VAERS 2021 Database www.vaers.hhs.gov

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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: 1812276
Sex: F
Age:
State: AZ

Vax Date: 05/04/2021
Onset Date: 05/01/2021
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: Test Date: 202104; Test Name: Blood test; Result Unstructured Data: Test Result:Normal

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Today she seems like really tired; It shot up her blood pressure a little bit; itching in hands and lower spine; Arm was initially sore/left arm pain/Her hand hurts; whole left side hurting; from arms down to legs, ankles, hands and stomach muscles; She could hardly sleep; Feeling dizzy; little confused; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: unknown, expiry date: 30Aug2021) (age at the time of vaccination was 85 years old) via an unspecified route of administration, administered in arm left on 04May2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history included allergies, allergies to sulfur and iron and was allergic to many things and would like to know if any of those things are in the vaccine. Has had the pneumonia shot and the flu shot and has never gotten sick. Concomitant medications included Losartan for blood pressure, Levothyroxine (has been taking probably since in her late 50's) for thyroid and vitamin D. Caller mentioned that she used to take one of those pills for bones and now just takes D. She cannot get too much calcium. She can build up calcium since she loves dairy foods. She is otherwise doing real well and her pressure was good. Was blood tested last month was ok just needed a little vitamin D. No prior vaccinations (within 4 weeks), last vaccine in the fall was flu and pneumonia, September and October at the doctor's office. On 04May2021, arm was initially sore but since then it feels like it's affecting her whole side, form her left arm down to her legs and even her ankles. Also states it's in her stomach muscles. Caller was feeling dizzy in May2021. Caller would like to know if she can get the second dose of the vaccine. Caller was also allergic to many things and would like to know if any of those things are in the vaccine. She was 85 and this was her first time. She got hers two days ago and had a reaction and does not know if it was normal. She had it in her left arm. It seems like it affected her whole left side. She is a little dizzy. Her arm was really really sore. The next day her arm was not sore but the rest of her body was. It went down her arm, legs and down to the ankles, even in her stomach muscle a little. The patient was wondering if she should not get the second one. She wears her mask every where she goes. She was really concerned. She had a good check up on the 29Apr2021 of last month and everything was good. The patient had lots of vaccines but never experienced this anything like this one. Is not going to take the second one. This really scared her. Never had a reaction to any other vaccine in her whole life except for a little sore in the arm. It kind of scared her. When she was at the grocery store with her debit card, she almost forgot to push the entry button. The patient was allergic to lots of things, like sulfur and things. Is wondering if there is something in them. There really has not been any proven literature that it prevents the virus itself. Is there maybe something in the shot. Left arm pain: Got the shot in the morning about 10:30. Was talking to her granddaughter after 7, it was afterwards that her arm got really sore and she could hardly sleep on 04May2021. The next morning the arm pain was gone. The next day, her whole left side started hurting. It was her stomach muscles, legs, ankles and hands on the left side. It started the evening she got the shot. It went probably until the next day. When she got up the next day, it shot up her blood pressure a little bit on 05May2021. She takes 2 pills, a thyroid pill and a blood pressure pill and a vitamin. Wasn't told to stop nothing and took her regular meds. Today she seems like really tired on 06May2021. Her hand hurts and itches in the corner. Thinks she had a bad reaction. Every once in a while, she feels it in her hands and leg. On 05May2021, her hand was itching, in the thumb, above the thumb. Is also in the lower part of her spine. The itching started really late yesterday. She took a shower and then the soreness in her arm went completely away. It comes and goes but not like the first time. It is better now. Still feels itchy. Is very allergic to sulfur and iron. Could have been something she was allergic to. The itching comes and goes, especially in her hands and lower spine. She was a little confused in May2021. She almost forgot to press the button. The patient did not receive any treatment for the events extremity, pain, feeling dizzy, pruritus, little confused, fatigue and insomnia. Thought maybe if she should take the second one? Is afraid and lives alone. Her grand daughter is a nurse practitioner and has a button and a machine she can press. She is mainly concerned about how she felt. Does not think she is going to take the second one. No one even told her to get it. Otherwise, feels pretty good, can still drive and feels safe. This was a reaction in her opinion. Reaction has still not gone away. The outcome of the events pain in extremity, pain and hypertension was recovered in May2021. The outcome of the event feeling dizzy, pruritus, little confused was not recovered/not resolved. The outcome of the event fatigue, insomnia was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

Other Meds: LOSARTAN; LEVOTHYROXINE SODIUM; VITAMIN D 2000

Current Illness:

ID: 1812277
Sex: F
Age:
State: UT

Vax Date: 05/03/2021
Onset Date:
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: Ear is achy.; runny nose/nose is kind of runny; left arm is sore; Headache; very tired; muscle tension; This is a spontaneous report from a contactable consumer (patient). A female patient of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: unknown) via an unspecified route of administration on 03May2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the first vaccine on Monday 03May2021 and wanted to ask a question about something she was experiencing. The patient had noticed especially yesterday my left ear started bothering me. My doctor looked at the ear there was no wax or infection. I received the vaccine on the same side. My left arm was sore, and ear was achy. I also have a runny nose with a headache. When I take Claritin, it goes away but when the medicine wear of it starts again. I also feel very tired. Caller clarified that she has allergies and got her first dose and next dose is due at the end of the month. The caller said that her left ear has been bothering her. She thought maybe that it was wax or maybe an infection in her ear. She said that she went to Instacare and the doctor there saw no wax build up or infection in her ear. It was bothering her. She said that they told her could be muscle tension that it could be causing her symptom. Caller said that her nose is kind of runny, but she feels better than she did. She said that she also had headaches along with it. Caller said that her ear aches and she forgot to ask the doctor if it could be a swollen gland. The outcome of the event runny nose/nose is kind of runny was recovering/resolving and outcome for other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812278
Sex: F
Age:
State: GA

Vax Date: 04/28/2021
Onset Date: 04/28/2021
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: Test Date: 202104; Test Name: Calcium; Result Unstructured Data: Test Result:High; Test Date: 202104; Test Name: Parathyroid; Result Unstructured Data: Test Result:High; Test Date: 20210430; Test Name: Blood pressure; Result Unstructured Data: Test Result:Came back down; Test Date: 20210430; Test Name: Blood pressure; Result Unstructured Data: Test Result:Went up; Test Date: 202104; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:plaque on her heart; Test Date: 202104; Test Name: a1c; Result Unstructured Data: Test Result:Good

Allergies:

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

Symptoms: Pain; Blood pressure went up; Very sleepy; Very Tired/Tired; Headache to the mid top right side of her head; Cool sensation in her mid-chest/felt airy chill inside her mid chest; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, administered on 28Apr2021 (age at vaccination 66-years-old), DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included diabetes, high blood pressure, cholesterol, all on an unknown date and in Apr2021, the patient had plaque on the heart in one of the arteries. Concomitant medications included metformin, amlodipine, colecalciferol (D3 VITAMIN), fish oil, losartan, pravastatin. The patient received her first vaccine dose on April 28th at noon and about 25 minutes later on the same day she experienced cool sensation in her mid-chest and it felt like anesthesia when they push it through the IV and you taste it. The patient felt airy chill inside her mid chest between the breast, it was like real like a chill on inside in the middle of her chest. It was the real cool airy some type of funny ceiling inside her middle of chest that was after the 25 minutes, and it lasts for may be for couple of hours. The patient had a headache to the mid top right side of her head that lasted for 10 minutes on the first day (28Apr2021) and then stopped and then came back again another day (29Apr2021) and then stopped. The headache was on the top of her head in a middle but right side only. That was an hour after she got home but it only lasted 20 minutes a little bit here 10 minutes to ease up that was not real hard. It was brief 10 minutes here and brief 10 minutes again. The patient was wondering if this is considered a severe side effect and she was afraid to go back for the second dose. On the next day, 29Apr2021 she was very sleepy and tired, very sleepy when she got home and the rest of the day because it was the day one, she got the shot but rest of the day very tired and sleepy even on second day very tired and sleepy like holyday after everything like something to ease. The third day also felt tired and sleepy. And then it this was not until dissipated; she was able do a little bit more, but those three days were very tired and sleepy after the shot. Those first three days were so bragging entirely tired and sleepy all day. The patient was very tired, and it incapacitated for about 3 to 4 days. On the third day after vaccination (30Apr2021), she noticed that her blood pressure went up but then it came back down. After getting the shot in the arm, patient kept it in the shower and run the warm water on. Her injection side was okay, and the arm was not the problem, however the patient was scared with sleepy for three days and that of headache. Patient took two Tylenol as a pre-medication. The patient stated that because I do not know what to expect because I cannot felt pain but I was so surprised that I still felt the pain and it was lazy like three hours before the 3 or 4 hours before the shot. Then I wait another 3 hours you know you have to wait 6 hours before taking the Tylenol then I take two more and that is all. On an unknown date in early Apr2021, patient had blood work, A1c was good, parathyroid was high, electrocardiogram observed plaque on her heart. To deal with sleepiness and everything she just stayed in the bed and drank lot of water, about 100 ounces of water for the whole day. The outcome of the event sensation of cold recovered on 28Apr2021, headache was recovered on 29Apr2021, sleepy and tiredness was recovered on an unknown date in Apr2021, event blood pressure raised was recovered on 30Apr2021 and outcome of the event pain was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

Other Meds: METFORMIN; AMLODIPINE; D3 VITAMIN; FISH OIL; LOSARTAN; PRAVASTATIN

Current Illness:

ID: 1812279
Sex: F
Age:
State: TX

Vax Date: 04/01/2021
Onset Date: 04/01/2021
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: Test Date: 20210413; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: some mild diarrhea; contact dermatitis/Poison ivy rash; shortness of breath; she hurt where they gave her the shot, on her upper arm, which was sore for a while/she was sore the first time; she had been hurting, but her right hip was hurting which was unusual; she has been losing sleep; chills; This is a spontaneous report from a contactable consumer (patient) via medical information team reported for herself. A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EP7533, Expiry date: unknown) via unspecified route of administration on 01Apr2021 (at the age of 48-year-old) in left arm as dose 1, single for covid-19 immunization. Patient had medical history of mental health and eye problems. She stated she was diagnosed with eye problems since she was 1 year old, she had a lazy eye, all that. She said she was diagnosed as schizoaffective, but she doesn't agree with that, they had her on psych meds a while, but she was not on those anymore. No further details provided about her psych meds. Patient stated that she did not have any other vaccinations the same days as her doses of the Pfizer COVID-19 vaccine, or in the four weeks prior. She stated she hasn't started any new medications. Patient stated she hasn't gotten any vaccines other than the COVID vaccines since she got the flu shot. No further information provided about unspecified flu shot. Patient had received her first dose of Pfizer BioNTech Covid 19 vaccine on 10Apr2021. Then on 13Apr2021 she had what she thought was poison ivy but not sure because she also was experiencing shortness of breath. She was however exposed to poison ivy. She went to urgent care and she was told it was contact dermatitis. She was given medicine but didn't take them and it finally went away. She had some mild diarrhea before the second dose, and it continued after the second dose which she received on 29Apr2021. Patient stated that she had other side effects, like she was sore the first time, which was more than the second time. She says she has been losing sleep, but she doesn't know if that was related, there was one night she slept for hours because she hadn't been sleeping. She says she had chills, and she hurt where they gave her the shot, on her upper arm, which was sore for a while. She says she had been hurting, but her right hip was hurting which was unusual, that was the second day or third day, or a couple days after this. She says the lymph node swelling was the most noticeable she has that is on the list. Patient says her first dose was 01Apr2021, then the second was on 29Apr2021, so four weeks apart. Patient doesn't clarify which events listed after beginning to talk about her first dose side effects were only for her first dose or second dose, or for both. Patient says she went to an urgent care before, because she was having shortness of breath and diarrhea and like poison ivy rash. She says that they tested her for COVID, but that was negative. She says that they didn't do other lab work. She says she thinks that was after her first dose but before her second dose. She says she doesn't know if it was related, she says she thinks they said eczema and not poison ivy, and she thinks it was the food quality for the diarrhea. She clarifies that she went to the urgent care 13Apr2021 for suspected contact with COVID-19 and cough, but she didn't have a cough. She says it also says she had contact dermatitis after contact with poison ivy. She says that was really itchy, she never had a reaction before, she doesn't know if that was related or not. She says her shortness of breath and her diarrhea kind of got better, they had gone away, it took a while. She says they gave her some steroids but she didn't take them, and it went away in a day or so. She says it shook her up though, because she had never had shortness of breath before. Outcome of all events was unknown and for event diarrhea it was recovered unspecified date in Apr2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812280
Sex: F
Age:
State: IN

Vax Date: 02/17/2021
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 erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: rash and red spots around her body.; The caller gets these little red things on her skin that itch a lot; This is a spontaneous report received from a contactable Nurse. A 80-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 17Feb2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Jan2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient experienced rash and red spots around her body and the caller gets these little red things on her skin that itch a lot. It was reported that She received the first dose of the Pfizer COVID-19 vaccine 27Jan2021 and the second dose 22Feb2021. She recently been developing rash and red spots around her body. The red area was itchy. This occurred 6 weeks after she received the second shot. She wants to know if this a latent response to the Pfizer COVID-19 vaccine. She states Its not uncommon for me. I always have rash around my neck and on my body. Its the itchiness that keep coming back. I tried some home remedies. I don't like to take medications. I was glad at least I have the antibodies against covid-19 infection. Maybe this was all part of immune response. I just don't know if this was something I was going to have to live with for the rest of my life or would this go away. She received the 2 doses of the Pfizer Biontech vaccine, caller had her first dose on 27Jan-year not provided as caller was unwilling to complete report, and second dose on 17Feb-year not provided as caller was unwilling to complete report. The caller had a rash develop on her upper body, a red diffuse rash. It wasn't really bothersome. It didn't show up right away, maybe 4-6 weeks after the vaccine. The caller gets these little red things on her skin that itch a lot. The caller gets them mostly on her arms and legs. She has noticed the last couple of days she has noticed at night when the caller gets undressed to shower, she has noticed a rash under her breast to her waist, it doesn't itch. These bumps will finally dry up and go away but they keep reappearing. The caller was 80 years old now. She has an appointment later this month with her primary care doctor just for a routine visit. She hasn't had any life-threatening sort of thing, does not feel like she was in danger or anything. The 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: 1812281
Sex: F
Age:
State:

Vax Date:
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: vaccines given in the same arm and at the same time/the area itched; This is a spontaneous report from a contactable consumer (patient). This 67-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) via an unspecified route of administration administered in the arm on an unspecified date (Batch/Lot number was not reported) as a single dose for immunization and influenza vaccine (FLU), via an unspecified route of administration administered in the arm on an unspecified date (Batch/Lot number was not reported) at an unknown dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The vaccines were given in the same arm and at the same time. The area itched. Outcome of the event was unknown. Pfizer is marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report in situations where another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1812282
Sex: M
Age:
State: AL

Vax Date: 04/23/2021
Onset Date: 04/24/2021
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: Pyrexia, White blood cell count decreased

Symptoms: Pain started in left arm near the injection; A very deep "joint" "nerve" pain; A very deep "joint" "nerve" pain; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 23Apr2021 at 16:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included secukinumab (COSENTYX) and methotrexate (MANUFACTURER UNKNOWN), both taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 02Apr2021 at 10:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021 at 00:00, the day after receiving the 2nd vaccine, the patient experienced pain which started in left arm near the injection site. Since then the patient had pain that came and went in the arm. The patient described it as a very deep "joint" "nerve" pain. On an unknown date in 2021, day 13, the patient was concerned and the pain was continuing to increase but not get better. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain started in left arm near the injection site and a very deep "joint" "nerve" pain was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: COSENTYX; METHOTREXATE

Current Illness:

ID: 1812283
Sex: F
Age:
State: WA

Vax Date: 04/28/2021
Onset Date: 04/29/2021
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: Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the right arm on 28Apr2021 at 15:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included depression, migraines and high blood pressure. The patient did not have any known allergies. Concomitant medications included escitalopram (MANUFACTURER UNKNOWN); bupropion (MANUFACTURER UNKNOWN); hydrochlorothiazide (MANUFACTURER UNKNOWN) and naloxone hydrochloride;buprenorphine hydrochloride (SUBOXONE); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0153) via an unspecified route of administration in the left arm on 07Apr2021 at 15:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 29Apr2021 at 09:00, the patient experienced extreme fatigue lasting four days post second COVID vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event extreme fatigue was resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.

Other Meds: ESCITALOPRAM; BUPROPION; SUBOXONE; HYDROCHLOROTHIAZIDE

Current Illness:

ID: 1812284
Sex: F
Age:
State: MI

Vax Date: 04/22/2021
Onset Date: 04/23/2021
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: Abdominal pain, Chills, Sleep disorder

Symptoms: Floaters in left eye which I have never had in my life. These appeared the next day after 1st shot.; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 at 00:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID) from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23Apr2021 at 10:00, the patient had floaters in left eye which she never had in her life. These appeared on the next day after 1st shot and made her nervous to get second shot. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event floaters in left eye which she had never had in her life, these appeared the next day after 1st shot was not resolved at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: SYNTHROID

Current Illness:

ID: 1812285
Sex: M
Age:
State: MA

Vax Date: 04/25/2021
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: Bones and joints popping, snapping and clicking; Bones and joints popping, snapping and clicking; pain in joints and fingers; pain in joints and fingers; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration, administered in left shoulder on 25Apr2021 at the age of 59 years old as a single dose for COVID-19 immunisation. The patient's medical history included Cholecystectomy from 31Mar2021. The patient's concomitant medications were not reported. The patient had not visited emergency room or physician office due to the event. On an unspecified date the patient experienced Bones and joints popping, snapping and clicking, pain in joints and fingers. The reporter reported that the same time as the popping, snapping, and clicking. It happened kind of after use, and after doing physical activity. The pain had stayed the same. NDC was unknown, does not have vaccine card or any thing with this information on it. The patient reported the time vaccination was given in mid morning. The patient had received the first dose of Pfizer vaccine probably 13 days, for this way the patient had second shot in 2 days, now his concern was since patient had the shot, the first shot all joints keep popping, like just popping, and clicking. The patient concerned was if he felt that it was a side effects and if the patient had the second shot will this get worst, or like patient was trying to pause of what we get from the second shot, or not which is due in 2 days, every time the patient move, click every time move his neck, knees, fingers, elbows, and knees it just keep clicking. The patient did not receive any treatment for events. The outcome of the events was not recovered. The caller was provided with phone number and hours of operation for COVID-19 vaccine inquiries, prior to warm transfer. Follow-up on 03May2021, This is a follow up spontaneous report from a contactable consumer included Patient's information, age at vaccination, and concomitant medication information updated. Follow-up attempts are completed. information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1812286
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: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Fatigue; Flu like sx; Headache; High fever; Diarrhea; Muscle pain; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 27-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 01May2021 at 11:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had known allergies to seafood. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ascorbic acid (VITAMIN C) and zinc (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 09Apr2021 at 11:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 01May2021, the patient experienced fatigue, flu like symptoms (sx), headache, high fever, diarrhea and muscle pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measure was taken as a result of the events which included treatment with paracetamol (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, flu like sx, headache, high fever, diarrhea and muscle pain was not resolved at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: VITAMIN C [ASCORBIC ACID]; ZINC

Current Illness:

ID: 1812287
Sex: F
Age:
State: MO

Vax Date: 05/01/2021
Onset Date: 05/02/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Date: 20210502; Test Name: Body temperature; Result Unstructured Data: Test Result:101; Comments: fever of 101

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Severe chills; Body aches; Fever; severe headache; Extremely tired; This is a spontaneous report from a non-contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 01May2021 at 07:45 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included cancer survivor and known allergies to penicillin, bee stings and adhesive. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN) and collagen (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 10Apr2021 at 08:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. On 02May2021 at 13:00, the patient experienced severe chills, body aches, severe headache, fever of 101 and was extremely tired. On 02May2021, the patient underwent lab test and procedure which included body temperature and the result was 101(unspecified units). No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe chills, body aches, severe headache, fever of 101 and extremely tired was not recovered at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds: AMLODIPINE; ATORVASTATIN; LOSARTAN; COLLAGEN

Current Illness:

ID: 1812288
Sex: F
Age:
State: IN

Vax Date: 04/01/2021
Onset Date: 04/29/2021
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: My period was late and only 1 day long, normally 5 days long.; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 16:15 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included escitalopram oxalate (LEXAPRO) and ethinylestradiol / norethisterone acetate (JUNEL) for unknown indication from unknown date and unknown if ongoing. On 29Apr2021, the patient's period was late and only 1 day long, normally 5 days long. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event period was late and only 1 day long, normally 5 days long was unknown at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: LEXAPRO; JUNEL

Current Illness:

ID: 1812289
Sex: F
Age:
State: UT

Vax Date: 04/09/2021
Onset Date: 04/12/2021
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: 'My' period is late by 3 weeks at the time of this report.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 11:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as none. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. On 12Apr2021, the patient's period was late by 3 weeks at the time of this report. The patient reported that usually it was very regular and had confirmed that she was not pregnant. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event period was late by 3 weeks was not resolved at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1812290
Sex: F
Age:
State: SC

Vax Date: 04/28/2021
Onset Date: 04/28/2021
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: Swollen lymph nodes on left side of neck from clavicle to mandible.; Painful lymph nodes throughout body (bilateral neck, sides of breasts, along sides of spine and sternum, around rib cage, lower abdominal wall, and bilateral groin).; I also have a mild headache; Severe fatigue; Injection site pain; This is a spontaneous report from a contactable healthcare professional, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021 at 13:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety and COVID-19. The patient had no known allergies. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included clonazepam (MANUFACTURER UNKNOWN) and colecalciferol (VIT D3); both for unknown indication from unknown date and unknown if ongoing. The patient did not receive other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 13:45, the patient experienced swollen lymph nodes on left side of neck from clavicle to mandible. The patient had painful lymph nodes throughout her body (bilateral neck, sides of breasts, along sides of spine and sternum, around rib cage, lower abdominal wall, and bilateral groin). The patient also had a mild headache, severe fatigue, and injection site pain. It had been 5 days, so far. Patient mentioned that her doctor told if she was not better by 06May2021, she would have to be seen again for blood work testing, and possible treatment. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph nodes on left side of neck from clavicle to mandible, painful lymph nodes throughout body, mild headache, severe fatigue, and injection site pain was not recovered at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: CLONAZEPAM; VIT D3

Current Illness:

ID: 1812291
Sex: F
Age:
State:

Vax Date: 04/30/2021
Onset Date: 04/30/2021
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: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: In the arm where "I" got the shot pain; In the arm where "I" got the shot redness; In the arm where "I" got the shot swelling; Tiredness; Headache; Muscle pain; Chills; Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the arm on 30Apr2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetic. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 30Apr2021 at 19:00, the patient experienced pain, redness and swelling in the arm where the patient got the shot and tiredness, headache, muscle pain, chills and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain, redness and swelling in the arm where patient got the shot and tiredness, headache, muscle pain, chills and diarrhea were resolving at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1812292
Sex: F
Age:
State: CA

Vax Date: 03/09/2021
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: Periods every two weeks; Heavy bleeding; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration on 09Mar2021 at 02:45 (at the age of 27-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm left on 30Mar2021 at 14:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. On an unknown date in 2021, the patient experienced periods every two weeks and heavy bleeding. The clinical outcome of the events periods every two weeks and heavy bleeding were unknown at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812293
Sex: F
Age:
State: OR

Vax Date: 05/06/2021
Onset Date: 05/06/2021
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:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Triggered migraine with aura. My migraines usually start with reduced vision (like when your eyes are tired) and this was triggered while driving an hour and a half after I received my first dose. tiredness; mild muscle weakness in the shoulder the shotwent in; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 06May2021 at 17:45 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included occasional migraine and COVID-19 ( Prior to the vaccination, the patient was diagnosed with COVID-19). Concomitant medications included etonogestrel (NEXPLANON IMPLANT) left arm, ibuprofen (ADVIL) and fluticasone propionate (FLONASE); all on an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06May2021 at 19:00 the patient experienced triggered migraine with aura, her migraines usually start with reduced vision (like when your eyes are tired) and this was triggered while driving an hour and a half after she received her first dose, also, tiredness and mild muscle weakness in the shoulder the shot went in. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events triggered migraine with aura, tiredness and mild muscle weakness in the shoulder the shot went in was resolving at the time of this report No follow-up attempts are needed. No further information is expected.

Other Meds: NEXPLANON; ADVIL [IBUPROFEN]; FLONASE [FLUTICASONE PROPIONATE.]

Current Illness:

ID: 1812294
Sex: F
Age:
State: MI

Vax Date: 05/05/2021
Onset Date: 05/06/2021
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:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Headache; Muscle and joint pain; Muscle and joint pain; Nausea; Chills; Fatigue; This is a spontaneous report from a contactable consumer (Pfizer employee), the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the right arm on 05May2021 at 16:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included probiotics (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN) and unspecified multivitamin (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 14Apr2021 at 15:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 06May2021 at 07:00, the patient experienced headache, muscle and joint pain, nausea, chills and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, muscle and joint pain, nausea, chills and fatigue was resolving at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: OMEPRAZOLE

Current Illness:

ID: 1812295
Sex: F
Age:
State: WY

Vax Date: 04/30/2021
Onset Date: 04/30/2021
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: Body aches; Muscle stiffness; Neck stiffness; muscle fatigue; Dizziness; Diarrhea; Exhaustion; Redness around the injection site; Swelling around the injection site; Injection site is also warm to touch; This is a spontaneous report from a contactable healthcare professional, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 30Apr2021 at 15:30 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, polycystic ovarian syndrome, and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included SERTRALINE, TOPAMAX, METFORMIN, and BOTOX for an unknown indications, from an unknown date and unknown if ongoing. The patient previously received RISPERIDONE and experienced drug allergy on an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 09Apr2021 at 15:30 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. On 30Apr2021 at 18:00, the patient experienced body aches, muscle and neck stiffness, muscle fatigue, dizziness, diarrhea, exhaustion/fatigue, redness and swelling around the injection site, and injection site was also warm to touch. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, muscle and neck stiffness, muscle fatigue, dizziness, diarrhea, exhaustion fatigue, redness and swelling around the injection site, and injection site is also warm to touch was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: SERTRALINE; TOPAMAX; METFORMIN; BOTOX

Current Illness:

ID: 1812296
Sex: F
Age:
State: VA

Vax Date: 04/22/2021
Onset Date: 04/23/2021
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: Test Date: 20210423; Test Name: Body temperature; Result Unstructured Data: Test Result:102.1; Comments: Fever 102.1

Allergies:

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

Symptoms: 102.1 fever; Severe joint pain in large and small joints; Tingling; Swelling right lower face; Rash; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 22Apr2021 at 16:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included citalopram (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23Apr2021 at 10:00, the patient experienced fever 102.1, severe joint pain in large and small joints, tingling and swelling right lower face and rash. On the same day, the patient underwent body temperature test and the result was 102.1 (unit unspecified). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever 102.1, severe joint pain in large and small joints, tingling and swelling right lower face and rash was resolved with sequelae on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.

Other Meds: CITALOPRAM

Current Illness:

ID: 1812297
Sex: F
Age:
State: OH

Vax Date: 04/07/2021
Onset Date: 04/07/2021
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: LA

Lab Data: Test Date: 20210407; Test Name: Fever; Result Unstructured Data: Test Result: 100.3 Fahrenheit; Test Date: 20210407; Test Name: heart rate; Result Unstructured Data: Test Result: 128 bpm-132 bpm; Test Date: 202006; Test Name: COVID19; Test Result: Negative; Test Date: 202101; Test Name: COVID19; Test Result: Negative.

Allergies:

Symptom List: Unevaluable event

Symptoms: She had a fever of 100.3F within 12 hours of having the vaccine the first time; blurred vision; nausea; extreme headache; massive migraine; Unwell; muscle pains and chills; muscle pains and chills; fast heartbeat then the nigh, heart rate is 128 bpm-132 bpm; Injection site pain; Joint pain; vomiting; Tiredness; Dizziness; weakness; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number, and Expiry date: not reported) age at the time of vaccination was 29 years, administered in Arm Left on 07Apr2021 at 09:30 as dose 1, single for COVID-19 immunization. The patient's medical history included thyroid problem about eight years ago that went away. The patient's concomitant medication was not reported. The patient did not take any other vaccine in four weeks prior COVID-19 vaccine. On 07Apr2021, after the first dose the patient had a fever of 100.3 Fahrenheit within 12 hours of having the vaccine the first time. The patient felt unwell causing blurred vision, nausea from extreme headache comparative to a massive migraine, vomiting. The patient had experienced muscle pains and chills. The patient have a fast heartbeat then the night, heart rate of 128 bpm - 132 bpm, tiredness, injection site pain, joint pain, dizziness, and weakness lasted for five days. The Pfizer was unable to make any treatment recommendations for individual patients who may receive the Pfizer vaccine. Clinical judgement made by your physician/HCP based on the medical history and the clinical status of a specific patient should dictate the appropriate actions to be taken. No investigation assessment. Therapeutic measures included IBUPROFEN for fever. The patient underwent lab tests and procedures, which included Fever 100.3 Fahrenheit, heart rate 128 bpm-132 bpm, Covid19 negative on an unknown date in Jun2020, Jan2021. The outcome of the events was fever, dizziness, weakness resolved, blurred vision, migraine, unwell, fast heartbeat then the nigh, heart rate is 128 bpm-132 bpm, was unknown, nausea, headache, muscle pains, chills, Injection site pain, Joint pain, vomiting, and Tiredness was not resolved. No follow-up attempts were needed, information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812298
Sex: F
Age:
State: NJ

Vax Date: 05/05/2021
Onset Date: 05/05/2021
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: Test Date: 20210425; Test Name: Nasal Swab; Test Result: Negative.

Allergies:

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

Symptoms: chest pressure; back pressure; pain in hardware; puking; migraines; nausea; fever; injection site pain; tired; muscles pain; chills; joint pain; feeling unwell; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 43-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and Expiration date was not reported) via an unspecified route of administration, administered in arm right on 05May2021 17:30 (at the age of 43 years old) as dose, 2 single for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing, Hyperglycemic, renal disorder from an unknown date and unknown if ongoing, attention deficit hyperactivity disorder from an unknown date and unknown if ongoing, limb discomfort from an When probed for other medical condition, consumer stated, I had hard legs (not clarified), multiple allergies from an unknown date, and unknown if ongoing, known allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and Expiration date was not reported) via an unspecified route of administration, administered in arm right on 14Apr2021 17:30 (at the age of 43 years old) as dose, 1 single for COVID-19 immunization. On 05May2021 17:30, patient experienced chest pressure, back pressure, pain in hardware, puking, migraines, nausea, fever, injection site pain, tired, muscles pain, chill, joint pain, and feeling unwell. The patient was not pregnant at the time of vaccination. The patient didn't receive any other vaccine in four weeks. The patient took other medications a bunch in two weeks. Adverse events resulted in emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 25Apr2021. The outcome of the events was not recovered. Information about the Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1812299
Sex: F
Age:
State: GA

Vax Date: 05/05/2021
Onset Date:
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: Swelling that has "gone underneath the skin, at the right arm pit"/I have swelling under my armpit; My arm that I got it in is really sore; I am facing swelling; My arm is really stuck; I am experiencing some swelling in my arm that I got in which; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 61-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP8731, Expiration date: unknown) via an unspecified route of administration, administered in arm on 05May2021 (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in arm on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization and she didn't have any problem just sore throat from the first one for a couple of days and experienced some swelling in her arm that she got in which. The patient received the second dose of the Pfizer-BioNTech COVID-19 Vaccine last Wednesday, 05May2021. On an unspecified date, the patient experienced some swelling that had "gone underneath the skin, at the right arm pit", little swelling under her armpit. Her arm that she got it in was really sore and she was facing swelling under her armpit. She experienced some swelling in her arm that she got in which. She knew it was normal because she had it with her first one but this time she had swelling under her armpit. Not more than the swelling under her armpit. Her arm was really stuck and it concerned her when she saw swelling under her armpit. On an unspecified date, the patient had facing swelling. She asked if that was normal. She asked for information on this possible side effect. The patient received the response stating that the Pfizer-BioNTech COVID-19 mentioned no information found on swelling that has "gone underneath the skin, at the right arm pit", and referred to HCP for guidance. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812300
Sex: F
Age:
State: MA

Vax Date: 05/04/2021
Onset Date: 05/04/2021
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: instantly when she came home she was tired and crashed; When she woke up she noticed that her forearms were itchy and then so were her shoulders and her hands were hivey; When she woke up she noticed that her forearms were itchy and then so were her shoulders and her hands were hivey; It was blotchy; she has developed hives and a rash all over her; it almost looked like eczema; This is a spontaneous report from a contactable consumer (patient). A 38-year-old old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8736), via an unspecified route of administration, administered in arm left on 04May2021 12:00 (at the age of 38-year-old) as single dose for COVID-19 immunization. Medical history included ongoing Graves' disease which was diagnosed 8 years ago, allergic reaction to Sulfa. Concomitant medication(s) included LEVOTHYROXINE taken for Graves' disease from an unspecified start date (taking this 8 years ago) and ongoing. The patient had no additional vaccines administered (on same date as Pfizer vaccine considered as suspect). The patient had no prior vaccination (within 4 weeks prior). The patient had no relevant family history related to AE(S). It was reported that patient would like to report the following side effect that she experienced post administration of the PFIZER-BIONTECH COVID-19 VACCINE. She mentioned she got her first dose noontime, EST. She came home tired, but she mentioned this might be just because of work. She had a nap and when she woke up and developed hives all over her body which was very itchy. Patient confirmed that she did not experience any difficulty in breathing at all. The patient's side effect was that she had developed hives and a rash all over her, but she did not experience any shortness of breathing or difficulty. Just the hives and all and being itchy. On 04May2021, when she came home after having her COVID vaccine she was tired, and said to her son that it could just be related to her running around with the medical field in general. She had been tired because she had worked a lot of double shifts lately. But instantly when she came home she was tired and crashed. When she woke up she noticed that her forearms were itchy and then so were her shoulders and also her hands were hivey. She has had a similar reaction when she had an allergic reaction to sulfa except her hives weren't as bright as they were now with the Sulfa. She was itchy from the top of her forehead all the way down to the MCT joint. Her toes didn't itch but she was itching all the way down to her metatarsals. She called the hospital and their emergency room to see about what to do but they were useless. She didn't go to her hospital because she didn't want people that she works with to know all about her and what was happening with her. She got her COVID vaccine on 04May2021, around 1200. She still had some hive spots but they were very light. She took Benadryl and it got better. As far as the spots being raised, they were not raised anymore but it almost looked like eczema. It was blotchy. AE(s) did not require a visit to emergency room or physician office. The patient had no relevant tests. Outcome of the event fatigue was not recovered, hives, itching was recovering, and other events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: LEVOTHYROXINE

Current Illness: Graves' disease

ID: 1812301
Sex: F
Age:
State: TX

Vax Date: 04/22/2021
Onset Date: 04/22/2021
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: Headache; a tender lump suddenly appeared either at the injection site; rash; left arm was slightly sore; This is a spontaneous report received from a contactable consumer (Patient) via a program. A 48-years-old female patient received bnt162b2 (COMIRNATY, PFIZER BIONTEC MRNA COVID-19 VACCINE, solution for injection, Batch No. not reported/Lot Number: EW0175) via an unspecified route, administered in left arm on 22Apr2021 at 10:00 AM (Age at vaccination 48 years old) as dose 2, single for covid-19 immunization. The patient medical history reported as none and concomitant medications was not reported. Family Medical History Relevant to AE were reported as none. Patient has received prior Vaccinations included Pfizer dose 1 within 4 weeks. AE(s) following prior vaccinations were reported as none. The historical vaccine included bnt162b2 (COMIRNATY, PFIZER BIONTEC MRNA COVID-19 VACCINE, solution for injection, Batch No. not reported/Lot Number: EP6955) via an unspecified route, administered on 30Mar2021 at 10:00 AM in left arm as dose 1, single for covid-19 immunization. Patient would like to discuss a delayed reaction to 2nd Pfizer vaccine. It was reported that, patient received second Pfizer COVID shot two weeks ago. On 22Apr2021 the day of vaccination, Patient experienced with his left arm was slightly sore and on 05May2021, at 12:00, the patient experienced a tender lump suddenly appeared either at the injection site or very close to it, patient found some information regarding delayed cutaneous sensitivity, but it seems to be related more to a rash appearing about a week out and on 06May2021, with headache. AE did not require a visit to Emergency Room and Physician Office. The reporter wanted to know whether or not this might be vaccine related. No Investigation assessment was reported. Relevant Tests were reported none. Treatment taken reported as None. The outcome of the event left arm was slightly sore was recovered on 24Apr2021, tender lump in her left arm close to where she was vaccinated, headache was not recovered, and rash was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812302
Sex: M
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: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: the patient had the second dose of Pfizer vaccine and broke into hives 3 days; This is a spontaneous report from a non-contactable pharmacist. A 32-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history not reported. The patient's concomitant medications were not reported. It was reported that the patient had the second dose of Pfizer vaccine and broke into hives 3 days after vaccine. The outcome of event was unknown.

Other Meds:

Current Illness:

ID: 1812303
Sex: U
Age:
State:

Vax Date:
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: whole left side is swollen/onto my left neck and my left shoulder, my left arm and my whole left side to my waist it feels like a jelly fish kind of swelling; My arm and my left arm started swelling; onto left neck and left shoulder, left arm and whole left side to waist it feels like a jelly fish kind of swelling/not just swollen arm its huge it's quarter of my body my left side is swollen; onto left neck and left shoulder, left arm and whole left side to waist it feels like a jelly fish kind of swelling/not just swollen arm its huge it's quarter of body my left side is swollen; onto left neck and left shoulder, left arm and whole left side to waist it feels like a jelly fish kind of swelling/not just swollen arm its huge it's quarter of body my left side is swollen; This is a spontaneous report based on information received by Pfizer from Concentrix via a contactable consumer (patient). A patient of unknown age and gender received second dose of received second dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date as Dose 2, single for Covid 19 Immunization. Medical history and family history was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: Solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration on an unspecified date for Covid-19 immunization. Patient did not experienced any event after first vaccine and was fine. The patient's concomitant medications were not reported. The patient had second Covid vaccine last thursday (unspecified date in 2021) and immediately under arm and left arm started swelling. Since then, the patients left neck, left shoulder, left arm and whole left side to waist felt like jelly fish kind of swelling, it was not hard its soft movable and it kept getting worst and it was not just swollen patients arm its huge it's quarter of patient's body. Left side was swollen but neck, shoulder, and arm, under arm down to waist and so half part of waist has movable swelling. The outcome of all events was unknown. No follow-up attempts are needed. information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1812304
Sex: M
Age:
State:

Vax Date: 05/05/2021
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:
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: Fever; Nausea; Headache; body aches; Fatigue; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional (the patient). A male patient of an unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number: eW0170, expiry date: not reported), via an unspecified route of administration on 05May2021 as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation solution for injection, Batch/Lot number: EW0170, expiry date: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On 06May2021, the patient experienced fever, nausea, headache, body aches, and fatigue. No treatment was received for all the reported events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1812305
Sex: M
Age:
State: NJ

Vax Date: 04/30/2021
Onset Date: 04/30/2021
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: Severe chills; Nausea; High fever; Body ache; Dizziness; This is a spontaneous report from a contactable consumer. A male patient of unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 30Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 30Apr2021, the patient experienced severe chills, nausea, body ache and dizziness. On 30Apr2021 night, the patient experienced high fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events. The clinical outcome of the event's severe chills, nausea, body ache and dizziness was resolved on an unknown date in 2021 and high fever was resolved by 03May2021 night. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1812306
Sex: F
Age:
State: AZ

Vax Date: 03/16/2021
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: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: developed a persistent cough that continues; This is a spontaneous report from a contactable consumer. A 75-year-female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number EN6206 and expiry date was not reported), via an unspecified route of administration on 16Mar2021, (age at vaccination: 74 years), as dose 2, single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Feb2021 (at the age of 74-years-old), as dose 1, single dose for COVID-19 immunization. The patient reported that a couple of days after she received the second dose, she developed a persistent cough that continues and it was her only symptom. Her doctor said that there have been reports of a Covid vaccine cough and it has been reported by a bunch of people. The doctor told her to call Pfizer about what to do about it. The patient's daughter stated that she had an allergic reaction to the first dose of the Pfizer covid vaccine which she reported on VAERs and to Pfizer. She was told not to get the second vaccine. The patient's stated that she had this vaccine in February the first dose and the second dose in the middle of March the second dose she started having severely persisting cough. On an unspecified date in Mar2021, the patient developed a persistent cough that continues. Outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812307
Sex: F
Age:
State: IN

Vax Date: 03/23/2021
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:

Allergies:

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

Symptoms: Arm hurting/arm was sore; The pain ended up on like her shoulder blade and it's still sore like someone punched her; Now, its moving to the back of the neck area; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that: A 53 years of age female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown) via an unspecified route of administration on 23Mar2021 (At the age of 53 years) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The Patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown) via an unspecified route of administration on unspecified date as dose 1, single for covid-19 immunisation. On an unspecified date in Mar2021, the patient had experienced arm hurting/arm was sore, pain ended up on her shoulder blade and for now pain moving to the back of the neck area. she states that it feels as though she has been punched in the area and she is concerned. At the time of reporting, the outcome of the events were unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812308
Sex: F
Age:
State:

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: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

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

Symptoms: fell asleep her tongue on the left side; headache; muscle pain; dizziness; This is a spontaneous report from a non-contactable consumer (herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date, as DOSE 1, SINGLE for covid-19 immunisation. Medical history was not reported. Concomitant medication included cresol (LYSOL [CRESOL]), via an unspecified route of administration from an unspecified date on an unspecified date, for unspecified indication. A Consumer called for information about the efficacy of Pfizer's COVID-19 vaccine if she accidentally inhaled some Lysol aerosol. The Consumer reported on 09May2021 that she accidentally inhaled some Lysol aerosol and fell asleep her tongue on the left side, which was the side where she was given the first dose of Pfizer's COVID-19 vaccine. The Consumer reported that she received the first dose of the vaccine yesterday and after administration of the first dose she suffered from headache, muscle pain and dizziness. The consumer response that today she has good health. The clinical outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained

Other Meds: LYSOL [CRESOL]

Current Illness:

ID: 1812309
Sex: F
Age:
State: NJ

Vax Date: 03/17/2021
Onset Date: 03/18/2021
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: Test Name: Bloodwork; Result Unstructured Data: Test Result:Unknown; Test Name: Temperature; Result Unstructured Data: Test Result:101 Fahrenheit; Comments: High

Allergies:

Symptom List: Tremor

Symptoms: Bad headache; Chills; Fever 101F (never went over 101)/Light fever; Nausea; Vomiting; This is a spontaneous report from a contactable consumer (patient herself). A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EP7534; Expiry Date: 31Jul2021), via an unspecified route of administration in arm right on 17Mar2021 18:15 as dose 1, single (at the age of 63-years-old) and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0162; Expiry Date: 31Jul2021), via an unspecified route of administration in arm right on 07Apr2021 18:15 as dose 2, single for COVID-19 immunisation. She did not receive any other vaccines prior to 4 weeks. The patient's medical history included diabetes mellitus, she was a juvenile diabetic, so she has had diabetes for like 40 years. The patient's concomitant medications included Levemir 8 units a day, she has taken it for a few years for diabetes mellitus. On 18Mar2021 03:00, the patient experienced bad headache, chills, fever 101 Fahrenheit (never went over 101) and light fever, nausea and vomiting. It was reported that the side effects were to be perfectly expected had then after both vaccines, seemed to be coming back intermittently. These side effects started after both vaccines about 8 hours after the injection. After the first dose, the side effects went away after about 2.5 days. After the second dose the side effects came back after 7 to 10 days and then came back again that week, Thursday, at 3 o'clock in the morning. The same thing lasted 18 hours. The events were over first 8 hours about 6 times with a total of 3 times with each re-occurrence. It was reported that the bad headache lasted about a day and a half. The vomiting only lasted about 8 hours. It was reported that after the second dose, she woke up next day on 08Apr2021 at 04:00 and her headache woke her up. It was pretty much the same progression as everything after the first dose. This was more like 24 hours after the second short, it lasted a little longer. It was 24 hours before her side effects were gone. That was on 09Apr2021 that all of her symptoms went away. It was reported that she woke up on 10Apr2021 and was feeling 100% better. She gets bloodwork done every 3 months and she has had it done since she had the vaccine. The patient underwent lab tests and procedures which included blood test: unknown, body temperature increased: 101 Fahrenheit. It was not required for patient to visit the emergency room or physician office. Therapeutic measures were taken as a result of fever 101f (never went over 101) and light fever (pyrexia) included Tylenol (It was for about 18 hours). The outcome of the events was recovered on 09Apr2021. No Follow-up attempts are needed. No further information expected.

Other Meds: LEVEMIR

Current Illness: Diabetes (She was a juvenile diabetic, so she has had diabetes for like 40 years. She takes insulin)

ID: 1812310
Sex: F
Age:
State: PA

Vax Date:
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: shortness of breath; she had allergies; fatigue; a head cold; drainage from nose; nausea; no sense of taste and smell; no sense of taste and smell; cough; that her doctor stated she got coronavirus while getting injected; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer reported for herself that: A 57-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation (age at the vaccination 57 years old). The patient medical history was not reported. The patient's concomitant medications were not reported. Patient reported that after her first dose of vaccine she had symptoms as if she had coronavirus, she experienced allergies, fatigue, shortness of breath, head cold, drainage from nose, then it went to the chest, cough, nausea and no sense of taste and smell, on an unspecified date. She would like to know how long will it last because she on the 8th after getting vaccinated. Added that her doctor stated she got coronavirus while getting injected. The outcome for the events was unknown. No follow-up attempts are possible. Information on Lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812311
Sex: U
Age:
State:

Vax Date: 05/01/2021
Onset Date: 05/01/2021
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: shoulder pain/when his family member rotates their shoulder, it hurts a little bit; swollenness/ might be swollen; still having injection site pain; maybe the injection didn't go into the muscle of the arm/maybe the injection went into the bursa of the shoulder; shoulder injury; hot in that area; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 7-decade-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number and expiry date: not reported ), via an unspecified route of administration on 01May2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number and expiry date: not reported), via an unspecified route of administration on 10Apr2021 (at age of 7 decade) as DOSE 1, SINGLE for covid-19 immunisation. In May2021, the patient still has shoulder pain, some swollenness and it should be hot in that area (was administered almost a week ago). Caller wanted to know if it could be a shoulder vaccination injury and was still having injection site pain and when his family member rotates their shoulder, it hurts a little bit and it might be swollen (May2021). The reporter doesn't believe that this was normal and he can not find any more information about it online and says that maybe the injection did not go into the muscle of the arm and maybe it went into the bursa of the shoulder. The reporter was asking if this has been reported. What are the next steps, does his family member need to see their doctor as doesnot sound normal. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1812312
Sex: F
Age:
State: IN

Vax Date: 04/23/2021
Onset Date: 04/24/2021
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 Date: 20201128; Test Name: Spit Test; Result Unstructured Data: Test Result:Negative

Allergies:

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

Symptoms: the dose was administered "too low, and into the fatty part of my arm".; dose 1st dose on 20Apr2021 and 2nd dose on 23Apr2021; have redness and swelling near the injection site, which traveled down her arm, and around to her back; have redness and swelling near the injection site, which traveled down her arm, and around to her back; the area is "very warm to the touch"; brusing; Spread past injection site from back of arm to back side of torso; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EW0162, Expiry date: unknown) (age at the time of vaccination was 55 years, patient was non-pregnant at the time of vaccination), administered in Arm Right on 23Apr2021 as dose 2, single for COVID-19 immunization. The patient's medical history included seizure, asthma, drug allergy to phenergan. The patient's concomitant medication included Lamotrigin, montelukast, cetrizine and losartan. The patient did not take any other vaccine in four weeks prior COVID -19 vaccine. She was not diagnosed with COVID prior vaccination and tested negative with COVID post vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: ER975), via an unspecified route of administration, administered in Arm Right on 20Apr2021 at 12:00 as dose 1, single for COVID-19 immunization. On 24Apr2021, the patient started to have redness and swelling near the injection site, which traveled down her arm and around her back. The patient reported that the area was warm to touch. The patient has been seen by primary care and visited the emergency room and they told to take an antihistamine treatment. The patient believe that the dose may have been given incorrectly. The patient stated that the person who administered the dose was joking around, walking too much and not paying attention to what she was doing, and thinks that the dose was administered too low and into the fatty part of her arm. On 20Apr2021 the patient took first dose and on 23Apr2021 the patient took the second dose. The patient's treatment included antibiotic. The outcome of the events was unknown. Follow-up attempts completed. No further information expected.

Other Meds: LAMOTRIGIN; MONTELUKAST; CETRIZINE; LOSARTAN

Current Illness:

ID: 1812313
Sex: M
Age:
State: NC

Vax Date: 05/06/2021
Onset Date: 05/06/2021
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: Test Date: 20210507; Test Name: Fever; Result Unstructured Data: Test Result:100 degrees; Test Date: 20210430; Test Name: COVID-19; Result Unstructured Data: Test Result:Negative

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Fever of 100 degrees; The "little" pain in his arm.; That night he could not sleep; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 41-years-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 06May2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On 6May2021 and reports that that night he could not sleep properly because of the "little" pain in his arm and stated that this morning (07May2021) has a fever of 100 degrees. Caller would like to know if it is normal to have a fever after the first dose of the vaccine. The patient underwent lab tests and procedures which included body temperature: 100 degrees on 07May2021 and covid-19: negative on 30Apr2021. The 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: 1812314
Sex: F
Age:
State:

Vax Date: 04/27/2021
Onset Date: 04/28/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Mild chills; Moderate headache; Moderate fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 27Apr2021 at 13:00 at the age of 41-year-old as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737 via an unspecified route of administration in the left arm on 06Apr2021 at 20:00 at the age of 41-year-old as a single dose for COVID-19 immunisation. On 28Apr2021 at 01:00, the patient experienced mild chills, moderate headache, and moderate fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department, or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of events mild chills, moderate headache, and moderate fatigue was resolved on an unknown date in 2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1812315
Sex: M
Age:
State: CA

Vax Date: 05/04/2021
Onset Date: 05/04/2021
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: This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 39, via an unspecified route of administration, on May 4, 2021, single dose, for COVID-19 immunisation. No medical history, known allergies or concomitant medications reported. Prior to the vaccination, patient was not diagnosed with COVID-19. On May 4, 2021, at 23:00, patient experienced difficulty sleeping, flu-like symptoms, body aches, feeling hot and cold, headache and sweating at night. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures taken as a result of the events. Since the vaccination, patient has not tested for COVID-19. The outcome of difficulty sleeping, flu-like symptoms, body aches, feeling hot and cold, headache and sweating at night: resolving (at the time of this report). No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 1812316
Sex: M
Age:
State:

Vax Date: 05/04/2021
Onset Date: 05/04/2021
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: Muscle soreness in area of vaccine injection when moving the arm or when touching the area; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 04May2021 at 10:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 13Apr2021 at 10:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 04May2021 at 12:00, the patient experienced muscle soreness in area of vaccine injection when moving the arm or when touching the area. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event muscle soreness in area of vaccine injection when moving the arm or when touching the area was resolving at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1812317
Sex: F
Age:
State:

Vax Date: 04/22/2021
Onset Date: 04/26/2021
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: experiencing sores around those implants/quite painful; hard to chew; the regions are blackening.; "I" have implants and I am experiencing sores around those implants; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 22Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included dental implant. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. 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 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an an unknown date as a single dose for COVID-19 immunisation. The patient had implants and on 26Apr2021 the patient experienced sores around those implants which makes it hard to chew and were quite painful, also those regions were blackening. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sores around those implants which makes it hard to chew and were quite painful and also those regions were blackening, were not resolved at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1812318
Sex: F
Age:
State: MA

Vax Date: 04/22/2021
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: Test Name: COVID-19; Test Result: Positive

Allergies:

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

Symptoms: Had a sore sport on her arm/sore arm from second dose; Had flu-like symptoms; Chills; achy joints/significant joint aches; headaches; Low grade fever; Body aches; Very thirsty; She kept going from hot and cold; sickness; had a severe case of total body arthritis in which she was crawling around the house; Muscle aches; This is a spontaneous report from a contactable consumer. This 63-year-old female consumer reported for herself reported via medical information team. A 63-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: EW0170, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 22Apr2021 11:30 as dose 2, single for COVID-19 immunization. Patient did not administer additional vaccines on same date of the Pfizer Suspect and did not vaccination with in 4 weeks. Medical history included ongoing arthritis (she was diagnosed with arthritis years ago sometime in her 40s), she had COVID at the start of the pandemic and seasonal allergy (She states she has been cleaning out a family home that is dusty but she has been wearing a mask. She states that she has some seasonal allergies from mowing the lawn but she is not allergic to anything she has allergies). The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2(PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: ER8732 or iR8732, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 30Mar2021 12:30 as dose 1, single for COVID-19 immunization and patient experienced sore arm from first dose and fatigue from first dose. On 23Apr2021, the patient experienced a sore sport on her arm/sore arm from second dose, had flu-like symptoms, chills, achy joints/significant joint aches, headaches, low grade fever, Body aches and very thirsty. On an unspecified date on 2021, the patient experienced muscle ache, had a severe case of total body arthritis in which she was crawling around the house, She kept going from hot and cold and sickness. Reporter is a 63 year old female patient who has already received both doses of the Pfizer COVID Vaccine. She mentioned that at the start of the pandemic, she was sick for a month with flu-like symptoms along with her son. She mentioned that she had a lengthy reaction to her 2nd dose of the vaccine. After the 2nd dose, she had a sore sport on her arm the next day and was fine for a few days. From 22Apr2021 to 03May2021 she mentioned that she had flu-like symptoms with chills, muscle aches, achy joints, headaches, low grade fever, and chills. She mentioned that she had arthritis but after the shot she had a severe case of total body arthritis in which she was crawling around the house. She mentioned that she viewed this as normal, because she and her family would often get sick for a day or 2 after their flu shots decades ago. As of calling, she mentioned that she is already feeling fine. She suspects that she had COVID at the start of the pandemic and would like to determine if people who had previously had COVID had a more intense reaction to the vaccine. She also mentioned that she has no pre-existing conditions, no medications, and is healthy. Reporter states that she was diagnosed with arthritis years ago, sometime in her 40s. She states that she can't play piano anymore and that the arthritis is pretty bad in her hands and feet and all her joint really. She states it is pretty common in old people. She says it did feel that more significantly worse after the second vaccine. She states that it was typical vaccination symptoms and more lengthy. She was wondering if there was any correlation between her age or her having COVID in the past which is why she called. She states that in the beginning of the pandemic she got sick and she didn't go to the doctor because her doctor left the practice. She had over a month of sickness, and she regrets not going to the doctor. She stated that the sickness kept going on and on and on. She states that she called in to see if there was any correlation with her having COVID in the past and lengthy side effects from the second dose. She states that she had no prior immune problems, no high blood pressure, no diabetes, she is not over weight, she just has arthritis. She states she had a humdinger of a reaction to the second vaccine. She states that it was easily 7 days and it started 22Apr2021 after the second injection and lasted till this past Monday 03MAY 2021, when she recovered. She states that she was surprised it was more lengthy then everyone else. She called to find out if she had COVID in the past and maybe she didn't know and that is why she reacted this way. She states that she was not afraid and was not grossly ill. She states that she is still such an advocate of the vaccine. She has friends who refuse to get the vaccine and she is trying to get her friends to get the vaccine. She states that her sickness was more lengthy then her friends and she was disappointed that it lasted so long but she is over it. She states that she knows young people who don't want to wear masks, even though most people do. She does states that some are not and some don't seem to recognize how important this is. She has been looking up links she can send to people, links that she is finding. Reporter stated that her first reaction was nominal, and with the second one, her daughter is a doctor, and her son, everyone was surprised that she did have a lengthy sickness. She states she did have the flu prior to the pandemic, but she wears masks religiously. She states it was just her second vaccine symptoms which were lengthy. She was not alarmed, she got through it and everything is fine. She is not even telling people she was sick, it's just personal thing. She states she had a mild flu for about a week, and she is normally very active. She couldn't get out and do what she normally does. She states she is rarely sick. She states that she only felt her arm being sore when she was sleeping on it. She noticed at night that it was sore. She states she did notice it during the day but it wasn't as bad because she was using it. Reporter stated that after the second dose the symptoms came on very quickly and significantly. She could still creep around the house. She states that normally her arthritis bothers her, its old age, everyone has it, but her joints ached so much worse than they normally do. She had chills and a low grade fever. She kept going from hot and cold. She said the low grade fever would come and go and she did take her temperature but she doesn't have it written down. She states that she tried to take her temperature accurately so she didn't bundle up. Her body aches were really surprising. She states the whole time she had chills, but everything seem to dissipate on Monday. She states that she is grateful it is over, and that's why she decided to call be-cause it lasted so long. She states that during the time she was sick she was suppose to get eyes checked but she said no way. She didn't want to go anywhere, do anything or see anyone. She states that she takes care of her neighbour but she had to call her and tell her to get someone else to come and help her because she was sick and didn't want to be around her just in case it was something she could give her. States that by Monday 03May2021 she was feeling better. She had very little arm pain, and she states that she heard people complain about how their arms hurt for a while but it didn't really bother her. She states that she was in a military family and they got the flu vaccine every year and her whole family would be grossly sick, and she points out this was decades ago. She states that her mom and dad realized that they should stagger getting the flu shot so that not everyone was sick at the same time. She states that her being sick after the second vaccine was nothing, she just did a lot of reading and drinking. She wondered if she was catching Covid at the time she got the vaccine. She suspects that she had COVID at the start of the pan

Other Meds:

Current Illness: Arthritis (Caller states that she was diagnosed with arthritis years ago sometime in her 40s)

ID: 1812319
Sex: M
Age:
State: MA

Vax Date: 05/03/2021
Onset Date: 05/03/2021
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 Date: 20210503; Test Name: Body temperature; Result Unstructured Data: Test Result:102; Comments: Fever

Allergies:

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

Symptoms: Extreme fatigue; Extreme chills; Extreme muscle aches; Fever 102; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 03May2021 at 15:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included Penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. 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 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 11Apr2021 at 16:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On 03May2021 at 18:30, the patient experienced extreme fatigue, extreme chills, extreme muscle aches, fever 102 (unspecified units). on the same day(03May2021) the patient checked body temperature and the result was found to be 102 (unspecified units). Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme fatigue, extreme chills, extreme muscle aches and fever 102 was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812320
Sex: M
Age:
State: MI

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: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: getting a tickle down at the bottom of our throat to our chest; coughing our heads off; This is a spontaneous report from a contactable consumer (reported for her husband) via medical information team. A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0172, Expiry date: unknown) via an unspecified route of administration in arm left on 27Apr2021 (at the age of 66-years-old) 14:00 as dose number 2, single for COVID-19 immunization. Patient was diabetic from an unknown date which was diagnosed 4 years ago and had blood pressure high from an unknown date and was diagnosed when he was 16 years old and patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0150, Expiry date: unknown) via an unspecified route of administration in left arm 06Apr2021 as dose number 1, single for COVID-19 immunization. The patient's concomitant medications were not reported. Patients wife stated that she and her husband (patient) both got vaccinated at the same time. They had no symptoms of anything and stayed there for 15 minutes. On their way home, 20 minutes into the drive, they started getting a tickle down at the bottom of their throat to their chest. Before they got home, they both started coughing their heads off. It has continued until yesterday (which was one week from receiving the vaccine) and now they still have a cough. The patient came down with a cough after receiving the shot which has lasted about a week. These events happened after the second dose, the first dose was fine, they did not have any side effects with the first one. Reporter and her husband experienced an adverse event with the second dose of the Pfizer Covid-19 vaccine. They received both doses. Outcome of event getting a tickle down at the bottom of our throat to our chest was recovering and coughing our heads off was recovered on unspecified date in May2021. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021503831 same reporter/drug/event, different patient

Other Meds:

Current Illness:

ID: 1812321
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: itching and "knot" in throat; superficial red bumps to upper right arm near vaccination site; itching and "knot" in throat; superficial red bumps to upper right arm near vaccination site; This is a spontaneous report from a contactable pharmacist. A 30-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8733), via intramuscular route of administration in the right arm on 29Apr2021 (at the age of 30-years-old) as dose 2, single for COVID-19 immunization, rubella vaccine (RUBELLA), via an unspecified route of administration on 29Apr2021, (Batch/Lot number was not reported), for immunization. Medical history included known allergies, HPV vaccine, penicillin, walnuts, amoxicillin, avocado, azithromycin, banana, ciprofloxacin, grapes and asthma, crohns disease, ulcerative colitis, migraines, allergies from an unknown date and unknown if ongoing. There were no concomitant medications. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8733), via intramuscular route of administration in the left arm on 08Apr2021 as dose 1, single for COVID-19 immunization. The patient did not receive any other medication in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that, patient developed mild itching and knot in throat, superficial red bumps to upper right arm near vaccination site. Patient was given 2 cups of water and symptoms resolved soon after. The patient did not receive any treatment for the events. The clinical outcome for the events was recovered on an unspecified date in 2021. No follow-up attempts are required. No further information is expected

Other Meds:

Current Illness:

ID: 1812322
Sex: F
Age:
State: NY

Vax Date: 04/09/2021
Onset Date: 04/10/2021
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: Test Date: 202012; Test Name: blood work; Result Unstructured Data: Test Result:Unknown

Allergies:

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

Symptoms: Her second dose was on April 09 and she had mild joint pain then now its progressed to moderate joint pain.; Her second dose was on April 09 and she had mild joint pain then now its progressed to moderate joint pain./joint pain had increased; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, administered in Arm Left on 09Apr2021 09:05 (Batch/Lot Number: EW0150) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included urinary retention from 2016 and ongoing, Interstim Implant for Bladder, ongoing electrocardiogram t wave inversion she had the inverted T waves all her life, clarifying she had issues since college, ongoing hypoglycaemia Stated she had hypoglycemia since high school. No further details provided, ongoing gluten sensitivity she had gluten intolerance, and another autoimmune issue referred to as leaky gut, ongoing asthma Stated she was diagnosed with moderate asthma as a child. No further details provided, Lobular carcinoma of breast from Dec2020 to an unknown date Stated she had a lumpectomy on her right breast in Dec2020. diagnosed with a lobular carcinoma that was not cancerous, but considered a high-risk lesion, and was removed. Concomitant medications were not reported. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6206) via unspecified route administered in Arm Left on 19Mar2021 at 9:48 AM On 10APR2021 DOSE 1, SINGLE for COVID-19 immunization. Reported after her first COVID-19 Vaccine shot, she got sick. She said she had joint pain and body aches, and her arm, and all that stuff. On 10Apr2021 Her second dose was on April 09, and she had mild joint pain then now its progressed to moderate joint pain and her second dose was on April 09 and she had mild joint pain then now its progressed to moderate joint pain. /Joint pain had increased. It was reported that with the 2nd COVID-19 Vaccine shot, she just had joint pain that started the next day (10Apr2021), and the joint pain had continued and increased was reported as worsened. Treatment: Reported she took ginger (clarified as Nature's Way Brand Ginger Root 1.1g capsule), and turmeric (clarified as Solgar Curcumin) for her joint pain, providing: Nature's Way Brand Ginger Root 1.1g capsule UPC Number: # Lot Number: Unknown Expiration Date: Unknown Stated she did not see a Lot Number and Expiration Date listed on the product packaging. Solgar Brand Curcumin (Curcuminoids 48mg) soft gel capsule UPC Number: 3398454708 Lot Number: 485875-04 Expiration Date: Nov2021. Patient underwent lab tests and procedures which included blood test: unknown on Dec2020. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness: Asthma (Stated she was diagnosed with moderate asthma as a child. No further details provided.); Bladder inability to empty (Verbatim: Interstim Implant for Bladder); Gluten intolerance (she had gluten intolerance, and another autoimmune issue referred to as leaky gut.); Hypoglycemia (Stated she had hypoglycemia since high school. No further details provided.); Inverted T waves (she had the inverted T waves all her life, clarifying she had issues since college.)

ID: 1812323
Sex: F
Age:
State: CA

Vax Date: 04/10/2021
Onset Date: 05/01/2021
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:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: 'My' period cycle started 10 days early and it is heavier than usual; 'My' period cycle started 10 days early and it is heavier than usual; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Apr2021 at the age of 33-years-old as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. The patient did not take any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 01May2021, the patient's period cycle started 10 days early and it was heavier than usual. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events period cycle started 10 days early and it was heavier than usual was resolving at the time of the report. No follow-up attempts are required, information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1812324
Sex: F
Age:
State:

Vax Date: 03/05/2021
Onset Date: 03/05/2021
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: Severe constant upper abdominal pain; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 67-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 05Mar2021 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to penicillin. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), budesonide, formoterol fumarate (SYMBICORT), atorvastatin (MANUFACTURER UNKNOWN), levothyroxine sodium (SYNTHROID) and metoclopramide hydrochloride (LIOTHYL): all from an unknown date for unspecified indication and unknown if ongoing. The patient previously took codeine (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. On 05Mar2021 at 17:00, the patient experienced severe constant upper abdominal pain and nausea. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of severe constant upper abdominal pain and nausea and included treatment with unspecified anti-nausea medications (meds) and pain killers. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe constant upper abdominal pain and nausea was recovered on unknown date on 2021. No follow-up attempts are possible. No further information is expected.

Other Meds: LISINOPRIL; SYMBICORT; ATORVASTATIN; SYNTHROID; LIOTHYL

Current Illness:

ID: 1812325
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: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

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

Symptoms: day before getting the first vaccine, a medication she took and to which she had not reacted in the past was increased; rash persisted and worsened after the second dose; crazy itchy rash travelling on [her] body; feels like a "deep sort of pain"; This is a spontaneous report from a contactable consumer (Patient). A 60-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history included rash from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, via an unspecified route of administration from an unspecified date (Lot: unknown) to an unspecified date, as a single dose for covid-19 immunization. Reporter reported patient took Shingles at a younger age. The patient experienced day before getting the first vaccine, a medication the patient took and to which the patient had not reacted in the past was increased. On an unspecified date the patient experienced rash persisted and worsened after the second dose, crazy itchy rash travelling on her body, deep sort of pain and rash after each dose of the vaccine. The reporter reported that after each dose patient developed a rash, but it was worse after the second dose, stated patient had a deep pain like shingles, not readily going away, crazy itching traveling on her body, has been 4 weeks that she has had the rash. The doctors decided to stop the medication. The reporter reported regardless, the rash was worse after the second dose of the vaccine. Doctors determined the rash was due to the vaccine and may be starting medication for shingles as the rash was persisting. The outcome of the events of Rash aggravated, Itchy rash, pain and Potentiating drug interaction was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am