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: 1774190
Sex: F
Age:
State: CA

Vax Date: 03/29/2021
Onset Date: 03/29/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: still have a round red circle and a black and blue mark where she got the injection/Round circle on arm/ Black and blue mark on arm; sneeze; scratchy throat; runny nose; still have a round red circle and a black and blue mark where she got the injection; This is a spontaneous report from a contactable consumer or other non hcp. A 57-years-old female patient received first dose bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: ER8732), via an unspecified route of administration, administered in Arm Right on 29Mar2021 09:15 (at the age of 57-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had her first shot on 29Mar2021 and experienced around circle on her arm and scratchy throat. The patient still had the circle on her arm and it had already been 8 days and patient was not sure how long it was supposed to last. scratchy throat was about the same or a little bit better. Over the weekend, Patient started to sneeze a lot and had a runny nose. Patient did not know if these were side effects because she was totally fine last week and prior to the shot. The sneezing started last week or early weekend. Patient confirmed that she was not sneezing a lot as of now. As of yesterday, the sneezing had not been as severe the sneezing was not all day long. The outcome of still have a round red circle and a black and blue mark where she got the injection was not recovered, recovering from vaccination site bruising, Otcome of the events scratchy throat and runny nose and sneeze was unknown. Follow up (06April2021): This is a follow up spontaneous report received from a contactable consumer included: Age, additional events, event onset date and narrative information were updated. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1774191
Sex: F
Age:
State: DC

Vax Date: 01/21/2021
Onset Date:
Rec V Date: 10/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: felt like there was something that was surrounding her breath and on her skin; She has rashes on her arms and at the back; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) reported that: A female patient of unspecified age 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 21Jan2021 as dose 1, single for covid-19 immunization and second 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 11Feb2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medication was not reported. On an unspecified date, she had rashes on her arms and at the back. She felt like there was something that was surrounding her breath and on her skin she mentioned that she was going to get an examination and see what it was. Patient said she had these experiences after she took the vaccine. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained

Other Meds:

Current Illness:

ID: 1774192
Sex: F
Age:
State: NY

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

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

Lab Data:

Allergies:

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

Symptoms: She reports that after having her first vaccine dose she had some pain to her knee but it went away; She had muscle pain. The muscle pain was not bad, it was her whole body and her knees.; felt tired; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3302), via an unspecified route on 18Feb2021 (at the age of 72-years) as dose 1, single in the right arm for covid-19 immunisation. The patient medical history included knee surgery, high blood pressure, stent in her heart. The patient concomitant medications included vitamin D 50,000 mg, once a week, every Saturday, Aspirin 81mg, Vitamin C, Fish oil from an unknown date and unknown if ongoing. On unspecified date, the patient reports that after having her first vaccine dose she had some pain to her knee but it went away. She had muscle pain. The muscle pain was not bad, it was her whole body and her knees. The muscle pain went away in a few days. She also felt tired. One week later, and she was okay. After she received the second dose of the covid vaccine, as soon as she got it, within a few minutes after, her throat was swelling up and she felt like something was walking on her lips. Clarifies that it is hard to explain what something walking on her lips feels like, her lips felt sandy. She drank a lot of water and then she was okay. She had surgery four and a half years ago on her right knee. Right after she received her second dose of the covid vaccine, her right knee started to hurt. Three days ago, she started taking Tylenol. Between three days ago to now, she has took six Tylenol tablets. Tylenol was helping her. She stopped taking Tylenol and her knee started to hurt again. Her leg feels so tight that she can not bend her knee. Her tendon and knee are really hurting. She spoke with the pharmacist at the pharmacy where she received her covid vaccine about her knee pain. The pharmacist told her to call her primary care doctor. Before she called her doctor, she thought she would call Pfizer to see if Pfizer can guide her. She was asking does she need to see her primary care physician or the surgeon who performed her knee surgery four and a half years ago. She does not knew if she needs to see a doctor or which doctor to see. She was asking if knee pain is an expected side effect after the vaccine. She was asking was her knee pain something that will get better on its own, or does she need to see a doctor for treatment. Before she took Tylenol, she used roll on Lidocaine. She put that on and it only helped a little bit. Tylenol has helped her the most, it has the longest effect. She forgot to mention, after receiving the second dose of the covid vaccine on Friday, she was tired, and in bed all day the day after receiving the vaccine on Saturday. Even now, she still gets tired sometimes. She is not the person she used to be. She feels drained. She was normally a very energetic person. After her Second dose her throat was swelling up: It lasted for about 10 minutes. She had to stay for about an hour until she felt better. She thought it was really nice that they called her about four hours after she got home, to check on her. Second dose: She felt like something was walking on her lips. Her lips felt sandy: Her throat swelling up and this happened together. She was scared. She had been reading up about the covid vaccine. She had hesitation with getting the second dose. She read that people have died, and it scared her. But she decided that she felt healthy. She kept reading more. She has asthma. She has food allergies, she was allergic to cranberry. She can only have fresh apples from the tree. She wants to help however she can. She thought that it would be good for Pfizer to know data about her. In the future, she hopes that her data will help the small amount of people like her who have allergies. Second dose: Her right knee started to hurt. Her leg feels so tight that she can not bend her knee. Her tendon and knee are really hurting: Began one or two days after receiving the second dose of the covid vaccine. She was expecting this, but she was not expecting it to last so long, or be so severe. Two or three days ago, whenever she started taking medication for it, it felt better. She could not feel any pain whenever she took Tylenol. She is not a doctor but she thinks it is inflammation. Whenever she was not taking Tylenol her pain comes back. Since yesterday morning, she has not taken any Tylenol and has not had any pain. Today she started to hurt again. Lidocaine released the pain a little bit, but nothing like Tylenol. Her daughter just bought the Lidocaine for her a few days ago. The Tylenol takes her pain away completely. She was tired, and in bed all day the day after receiving the vaccine. Even now, she still gets tired sometimes. She was not the person she used to be. She feels drained: She felt so tired on Saturday, 20 Mar 2021. She had a cup of coffee, and then went walking for half an hour. She felt so tired, she went back to bed. She was in and out of bed the whole day. Her tiredness has gotten better, but it is ongoing. Sometimes she still feels drained, it is coming and going. Her tiredness is nothing now compared to how it was on Saturday, 20Mar2021. The outcome of the events muscle pain was recovering, and other events was resolved on unspecified date of 2021. No follow-up attempts are needed; No further information is expected.

Other Meds: VITAMIN D [VITAMIN D NOS]; ASPIRINE; VITAMIN C [ASCORBIC ACID]; FISH OIL

Current Illness:

ID: 1774193
Sex: F
Age:
State: NV

Vax Date: 03/23/2021
Onset Date: 04/03/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Date: 20210517; Test Name: Blood test; Test Result: Positive ; Comments: positive for MAC lung, collected on 17May2021, report came out on 27May2021

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: sinus infection; I got shingles; MAC lungs; did not feel well; nausea/sick to her stomach/wants to throw up; headache; achy all over, aching for two days; low grade temperature; inside of her nose has been sore; Initial case contained only non-serious AEs (not fully processed yet), upon FU PRD/SRD (30Sep2021), event: mycobacterium avium complex infection pertains to MedDRA CTL. FU PRD/SRD (30Sep2021) is considered as significant. This is a spontaneous report from a contactable consumer (patient). This 71-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Batch/Lot Number: ER8727; Expiration Date: 31Jul2021), dose 2, via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 71-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing eczema, ongoing psoriasis and arthropathy from an unknown date and unknown if ongoing. The patient previously received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Batch/lot number: EN6200, Expiration date: 30Jun2021), dose 1, via an unspecified route of administration on 01Mar2021 as DOSE 1, SINGLE for COVID-19 immunization and experienced a "delayed reaction". Concomitant medication included chondroitin sulfate, glucosamine hydrochloride (OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]) taken for arthropathy from an unspecified start date and ongoing; vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]) taken for an unspecified indication from an unspecified start date and ongoing; colecalciferol (D3) taken for an unspecified indication from an unspecified start date and ongoing; vitamin e nos (VITAMIN E [VITAMIN E NOS]) taken for an unspecified indication from an unspecified start date and ongoing; bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]) taken for an unspecified indication, start and stop date were not reported; fish oil, tocopherol (OMEGA 3 [FISH OIL;TOCOPHEROL]) taken for an unspecified indication from an unspecified start date and ongoing; clobetasol propionate (CLOBETASOL PROPIONATE) taken for eczema from an unspecified start date and ongoing; desonide (DESONIDE) taken for eczema from an unspecified start date and ongoing; ketoconazole (KETOCONAZOLE) taken for eczema from an unspecified start date and ongoing; and triamcinolone acetonide (TRIAMCINOLONE ACETONIDE) taken for psoriasis, eczema from an unspecified start date and ongoing. The reporter stated she did not have any side effects until 05Apr2021 (Day 13) after the injection. On 05Apr2021, the patient experienced a headache, aching for two days and a low grade temperature. On 06Apr2021, the patient was sore all over, did not feel well, experienced nausea, sick to her stomach, that has been so bad she wants to throw up but has not thrown up, and the inside of her nose has been sore since Saturday (03Apr2021). The low grade temperature was gone. The patient mentioned having high winds in her area and sometimes this can cause issues with her nose and sinuses. She thought maybe she was getting a sinus infection but she also wants to know if it is possible to have side effects from the vaccine this many days after receiving the second dose. On 17May2021, the patient tested positive for a blood test indicating mycobacterium avium complex (MAC) lung. The patient reported she was asymptomatic on the MAC lung. On 16Jul2021, the patient experienced shingles. The patient underwent lab tests and procedures which included blood test (17May2021): positive for MAC lung (blood test on 17May2021 and the report came out on 27May2021). Clinical outcome of the events nausea/sick to her stomach, did not feel well, aching all over, headache and inside of her nose has been sore was not resolved. Clinical outcome of the events low grade temperature was resolved. Clinical outcome of sinus infection, MAC lung and shingles was unknown.

Other Meds: OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]; B COMPLEX [VITAMIN B COMPLEX]; D3; VITAMIN E [VITAMIN E NOS]; PROBIOTIC [BIFIDOBACTERIUM LACTIS]; OMEGA 3 [FISH OIL;TOCOPHEROL]; CLOBETASOL PROPIONATE; DESONIDE; KETOCONAZOLE; T

Current Illness: Eczema; Psoriasis

ID: 1774194
Sex: U
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
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: "I took vaccine of Pfizer, was it yesterday at 9:15 and I was okay but now after 2 or 3 hours I got a fever."; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender 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 on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date it was reported that, patient took the Pfizer vaccine at 9:15, patient was fine but currently after 2 or 3 hours patient got a fever. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774195
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: she was bending down and had a heavy nose bleed from one nostril; lips and mouth were dry; lips and mouth were dry; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 83-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, Solution for injection, Lot Number and Expiration date was not reported) via an unspecified route of administration on 03Mar2021 as dose 1, single for COVID-19 immunization. Medical history included ongoing epistaxis. The patient concomitant medications were not reported. It was reported that the day that she received her first vaccine on 03Mar2021, she was bending down and had a heavy nosebleed from one nostril. She had nose bleeds in the past but was not sure if this one might have been triggered from the vaccine. She also mentioned that her lips and mouth were dry. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Other Meds:

Current Illness: Nose bleeds

ID: 1774196
Sex: F
Age:
State: MI

Vax Date: 04/02/2021
Onset Date: 04/04/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Lymph node (under armpit) tenderness; swelling; very mild pain; This is a spontaneous report from a contactable consumer. This 38-year-old female consumer (patient) reported that. A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8730), dose 2 via an unspecified route of administration, administered in Arm Left on 02Apr2021 12:30 as (At the age of 38-years) dose 2, single for covid-19 immunisation. Medical history included, Mild Hypertension, and seasonal allergies from an unknown date and unknown if ongoing. List of any other medications the patient received within 2 weeks of vaccination included Losartan, Montelukast, Hydrochlorothiazide, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) all are taken for an unspecified indication, start and stop date were not reported. Patient was not diagnosed with COVID-19 Prior to vaccination. Patient was not tested for COVID-19 Since the vaccination. No Allergies to medications, food, or other products were reported. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6207), dose 1 via an unspecified route of administration, administered in Arm Left on 12Mar2021 12:30 PM as dose 1, single for covid-19 immunisation. The patient experienced lymph node (under armpit) tenderness, swelling, and very mild pain on 04Apr2021 03:00. Patient did not receive any tenement for events. The outcome of event was not recovered. information about lot/batch number is available. No follow-up attempts are needed. No further information is expected.

Other Meds: LOSARTAN; MONTELUKAST; HYDROCHLOROTHIAZIDE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness:

ID: 1774197
Sex: F
Age:
State: CO

Vax Date: 04/02/2021
Onset Date: 04/03/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Name: x-ray; Result Unstructured Data: Test Result:Unknown result; Comments: Nothing found in report

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Limited range of movement; Right wrist is swollen; pain in her hand and wrist/ Right hand hurting; pain in her hand and wrist/ Right wrist hurting; Right hand is quite swollen; This is a spontaneous report from a contactable consumer or other non hcp. A 31-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number ER8737) dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 11:30 (age at vaccination 31) as dose 1, Single for covid-19 immunisation. Medical history was not reported and concomitant drug was Antibiotic eye cream. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Caller got the first dose of the Covid Vaccine on 02Apr2021, this past Friday. She got it in her left arm. On 3Apr2021, the next day her right hand and wrist started hurting. She thought it was unrelated, but it got worse. Her hand is quite swollen. She has no other symptoms. She has never had any issues with arthritis or anything like that. She went to Urgent Care. X-rays didn't show anything. They suggested it was a potential vaccine reaction. It hasn't gotten worse or better. Another doctor said it could be a vaccine thing and to reach out to Pfizer and see if we have heard about anything like this happening before or have any tips on what to do about it. Antibiotic eye cream took it for a few days a week or 2 weeks before she got the vaccine. She was not currently taking it, she finished it. The patient had Right hand and wrist felt like a sprain at first. It was not severe the first day, but towards the evening it got worse. The pain has decreased a bit. She has been taking Tylenol. On 4Apr2021, Her hand and wrist are swollen, and she has a limited range of movement. She can't bend it. The pain started out not too bad. On 5Apr2021, that Sunday it was bad enough to go to Urgent Care. She has been in a brace and since then it has gotten better. If she moves it, it is worse. The swelling started Saturday, but she didn't notice it until Sunday. She can move it a little bit, it was pretty swollen. She thinks the 4th character in the lot number is a 7 or a 1, but she is pretty sure it is a 7. She hates needles, and having a reaction was something she was scared of. This is the worst thing that could have happened. She will still get the second dose. She is not 100 percent sure, she is not a doctor, but it is suspicious that it happened right after getting the vaccine and she had never had any problems. The patient underwent lab tests and procedures which included x-ray: unknown result as Nothing found in report on an unknown date. The outcome of event right wrist is swollen was not recovered, pain in her hand and wrist/ right hand hurting was unknown, pain in her hand and wrist/ right wrist hurting was unknown , right hand is quite swollen was not recovered , limited range of was not recovered.

Other Meds:

Current Illness:

ID: 1774198
Sex: F
Age:
State:

Vax Date: 03/20/2021
Onset Date: 03/21/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: had a large bump on her arm; Hives on upper chest next to her neck; She is breaking out in welts and if you saw what is happening to her, it is nasty.; redness halfway up arm past her elbow and then got many other bumps; itching crazy at night; red and swollen on both sides of her waist; swollen on her butt.; rashes; hurt; extremely tired; She has been getting up at 830 when use to get up at 5, and when she does get up at 8:30 she doesn't want to get out of bed.; threw up/vomiting; This is a spontaneous report from a contactable consumer(patient). A 54-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EP6955), via an unspecified route of administration, administered in Arm Left on 20Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included allergic to cats, allergic to pollen, allergic to watermelon, influenza She gets the flu shot every year, neuropathy peripheral. The patient's concomitant medications were not reported. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient has no adverse events prior to vaccination. Patient has no illness at time of vaccination. Patient has no family history relevant to adverse event. Patient had Pfizer COVID shot and basically, she needs to know if she should get a second dose after her side effects. She is supposed to go back on the 10th for her second dose. She stated it was not until the next day that her symptoms started. She is breaking out in welts and if you saw what is happening to her, it is nasty. Two days later she thought she had hives or something but then had a large bump on her arm and then redness halfway up arm past her elbow and then got many other bumps. She was waking up itching crazy at night on the left side, it was so severe that she couldn't figure out where it was and was itching in between her fingers and up her arm, it was to the point you want to jump out a window or scream, it was so severe for 2 straight nights. Then many other bumps came up. This morning she woke up with 4-inch lines that were really red and swollen on both sides of her waist, which is bizarre, but they don't itch and don't hurt. She also had one "something" swollen on her butt. This has been consistent since she got the shot. She stated she even called an exterminator to make sure it was not bugs, and she confirmed it is not a bug. She is not sure when this is going to end, these rashes, bumps, welts. She has several pictures of them. She stated it is severe and she isn't sure if it is an allergic reaction. She called the doctor's office, and they don't have any appointments. She asked if this has been reported and for how long and if she should get her second dose? Will this get worse after the second dose? The first day she felt good, and her arm was a little sore and she kept hearing about the sore arm from other people. The only thing that has changed in her life is that she got that shot. Stated the shot is 80 percent effective, right? She says something has changed. She has been extremely tired. She has been getting up at 830 when use to get up at 5, and when she does get up at 8:30 she doesn't want to get out of bed. Last night she stated she threw up. She was vomiting but she doesn't know if that was part of it or just her nerves. The outcome of the events Urticaria and Peripheral swelling was recovered and all other events was unknown. No Follow-up attempts are needed. No further information expected.

Other Meds:

Current Illness:

ID: 1774199
Sex: F
Age:
State: OH

Vax Date: 03/31/2021
Onset Date: 03/31/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Date: 20210331; Test Name: blood pressure; Result Unstructured Data: Test Result:elevated; Test Date: 20210331; Test Name: Heart rate; Result Unstructured Data: Test Result:elevated; Test Date: 20210331; Test Name: Fever; Result Unstructured Data: Test Result:100 degree

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: ringing in her ears; severe allergic reaction; Short of breath; arm was a little sore; severe vertigo/very bad vertigo; elevated heart rate/elevated HR; Weakness/bed she couldn't get out of bed and couldn't get out of bed for days; elevated blood pressure; Headache; foggy/fogginess; really tired; Nauseated; Chills; Fever; Dizziness/ Light-headed; achy; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date were not reported), via an unspecified route of administration, administered in left arm on 31Mar2021 10:34 (at the age of 57 years) as dose 1, single for covid-19 immunization. Patient had no medical history. The patient's concomitant medications were not reported. No other vaccinations within 4 weeks, prior to vaccination and no additional vaccines administered on same date of the Pfizer suspect. No reports of vertigo, specifically, listed in the fact sheet. It was also reported that, an increased heartbeat, dizziness, and weakness as possible signs of severe allergic reaction. Also, provided that severe allergic reactions are expected to occur minutes to and hour after vaccine administration. On 31Mar2021, patient experienced very bad vertigo/severe vertigo, along with elevated heart rate and blood pressure, ringing in her ears, weakness, headache, and was foggy/fogginess. Also, patient's arm was a little sore that started within hours on the same day. It was reported that, within about an hour of getting the shot patient felt nauseated and really tired, and she came home and slept for 3 hours and woke up feverish with chills and had a fever of 100 degrees she believes. States she then had dizziness and started to feel achy on 31Mar2021. The next morning she could not get out of bed and couldn't get out of bed for days. Patient reported that, she had weakness to this day and it has been about the same the last couple of days and the vertigo is just there and she is lightheaded. Her headache is off and on and she was really really weak. Patient states that, she does things to get her blood pressure down. On 04Apr2021, the patient felt short of breath, but yesterday and today her breathing was ok. The outcome of events severe vertigo, weakness, headache, foggy, and ringing in her ears was not recovered, and outcome of rest all events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1774200
Sex: U
Age:
State: MO

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

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

Lab Data:

Allergies:

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

Symptoms: I lost my taste 5 days after receiving my 2d covid 19 vaccination; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on unspecified date as single dose for COVID-19 immunization. The patient lost his/her taste 5 days after receiving the 2nd dose of COVID-19 vaccination on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible; information on batch/lot number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 1774201
Sex: U
Age:
State: VA

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

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

Lab Data: Test Name: Fever; Result Unstructured Data: Test Result:between 99 and 102

Allergies:

Symptom List: Rash, Urticaria

Symptoms: fever between 99 and 102; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reporting for self. A patient of unspecified age and gender received BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient had a fever between 99 and 102 for the whole three weeks since first vaccine on an unknown date. The patient underwent lab tests and procedures which included body temperature: between 99 and 102 (units unspecified) on an unknown date. The outcome of the event was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774202
Sex: F
Age:
State: PA

Vax Date: 03/31/2021
Onset Date: 04/01/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: hives; fever; chills; headache; muscles and joint pain; muscles and joint pain; fatigue for several days; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 70 year old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 31Mar2021 08:30 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included multiple sclerosis from an unknown date and unknown if ongoing, chronic obstructive pulmonary disease from an unknown date and unknown if ongoing, arthritis from an unknown date and unknown if ongoing, irritable bowel syndrome from an unknown date and unknown if ongoing, lung neoplasm malignant from an unknown date and unknown if ongoing and surgery, the oncologist said that's body's reaction to gaining antibodies. they weren't itchy, no other effect on her. Concomitant medication(s) included phenazepam (PHENAZEPAM) taken for an unspecified indication, start and stop date were not reported; nitrazepam (NITRAZEPAM) taken for an unspecified indication, start and stop date were not reported. The patient experienced fever on 01Apr2021 02:00 with outcome of recovered, chills on 01Apr2021 02:00 with outcome of recovered, headache on 01Apr2021 02:00 with outcome of recovered , muscles and joint pain causing myalgia on 01Apr2021 02:00 with outcome of recovered, muscles and joint pain causing arthralgia on 01Apr2021 02:00 with outcome of recovered, fatigue for several days on 01Apr2021 02:00 with outcome of unknown and hives causing urticaria on 01Apr2021 08:30 with outcome of unknown. Therapeutic measures were taken as a result of this with Tylenol. Follow-up(05Apr2021) : This is a follow-up spontaneous report from the same contactable consumer, new information received which includes that : relevant medical history added and concomitant drugs added. No follow-up attempts are needed. No further information is expected.

Other Meds: PHENAZEPAM; NITRAZEPAM

Current Illness:

ID: 1774203
Sex: M
Age:
State: MA

Vax Date: 03/29/2021
Onset Date:
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: just "some fatigue."; his throat is "very sore" and "very dry"; his throat is "very sore" and "very dry"; reports that it is difficult to swallow; his throat does still feel "a bit swollen."; This is a spontaneous report from a Pfizer-sponsored program with Regulatory Authority Support from a contactable consumer or other non HCP. A 57-year-old male patient received bnt162b2 (BNT162B2, solution for injection, Lot number was unknown), via an unspecified route of administration on 29Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced, fatigue, oropharyngeal pain, dry throat, dysphagia, pharyngeal swelling. The outcome of the events was unknown. Caller states that he received his first dose of the Pfizer BioNTech COVID-19 vaccine on 29MAR2021 and states his second dose has been scheduled for 12ARP2021 which is 14 days and would like to know if this is okay as he states that he knows the recommended interval is 21 days. Caller also reports that after his first dose, he did not experience any side effects initially, just some fatigue. However, he states that this morning his throat is very sore and very dry and reports that it is difficult to swallow. He states that it has been a couple of hours and he feels a bit better but reports that his throat does still feel a bit swollen. E-transmitting AE due to long hold time. Response: Spoke from the attached document regarding CDC's considerations that the second dose may be given as early as 17 days and if given mistakenly earlier than this, the dose does not need to be repeated. He would like to know if these side effects he is experiencing with his throat are common with the vaccine or if he could just be getting a cold. He states that he did read that there is an issue with lymph nodes and thinks that the throat is a common area where lymph nodes are. Response: Spoke from the attached document to let caller know that while the commonly reported side effects does not mention anything about the symptoms he's experiencing with his throat, this list does not include all possible side effects of the vaccine. Referred caller back to HCP for further guidance. No follow-up attempts are possible; No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: Events off label use, inappropriate schedule of vaccine administered were deleted and narrative was amended.

Other Meds:

Current Illness:

ID: 1774204
Sex: F
Age:
State: TX

Vax Date: 04/05/2021
Onset Date: 04/05/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: I am a Pfizer employee. My mother received the second vaccine shot and told me her face got swollen afterwards.; This is a spontaneous report from a contactable reporter reported for a 64-year-old female consumer. A 64-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 05Apr2021 (at the age of 64-years) as dose 2, single for covid-19 immunisation. The patient medical history included known allergies to penicillin. The patient concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 05Mar2021 as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Apr2021, the patient experienced her face got swollen. Reporter stated that mother received the second vaccine shot and told me her face got swollen afterwards. Patient did not received treatment for events. The outcome of the events was recovered on unspecified date of 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774205
Sex: F
Age:
State:

Vax Date: 04/02/2021
Onset Date:
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: She experienced ear sensitivity to high pitch noises; severe headache; not feeling well after that night; tightness around neck, chest, arm again; could not eat or drink water for 43 h; could not tolerate anything; could not eat or drink water for 43 h; felt week; felt extremely dizzy and nauseated; felt extremely dizzy and nauseated; auras; arm hurt a lot; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 02Apr2021 as single dose for COVID-19 immunization. Medical history included migraine neurologic condition not diagnosed yet, but she gets migraines often. The patient's concomitant medications were not reported. It was reported that She experienced ear sensitivity to high pitch noises. She felt ok during the first night, not feeling well after that night. She had on the second day after the second dose severe headache that she catalogued as extreme. She felt tightness around neck, chest, arm again, could not eat or drink water for 43 h, could not tolerate anything. On Saturday 54 h later from the vaccinate in bed for 24h straight, she felt week when she raised up and that afternoon, she got a lot of auras when she went to do the grocery and also felt extremely dizzy and nauseated. On Sunday Morning her body did not want to drink water and she did not eat until 3 pm; her arm hurt a lot and at 6 pm auras started again. She experienced for both doses water retention. She said that if she would know what the vaccine would do to her, she would have not been vaccinated with the Pfizer vaccine. She wanted to know how the vaccine works so to know if it overrides your system to product antibodies. 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: 1774206
Sex: F
Age:
State: PA

Vax Date: 01/14/2021
Onset Date:
Rec V Date: 10/09/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: for her first dose the only thing was a sore arm, it was very sore; slight bit of fatigue; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 54-year-old female patient received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN5318), via an unspecified route of administration, administered in Arm Right on 14Jan2021 (at the age of 54-year-old) as single dose for COVID-19 immunization. The patient's medical history included history of three spinal surgeries (takes no pain meds, she is not on pain meds, she has never been on or kept taking them); and had "neuropathy and nerve related issues" that were not this bad since ten years ago, clarified that what she has is not actually neuropathy, something with the peripheral nerve, she says she doesn't remember actual verbiage). She doesn't react well to pharmaceuticals anyway (unspecified). Her medications are that she takes the minimum amount of medications, very minimal (unspecified). There were no concomitant medications. There was no other products. Also, she has not had any other recent vaccinations or started any new medications. For past drug, she didn't take anything other than 5mg of zolpidem tartrate (AMBIEN) to sleep at night because of her spine. Patient previously also took pregabalin (LYRICA) and was off it, was also on gabapentin or neurontin (patient did not have those medications to provide NDC/LOT/EXP for either of them because she took them back to the pharmacy or turned them in to the police station because she doesn't keep medications in her house if she isn't taking them, and she couldn't take that medication). It was reported that for her first dose the only thing was a sore arm, it was very sore, and the patient only experienced a slight bit of fatigue after her first dose. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1774207
Sex: M
Age:
State: MI

Vax Date: 03/31/2021
Onset Date: 04/03/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Date: 20210406; Test Name: temperature; Result Unstructured Data: Test Result:102; Test Date: 20210407; Test Name: temperature; Result Unstructured Data: Test Result:100

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: fever, temperature of 102 degrees; cold spells; general fatigue; patient was not felt good,general malaise; felt weak; patient felt hot and then cold; headache; This is a spontaneous report from a contactable consumer (patient) or other non hcp reporting for self. A 60-year-old male patient received BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EV0150, Expiry date: Unknown) via an unspecified route of administration, administered in Deltoid Right on 31Mar2021 at 10:10 as dose 1, single (at the age of 60-year-old) for COVID-19 immunisation. Medical history included hang nail from an unknown date and ongoing (hang nail that got infected). Concomitant medication included sulfamethoxazole, trimethoprim (BACTRIM F) taken for Infected hangnail 2x/day. Prior Vaccinations (within 4 weeks) was reported as None. Patient stated that, he feels cold. It is really warm there. Last night, he had a temperature of 102 degrees. This morning he took his temperature and it was 100 degrees. He has general fatigue. He just does not feel good. He feels weak. He was hot and then he was cold. slightly better. He was drinking a lot of water to stay hydrated. He just does not feel good. He thinks its called general malaise: The day was still early so he was not for sure, but he thinks it was improving. He has a headache that has not gone away: He took Tylenol for his headache. He does not like taking medications. But the Tylenol really helped his headache. He had a hang nail that got infected. His doctor put him on an antibiotic called Bactrim. He takes two doses a day. On 03Apr2021, the patient experienced headache, patient was not felt good, general malaise, general fatigue, felt weak, patient felt hot and then cold; cold spells on 04Apr2021; fever, temperature of 102 degrees on 06Apr2021. Seriousness of the event was not specified. Events were not resulted in visit of emergency room or physician office. The patient underwent lab tests and procedures which included temperature: 102 on 06Apr2021 and 100 on 07Apr2021. Therapeutic measures were taken as a result of all events and Tylenol for headache. The outcome of the events headache, cold spells, patient was not felt good, general malaise, patient felt hot and then cold was recovering, fatigue was unknown, fever, temperature of 102 degrees, felt weak was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: BACTRIM F

Current Illness: Hangnail (hang nail that got infected)

ID: 1774208
Sex: F
Age:
State:

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Her face and ears were rashy and red; Her face and ears were rashy and red; eyes swollen 3 day after taking; it feels like her body is heating up like she has menopause; This is a spontaneous report from a non-contactable consumer via Pfizer sponsored program. An unspecified age of female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 19Feb2021 as a single dose for COVID-19 immunisation. The patient had received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient medical history included menopause. The concomitant medications were not reported. On an unspecified date, her face and ears were rashy and red and on 22Feb2021, eyes swollen 3 day after taking. States that her neck looks like it is burnt and it feels like her body is heating up like she has menopause. She states that it has been this way since 19Feb2021.The outcome of the events was unknown. No follow-up attempts are needed; Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774209
Sex: U
Age:
State: MA

Vax Date: 03/30/2021
Onset Date: 03/31/2021
Rec V Date: 10/09/2021
Hospital:

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: lot of fever; lot of pain on my arm; body chills; felt very tired; was not feeling very well, I felt bad the whole day; was not feeling very well, I felt bad the whole day; slept the whole day and night; This is a spontaneous report from a contactable consumer. This 36-year-old consumer (patient) reported. A 36-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: ER8733), via an unspecified route of administration, administered in Left arm on 30Mar2021 (at the age of 36-years-old) as dose number unknown, single for covid-19 immunisation. The patient medical history was reported as none. The patient's concomitant medications were none. On 31Mar2021, the patient experienced lot of fever, lot of pain on my arm, body chills, felt very tired, was not feeling very well, I felt bad the whole day and slept the whole day and night. The reporter stated that reporter had the COVID vaccine on 30Mar2021, around 5 pm, 5:30 more or less and patient had a lot of fever 31Mar2021 and had a lot of pain in arm, fever and body chills and felt very tired and when it was around 9pm, 8:30, I 8 O'clock, 8, the patient took ibuprofen, 2 tablets of Ibuprofen(treatment) of 20 Millimeter (further clarification unknown). The reporter stated, "Today I feel better but yesterday I was not feeling very well, I felt bad the whole day, I slept the whole day and night I needed to do some work for my university so, after I ate, I decided to take the 2 Ibuprofen of 200 Millimeter, more or less it was already 24 hours after I took the vaccine. The patient took 2 Ibuprofen tablets of 200 millimeter as therapeutic measures for events. The clinical outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1774210
Sex: F
Age:
State: NY

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

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

Lab Data: Test Date: 202103; Test Name: bloodwork; Result Unstructured Data: Test Result:normal; Comments: fine; Test Date: 202103; Test Name: Fever; Result Unstructured Data: Test Result:97-98.6; Comments: temperature elevated slightly from her normal of 97 to around 98.5, 98.6 or so; Test Date: 202103; Test Name: cardiology; Result Unstructured Data: Test Result:Normal; Comments: fine; Test Date: 202103; Test Name: x-ray; Result Unstructured Data: Test Result:Normal; Comments: fine

Allergies:

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

Symptoms: Headache; fatigue; Palpitations; experiencing dizziness; weakness; sometimes chills; Fever/ her temperature elevated slightly from her normal of 97 to around 98.5, 98.6 or so; feels anxious; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6205), dose 2 via an unspecified route of administration, administered in Arm Left on 03Mar2021 at 15:00 as dose 2, single for COVID-19 immunisation at hospital clinic. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot no: EN9581), dose 1 via intramuscular in Left arm on 10Feb2021 for COVID-19 immunisation, Flu shot for immunization and felt sick. On 07Mar2021, about 4 or 5 days after patient experienced dizziness and weakness and sometimes chills. Those episodes go away and come back, and they were not all the time. When she does get these episodes, she feels anxious. She has been to the doctor 3 times and did all the exams and saw a cardiologist and everything was fine. She said she would just like to understand if these symptoms will go away and if other people experienced this for this long. She said her doctor was saying it was probably her body overreacting and that it will probably go away. Exams including bloodwork, cardiology and x-ray were fine. Consumer reported having dizziness, weakness, chills, and palpitations. She had a low fever for 1 day. Consumer reported that she recovered from the fever but did feel weak and weakness has not gone away. The weakness comes and goes. In general, at night and even during the day consumer was fine. At night consumer has headache and fatigue. Consumer reported since she got the Pfizer COVID 19 Vaccine on 03Mar2021, she doesn't feel sick. It was like a mild stage of recovering from something. The episodes of dizziness worry her and were unsettling. The dizziness came back last night 06Apr2021. It had been about a week since the last episode of dizziness. The episodes seem to be spacing out. Consumer stated that she was pretty healthy. The weakness, palpitations, headache, fatigue came on about the same time as the dizziness, 4 or 5 days after 03Mar2021. Chills maybe came on with the fever the day after the Pfizer COVID 19 Vaccine second dose. Fever has improved, clarifies it disappeared. Headache has never been very strong, comes on every night, which consumer reported more as a fatigue feeling. Over the last 3 weeks, consumer didn't have a real fever but when she was having chills, palpitations, dizziness episodes her temperature elevated slightly from her normal of 97 to around 98.5, 98.6 or so. Consumer was not taking her temperature anymore. Episodes of symptoms were about the same, maybe less. Consumer had chills on Sunday 04Apr2021 but then had not experienced any dizziness since last week. The episodes were not very strong and were maybe getting less strong when they come but was definitely still coming. Consumer reported having a headache last night 06Apr2021 that came on before her dizziness. Consumer reported that the headaches felt more like pressure on her head, not very strong, they come every night. Consumer mentioned sometimes she still felt the place on her left arm where she got Pfizer COVID 19 Vaccine when the episodes come. Consumer stated that it was not significant. No further details. Consumer was given some dizziness pills, an antihistamine pill but the dizziness pill didn't work. Consumer received Meclizine 12.5 mg tablet by mouth to take when needed. Consumer reported she took the Meclizine for a few days after seeing the cardiologist and then she stopped. Consumer took the Meclizine yesterday when dizziness kind of started 06Apr2021, but it didn't work, it did not help. She does not see lot number on the pharmacy bottle. Consumer received flu shot twice in her life. Consumer reported both times she was sick so she stopped getting the flu shot. Consumer stated she did not have an allergic reaction but felt sick like she had the flu for a few days. Consumer has no further details on the flu shot, she received a few years ago. Consumer was given some dizziness pills, an antihistamine pill but the dizziness pill doesn't work. Caller received Meclizine 12.5mg tablet by mouth to take when needed. Caller reports she took the Meclizine for a few days after seeing the cardiologist and then she stopped. Caller took the Meclizine yesterday when dizziness kind of started 06Apr2021, but it didn't work, it did not help. She does not see lot number on the pharmacy bottle. Consumer reported receiving flu shot twice in her life. Consumer reported both times she was sick, so she stopped getting the flu shot. Consumer reported she did not have an allergic reaction but felt sick like she had the flu for a few days. Consumer has no further details on the flu shot, she received a few years ago. Patient was visit to Emergency Room and Physician Office. The outcome of dizziness was recovered on an unspecified date in Mar2021, for fever was recovered on 05Mar2021, for Anxiety, fatigue was unknown while for rest events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1774211
Sex: M
Age:
State: IL

Vax Date: 04/02/2021
Onset Date: 04/03/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:High; Test Date: 20210403; Test Name: rapid HR/ fast heartbeat; Result Unstructured Data: Test Result:fast

Allergies:

Symptom List: Unevaluable event

Symptoms: blood pressure and it was high; tingly/tingling in left hand; Rash, hot red tone to skin; Rash, hot red tone to skin; Difficulty Breathing; Fast Heartbeat/rapid HR; sore arm; nausea a little bit; SOB; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 41-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration, administered in left arm on 02Apr2021 (at the age of 42-years-old) as dose 1, single for covid-19 immunization. Medical history included prone to get pneumonia, bronchitis and airway issues when sick, attack and flares his anxiety. The patient's concomitant medications were not reported. Patient had not received Prior Vaccinations (within 4 weeks), states this was his first vaccine in years. No AE(s) prior to vaccination. History of all previous immunizations with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was None Additional Vaccines Administered on Same Date of the Pfizer Suspect not received. On 03Apr2021, patient undergo lab test which included rapid HR/ fast heartbeat resulted Fast and on an unspecified date blood pressure resulted high. On 03Apr2021, patient started with a sore arm, nausea a little bit, difficulty breathing, "rapid HR/ fast heartbeat", SOB and tingling in left hand. That "would come and go". on 06Apr2021 patient experienced rash, hot red tone to skin. On 07Apr2021, tingly/tingling in left hand and blood pressure and it was high experienced on and unspecified date. Patient is a "war veteran and the symptoms kicks my anxiety into gear." He went to his doctor, who "told me I needed to see a psychiatrist" and the psychiatrist said he felt these were symptoms/ side effects of the Pfizer vaccine. Caller denies hospital visit and is able to walk around today and do the treadmill today and SOB is not bad, "BP is a little high for me." Caller states he "felt better today and than it started again. States he was feeling a little better this morning. When he sat down on the couch he had an attack. States it doesn't help that when it happens it flares his anxiety. Says he was feeling tingly and was red. Checked his blood pressure and it was high so he knows his heart rate was high. he is not a HCP but that he is a military veteran. States maybe veterans have been having different reactions because of all the drugs they are given in the military. The outcome of events difficulty breathing, "rapid HR/ fast heartbeat was not recovered rest all events outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1774212
Sex: F
Age:
State: TX

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

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

Lab Data:

Allergies:

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

Symptoms: lethargy; aches/some lingering aches; fevers; severe stabbing pains in the center of her chest/stabbing chest pain; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration, administered in Arm Right on Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient Concomitant medications included levothyroxine sodium (SYNTHROID). The patient reported was received the first dose of the Pfizer COVID Vaccine last January and had a pretty significant response to it. She mentioned that she had all the expected side effects such as lethargy, aches/ some lingering aches, and fevers but by the second day she had severe stabbing pains in the center of her chest/ stabbing chest pain. Because of this she opted not to get the second dose. She mentioned that because of the changing times and states requiring full vaccination, she is considering of getting vaccinated. She is asking when she can receive her second dose and for what to do if her side effects arise again after the second dose. She states she made it through it by taking Tylenol. She is a little concerned about taking the second one. She says that with everything going on it looks like she made need to do that. She wants to know are here things she can do to ward off the side effects. She doesn't have an anaphylactic reaction but since its been such a long time should she get the vaccine if she wants to do. she says that with everything going on it looks like she made need to do that all from an unspecified date. The clinical outcome of the events was recovered on unspecified date. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.

Other Meds: SYNTHROID

Current Illness:

ID: 1774213
Sex: F
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Name: Fever; Result Unstructured Data: Test Result:the skin on her back and face was warm

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: low grade fever; felt tired; the skin on her back and face was warm; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on 2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced low grade fever, felt tired and the skin on her back and face was warm. Patient called in to ask if weight was a factor in the dosage for bnt162b2 vaccine. She explained that after the first dose she had a low grade fever, felt tired, and the skin on her back and face was warm. Patient mentioned that she is 99 to 100 pounds and felt like the dosage was too high. The patient underwent lab tests and procedures which included body temperature: the skin on her back and face was warm on an unspecified date. The outcome of the events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1774214
Sex: F
Age:
State: NY

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Developed hives all over my body, torso, arms and legs; I have allergic reaction after first shot of Pfizer covid 19; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number was not reported) via an unspecified route of administration on 19Mar2021 (age at the time of vaccination was 52-years-old) as DOSE 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 19Mar2021, the patient experienced I have allergic reaction after first shot of Pfizer COVID 19. On 21Mar2021 (2 days after the vaccination), the patient developed hives all over my body, torso, arms and legs. The patient stated she had allergic reaction after first shot of Pfizer COVID- 19 vaccine on 19Mar2021, 2 days later, developed hives all over my body that lasted more than a week. It just calmed down on Monday, she was scheduled to have 2nd shot this Friday, 09 APR 2021. She can not seem to get a straight information from doctor on whether to get second dose. Her husband went to get 2nd shot this morning, the doctor at vaccination site station, told her that she should not get it, because he is afraid the second vaccine is stronger than the first one, and may have a more severe reaction to the second. She asked if she should get the second shot, if she take second shot would it be worse or what would she do. She was not confident in her doctor. If you received a second shot, Side effects after your second shot may be more intense than the ones you experienced after your first shot. These side effects are normal signs that your body is building protection and should go away within a few days. Explained that Pfizer was unable to assess the causality of what she was experiencing was related to the COVID-19 vaccine and referred to HCP for determining whether or not she was experiencing a severe allergic reaction to the vaccine and if she should received the second dose. The Investigation Assessment was Not Provided. Additional Information: Caller confirmed that she was calling about the Pfizer COVID-19 Vaccine. She stated that she was concerned about getting the second shot this Friday. She that she got her first vaccine on 19Mar2021, and then two days after the first shot, she developed hives all over her body, starting on the torso, arms, and legs, which lasted for over a week. She stated the hives cleared up this past Monday. She reclarified that she could not find any information if she should go ahead and get the second shot. She stated that she was getting mixed messages from her doctor and other people regarding if she should get the second vaccine. She stated that Pfizer was the manufacturer, and wanted to know if there was information regarding this reaction. She asked if information has been collected on what happens to people that have had this reaction, and what happens after the second shot. She reclarified that this morning she talked to her doctor and he did not knew much. She reclarified, and stated on Monday she talked to her doctor again, and asked if she should switch to the other vaccine. She stated her doctor thinks that she should go ahead with the Pfizer vaccine. She stated this morning, her husband went to get his second shot, and talked to a different doctor, who supervised the vaccination site, about her condition. She stated that doctor did not recommend that she go ahead with the second shot with Pfizer, because he, the doctor, thought it was an allergic reaction to the protein in Pfizer's vaccine. She notified that Medical Information and/or Pfizer was unable to provide medical advice but may have resources to help answer some questions. The outcome of the event developed hives all over my body, torso, arms and legs was recovering and outcome of the other event was unknown No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1774215
Sex: F
Age:
State: VA

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

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

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: swelling of tongue and turned purple/tongue started to swell and turn purple; swelling of tongue and turned purple/tongue started to swell and turn purple; This is a spontaneous case received from a contactable consumer (patient) reported for herself that: A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1 via an unspecified route of administration on 23Mar2021 (Batch/Lot Number: ER8730) as DOSE 1 SINGLE for covid-19 immunization. The patient past medical history included hypertension from an unknown date and unknown if ongoing. Caller states she has recent HX of reaction to medications. Concomitant medication(s) included atenolol (TENORMIN) taken for hypertension, start and stop date were not reported. On 23Mar2021 after the first vaccination between 2-3 hours later her tongue started to swell and turn purple. Patient states over the past few years at different times her tongue has swelled and turned purple. States she went to the doctor on Tuesday about it doing it again but by the time she saw the doctor the swelling was gone. Patient says today at 0500 her tongue was pink and normal also but by 0700 it was purple, says this has happened over the years to her. The patient Sick for a few months after flu vaccines, lost 7 pounds one time and 13 pounds another; states she doesn't know if it was from the vaccine or not. If patient receive one dose of the Pfizer-BioNTech COVID-19 Vaccine, he should receive a second dose of this same vaccine 3 weeks later to complete the vaccination series.1Side effects that have been reported with the Pfizer BioNTech COVID-19 Vaccine include: These may not be all the possible side effects of the Pfizer BioNTech COVID-19 Vaccine. Serious and unexpected side effects may occur. Pfizer BioNTech COVID-19 Vaccine is still being studied in clinical trials.1. Patient states she is trying to get more information to decide if she should take the second vaccine she is scheduled for on 13 Apr 2021. Patient mentions at the end of the call that she was outside to help read the Lot number. States she hasn't gotten new glasses since Covid shut everything down. Mentions she is going tomorrow to get her eyes checked. States hopefully soon life can start again in 2021.The event outcome was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: TENORMIN.

Current Illness:

ID: 1774216
Sex: F
Age:
State: NY

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

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: she was tired; feels drained; something walking on her lips feels like, her lips felt sandy; throat was swelling up; leg feels so tight she can not bend her knee; tendon and knee are really hurting; it really started to hurt me, the pain was really bad/ her right knee started to hurt; knee puffed up; the muscles hurt; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot/batch number: EP6955) via an unspecified route of administration, administered in deltoid right on 19Mar2021 04:55 PM (age at the time of vaccination 72 years) as dose 2, single for covid-19 immunisation. The patient's medical history included high blood pressure, stent in her heart, asthma. Caller reported that she had knee surgery 4 and a half years ago (in 2016). She had food allergy, allergic to cranberry. The patient's concomitant medications included acetylsalicylic acid (ASPIRIN 81), vitamin D, vitamin C [ASCORBIC ACID], fish oil and blood pressure medication. The vitamin D was prescribed to her by her doctor two years ago. The vitamin D is a huge dose, she thought it was 50,000mg. She took it once a week, every Saturday. She received previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot/batch number: EL3302), via an unspecified route of administration in right shoulder on 18Feb2021 on 5:00 PM as dose 1, single for covid-19 immunisation. She reported that after having her first vaccine dose she had some pain to her knee, muscle pain, body pain, tired but it went away. But after her second dose, which was 3 weeks ago this coming Friday, she reported that 1-2 days after her second dose, it was really started to hurt her, the pain was really bad, knee puffed up and the muscles hurt. After she received the second dose of the covid vaccine, as soon as she got it, within a few minutes after, her throat was swelling up and she felt like something was walking on her lips on 19Mar2021 . Clarified that it was hard to explain what something walking on her lips feels like, her lips felt sandy. She drank a lot of water and then she was okay. After she received her second dose of the covid vaccine, her right knee started to hurt. Three days ago, she started taking Tylenol. Between three days ago to the time of reporting, she took six Tylenol tablets. Tylenol was helping her. She stopped taking Tylenol and her knee started to hurt again. Her leg felt so tight that she could not bend her knee. Her tendon and knee were really hurting. Before she took Tylenol, she used roll on Lidocaine. She put that on and it only helped a little bit. Tylenol has helped her the most, it had the longest effect. She was tired, and in bed all day the day after receiving the vaccine on Saturday on 20Mar2021. Even on the time of reporting, she still got tired sometimes. She was not the person she used to be. She felt drained. Her tiredness has gotten better, but it was ongoing. Sometimes she still felt drained, it was coming and going. Her tiredness was nothing now compared. She was normally a very energetic person. The outcome of events throat was swelling up and her lips felt sandy was recovered on 19Mar2021 and outcome of events feels drained and tired was recovering, outcome of muscle pain was not recovered, and outcome of other events was unknown. No follow-up attempts were possible. No further information was expected.

Other Meds: VITAMIN D NOS; VITAMIN C [ASCORBIC ACID]; ASPIRIN 81; FISH OIL

Current Illness:

ID: 1774217
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: His son had a sore arm too; This is a spontaneous report received from a contactable consumer (parent/father). A male patient of unspecified age received unknown number dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, after receiving vaccination patient experienced sore arm. Outcome of the event was unknown. No Follow-up attempts are needed. No further information expected. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774218
Sex: F
Age:
State: MN

Vax Date: 03/17/2021
Onset Date: 03/01/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: I was also short of breath, feeling breathless; my face was swollen; about a week and a half later the same type of rash showed up on my face and neck area. This time it was worse than the first time to the point that my ear lobe was weeping; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EP7534), via an unspecified route of administration on 17Mar2021 (at the age of 74-years-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6205), via an unspecified route of administration on 24Feb2021 (at the age of 74-years-old) as dose 1, single for COVID-19 immunization and experienced rash basically on her face and neck. The patient stated that she received her second dose on 17Mar2021 and reported that about a week and a half later the same type of rash (as after first dose) showed up on her face and neck area. This time it was worse than the first time to the point that her ear lobe was weeping. She was also short of breath, feeling breathless and her face was swollen. When the rash was the worst the breathing was also worse. It does seem to be going away and it was getting better then. The clinical outcome for the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1774219
Sex: F
Age:
State: WI

Vax Date: 04/06/2021
Onset Date: 04/06/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: body started tingling all over/last night her feet just had tingling; her lips started feeling like they were swelling; Her left arm hurt so bad and was throbbing so bad and she was so restless she could not sleep/ arm was hurting very bad; Her left arm hurt so bad and was throbbing so bad and she was so restless she could not sleep; Her left arm hurt so bad and was throbbing so bad and she was so restless she could not sleep; Her left arm hurt so bad and was throbbing so bad and she was so restless she could not sleep; broke into a clammy sweat, felt so weak like she was going to faint; feels like she is sweaty and kind of clammy; blood pressure went up; got chills; got nausea; had swollen ankles; exhausted; not feel well; severe allergic reaction; This is a spontaneous report from a contactable consumer (patient) or other non hcp reporting for herself (patient). A 62-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection; Lot number: EW0150, expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 06Apr2021, 14:15 (at the age of 62-years-old) as DOSE 1, SINGLE for covid-19 immunization. Medical history included type 1 diabetes mellitus from 2005 and ongoing, ongoing basedow's disease, melas syndrome from 2005 and ongoing as (Mitochondrial disease MELAS diagnosed officially in 2005 but is sure she had this her whole life). Patient also stated she think she had covid in mid Nov2020 and had a severe runny nose, fatigue, loss of taste and smell and it lasted about 11 days The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient stated she was calling to report a severe reaction and many side effects she had yesterday and ended up in the emergency room related to the Pfizer Vaccine. Stated 7 minutes of having the vaccine first dose on 06Apr2021, her body started tingling all over, her lips started feeling like they were swelling, last night her feet just had tingling and her left arm hurt so bad and was throbbing so bad and she was so restless she could not sleep. Patient Stated she is exhausted this morning and felt like a limp noodle; states she did not feel the vaccine administered at all into her left arm and did not know the person gave it to her; stated she was left-handed. She further stated she broke into a clammy sweat, felt so weak like she was going to faint, her blood pressure went up and this lasted hours; her arm was hurting very bad and she just felt like she was sitting there holding the phone with her arm on the table and just feel exhausted and does not feel well, blood pressure went up, severe allergic reaction. Patient explained she could not wait to come home and take some Benadryl. Stated the side effects were horrible and she felt terrible; she got home and couldn't do anything and felt buzzing and tingling and felt like she couldn't walk; had swollen ankles, she walked like a sloth going up and down stairs and held onto railing; then her arm got extremely painful and still is painful; couldn't sleep all night; got chills, got nausea and states she did not try eating anything this morning yet. Stated she does not have chills at the moment but feels like she was on the edge of prickly feeling and feeling off like she could feel prickly underneath her skin and it is subtle but she can still notice it; stated she is very sensitive to getting reactions to things and is very reactive to things and she was a little nervous getting the Pfizer vaccine; no further details provided. Patient further stated then she had swollen ankles and noticed that when she took her socks of at night going to bed. Patient further reported that they took her to the emergency room yesterday and wanted her to take off her clothes and put a gown and monitors on and she just wanted to go home and take Benadryl if they were not going to give her anything so she had them wheel her in a wheelchair to her car; stated she sat for a few minutes and drove home which was horrible and got into the house and her husband came home and she asked him to do everything. Stated she was sitting in a chair and couldn't do anything. Reporter stated she does not think she had a fever but feels like she was sweaty and kind of clammy. Patient stated she has not had a vaccine in years of any kind of vaccine and that she assumes she should not get the 2nd dose of the vaccine. Patient stated on the papers they gave her when she got the Pfizer Vaccine, it was stated that who should not get the Pfizer vaccine if they had a severe allergic reaction after the previous dose and stated she would not know if she was allergic to a specific ingredient and know she did have a severe allergic reaction. Outcome of event chills which recovered on an unknown date in 2021, while outcome of other events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness: Graves' disease; MELAS syndrome (Mitochondrial disease MELAS diagnosed officially in 2005 but is sure she had this her whole life); Type 1 diabetes mellitus (Verbatim: type 1 diabetes)

ID: 1774220
Sex: F
Age:
State: KY

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Muscle tightness on her neck; Felt numbness at the injection site; Sores in her head that felt like it had fluid under them; Joint and Arm Pain; Joint and Arm Pain; Swelling, like it affected her brain; She had these sores under her hair, under her skin; Like bruises all over her head; They felt like they were full of fluid so she had to squeeze them; Swelling, like it affected her brain, sores felt like full of fluid and bruises under her hair all over her head was reported as worsened; Slight headache; Chills; Fever; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration, administered in Arm Right on 01Apr2021 14:30 (Batch/Lot number was not reported) (at the age of 64-years-old) as SINGLE for covid-19 immunization. It was reported that vaccine was not administered at (privacy) facility. Historical vaccine included received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Right on an unspecified date (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. Patient denied for any medications, medical conditions, labs, testing, or treatments relevant to her symptoms. The patient denied for prior vaccinations within 4 weeks. Patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced muscle tightness on her neck, felt numbness at the injection site. On an unspecified date in Apr2021, patient developed sores in her head that felt like it had fluid under them, had chills, fever, joint and arm pain (stated that the pain in her arm has improved), swelling, like it affected her brain, she had these sores under her hair, under her skin, like bruises all over her head, they felt like they were full of fluid so she had to squeeze them and felt it has gotten worsened and stated that now it is just on one side of her head and the other side is back to normal and slight headache. Patient wants to know if there have been any reports of the same reaction with the vaccine. On 05Apr2021, the outcome of chills, fever and slight headache was recovered whereas, sores in her head that felt like it had fluid under them, swelling, like it affected her brain, she had these sores under her hair, under her skin, joint pain and like bruises all over her head was not recovered, arm pain was recovering and for remaining of the events it was unknown. No follow-up attempts are needed, information about lot/Batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774221
Sex: M
Age:
State: FL

Vax Date: 03/31/2021
Onset Date: 04/02/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: chills; dizziness; just did not feel well; sick; upset stomach; taste was off; not feeling like himself; freezing; feeling really, really tired, and slept almost all weekend; feeling really, really tired, and slept almost all weekend; Left eye felt like there was something in it; throwing up; face was swollen; it was red and blotchy like a rash/blotchy face with rash on his face; This was a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for 71-year-old male patient (reporter's husband) that who bnt162b2 (BNT162B2) formulation solution for injection, dose 1 (Lot Number: ER8737 expiry date was unknown) via an unspecified route of administration at arm on 31Mar2021 10:49 (at the age of 71-years-old) as a single dose for covid-19 immunisation. Medical history included hepatic cirrhosis from an unknown date and unknown if ongoing, platelet count increased from an unknown date and unknown if ongoing platelets run between 50-60 which is normal for him because it has been like that for years. The patient's concomitant medications were not reported. Reporter adds that other than this, her husband is in good health. She has known him for 10 years and he had this then. Unclear diagnosis date. Reporter adds that he was in pretty good health. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Reporter was calling about her husband. Reporter husband got his vaccine last Wednesday, a week ago today. On Thursday evening, the next day, in the evening probably between 11 and 11:30 at night, throwing up was just the one time. Then, on Friday morning, he got up and his face was swollen, and it was red and blotchy like a rash. It was swollen Friday and Saturday and then he was, over the weekend Face was swollen this occurred Friday and Saturday, his face was swollen, reporter clarifies this was 02Apr2021 and 03Apr2021, Chills have been off and on all weekend. Monday and Tuesday reporter husband would be sitting watching TV and caller's husband would say he is freezing, and caller would be burning up. Reporter adds that this started over the weekend and through Monday and Tuesday. He said that he just did not feel well. He said that he was kind of dizzy over the weekend and not feeling like himself until yesterday. Reporter was reading papers and they said that with the second vaccine, the side effects could be worse than the first. Reporter wants to know if her husband should even get his second vaccine shot?. Reporter adds that she told her husband she does not know if he should get the second vaccine with what he experienced with the first one. Reporter husband did call his physician. The nurse said that the nurse also had some side effects too, but reporter does not think her husband explained fully what he experienced and the symptoms he experienced. Reporter adds that her husband has cirrhosis of the liver and platelets run between 50-60 which is normal for him because it has been like that for years. Reporter adds she does not want to report on the nurse, because she does not know who he talked to, and if she had really serious side effects that would be up to her to call. Reporter adds that it did not sound like the nurse had serious side effects that her husband had. Reporter was not really sure that her husband told the nurse how serious his side effects were, to her the side effects were really serious and her husband was sick. Reporter adds that 02Apr2021 was her husband's birthday. Upset stomach reporter adds that even last night, her husband said his stomach is not right, and that was over the weekend also. Reporter adds that last night her husband was also complaining of upset stomach, he had it over the weekend too. He had it last night, so she does not know if he still has this. Taste was off reporter stated that her and her husband went out to eat for reporter husband's birthday Friday and her husband said that it just did not taste right to him. Reporter adds that the food was absolutely delicious, so her husband's taste was off. This started on Friday. Reporter confirms that all mentioned dates are from this past weekend. Yesterday, reporter husband felt better but last night his stomach was really upset. Reporter does not know. Reporter adds she does not know if it is still the effects of what. Dizziness reporter adds that this was just like one day and it was either Saturday or Sunday. Left eye felt like there was something in it: reporter adds there was one other thing, reporter husband was complaining of his left eye that he just felt like there was something in it over the weekend. Reporter adds that it is not still going on. Patient not feeling like himself, just did not feel well: reporter adds that her husband just not feeling like himself and not feeling well are all related to the events she reported. Treatment: reporter told her husband to take some Tylenol the first night when he was throwing up. She told him to take Tylenol. Time the Vaccination was Given: 31Mar2021, this was the first vaccine, reporter stated she was going to look on the papers and it says 10:49 am. Communication: reporter informed cannot provide medical advice. She asks how long it might be that she will be talking. Reporter has to go to an appointment. Reporter given call back number, hours, and option. Reporter given report reference number. Attempted warm transfer to USMI, no available agents, placed reporter in queue per request. Report 1 of 2 In general, local side effects; the ones you get on the arm where you got the shot (such as injection site redness and injection site swelling) were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Side effects that you may experience throughout the rest of your body; (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. Swollen lymph nodes, which generally resolved within 10 days, is likely to have resulted from a robust vaccine-elicited immune response. Outcome of the events was unknown No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774222
Sex: M
Age:
State:

Vax Date: 03/26/2021
Onset Date: 03/01/2021
Rec V Date: 10/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

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

Symptoms: Fever; Muscle cramps; Headache; chills; Cold; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8734, and Expiration date: Unknown), via an unspecified route of administration on 26Mar2021 (at the age of 29-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, in afternoon the patient experienced fever, muscle cramps, little of headache, and then like some chills and cold. The patient reported he got the Covid-19 Vaccine last Friday and just last night he was having some sides effects. So, he wanted to know how affects him that long, a weeklong or for its side effects or should he look into giving a COVID Test. The patient did not receive second dose of vaccination. Further probing could not be done as consumer hung up abruptly. Thus, limited information available over the call. The outcome of events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774223
Sex: U
Age:
State: NM

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

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: inflammatory nodules; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced inflammatory nodules on an unspecified date. Therapeutic measures were taken as a result of inflammatory nodules. Outcome of the event was unknown. No follow-up attempts are needed. information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774224
Sex: F
Age:
State: MA

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

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: voice is still kind of gravely; Mostly a sinus thing; Coughing; she caught either a really bad cold or regular flu; she caught either a really bad cold or regular flu; pain in her knee/suddenly got this very sharp pain in caller's knee; arm soreness; This is a spontaneous report from a contactable consumer or other non-HCP (Patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: ER8727) via an unspecified route of administration (age at vaccination 69-year) in left arm on 24Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient received no prior vaccinations (within 4 weeks). On 24Mar2021 the patient experienced arm soreness; on 25Mar2021 the patient experienced pain in her knee/suddenly got this very sharp pain in caller's knee; on 27Mar2021 the patient experienced she caught either a really bad cold or regular flu, coughing; on an unspecified date the patient experienced her voice was still kind of gravely, mostly a sinus thing. It was reported that "Caller was a consumer reported she received the Pfizer Covid 19 Vaccine and thinks she was having a side effect. Reports caller received first dose Pfizer Covid 19 Vaccine on 24Mar2021 and the day after caller suddenly got this very sharp pain in caller's knee on the same side where caller received first dose Pfizer Covid 19 Vaccine. Caller received the first dose Pfizer Covid Vaccine in left arm, reports the sharp pain was in caller's left knee. Suddenly got this very sharp pain in the left knee: Caller reports the pain in the left knee came and went but it was so sharp that caller would had to sit down. Suddenly got this very sharp pain in the left knee: The knee pain came and went and got a little bit worse and started getting better. Then yesterday it felt like really getting better until around 7 or 8 last night and suddenly it was the worse pain the caller had so far. Caller reports it feels like someone was sticking a nail in her knee, it's just so painful. Stated she sure can't move and was sitting on the bath. Reported she was in touch with her healthcare provider but in the middle of what was going on with caller's knee, she caught either a really bad cold or regular flu. Really bad cold or regular flu: Reports her voice was still kind of gravely. She heard that the second shot was worse. Sore arm: Reported her arm soreness began the same day caller received the Pfizer Covid 19 Vaccine. As the day wore on, the callers arm got a little bit sore. Reports it went away completely. The only thing with lasting effects was the caller's knee symptom. Reported the arm soreness went away in 2 days at the most, lasted about 2 days." The clinical outcome of the event "arm soreness" was resolved on an unspecified date in Mar2021, while the outcome of the other events was known. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1774225
Sex: F
Age:
State: FL

Vax Date: 03/30/2021
Onset Date: 04/03/2021
Rec V Date: 10/09/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

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

Symptoms: Pain in her armpit and shoulder/sore arm pit, left, into the shoulder; Pain in her armpit and shoulder/sore arm pit, left, into the shoulder; Felt like I had a golf ball under my arm; Slight headache; Injection site is tender; Her arm was sore from the injection; lymph nodes can swell after; This is a spontaneous report from a contactable consumer. A 58-year-old female contactable consumer(patient) reported A 58-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: (Vaccine LOT number difficult to read for caller, she verified it must be ER8737, but initially said it looked like an S), via an unspecified route of administration, administered in Left arm on 30Mar2021 14:37 (58-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not take any other vaccines within 4 weeks, prior vaccinations. The Patient immunologist said she could develop something in the next 2 to 10 years, similar to lupus or similar to that. Her dad and sister, both have autoimmune disease. On 03Apr2021, the patient experienced pain in her armpit and shoulder/ sore arm pit, left, into the shoulder. on an unspecified date on 2021, the patient also experienced felt like i had a golf ball under my arm, slight headache, injection site is tender, her arm was sore from the injection, lymph nodes can swell. On 03Apr2021 she woke up in the middle of the night with pain in her armpit and shoulder that is still ongoing. The Reporter stated, she felt like she had a golf ball under my arm. The patient also had a slight headache and took Tylenol for that and that has gotten better. The pain under her arm is still there though and if she don't take Tylenol every 4-6 hours it get pretty bad. She can tolerate it as long as she take Tylenol for it. The patient stated that she had a side effect after the first dose of the vaccine. The reporter stated that She knew there might be some arm pain, but since the 2nd or 3rd night after the vaccine, she started to have pain in her armpit and her shoulder. She added the injection site is tender, but not like it was in initially. She is concerned about going back for the 2nd dose. She understood that lymph nodes can swell after, but will this happen again to her after the 2nd dose. The reporter asked if she should use the same arm or put off the second dose until it feels better. She is concerned about having the same reaction. Should she change arms or wait until the arm heals. The pain started the 2nd or 3rd night, probably the 3rd night after. Her arm was sore from the injection. The reporter didn't know if this was related, but she went through testing last year for autoimmune problems. The results came back inconclusive. Her immunologist said she could develop something in the next 2 to 10 years, similar to lupus or similar to that. Her dad and sister, both have autoimmune disease. The patient noticed the armpit change in the middle of the night and it freaked her out. The reporter added she is a wait and see what's happening kind of girl before she goes to the doctor, but it if was affecting her breathing she would have gone right away. She is taking Tylenol every 4-6 hours. It has helped tremendously. If she doesn't take it in that time, it does hurt. The reporter asking should she get the second dose, in the same arm, or wait on the second dose. She is concerned about having the same reaction. Therapeutic measures taken as a result of events. The outcome of events Pain in her armpit and shoulder/sore arm pit, left, into the shoulder, Felt like I had a golf ball under my arm were not resolved, Slight headache was resolving and other events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained

Other Meds:

Current Illness:

ID: 1774226
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: nausea; vomiting; The pain was especially in her joints.; chills, chattering teeth; fever; had a steroid injection yesterday, for body pain; This is a spontaneous report received from a contactable other HCP (Patient). This 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8727, Expiry date: not reported) via an unspecified route of administration on 23Mar2021 as DOSE 1, SINGLE for covid-19 immunization (at the age of 65 years old). Medical history included covid-19 from Oct2020 to an unknown date stated she still has no sense of taste or smell (since Oct 2020 when she had Covid 19). The patient previously received flu vaccine and experienced sore arm. Medical history (Including any illness at time of vaccination) was none. Relevant Tests was none. History of all previous immunizations with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations: Adverse Event: Sore arm after flu vaccines; has no dates or ages for vaccines. No brand name, ndc, lot number, or expiration dates. States her last one was years ago and she has stopped getting them. The patient's concomitant medications were not reported. The patient states she was fine at noon when she got her vaccine and fine that day (23Mar2021) until 01:00 when she woke up. On 24Mar2021, the patient experienced some chills, chattering teeth, nausea, vomiting, the pain was especially in her joints and on unspecified date in 2021, fever and had a steroid injection yesterday, for body pain. States that she went to the doctor yesterday (07Apr2021) and he gave her a steroid injection in her hip. The patient was wondering if this injection will interfere with the second dose of the vaccine she has scheduled for 14Apr2021. The patient stated that her symptoms, except pain, went away in 24 hours (25Mar2021). The chills she experienced only lasted a few hours. The patient was recovered completely from all events except for the pain in her joints. States she was hoping the injection she got will help with that. Caller mentions again that she just wants to know if the vaccine would interact with the steroid shot. Her doctor gave her a steroid yesterday for her hip pain and she would like to know if this would affect her getting the second dose and was due in a week. The patient enquired was it needed to reschedule second dose of vaccine appointment because of the steroid injection or was it okay. The outcome of outcome of nausea, vomiting recovered on 25Mar2021, chills, chattering teeth recovered in Mar2021, fever recovered in 2021 and outcome of had a steroid injection yesterday, for body pain and The pain was especially in her joints was not recovered. The causality of chills, chattering teeth,nausea, vomiting and pain, especially in joints was related to BNT162B2. No follow up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1774227
Sex: M
Age:
State: CA

Vax Date: 03/31/2021
Onset Date:
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: sweating; little appetite; joint pain; pain in the throat; sleeping alot; strange rash; body aches; This is a spontaneous report received from a contactable consumer or other non hcp. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 31Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced sweating, little appetite, joint pain, pain in the throat, sleeping a lot, strange rash, body aches. She spoke previously with another department of Pfizer, his husband received the second dose of the Pfizer COVID-19 vaccine 8 days ago, since then he haven?t have much progress with his symptoms, the patient is presenting: sweating, little appetite, joint pain and pain in the throat, she wants to know if it is normal for these side effects to be around for this long and what should they do about this. Response: Per PI, 6 OVERALL SAFETY SUMMARY, LAB-1457-7.0, Revised: 06 April 2021. Some of the side effects mentioned are not reported as side effects of the vaccination. Per attached CONS, patients might develop some side effects that are normal signs that your body is building protection. Some side effects like swollen lymph nodes take around 10 days to be resolved, others like injection site swelling take from 1 to 8 days. Referred to his physician for treatment recommendation, Pfizer cannot make treatment recommendations for individual patients. Her husband has been constantly sweating, sleeping a lot, woke up with a strange rash, has sore throat, body aches, no appetite. The clinical outcome of the event was unknown. No follow up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1774228
Sex: F
Age:
State: TX

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: she is experiencing mild fever now.; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer reported for a female patient (reporter's wife) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 01Apr2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 11Mar2021 as DOSE 1, SINGLE for COVID-19 immunization. It was reported that, patient got the 2nd dose of COVID-19 vaccine and currently she was experiencing mild fever on an unspecified date in Apr2021. Caller was asking if his wife could take Tylenol for her fever. The outcome of event was unknown. No follow-up attempts are possible; information about batch/ lot number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774229
Sex: F
Age:
State: CT

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

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

Lab Data:

Allergies:

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

Symptoms: vomiting; numbness; tongue swelling; fever; extreme tiredness; chills; joint pain; a rash that resembled measles covering torso, arms and legs; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration, administered in arm left on 23Mar2021 11:00 as dose 2, single (at the age of 50-years-old) for covid-19 immunisation. Medical history included Hashimotos, anxiety and allergies to oranges. The patient concomitant medication included unspecified medications. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration, administered in arm left on 01Mar2021 09:15 as dose 1, single for covid-19 immunisation. The patient previously received progesterone and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Mar2021 12:00, the patient experienced vomiting, numbness, tongue swelling, fever, extreme tiredness, chills, joint pain and a rash that resembled measles covering torso, arms and legs. The patient had not diagnosed with COVID-19 prior to the vaccination and had not been tested for COVID-19 since the vaccination. The patient visited doctor or other healthcare professional office/clinic for the events. The patient did not receive any treatment for the events. The outcome of the events was recovering. No follow-up attempts were needed, information about lot/batch number could not be obtained.

Other Meds:

Current Illness:

ID: 1774230
Sex: M
Age:
State: IN

Vax Date: 03/31/2021
Onset Date: 04/05/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: the arm where he had the injection resulted to a sore and swollen armpit (lymph nodes).; the arm where he had the injection resulted to a sore and swollen armpit (lymph nodes).; his affected armpit feels slightly warmer; This is a spontaneous report from a contactable consumer or other non hcp (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not reported) via an unspecified route of administration on 31Mar2021 as dose 1, single for COVID-19 immunization. Medical history included COVID-19 from 2020 to an unknown date (Positive during Christmas (2020)). The patient's concomitant medications were not reported. It was reported that caller got his first dose on 31Mar2021. He mentioned that he and his wife tested positive during Christmas (2020) and did the quarantine deal. Before he got his first dose, he had an antibody test and he developed both types of antibodies. After receiving the first dose, on 05Apr2021 the arm where he had the injection resulted to a sore and swollen armpit (lymph nodes). He wants to know how come this happened and added if he need to be concerned about this matter. He was worried to get the second dose because of this. Although the swelling under his armpit was beginning to go down. He added his affected armpit feels slightly warmer on 05Apr2021. The outcome of the event the arm where he had the injection resulted to a sore and swollen armpit (lymph nodes) was recovering and other events it was unknown. Information about lot/batch number cannot be obtained.No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1774231
Sex: F
Age:
State: OR

Vax Date: 03/14/2021
Onset Date: 03/01/2021
Rec V Date: 10/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: nausea and feeling unwell; nausea and feeling unwell; Headache; Chills; husband bought her juice on 19 Mar 2021/States that it may have been too much and may have caused diarrhea; husband bought her juice on 19 Mar 2021/States that it may have been too much and may have caused diarrhea; Tiredness; muscles in back feel tight and sore; muscles in back feel tight and sore; really sick; Fever; Weakness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration on 14Mar2021 14:00 (at the age of 70-year-old) as dose 1, single for covid-19 immunisation. Medical history included blood cholesterol increased from an unknown date and unknown if ongoing Caller states that she is pretty healthy and controls with a good diet and eats just right. Is not on any medications for this. States that she is fairly active, coagulopathy from an unknown date and unknown if ongoing States that her and all of her sisters have this clotting disorder. Concomitant medications included aspirin [acetylsalicylic acid] taken for coagulopathy from 2011 and ongoing; diphenhydramine taken for hypersensitivity, start and stop date were not reported; melatonin taken for insomnia, start and stop date were not reported. The patient previously took flu vaccine vii for immunisation, statins for blood cholesterol increased and experienced myalgia. On 17Mar2021, patient experienced tiredness. On 19Mar2021, patient experienced husband bought her juice on 19 mar 2021/states that it may have been too much and may have caused diarrhea. On 20Mar2021, patient experienced nausea and feeling unwell, chills, headache. On an unspecified date in Mar2021, patient experienced muscles in back feel tight and sore. On an unspecified date in 2021, patient experienced fever, weakness, sick. Therapeutic measures were taken as a result of headache included tylenol. The outcome of the events nausea and feeling unwell, chills was recovered on 22Mar2021. The outcome of the event weakness was recovering and the outcome of tiredness, husband bought her juice on 19 mar 2021/states that it may have been too much and may have caused diarrhea, fever, headache, sick, muscles in back feel tight and sore was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]; DIPHENHYDRAMINE; MELATONIN

Current Illness:

ID: 1774232
Sex: M
Age:
State: MA

Vax Date: 03/23/2021
Onset Date: 03/01/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Nausea; Exhausted; Every bone in his body hurt, and it feels like he has he Flu; Every bone in his body hurt, and it feels like he has he Flu; Dizzy; Headache, a splitting headache; Body aches, every joint in his body hurt; Rash, red, looks like fungus, from wrist up the arm, spots of white in between; Rash, red, looks like fungus, from wrist up the arm, spots of white in between; This is a spontaneous report received from a contactable consumer or other non-health care professional via Pfizer sponsored program. A 71-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch number: not reported/ Lot number: Unknown) via an unspecified route of administration in arm left on 23Mar2021 (at the age of 71-year-old) as dose 1, single for COVID-19 immunization. Patient's relevant medical history included ongoing allergy to sulfa and undiagnosed skin condition of the hand from an unknown date and unknown if ongoing. Patient's concomitant medications noted steroid for an undiagnosed skin condition of the hand. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations taken within 4 Weeks. No Family Medical History Relevant to AE. On 23Mar2021, patient experienced nausea; exhausted; every bone in his body hurt, and it feels like he has he flu; dizzy; headache, a splitting headache; and body aches, every joint in his body hurt. On an unspecified date in Mar2021, patient experienced rash, red, looks like fungus, from wrist up the arm, spots of white in between. at first it was a light colored rash and It was all red, and she and the Pharmacist thought it looked like fungus. It was not itchy, it was not sore, it was not one whole patch, and had white in between. Nausea started the night he had the vaccine, exhausted started in the evening of the vaccine, body aches, every joint in his body hurt, Dizzy, Headache, splitting headache at night and all of his symptoms continued. Patient symptoms have lasted for 14 days today. Adverse events did not require a visit to emergency room and no visit to physician's office. Outcome of the events was not recovered. No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected

Other Meds:

Current Illness: Sulfonamide allergy

ID: 1774233
Sex: F
Age:
State: NC

Vax Date: 04/06/2021
Onset Date: 04/06/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:negative

Allergies:

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

Symptoms: Chest tightness; The caller's chest burned yesterday; Shortness of breath; The caller has been taking deep breaths; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A 47-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 06Apr2021 (Batch/Lot Number: ER8737) as DOSE 1 SINGLE for covid-19 immunization. The patient medical history included slight heart murmur from an unknown date and unknown if ongoing, Blood pressure high Diagnosed about 20 years ago and Allergic to sulfa from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The caller had shortness of breath last night 06Apr2021 and her chest was tight this morning 07Apr2021. The caller has been taking deep breaths, the tightness is gone but she is still having to have deep breathe on Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 test negative on unspecified. The event outcome was recovering for Chest tightness, Unknown for Chest burning and breathing abnormally deep and Not recovered Shortness of breath. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness: Blood pressure high (Diagnosed about 20 years ago)

ID: 1774234
Sex: F
Age:
State: VA

Vax Date: 03/30/2021
Onset Date:
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: facegot swollen; itchy; This is a spontaneous report from a Pfizer sponsored program support from a contactable female consumer(patient). A female patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 30Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced face got swollen and itchy after the 1st dose. The outcome of the events was unknown. No Follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1774235
Sex: F
Age:
State: CO

Vax Date: 02/24/2021
Onset Date: 02/25/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Date: 20210324; Test Name: X-Ray of Left Arm; Result Unstructured Data: Test Result:Normal

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Left arm is killing her; really sore, if lays on it at night wakes her up. goes from shoulder to 2" above elbow. It really hurts.; Left arm is killing her; really sore, if lays on it at night wakes her up. goes from shoulder to 2" above elbow. It really hurts.; Dizzy spells; arm does still hurt and goes from her neck to her shoulder down through there almost to her elbow; This is a spontaneous report received from a contactable consumer or other non-health care professional reporting for herself (patient). A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number, UPC number, NDC number and Expiry Date are unknown), via an unspecified route of administration, administered in Left arm on 24Feb2021 14:00 at the age of 76-years-old as dose 1, single for covid-19 immunisation at Clinic. The patient's medical history and concomitant medications were not reported. The patient previously took historical vaccine, flu shot on 01Oct2020 at the age of 76-years-old for immunisation and experienced big hive like itching and it goes away but never hurt like this does, this one talks to her. Every year for last 12 years, after getting the flu shot (NDC, Lot, Expiration Unknown) her arm gets big red and puffy and itches and then it goes away but she has never had the pain that has with this. Prior Vaccinations within 4 weeks included patient has received both doses of the Pfizer Covid Vaccine. Additional vaccines administered on same date of the pfizer suspect were none. Family medical history relevant to AE(s) was none. On 25Feb2021, the patient experienced left arm is killing her; really sore, if lays on it at night wakes her up. goes from shoulder to 2" above elbow. it really hurts, dizzy spells, arm does still hurt and goes from her neck to her shoulder down through there almost to her elbow. The clinical course was reported as follows: the reporter states that she was calling about her first Covid Vaccine injection that she had on 24Feb2021. She states she is really concerned about it. States she went to see her primary physician and he strongly suggested she report it and she was calling to see if we know anything that can be done for it or what is going on. She states her left arm is killing her, it won't stop hurting. States she is not one to complain and run to the doctor for every little thing either. Clarifies her arm does still hurt and goes from her neck to her shoulder down through there almost to her elbow. States the last two days her elbow has been hurting too. States she told her son and he said to put ice packs on it and said it is from the injection. States her elbow is 80% better but the arm isn't. States she is not sick just her arm is hurting so bad. States oh, how did she forget to mention she has been having dizzy spells. Treatment included warm packs, cold packs, Voltaren cream or gel, and the anti-inflammatory Mobic but nothing is helping her arm pain. UPC, NDC, Lot, Expiration are Unknown. States she threw the box away for the Voltaren cream but she just got it about two weeks ago, so she knows it isn't expired. Mobic: states she has the prescription because once in a while gets arthritis. States it was filled 17Dec2020 and good till 17Dec2021. Stats she needs a triple magnifying glass to read the Voltaren bottle. States she reads on TV about this Voltaren cream and how good it is, maybe it is a myth. It was reported that second vaccine received on 17Mar2021, LOT: Unknown. Adverse event occurred after first dose. She states she can't locate the card right now. States that if she touches it really hurts. States it is hard for her to turn her neck and she keeps putting hot warm water packs on it. She states that on Wednesday 24Mar2021, she went to her primary and he said lets get an x-ray to see if anything is broken or if they see any extra arthritis. States the x-ray was fine and she never had any problems with her arm before. States he wanted an x-ray because he thought maybe she broke it. States she wonders why this is happening. States she has to take different bags because it is too heavy on her arm to carry a purse. Dizzy Spell: She states that her doctor said to be really careful and he is not letting her drive. She states she had a couple of days of walking into things and she thought what is this? States her doctor said he doesn't want her driving or doing much of anything and she has really been being careful and trying to watch it. She states that she doesn't really want to come back in to see her primary. States she is a very healthy person for as young as she is, she stays very active and this is new for her. States she wanted to call because this was new and it wouldn't hurt to report it so it is on record. Next morning after the first vaccine; states she said oh my gosh her arm hurts her, and her sons are both doctors and they said to use ice packs and massage it and she has been doing that as often as she can. The adverse events did not require a visit to Emergency Room but required Physician Office on 24Mar2021 at 14:45. The patient underwent lab tests and procedures which included X-Ray of Left Arm (x-ray limb): normal on 24Mar2021. Reporter seriousness for Left arm is killing her; really sore, if lays on it at night wakes her up. goes from shoulder to 2" above elbow. It really hurts and Dizzy spells was unspecified. The outcome of events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774236
Sex: M
Age:
State: NC

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

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

Lab Data:

Allergies:

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

Symptoms: About 4 hours after vaccine a very large blood blister came up in the right side of my tongue.; busted blood blister and dentist checked area; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot Number EN6202) via an unspecified route of administration in arm left on 01Mar2021 13:00 as dose 2, single (age at vaccination: 67 years) for COVID-19 immunisation. Medical history included prinzmetal angina, thyroid, both from an unknown date and unknown if ongoing. Concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot Number EL9264) via an unspecified route of administration in arm left on 06Feb2021 11:30 AM as dose 1, single (age at vaccination: 67 years) for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies to medications, food, or other products. The most recent COVID-19 vaccine was administered at hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and the patient received other medications within 2 weeks of vaccination. On 01Mar2021, the patient experienced about 4 hours after vaccine a very large blood blister came up in the right side of my tongue, busted blood blister and dentist checked area. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment was received for the adverse event. The clinical outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1774237
Sex: F
Age:
State: NJ

Vax Date: 04/06/2021
Onset Date: 04/06/2021
Rec V Date: 10/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210407; Test Name: fever; Result Unstructured Data: Test Result:100; Comments: Dates for Fever 100 degrees: (From: 7 Apr 2021 To: Ongoing)

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: weak; Fever 100 degrees; Pretty Darn Weak and Dizzy; Arm Pain; This is a spontaneous report received from a contactable consumer reporter. This reporter reporting for his 56-years-old wife (patient) that a 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 06Apr2021 at 10:30 (at the age of 54 years old) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive additional vaccines on same date of the Pfizer suspect. The patient did not have adverse event prior vaccinations. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EP6955) on 17Mar2021 (at the age of 54 years old) for covid-19 immunisation and patient experienced arm pain. The patient experienced arm pain on 06Apr2021. She stated with this one the patient was pretty good for the afternoon but in the middle of the night she got weak and dizzy and this morning she was still pretty darn weak and dizzy and had a 100 degree fever on 07Apr2021. She stated he gave her Tylenol and it was starting to go down. She stated he figured he would call, he doesn't know that 100 was something to worry about. Reporter stated he was calling to report it and secondly in the packet they got, it just says fever, tiredness, muscle pain and lists possible side effects. He stated this doesn't seem to be a severe allergic reaction. Reporter stated the packet says what should a person do about side effects, if severe go to the hospital, report side effects, and call the provider if there are side effects that bother or don't go away. He was asking how common this was? he would say let her spend the day in bed and if fever never goes above 100 degrees it will be alright. He doesn't know what doesn't go away means, how long will this last? Therapeutic measures were taken as a result of Fever 100 degrees and included treatment with Tylenol. The patient underwent lab tests and procedures which included pyrexia: 100 degrees on 07Apr2021. The patient did not visit emergency room or physician office. He stated that was why he was calling to see if he should take her to the doctor. No family medical history relevant to adverse events was provided. The outcome of arm pain was unknown, weak, pretty darn weak and dizzy was not recovered, fever 100 degrees recovering. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1774238
Sex: F
Age:
State: NY

Vax Date: 03/24/2021
Onset Date: 03/01/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Headache; coughing; lot of phlegm; body pain; roller coaster- with her sinuses; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 58-years-old female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Left on 24Mar2021 at 10:00 (Batch/Lot Number: ER8733; Expiration Date: 31Jul2021) as dose 1, single for covid-19 immunization (at the age of 58-years-old). Medical history included ongoing glucose tolerance impaired Verbatim: Pre-diabetic), thyroid disorder (had thyroid taken out at age 28), irregular heartbeat, blood cholesterol and gastroenteritis. Concomitant medication(s) included metoprolol taken for irregular heartbeat (has been taking for a while, many years); levothyroxine sodium (LEVOTHROID, has been taking for years) taken for thyroid disorder; rosuvastatin calcium (CRESTOR) taken for blood cholesterol (has been taking for a while but cholesterol is good); metformin taken for glucose tolerance impaired (prediabetic), and esomeprazole magnesium (NEXUM) taken for gastroenteritis, for all start and stop date were not reported. It was reported that on Tuesday 24Mar2021, the patient received first dose of vaccine and stated that the coughing started that Friday, 3 days later on 27Mar2021 and mentioned that the coughing has not stopped and was still the same and she has been coughing with a lot of phlegm in her chest and stated that the body pain started on Friday after the shot and she still has a little bit of body pain. She further mentioned that after vaccination from an unspecified date in Mar2021, it has been a roller coaster-with her sinuses. She has been coughing non-stop and her doctor gave her Claritin but it didn't work, so now she gave her Zyrtec because Claritin actually doesn't help. She Stated that she has been having a lot of phlegm and mentioned that it has been 10 days. She also reported that Today was 07Apr2021 and her coughing was still going on and she has a headache also. The headache was still going on as the caller was speaking. As a treatment she has been drinking lots of hot tea, ginger and was taking Motrin for the pain in her body but trying not to take too much because Motrin messes up her stomach. Then, the doctor gave her Claritin which doesn't help, it doesn't do nothing. So, she was given Zyrtec which the caller started on 07Apr2021. She also reported that she put away the vaccine card and now she can't find it. She has documents that they gave her while she was there like when she has to return and all of that. She wanted to know if she will have a problem when she goes there for her second dose, should she go before her scheduled appointment so that way she can get another card. Stated that they may have it on file and mentioned that she was supposed to go on 14Apr2021 for the second dose. She heard the second shot is worse and she can't imagine because she has been on bedrest and everything the past couple of days. The patient was recovering from the event of general body pain at the time of report and outcome was unknown for the event sinusitis and the patient was not recovered from rest of the other events. No follow up attempts are needed. No further information is expected.

Other Meds: METOPROLOL; LEVOTHROID; CRESTOR; METFORMIN; NEXUM

Current Illness: Arrhythmia (Verbatim: Irregular heartbeat); Blood cholesterol; Gastroenteritis; Pre-diabetic (Verbatim: Pre-diabetic); Thyroid disorder (Verbatim: Thyroid, Had thyroid taken out at age 28)

ID: 1774239
Sex: F
Age:
State: MO

Vax Date: 03/08/2021
Onset Date: 03/18/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: I had really bad reaction to it; the arm hurt,; headache; sore muscles; fever; My muscle, my jaw and my neck were extremely tight.; In my eyes it's almost black like around it.; Dizziness; My muscle, my jaw and my neck were extremely tight.; This is a spontaneous report from a contactable consumer (patient). A 55-years-old non female patient received first dose of bnt162b2 (Solution injection; Batch/Lot Number: EP754), via an unspecified route of administration, administered in Arm Left on 08Mar2021 (at the age of 55-years-old) as single dose for covid-19 immunisation. Medical history included hypothyroidism. Concomitant medications included thyroid (ARMOUR THYROID). Patient reported that she took the Pfizer vaccine on 08Mar and had really bad reaction to it. On 18Mar2021, her arm hurt, the headache, the sore muscles, the fever she had all that but then it continued. She did not not expect that maybe last a day or 2 but then she continued to had extremely bad headache, and then her muscle, her jaw and her neck were extremely tight and headache was really bad, in her eyes it was almost black like around it, it would not go away and she had dizziness also. She tried all medicine. She took anacin, aspirin, ibuprofen, Tylenol. She took tension headache medicine, migraine medicine. She took muscle relaxers. She took more advanced Ibuprofen extended release that the doctor has given her. She put heat on her, she put ice on her. She went for chiropractor 3-4 times. She tried to exercise like trying to loosen the muscle, she did a lot of stuff for it and then they gave her a shot in doctor's office. She don't know what that was, they supposed to relieve the headache it didn't and then the only thing that relieved her headache finally has been the steroid pack that's the prednisone pack and that was kind of like allergic reaction, like a high information of body allergic reaction, that's why she gave that to her. She went to chiropractor, and they tried to give her a shock to stop her headache that didn't work she thought that using work in 20 minutes, since then, now they finally put her on steroid pack massive a prednisone a pack. She called to asked if she should supposed to get her second shot. She felt like she had really bad reaction to it and she don't feel like I she should get the second shot. The outcome of all the events was unknown. No follow up attempts are possible. No further information is expected.

Other Meds: ARMOUR THYROID

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am