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**
PLEASE CHECK BACK SOON
Download the files above while you wait.







Manufacturers

Total Manufacturer
199,106MODERNA
36,710JANSSEN
5,381PFIZER\BIONTECH
2,555GLAXOSMITHKLINE BIOLOGICALS
1,469UNKNOWN MANUFACTURER
897MERCK & CO. INC.
627SEQIRUS, INC.
112DYNAVAX TECHNOLOGIES CORPORATION
91SANOFI PASTEUR
75NOVARTIS VACCINES AND DIAGNOSTICS
40EMERGENT BIOSOLUTIONS
14PAXVAX
12TEVA PHARMACEUTICALS
12PROTEIN SCIENCES CORPORATION
9PFIZER\WYETH
4BERNA BIOTECH, LTD.
4SMITHKLINE BEECHAM
3INTERCELL AG
1MEDIMMUNE VACCINES, INC.
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL7,949
7,473
2,547
1,506
1,187
1,051
1,049
s0294561,043
866
IMM209861
816
UT7065MA766
657
579
U62828AA563
557
538
U6737AA516
515
S034636506
4F472471
458
P100253275449
444
276563436
429
418
4BH32414
MENVEO404
PP9L5362
UJ446AA337
319
306
290
271
49TM3270
R1B252M253
4F472179
933622147
C5763AA144
CW3116134
3Y7NL126
UNK114
113
ARBA141A105
104
103
96
300057A90
79
1F4EB73
R1B743M62
56
UJ090AA55
51
UH894AB46
45
UNK44
UNK42
42
EJ168638
Unknown36
35
34
32
32
26
el128424
24
A115A22
22
EN620222
21
UNK20
20
19
Z127A19
19
17
JEV18K95E15
12
111798PI12
10
A739088
No batch number8
3333324181078
6
6
TAR356
5
5
U6935AA5
UNK5
4
unknown4
3
2
55RB72
2
2
2
2
2
U7124AA2
JEV18A68E2
2
ABYB05BA1
1
1
1
1
AMVA436A1
1
1
TJ3521
A130A; VIS give1
1
U7140BB1
1
1
SP UP016AA1
1
1808P08802/ESV01
037K20A300,947
EL1284288,578
57,766
1,432

Incidents per State

State Total
82,750
CA62,821
FL38,209
TX36,512
NY34,921
PA23,646
IN23,622
IL20,597
MI19,590
OH19,426
NJ18,413
NC16,769
GA15,932
WA15,351
VA15,234
MA14,876
AZ14,206
MN12,940
MD12,656
CO11,908
WI11,425
MO10,240
TN9,685
OR8,768
KY8,437
CT8,300
SC6,700
OK6,293
AL5,692
LA5,025
IA4,825
KS4,821
UT4,637
NV4,374
NM3,967
AR3,807
ME3,161
NH3,096
NE2,918
MS2,859
ID2,785
WV2,469
HI2,459
PR2,417
MT2,414
RI2,076
DE1,868
AK1,830
VT1,734
DC1,715
ND1,388
SD1,269
WY866
GU118
VI69
AS47
MP29
MH8
XB6
FM4
QM3
XV2
XL1

ID: 1773890
Sex: F
Age:
State: IL

Vax Date: 03/22/2021
Onset Date: 03/24/2021
Rec V Date: 10/09/2021
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: swelling under her armpit, it is painful because it is going down the arm; swelling under her armpit, it is painful because it is going down the arm; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER2613) via an unspecified route of administration, administered in left arm on 22Mar2021 around 16:00 (at the age of 42-year-old) as dose 1, single for covid-19 immunisation. Medical history included ongoing sinus issues, patient stated she started having sinus issues when she turned 40. Concomitant medication included ongoing Lisinopril taken for high blood pressure from 2019, ongoing Montelukast taken for nasal sinus issues from 2019 and ongoing Cefdinir taken for sinus issues from 15Mar2021. On 24Mar2021, the patient experienced swelling under her armpit, it was painful because it was going down the arm. She stated that it could have been last night but she knew she had to go to work and wasn't going to get out of bed.The patient was taking Pfizer COVID Vaccine for asthma, wanting to travel, want to get back to normal. No additional vaccines administered on same date of the Pfizer Suspect. Patient had no prior vaccination within four weeks. No adverse event prior vaccination. No emergency room and physician office visit. At the time of reporting,outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: Lisinopril; Montelukast; Cefdinir

Current Illness: Sinus disorder (Verbatim: sinus issues).

ID: 1773891
Sex: U
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 10/09/2021
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: Sore arm; fever; chills; body aches; fatigue; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date a the patient experienced sore arm, fever, chills, body aches and fatigue. The outcome of all the events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1773892
Sex: M
Age:
State: CA

Vax Date: 03/23/2021
Onset Date: 03/24/2021
Rec V Date: 10/09/2021
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: chills; sore arm; body aches; feverish; small lump in the arm pit; headaches; This is a spontaneous report from a contactable consumer or other non hcp. A male unspecified age (45 units not reported) patient received bnt162b2 (Pfizer covid vaccine, Formulation: Solution for injection in pre-filled syringe, Batch/lot number : Unknown), dose 1 via an unspecified route of administration on 23Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 23Mar2021, patient received Pfizer covid vaccine. On 24Mar2021, patient reported he experienced chills, sore arm, body aches, feverish, small lump in the arm pit and now headaches. The outcome for all the events was unknown. No follow-up attempts are Possible.

Other Meds:

Current Illness:

ID: 1773893
Sex: U
Age:
State:

Vax Date: 03/03/2021
Onset Date:
Rec V Date: 10/09/2021
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: mosquito bite appeared on my body;clear and itchy; appear around my elbow and my, around my armpit area and my thighs.; This is a spontaneous report from a contactable consumer (patient) reported for self. A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6204, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 03Mar2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had called to report side effects of Pfizer vaccine. On an unspecified date, after the patient got the first dose of Pfizer vaccine, things began on third day, there were mosquito bites appeared on the patient's body. It just looked like mosquito bite, clear and itchy and it was not a lot but to the point the patient noticed that they were. It usually appeared around the patient's elbow and around armpit area and thighs. It was still going on till that day and the patient was supposed to get second dose of Pfizer vaccine that day. The patient wanted to know if it would be okay to get the second dose of vaccine or was there any data about those symptoms. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1773894
Sex: F
Age:
State: NY

Vax Date: 03/23/2021
Onset Date: 03/23/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Date: 20210323; Test Name: Temperature; Result Unstructured Data: Test Result:100.3

Allergies:

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

Symptoms: Eye swelling right under my eyebrow on both sides, more pronounced on the right side.; inflamed lymph node left armpit area; I have mild psoriasis on my forehead. I noticed that a day after the vaccination, the redness of my psoriasis flare was barely noticeable; I have mild psoriasis on my forehead. I noticed that a day after the vaccination, the redness of my psoriasis flare was barely noticeable; Sore arm; body aches; headache; 100.3 temperature; This is a spontaneous report from a non-contactable consumer (patient). A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration, administered in arm left on 23Mar2021 13:00 as dose 2, single for COVID-19 immunization (at the age of 38-year-old). Medical history included psoriasis and underactive thyroid. Concomitant medications included vitamin d3 and vitamin b12 nos (other medications in two weeks). No known allergies. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration, administered in arm left on 02Mar2021 13:15 as dose 1, single for COVID-19 immunization (at the age of 38-year-old). The patient did not took any other vaccine in four weeks. The patient did not had COVID prior vaccination and not tested for COVID post vaccination. On 23Mar2021 23:00, the patient experienced sore arm, body aches, headache and 100.3 temperature. On 24Mar2021, the patient experienced inflamed lymph node left armpit area, have mild psoriasis on his forehead. He noticed that a day after the vaccination and the redness of his psoriasis flare was barely noticeable. On 27Mar2021 07:00, the patient experienced eye swelling right under his eyebrow on both sides, more pronounced on the right side. The patient did not received any treatment for adverse events. On 23Mar2021, the patient underwent lab tests and procedures which included body temperature: 100.3. The outcome of the event eye swelling right under his eyebrow on both sides, more pronounced on the right side was not recovered and for all other events was recovering. No follow-up attempts are needed. No further information is expected.

Other Meds: VITAMIN D3; VITAMIN B12 NOS

Current Illness:

ID: 1773895
Sex: F
Age:
State: NY

Vax Date: 03/20/2021
Onset Date: 03/21/2021
Rec V Date: 10/09/2021
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: Test Name: fever; Result Unstructured Data: Test Result:102.1

Allergies:

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

Symptoms: I haven't felt better, I still have the reaction of the vaccine; Body ache; Sore throat; Headache; Fever; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9266), via an unspecified route of administration, administered in left arm on 20Mar2021 (at the age of 53-year-old) as dose 1, single for covid-19 immunization. The patient medical history reported as none. The patient's concomitant medications included levothyroxine sodium (SYNTHROID) Once a day, oral and Vitamins. The patient reported that I had vaccine, Saturday on 20Mar2021 and till today I haven't felt better, I still have the reaction of the vaccine. I had body ache, sore throat, headache, fever 102.1, I took Tylenol to control the fever and the symptoms I had, I took Tylenol (later clarified as treatment) every 4 hours, because I can't take these symptoms, I wasn't getting concerned but now since it has got two days from the vaccine, all I hear is the first dose, it should be very mild, it's the second dose that is difficult. Patient stated I called to make sure if the symptoms that I am feeling are safe or not, is it usual to feel this or not. Patient stated since I got the vaccine, symptoms mostly I started that night, but I truly felt that on 21Mar2021, and still experiencing the symptoms. The patient also stated that he was due to receive second shot, after 21 days, which was scheduled in April. The patient underwent lab tests and procedures which included body temperature: 102.1 on an unspecified date. Therapeutic measures were taken as a result of the events with Tylenol every 4 hours. The outcome of the events was not recovered at the time of report. No follow-up attempts are possible. No further information is expected.

Other Meds: SYNTHROID

Current Illness:

ID: 1773896
Sex: M
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 10/09/2021
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: he has a cough, he is coughing; he develop side effects with the first vaccine a day after the vaccination; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received first dose of bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter mentioned I have a question which I could not find it anywhere on internet and I am very good at research. What happened was my whole family got vaccinated but my brother, he did not have one of those significant medical condition and he is under 60 so he just got vaccinated, his first vaccine, Pfizer vaccine with facility and then he develop side effects with the first vaccine a day after the vaccination. The side effects were similar to what I experienced when I got my second vaccine of Moderna but the only difference is that he has a cough, he is coughing and I could not find that as a side effect on any of the websites like. I looked everywhere and I got worried about it and I just wanted to know if anyone have reported having cough as the side effect from the vaccine. 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: 1773897
Sex: F
Age:
State: NY

Vax Date: 03/18/2021
Onset Date: 03/23/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Date: 20210310; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Negative

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: muscle pain in arm, shoulder and scapula; tightness of neck; some tingling in arm, all on left side; This is a spontaneous report from a contactable patient. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 18Mar2021 14:30 (at the age of 54 year old) as dose 1, single for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD) and mitral valve prolapse from an unknown date. Concomitant medications included ergocalciferol (VITAMIN D); and topical minoxidil (ROGAINE FOR WOMEN) both for an unspecified indication. The patient was not pregnant at the time of vaccination. No allergies to medications, food, or other products. Prior vaccination, patient did not receive any other vaccines within four weeks and was not diagnosed with COVID 19. On 23Mar2021 02:00, the patient experienced muscle pain in arm, shoulder and scapula, tightness of neck, and some tingling in arm, all on left side. Since the vaccination patient took COVID-19 test (Nasal swab) on 10Mar2021, where result was negative. No treatment was received in response to the events. The outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: VITAMIN D [ERGOCALCIFEROL]; ROGAINE FOR WOMEN

Current Illness:

ID: 1773898
Sex: M
Age:
State: WA

Vax Date:
Onset Date:
Rec V Date: 10/09/2021
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: rash on his arms; kinda itchy; little red rash in his elbow; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored Program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date, at dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced rash on his arms, little red rash in his elbow and kind of itchy on an unspecified date. The outcome of the events was unknown. Follow-up (23Mar2021/24Mar2021): new information received from same contactable consumer includes: New event details (little red rash in his elbow and kind of itchy). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1773899
Sex: M
Age:
State: MI

Vax Date: 03/09/2021
Onset Date: 03/09/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Histamine level; Result Unstructured Data: Test Result:Pretty High; Test Date: 20210324; Test Name: Covid Test; Result Unstructured Data: Test Result:Unknown

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: slight tingling on the tongue; This is a spontaneous report from a contactable Consumer or other non-health professional (patient). A 28-years-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch number: not reported/ Lot number: EN6206) via an unspecified route of administration in deltoid left on 09Mar2021 14:00 (at the age at vaccination of 28-year-old) as dose 1, single for CVOID-19 immunization. Patient's relevant medical history included ongoing Asthma which was recently diagnosed, and concomitant medications included ongoing Montelukast sodium (MONTELUKAST SODIUM) taken for asthma from an unspecified start date and ongoing Tiotropium bromide (TIOTROPIUM BROMIDE) taken for asthma symptoms from an unspecified start date. Patient had historical vaccine of booster shot of for the flu in Nov2020. He was mostly taking supplements and allergy medications. Family Medical History Reported as Maternal Grandfather had heart problems. History of all previous immunizations with the Pfizer vaccine considered as suspect were reported as None and no additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations taken within 4 weeks and no AE were reported following prior vaccinations. On 09Mar2021, patient experienced a slight tingling on the tongue that he had right after his Covid vaccination that subsided after 5 minutes or so. He has been exposed directly, more than likely and got a test kit on 24Mar2021 (reported as today) and he do not know whether or not he was positive for another few days for the virus and he said he got his first dose of the vaccine just over two weeks ago. Also, he went to the doctor recently and found out he was Asthmatic and he was referred to a pulmonologist in April. And his histamine levels were pretty high, that was out of blood work he had a month or so ago, it has been a consistent issue for the last year to him and his doctor have been trying their best to get this level down. Adverse event did not require visit to emergency room and physician office. Patient said he got his first dose of the vaccine just over two weeks ago. Also stated if his test comes back positive does he have to start the vaccination process over again and what are his options. The patient underwent lab tests and procedures which included on an unspecified date in 2021, histamine level was pretty high and on 24Mar2021, COVID test and results was unknown. Outcome of the event was recovered on 09Mar2021. No follow-up attempts are possible. No further information is expected.

Other Meds: MONTELUKAST SODIUM; TIOTROPIUM BROMIDE

Current Illness: Asthma (Structured information (Patient episode name): Asthma. Patient Medical continuing: Yes.)

ID: 1773900
Sex: M
Age:
State: NY

Vax Date: 03/19/2021
Onset Date: 03/20/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Name: heart rate; Result Unstructured Data: Test Result:Elevated

Allergies:

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

Symptoms: Chest discomfort; Heart palpitations; Elevated heart rate; This is a spontaneous report from a contactable Consumer. This Consumer reported for a 43-year-old male patient (Husband) who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EP7534) via an unspecified route of administration on 19Mar2021 at 11:00 hours (at 43-year-old) on left arm as dose 1, single for COVID-19 immunization. No prior vaccinations (within 4 weeks) and other products were received, no investigation assessment was done, no events were reported following prior vaccinations and no family medical history was reported relevant to events. The relevant tests and medical history were reported as none. On 20Mar2021 the patient had chest discomfort, heart palpitations and an elevated heart rate since receiving the first dose of the Pfizer Covid-19 vaccine. Caller reported that the patient was considering going to the emergency room since he had been experiencing side effects. Caller reported that the patient described the event as it feels like there was something weird in his chest and described it as a strange sensation. Caller reported that the patient had no history of heart problems and was not on any medications. The patient spoke with the callers cardiologist and urgent care. Caller reported that the physician and urgent care staff informed patient that if the chest discomfort, heart palpitations, and elevated heart rate continue to go to the emergency room. The patient did not require emergency room and physician office visit. The patient had not recovered. No follow-up attempts were possible. No further information was expected.

Other Meds:

Current Illness:

ID: 1773901
Sex: F
Age:
State: VA

Vax Date: 03/17/2021
Onset Date: 03/19/2021
Rec V Date: 10/09/2021
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: Facial swelling; eye actually swelled up; looked like a black eye; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration, administered in left arm on 17Mar2021 at 09:45 (Age at vaccination was 31 years) as dose 1, single for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. There were no concomitant medications. No other vaccinations within four weeks prior administration date of the suspect vaccine. On 19Mar2021 after the first dose of the COVID 19 vaccine patient experienced some side effects and the most concerning was facial swelling and her eye actually swelled up and looked like she had a black eye and wondering if it would be safe for her to get the 2nd dose. She did not have a doctor. The patient took Benadryl as therapeutic measures. The outcome of events was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1773902
Sex: F
Age:
State: SC

Vax Date: 03/18/2021
Onset Date: 03/23/2021
Rec V Date: 10/09/2021
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: Sore throat; tongue felt fat and it hurt/her tongue still hurts /feels like her tongue is a little swollen; tongue felt fat and it hurt/her tongue still hurts /feels like her tongue is a little swollen; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6207), via an unspecified route of administration, administered in arm left on 18Mar2021 as dose 1, single for COVID-19 immunization (at the age of 57-year-old). Medical history included ongoing high blood pressure, ongoing type 2 diabetes mellitus, ongoing hypothyroidism, ongoing chronic depression, ongoing uric acid high, gout and severe reaction to sulfa drugs. Concomitant medications included oral levothyroxine sodium (L-THYROXINE) 50mcg once a day by mouth) for Hypothyroidism, bupropion hydrochloride (WELLBUTRIN) 450mg one time a day for Depression, metoprolol (50mg one time a day) for high blood pressure, allopurinol (300mg one time a day) for gout prevention, linagliptin (TRADJENTA) (5mg one time a day) for type 2 diabetes. On 23Mar2021 (5 days after the vaccination), the patient experienced tongue felt fat and it hurt, just feels like her tongue is a little swollen. On 24Mar2021 (6 days after the vaccination), the patient experienced sore throat. Stated today her tongue still hurts. it just feels like her tongue is a little swollen, says she cannot tell if it is swollen when she looks at it, it just feels that way. Patient stated they monitored her after her dose for 30 minutes instead of 15. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: L-THYROXINE [LEVOTHYROXINE SODIUM]; WELLBUTRIN; METOPROLOL; ALLOPURINOL; TRADJENTA

Current Illness: Blood pressure high; Chronic depression; Hypothyroidism; Type 2 diabetes mellitus; Uric acid high

ID: 1773903
Sex: M
Age:
State: CT

Vax Date:
Onset Date:
Rec V Date: 10/09/2021
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: Test Name: body temperature; Result Unstructured Data: Test Result:light fever

Allergies:

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

Symptoms: Flu like symptoms; light fever; extreme fatigue; whole body soar; This is a spontaneous report from a contactable consumer, the mother. A 19-years-old male patient received first dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE formulation: solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single (age at vaccination 19 years) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced flu like symptoms, whole body soar, light fever and extreme fatigue on an unknown date. It was reported that the patient does not take any medications and was a healthy young man and that event took place after use of product. The patient lab data included light fever. The reason for it being past the 24 hours was because it was my son. The reporter was the one observing him and the symptoms lasted more than two days. She thought it would be normal for him to have some symptoms so that was why she didn't report it right away. The patient received the vaccine on a Tuesday and then missed three days of work. By that Saturday he was back to normal. The outcome of the events was recovered on an unknown date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1773904
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/09/2021
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: Had like an episode of sleep apnea; My mouth was real dry; I was sleeping and it was like I couldn't breathe; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9267), via an unspecified route on unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced like an episode of sleep apnea, mouth was real dry and patient stated that she was sleeping and it was like she couldn't breathe. Patient stated, "I am going to take the second vaccine today from the Pfizer for the COVID and I don't know, I had not reported this but before, like I said I don't know if this is the side effect or not of the first one but after I took the first one, maybe about a week later or so I had like an episode of sleep apnea and my mouth was real dry, I was sleeping and it was like I couldn't breathe you know and I had that in the past a long time ago and stuff. It happened twice." The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1773905
Sex: F
Age:
State: NC

Vax Date: 03/19/2021
Onset Date: 03/20/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Date: 20210315; Test Name: Covid 19 virus test; Test Result: Negative

Allergies:

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

Symptoms: bruise showed up on the calf muscle of the back of her left leg and oddly enough it showed up after the vaccine; feels like knot is in that left leg and it is painful; feels like knot is in that left leg and it is painful; This is a spontaneous report from a contactable consumer or other non hcp. This report is in reference to the reporter's mother. This is report 2 of 2. A 64-years-old female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EN6207, Expiry Date: unknown), via an unspecified route of administration, administered in Arm Left on 19Mar2021 13:00 (at the age of 64-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No prior vaccinations within 4 weeks. On 20Mar2021 the patient experienced bruise showed up on the calf muscle of the back of her left leg and oddly enough it showed up after the vaccine, feels like knot is in that left leg and it is painful. On 15Mar2021, the patient underwent lab tests and procedures which included Covid 19 virus test, sars-cov-2 test: Negative. The outcome of events recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1773906
Sex: F
Age:
State: VA

Vax Date: 03/25/2021
Onset Date: 03/01/2021
Rec V Date: 10/09/2021
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: restless; inability to sleep; chest pains; she was tossing and turning and had a poor nights rest; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (mother) that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on 25Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took historical vaccine bnt162b2 dose 1, single for covid-19 immunisation. On Mar2021, the patient experienced restless, inability to sleep, chest pains and she was tossing and turning and had a poor nights rest. 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: 1773907
Sex: F
Age:
State: OH

Vax Date: 03/04/2021
Onset Date:
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: blood test; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: I am breaking out a rash; This is a spontaneous report from a contactable consumer (Patient). A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EN6198) via an unspecified route of administration, administered in the right arm on 04Mar2021 (at the age of 70-years-old) as dose 1, single for COVID-19 immunization. Medical history was not reported. Concomitant medications were reported as, patient was on just one medication (not specified, Other Products: Yes). Patient took the first dose of vaccine about 3 or 4 weeks ago (at the time of report) and she was breaking out a rash on an unspecified date in 2021 after vaccination. Patient haven't seen a doctor for it but was going to. Patient would like to know that can she take the second shot. The patient underwent lab tests and procedures which included blood test with unknown results 2 days ago (at the time of report) on an unspecified date in 2021. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1773908
Sex: F
Age:
State:

Vax Date:
Onset Date: 03/24/2021
Rec V Date: 10/09/2021
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: hives all over [her] arms and legs/woke up with hives again; fever; aches; This is a spontaneous report from a non-contactable consumer. A 4-decade-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as dose 2, single, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient developed huge hives all over arms and legs 5 days after her second dose of the Pfizer covid vaccine. On 24Mar2021, the patient experienced fever and aches, and woke up with hives again. It was reported that, the patient would be seeing her doctor on 25Mar2021 (reported as today). The outcome for the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1773909
Sex: F
Age:
State: TX

Vax Date: 03/23/2021
Onset Date: 03/23/2021
Rec V Date: 10/09/2021
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: Night sweats; couldn't sleep; really tired; severe headache; body aches and pain; Fever; sweaty; feels super cold; feels bad; she was unable to move; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER2613, age at vaccination 30 years), via an unspecified route of administration, administered in Arm Left on 23Mar2021 as DOSE 2, SINGLE for Covid protection. The patient medical history was not reported. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for vitamin d decreased at a dose of 10,000 units weekly, from an unspecified start date and ongoing (has been taking for maybe 6 months); hydrocodone at a dose of 10mg twice daily taken for pain and back problems, start and stop date were not reported (has been taking for a couple of years for back problems). The patient previously took first dose of bnt162b2 (Lot: EN6205) via an unspecified route of administration, administered in arm on 02Mar2021 as DOSE 1, SINGLE for covid-19 immunisation and received a Vitamin b12 injection the day before in the same arm. The patient experienced severe headache, body aches and pain, fever, couldn't sleep, really tired on 23Mar2021, night sweats on 24Mar2021, sweaty, feels super cold, feels bad, she was unable to move on an unspecified date in 2021. It was reported that, the patient received the vaccine and was having bad reactions. She wanted to see if this was normal and why her body was acting like this. She had a severe headache, body aches and pain that was like being beat so hard all over, fever and night sweats, sweaty and cold really bad, could not sleep, was really tired, started feeling most of these last night, reporter still felt bad this morning. Took Children's Tylenol because her fever was going up, also taken some Aleve. Did not have a fever right now, but she felt super cold and sweaty, fever went down and was unable to move. Therapeutic measures taken as a result of the events included Children's Tylenol (Children's Tylenol liquid acetaminophen. Confirmed the brand name. Strength 160mg/5ml, Lot: SFM002, Expiry May2022) because her fever was going up. She also took some Aleve. No AE(s) required a visit to: Emergency Room, physician Office. The outcome of the events of headache and fever was recovering, the outcome of rest of the events was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: VITAMIN D [COLECALCIFEROL]; HYDROCODONE

Current Illness:

ID: 1773910
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/09/2021
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: Headache; chills; fatigue; fever; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache, chills, fatigue, fever. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected

Other Meds:

Current Illness:

ID: 1773911
Sex: U
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 10/09/2021
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: Dizziness; nausea; body aches; fever; This is a spontaneous report from a contactable consumer (patient) via Pfizer sales representative. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot Number: not reported, Expiration Date: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history included seasonal allergy. The patient concomitant medications were not reported. The patient experienced dizziness, nausea, body aches, fever on an unspecified date. The outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1773912
Sex: F
Age:
State:

Vax Date: 03/22/2021
Onset Date: 03/23/2021
Rec V Date: 10/09/2021
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: Test Date: 20210323; Test Name: Body temperature; Result Unstructured Data: Test Result:98.2 Fahrenheit; Test Date: 20210323; Test Name: Body temperature; Result Unstructured Data: Test Result:101.1 Fahrenheit

Allergies:

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

Symptoms: a bad headache; a fever of 101.1; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 22Mar2021 (at the age of 47-years-old) as dose 2, single for COVID-19 immunization. Medical history included hypothyroidism and mood disorder. The patient was in excellent health. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism; bupropion taken for mood disorder. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced a bad headache and a fever of 101.1 on 23Mar2021. It was reported that headache lasted for 24 hours. The fever gradually fell throughout the day and returned to normal 98.2 by 6 p.m. Outcome of events was resolved on 24Mar2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: SYNTHROID; BUPROPION

Current Illness:

ID: 1773913
Sex: F
Age:
State: NV

Vax Date: 02/24/2021
Onset Date:
Rec V Date: 10/09/2021
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: I just have a tiny bruise; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown) via an unspecified route of administration on 24Feb2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, patient reported that When they got it they did not have any soreness in our arm. She just had a tiny bruise on an unspecified date in 2021, but her husband got the bunch of side effects and that was a day later. Patient enquired do they need to continue that shot as her husband didn't want to take that shot. They cancelled the shot as they do not want to continue because we do not want that to happen again. Outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1773914
Sex: M
Age:
State: MD

Vax Date: 03/23/2021
Onset Date: 03/24/2021
Rec V Date: 10/09/2021
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: he woke up soaking wet; really bad chills with second dose; muscle aches with second dose; joint pain with second dose; throwing up with second dose; felt way hot with second shot; must have broken a fever; dehydrated; he is just a little lightheaded and feels like he was thrown down a flight of stairs; This is a spontaneous report from a contactable consumer(patient). A 68-year-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 23Mar2021 14:30 (at the age of 68 years) as single dose for COVID-19 immunization. Medical history included ongoing type 2 diabetes he was diagnosed almost 30 years ago. Concomitant medications included insulin degludec (TRESIBA) taken for diabetes mellitus from 2015 and ongoing; semaglutide (OZEMPIC) taken for diabetes mellitus from an unspecified start date and ongoing; dapagliflozin propanediol monohydrate (FARXIGA). Historical Vaccine included black plague shots a long time ago the black plague shots, states it kicked the hell out of him, had a lowgrade case of the black plague and it made him feel pretty miserable. He got it overseas, when he went out of Country. It was so long ago, over 15 years ago. Previously patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number EN6198) via unspecified on 02Mar2021 as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient states he is not sure if it's ENG or EN6. Patient states that after his first shot he felt pretty good, it didn't bother him, felt like mild tetanus and a stiff arm for a couple of hours. Ache in his arm with the first dose, patient confirms started the day after he got the first dose, but only lasted a few hours. Patient clarifies his muscles aches recovered 80-90%, states it is fading away, it is more like he is just worn out. Patient states that his hips were aching, but that is gone now. On 24Mar2021 03:00 the patient experienced really bad chills with second dose, muscle aches with second dose, joint pain with second dose, throwing up with second dose, felt way hot with second shot, must have broken a fever, he woke up soaking wet on 24Mar2021 07:00, dehydrated, he is just a little lightheaded and feels like he was thrown down a flight of stairs. It was reported that Caller states he had the second dose of the Pfizer COVID vaccine yesterday 23Mar2021 at 2:30 pm and states that after his first shot he felt pretty good, it didn't bother him, felt like mild tetanus and a stiff arm for a couple of hours. Caller states he woke up at 3 am 24Mar2021 with really bad chills, muscle aches, joint pain, throwing up, but not productive, just stomach bile, and caller got the chills and then felt way hot, and he must have broken a fever as he woke up soaking wet at 7 am. Caller states he threw up again but no more chills at 12 pm and the last time he threw up was at 3 pm and states it was his throw up was a yellow bile at that time. Caller states that he feels very dehydrated and wants to drink Gatorade to bring electrolytes back up. Caller wants to know how long this will last and if he can start taking Tylenol and would like to drink Gatorade but wants to know if he can after he talks to us. Caller wants to know what the normal course of this was, asks if it was 12 hours or 24 hours. Caller states that the last time he threw up was about 24 hours after receiving the second dose of the vaccine. Caller states that he feels a little bit better now, he is just a little lightheaded and feels like he was thrown down a flight of stairs. The outcome of the events was really bad chills with second dose was recovered on unspecified date, joint pain with second dose was recovered on 24Mar2021, felt way hot with second shot recovered on unspecified date. Muscle aches with second dose, throwing up with second dose recovering. must have broken a fever, he woke up soaking wet, dehydrated, he is just a little lightheaded and feels like he was thrown down a flight of stairs outcome of the events unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Other Meds: TRESIBA; OZEMPIC; FARXIGA

Current Illness: Type 2 diabetes mellitus (Caller states he was diagnosed almost 30 years ago.)

ID: 1773915
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/09/2021
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: tongue swelling; sore arm; dehydration; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer Sales Representative. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that after receiving the first dose of the Pfizer COVID-19 vaccine, she had tongue swelling, dehydration for approximately 45 minutes, and a sore arm. Patient reported being fine after this. 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: 1773916
Sex: F
Age:
State: NY

Vax Date: 03/23/2021
Onset Date: 03/25/2021
Rec V Date: 10/09/2021
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: Test Name: temperature; Result Unstructured Data: Test Result:seems to be fine

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Headache; Low grade fever; Vomiting; Tremors; This is a spontaneous report from a contactable consumer or other non hcp (Patient mother). A 22-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8727), via an unspecified route of administration on 23Mar2021 (Age at vaccination: 22-years-old) as unknown dose single for covid-19 immunization. The patient medical history was not reported. Concomitant medication included thioridazine (THIORIDAZINE), omeprazole (OMEPRAZOLE), propranolol (PROPRANOLOL), folic acid (FOLIC ACID), methotrexate (METHOTREXATE), ethinylestradiol, ferrous fumarate, norethisterone (KAITLIB FE), aripiprazole (ARIPIPRAZOLE), escitalopram oxalate (ESCITALOPRAM [ESCITALOPRAM OXALATE]), adalimumab (HUMIRA) all taken for an unspecified indication, start and stop date were not reported. It was reported as 25Mar2021 morning patient had a reaction from the Pfizer vaccine she was vaccinated on Tuesday afternoon. she had a headache, low grade fever, vomiting and tremors. Patient received treatment for the events with Tylenol. The patient underwent lab tests and procedures which included body temperature: seems to be fine. The outcome for the events was reported as resolved on 25Mar2021. No follow-up attempts are possible. No further information is expected.

Other Meds: THIORIDAZINE; OMEPRAZOLE; PROPRANOLOL; FOLIC ACID; METHOTREXATE; KAITLIB FE; ARIPIPRAZOLE; ESCITALOPRAM [ESCITALOPRAM OXALATE]; HUMIRA

Current Illness:

ID: 1773917
Sex: F
Age:
State: CT

Vax Date: 03/02/2021
Onset Date: 03/18/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:fever maybe a degree

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: slight chills; fever, maybe a degree; Muscle ache; Joint ache; she ached all over; Headache; Nausea; she sleeping around the clock. She would wake up and fall back asleep; felt tired/Exhaustion; This is a spontaneous report from a contactable nurse (Patient). A 77-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6200, expiration date: not reported) via an unspecified route of administration, administered in left arm on 02Mar2021 at 09:15 (at the age of 77-years-old) as dose 2, single for covid-19 immunization. Medical history included Chronic Lyme disease, she got it again in 2018 she thinks, she had it in 2017. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE; Lot Number: EL9264, expiry date: not reported), via an unspecified route of administration on unspecified date (at the age of 77-years-old) as a single dose for COVID-19 immunization and she takes a flu vaccine every and it's fine. Concomitant medication(s) included ibuprofen (IBUPROFEN) taken for chronic lime disease, start and stop date were not reported. On 18Mar2021, patient experienced slight chills, fever, maybe a degree, muscle ache, joint ache, exhaustion, headache, nausea, she sleeping around the clock. she would wake up and fall back asleep and felt tired. Patient took ibuprofen for events chills and fever maybe a degree. On 18Mar2021, patient underwent lab tests and procedures which included body temperature resulted fever maybe a degree. At the time of reporting, the outcome of the events were unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: IBUPROFEN

Current Illness:

ID: 1773918
Sex: F
Age:
State: MT

Vax Date: 03/24/2021
Onset Date: 03/01/2021
Rec V Date: 10/09/2021
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: Test Date: 20210309; Test Name: Covid-19; Test Result: Positive

Allergies:

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

Symptoms: left arm on 25Mar big red spot abd bruise abd hot; left arm on 25Mar big red spot abd bruise abd hot; left arm on 25Mar big red spot abd bruise abd hot; Arm Swelling Reaction; left arm got a large round rash; very painful; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6207, Expiry date: Jul2021) intramuscularly administered in Arm Left on 24Mar2021 15:45, as dose 2, single (at the age of 60-years-old) for COVID-19 immunization. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6203, Expiry date: Jun2021) via Intramuscularly administered in Arm Left on 03Mar2021 15:00 for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included diabetes mellitus, pre-diabetes and hypertension from an unknown date and unknown if ongoing, COVID-19 from 09Mar2021 taken to physician office patient was treated with inhaler Albuterol, patient recovered on 04Apr2021. Concomitant medications included acyclovir sodium (ACYCLOVIR SODIUM) taken for an unspecified indication, start and stop date were not reported; dulaglutide (TRULICITY) taken for Pre-Diabetes from an unspecified start date and ongoing; hctz (HCTZ) taken orally for High Blood Pressure from an unspecified start date and ongoing; lisinopril (LISINOPRIL) taken orally from an unspecified indication from an unspecified start date and ongoing; levothyroxine sodium (SYNTHROID) taken orally from an unspecified indication from an unspecified start date and ongoing. On 24Mar2021 the Patient experienced arm swelling reaction. On 25Mar2021, the patient experienced left arm on 25mar big red spot abd bruise abd hot. On unspecified date in Mar2021 patient experienced left arm got a large round rash, very painful. The patient went to physician office for the events arm swelling reaction, left arm on 25mar big red spot abd bruise abd hot and it was unknown if treatment was received for these events. It took 4-5 days to diminish. The patient underwent lab tests and procedures which included sars-cov-1 test: positive on 09Mar2021. Patient didn't receive any treatment for event arm swelling reaction. The outcome for arm swelling reaction was recovered on unspecified date of Mar2021, for left arm on 25mar big red spot abd bruise abd hot, left arm got a large round rash, very painful was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds: ACYCLOVIR SODIUM; TRULICITY; HCTZ; LISINOPRIL; SYNTHROID

Current Illness: COVID-19 (Physician Office, Recovered, Treatment: Inhaler Albuterol)

ID: 1773919
Sex: F
Age:
State: CA

Vax Date: 03/01/2021
Onset Date: 03/02/2021
Rec V Date: 10/09/2021
Hospital: Y

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

Lab Data: Test Date: 20210319; Test Name: Thoracentesis; Result Unstructured Data: Test Result:see additional context; Test Date: 20210318; Test Name: Chest X-ray; Result Unstructured Data: Test Result:pleural effusion; Test Date: 20210322; Test Name: CT scans; Result Unstructured Data: Test Result:see additional context; Test Date: 20210323; Test Name: Brain MRI; Result Unstructured Data: Test Result:see additional context

Allergies:

Symptom List: Nausea

Symptoms: Pleural effusion; Possible progression of her lung cancer/ new brain cancer; Stroke; Anxiety; Stress urinary incontinence; Enlarged lymph node; She had a little cough, it started to get a little worse; Could not take a deep breath and could not expand ribcage because there was immense pain; Pain in the right side under the ribcage muscle in the serratus anterior muscleshe thought she cracked her ribs; This is a spontaneous report from a contactable physician (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right deltoid (arm) on 01Mar2021 (at the age of 39-year-old) (Lot Number: EN6201) as dose 2, single for COVID-19 immunization. Medical history included dyslipidemia due to taking LORBRENA, hypertension from 2007, lung cancer from 03Jul2017 and metastatic disease from lung cancer from Dec2018, all ongoing. Concomitant medication(s) included losartan taken for hypertension from an unspecified start date and ongoing; atorvastatin taken for blood cholesterol from an unspecified start date and ongoing; lorlatinib (LORBRENA) taken for lung neoplasm malignant from 26Jun2019 and ongoing; vitamin D 3 taken for an unspecified indication from an unspecified start date and ongoing; ubidecarenone, vitamin e nos (COQ10 COMPLEX) taken for an unspecified indication from an unspecified start date and ongoing. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left deltoid (arm) on 08Feb2021 14:25 (at the age of 39-year-old) (Lot Number: EN6201) as dose 1, single for COVID-19 immunization and experienced bone pain and muscle pain. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. The patient reported possible progression of her lung cancer. The patient stated that stated that there was severe pain after the second dose which started with a little cough, which progressively got worse. The patient had pain so bad that she thought she cracked her ribs. On 02Mar2021, patient had pain in the right side under the ribcage muscle in the serratus anterior muscle. On 06Mar2021, the patient could not take a deep breath and could not expand ribcage because there was immense pain. Patient stated she took some CBD and went to sleep and this lasted about 2 days and after that it got a little better. Patient stated it was improved but had slight lasting effects. The patient reported the whole next week the cough got worse, stated it was so bad and it was productive. She stated that by Thursday 11Mar2021, she started to have massive pain that started in the serratus anterior muscle, under her arm pit and around the rib cage. Patient stated that then over the weekend it precipitated towards extreme bone and muscle pain spanning over left upper torso and pain got so bad she thought she cracked her ribs and this lasted for 3 weeks. The patient's cough got worse and it was productive, had stress urinary incontinence. On 13Mar2021, patient had enlarged lymph node. On 18Mar2021, patient had a chest x-ray and it showed pleural effusion and fluid in her pleural space around her lungs. The patient had a thoracentesis 19Mar2021 to drain the fluid and they tested it and it was confirmed as cancer. The patient stated that it seemed to her there was a correlation with getting the COVID vaccine. The patient said that she knows that the immune system has to work very hard to combat COVID and she was wondering if it made her immune system fail and go haywire and wondering if it perpetrated, and stated if the immune system could have dealt with both. On 22Mar2021, the patient got CT scans which showed progression in her body and stated the pleural effusion had been drained and was less, but was still present. The patient reported thoracentesis caused her anxiety. On 23Mar2021, patient stated she felt weird and had neurological symptoms and thought she had a stroke or something because she has had that in the past. The patient was discharged on night of 24Mar2021. The patient received treatment with oral steroids. The outcome of the events was unknown. The patient said that it was all related to her lung cancer. On the same day, patient got hospitalized for getting more imaging. It was reported that new brain cancer was found and patient stated that all this was new worsening disease. The patient further stated that it her a little nervous all the side effects after she got it. The patient reported that she did not believe urinary incontinence was caused by the COVID 19 vaccine, she has had it for years. The patient stated that bone pain, not being able to take a deep breath, muscle pain, lymph node were in conjunction with the timing of the vaccine. The patient stated that anxiety was only in relation to psychological symptoms due to the stroke situation. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events Pleural effusion, Lung cancer metastatic, Cerebrovascular accident and suspect drug BNT162B2 cannot be completely 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: LOSARTAN; ATORVASTATIN; LORBRENA; VITAMIN D3; COQ10 COMPLEX

Current Illness: Hypertension (Verbatim: Hypertension); Lung cancer (Verbatim: Lung cancer); Metastatic disease (Verbatim: metastatic disease from lung cancer)

ID: 1773920
Sex: F
Age:
State: TN

Vax Date: 03/17/2021
Onset Date: 03/17/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Date: 20210121; Test Name: COVID-19; Result Unstructured Data: Test Result:Positive

Allergies:

Symptom List: Injection site pain

Symptoms: Muscle weakness/Tingling, weakness, and heaviness in my left arm and hand; Tingling in face and body/Tingling in my left arm and hand/Tingling and clinching in my jaw (both).; chills; some shortness of breath; some confusion; fatigue; heaviness in my left arm and hand.; clinching in my jaw (both); This is a spontaneous report from a contactable other healthcare professional (patient). A 46-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: ER2613, expiration date was not reported) via an unspecified route of administration, in left arm, on 17Mar2021 08:00 (at the age of 46-years-old), at dose 1, single for covid-19 immunization from hospital. Medical history included covid-19 on 21Jan2021 and continued with some long-haul symptoms since diagnosis (shortness of breath), acid reflux and constipation. Concomitant medications included azithromycin (Z-PAK); hydroxyzine hydrochloride (VISTARIL); fexofenadine hydrochloride (ALLEGRA); lansoprazole (PREVACID); bupropion hydrochloride (WELLBUTRIN); xylometazoline hydrochloride (NASAL SPRAY II). The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 since the vaccination. The patient experienced muscle weakness/weakness in left arm and hand, tingling in face and body/tingling in left arm and hand/tingling and clinching in jaw (both), chills, some shortness of breath, some confusion, fatigue and heaviness in left arm and hand on 17Mar2021 08:30. The reporter assessed the case as non-serious. No treatment was received for the events. The patient underwent lab tests and procedures which included covid-19: positive on 21Jan2021. The outcome of the events was recovering. Follow-up #1 (27Mar2021): New information received from the same contactable other healthcare professional (patient) which includes: medical history details (shortness of breath, onset date for covid-19), concomitant drug details (Prevacid), reaction data (muscle weakness, some shortness of breath) No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: Z-PAK; VISTARIL [HYDROXYZINE HYDROCHLORIDE]; ALLEGRA; PREVACID; WELLBUTRIN; NASAL SPRAY II

Current Illness:

ID: 1773921
Sex: F
Age:
State: FL

Vax Date: 03/23/2021
Onset Date: 03/24/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Name: Height; Result Unstructured Data: Test Result:shrunk another inch; Comments: her height has shrunk another inch or so and she used to be at least 5'0'' and the elderly shrink.; Test Name: weight; Result Unstructured Data: Test Result:fluctuates above or below a little bit down; Comments: her weight fluctuates above or below a little bit down from 100 pounds and she does not regularly weigh herself

Allergies:

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

Symptoms: injection site pain; muscle pain; redness at the injection site; tiredness and that was much more than she had with the 1st dose; headache; nausea; weakness; feeling of unwell; joint pain/a lot of burning and a lot of pain in the joint in there and has been having a lot of pain there; chills; feeling cold and hot off and on; she has aches and pains and the pain is mostly her upper back and pain in her ankles, legs, neck; pain in her ankles, legs; pain in neck; below the finger there is a lot of burning; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EP7534 and expiration date not reported), via an unspecified route of administration, administered in Arm Left on 23Mar2021 (at the age of 82-year-old), as dose 2, single, for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6198 and expiration date not reported), via an unspecified route of administration, administered in Arm Left on 02Mar2021 (at the age of 82-year-old), as dose 1, single, for COVID-19 immunisation and experienced muscle pain, tired, sick and achy. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. On 24Mar2021, the patient had injection site pain, tiredness, had muscle pain, and had redness at the injection site. The patient did not put on ice it. She noticed an uneven kind of redness around the injection site. The patient woke up at 2:30am or 3:00am and had no pain in her arm and had the worst headache in her life and she took Advil (expiry date she remembers was 02Nov2021). The patient wasn't sure if she was taking too many Advil, 6 pills of it per day. Took Advil every 4-6 hours as soon as she had severe headache. The patient experienced some nausea, a lot of weakness and just generally feeling of unwell. The patient does not know if she had a fever, because all her life she has not had a fever. The patient had joint pain especially in her left hand and her index finger, below the finger there was a lot of burning and a lot of pain in the joint, had chills and the chills started a little bit and went away and kept feeling cold and hot off and on. The patient experienced aches and pains and the pain was mostly her upper back and pain in her ankles, legs, neck, and her headache. It was reported that, due to her age, her height has shrunk another inch or so and she used to be at least 5'0'' and the elderly shrink; her weight fluctuates above or below a little bit down from 100 pounds and she does not regularly weigh herself but when she goes to the health care professional, she tries to stay very healthy and eats healthy. Did not visit to ER or MD office and she did not feel like the events were severe and they were bad but not to go to the hospital. No relevant tests done. It was reported that, Advil was upsetting her stomach because she was not used to taking it and never takes it. The patient asked if she should keep taking Advil every 4-6 hours if she starts having the headache and she wants to take Advil pills right away or her headache flared up so bad that she was in tears and was crying. The patient stated that, tiredness and aches and pains will go once she starts moving and exercising a little bit. The outcome of chills was recovered while the outcome of other events was unknown. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1773922
Sex: F
Age:
State: WI

Vax Date:
Onset Date:
Rec V Date: 10/09/2021
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: Sore arm; nausea; body aches; Chills; fever; headache; This is a spontaneous report received from a contactable consumer or other non HCP. A 33-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm, nausea, body aches, chills, fever, headache on an unspecified date. The clinical outcome of the event was unknown. No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1773923
Sex: F
Age:
State:

Vax Date: 03/03/2021
Onset Date: 03/01/2021
Rec V Date: 10/09/2021
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: Achy Joints; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old female patient received BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6204), via an unspecified route of administration on 03Mar2021 11:00 (at the age of 40-years-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing hypothalesemia, asthma and allergy to Percocet. Concomitant medications included cetirizine hydrochloride (ZYRTEC), beclometasone dipropionate (QVAR) and lorazepam (ATIVAN). The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced achy joints in Mar2021. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for this event. The clinical outcome of achy joints was recovered in Mar2021. No follow-up attempts are possible. No further information is expected.

Other Meds: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; QVAR; ATIVAN

Current Illness:

ID: 1773924
Sex: F
Age:
State:

Vax Date:
Onset Date: 03/24/2021
Rec V Date: 10/09/2021
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: rash on neck area/itching; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the Covid-19 vaccine on Saturday morning and noticed the day prior (24Mar2021) that she has a rash on the neck area where the throat is and travelling up to Adam's apple, it's a pretty good size rash. The patient applied Benadryl gel on it for the itching as it was unbearable. The patient stated she is a senior and she has a healthcare person who comes in to care for her. The patient then asked what she should do. The outcome of the event was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1773925
Sex: F
Age:
State: OH

Vax Date: 03/26/2021
Onset Date: 03/26/2021
Rec V Date: 10/09/2021
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: underneath her armpit but towards the front of her torso, she has developed a huge painful lump; She states it hurts to touch it; Flu like symptoms; joints were hurting; Headache; Very Tired; nauseated; Flushed; it was hurting under her arm; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: ER8727, Expiry date: 31Jul2021), via an unspecified route in the left arm on 26Mar2021 at 08:30 (age at vaccination: 70-year-old), as a single dose for covid-19 immunization. Medical history included that she has ongoing issues, but nothing related. The patient concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 05Mar2021 as a single dose for covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Mar2021 evening, patient noticed it was hurting under her arm. She did not look at it actually that next morning. She couldn't even lie on that side, and the next morning she looked in the mirror and noticed the lump just under the skin. On the side of patient, underneath her armpit but towards the front of her torso, she has developed a huge painful lump. She states it hurts to touch it. She says you know how that muscle goes well above the rib cage not under the armpit, but next to the armpit, if her arm is down its right next to her arm at the top of it. Her joints were hurting/achy, and she knew what to expect. She had flu like symptoms, headache and what not. She states that she got the covid vaccine early in the morning and then a couple hours after the vaccine she started to feel the symptoms. Her arm feels a little weird where they gave her the shot and she have a lump but other than that she feels fine. It was basically only two days, it started on the 26Mar2021 a couple hours after the vaccine and it was the worst on Saturday 27Mar2021, and then she was fine by Sunday, 28Mar2021. She felt very tired, nauseated and flushed. She expected to feel that way. She confirms that everything started on the 26Mar2021 after the shot, a couple hours, and on 27Mar2021 everything was worse and then 28Mar2021 everything was better except for the lump. She states that no treatment was sought after. She states that the is grateful to be able to get the vaccine and she doesn't want to become ill and die and because that she hasn't left home for a year and her daughter is having a baby and she wants to be able to see the baby. She doesn't want to spread the virus to anyone else. Patient wanted to know if Pfizer has a recommended time between her second covid vaccine shot and getting a vaccine shot for shingles. The clinical outcome of huge painful lump, arm feels a little weird was not recovered/not resolved and hurting under her arm, flu like symptoms, aching joints, headache, very tired, nauseated, flushed was recovered on 28Mar2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1773926
Sex: F
Age:
State:

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 10/09/2021
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: from 7-14 days after the first shot, she developed a small rash (irritated rash) on her neck and arm which has since resolved and recently a cough like a cold.; from 7-14 days after the first shot, she developed a small rash (irritated rash) on her neck and arm which has since resolved and recently a cough like a cold.; from 7-14 days after the first shot, she developed a small rash (irritated rash) on her neck and arm which has since resolved and recently a cough like a cold.; This is spontaneous report from a contactable consumer (patient). A 65-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history included respiratory problems from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. On unspecified date, the patient took first dose of Pfizer COVID vaccine about 3 weeks ago and had no problems afterwards but states anywhere from 7-14 days after the first shot, she developed a small rash (irritated rash) on her neck and arm which has since resolved and recently a cough like a cold. Patient states she applied antiitch topically to her rash. States she was due for her second shot today. States she read that if she experienced a rash then she shouldn't get the second shot. The outcome of events was unknown. No follow-up attempts are completed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1773927
Sex: M
Age:
State: NH

Vax Date: 03/20/2021
Onset Date: 03/24/2021
Rec V Date: 10/09/2021
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: rash developed in left armpit.Rash stayed predominantly in arm pit, but a few spots on upper arm and chest over the next couple days; This is a spontaneous report from a contactable consumer. A 56-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 20Mar2021 08:30 as (at the age of 56 years old) dose 1, single for covid-19 immunization. Medical history included tongue cancer metastatic from 2017 to 2017 (diagnosed/treated 2017), spleen disorder from 2017 to 2017 spleen removed. The patient's concomitant medications were not reported. The patient had not received any other vaccine within 4 weeks. It was reported unknown if patient taken any medication 2 weeks prior to vaccination. Patient had no known allergies. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 24Mar2021 four days after vaccine the patient experienced rash developed in left armpit, rash stayed predominantly in arm pit, but a few spots on upper arm and chest over the next couple days. Upon follow-up (01Apr2021) it was questioned to confirm awareness date that reporter became aware of the adverse events in this report as this effects regulatory reporting timelines for report # Submitted on 29Mar2021. This awareness date is the date reporter became aware of the occurrence of the reported events. It was reported that, if you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events was 29Mar2021 as per the response. Therapeutic measures were taken as a result of rash developed in left armpit, rash stayed predominantly in arm pit, but a few spots on upper arm and chest over the next couple days included with Steroids-oral & topical. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered. Follow-up (01Apr2021): This is a follow-up spontaneous report in response to mail trail sent regarding the confirmation of below mentioned query. This report included that: Awareness date confirmed. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1773928
Sex: F
Age:
State: FL

Vax Date: 03/27/2021
Onset Date: 03/28/2021
Rec V Date: 10/09/2021
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: Caller states she started having "a headache, chills that started last night at 11pm, I am also tired and weak."; Caller states she started having "a headache, chills that started last night at 11pm, I am also tired and weak."; Caller states she started having "a headache, chills that started last night at 11pm, I am also tired and weak."; she has a flu; eyeballs hurt; her joints and muscles hurt; her joints and muscles hurt; she had no energy/ I am also tired and weak."; She was cold around 11:something pm; This is a spontaneous report received from contactable consumer. A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6298) via intramuscular, administered in Arm Left on 27Mar2021 11:00 (age at vaccination 63-years-old) as dose 1, single for covid-19 immunisation. Medical history included lupus-like syndrome from 2008 to an unknown date and it is in remission now, ongoing kidney diseases maybe from 2 year ago or 3 years ago, deteriorated discs in the neck and the back from 2010 and ongoing. The patient concomitant medications were not reported. On 28Mar2021 23:00, patient stated that she started having a headache, chills that started last night at 11pm, I am also tired and weak, she has a flu, eyeballs hurt, her joints and muscles hurt, she had no energy/ I am also tired and weak. She was cold around 11 something pm. She was weak, she had no energy at all. Reporter asked are these normal side effects of the vaccine. No treatment was received. No other vaccine was received prior to vaccination with in four weeks. No ae prior to vaccination. she does not even get the flu shot. Outcome of the event cold was unknown and other events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness: Back discomfort (Verbatim: deteriorated discs in the neck and the back); Kidney infection (maybe 2 year ago or 3 years ago)

ID: 1773929
Sex: F
Age:
State: NC

Vax Date: 03/25/2021
Onset Date: 03/25/2021
Rec V Date: 10/09/2021
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: Test Date: 20210325; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Pending; Comments: covid test type post vaccination= Nasal Swab, covid test date= 25Mar2021, covid test result= Pending

Allergies:

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

Symptoms: Saturday morning, I woke up with swollen lymph nodes Specifically my neck, and my armpit of the arm I had gotten the shot in.; At 2:30 a.m. on Friday, I woke up drenched in sweat, freezing cold, burning hot, feeling like I was going to crawl out of my skin.; At 2:30 a.m. on Friday, I woke up drenched in sweat, freezing cold, burning hot, feeling like I was going to crawl out of my skin.; At 2:30 a.m. on Friday, I woke up drenched in sweat, freezing cold, burning hot, feeling like I was going to crawl out of my skin.; At 2:30 a.m. on Friday, I woke up drenched in sweat, freezing cold, burning hot, feeling like I was going to crawl out of my skin.; My entire body HURT SO BAD. My head was pounding. I was running a low grade fever.; My entire body HURT SO BAD. My head was pounding. I was running a low grade fever.; All next day (Friday) I had flu-like symptoms. Fever, chills, body aches, tired, dizziness, headache, diarrhea, nausea; All next day (Friday) I had flu-like symptoms. Fever, chills, body aches, tired, dizziness, headache, diarrhea, nausea; All next day (Friday) I had flu-like symptoms. Fever, chills, body aches, tired, dizziness, headache, diarrhea, nausea; All next day (Friday) I had flu-like symptoms. Fever, chills, body aches, tired, dizziness, headache, diarrhea, nausea; All next day (Friday) I had flu-like symptoms. Fever, chills, body aches, tired, dizziness, headache, diarrhea, nausea; All next day (Friday) I had flu-like symptoms. Fever, chills, body aches, tired, dizziness, headache, diarrhea, nausea; After my second shot at 11:30 a.m. on a Thursday, I had a headache all afternoon and was tired.; After my second shot at 11:30 a.m. on a Thursday, I had a headache all afternoon and was tired.; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 25Mar2021 11:30 AM (Age at vaccination: 43 years), as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included idiopathic congenital growth hormone deficiency and known allergies to adhesives, sulpha drugs. Concomitant medications included somatropin (NORDITROPIN), alprazolam, and fluoxetine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 04Mar2021 at 11:30 AM (Age at vaccination: 43 years), as a single dose for COVID-19 immunization and after her first shot, she was tired, and her arm was sore. She had a mild headache. The patient did not receive any other vac-cine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was tested for COVID post vaccination. The patient reported that after her second shot on 25Mar2021 at 11:30 a.m. on a Thursday, she had a headache all afternoon and was tired. On 26Mar2021 at 2:30 a.m. on Friday, she woke up drenched in sweat, freezing cold, burning hot, feeling like she was going to crawl out of her skin. Her entire body hurt so bad. Her head was pounding. She was running a low grade fever. All next day (Friday) she had flu-like symptoms and fever, chills, body aches, tired, dizziness, headache, diarrhea, and nausea. She alternated ibuprofen and tylenol all day. On 27Mar2021, Saturday morning, she woke up with swollen lymph nodes. Specifically, her neck, and her armpit of the arm she had gotten the shot in. Naturally, she thought she had cancer and was going to die. Turns out other people had this armpit lymph node experience too. The patient did not receive any treatment for the events. The patient underwent lab test and procedure included COVID test (nasal swab) with pending result on 25Mar2021. Outcome of the events was recovering. No follow-up attempts are possible: Information about lot/batch number can-not be obtained.

Other Meds: NORDITROPIN; ALPRAZOLAM; FLUOXETINE

Current Illness:

ID: 1773930
Sex: M
Age:
State: IN

Vax Date:
Onset Date:
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Name: fever; Result Unstructured Data: Test Result:102.9 Fahrenheit

Allergies:

Symptom List: Pain in extremity

Symptoms: When he came home from work, he ran a fever of 102.9F.; This is a spontaneous report from a contactable consumer or other non hcp (parent). This consumer reported for a 30-year-male (Son) Patient. A 30-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced when he came home from work, he ran a fever of 102.9f. The patient underwent lab tests and procedures which included body temperature: 102.9 Fahrenheit on an unspecified date. The clinical outcome of the event was unknown at the time of vaccination. No follow-up attempts are possible, information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1773931
Sex: F
Age:
State:

Vax Date: 03/08/2021
Onset Date: 03/01/2021
Rec V Date: 10/09/2021
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: swollen gland in my neck; some tenderness in my neck glands but it was not swollen as much; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 08Mar2021 18:30 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, patient had her first dose on 08Mar2021 and a few hours later she had swollen gland in her neck on an unspecified date in Mar2021. The next morning when she woke up it was gone. However a couple of days ago she noticed some tenderness in her neck glands but it was not swollen as much. She was not sure if it was related to some yard work that she was doing and/or allergies. Consumer stated, she was calling to find out if it was okay to get her second vaccine because her glands were a little tender and swollen a little bit when she took the first shot. The outcome of both the events was unknown. No follow-up attempts are possible; Information about lot/batch number cannot been obtained.

Other Meds:

Current Illness:

ID: 1773932
Sex: F
Age:
State: PA

Vax Date: 03/22/2021
Onset Date: 03/01/2021
Rec V Date: 10/09/2021
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: she has experienced pain in her shoulder blades; she has experienced pain in her jaw; and has had a headache; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955; Expiration Date: 30Jun2021), via an unspecified route of administration on 22Mar2021 at the age of the 51-year-old as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On Mar2021 patient experienced pain in her shoulder blades, jaw, and has had a headache. Taking Advil helps the pain go away but it comes back. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1773933
Sex: M
Age:
State: NM

Vax Date: 03/05/2021
Onset Date: 03/05/2021
Rec V Date: 10/09/2021
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: he was sick for three days from the first vaccine; Still feels ill; Really sick to his stomach, he couldn't go to the bathroom, his stomach was all bloated and he lost his appetite; Really sick to his stomach, he couldn't go to the bathroom, his stomach was all bloated and he lost his appetite; Everything smelled like cigarette smoke and every he ate tasted nasty like stale cigarettes; Everything smelled like cigarette smoke and every he ate tasted nasty like stale cigarettes; Every joint in his body ached/joints ached all day; he felt like crap all day long; warm sensation; Headache with burning in his head/ his head was pounding; burning/bad burning sensation; Eyes were getting a burning sensation like someone was taking a blow torch to both eyes; every joint in his body ached, then on the third day it went to the organs in his stomach; really sick to his stomach; This is a spontaneous report from a contactable consumer, the patient. A 58-years-old male patient received bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number: EN6202) via an unspecified route of administration, in deltoid right on 05Mar2021 at 13:30 as dose 1, single (age at vaccination 58 years) for covid-19 immunisation . Medical history included diabetes mellitus from an unknown date in Mar2020 and ongoing , hiatal hernia from an unknown date in 1992 and ongoing , acid reflux from an unknown date in 1992 and ongoing, prostate, and he broke his collar bone 10 years ago. Concomitant medication(s) included metformin taken for diabetes mellitus he stated that he didn't have the bottles with him and that he had been taking it for a year, ongoing; omeprazole taken for acid reflux, he stated that he didn't have the bottles with him and that he has been taking it for 15 years, ongoing; tamsulosin taken for prostate, stated that he didn't have the bottles with him and that he had been taking it for 3-4 years. After his first shot, the first three days were like a fire storm through his body, states he doesn't know how many people get that with the first one. The patient stated that the headache and burning started shortly after he left, that he had a headache with burning in his head, his eyes were burning on 05Mar2021, then, every joint in his body ached on 06Mar2021, then on the third day it went to the organs in his stomach and made him really sick to his stomach on an unknown date in 2021. On 05Mar2021, he states that he sat down for 15 minutes and felt a warm sensation. He stated that he went home and within a couple of hours his head was pounding, and his eyes were getting a burning sensation like someone was taking a blow torch to both eyes, on 05Mar2021 and the next morning, on 06Mar2021 his head was still aching and he woke up and still bad burning sensation and still had a headache and his joints ached all day and he felt like crap all day long. He states that on Sunday when he woke up it was still lingering and he couldn't go to the bathroom, his stomach was all bloated and he lost his appetite on 07Mar2021. States that he tried to eat but everything smelled like cigarette smoke and every he ate tasted nasty on 07Mar2021. He stated that lingered until Monday and through Tuesday morning it lifted. He states that every now and then he will get a whiff of stale cigarette smoke. Stated he attributed it to the shot because it had never happened before, he had never smelled nasty cigarette smells in his house and every now and then he has a nasty smell in his sinuses. States he was feeling back to normal until last Friday. He states that it is like someone has been smoking in his house and nobody smokes in the house. Therapeutic measures were taken as a result of headache with burning in his head/ his head was pounding (headache). No additional vaccines were administered on same date of the pfizer suspect. No prior vaccinations were taken within 4 weeks. The patient stated that the was taking Excedrin for his headaches.There were no adverse events following prior vaccinations. The outcome of the events he was sick for three days from the first vaccine was not recovered; headache, eyes, every joint in his body ached were getting a burning sensation, his stomach was all bloated and he lost his appetite was recovered on 09Mar2021, of everything smelled like cigarette smoke was recovering, for every he ate tasted nasty like stale cigarettes was recovered on an unknown date in Mar2021 and for the rest was unknown. Description of Product Complaint: the patient was calling to report adverse events from the Covid Vaccine. Stated he was taking Excedrin for his headaches. He states that it helps some but not completely. No follow-up attempts are needed. No further information is expected.

Other Meds: METFORMIN; OMEPRAZOLE; TAMSULOSIN

Current Illness: Acid reflux (esophageal) (Acid reflux); Diabetes; Hiatal hernia

ID: 1773934
Sex: M
Age:
State:

Vax Date: 03/06/2021
Onset Date:
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Name: fever; Result Unstructured Data: Test Result:99 Fahrenheit

Allergies:

Symptom List: Vomiting

Symptoms: Dose 1 had only very mild symptoms (mild fever (99 F); Dose 1 had only very mild symptoms (injection site soreness day after); This is a spontaneous report from a non-contactable consumer (patient himself). A 60-years-old male patient received first dose of bnt162b2 (Solution injection; Batch/Lot Number: EN6208), via an unspecified route of administration, administered in Arm Left on 06Mar2021 at 01:15 (at the age of 60-years-old) as single dose for covid-19 immunisation. Medical history included moderate hypertension. Patient had no known allergies. The patient's concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with covid prior vaccination. Patient was not tested for covid post vaccination. Patient reported that he experienced only very mild symptoms of injection site soreness day after and mild fever (99 F) 4 days after dose 1. All the dose 1 symptoms resolved on their own without treatment. The patient underwent lab tests and procedures which included body temperature which was 99 fahrenheit. The outcome of the events was recovered on unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1773935
Sex: F
Age:
State: CA

Vax Date: 03/24/2021
Onset Date: 03/01/2021
Rec V Date: 10/09/2021
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: I developed hives on my elbow; Tired the next day; Soreness in arm; It has returned to both my arms and legs above the knee, and it is light red and it itches.; Chills; Disappear a bit then the area becomes light red or like dark pink; This is a spontaneous report from a contactable consumer or other non hcp. A 77-years-old female patient received (BNT162B2) PFIZER-BIONTECH COVID-19 VACCINE, dose 2 (Lot Number: ER8732 expiry date was unknown) via an unspecified route of administration on 24Mar2021 (at the age of 77-years-old) as dose 2 single for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing, glaucoma from an unknown date and unknown if ongoing. Concomitant Products (s) included levothyroxine sodium (SYNTHROID) taken for hypothyroidism, start and stop date were not reported; latanoprost (LATANOPROST) taken for glaucoma, start and stop date were not reported; Consumer stated, "she takes eye drops, they are Dorzolamide-Timolol, it does not say but she put 1 drop in each eye in morning and evening and Brimonidine-Tartrate Ophthalmic solution 0.2% (Units were not appropriately clarified, hence not captured in tab); dorzolamide hydrochloride, timolol maleate (TIMOLOL + DORZOLAMIDA ACTAVIS) taken for an unspecified indication, start and stop date were not reported. LOT# and expiration date (First dose): Consumer stated, "That was written on it, and it was really hard to read, it says Pfizer, then it looks like EN6205." Question: When you get side effects like these, does it mean the vaccine didn't work or is it working?. Response: Disclaimer provided. She asked is the vaccine working if she didn't have any side effects?. If a vaccine does not cause any side effects, to our knowledge, this is not related to the dose being less effective than what would be expected in a patient who did have side effects. Historical vaccine dose 1 BNT162B2 (LOT#: EN6205 expiry date was unknown) via unspecified route of administration on an unspecified date as dose 1 single for COID-19 immunisation. Consumer stated, she received her second Pfizer vaccine on 24Mar2021 Wednesday and yesterday at about noon she developed, it was like hives on her arms and leg and she took cotton pad and put some alcohol on it and wipe them because they itch, they maybe 3-4 hours they disappear but later in evening it came back worse and both her arms and her legs above her knees in the back are splotchy and it itches real bad it looks like a hive that after a while disappear a bit then the area becomes light red or like dark pink. When paraphrased the above concern, consumer stated, "So then about four days, she didn't have any symptoms after the first one and she didn't have any symptoms from the second one until 4 days later and she do not know if this was from the vaccine." Consumer added, "When she read the side effects, this was listed as one of them. She will give them a call right now and see what they have to say but it itches, and she have the chills too but she normally on the cold side and she have the chills, but it seems a little more severe now. Consumer stated, no treatment was given. Outcome of the events pain in extremity, fatigue, pruritus, chills, erythema was unknown, urticaria, was not recovered

Other Meds: SYNTHROID; LATANOPROST; BRIMONIDINE TARTRATE; TIMOLOL + DORZOLAMIDA ACTAVIS

Current Illness:

ID: 1773936
Sex: U
Age:
State: MI

Vax Date: 03/23/2021
Onset Date: 03/01/2021
Rec V Date: 10/09/2021
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: intense swelling in hands and feet making it difficult to walk/grasp; intense swelling in hands and feet making it difficult to walk/grasp; intense swelling in hands and feet making it difficult to walk/grasp; hives on legs/hives covered most all of body to include face and neck; mild fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3248; Expiration Date: Apr2021), via an unspecified route of administration on 23Mar2021 08:00 as dose 2, single for COVID-19 immunization. Medical history included ongoing Scalp disorder. Concomitant medication included ongoing topical steroid for scalp. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced mild fatigue and headache on an unspecified date in Mar2021, hives on legs/hives covered most all of body to include face and neck on 26Mar2021 and intense swelling in hands and feet making it difficult to walk/grasp on 27Mar2021. It was reported that morning of 26Mar2021, began to notice hives on legs. By end of day 26Mar2021, hives covered most all of body, went to urgent care, and began taking Benadryl to no effect. By morning 27Mar2021, hives covered all of body to include face and neck, intense swelling in hands and feet making it difficult to walk/grasp. Returned to urgent care, no life-threatening danger, received prescription strength antihistamine which helped reduce symptoms. Morning 29Mar2021, back to regular fatigue and mild swelling, no hives. Outcome of event mild fatigue was not resolved; Outcome headache was unknown. Event hives on legs/hives covered most all of body to include face and neck was resolved on 29Mar2021; intense swelling in hands and feet making it difficult to walk/grasp was resolving. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness: Scalp disorder

ID: 1773937
Sex: M
Age:
State: IL

Vax Date: 03/25/2021
Onset Date: 03/25/2021
Rec V Date: 10/09/2021
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: Test Date: 20210326; Test Name: Body temperature; Result Unstructured Data: Test Result:100.1-100.5

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Hedaches; Fever; General soreness and aching across entire body; A little soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 25Mar2021 at approximately 8:30 (at the age of 32-year-old) (Lot Number: EK5730) as dose 2, single for COVID-19 immunization. Medical history included high blood pressure. The patient's concomitant medications included lisinopril for unknown indication, start and stop date not provided. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 04Mar2021 (at the age of 32-year-old) (Lot Number: EJ1685) as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced besides a little soreness at injection site on Thursday 25Mar2021 and had hedaches, fever of 100.1-100.5, general soreness and aching across entire body (not just at site of injection) symptoms subsided after 36 hours on 26Mar2021 (reported as between 24 -36 hours after taking vaccination and between 8 to 9:30). The patient received treatment with ibuprofen (ADVIL) for fever. The outcome of event pain was recovered and the outcome of other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds: LISINOPRIL

Current Illness:

ID: 1773938
Sex: F
Age:
State: IL

Vax Date: 03/22/2021
Onset Date: 03/22/2021
Rec V Date: 10/09/2021
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: had my second Covid vaccination Pfizer 6 days ago in my left shoulder and my left shoulder is really hurting it, it's radiating into my scapula and having trouble slee; had my second Covid vaccination Pfizer 6 days ago in my left shoulder and my left shoulder is really hurting it, it's radiating into my scapula and having trouble slee; Weakness so bad she can hardly get out of bed and; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that. A female patient of an unspecified age received (BNT162B2, formulation: Solution for injection, Lot Number: EN6207), via an unspecified route of administration, administered in Arm Left on 22Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included High blood pressure from an unknown date and unknown if ongoing. Concomitant medications included lisinopril taken for blood pressure measurement, start and stop date were not reported. Historical vaccine included (BNT162B2, formulation: Solution for injection, Lot Number: EN6201), via an unspecified route of administration on 17Mar2021 as dose 1 single for covid-19 immunisation. It was reported stated she had her second Covid vaccination Pfizer 6 days ago in she left shoulder and she left shoulder is really hurting it, it's radiating into she scapula and having trouble sleeping, weakness so bad she can hardly get out of bed and go to the bathroom on 22Mar2021. She just wondered if there is something she could or should do about that. The clinical outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021329823 similar report from same reporter

Other Meds: LISINOPRIL

Current Illness:

ID: 1773939
Sex: F
Age:
State: KY

Vax Date: 02/26/2021
Onset Date: 03/14/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Name: Blood Pressure; Result Unstructured Data: Test Result:Elevated

Allergies:

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

Symptoms: Elevated blood pressure; shortness of breath; swelling in feet; aching joints; This is a spontaneous report from a contactable consumer. A 70-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EN6202), dose 1 via an unspecified route of administration, administered in Arm Right on 26Feb2021 08:30 as dose 1, single, dose 2 via an unspecified route of administration, administered in Arm Left on 19Mar2021 (Batch/Lot Number: EN6207) as dose 2, single for covid-19 immunisation (at the age of 70 years). Medical history included allergies from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Mar2021 05:00 PM patient experienced Elevated blood pressure, shortness of breath, swelling in feet, aching joints. When confirmed that the side effects happened with the first shot and confirmed the side effects from the second dose, consumer stated, I am having same problem except it's little worst. The patient was not received treatment. The adverse event result in any doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am