VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1770863
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Big hives that itches about half an inch away where I got the vaccine; Big hives that itches about half an inch away where I got the vaccine; This is a spontaneous report from a contactable consumer or other non-health professional (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, formulation: solution for injection, lot number: ER8727, expiry date: not reported), via an unspecified route of administration on 18Mar2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced big hives that itches about half an inch away where patient got the vaccine. Patient did not saw anything on the paper that says you could get hives so much (intent not clarified, hence MI not documented). The patient stated, "No, all I know is that I got an injection yesterday and just about a "quarter of an inch" (not clarified) away I have a big hives that is itching, about a quarter of an inch. Clinical outcome of the events was reported as unknown. No follow-up attempt are possible. No further information expected.

Other Meds:

Current Illness:

ID: 1770864
Sex: F
Age:
State:

Vax Date: 03/19/2021
Onset Date: 03/19/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data: Test Date: 20201212; Test Name: COVID-19; Test Result: Negative ; Comments: She tested negative afterward on 12Dec2020.; Test Date: 202103; Test Name: COVID-19; Test Result: Negative

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: chest pain; wheezing; complaining of breathlessness; This is a spontaneous report from a contactable consumer (patient son). A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 19Mar2021 (at the age of 65-year-old) as single dose for COVID-19 immunization. Medical history included a SARS-CoV-2 infection back in Nov2020 and tested negative afterward on 12Dec2020. The patient's concomitant medications were not reported. It was reported that recently, the patient received her first dose of Pfizer-Biontech Covid19 vaccine on 19Mar2021. That evening, the patient experienced some chest pain and she's been wheezing and complaining of some breathlessness since then. They had noticed that from that day she had been experiencing breathlessness. Of note, she had a SARS-CoV-2 infection back in Nov2020 and tested negative afterward on 12Dec2020. The caller stated he had seen the CDC guidelines that recommended waiting 90 days after infection before getting vaccinated and the interval between infection and vaccination for his mom was 96 or 97 days. He wanted to know if this is commonly reported, and what he should do next. He asked if they should take her to the urgent care or the ER. It was reported that the patient even had a negative covid19 test last week (Mar2021). Outcome of the events was unknown. No follow-up attempts are possible; Information about lot/batch number cannot been obtained.

Other Meds:

Current Illness:

ID: 1770865
Sex: F
Age:
State: ME

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

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

Lab Data:

Allergies:

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

Symptoms: Chills; Achy; Headache; had spasms in her stomach and diarrhea; had spasms in her stomach and diarrhea; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on an unknown date for covid-19 immunisation. The patient experienced chills, achy, headache, had spasms in her stomach and diarrhea on an unspecified date. Therapeutic measures were taken as a result of events. It was reported states that she had the vaccine on Wednesday morning at 9am, and for the next 2 days she went through the whole list of side effects; she had chills, was achy, had a headache; she had everything but no fever. States that when she woke up this morning, she felt great. Then about 2 hours after waking up, she had spasms in her stomach and diarrhea; this has happened 4 times so far today and it's wearing her out. States that the last 2 times were very watery. Is there anything she can do for this? Is this usual? She knows it's on the list of possibilities, the diarrhea, but it doesn't say anything about spasms in the stomach. States the she has pressed down all over her stomach and nothing hurts. She took 1 Imodium a little while ago, is there anything else she should do or take. No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1770866
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/08/2021
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: Terrible headache; Joint pains all over her body; Was up all night; Sick; This is a spontaneous report from a contactable consumer (wife). A female patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number and Expiration date were not provided), via an unspecified route of administration on unspecified date as dose 2, single for COVID-19 immunization. The patients medical history and concomitant medications were not reported. Reporter (calling on behalf of her wife) stated that his wife had her second vaccination yesterday and on unspecified date she was up all night and was sick today with a terrible headache and joint pains all over her body. Reported further stated that was wondering how long this last. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained

Other Meds:

Current Illness:

ID: 1770867
Sex: F
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 10/08/2021
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: This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). This 61-year-old female patient received the 1st dose of BNT162B2 (Comirnaty, Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via unspecified route of administration, on an unknown date, single dose, for COVID-19 immunization. Patient's medical history and concomitant medications not reported. Patient was not in poor health and exercised daily. Reportedly, after the first dose of the Pfizer-BioNTech COVID-19 vaccine, for 3 days patient had very bad side effects. She didn't have to go to the hospital. On an unspecified date, patient was "sick as a dog" and the vaccine really knocked her down for 2 to 3 days. She felt like her legs were being cut off. Her legs ached really very bad and they ached for 2 nights so much she could not sleep. She felt like she had a fever. She hyperventilated and remembered getting up to turn the fan on. She had no appetite and was nauseated but did not regurgitate. She was also dizzy and had a headache. She spoke with her doctor about the events she experienced. It was advised to still get the second dose because she was not fully protected. The outcome of all the events: unknown. No follow-up attempts needed. Information about lot/batch number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 1770868
Sex: F
Age:
State: IL

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 10/08/2021
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: At night her face had swelling which was only in her face; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 61-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration on 18Mar2021 as dose 2, single (at the age of 61-years-old) for COVID-19 immunization. The patient previously received first dose of BNT162b2 (COMIRNATY, Solution for injection) via an unspecified route of administration on an unspecified date as dose 1, single (at the age of 61 years old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced at night her face had swelling which was only in her face on 18Mar2021 (reported as ongoing). Patient wanted to know what she should take or what is the cure for the swelling or is this normal. The outcome of event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1770869
Sex: F
Age:
State: NM

Vax Date: 03/06/2021
Onset Date: 03/06/2021
Rec V Date: 10/08/2021
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: Feeling congestion and itching to arms and throat; Feeling congestion and itching to arms and throat; Feeling congestion and itching to arms and throat; This is a spontaneous report from a contactable Other HCP. A 23-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported, Expiry date: unknown) via intramuscular route of administration on 06Mar2021 15:00 (at the age of 23-years-old) as dose 1, single for COVID-19 immunization administered at Public Health Clinic/Veterans Administration facility. It was unknown if patient was pregnant at the time of vaccination. The patient other medical history was unknown. It was unknown if the patient had allergies to medications, food or other products. The patient concomitant medications were not reported. It was unknown If the patient was diagnosed with COVID-19 prior to vaccination. It was unknown since the vaccination, has the patient been tested for COVID-19. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine and list of any other medications the patient received within 2 weeks of vaccination. On 06Mar2021 15:00, the patient reported she was feeling congestion and itching to arms and throat. The reporter assessed the events as non-serious. The patient received Benadryl 50mg PO total. Patient was able to drink water without difficulty. Patient discharged home after 60 minutes of observation for the events. The outcome of the events was recovered on an unspecified date in 2021. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1770870
Sex: F
Age:
State: AZ

Vax Date: 03/21/2021
Onset Date: 03/01/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Rash; red/irritated skin; red/irritated skin; itchy skin all over both legs, front and back; hives; This is a spontaneous report from contactable consumer. This 27-years-old female (Patient) reported for herself. A 27-years-old non-pregnant female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7534), via an unspecified route of administration, administered in Right arm on 21Mar2021 04:00 am (27-years-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The medical history was not reported. The patient concomitant medications were not reported. The patient previously received Penicillin (PENICILLIN [PENICILLIN NOS]), Amoxicillin (AMOXICILLIN) and Azithromycin (AZITHROMYCIN) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Prior to Covid vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date on Mar2021, the patient experienced rash, red/irritated skin, itchy skin all over both legs, front and back and hives. The patient did not receive any treatment. The outcome of the events was recovered on an unspecified date in Mar2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1770871
Sex: M
Age:
State: MS

Vax Date: 03/06/2021
Onset Date:
Rec V Date: 10/08/2021
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: he is exposed with people who got tested positive with the virus and he stated that he got the same symptoms; This is a spontaneous report from a Pfizer sponsored program a contactable consumer(patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported) via an unspecified route of administration, administered on 06Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. On an unspecified date the caller reported that his 2nd appointment would be tomorrow 20Mar2021 he got the 1st dose last on 06Mar2021 (early than 21 days). He stated as well that he was exposed with people who got tested positive with the virus and he stated that he got the same symptoms. The outcome of the event was unknown. Information about lot/batch number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 1770872
Sex: F
Age:
State: FL

Vax Date: 03/20/2021
Onset Date: 03/21/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: red; Injection site redness; swelling; Pain; Itching; Tiredness; Neck pain; Lower back pain; This is a spontaneous report from a contactable consumer. A 75-year-oldnon pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6208) via an unspecified route of administration, administered in Arm Right on 20Mar2021 13:15 (at the age of 75 years) as single dose for COVID-19 immunization at Pharmacy or Drug Store. Medical history included arthritis, low thyroid. Concomitant medications included Selenium, Kelp [ASCOPHYLLUM NODOSUM) and Vitamin D Nos, Multiple Daily Vitamin. Patient had no Known allergies. Previously patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6198) via an unspecified route of administration, administered in left arm 27Feb2021 01:15 PM as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have covid prior vaccination and no covid tested post vaccination. On 21Mar2021 13:45 the patient experienced injection site redness, swelling, pain, itching, tiredness, neck pain, lower back pain, on unspecified date patient had red (erythema). It was reported that the caller, called to say that she got both of the doses of covid 19 vaccine, and she was reporting adverse events like red, swollen and itchiness in the Injection site. She got the first dose of the covid 19 vaccine last 27Feb2021 and the second dose last 20Mar2021. Patient had no treatment received. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: SELENIUM; KELP [ASCOPHYLLUM NODOSUM]; VITAMIN D NOS

Current Illness:

ID: 1770873
Sex: F
Age:
State: FL

Vax Date: 03/10/2021
Onset Date: 03/10/2021
Rec V Date: 10/08/2021
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: allergic reaction; face became tingly and numb; face became tingly and numb; real bad heart palpitations/heart racing; nauseousness; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 41-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 10Mar2021 (age at vaccination was 41 years) as dose 1, single for COVID-19 immunization. The patient's medical history included food allergies. The patient was allergic to esters and anything that ends in "caine" like Novacaine (any esters in product, ie: something that ends in "caine" like novacaine). The patient's concomitant medications were not reported. On 10Mar2021, the patient experienced what she considered was a mild allergic reaction after first dose. Because she had some sensitivity to medications, she waited and was observed for 30 minutes after the first dose. Approximately 3 minutes into the drive home, on 10Mar2021, her face became tingly and numb, which lasted about 9-10 hours. That was a similar reaction she had before with food allergies or other sensitivities. She had real bad heart palpitations or heart racing, felt like a lot of adrenaline, to the point she did not fall asleep until 3:00 am. It was an uncomfortable feeling with the heart. She had mild nauseousness for 8 hours. Everything resolved by about 1:00-2:00 am and was able to sleep by 3:00 am. The patient's second dose was scheduled on 31Mar2021. The patient wanted to know if it was advisable for next dose. The patient's neighbor who was ER nurse suggested taking Benadryl before next dose. The outcome of the events was resolved on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1770874
Sex: F
Age:
State: TX

Vax Date: 03/22/2021
Onset Date: 03/22/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: developed swelling and redness of both hands; developed swelling and redness of both hands; the left side (side which I got the shot) swelling was also in the feet, under the big toe and also in the right.; she felt pain in her left arm; But my forearm rash left hand to right forearm; rash fading this afternoon, warm to touch and swelling. The discoloration went from dark red to more like lighter red; You can feel the warmth; I also got the muscle aches; localized swelling and pain at injection site.; localized swelling and pain at injection site.; felt a little dizzy but that went away after the 30 minutes; throbbing at the injection site that is only a little pain today but no more throbbing; Adds she also got a muscular or nerve like pain in her neck and down the left side of her back.; Adds she also got a muscular or nerve like pain in her neck and down the left side of her back.; This is a spontaneous report from a contactable other healthcare professional (nurse, patient). A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EP6955), via an unspecified route of administration, administered in left arm on 22Mar2021 09:20 (at the age of 65 years) as dose 1, single for COVID-19 immunization. The patients medical history included lupus (autoimmune disease) from 2010, gout and reacted severely to the shingles vaccine (Shingrix) in Sep and was sick for 3 weeks almost having shingles and like lupus my whole back was red and along the nerve pain and joint pain. Concomitant medications included allopurinol (ALLOPURINOL, 200mg) for gout taken one daily by mouth from Jan2020 and ongoing; levothyroxine sodium (SYNTHROID, 25mcg) for hypothyroidism take once daily by mouth from Mar2020 and ongoing; metoprolol (METOPROLOL, 25mg) for blood pressure taken one half once daily by mouth from Nov2020. The patient previously took plaquenil and developed toxicity about 3 years ago. She took it for 8 years and then she lost her central vision as a result of the toxicity. Before taking metoprolol she used to take Inderal 60mg for blood pressure. History of all previous immunization with the Pfizer vaccine considered as suspect were none. Additional Vaccines Administered on Same Date of the Pfizer Suspect were none. Prior Vaccinations (within 4 weeks) were none. On 22Mar2021 after vaccination patient waited for 30 minutes, felt a little dizzy but that went away after the 30 minutes then she went home. Adds she felt pain in her left arm, throbbing at the injection site that is only a little pain today but no more throbbing. She also got the muscle aches, localized swelling and pain at injection site. She did take Tylenol for the throbbing. Adds she also got a muscular or nerve like pain in her neck and down the left side of her back. That afternoon she noticed swelling in her hands and feet and the skin on her hands and feet was red like it was burned. The left side (side where she got the shot) swelling was also in the feet/ feet red, under the big toe and in the right. At first she thought it was topical but realized she hadn't used anything at the vaccination site. She had not used anything at the hospital on her hands so she knew it was not a topical rash. But my forearm rash left hand to right forearm; Adds she had a light rash up her left forearm that is slowly disappearing this afternoon, warm to touch and swelling. She took pictures of her hand to see the extend of the swelling and the rash. On 23Mar2021 (this morning) the swelling and redness in both feet is gone. Adds the left hand and left foot had more swelling and redness. Also the swelling and redness in her hands is still there but it is getting lighter and going down. The discoloration went from dark red to more like lighter red. It was so swollen the skin on top of her hand, it was shinny couldn't see my knuckles. You can feel the warmth. She was not sick enough to go to the doctor's office. She knows the swelling and rash are unusual. Since the next dose is scheduled she was wondering if you had any information. She knows her family reacts differently than others. She is asking if we recommend her getting the second dose?. Therapeutic measures Tylenol was taken because of throbbing at the injection site. The outcome for event "felt a little dizzy but that went away after the 30 minutes" recovered on 22Mar2021. Outcome of the events "developed swelling and redness of both feet"," the left side (side which I got the shot) swelling was also in the feet, under the big toe and also in the right on", "throbbing at the injection site that is only a little pain today but no more throbbing" was recovered on 23Mar2021, Events "developed swelling and redness of both hands", "Adds she also got a muscular or nerve like pain in her neck and down the left side of her back" was recovering. Outcome for events "she felt pain in her left arm", "You can feel the warmth", "I also got the muscle aches, localized swelling and pain at injection site" was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: ALLOPURINOL; SYNTHROID; METOPROLOL

Current Illness:

ID: 1770875
Sex: F
Age:
State: NJ

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

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

Lab Data: Test Name: Fever; Result Unstructured Data: Test Result:101.2

Allergies:

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

Symptoms: I have a fever of 101.2; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (lot number: EP7534; expiry date: unknown) at the age of 69-years-old, as dose 2, single, for Covid-19 immunisation. Medical history included ongoing high blood pressure (takes medication so it's under control). Concomitant medications included losartan and hydrochlorothiazide taken for unspecified indications, start and stop dates were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for Covid-19 immunisation. The patient experienced fever of 101.2 on an unspecified date. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.

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

Current Illness: Hypertension (Verbatim: High blood pressure)

ID: 1770876
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/08/2021
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: Body ache/she is in pain; Chills; Her heart beat is a little bit faster than normal; Feeling so bad in heart; Little bit of chest pain coming from the front to the back; Don't feel good; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received BNT162B2 PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported, dose unknown via an unspecified route of administration, on an unspecified date, as dose number unknown, single for COVID-19 immunization. The patient medical history included anxiety. The concomitant medications were not reported. The consumer reported that, he was calling on behalf of his wife who recently, on Saturday, took Corona virus Covid-19 vaccine by Pfizer. On an unspecified date, the patient experienced some body ache and had chills. Her heartbeat was a little bit faster than normal, feeling so bad in heart and little bit of chest pain coming from the front to the back. She used to take medication for anxiety occasionally and she wanted to know if she would take her medication for anxiety to help possibly with the pain of heart because did not feel good and experienced pain. Outcome of the events was unknown. No follow-up attempt are needed. Information about lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 1770877
Sex: F
Age:
State: PA

Vax Date: 03/16/2021
Onset Date: 03/16/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data: Test Date: 20210317; Test Name: fever; Result Unstructured Data: Test Result:101 Fahrenheit

Allergies:

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

Symptoms: side effects just took her energy completely out of her; It was like she was aching in her bones; being tired; all of sudden got chills; ended up running a fever over 101 degrees Fahrenheit; she slept the whole day, for like 12 to 14 hours and that was after sleeping the night before; didn't really feel like eating; had a slight ache in her arm not long after she got the COVID vaccine; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN5318 and expiration date was not reported), via an unspecified route of administration, administered in Left Arm on 16Mar2021 11:00 (at the age of 74-years-old) at dose 2, single for covid-19 immunization. The patient had no medical history. There were no concomitant medications. It was reported that she was experiencing bad side effects from the second dose of the Pfizer COVID vaccine. She had both doses and she only had side effects with the second dose. She got the second dose of her COVID vaccine around 11:00 on 16Mar2021 and she had a slight ache in her arm not long after she got the COVID vaccine. She had that same experience when she had the first COVID vaccine as well. Nothing bothered her after that until the next day, about 22 hours later she thought, she all of sudden got chills, ended up running a fever over 101 degrees Fahrenheit and she slept the whole day, for like 12 to 14 hours and that was after sleeping the night before. That night she thought that she had to eat something, so she tried to eat and then she went back to bed again. She didn't eat anything really; she didn't really feel like eating and she just was chilled to the bone. It was like she has aching in her bones. That first night, 17Mar2021 when she thought that she could be having a reaction, she took 650 mg of Tylenol and before that, during the daytime, she took a regular 500 mg Tylenol when she thought that she was having this reaction. She thought that she had heard about some people not having reactions and then some people might have slight reactions. She also heard that younger people usually have worse reactions than older people. So, she must be with the younger population she jokingly said. Probed from caller for further information on younger people that have had worse reactions and she said that was a general statement that she had seen on the internet. She had tried to find something online to see if anyone else was having this kind of reaction, such as a high fever. She hasn't been sick all winter long and she thinks that it is because everyone has been wearing masks and they were a lot safer than they normally were. Caller confirmed that the fever, her being tired, and her having chills all began on 17Mar2021. She said the side effects began close to 24 hours after her COVID vaccine and then 48 hours after her COVID vaccine she was fine. She felt a lot better yesterday, 18Mar2021. She has 2 dogs, and she has to get up and walk them and all of that and she felt a lot better but then she realized that she was still tired. She said that all of her symptoms were gone yesterday, 18Mar2021 and she thinks that the tiredness was gone then to, but it was hard to say. She thinks that what happened was that she was so tired, and the side effects just took her energy completely out of her, so yesterday, 18Mar2021 it was like she was just catching up. Plus, yesterday (18Mar2021), was a weird day with the weather anyways. She confirmed that her arm was sore beginning on 16Mar2021, and she said that she was still feeling it, it was still achy if she touches it. It has improved since then. The thing that scared her was that this thing, COVID, is never going to go away, it would dissipate but it was not going away, so she wanted to know how it was going to be if it was boosters. She wanted to know if the boosters also going to cause reactions like this, too. Her first COVID vaccine was on 23Feb2021 with lot number EL9266 (at the age of 74-years-old) via unspecified route of administration in right arm for covid-19 immunization and had slight ache in her arm, caller did not have NDC and expiry date since they were not on the COVID vaccine card either. She wanted to be protected but she was more concerned about being protected for her husband since he was a kidney transplant recipient, and they don't want to mess with the transplant. They can't afford to get sick. And even though she doesn't feel like it, they were senior citizens. She said her immune system must be working better than it should, even though that was the better option than it was declining. She said this because of her statement earlier in regard to the younger population having worse reactions after the COVID vaccine that the older population. She said that if the information she was giving in this report would help others then she would complete the report. She actually volunteered to test the COVID vaccine before it ever rolled out to the public and everyone said that she was crazy for wanting to do that because of her age so she had decided not to do it. She was going to go up there and get them and then everyone talked her out of it. The Adverse events did not require a visit to Emergency Room or Physician Office but if she had a high fever the next day, she was thinking about getting in touch with someone at that point if that were to occur, but it didn't. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. she was basically very healthy. Relevant Tests were none. Forever, they used to tell her to not have the flu vaccine because of the eggs that were in it because she had allergies when she was little. The doctor finally said it was better to take the vaccine than deal with the consequences for the flu. She has been taking it for the past 20 years. But that's a normal vaccine and this one, the COVID Vaccine, was an MRNA vaccine. She confirmed that she had no reactions to any of the flu vaccines and the last one that she got was back in early Sep2020. She has looked online, and she has tried to put in for a search ''whether the reactions like high fevers were there for the COVID 19 vaccine or Pfizer COVID vaccine''. She was sort of surprised and thought that since the COVID vaccine was so new that she would want to have as much information out there to be sure that everyone was so well protected and that there was no fear of having the COVID vaccine. Her nephew and his wife, he is an EMT, and his wife works in the hospital, they haven't taken the vaccine yet. She doesn't know whether it is from all of the misinformation out there and then she got nervous and said, this was dumb, but then she thinks what she needs to do. The more information that is out there about people and their side effects will better inform the public to say that it was okay to get the COVID vaccine and that the side effects may only last for half a day. Many have had the flu or a bad cold, so they can handle that. It seems to be an appropriate positive that the pharmaceutical companies should put out there for the COVID vaccine. The transfer agent she spoke with previously said that fortunately, or unfortunately, all of this is government controlled so people don't know what all can or can't happen. She says when someone gets the flu vaccine, they get information that says if they have a reaction to contact this certain number but all she got was this COVID vaccine record card and was told to laminate it and carry it with her at all times. It would be nice to give out a flyer along with the COVID vaccine record card that says if a reaction occurred then could go to this webpage to tell about the reactions they had or call at this number. But when she got her COVID vaccine it was just like "see ya" after she had waited for 15 minutes for the vaccine. She says that she doesn't want to spend too much more time on the phone today at the time of report. But stated to look at what was going on with AstraZeneca. They were danged if they do and danged if they don't. Further stated that they live in such a so

Other Meds:

Current Illness:

ID: 1770878
Sex: F
Age:
State:

Vax Date: 03/19/2021
Onset Date: 03/20/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: She is feeling weak because she has pain all over her body; She is feeling weak because she has pain all over her body; getting hot and cold, fever like she was feeling hot and then cold, hot and cold both back and forth; getting hot and cold, fever like she was feeling hot and then cold, hot and cold both back and forth; This is a spontaneous report from contactable consumer (patient daughter) reported for her mother. A female patient of unknown age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6207, Expiry Date: unknown, Solution for injection), via an unspecified route of administration on 19Mar2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. Historical vaccine included bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number unknown), via an unspecified route of administration on an unknown date as dose 1, single for covid-19 immunisation. Consumer stated, yesterday on 19Mar2021 her mother got her second shot for the vaccine and today 20Mar2021 she was feeling weak because she has pain all over her body, she was getting hot and cold, fever like she was feeling hot and then cold, hot and cold both back and forth." Reporter confirmed the vaccine as Pfizer Covid 19 vaccine. The outcome of event was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1770879
Sex: F
Age:
State: VA

Vax Date: 03/20/2021
Onset Date: 03/20/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: started feeling something weird on my upper lip, the left one; feeling something like it was, the lips is something wrong; I am been swollen from the lip, the upper left lip; This is a spontaneous report from a contactable consumer. This 67-years-old female consumer (patient) reported for herself. A 66-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20Mar2021 10:40 (at the age of 66-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 20Mar2021 20:30, the patient experienced started feeling something weird on my upper lip, the left one, feeling something like it was, the lips is something wrong and i am been swollen from the lip, the upper left lip. The patient reported regarding COVID vaccine reaction. After the vaccine it is been 15 minutes everything was okay but the on 20Mar2021 about 8:30 she started feeling something weird on my upper lip, the left one and I was feeling something like it was, the lips is something wrong. It looks like swollen but I am been swollen from the lip, the upper left lip." The patient not received any treatment (No, because I do not know what to take). The outcome of events was unknown. Information on the lot/ batch number has been requested. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1770880
Sex: F
Age:
State: PA

Vax Date: 03/20/2021
Onset Date: 03/01/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data: Test Date: 202103; Test Name: Fever; Result Unstructured Data: Test Result:over 100

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: I just got progressively tired; Headache a still a bit. It is still affecting my eyesight; Headache a still a bit. It is still affecting my eyesight; Injection site is very sore; I am freezing, I have the chills on badly.; Fever over 100; Severe muscle aches; Pains in my joint; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number and expiry date were not reported), via an unspecified route of administration, on 20Mar2021 (age at vaccination: 68 years), as a dose 1, single for COVID-19 immunization. The patient's medical history includes asthma (Start: Unspecified Stop: Unspecified). The patient concomitant medications include levothyroxine sodium (Synthroid) (Start: Unspecified Stop: Unspecified), montelukast sodium (singulair) for asthma (Start: Unspecified Stop: Unspecified), pitavastatin calcium (livalo) (Start: Unspecified Stop: Unspecified). On an unspecified date in Mar2021, later in the night, the patient got severe headache, chills and the patent have fever over 100. Reportedly the patient muscles and joints ache like crazy and her headache was so bad, it was affecting patient eyesight. Reportedly the patient felt tired when they gave her injection. The patient was fine yesterday. It was reported that 3 hours afterwards the patient walked out of there at 10:45. The patient stayed there for 15 minutes and then just got progressively tired, and at about 7 O'clock late night, I started getting the chills. the patient was freezing and cannot get warm. Reportedly the patient was freezing and have the chills on badly. Patient heated blanket around her. The injection site was very sore. It was reported that the patient had a Covid-19 first dose yesterday. The patient did not receive the treatment because the patient was told to not take any kind of Aspirin or Ibuprofen because it has an adverse effect on the needle and the patient dont not know what to do. That why the patient was calling. Outcome of the event was unknown. No follow-up attempts are possible. information about batch/ lot number cannot be obtained.

Other Meds: SYNTHROID; SINGULAIR; LIVALO

Current Illness:

ID: 1770881
Sex: M
Age:
State: MA

Vax Date: 03/13/2021
Onset Date: 03/01/2021
Rec V Date: 10/08/2021
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: bruised the side of his underarm okay; that night, in bed he experienced severe vertigo; light headedness; dizziness; This is a spontaneous report from contactable consumer. This consumer reported for a 66-year-old male (Husband) patient. A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6207, Expiration Date: 31Jul2021) via an unspecified route of administration on 13Mar2021 at 10:13 (at the age of 66-years-old) as dose number unknown, single for covid-19 immunization. Patient medical history included acid reflux disease from an unknown date and unknown if ongoing. Concomitant medications included omeprazole; sertraline and ascorbic acid, tocopherol (VITAMIN C AND E). Reporter stated that well, she was calling on behalf of her husband, who received the Pfizer vaccine on 13Mar2021, 10:13 in the morning, that night, in bed patient experienced severe vertigo, when he rolled over he thought the bed was going to flip over, patient got up the next morning and did not say anything to her, she did not know what happened patient went to sit down on the toilet, it happened again and he fell into the vanity and bruised the side of his underarm okay (14Mar2021), he has had on and off vertigo, light headedness (Mar2021), dizziness (Mar2021), since he got the shot, she was trying to find out, if this was going to go away, he had doctor's appointment on Friday which she was not sure what they are going to tell them if this was the result of shot or if there was anything he can do, but they both felt that this was the result of the shot within 24 hours patient had been experiencing that, she was, from what she could see online on message boards there were many people that have experiencing that. Reporter stated, that would be, it would be going to bed on 13Mar2021 and waking up in the middle of the night and experiencing that, so within 24 hours that's why she can't help but thought that these were related and then he had periodic episode of these for the last week since he had it. Reporter stated, it has been 8 days now, she was trying to report a problem that healthy man has experienced in 24 hours of getting the shot and now the problem was, she does not know whether or not when this was going to go away patient experienced dizziness he can't drive, he has like vertigo situation. Reporter stated that the events had improved somewhat and want to know was this common or does it go away in a week. It was stated that other vaccine people were fine within day or two, now they are on day 8 and this was reporter concern why the events had not gone, and patient felt little off since he had the vaccine. Therapeutic measures were taken as a result of the event vertigo and reporter stated all he has taken was over the counter, Meclizine it was motion, it was over the counter, no prescription, since patient could not get the doctor appointment until Friday. Outcome of all the events was recovering. No follow-up attempts are Possible. No further Information is expected.

Other Meds: OMEPRAZOLE; SERTRALINE; VITAMIN C AND E

Current Illness:

ID: 1770882
Sex: F
Age:
State: PA

Vax Date: 03/20/2021
Onset Date: 03/21/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Inability to focus thinking; Sore arm around injection site; tired; sneezing; This is a spontaneous report from a contactable Pharmacist (parent). A 26-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP6955), via intramuscular route of administration in right arm on 20Mar2021 at 16:00 (at the age of 26-year-old) as dose 1, single for COVID-19 immunisation at other facility. Medical history was not reported. Concomitant medications included loratadine taken for an unspecified indication, start and stop date were not reported; multivitamins [vitamins nos] taken for an unspecified indication, start and stop date were not reported; birth control pill taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient had no known allergies. The patient experienced sore arm around injection site, tired on 21Mar2021 at 20:00, sneezing on 21Mar2021 and inability to focus thinking on 22Mar2021 at 10:30. The ice and acetaminophen were given as treatment for soreness. The outcome of sore arm around injection site, tired, sneezing was resolving and inability to focus thinking was resolved on an unknown date. No follow-up attempts are possible. No further information is expected.

Other Meds: LORATADINE; MULTIVITAMINS [VITAMINS NOS].

Current Illness:

ID: 1770883
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/08/2021
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: Same side received the vaccine arm pit, groin lymph node are swelled, annoying and it's painful; multiple nodes in my arm pits; I have two lumps and stuffs; Same side received the vaccine arm pit, groin lymph node are swelled, annoying and it's painful; multiple nodes in my arm pits; I have two lumps and stuffs; It feels like you got something in between your legs when you are walking because it's swollen; Felt sick; Cold; it's like nausea; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EN6207) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's family history included patient's brother has Lymphedema really bad, so his body, he had Lymphedema was really bad Lymphedema and patient's mother had Lymphedema in her leg where it's the stuff, so patient don't know if it's family history or patient have the side effects. The thing was patient's family had the problem with but patient don't know if that was why patient was getting this because patient don't know. On an unspecified date, when probed for the concern, consumer stated, So, patient was reporting, patient took the Pfizer vaccine on Sympatric spe (not clarified) and patient was reporting that patient had the side effects. patient had the swollen arm pit and on the same side on groin, the lymph node all swelled and on the same side as (received the vaccine) but it's pretty annoying. It's painful and then the groin was where your leg was swollen in bigger, it feels like you got something in between your legs when you are walking because it's swollen and your arms, in fact in it's multiple, so it's multiple nodes in my arm pits, so not just one it's two, patient had two lumps and stuffs, you wouldn't read the paper before you got shot and it's like nausea. Patient felt sick this morning like that patient woke up and had a cold and patient was seeing all that but this, want to know this stuff was a bigger issue on the symptoms. When probed to confirm the concern, consumer stated, "Well, I do. I want to know do I take this, what can it happen when I take the second shot in 21 days because I already got this". The outcome of events was unknown. No follow-up attempts are possible. No further information was expected.

Other Meds:

Current Illness:

ID: 1770885
Sex: U
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 10/08/2021
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: This is a spontaneous report from a contactable consumer or other non-HCP. A 48-year-old patient, of an unspecified gender, received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported, expiry date: unknown), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unspecified date, patient experienced headache, fever and body aches for 36 hours; with outcome of recovered on unspecific date. No follow-up attempts possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1770886
Sex: F
Age:
State:

Vax Date: 03/12/2021
Onset Date: 03/15/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: facial eruptions, redness; facial eruptions, redness; Swelling; This is a spontaneous report from a contactable consumer. This report was received via a sales representative. A female patient of an unspecified age received bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on 12Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 15Mar2021, patient experienced facial eruptions, redness. Swelling and redness persist as of 18Mar2021. Patient was treated with benadryl and steroids by PCP who immunized patient Guidance on cause effect management, and need for second vaccination requested. Patient stayed on Pfizer Med info for about 5hours without a response. Therapeutic measures were taken as a result of facial eruptions, redness and swelling and patient was treated with benadryl and steroids. The outcome of facial eruptions, redness (rash) was unknown while the outcome of the events facial eruptions, redness (erythema) and swelling was not recovered. No follow-up attempts are possible; information about lot/batch number cannot been obtained

Other Meds:

Current Illness:

ID: 1770887
Sex: M
Age:
State: TX

Vax Date: 03/14/2021
Onset Date: 03/01/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data: Test Date: 20210319; Test Name: Fever; Result Unstructured Data: Test Result:101.5; Comments: highest fever

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: fever/his highest fever is 101.5; chills; This is a spontaneous report from a contactable consumer (patient's wife). A 67-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Mar2021 at 11:45 (lot number: EN6207; expiry date: 03Jul2021) at the of 67-years-old, as dose number unknown, single, for Covid-19 immunisation. Medical history included blood pressure high. Concomitant medications included amlodipine besylate; hydrochlorothiazide; clomiphene citrate; tadalafil taken for unspecified indications, start and stop dates were not reported. On unspecified date in Mar2021, the patient experienced chills. On 19Mar2021, the patient experienced fever, his highest fever was 101.5. Outcome of the event his highest fever is 101.5 was not recovered, while for the other event was unknown. No follow-up attempts are possible. No further information is expected.

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

Current Illness:

ID: 1770888
Sex: F
Age:
State: MD

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 10/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: foggy; dizzy; hurt; got a bump near where she had the vaccine that itched like crazy; got a bump near where she had the vaccine that itched like crazy; hive; This is a spontaneous report from a contactable consumer reported for herself. A 73-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6205, Expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 01Mar2021 (age at vaccination was 73 years) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were unknown. On an unspecified date the patient experienced foggy, dizzy, hurt, got a bump near where she had the vaccine that itched like crazy and hive. Patient had the usual symptoms and was foggy, dizzy, she hurt, and was out of it. Patient said that Saturday night she got a bump near where she had the vaccine that itched like crazy. Patient took 2 Benadryl to treat it, the next day she took a Benadryl and the day after that she took a Benadryl and it went away. Patient said that it was like a itchy bumpy hive. Patient was told to come back on 29Mar2021 but she found one to where she could get it on 23Mar2021. Patient was able to get a second Pfizer dose scheduled for Tuesday 24Mar2021. Therapeutic measures were taken as a result of got a bump near where she had the vaccine that itched like crazy and hive. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1770889
Sex: U
Age:
State: TX

Vax Date: 02/23/2021
Onset Date: 02/23/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Swelling in my nose and around my mouth, it begin slowly and it didn't get too big; This is spontaneous report from a contactable consumer (Patient). A 65-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9267), via an unspecified route of administration on 23Feb2021(at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included kidney disease, atrial fibrillation (all from an unknown date and unknown if ongoing). On 23Feb2021, the patient experienced Swelling in my nose and around my mouth, it begin slowly and it didn't get too big. It was reported that I just wanted to report that when I took the shot on 23Feb, I have swelling in my nose and around my mouth and the first 15 minutes is when it begin slowly and it didn't get too big. But I am wrinkly and my wrinkle were like I took 'Botox', it was very 'cool' (voice not clear) I must say. And so, I got the e-mail to take my second dose I thought I better call you and might e-mail that I had an adverse reaction. But it went away. I just got the e-mail yesterday telling me I could take the second dose, given me a day which is Tuesday and I think may be I shouldn't take it because of the swelling. Consumer was informed the role of Pfizer Medical Information and offered the number. Consumer was informed about Pfizer Drug Safety. Patient stated that event was gone that same day. Patient stated about concomitant product Lot, yes. Therapeutic measures were taken as a result of adverse event and treatment included Benadryl, children Benadryl actually its not adult Benadryl, its children Benadryl. The clinical outcome of the events was recovered on an unknown date 2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1770890
Sex: F
Age:
State: NJ

Vax Date: 02/24/2021
Onset Date:
Rec V Date: 10/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Fever; Fatigue; Chills; Body aches; This is a spontaneous report from a contactable consumer (patient). A 48-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration in arm left on 24Feb2021 14:15 as dose 1, single (age at vaccination: 48 years) for COVID-19 immunisation. Medical history included Known allergies: Sulfa from an unknown date and unknown if ongoing, COVID-19 from an unknown date and unknown if ongoing If covid prior vaccination: Yes. Concomitant medications included paracetamol (TYLENOL), multi vitamin taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. COVID prior vaccination and did not tested COVID post vaccination. On an unspecified date 2021, the patient experienced fever, fatigue, chills, body aches after both vaccines. No treatment was received. The clinical outcome of the events on an unspecified date 2021 was resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: Pfizer, Inc. EUA 027034

Current Illness:

ID: 1770891
Sex: U
Age:
State: OH

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

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: one other person had a nosebleed too; This is a spontaneous report from a contactable consumer or other non-HCP. A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose number unknown, single for COVID-19 immunization. Vaccination facility type was reported as Pharmacy/drug store. Patient medical history and concomitant medications were not reported. The pharmacy said they did not think that was a reaction, but they thought it was odd because one other person had a nosebleed too. The outcome of the events was unknown. No follow-up attempts are Possible. Information on lot/batch cannot be obtained.

Other Meds:

Current Illness:

ID: 1770892
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: pain and swelling where she got the shot; Weakness; Dizziness; pain and swelling where she got the shot; This is a spontaneous report from a contactable other hcp (nurse) reporting for herself. A 99-year-old female patient received bnt162b2 (BNT162B2, Formulation: solution for injection, Lot number: not reported, Expiry date: not provided), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medication was not reported. On an unspecified date, the patient experienced pain and swelling where she got the shot, weakness and dizziness. Caller stated that last monday afternoon the caller got the second dose of the pfizer covid vaccine and she felt fine until the evening when she had pain and swelling where she got the shot. The next day the caller was so weak she couldn't do anything. Today the dizziness has gone away, and the caller is considerably better. The caller wanted to know how long to expect these symptoms. The clinical outcome of the events pain and swelling where she got the shot and weakness was reported as unknown and dizziness was reported as recovered on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Other Meds:

Current Illness:

ID: 1770893
Sex: F
Age:
State: CA

Vax Date: 01/15/2021
Onset Date:
Rec V Date: 10/08/2021
Hospital:

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

Lab Data: Test Date: 20210311; Test Name: COVID-19; Test Result: Negative

Allergies:

Symptom List: Nausea

Symptoms: Nose Bleed/almost daily/same after second dose of shot. Both times acute reaction to shot; This is a spontaneous report from a contactable other health care professional (patient herself). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, formulation: solution for injection and Lot Number: EL1283, expiry date: unknown) intramuscular, in Left Arm on 15Jan2021 as dose 1, single for COVID-19 immunization (Age at time of vaccination: 49 years-old). The patient had not received other vaccines prior to the vaccination. Medical history included asthma. Concomitant medications included salbutamol sulfate (ALBUTEROL SALBUTAMOL SULFATE]) and fluticasone propionate salmeterol (WIXELA INHUB) taken for asthma. Both were taken from an unspecified start date and ongoing. Patient took Hydrochlorothiazide 25mg Tab, and Diphenhydramine 25 mg as needed. On an unspecified date the patient experienced nosebleed/almost daily/same after second dose of shot. both times acute reaction to shot. On 11Mar2021 the patient underwent lab tests and procedures which included COVID-19 which was negative. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds: ALBUTEROL [SALBUTAMOL SULFATE]; WIXELA INHUB

Current Illness:

ID: 1770894
Sex: U
Age:
State: WI

Vax Date: 03/06/2021
Onset Date: 03/16/2021
Rec V Date: 10/08/2021
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: I started to have a shoulder and the neck sore and this I couldn't turn my head aside evenly; I started to have a shoulder and the neck sore and this I couldn't turn my head aside evenly; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 06Mar2021 (Lot Number: EN6199) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.The patient had the vaccine on 06Mar2021 and on 16Mar2021, started to have a shoulder and the neck sore and patient couldn't turn head aside evenly. So that last till the time of reporting, it had been 4 days. The outcome of the event unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1770895
Sex: F
Age:
State: OH

Vax Date: 03/19/2021
Onset Date: 03/20/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data: Test Date: 20210320; Test Name: popped up today; Result Unstructured Data: Test Result:noticed one in leg

Allergies:

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

Symptoms: Rash on chest; it was kind of warm to the touch; it was a little itchya and kind of felt itchy all over; This is a spontaneous report from a contactable consumer (patient) reporting for self. A 55-year-old female patient received BNT162B2 (BNT162B2, Solution for injection, Lot Number: ER2613; Expiration Date: 31Jul2021, PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Right on 19Mar2021 as dose 1, single (at the age of 55 year) for covid-19 immunisation (CDC). Medical history included ongoing seizure, ongoing cholesterol and ongoing allergy, Heart stent and epilepsy. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)) at 81 mg; escitalopram oxalate (LEXAPRO) at 10 mg; ezetimibe (ZETIA) taken for cholesterol, at 10 mg; montelukast sodium (SINGULAIR) taken for allergy, at 10 mg; omeprazole (PROTONIX) taken stomach, start and stop date were not reported; alirocumab (PRALUENT) at 75 mg, zonisamide (ZONEGRAN) taken for seizure; cyclobenzaprine hydrochloride (FLEXERIL) taken as muscle relaxant, at 10 mg. The patient experienced rash on chest, it was kind of warm to the touch and it was a little itchy and kind of felt itchy all over on 20Mar2021 with outcome of unknown. Patient underwent laboratory test and procedures reported as popped up today and now have noticed one in leg on 20Mar2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: ASPIRIN (E.C.); LEXAPRO; ZETIA; SINGULAIR; PROTONIX [OMEPRAZOLE]; PRALUENT; ZONEGRAN; FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]

Current Illness: Allergy; Cholesterol; Seizures (Verbatim: Seizures)

ID: 1770896
Sex: M
Age:
State: IL

Vax Date: 03/20/2021
Onset Date: 03/20/2021
Rec V Date: 10/08/2021
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: Tremendous burning pain, killing pain, in his right arm from his shoulder down to his fingers; Injection site pain and tenderness; Headache; Muscle pain; Pain kills his bones and joints, the pain is terrible; Pain kills his bones and joints, the pain is terrible; Had the taste of the Pfizer-BioNTech COVID-19 Vaccine that came out; Nausea; Nose running; Right arm was a little red; This is a spontaneous report from a contactable consumer (patient). An 86-years-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot number: could be EN6204 or EV6204; Expiry Date: unknown), via an unspecified route of administration, administered in Arm Right on 20Mar2021 09:45 (at the age of 86-years-old) as dose 1, single for COVID-19 immunisation. Medical history included heart operation (After this operation the operating doctor gave him 1 pill that might be Entresto, and an Aspirin and he is not sure about further information, this was 6 years ago) and history of blood clots (He was hospitalized about 4 years ago, told his bleeding was bad, artery is clogged, they cleaned him out and started him on Eliquis for blood thinner about 4 years ago. He was then referred to see a Cardiologist semi-annually. He does not always feel ok with the daily medications he takes: Entresto and Eliquis and they are expensive; but the events he was reporting today are not related to those medications). Concomitant medication included ongoing sacubitril valsartan sodium hydrate (ENTRESTO) taken for heart operation from 2015 and ongoing apixaban (ELIQUIS) taken for blood clots from 2016. On 20Mar2021 the first dose of Pfizer-BioNTech COVID-19 Vaccine was administered and the injection itself was not painful, but right arm was a little red the first day, evening of 20Mar2021 which he noticed when he peeled off the protection bandage. He noticed on 21Mar2021, the morning after he was administered the first dose of Pfizer-BioNTech COVID-19 Vaccine that he had the taste of the Pfizer-BioNTech COVID-19 Vaccine the next morning that came out. He did not have a fever. He had a little side effect of nausea and nose running. Night of 22Mar2021 he reported having tremendous burning pain, killing pain, in his right arm from his shoulder down to his fingers; injection site pain and tenderness; headache; muscle pain. Pain kills his bones and joints, the pain is terrible. 23Mar2021 07:00 he woke in tremendous pain in his right arm from his shoulder down to his fingers. He got up and went in the bathroom and got Aspercreme liquid which was an over the counter lidocaine liquid cream for massaging, a pain reliever. While the Aspercreme did for a short time, when he woke again at 08:45 on 23Mar2021 he again had tremendous pain in his right arm from his shoulder down to his fingers, pain so bad that he almost screamed but was conscious because his wife was sleeping with him in the same bed so he just shut up got up in bathroom and got under lukewarm water and tried to relieve the pain. He is wondering if he should or should not get the second dose of the Pfizer-BioNTech COVID-19 Vaccine because of these events. Caller verified events have not yet required a visit to the physicians office, emergency room or hospitalization; but he has an appointment with his family doctor who is also a pain doctor tomorrow regarding these events. He is going to ask about these events and whether he should or should not get the second dose of the Pfizer-BioNTech COVID-19 Vaccine relative to these events and will do as his doctor recommends. He asked for USMI telephone number to provide to the doctor in case he wants to reach out with questions. Doctor will tell him something about inflammation or will say do not go for the second dose or just for your protection do it; he is well known doctor. Patient will listen to the doctor; doctor said what he is using, the Entresto and Eliquis is through the Cardiologist and patient has to use it or his life is hanging by a thread because the blood clots will take it. Aspercreme: Label shows powerful pain relieving liquid; temporarily relieves pain but not like aspirin for headache; massaging cream for spots where he hurts like the bones, he will apply a few drops to affected area and massage it in but Aspercreme did not help the pain he is having with these events. Aspercreme: Net weight: 2.5 ounces, Lot: Unknown, it shows this number near the Expiry date but does not say the meaning of the number: #; Expiry: 01Jul2022, UPC: Unknown. Manufacturer: Sanofi. His second dose appointment for the Pfizer-BioNTech COVID-19 Vaccine was 17Apr2021. Outcome of events of Pain in extremity, Vaccination site pain, Joint pain and Bone pain was not recovered and other events was unknown No follow-up attempts are possible. No further information is expected.

Other Meds: ENTRESTO; ELIQUIS.

Current Illness:

ID: 1770897
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 10/08/2021
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: severe brain fog; body high; dilated pupils; flushed skin; acting "silly"; This is a spontaneous report from a contactable consumer (Patient's daughter). An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history was not reported. The patient previously received Valium and was extremely hyper. The patients concomitant medications were not reported. On an unknown date after vaccination, the patient had severe brain fog, body high, dilated pupils, flushed skin and acting silly. The outcome of the events was unknown at the time of report. No follow-up attempts are needed. No further information expected.

Other Meds:

Current Illness:

ID: 1770898
Sex: F
Age:
State: TX

Vax Date: 03/18/2021
Onset Date: 03/19/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Caller reports that her symptoms worsened; chest pain, hurts really bad; little bit of shortness of breath; Cough; fatigue- slept all day; nose and throat pain; nose and throat pain; feeling congested; Runny nose; This is a spontaneous report from a contactable consumer. This consumer reported that 26-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 15:00 (Age at vaccination 26 years) as dose 1, single for covid-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. Patient family medical history was unknown (she knows someone has Diabetes, but none related to adverse event). On 19Mar2021, the patient experienced nose and throat pain; nose and throat pain; feeling congested; runny nose; On 20Mar2021, fatigue- slept all day; On 21Mar2021, chest pain, hurts really bad; little bit of shortness of breath; cough; On an unspecified date, caller reports that her symptoms worsened. No relevant test was performed. It was reported that nose and throat pain was reported as worsened. Caller reports that her symptoms worsened and it is now day four after she took the shot. Caller reports she received the shot on Thursday 18Mar2021. Caller reports on the day of the shot, she had no symptoms. The next day, Friday, she had nose and throat pain, she felt congested, and had a runny nose in the morning. On Saturday, she experienced fatigue and slept all day, on top of the nose and throat pain. On Sunday, she had chest pain that hurt really bad and she had a little bit of shortness of breath. Caller reported she doesn't have an HCP. Caller reports that the nose and throat pain are getting worse because she did not have a cough before and now she has a cough. Caller clarified the cough started on Sunday night. Caller states for the congestion and runny nose, its either one or the either. Caller explains one second her nose was running and then she cant breathe through it. Outcome unknown for little bit of shortness of breath. Caller reports the shortness of breath was really bad yesterday, but she was not noticing it as much today. Caller reports the shortness of breath is still going on and from time to time she can feel a little bit of shortness of breath, but compared to yesterday its not as bad. Caller states that it's kind of hard to tell the outcome. Nose and throat pain along with feeling congested and runny nose started in morning, it went away and came back in the evening. Fatigue started on Saturday night. Chest pain and Shortness of breath started in the evening. Vaccine was not administered at military facility. Patient history of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Patient was not visited to emergency room and physician room. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse event following prior vaccinations was none. The clinical outcome of events little bit of shortness of breath and caller reports that her symptoms worsened was unknown; while outcome of other events was not recovered. Investigation Assessment: No Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1770899
Sex: F
Age:
State: NY

Vax Date: 03/15/2021
Onset Date: 03/17/2021
Rec V Date: 10/08/2021
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: I noticed a rash across my ribs from one side to other flat non itchy rash across my stomach; One side form my left side of my waist to right side like under my breast right to my navel right in that area; This is a spontaneous case received from a contactable consumer (patient). A 70-year-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot: EL9266) via an unspecified route of administration on 15Mar2021 as DOSE 2, SINGLE (age at vaccination 70-year-old) for COVID-19 immunisation. The patient medical history included blood pressure from an unknown date and unknown if ongoing. Concomitant medication included METOPROLOL 25 mg for blood pressure from unspecified date in 2020 to unknown stop date. The patient historical vaccine included first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot: EN5318) via an unspecified route of administration on 22Feb2021 for COVID-19 immunisation. On 17Mar2021, the patient reported that she noticed a rash across her ribs from one side to other, flat non-itchy rash across her stomach and one side form my left side of my waist to right side like under my breast right to my navel right in that area. Therapeutic measures were taken as a result of the events which included treatment with Benadryl cream. The outcome of the events was recovering. No follow-up attempts are possible. No further information was expected.

Other Meds: METOPROLOL

Current Illness:

ID: 1770900
Sex: U
Age:
State:

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 10/08/2021
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: I did get an allergy started from underneath from where tears comes up bottom of eye, eye lid was uncomfortable; I did get an allergy started from underneath from where tears comes up bottom of eye, eye lid was uncomfortable; felt cheek little hard and bone little tougher; An allergy reaction on corner right side of lip that side I received vaccine, not thicker but different; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date not reported), via an unspecified route of administration, in right side, on 18Mar2021, as dose number unknown, single, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 18Mar2021, after receiving the COVID vaccine, the patient experienced an allergy it was not severe, was like a mild allergy, started from underneath eye lid, from where the tears come up bottom of eye, and was little like uncomfortable. After 40 minutes taking the vaccine, the corner of right side of lip was like the little, not thicker but, different and then felt cheek a little hard and on cheek bone just like a little tougher. It was reported that, the patient does not know how to explain it. The patient called doctor and she recommended to take Benadryl and she said that was a reaction, because that was not really swollen it was tiny. The patient didn't take anything. The patient woke up on 19Mar2021 (reported as today) in the morning and it was little bit swollen. So, the patient took Benadryl. The patient asked how long this would stay, for how long to be taken the Benadryl. The outcome for the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1770901
Sex: F
Age:
State: FL

Vax Date: 03/17/2021
Onset Date:
Rec V Date: 10/08/2021
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: Slight rash around her neck; Little soreness in her arm; This is a spontaneous report from a contactable consumer (patient's parent). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7534), via an unspecified route of administration on 17Mar2021 (at the age of 62 year old) as dose number unknown, single for COVID-19 immunisation. Medical history included thyroid, rashes, rash from penicillin (sensitivity), Concomitant medications included levothyroxine sodium for an unspecified indication. On an unspecified date in Mar2021, the patient experienced slight rash around her neck and little soreness in her arm. No other reported side effects. At the time of report, rash disappeared. No treatment was received for the events. The outcome of the event slight rash around neck was recovered and of other event was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: LEVOTHYROXINE [LEVOTHYROXINE SODIUM]

Current Illness:

ID: 1770902
Sex: M
Age:
State: CO

Vax Date: 03/17/2021
Onset Date:
Rec V Date: 10/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: now my husband has the cough, it's just that he is not he is not blowing his nose that much, but we both had our shot on same day.; now my husband has the cough, it's just that he is not he is not blowing his nose that much, but we both had our shot on same day.; This is a spontaneous report from a contactable consumer (Reporter's husband). An 80-year-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for Injection, Batch/Lot number: unknown) via unspecified route of administration on 17Mar2021 (at the age of 80-year-old) as dose 2, single for COVID-19 immunization. The patient medical history was reported as none. The patient received unspecified concomitant medications. On an unspecified date in 2021, the patient experienced now my husband has the cough, it's just that he is not he is not blowing his nose that much, but we both had our shot on same day. This is the second case out of two cases in which reporter is reporting for her husband. Reporter stated, well, we got our final shot on the 17th and I had a cold when I went in or when they called me about it, anyway when I went in, I told them I had a cold, they say no come-on in we can still give you the shot. Then when I got in there, I told them I so had cold and they checked with the pharmacist and he said that would be okay, but then I also got a cough and now my husband has the cough, it's just that he is not he is not blowing his nose that much, but we both had our shot on same day. And I don't think I have run a fever with it all. I did have a fever when they gave me the shot. And then I am just wondering if this a reaction to some of the Pfizer. Reporter added, no fever and I went in with the cold and then my husband come down with the cough now and we both got them on 17th and we got the second one. I have a cough too. When confirmed that the reporter wanted to know if this is the side effect from the Pfizer COVID 19 Vaccine, reporter stated, right. LOT: Reporter stated, I don't see a LOT over here, EN6207, this is for me, and my husband had the same one. When confirmed if it is for the Reporter or her husband, Reporter stated, this is for me, and my husband had the same one (Further clarification unknown hence not captured in tab). Expiration date: Reporter stated, I do not know what date that is. Where would that be. It just says 17MAR2021 at (name). Concomitant medication: Reporter stated, yes. Name of the medication: Reporter stated, no, I don't know them. Outcome of all the events was unknown. No follow-up attempts were possible; information about lot/batch number cannot be obtained. No further information was expected.

Other Meds:

Current Illness:

ID: 1770903
Sex: U
Age:
State: NV

Vax Date: 03/18/2021
Onset Date:
Rec V Date: 10/08/2021
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: I am feeling a little bit of pain in just one knee; my left knee and today I cannot even move it. It is so swelled up; my left knee and today I cannot even move it. It is so swelled up; This is a spontaneous report from a contactable consumer (patient). A 67-year-old patient of an unspecified gender received first dose of bnt162b2 (Pfizer covid-19 vaccine, solution for injection, Batch/lot number: EN6205, Expiry date: unknown), via an unspecified route on 25Feb2021 and second dose of bnt162b2 (Pfizer covid-19 vaccine, solution for injection, Lot number: EN6206, Expiry date: unknown), via an unspecified route on 18Mar2021 (age at vaccination: 67-year-old), as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient had the vaccine on Thursday and on an unknown date on Friday patient was feeling a little bit of pain in just one knee, left knee and today patient cannot even move it. It was so swelled up and it was just left knee. The clinical outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1770904
Sex: F
Age:
State: NJ

Vax Date: 03/19/2021
Onset Date: 03/19/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data: Test Date: 20210319; Test Name: heart rate; Result Unstructured Data: Test Result:124 beats per minute; Test Name: pulse oximeter; Result Unstructured Data: Test Result:91-94%

Allergies:

Symptom List: Pain in extremity

Symptoms: wheezing; breathlessness/elevated breathing like she was breathing hard; couldn't sleep well; little bit of fever; tiredness; body aches; heart rate is coming up to 124 beats per minute; chest pain, like a heaviness in the chest; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EP7534, Expiry Date: Unknown) via an unspecified route of administration, administered in Arm Right on 19Mar2021 (at the age of 65-year-old) at 09:00 as dose 1, single for covid-19 immunisation (patient's spouse died from COVID 19, got vaccine for protection). The patient medical history included ongoing hypertension (high blood pressure), ongoing diabetes mellitus (diabetes), and COVID-19 from Nov2020 to 12Dec2020 (The patient was a COVID patient. She had the COVID 19 virus in Nov2020. She had recovered by 12Dec2020, and she is cleared from the Covid 19 virus. Her covid is gone). The patient concomitant medication amlodipine besilate, atenolol (STAMLO BETA) taken (has taken for a while) for hypertension 50mg 1 per day in the morning from an unspecified start date and ongoing; teneligliptin hydrobromide (TENALI) taken (had taken for 2 months) for diabetes mellitus 20mg once a day from an unspecified start date and ongoing; rosuvastatin calcium (ROSUSON) taken (had taken for 2 months) for diabetes mellitus 10mg once per day from an unspecified start date and ongoing. 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) were none. Additional Administered Vaccines If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was none. Prior Vaccinations (within 4 weeks) and following prior vaccinations were none. The reporter stated, Friday morning 19Mar2021, after receiving the COVID 19 vaccine, his mother was alright. Friday night 19Mar2021 she was complaining of chest pain, like a heaviness in the chest. On 19Mar2021, the patient experienced wheezing, breathlessness, half an hour after receiving the COVID-19 vaccine the patient had no reaction but later that night the patient complained that she couldn't sleep well, next day the patient had elevated breathing like she was breathing hard. The next 2 days, she had a little bit fever but then the fever was gone, she also had tiredness, she also had pain and that is gone. Clarified pain as body aches. The reporter was using a pulse oximeter on his mother and was getting a reading of 91-94%. But her heart rate was coming up to 124 beats per minute and that was not normal. After the COVID 19 vaccine the patient continues to have issues with breathing while climbing steps. When she received the vaccination, the facility asked that question, if she had had COVID 19 the virus. The CDC guidelines say you can get the Covid 19 vaccine 90 days after having the COVID 19 virus. The reporter was asking does that have anything to do with this or not. The reporter is also asking if his mother should wait with these symptoms or should they go to an urgent care. They haven't visited or seen any relatives that could check his mother. The reporter is calling to be cautious. The patient was given Tylenol PM on Friday night, 19Mar2021 through Sunday night 21Mar2021. When the patient received the COVID 19 vaccine at the facility, she stayed 15 minutes after she got the vaccine and nothing happened, so she left. Reporter was asking if this was something that will go away in few days. The adverse event did not lead to emergency room, Physician office visit. The patient underwent lab tests and procedures which included heart rate that was 124 beats per minute on 19Mar2021, oxygen saturation that was 91-94% on an unspecified date. Reporter stated, Friday morning 19Mar2021, after receiving the Covid 19 vaccine, his mother was alright. Friday night 19Mar2021 she was complaining of chest pain, like a heaviness in the chest. The next day she was wheezing, and the reporter could see she's not breathing normally. She's trying hard to breathe. For the first 3 days after the Covid 19 vaccine the reporter waited because he expected a reaction but today is the 4th day. The wheezing has improved a little bit but at nighttime it's worse. And when she tries to sleep it gets worse. The breathlessness improved but during the night she was having trouble. His mother's tiredness is related to her breathing he would guess. The reporter states he has given his mother Tylenol PM on Friday night, 19Mar2021 through Sunday night 21Mar2021. She takes nothing during the daytime, only at nighttime. The reporter states his dad passed away because of the COVID 19 virus. When his mother received the Covid 19 vaccine at the facility, she stayed 15 minutes after she got the vaccine and nothing happened, so she left. The reporter was asking if this is something that will go away in a few days. Event did not require a visit to Emergency Room or Physician Office. Relevant Tests were none. Outcome of event little bit of fever and body aches was recovered on 20Mar2021 and 22-Mar-2021 respectively and wheezing was resolving. Outcome of event heart rate is coming up to 124 beats per minute and chest pain, like a heaviness in the chest was unknown and for other all events outcome was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: STAMLO BETA; TENALI; ROSUSON.

Current Illness: Blood pressure high (high blood pressure); Diabetes (diabetes).

ID: 1770905
Sex: F
Age:
State: MI

Vax Date: 03/20/2021
Onset Date: 03/01/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data: Test Date: 202103; Test Name: Body temperature; Result Unstructured Data: Test Result:100.2 Fahrenheit; Test Date: 202103; Test Name: Body temperature; Result Unstructured Data: Test Result:99.2 Fahrenheit

Allergies:

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

Symptoms: Fever; feeling very week; very bad chills; body aches so bad that she was unable to walk on Sunday/she could not get up because everything hurt; body aches so bad that she was unable to walk on Sunday; could not sleep; Headache; Her legs and everything hurt; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number, expiration date, NDC number were reported as unknown), via an unspecified route of administration, administered in left arm on 20Mar2021 at 11:50 (at the age of 53 years) as dose 1, single for covid-19 immunization. Patient's medical history, prior vaccinations (within 4 weeks), adverse events following prior vaccinations, family medical history, additional vaccines administered on same date of the Pfizer suspect were reported as none. No history of all previous immunization with the Pfizer vaccine considered as suspect. There were no concomitant medications. On 21Mar2021, the patient experienced very bad chills at 02:00, felt very week at 08:30, and fever at 12:00. On an unknown date in Mar2021, the patient experienced body aches so bad that she was unable to walk on Sunday. It was reported that, she took vaccination on Saturday and was ok. On Sunday, she was very weak and was still weak at the time of reporting. She also had headache. In the morning, she could not get up because everything hurt. She could not sleep and was in bed. Her legs and everything hurt. The patient underwent lab tests and procedures which included body temperature: one time she took it, and it was 100.2 and another time it was 99.2 degrees Fahrenheit in Mar2021. She wanted to know if she would be ok if she takes the second dose of vaccine with symptoms. She was much better than Sunday, but she was weak. No ER or physician's office required. She felt bad but did not go anywhere. She had read on the paper that said she may have some of the events. The outcome of the events very bad chills, feeling very week, and fever was recovering, and for all other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1770906
Sex: F
Age:
State: FL

Vax Date: 03/15/2021
Onset Date: 03/18/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: I had severe headaches; Nausea; Inability to walk; Fever; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6206) via an unspecified route of administration on 15Mar2021 as dose number unknown, single for COVID-19 immunization (at the age of 74-year-old). Medical history included thyroid disorder and hormone therapy. Concomitant medications included levothyroxine taken for thyroid disorder; estradiol taken for hormone therapy, start and stop date were not reported. The patient experienced i had severe headaches, nausea, inability to walk and fever on 18Mar2021. It was reported that, patient had the Pfizer vaccine, week ago today, she had an undiagnosed case of Covid and when she was checked with 7 different doctor's they all said there was nothing wrong with her, then she came down with long-hauler syndrome for months and quite miserable that there was nothing wrong with her, she would up getting the same symptoms 3 days after, had the injection Monday, she had severe headaches, nausea, Inability to walk, fever those were the main things. Patient still had the headache and got low grade fevers. The patient did not receive any treatment for the events. The outcome of the event fever was recovering, severe headache was not recovered and for nausea and inability to walk was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: LEVOTHYROXINE; ESTRADIOL

Current Illness:

ID: 1770907
Sex: F
Age:
State:

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

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

Lab Data: Test Name: Blood work; Result Unstructured Data: Test Result:Normal

Allergies:

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

Symptoms: Nose bleeds; This is a spontaneous report from a contactable Pharmacist reported for consumer (Patient). A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was unknown), via an unspecified route of administration on an unknown date at single dose for COVID-19 immunization (age at vaccination was 54 years). The patient medical history included Penicillin allergy. Concomitant medication was none. On an unknown date, after receiving first dose patient had a minor nosebleed that night and then had 3 nose bleeds in the days after. The event was considered as non-serious. Upon the latest nosebleed the physician drew blood work, and everything was normal. The patient is worried about the 2nd dose. The patient underwent lab tests and procedures which included blood test: normal on unspecified date. Follow-up (11May2021): Follow-up attempts completed. No further information expected. Upon follow up on 24Mar2021new information has been updated. This is a follow up spontaneous report from a contactable consumer. This consumer reported for a female patient about drug information (Pfizer Biontech covid 19 vaccine, dosage text about 1st dose, action(s) taken with drug was unknown, dates, NDC number, Expiry Date for Pfizer was unknown), reason for no lot number of Pfizer covid19 vaccine states student pharmacist who was calling on behalf of patient female he has no lot, expiry date or NDC for the patient's Pfizer COVID19 Vaccine. Patient history was not provided. Investigation assessment was not provided. The outcome of the event was not recovered. Follow up (24Mar2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported for a female patient that This is a follow up spontaneous report from a contactable consumer. This consumer reported for a female patient about drug information (Pfizer Biontech covid 19 vaccine, dosage text about 1st dose, action(s) taken with drug was unknown, dates, NDC number, Expiry Date for Pfizer was unknown), reason for no lot number of Pfizer covid19 vaccine states student pharmacist who was calling on behalf of patient female he has no lot, expiry date or NDC for the patient's Pfizer COVID19 Vaccine. Patient history was not provided. Investigation assessment was not provided. Follow-up attempts are completed. No further information is expected

Other Meds:

Current Illness:

ID: 1770908
Sex: F
Age:
State: TX

Vax Date: 03/09/2021
Onset Date: 03/01/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data: Test Date: 202103; Test Name: TSH level; Result Unstructured Data: Test Result:5.61; Comments: Her TSH was like 5.61, she thinks, she doesn't remember exactly- it was in that range.

Allergies:

Symptom List: Vomiting

Symptoms: Small bruises on her leg / little bit of bruising; Skin lesion on her leg; Knees swelled up/swelling of knee; the swelling has gone down although it is still tender; Scabbed over with redness. It looks like a scab with redness; Scabbed over with redness. It looks like a scab with redness; Muscle pain; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program [COVAX US Support]. A 54-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6206, expiration date: not reported) via an unspecified route of administration, administered in left arm on 09Mar2021 at 17:05 (at the age of 54-years-old) as dose 1, single for covid-19 immunization. Medical history included Hashimoto's disease, she had her TSH level checked a couple weeks ago for her thyroid because she has Hashimoto's. reporter states she is in what they call "subclinical ranges" and treatment was not recommended. She is slightly elevated, but her doctor doesn't feel she should be medicated for it. She has autoimmune illnesses that are not understood in women, especially middle-age, Diabetes, She even had family members with diabetes and never saw skin lesions on them. energy to get through/ cant work a full time job. Muscle pain, She does experience muscle pain anyway as a part of her chronic illness so muscle pain is nothing new to her, but this pain was extreme for her. She has lost weight during the pandemic, she makes the comment "when you're under stress, some people eat more and some people eat less, I am in the eat less category." 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. No Prior Vaccinations (within 4 weeks), she a had tetanus shot about 4 years ago; that was the last shot before the COVID-19 vaccine. She has a small skin lesion on her left leg that seems to be getting better. She got the first dose of the vaccine 2 weeks and 2 days ago now, and the lesion showed up over a week after, with some unexplained bruising on the same leg.She clarifies she has one skin lesion on her left leg. She confirms its not a rash. its a scabbed over type of a lesion and there is bruising and swelling with it. She clarifies further there was bruising and swelling with the lesion a few days ago that is getting better. The swelling is gone and bruising is diminishing. Reporter confirms she did not have that kind of swelling. It was localized. She didnt swell up at the injection site, she only had the normal kind of side effects she was told to expect- sore arm, fatigue. Nothing else on the arm, just the leg. She has hashimotos disease, but that is not the only autoimmune illness she has. Every single symptom long haulers get after COVID-19, she has lived with those symptoms for years with her autoimmune illness which is why she wanted the vaccine. People dont understand what chronic illness is like. She already has long haulers, she has had it for years, she doesnt need COVID-19 disease. Because of her autoimmune diseases, she is already hanging on by a thread most days, in terms of having enough energy to get through it. She has to take naps and cant work a full time job. She has enough issues. Concomitant medications included cholecalciferol VIT D [COLECALCIFEROL] and zinc (ZINC) start and stop date unknown. On Mar2021, patient experienced small bruises on her leg / little bit of bruising, knees swelled up/swelling of knee, the swelling has gone down although it is still tender, Scabbed over with redness. It looks like a scab with redness, muscle pain. Time of onset was 10 days after Vaccine. On Mar2021, patient underwent lab tests and procedures which included blood thyroid stimulating hormone resulted 5.61, Her TSH was like 5.61, she thinks, she doesn't remember exactly- it was in that range. The outcome of event scabbed over with redness. it looks like a scab with redness was not recovered, events small bruises on her leg / little bit of bruising, skin lesion on her leg and muscle pain was recovering and outcome of events knees swelled up/swelling of knee and the swelling has gone down although it is still tender was recovered in Mar2021 No follow-up attempts are needed. No further information is expected.

Other Meds: VIT D [COLECALCIFEROL]; ZINC

Current Illness:

ID: 1770909
Sex: M
Age:
State: CA

Vax Date: 03/18/2021
Onset Date: 03/20/2021
Rec V Date: 10/08/2021
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: 202103; Test Name: X-ray; Result Unstructured Data: Test Result:Unknown.

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Saturday, 20Mar2021 was when I had noticed the same adverse event (joint pain) on my left foot after I had received the 2nd dose of Pfizer vaccine on Thursday, 18Mar2021; Another flare up (worse than 1st time) occurred after the 2nd vaccine shot - within 2 days; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6199), via an unspecified route, administered in Left Arm on 18Mar2021 (48-year-old at vaccination) as Dose 2, Single for COVID-19 immunization. Facility type vaccine was reported as Workplace clinic. The patient's medical history was concomitant medications within two weeks was reported as none. No known allergies. The patient had not received any other vaccine within four weeks to prior vaccination. The patient was not diagnosed with COVID prior vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN 5318), via an unspecified route, administered in Left Arm on 24Feb2021 at 3:30 PM as Dose 1, Single for COVID-19 immunization. Left foot joint pain (gout) several days after receiving 1st vaccine shot. Another flare up (worse than 1st time) occurred after the 2nd vaccine shot - within 2 days. On 20Mar2021 at 12:00 (Saturday), the patient experienced the same adverse event joint pain on his left foot. The patient underwent lab test and procedure which included X-ray left foot: unknown results. Post vaccination the patient was not tested for COVID. The patient was prescribed Colchicine for resulted events. Clinical outcome of the events was reported as not recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1770910
Sex: F
Age:
State: NY

Vax Date: 03/23/2021
Onset Date: 03/01/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data: Test Date: 20210324; Test Name: Body temperature; Result Unstructured Data: Test Result:101.3 Fahrenheit; Comments: I woke up this morning with 101.3 fever

Allergies:

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

Symptoms: nauseous; definitely achy; fever/101.3 fever/feverish; feels un well/I was feeling a little off; chills; sore; tiredness.; Flu like 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, Batch/Lot number was not reported), via an unspecified route of administration on 23Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller reported that she received the second dose of vaccine yesterday afternoon. Today (24Mar2021) she had a fever of 101.3, and she felt unwell. Caller reported that she took Tylenol. She said last night (23Mar2021) she was feeling a little off. She woke up, she had chills, achy and sore all night and she woke up this morning (24Mar2021) with 101.3 fever and just feeling off like little nauseous and definitely achy and feverish. Reporter (patient) was experiencing flu-like symptoms like 101.3?F fever, body aches and tiredness. She would like to report these symptoms. She also was asking if she can infect her son who was at home. The patient underwent lab tests and procedures which included body temperature: 101.3 Fahrenheit on 24Mar2021. Therapeutic measures were taken as a result of pyrexia, malaise, nausea, definitely achy, feverish and chills. The outcome of all events was unknown. No follow-up attempts are needed, information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1770911
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/08/2021
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: Extreme joint pain for several weeks; Water in the inner ear; Curvature of the penis; This is a spontaneous report received from a non-contactable nurse, (patient himself). A 62-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown, Expiration date was not reported), via an unspecified route of administration on an unspecified date (at the age of 62-years-old) as a dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. On an unspecified date, the patient experienced extreme joint pain for several weeks, water in the inner ear, curvature of the penis. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient received vitamin d, pain killers as treatment medications for the resulted events. The outcome of the events was not recovered. No follow-up attempts are possible, information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1770912
Sex: U
Age:
State:

Vax Date:
Onset Date: 03/21/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Arm was swollen and all red; Arm was swollen and all red; A big spot and it was sore and now it is itchy; A big spot and it was sore and now it is itchy; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date in an unspecified arm as dose 2, single for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. It was reported that patient had Pfizer Covid Vaccine, the second shot (on Saturday) and on 21Mar2021, patients arm was swollen and all red, a big spot and it was sore and now it was itchy. The outcome of all the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1770913
Sex: M
Age:
State: CA

Vax Date: 02/23/2021
Onset Date: 03/18/2021
Rec V Date: 10/08/2021
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 Date: 20210318; Test Name: body temperature; Test Result: 103.7 {DF}; Test Date: 20210318; Test Name: Covid-19 virus test; Result Unstructured Data: Test Result:Negative; Comments: Negative

Allergies:

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

Symptoms: body pain; headache; chills; sweats; fever (high 103.7); sore lower back; This is a spontaneous report from a non-contactable consumer. This consumer (patient) reported that a 46-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6198), dose 2 via an unspecified route of administration, administered in Arm Left on 23Feb2021 (Age at vaccination 45 years) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications. Patient not had allergies to medications, food, or other products. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL9261), via an unknown route of administration at left arm on 02Feb2021 at 08:30 as dose 1, single for covid-19 immunisation. On 18Mar2021 05:45, the patient experienced body pain; headache; chills; sweats; fever (high 103.7) and sore lower back. Patient was not received treatment for events. The patient underwent lab tests and procedures which included body temperature: 103.7 df on 18Mar2021, sars-cov-2 test: negative on 18Mar2021 Negative (12 hrs after symptoms). It was reported that patient commencing on morning of 18Mar2021 thru current (21Mar2021), body pain, chills, sweats, sore lower back, fever (high 103.7), persistent tension/headache. Facility where the most recent COVID-19 vaccine was administered at hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. Patient did not received any other medications the patient received within 2 weeks of vaccination. The clinical outcome of events was recovering. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am