VAERS 2021 Database www.vaers.hhs.gov

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

Total Manufacturer
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: 1812477
Sex: F
Age:
State:

Vax Date: 04/19/2021
Onset Date: 04/21/2021
Rec V Date: 10/23/2021
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: the chapped/dryness is moving outside the lips and into nose area; it's getting worse; chapped/swollen lips; chapped/swollen lips; the gums on left side of mouth were tender/The tenderness in the gums; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 54-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8734, 8733), via an unspecified route of administration on 19Apr2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Two days after second dose on 21Apr2021 the patient experienced chapped/ swollen lips/ blown up lips, the gums on left side of mouth were tender. The tenderness in the gums had resolved but her lips were swollen, and the chapped/dryness was moving outside the lips and into nose area. She states it was getting worse and wanted to know if this had been reported before. The outcome of event tenderness in the gums was resolved on an unspecified date in 2021. For the rest of the events the outcome was not resolved. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812478
Sex: M
Age:
State: CA

Vax Date: 05/05/2021
Onset Date: 05/01/2021
Rec V Date: 10/23/2021
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: blisters; left leg right by, the upper side of his leg right next to, beside his parts, there is a muscle that is tender; little rash behind the knee cap on the upper side of his leg; red spots behind knee cap, upper side calf/dots on the joint before foot and leg/three little dots on top of the upper side of his foot where his leg bone meets his foot; redness; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0179, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 05May2021 11:40 (at the age of 56-year-old) as dose 2, single for COVID-19 immunization, at pharmacy. The patient medical history and concomitant medications were none. The patient had no family medical history relevant to adverse events. The patient stated "he takes no medications, does not drink". No investigation assessment was performed. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8729, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 07Apr2021 (at the age of 56-year-old) as dose 1, single for COVID-19 immunization. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. No adverse events following prior vaccinations. It was reported that, the patient received the second shot of Pfizer COVID Vaccine on 05May2021. He noticed on 07May2021 (Friday), some red spots behind knee cap, upper side calf and thought it was spider bite. The patient stated on 07May2021, he kind of developed a little rash behind the knee cap on the upper side of his leg. The patient stated it was on his "left leg right by, the upper side of his leg right next to, beside his parts, there is a muscle that is tender" and it started about the same time Friday (on 07May2021) and it was ongoing. It was like when he splits like when he was exercising and splits a little bit too much for too long. The patient confirmed it was persisting. Over the weekend, it got worse, and it became like blisters after 2 days or on 08May2021 (Sunday). The patient stated he did not know anything about the side effects other than rashes on his arm but to him it was already blisters and he thought maybe he got bitten by a spider. Monday night it got worse. He also noted that yesterday morning on 11May2021, he again noticed "dots on the joint before foot and leg /three little dots on top of the upper side of his foot where his leg bone meets his foot", its not really on his foot, just when it becomes your foot and that one got a little bit more red, more rash, but it had not expanded or anything. The patient reported it was on the upper side of his calf, left, the rash. It probably started Saturday and got bigger on Sunday. On an unspecified date in 2021 (maybe yesterday 11May2021), there was redness on the outside, like around it, and the redness kind of disappeared but the blisters turned a darker color with a little bit of redness on the side. On Sunday, it was pretty bad, the blisters and redness. On Monday, the redness around it, he would say a quarter inch around, it kind of disappeared. The redness beyond the affected area, its gone. The blisters turned a brownish dark color, it got better in the sense that there was no redness around it, the blisters itself. The patient was told not to pop them, it was just red around the blisters now. The patient tried to make a doctor's appointment on 10May2021 (Monday) and the next available appointment was today (on the day of reporting 12May2021) and he thought he could last that long but then on Tuesday (on 11May2021), he went to an urgent care and when he was talking to the doctor there at the urgent care, at the end of the conversation, she told him about the second shot, that is the only thing out of the norm for him. He stated the doctor said people had reported blisters on their fingers and toes and rash, so most likely that was what it was, and they were going to leave it alone. The patient stated the doctor did not do any treatment for the events. The doctor told patient not to touch the blisters, it might go away and if it got worse to come back to see her. The patient asked how long it would take to get better and how long will the rash/blisters would last, and what should he expect. The doctor did not give any guidance. The events resulted in emergency room and physician office visit. No relevant testes. The outcome of events blisters, redness, and little rash behind the knee cap on the upper side of his leg was reported as resolving. The outcome of event "left leg right by, the upper side of his leg right next to, beside his parts, there is a muscle that is tender" was reported as not resolved. The outcome of event "red spots behind knee cap, upper side calf/dots on the joint before foot and leg/three little dots on top of the upper side of his foot where his leg bone meets his foot" was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812479
Sex: F
Age:
State: NC

Vax Date: 02/04/2021
Onset Date:
Rec V Date: 10/23/2021
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: high blood pressure; confusion; memory loss; thyroid issues/ thyroid was out of wack.; fatigue; This is a spontaneous report from a contactable consumer (patient's husband) from a sponsored program. A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported) via an unspecified route of administration on 04Feb2021as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced high blood pressure, confusion, memory loss, thyroid issues/ her thyroid was out of wack and fatigue. Patient had been on medication for thyroid for more than 30 years now. Amlodipine for 1 week was taken for high blood pressure as a therapeutic measure. Patient received second dose of BNT162B2 on 25Feb2021 for COVID-19 immunisation. Outcome of high blood pressure was not recovered and rest all events was unknown at the time of reporting. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1812480
Sex: M
Age:
State: CA

Vax Date: 05/11/2021
Onset Date:
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies: Food allergy (peanut, egg and typically almonds)

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: This is a spontaneous report from a contactable consumer reported for patient (reporters' son). A 23-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), at the age of 23, via an unspecified route of administration, in left arm, on May 11, 2021, at 10:00, single dose, for COVID-19 immunisation. Medical history included allergy to peanut, egg and typically almonds from an unknown date and unknown if ongoing. The patient's concomitant medications not reported. The patient previously received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. On an unspecified date (a couple of hours after the patient got his second dose), patient experienced twitching in different parts of the body. Second shot was reaction was a little different than first shot. He noticed he got slight twitching here and there. He gets twitch here and there in his foot, his shin muscles and his arm. It was not a constant twitching the whole entire time, but it was definitely twitching. The twitching was intermittent going from 10 minutes to an hour. The twitching was still there but not as bad. The patient also developed a couple of rashes. It's actually a dot and happens differently on different part of his body. He also had itchy spots in different areas but was particularly concerned with the twitching. Therapeutic measures taken as a result of the events: Tylenol. The outcome of twitching: not resolved. The outcome of the other events: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 1812481
Sex: F
Age:
State: IL

Vax Date: 04/21/2021
Onset Date: 04/01/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: 2nd dose is due today but the technician and the pharmacist advised her not to take it as her experience might indicate mild anaphylaxis; stiff neck; both shoulders were stiff; in pain; eyes were red; swollen from her eyes extending to where her cheeks start; one eye had discharge; muscle pain; This is a follow-up spontaneous report received from a contactable consumer(patient). This female consumer (patient) reported for herself stating that. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported, expiry date: unknown) via an unspecified route of administration on 21Apr2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unspecific date in Apr2021the patient experienced stiff neck, both shoulders were stiff, in pain, eyes were red, swollen from her eyes extending to where her cheeks start, one eye had discharge and muscle pain. On an unspecified date, 2nd dose was due today but the technician and the pharmacist advised her not to take it as her experience might indicate mild anaphylaxis. It was reported that, patient didn't seek medical attention because she didn't think it was that bad. She went to the pharmacy to receive her second dose and the pharmacist and technician refused to give the second dose because they believed that her side effects may have been an anaphylactic reaction. She was advised to check first with her own physician about her symptoms. Stated she heard that the vaccine was 75% effective after the first dose. The patient had not received treatment for all the events. The outcome of the events stiff neck, both shoulders were stiff, and swollen from her eyes extending to where her cheeks start was recovering. The outcome of the event eyes were red, and one eye had discharge was recovered on unspecific date in Apr2021. The outcome of other events was unknown. No follow-up attempts are needed; information about lot/batch no. cannot be obtained.

Other Meds:

Current Illness:

ID: 1812482
Sex: M
Age:
State: TX

Vax Date: 02/21/2021
Onset Date:
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: arm got sore; This is a spontaneous report from a contactable nurse (wife). A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on 21Feb2021 as dose number 2, single for COVID-19 immunisation. Medical history included anemic from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Jan2021 as dose 1, single for COVID-19 immunisation and experienced rashes all over/ shingles/all red, vomiting, headache, stomach upset, looking really sickly and scar was a little bit deep and brown. The patient experienced his arm got sore on an unspecified date. 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: 1812483
Sex: F
Age:
State: NC

Vax Date: 05/10/2021
Onset Date: 05/11/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Name: temperature; Result Unstructured Data: Test Result:102.4; Test Name: temperature; Result Unstructured Data: Test Result:99.7

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: nausea; Shivering and Extreme Chills; shaking violently, teeth rattling; fever of 102.4 and she couldn't bring it down; Caller states she threw up violently 9 times; lost control of her bladder while sleeping twice; Severe Soreness; Headache; Muscle Aches; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0167), via an unspecified route of administration, administered in Arm Left on 10May2021 at 15:45 (at the age of 53-years-old) as dose 2, single for COVID-19 immunization. The patient medical history included ongoing hypothyroidism (Early 30s diagnosed. Runs in her family, grandmother had it. Genetic type, not complicated, normal thyroid doesn't release enough. Normal Uncomplicated). The patient's concomitant medications were not reported. Previously patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8736), via an unspecified route of administration, administered on 19Apr2021 as dose 1, single for COVID-19 immunisation. It was reported that on 11May2021 at 03:00, the patient experienced nausea, shivering, extreme chills. On 11May2021, fever of 102.4 and she couldn't bring it down, caller states she threw up violently 9 times, lost control of her bladder while sleeping twice, severe soreness, headache, muscle aches. Addition information provided as, patient was calling about the Covid 19 Vaccine, patient's second shot. Verified Pfizer. they day before yesterday patient had second dose. Patient wanted to report patient experience with the shot so it can be put in the database. patient used to work, so patient knows it was helpful. Patient had some unusual side effects. patient was a yoga instructor, athletic and healthy, with no underlying conditions that should've caused this at all. patient was patient in the age group that according to research, really shouldn't have such violent side effects given patient was 53, so that was another thing, patient didn't expect to have that. Patient couldn't find severe vomiting anywhere. Patient looked it up on the internet, even the CDC site, was listed nausea but not vomiting and loss of bladder during sleep. PCP as, patient almost went to the hospital due to the fever was not coming down but patient did not. Patient states if it would've continued longer than the 15 hours, patient probably would've went, due to the extreme reactions. this morning patient feels much better and patient goes to see doctor for patient annual on 24May2021 and patient will report this to patient as well so patient will be aware of what she recently went through because patient blood work may not be right. 12 hours after the shot, patient had the normal stuff, shivering, extreme chills, all of that normal stuff and by the 20th hour after the vaccine patient woke up and she had a fever of 102.4 and patient couldn't bring it down and patient kept administering Tylenol to bring the fever down. After 3hrs 32 min, patient brought it down to 101, and it took all day to get patient fever down to 99, still today it was 99.7, which she considers a low grade fever. Patient threw up violently 9 times yesterday, starting at the 12th hour after the vaccine all of the way until 4:00p.m. yesterday afternoon. Patient couldn't drink water or keep anything down. Caller states she lost control of her bladder while sleeping twice. Caller states she has no health problems and she is healthy, well except hypothyroidism but other than that no health problems. Caller states losing control of patient bladder was very scary and the violent throwing up, patient couldn't find anything online about those side effects. Patient side effects started at 03:00a.m. and patient received the vaccine at 15:45p.m. States the chills lasted an hour and the nausea and vomited started at 3:00a.m. until 4:00p.m. Nausea and Severe Vomiting AE as, patient threw up so violently, patient broke the capillaries under the skin in eyes, face, and neck. Patient was throwing up was water and foamy substance, patient was taking that was acid from stomach. Fever AE as, patient son took patient temperature and it was 102.4. Patient used ice and took more Tylenol and patient tried to quickly reduce the temperature. even with Tylenol, patient fever was still 99.7. Severe Soreness and Muscle Aches AE: The patient felt like, patient was on fire. Lost Control of Bladder AE as, It was happened twice while patient was sleeping. patient doesn't know if it was fever related. both times it was happened while patient was sleeping and patient wasn't taking any fluids in because patient was throwing up. The patient doesn't know what patient was voiding but patient does know that patient can have fluid in patient body and patient body was trying to get rid of everything. Headache AE as, the worse headache patient has every had. Headache was gone right now since the Tylenol was working. Caller states nothing would take it away no matter how much patient took last night. Patient doesn't know if it was a headache or the muscles seizing up. The patient was getting some fresh air and spending time with patient's dogs, a lab and cocker spaniel. The patient was bouncing the ball and able to play with them, which was a drastic improvement from yesterday. The patient was able to eat a piece of toast this morning, patient was not sure if patient will able to finish it all but patient did eat half of it. The patient had vaccine through UNC Hospital, and states patient got it 2 weeks apart. Call handler asked for confirmation that patient vaccines were two weeks apart or 3 weeks. Caller states patient thought it was two weeks and states maybe that was why patient felt so sick. The patient was guarding the vaccine guard because patient never wants to go through it again. The patient has birthed two children with no pain medication and patient was tough as nails, patient would never complain if it wasn't this bad. The patient was going to go get patient card to check the dates. Caller confirms the vaccines were given 21 days apart. Reporter states, that was right, the two weeks for after the vaccine, when patient will have full immunity. Therapeutic measures were taken as a result of fever of 102.4 and she couldn't bring it down, headache. On unspecified date, the patient underwent lab tests and procedures which included body temperature was 102.4. On unspecified date, body temperature: 99.7, The outcome of the events for nausea and severe vomiting, shivering and xtreme Chills; shaking violently, teeth rattling and lost control of bladder was recovered/resolved; for event fever of 102.4 and she couldn't bring it down, severe soreness, headache and muscle aches was recovering/ resolving. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness: Hypothyroidism

ID: 1812484
Sex: F
Age:
State: WA

Vax Date: 05/09/2021
Onset Date: 05/09/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: afterward, normal marginally sore arm; left armpit became tender and started hurting (there was no lymph-node type lump that could palpate; The injection site bled at the time of injection; This is a spontaneous report from a contactable consumer (patient). A 45-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 intramuscular, administered in Arm Left on 09May2021 13:30 (at the age of 45-years-old) (Batch/Lot Number: EW0182) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was none. Concomitant medication included multivitamin (within 2 weeks of vaccination). Patient had no allergies. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient previously took first dose of bnt162b2 (Lot number: EW0164) administered in Arm right on 18Apr2021 at 12:30PM (at the age of 45-years-old), Intramuscular for covid-19 immunisation. On 09May2021, the patient experienced the injection site bled at the time of injection, afterward, on 10May2021 16:00, normal marginally sore arm, around 24h after the injection and left armpit became tender and started hurting (there was no lymph-node type lump that could palpate). Patient received no treatment for the events. It was reported that the patient was not hospitalized. Seriousness of events were reported as non serious by the reporter. Outcome of events were recovering. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812485
Sex: F
Age:
State: FL

Vax Date: 03/06/2021
Onset Date: 03/01/2021
Rec V Date: 10/23/2021
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: 202102; Test Name: glucose level; Result Unstructured Data: Test Result:80's; Test Date: 20210510; Test Name: glucose level; Result Unstructured Data: Test Result:108; Test Date: 202102; Test Name: thyroid level; Result Unstructured Data: Test Result:2.0; Test Date: 20210510; Test Name: thyroid level; Result Unstructured Data: Test Result:6.2

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: The first dose caused a slight arthritis flare with the first shot; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6199, Expiry date: Unknown), via an unspecified route of administration, administered in left arm (reported as left upper arm) on 06Mar2021 (reported as in the afternoon) (at the age of 46-years-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing crohn's disease (had this for pretty much her whole life) and ongoing arthritis inflammatory (reported as this is related to the Crohns disease). Patient was allergic to several antibiotics: Tetracycline, Penicillin, Cipro, and Bactrim (this was 20+ years ago). Concomitant medications were not reported. The patient previously received flu vaccine and experienced a sore arm, and she even had the pneumonia vaccine 5 years ago with no issues. No history of any previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. It was reported that patient had blood work before the first dose and it was normal. Reported that the original lab works was done at the end of Feb2021. On an unspecified date in Mar2021, after first dose of vaccination, patient experienced slight arthritis flare. Reported that, It was expected and the doctor told her it would go away and it did. It lasted 48 hours, started a few days after the first dose. Adverse event required a visit to Physician Office. No relevant Family Medical History related to Adverse event. The patient underwent lab tests and procedures which included blood glucose resulted in 80's and thyroid function test resulted 2.0 on an unspecified date in Feb2021; blood glucose resulted 108 and thyroid function test resulted 6.2 on 10May2021. The outcome of the event was recovered on an unspecified date in 2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness: Crohn's disease (Verbatim: Crohn's disease had this for pretty much her whole life); Inflammatory arthritis (Verbatim: arthritis, inflammatory This is related to the Crohns disease.)

ID: 1812486
Sex: F
Age:
State: PA

Vax Date: 04/15/2021
Onset Date:
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: a slight cough/ dry cough; scratchy throat; This is a spontaneous report from a contactable female consumer (patient) reported for herself via Medical Information Team. A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 15Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She stated that she was due for her second dose of the Pfizer Covid 19 vaccine today but she has a slight cough/dry cough and scratchy throat; she have like a little tickling. She was due to get her second one. She was due to take it today that's why she was calling to ask should she still take it as her throat was scratchy and she have a slight cough. Asking if she should take her second dose of the vaccine. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812487
Sex: M
Age:
State: IL

Vax Date: 05/11/2021
Onset Date: 05/12/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: chills; achy; flu-like symptoms; fever; sweating; weakness/Very Weak; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6206, Expiration date: not reported) via an unspecified route of administration, administered in left arm on 11May2021 at 13:55 (at the age of 61-years-old) as dose 1, single for covid-19 immunization. Medical history included covid-19, He had a history of covid infection 6-7 weeks ago for which he was hospitalized for rehab and quarantine, Verbatim: Covid 19 Virus. History of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient did not receive any other vaccines within four weeks prior. No adverse events following prior vaccinations. There were no concomitant medications. On 12May2021, patient experienced chills, flu-like symptoms, achy, fever, sweating and weakness/Very Weak. It was reported that last night (12May2021) was rough and he is still chilling today and sweating. Therapeutic measures were taken as a result of fever included acetaminophen. The events did not result in emergency room or physician office visit. The outcome of event weakness was not recovered and rest all events was recovering. No follow-up activities are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1812488
Sex: M
Age:
State: NH

Vax Date: 04/07/2021
Onset Date:
Rec V Date: 10/23/2021
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: having a rashy bump/whitish bumps where he was jabbed; Over the last few weeks he's had palpitations; a little bit of discomfort in his arm; red rashy bump; its itchy; some whitish bumps where he was jabbed.; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8734), via an unspecified route of administration on 07Apr2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6202), via an unspecified route of administration on 16Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. On an unspecified date in 2021, the patient experienced having a rashy bump/whitish bumps where he was jabbed, over the last few weeks he's had palpitations, a little bit of discomfort in his arm, red rashy bump, its itchy, some whitish bumps where he was jabbed. Therapeutic measures were taken as a result of having a rashy bump/whitish bumps where he was jabbed, a little bit of discomfort in his arm, red rashy bump, its itchy, some whitish bumps where he was jabbed. It was reported that after taking the second dose of Pfizer vaccine patient experienced a rashy bump and kind of having a reaction. The doctor said it was a possible reaction due to the preservatives used in the lot number. The doctor thought it would go away in a couple months. Patient heard that there was some kind of fat in the vaccine and wondered if the vaccination provider may have thought she pushed it all it but pulled back some and maybe didn't get it all in the muscle. Reported that patient thought it was natural to have a little bit of discomfort in his arm but several weeks after he realized he was developing a red rashy bump, some whitish bumps where he was jabbed. He thought it was strange. He usually puts on moisturizer and thought it would help he used antibiotic cream and started to get concerned. Its been maybe 5 weeks since the Covid vaccine and he still has the bump and all that, its itchy at times. Patient asked if there have been other reports of palpitations or tachycardia as a reaction to the vaccine or preservative. Patient did not specify having tachycardia, only asked that as part of his question. The outcome of event (some whitish bumps where he was jabbed.) was not recovered; the outcomes of events (having a rashy bump/whitish bumps where he was jabbed, Over the last few weeks he's had palpitations, a little bit of discomfort in his arm, red rashy bump, its itchy) were unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812489
Sex: F
Age:
State: OK

Vax Date: 05/12/2021
Onset Date: 05/12/2021
Rec V Date: 10/23/2021
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: Lightheaded; Felt a tightness in her chest; Horrible chest pain; Feeling completely out of it and confused; Feeling completely out of it and confused; Horrible headache; This is a spontaneous report from a contactable consumer or other non-health care professional(patient). A 25-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8735) via an unspecified route of administration in left arm on 12May2021 at 15:15 (at the age at vaccination of 25-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient's medical history included ongoing migraine headaches, started a year to a year and a half ago, but it was rare if she gets one. She had not had a migraine in a while, not since she gave birth and had that. The patient's concomitant medications were not reported. On 12May2021, the patient experienced horrible headache, lightheaded (at 21:00), horrible chest pain, felt a tightness in her chest and feeling completely out of it and confused. It was reported that on 12May2021 (also reported as yesterday) an hour to an hour and a half later (also reported as between 16:30-17:00), patient experienced horrible headache. It was getting worse and was to the point she was feeling out of it. Around at 12:00 (on 12May2021), she went to take a warm, not cold shower to relax her body and she started feeling really lightheaded, that continued on 13May2021 (also reported as today), it was on and off and was felt about the same and was just there. When she was out of the shower, she went to lay down. She fell asleep for 5 minutes or so and felt a tightness in her chest. It got to the point, she would sleep 1 to 1 and a half to 2 hours. It continued on and off. It first she thought she was having an anxiety attack, if it matters, it made her feel she was out of it because it was with light headedness and stuff like that. Patient also experienced horrible chest pain, feeling completely out of it and confused. That came with the chest pain and light headedness. She had an episode 20 minutes or so before the call. It started on 12May2021 (reported as yesterday). She laid on the couch and propped herself up. She thought it would help a little bit, but it did not, and she went to lay in her bed. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Adverse events did not require emergency room or physician office visit. Prior vaccination within 4 weeks was noted as no. Outcome of the events was not resolved. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness: Migraine headache (started a year to a year and a half ago, but it was rare if she gets one.)

ID: 1812490
Sex: M
Age:
State: NJ

Vax Date: 03/02/2021
Onset Date: 03/02/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Lips swollen up; mouth was swollen; Lips swollen up; mouth was swollen; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6203, NDC number and UPC number are unknown, Expiration Date: 30Jun2021), intramuscularly, administered in arm on 02Mar2021 at the age of 78-years-old as dose 1, 0.3 ml single for covid-19 immunisation. Medical history included Blood pressure high, diagnosed 20 years ago on an unspecified date; the patient has no idea when that was. Concomitant medications included allopurinol (ALLOPURINOL) taken 100 mg, tablet twice a day for an unspecified indication, start and stop date were not reported; azelastine hydrochloride, fluticasone propionate (DYMISTA, Dosage: 137mcg-50 mg) taken as Nasal Spray, twice a day for an unspecified indication, start and stop date were not reported; metoprolol tartrate (METOPROLOL TARTRATE, Dosage: 50 mg) taken one tablet twice a day for Blood pressure high, start and stop date were not reported; Alfuzosin Hcl ER (ALFUZOSIN HYDROCHLORIDE, Dosage: 10 mg) taken once a day for an unspecified indication, start and stop date were not reported; fluticasone propionate, salmeterol xinafoate (ADVAIR) taken as insulation twice a day for an unspecified indication, start and stop date were not reported. There was no investigation assessment. On 02Mar2021, the patient experienced lips swollen up and mouth was swollen. The clinical course was reported as follows: the patient had the vaccine on 02Mar2021 at the drug store. He had a reaction where his mouth, lips swollen up. It was reported that he talked to his primary physician and his primary physician told him they wont give him the second shot because of the reaction. The reporter asked, what does he do from here. He went for the second shot but they refuse to give the second shot because he had reaction to the first and so then told him to call his primary physician. He called his primary physician and his primary physician told him to talk to allergist. The allergist suggested that he only get withheld vaccination. But when he went to pharmacist to get the withheld, they dont want to give him the shot because he had the reaction to first dose of the Pfizer vaccination. So, there was no one there, they dont want to take responsibility, they are afraid that there might be response to that. So, where does he go from here. When probed for the exact date of the adverse event, the reporter stated that, Actually it wasnt sore, there was no pain. It was just that if he did not look in the mirror, he would have not known that his mouth was swollen. So he never had anything it was just he looked in the mirror and looked what was going on there the mouth was swollen. When probed if the patient is still experiencing the events, consumer stated that, "No, they only lasted about a day. It was gone within two days" The patient took Aleve, allergy medicine as treatment for adverse events. He cannot spell the name right now. Reporter seriousness for Lips swollen up; mouth was swollen was Unspecified. The outcome of events was recovered on an unspecified date in Mar2021. No follow-up attempts are needed. No further information is expected.

Other Meds: ALLOPURINOL; DYMISTA; METOPROLOL TARTRATE; ALFUZOSIN HYDROCHLORIDE; ADVAIR

Current Illness:

ID: 1812491
Sex: F
Age:
State: PA

Vax Date: 03/01/2021
Onset Date: 03/31/2021
Rec V Date: 10/23/2021
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: itchy rash; Red rash inside left elbow/Red itchy rash would appear intermittently inside left elbow.; This is a spontaneous report from a non-contactable consumer (patient). A 23-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0161), via an unspecified route of administration, administered in left arm on 20Apr2021 (at the age of 23-year-old) as dose 2, single, and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8730), via an unspecified route of administration, administered in left arm on an unspecified date in Mar2021 (at the age of 23-year-old) as dose 1, single for covid-19 immunization in a Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. The patient medical history included congenital heart disease and 22Q deletion variant. The patient's concomitant medication included daily vitamins. The patient had not received any other vaccine within 4 weeks prior to vaccination. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 31Mar2021, the patient had experienced red rash inside left elbow and on 21Apr2021, the patient had red itchy rash which appeared intermittently inside left elbow. The patient had not received any treatment for the events. The outcome of events was recovered at the time of report. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1812492
Sex: F
Age:
State: IL

Vax Date: 05/10/2021
Onset Date: 05/10/2021
Rec V Date: 10/23/2021
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 Name: temperature; Result Unstructured Data: Test Result:98.2; Comments: Her temperature has also been 98.2ish; Test Date: 20210513; Test Name: temperature; Result Unstructured Data: Test Result:98.6

Allergies:

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

Symptoms: joint pain; She has chills; headache; arm soreness; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0179, NDC number and Expiry Date are unknown), via an unspecified route of administration, administered in Left arm on 10May2021 12:10 at the age of 32-years-old as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 10May2021, the patient experienced arm soreness, muscle pain and headache. On 13May2021, the patient experienced joint pain and chills. The clinical course was reported as follows: She received her first dose of the Covid vaccine about noon on Monday, 10May2021. On the first day, she had arm soreness. On the second day, her arm soreness was gone. She has started getting joint pain. She has chills, a temperature of 98.6, and she definitely has a headache. The muscle pain and arm soreness began two to three hours after the injection. It was reported that the joint pain and temperature of 98.6 started an hour ago. Clarifies that whenever she says joint pain, she also means muscle pain. Began one hour ago. Chills began one hour ago. Her temperature has also been 98.2ish. She definitely has a headache began on day one, 10May2021, about two or three hours after the injection. It started again, an hour ago today. It was 72 hours after she received the first dose of the Covid vaccine. She was asking if this was normal. She wanted to report these side effects. She was trying to figure out if other people have had these side effects. The patient underwent lab tests and procedures which included body temperature: 98.6 on 13May2021 and body temperature: 98.2 on an unspecified date. Reporter seriousness for Arm soreness, Joint pain, Chills and headache was unspecified. The outcome of event, arm soreness was recovered on 11May2021 while other events were not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812493
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: bruise on the hand side tip of her finger and it is tingling and hurting; bruise on the hand side tip of her finger and it is tingling and hurting; bruise on the hand side tip of her finger and it is tingling and hurting; I have had a couple of injuries on that side of my body and the all seem to be inflamed; I have had a couple of injuries on that side of my body and the all seem to be inflamed; I had a shoulder injury which is not sore and hurting on that side; tendon and had nerve damage; pain and sore in the injury to my shoulder and my hand; pain and sore in the injury to my shoulder and my hand; This is a spontaneous report from a contactable consumer or other non-HCP via Medical Information Team. A 44-year-old female 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 for COVID-19 immunisation. The patient medical history included arthritis on an unknown date unknown if ongoing. The concomitant medications were not reported. On an unspecified date, after first dose of vaccine, all of sudden the last day or two the patient experienced bruise on the hand side tip of her finger and it is tingling and hurting, she have had a couple of injuries on that side of my body and the all seem to be inflamed, she had a shoulder injury which is not sore and hurting, the injury she had to her hand and arm was a cat bite that went through the tendon and had nerve damage to that area It has since healed pretty well but it feels like it may be inflamed and I haven't reinjured it, pain and sore in the injury to her shoulder and her hand was nothing severe but she was just surprised to wake up and have the pain and a bruised mark on the pad of that fingertip and it was tingling and hurting, pain in this arm was little sore. The outcome of events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812494
Sex: M
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: EKG; Result Unstructured Data: Test Result:Normal

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: He developed on the right chest, a circular rash that was painful to touch; A burning/pins and needles sensation after the vaccine on his left chest area/Abnormal sensation increased; A burning/pins and needles sensation after the vaccine on his left chest area; This is spontaneous report from a contactable Health care professional. A 20-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection Batch/Lot number: Not reported Expiration Date: Unknown ) via an unspecified route of administration, administered in Right Arm on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history concomitant medications were not reported. On an unspecified date, it was reported that two days after his first dose, the patient developed a circular rash on the right side of his chest, it proceeded to spread bigger, and was painful to the touch. The rash later presented the same way on the left side of his chest, also very painful to the touch. The patient is due for his second dose tomorrow. The caller would like to know if we have reports of a rash like this occurring, and if this is a contraindication to vaccination. A 20 y/o pt. received the Pfizer COVID-19 vaccine first dose and experienced pain a burning/pins and needles sensation after the vaccine on his left chest area. He received the vaccine on his right arm. She wants to provide updated information that there was no report of a rash or discoloration of the skin, as was reported in the crosslinked INT. The caller wanted to let Pfizer know that this was incorrect. She states the area of abnormal sensation increased, he went to the ER, had an EKG done (which resulted as normal) and was prescribed Valtrex. The sensation slowly improved. 2 days after stopping the Valtrex, he developed the abnormal sensation on the other side of his chest (right side). She wants to know if it is ok for him to get the second dose. The patient underwent lab tests and procedures which included electrocardiogram: normal on an unknown date 2021.Therapeutic measures were taken as a result of adverse event and treatment included Valtrex. Outcome of all events was recovered on an unspecified date. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812495
Sex: F
Age:
State: NY

Vax Date: 05/12/2021
Onset Date: 05/01/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Date: 20210513; Test Name: fever; Result Unstructured Data: Test Result:98.8-99F Fahrenheit

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: fever/ 98.8-99F; nose feels dry; has not had an appetite to eat anything; slight soreness in her left shoulder; headache; This is a spontaneous report from a contactable consumer (patient herself). A 80-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: EW0179, Expiry date was not reported), via an unspecified route, administered in Arm Left on 12May2021 (Age at vaccination 80-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: EW0164, Expiry date was not reported), via an unspecified route, on 21Apr2021 as dose 1, single for covid-19 immunisation. The patient asked about some slight side effect on her second dose of the Pfizer Covid Vaccine. Caller stated she has some questions about the side effects. Caller stated her first shot she just felt soreness in her shoulder and so she took Tylenol and that was fine. Caller stated she got the second shot yesterday and she started getting a headache, woke up with a fever on 13May2021. She said she usually got a temperature of 97.7F but today her temperature is 98.8-99F something. She also took Tylenol earlier today. She is asking if she could expect the side effect to go away. She also added she has dryness of the nose and asked if it's from the vaccine and how long can she expect this. Caller also wanted to know if these symptoms has been reported side effects from the COVID 19 vaccine. Caller stated headache started during the night either late in the night on 12May2021 or early morning on 13May2021. Caller stated once she took a Tylenol and her other vitamins she started feeling ok. Caller stated her nose feels dry on 13May2021 and she has not had an appetite to eat anything on 13May2021. Caller stated temperature could still be going on because she drank tea or something. Caller stated she did not notice this yesterday and since she did not feel anything yesterday she was wondering if the lady administering the shot even gave it to her since she could not feel anything. Caller stated but now when she moves her shoulder she feels something but it is not uncomfortable. Caller stated when she moves her arm around it is a slight soreness on 13May2021 but not uncomfortable like the headache was and fever. Nose feels dry. Caller stated she expected some soreness in her shoulder so that is not upsetting. Caller stated she is just wondering about the headache and fever. To her they are the usual things that you would expect after getting the vaccine. The first night she felt nothing after the second vaccine, it was when she woke up with a headache during the night that she noticed her symptoms. She only had soreness in her shoulder with the first dose and she treated it with Tylenol a couple of times and it eased off. The patient received Tylenol and other vitamins treatment for the events. The clinical outcome of the events headache was recovered on 13May2021, fever was not recovered, nose feels dry was recovering, has not had an appetite to eat anything was not recovered, slight soreness in her left shoulder was not recovered. No follow-up attempts are needed. No further information is expected

Other Meds:

Current Illness:

ID: 1812496
Sex: M
Age:
State: IL

Vax Date: 03/31/2021
Onset Date:
Rec V Date: 10/23/2021
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: This is a spontaneous report from a contactable consumer (patient reported). A 60-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; solution for injection, batch/lot# unknown), via an unspecified route of administration, on Mar 31, 2021, single dose, for COVID-19 immunization. Patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; solution for injection, batch/lot# unknown), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. Medical history included arthritis and pain. He had pain and arthritis in both his legs, ankles and knees since before the vaccination. The patient's concomitant medications not reported. A few days ago, 6 weeks after his 2nd dose, patient experienced exacerbated pain in both his legs, ankles and knees; but it became way worse after he received the vaccine. He always has aches and pains throughout his body (normally). He believes his weight isn't helping and his age caught up on him. Outcome of the event: unknown. No follow-up attempts needed. Information about batch/lot number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812497
Sex: F
Age:
State:

Vax Date: 05/12/2021
Onset Date: 05/13/2021
Rec V Date: 10/23/2021
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: didn't bite her tongue but her blood vessels burst/didn't bite her lip, but a blood vessel burst in her lip; the blood was gushing and gushing; A blood vessel burst in her lip. It kept bleeding; This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team. A 63-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 12May2021 (yesterday) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included dimeticone (CHAPSTICK) taken for an unspecified indication, start and stop date were not reported. The patient reported that she got the 2nd shot of the Pfizer Covid Vaccine yesterday. On 13May2021, she did not bite her tongue, but her blood vessels burst this morning, the blood was gushing and gushing. She never had this before not even nosebleeds. This morning, she didn't bite her lip or anything, but a blood vessel burst in her lip; It kept bleeding. It stopped a few hours, but later started again. There was a lot of blood she wanted to go to Medical Information, was asking what information they have on that and was her blood vessels inside our gonna burst. She questioned will she die? and stated that that she does not have any bleeding disorders. She took treatment with Tylenol, she did apply Chapstick and was asking if this was okay. Outcome of events was not recovered/not resolved. No follow-up attempts are needed. No further information is expected.

Other Meds: CHAPSTICK

Current Illness:

ID: 1812498
Sex: F
Age:
State:

Vax Date: 05/01/2021
Onset Date: 05/01/2021
Rec V Date: 10/23/2021
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: antibodies for COVID-19; Test Result: Negative ; Comments: 0 antibodies

Allergies:

Symptom List: Unevaluable event

Symptoms: She is mostly concerned about the swelling of her lymph nodes that occurred all over her body. They were swollen 2 areas at a time per day.; She had swelling behind her neck, on her neck, behind her knee, there were lumps above her knee, and her arms feel bruised.; She had swelling behind her neck, on her neck, behind her knee, there were lumps above her knee, and her arms feel bruised.; She had swelling behind her neck, on her neck, behind her knee, there were lumps above her knee, and her arms feel bruised.; has shooting pain in her thumb, shin bones, and wrist; She also had sore and achy pain in the front of her foot like she just ran a long distance. She said her foot felt very tender to touch.; She is uncomfortable; arm pain; muscles felt tight, calf muscles were tight; She also has pain in the tongue that may feel like arthritis; She also has pain in the tongue that may feel like arthritis; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration in May2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included arm pain. The patient's concomitant medications were not reported. The patient experienced "she is mostly concerned about the swelling of her lymph nodes that occurred all over her body. They were swollen 2 areas at a time per day" (lymphadenopathy) (non-serious) in May2021 with outcome of unknown, she had swelling behind her neck, on her neck, behind her knee, there were lumps above her knee, and her arms feel bruised (swelling, joint swelling, contusion) (non-serious) in May2021 with outcome of unknown, has shooting pain in her thumb, shin bones, and wrist (pain) (non-serious) in May2021 with outcome of unknow , she also had sore and achy pain in the front of her foot like she just ran a long distance; she said her foot felt very tender to touch (pain in extremity) (non-serious) in May2021 with outcome of unknown, she is uncomfortable (feeling abnormal) (non-serious) in May2021 with outcome of unknown, arm pain (pain in extremity) (non-serious) in May2021 with outcome of recovered in May2021, muscles felt tight, calf muscles were tight (muscle tightness) (non-serious) on May2021 with outcome of unknown, she also has pain in the tongue that may feel like arthritis (glossodynia, arthritis) (non-serious) in May2021 with outcome of unknown. The patient wanted to know if there is any way to know if a person had a previous COVID-19 infection after having worse adverse events after getting the first dose of the Pfizer COVID-19 vaccine. She said that she isn't sure if she got COVID-19 last December 2019. She said that while she was on an 18-hr flight, she came in contact with very sickly Asian woman (age: late 60s) and she got sick after her flight. Caller recently had the first dose of the Pfizer COVID-19 vaccine and developed adverse events. She is mostly concerned about the swelling of her lymph nodes that occurred all over her body. They were swollen 2 areas at a time per day. This went on for 8 days. She had swelling behind her neck, on her neck, behind her knee, there were lumps above her knee, and her arms feel bruised. She also has pain in the tongue that may feel like arthritis. She also mentioned that she has shooting pain in her thumb, shin bones, and wrist. She also had sore and achy pain in the front of her foot like she just ran a long distance. She said her foot felt very tender to touch. She said that she tested herself for antibodies for COVID-19 and she said it was negative (0 antibodies). She has researched that worse adverse events happen to those who had a previous COVID-19 infection. She is curious whether she had a previous COVID-19 infection. She commented she does not have a GP or anything. She is trying to talk to someone about the side effects she is having from the first shot. She stated it has been like eight days now and she is having a different side effect each day. She is uncomfortable. Initially stated she received the vaccine eight days ago. However, she is not sure the exact date, later stated it was about eight day ago. The first day she was fine. The second day she started to have arm pain. Stated something incomprehensible and attempted to clarify statement. She mentioned she gets vaccines all the time and knows it's normal to get arm pain, she has had arm pain before with vaccines, knows it can happen, so not trying to report on that. She confirmed the arm pain is gone, it went away by day 4 and she has recovered completely from the arm pain. The third day she had pain in her shin. It is the bones at front of knee and ankles, that is what they call it in Ireland. She had shooting pain there and the back of her leg. Her muscles felt tight, calf muscles were tight. It was as if she was running a marathon. Her feet top of her feet were uncomfortable. It was uncomfortable to walk on she felt this on balls of her feet. The following night, her foot was sore and tender. She could feel it while sleeping. The top of her foot was sore, very tender. It was like she had been in accident. She is concerned about going for the second shot. She has nine other symptoms she has not reported yet that are directly from the vaccine. She wants to know about previous infections vs the vaccine. If she was previously infected could this be the reason why she is having such adverse reactions. If she was how can she find out if she was infected . If she was it has been over a year ago and she was never tested. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812499
Sex: F
Age:
State: NJ

Vax Date: 05/13/2021
Onset Date: 05/13/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: The itchiness started in her left eye and it went down to her left mouth; the daughter had a mouth reaction. The itchiness started in her left eye and it went down to her left mouth. It was described as "not the best feeling".; had a reaction in her mouth; she is not feeling the greatest/ not the best feeling; This is a spontaneous report from a contactable reporter, patient's mother. A 33-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number was not reported) via an unspecified route of administration on 13May2021 (age at vaccination 33-years-old), as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter and the patient had their COVID shots on 13May2021, but the reason the reporter was calling was because her adult daughter and herself went to get the first dosage of the COVID vaccine and everything went fine but while they were waiting after about 5 minutes her daughter had a mouth reaction that was like an itchy feeling on the left side of her mouth and she was not feeling the greatest. She was just sitting still right now. But it started at her left eye and went to the center of her mouth and they talked to the person that was giving the vaccination and they claimed that her daughter was having some kind of a minor reaction because it was something new that was going into her body and the body may respond in different ways. They thought eventually it may go away and they came home. The reporter wanted to know if that adverse event has been reported. The itchiness started in her left eye and it went down to her left mouth and had a mouth reaction, was described as not the best feeling on 13May2021. The outcome of all the event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812500
Sex: M
Age:
State: MN

Vax Date: 04/21/2021
Onset Date: 04/21/2021
Rec V Date: 10/23/2021
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: he only had sweats; Confusion; muscle pains; Foggy headedness; Severe headaches; It was hard for him to speak; Swollen lymph nodes; Dizziness; Liver hurting; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 21Apr2021 (at the age of 62-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications included Naltrexone from an unknown date and unknown if ongoing. The patient experienced after the 1st dose, he said he only had sweats, confusion, muscle pains, foggy headedness, headaches, it was hard for him to speak, swollen lymph nodes, dizziness, liver hurting. However, after receiving his 2nd dose last night, he experienced sweats, and numbness in his left leg and all the way down to his ankle. Patient said it was hard for him to walk. He said he had confusion, muscle pain, foggy headedness, and severe headache. He also said that it was hard for him to speak. He mentioned that he even came to consult a chiropractor. Patient also said that he had all the side effects that have been reported with the vaccine, including swollen lymph nodes, and dizziness. He said that the side effects he had with the 2nd dose were much worse than what he had with the 1st dose. Patient states after the first dose he only had sweats, however after the second dose last night he has had sweats, numbness in left leg all the way down to the ankle and he can't walk right. Has had confusion, muscle pains, foggy headedness, severe headaches, and it was hard for him to speak. Also had all other side effects reported with the vaccine along with swollen lymph nodes and dizziness. States the reaction with the second dose was much worse than with the first dose. Patient clarifies he had the all the same reactions with the first dose and second dose, all except for the body rash and more. With the first dose his liver also was hurting and he knows right where the liver is. Had this also last night. What he went through with the first dose was not as hard as this second dose. Had the first vaccine 21Apr2021 around 1pm and states symptoms happened right away, but he didn't have the leg numbness to the ankle. Had the second vaccine last night and again had all the same symptoms as the first dose, but this time he had the numbness in legs, low back to hip area and down to his food/ankle. That was new and his leg is not working right. The numbness he has been having started this afternoon and is not right. His heart feels like it wants to/feels as though it will pound out of his chest. Did not have to go to emergency room or see provider. Does state he went to emergency room a couple times in past with the same crap and an doctor monitored him and whatever they tried wouldn't work. They gave him Valium in his buttocks and Dilaudid and they didn't work. His body started cramping and one time his body would go through convulsions and it got better. Then mentions he had been on a new medicine for a weeks now, a low dose of Naltrexone. Was on 2mg at one time and up to 4.5mg and now on 0.5mg dose. It will go up each week until they get the right amount. Was taking a 0.5mg 1 in the morning and 1 at night. Now they have him on 1 in the morning and 0.5mg at night stating it's used for everything. The outcome of the events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds: NALTREXONE

Current Illness:

ID: 1812501
Sex: M
Age:
State: KS

Vax Date: 05/12/2021
Onset Date: 05/13/2021
Rec V Date: 10/23/2021
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: his allergies "fired up" today; Runny Nose; Watery Eyes; This is a spontaneous report from a Pfizer sponsored program COVAX US support (CEP:159558) by a contactable consumer (patient). A 26-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8736, Expiry Date: unknown), via an unspecified route of administration in left arm on 12May2021 at 14:00 (at the age of 26-years-old) as dose 1, single for COVID-19 immunization at public health department. The patient's medical history included allergies from an unknown to ongoing. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Family medical history relevant to events was none. Concomitant medication was not reported. Additional vaccines administered on same date of the Pfizer suspect was none. Prior vaccinations within 4 weeks and events following prior vaccinations were none. The patient received his Pfizer covid vaccine yesterday and his allergies fired up today (13May2021). On 13May2021, the patient experienced runny nose and watery eyes; however, during this season, he usually gets that. He already has allergies this time of year, it was nothing new. Caller confirms that the runny nose and watery eyes started after receiving the COVID vaccine. Any events did not require a visit to emergency room and physician office. Relevant tests were none. The clinical outcome of events ?runny nose' and ?watery eyes' was not recovered, while the outcome of the remaining vent was unknown. No follow-up attempts are needed. No further information was expected.

Other Meds:

Current Illness: Allergy

ID: 1812502
Sex: F
Age:
State: MT

Vax Date: 02/11/2021
Onset Date: 02/01/2021
Rec V Date: 10/23/2021
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: sore arm; This is a spontaneous report from a contactable consumer. This consumer (patient) reported. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EL9266), dose 1 via an unspecified route of administration, administered in Arm Left on 11Feb2021 (at the age of 72-years-old) as a single dose for covid-19 immunization. Medical history included ovarian cancer stage iii from an, surgery from Sep2020 to an unknown date, hypertension, blood cholesterol, depression takes a mild antidepressant Venlafaxine 37.5mg twice per day, blood pressure measurement from 1979 to an unknown date. Concomitant medication(s) included metoprolol; simvastatin; venlafaxine taken for depression. The patient previously took lynparza for ovarian cancer stage iii. Consumer said that her main concern is that she is currently taking a cancer management treatment, Lynparza. She said she has been on this medication prior to receiving the vaccine. She said it takes away some of her immune system, and wants to know how it could affect the vaccines efficacy or if she has to stay isolated. Caller states she had a big surgery in Sep2020 and they wanted her to wait to heal from that before starting the Lynparza and she began taking it on 04Nov2020. The patient experienced sore arm on Feb2021. Outcome of the event was unknown. Description of Product Complaint: Vaccine Supplemental Form completed in additional context. Caller on the line who had the 1st dose of the Pfizer COVID vaccine on 11Feb2021 and the 2nd dose on 04Mar2021; states the caller is taking three medications and the medication is Lynparza and she is taking four tablets of Lynparza as a cancer maintenance pill; Caller asks if taking the Lynparza would lessen the Pfizer Vaccine immunization protection. States for the Pfizer COVID vaccine, the 1st dose lot is EL9266 and the 2nd dose has lot EN6205 and her patient card has no expiry date or NDC written on it. States she has been on other medicaitons for a while and takes a blood pressure medication Metoprolol 50mg, takes Simvastatin for cholesterol 40mg once per day by mouth, takes a mild antidepressant Venlafaxine 37.5mg twice per day; states she was on other blood pressure medications since 1979 and she was on and off of them since then and some of the blood pressure medications she was on just kind of quit working and it was many years ago and she has no names, dosages or lots, expiry dates or NDC numbers to provide. Caller states she sees her HCP on the 3rd next month and was seeing him once per month and how sees the HCP every 5 weeks. States her HCP said there is not enough information yet and he did not know if the Lymparza which lowers the immune system somewhat could have an affect on the Pfizer COVID vaccine. No follow-up attempts are needed. No further information is expected.

Other Meds: METOPROLOL; SIMVASTATIN; VENLAFAXINE

Current Illness:

ID: 1812503
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: antibody test; Result Unstructured Data: Test Result:Unknown; Test Name: Ultrasound; Result Unstructured Data: Test Result:Abnormal; Comments: lymphatic

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Rash; Lymph nodes were swollen; Swelling on her face, ankle; Swelling on her face, ankle; Lymphatic bumps all over her clavicle, elbow, thigh, knee; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced rash, lymph nodes were swollen, swelling on her face, ankle and lymphatic bumps all over her clavicle, elbow, thigh, knee. Patient asking how long will the vaccine last in regards to efficacy of a single dose. Patient stated her doctor told her she should wait for her 2nd dose because she broke out in a rash, her lymph nodes were swollen, she had swelling on her face, ankle, and below her elbow she had a rash there. They recommended her to wait for 2nd dose. Patient stated she had lymphatic bumps all over her clavicle, elbow, thigh, knee. An ultrasound was done and the HCP stated it was lymphatic. Patient stated the bumps were 3-4 inch bumps like huge soft plums. Patient asking if anybody has reported lymphatic bumps and swelling 3 to 4 inches. Patient stated she read something about T-cells that will have the memory to fight off Covid. T-cells will recognize the Covid virus and will have a memory on it and will be able to fight it. Patient is asking what does your study say about T-cells about recognizing and being able to fight it again. Patient also wondering if Pfizer is in the works of making a booster shot. Has Pfizer provided a statement on the need for a booster dose (3rd dose). Is Pfizer investigating the need for a booster dose. Patient stated her doctor told her to wait for her second dose and it's been almost over 42 days. Patient is wondering if she needs to restart. Verbatim and Event Description: swap from FC- Patient stated she got her 1st dose of the vaccine and she was tested for anti-bodies. She broke out with bumps under her elbow, swelling on her face, her lymph nodes. Patient wants to know how long does this vaccine last after the anti-bodies fade away. Her doctor told her to wait to get the 2nd dose. She wanted to know if just the one dose will protect her. The patient underwent lab tests and procedures which included antibody test was unknown and ultrasound was abnormal (lymphatic) on an unspecified date. The outcome of all the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812504
Sex: F
Age:
State: TX

Vax Date: 04/29/2021
Onset Date:
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: This is a spontaneous report received from a contactable consumer (patient reported for herself). A 34-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiration date: unknown), at the age of 34, via an unspecified route of administration, administered at an unspecified anatomical location, on Apr 29, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient had a side effect after the first dose of the vaccine. On an unspecified date, patient had swelling around the back part of her neck. The swelling has not gone down and there are swollen lymph nodes. She said 14 days ago she was told to wait for 10 days until symptoms go away or lower. Some symptoms gone already, but others were not, such as swollen lymph nodes. She wanted to know if she should see her doctor again or not since they were still swollen. She asked if it was normal and should she consult with her doctor as to if she should get the second dose. She received a response stating that you should not get the Pfizer-BioNTech COVID-19 vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. They referred her to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. The outcome of the events: not resolved. No follow-up attempts needed. Information about batch/lot number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812505
Sex: F
Age:
State: OK

Vax Date: 05/07/2021
Onset Date: 05/10/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Arm Pain; There is small bumps and now there is like larger rash all over my face and scalp/rash on the face; This is a spontaneous report from a contactable consumer or other non hcp (Patient herself) via medical information team. A 21-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported, Expiry date: 31Jul2021) via an unspecified route of administration, administered in Arm Left on 07May2021 (at the age of 21-years-old) as dose 1, single for COVID-19 immunization. Medical history included Birth control like a Contraceptives from an unknown date and ongoing. Concomitant medication(s) included ethinylestradiol, norethisterone acetate (LOESTRIN) taken for contraception, start and stop date were not reported. On 10May2021 the patient got vaccine on Friday, and she notice symptoms when she woke up on Monday, she doesn't know it was 36 hours or more than that she guess like two and half day after that she got it Friday afternoon. the symptoms are persisting and actually got worse because first there is small bumps and now there is like larger rash all over my face and scalp and on unspecified date patient experienced arm pain. Patient just called to report the symptom that she had and called because she was not sure if she should get the second dose or if she should take a different vaccine. Therapeutic measures were taken which includes Ibuprofen for arm pain. The outcome of event there is small bumps and now there is like larger rash all over my face and scalp/rash on the face was not recovered and the outcome of arm pain was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds: LOESTRIN

Current Illness: Birth control

ID: 1812506
Sex: F
Age:
State: NY

Vax Date: 04/21/2021
Onset Date: 04/21/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Felt soreness in her shoulder; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0164; Expiry date was not reported) via an unspecified route, administered in Arm Left on 21Apr2021 (at the age of 80-year-old) as single dose for COVID-19 immunization. There were no medical history and concomitant medications. On 21Apr2021 after her first shot the patient just felt soreness in her shoulder and so she took Tylenol and that was fine. She only had soreness in her shoulder with the first dose and she treated it with Tylenol a couple of times and it eased off. Outcome of the event was recovered on 22Apr2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812507
Sex: F
Age:
State: TX

Vax Date: 02/02/2021
Onset Date: 02/01/2021
Rec V Date: 10/23/2021
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: 202105; Test Name: blood work; Result Unstructured Data: Test Result:They did all kind of blood work; Comments: They have routine blood work about every 3-6 month.

Allergies:

Symptom List: Injection site pain

Symptoms: Terrible muscle and joint pain; Terrible muscle and joint pain; arthritis; Terrible joint pain; Second dose: Red, swollen rash around injection site; Second dose: Red, swollen rash around injection site; Second dose: Red, swollen rash around injection site; itch; Second dose: A little achy; inflammation of her bursa; was not able to sleep last night; This is a spontaneous report from a contactable consumer (patient). A 91-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9264), via an unspecified route on 02Feb2021 at 14:50 (at the age of 91-years) as dose 2, single in the left arm for covid-19 immunisation. The patient medical history included High blood pressure, thyroid. The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EC1283), via an unspecified route on 14Jan2021 at 14:35 (at the age of 91-years) as dose 1, single in the left arm for covid-19 immunisation and experienced shot site a little bit pink and sore. Patient received a Flu shot in fall, but that is longer than a month. She takes for her thyroid, and for her High Blood Pressure. She uses drops for her eyes. The patient experienced a little achy on 02Feb2021. A little achy: It started the day of 02Feb2021 and lasted a week. It wasn't bad. Caller is not 100% sure when it ended, but she recovered completely, Red, swollen rash around injection site on 05Feb2021, Terrible muscle and joint pain on unknown date, Not able to sleep after taking Tylenol; Interfering with my sleep; did not help and could not sleep, After her first dose, the 1st site, the shot site was no more than after a flu shot. After her 2nd dose, the shot site was more red and more swollen. She also experienced a rash that was gone in 10 days. Patient added she also experienced little bits of aches and pain. She contacted her Primary Medical Doctor and of course her neighbour has a phone to take pictures and talk. The doctor advised her don't get excited and put something on it for the itch. It took 10 days to clear up. The muscle soreness was not much. It got more red and more swollen and lasted 3 to 4 days. She recovered completely. She was advised to put calamine lotion on it for the itch and she did. It started on 05Feb2021, it started when her rash appeared. Clarified it ended around the 11Feb2021 or 12Feb2021. Terrible muscle and joint pain: For about the last, at least a month or 5 weeks, she had been having terrible muscle and joint pain. She normally doesn't get headaches and doesn't take Tylenol often, so when she does take it, it was effective and she hardly takes it. She took it last night, but the achiness in her muscles wouldn't let her sleep. She had been awake since 0300 this morning. Patient was not sure of start date, but it was about 5 weeks ago. It continues, and was not improving. The Tylenol won't take care of it, she was calling Pfizer, before she calls her doctor to send her to a specialist. Patient added it feels like, if a person has a pain in the shoulder joint. They put their fingers in the soft spot, the spot between the soft spot and between the bone, and they push in there. She looked up bursa. Patient thought it may be inflammation of her bursa, because the sore ness in between the bones. She normally takes Tylenol for headaches, but she didn't have a headache with the vaccines. Tylenol PC: dose suggested is 500 mg, she takes 2 at a time. She hasn't taken them all, there were 24. Patient added fortunately, all her neighbours are young, but have arthritis all over them and she has never had it. It started 5 weeks ago, all the aches, she thought it may be arthritis. Patient needed to get her magnifying glass to read the label, she blames it on old age. Patient stated, "Yes. The first part of this Month (May). They did all kind of blood work. They have routine blood work about every 3-6 month." When probed for any treatment, consumer, "No, because not even sure that this. This is terrible achiness in my muscles and in my joints, so I thought I would call first before I call my doctor. It is now interfering with my sleep. I don't normally have to take Tylenol it's very effective but I took 2 before going to bed and that did not help. I could not sleep because of the pain." The outcome of the events red, swollen rash around injection site, itch was recovered on Feb2021, a little achy was recovered on 2021, terrible muscle and joint pain, terrible joint pain was not recovered, inflammation of her bursa, arthritis, was not able to sleep last night was unknown. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1812508
Sex: F
Age:
State: NC

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: made me sick; This is a spontaneous report from a contactable consumer, based on information received by Pfizer (manufacturer control number: EC-2021-091505), for BNT162B2. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation; lenvatinib mesilate (LENVIMA), oral from Feb2021 (Batch/Lot Number: 1391900; Expiration Date: 30Apr2024) to an unspecified date, at 10 mg, daily (5day pk) for uterine cancer. Medical history included hysterectomy; lung neoplasm malignant. The patient had no known allergies. Concomitant medications included ondansetron 4 mg tablet; pembrolizumab (KEYTRUDA), 100 MG/4ML VIAL; ibuprofen (MOTRIN CHILDREN) 200 mg capsule; paracetamol (TYLENOL) 325 mg tablet; promethazine hcl 12.5 mg tablet; paracetamol, tramadol hydrochloride (TRAMADOL HCL AND ACETAMINOPHEN); rosuvastatin 10 mg tablet; lisinopril 10 mg tablet; esomeprazole magnesium; levothyroxine 100 mcg capsule. The patient had a reaction to her 2nd COVID-19 VACCINE made me sick on an unspecified date. The action taken in response to the events for LENVIMA was unknown. The outcome of event was unknown. Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.

Other Meds: ONDANSETRON; KEYTRUDA; MOTRIN CHILDREN; TYLENOL; PROMETHAZINE HCL; TRAMADOL HCL AND ACETAMINOPHEN; ROSUVASTATIN; LISINOPRIL; ESOMEPRAZOLE MAGNESIUM; LEVOTHYROXINE

Current Illness:

ID: 1812509
Sex: F
Age:
State: MT

Vax Date: 03/04/2021
Onset Date:
Rec V Date: 10/23/2021
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; developed a big red spot on her left arm/she got a great big red spot that stayed on her arm and it was sore; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program COVAX US Support. A 72-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6205, expiration date was not reported), via an unspecified route of administration administered in left arm on 04Mar2021 13:20 (at the age of 72-years-old) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took Lynparza (Batch/lot number:NA0190, Dosage text:150mg, takes two tablets in the morning and two, tablets at night by mouth, Pharmaceutical form(Dosage form) :tablets, Lynparza manufacturer: Optima, NDC number of Lynparza: 00310-0679-12 Expiry Date of Lynparza: Jan 2024) for ovarian cancer stage iii from 04Nov2020, metoprolol (metoprolol 50mg) for blood pressure, simvastatin (Simvastatin for cholesterol 40mg once per day by mouth) for cholesterol, venlafaxine (venlafaxine 37.5mg twice per day) for depression. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EL9266, expiration date was not reported), via an unspecified route of administration, administered in left arm on 11Feb2021 as dose 1, single for covid-19 immunization. Patient age at the time of vaccination was 72 years. No additional vaccines administered on same date of the pfizer suspect. No prior vaccinations were received within 4 weeks. It was reported that, a 72-year-old female consumer said she already had both doses of the Pfizer-BioNTech Covid-19 Vaccine. She said she had a sore arm again and developed a big red spot on her left arm after her 2nd dose. She said these symptoms have already subsided and lasted for about 3 days. She said that her main concern is that she is currently taking a cancer management treatment, Lynparza. She said she has been on this medication prior to receiving the vaccine. She said it takes away some of her immune system and wants to know how it could affect the vaccine's efficacy or if she has to stay isolated. Patient had the 1st dose of the Pfizer COVID vaccine on 11Feb2021 and the 2nd dose on 04Mar2021 states the patient is taking three medications and the medication is Lynparza and she is taking four tablets of Lynparza as cancer maintenance pill and it is 150mg and she takes it 12 hours apart and the last one she took was today. The patient took the Lynparza in between the Pfizer COVID vaccines and has taken it since a while back and he heard her say she stopped it today. She stated her questions are does she need to wear a mask now that she has had the Pfizer COVID vaccine and also does the Lynparza affect the efficacy of the Pfizer COVID vaccine. She states she had a big surgery in September 2020 and they wanted her to wait to heal from that before starting the Lynparza and she began taking it on 04Nov2020. She states the ovarian cancer had spread and the Lynparza is supposed to give her maintenance therapy and she has the kind of cancer that comes back and within a year and a half if she was not on the Lynparza, her cancer would come back that fast so being on the Lynparza is giving her an extra year and a half. She asks if taking the Lynparza would lessen the Pfizer Vaccine immunization protection; states is it still wise to wear masks even though she has had the Pfizer vaccine. She declined to provide further contact information for her HCP and said she did not know if ok for consent for contacting the HCP. States for the Pfizer COVID vaccine, the 1st dose lot is EL9266 and the 2nd dose has lot EN6205 and her patient card has no expiry date or NDC written on it. States she got the Pfizer COVID vaccine because they did not want covid and are old and the HCP told her it would not be good if she got covid and it would probably his her pretty hard and her husband also has health issues too and so they were wanting the COVID vaccine and her HCP agreed with them. States she has been on other medicaitons for a while and takes a blood pressure medication Metoprolol 50mg, takes Simvastatin for cholesterol 40mg once per day by mouth, takes a mild antidepressant Venlafaxine 37.5mg twice per day; states she was on other blood pressure medications since 1979 and she was on and off of them since then and some of the blood pressure medications she was on just kind of quit working and it was many years ago and she has no names, dosages or lots, expiry dates or NDC numbers to provide. She states she sees her HCP on the 3rd next month and was seeing him once per month and how sees the HCP every 5 weeks. States her HCP said there is not enough information yet and he did not know if the Lymparza which lowers the immune system somewhat could have an affect on the Pfizer COVID vaccine. She states she had a really sore arm with both doses of the Pfizer COVID Vaccine and for a few days could not lay on her left side and the 2nd dose she got a great big red spot that stayed on her arm and it was sore but this is all cleared up and was there for just a few days and she had nothing bad. She states she wondering because she found out about her ovarian cancer in Mar2020 just before the virus began regarding covid and she had chemo and all that and was isolated and could not be anywhere because chemo takes all the immune system away and she has some immune system but it is lowered due to the Lymparza. States the HCP told her no crowds and told her that this month and she can see people though; states she was diagnosed with ovarian cancer on 10Mar2020 and she does not know the name or lot number of her chemotherapy she had at that time. The outcome of the events was recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812510
Sex: F
Age:
State:

Vax Date: 12/11/2020
Onset Date:
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:Well controlled; Test Date: 202102; Test Name: CT scan; Result Unstructured Data: Test Result:improvement with the nodules

Allergies:

Symptom List: Tremor

Symptoms: had her first Pfizer COVID-19 vaccine and her arm was a little sore - new and resolved,; CT scan at the end of February that the showed that the "saw improvement with the nodules" - new, is a "little slow" -new; This is a spontaneous report from a contactable consumer based on information received by Pfize (manufacturer control number HK-Fosun-2021FOS000486), license party for bnt162b2 (COMIRNATY). A 63-year-old non-pregnant female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose 1, single for covid-19 immunisation; lenvatinib mesilate (LENVIMA), oral from 11Dec2020 (Batch/Lot Number: 1330511) and ongoing, at 14 mg, 1x/day, oral from 11Dec2020 (Batch/Lot Number: 1265576) and ongoing, at 14 mg, 1x/day for malignant neoplasm of endometrium. Medical history included malignant neoplasm of endometrium. Concomitant medications were not reported. Description of the event: Patient reported she had her first Pfizer COVID-19 vaccine and her arm was a little sore - new and resolved, CT scan at the end of February that the showed that the "saw improvement with the nodules"' - new, is a "little slow"-new. Description of the event: Patient reported 'the doctor told me to take 10 mg daily to help with being so tired and it seems to be helping'- New. 'my right foot has pain" - New, "my blood pressure is well controlled now'- Resolved, 'I had my 2nd Covid vaccine and my arm was sore and I felt achy for a day' - New, Resolved (patient gave verbal consent to be contacted by the manufacturer). Outcome: Unknown. Was the event considered a drug interaction: No. The patient underwent lab tests and procedures which included blood pressure measurement: well controlled on an unspecified date, computerised tomogram: improvement with the nodules on an unspecified date Feb2021. Patient received treatment for the adverse events. The action taken in response to the events for lenvatinib mesilate was dose not changed. Outcome of the event her arm was a little sore was resolved and saw improvement with the nodules" - new, is a "little slow"-new was unknown.

Other Meds:

Current Illness:

ID: 1812511
Sex: U
Age:
State:

Vax Date: 04/22/2021
Onset Date:
Rec V Date: 10/23/2021
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: allergy symptoms due to first dose; throat irritation; like allergic reaction to pollen; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown), via an unspecified route of administration on 22Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced allergy symptoms due to first dose, throat irritation and like allergic reaction to pollen on an unspecified date. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021544988 same reporter/vaccine different patient/AE

Other Meds:

Current Illness:

ID: 1812512
Sex: F
Age:
State: PA

Vax Date: 03/21/2021
Onset Date: 03/01/2021
Rec V Date: 10/23/2021
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: Itching; Yes, the 1st shot I receive a small rash on my head yet same side on the arm that it was given on left side.; Yes, the 1st shot I receive a small rash on my head yet same side on the arm that it was given on left side.; little hive on her hip; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that, A 72-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EN6208), dose 1 via an unspecified route of administration, administered in arm left on 21Mar2021 as dose 1, single for covid 19 immunisation, (age at the vaccination 72 years old) and patient took ascorbic acid, lycopene, omega-3 fatty acids, tocopherol (EVION [ASCORBIC ACID;LYCOPENE;OMEGA-3 FATTY ACIDS;TOCOPHEROL]), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at for an unspecified indication. Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included insulin aspart, insulin aspart protamine (NOVOLOG MIX) taken for an unspecified indication, start and stop date were not reported; olmesartan medoxomil (BENICAR) taken for an unspecified indication, start and stop date were not reported; spironolactone (SPIRONOLACTON) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication, start and stop date were not reported; amlodipine besilate (NORVASC) taken for an unspecified indication, start and stop date were not reported; atorvastatin (LIPITOR [ATORVASTATIN]) taken for an unspecified indication, start and stop date were not reported; insulin detemir (LEVEMIR) taken for diabetes mellitus, start and stop date were not reported. It was reported that she received the first one in March 2021 and noticed a little hive on her hip, on the left side, the same side she received the needle. On an unspecified date in Mar2021, the patient experienced, little hive on her hip on the left side, the same side she received the needle and Yes, the 1st shot she receive a small rash on my head yet same side on the arm that it was given on left side, and on an unknown date patient experienced itching. When probed for the laboratory test, the patient stated, "she had laboratory test last week, she had at my doctor's office." The patient stated, she took, she did tried putting some cream on it some put it down cream (Captured as suspect) but that really didn't helped, made it worth and then she had Benadryl by mouth, she took Xyzal by mouth, she took Xyzal last night, she thought that would help she was mean itching, Evion Cream, Benadryl tablet 5mg, Xyzal tablet, 5mg. The outcome for the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: NOVOLOG MIX; BENICAR; SPIRONOLACTON; ASPIRIN (E.C.); NORVASC; LIPITOR [ATORVASTATIN]; LEVEMIR

Current Illness:

ID: 1812513
Sex: F
Age:
State: VA

Vax Date: 03/29/2021
Onset Date: 03/29/2021
Rec V Date: 10/23/2021
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: lost weight; figure out how to straighten herself up to walk; left ankle is swelling; shaking; joint pain and weakness; joint pain in shoulders and hips; sore at injection site; Stiff and sore; This is a spontaneous report from a contactable consumer or other non-health care professional reported for patient. A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 29Mar2021 at 13:30 (Lot Number: EP7533, Expiry date: not reported, age at vaccination was 63-year-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing renal cancer stage II Verbatim: Stage II kidney disease. Concomitant medications included calcium (CALCIUM); calcium citrate, colecalciferol (CALCIUM CITRATE WITH VITAMIN D3); curcuma longa rhizome, piper nigrum fruit (TURMERIC +); krill oil (KRILL OIL); colecalciferol, collagen, fish oil (COLLAGEN II); cyanocobalamin (B12-VITAMIIN), Multivitamin active woman taken for an unspecified indication, start and stop date were not reported. Reporter stated that she only took 2 tablets but the recommended is 4 tablets. She stated that she thinks that it too much. The whole dose was 24 g, but she took 12. The patient experienced stiff and sore on 29Mar2021, sore at injection site on 30Mar2021, joint pain in shoulders and hips on 05Apr2021, joint pain and weakness on 06Apr2021, left ankle was swelling on 13Apr2021, shaking on 13Apr2021, figure out how to straighten herself up to walk, lost weight on an unspecified date. Reporter said that about a week after the 1st dose she was fine the first day, she was a little stiff and sore but that went away. She said a week later she started having joint pain in her shoulder and hips. She stated that it was increasing joint pain, and she was a bit worried about it. She stated that after that, a week later she started getting very weak, and loosing strength. She said she was a fitness instructor. She said she started having pain and getting weaker, so she called her doctor before the 2nd dose because she was afraid to get it. She stated that the second time she called the doctor they got her to have COVID test which came back negative. She stated that she got the second shot and was sitting on the sofa at midnight and stated that she did not have an email for her doctor at this time. She stated that they do send her emails, but she was not sure that they were ones that allow contact threw. She stated that the emails were generated through the patient portal, reporter stated that on 30Mar2021 she had soreness at site, probably went away might be the next day she said it didn't last very long. She said that on 06Apr2021 she really started getting weak, and the way she could tell she was weak was because she thought senior fitness classes virtually, and that Tuesday she could not do a front arm raise with 5 lbs. worth of weight. She stated she was that weak. She said she couldn't do it. She said that it was mainly her left arm that is weaker than right arm. She said she has a previous injury on right arm, so she sometimes had trouble with that arm. She said that her left arm was her strong arm normally and now it was weak. She said it seems to have gotten a little better now, but she could not sit for a long period of time she has to figure out how to straighten herself up to walk. She said starting this week she had been having trouble with opening the cap of a water bottle. She said the weakness is getting worse. She said that the shaking started on the 13Apr2021 still ongoing, not a constant, the shaking body or trembling happens when she hinges from her hips, when she was leaning over or bends over. She stated that it also happens when she is extending her arms out to reach. She said that was when she trembles getting worse. She stated that her ankle growing, started 13Apr2021 and right now she was looking at her ankle and she can see the bones. She could see her ankles, but the left side of her foot was slightly, just a little bit bigger, but it had gone down. She stated that it appeared randomly, and it did not stay, it happened and then went away. Caller confirmed there was not an expiration for the first dose, NDC number, or dosing information on the vaccine card. She was reluctant to do it, but she was a fitness instructor for seniors and the adult population ages 55 and over. She stated that most of her job is in senior living facilities and for her to get back in there she must get the vaccine. She was still doing most of her classes virtually but had started going back to the community. She was currently going down the steps while talking to the CH. She had a client picking up Zumba toning sticks and the client was in parking lot waiting for her. She stated the client is 84. No other vaccines were administered 4 weeks prior vaccinations NO, had not past fall had pneumonia vaccine and flu vaccine had to get booster for shingles. had those three this past fall no reactions to them. Reporter says that she was asking if someone had the same experience or side effects with her with regarded to the Pfizer COVID Vaccine. 6 days after the first dose patient experienced joint pain and weakness, she was getting weaker and weaker. The outcome of event stiff and sore was recovered on 30Mar2021, sore at injection site was recovered on 31Mar2021. Outcome of joint pain in shoulders and hips, left ankle is swelling was resolving. Outcome of joint pain and weakness was not resolved, and outcome of remaining events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: CALCIUM; CALCIUM CITRATE WITH VITAMIN D3; TURMERIC +; KRILL OIL; COLLAGEN II; B12-VITAMIIN; MULTIVITAMIN ACTIVE WOMAN

Current Illness: Kidney cancer stage II (Verbatim: Stage II kidney disease)

ID: 1812514
Sex: M
Age:
State: MI

Vax Date:
Onset Date: 05/13/2021
Rec V Date: 10/23/2021
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: fatigue; slept 9 hours which in unnormal; felt like an irritation in my lungs or inflammation in my chest; felt like an irritation in my lungs or inflammation in my chest; general malaise; irritation in his chest and cough; irritation in his chest and cough; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (BNT162B2) solution for injection, dose 1 (Lot Number: EM9810) via an unspecified route of administration on an unspecified date as dose 1 single for covid-19 immunisation. Medical history included ongoing asthma. Concomitant medication(s) included dupilumab (DUPIXENT) taken for asthma from an unspecified start date and ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Another operator transferred call in. Stated reporter did not provide his age but says he was born in#. he got his first vaccine at the hospital yesterday about 2pm. Within 3 hours he had general malaise and slept 9 hours which in unnormal. He noticed some irritation in his chest that started yesterday. He didn't notice it today when he woke up, but it is back now after taking a walk. It was causing an odd cough yesterday and felt like an irritation in his lungs or inflammation in his chest. He woke up this morning feeling better, feeling refreshed. Reporter stated he got the Pfizer Covid vaccine yesterday and the guy told him he should experience limited or no side effects. Reporter stated that he did experience very serious fatigue after the injection. States he slept for 9 hours and because he was an older man, so he typically gets 5, 6, or 7 hours of sleep. Reporter stated he had just a general feeling of malaise but what concerned him the most is that he felt this irritation, inflammation in his chest and an odd cough, states it's not deep or heavy just an odd cough. Stated this all set in within 3 hours of the vaccination, felt like it may have improved this morning, he went on a walk in the sunshine and then he started feeling it again. Reporter stated the symptoms he was experiencing are not listed on the sheet, wants to know if they could be due to the vaccine. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: DUPIXENT

Current Illness: Asthma

ID: 1812515
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Severe joint pain, in thumb joint, both thumbs, after first vaccine, and hurts more after the second vaccine; experienced pain after the first dose; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number: Not reported), via an unspecified route of administration on an unspecified date as, dose 1, Single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced severe joint pain, in thumb joint, both thumbs, after first vaccine and experienced pain after the first dose. The outcome of events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812516
Sex: M
Age:
State: NJ

Vax Date: 05/06/2021
Onset Date: 05/06/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: extreme anxiety; chest tightness and pain; chest tightness and pain; This is a spontaneous report from a contactable consumer. A 24-years-old male patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 2 via an un-specified route of administration, administered in Arm Left on 06May2021 as dose 2, single for covid-19 immunisation (at the age of 24 years). The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 on an unspecified date for covid-19 immunisation. Reporter reporting on behalf of her son. He received his second dose of the Pfizer Covid vaccine on 06May2021 and has since experienced extreme anxiety, chest tightness and pain. Caller wants to know if this has bene reported before. His MD diagnosed him with anxiety. Reporter stated that her son received his second dose last Thursday, and he has tightness in his chest and a little bit of pain in his chest every so often, and he is anxious for over a week, and it is still going on. Caller states he has been checked by a physician and she thinks it is anxiety. Caller states she is calling to see if anyone has reported this or if it is common. Caller states it is very concerning. Reporter stated that her son received his second dose of the Covid 19 vaccine last Thursday, 06May2021 and he's experienced tightness in his chest, a little bit of pain, and anxiety over it. He went to the doctor and the doctor thought he was having anxiety and that was what's causing it. He's 24 years old. She's filed a safety report already. Report number 4M8CBO0J. She just wants to speak to someone about her son's symptoms. The outcome of the event anxiety was not recovered, outcome of the events chest tightness and pain was recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812517
Sex: F
Age:
State: NY

Vax Date: 04/27/2021
Onset Date: 04/27/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: felt some tightness in her chest, "like a weak compression" that lasted about 20 minutes; rash around her eyes; swollen eyes all week long; the skin around her eyes is very wrinkly, like an elephant, and burgundy colored; dark circles around the whole eye; the skin around her eyes is very wrinkly, like an elephant, and burgundy colored; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route administered on 27Apr2021 (age at vaccination 53-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Apr2021 the patient experienced felt some tightness in her chest, like a weak compression that lasted about 20 minutes. The patient reported that she received her first dose of the Pfizer-Biontech Covid19 vaccine on 27Apr2021.She reported that when leaving the vaccination site, she felt some tightness in her chest, like a weak compression that lasted about 20 minutes, and was resolved within 30 minutes after vaccination. She thought about going back to the vaccination site, but was too far away, and the symptoms resolved. In 2021 the patient experienced rash around her eyes with, swollen eyes all week-long, the skin around her eyes is very wrinkly, like an elephant, and burgundy coloured and dark circles around the whole eye. She was most concerned about the rash around her eyes that has developed, this week. Her friend told her to call and let this know, Is it the symptom of the vaccine of the first shot. The patient spoke to her doctor and the doctor prescribed the Claritin, loratadine (lot and NDC were Unknown, expiration date 13May2022) 1 tablet a day. The swelling around the eyes was gone down a little bit but she was still had the effect. She was asking if the rash/eye swelling could be caused by the vaccine (Is this from the vaccine or a food allergy), and if she should get her second dose? She had spoken with her HCP prior to calling, and they think the reaction may be a food allergy. She was scheduled for her second dose of Pfizer Covid vaccine 18May2021.Therapeutic measures were taken as a result of events Skin wrinkling, swollen eyes, rash around her eyes, skin discoloration. The clinical outcome of the event tightness in her chest was recovered on 27Apr2021 and recovering for swollen eyes and unknown for other events. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812518
Sex: M
Age:
State:

Vax Date: 04/25/2021
Onset Date:
Rec V Date: 10/23/2021
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: He has a cold with a cough and a sore throat.; He has a cold with a cough and a sore throat.; He has a cold with a cough and a sore throat.; not feeling well; This is a spontaneous report from a contactable consumer reported. A 39-year-old male patient received PFIZER-BIONTECH COVID-19 VACCINE (Formulation: Solution for injection, Batch/Lot Number was unknown, Expiration Date: Unknown), dose 1 Single, via an unspecified route of administration on 25Apr2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.On an unknown date patient stated as of two days ago, he started presenting cold symptoms consisting of a cough and sore throat. The patient reported that for his throat hurting and a cold started a couple of days ago but today he was feeling much better although he still has the throat condition. The patient stated that he was possibly missing the second dose of the COVID vaccine on Sunday, 16May2021, since he was not feeling well as of two days ago. The outcome of all the events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812519
Sex: F
Age:
State: IN

Vax Date: 04/04/2021
Onset Date: 04/23/2021
Rec V Date: 10/23/2021
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: Pain in the teeth; Had a strong general malaise; Throat pain; Severe nasal congestion; I could not get out of bed for 5 days/I have had to be in bed for several days/does not allow me to do my normal activities; Severe daily headaches; A sensation of having my head inside a bubble; General discomfort; A lot of coughing; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 47-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation : solution for injection, Batch/Lot Number: EW0153; Expiration Date: not reported), via an unspecified route of administration, administered in Arm Left on 04Apr2021 11:00 (at the age of 47-years old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypothyroidism and covid-19 (if covid prior vaccination: Yes). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient has not been tested for COVID-19.Concomitant medication(s) included levothyroxine sodium, vitamin c (ascorbic acid), vitamin d, zinc and ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN) taken for an unspecified indication, start and stop date were not reported. The patient previously took dipyrone and experienced allergies, tramadol and experienced allergies (known allergies: dipyrone, tramadol). On 23Apr2021, the patient experienced pain in the teeth, strong general malaise, throat pain, severe nasal congestion, she could not get out of bed for 5 days and had to be in bed for several days and it did not allow her to do her normal activities, severe daily headaches, a sensation of having my head inside a bubble, general discomfort, a lot of coughing. The patient had to be in bed for several days and had a strong general malaise, throat pain, severe nasal congestion and could not get out of bed for 5 days. The patient still continue with severe daily headaches and a sensation of having my head inside a bubble, continues with general discomfort, a lot of coughing, throat pain, pain in the teeth. The headache does not go away and it does not allow me to do my normal activities. The patient got headaches after the first dose and with second dose were worse. The reporter assessed the case as non serious. No treatment was received for events. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation : solution for injection, Batch/Lot Number: EW0173; Expiration Date: not reported), via an unspecified route of administration on 02May2021 11:00 as DOSE 2, SINGLE for covid-19 immunisation. The outcome of the events pain in the teeth, strong general malaise, throat pain, severe nasal congestion, she could not get out of bed for 5 days and had to be in bed for several days and it didnot allow her to do her normal activities, a sensation of having my head inside a bubble, general discomfort, a lot of coughing was recovering. The outcome of the event severe daily headaches was not recovered Follow-up attempts completed. No further information expected.

Other Meds: LEVOTHYROXINE SODIUM; VITAMIN C [ASCORBIC ACID]; VITAMIN D [VITAMIN D NOS]; ZINC; MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYR

Current Illness:

ID: 1812520
Sex: M
Age:
State: TX

Vax Date: 05/11/2021
Onset Date: 05/12/2021
Rec V Date: 10/23/2021
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: Some little bumps under in his arm; Fever; Chills; This is a spontaneous report from a contactable consumer. A 41-years-old male patient (reporter's husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Right on 11May2021 (at the age of 41-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Patient took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date as dose 1, single for COVID-19 immunisation. Reporter stated, I would like to know because my husband he got the second COVID-19 Vaccine already the day before yesterday and now 13May2021 he has some little bumps under in his arm. Reporter added, Yesterday night on 12May2021 he has fever and chills and now he had the bump under his arm. Patient did not receive any treatment for the event. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812521
Sex: M
Age:
State: MN

Vax Date: 05/11/2021
Onset Date: 05/13/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: armpit is swollen and tender/lymph nodes in the arm pit and that could be the swelling and tenderness; armpit is swollen and tender/lymph nodes in the arm pit and that could be the swelling and tenderness; This is a spontaneous report from a contactable consumer (patient). A 23-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route, administered in the right deltoid on 11May2021 at 13:50 (at the age of 23 years old) (Batch/Lot Number: EW0179) as dose 1, single for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient did not receive any prior vaccinations (within 4 weeks) and any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 13May2021, around 17:00, the patient experienced his armpit was swollen and tender/ lymph nodes in the arm pit and that could be the swelling and tenderness. He got his shot-on Tuesday afternoon in his right shoulder and then he started to notice on Friday, 3 days after shot the arm he got the shot in, his arm pit was swollen and tender. The patient stated there are lymph nodes in the arm pit and that could be the swelling and tenderness. He was wanting to know if this is normal or a side effect. He took Advil a day before this report and he had not taken any on the day of this report. The patient was treated with Advil. The outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812522
Sex: F
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: Felt sick; Had a fever; Body ached; Headache; Feeling weak; This is a spontaneous report from a contactable consumer (patient) reported that: A 55-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), (At the age of 55 years) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient was scheduled for her second Covid 19 vaccine on 17May2021. The patient medical history was not reported. The patient's concomitant medications were not reported. About 2 weeks after receiving her Covid 19 vaccine. On an unspecified date, the patient had experienced feeling really sick, Fever, body aches, headaches and feeling kind of weak. At the time of reporting, the outcome of the events were unknown. No follow-up attempts are needed; No further information expected.

Other Meds:

Current Illness:

ID: 1812523
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: Experienced rash in both arms; This is a spontaneous report from a non-contactable consumer (patient) reporting for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, NDC number and Expiry date are not provided), via an unspecified route of administration, administered in arm on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Investigation assessment was not provided. On an unspecified date, the patient experienced rash in both arms. The clinical course was reported as follows: The reporter stated that she received her first Pfizer covid vaccine and experienced rash in both arms. Started in the injection arm below the site. The rash was on the arm the shot was in, but not where they put it, it was right below it. Now, it's moved to the other arm. She wanted to know about it. She was wondering if it was normal to have a rash after the first Pfizer Covid vaccine. The paperwork given where she got the shot didn't say anything about a rash. The case was reported as non-serious. The outcome of event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812524
Sex: F
Age:
State: NY

Vax Date: 05/13/2021
Onset Date: 05/13/2021
Rec V Date: 10/23/2021
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: 20210514; Test Name: Fever; Result Unstructured Data: Test Result:100.6

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Couldn't sleep; Diarrhea; tired; Chills; I have temperature of 100.6; Extremely lethargic; Severe sore arm; This is a spontaneous report received from a contactable consumer (patient). A 79-years-old female patient received 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, on 13May2021 (age at vaccination: 79 years), as dose 1, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had severe sore arm (arm hurt and hurt through the night) on 13May2021, and she couldn't sleep. However, the next day (today 14May2021) she was experiencing she was burning in fever chills (I have a temperature of a 100.6) and was feeling lethargic, tired and she also had diarrhea on an unspecified date. Everyone else she knows just had side effects after the second dose and asked was it normal to have side effects after the first dose. Now was this normal or she felt the people who had the first injection have no reaction with just with the second injection, so she was a little bit concerned. She could only take tylenol not any other medicines. The patient underwent lab test and procedure included Fever 100.6 on 14May2021. Outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812525
Sex: M
Age:
State:

Vax Date: 05/04/2021
Onset Date: 05/07/2021
Rec V Date: 10/23/2021
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: loss of taste; metallic taste; small cough; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection via an unspecified route of administration on 04May2021 (Batch/Lot number was not reported, expiry date: unknown) as dose 2, single for COVID19 immunisation. The patient's medical and concomitant medications were not reported. The patient had previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection via an unspecified route of administration on unspecified date (Batch/Lot number was not reported, expiry date: unknown) as dose 1, single for COVID19 immunisation. On 07May2021 the patient reported ''started get-ting very small cough and non other he got but also to had what's his taste, his taste almost like metal, he almost feel like metal taste and he told he know it was reaction that happens like three days after the shot and he was fine before but he took on the for since today's like 10 days later was that normal to last this long (loss of taste, metallic taste, and small cough). Patient was asking whether is it normal after 14 days to still have side effects and what he should do about it. Patient stated he would rather speak to doctor right now considering un-comfortable. The outcome of the events was recovered on unspecific date in May 2021 No follow-up attempts are needed; Information related to batch/Lot number could not be re-quested.

Other Meds:

Current Illness:

ID: 1812526
Sex: F
Age:
State: CA

Vax Date: 05/01/2021
Onset Date: 05/05/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: swelling of her legs, that was painful/ legs were like swollen and hurting a lot, and it did not go away; swelling of her legs, that was painful/ legs were like swollen and hurting a lot, and it did not go away; inflammation; This is a spontaneous report from a contactable consumer (patient, self-reported) via medical information team. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0173 and expiry date was not reported), via an unspecified route of administration in right arm, on 01May2021 (age at vaccination: 50 years), as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were none. On 05May2021, 3-4 days after the patient presented swelling of her legs, that was painful/ legs were like swollen and hurting a lot, and it did not go away and inflammation. The patient queried what she should take to reduce inflammation. The patient used cold water as treatment. 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