VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1712221
Sex: F
Age:
State: HI

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 09/18/2021
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: Immediate pain in left shoulder; muscle spasm to left shoulder and cervical spine,reduced range of motion to head/neck and left Shoulder that is ongoing one month following 2nd vaccine; This is a spontaneous report from a contactable nurse. A 39-year-old female nurse non-pregnant received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EL1283 ), dose 2 via an unspecified route of administration, administered in the left arm on 13Jan2021 at 08:00 am as a single dose for (at the age of 39-year-old) COVID-19 immunisation. The patient previously received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EL1284) dose 1 via an unspecified route of administration, administered in left arm on 23Dec2020 at 07:30 pm as a single dose for (at the age of 39 year) COVID-19 immunisation in hospital. The patient's medical history included headache. She previously took bnt162b2, amoxicillin and experienced drug hypersensitivity. Concomitant medications included sulfamethoxazole, trimethoprim (MOTRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine and received other medication in two weeks include motrin. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID-19. The patient experienced Immediate pain in left shoulder, muscle spasm to left shoulder and cervical spine. Ongoing pain, severe in nature. muscle spasm, reduced range of motion to head/neck and left Shoulder that was ongoing one month following 2nd vaccine. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of events include Cervical x-ray, prescriptions and Physical therapy. The outcome of events was not recovered. Follow-up attempts completed. No further information expected.

Other Meds: MOTRIN

Current Illness:

ID: 1712222
Sex: F
Age:
State:

Vax Date: 02/13/2021
Onset Date:
Rec V Date: 09/18/2021
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: little pain and itchiness by the injection site; little pain and itchiness by the injection site; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on 13Feb2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced little pain and itchiness by the injection site on an unspecified date. The outcome of the event was unknown. Information about lot/Batch number has been requested. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1712223
Sex: M
Age:
State: GA

Vax Date: 02/17/2021
Onset Date: 02/20/2021
Rec V Date: 09/18/2021
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: This is a spontaneous report from a contactable consumer (patient). A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 17Feb2021 11:45 (Lot Number: EL9264) (at the age of 63-years old) as dose 1, single for covid-19 immunisation. Medical history included hepatitis b, psoriasis, hypothyroidism. Patient had no allergies to food. Concomitant medications included apremilast; entecavir; levothyroxine sodium, all taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks of vaccination. The patient did not have covid-19 prior to vaccination and was not tested for covid-19 post vaccination. On 20Feb2021 15:15, the patient experienced chest pain, nausea, cold sweat and dizziness. The events resulted in emergency room/department or urgent care visit. The patient did not receive any treatment for the adverse events. The outcome of the events was recovering. Follow-up (17May2021): Follow-up attempts were completed. No further information expected.

Other Meds: APREMILAST; ENTECAVIR; LEVOTHYROXINE SODIUM

Current Illness:

ID: 1712224
Sex: F
Age:
State: CA

Vax Date: 02/18/2021
Onset Date: 02/19/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 20210219; Test Name: Qualitative PCR; Result Unstructured Data: Test Result:Pending

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Headache; fatigue; nausea; This is a spontaneous report from a contactable nurse or other hcp (patient). A 66-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot number: EN6200, Expiration date was not reported) via an unspecified route of administration, administered in left arm on 18Feb2021 at 09:15 AM (at the age of 66-years-old) as dose 1, single for covid-19 immunisation. The patient's medical history included hypertension from an unknown date and unknown if ongoing and patient had no known allergies. The patient's concomitant medications included lisinopril and metoprolol both taken for an unspecified indication, start and stop date were not reported. patient did not tested COVID prior vaccination. patient did not received any other vaccine within four weeks. On 19Feb2021 at 12:00PM, 1 day after first dose the patient experienced headache, nausea and fatigue. The patient underwent lab tests and procedures which included nasal swab or qualitative PCR sars-cov-2 test on 19Feb2021 which result was pending. Therapeutic measures were taken as a result of headache however not relieved by Advil and no treatment received for nausea and fatigue. The outcome of the events was unknown. Follow-up attempts completed. No further information expected.

Other Meds: LISINOPRIL; METOPROLOL

Current Illness:

ID: 1712225
Sex: F
Age:
State: NV

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

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

Lab Data:

Allergies:

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

Symptoms: tickling her throat; severe cough; nauseous; stomach ache; headache; cramps; regurgitation; lightheadedness; This is a spontaneous report from a program. A 90-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 18Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation (at the age of 90 years). Medical history included cough on and off from an unknown date and unknown if ongoing (had this cough on and off before receiving the vaccine, from the dust, and it comes through the air vents). The patient's concomitant medications were not reported. 159558 stated that she was about to report this, but patient wanted to know if it was safe, since she had the first dose. Call received on 18Feb2021 the 1st dose of the Pfizer covid vaccine has a severe cough, tickling her throat. After the first dose on the 18Feb2021, the caller who is 90 years old is now experiencing stomach-ache, headache, cramps, regurgitation, and light-headedness. Also asking if it was advisable to get her second dose on 11Mar2021. Patient was a 90-year-old female who stated, I have had this cough on and off before receiving the vaccine, from the dust, and it comes through the air vents, Patient takes benzonatate 100 mg, One every 8 hours. One in the morning and one at night when I went to bed. It was a cough medicine. I am feeling nauseous now, it started yesterday, I feel nauseous now. I had a geriatric center that comes to my house. Since I cannot go out to the doctor, I saw a PA. I called the Pharmacist and pharmacist replied, please consult with your doctor or pharmacist for further guidance and ensure that your health care providers know all the medications, including over the counter (OTC) products, that you are taking, have recently taken or are planning to take. The clinical outcome of the events was unknown at the time of report. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1712226
Sex: F
Age:
State: IA

Vax Date: 02/08/2021
Onset Date: 02/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: blood work; Result Unstructured Data: Test Result:Unknown results; Test Name: physical tests; Result Unstructured Data: Test Result:Unknown results; Test Name: MRI; Result Unstructured Data: Test Result:Unknown results; Test Name: urinalysis; Result Unstructured Data: Test Result:Unknown results

Allergies:

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

Symptoms: small rash on her right forearm; allergic reaction; fatigue/tiredness; dizziness; balance issue; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 08Feb2021 (Batch/Lot Number: EL1283) (at the age of 73 years old) as single dose for Covid-19 immunisation. Medical history included high cholesterol from 2008 and ongoing, type 2 diabetes (uses diet and exercise to keep her A1C under 7), sinus issues, leaky valve (saw her cardiologist a year ago and said everything was fine and there had been no changes), ear infection. The patient had flu shot (Influenza vaccine) on an unknown date. Concomitant medications included fexofenadine, pseudoephedrine hydrochloride (ALLEGRA-D [FEXOFENADINE;PSEUDOEPHEDRINE HYDROCHLORIDE]) taken for an unspecified indication from 2009 and ongoing; fluticasone propionate (FLUTICASONE PROPIONATE) taken for sinusitis from 2009 and ongoing; olopatadine hydrochloride (OLOPATADINE HYDROCHLORIDE OD) taken for sinusitis from 2013 and ongoing; atorvastatin (ATORVASTATIN) taken for blood cholesterol increased, start and stop date were not reported. The patient experienced dizziness on 16Feb2021; fatigue/tiredness on 17Feb2021; balance issue on an unknown date in Feb2021; and small rash on her right forearm and allergic reaction on an unspecified date. Additional information: The patient had her Covid-19 vaccine on 08Feb2021. She stated that she had no telltale signs that she got a vaccine, like when she got a flu shot, until 16Feb2021. Patient stated that on the 16Feb2021, she began having dizziness in the evenings. Patient was alarmed after reading the brochure with the adverse events for the product, and she did go to the Emergency Room. The patient stated that the ER staff told her that she has a balance issue. She would say that while the people were good there, they were not familiar with the signs and symptoms of this vaccine. She was sent home from the ER with script for balance help. The patient states that she really noticed the dizziness on the 17Feb2021, and it continued with tiredness, increasing tiredness that continued on the 18Feb2021, and continued until today. Patient stated that the dizziness usually occurs in the evening, after dinner or another meal like lunch. She was wondering if these were known side effects and if there was a connection with food. She noticed the dizziness at night, before bed, and she put up a fight against negative thought processes, and she drank lots of water and noticed that being cold helped make it easier to overcome the tiredness. She stated that she woke up and had breakfast and it started all over again. The dizziness went away later on the 16th and on the 17th, she felt okay, nothing unusual, and she took her normal maintenance medications in the morning, and then by 5:30PM that evening, she was having the severe dizziness again. She went to the ER because of dizziness and she was seen and discharged that same day. Treatment was provided for dizziness. She stated that when she made it to the ER, the staff went through the process of eliminating the possibility that her symptoms were due to the vaccination. She also noticed a small rash on her right forearm. She did not know if this was an allergic reaction to a food she ate or to the vaccination. She stated that these symptoms were confusing with the covid vaccine, and with her sinus stuff, because she has sinus issues and in this region where she lives, is a farmland, and there are unsurmountable sinus conditions and allergies and there was always something in the air. Investigations: Patient reported that the ER did an MRI to see if there was something there creating her dizziness, and they did physical tests to check for dehydration, and they did blood work and a urinalysis, but patient has not gotten the results yet, and can only suspect that her primary care doctor would have that information. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: ALLEGRA-D [FEXOFENADINE;PSEUDOEPHEDRINE HYDROCHLORIDE]; FLUTICASONE PROPIONATE; OLOPATADINE HYDROCHLORIDE OD; ATORVASTATIN

Current Illness: High cholesterol

ID: 1712227
Sex: F
Age:
State: MI

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 09/18/2021
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: left upper arm was warm to the touch; left upper arm has become redder; upper left arm was swollen; spotty discoloration all over her left upper arm that starts about 2" above her left elbow; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 17Feb2021 11:05 (Batch/Lot Number: EN6200) at the age of 71 years, as dose 2, single for COVID-19 immunisation. Medical history included lung cancer diagnosed about 3 years ago and has been in remission for approximately 2 years. There were no concomitant medications. The patient previously received her first dose of BNT162B2 via intramuscular route in the same arm (Arm, Left Upper) on 27Jan2021 (Lot number: EL9264). The patient had no other prior vaccinations within 4 weeksThe patient stated she seems to be having a reaction to the arm that she had received the COVID-19 Vaccine shot. On 17Feb2021, the patient experienced upper left arm was swollen and she had a spotty discoloration all over her left upper arm that starts about 2" above her left elbow. On 22Feb2021, left upper arm was warm to the touch and has become redder. The patient asked if it was common to have that type of reaction, and to have the reaction last as long as 5 days after getting the COVID-19 Vaccine. Patient declined any treatment. Events did not require emergency room or physician office visit. She clarified that her left upper arm swelling seems to have worsened. She said her left upper arm has become slightly bigger and redder. She said she noticed her left upper arm was warm to the touch. Patient had no relevant test. Reported she signed up for COVID-19 Vaccine tracker on the (smartphone based tool name). No further details were provided. Outcome of the events was not recovered. Events were reported as non-serious. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1712228
Sex: F
Age:
State: GA

Vax Date: 02/04/2021
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: Covid-19 test; Test Result: Negative ; Test Name: Covid-19 test; Test Result: Negative

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: rashy at injection sitewent down almost to the elbow (stayed for 4 days, itchy at the site)/arm was red and rashy to her elbow; rashy at injection sitewent down almost to the elbow (stayed for 4 days, itchy at the site)/arm was red and rashy to her elbow; The injection site was swollen and hot, there was redness all the way down to her elbow, and it itched; The injection site was swollen and hot, there was redness all the way down to her elbow, and it itched; The injection site was swollen and hot, there was redness all the way down to her elbow, and it itched; She was very tired; had a headache all day long that was real bad; had muscle pain at the joints; joint pain; she still shook; she felt her head and it was hot; she had nausea and had to take a pan with her to the bathroom in case she vomited; She was dizzy; Her bowels were cleaned out, it wasn't watery but it was complete- she went about 3 times; she was not feeling well; still weak; wind pipe was mucosy/her wind pipe she felt like a big lump of phlegm; Her heart was having fast heartbeats that day; body aches and pains; chills; fever; loose stools; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer patient of unknown age reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 04Feb2021 as dose 1, single for COVID-19 immunization. The medical history of the patient included strokes. She stated later her daughter-in-law, son, and granddaughter came down with covid but the caller and her son were negative. She stated she even slept with her granddaughter during that time. They tested 7 days later and were still negative. The concomitant medications were not reported. On an unknown date the post vaccination patient had all the side effects. The injection site was swollen and hot, there was redness all the way down to her elbow, and it itched. She was very tired, had a headache all day long that was real bad, had muscle pain at the joints, joint pain, and chills all day long. Even with a blanket over her and thick pants, socks, and shoes she still shook. She did not take her temperature but she felt her head and it was hot, she had nausea and had to take a pan with her to the bathroom in case she vomited. She was dizzy when she got up to bathroom. Her bowels were cleaned out, it was not watery but it was complete- she went about 3 times. She does not know about her lymph nodes but she was not feeling well. She went from the couch to the bed at 10:00 to sleep and got up the next morning and was okay but still weak. She stated over her windpipe she felt like a big lump of phlegm. Her heart was having fast heartbeats that day. She asked if she should she go back for the second dose of the vaccine given all of these symptoms. The event outcome was unknown. No follow-up attempts were possible, information about lot/batch number could not be obtained.

Other Meds:

Current Illness:

ID: 1712229
Sex: F
Age:
State: AK

Vax Date: 01/29/2021
Onset Date: 02/01/2021
Rec V Date: 09/18/2021
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: her hands and feet became extremely tingly and itchy; her hands and feet became extremely tingly and itchy; her joints and muscles hurt/arthritic joint and muscle pain/arthritic feeling, where her joints and muscles hurt; her joints and muscles hurt/muscles aches; arm was a little sore; feels like the "nerves are on".; arthritis feeling in her hands and feet; hands are swollen; allergic reaction; This is a spontaneous report from a contactable consumer (patient) via Medical Information team. This consumer reported for herself and another one patient (friend). This is 1st of 2 reports (for reporter). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL3249, Expiry Date: May2021) dose 1 intramuscular in left arm (Left arm, upper arm. It was not in the shoulder but up high) on 29Jan2021 at 20:10 (at the age of 53-year-old) as dose 1 single for COVID-19 immunisation. Patient's medical history (including any illness at time of vaccination) was none. Concomitant medications were none. Historical Vaccine included influenza vaccine (FLU shot) in Sep2020 for immunization. No prior vaccinations (within 4 weeks). She received the first dose of the Pfizer-BioNTech COVID-19 vaccine on 29Jan2021. She is due to get another one on 23Feb2021 (tomorrow as reported). In Feb2021, she explained her hands and feet were tingly and itchy 1.5 weeks after the injection. She then specified it felt more like a "needle prick pain" than a tingly sensation and described it as "acute". She said this symptom is gone now but when she "open and close [her] hands" she feels an "arthritic joint and muscle pain". After receiving the first vaccine, she had no symptoms. Her arm was a little sore, but she did a couple of push ups and was fine. It was barely anything. A week and a half in, her hands and feet became extremely tingly and itchy from the inside. She has come close to frostbite a lot, and it kind of felt like that. Like when a person is outside where its super cold and your extremities freeze and then come inside to warmth and it feels like the "nerves are on". This kind of feeling was acute for 2-3 days and then it kind of went through her whole body. She tried to read and see if anybody else had anything like it. It started to feel like an arthritis feeling in her hands and feet with muscles aches. She even has taken her rings off of her hands because her hands are swollen. She doesn't take medicines. She is really healthy and she can't imagine how this isn't related to the vaccine. She mentions she did go through a litany of questions with a nurse. It was more so to diagnose if she should go to the ER or not. Once she informed the person it had been more than 3 days, she was told it wouldn't count as anything and it couldn't be attributed to the vaccine if it had been more than 3 days. She explains her hands and feet are still slightly tingly. However, it was more of an arthritic feeling, where her joints and muscles hurt. She read joint and muscle pain is more common. The tingliness is still occurring slightly. She makes the comment she took all of her rings off of her fingers but it frightened her, the itching. She still has them off of her hands. She didn't have if it was like an allergic reaction to the metal. She wasn't sure so she took off all metal. The lady she spoke to when she called (withheld) said typically with this type situation to wait 2 weeks and see if it goes away and the caller went with her recommendation. She never had a COVID test or any other test related to the vaccine. She asked if she could receive the second dose of the Pfizer-BioNTech COVID-19 vaccine after her reaction to the first dose. A visit to Emergency Room or Physician Office was not required. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021197083 same patient, different drug/AE

Other Meds:

Current Illness:

ID: 1712230
Sex: F
Age:
State: NJ

Vax Date: 02/18/2021
Onset Date: 02/19/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: rash on her torso, back, and stomach; itchy; raised and blotchy; redder than her normal skin, as if she was flushed; This is a spontaneous report from a contactable consumer. An 88-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in right arm on 18Feb2021 08:20 (Batch/Lot Number: EL9264), at the age of 88 years old, as dose 1, single for covid-19 immunisation. Medical history included allergy, high blood pressure, stomach discomfort, and allergic to penicillin, it happened recently, she was never allergic to penicillin for her whole life, and in the last couple months around summer she was. Concomitant medication included famotidine (PEPCID) taken for "stomach"; acetylsalicylic acid (BABY ASPIRIN); and a high blood pressure pill (unspecified). The reporter was stated that the patient received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 18Feb2021, and on 19Feb2021 reporter noticed that patient had a rash on her torso, back, and stomach. She does not have a rash at the injection site. She spoke to the doctor, the doctor said to call the experts at Pfizer. The reporter found out that patient should get the second shot in 21 days, but her second dose was scheduled in 18 days. She wanted to know if that is okay. The rash started the next day after the vaccination, it first started on the stomach and is now on her back, she also notices it is itchier. She has put her on diphenhydramine (BENADRYL). The rash had gotten lighter at the time of report. It was itchy. The reporter did not touch patient's rash and so the temper of her skin was unknown, she had been putting diphenhydramine cream on with Q-tips. She didn't have a fever. In texture the rash was raised and blotchy. In color, the rash was redder than her normal skin, as if she was flushed. The itchiness has improved, when it starts to itch again, she takes another diphenhydramine and it takes 4-6 hours then it wears off. The patient was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds: PEPCID [FAMOTIDINE]; BABY ASPIRIN

Current Illness:

ID: 1712231
Sex: F
Age:
State: MI

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: half of her face and neck got swollen along her jawline and down her neck; her neck got swollen; face was touchy/tender; neck tender; jaw tender; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER-BIOTECH COVID-19 VACCINE), dose 1 at vaccination age of 72-year-old via an unspecified route of administration in the left arm on 19Feb2021 (Lot Number: EL9267) as dose 1, single for covid-19 immunisation. Medical history included blood pressure abnormal (not sure if high or low blood pressure). Concomitant medication included hydrochlorothiazide for blood pressure abnormal with start (reported to be maybe about 4 years ago) and stop date not reported and unspecified vitamins. On 19Feb2021 at 12:45, the patient experienced her face and neck got swollen. It was further reported that the patient reported that approximately three hours later (19Feb2021 at 12:45), half of her face and neck got swollen along her jawline and down her neck. She measured the swelling to be about 4.5 inches long. She added that the left side of the patient's face, and jaw, down into her neck, about 4 and a half inches long, was swollen and tender and hard. She went back downstairs to see the paramedics because the paramedics were still there in her building and the paramedic looked at the patient's face and said he could see that it was swollen and hard, and when he touched a certain spot on the patient's face, it was touchy. The paramedic wanted the patient to go to the emergency room, but the caller said no. She was monitored, but not taken to the ER. The paramedics monitored her for 20 minutes after that, and then they sent her back home. She used an ice pack on her face after that. She still has some mild swelling left today but it's definitely improving. The next day (Saturday, 20Feb2021), the swelling had gone down some, and yesterday it was down even more (21Feb2021), and today (22Feb2021), it is just a small little spot. The patient stated that she is thinking it will be gone in the next day or two, but she just wanted to report it. She also mentioned that she has also called and reported the event to her primary care doctor. She inquired if she could get the second shot. A nurse told her that if you have a reaction to the first vaccine you won't have one to the second. So, she inquired if it was true. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds: HYDROCHLOROTHIAZIDE

Current Illness:

ID: 1712232
Sex: F
Age:
State: IL

Vax Date: 02/21/2021
Onset Date: 02/21/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: facial flushing; eyes were bloodshot; dizziness and weakness; dizziness and weakness; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm right on 21Feb2021 12:30 (lot number: EN6200; expiry date: unknown) at the age of 77-years-old, as dose 1, single for Covid-19 immunisation. Medical history included allergic to penicillin (did not experience any swelling or trouble breathing). The patient had no relevant family history. The patient was not taking concomitant medications. The patient previously received influenza vaccine many years ago and got sick. The patient did not receive other vaccine on the same date or within four weeks prior to the first administration of Pfizer vaccine. The events did not require emergency/ physician visit. The patient stated that she and her husband got the first Pfizer shot yesterday, 21Feb2021. Both of them got real flushed in their faces (facial flushing), stated their eyes got blood shot. She also experienced dizziness and weakness, her husband did not. The patient recovered from the events on 21Feb2021. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021211948 same reporter/events, different patients

Other Meds:

Current Illness:

ID: 1712233
Sex: F
Age:
State: NH

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer. This 53-year-old non-pregnant female consumer reported that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247, Expiry Date: not reported), via an unspecified route of administration, administered in right arm on 17Feb2021 at 12:45 (at the age of 53 years) as dose 2, single for covid-19 immunization. Medical history included cancer diagnosis 28Dec2020. Lumpectomy for successful removal of breast cancer left side 01Feb2021. No known allergies. Concomitant medication(s) in two weeks included levothyroxine sodium (LEVOXYL) 137mcg; hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ) 100-25 mg; colecalciferol (D3) 2000IU. No Covid prior vaccination and post vaccination. She received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247, Expiry Date: not reported), via an unspecified route of administration, administered in right arm on 26Jan2021 at 12:45 (at the age of 53 years) as dose 1, single for covid-19 immunization. Severe pain and heavy feeling in my right arm at and around the site of injection on 17Feb2021 at 15:00. Her second dose was on 17Feb, that day she had symptoms of soreness and heaviness in the arm that received the injection. She did not submit her adverse event right away because she didn't have the full story until she recovered from the soreness and heaviness. She did not remember exactly what day, she submitted the adverse event form. She waited until she was fully recovered. According to the information, she did submit on 23Feb2021. AE treatment: Tylenol for pain. The outcome of events was recovered on an unspecified date of 2021. Follow-up attempts completed. No further information expected.

Other Meds: LEVOXYL; LOSARTAN HCTZ; D3

Current Illness:

ID: 1712234
Sex: F
Age:
State: OH

Vax Date: 02/10/2021
Onset Date: 02/11/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 20210211; Test Name: Body temperature; Result Unstructured Data: Test Result:102.6; Comments: 102.6 temperature,

Allergies:

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

Symptoms: Neck is a little bit swollen; Colds; Bruised/ Has a bruise in right arm; Had a 102.6 temperature / high fever; Aches and Pains; Arm real sore; Headache; Very tired; Vomiting; This is a spontaneous report from a contactable consumer (patient herself). A 60-years-old non-pregnant female patient received bnt162b2 (BNT162B2, formulation: solution for injection, Lot Number: EL9267) via an unspecified route of administration in Arm Right on 10Feb2021 15:45 as dose 1, single (at the age of 60 years) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Medical history included penicillin allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 11Feb2021 at 09:00, the patient experienced bruised/has a bruise in right arm, had a 102.6 temperature/high fever, vomiting, aches and pains, arm real sore, headache, very tired. On an unspecified date in Apr2021, the patient experienced neck is a little bit swollen, colds. The patient underwent lab tests and procedures which included body temperature: 102.6 on 11Feb2021 102.6 temperature. Patient took Tylenol and rested as therapeutic measures for bruised/has a bruise in right arm, had a 102.6 temperature/high fever, vomiting, aches and pains, arm real sore, headache, very tired. The outcome of the events bruised/has a bruise in right arm, had a 102.6 temperature/high fever, vomiting, aches and pains, arm real sore, headache, very tired was recovered with Sequel and other events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1712235
Sex: F
Age:
State: DE

Vax Date: 02/05/2021
Onset Date: 02/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 20210210; Test Name: Covid-19 Test; Test Result: Negative

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: sore throat; Sneezing; Coughing; Runny nose; Headache; felt like mucus was running down the back of her throat; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EM9808) via an unspecified route of administration, administered in left arm on 05Feb2021 (at the age of 76-year-old) as dose 1, single for COVID-19 immunization. Medical history included blood pressure abnormal. There were no concomitant medications. The patient experienced sore throat on 08Feb2021. Patient also experienced sneezing, coughing, runny nose, headache and felt like mucus was running down the back of her throat on Feb2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 10Feb2021. Outcome of the event headache recovered on 15Feb2021; outcome of events sore throat and runny nose was recovering while the outcome of all other events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1712236
Sex: F
Age:
State: OH

Vax Date: 02/02/2021
Onset Date:
Rec V Date: 09/18/2021
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: joint pain; burnt sensation on the tongue; throat sensitivity; bad taste in the mouth; muscle pain; joint pain (in hips, wrist, and elbow); joint pain (in hips, wrist, and elbow); fever; chills; achy; did not feel well; problems with energy level; fatigue; This is a spontaneous report from a contactable Nurse (patient herself). A 40-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number- EL9264, Expiry Date-UNKNOWN) via an unspecified route of administration on 02 Feb2021 (a 40-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, LOT Number- EL3249), dose 1, on 12Jan2021 for covid-19 immunization. On an unspecified date, patient experienced some symptoms, burnt sensation on the tongue, throat sensitivity, bad taste in the mouth, muscle pain, joint pain (in hips, wrist, and elbow) fever, chills lasted about 24 hours but again a week later she experienced achy, fever, did not feel well, bad taste and joint pain. she said she had a friend who had some symptoms and her friend said other people had experienced symptoms also. Reporter stated, "I had the Covid vaccine, chills you know I had lot of symptoms that I reported to the number they gave me to report to but I noticed that about like after 7 days later I was having some chills again and the muscle ache and joint pain and I thought maybe it was not related, I mean I do not think about related to that I just know having a lot of problems with energy level, fatigue and then those issues and it was kind of dissipated a little bit but I am still having the joint and muscle aches I noticed that about like and then it is also weird burnt like sensation and taste in my mouth and it never burnt my mouth and it has not gone away. It has been persistent for probably about a week and a half now or 10 days and I did not know was that anything you had heard of or not, but I know that I have friends in the medical field who are saying they have heard some lot of stories of people after they take their vaccine. Reporter stated, I am not. On the first one I was taking Celebrex (Treatment), the first vaccine and I stopped that shortly after that that is why I stopped it on the 21Jan. Reporter stated, It was treatment for like a joint issue. Reporter stated, I took 1 Ibuprofen when I needed it. Reporter stated, I do not know. I think it went right after because I was within 72 hours I think after 24 hours right after the second one that I had and then it went away and came back like I said. The therapeutic measure was taken with all events. The outcome of all the events were unknown. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1712237
Sex: F
Age:
State: TX

Vax Date: 02/20/2021
Onset Date: 02/21/2021
Rec V Date: 09/18/2021
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: rash on hands, head, face, forehead, and nose; rash hurting the patient's hands; Fingers swelling; Itching; chills; This is a spontaneous report from a contactable consumer or other non hcp.A 73-years-old female patient received second dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine,solution for injection,Batch/Lot Number: EN6198, Expiration Date: 30Jun2021), via an unspecified route of administration, administered in Arm Left on 20Feb2021(age at vaccination 73 years) as DOSE 2, SINGLE for covid-19 immunization.The patients medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number-EN5318,Expiration Date:31May2021) via an unspecified route of administration on 30Jan2021 as dose 1, single for COVID-19 immunization.Patient thought taking BioNTech COVID 19 vaccine was the right thing to do.It was reported that patient was an at-home care provider (not in the medical field) and was reporting on behalf of the patient under her care.Reporter stated that patient got the second dose of the Pfizer covid vaccine on Saturday 20Feb2021. Sunday 21Feb2021 morning, the patient was fine after she woke up. Sunday evening, the patient had chills, not for very long. On Monday 22Feb2021 the patient developed a rash on her hands, head, face, forehead, and nose but her breathing was okay.The rash was hurting the patient's hands, her fingers were swelling and she was itching. Reporter was asking on behalf of patient what is the patient supposed to do about the rash.patient did not receive any treatment for adverse events.The outcome of event chills was recovered on 21Feb2021,outcome of events rash on hands/head/face/forehead /nose,rash hurting the patients hands,fingers swelling and itching was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1712238
Sex: F
Age:
State:

Vax Date: 01/28/2021
Onset Date:
Rec V Date: 09/18/2021
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: fever; Result Unstructured Data: Test Result:Unknown result; Comments: Fever is coming

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: chills; shortness of breath; she has lost weight over the past month; it feels like a fever is coming; Some days it is tiredness; Some days it is nausea; She started to feel the soreness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 34-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL8982 and expiration date was 31may2021), via an unspecified route of administration, administered in Left Arm on 28Jan2021 in the afternoon between 12:00 and 13:00 hours (at the age of 34 years) as DOSE 2, SINGLE for COVID-19 immunization. Medical history was none. There were no concomitant medications. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date was not reported), via an unspecified route of administration, administered in Left Arm on 07Jan2021 in the afternoon between 12:00 and 13:00 hours (at the age of 34 years) as dose 1, single for COVID-19 immunization. Patient did not take any vaccine within four weeks of getting the COVID19 Vaccine. The reason patient was calling was because she had her vaccine shot. It was running into February now. She was not sure who to call. She took the shot and was still feeling some of the symptoms. She wasn't sure if the side effects could be that long. In 2021 the patient experienced the symptoms she has have been different over the course of the month. Some days it was more chills and some days it feels like a fever is coming. Some days she has shortness of breath. Some days it is tiredness. Some days it is nausea. Patient had lost weight over the past month, She would say her weight was in the 130's, She started to feel the soreness within two hours and the rest of the symptoms were felt by the evening. The patient underwent lab tests and procedures which included body temperature: unknown result on fever was coming. Patient has not had any test, but feels like she should now. The outcome of all the events was unknown. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1712239
Sex: M
Age:
State: OH

Vax Date: 02/04/2021
Onset Date: 02/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: bad rash on both of his arms and legs; itching/felt itchy; scabbed over; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 73-years-old via an unspecified route of administration, administered in Arm Right on 04Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included blood cholesterol from an unknown date (states that the only medication he had trouble with in the past, was on Statin for Cholesterol, but he was taken off of it). The patient's concomitant medications were not reported. The patient experienced rash that developed on his legs and arms on Feb2021 after receiving his first dose of the Pfizer-Biontech Covid19 vaccine. He states that he "felt itchy" on Feb2021 before the rash, and that it got so bad that it ended up "scabbed over" on Feb2021. This was a delayed reaction, it did not occur within the first hour after the vaccination. He wants to know if he should get the second dose of vaccine. His HCP told him if he does, he should get the dose at a hospital, just in case he needs medical intervention, and he is hesitant to go to a hospital during a pandemic due to the risk of Covid exposure. The patient reported a severe reaction he had from the first dose of the COVID vaccine. He had a bad rash on both of his arms and both legs. He states that it was probably four or five days later that he started itching, and then the rash just broke out suddenly. The patient was using a salve on the rash that was given to him by the doctor at the urgent care and with the salve, the rash is starting to disappear but it is still on his legs. He is considering not getting the second dose due to his reaction from the first. The patient was recovering from rash on both his arms and legs, while the outcome of the other events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1712240
Sex: F
Age:
State: AZ

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 09/18/2021
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: She was hot and cold; achy; joints were achy; Dizziness; Sensitivity to light; feverish; fatigue/tiredness; Headache; soreness in her arm; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 24-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 17Feb2021 at 14:00 pm (age at vaccination was 24 years) as dose 2, single for COVID-19 immunization. The patient's medical history included aura migraines from an unknown date. She use to have aura migraines. They would appear when the weather changed. These headaches felt very similar especially with light sensitivity. She didn't have them anymore since she moved from California to Arizona where the weather was stable. It had been probably two and a half years since she had actual aura migraine. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date in late Jan2021 (age at vaccination was 24 years) as dose 1, single for COVID-19 immunization. No additional vaccines were administered on same date of the Pfizer suspect. She has had typical side effects from vaccines. The facility where the most recent COVID-19 vaccine was administered was hospital chain called COVID vaccine facility. The patient stated that she received her second dose of the Pfizer COVID vaccine on last week on Wednesday, 17Feb2021, six days ago. She got over there about 13:30 pm and by 14:00 pm had vaccine. On 17Feb2021, the patient experienced fatigue and headaches that last all day since the second dose was given. She stated the headaches shift from the left side of her head to the right side and then down to the back of her neck. She was still having a lot of fatigue and a headache every day that last all day or most of the day. The headache starts on the left and goes to the right and down to the bottom and back of her neck. It was almost as if the headache shifts. It ends up on the back towards were head and neck meet. She got the shot in the early afternoon and by that night on 17Feb2021, she had soreness in her arm, tiredness and a tiny headache on the left side. The next day she was ok for the first part of the day. By the next part of the day, on 18Feb2021, she felt feverish. On an unspecified date, she was hot and cold, she was really achy and all of her joints were achy. She was really tired. She went to bed early. That first day the headache moved from the left to the right. The next day which was 18Feb2021 the headache was only at the back. The headache was still shifting. That morning it felt like someone hit her in the head on the left side. It was a heavy feeling. Right now it was kind of in the front and moving towards the right side. That was what it typically does. On an unspecified date, she got almost dizziness and had sensitivity to light, especially to blue light. She was worried because it was lasting longer than 48 hrs which she was told would be the length of time side effects could last. She just wanted to call to find out if the duration of symptoms of the second dose are normal. She wanted to know if that was typical or she was slowing dying and need to go to a doctor or others had experienced it. It wasn't detrimental, but it was worrisome that is had lasted longer than 48 hours which was what she was told it would last. The adverse event did not require visit to Emergency Room or Physician Office. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. .

Other Meds:

Current Illness:

ID: 1712241
Sex: F
Age:
State: CA

Vax Date: 02/20/2021
Onset Date: 02/20/2021
Rec V Date: 09/18/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: really bad migraine/pain in her neck turned into a migraine headache; body aches; Runny nose; trouble swallowing; Dry cough; could barely move; joint and muscle pain; could barely move; joint and muscle pain; could barely move; joint and muscle pain; Chills; pain in her neck; Dizziness; Headache on her way home from vaccine; feeling bad; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9266), via an unspecified route of administration, administered in arm right on 20Feb2021 23:28 (at the age of 72-year-old) as dose 1, single for covid-19 immunisation (not at military facility). Medical history included breast cancer from 2007, Took out 8 Lymph nodes in left arm, polymyalgia, connective tissue disease, pain, arrythmia, Glaucoma in left eye. There was no illness at the time of vaccination and family history relevant to Ae was reported as none. History of all previous immunization with the Pfizer vaccine considered as suspect was none. The list all vaccines administered on same date with the Pfizer vaccine considered as suspect was none, Prior to the first administration date of the suspect vaccine list any other vaccinations within four weeks was none. AE prior vaccinations was none. Concomitant products included ongoing prednisone for polymyalgia and connective tissue disease, ongoing oxycodone hydrochloride, paracetamol (PERCOCET) for Pain (She never takes a whole pill of Percocet at once. Takes half, then waits 30 minutes then takes the other half. If she takes a whole one, it makes her too spacey and nauseous), ongoing Verapamil SR for arrhythmia and this also lowers her blood pressure, ongoing Xalatan for glaucoma in left eye (Only takes it every other day. No Lot/NDC/Expiry because it was really little, she could not read it even with her glasses). On 20Feb2021, the patient had pain in her neck (20 min after vaccine), dizziness (40 mins after vaccine), headache on her way home from vaccine. On 20Feb2021 18:00, the patient could barely move; joint and muscle pain, chills. On 21Feb2021 2:00 AM, the patient experienced trouble swallowing, dry cough, runny nose. On an unspecified date in 2021, the patient had really bad migraine/pain in her neck turned into a migraine headache, body aches. Patient takes 4mg prednisone daily. The patient asked other doctors if it was ok to continue prednisone while around vaccination and stated that she really cannot move without taking the prednisone. After she got the vaccine she had an episode got really dizzy and a really bad migraine, pain in her neck turned into a bad headache, joint pains and body aches, steroids were not working, had trouble swallowing for a couple of hours, she was concerned about getting second dose. The patient questioned that it would it be ok to take the steroids. She also experienced runny nose and dry cough 2 a.m. Sunday. The reporter wanted to know the efficacy after first dose of Pfizer-BioNTech COVID-19 Vaccine and about the second dose timing (receiving it later than 3-weeks). The patient took Covid-19 vaccine because she does not want to die. She got her 1st dose on Saturday and she got really sick. Patient stated that she has other medical conditions and takes 4mg prednisone daily. She asked her Oncologist and Rheumatologist if it was okay to get the vaccine and to continue taking the steroid and was told yes. She does not take the prednisone then she can't move due to underlying conditions. She also takes Percocet for pain, and a heart pill. After she took the vaccine, about 20 minutes after she left, she had a strange pain in her neck but she just thought she slept wrong. About 20 minutes later, she started to get dizzy, then the pain shot up from her neck up into her head and she got this awful headache. She went home and she started feeling bad about 3pm, by 6pm, she could barely move, meaning that the steroids that she takes to be able to move weren't working. States that she had a really bad night, had chills, and she had trouble swallowing at about 2am Sunday morning. Stated that she got a little panicked, but she had no trouble breathing. The patient stated that when she was getting the injection, she was told that the 2nd injection would be worse, but there was another nurse there that said that she had to take a Benadryl before her injection because she was allergic to a lot of things, so her doctor advised her to take a Benadryl before getting the vaccine. She also asked her Cardiologist about this and he said not to take steroids for 2 days, but she knew that she would be in trouble if she don't take the steroids, so then she asked her Oncologist and Rheumatologist what they thought. Patient stated the pain in her neck turned into a migraine headache. She was just a little lightheaded. It gets better every day and was not there all the time. She knew that joint and muscle pain are part of the side effects, and she had that normally, but this was magnified horribly. She could barely move at all on Saturday night and it still hurts to move. She had trouble swallowing for about 4 hours around 2am Sunday morning. She needs back surgery, but she was too old to do it due to pain and also because it was a 10 hour procedure. The patient took Tylenol in between all this, about 1 every 6 hours, to help her feel better and maybe half a Percocet at night to help her sleep because she felt bad. Therapeutic measures were taken for all events. Patient did not visit emergency room and physician office for AE. No other relevant diagnostic and confirmatory tests for events. Outcome for trouble swallowing recovered on 21Feb2021, pain in her neck recovered on 20Feb2021, headache recovered on 21Feb2021 (around 6am the next morning), outcome for dry cough, chills, runny nose, really bad migraine/pain in her neck turned into a migraine headache, body aches was unknown, outcome for dizziness, could barely move; joint and muscle pain was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds: Prednisone; Percocet [Oxycodone Hydrochloride; Paracetamol]; Verapamil; Xalatan

Current Illness:

ID: 1712242
Sex: F
Age:
State: NJ

Vax Date: 02/17/2021
Onset Date: 02/18/2021
Rec V Date: 09/18/2021
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: itching; This is a spontaneous report from a contactable physician (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) intramuscular, administered in left arm on 17Feb2021 at 09:00 (Batch/Lot Number: EL9266) (at the age of 81-years-old) as dose 1, single for COVID-19 immunisation. The patient got the vaccine so she can go out and not get sick, since she is over 65. Vaccination facility type was hospital and vaccine was not administered at military facility. No other vaccines were administered on same date with the Pfizer vaccine. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient had no adverse events following prior vaccinations. Medical history included anaphylaxis to shellfish, anaphylactic reaction to CAT scan dye, and ongoing osteoporosis or osteopenia with onset date: 72 years. She developed an anaphylactic reaction to shellfish in her 20s and an anaphylactic reaction to CAT scan dye in her 50s, with the CAT scan dye causing hives and itching. The patient has no family medical history relevant to adverse event. Concomitant medications included vitamin D3 2000 units daily for osteoporosis from an unspecified start date and ongoing; and acetylsalicylic acid (ASA) 81 mg taken for an unspecified indication from an unspecified start date and ongoing. The patient experienced itching on 18Feb2021 at 01:00. Course of event was as follows: The patient was a retired physician who would like to know if the chances of having an anaphylactic reaction to the second dose of the Pfizer BioNTech COVID-19 vaccine are higher or lower. She received her first dose of the vaccine on 17Feb2021. She got her shot and waited 30 minutes before she left and was fine all that day. At 1am on 18Feb2021, she woke up itching. Patient stated it wasn't severe, just enough to wake her up, and it only lasted for about an hour. The event did not require a visit to an Emergency Room or physician office. The patient has no relevant diagnostic and confirmatory test results for the event. The event required the initiation of Prednisone 40mg slot dose once. She thought she might take some prednisone before getting the 2nd dose. She stated that she is 81, so her immune system may not be as active. She was planning on taking 100mg of Prednisone before receiving her second shot. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) intramuscular administered in right arm on 10Mar2021 (Batch/Lot number: EN6205) (at the age of 81-years-old) as dose 2, single for COVID-19 immunisation. Vaccination facility type was hospital. The outcome of the event was recovered on 18Feb2021 at 02:00. The patient did not consider the Pfizer product had a causal effect to the adverse event. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the close temporal relationship, the association between the event itching with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: VITAMIN D3; ASA.

Current Illness: Osteopenia (Onset date: 72 years); Osteoporosis (Onset date: 72 years.)

ID: 1712243
Sex: F
Age:
State: KS

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

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

Lab Data:

Allergies:

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

Symptoms: Low grade fever; Achy all over; throat started swelling; had an allergic reaction after the first dose; This is a spontaneous report from contactable consumers (including the patient) and from a Pfizer-sponsored program COVAX US Support. A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 02Feb2021 11:20 (Lot Number: EL9264) as single dose (at the age of 41-years-old) for COVID-19 immunisation. Medical history included rheumatoid arthritis from 2005 and ongoing. Concomitant medication included certolizumab pegol (CIMZIA) taken for rheumatoid arthritis from an unspecified start date and ongoing. The patient experienced throat started swelling on 02Feb2021 11:50, low grade fever on 03Feb2021, achy all over on 03Feb2021, had an allergic reaction after the first dose on 2021. The time of onset of events: Throat swelling -within 1 hour after getting vaccine (as reported), Low grade fever and achy all over - 03Feb2021. Therapeutic measures were taken as a result of throat started swelling. Reported as: the patient received the 1st dose of the Pfizer covid vaccine 02Feb2021, 30 minutes later when she got home, her throat started swelling. The location had her wait 20 minutes before she left. She went home, and about 25-30 minutes later, her throat started swelling. She went to urgent care where she received Benadryl, peptides, etc. States that she went to an urgent care at 12:15pm, and they prescribed her Benadryl, steroids, and Pepcid, which she started that day and took for 5 days. By Friday she noticed significant improvement. States that she spoke with the supervising nurse at the facility where she got her vaccine and the nurse still recommended that she get her 2nd dose. She has rheumatoid arthritis, so she also asked her Rheumatologist, who also said to still get the 2nd dose. But her primary care physician was hesitant about her getting it, so she said they could start her on Pepcid ahead of time and give her an EpiPen to bring with her. States that she went to get her 2nd dose today, and when she put yes on the form that she had a reaction to the first dose and that she had an EpiPen with her, they had an anesthesiologist and a doctor consult on whether or not she should get it. They both said that they wouldn't give her the vaccine because Pfizer has found out in the last week that people are reacting to the polypropylene glycol in the vaccine. They told her to call and ask what Pfizer recommended, and said that if she did receive the 2nd dose, that they recommended that she got it in an urgent care or ER setting. She also had a low grade fever, and was achy all over, which only lasted a few days. States that she felt completely back to normal by Sunday. Patient had an allergic reaction after the first dose. Her second dose should be today however, they put her on hold and asked to call our number to ask what is the next step. Will she be able to get the second dose or not. The people at the facility assumed that she might be allergic to propylene glycol since it was the most common ingredient people were allergic to from the Pfizer COVID-19 vaccine. The outcome of the events Allergic reaction was unknown while for the rest of the event was recovered on 07Feb2021. No follow-up attempts are possible. No further information is expected.

Other Meds: CIMZIA

Current Illness: Rheumatoid arthritis

ID: 1712244
Sex: F
Age:
State: CA

Vax Date: 12/19/2020
Onset Date:
Rec V Date: 09/18/2021
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: arm soreness; This is a spontaneous report from a contactable physician (patient). A 43-years-old female patient received first dose of bnt162b2 (Solution injection; Batch/Lot Number: EH9898), via intramuscular, administered in Deltoid Left on 19Dec2020 (at the age of 43-years-old) as single dose for covid-19 immunisation. Medical history included coeliac disease from 01Sep2018 to ongoing and hypothyroidism. The patient's concomitant medications were not reported. On an unspecified date, patient experienced arm soreness (mild). The outcome of the event was unknown. Follow-up attempts completed. No further information expected

Other Meds:

Current Illness: Celiac disease; Hypothyroidism

ID: 1712245
Sex: M
Age:
State: TN

Vax Date: 02/12/2021
Onset Date: 02/13/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: CT scan; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Upset stomach; loose bowel movements; Dry heaves; could not sleep at all because all night he was sick; could not sleep at all because all night he was sick; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 74-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9269), dose 1 via an unspecified route of administration, administered in right arm on 12Feb2021 at 10:55 (at the age of 74-year-old) as dose 1, single for COVID-19 immunisation. Medical history included lung neoplasm malignant from 2018 to an unknown date, herpes zoster from Dec2019 and ongoing, musculoskeletal discomfort from an unknown date and unknown if ongoing he has a bad left shoulder, its arthritic, chronic obstructive pulmonary disease from an unknown date and unknown if ongoing Minor COPD. He had lung cancer that started in 2018, it is gone, and he had it treated. Last year there was a nodule but that has not grown at all. He gets a CT scans every 3 months to check this. He had Shingles 2019 Christmas Eve, 24Dec2019, and that is still ongoing. Investigation assessment was reported as yes. he has a bad left shoulder, its arthritic, he was supposed to go see doctor on this Thursday to find out if he will be having an operation on it for a shoulder surgery replacement, but in their state, it is now locked down, with ice or snow. There were no concomitant medications. His Last vaccine was the flu vaccine at either end of Oct2020 or beginning of Nov2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other vaccines on same day. The patient did not diagnose with COVID-19 prior to vaccination. On 13Feb2021, the patient experienced upset stomach, loose bowel movements, dry heaves and could not sleep at all because all night he was sick. He has not had to make any appointment with a doctor or go to the ER for his symptoms. It was reported that he was calling about the covid vaccine. He thinks he had a reaction. He had vaccine first dose on 12Feb2021, had the Pfizer Lot# EL9269. On Saturday, after the vaccine he was fine, till Saturday evening his stomach started to bother him, then Saturday night into Sunday he could not sleep at all because all night he was sick, he had loose bowels, he was dry heaving because nothing was in his stomach, he ate a little oatmeal, had none of the pills, he had bread and jelly in the afternoon, basically then Monday he had a soft-boiled egg chicken, mash potatoes. Today he feels like nothing ever even happened. He Confirms First Dose 12Feb2021 at 10:55 Friday. Then Saturday 13Feb2021 his stomach started bothering him, then the night of 13Feb2021 going into the 14Feb2021 He started to experience the loose Bowel movements and dry heaving causing him to not sleep that night. On 14Feb2021 he ate a little and did not have his pills, he still had the loose bowel movements, and his stomach was still upset. He clarifies that this continued into Monday 15Feb2021, he still had effects that day. The patient underwent lab tests and procedures which included computerised tomogram: unknown results. He was scheduled for the second dose on 05Mar2021. The outcome of the events upset stomach and loose bowel movements was reported as resolved on 15Feb2021 and the other event dry heaves was resolved on 14Feb2021 and outcome of the other events was reported as unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness: Shingles

ID: 1712246
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: Developed a lymph node on the right side of my neck; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: unknown) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated, "I had my first vaccine on the first of this month, it had been two weeks now and yesterday, I developed a lymph node on the right side of my neck, it was not very severe. But I figured that I should call it in to see what your views on it were. Let me ask you one question, I was due to get my next shot next week, is it okay if I go do that? "Consumer was informed about the role of Pfizer Drug Safety and also informed about Pfizer Medical Information department in response to probing, consumer stated, "No, I don't know that is it. I will just call this number and see what they say. I will call you back." Further probing could not be initiated as consumer was unwilling to further answer the questions. Hence, further details were unknown and limited information was available over the call. The patient did not receive any treatment for the events. The clinical outcome of the event was unknown at the time of report. Information about lot/batch number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 1712247
Sex: M
Age:
State: NY

Vax Date: 02/15/2021
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: antibody levels; Result Unstructured Data: Test Result:immunocompromised due to MS; Test Name: temp; Result Unstructured Data: Test Result:100 degrees

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: one of 81 people possibly effected by a temperature excursion; Fatigue; Achiness; Flushing; Temp of 100 degrees; This is a spontaneous report from a contactable consumer or other non hcp. A 43-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration on 15Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included immunodeficiency He is immunocompromised due to MS and takes immunosuppressant medication, multiple sclerosis from an unknown date and unknown if ongoing He is immunocompromised due to MS and takes immunosuppressant medication. Patient took Historical Vaccine BNT162B2 received the first dose of the Pfizer Covid 19 vaccine on 25Jan2021 for COVID-19 immunisation. The patient's concomitant medications were not reported. on an unspecified date patient received the first dose of the Pfizer Covid 19 vaccine on 25Jan2021. He received a second dose at the (Name) location on 15Feb2021. He had no side effects from the first dose but experienced a lot of fatigue, achiness, flushing and a temp of 100 degrees that night. He received a call that he was one of 81 people possibly effected by a temperature excursion. A hand warmer got into the cooler. This has been reported to the Department of Health. They are recommending he get a third dose which is scheduled for 13Mar2021. Caller wants to know what Pfizer recommends about getting 3 dose, should he have it right away or wait awhile. The patient underwent lab tests and due to ms on, body temperature: 100 degrees on. Outcome of the procedures which included antibody test: immunocompromised events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained

Other Meds:

Current Illness:

ID: 1712248
Sex: F
Age:
State: FL

Vax Date: 02/10/2021
Onset Date: 02/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 20210217; Test Name: covid test; Result Unstructured Data: Test Result:Pending; Comments: Nasal Swab,Pcr,Antigen

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: out of breath at times; Tiredness, fatigue; Sinus allergy; cold; sore throat; dryness feeling throat and nose; dryness feeling throat and nose; congestion; runny nose; cough; This is a spontaneous report from a contactable consumer (Patient). A 52-year-old non-pregnant female consumer received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9269) via an unspecified route of administration, administered in arm left on 10Feb2021 at 12:30 PM (at the age of 52-year-old) as dose 1, single for covid-19 immunisation . The patients medical history included allergies, known allergies to Aspirin, Penicillin, and Sulfas. The patients past drugs included Tetracycline, Advil, Ibuprofen, and experienced allergies. Concomitant medication in two weeks included cetirizine hydrochloride (ZYRTEC), taken for unspecified indication, start and stop dates were not reported. Patient did not receive other vaccine in four weeks. On 16Feb2021 at 01:30 AM, five days later, she experienced tiredness, fatigue, out of breath at time, cold or sinus allergies. It started with a sore throat, dryness feeling throat and nose, congestion, runny nose and cough. Adverse events resulted in physician office visit. The patient did not receive treatment for adverse events. The patient had no COVID prior vaccination and was tested for COVID post vaccination. The patient underwent lab test and procedure which included SARS-CoV-2 test (Nasal Swab, polymerase chain reaction, and Antigen): result unknown, on 17Feb2021. The clinical outcome of all the events was resolving. Follow-up attempts completed. No further information expected.

Other Meds: ZYRTEC

Current Illness:

ID: 1712249
Sex: F
Age:
State: GA

Vax Date: 02/18/2021
Onset Date: 02/18/2021
Rec V Date: 09/18/2021
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: This is a spontaneous report from a contactable nurse (patient) via Medical information team. A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9265, Expiry Date: 31May2021) via an unspecified route of administration in left arm on 18Feb2021 (at the age of 70-year-old) as dose 2, single for COVID- 19 immunisation. Relevant medical history included ongoing secondary hypoadrenalism (diagnosed 8 years ago, she takes steroids for it). It was further clarified that secondary hypoadrenalism came from her having a pituitary brain tumor benign that was diagnosed 8 years ago, and radiation to that in Feb2018; ongoing Hypothyroidism (she has had this for 20 years, she takes a thyroid medication). Concomitant medications were none (the patient had not received any other recent vaccinations or medications). The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown) on 26Jan2021 (at the age of 70-year-old) as dose 1, single for Covid-19 immunization. The patient received her second dose of the Pfizer covid vaccine on the 18Feb2021 and clarified that she had muscle achiness, she had joint pain in her knees and shoulder. The patient had facial skin sensitivity. She said for the sensitive skin on face treatment she was going to see her doctor today to see if it could be shingles, thought there was no rash, it was just sensitive around her right eye. At the time of reporting, the patient aching got better. Seriousness was not provided. The outcome of the event of hyperaesthesia was unknown and other events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness: Hypoadrenalism (diagnosed 8 years ago, she takes steroids for it); Hypothyroidism (Patient has had this for 20 years, takes a thyroid medication.)

ID: 1712250
Sex: F
Age:
State: IL

Vax Date: 02/19/2021
Onset Date: 02/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:144 over 70; Test Name: blood pressure; Result Unstructured Data: Test Result:123 over 70

Allergies:

Symptom List: Nausea

Symptoms: The arm where I got the injection, it is starting to itch in the muscle; trouble sleeping; like having a hangover; her arm hurt in the muscle where [they] gave [her] the shot for 3 days; feeling groggy; leg pain; Headache; don't feel like normal; Charley horses/leg cramps; couldn't think straight; a headache "that felt like i was drunk"; troubled sleep; loose bowel movement; the index fingers of both my hands were swollen a little bit stiff.; the index fingers of both my hands were swollen a little bit stiff.; This is a spontaneous report from a contactable consumer or other non hcp. A 81-year-old female patient received bnt162b2 (BNT162B2 Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm on 19Feb2021 15:15 (Batch/Lot Number: EN6198) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing hypertension, allergy, 3 broken bones, the sacrum, the pelvic and the tail from an unknown date and unknown if ongoing. Concomitant medication(s) included nebivolol hydrochloride (BYSTOLIC) taken for hypertension, start and stop date were not reported; acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were not reported. Patient received first dose on Friday. Four hours later she had headache for 3 days, she felt like she couldn't think straight, gorging and "like having a hangover". On Friday night she had terrible leg cramps that lasted for a couple hours. Her am is still sore and itching(She lastly explained her arm hurt in the muscle where [they] gave [her] the shot for 3 days, then it itched). patient stated, "I have a lot of allergies. I sat in the waiting area for a half an hour. I got home and about 8 o'clock at night, I start getting a headache so. I took a Tylenol, it didn't help, (PC Filed) I took another one and it somewhat helped. I went to bed, I had a very troubled sleep and I woke up with terrible pains in my right leg like a Charley horse, I had them before if I don't drink enough water. I got up, I took some water, went back to bed, by 2 hours later the pain happened again so I took some more water went back to bed, by 2 hours later got the pain in my left leg and I got up and I took a little milk. I tried to stand, it was very difficult. I had, it feels still since Friday like I am drunk. If you say is it a headache, not exactly but I don't feel like normal. On Saturday night I took 2 Dulcolax which are laxatives because I didn't go, have a bowel movement for couple of days and when I always take Tylenol I get constipated, so I took it so yesterday afternoon I was tired laid down in the afternoon and I had panty liners thinking that if I have a loose bowel movement or whatever, it was all like diarrhea a little more consistency all the way up to the slacks belt of my slacks, I had to clean myself up of course and then I was very very careful if I pass gas so I wouldn't be passing stool. This morning I went to the washroom and I still had a loose bowel movement but it wasn't diarrhea. My head still feels like I have been all drinking and I never drink, I am 81. The arm where I got the injection, it is starting to itch in the muscle and this morning I don't know if this is just arthritis or my age, the index fingers of both my hands were swollen a little bit and stiff. Whether that is from the Covid, I don't know but I don't feel right.", also reported that felt kind of groggy like if almost being drunk. The patient reported "I do have hypertension but last time I went to the doctor couple of weeks ago, it was 144 over 70 and he said fine. I was in a skilled nursing facility 9 days and my blood pressure was always 123 over 70." also reported that probably 3 weeks her blood Creatinine were a little elevated but other than that nothing. Also reported , "I would give them a call because you see the diarrhea could have been due to the Dulcolax, the laxative and then I had fiber or it could have been that it was just diarrhea because of the shot, I don't believe that. The muscle pain, leg pain, the cramps in the leg that is muscle pain I believe I had that, I did walk a great distance to get to the location, it could have been that maybe I didn't drink enough water, it could be relative things but the underlying headache, it's still I feel groggy it feels like I am almost, I had too much to drink." The patient underwent lab tests and procedures which included blood pressure measurement: 144 over 70, 123 over 70. Therapeutic measures were taken as a result of charley horses/leg cramps, headache, leg pain. The outcome of the event charley horses/leg cramps and headache was recovered and for other events it was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: BYSTOLIC; BABY ASPIRIN

Current Illness: Hypertension

ID: 1712251
Sex: M
Age:
State: FL

Vax Date: 02/20/2021
Onset Date: 02/20/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 20210224; Test Name: Blood sugar; Result Unstructured Data: Test Result:108

Allergies:

Symptom List: Injection site pain

Symptoms: they are like water blisters inside the lymph of my mouth and inside of my lips; headache; water blisters on roof of mouth that pop and have a slight blood discharge; water blisters on roof of mouth that pop and have a slight blood discharge; have a little bit of sore arm; This is a spontaneous report from a contactable consumer or other non hcp. An 82-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 20Feb2021 14:00 as 2nd dose, single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease, COPD, he takes Symbicort for that, dose says 160/4.5. caller said that this was diagnosed 20 years ago, type 2 diabetes mellitus and takes Onglyza and Glipizide for this. Caller said he had that probably 30 years. Concomitant medication(s) included budesonide; formoterol fumarate (SYMBICORT) taken for chronic obstructive pulmonary disease; saxagliptin hydrochloride (ONGLYZA) taken for type 2 diabetes mellitus; glipizide (GLIPIZIDE) taken for type 2 diabetes mellitus. It was Reported that, the patient experienced headache on 21Feb2021 with outcome of recovered, water blisters on roof of mouth that pop and have a slight blood discharge on 20Feb2021 with outcome of unknown, have a little bit of sore arm on 20Feb2021 with outcome of unknown, they are like water blisters inside the lymph of my mouth and inside of my lips on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included blood glucose fluctuation: 108 on 24Feb2021. Therapeutic measures were taken as a result of headache (headache). Information on the lot/batch number has been requested.

Other Meds: SYMBICORT; ONGLYZA; GLIPIZIDE

Current Illness:

ID: 1712252
Sex: F
Age:
State: OH

Vax Date: 02/08/2021
Onset Date: 02/08/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: covid test; Test Result: Negative

Allergies:

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

Symptoms: My eyes itched; My lips itched; My eyes swollen; My tongue itched; My tongue swollen; My lips swollen; I itched all over and still itch; This is a spontaneous report from a contactable consumer or other non hcp. A 49-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection with Batch/Lot Number: em9810) via an unspecified route of administration, administered in arm left on 08Feb2021 14:00 (at the age of 49-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included asthma, hypertension and drug hypersensitivity. Concomitant medications included telmisartan taken for blood pressure. The patient previously took Benadryl and sulfa and experienced allergies. Patient did not have COVID prior vaccination. Patient was tested for COVID post vaccination. On 08Feb2021 at 02:00PM the patient lips tongue and eyes itched and became swollen. The patient itched all over and still itching and had to rush to the urgent care for treatment and the went to an allergist a few days later. The patient was advised not to take the second shot and was given epi pen. The patient received treatment with steroids and allergy medication. Patient underwent lab test on an unspecified date: COVID test result: negative. The outcome of the events was recovering. Follow-up attempts completed. No further information expected.

Other Meds: TELMISARTAN

Current Illness:

ID: 1712253
Sex: F
Age:
State: FL

Vax Date: 01/30/2021
Onset Date: 01/30/2021
Rec V Date: 09/18/2021
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: This is a spontaneous report from a contactable consumer. A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown) unspecified route of administration on 30Jan2021 (at the age of 66-years) as dose 1, single for covid-19 immunization. The patient concomitant medications were not reported. There were no allergies to medications, food, or other products. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021, the patient had migraine headache that got worse after the shot and she said she had sensitivity and tasted soap for about a day. The migraine was reported better the next day. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. On an unspecified date in 2021, the outcome of the events were recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1712254
Sex: F
Age:
State: WA

Vax Date: 02/17/2021
Onset Date: 02/01/2021
Rec V Date: 09/18/2021
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: 20210217; Test Name: Heart rate; Result Unstructured Data: Test Result:Went up; Test Date: 20210217; Test Name: pulse; Result Unstructured Data: Test Result:Normal; Comments: Nurse said everything was fine.; Test Name: weight; Result Unstructured Data: Test Result:Lost; Comments: Weight: she just lost a bunch of weight

Allergies:

Symptom List: Tremor

Symptoms: it hurt to walk. Her ankles felt like they were going to snap/ankle pain. When she walked it hurt. It felt like her ankles were going to snap; muscle and joint tightness; muscle and joint tightness; she just lost a bunch of weight; on her right ankle on the inside of the ankle bone and about 4 inches above that she had bright pink mark; had pain in the arm where the shot was given in the shoulder area. It was very painful when she got the shot. It felt like it went in the bone; heart rate went up; breathing was heavier than usual; entire night and into the morning she was woken by both of her legs, calves, and ankles terribly cramping; tightness in her neck at the hairline that came around the left side where her carotid artery is; tightening in her left arm where she got the shot down into her wrist; it hurt to walk. Her ankles felt like they were going to snap/ankle pain. When she walked it hurt. It felt like her ankles were going to snap; She started having horrible pain yesterday in her right arm; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6201), via an unspecified route of administration, administered in left arm on 17Feb2021 (at the age of 56-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included diverticulitis, upper respiratory infection that every year she gets a terrible upper respiratory infection and this winter she did not surprisingly, but she did in 2020 and walking pneumonia before too and she thought it was important to get the vaccine. The patient's concomitant medications were not reported. The patient had no prior vaccinations within 4 weeks. On 17Feb2021, shortly after vaccination when she was sitting during the waiting time, she felt like her heart rate went up and her breathing was heavier than usual. The nurse checked her pulse and said every-thing was fine. She sat for a longer amount of time. On Feb20021, that night when she went to bed she was awaken within an hour having leg cramps. She doesn't ever get leg cramps. She drinks water all day long. She drinks a lot of water. She wasn't dehydrated at all. The entire night and into the morning she was woken by both of her legs, calves, and ankles terribly cramping. She would wake up in a stretching position. Then around nine when she got out of bed it hurt to walk. Her ankles felt like they were going to snap. She took it easy that day and sat on the couch with her feet up. On Feb20201, the patient had pain in the arm where the shot was given in the shoulder area. It was very painful when she got the shot. It felt like it went in the bone. She had read to expect her arm to be sore. Then she had this tightening in her left arm where she got the shot down into her wrist. Her arm felt like she had a major workout. It felt tight like it was going to burst. Nothing like she had felt before. She had tightness in her neck at the hairline that came around the left side where her carotid artery was. It was very tight. No breathing issues but muscle and joint tightness. That actually lasted throughout the day. Then the next day she continued to have the ankle pain. When she walked it hurt. It felt like her ankles were going to snap. On Feb2021, she noted a spot left, but the other spots have gone. On her legs on 18Feb2021, after she had all the cramping, on her right ankle on the inside of the ankle bone and about 4 inches above that she had bright pink mark. It was a little smaller than a dime. On the right side of the right ankle, just barely above the bone, she has a bright red mark. It was about probably three fourths of an inch long and perfect rectangle. On the left leg above the ankle there was a spot. The other spots on the right were still there. On the left side of the left ankle just 3 inches above the bone she has a bright mark. That has remained with her but it is starting to dissipate. They are now the colour of a scar. They are turning a purplish and pinkish colour now. Today she hasn't had any of the side effects but it was up until yesterday it hurt to walk. She started having horrible pain yesterday in her right arm. She would just be massaging and rubbing her forearm area and it worked its way into the upper arm. It was bizarre. It was that whole tight pressure like someone squeezing from the inside out. It was really painful. Then the pain went down into her hand. It just felt like pressure, like it was going to burst. Never has she had something like this. she just lost a bunch of weight. The patient underwent lab tests and procedures which included weight with result she just lost a bunch of weight and pulse result as normal and heart rate: went up on 17Feb2021 and nurse said everything was fine. The patient did not had any AE(s) following prior vaccinations. Patient did not any AE(s) require a visit to emergency room and physician office. The outcome of the events were unknown. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1712255
Sex: M
Age:
State: NC

Vax Date: 02/23/2021
Onset Date: 02/23/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: Stress Test; Result Unstructured Data: Test Result:Normal

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: headache; muscle and joint pain; muscle and joint pain; soreness at the injection site; unable to sleep; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 75-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6202) via an unspecified route of administration, administered in arm left on 23Feb2021 13:15 (at the age of 75-year-old) at dose 1, single for covid-19 immunisation. Medical history included hypertension from 2008 and arthritis. Concomitant medications included clonidine (CLONIDINE) taken for blood pressure measurement from an unspecified start date and ongoing; irbesartan (IRBESARTAN) taken for blood pressure measurement from 2019 and ongoing. On 23Feb2021 the patient experienced unable to sleep, muscle and joint pain, soreness at the injection site, soreness at the injection site on 24Feb2021 headache. Reports unable to sleep, took 3 mg Melatonin. Reports muscle pain, joint pain, and soreness at the injection site. Additional Context: Reporter received the Covid-19 vaccine yesterday/ Last night he was unable to sleep. He was unable to sleep last night. He has muscle pain, joint pain and headache. His arm is not red but it is sore. How long will he feel like this. He received the injection at 1:15. He did not have any symptoms until last night. He normally walks 2 miles a day. He has joint pain in both ankles. It is ok if he is moving but hurts when he is not moving. The headache comes and goes. He took two Tylenol this morning. He will take two more at 2:00pm and then again later this evening. When providing concomitant medications, caller states he was taking Clonidine 1mg, 2 tablets three times daily. His blood pressure was going up so the doctor increased the dose to 3mg, three tablets daily. The order was written on Friday. He received the changed dose in the mail yesterday. Unable to provide NDC, Lot or Expiry from Clonidine 1mfg. Product is filled in pharmacy bottle. He saw his doctor on 05Nov2020 and received a flu shot in Then he got sick. He went to the Emergency Room. The doctor said it had nothing to do with the flu shot. He saw his primary care provider and a cardiologist. He had a stress test and was told everything was good. He usually gets the flu shot every year. The Friday after getting the flu shot he woke and was short of breath. His heart was beating fast so he drove himself to the emergency room. He didn't know what the side effects of the flu shot were. He received an inactivated influenza vaccine. NDC, Lot and Expiry are not documented. He provides 300AA-26 from the papers that he has. He does not know what this represents. Additional Context: Reporter stated that he has called in previously due to events he was experiencing after his first dose of Pfizer COVID-19 vaccine. Reporter stated that his first Pfizer COVID-19 vaccine was on 23Feb2021. He called in due to the same events he is experiencing now and was told that the events should go away after about 7 or 8 days. Reporter stated does confirm that they did go away and he was fine. Reporter stated that his 2nd dose of Pfizer COVID-19 vaccine was administered on 15Mar2021. He notes that it was originally scheduled sooner than that but due to snow and bad weather it was rescheduled for the 15Mar2021. Reporter stated after he got his second dose on 15Mar2021 the electricity feeling in his legs began that night. Reporter stated it feels like electricity going through his veins down to his toes and comes back up. Reporter stated it does not happen 24/7, it comes and goes. Reporter stated the leg cramps, headache and muscle and joint pain, started the next day. Reporter stated the muscle and joint pain are not 24/7 either, it comes and goes. Reporter stated he is able to move around but feels it when he walks around. Treatment: Reporter stated he has been taking extra strength Tylenol three times when it first started, and now he is taking it 2 times a day. Reporter stated that he went through the same thing after he got his first Pfizer COVID-19 vaccine, and the events went away after 7-8 days and these are not. Reporter stated to know if this is something that he is going to have to deal with for the rest of his life. Will it go away. Reporter stated also stated saw on the news people taking the Johnson and Johnson vaccine and fainting. Caller also adds that he also saw on the news that a lot of doctors and nurses are refusing to take the COVID-19 shot. History: Reporter stated he takes medication for high blood pressure. Caller declines to list specific medications stating that he listed them the last time he called in and we should have it. AE following prior vaccinations: Adverse Event arm hurt, headache, leg cramps like electricity going through veins and toes, joint pain comes and goes in his back, knees ankle and toes, leg muscle pain part of thigh and knees comes and goes, most of time it is in his calf. The patient underwent lab tests and procedures which included stress Test: normal on an unspecified date. Outcome of the event unable to sleep was unknown and remaining other events was not resolved. No follow up attempts are possible. No further information is expected.

Other Meds: CLONIDINE; IRBESARTAN

Current Illness:

ID: 1712256
Sex: F
Age:
State: SC

Vax Date: 02/23/2021
Onset Date: 02/24/2021
Rec V Date: 09/18/2021
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: Test Date: 20210224; Test Name: temp; Result Unstructured Data: Test Result:101 Fahrenheit

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: 101?F temp; chills; headache; muscle aches from hip to foot; muscle aches from hip to foot; coughing; sore throat; little dizzy; muscle aches from hip to foot; This is a spontaneous report received from a contactable consumer (patient). A 72-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and lot number: EN6198) via an unspecified route of administration, in left shoulder 24Feb2021 a little after 12:00 PM (at the age of 72-years-old) as single dose for COVID-19 immunization. Medical history included ongoing blood pressure, ongoing acid reflux, ongoing sinus and stress from an unknown date. Concomitant medications included Famotidine taken for acid reflux; Amlodipine at 2.5 mg taken for blood pressure, montelukast sodium (SINGULAIR) taken for sinusitis, and loratadine (CLARITINE) taken for sinusitis. Previously patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EZ9204) via an unspecified route of administration, in left arm on 02Feb2021 (at the age of 72-years-old) as single dose for COVID-19 immunization. On 24Feb2021 patient experienced 101degree F temp, chills, headache, muscle aches from hip to foot, coughing, sore throat, little dizzy, muscle aches from hip to foot. Caller mentions that she had her second dose of the covid 19 vaccine yesterday and she got today 101 degree F temp and chills, headache, muscle aches from hip to foot that got her awake since 3 o clock because she was freezing. She would like to know if fever was expected after the second dose. She has been awake since 3AM. She has 101 temperature, chills, coughing, and a sore throat. She took Tylenol and was doing a little better now. She was freezing. She couldn't get warm. She almost burned her husband up. She had on two sweaters. Her hands felt like ice cubes. Caller clarified product as COVIID19 Vaccine. She knows it was a side effect. She wanted to know about the 101 temperature. She had so much covers on the bed. She was a little dizzy and has a sore throat and she is coughing some. She had a headache after the first dose for 3 to 4 days. She didn't have fever, chills, cough, or sore throat with the first dose. Her arm was a little sore and it went away on the second day. This time she was coughing and her chest hurts. Her right ear was aching too when she has the headache. She got the second dose yesterday, 23Feb2021, a little after 12:00PM. She got the fever and chills yesterday around 3:30PM or 4:00PM. She had to put her whole head under the cover. If there was any crack she felt like ice was coming under the cover. She also had muscles aches. The coughing and sore throat started this morning, 24Feb2021.Caller reporting adverse event with COVID19 Vaccine. She has been awake since 3AM. She has 101 temperature, chills, coughing, and a sore throat. She took Tylenol and was doing a little better now. She was freezing. Tylenol: lot number: MEA092, expiry: Mar2020. She took two of the extra strength Tylenol about an hour ago and she is feeling a little better now. She was still dizzy. Patient underwent lab test and procedure which include temp 101 Fahrenheit on 24Feb2021.Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: FAMOTIDINE; AMLODIPINE; SINGULAIR; CLARITINE

Current Illness: Acid reflux (esophageal); Blood pressure; Sinus infection

ID: 1712257
Sex: F
Age:
State: IN

Vax Date: 02/12/2021
Onset Date: 02/12/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:99; Test Date: 20210212; Test Name: body temperature; Result Unstructured Data: Test Result:102.5; Test Date: 20210212; Test Name: body temperature; Result Unstructured Data: Test Result:101

Allergies:

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

Symptoms: she really just felt terrible, felt like she had the flue; she really just felt terrible, felt like she had the flue; hives; chills; high temperature/sometimes having a fever; This is a spontaneous report from a contactable consumer (patient). An 80-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: EM9810) via an unspecified route of administration, administered in Arm Left on 12Feb2021 (at the age of 80-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history included covid-19 from 07Oct2020 to an unknown date (Tested positive for coronavirus on 07Oct2020). The patient's concomitant medications were not reported. On 12Feb2021, 12 hours later in the middle of the night the patient experienced chills, high temperature, it was up to102.5 and naturally that day it was about 101 and slowly started going down, states that she is still sometimes having a fever of about 99 or so, no tall the time. On 13Feb2021 hives on next night, on an unspecified date, she really just felt terrible, felt like she had the flue. On 12Feb2021, the patient underwent lab tests and procedures which included body temperature: 99, body temperature: 102.5, body temperature: 101. The outcome of events chills, high temperature was recovering, while the outcome of other events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1712258
Sex: F
Age:
State: MO

Vax Date: 02/22/2021
Onset Date: 02/22/2021
Rec V Date: 09/18/2021
Hospital:

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

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

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: quiver in her lip on the left side; soreness and swelling in my arm; Her right upper arm is swollen after getting her second COVID-19 Vaccine shot; her said her right upper arm is sore & swollen & feels like someone had fist bumped her; The right side of her face became swollen later in the day on 22Feb2021/Puffiness face; right sided facial edema going under her ear, where she reports a knot the size of a penny was noted; lobe and patient couldn't open her mouth without feeling pain; face was sore where the swelling is; if she tries to open her mouth, her mouth doesn't open as wide as it should. Her face has a TMJ like feeling; This is spontaneous report from a contactable consumer (patient). A 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EL3247; expiration date: 31May2021) via an unknown route of administration in right arm on 22Feb2021 (Monday afternoon) between 15:30-16:00 (at the age of 73-year-old) as single dose for COVID-19 immunization at Hospital. Medical history of the patient included kidney stones from Nov2019, nosebleed in Jan2021. She said she woke up at 5:00 to go to the bathroom. She said when she stood up from the side of her bed, her nose wouldn't stop bleeding. She stated she doesn't remember exactly when she had gone to the Emergency Room for her nose bleed in Jan2021. No further details provided. Concomitant medications included Potassium Citrate started in Dec2020 taken for Kidney stones. Patient did not receive any Prior Vaccinations (within 4 weeks) of covid vaccine. Patient previously received Shingle vaccine in 2020 and received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EN5318; expiration date: 31May2021) Intramuscular in right arm on 01Feb2021 as single dose for COVID-19 immunization. On 22Feb2021, later at night patient developed soreness and swelling in arm where she received the vaccine. She had swelling on the right side of face that she noticed later in the day on Monday and experienced right sided facial edema going under her ear, where she reports a knot the size of a penny was noted. The swelling was under eye to the cheek to right ear lobe and patient couldn't open her mouth without feeling pain. Patient have heard that some people have developed bells palsy after getting the vaccine. Patient spoke with her doctor and the doctor told to visit ER. The right side of her face was sore where the swelling is & if she tries to open her mouth, her mouth doesn't open as wide as it should. Her face has a TMJ like feeling. She clarified her right upper arm was sore and swollen and feels like someone had fist bumped her. On an unspecified date, not often but at times caller notices a quiver in her lip on the left side. She clarified she received the COVID-19 Vaccine in her right arm, and the swelling and soreness started on Monday night (22Feb2021). She said her right arm has improved, and her right arm now feels like it would if she were to get a regular flu shot in it. She said prior to today, her arm soreness felt like it was 5 times that of a flu shot. She said her right arm soreness and swelling didn't concern her. Reportedly, the right side of her face became swollen later in the day on Monday (22Feb2021). She clarified that the swelling started under her right eye and continued down her right cheek. She said the swelling continued from her right cheek to under the front of her right earlobe (where an earring would hang). She said the right side of her face was sore where the swelling was. She said if she tries to open her mouth, her mouth doesn't open as wide as it should. She said it is like a TMJ feeling. She said if she puts her finger in front of her right ear, and then opens her mouth, she can feel something. She said the right sided facial swelling and soreness has improved a little bit, but the right side of her face continues to be puffy with some swelling on 24Feb2021. She said she heard some people have a problem with Bells Palsy after getting the COVID-19 Vaccine. She said she called her doctor, and he told her to go the Emergency Room. She said she called the facility that administered both doses of the COVID-19 Vaccine to her, and the facility told her to go to the Emergency Room. She said it appeared that nobody wanted to get involved with helping her, so she figured she would call Pfizer. She said she was wondering if Pfizer had some type of treatment for her to try. She said the Emergency Room is very busy and she would probably have to wait 2-6 hours to get in to see a doctor, and she didn't want to wait around with a bunch of people who haven't been vaccinated for the COVID-19 Virus. Reported she has only had a mammogram in the last couple of weeks, and no other testing. Caller was advised by HCP to be seen in the ER. She was prescribed Prednisone for 3 days at ER but was advised by nurse with HCP to hold off on taking. Caller has been taking Tylenol. Edema has improved, continues to have a little facial puffiness. Outcome of the event quiver in her lip on the left side was unknown and for all other events was resolving. No follow-up attempts are possible. No further information is expected.

Other Meds: POTASSIUM CITRATE

Current Illness:

ID: 1712259
Sex: F
Age:
State: OK

Vax Date: 02/23/2021
Onset Date: 02/01/2021
Rec V Date: 09/18/2021
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: Swelling at the injection site; Redness at the injection site; Itching at the injection site; Has a small place on her foot in which it looks like she is getting a hive or rash/ rash on her foot; This is a spontaneous report from a Pfizer-sponsored program. A contactable (age: 79; Unit: unknown) female consumer who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date in 23Feb2021 as DOSE 2, SINGLE for covid-19 immunization. Historical vaccine included received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. Medical history she used to having allergic reactions and she has a history of swelling, done this for years. She has been prescribed an Epipen that she keeps on hand and she never had to use it. The patient's concomitant medications were not reported. In Feb2021, she was experiencing redness, swelling, itching at the injection site, and has a small place on her foot in which it looks like rash. She has been prescribed with an Epipen that she kept on hand and she never had to use it. Reporter asked if she can take an antihistamine that she has on hand and wanted to know if it will interfere with the vaccine. The reporter considered the events as non-serious. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Other Meds:

Current Illness:

ID: 1712260
Sex: F
Age:
State: NC

Vax Date: 01/14/2021
Onset Date:
Rec V Date: 09/18/2021
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: sinus issues/sinus pain; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 14Jan2021 (Lot number and expiry date was not provided) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sinus issues/sinus pain on an unspecified date. She had sinus issues and she was wondering if she could take a Tylenol due to the sinus pain not the vaccine. The outcome of the event was unknown. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1712261
Sex: F
Age:
State: IL

Vax Date: 02/17/2021
Onset Date:
Rec V Date: 09/18/2021
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: aches all over after taking the first dose; she has arthritis and her pain is worse than she had before; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable female consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (BNT162B2 Formulation: Solution for injection), dose 1 via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing. The concomitant medications were not reported. The patient experienced aches all over after taking the first dose on an unknown date. It was reported that patient had arthritis and her pain worsen than she had before. The patient asking if she can take Tylenol. The outcome of events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1712262
Sex: F
Age:
State: CA

Vax Date: 01/26/2021
Onset Date: 01/27/2021
Rec V Date: 09/18/2021
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: arm soreness; headache; This is a spontaneous report from a contactable consumer. A 59 year old female patient had received bnt162b2 (Pfizer-biontech COVID-19 vaccine, Solution for injection, Batch/lot number: EL1283 was reported) via an unspecified route of administration on 26Jan2021 as DOSE 1, SINGLE for COVID-19 immunization(at age of 59 years). The patient medical history had included type 2 diabetes and concomitant medications was Metformin hydrochloride, Sitagliptin(JANUMET,500-100mg , take two tablets once a day).The patient did not take any vaccination within 4 weeks prior to vaccination. On 27 Jan 2021 the patient had experienced arm soreness and a slight headache. On Jan 2021 the clinical outcome of the event was recovered. Follow-up (28May2021): Follow-up attempts completed. No further information expected.

Other Meds: JANUMET [METFORMIN HYDROCHLORIDE;SITAGLIPTIN.]

Current Illness:

ID: 1712263
Sex: M
Age:
State: CA

Vax Date: 02/17/2021
Onset Date: 02/18/2021
Rec V Date: 09/18/2021
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: 20210218; Test Name: body temperature; Result Unstructured Data: Test Result:102.2 Fahrenheit

Allergies:

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

Symptoms: body temperature was 102.2 F; I started feeling body aches mainly of my legs; This is a spontaneous report from a contactable other hcp (Patient). A 46-year-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: 5318) dose 2 via an unspecified route of administration on 17Feb2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on an unspecified date as single for COVID-19 immunization. On 18Feb2021 13:30 the patient started feeling body aches mainly of my legs and body temperature was 102.2 f. On 18Feb2021 the patient underwent lab tests and procedures which included body temperature result with 102.2 Fahrenheit. No other potential adverse events to report at this time. Patient was in good physical health. The outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1712264
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: I am really upset; I got the first shot and I got a reaction through that; sick; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL9263) via an unspecified route of administration on an unspecified date as dose 1 single for COVID-19 immunization. Medical history included AFib, breathing problem. Concomitant medications were not reported. On an unspecified date, patient got the first shot and patient stated I got a reaction through that, I got all the symptoms. Patient stated I am really upset from that shot so patient was calling about should I go tomorrow to get the second shot.The patient also experienced sick. Patient stated thatI am alright now, I come out if it, right now. It lasted for a few days and it left. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1712265
Sex: F
Age:
State: CT

Vax Date: 02/16/2021
Onset Date: 02/17/2021
Rec V Date: 09/18/2021
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: Soreness at injection site; fatigue; headache; body aches; This is a spontaneous report from a contactable consumer (patient herself). A 22-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 16Feb2021 at 09:00 (Batch/Lot Number: EL3247) as DOSE 2, SINGLE (age at vaccination was 22 years old) for covid-19 immunisation at a Workplace clinic. The patient medical history was not reported. Concomitant medication(s) included birth control, loratadine, ibuprofen and paracetamol (TYLENOL), all taken for an unspecified indication, start and stop dates were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 26Jan2021 at 09:00 (Batch/Lot Number: EL3247) as DOSE 1, SINGLE. No other vaccine was administered to the patient in four weeks. She was not tested for covid prior to vaccination and post vaccination. On 17Feb2021, at 07:00 hrs, the patient experienced soreness at injection site, fatigue, headache and body aches. No treatment was received by the patient. At the time of this report, the outcome of all the events was recovering. Follow-up attempts completed. No further information expected.

Other Meds: LORATADINE; IBUPROFEN; TYLENOL

Current Illness:

ID: 1712266
Sex: F
Age:
State: NV

Vax Date: 02/12/2021
Onset Date: 02/12/2021
Rec V Date: 09/18/2021
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: General malaise; Eyes were achy; Decreased appetite; Stomach was hurting; Indigestion; Took expired Aleve; Arm was sore after getting the injection; This is a spontaneous report from a contactable consumer (patient) or other non HCP. A 67-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Formulation: Solution for injection; Lot number: EL9267, Expiration date: 31May2021 via unspecified route of administration in Arm Left on 12Feb2021, at 11:30 (Age at vaccination: 67-years-old) as dose 1, single for COVID-19 immunization and patient received ALEVE (NAPROXEN SODIUM; Lot number: NAA5E5D, Expiration date: Mar2020) via oral route of administration on 12Feb2021 for her sore arm. The patient's medical history included osteoporosis. She takes medication for osteoporosis. Concomitant medications were not reported. On 12Feb2021, patient stated arm was sore after getting the injection, took expired Aleve, on 15Feb2021 after 3 days, patient had Indigestion. on 16Feb2021, after 4 days patient experienced stomach was hurting, Decreased appetite. on 17Feb2021, 5 days after second dose patient experienced General malaise, eyes were achy. Patient stated she took the first dose of the Covid-19 vaccine on Friday 12Feb2021. She received it around 11:30am. Her arm was sore that day. She moved it around and also used the rowing machine. She took 2 Aleve at bedtime. She woke up feeling great. On Monday she had indigestion which she has from time to time. She is healthy. She has annual check ups. She takes medication for osteoporosis. She adds that her stomach hurt. She did not have any aches or nausea. She was careful about what she ate. She felt worse yesterday and her stomach hurt more. It was like with having the flu. She had general malaise and her eyes were achy. She didn't see that these were reactions to the first dose. Her stomach felt better with food. She was still eating but she wasn't as hungry as normal. Two to three weeks ago she had food poisoning and was throwing up. She has a sensitive digestive system. She took Aleve the night that she received the vaccine. Prior vaccinations (within 4 weeks) were none. Relevant test was none. The outcome of events Decreased appetite, General malaise, Stomach was hurting, was recovered on 18Feb2021, outcome of event Indigestion recovered with Sequel on 18Feb2021, outcome of evet arm was sore after getting the injection recovered on 14Feb2021, outcome of event eyes were achy was recovering, while outcome of other event was unknown. Follow-up attempts completed. No further information expected.

Other Meds: ALEVE

Current Illness:

ID: 1712267
Sex: F
Age:
State: MA

Vax Date: 02/14/2021
Onset Date:
Rec V Date: 09/18/2021
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: she had arthritis, extreme pain in her shoulder after her first dose; she had arthritis, extreme pain in her shoulder after her first dose; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and Expiration date: Unknown) via an unspecified route of administration on 14Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced arthritis, extreme pain in her shoulder after her first dose on an unspecified date. The outcome of both events was unknown. Follow-up (13May2021): Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1712268
Sex: F
Age:
State: MA

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 09/18/2021
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: Headache, fatigue, injection site pain after second dose; Headache, fatigue, injection site pain after second dose; Headache, fatigue, injection site pain after second dose; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient (Non pregnant) received bnt162b2 (BNT162B2, Formulation:Solution for injection, Batch/Lot Number: EL3247) , dose 2 via an unspecified route of administration, administered in left arm on 17Feb2021 at 10:30 am as a single dose for (at the age of 50 year) Covid-19 immunisation at Workplace clinic. The patient medical history and concomitant medications were not reported. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine and received other medications in two weeks include birth control pills. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID-19. Historical vaccine include bnt162b2 (BNT162B2,Formulation: Solution for injection Batch/Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in left arm on 27Jan2021, at 12:15 pm as a single dose for (at the age of 50 year) Covid-19 immunisation at Workplace clinic and experienced Enlarged lymph nodes on left side (vaccination side) in recent mammogram on 16Feb2021 after first dose. The patient experienced, headache, fatigue, injection site pain after second dose on 17Feb2021. Treatment not received for the events. Outcome of the event was unknown. . No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1712269
Sex: F
Age:
State:

Vax Date: 02/12/2021
Onset Date: 02/16/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: Severe headaches; This is a spontaneous report from a contactable Nurse. A 38-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 38 years), dose 2 intramuscular, administered in Arm Left on 12Feb2021 16:00 PM as dose 2, single for COVID-19 immunisation administered in hospital. Medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 38 years), dose 1 intramuscular, administered in Arm Left on 22Jan2021 16:00 PM as dose 1, single for COVID-19 immunisation. The patient did not receive any other medications within 2 weeks of vaccination. The nurse reported, the patient experienced severe headaches on 16Feb2021. The reporter assessed the event as non-serious. Covid was not tested prior to or post vaccination. The outcome of event was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1712270
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: Very sore pain from muscle of injection site as early as an hour post vaccination; Limited arm movement going into the next day; This is a spontaneous report from a non-contactable consumer. This consumer reported that, A 20-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6198) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization (age at vaccination 20-years-old). The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient experienced very sore pain from muscle of injection site as early as an hour post vaccination, limited arm movement going into the next day on an unspecified date. Outcome of events was unknown. 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