. INC.
221UNKNOWN MANUFACTURER
62SEQIRUS, INC.
25DYNAVAX TECHNOLOGIES CORPORATION
13EMERGENT BIOSOLUTIONS
12SANOFI PASTEUR
9NOVARTIS VACCINES AND DIAGNOSTICS
5PFIZER\WYETH
5PAXVAX
2TEVA PHARMACEUTICALS
2PROTEIN SCIENCES CORPORATION
1BERNA BIOTECH, LTD.
1INTERCELL AG
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL1,906
1,575
289
IMM209286
252
236
229
s029456178
171
UT7065MA166
155
149
145
S034636133
107
U62828AA103
100
98
P10025327596
U6737AA85
UJ446AA79
78
78
59
57
4BH3254
4F47253
52
27656352
50
PP9L548
49TM346
42
40
38
MENVEO38
4F47237
R1B252M36
34
C5763AA30
93362229
25
300057A24
UNK24
22
CW311621
18
17
15
UH894AB15
3Y7NL12
R1B743M12
EJ168611
el128410
10
10
10
9
ARBA141A9
UNK9
8
UNK8
8
1F4EB8
Unknown7
7
No batch number6
5
5
UJ090AA5
5
5
4
4
4
UNK4
JEV18K95E4
UNK3
A115A3
Z127A3
3
3333324181073
2
2
2
TAR352
1
1
1
1
1
A739081
1
1
1
1
1
037K20A68,542
EL128447,700
133

Incidents per State

State Total
15,185
CA14,096
NY7,507
TX7,196
FL6,939
IN5,527
PA4,560
IL4,179
OH4,054
AZ3,856
MI3,771
NJ3,411
MA3,278
VA3,208
NC3,114
WA3,034
GA2,864
MD2,652
MN2,534
CO2,532
WI2,457
MO2,029
OR1,943
TN1,715
CT1,693
KY1,603
OK1,226
AL1,201
KS1,162
IA1,157
SC1,106
NM1,065
UT973
AR951
LA945
NE829
NV797
ME795
MT789
NH756
ID674
AK661
WV661
PR650
MS585
HI536
RI510
VT441
SD361
ND356
DE350
DC239
WY209
GU32
AS16
VI13
MP9
MH3
FM2
QM1
XB1

Date Died: 02/07/2021

ID: 1017051
Sex: M
Age: 77
State:

Vax Date: 02/03/2021
Onset Date: 02/04/2021
Rec V Date: 02/09/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: pt received vaccine on 2/3. early on 2/4 developed chest pain, dyspnea, and was seen in ED and diagnosed with acute exacerbation of CHF and NSTEMI type 2, and anemia. on 2/5 transfusion was started and pt developed worsening dyspnea and then PEA arrest. Pt achieved ROSC and was transferred to the cardiac intensive care unit where he required vasopressor support. he subsequently declined and died on 2/7

Other Meds:

Current Illness:

ID: 1017053
Sex: M
Age: 77
State: NC

Vax Date: 01/19/2021
Onset Date: 02/01/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data: None

Allergies: None

Symptoms: Extreme fatigue then a break out of shingles right upper back and around and under arm

Other Meds: Lisinopril 10 MG, Crestor 20 mg, Allopurinol 300 mg, Vitamin D3 10, 000 U, 81 mg aspirin

Current Illness: None

ID: 1017056
Sex: F
Age: 69
State: TX

Vax Date: 01/27/2021
Onset Date: 02/04/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Day after injection, tired, arm sore & redness, all went away. On Day 8 2"x2" raised red patch on skin, Day 14 patch is larger with welts and itches. No medicine taken or applied.

Other Meds: Metropolol 25mg Rovustatin 10mg Aspirin 81 mg CoQ10 200 mg Olopatadine HCL 2% Restasis .05% Rhinocort 32 mcg Azithromycin 5 day

Current Illness: Sinus drainage, sore throat

ID: 1017059
Sex: F
Age: 79
State: TN

Vax Date: 01/22/2021
Onset Date: 01/29/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data: none

Allergies: Cipro, Avelox, Codine, Lidocrane with epi,

Symptoms: one week after vaccine noted red spot 2 inches below injection site sl itch note. Two weeks after vaccine was red to elbow and was not feeling well, itching was worse, went to Urgent Care saw Doctor who order Preisone and K-flex

Other Meds: Metoprolol 25 mg bid, Triamterne/HTCZ 37.5/25 one a day, Premine .625mg one a day, One- A-Day Vitamin, vitamin E,

Current Illness: none

ID: 1017060
Sex: F
Age: 33
State:

Vax Date: 02/02/2021
Onset Date: 02/03/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: symptoms included: body aches, chills, possible fever, vomiting, and fatigue Treatment included: Tylenol (as directed) and rest Time course: Body aches, chills, fever, and vomiting only lasted about 2 hours. Fatigue persisted for about 15 hours.

Other Meds:

Current Illness:

ID: 1017061
Sex: F
Age: 74
State: CA

Vax Date: 02/06/2021
Onset Date: 02/06/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data: None

Allergies: Lactose, sulfa, tramadol, some antibiotics

Symptoms: Weakness, slight swelling of upper lip and construction of throat. Weakness after 15 minutes, swelling and construction after 40 minutes, on drive home. Went to ER but swelling and construction better by the time I saw doctor. Monitored for about an hour and released. Weakness on and off for several days after. Followed up with primary care doctor and referred to an allergist. Waiting for appointment.

Other Meds: Yuvafem, D-mannose, fish oil, Allegra, Astragalus, Eyebright, Pepcid AC, vitamins

Current Illness: None

ID: 1017064
Sex: F
Age: 71
State: MI

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Stated fingers and palm were tingling/numb when she went to go home. Vitals taken, juice given, stable, decided she was ok to go home.

Other Meds:

Current Illness:

ID: 1017066
Sex: M
Age: 67
State: PA

Vax Date: 02/04/2021
Onset Date: 02/05/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies: NONE

Symptoms: Patient called on Monday 2/8 complaining of flu like symptoms, Advised to take acetaminophen, drink plenty of fluids and rest. Called him back Tues 2/9 said he spoke to his nurse and was going to the hospital. Didn't describe symptoms before he hung up.

Other Meds: NONE THAT WE KNOW OF

Current Illness: NONE

ID: 1017068
Sex: F
Age: 30
State:

Vax Date: 02/05/2021
Onset Date: 02/07/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 5 hours later after the 2nd dose of vaccine. I had aching pain at the injection site and throughout my left arm, radiating to my chest (like squeezing or feels heavy) as well as nausea. On Sunday morning around 330 am, I had bad chills and temperature of 100.5 and had taken Tylenol prior to having chills. Later in the day, I had severe headache and fatigue.

Other Meds:

Current Illness:

ID: 1017070
Sex: U
Age:
State: CA

Vax Date: 01/25/2013
Onset Date:
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: pulmonary edema; congestive heart failure; Undifferentiated spondyloarthritis.; herpes zoster; post herpetic neuralgia; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a currently 54-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medication were not provided. On or about 25-JAN-2013, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to the patient vaccination, the patient presented multiple outbreaks of herpes zoster, post herpetic neuralgia, congestive heart failure, pulmonary edema and undifferentiated spondylarthritis. As a direct and proximate result, the patient had been treated by provider. At the reporting time, the outcome for all the events was unknown. The reporter considered all the events to be related to zoster vaccine live (ZOSTAVAX). Upon internal review the events of pulmonary edema and congestive heart failure were considered as medically significant.

Other Meds:

Current Illness:

ID: 1017071
Sex: F
Age: 33
State: VA

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

Lab Data: Unknown

Allergies: Flagyl

Symptoms: Patient was received her Covid vaccination in her right arm approximately 9:15am. With about 5 minutes she became shaky, sweaty, flushed, and stated she had a ?medication taste in mouth?. She had eaten breakfast, but was given a snack & juice. Nurse reported slightly elevated BP (exact numbers not given). Patient was taken to ER for care.

Other Meds: Unknown

Current Illness: Unknown

ID: 1017072
Sex: U
Age:
State: CA

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

Lab Data:

Allergies:

Symptoms: This spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unspecified age and gender. No information was provided regarding the pt's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. On an unspecified date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, after receiving zoster vaccine live (ZOSTAVAX), the pt suffered herpes zoster, postherpetic neuralgia, encephalitis, right eye vision loss (blindness unilateral), headaches and balance issues (balance disorder). As a result of these symptoms, the pt was seen and treated by medical providers and is still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to using this product. The pt sustained serious, severe, permanent, progressive and incurable personal injuries, as well as significant conscious pain and suffering, mental anguish, mental and emotional distress, loss of enjoyment of life, physical impairment and injury due to resulting physical limitations and seriousness of the condition. The pt have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered not recovered and causality was related to zoster vaccine live (ZOSTAVAX). The reporter considered the events to be disabling. Upon internal review, the pt's encephalitis and blindness unilateral were determined to be medically significant events.

Other Meds:

Current Illness:

ID: 1017073
Sex: F
Age: 62
State: AR

Vax Date: 02/02/2021
Onset Date: 02/03/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data: CT scan, CT with contrast, MRI, echocardiogram, chest x-ray, BMP, CMP, PT, CBC.

Allergies: none

Symptoms: Pfizer-BioNTech COVID-19 vaccine EUA---- 2/4/21 0430am woke up with numbness in left leg which progressed to entire left side of body. 02/05/21 03:30 PM presented to ER for evaluation of left side body numbness. Numerous test & blood work performed. D/C home with diagnosis of transient cerebral ischemia & instructed to follow up with neurologist.

Other Meds: Aspirin 81mg, Lipitor 40mg, Humalog 100u/ml sliding scale

Current Illness: none

ID: 1017074
Sex: M
Age: 87
State: TN

Vax Date: 01/02/2021
Onset Date: 01/06/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Pneumonia on both lungs; A report was received from a consumer who was an 87 year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced the serious adverse event pneumonia on both lungs. The patient's medical history was not provided. Concomitant medications reported included carvedilol, digoxin, furosemide, lisinopril, simvastatin, codeine phosphate hemihydrate/paracetamol, testosterone, acetylsalicylic acid, and multivitamins. On 02 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient reported receiving the first dose of Moderna Covid-19 vaccine on 02 Jan 2021. On 04 Jan 2021, he was having a very difficult time breathing. He went to the doctor on 06 Jan 2021 and found out he had pneumonia on both lungs and was positive for COVID-19. He was treated by the doctor. Treatment for the event included antibiotics, 1 week of steroids, and a bamlanivimab injection on 11 Jan 2021. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, pneumonia on both lungs, was unknown/not reported.; Reporter's Comments: This spontaneous report concerns an 87-year-old male patient serious adverse event pneumonia on both lungs. The event occurred 5 days after the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: 025L20A, expiration date-unknown). Treatment administered included antibiotics, steroids and bamlanivimab injection, and outcome was unknown. Although a temporal association exist, there is not enough information to adequately assess the causal association between the reported event and mRNA-1273 vaccine administration. Critical details such as diagnostic test for COVID infection prior to vaccination was not established or ascertained. Causality is also confounded by the patient's advanced age. Main field defaults to ?possibly related'

Other Meds: CARVEDILOL; DIGOXIN; FUROSEMIDE; LISINOPRIL; SIMVASTATIN; ALTERMOL; TESTOSTERONE; ASPIRIN [ACETYLSALICYLIC ACID]; MULTIVITAMINS [VITAMINS NOS]

Current Illness:

ID: 1017075
Sex: F
Age: 33
State: CA

Vax Date: 02/08/2021
Onset Date: 02/08/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies: No known allergies

Symptoms: Systemic: Other- patient had blueness in one hand, states she had problems breathing, and vomiting, epipen was given and paramedics were called, she was taken to the hospital, not believed to be anaphylaxis

Other Meds:

Current Illness:

ID: 1017076
Sex: F
Age: 25
State: NC

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/09/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Paralyzed on the right side down to her foot; Numbness in her hands and feet; Slurred speech; Felt really heavy in her face area, hurt really bad; Shooting pain; Feels tingly; Felt really heavy in her neck, hurt really bad; unable to walk; A spontaneous report was received from a consumer who was also a 25-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed heaviness in her face and neck, numbness in hands and feet, slurred speech, completely paralyzed on her right side, right fingers tingly, unable to walk and shooting pain feelings. The patient's medical history was not provided. Concomitant product use was not provided. On 21 Jan 2021, approximately two hours prior to the start of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 032L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. Approximately two hours after receiving the vaccine at 12:30 pm, the patient experienced heavy feeling in her neck and face area that hurt really bad. Later, she noticed numbness in her hands and feet. Slurred speech was reported from a bystander. By 3:30pm, the patient was completely paralyzed on her right side. She was taken to the hospital, and a code stroke was initiated; however, all labs were normal. On 26 Jan 2021, the patient was still paralyzed on her right side, unable to walk, had shooting pain feeling, and two fingers on her right hand were able to move but still felt tingly. The doctors planned to discharge her on the next day to a rehab center because she could not function alone. Treatment for the event included pain medication and hospitalization. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, developed heaviness in her face and neck, numbness in hands and feet, slurred speech, completely paralyzed on her right side, right fingers tingly, unable to walk and shooting pain feelings were considered unknown.; Reporter's Comments: A spontaneous report concerns a 25-year-old, female, patient, who experienced heaviness in her face and neck, numbness in hands and feet, slurred speech, completely paralyzed on her right side, right fingers tingly and shooting pain feelings. The events of heavy feeling in her neck and face area, numbness in her hands and feet, slurred speech, completely paralyzed on her right side occurred on the same day after the administration of the first dose of mRNA-1273 (Lot number 032L20A, expiration date unknown). The events of inability to walk, had shooting pain feeling and two fingers on her right hand were able to move but still felt tingly occurred the following day after the vaccine administration. Treatment included pain medication and outcome is unknown. Based on the information provided, which indicates a strong temporal association between the reported events and administration of mRNA-1273 vaccine (onset latency of 2 hours), a causal association cannot be excluded.

Other Meds:

Current Illness:

ID: 1017077
Sex: F
Age: 35
State: CO

Vax Date: 01/22/2021
Onset Date: 01/01/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data: Test Date: 202101; Test Name: White blood cell count; Result Unstructured Data: Decreased - severe leukopenia.

Allergies:

Symptoms: Severe arm rash the size of a baseball welt; Muscle pain; Had a fever for five days; Severe leukopenia; Could not walk; A spontaneous report was received from a pharmacist who was a 35-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe leukopenia, had a fever for five days, muscle pain, could not walk, and severe arm rash the size of a baseball welt. The patient's medical history was not provided. No concomitant medication use was reported. On 22 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date in Jan 2021, the patient's white blood cell count decreased which was considered severe leukopenia. Additionally, she experienced a fever for five days that would not decrease with paracetamol or ibuprofen, had muscle pain, and could not walk. On 25 Jan 2021, the patient had a severe arm rash the size of a baseball welt. Treatment for the arm rash included diphenhydramine. Action taken with mRNA-1273 in response to the events was not reported. The outcome for the events, severe leukopenia, had a fever for five days, muscle pain, could not walk, and severe arm rash the size of a baseball welt, was unknown.; Reporter's Comments: This case concerns a 35-years-old female patient, who experienced a serious unexpected event of leukopenia, a non-serious unexpected event of gait disturbance, rash and non-serious expected event of myalgia, and pyrexia. The event of rash occurred on day 4 after first dose of mRNA-1273, lot # unknown. Remaining events occurred on an unspecified date after first dose of mRNA-1273, lot # unknown. Laboratory tests revealed severe leukopenia (details not provided). Treatment included Tylenol, Ibuprofen and Benadryl. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1017078
Sex: F
Age: 49
State: TX

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

Lab Data: labs

Allergies: clindamycin cream, erythromycin cream, lasis, latex, levaquin, morphine, penicillin, silicone, tramadol

Symptoms: full body itching

Other Meds: symbicort asthma puff, oneprazole, diazepam, multi vitamin, stool softener, hydrocodone 10mg, benefiber, restatis

Current Illness:

ID: 1017079
Sex: U
Age:
State: CA

Vax Date: 01/23/2021
Onset Date: 01/23/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Fainted; Had a seizure; A spontaneous report was received from a physician concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and fainted and had a seizure. The patient's medical history was not provided. No relevant concomitant medications were reported. On 23 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 23 Jan 2021, after vaccine administration, the patient fainted and had a seizure. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the events, fainted and seizure, were unknown.; Reporter's Comments: This case concerns a patient, who experienced events of fainted and seizure. The events occurred the same day after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.

Other Meds:

Current Illness:

ID: 1017080
Sex: F
Age:
State:

Vax Date: 01/26/2021
Onset Date: 01/01/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: fainted; body aches; fever; Chills; A spontaneous report was received from a consumer who is a female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced fainting, body aches, fever and chills. The patient's medical history was not provided. Concomitant medications were not reported. On 26 Jan 2021, the patient received their second dose of two planned doses of mRNA-1273 (Batch number: unknown) for the prophylaxis of COVID-19 infection. On 26 Jan 2021, the patient experienced body aches, fever and chills and she got up in the middle of the night and fainted. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events fainting, body aches, fever and chills, were considered not resolved.~; Reporter's Comments: This case concerns a female patient, who experienced events of fainting, body aches, fever and chills. The events occurred the same day after the second and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.

Other Meds:

Current Illness:

ID: 1017081
Sex: M
Age:
State:

Vax Date: 01/14/2021
Onset Date:
Rec V Date: 02/09/2021
Hospital:

Lab Data: Test Date: 2021; Test Name: COVID-19 test; Test Result: Positive

Allergies:

Symptoms: Difficulty breathing/ shortness of breath; Tested positive for COVID-19; Pain; Not feeling well / very sick; Vaccine is defective; Bad headache; Fever; A spontaneous report was received from a consumer concerning a 65-years-old, male patient who received Moderna's COVID-19 Vaccine, and who experienced bad headache, pain, fever, not feeling well, difficulty breathing/ shortness of breath, and tested positive for COVID-19. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 14 Jan 2021, approximately two to three days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 04L20) intramuscularly for COVID-19 infection. On unknown date, the patient experienced a bad headache, pain, fever and was still not feeling well. Patient went to emergency room and had difficulty breathing, shortness of breath and ended up receiving an infusion of casirivimab imdevimab. Patient tested positive for COVID-19 as well. Treatment for the event included casirivimab/ imdevimab. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, bad headache, pain, fever, not feeling well, difficulty breathing/ shortness of breath, and tested positive for COVID-19, was unknown.; Reporter's Comments: A spontaneous report concerns a 65-years-old, male patient who experienced the unexpected serious event difficulty breathing/ shortness of breath bad and non-serious events of headache, pain, fever, not feeling well and tested positive for COVID-19. The events occurred approximately two to three days after administration of mRNA-1273 vaccine (Lot number 04L20). Treatment provided included casirivimab/imdevimab and outcome of the events is unknown. Based on the known information about COVID and duration to diagnosis, it is very unlikely to be associated with the vaccine administration. The other events are temporally associated with the administration of mRNA-1273, a causal relationship cannot be excluded. Headache and fever are consistent with the known safety profile of the vaccine

Other Meds:

Current Illness:

ID: 1017082
Sex: F
Age: 65
State: CA

Vax Date: 01/24/2021
Onset Date: 02/01/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies: Codeine

Symptoms: Started itching mu upper arm where I had gotten the Moderna shot and it felt like a mosquito bite. Later when I looked at my arm is was very red and swollen the size of a grapefruit. I used topical Benadryl cream on it, but it continued to get worse and spread out. I took 2 Benadryl tablets before bedtime and it was much improved the next morning. The redness was still there, but the swelling had gone down. By the next day it was mostly back to normal without taking any more Benadryl. Now a week later on 02/08/2021 I developed bumps or hives in the exact same area. I again took 2 Benadryl before going to bed and this morning the hives have lessened, but the redness is still there and itches. Prescriptions I take are 10 mg tablet atorvastatin once a day and 60mg capsule of duloxetine once a day. I take Calcium tablets 630mg a day. I just started on vitamin D capsules 125 mcg two days ago.

Other Meds:

Current Illness: none

ID: 1017083
Sex: M
Age: 71
State:

Vax Date: 01/19/2021
Onset Date: 01/20/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data: Test Date: 20210120; Test Name: Chest x-ray; Result Unstructured Data: Chest x-ray revealed pneumonia; Test Date: 20210120; Test Name: COVID-19 Test; Test Result: Negative ; Result Unstructured Data: Negativw

Allergies:

Symptoms: Pneumonia; coughing up blood; A spontaneous report was received from a consumer who was also a 71-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced pneumonia and coughing up blood. The patient's medical history, as provided by the reporter, included COVID-19. No relevant concomitant medications were reported. On 19 Jan 2021, approximately 1 day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 20 Jan 2021, the patient began to cough up blood and was seen and treated by a healthcare professional. A chest x-ray was done and revealed pneumonia. Treatment for the event included doxycycline, prednisone and an inhaler. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, pneumonia and coughing up blood, were unknown.; Reporter's Comments: This case concerns a 71-year-old male subject, who experienced a serious unexpected event of Pneumonia, and non-serious unexpected event of Hemoptysis. The events occurred one day after the first dose of the mRNA-1273 administration. Treatment for the event included doxycycline, prednisone and an inhaler. Since Pneumonia has insidious onset rather than acute onset, the event was possibly related to underlying condition confounded by elderly age of patient. Very limited information regarding these events have been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event of Pneumonia and Hemoptysis, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1017084
Sex: F
Age: 50
State: NY

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Moderna COVID-19 Vaccine EUA Fever starting night of shot lasting 4 days fever as high as 103.2 Chills, fatigue,body aches, sores in mouth and one outside of bottom lip, ringing in ears Felt just like I had Covid-19 all over again!!!!! Called Doctor and was told I was probably having a allergic reaction to the shot and should feel better in a couple days. It took 4. Also asked if I should get the 2nd shot and was told yes, and I probably would have adverse side effects from that one as well. I am supposed to receive that on March 4th 2021. I cant wait LOL

Other Meds:

Current Illness:

ID: 1017085
Sex: F
Age: 40
State: AZ

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

Lab Data: N/A

Allergies: Latex - Contact Septra - Nausea Vomiting Lactose intolerant

Symptoms: Client was observed for 15 min. after vaccination with no issues and left Clinic. Client returned to Clinic approx. 5 min. later. She complained of feeling her lips swollen and a little tingling. Client observed in Clinic. Benadryl 50 mg was given. Vitals remained stable. Client reported no tingling to lips and less swollen 1/2 hour after Benadryl. Client remained in Clinic for 1 hr. and 40 min. after Benadryl given as she was waiting for husband to pick her up. Upon leaving Clinic Client stated felt better, Lips feeling normal.

Other Meds: N/A

Current Illness: None

ID: 1017086
Sex: F
Age: 41
State: NC

Vax Date: 01/28/2021
Onset Date: 02/08/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies: None known

Symptoms: Trigeminal neuralgia - ongoing for last two days

Other Meds: Adderall, Lysine, birth control

Current Illness: None

ID: 1017087
Sex: F
Age:
State: TN

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: lips became numb; throat started to sound very scratchy and itchy; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 22Jan2021 at 16:15 (at the age of 52-years-old) as a single dose for COVID-19 immunization. Medical history included asthma, hypertension, morbid obesity, anemia, arthritis, allergic to fish (shell & fin) and all nuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported, but it was reported that the patient took other medications within 2 weeks of the vaccination. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 22Jan2021, at 16:15 (also reported as after 15 minutes), the patient's lips became numb and the throat started to sound very scratchy and itchy. This resulted in a doctor or other healthcare professional visit. Treatment for the events included the patient taking her own diphenhydramine (BENADRYL), epinephrine (EPIPEN) and albuterol. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of lips became numb and the throat started to sound very scratchy and itchy was resolved with sequel on Jan2021. Information on the batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1017088
Sex: F
Age: 41
State: ID

Vax Date: 01/12/2021
Onset Date: 01/27/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies: None

Symptoms: Developed a large hive around the injection site 2 weeks after the first dose

Other Meds: Bupropion XL 150 Vitamin D3 5,000

Current Illness: None

ID: 1017089
Sex: M
Age:
State: NY

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data: Test Name: Height; Result Unstructured Data: Test Result:5ft 9.5; Test Name: Height; Result Unstructured Data: Test Result:shrunk a 1.5 inches over the years; Test Name: weight; Result Unstructured Data: Test Result:>300 lbs; Test Name: weight; Result Unstructured Data: Test Result:310 lbs

Allergies:

Symptoms: walking is still very bad; lower back pain; he reported lower back pain, that has migrated more to the right hip and into the glute; he reported lower back pain, that has migrated more to the right hip and into the glute; it might be kidney pain; arm pain; This is a spontaneous report from a contactable other Health Professional (HCP). A 71-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3302), intramuscular on 22Jan2021 15:10 at 0.3 mL, single (0.3ml by intramuscular injection left shoulder) for COVID-19 prophylaxis. Medical history included ongoing high blood pressure (diagnosed about 21 years ago), ongoing gout (Diagnosed about 2 years ag), ongoing ankle spur right foot, ongoing diminished cartilage both knees, joint pain. The concomitant medications included torsemide. The patient reported adverse event (AE) after his first Pfizer-Biontech covid19 vaccine at 15:10 on 22Jan2021. He reported arm pain starting 3 hours after vaccination until noon the next day (23Jan2021). When he woke up on 23Jan2021 he reported lower back pain, that has migrated more to the right hip and into the glute. The pain inhibits walking, standing, etc. He did note that he is >300lbs and has had joint pain in the past, but the hip pain is new. He also thought it might be kidney pain, as he takes a daily diuretic. He stated he has been treating with Aleve twice a day, but that walking is still very bad. The patient is an optometrist that was calling about the Covid-19 vaccine and said that he did not know if the Lot number written on the vaccination card is EL3302, E13302, or EI3302. He got the vaccine on 22Jan2021 and reported that he got a sore arm about 3 hours after receiving the injection. He woke up with a sore lower back pain. He is 5ft 9.5 and 310 lbs and he is on Torsemide, a pretty strong diuretic. He woke up with the back pain and stated that it moved right and middle to his buttocks, a little lower than the end of his spine and to the right. He did not think it was his kidneys. He said that Torsemide can make kidneys work overtime. His knees were pretty shot, the left worse than the right. No further details provided. He was upset to know that he has shrunk a 1.5 inches over the years. He has been taking 2 Aleve a day since Saturday, this morning was his 4th pill. He said that it is really odd when he stands equally on both feet his lower back hurts. He has to sleep on his right side and that it hurts more when he sleeps on his back and on his left side. He was fearful doing eye exams next to his patient and how the lower back pain would affect him. Reporter considered seriousness for Lower back pain was Medically significant. The outcome of event lower back pain was not recovered; of event arm pain was recovered on 23Jan2021; of other events was unknown.; Sender's Comments: Based on the time association, the possible contribution of suspect vaccine BNT162B2 to the event low back pain cannot be excluded. The ongoing gout and concomitant drug torsemide may also play contributory roles to the event. 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: TORSEMIDE

Current Illness: Blood pressure high (diagnosed about 21 years ago); Cartilage damage (Diminished cartilage both knees); Gout (Diagnosed about 2 years ago); Heel spur syndrome (Ankle spur right foot)

ID: 1017090
Sex: F
Age: 24
State: VA

Vax Date: 01/21/2021
Onset Date: 02/01/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data: 2/2/21- flue, covid and strep tests negative, chest X-ray clear. Blood work shows high white blood count blood cultures drawn and results will be read 2/8/21.

Allergies: penicillin, omnisef, cinnamon, avocados, celery, lettuce, mold

Symptoms: started with headache and sore throat, then high fever (103) a few hours after first symptoms. body aches, chills and vomiting.

Other Meds: Zyrtec, lo loestrin fe

Current Illness:

ID: 1017091
Sex: M
Age:
State: FL

Vax Date: 01/22/2021
Onset Date: 01/24/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: severe shaking convulsive; chills; nausea; leg cramps; difficulty breathing; vomitting; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received single dose of BNT162B2 (PFIZER, Solution for injection, batch/lot number and exp date not reported ), via an unspecified route of administration (vaccine location: left arm) on 22Jan2021 10:45 for COVID-19 immunization. Medical history included diabetes and high cholesterol. The patient did not have Covid prior vaccination. The patient had no known allergies. Concomitant medication/other medications within two weeks included rosuvastatin calcium (CRESTOR), telmisartan, empagliflozin, metformin hydrochloride (SYNJARDY), and atenolol. There was no other vaccine within four weeks. On 24Jan2021 02:00, the patient experienced severe shaking convulsive, chills, nausea, leg cramps, difficulty breathing, and vomiting. No treatment was received for the events. The patient was not Covid tested post vaccination. The patient recovered from the events on an unspecified date in Jan2021. Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.

Other Meds: TELMISARTAN; SYNJARDY; ATENOLOL; CRESTOR

Current Illness:

ID: 1017092
Sex: F
Age:
State: GA

Vax Date: 01/09/2021
Onset Date: 01/11/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:fine

Allergies:

Symptoms: little depressed; not feeling like herself; weak; tired; This is a spontaneous report from a contactable nurse (patient). A 78-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140 and expiry date unknown), via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. The patient received the first dose on the left arm on 19Dec2020 10:30 (lot number: EL0140). Medical history included hypertension. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no side effects after the first vaccine except for a little tenderness which went away. On 11Jan2021, after receiving the second dose, she felt really tired but which went away. On 20Jan2021 (last Wednesday), she started to feel tired, weak, and not feeling like herself. On 22Jan2021, the patient was a little depressed. She did not have a headache. Her blood pressure was fine and she never had a fever. She had an X-ray back in Sep2020. Her vision is good. She is not hurting anywhere. She doesn't feel as strong. She doesn't understand the tiredness, weakness, and depression. Outcome of the event tired was recovered on 11Jan2021, of the events doesn't feel like herself and weak was not recovered, and of the event depression was recovering. The reporter assessed all the events as related to the bnt162b2. The events depression and doesn't feel like herself were reported as serious: medically significant while the other events were reported as non-serious.; Sender's Comments: A possible contributory role of bnt162b2 in triggering the onset depression and doesn't feel like herself cannot be excluded, considering the plausible temporal relationship. 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: 1017093
Sex: F
Age:
State: WV

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: swollen eyes; a rash on her forehead , around her eyes and both cheeks; very itchy eyes; This is a spontaneous report from a contactable Nurse (patient's mother). A 22-year-old female patient received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on 06Jan2021 17:30 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Nurse stated her daughter received her first Pfizer vaccine on 06Jan2021 around 5:30 pm. The patient's signs and symptoms began shortly after receiving the shot. That evening at 19:00, she had very itchy eyes, the next morning (07Jan2021) she woke up with swollen eyes, a rash on her forehead, around her eyes and both cheeks. She took benedryl and zyrtec on 07Jan2021. The symptoms clear up by 10Jan2021, following a visit to her HCP, on 08Jan2021. She received a steroid shot, a prednisone dose pack her HCP. Her HCP recommended she not take dose 2 and instructed her mother to call Pfizer for recommendations. The outcome of the events was recovered on 10Jan2021. The reporting nurse considered the case as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: The reported events of swollen eyes, itching eyes and rash on face were likely related to first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), due to plausible temporal relationship. 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: 1017094
Sex: F
Age: 38
State: MD

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

Lab Data: in progress

Allergies: Iodine Midodrine

Symptoms: patient became sweaty and flushed

Other Meds:

Current Illness:

ID: 1017095
Sex: F
Age:
State: OR

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data: Test Name: COVID test post-vaccination; Result Unstructured Data: Test Result:Unknown result

Allergies:

Symptoms: tingling with pins and needles feeling all through arms, legs, face; nausea; dizziness sight; chills; This is a spontaneous report from a contactable other healthcare professional (patient). A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration on the left arm on 21Jan2021 09:30 at a single dose for COVID-19 immunization. Medical history included "Celtics disease", allergies to gluten and negative COVID-19 test nasal swab on 10Oct2020. Concomitant medication included birth control and prenatal vitamin. Patient did not have COVID prior to vaccination and was not pregnant. Vaccination was received in the hospital and no other vaccine was received four weeks prior. On 21Jan2021 16:00, the patient reported nausea, dizziness sight and chills were normal then she had tingling with pins and needles feeling all through arms, legs, face. She still had prickling feeling in arms and her left foot was tingling and it had been four days later. The adverse events pins and needles reportedly resulted in disability or permanent damage. Patient has been tested for COVID post-vaccination on an unspecified date with unknown results. Treatment was received for the events. Outcome of the events was not recovered.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of prickling feeling in arms and her left foot tingling cannot be excluded, considering the plausible temporal relationship. 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: 1017096
Sex: F
Age:
State: CA

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: pain in my chest/stomach; pain in my chest/stomach; she couldn't sleep last night at all she was awake all night; had strange visions flashing in my head while trying to sleep; acid reflux/burping up acid; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: TL9261, expiration date not provided), via an unspecified route of administration on 25Jan2021 16:30 at a single dose for COVID-19 immunization. The patient has no medical history and there were no concomitant medications. On 25Jan2021, the patient experienced having acid reflux, pain in her chest/stomach that lasted all night last night and was worse when lying down. When she burped, it relieved some pressure. She had strange visions flashing in her head while trying to sleep on 25Jan2021. The patient was wondering if she was having a reaction from the vaccine. On 25Jan2021, after over an hour after the vaccine, she started having severe pain in the chest and stomach area and she couldn't sleep last night at all. She was awake all night, burping up acid. She was wondering if those were reaction to the vaccine, should she go see her doctor or what should she do about that. She got her first dose on 25Jan2021 and she started having chest and stomach pain the same day at about 6 PM. She was burping acid all night and early in the morning of 26Jan2021 and she was having these strange things like pictures going to her head that were weird. She was not sleeping but they were strange images, they were strange, they weren't normal. She says with that added in it sounds crazy. She has her vaccine card that says she should get the next one 15Feb2021. She wanted to avoid catching the corona. She had drank acid yesterday and she was wondering if that was causing her to have acid reflux. She clarified that she drank a lot of acidic liquids on 25Jan2021 and she was wondering if that might have had something to do with it, like orange juice and cranberry juice so she is wondering did that have anything to do with it, the acidity maybe made her stomach have acid reflux because she has had that in the past. She asked if she should go to the doctor. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1017097
Sex: F
Age: 53
State: IN

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies: None

Symptoms: Very sore and swollen upper left arm I could barely raise my arm half way up for two days. There was stiffness in the back of my neck,. I also had a headache, runny nose and was very tired and sleepy the next day. Additionally, I could taste the vaccine which was coming from the back of my throat and my menstrual cycle started one day late.

Other Meds: Vitamin C, Eldeberry, liquid zinc, Olive leaf, Sea Moss Gel, Alive Multivitamins, 5 mgs of blood pressure medicine.

Current Illness: None

ID: 1017098
Sex: M
Age:
State: FL

Vax Date: 01/23/2021
Onset Date: 01/24/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data: Test Date: 20210124; Test Name: pressure; Result Unstructured Data: Test Result:High

Allergies:

Symptoms: Edema of glottis; General malaise / indisposition; nausea; dizziness; body pain; pain in the joints; swelling of the throat; high pressure; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: El9263) solution for injection, via an unspecified route of administration in left arm on 23Jan2021 09:15 at a single dose for Covid-19 immunization. Medical history included high blood pressure, and diabetes. Concomitant medications included losartan, metformin, and simvastatin. The patient experienced edema of glottis, general malaise, nausea, dizziness, body pain, pain in the joints, indisposition, swelling of the throat, and high pressure; all on 24Jan2021 21:00. Patient visited the physician and received treatment for the adverse events (general examination). The patient was not diagnosed with Covid-19 prior to vaccination. Patient has not been tested for Covid-19 since the vaccination. Outcome of the events was recovering. No follow-up activities are needed. Information regarding the batch/lot number has been obtained. No further information is expected.

Other Meds: LOSARTAN; METFORMIN; SIMVASTATIN

Current Illness:

ID: 1017099
Sex: M
Age:
State: IL

Vax Date: 01/05/2021
Onset Date: 01/07/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Diplopia due to left 6th (abducen) cranial nerve palsy; Diplopia due to left 6th (abducen) cranial nerve palsy; This is a spontaneous report from a contactable physician. A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), intramuscular, in the left arm, on 05Jan2021 07:30 at a single dose for covid-19 immunization. Medical history included type 2 diabetes. Concomitant medications were unspecified. The patient took unspecified medications in two weeks. The patient did not have any other vaccine in four weeks. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 post vaccination. The patient had no known allergies. On 07Jan2021, the patient experienced diplopia due to left 6th (abducen) cranial nerve palsy. The event resulted in doctor office/clinic visit, and emergency room visit. Therapeutic measure was taken as a result of the event which included fresnel prism on current glasses to alleviate diplopia. Outcome of the event was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported diplopia due to left 6th (abducen) cranial nerve palsy and the administration of COVID-19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. 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 RA, IEC, as appropriate.

Other Meds:

Current Illness:

ID: 1017100
Sex: F
Age: 72
State: MO

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data: none

Allergies: none

Symptoms: 02/04 - chills and headache all day; 02/05 - headache, fatigue, nausea; 02/06 - headache (partial day), nausea (am); fatigue all day; 02/07 - minor fatigue most of day

Other Meds: carvedilol 6.25 mg; cetirizine 10 mg; furosemide 40mg; lisinopril 5mg; mirabegron 25mg; multivitamin; spironolactone 25mg; vitamin D3; zinc; vitamin C.

Current Illness: none

ID: 1017101
Sex: F
Age:
State: GA

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Tip of tongue feels slightly enlarged; Salty taste in mouth; Tingle sensation on tip tongue; This is a spontaneous report from a contactable consumer (patient). This 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL3302), via an unspecified route of administration on 22Jan2021 08:00 at single dose on the right arm for COVID-19 immunization. Medical history included high blood pressure and COVID-19. No allergies to medications, food, or other products. The patient's concomitant medications included amlodipine and ethinylestradiol/ferrous fumarate/norethisterone acetate (LO LOESTRIN FE) received within 2 weeks of vaccination. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Jan2021 12:00, the patient experienced salty taste in mouth for over 2days. Tingle sensation on tip tongue. Tip of tongue feels slightly enlarged. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No treatment received for the adverse event. Outcome of the events was not recovered.

Other Meds: AMLODIPINE; LO LOESTRIN FE

Current Illness:

ID: 1017102
Sex: M
Age:
State: FL

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

Lab Data:

Allergies:

Symptoms: eye infection; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (wife) reported that a male patient of an unspecified age received the first dose of bnt162b2 (UNSPECIFIED TRADE NAME, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller reported that her husband received the 1st dose of the Pfizer vaccine 2 weeks ago (Jan2021) and he had an eye infection unrelated to the vaccine. Caller was asking if he can take antibiotics and asking if that would be contraindicated with the vaccine that he got. Caller also mentioned that her husband was afraid to take antibiotics and wanted to know if it was okay to take antibiotics which was prescribed by his Doctor. Her husband was also an healthcare professional but he was an Orthopedic Surgeon and it's not his field. The reported wanted to know if that would reduce the immunity that he got from the vaccine. The patient developed the eye infection a week ago (Jan2021). He had not taken the antibiotic before. Second dose would be on 01Feb2021. The outcome of the event was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: The eye infection is most likely an intercurrent condition and unrelated to suspect vaccine BNT162B2.

Other Meds:

Current Illness:

ID: 1017103
Sex: F
Age:
State: FL

Vax Date: 01/11/2021
Onset Date: 01/01/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data: Test Name: Biopsy; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptoms: reaction for 14 days. She went to dermatologists to check about those marks if it's cancerous or something/did a biopsy; she's not feeling well; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021 at SINGLE DOSE for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient got her 1st dose of Covid 19 Vaccine on 11Jan2021 and now already experiencing a reaction for 14 days. She went to dermatologists to check about those marks if it's cancerous or something, she was there 4days ago and did a biopsy, then after that Doctor asked if she took the covid 19 vaccine because they knew about it. She wanted to ask as well if it's Okay if she will not take the 2nd dose because she's not feeling well now and can't take it. The outcome was unknown. Information about Lot/Batch has been requested.

Other Meds:

Current Illness:

ID: 1017104
Sex: F
Age: 53
State: WA

Vax Date: 01/26/2021
Onset Date: 02/07/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data: None

Allergies: No known allergies

Symptoms: Noticed a red lesion around the injection site that didn't show up until 12 days after I got my first shot. It's slightly itchy and warm to the touch. No pain. I reported it because I saw that others had the same reaction and it scared me until I found out that it was a known side effect. * I received a shingrix vaccine on November 23rd 2020 but it wasn't within a month of the Covid vaccine so I didn't mark it on this form. I wanted to give the info just in case it might be helpful.

Other Meds: Levothyroxine Liothyronine Bupropion Phentermine Vitamin D Iron supplement

Current Illness: none

ID: 1017105
Sex: M
Age:
State: PA

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Had a near death one night; crawled from the bathroom to the couch, and his wife would help him walk; blacked out a couple times; Palpitation; Lower Legs started to get numb; Diarrhea; Nausea; Getting itchy, entire body; Weak/Weakness; This is a spontaneous report from a contactable physician (patient) A 71-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot: EL3248), via an unspecified route of administration in the left arm on 25Jan2021 at single dose for COVID-19 immunisation. Medical history included seasonal allergy. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (Batch/lot number: EK9231) on 04Jan2021 at single dose in left arm for COVID-19 immunisation and experienced non serious slightly sore arm lasted for 2 to 3 days. On 25Jan2021 the patient experienced blacked out a couple times (serious due to disability, life threatening), palpitation (serious as life threatening), lower legs started to get numb (medically significant) with outcome of recovered on 25Jan2021, diarrhea and nausea (both medically significant) with outcome of recovered on 26Jan2021; Getting itchy, entire body and weak/weakness (both medically significant) with outcome of recovering. The patient has also a near death one night with outcome of unknown. The patient reported that received the second was on 25Jan2021, and about 10 hours later, he started getting itchy, his entire body was itchy, this was all in about 20 minutes, he was weak, then he got diarrhea, nausea, he blacked out a couple times, he had the weakness, then he crawled from the bathroom to the couch, and was afraid and his wife would help him walk, as he didn't think he would make it, he was on the couch with palpitations and was itchy all over, and after an hour he fell asleep, and he came within seconds of going to the ER, the palpitations got worse, and he has no heart problems in the family, but it was a terrible reaction, he didn't think he would make it through the night, and he was not an allergic person, the only thing he was allergic to was seasonal, in the spring time. Also, his lower legs started to get numb in between all that. Started to get itchy 10 hours after the second shot. He was much better the following morning, he just has a little weakness from the havoc on the body. Numbness in lower legs lasted only about 10-15 minutes.; Sender's Comments: Based on a compatible temporal association, a causal relationship between reported events and BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE) 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.,Linked Report(s) : US-PFIZER INC-2021082193 Same Reporter/Patient, Different Dose of vaccine/Event

Other Meds:

Current Illness:

ID: 1017106
Sex: F
Age: 43
State: MI

Vax Date: 02/08/2021
Onset Date: 02/08/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data: None

Allergies: None

Symptoms: Shaking, diaphoretic, head ache, nausea, body aches

Other Meds: Every day womens mulitvitamin

Current Illness: None

ID: 1017107
Sex: F
Age:
State: IN

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

Lab Data:

Allergies:

Symptoms: anaphylactic shock; bleeding disorder (blood clots); atrial fibrillation; little sore arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient calling-in because she received her 1st shot of vaccine earlier today. She claims that it is too late when she reads the fact sheet. she called-in because she has bleeding disorder (blood clots) or atrial fibrillation and taking xarelto. She also reported that she had anaphylactic shock. Reporter stated she never experienced an anaphylactic reaction just a little sore arm, she just called to obtain information as she currently takes an anti-coagulant. Therapeutic measures were taken as a result of bleeding disorder (blood clots), atrial fibrillation. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1017108
Sex: F
Age:
State: TN

Vax Date: 01/15/2021
Onset Date: 01/17/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data: Test Name: regular check up; Result Unstructured Data: Test Result:unknown results

Allergies:

Symptoms: Shortness of breath; This is a spontaneous report from a contactable consumer. An 89-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283, Expire Date: Apr2021), via an unspecified route of administration on 15Jan2021 09:00 at single dose, right arm for covid-19 immunization. Indication reported as "Hopes she wouldn't get COVID", Stated that was why she got the Measles vaccination. The patient's medical history and concomitant medications reported as none. The patient previously got flu shot for immunization in Oct2020. The patient experienced shortness of breath on 17Jan2021. Caller told the woman administering it that she had been short of breath and was advised it was alright to receive the COVID-19 Vaccine. The patient had been really short of breath ever since. She wasn't very short of breath before the COVID-19 Vaccine. She was more so short of breath after the COVID-19 Vaccine. Shortness of Breath was noticed increase on 17Jan2021 at night. She was fine during the day, but could not lie down to go to sleep in bed. Sat up all night. Then it just came and went. Sometimes thought it was gone, but shortness of breath came back. The patient called doctor and was advised to go into an urgent care. She was going at time of the report. Relevant tests reported as none, regular check up at doctor. She wanted to know if she could get the second COVID-19 vaccine on 06Feb2021. The outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1017109
Sex: F
Age: 47
State: MA

Vax Date: 01/08/2021
Onset Date: 01/24/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data: Blood work being done and MRI to be scheduled

Allergies: None

Symptoms: Visual problems, diplopia, concerns for left 4th cranial nerve paralysis

Other Meds: None

Current Illness: None

ID: 1017110
Sex: M
Age:
State: MD

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data: Test Date: 20210122; Test Name: Blood pressure; Result Unstructured Data: Test Result:180/100; Comments: Severe elevation

Allergies:

Symptoms: Severe elevation of blood pressure as high as 180/100; vesicular pruritic erythematous patches in multiple locations of my left arm, left arm pit, left upper back, left chest occurred/Blisters have opened leaving behind painful ulcers; vesicular pruritic erythematous patches in multiple locations of my left arm, left arm pit, left upper back, left chest occurred; vesicular pruritic erythematous patches in multiple locations of my left arm, left arm pit, left upper back, left chest occurred/Blisters have opened leaving behind painful ulcers; Painful ulcers; Painful ulcers; vesicular pruritic erythematous patches in multiple locations of my left arm, left arm pit, left upper back, left chest occurred/leaving behind painful ulcers; vesicular pruritic erythematous patches in multiple locations of my left arm, left arm pit, left upper back, left chest occurred/leaving behind painful ulcers; vesicular pruritic erythematous patches in multiple locations of my left arm, left arm pit, left upper back, left chest occurred/leaving behind painful ulcers; vesicular pruritic erythematous patches in multiple locations of my left arm, left arm pit, left upper back, left chest occurred/leaving behind painful ulcers; This is a spontaneous report from a contactable physician (patient/reported for himself). A 35-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), via intramuscular on the left arm, on 21Jan2021 at 16:00 at single dose for covid-19 immunisation. The patient had no medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications the patient received within 2 weeks of vaccination. The patient had no allergies to medications, food, or other products. No history of allergic reactions to any meds (medication) in the past or other vaccines in childhood. Otherwise young healthy male with no history of hypertension. The patient was not diagnosed with COVID-19 prior to vaccination. The patient concomitant medications were not reported. The patient previously took first dose of BNT162B2 (Lot number: EJ1686) via intramuscular on the left arm on 30Dec2020 at 16:00 for COVID-19 immunization and experienced severe elevation of blood pressure. On 22Jan2021, at 12:00 AM, after the 2nd dose in left arm, after about 24 to 48 hours, the patient experienced vesicular pruritic erythematous patches in multiple locations of my left arm, left arm pit, left upper back, left chest occurred, peaking on day three and still remain after one week. The blisters have opened leaving behind painful ulcers. This is not a rash that disappears in a few days. It will take much longer than that to heal. No rash with the first dose. Also, with both doses, had severe elevation of blood pressure as high as 180/100 within 2 to 5 hours on 22Jan2021, requiring about 3 doses of clonidine over 7 days where bp would cycle up and down. The seriousness of the events was reported as non-serious. Since the vaccination, the patient has been not tested for COVID-19. Therapeutic measures were taken as a result of events and included Benadryl, mometasone cream and clonidine. The outcome of the events was reported as recovering. No follow-up attempts are needed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm