VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1817348
Sex: M
Age:
State: NC

Vax Date: 09/14/2021
Onset Date: 09/14/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: Test Name: heart rate; Result Unstructured Data: Test Result:elevated; Comments: heart is beating really fast

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Headache; heart beating really fast; trouble sleeping; This is a spontaneous report from contactable consumer (patient). A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered in arm left on 14Sep2021, given around 13:00 (at the age of 38-years) as dose 2, single for covid-19 immunization. Patient had no relevant medical history. The patient concomitant medications were not reported. The patient past drug event includes Anthrax. some 20 years ago, the patient 2002 or 2003 he had the anthrax shots and had a bad reaction to it. The patient was in the navy and had a booster at 6 months and then every 12 months. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch number: FC3182) (at the age of 38-years), via an unspecified route of administration, administered in arm left on 24Aug021 given around 13.00 as dose 1, single for covid-19 immunization. Caller reporting on the Pfizer COMIRNATY, the covid shot and who explains the patient took it yesterday and was told to call if felt anything afterward. It was his second dose. Last night the patient had trouble sleeping. Patient just hopes he was really tired to night and will be able to catch up on his sleep. His heart had been, the patient feel like he ran a marathon for 12-13 hours it had been beating really fast, which started around 22:00 last night, was about the same, the patient just feels like he ran a marathon, his heart was beating really hard and fasting. He drank water. Patient also had a slight headache which started about 9-10pm last night, it was about the same. The patient explains that he gets migraines so it was nothing like normally gets. He was treatment with excedrin. The patient did not visit in emergency. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reports the patient thinks he was doing fine but his heart was beating really fast. The patient underwent lab test: heat rate: elevated (heart is beating really fast). The outcome of the events headache and heart beating really fast was not recovered while the outcome of the event insomnia was unknown. The lot number for [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1817349
Sex: F
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
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: Reaction occurred after the second dose/she got really bad anxiety; This is spontaneous report from a contactable consumer (Patient). A 71-years-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Batch/Lot Number and expiration date was not reported) via an unspecified route of administration, as dose 2, single for COVID-19 immunization. The patient medical history included She is very addicted to the nicotine, and She took Chantix, got sick off of one of the pills was afraid to take this new Chantix. The patient concomitant medications were not reported. The patient previously received historical vaccine of first dose of BNT162B2 vaccine, on an unspecified date for COVID-19 immunization. On an unspecified date, Reaction occurred after the second dose/she got really bad anxiety. On an unspecified date, the patient experienced Reaction occurred after the second dose/she got really bad anxiety. The Caller stated she then did not took any more. She got a different prescription instead of the drug mart she previously went to. Was afraid to take this new CHANTIX.S he was now vaping again. She Stated she did take one of the new CHANTIX this morning while speaking with the agent. She did not thought she will get sick on this new CHANTIX she started today. She did not knew if the previous CHANTIX was just old. She also had a reaction to the vaccine. Is not sure. She clarified she had both Pfizer COVID vaccines, first and second dose. Reaction occurred after the second dose. She was very addicted to the nicotine. She stated she was not vaping at the time she took the CHANTIX. Stated she was also on CHANTIX a year ago and did quit vaping. She really likes CHANTIX. She did not got side effects a year ago. All she got was colourful dreams, which did continue for a while after she stopped the CHANTIX. She had no nightmares. Clarified she got sick off of one of the pills: She got very bad headaches like never before. Felt sick to stomach even though she had eaten, which never happened before. Only thing that was different was she was taking the CHANTIX. She got scared and stopped taking it before Pfizer came out with the lot numbers. Began: Dec2020 or Jan2021, she had the COVID vaccine by then so she did not knew what caused it. She took CHANTIX in the beginning of August, stating it was an old prescription she got out of the drawer and that was what she got sick on. She clarified that got sick after taking CHANTIX in Jan2021. Then she got the new one, it had the same number, so it was the same product, and she just took it. Wanted to add, when she got the COVID vaccine, she got really bad anxiety. Takes Xanax at night to sleep, had take Xanax during the day, which is unusual for her. She usually takes 2 Xanax, but only took 1. She then woke up at 3AM and took one more Xanax, so she was taking her full dose. She was originally diagnosed and put on Xanax three times a day, but it is too much for her. So she cut it down to two Xanax at night. The outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1817350
Sex: M
Age:
State: NH

Vax Date: 09/17/2021
Onset Date: 09/01/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: Test Date: 202109; Test Name: heart rate; Result Unstructured Data: Test Result:little higher than normal; Test Date: 202109; Test Name: heart rate; Result Unstructured Data: Test Result:higher

Allergies:

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

Symptoms: He got the Pfizer Covid 19 Vaccine and afterwards now his heart rate has been high; I did check it here today and seems little higher than normal first one I roam around and it goes even higher; This is a spontaneous report from a Pfizer sponsored program. This is a spontaneous report from a contactable 57-year-old male consumer (patient) .A 57-year-old male received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on 17Sep2021 as DOSE 2, SINGLE for covid-19 immunization.The patient medical history had included blood clots and received blood thinner for blood clots. The patient concomitant had included vitamin B-complex and vitamin D. It was reported that patient did not receive any vaccination prior to the vaccination. The patient previously took bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number:FC3180 ) via an unspecified route of administration on 27Aug2021 as DOSE 1, SINGLE for covid-19 immunization.On Sep 2021 the patient had experienced that after getting Pfizer Covid 19 Vaccine and afterwards now his heart rate has been high and reported that check it here today and seems little higher than normal first one I roam around and it goes even higher. The clinical outcome of the events were unknown. The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow up.

Other Meds: VITAMIN B COMPLEX; VITAMIN D [VITAMIN D NOS]

Current Illness:

ID: 1817351
Sex: U
Age:
State: TN

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: had a lump and breast issues; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRna VACCINE, solution for injection, date (Batch/Lot number was not reported)), via an unspecified route of administration on an unspecified as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had a lump and breast issues. At the time of this report, the outcome of events was unknown. The lot number for, the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1817352
Sex: F
Age:
State: ME

Vax Date: 09/24/2021
Onset Date: 09/25/2021
Rec V Date: 10/26/2021
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: Severe left sciatic nerve pain; This is a spontaneous report from a contactable consumer (patient). A 26-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 24Sep2021 13:00 (Batch/Lot number was not reported) age at vaccination of 26-years-old, as single dose, for covid-19 immunisation. The patient medical history was not reported. The patient was not pregnant and was not pregnant at the time of vaccination. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 03Sep2021 13:00 (Batch/Lot number was not reported) age at vaccination of 26-years-old, as single dose, for covid-19 immunisation. The patient previously took ceclor and experienced drug hypersensitivity. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]) taken for an unspecified indication, start and stop date were not reported; paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe left sciatic nerve pain on 25Sep2021 05:00. Facility type vaccine: Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds: ADVIL [IBUPROFEN]; TYLENOL

Current Illness:

ID: 1817353
Sex: M
Age:
State: CT

Vax Date: 09/22/2021
Onset Date: 09/23/2021
Rec V Date: 10/26/2021
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: dizziness; some eye ache; focus issues.; Lethargy; This is a spontaneous report from contactable consumer (patient). A 75-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 22Sep2021 10:30 (Batch/Lot Number: FF2588) age at vaccination of 75-years-old, as single dose, for covid-19 immunisation. Medical history included granulomatosis with polyangiitis from an unknown date and unknown if ongoing Wegener's GPA. The patient previously took tamiflu and experienced hypersensitivity, antibiotics and experienced hypersensitivity. The patient previously BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 01Sep2021 10:30 (Batch/Lot Number: FF2588) age at vaccination of 75-years-old, as single dose, for covid-19 immunisation. Concomitant medications included prednisone (PREDNISONE) taken for an unspecified indication, start and stop date were not reported; sulfamethoxazole, trimethoprim (BACTRIM) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Beginning one day after second shot on 23Sep2021 at 01:45 AM (and continuing into third day after second shot) the patient experienced dizziness, he also experienced while walking or standing, when sitting he had some eye ache and focus issues. The patient also experienced lethargy on 23Sep2021 at 01:45 AM. No treatments were administered. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not recovered from the events.

Other Meds: PREDNISONE; BACTRIM

Current Illness:

ID: 1817354
Sex: F
Age:
State: IL

Vax Date: 09/24/2021
Onset Date: 09/24/2021
Rec V Date: 10/26/2021
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: Terrible arm pain; This is a spontaneous report from a contactable other HCP (Patient's parent). A 29-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in Arm Right on 24Sep2021 13:00 (Batch/Lot number was not reported) age at vaccination of 29-years-old, as single dose, for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing (Penicillin allergy), covid-19 from an unknown date and unknown if ongoing if covid prior vaccination. The patient was not pregnant and was not pregnant at the time of vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced terrible arm (non-serious) on 24Sep2021 13:30. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1817355
Sex: F
Age:
State: PA

Vax Date: 09/24/2021
Onset Date: 09/25/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: Test Date: 20210925; Test Name: Blood pressure; Result Unstructured Data: Test Result:unknown results; Test Date: 20210925; Test Name: Body temperature; Result Unstructured Data: Test Result:102 Fahrenheit; Comments: 25Sep2021; Test Date: 20210926; Test Name: Body temperature; Result Unstructured Data: Test Result:101 Fahrenheit; Comments: 26Sep2021; Test Date: 20210926; Test Name: Body temperature; Result Unstructured Data: Test Result:101.2 Fahrenheit; Comments: degree Celsius; Test Date: 20210927; Test Name: Body temperature; Result Unstructured Data: Test Result:100.3 Fahrenheit; Comments: 27Sep2021

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Suddenly sick to stomach; Started throwing up; Had headache when I woke up; like it felt like nerve pains running down my arms/Pain up and down arms + legs nerve like; Still have fever; tired; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 intramuscular, administered in Arm Right on 24Sep2021 13:30 (at the age of 63-years-old) (Batch/Lot Number: EN0167) as DOSE 3, SINGLE for covid-19 immunisation. Medical history included blood pressure abnormal. The patient have had cancer twice but nothing recently, breast cancer stage ii from 1989, breast cancer from 1995, AFib, GERD. The patient received first dose of BNT162B2 on 04Jan2021 (DOSE 1, SINGLE, Administration Date: 04Jan2021, Administration time: 14:00, Anatomical site of Injection: Right Arm, Route of administration: Intramuscular, Batch/Lot number: 651685), and received second dose of BNT162B2 on 25Jan2021 (DOSE 2, SINGLE, Administration Date: 25Jan2021, Administration time: 14:00, Anatomical site of Injection: Right Arm, Route of administration: Intramuscular, Batch/Lot number: FL3246); for COVID-19 immunization. The patient received Influenza on 16Sep2021 (Manufacturer: (Company name withheld) Batch/Lot No. 33090, Route: IM, Anatomical site of injection: RT arm, No. of previous doses: 16Nov2021). Concomitant medications included metoprolol taken for blood pressure abnormal, atrial fibrillation from an unspecified start date and ongoing; omeprazole (PROTONIX [OMEPRAZOLE]) taken for gastrooesophageal reflux disease from an unspecified start date and ongoing. It was reported the patient got her booster shot on Friday afternoon (on 24Sep2021), her third shot. Fell back asleep, woke about 1:30 AM with fever of 102 degree Celsius. Took 2 Tylenol, tired so laid around. Awakened 03:00 25Sep2021 with pain up and down arms + legs nerve like/ pains all over her body like it felt like nerve pains running down her arms (medically significant). About 15:00 25Sep2021, had tea and went to lay down. Suddenly sick to stomach, vomiting repeatedly with headache. The patient had I had some Zofran (intent treatment), so the patient took Zofran under the tongue. "This didn't resolve until 22:30. Slept this thru night feverishly of awakened with fever still. 26Sep fever 101.2 degree Celsius, 27Sep2021 100.3. Then stated to better. The patient underwent lab tests and procedures which included blood pressure measurement: unknown results on 25Sep2021, body temperature: 102 fahrenheit on 25Sep2021 25Sep2021, body temperature: 101 fahrenheit on 26Sep2021 26Sep2021, body temperature: 101.2 fahrenheit on 26Sep2021 degree Celsius , body temperature: 100.3 fahrenheit on 27Sep2021 27Sep2021. Therapeutic measures were taken as a result of like it felt like nerve pains running down my arms/Pain up and down arms + legs nerve like, started throwing up, still have fever, had headache when i woke up. The outcome of the event nerve pain was recovered, Suddenly sick to stomach, Started throwing up, Had headache when I woke up was recovered on 25Sep2021 22:30, fever, tired was not recovered.

Other Meds: METOPROLOL; PROTONIX [OMEPRAZOLE]

Current Illness:

ID: 1817356
Sex: F
Age:
State: CA

Vax Date: 10/04/2021
Onset Date: 10/04/2021
Rec V Date: 10/26/2021
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: body aches; headaches; weak for 2 days; dose number=3; dose number=3; This is a spontaneous report from a contactable consumer (patient). A 51-years-old non-pregnant female patient received booster dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ff8839, patient was not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 04Oct2021 at 16:45 (at the age of 51-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number was not reported, patient was not pregnant at the time of vaccination), via an unspecified route of administration, on 20Jan2021 (at the age of 50-year-old) as DOSE 2, SINGLE; second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number was not reported, patient was not pregnant at the time of vaccination), via an unspecified route of administration, on 30Dec2020 (at the age of 50-year-old) as DOSE 1, SINGLE both for covid-19 immunisation. No other vaccine received in four weeks. No covid prior vaccination and no covid tested post vaccination. On 04Oct2021, the patient experienced dose number=3, on 05Oct2021 patient experienced body aches, headaches, weak for 2 days. No treatment received for events. The outcomes of events (body aches, headaches, weak for 2 days) were recovering. Follow-Up (15Oct2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1817357
Sex: M
Age:
State: FL

Vax Date: 10/05/2021
Onset Date: 10/05/2021
Rec V Date: 10/26/2021
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 Name: Body temperature; Result Unstructured Data: Test Result:going up and down from 99 to 100.8; Comments: a fever going up and down from 99 to 100.8.; Test Date: 20211005; Test Name: Body temperature; Result Unstructured Data: Test Result:100.4; Comments: Upon calling back, caller stated his current temperature is 100.4.; Test Date: 20211005; Test Name: Body temperature; Result Unstructured Data: Test Result:100.8; Comments: He did a thermometer check and his temperature was 100.8. The lowest reading he got last night was 99.3, and this morning it was back at 100.; Test Date: 20211005; Test Name: Body temperature; Result Unstructured Data: Test Result:99.3; Comments: He did a thermometer check and his temperature was 100.8. The lowest reading he got last night was 99.3, and this morning it was back at 100.; Test Date: 20211007; Test Name: Body temperature; Result Unstructured Data: Test Result:100; Comments: He did a thermometer check and his temperature was 100.8. The lowest reading he got last night was 99.3, and this morning it was back at 100.

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Diarrhea; Headache; queasiness; fever going up and down between 99-100.8; problem breathing; sore arm; Vomiting; injection site pain; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: 301558A) via an unspecified route of administration, administered in right arm on 05Oct2021 at approximately 11:00 (age at the time of vaccination was 55-year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history included covid-19 (he already had covid, he already gave blood to senior homes for people that did not have antibodies), obesity and overweight from unknown date and unknown if ongoing. Concomitant medications included vitamin D, Vitamin C and Zinc. No prior vaccination within four weeks. On 05Oct2021, from 7 pm he started experiencing diarrhea, headaches, queasiness, his fever goes up and down between 99-100, he had a problem breathing, he had to stand up and try to stretch to catch his breath, soreness of his injection arm and he vomited last night as well but hasn't since. He did a thermometer check and his temperature was 100.8. The lowest reading, he got last night was 99.3, and this morning it was back at 100. He had diarrhea two times late at night, and early in the morning. He just recently a little more. It was thicker than in the past. He had vomiting and injection site pain described as a throbbing pain in addition to the other reported side effects stated was like his body is acting like it is fighting the virus all over again. Patient asked are these side effects because he already had the virus, and it was overdriving his system making it like he had covid again. Patient took Tylenol for headache and queasiness and his breathing issue went away last night after using the restroom, stretching, and using nasal spray. The patient underwent lab tests and procedures which included body temperature resulting going up and down from 99 to 100.8 on an unspecified date (a fever going up and down from 99 to 100.8), body temperature resulting 100.4 and 100.8 on 05Oct2021. outcome of the events problem breathing, and vomiting was recovered on and unspecified date in Oct2021, outcome of fever was not recovered, diarrhea and headache was recovering and rest all events outcome was unknown at the time of reporting. Follow-up attempts are completed. No further information is expected.

Other Meds: VITAMIN D [VITAMIN D NOS]; VITAMIN C [ASCORBIC ACID]; ZINC.

Current Illness:

ID: 1817358
Sex: F
Age:
State: TX

Vax Date: 09/17/2021
Onset Date: 09/26/2021
Rec V Date: 10/26/2021
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: lump underneath the arm pit; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0173; Expiration Date: 30Nov2021), via an unspecified route of administration in right arm on 17Sep2021 at 19:44 (at the age of 52 years old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have history of all previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive any additional vaccines on same date of the Pfizer suspect. She noticed early last week on 26Sep2021 a lump underneath the arm pit. She was aware from her doctors office it might be a side effect, she had a virtual visits on 14Sep2021 before getting the shot and was told that one of side effects that has been reported. She explained that prior to this, she remembered she had a small bump under her arm from her deodorant that comes and goes, it was a little lump in a certain location. It was noticed that he little lump she had before the shot disappeared or moved locations, to center of her arm pit. The lump from her deodorant was the size of a dime but the new one was the size of nickel. She was calling because she was supposed to take the second shot today and was wondering should she hold off on this second dose. The one, the lump, that was there previously, it went away about 3 days after the shot. Both lumps were in the opposite side the shot was given, in the left arm. She stated that her doctor told her that the lump was normal and was experienced by that person but went away. On 21Oct2021 she is to go to the doctor related to this. No family medical history relevant to adverse events was provided and no relevant tests were performed. The adverse event resulted in a visit to the physician office. The outcome of event was unknown. Follow-Up (12Oct2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1817359
Sex: U
Age:
State: UT

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
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: Lab test; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptom List: Rash, Urticaria

Symptoms: My eye sight kind of sort of dead; Seizures; tearing my left tendon; Nausea; Pain in ankle; This is a spontaneous report from a contactable consumer (patient). A 55-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: FE3592), via an unspecified route of administration, administered in Left arm on an unspecified date as dose 3, single for COVID-19 immunization. Medical history included asthma, where patient don't use the inhaler every day, and migraine from an unknown date and is Immunocompromised. Concomitant medications included oxcarbazepine; cefaclor; fluticasone; quetiapine fumarate (SEROQUEL) and amitriptyline hydrochloride (TRIPTA) all for an unspecified indication. Historical vaccine included first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date, as single dose for COVID-19 immunization and the patient experienced seizures and had a bad reaction/wicked reaction on an unspecified date after the second dose. On an unspecified date, after the third dose, patient had reaction, patient experienced nausea and had pain in the ankle, also was ended up in tearing of left tendon, which lead to calling of ambulance. Patient had taken all of ondansetron and Oxycodone 5 mg was used in the emergency room and was sent out with prescription too. Patient was given Geodon (off label use). Also reported, that patient had seizures. Patient had bunch of lab tests, where results were unknown. The events nausea, pain in the ankle, tearing of left tendon resulted in emergency room visit. The outcome of the event arthralgia was recovering, while of other events was unknown.

Other Meds: OXCARBAZEPINE; CEFACLOR; FLUTICASONE; SEROQUEL; TRIPTA

Current Illness:

ID: 1817360
Sex: F
Age:
State: GA

Vax Date: 10/09/2021
Onset Date: 10/10/2021
Rec V Date: 10/26/2021
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: I was having severe sharp pains on my left side my hip and my entire leg; I still got this pain; I was having severe sharp pains on my left side my hip and my entire leg; I still got this pain; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FD0810, Expiry Date, NDC number, UPC number: Unknown) via an unspecified route of administration, administered in Arm Left on 09Oct2021 at 11:50 (Age at Vaccination: 67 years-old) as DOSE 3, SINGLE for COVID-19 immunisation. When she was asked about NDC, UPC and Expiration date she stated it might be on the card, but she was not sure and the card was in her wallet and she cannot get to her wallet; asked to Hold on Please and then stated Okay so COVID vaccine 09Oct2021 and then FD0810. she did not see a booster number, but this said Pfizer for COVID-19 vaccination vial FD0810 (Further clarification unknown). Medical history included blood pressure from an unknown date and unknown if ongoing. Concomitant medication included was taking Blood Pressure Medicine (unspecified) from unknown date and for Blood Pressure. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration on 09Mar2021 (Batch/Lot Number: EN62O3) (Age at Vaccination: 66 years-old) as DOSE 1, SINGLE and dose 2 via an unspecified route of administration on 01Apr2021 (Batch/Lot Number: ER2613) (Age at Vaccination: 66 years-old) as DOSE 2, SINGLE both taken for COVID-19 immunisation. When patient was probed for lot number for second dose, she stated she only had one dose. No, she had both Pfizer COVID-19 shot, was that what they were asking. Okay the first number EN62O3 (Confirmed for first dose) the second dose was Pfizer CR she means ER2613. Patient stated that she was calling because she received the Pfizer booster shot yesterday which was the 9th at her local pharmacy at public and she woke up this morning, was having severe sharp pains on her left side her hip and entire leg; still got this pain (10Oct2021, this morning). When probed for the confirmation of vaccine name as COVID-19 booster vaccine and date for booster shot as 09Oct2021, she stated Yes and Correct. She was informed about the role of Pfizer Drug Safety, she questioned, was she a doctor or nurse and answered no she was not. For mailing address, telephone patient stated No, she did not have the address at hand and nor have the telephone. When it was probed for if she was still experiencing issue, she stated Yes; All she know was the reaction started at this point and right now she was using a cane, a cart to help her get up and move around, that was all, she had not received any treatment she had put some pain cream (Treatment) on it to try to lessen the pain in my hip and my leg, it was like a Spasm. Lastly the patient stated that she just wanted to report it because she was going to call her (call primary care) physician's office tomorrow if she still got this pain or if still having the side effect in morning. The patient had an X-ray. Outcome of events was unknown. No Investigation Assessment was there. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1817361
Sex: F
Age:
State: OH

Vax Date: 09/27/2021
Onset Date: 09/27/2021
Rec V Date: 10/26/2021
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: There was severe pain in the left arm for 48 hours; constant tingling in the left arm from the shot site down to my wrist; constant tingling in the left arm from the shot site down to my wrist; This is a spontaneous report from a contactable consumer reported for herself. A 59-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in Arm Left on 27Sep2021 13:45 (Batch/Lot Number: FF8839) (at the age of 59-years-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included Diabetes type 2 from an unknown date, neck surgery from 2007 to an unknown date. There were no known allergies. The patient did not get covid prior vaccination. The patient did not get other vaccine in four weeks. There were no other medications in two weeks. There were no concomitant medications. Historical vaccine included the patient received first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 27Jan2021 (Batch/Lot No: EL1283) (at the age of 58 years old) as dose 1 single for Covid-19 immunization; The patient received second dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 (Batch/Lot No: EN5318) (at the age of 58 years old) as dose 2 single for Covid-19 immunization. On 27Sep2021 02:00 PM, there was severe pain in the left arm for 48 hours. Afterwards she had constant tingling in the left arm from the shot site down to her wrist. The events resulted in Disability or permanent damage. There was no treatment received. The outcome of the events was not resolved. The patient did not get covid tested post vaccination.

Other Meds:

Current Illness:

ID: 1817362
Sex: F
Age:
State:

Vax Date: 10/07/2021
Onset Date: 10/01/2021
Rec V Date: 10/26/2021
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: allergic reaction; It just grew in my left arm, is red, swollen, and itchy, like contact dermatitis; It just grew in my left arm, is red, swollen, and itchy, like contact dermatitis; they started small and then grew up like a size of a golf ball, it's itchy and painful; It just grew in my left arm, is red, swollen, and itchy, like contact dermatitis; It just grew in my left arm, is red, swollen, and itchy, like contact dermatitis; red swollen and itchy like rash; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 07Oct2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. Medical history included allergies. A couple of months ago she was rushed to the emergency room after eating pine nuts. They gave her some medicines and she had to stay there for couple of hours and then she went home. The patient's concomitant medications were not reported. The patient stated she took the Pfizer covid vaccine, and had an allergic reaction in Oct2021. She stated she had red and swollen, red swollen and itchy like rash like contact dermatitis, clarifying "It just grew in my left arm, is red, swollen, and itchy, like contact dermatitis". She described it as putting your hands touching up plant and than they started small and then grew up like a size of a golf ball, it's itchy and painful, clarifying it just raised the swelling from the arm, 3 days later and was still itching. She stated that she took Benadryl last night (10Oct2021) but this morning (11Oct2021) three days later it was still itching. She also tried putting cold compressed arm. The patient stated she had an allergic reaction before and she stayed away from she was allergic to. She tried to stay away from things that aggravate her allergies. The outcome of the events was not recovered. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1817363
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
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: One who went to the doctor and was now diagnosed with Parkinson's; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer (patient's friend) reported that a patient of unspecified age and gender received BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient went to the doctor and was diagnosed with Parkinson's, all of a sudden on an unspecified date. Outcome of the event was unknown. No follow-up attempts possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1817364
Sex: F
Age:
State: IL

Vax Date: 03/04/2021
Onset Date: 03/01/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: blood work; Result Unstructured Data: Test Result:unknown results; Test Date: 2021; Test Name: stress test; Result Unstructured Data: Test Result:unknown results

Allergies:

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

Symptoms: her heart brain and breathing was all shutting down/Her brain hurt; unable to void; not being able to breathe; heart was racing; arthritis was inflamed; heart murmur; nightmares; dehydrated; her body was on fire; her heart brain and breathing was all shutting down; muscles were aching; she could not move her leg; her muscles and joints was all aching and inflamed, the pain was extreme, the inflammation was visible on her fingers; her muscles and joints was all aching and inflamed, the pain was extreme, the inflammation was visible on her fingers; severely sick; This is a spontaneous report from a contactable Nurse. A contactable nurse(patient) reported for herself that the 62-year-old female patient received bnt162b2 (BNT162B2) at the age of 62-year-old, dose 2 via an unspecified route of administration, administered in Arm Left on 04Mar2021 (Batch/Lot Number: EN6203) as dose 2, single for covid-19 immunisation. Medical history included rheumatoid arthritis, osteoarthritis. There were no concomitant medications. The patient previously took first dose of bnt162b2 (the Lot is Handwritten so she is unsure if it is EN9810 or CM9810. left arm both times) at the age of 62-year-old on 11Feb2021 for covid-19 immunization and it was weird, her brain felt weird and it was a pain wave going to the brain. The patient experienced her heart brain and breathing was all shutting down/her brain hurt on Mar2021 with outcome of unknown, unable to void on Mar2021 with outcome of not recovered, not being able to breathe on Mar2021 with outcome of unknown, heart was racing on Mar2021 with outcome of unknown, arthritis was inflamed on Mar2021 with outcome of unknown, heart murmur on Mar2021 with outcome of not recovered, nightmares on Mar2021 with outcome of unknown, dehydrated on Mar2021 with outcome of unknown, her body was on fire on Mar2021 with outcome of unknown, her heart brain and breathing was all shutting down on Mar2021 with outcome of unknown, muscles were aching on Mar2021 with outcome of unknown, she could not move her leg on Mar2021 with outcome of unknown, her muscles and joints was all aching and inflamed, the pain was extreme, the inflammation was visible on her fingers on Mar2021 with outcome of unknown, her muscles and joints was all aching and inflamed, the pain was extreme, the inflammation was visible on her fingers on Mar2021 with outcome of unknown , severely sick on Mar2021 with outcome of unknown. The patient underwent lab tests and procedures which included blood test: unknown results on 2021, cardiac stress test: unknown results on 2021. The clinical course was reported as follows: HCP is calling about getting the Pfizer covid BT vaccine Booster dose. She received her 1st Pfizer BT Covid vaccine on 11Feb2021 and her 2nd dose was on 04Mar2021. Following the 2nd dose, the caller became severely sick, not being able to breathe, heart was racing and her arthritis was inflamed. Are these normal side effects? and are the side effects long lasting because she has a heart murmur now. She stated something happened to her kidneys and she was unable to void. Should she get the third dose? "I pretty scared to get the booster dose because I was so sick after the 2nd dose, from my brain to my feet and toes every part of my body were shutting down." Caller states her Dr never reported anything to Pfizer when she was so very sick, he has been no help to me." She has a friend who was in the ER and her friend's Dr didn't want to take time to report her friend's side effects. Pt's mother has heart disease and she will not be getting vaccinated. As of 11Oct2021, report is related to a study or programme. The product is the Pfizer Covid Vaccine, she is calling in regards to being very sick after the 2nd dose, she thought she was dying. She was very anxious to begin with about getting the first dose but she got both doses. Since she was so severely sick after getting the 2nd dose, she is very scared to get the booster shot. Her doctor has no advice to give, agent states that she has made the caller aware that she cannot get medical advice. Caller states that she would like to speak to someone anyway. Agent provide the caller with the phone number to USMI. Caller confirms information provided by the transferring agent. Caller states to ask her anything as she used to be a nurse. She will answer with no hesitation, this is important for the future. First Dose: Date 11Feb2021, the Lot is Handwritten so she is unsure if it is EN9810 or CM9810. After the first dose she felt different after 1 hour, it was weird , her brain felt weird, it was like she was coming down with something but it was only effecting the brain, it was a pain wave going to the brain. This has Never happened before. It lasted, the weird feeling, lasted for a while but the pain went away, she could not concentrate, it all ended after 2 hours and she was fine after that. Second Dose: Date 04Mar2021 and Lot EN6203. She got the second dose in the afternoon, nothing at first, like how she experienced the wave with the first dose, nothing like that. She woke up at 3AM, thats when the nightmares started, she was dehydrated, her body was on fire, her heart brain and breathing was all shutting down, she couldn't breathe. Her muscles were aching so bad, she could not move her leg. She does have problems with arthritis in the hand since she is 63 years old but this was like the whole body her muscles and joints was all aching and inflamed, the pain was extreme, the inflammation was visible on her fingers, it's a nightmare she will never forget. When she was trying to get up she could not, her brain, she couldn't even lift her head. Her brain hurt, her heart was racing, there was nothing pulmonary, but she felt the breathing issues were related to the heart. Caller states that she has a withheld of medication, caller made this statement when obtaining her covid vaccine card. HCP: Declined, she does not want to provide all types of information. Caller was probed for what is ongoing today, caller states that she has to slow down, she will call back with deeper information, she wanted to take some test in the future to compare. Caller states that she has had a lot of test done since the vaccine, she had a stress test,blood work. She wants to compare it. She does know what happen to her kidney but she couldn't urinate, and that's never happened before. Her heart is still getting murmurs, sometimes she has a different feeling when just like when she couldn't breathe. She knows she got the vaccine on the left arm both times because she took a picture. Investigation: Caller states that nobody listens to her, the doctors dont listen to her. Caller states that we all have to live with this virus going forward. Caller has no results to share from her tests.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Brain injury, Urinary retention and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1817365
Sex: F
Age:
State: IL

Vax Date: 10/07/2021
Onset Date: 10/01/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: already had the nerve damage in her legs to begin with and after the stroke and now believes the shot has aggravated it, the nerves in the left side; high blood pressure/ blood pressure went up to 218/110; high fever; very bad headache; a lot of muscle and joint aching; a lot of muscle and joint aching; cold chills; still has a little tremors in her hands/ tremors are in her left hands and leg; already had the nerve damage in her legs to begin with and after the stroke and now believes the shot has aggravated it, the nerves in the left side; already had the nerve damage in her legs to begin with and after the stroke and now believes the shot has aggravated it, the nerves in the left side; she was very sick for a day or so.; This is a spontaneous report from a contactable consumer (patient) who reported for herself. The 73-year-old female patient received bnt162b2 (BNT162B2) at the age of 73-year-old, dose 1 via an unspecified route of administration, administered in Arm Right on 07Oct2021 11:00 (Batch/Lot Number: EW0217) as dose 1, single for covid-19 immunisation. Medical history included stroke, hypertension, migraine, spinal stenosis, nerve injury and she did have an allergic reaction to a certain vaccine in the past, Penicillin vaccine. Family Medical History was none. Concomitant medications were received. The patient experienced high blood pressure/ blood pressure went up to 218/110 on 07Oct2021 with outcome of recovering, already had the nerve damage in her legs to begin with and after the stroke and now believes the shot has aggravated it, the nerves in the left side on Oct2021 with outcome of unknown, she was very sick for a day or so on Oct2021 with outcome of recovered, high fever on 07Oct2021 with outcome of recovering, very bad headache on 07Oct2021 with outcome of recovering, a lot of muscle and joint aching on 07Oct2021 with outcome of recovering, a lot of muscle and joint aching on 07Oct2021 with outcome of recovering, cold chills on 07Oct2021 with outcome of recovering, still has a little tremors in her hands/ tremors are in her left hands and leg on 07Oct2021 with outcome of not recovered , already had the nerve damage in her legs to begin with and after the stroke and now believes the shot has aggravated it, the nerves in the left side on an unspecified date with outcome of unknown. The clinical course was reported as follows: Caller reports receiving her first dose of the Pfizer BioNtech covid 19 vaccine on 07Oct2021. She experienced side effects of high fever, high blood pressure, very bad headache, a lot of muscle and joint aching, and cold chills. She sought treatment at the ER. caller states that the vaccine did a number on her and she was very sick for a day or so. Caller also reports history of stroke, migraines, and spinal stenosis. Seeking recommendations based on the side effects she experienced if she should get a second dose of the vaccine? Upon follow-up on 11Oct2021, the report is not related to a study or program. Caller reports she had to go to the emergency room after receiving the Pfizer Covid shot and she is calling to report this side effects/adverse event. States she had a really high fever, her blood pressure went up to 218/110, really cold chills, a very, very bad headache, muscle and joints aching a lot. They all started around 8pm on 07Oct2021. They have improved and are slowly going away, but she still has a little tremors in her hands. States she had a stroke some time ago and she believes it affected her left side. The tremors are in her left hands and leg. She already had the nerve damage in her legs to begin with and after the stroke and now believes the shot has aggravated it, the nerves in the left side. Clarifies she stroke and nerve damage were prior to the shot, before she got it. No further details provided. Went to the emergency room on the 07Oct2021 and they kept her overnight and she was discharged on 08Oct2021 at 8am in the morning. Was not hospitalized. No further details provided. Received the first Covid shot dose on 07Oct2021. Unable to provide the NDC, expiry, or dose/strength. No other vaccines given the same day or 4 weeks prior. States she did have an allergic reaction to a certain vaccine in the past, Penicillin vaccine. Is on medications since she had the stroke and hypertension and for migraine headaches. No further details provided. Wondered since she had a reaction to the first vaccine dose is it still necessary for her to get the second dose. Vaccination Facility Type was physician Office. No Vaccine Administered at Facility. History of all previous immunization 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. The events really high fever, blood pressure went up to 218/110, really cold chills, muscle and joint aches, really bad headache, still has a little tremors in her hands; tremors are in her left hands and leg required a visit to Emergency Room not to physician Office. Prior Vaccinations (within 4 weeks) was none. Relevant Tests was unknown.

Other Meds:

Current Illness:

ID: 1817366
Sex: F
Age:
State: TX

Vax Date: 04/19/2021
Onset Date: 04/01/2021
Rec V Date: 10/26/2021
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: Severe allergic reaction; Itchiness; Right arm was painful; Felt tired; Itchiness which was bumpy on her back; Almost like shingles; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program, Support. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration on 19Apr2021 (lot number: EW0169; expiration date: 31Aug2021) as dose 1, single for COVID-19 immunization. Medical history included allergy to and penicillin COVID-19 infection from Jan2019 (as reported). The patient's concomitant medications were not reported. In Apr2021 (between 6 to 9 days after the vaccination), the patient experienced itchiness which she described was "bumpy" on her back and "almost like shingles". The patient also felt tired and her right arm was painful. Due to this severe allergic reaction, she has not had the second dose of COVID vaccine yet. The patient is a flight attendant and her job was forcing her to be vaccinated, she was wondering if she can taken the vaccine because she had a severe reaction. The patient was also considering of getting vaccine from another company and wonder if its allowed. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1817367
Sex: F
Age:
State: CA

Vax Date: 09/24/2021
Onset Date: 09/24/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: Test Date: 20210930; Test Name: Rapid Covid test Nasal Swab; Test Result: Negative

Allergies:

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

Symptoms: Numbness in tongue, lips; Numbness in arms, legs and feet; heart palpitations; chest pressure; hard to swallow; double vision; This is a spontaneous report from a contactable other hcp (patient). This 29-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 24Sep2021 18:15 (Lot Number: FC3184) at age of 29-years-old as dose 2, single for COVID-19 immunization. Medical history included COVID-19 (If COVID prior vaccination: Yes). There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0217), on 28Aug2021 09:00 AM at age of 29-years-old in Left arm for COVID-19 immunization, sumatriptan and experienced known allergies: Sumatriptan, topiramate and experienced known allergies: Topiramate, norco and experienced known allergies: Norco, metoclopramide hydrochloride (REGLAN) and experienced known allergies: Reglan. No other vaccine in four weeks. No other medications in two weeks. The patient experienced Numbness in tongue, lips, arms, legs and feet, Heart palpitations, Chest pressure, Hard to swallow, Double vision on 24Sep2021 18:45. The events resulted in Emergency room/department or urgent care. Treatment received for the events included IV fluids, Ativan, Steroid medication and Benadryl. The patient underwent lab tests and procedures which included Rapid Covid test Nasal Swab: negative on 30Sep2021. The outcome of the events was Recovered with Sequel in 2021.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Hypoaesthesia oral, Hypoaesthesia Palpitation, Chest discomfort, Dysphagia, Diplopia and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1817368
Sex: F
Age:
State: OH

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

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

Lab Data:

Allergies:

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

Symptoms: diagnosed with myasthenia gravis; This is a spontaneous report from a contactable consumer reported for a female patient in her 80s that who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. Caller stated the person that also was diagnosed with myasthenia gravis was a friend of her cousin and her cousin went home to pick up the cousin's medications and met someone who worked with her and was telling the caller that it was really odd that this friend or her friend's sister came down four weeks ago and had her two vaccines and her age was in the low 80s and she did not know what vaccine this lady received but thought it was the Pfizer COVID vaccine but stated she has no other patient information and has no lots, expiry dates or NDC numbers for this patient's vaccine and did not know this person but the person is a friend of her cousin's. Stated the patient was diagnosed 4 weeks ago in Sep2021. Outcome of the event was unknown. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1817369
Sex: M
Age:
State: NY

Vax Date: 05/21/2021
Onset Date: 10/11/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Rigors; Hives; Rash; This is a spontaneous report from a contactable nurse via a sales representative. This nurse reported for a 55-year-old male patient that who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization; started to receive immunoglobulin human normal (PANZYGA) via an unspecified route administration, from 21May2021 at unknown dose and frequency, then on 11Oct2021 at 08:45 am (lot number: L043A8251) at 10 g, for an unspecified indication. Medical history included CIDP. Concomitant medications were not reported. The patient previously received first single dose of BNT162B2 on an unspecified date for COVID-19 immunization. It was reported that patient had been receiving PANZYGA since 21May2021. Patient did not have any allergies to other IVIGs and had received other brands in the past. Patient received dosage this morning, 11Oct2021, approximately 08:45 am. Had a reaction, with rigors, hives and rash. It was at the tai end of his infusion (-95%). He was instructed to administer his epi-pen and then when RN got back to his home he was sent to Emergency Department via ambulance at 12:00 and discharged home at 14:30. The action taken to the events for immunoglobulin human normal was unknown. Outcome of the events was unknown. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available,The casual association between the reported event "Chills, Urticaria and Rash" and suspected vaccine BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: PANZYGA

Current Illness:

ID: 1817370
Sex: M
Age:
State: UT

Vax Date: 09/02/2021
Onset Date: 09/18/2021
Rec V Date: 10/26/2021
Hospital: Y

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

Lab Data: Test Name: blood work; Result Unstructured Data: Test Result:unknown results; Test Name: CT scan; Result Unstructured Data: Test Result:unknown results; Test Name: MRI; Result Unstructured Data: Test Result:unknown results

Allergies:

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

Symptoms: Stroke; Blood clot; currently is not communicating; may never walk again or have a life; This is a spontaneous report from a contactable consumer (parent). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), vaccinated at 35 years old, dose 1 via an unspecified route of administration, administered in Arm Left on 02Sep2021 as DOSE 1, SINGLE for covid-19 immunisation. There were no medical history and concomitant medications. No other vaccination (4 weeks prior). Patient currently was not communicating. Patient might never walk again or have a life because of the Pfizer vaccine. Patient after receiving the Pfizer vaccine suffered a stroke; he got a blood clot and 'separated' stroke (further not clarified) on September the 18th after receiving the vaccine. Patient was 'night ridden' to an ICU so there has been MRI's, CT scan, blood work with unknown results, but prior to the vaccine no." On 18Sep2021, patient was hospitalization, that's when he had the stroke. The patient was hospitalized for stroke and blood clot from 18Sep2021. The outcomes of events were unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1817371
Sex: M
Age:
State: TX

Vax Date: 03/02/2021
Onset Date: 09/20/2021
Rec V Date: 10/26/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: diagnosed with Guillain-Barre Syndrome; This is a spontaneous report from a contactable consumer (patient). A 55 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose, via an unspecified route of administration on 02Mar2021 (Batch/Lot Number: ENN6202) (age at vaccination was 54 years old) as dose 2, single for covid-19 immunisation. Medical history included Chrohns, heart disease (2 stints following heart attack), covid-19 (Prior to vaccination). Concomitant medications included infliximab (REMICAID); fluticasone propionate (FLONASE); atorvastatin; colecalciferol (VITAMINE D); clarithromycin (CLARITAB). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL9269) on 02Feb2021 (age at vaccination was 54 years old) for covid-19 immunisation, Ceftriaxone Sodium, Tazobactam Sodium (BACTRUM T) and experienced allergy. There was no other vaccine in four weeks. The patient was diagnosed with guillain-barre syndrome on 20Sep2021. Event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was hospitalized for guillain-barre syndrome for 12 days. Treatment IVIG was received. The outcome of the event was unknown. Since the vaccination, the patient had not been tested for COVID-19.

Other Meds: REMICAID; FLONASE [FLUTICASONE PROPIONATE]; ATORVASTATIN; VITAMINE D; CLARITAB

Current Illness:

ID: 1817372
Sex: F
Age:
State:

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

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

Lab Data: Test Date: 202110; Test Name: diagnosed with Covid-19; Test Result: Positive

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: diagnosed with Covid-19 last week; diagnosed with Covid-19 last week; super tired; This is a spontaneous report from a contactable nurse. This Nurse (patient's grandmother) reported for a 14-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. HCP also states that her 14 years old granddaughter received the Pfizer Covid-19 vaccine and was super tired and diagnosed with Covid-19 last week on Oct2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Oct2021. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: The possibility of occurrence of COVID -19 and Drug Ineffective cannot be ruled out. The response to the vaccine can vary from one person to another and hence the occurrence of the event post vaccination cannot be completely ruled out.

Other Meds:

Current Illness:

ID: 1817373
Sex: F
Age:
State: PA

Vax Date: 10/08/2021
Onset Date: 10/08/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: Test Date: 20211009; Test Name: body temperature; Result Unstructured Data: Test Result:102.3; Test Date: 20211009; Test Name: Rapid test; Test Result: Negative; Comments: Nasal Swab.

Allergies:

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

Symptoms: Very weak; Arm at injection site is swollen, red and painful; Arm at injection site is swollen, red and painful; Arm at injection site is swollen, red and painful; Vomiting; Very intense headache; Cold chills; Hot sweat; Extremely dizzy when standing; Fever of 102.3; off label use; booster; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received bnt162b2 (Pfizer COVID 19), dose 3 via an unspecified route of administration, administered in left arm on 08Oct2021 12:45 (Batch/Lot number was not reported) as dose 3 (booster), single at the age of 42 years old for COVID-19 immunization. Medical history included fibromyalgia, rheumatoid arthritis, hypothyroidism, covid-19 in Mar2020, stroke in Mar2020, allergy to sylfa drugs. Concomitant medication included gabapentin within 2 weeks of vaccination. The patient previously dermoral and bactrim, both experienced allergy. Historic vaccine was bnt162b2 dose 1 administered in left arm on 04Mar2021 (lot En6199); dose 2 administered in left arm on 25Mar2021 (lot Ep7534), both as a single dose at the age of 42 years old for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Oct2021 06:00, very intense headache, felt like a jackhammer going through head, cold chills, hot sweat, extremely dizzy when standing, fever of 102.3, vomiting, day 3 on 11Oct2021 finally able to keep food down still very weak and dizzy, arm at injection site was swollen.red..and painful. Had covid rapid test and it was negative, (had covid and a stroke in march of 2020, sever on vent for 2 weeks and hospital for 2 months). Event resulted in emergency room/department. Treatment received which included Iv zofran. The patient underwent lab tests and procedures which included body temperature: 102.3 on 09Oct2021, Nasal Swab Rapid test: negative on 09Oct2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovering. The lot number for bnt162b2, was not provided and will be requested during follow up.

Other Meds: GABAPENTIN.

Current Illness:

ID: 1817374
Sex: F
Age:
State: TX

Vax Date: 09/27/2021
Onset Date:
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Blood work; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210927; Test Name: covid test PCR; Test Result: Negative; Comments: Nasal Swab.

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Heart burn; Abdominal pain; This is a spontaneous report from a contactable consumer (patient). A 17-year-old non- pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration at age of 17 years on 27Sep2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. No covid prior vaccination. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at age of 17 years on 09Sep2021 for COVID-19 Immunization. The patient experienced heart burn, abdominal pain, and more (as reported) in 2021. The events resulted in emergency room/department or urgent care and received treatment of antibiotics, blood work, pain medicine (in 2021). Covid test post vaccination was PCR via nasal swab on 27Sep2021 and negative. The outcome of the events was unknown. The lot number for BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1817375
Sex: F
Age:
State: KY

Vax Date: 02/06/2021
Onset Date: 02/23/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: Test Date: 20210524; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210618; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210816; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: pneumonia; This is a spontaneous report from a contactable consumer (patient). A 71-years-old non-pregnant female patient received first dose of BNT162B2, via an unspecified route of administration at the age of 71-years-old on 06Feb2021 (Lot Number: EL 9269; Expiration Date: 31May2021) as single dose for covid-19 immunisation. Medical history included diabetes II, arthritis, gastroparesis, hypertension, hyperlipidemia, post hero neur, recent ILD and St 3 CKD. Concomitant medications included nabumetone; VIT D; fexofenadine hydrochloride (ALLEGRA); dexlansoprazole (DEXILANT); allopurinol. The patient first diagnosed with pneumonia 23Feb2021 (subsequent multiple times). Adverse event resulted in doctor or other healthcare professional office/clinic visit and treatment with antibiotic. Covid test post vaccination: covid test type post vaccination(Nasal Swab) on 24May2021, on 18Jun2021 and on 16Aug2021: negative. The outcome of the events was not recovered.

Other Meds: NABUMETONE; VIT D [VITAMIN D NOS]; ALLEGRA; DEXILANT; ALLOPURINOL

Current Illness:

ID: 1817376
Sex: F
Age:
State: OH

Vax Date: 03/15/2021
Onset Date:
Rec V Date: 10/26/2021
Hospital: Y

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

Lab Data: Test Name: blood tests; Result Unstructured Data: Test Result:Unknown RESULTS; Test Name: Height; Result Unstructured Data: Test Result:5'1'' or 5'2''; Comments: Caller states she is shrinking and her height is now 5'1'' or 5'2''

Allergies:

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

Symptoms: diagnosed with myasthenia gravis; could not breathe; eye started closing halfway;had an eye problem; she is shrinking and her height is now 5'1'' or 5'2''.; tumor; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received bnt162b2 (BNT162B2), first dose via an unspecified route of administration at the age of 76-years-old on 22Feb2021 (Lot Number: EN6198) as single dose, second dose via an unspecified route of administration, administered in right arm at the age of 76-years-old on 15Mar2021 10:50 (Lot Number: EN6204) as single dose for covid-19 immunisation. Medical history included blood pressure and cholesterol (had been on the same medications for years and takes one blood pressure pill at a low dosage of 20mg and takes cholesterol medication and takes 20mg of that and those are her only prescription medications). Concomitant medication included vitamin d. She stated the next doctor took one look and said yes it was myasthenia gravis and told her if she has trouble breathing to go to the emergency room immediately; stated that next Sunday night she thought she was going to die and could not breathe and drove to the emergency room and she was admitted to the hospital for 10 days and they did five plasma exchanges. She stated she thought this came on all of a sudden but thought about it and was noticing little things and she was extremely healthy and does not have any problems and has no heart issues or diabetes or anything and noticed maybe she would breathe a little heavier when she was doing something and started having incontinence which she had never had before and the incontinence is not all the time and is very subtle and would come and go and the more she thought about it later she now realized that this may be working on her longer than she realized. Caller stated she was shrinking and her height was now 5'1'' or 5'2''; stated the listed HCP was her regular doctor and she sees another doctor for this condition and her primary care doctor was not really involved in this diagnosis or anything; states she was diagnosed by withheld and her eye started closing halfway and thought she had an eye problem and went to an eye doctor and saw three different eye doctors in 4 days and they thought it was her retina and the retina surgeon took a look and said there is nothing wrong with her eyes they were perfect and was thinking it was myasthenia gravis and sent her for emergency blood tests and she saw another HCP; she stated the next doctor took one look and said yes it is myasthenia gravis and told her if she has trouble breathing to go to the emergency room immediately; stated that next Sunday night she thought she was going to die and could not breathe and drove to the emergency room and she was admitted to the hospital for 10 days and they did five plasma exchanges. Caller stated she had been home all week and is going tomorrow to visit the surgeon and they think it was her sinus and she has a tumor and they think that is what is causing her eyes to not open right and she was hoping they will take that out. Caller stated they admitted her to the hospital and she saw a neurologist also and states for the breathing it is slightly a little bit better and she was on another medication and on about three different medications; no further details provided by the caller. She stated her eyes were open yesterday and she really couldn't control it and they pop open and go shut and she couldn't drive and can not be by herself at this time. She stated she thought this came on all of a sudden but thought about it and was noticing little things and she was extremely healthy and does not have any problems and has no heart issues or diabetes or anything and noticed maybe she would breathe a little heavier when she was doing something and started having incontinence which she had never had before and the incontinence is not all the time and is very subtle and would come and go and the more she thought about it later she now realized that this may be working on her longer than she realized. The events required a visit to emergency room and physician office. The patient was hospitalized for the events from 20Sep2021 to 30Sep2021. The outcome of the event dyspnoea was recovering; of the other events was unknown. Follow-up (13Oct2021): Follow-up attempts are completed. No further information is expected.

Other Meds: VITAMIN D [VITAMIN D NOS]

Current Illness:

ID: 1817377
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: Test Name: fever; Result Unstructured Data: Test Result:fever; Test Name: COVID-19 test; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptom List: Nausea

Symptoms: Now it feels like pneumonia; Fatigue; Then extremely ill with fever; Fever; Chills for a couple of weeks; I am having a lot of wheezing over a month later; This is a spontaneous report from a non-contactable other hcp (patient). A 39-year-old female patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), at the age of 39 years old, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's medical history and concomitant medications were not reported. The patient did not receive other vaccine in four weeks of vaccination. Fatigue the day after, and then extremely ill with fever, and chills for a couple of weeks. Now it felt like pneumonia, and patient was having a lot of wheezing over a month later. Events resulted in emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown results, fever. No treatment received. Outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event Pneumonia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

Other Meds:

Current Illness:

ID: 1817378
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
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: Has scheduled epidural with steroids for bad back; Little sore arm for a day or two; This is a spontaneous report from a contactable physician received from a Pfizer sponsored program. A 76-year-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown) on an unspecified date and the first dose of BNT162B2 (lot number: unknown) on an unspecified date, both via an unspecified route of administration at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had received both doses of BNT162B2 and was due for a booster shot. The patient also had an epidural with steroids scheduled and the caller was asking if they need to postpone her booster. Caller came onto the line and verified information received from the transferring agent. Stated the epidural was for the patient's very bad back and it won't get postponed. Caller stated that the patient had all kinds of other problems. Stated her epidural was for next week. Caller stated that his gut told him they ought to postpone the booster shot. He was questioning if they should or should not and asked if there any information on how long it can be postponed for. Caller stated that he doesn't want to do the whole report thing. Stated there was nothing wrong with the patient involving the previous 2 vaccines. Stated the patient just had a little sore arm for a day or two, nothing unexpected. Caller stated that if she got the epidural and then the booster and anything occurred he would be willing to provide more information. Caller then stated he felt the vaccine was a grand experiment. He then discussed his own experiences and declined to complete a safety report for himself. Outcome of events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, the causal relationship between the event Back disorder and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1817379
Sex: F
Age:
State: FL

Vax Date: 08/23/2021
Onset Date:
Rec V Date: 10/26/2021
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: This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EC31W1 and expiration date: not reported), via an unspecified route of administration, in Right Arm, on 23Aug2021, as DOSE 1, SINGLE for covid-19 immunization. Medical history included breast cancer and lymph node removed 10 years ago when patient had breast cancer. The patient experienced headache and regular symptoms after words the entire forearm pain on an unspecified date. By the 3rd day afterword patient was fine. The outcome of the events was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1817380
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
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: Rheumatoid arthritis flare up; This is a solicited report (FACILITATED COLLECT) based on information received by Pfizer from Regulatory Authority (manufacturer control number: 21K-163-4111476-00).A contactable consumer (patient) reported for herself. Solicited report from a consumer of an adult female with an event of non-serious Rheumatoid Arthritis flare up with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced Rheumatoid Arthritis flare up. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. The patient received 1st dose Covid-19 Vaccine manufactured by Pfizer via intramuscular on an unspecified date at single dose for COVID-immunization. The outcome of event was not recovered. Causality between event Rheumatoid Arthritis flare up and bnt162b2 per reporter was possible. Causality between event Rheumatoid Arthritis flare up and Adalimumab per reporter was not reported. No follow-up attempts possible, information about batch number cannot be obtained. No further information expected.; Sender's Comments: Based on possible dose- event relationship post-vaccination the causal role of BNT162B2 vaccine cannot be excluded for the reported event.. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

Other Meds: HUMIRA

Current Illness:

ID: 1817381
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
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: feeling clouded; Rash; Not feel well; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A patient of unspecified age and gender received bnt162b2, via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient have now broken out with a rash as well so not feel well. If this gets worse patient will go to ER. As patient was also feeling clouded and not clear headed. The outcome of events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1817382
Sex: F
Age:
State: AZ

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

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

Lab Data: Test Date: 2021; Test Name: Body temperature; Result Unstructured Data: Test Result: 103 Fahrenheit; Comments: It sat for days at 103 F.

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: week later still hurt like being run over by a truck; Off label use; booster; Fever; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date in Oct2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historically the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on unspecified dates as 1st dose and 2nd dose both for covid-19 immunisation. On an unspecified date in Oct2021, the patient experienced week later still hurt like being run over by a truck. On an unspecified date in 2021, the patient experienced fever. It was reported that the patient received the booster last Monday and a week later still hurt like being run over by a truck. Her fever finally broke overnight, thankfully. It sat for days at 103 F. Her question was that with the first two shots she received messages asking how she was doing, her side effects, etc. She would like to know if Pfizer was doing this for the booster also. She would like to report on her side effects because it was one of the worst things she had ever dealt with in her lifetime. On an unspecified date in 2021, the patient underwent lab tests and procedures which included body temperature: 103 fahrenheit (It sat for days at 103 F). The outcome of the events week later still hurt like being run over by a truck was not recovered. The outcome of the event fever was recovered on an unspecified date in 2021. The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1817384
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
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: knuckle pain in left hand; Rheumatoid arthritis flare up; feeling bad; Limbs stiffness/left hand stiff; This is a Solicited report from a contactable consumer (patient) based on the information received by Pfizer from Regulatory Authority (Manufacturer Control No: 21K-163-4111174-00). A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 1 and dose 2; both intramuscularly in 2021 as single dose for covid-19 immunisation; upadacitinib (RINVOQ), from an unspecified date to 2021, then from 2021 to 2021; both orally at unspecified dose for moderate to severe rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. The patient experienced rheumatoid arthritis flare up, feeling bad, and limbs stiffness in 2021, knuckle pain in left hand on an unspecified date. The case was serious per medically significant. Events details: Four months ago in Jun2021, the patient had a knuckle replacement surgery in left hand due to knuckle pain. The physician had advised her to stop upadacitinib for a week in order to evaluate how she did without upadacitinib. It was horrible after three days with her left hand stiff, but she no longer had the pain. She had a terrible feeling with rheumatoid arthritis flare ups with every single symptom after receiving the covid vaccine. She had stopped upadacitinib two days prior to the second injection. The action taken in response to the events for upadacitinib was unknown. The outcome of event knucle pain in left hand was resolved, outcome of other events was unknown. Causality for upadacitinib: The reporter's causality for the event of knuckle pain in left hand with upadacitinib was a reasonable possibility. The reporter's causality for the events of feeling bad, limbs stiffness and rheumatoid arthritis flare up was not provided. Regulatory Authority opinion is that there is no reasonable possibility that the events of knuckle pain in left hand, feeling bad, limbs stiffness and rheumatoid arthritis flare up are related to upadacitinib. The reporter's assessment of the causal relationship of the events with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of knuckle pain in left hand, feeling bad, limbs stiffness and rheumatoid arthritis flare up.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

Other Meds: RINVOQ

Current Illness:

ID: 1817385
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
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: Headaches whenever she's around someone who is fully vaccinated; This is a spontaneous report from contactable consumer (patient) via a Pfizer sponsored Program Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patients medical history and concomitant medications were not reported. The patient experienced headaches whenever she was around someone who was fully vaccinated. The outcome of event was unknown. Follow-up attempts were completed. Information about lot/batch number cannot be obtained. No further information was expected.

Other Meds:

Current Illness:

ID: 1817386
Sex: M
Age:
State:

Vax Date:
Onset Date: 05/11/2021
Rec V Date: 10/26/2021
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: irritation at covid Vaccination site; Fatigue; Chronic obstructive pulmonary disease; motor vehicle accident; Back pain; received 3rd dose covid-19 vaccine; received 3rd dose covid-19 vaccine; artery in one leg was pinched; cracked vertebrae; This is a solicited report from a program based on information received by Pfizer from AbbVie, (MFR Control No. 21K-163-4109576-00). A contactable 59-year male consumer (patient) reported for himself that: Solicited report by a consumer of a 59 year old male with events of artery in one leg was pinched and non-serious irritation at covid vaccination site, cracked vertebrae, fatigue, chronic obstructive pulmonary disease, motor vehicle accident and back pain with Humira (adalimumab). there was no reported medical history. On unknown dates, the patient experienced irritation at covid vaccination site, fatigue and chronic obstructive pulmonary disease. In 2021, the patient experienced artery in one leg was pinched, cracked vertebrae and back pain. on 11May2021, the patient experienced motor vehicle accident. on unknown dates, irritation at covid vaccination site and fatigue resolved. Pfizer BioNTech covid-19 vaccine (tozinameran) was also considered suspect. On 11May2021, the patient had motor vehicle accident and an artery was pinched and had undergone surgery to place stent in that artery. he also had cracked vertebrae in the accident and had back pain. he had chronic obstructive pulmonary disease. he had irritation and fatigue after third dose of Pfizer vaccination. it was unknown if patient was enrolled in a covid-19 vaccine trial. on unknown date, patient received 1st dose covid-19 vaccine manufactured by Pfizer. on unknown date, patient received 2nd dose covid-19 vaccine manufactured by Pfizer. on unknown date, patient received 3rd dose covid-19 vaccine manufactured by Pfizer. Primary reporter did not have the lot number information, because the information was not accessible to the physician at his/her clinical setting. Causality for Humira (adalimumab): The reporter's causality for the event(s) of artery in one leg was pinched, irritation at covid vaccination site, cracked vertebrae, fatigue and back pain with Humira (adalimumab) was no reasonable possibility. the reporter's causality for the event(s) of chronic obstructive pulmonary disease and motor vehicle accident was not provided. AbbVie's opinion is that there is no reasonable possibility that the events of artery in one leg was pinched, irritation at covid vaccination site, cracked vertebrae, fatigue, chronic obstructive pulmonary disease, motor vehicle accident and back pain are related to Humira (adalimumab). The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the events of artery in one leg was pinched and cracked vertebrae.

Other Meds: HUMIRA

Current Illness:

ID: 1817387
Sex: F
Age:
State:

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

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

Lab Data: Test Date: 2021; Test Name: COVID TEST; Test Result: Positive

Allergies:

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

Symptoms: tested positive for Covid; tested positive for Covid; This is a Solicited report based on information received by Pfizer from (Manufacturer Control Number#: 21K-163-4111738-00). A contactable consumer (patient) reported that a 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 in Mar2021 and dose 1 in Feb2021 (Batch/Lot number was not reported), both via intramuscular as single dose for COVID-19 immunisation; adalimumab (HUMIRA) subcutaneous from an unspecified date at unspecified dose for hidradenitis. The patient medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In 2021, the patient experienced tested positive for Covid. The action taken in response to the event for adalimumab was unknown. The outcome of event was not recovered. The reporter's causality for the event of tested positive for Covid with adalimumab was not provided. The reporter's causality for the event of tested positive for Covid with bnt162b2 was not provided The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Drug ineffective and COVID-19 and BNT162B2.

Other Meds:

Current Illness:

ID: 1817388
Sex: F
Age:
State: MA

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
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: Facial paralysis; Rash; Blisters; Pimples; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: Unknown, Expiration date: Unknown), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced adverse effects from the vaccine which included facial paralysis, rash, blisters and pimples on an unspecified date. The patient went to get a second dose but they didn't want the liability and said no (dose might be missed) and still experiencing the side effects from the first shot. The patient wasn't able to get the second shot. They felt that they didn't got the satisfactory results when reported to nurse. They also spoke with a nurse at the Pfizer and reached out to them to see if they could help to get an appointment for them. The patient wanted to know if the Pfizer can connect them to somebody regarding this issue who can help her. The outcome of all these events was not recovered at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1817389
Sex: F
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
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: convulsions; Tremor/ shakiness; crippled hands; tightness in the mid-section; a foggy head; wheelchair bound; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer sponsored Program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 2021, as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced convulsions, tremors, shakiness, crippled hands, tightness in the mid-section, a foggy head, and was wheelchair bound. The outcome of the events was unknown at time of report. The patient stated that events directly related to her vaccination No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1817390
Sex: F
Age:
State: MO

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: Test Name: mammogram; Result Unstructured Data: Test Result:rash; Comments: had a rash with both doses

Allergies:

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

Symptoms: she had a rash; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) dose 1 and dose 2 (lot number, expiration date was not reported); both via an unspecified route of administration, on an unspecified date for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had a rash on an unspecified date after both doses of vaccination. The patient underwent lab tests and procedures which included mammogram appointment and the imaging technician informed that she had a rash with both doses. The patient was still intended to get a booster dose. Therapeutic measures taken included Benadryl. The outcome of the events was recovered on an unspecified date in 2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1817391
Sex: M
Age:
State: MI

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Antibody test; Result Unstructured Data: Test Result:he had Covid four months ago after the second shot; Comments: he went to get an antibody and was told that he had Covid four months ago after the second shot.

Allergies:

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

Symptoms: Chicken cooked a certain way does not taste right; was told that he had Covid four months ago after the second shot; was told that he had Covid four months ago after the second shot; This is a spontaneous report from a contactable nurse (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 (lot number was not reported) as single dose, dose 2 via an unspecified route of administration in 2021 (Lot Number: EWO175) as single dose, both at the age of 62-year-old for covid-19 immunization. There were no medical history and concomitant medications. It was reported that on an unspecified date in 2021, the patient went to get an antibody and was told that he had Covid four months ago after the second shot. The patient reported that in Jul2021, chicken cooked a certain way did not taste right. Stated that if it was broiled that he could taste it. Stated that he ate different vegetables. Stated that he is a homecare nurse for his better half who has cancer. Stated that they were into smoothies and eating good. Stated that he had not had smoothies in 3 months because he had not had the desire. Stated that he was back into the habit of eating bananas, grapes and strawberries. This was after the second shot. Stated that he tells himself every morning that he would make a smoothie but he did not had desire. Stated that when he gets hard he gets hard. Outcome of the event covid was recovered in 2021; did not taste was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on possible dose- event relationship post-vaccination the causal role of BNT162B2 vaccine cannot be excluded for the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

Other Meds:

Current Illness:

ID: 1817392
Sex: M
Age:
State: FL

Vax Date: 08/02/2021
Onset Date:
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: it obviously effected my brain system and causing damages and symptoms and stuff which obviously resulting in me not perform in a regular basis,; sleep disorder; breathing thing; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 02Aug2021 (pending clarification) (Lot Number: FA7485) as single dose for covid-19 immunisation at the age of 44-year-old. There were no medical history and concomitant medications. Patient didn't have other medical condition other than Pfizer vaccine have given him. Patient got some side effect through the COVID vaccine shot from Pfizer and very serious side effect to the point when he first got the vaccine. He had a sleep disorder from taking 1st vaccine in 2021. He never had sleeping problem before and he never had any issue before with breathing thing and ever since I took the vaccine 1 and 2, he had been having all of these problems and health issues in 2021. He had never had issues with any of this with sleeping pattern with having a weird motion it obviously effected his brain system and causing damages and symptoms and stuff which obviously resulting in him not perform in a regular basis in 2021, need someone to contact him right away this was going on for a week. Outcome of events was unknown. Follow-Up (25Oct2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101358597 same reporter/patient/product, different dose/event.

Other Meds:

Current Illness:

ID: 1817393
Sex: F
Age:
State:

Vax Date: 05/07/2021
Onset Date: 07/09/2021
Rec V Date: 10/26/2021
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: low blood counts; muscle pain; low WBCs; hip pain; This is a spontaneous report from a contactable other hcp and consumer. A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at dose number unknown, single for covid-19 immunisation; palbociclib (IBRANCE) TAB 100MG, via an unspecified route of administration from 07May2021 (Batch/Lot number was not reported) to an unspecified date, at 100 mg for an unspecified indication. Medical history and concomitant medications were not reported. Verbatim and Event Description: Patient reports adverse events of low blood counts, muscle pain, pain in hip. Duration: hip pain started 09Jul2021 after getting COVID19 injection. Patient saw provider and was prescribed anti-flammation medication (patient does not recall name of medication) which gives relief. Patient also administers Zarxio for low WBCs. Outcome of the events was unknown. The lot number for [BNT162B2], was not provided and will be requested during follow up.

Other Meds: Ibrance

Current Illness:

ID: 1817394
Sex: F
Age:
State: PA

Vax Date: 04/09/2021
Onset Date: 04/09/2021
Rec V Date: 10/26/2021
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: 20211012; Test Name: PCR; Test Result: Positive ; Comments: Nasal Swab

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: PCR, covid test result - Positive, date 12Oct2021; PCR, covid test result - Positive, date 12Oct2021; Patient received 1st dose and 2nd dose on same day (09Apr2021); This is a spontaneous report from a contactable consumer. A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ep6955) via an unspecified route of administration, administered in Arm Left on 09Apr2021 at 09:00 (Age at vaccination was 47-years-old) DOSE 2, SINGLE and DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included ibuprofen (ADVIL [IBUPROFEN]) taken for an unspecified indication, start and stop date were not reported. On 09Apr2021, patient received 1st dose and 2nd dose on same day (09apr2021) (inappropriate schedule of product administration). on 08Oct2021, the patient experianced loss of smell and taste and eye irritation. on 12oct2021, the patient experienced pcr, covid test result - positive (drug ineffective) and Covid 19. The patient underwent lab tests and procedures which included sars-cov-2 test: result was positive on 12Oct2021 (Nasal Swab). Patient did not received any treatment. The outcome of loss of smell and taste and eye irritation was recovering and for remaining events unknown.

Other Meds: ADVIL [IBUPROFEN]

Current Illness:

ID: 1817396
Sex: M
Age:
State: NY

Vax Date: 02/10/2021
Onset Date: 10/01/2021
Rec V Date: 10/26/2021
Hospital: Y

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

Lab Data: Test Name: kidney function; Result Unstructured Data: Test Result:elevated a little bit; Comments: his kidney function was elevated a little bit but has now returned to normal.; Test Date: 20211006; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: he was tested for covid on 06Oct2021 and it came back positive.

Allergies:

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

Symptoms: just diagnosed with covid, breakthrough cases; covid pneumonia; kidney function was elevated a little bit; just diagnosed with covid, breakthrough cases; This is a spontaneous report from a contactable consumer or other non-health professional (wife reporting for her husband). A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration in arm on 10Feb2021 in the morning as DOSE 2, single for COVID-19 immunisation (age at vaccination: 71-years-old). The patient medical history included: High blood pressure. The patient was also taking other products. The reporter mentioned that the patient was diagnosed with other unspecified conditions most of his life. No additional vaccine was administered on same date of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not report any AE (s) prior vaccination. The concomitant medications include Enalapril for blood pressure from an unspecified date at an unknown dose once a day by mouth. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL8982), via an unspecified route of administration in upper left arm on 20Jan2021 in the morning as DOSE 1, single for COVID-19 immunisation. The symptoms started on 01Oct2021, and he was tested for covid on 06Oct2021, which came back positive and just got diagnosed with covid, breakthrough cases. On 01Oct2021 the patient had covid pneumonia and the patient was in hospital due to that since 12Oct2021 till the date of the report. Patient treatment included: He was on oxygen, steroids and antibiotics. He does not qualify for Remdesivir since his kidney function was elevated a little bit but has now returned to normal. The outcome of the events covid pneumonia and just diagnosed with covid, breakthrough cases (COVID-19)) was not resolved. The oxygen intake was improved but he was still on oxygen. The outcome of the event kidney function was elevated a little bit was resolved on an unspecified date. The outcome of the event just diagnosed with covid, breakthrough cases (Vaccination failure) was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: ENALAPRIL

Current Illness:

ID: 1817397
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: worsening pre-existing conditions due to stressful events; worsening pre-existing conditions due to stressful events; decreased mobility (surgery); increase anxiety; flares-ups of fibromyalgia/osteoarthritis.; flares-ups of fibromyalgia/osteoarthritis.; blood pressure elevated; foot pain; Low vitamin D (before therapy) improved for the first time; This is a spontaneous report from contactable other health professional and consumer (patient) via a Pfizer-sponsored program. A 51-year-old female patient started to receive tofacitinib citrate (XELJANZ XR; strength 11mg), oral from Mar2021 (Batch/Lot number was not reported) to 21Jun2021, at 11 mg once daily and via oral from Sep2021 (Batch/Lot number was not reported) and ongoing, at 11 mg once daily for rheumatoid arthritis; BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation; and influenza vaccine (Manufacturer unknown) via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date at dose number unknown, single for immunisation. Medical history included low vitamin D. The patient has unspecified concomitant medication. The patient initially started therapy with XELJANZ XR from Mar2021 to 21Jun2021 and restarted at the end of Sep2021. Most recent shipment was on 07Oct2021 due to right ankle reconstruction/tibial bone graft from 06Jul2021 to 07Jul2021 (2 days hospitalization), COVID-19 vaccine (Pfizer), and flu shot. In 2021, the patient experienced worsening pre-existing conditions due to stressful events, out of work, disability, decreased mobility (surgery)/increase anxiety after being off therapy resulting in flares-ups of fibromyalgia/osteoarthritis. The patient is coping and taking unspecified medication for the events. MD was aware. The patient also experienced blood pressure elevated (onset eight months ago) could be due to foot pain. Low vitamin D (before therapy) improved for the first time. The action taken of tofacitinib citrate in response to the events was dose not changed. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The reported events are likely intercurrent conditions and are not related to the suspect drugs.

Other Meds: XELJANZ XR

Current Illness:

ID: 1817398
Sex: M
Age:
State: MI

Vax Date: 10/06/2021
Onset Date: 10/09/2021
Rec V Date: 10/26/2021
Hospital: Y

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

Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:190-180/90-100; Comments: 190-180/90-100, it's been fluctuating; Test Name: blood pressure; Result Unstructured Data: Test Result:150/90; Test Name: blood pressure; Result Unstructured Data: Test Result:170/110; Test Date: 20211009; Test Name: blood pressure; Result Unstructured Data: Test Result:210; Comments: 210/ something; Test Date: 20211009; Test Name: blood pressure; Result Unstructured Data: Test Result:190/120; Test Date: 20211010; Test Name: blood pressure; Result Unstructured Data: Test Result:very high; Test Date: 20211009; Test Name: Blood tests; Result Unstructured Data: Test Result:Nothing to indicate a stroke; Test Date: 20211009; Test Name: Blood tests; Result Unstructured Data: Test Result:no notable results

Allergies:

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

Symptoms: checked Blood pressure it was 210/ something; Felt faint, lightheaded, like he was going to faint/Really dizzy; very weak; challenge walking long distances; This is a spontaneous report from a contactable consumer. A 70-years-old male patient received third dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on unknown shoulder (age at vaccination was 70-years-old) on 06Oct2021 at 12:00 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included hypertension from 2011 and ongoing. Concomitant medication included losartan potassium (LOSARTAN POTASSIUM) taken for hypertension from 2011 and ongoing. Patient historical vaccine included first dose of COMIRNATY on Feb2021 and second dose of COMIRNATY on unknown other than what caller thinks was in Feb2021, about 2 weeks after first dose (Feb2021). On 09Oct2021 Starting around 02:00-03:00, the patient experienced checked blood pressure it was 210/ something (hypertension), felt faint, lightheaded, like he was going to faint/really dizzy (dizziness), very weak (asthenia) and challenge walking long distances. Patient had the first two Pfizer COVID-19 vaccines and had no reactions to any vaccine in his history and as well with the two doses no issues, he received his third dose of the Pfizer COVID-19 vaccine and about 3 days after the third dose he woke up in the middle of night to go to the bathroom felt like he was going to faint, and all day the next day felt very faint and very weak, checked Blood pressure it was 210/ something, too him to the hospital at night and had blood work done, nothing going on no stroke, and he was released. He takes a blood pressure medication to begin with he has had that for about 10 or 15 years and that keeps him very steady. And since that time of the hospital he has continued to have really high blood pressure anywhere from 190-180/90-100, it's been fluctuating up and down but has continued to have a lot of lightheadedness, feeling like he might faint, challenge walking long distances and the blood pressure is still really high. So he is cornered about what is taking place, if there are any recommended tests or anything they can be doing, he has been in touch with his Primary care physician but wanted to report it back to Pfizer because it all seemed very sequential after receiving the vaccine. At initial onset of these events his blood pressure was like 210 over a very high number. He was admitted to the hospital in the emergency room on 09Oct2021 for all of these events. He was seen by the emergency room doctor. They performed blood tests to see if there were any signs of a stroke, but there wasn't anything they could see on the blood work to indicate a stroke, no notable results from the blood test. He was discharged home that same date on 09Oct2021. His blood pressure remains very high since onset, bouncing between like 190/120 and 150/90; last blood pressure taken was 170/110. All events reported by caller as remaining persistent since onset. His blood pressure has been up and down but all the while still high. It was very, very high on 09Oct2021 and 10Oct2021 and kind of just continued to go up and down since then. The outcome of the event hypertension and dizziness was not recovered and unknown for remaining events. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: LOSARTAN POTASSIUM

Current Illness: Blood pressure high

ID: 1817399
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:diagnosed with COVID; Comments: diagnosed with COVID

Allergies:

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

Symptoms: sister has had 2 shots of the covid vaccine by pfizer and diagnosed with Covid; sister has had 2 shots of the covid vaccine by pfizer and diagnosed with Covid; This is a spontaneous report based on information received by Pfizer/Merck and Co., Inc. from a contactable consumer or other non-health care professional reported for her sister. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: not reported), via an unspecified route of administration, administer at an unspecified anatomical location on an unspecified date as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: not reported), via an unspecified route of administration, administer at an unspecified anatomical location on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sister has had 2 shots of the covid vaccine by Pfizer and diagnosed with covid. The patient underwent lab tests and procedures which included sars-cov-2 test diagnosed with covid on diagnosed with COVID. The outcome of the event was unknown. The lot number for (BNT162B2), was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am