VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1743988
Sex: M
Age:
State: CT

Vax Date: 03/05/2021
Onset Date: 03/05/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Developed an allergic reaction; reaction I had sort of looked like eczema, was a skin reaction; Rash up and down my both legs from my hip to my ankle; Developed an allergic reaction; reaction I had sort of looked like eczema, was a skin reaction; Developed an allergic reaction; reaction I had sort of looked like eczema, was a skin reaction; This is a spontaneous report from a contactable consumer or other non hcp. A 68-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 as DOSE 1, SINGLE for covid-19 immunisation; bromocriptine mesilate (BROMIDINE), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at UNKOWN for glaucoma. Medical history included hypertension from an unknown date and unknown if ongoing, Blood pressure high, blood cholesterol from an unknown date and unknown if ongoing, Cholesterol, glaucoma from an unknown date and unknown if ongoing Verbatim: Glaucoma. Concomitant medications included losartan (LOSARTAN) taken 100 mg for hypertension, start and stop date were not reported; rosuvastatin (ROSUVASTATIN) taken 10 mg for blood cholesterol, start and stop date were not reported; nebivolol hydrochloride (BYSTOLIC) taken 5mg for an unspecified indication, start and stop date were not reported; timolol (TIMOLOL) 2mg, Brimonidine taken Two mg for glaucoma, start and stop date were not reported. The patient experienced developed an allergic reaction; reaction I had sort of looked like eczema, was a skin reaction on 05Mar2021 with outcome of unknown, rash up and down my both legs from my hip to my ankle on 05Mar2021 with outcome of unknown, developed an allergic reaction; reaction i had sort of looked like eczema, was a skin reaction on 05Mar2021 with outcome of unknown , developed an allergic reaction; reaction i had sort of looked like eczema, was a skin reaction on 05Mar2021 with outcome of unknown, rash up and down my both legs from my hip to my ankle on 05Mar2021 with outcome of unknown, rash up and down my both legs from my hip to my ankle on 05Mar2021 with outcome of unknown. Therapeutic measures were taken as a result the events. Follow-up (11May2021): Follow-up attempts completed. No further information expected.

Other Meds: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034

Current Illness:

ID: 1743989
Sex: F
Age:
State: NY

Vax Date: 03/22/2021
Onset Date: 03/23/2021
Rec V Date: 09/29/2021
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: wheezing; Entire body aches; coughing; lymph nodes in the left arm out are swollen; head hurts; Exhausted; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, in the right arm on 22Mar2021 at 18:15 (at the age of 47-year-old) as dose 1, single for COVID-19 immunization. Medical history included COVID-19. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23Mar2021 at 07:00, the patient's lymph nodes in her left arm out were swollen. The patient had entire body aches. The patient was wheezing and coughing. Her head was hurting and was exhausted. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events . The outcome of the events was not recovered at the time of the report.. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1743990
Sex: F
Age:
State: PA

Vax Date: 03/11/2021
Onset Date: 03/01/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: itchy rash on left shin and calf; After second dose, rash continued in these areas and spread to left forearmand hand, right hand, behind bothknees, chest, lower back; This is a spontaneous report from a consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6199) via an unspecified route of administration in the left arm on 11Mar2021 at 09:45 (at the age of 65-year-old) as dose 2, single for COVID 19 immunisation. Medical history included hypertension and fibromyalgia. Concomitant medication included atenolol, simvastatin and diphenhydramine Hydrochloride, all for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL9269) via an unspecified route of administration in the left arm on 15Feb2021 at 09:45 (at the age of 65-year-old) as single dose for COVID 19 immunisation and experienced diffuse bumpy intensely itchy rash on left shin and calf where her rash continued to spread right leg. The patient had history of allergy to erythromycin. Prior to the vaccination,the patient was not diagnosed with COVID-19 and did not receive any other vaccine within four weeks. The patient was not pregnant at the time of vaccination. After taking the second dose, on an unspecified date in Mar2021, the patient had experienced itchy rash on left shin and calf and spread to left forearm and hand, right hand, behind both knees, chest, lower back. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient was not tested positive for COVID-19 since the vaccination. Therapeutic measures in response to the events included, topical and oral steroids. The outcome of the events was not resolved at the time of report. No follow-up attempts are needed. No further information is expected.

Other Meds: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034

Current Illness:

ID: 1743991
Sex: M
Age:
State: NC

Vax Date: 03/03/2021
Onset Date: 03/16/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 70-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EN6204), at the age of 70, via an unspecified route of administration, left arm, on Mar 3, 2021, at 12:30, single dose, for COVID-19 immunisation. Patient also took oral amoxicillin 500mg 2x/day (batch/lot# not reported) from Mar 12, 2021 to Mar 15, 2021, for swollen gums. No medical history or concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. No additional vaccines administered on same date of the Pfizer suspect. On Mar 16, 2021, at 22:00, patient experienced itching on sides of stomach/back (from lower back to shoulders), mild rash and very minor redness. Patient stated he took the vaccine on Mar 3, 2021 and it didn't seem like he had any side effects. He stated last week around Mar 16, 2021 (almost 2 weeks after the shot), he started itching a lot. Mar 16, 2021 through yesterday, he stated he had a mild, itchy rash; with itching on his sides and back. Patient stated he had never had a problem with amoxicillin before. On Mar 15, 2021, his doctor switched him to azithromycin 250mg pill by mouth. Therapeutic measures taken as a result of events included Cortisone, lotion, and Gold-Bond powder. The events did not result in physician office or emergency room visit. The outcome of the events: recovering. No follow-up attempts possible. No further information expected.

Other Meds:

Current Illness:

ID: 1743992
Sex: M
Age:
State: AR

Vax Date: 03/22/2021
Onset Date: 03/22/2021
Rec V Date: 09/29/2021
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: 20210322; Test Name: Body temperature; Result Unstructured Data: Test Result:100; Comments: Fever running upwards to 100 (unspecified units)

Allergies:

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

Symptoms: Fever running upwards to 100.; Muscle aches; Could not sleep night of shot; This is a spontaneous report from a contactable other healthcare professional (patient). A 69-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 22Mar2021 at 12:30 (at the age of 69-year-old) as dose 2, single for COVID-19 immunisation. The patient had no medical history and did not have any allergies to food, medications, or other products. The patient did not take any concomitant medications. The patient previously 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 01Mar2021 at 12:30 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 22Mar2021 at 20:00, the patient experienced fever and muscle aches. Fever was running upwards to 100 (unspecified units) and the patient could not sleep at night of shot. The adverse event did not result in a visit to the doctors 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. No treatment was received for the reported events. The outcome of the events could not sleep at night of shot, fever and muscle aches 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:

Current Illness:

ID: 1743993
Sex: M
Age:
State: NY

Vax Date: 02/18/2021
Onset Date: 02/01/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Date: 20210302; Test Name: DEXA scan; Result Unstructured Data: Test Result:Unknown results; Comments: She said the good news, is the cancer did not spread to any part of his body. It did not go to his bones and his PSA dropped tremendously. Bad news is that there is severe arthritis throughout his body.; Test Name: bone scan imaging; Result Unstructured Data: Test Result:Unknown results; Comments: a bone mineral density; Test Date: 20210310; Test Name: CT scan; Result Unstructured Data: Test Result:Unknown results; Comments: She said the good news, is the cancer did not spread to any part of his body. It did not go to his bones and his PSA dropped tremendously. Bad news is that there is severe arthritis throughout his body.; Test Date: 20201216; Test Name: PSA reading; Result Unstructured Data: Test Result:5.07

Allergies:

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

Symptoms: minor pain on left shoulder; severe pain in wrist,shoulders and left clavicle.; there is severe arthritis throughout his body; he is experiencing lethargic feelings; he wants to sleep all day; constantly tired; he lost a few pounds; He has low appetite; This is a spontaneous report received from a contactable consumer. This 73-year-old male consumer received 2nd dose of Pfizer COVID vaccine (Batch/Lot Number: EN9581),intramuscular on 18Feb2021,at the age of 73 years old,as Dose 2,single for covid-19 immunization.Medical history included prostate cancer from an unknown date and unknown if ongoing He had Prostate cancer for many years and is being treated by hormone therapy.That is consisting of an injection of a hormonal drug called Lupron and arthritis from an unknown date and unknown if ongoing The Tylenol for Arthritis is 650 mg. He took 2. Lot SJ8033, expiration Jul2023. Count size 24 caplets.It was sealed.He had arthritis before with just minor back pain.Concomitant medication(s) included leuprorelin acetate (LUPRON) taken for prostate cancer from 11Apr2016 to an unspecified stop date.The patient previously took lupron for prostate cancer and experienced therapeutic response shortened, bnt162b2 for covid-19 immunisation and experienced pain in extremity.The patient experienced severe pain in wrist,shoulders and left clavicle there is severe arthritis throughout his body,he is experiencing lethargic feelings, he wants to sleep all day,constantly tired on Feb2021, he lost a few pounds, he has low appetite on Feb2021 and minor pain on left shoulder on 28Feb2021.The patient underwent lab tests and procedures which included bone densitometry: unknown results on 02Mar2021 She said the good news, is the cancer did not spread to any part of his body. It did not go to his bones and his PSA dropped tremendously. Bad news is that there is severe arthritis throughout his body,bone scan: unknown results on a bone mineral density,computerised tomogram: unknown results on 10Mar2021 She said the good news, is the cancer did not spread to any part of his body.It did not go to his bones and his PSA dropped tremendously. Bad news is that there is severe arthritis throughout his body, prostatic specific antigen: 5.07 on 16Dec2020. Therapeutic measures were taken as a result of there is severe arthritis throughout his body.Patient asked the doctor if the vaccine injection could cause a flare up of his arthritis.The doctor could not tell him if there were a reports because the studies were not conclusive yet.The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: Pfizer, Inc. EUA 027034

Current Illness:

ID: 1743994
Sex: F
Age:
State:

Vax Date: 03/12/2021
Onset Date: 03/16/2021
Rec V Date: 09/29/2021
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: hypersensitivity; swelling; This is a spontaneous report from a contactable consumer (patient) via Sales Rep originating from a Nursebased on information received by Pfizer(Mfr. Control number: 21121474US). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration on 15Mar2021 as dose 1, single for COVID-19 immunization. Patient also received botulinum toxin type a (BOTOX COSMETIC, Powder for injection), 10 UNITS to forehead and 10 UNITS to glabella on 12Mar2021 (Lot Number: C6736, Expiration Date: 30Nov2023), at 10 iU, single for skin wrinkling. The patient medical history and concomitant medications were not reported. On 16Mar2021 the patient experienced swelling and allergic reaction/hypersensitivity. The patient was going on vacation and was treated with Medrol Dose Pack to relieve the swelling on 16Mar2021. At the time of the report, the outcomes of hypersensitivity and swelling were reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1743995
Sex: U
Age:
State:

Vax Date: 02/24/2021
Onset Date: 03/01/2021
Rec V Date: 09/29/2021
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: I had little bit of a rash on my arm and back; might be some shrimp ate or the shrimp crostini that I ate the night before/could be a reaction to the shrimp maybe it was not fully cooked; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EN6200, and expiration date was not reported), via an unspecified route of administration on 24Feb2021 as single dose for covid-19 immunization. Patient medical history and concomitant medications was not reported. The patient took first dose on 24Feb2021 did not feel a thing, everything was great, not any kind of symptoms or anything. On an unspecified date in Mar2021, on 10 day the patient felt like if the patient had little bit of a rash on arm and back but, patient was concerned if it could have been an effect with the first dose of vaccine or might be some shrimp ate or the shrimp crostini that I ate the night before so did not pay attention to it then on the second vaccine. The patient went to get the second vaccine, that was on the 17Mar2021, so had a little bit of the rash on the arm. The patient mentioned it to the nurse and then she said do you want to tell your doctor first before having the second dose and then I said oh no, no of course not, I said I am not going to let the little, tiny rash get in the way of getting the second dose of the vaccine. So, then I had the second dose and then coincidentally or not but the rash that I have on my back became like more intense like itchy and both arms and my back. I do not have it on the lower body it just kind of like on my lower neck, my lower back and both arms, that's kind of very itchy, so then I went to the urgent care centre on Sunday and then the doctor gave me 3 medications including the one that was called Prednisone 10 mg, so this was steroid. Then when I spoke with my doctor on Monday afternoon, he told me that he was very concerned, he told me to stop taking Prednisone (Captured suspect conservatively) right away. He said this was steroid and it could potentially block the effect or the effectiveness of the vaccine, so I don't advise to take steroid at all. So now my concern is the following, could I have potentially slow or blocked the effectiveness of the vaccine. I started taking the steroid or Prednisone, it was 4 days after the second dose of Pfizer vaccine, so I had my second dose on the 17Mar2021 around 15:30 in the afternoon and I took 10 mg of Prednisone on Sunday afternoon, so it would have been exactly 4 days after the second dose. So then on Monday morning at 9:30 in the morning I took 1 Prednisone another one at 14:30. So a total of 3 that would have been a total of 30 mg in 2 consecutive days until I spoke with the doctor in the afternoon or the evening of Monday night, and he told me stop taking it, he said I don't want you to take any chances of you blocking the effectiveness of the vaccine and then you having to maybe another boost of the vaccine or having to redo all over again, I am not taking it. But then the reason I waited hours to speak with you, is that now I am concerned, should I be worried that maybe taking those 3 pills of the steroid Prednisone, should I be concerned that maybe the effectiveness of the vaccine was not going to be like full effect like normally what it would have done without the steroid or am I safe. The patient thought that it could be something else, it could have been, because it was 10 days later, it could have been because I ate the shrimp crostini the night before and maybe it could be a reaction to the shrimp maybe it was not fully cooked. Outcome of events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1743996
Sex: F
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
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: The area where the cyst was became very agitated/much more agitated. It feels like a bad sunburn that you cannot see, shocks up my arm; The shoulder and armpit on that side also became sore and tingly; The shoulder and armpit on that side also became sore and tingly; The shoulder and armpit on that side also became sore and tingly/like someone is tingling my armpit; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, in Arm, on an unspecified date in 2021 (at the age of 57-year-old) as DOSE 1, SINGLE and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration on 19Mar2021 at 19:00 as DOSE 2, SINGLE, both for covid-19 immunization. Medical history included cyst and that cyst removed from back in the fall and type 2 diabetes (controlled by diet and exercise). Concomitant medications included Inositol supplement, fish oil, vitamins. The patient had no Allergies to medications, food, or other products. No known allergies. The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. The Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient stated that, on an unspecified date in 2021, after both doses, the area where the patient had cyst was became very agitated. The shoulder and armpit on that side also became sore and tingly. That side that was agitated became much more agitated. It felt like a bad sunburn that cannot see, shocks up the arm, randomly like someone is tingling on her armpit. The patient's health provider said to just let it go and that it is just a reaction to the shot. They examined patient but the ironic part is there is nothing to see--no rash, etc. It is over a week now and patient becoming concerned and plan to call doctor again today. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The outcome of the events was not recovered at time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034

Current Illness:

ID: 1743997
Sex: F
Age:
State:

Vax Date: 03/25/2021
Onset Date: 03/26/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Date: 20210326; Test Name: Body temperature; Result Unstructured Data: Test Result:99.9 (unspecified units)

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Slept most of the day; very lethargic; low fever (99.9); arm sore; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration, on 25Mar2021 at 13:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no concomitant medications. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration, on 04Mar2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced arm sore the day of the second vaccine. The next day the patient had a low fever (99.9) and felt very lethargic, slept most of the day with an on and off fever. However, the next morning the patient felt fine and no longer had a fever. The patient did not receive treatment for the reported events. The events neither resulted in doctor or other healthcare professional office/clinic visit nor emergency room/department or urgent care. The clinical outcome of the events arm sore, low fever, very lethargic and slept most of the day were recovered on an unknown date at the time of report. No follow-up attempts are possible. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination Facility Country added. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1743998
Sex: F
Age:
State: IL

Vax Date: 03/19/2021
Onset Date: 03/19/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Date: 20210319; Test Name: Body temperature; Result Unstructured Data: Test Result:99; Comments: 99 degree fever

Allergies:

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

Symptoms: Sore arm; abdominal pain; migraine; intense body pain; joint pain; swollen ankles; 99 degree fever; fatigue; insomnia; This is a spontaneous report from a contactable consumer (patient). A 62-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 right arm on 19Mar2021 at 13:45 at the age of 62-year-old as a dose 1, single for COVID-19 immunisation. Medical history included Post-traumatic stress disorder, fibromyalgia-in remission. The patient was allergic to yellow jackets, lactose intolerant, some anaesthesia shut the patient's bladder done. Concomitant medications included suvorexant (BELSOMRA), quetiapine fumarate (SEROQUEL), alprazolam, citalopram hydrobromide (CELEXA) and aspirin all started on an unknown date for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 19Mar2021 at 13:45, after the vaccination, the patient experienced sore arm, abdominal pain, migraine, intense body and joint pain, swollen ankles, 99-degree fever, fatigue and insomnia. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures and treatment were not taken for the reported events. The outcome of the events was recovered on an unknown date in Mar2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds: Pfizer, 027034; Pfizer, 027034; Pfizer,. EUA 027034; Pfizer, 027034; Pfizer 027034

Current Illness:

ID: 1743999
Sex: M
Age:
State: CT

Vax Date: 03/24/2021
Onset Date: 03/24/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Soreness at injection site in right deltoid; Low grade fever; Headache; General aching; Fatigue; This is a spontaneous report from a contactable physician. A 63 year old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 24Mar2021 11:45 (Batch/Lot Number: EP-6955) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 11:45 (Batch/Lot Number: EL3247) as DOSE 1, SINGLE for covid-19 immunisation. triamcinolone acetonide (NASACOR T), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history and concomitant medications were not reported. The patient experienced soreness at injection site in right deltoid causing vaccination site pain on 24Mar2021 21:00 with outcome of recovering, low grade fever causing pyrexia on 24Mar2021 21:00 with outcome of recovering , headache on 24Mar2021 21:00 with outcome of recovering, general aching on 24Mar2021 21:00 with outcome of recovering, fatigue on 24Mar2021 21:00 with outcome of recovering. Therapeutic measures were taken as a result of this with Tylenol 500mg x 1 Follow-up (30Mar2021): This is a follow-up spontaneous report from a contactable physician. This physician reported for the patient in response to the below mentioned query: Query: The Pfizer Drug safety unit recently received the attached report submitted by you. Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events. Please ensure to reply all to this email. Response: This report was for events that occurred after my second COVID vaccine and so awareness dates would be the same as the AE start dates. Soreness at injection site in right deltoid started on 24th March 2021 and so this would be the awareness date for that event. The other reported AEs of low grade fever, headache, general aching and fatigue all started on 25th March 2021 and so that would be the awareness date for each of these events. Hopefully this will provide the information that you require around these events. The Pfizer Drug safety unit recently received the attached report submitted by you via Pfizer safety reporting.com. Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that Pfizer became aware of the adverse events. Please ensure to reply all to this email. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1744000
Sex: M
Age:
State: TX

Vax Date: 03/21/2021
Onset Date: 03/22/2021
Rec V Date: 09/29/2021
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: 20210322; Test Name: Body temperature; Result Unstructured Data: Test Result:102; Comments: in the morning it was 102 and spikes in night goes up to 103; Test Date: 20210322; Test Name: Body temperature; Result Unstructured Data: Test Result:103; Comments: in the morning it was 102 and spikes in night goes up to 103

Allergies:

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

Symptoms: I had continuous fever and its fluctuate it doesn't drop; in the morning it was 102 and spikes in night goes up to 103; Chills; Joint pain; It burns to urinary; The second dose did not work for me; I am having trouble with pain relief medicine not doing their job; This is a spontaneous report from a contactable consumer (Patient). A 69-years-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch no: not reported/Lot number- ER8727) via an unspecified route of administration in arm left (reported as left) on 21Mar2021 (at the age of vaccination of 69-years-old) as dose 2, single for COVID-19 immunization. Patient also received ibuprofen (oral suspension) via an unspecified route of administration on an unspecified date. Patient's relevant medical history included with blood pressure, cholesterol, gout, kidney stones and enlarged prostate. Concomitant medications included ongoing amlodipine for the Indication of Blood pressure, ongoing Atorvastatin for the Indication of Cholesterol, ongoing allopurinol for the Indication of Gout, ongoing potassium citrate for the Indication of Kidney stones and ongoing tamsulosin for the Indication of Enlarged prostate, all were from unknown start date. On 22Mar2021, patient had continuous fever and it was fluctuated it does not drop; in the morning it was 102 and spikes in night goes up to 103, chills, joint pain, it burns to urinary, and he had trouble with pain relief medicine not doing their job. Patient reported as he had Covid-19 Vaccine on 21Mar2021, and the nurse told me that he could expect the side effects and they would last for 24-36 hours. On 22Mar2021, patient started experiencing side effects however this was his 4th day which he had continuous fever and it was fluctuate it does not drop, in the morning it was 102 and spikes in night goes up to 103 that's pretty much the fever for 4 days that kind he had and he taken Ibuprofen as Treatment for which it worked for the first dose and for the second dose did not work. Patient had trouble with pain relief medicine not doing their job and asked for any better option for this, hence Ibuprofen coded as Conservatively captured as co-suspect. Also, he had chills, joint pain and have been treated for enlarge prostate, drinking lot of water like he supposed to but it burns to urinary some and it does not a big urgency, so he had some effects with prostate. Investigation Assessment was reported as No. Treatment was received with Ibuprofen for the events. Outcome of the events was not recovered. No follow-up attempts are possible. Information on Batch number, Lot number cannot be obtained. No further information is expected.

Other Meds: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034

Current Illness:

ID: 1744001
Sex: M
Age:
State: TX

Vax Date: 03/05/2021
Onset Date:
Rec V Date: 09/29/2021
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: cough; headache; feeling sick; This is a spontaneous report from a Pfizer-sponsored program Covax US Support. A contactable consumer reported for male patient of an unspecified age (Father) that he received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on 05Mar2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced cough, headache, feeling sick on an unspecified date. His second dose was scheduled on 26Mar2021. Reporter asked if it was okay to get the second dose. The outcome of event was unknown. Follow up attempts are Completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1744002
Sex: M
Age:
State: AR

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 09/29/2021
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: Renewed itching after 2nd dose; This is a spontaneous report received from a contactable consumer (patient) reported in response to non-HCP letter sent in cross reference case. A 77-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL92102) (also reported as EL9262 May2021), dose 2 intramuscular, administered in Arm Left (upper) on an unspecified date in Jan2021 (Mid-afternoon, at the age of 77-years-old) as dose 2, single for COVID-19 immunisation. Patient's medical history (including any illness at time of vaccination) was unknown and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EK4176, expiration date: Mar2021), dose 1 intramuscular, administered in Arm Left (upper) on 31Dec2020 (at the age of 77-years-old) as dose 1, single for COVID-19 immunisation and experienced It's really itchy on his back and several other places left upper arm and bum (Urticaria and Itchy) from 14Jan2021. Vaccination Facility type was Pharmacy or drug store. The patient experienced Renewed itching after 2nd dose on an unspecified date in Jan2021 (3rd week) and the patient stated First dose after 2 weeks was getting better but got worse after the 2nd dose. To the question on event required the initiation of new medication/ other treatment procedure, the patient answered that to many people in waiting room first, was very nervous. No social distance has not gone back for more treatment itching not severe to go back in there. The event outcome was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1744003
Sex: F
Age:
State: DE

Vax Date: 03/17/2021
Onset Date: 03/29/2021
Rec V Date: 09/29/2021
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: Fever; Chills; Dizziness; knots under skin; fell flat on my face; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported) via an unspecified route of administration, in the right arm on 17Mar2021(at the age of 63-years-old) as Dose 2, single for COVID-19 immunization. Medical history was not reported. The patient reported that he was not allergic to medication he used every day. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN620G) via an unspecified route of administration, in the left arm on 24Feb2021(at the age of 63-years-old) as Dose 1, single for COVID-19 immunization and on 24Mar2021 at 16:00 experienced swollen arms and lymph node, arms and wrists hurt. The patient concomitant medication included other unspecified medications in two weeks of vaccination. The patient was not pregnant at time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 29Mar2021, the patient experienced fevers, chills, knots under skin, dizziness when outside and fell flat on his face and he was back in bed. 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: 1744004
Sex: M
Age:
State: CA

Vax Date: 03/25/2021
Onset Date: 03/26/2021
Rec V Date: 09/29/2021
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: Myalgia; Slight fever; Joint pain; Fatigue; Chills; Worsening of tinnitus; Headache; Gastrointestinal distress; Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 50-years-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6199, expiration date: unknown) via an unspecified route of administration, administered in Arm Right on 25Mar2021 11:15 (at the age of 50-years) as dose2, single for covid-19 immunization at workplace clinic. Historical vaccine included received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration. administered in Arm Right on 04Mar2021 11:00 (Batch/Lot Number: EN5318) (at the age of 50-years-old) as SINGLE for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient medical history included hypertension and had covid-19 from an unknown date and unknown if ongoing. Patient concomitant medications included Losartan, Lexapro and Eliquis all were taken for an unspecified indication, start and stop date were not reported for any. The patient previously took avelox and experienced drug allergy. On 26Mar2021, the patient experienced myalgia, slight fever, joint pain, fatigue, chills, worsening of tinnitus, headache, gastrointestinal distress and had swollen lymph nodes. The patient did not received any treatment for the events. The outcome of all the events was not recovered. No follow-up attempts were needed. No further information was expected.

Other Meds:

Current Illness:

ID: 1744005
Sex: F
Age:
State: TX

Vax Date: 03/28/2021
Onset Date: 03/28/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:103; Comments: fever

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: High fever (103), injection site issues (hot, swollen, painful), swollen painful lymph nodes (radiating pain); High fever (103), injection site issues (hot, swollen, painful), swollen painful lymph nodes (radiating pain); High fever (103), injection site issues (hot, swollen, painful), swollen painful lymph nodes (radiating pain); High fever (103), injection site issues (hot, swollen, painful), swollen painful lymph nodes (radiating pain); This is a spontaneous report received from a contactable consumer (patient herself). A 35-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6206, expiry date: unknown) via unspecified route of administration in right arm on 07Mar2021 15:00 as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: ER8733, expiry date: unknown) via unspecified route of administration in right arm on 28Mar2021 15:00 (age at vaccination: 35-years) as dose 2, single for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Doctor's office/urgent care. Patients medical history included Factor 5 Leiden, Hiatal hernia and egg allergy from an unspecified date and unknown if ongoing. Concomitant medication included Protonix, taken for unspecified indication, start and stop date not reported, received within 2 weeks of vaccination. Patient experienced high fever (103), injection site issues (hot, swollen, painful), swollen painful lymph nodes (radiating pain) on 28Mar2021 04:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No treatment as received due to the adverse events. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number are available.

Other Meds: Pfizer, Inc. EUA 027034

Current Illness:

ID: 1744006
Sex: F
Age:
State: AL

Vax Date: 03/15/2021
Onset Date: 03/16/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Date: 20201216; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Positive; Test Date: 20210108; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Positive

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: extremely sick; huge fever; chills; nauseated; extremely tired; sleepy; hurt all over/ every bone in her body was hurting; diarrhea; it flet like the flu; felt out of it; headache; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 63-years-old female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: EN6205, NDC number: unknown, Expiry Date: unknown), via an unknown route of administration in left arm on 15Mar2021 at 14:40 (at the age of 63-years-old) as dose 1, single for COVID-19 immunization. Limited information available as consumer hung up the call abruptly, hence product details (NDC, UPC, LOT and expiration date) and further details were unknown. The patient's medical history included asthma and had allergies; both were from unknown date and unknown if ongoing. Concomitant medications included amlodipine (AMLODIPINE), montelukast sodium (SINGULAIR MINI), ascorbic acid, rosa canina fruit (VITAMIN C & ROSEHIP), cetirizine hydrochloride (ZYRTEC ALLERGY) and zinc; all were taken for an unknown indication from an unknown date. On 16Mar2021, twelve hours after the vaccine at about 2:00 am, the patient experienced huge fever, chills, nauseated, extremely tied, diarrhea, felt out of it, headache, it felt like the flu and was sleepy, hurt all over/ every bone in her body was hurting. On an unknown date, she got extremely sick. She received the first dose of the Pfizer COVID 19 vaccine on 15Mar2021. Caller stated her second dose scheduled on 05Apr2021, but she does not know if she should get the second dose because she got extremely sick after first dose. Twelve hours after the vaccine at 02:00 am, she woke up with a huge fever, chills, nauseated, extremely tied and sleepy, hurt all over and had diarhea. She never felt that bad before stating every bone in her body was hurting. Described it as the weirdest thing stating it felt like the flu. She thought she should wake her husband up and go to the ER. Her husband called her HCP because she was so sick. She would not call her symptoms severe or call it an allergic reaction. Her HCP advised to take two Benadryl and sleep it off. The caller basically had every side effect on the list and it lasted almost 2 days, it was so weird. Usually did not have anything go wrong, it was so bizarre and she was leery about getting the second vaccine scheduled on 05Apr2021. The caller felt worse after the vaccine than when she had covid itself. She had COVID on 16 December2020 (around Christmas) and waited 90 days to get the first dose of the vaccine. On 8Jan2021, she had a positive antibody test. Caller stated HCP advised to do antibody titers and when they wane, get the second dose. The outcome of events ?huge fever', ?chills', ?nauseated', ?diarrhea', ?felt out of it', ?headache', ?it felt like the flu' and ?sleepy' was recovered on an unknown date in 2021, the outcome of the remaining events was unknown. Follow up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1744007
Sex: F
Age:
State: TN

Vax Date: 03/30/2021
Onset Date: 03/31/2021
Rec V Date: 09/29/2021
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: Itching in her head, neck and around her shoulder/itching on head, on my scalp and my neck; Itching in her head, neck and around her shoulder/itching on head, on my scalp and my neck; Itching in her head, neck and around her shoulder/itching on head, on my scalp and my neck; just scratched and finely it went away; Psoriasis has flared up/aggravated my Psoriasis; Psoriasis has flared up/aggravated my Psoriasis; Body, muscle and joint aches; Body, muscle and joint aches/muscle and joints ache a lot; Body, muscle and joint aches/the muscle and joints ache a lot; Pain in arm where she was given the shot; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8734 and expiry date were not reported), via an unspecified route of administration, on 30Mar2021 at 16:15 PM (age at vaccination: 68 years), as a single dose for COVID-19 immunization. The patient's medical history included diabetes, high blood pressure, high cholesterol, anaphylactic reaction to shellfish (caller also mentioned that in the past (less than 10 years ago) she had an anaphylactic reaction to shellfish, the reaction went down pretty fast, she can't remember if she took medication, her doctor told her that if she eats shellfish again she should have benadryl; caller is also allergic to iodine (in shellfish) and latex), psoriasis, allergic to iodine (in shellfish) and latex, and sometimes when her blood sugar levels are high it makes her skin itch. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.), vitamin D [VITAMIN D NOS], simvastatin (STATIN), and insulin. 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, on an unspecified date (age at vaccination: 68 years), as a single dose for COVID-19 immunization. She experienced itching in her head, neck and around her shoulder, she has psoriasis in her scalp and her neck on 31Mar2021, the psoriasis has flared up she didn't have a rash or itching anywhere else and it didn't itch all the time, she would like to know if the itching in the areas where she has psoriasis could be related to the Pfizer-BioNtech Covid-19 vaccine, she stated that she has diabetes, high blood pressure and high cholesterol, sometimes when her blood sugar levels were high it makes her skin itch and she hadn't checked her blood sugar levels this morning, she mentioned that this could relate to diabetic neuropathy because it deals with nerves. She also experienced other side effects; body, muscle and joint aches, pain in arm where she was given the shot and she had the same feeling in the other arm. The patient stated, she got my second pfizer vaccine yesterday and she started itching on head, on her scalp and her neck while she was trying to sleep, she just did not have any Benadryl or anything like that so she just scratched and finely it went away but she noticed that the side effects included rash but she didn't have rash all over her body, she was just having itching on her head and on her neck and she also have psoriasis on her neck and some on her head so she started wondering was this a severe allergic reaction or was this something will go away because she was not feeling much right now and sometimes her Psoriasis did this, it itches quite a bit and then it goes away, so she called your number just to make sure, its not an emergency or anything, she just called to make sure that she should be okay because she have been reading something that people who get terrible allergic itch reaction they had to go to the hospital and their skin was really messed up and she didn't think thats her situation. The patient stated that she did not have anything for itching so she just scratch and hopefully it will go away, it was not extreme, but like she said she had Psoriasis, on the bottom of her, on her neck, you know down below her neck, below the hairline, she had Psoriasis, and that aggravated her Psoriasis, thats might be why it itching. She did not feel like getting up and taking Tylenol, it was just miserable but as soon as she woke up this morning she took 2 Tylenols and she was feeling better already and surely she thought that was only other side effect that she had, she didn't have fever or anything like that. Outcome of the events Itching in her head, neck and around her shoulder/itching on head, on my scalp and my neck was not recovered and for all other events, it was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034

Current Illness:

ID: 1744008
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
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 Name: CAT scan; Result Unstructured Data: Test Result:Unknown result

Allergies:

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

Symptoms: headaches; neck and shoulder pain; neck and shoulder pain; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number and expiry date was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization and denosumab (PROLIA), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included cancer. The patient concomitant medication was not reported. On an unspecified date patient got Prolia injection last time with first dose and had headaches, neck and shoulder pain. Patient had cancer and goes for her regular CAT scan. Patient wants to know: the CAT scan gives contrast, will that cause an interaction. The patient underwent lab tests and procedures which included computerised tomogram and the result was unknown. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be requested. No further information expected.

Other Meds:

Current Illness:

ID: 1744009
Sex: U
Age:
State: FL

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

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Start tasting the medication (Unspecified Medication); I felt was I take the medication for 2 days; Pain; felt like a little swelling; Soreness of arm/the pain in shoulder going down the arm/arm was in pain; Arm muscles is still achy; Dryness in my mouth for 2 days; Tenderness; swelling in upper lip; My left lip was swollen and my toe was swollen; Pain in my shoulder going down the arm and like it start shaking; Pain in my shoulder going down the arm and like it start shaking; I start having anxiety because of the fear I guess; lot of anxiety started kicking around I guess because of the pain of the chest; I start having anxiety because of the fear I guess; lot of anxiety started kicking around I guess because of the pain of the chest; I could not sleep; Tingling; This is a spontaneous report from a contactable consumer (patient). A 61-year-old patient of unspecified gender received unknown dose number of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date on Monday (at the age of 61-year-old) as single dose for COVID-19 immunization and received Cortisone injection one week prior to the COVID-19 vaccine. Medical history included preexisting health condition (unspecified) and concomitant medications of the patient included some unspecified medication. When patient received the vaccination, patient informed them about preexisting conditions and with the preexisting condition and had cortisone shot prior a week. On an unspecified date on the very first day of vaccination patient start tasting the medication (unspecified), patient take the medication for 2 days. On the second day of vaccination, patient experienced the pain, the soreness of the arm, felt like a little swelling, dryness in mouth for 2 days, on Wednesday [third day] patient was feeling a little better but still had little soreness of the arm and little dryness and then I went to bed. On Thursday patient was not feeling bad, was feeling okay, a little dryness and felt a little tenderness and soreness of the arm, not much and then woke up at about 4 am in the morning [Friday] and had like swelling in toe and swelling in upper lip and the pain in shoulder going down the arm/arm was in pain/ arm muscles was still achy and like it start shaking and then patient had anxiety because of the fear and pain of the chest. This morning when patient woke up, patient could not sleep and went to sleep again and when woke up around 10 started to feel a little better, the swelling was gone, and the pain of the arms was gone but it still had a little tingling. So patient was just calling to find out are those things normal. Outcome of the event swelling, dry mouth, pain in arm, lip swelling, toe swelling were resolved and for other events were unknown. No follow-up attempts are possible. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1744010
Sex: F
Age:
State: NY

Vax Date: 03/25/2021
Onset Date: 03/26/2021
Rec V Date: 09/29/2021
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: 20210326; Test Name: Body temperature; Result Unstructured Data: Test Result:102.8(unspecified units); Comments: 102.8(unspecified units); Test Date: 20210326; Test Name: Body temperature; Result Unstructured Data: Test Result:100.9(unspecified unit); Comments: 100.9(unspecified unit)

Allergies:

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

Symptoms: fever of 100.9/eventually peaking at 102.8; Chills; Body aches; bad body aches it hurt to walk across her apartment to the bathroom even; This is a spontaneous report from a contactable consumer (patient). A 23-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 25Mar2021 at 14:45 (at the age of 23-year-old) as a dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. The patient was allergic to Zythromax. The patient received Loloestrin birth control within two weeks of vaccination. The patient also received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FN6205) via an unspecified route of administration in the right arm on 04Mar2021 at 15:45 (at the age of 23-year-old) as a single dose for COVID-19 immunization and on 05Mar2021 at 14:00, the patient was tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. On 26Mar2021 at 02:00, the patient woke up with a fever of 100.9. The patient called out of work and spent entire next day in bed with horrific chills and an off and on fever eventually peaking at 102.8 around 17:00. Sometime after that, the patient felt asleep and slept until around 7:00 the next morning and by then her fever had broken. The whole day that she was feverish, she had such bad body aches it hurt to walk across her apartment to the bathroom even and she spent the day off and on sleeping. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken for the resulted adverse events. The outcome of the events fever, chills and body aches were recovered on an unknown date in Mar2021 and of other event was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: Pfizer, Inc. EUA 027034

Current Illness:

ID: 1744011
Sex: F
Age:
State: MN

Vax Date: 03/31/2021
Onset Date: 03/31/2021
Rec V Date: 09/29/2021
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: allergic reaction of hives/Hives on bilateral arms; This is a spontaneous report from contactable consumer. A 39-year-old female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: ER8733), via intramuscular, administered in left arm (as reported Injected in left arm in the muscle) on 31Mar2021 08:25 (at the age of 39-year-old) as dose 1, single for covid-19 immunisation at clinic. The patient took paracetamol (TYLENOL; Lot Number: SLA051; Expiration Date: Jun2024) at 500 mg, via an unspecified route of administration from 31Mar2021 to an unspecified date, for an unspecified indication. Medical history included patient had severe food allergies diagnosed first in 1986: allergic to oranges, milk, mild reaction to eggs, compromised immune system, respiratory illness: Asthma, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes), anal cancer (previously) and obesity. The patient's family medical history included mother had lung cancer. The patient's concomitant medications were not reported. Patient took 2 of Tylenol about half an hour after getting the shot. Patient was not administered with any other additional vaccines on same date of the Pfizer vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No adverse events after prior vaccinations were reported. Caller stated she received the first dose of the Pfizer COVID vaccine this morning and she had an allergic reaction of hives/ hives on bilateral arms which occurred around 4pm today (on 31Mar2021 16:00). Caller would like to know if she should go to her doctor's office or if she can treat them on her own. There was no prescriber. No ER or physician's office required, and she can ride it out at home. Patient has Benadryl if she needs it. Patient wanted to be sure that taking the Benadryl and Tylenol should be all right for this type of response. At the time of this report, the outcome of event was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1744012
Sex: M
Age:
State: TX

Vax Date: 03/05/2021
Onset Date: 03/05/2021
Rec V Date: 09/29/2021
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: A little tired, first vaccine/ only felt a little tired but not too much; Pain on left side of shoulder, intense, first vaccine/ had intense pain on his left side of shoulder; This is a spontaneous report from a contactable consumer, the patient. A 52-years-old male patient received first dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported) via an unspecified route of administration on 05Mar2021 at 11:00-11:30 (not specified) as dose 1, single (age at the time of vaccination 52 years) for covid-19 immunisation in the left upper shoulder. The patient medical history included prostrate. He also stated he had a history of bronchitis since he was small. The bronchitis was worrisome with bad weather and a month prior there was bad weather and he had the chills. The patient stated his family did not have any medical history to report. Concomitant medication(s) included tamsulosin and finasteride started about a year and a half ago for his prostate. The patient stated with his first vaccine on 05Mar2021 he only had intense pain on his left side of shoulder, it was still there on Saturday and by Sunday the pain was much better. By Monday he was back to normal, only felt a little tired but not too much and he was able to do things on an unspecified date. Tuesday/Wednesday he was fine. The patient did not undergo any lab test. The patient did not take any therapeutic treatment for events. No additional vaccines were administered on same date as of the Pfizer suspect. No other vaccinations were taken within four weeks prior to the first administration date of the suspect vaccine. The patient did not visit emergency room or the physician's office. The outcome of event pain on left side of shoulder was recovered on an unknown date in Mar2021 and event only felt a little tired was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1744013
Sex: M
Age:
State: MI

Vax Date: 03/29/2021
Onset Date: 03/30/2021
Rec V Date: 09/29/2021
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: Rash on most of body, with concentration on feet, lower back, and back of thighs/very itchy, with bumps and blisters; Rash on most of body, with concentration on feet, lower back, and back of thighs/very itchy, with bumps and blisters; Rash on most of body, with concentration on feet, lower back, and back of thighs/very itchy, with bumps and blisters; Feet and lower back swelling; Feet and lower back swelling; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6202), via an unspecified route of administration in the right arm on 29Mar2021 at 18:30 (at the age of 57-year-old), dose 1, single for COVID-19 immunisation. The patient had no medical history and there were no concomitant medications. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. On 30Mar2021 at 12:00, the patient experienced rash on most of body, with concentration on feet, lower back, and back of thighs. It was very itchy, with bumps and blisters. The patient also had feet and lower back swelling. The event was reported as non-serious and resulted in doctor or other healthcare professional office/clinic visit. The patient received prescription for prednisone, and, hydroxyzine for the events. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was not recovered. No follow-up attempts are possible; No further information is expected.

Other Meds:

Current Illness:

ID: 1744014
Sex: F
Age:
State: SD

Vax Date: 02/26/2021
Onset Date: 02/27/2021
Rec V Date: 09/29/2021
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: 20210301; Test Name: Body temperature; Result Unstructured Data: Test Result:Fever; Comments: Fever That went away

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: sickness (Illness); Muscle pain; Joints on fire; Headache; Fever; Chills; Sweats; Cold sores; Diarrhea; This is a spontaneous report from a contactable other hcp reporting on behalf of patient. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown, expiry date: unknown), via an unspecified route of administration on 26Feb2021 (at the age of 58-year-old) as dose number unknown, single dose for covid-19 immunization. Patient's medical history included ongoing otitis externa, covid-19 from Nov2020 to an unknown date (patient was hospitalized for Covid-19 for 5 days) and ongoing osteoporosis from 01Mar2021. Concomitant medications included abaloparatide (TYMLOS) taken subcutaneously for osteoporosis from Jun2020 to 26Feb2021 at 80 mcg OD. On 27Feb2021, the patient experienced sickness (Illness), muscle pain, joint on fire, headache, fever, chills, cold sore, diarrhea and sweats. The patient underwent lab tests and procedures which included body temperature: Fever that went away on 01Mar2021. The outcome of all the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: Pfizer, Inc. EUA 027034

Current Illness: Osteoporosis; Otitis externa

ID: 1744015
Sex: F
Age:
State: CT

Vax Date: 03/31/2021
Onset Date: 03/31/2021
Rec V Date: 09/29/2021
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: Extremely thirsty I drank 3 times more water than normal and still couldn't seem to get enough; dry mouth; tired; slight muscle aches in my back and shoulders; headache; flushed/warm face; flushed/warm face; slight pain and a bruise at the spot of the injection.; slight pain and a bruise at the spot of the injection.; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP6955), via an unspecified route of administration, in left arm on 31Mar2021 09:45 (at the age of 38-years-old) as dose 2, single for COVID-19 immunization. Medical history included rosacea and seasonal allergies. Concomitant medications included xylometazoline hydrochloride (NASAL SPRAY II), metronidazole (METROGEL), loratadine (CLARITINE). The patient did not have any allergy to medications, food or other products. No other vaccine was given in 4 weeks, Prior to vaccination, was the patient was not diagnosed with COVID-19 and since the vaccination, has the patient been tested for COVID-19. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ET3247), via an unspecified route of administration, in left arm on 10Mar2021 09:45 as dose 1, single for COVID-19 immunization. The patient did not have COVID-19 prior to vaccination and has not been tested since vaccination. The patient was extremely thirsty, he drank 3 times more water than normal and still couldn't seem to get enough, had dry mouth, tired, slight muscle aches in his back and shoulders, headache, flushed/warm face and slight pain and a bruise at the spot of the injection on 31Mar2021. Treatment of the event included Tylenol. The outcome of the event was recovering. No follow-up attempts are needed. No further information is expected.

Other Meds: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034

Current Illness:

ID: 1744016
Sex: M
Age:
State: CT

Vax Date: 03/31/2021
Onset Date: 03/31/2021
Rec V Date: 09/29/2021
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: felt tired; headaches; myalgia; chills; slightly elevated body temperature; Fall asleep around 13 hours and woke up around 16 hours; fever; not able to sleep all night; This is a spontaneous report from a contactable consumer(patient). A 33-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP6955 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 31Mar2021 09:30 (at the age of 33-years-old) at dose 2, single for covid-19 immunization. Medical history included muscle aches. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have allergies to medications, food, or other products. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 10Mar2021 09:30 (at the age of 33-years-old) at dose 1, single for covid-19 immunization. The most recent COVID-19 vaccine was administered at workplace clinic. It was reported that patient was good in first 12 hours after vaccination. Later on 31Mar2021 22:00, patient experienced chills and slightly elevated body temperature, fall asleep around 13 hours and woke up around 16 hours and also had fever and myalgia, was not able to sleep all night and relived all muscle aches he had over last couple years. After 24 hours (01Apr2021 9:30), patient felt tired and had headaches. At 36 hours, chills came back but only stay around half an hour. At 48 hours, only leftover headache left. No treatment was given for the events. The outcome of the events was recovered on 02Apr2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1744017
Sex: F
Age:
State: IL

Vax Date: 04/01/2021
Onset Date: 04/02/2021
Rec V Date: 09/29/2021
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: tongue really swollen; Sore throat; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: er8730), via an unspecified route of administration in the right arm on 01Apr2021 at 10:00 (at the age of 45-year-old), dose 1, single for COVID-19 immunisation. Medical history included hysterectomy in 2013 and her throat was closing up, and they think it was the pain medication in the hospital and had a reaction to Tramadol and Vicodin. The patient stated that she did not know if the vaccine and pain medications would have something similar in them. Family history included mother died of lung cancer. There were no concomitant medications. The patient previously took tramadol; hydrocodone bitartrate paracetamol (VICODIN) and had unspecified reaction. The patient had no history of previous immunisation with the COVID-19 vaccine. The patient did not administer additional vaccines on same date of the COVID-19 vaccine. The patient did not receive any vaccine within 4 weeks prior to COVID-19 vaccine. The patient stated she had the first shot on 01Apr2021 at pharmacy and on 02Apr2021, she woke up in the morning and her tongue was really swollen and she had sore throat. Nothing too severe, but she could feel it when she swallows. The patient called the pharmacy and they told her to take Benadryl. The patient had only been up for a couple hours and just took 25 mg of Benadryl at 09:00. They told her if she had trouble breathing then to go to the hospital. The reporter would like to know if there was anything else to do regarding their side effects other than what the pharmacist advised her, should she go to her primary care physician. The patient did not undergo lab tests and procedures. The patient did not visit emergency room or physician office for the events. The outcome of the events was not recovered. No follow-up attempts are possible; No further information is expected.

Other Meds:

Current Illness:

ID: 1744018
Sex: F
Age:
State: FL

Vax Date: 03/05/2021
Onset Date: 03/01/2021
Rec V Date: 09/29/2021
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: arm hurt; Dizzy; Fatigued; couldn't sleep; sore where she had the rash and then it broke open; extremely sore in her right arm where she got the shot; didn't feel well; rash on her left arm/scratching on whole left arm, right hip had hives, hives that itched, itched all over her body, inside, back and forth; rash on her left arm/scratching on whole left arm, right hip had hives, hives that itched, itched all over her body, inside, back and forth; rash on her left arm/scratching on whole left arm, right hip had hives, hives that itched, itched all over her body, inside, back and forth; This is a spontaneous report received from contactable consumer (patient) via medical information team. A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 05Mar2021 (at the age of 59-year-old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included low thyroid, stroke from 2018 to an unknown date, allergies, head injury, allergies to yeast, wheat, fungus, mold and penicillin. The patient concomitant medications included thyroid medicine and allergy shots. Caller reported different reactions she had to the 1st dose of the Pfizer BioNTech covid vaccine she received on 5Mar2021. On an unspecified date in Mar2021, she did not feel well after the past few weeks, she had a rash on her left arm, although the injection was in her right arm, scratching on whole left arm, right hip had hives, hives that itched, itched all over her body, inside, back and forth. She received an allergy shot too: allergy to mold, fungus, penicillin, cats. The second dose was due today 02Apr2021 and she did not know if she should get it since she still was not feeling great. The caller was extremely sore in her right arm where she got the shot and the third day her arm was fine. The caller had not felt well since the vaccine and it scares her. The caller could not sleep her arm hurt really bad on 05Mar2021; this was the same arm she got her vaccine in. The rash happened the first week after the caller had the vaccine, then she had a sore where she had the rash and then it broke open and the rash left her. The caller hip hives started the same time as her left arm rash, this dissipated recently within the last few days. She was dizzy and fatigued; she did not know if it was from stress of the vaccine or the actual reaction to the vaccine. The caller mentions that she had allergies to yeast, wheat, fungus, mold, penicillin and she did not know if this was contraindicated with the vaccine or if it was in the vaccine. Therapeutic measures were taken as a result of rash on her left arm/scratching on whole left arm, right hip had hives, hives that itched, itched all over her body, inside, back and forth. The outcome of the event extremely sore in her right arm where she got the shot was recovered on an unspecified date in 2021 whereas outcome for the other events were unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1744019
Sex: M
Age:
State: CO

Vax Date: 03/25/2021
Onset Date:
Rec V Date: 09/29/2021
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: low-grade fever; achy body; chills; This is a spontaneous report from a contactable consumer (wife of the patient) via Pfizer-sponsored program Support. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 25Mar2021 on last Thursday as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced low-grade fever, achy body and chills. The reporter would like to know if the side effects were taking that long before it would be experienced. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1744020
Sex: F
Age:
State: AZ

Vax Date: 03/21/2021
Onset Date: 03/30/2021
Rec V Date: 09/29/2021
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: Itching at vaccination site; Swelling, the size of a chicken or goose egg; Injection site warm and red; Injection site warm and red; Tender, injection site, only when touched; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 02Apr2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EP7534), via an unspecified route of administration on 21Mar2021 (at the age of 64-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. The patient received unspecified medication as concomitant drug. The patient states that she did feel great for basically the first 8 and a half days, she had no side effects. On 30Mar2021, she decided to put rubbing alcohol and swab the area, as she hadn't done that before. She was in the car, with the sun on her shoulder and she noticed that it was starting to itch at the vaccination site, but she tried not to itch it. Later that night, she went to bed and it started itched again. She realized she had swelling the size of a chicken or goose egg. She got up and took her temperature, it was normal. She noted the site was warm and red, not alarmingly, but red with a 2.5-inch circumference, and it was swollen. She did not panic because she did not have a temperature. it remained swollen for the next day, but she still had no temperature, but it was itchy and warm. She stated she didn't do anything and tried to stay calm. She looked over the pamphlet that she got, and saw what it might be. The outcome was recovered for swelling, the size of a chicken or goose egg on 31Mar2021 and recovering for rest of the events. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1744021
Sex: F
Age:
State: FL

Vax Date: 03/24/2021
Onset Date: 03/25/2021
Rec V Date: 09/29/2021
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: 20210328; Test Name: Nasal swab; Result Unstructured Data: Test Result:Negative

Allergies:

Symptom List: Tremor

Symptoms: Chills; shakiness; headache; joint pain; tiredness; nausea; metallic taste in mouth; injection site pain; redness; This is a spontaneous report from a contactable other health professional (patient). A 47-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8730) via an unspecified route of administration, administered in Arm Right on 24Mar2021 at 15:00 (at the age of 47-year-old) as dose 2, single for COVID-19 immunisation. Medical history included rhinitis allergic, hypertension, diverticulum and Penicillin allergy. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Historical vaccine included bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6198) via an unspecified route of administration, administered in Arm Right on 03Mar2021 at 15:00 (at the age of 47-year-old) as dose 1, single for COVID-19 immunisation. On 25Mar2021 at 02:00 the patient experienced Chills, shakiness, headache, joint pain, tiredness, nausea, metallic taste in mouth, injection site pain, redness. Patient visited emergency room for the events. Patient was treated with antibiotics. The patient underwent lab tests and procedures which included sars-cov-2 (Nasal swab): negative on 28Mar2021. Since the vaccination the patient been tested for COVID-19 and results were negative. Outcome of the events was recovered on unknown date in 2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1744022
Sex: F
Age:
State: WI

Vax Date: 03/31/2021
Onset Date: 03/31/2021
Rec V Date: 09/29/2021
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: Swollen tongue; throat; itching; dizzy; This is a spontaneous report from a contactable consumer or other non health care professional (patient). A 37-year-old non pregnant female patient received first dose of BNT162B2 (solution for injection, Batch/Lot Number: Ew0150, Expiry date: not reported) via an unspecified route of administration, administered in Left Arm on 31Mar2021 (at the age of 37 years old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was reported as none and concomitant medications were not reported. The patient has no other medical history. The patient had no allergies to medications, food or other products. The patient had not received any other vaccine within 4 weeks and other medication in 2 weeks. Patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID post vaccination. On 31Mar2021, the patient experienced swelling tongue, throat, itching, dizzy. Therapeutic measures were taken as a result of events at Medical help at vaccine injection facility, Benadr. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1744023
Sex: F
Age:
State: NJ

Vax Date: 04/03/2021
Onset Date: 04/01/2021
Rec V Date: 09/29/2021
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: it is stiff; entire arm went numb, her hand fell asleep/numbness/it moved up her arm to her shoulder and into her neck, all on her left side/her neck and shoulder are not feeling as it should; left arm is weak; hives/spread to extremities (arms and legs)/specifically her chest, then expanded mostly to her left hip, her right thigh, more on her left side of her body/on her chest it is on the right side too; This is a spontaneous report reported from a contactable female consumer (patient). A 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN5318, NDC and Expiration date: unknown), via an unspecified route of administration in arm left on 03Apr2021 (at the age of 33-years-old) as a dose 1, single for COVID-19 immunization. The patient's medical history was reported as no. The patient's concomitant medications were not reported, the caller stated that, they have not had any other recent vaccinations or started any new medications. Enquired, the reporter wanted to report side effects with vaccine, received first dose of Pfizer covid vaccine on 03Apr2021 and developed hives (started day after dose) and has since spread to extremities (arms and legs). It was queried that, was this reported during clinical trials. It was reported that, the consumer called about the Pfizer COVID-19 vaccine who said she wanted to report two AEs she was experiencing. The caller stated that, her first dose was injected around 15:30-15:45. Stated that, her first adverse event started about 5 minutes after her first dose. On 03Apr2021, her entire arm went numb, her hand fell asleep. Stated that, she was still in the pharmacy for observation. Stated that, the numbness was still there, it did subside some and the pharmacist stated that, she thinks she was fine to go if she wanted to. The caller stated that, 20 minutes afterwards, it moved up her arm to her shoulder and into her neck, all on her left side. She stated that, it has gotten better, but her left arm was weak and her neck and shoulder are not feeling as it should. She stated that, it might have been that she might have hit something while she was doing needle, but it was stiff and still not 100% yet. Stated that, her second adverse event was now she has hives, which started approximately 24 hours after her initial dose on her core, specifically her chest, then expanded mostly to her left hip, her right thigh, legs and arms more on her left side of her body. She stated that, on her chest it was on the right side too. She stated that, her hives are very far apart, there are no clusters, she has done no treatment yet, the hives got bad this morning. Stated that, she was seeking recommendations for treatment so she called Medical Information first to find out whether these were common AEs documented from clinical studies, which they were not. She stated that, after this, she was calling her PCP for advice about treatment. The reporter seriousness for the events was reported as unspecified. The investigation assessment was reported as no. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1744024
Sex: F
Age:
State: NJ

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

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

Lab Data:

Allergies:

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

Symptoms: Some reason after vaccine side effects of joint pain, muscle soreness went away so did my hip pain; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program ]. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included hip pain and inflammation in my right hip, muscle soreness and joint pain. The patient's concomitant medications were not reported. On an unspecified date, patient experienced some reason after vaccine side effects of joint pain, muscle soreness went away so did my hip pain. Patient inquired if vaccine boost her immune system. The outcome of 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: 1744025
Sex: M
Age:
State:

Vax Date: 03/29/2021
Onset Date: 04/01/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: achiness/a little achy; general unwell; don't have fever but feeling off; he could not do anything beyond 15-20 min; anxious; paranoid; got winded; stress; fatigue/felt a little out of it/really just fatigued; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 29Mar2021 (at the age of 58-years-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, patient stated he received his First dose of the Pfizer covid vaccine a week ago and starting day 4 to 7 he experienced fatigue achiness/ general unwell, don't have fever but feeling off , took Tylenol and ibuprofen which helped some. Patient stated he could not do anything beyond 15-20 min, he is anxious and paranoid. Patient wanted to know about if these symptoms from day 4-7 day and beyond day 7. Patient wanted to know should he take second dose if he is feeling unwell. Patient states his phone is choppy with service and is afraid he will get disconnected. States he is very concerned about whether to check side effects. He got the Pfizer Covid shot exactly one week ago today and the reason that he is calling, he is 58 years old and is experiencing side effects on day 3 or 4 and he is really just fatigued. Patient provides that he was out gardening and found he got winded after about half of an hour and he was not doing a lot and he came in. States the main thing is fatigue and he thought it was a side effect and hasn't had anything else, no headaches or anything, that he slept fine. States the next day he went to see friends and he felt a little out of it around 9:00. States yesterday over the weekend he went to do basic housework and he was fatigued after a little bit and is wondering if this is a side effect. Patient states this morning he is sitting remotely and starting in the last hour he is a little achy and he took his temperature and does not have a temperature. Patient states something is going on and he is really, really concerned what is going on with him. States he contacted his doctor and he said he may want to get tested for Covid as this falls in the range. Patient states he has not been tested for Covid yet he has one scheduled for Tuesday. States the stress and anxiety and would like to check literature to see if it populates for experience for his age group, are these side effects normal range time and what does the literature say for after the shot. Patient states he was a therapist in a group patient assisted living transition facility. States it was behavioral health. Patient clarifies he was not a doctor. Patient states there have been 28 data breaches and he is paranoid and data security is unknown and it's just another side effect. Patient states the main reason he is calling is to see if what he is experiencing falls in range or out of range for side effects. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1744026
Sex: F
Age:
State: OR

Vax Date: 02/20/2021
Onset Date: 03/01/2021
Rec V Date: 09/29/2021
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: joint pain; pain; I got very sick; Shaking; Fever; This is a spontaneous report from Pfizer-Sponsored program. This contactable 28-year-old female consumer(patient) reported which includes that : A 28 years female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247) dose 1 on 04Feb2021 and dose 2 (Lot number: EN5318) on 20Feb2021 via an unspecified route of administration administered on left arm (At the age of 28 years) at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. On an unspecified date in Mar2021, Patient had stated I got very sick, I had pain all over my body specially my joint, Shaking and Fever. Treatment They just gave me medication for pain, I stopped it so I am not taking any medication now. I just use only Aleve Every time I have pain I take 2 pills. I did use Meloxicam but I stopped using it." At the time of reporting, the outcome of the events were unknown. Additional Context: Consumer stated, "I wanted to tell you my experience about the vaccine Covid vaccine Pfizer. After few weeks I got some symptoms that I never had in my life. I got very sick and it stated pain like I had pain all over my body specially my joints and other symptoms like I have shaking, sometimes fever not all the times. I went to ER and I went to another doctor they sent me to neurologist and he write I didn't had any problem before and he thought it might be from the vaccine because sometimes what happen that chemical can attack our joints and he did some test. My test number was so high which means my immune system has antibody. I want to know if somebody called you and had some history about that because it is so strange and I never had joint problem and the test result is showing I have joint problem. And is this possible from the vaccine is somebody has these symptoms?" No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1744027
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
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: coughing; wheezing; This is a spontaneous report from a non-contactable consumer, patient's friend. A female patient of an unspecified age received unknown dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the covax and was coughing and wheezing. It was suggested that she get tested to rule out if she had the virus but this could also a side effect. It was reported that the patient did not have on a mask. The outcome of all the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained

Other Meds:

Current Illness:

ID: 1744028
Sex: M
Age:
State:

Vax Date: 03/27/2021
Onset Date: 03/29/2021
Rec V Date: 09/29/2021
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: 2nd Pfizer vaccine on 27Mar, and on 29Mar woke up with rash and hives on both legs the entire legs.; 2nd Pfizer vaccine on 27Mar, and on 29Mar woke up with rash and hives on both legs the entire legs.; This is a spontaneous report from Pfizer-sponsored program. A contactable consumer reporter for a male patient of unknown age who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 27Mar2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunization. On 29Mar2021, two days after vaccination the patient woke up with rash and hives on both legs the entire legs. The event outcome was unknown. No follow-up attempts were needed. Information about lot/batch number could not be obtained.

Other Meds:

Current Illness:

ID: 1744029
Sex: F
Age:
State: GA

Vax Date: 01/30/2021
Onset Date: 01/31/2021
Rec V Date: 09/29/2021
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: itchy; Burning skin; This is a spontaneous report from a contactable other HCP (nurse). A 39-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via intramuscular route, administered in left arm (Left Deltoid) on 30Jan2021 at 10:15 (Batch/Lot Number: EL3246) as SINGLE (age at vaccination was 39-years-old) for covid-19 immunization. Medical history included seasonal allergies and urticaria. The patient's concomitant medications were not reported. On 31Jan2021, at 06:00, the patient was itchy. On an unspecified date in 2021, the patient experienced burning skin. On 23Feb2021, at 12:30, patient received second dose of bnt162b2 via intramuscular route, administered in left arm (Batch/Lot Number: EL3302) as SINGLE for covid-19 immunization. Therapeutic measures were taken for both the events (Benedryl/ topical steroid). The outcome of pruritis was unknown whereas, burning skin was recovered on an unknown date in 2021. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1744030
Sex: F
Age:
State: NC

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

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

Lab Data:

Allergies:

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

Symptoms: sore arm; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot number: EN6208, expiration date: 30Jun2021) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included high blood pressure she has had this condition for 3 or 4 years and arthritis. Concomitant products included patient has been on Celebrex at a dose of 200 mg twice a day for about 2 weeks. Patient was taking Celebrex for arthritis and lisinopril with HCTZ 20mg/25mg 1x/day for high blood pressure, she has been taking this for 3 or 4 years. It was reported that after the first shot the patient experienced sore arm. The outcome of event was unknown. No follow-up attempts are needed. No further information was expected.

Other Meds:

Current Illness:

ID: 1744031
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: swelling of the hands and arms and more recently swelling in his face; swelling of the hands and arms and more recently swelling in his face; swelling of the hands and arms and more recently swelling in his face; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient experienced swelling of the hands and arms and more recently swelling in his face. The outcome of the events was unknown. No follow up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1744032
Sex: F
Age:
State: GA

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 09/29/2021
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: Chills; Itching rash on arms, back, neck and chest; Diarrhea; nauseated; stomach started turning like she had a strong laxative and cramping real bad; stomach started turning like she had a strong laxative and cramping real bad / Stomach pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 67-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number), via intramuscular route of administration in arm left on 01Apr2021 (at the age of 67-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included compromised immune status, gentic/ chromosomal abnormalities, endocrine abnormalities, obesity, asthma and respiratory illness all from an unknown date and unknown if ongoing. The patient is allergic to Codeine, Penicillin, Sulfa, Iodine, Epinephrine, Morphine, Clindamycin, Food allergies to Gluten, dairy, artificial sweeteners including Sorbitol and Xylitol, Broccoli, Cauliflower, Cabbage, Brussel Sprouts, Asparagus, all percifirous (transcribed as provided) vegetables, allergic to pollen, trees, grass, ragweed, mold, mildew, dust and allergic to cats. The concomitant medications of the patient were not reported. The Family medical history was reported as none. On 01Apr2021, the patient experienced chills, itching rash on arms, back, neck and chest, diarrhea, nauseated, stomach started turning like she had a strong laxative and cramping real bad. The patient reported that she got second shot on 01 Apr 2021, and felt good and was excited. She did not feel the weakness previous day, but what she did feel was the stomach started turning like she had a strong laxative and cramping real bad. She ended up with diarrhea like she never had before and it was persistent. She was having very bad stomach pains and on the sides of stomach where large intestines are on left side. She was also nauseated but can't seem to throw up. The nausea had been from previous night. It was hard to eat when you are nauseated and the diarrhea was still going on. She had been taking the same prescription medications for years. She did not felt they were relevant. She wanted to know what to do to help her feel better and with the stomach thing, what would they recommend for severe pain and diarrhea. Therapeutic measures were taken as a result of diarrhea, stomach started turning like she had a strong laxative and cramping real bad / stomach pain that included Tylenol and Pepto Bismol. The outcome of the events chills, diarrhea, nauseated, stomach started turning like she had a strong laxative and cramping real bad was reported as not recovered and the outcome of the event itching rash on arms, back, neck and chest was reported as resolving. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1744033
Sex: F
Age:
State: MN

Vax Date: 03/18/2021
Onset Date: 04/01/2021
Rec V Date: 09/29/2021
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: some allergies; body ache; a kind of sore throat but not that bad; feeling tired / fatigue; This is a spontaneous report received from a contactable consumer (patient reported for herself) from Pfizer sponsored program COVAX US Support A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration, on 18Mar2021 (at the age of 69-years-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had her first dose on 18Mar2021. Just this morning (01Apr2021), the patient had experienced body ache, a kind of sore throat but not that bad and feeling tired. The patient stated, it lasted for that short period of time, some allergies too that could be in the mix here. She had been fine since. Their next shot was on Thursday and knew they will be fine. Patient and her husband (age 73) both experienced fatigue the next day. They were relaxing. Patient wants to know if it was just side effects of the vaccine or if she was having a reaction to the vaccine. Outcome of the events was recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1744034
Sex: M
Age:
State:

Vax Date: 03/31/2021
Onset Date: 04/01/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Sore muscles/ Muscle aches; Chills; Headache; Little bit of fever; This is a spontaneous report from a contactable consumer (patient) reported himself.A 38-Year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on 31Mar2021 ( at the age of 38-Year-old) as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE; Lot Number and expiry date: not reported) via an unspecified route of administration on unspecified date as dose 1, single for COVID-19 immunization.The patient reported that events experienced on next day. On 01Apr2021, he had chills, a little bit of fever, muscle aches, headache and he got sore muscles. The outcome of 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: 1744035
Sex: M
Age:
State: NC

Vax Date: 03/09/2021
Onset Date: 03/10/2021
Rec V Date: 09/29/2021
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: Hives all over body; rash; itching; This is a spontaneous report received from a from a contactable consumer (wife) reported for a 65-year-old male patient (husband). A 65-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not provided), via an unspecified route on 09Mar2021 at 12:00, as a single dose for covid-19 immunization. Medical history included diabetes. The patient concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies were reported. On 10Mar2021 at 00:00, patient had hives all over body, rash and itching the day after his second dose of the Pfizer Covid vaccine. He still has it and it has been a month since he had vaccine. Doctors seem to be clueless on what to do. Pfizer is not able to make any treatment recommendations for individual patients. During the clinical trials, systemic symptoms (symptoms throughout your body) were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. However, everyone's body is different, and some symptoms may last longer in certain individuals. Please continue to discuss this with his HCP so they can evaluate his symptoms to determine the best treatment recommendations. Adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures taken as a result of the events included steroid shot. The clinical outcome of the events was reported as it has been a month with no relief from itching. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1744036
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
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: Dizzy; Tired; Headache; Nauseaus; Constipation; Swollen face; This is a spontaneous report received from a Pfizer sponsored program COVAX US support. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced dizzy, tired, headache, nauseaus, constipation, swollen face. The outcomes of events were 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: 1744037
Sex: F
Age:
State:

Vax Date: 03/27/2021
Onset Date: 03/27/2021
Rec V Date: 09/29/2021
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: red like a rash; heart rate for 1 minute or 1.5 minutes went up to 209 bpm; dizzy; extremely exhausted; nauseous; lack of appetite; had a little bit of fever, a 99.3?F~99.4?F fever; Pain in left jaw -pretty intense; Lips and cheeks were numb; Lips and cheeks were numb; Numb mouth; This is a spontaneous report from a contactable consumer (patient herself). A 44-year-old female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number ER8732, Expiry date: 31Jul2021, Age at vaccination: 44years) via an unspecified route of administration on 27Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced pain in left jaw -pretty intense, red like a rash, heart rate for 1 minute or 1.5 minutes went up to 209 bpm, dizzy, extremely exhausted, nauseous, lack of appetite, had a little bit of fever, a 99.3 degree F 99.4 degree F fever. On 27Mar2021 it was reported that patient lips and cheeks were numb, numb mouth. She got received the vaccine on Saturday and 20 mins after received it my mouth, cheeks and lips got numb little numb, pretty strong jaw king in my left jaw joints, her face when she looked into the mirror was blushy and red. It was weird, she don't know. Seems like she was fine, after that, after a while, 2 days later, she felt extremely high heart rate of about 209 or some around 200 for she don't know exactly about the whole time but for a minute or minute and a half and I got completely exhausted and nauseous she did have very mild temperature like 99.4 or something like that and she have read on the internet that If you have any reaction then you should probably get allergy tested and also perhaps not receive the second vaccine but she really would like to receive it but she need to check that there is something considered as allergic reaction. The outcome of the events was unknown. Follow-up (PRD 02Apr2021/ SRD 09Apr2021) New information was received from a contactable consumer includes: lot number, expiry date, events onset date. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am