VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1725692
Sex: F
Age:
State: IL

Vax Date: 03/03/2021
Onset Date: 03/06/2021
Rec V Date: 09/23/2021
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: Red, very itchy, swollen eyelids three days after vaccinated. Right eyelid was swollen shut, left eyelid was just a little red; Red, very itchy, swollen eyelids three days after vaccinated. Right eyelid was swollen shut, left eyelid was just a little red; Red, very itchy, swollen eyelids three days after vaccinated. Right eyelid was swollen shut, left eyelid was just a little red; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 14:15 (Batch/Lot Number: EN6202) as SINGLE DOSE for covid-19 immunisation. Medical history included obesity from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing. Concomitant medication included metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported; montelukast (MONTELUKAST) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. There were no known allergies. The patient experienced red, very itchy, swollen eyelids three days after vaccinated. right eyelid was swollen shut, left eyelid was just a little red on 06Mar2021 07:00, red, very itchy, swollen eyelids three days after vaccinated, right eyelid was swollen shut, left eyelid was just a little red on 06Mar2021 07:00, red, very itchy, swollen eyelids three days after vaccinated. right eyelid was swollen shut, left eyelid was just a little red. Therapeutic measures were taken as a result of the events. The outcome of the events were recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: METOPROLOL; MONTELUKAST; HYDROCHLOROTHIAZIDE

Current Illness:

ID: 1725693
Sex: F
Age:
State: MN

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

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: rt arm and shoulder pain with edema; rt arm and shoulder pain with edema/joint pain; rt arm and shoulder pain with edema; body aches; headache; tired; not feeling well; This is a spontaneous report from a contactable consumer. A 68-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 04Mar2021 17:15 (Batch/Lot Number: EN6204) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included pain, stage 3 kidney failure, a fib, auto immune, osteoporosis and many med sides effects from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included gabapentin (GABAPENTIN), atenolol (ATENOLOL), chlorthiazide (CHLORTHIAZIDE), vitamin b complex (VITAMIN B), calcium (CALCIUM) taken for an unspecified indication, start and stop date were not reported. On 04Mar2021 patient experienced rt arm and shoulder pain with edema, joint pain, body aches, headache, tired, not feeling well. The patient did not received treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: GABAPENTIN; ATENOLOL; CHLORTHIAZIDE; VITAMIN B; CALCIUM

Current Illness:

ID: 1725694
Sex: M
Age:
State: MO

Vax Date: 02/24/2021
Onset Date: 02/28/2021
Rec V Date: 09/23/2021
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: full body rash; This is a spontaneous report from a contactable Nurse. This Nurse reported for a 33-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6198; Expiration date: unknown) intramuscular, administered in Arm Left on 24Feb2021 13:30 (at the age of 33-years-old) as DOSE 2, SINGE for COVID-19 immunization. Medical history included diabetes mellitus, blood cholesterol increased, blood pressure increased from an unknown date and unknown if ongoing. Concomitant medications included metformin (METFORMIN), empagliflozin (JARDIANCE), fluoxetine (FLUOXETINE), lisinopril (LISINOPRIL), atorvastatin (ATORVASTATIN), omeprazole (OMEPRAZOLE) taken for an unspecified indication. Patient had not known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL9264; Expiration date: unknown) intramuscular, administered in Arm Left on 29Jan2021 13:30 (at the age of 33-years-old) as DOSE 1, SINGE for COVID-19 immunization. The patient experienced full body rash 4 days after the vaccine on 28Feb2021 22:00. AE resulted in emergency room/department or urgent care visit. Patient had received treatment for adverse event with cotisone shot and Zyrtec. Rash would not resolved with a cortisone shot. Benedryl helped somewhat. Since the vaccination, patient has not been tested for COVID-19. The outcome of event was recovered on 04Mar2021. No follow-up attempts are possible. No further information is expected.

Other Meds: METFORMIN; JARDIANCE; FLUOXETINE; LISINOPRIL; ATORVASTATIN; OMEPRAZOLE

Current Illness:

ID: 1725695
Sex: F
Age:
State: MO

Vax Date: 03/04/2021
Onset Date: 03/01/2021
Rec V Date: 09/23/2021
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: she also said it itches a lot/itching a lot off and on; injection site pain, which she still had pain every once in a while/pain was not that bad now; having injection site pain the redness/injection site was still red on her arm kind of; Headache; Muscle pain; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206, expiration date: not reported), dose 2 via an unspecified route of administration, administered in arm right on 04Mar2021 09:10 (at the age of 79-years-old) as DOSE 2, SINGLE for covid-19 immunisation (COVID-19 vaccination) at hospital. Medical history included hypertension/high blood pressure (this was diagnosed in 1993-1994 and at first, she wasn't taking medication for her high blood pressure for a few years, then 2000 something she started taking medication for it and was taking medication for this), diabetes from 1995. There were no concomitant medications (not had any other recent vaccinations or started any new medications; other products: no). Historical vaccine included that the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number EL9264), dose 1 via an unspecified route of administration in arm right on 11Feb2021 (at the age of 79-years-old) as DOSE 1, SINGLE for covid-19 immunisation at hospital and experienced nothing. Reportedly, the patient got both doses of the Pfizer COVID-19 vaccine and had a reaction to the second dose, and nothing to the first. Provider information was unknown, the patient said that she doesn't know whether it was her primary care, or her diabetic doctor/endocrinologist and it is a medical group. The patient got second dose of the Pfizer covid vaccine and was having injection site pain, the redness in Mar2021. The patient wanted to know if she can use cold compress or something to treat that and she also said it itched a lot (start: Mar2021). She said she had an appointment with her endocrinologist tomorrow (unspecified date) and they might suggest something. In Mar2021, she had injection site pain, which she still had pain every once in a while. She said she had a headache, and muscle pains, and her injection site was still red on her arm kind of (start: Mar2021 for all). As treatment, the patient took TYLENOL 500mg, she was taking one, and she didn't put nothing on the site where injection was. She said that the pain was not that bad now, it had a red circle around the site, and it was itching a lot off and on. No further details provided about her TYLENOL she took. The outcome for injection site pain, which she still had pain every once in a while/pain was not that bad now was recovering; for she also said it itches a lot/itching a lot off and on and having injection site pain the redness/injection site was still red on her arm kind of was not recovered; and unknown for rest all other events. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1725696
Sex: M
Age:
State: AL

Vax Date: 02/18/2021
Onset Date: 03/04/2021
Rec V Date: 09/23/2021
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: rash; spots and bumps on his limbs and chest./he also has different spots on the chest and another one on the left leg, 2 on the right leg.; This is a spontaneous report from a contactable consumer. This male consumer reported about himself that: A 78-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EK4176) via an unspecified route of administration, administration on left arm on 18Feb2021 14:00 as dose 1, single (at the age of 78-years) for covid-19 immunization. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (age at vaccination 78-years-old), dose 1, on 28Jan2021 for covid-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. The patient got the first dose of the vaccine on 28Jan2021 and the second dose on 18Feb2021. On 04Mar2021, the patient started to break out in a rash and this rash was on left arm on the bottom part of the forearm on the tender skin, the patient clarified that there was more rash on the left arm than anywhere else on his body. The left arm was also where he got injection. After the left arm the patient began to notice it on right arm and there was less rash on right arm. The patient had spots on chest and another one on the left leg, 2 on the right leg. Later noticed the left arm pinky and ring finger got rash in between the 2 fingers. On the right arm, the rash was on ring finger on the top part. There was little spot on the left chest and little spots as big as finger on the left leg on the thigh and the patient also had it down around the ankle on the left leg. The patient describe the spots as being reddish pinkish spots and they was bumps and some was spread out. The patient tried putting Cortisone 10 on it and that made it worse so he washed it off. The patient started using Bactine pain relieving cleansing spray on 04Mar2021 and that helped to dry it up a little but it was still not well yet and the patient still using this. The patient stated that he called on Saturday and held for an hour and a half but the number of callers ahead of him did not change so he called back today but it still took a long time. The outcome of the events were unknown. No follow-up attempts are possible; information about batch/ lot number cannot be obtained. .

Other Meds:

Current Illness:

ID: 1725697
Sex: M
Age:
State: CA

Vax Date: 03/04/2021
Onset Date: 03/06/2021
Rec V Date: 09/23/2021
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: Saturday 06Mar started getting a few red bumps on butt. Woke up on Sunday 07Mar had many more bumps on butt, stomach area, a few on the chest area, a few on each leg and about 30 on each side; Hives; This is a spontaneous report from a contactable Other HCP (Patient). A 56-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 10:30 (at the age of 56-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included Latex: allergies. The patient's concomitant medication(s) included diphenhydramine hydrochloride (BENADRYL) and ibuprofen. The patient previously took Sulfonamide/sulfa antibiotics and Erythromycin and experienced known allergies. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. The patient was not covid tested post vaccination. On Saturday 06Mar2021 (12:00 PM) started getting a few red bumps on butt. Woke up on Sunday 07Mar2021, the patient had many more bumps on butt, stomach area, a few on the chest area, a few on each leg end about 30 on each side of my torso. Looks like mosquito bites but most likely hives (on 06Mar2021). Size of red bumps are 1 to 5mm in diameter and raised with some looking to have a white center. As a result of event patient required Doctor or other healthcare professional office/clinic visit. It was unknown if patient received treatment for events. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: BENADRYL; IBUPROFEN

Current Illness:

ID: 1725698
Sex: M
Age:
State: GA

Vax Date: 02/26/2021
Onset Date: 03/05/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data: Test Name: potassium level; Result Unstructured Data: Test Result:level high, 5.9; Comments: states this was all way before the vaccine; Test Name: potassium level; Result Unstructured Data: Test Result:second time it 5.3; Comments: states this was all way before the vaccine; Test Name: potassium level; Result Unstructured Data: Test Result:came back 5.3; Comments: states this was all way before the vaccine

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: rash all over his body; rash is a little itchy; This is a spontaneous report received from a contactable consumer or other non hcp. A 65-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL9266; Expiration Date: 31May2021) via an unspecified route of administration in Arm Right on 26Feb2021 (age at vaccination 65years old) as single dose for covid-19 immunisation. Medical history included diabetes mellitus, blood cholesterol increased, thyroid disorder, drug hypersensitivity (Caller stated that he is not allergic to anything but penicillin that he is aware of), all from an unknown date and unknown if ongoing. Concomitant medication(s) included metformin (METFORMIN) taken for diabetes mellitus, start and stop date were not reported. On 05Mar2021 the patient experienced rash all over his body, rash is a little itchy. Clinical course was reported as he received the first dose of the Pfizer covid19 vaccine on 26Feb2021. He reported he developed a rash all over his body on 05Mar2021. His dermatologist took a sample of the rash and gave him Benadryl and a cream. He was not allergic to anything but penicillin that he was aware of. He wanted to know if this is a common side effect. The patient underwent lab tests and procedures which included blood potassium: level high, 5.9 on unspecified date, blood potassium: second time it 5.3 on unspecified date, blood potassium: came back 5.3 on unspecified date this was all way before the vaccine. The clinical outcome of the event was not recovered. Therapeutic measures were taken as a result of rash all over his body, rash is a little itchy. No follow-up attempts are possible. No further information is expected.

Other Meds: METFORMIN

Current Illness:

ID: 1725699
Sex: F
Age:
State: AZ

Vax Date: 02/17/2021
Onset Date:
Rec V Date: 09/23/2021
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 on hands/it went on both arms, neck, and ears; raised red patches and they itch; raised red patches and they itch; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EL9267) via an unspecified route of administration in right arm on 17Feb2021 at 12:00 (at the age of 67-year-old) as single dose for COVID-19 immunization. Medical history of the patient included Controlled high blood pressure, Heart arrhythmia. Patient did not receive any other vaccine in four weeks. Patient did not have covid prior vaccination and was not tested for covid post vaccination. Patient previously took Cipro antibiotics and experienced allergy. On an unspecified date in 2021 after receiving vaccination, patient experienced rash on hands which went away in approximately 1 week, 2nd week it went on both arms, neck, and ears. Patient was still having it and she was scheduled for second shot tomorrow. On an unspecified date in 2021, patient experienced raised red patches and they itch. Patient have an appointment to see her Primary Care Doctor in 2 days. AE resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient received any treatment. Outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1725700
Sex: F
Age:
State: NY

Vax Date: 03/06/2021
Onset Date: 03/07/2021
Rec V Date: 09/23/2021
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: Swollen eyelids; red eyelids; dry itchy eyes; dry itchy eyes; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 68-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6203), via an unspecified route of administration, administered in arm left on 06Mar2021 at 16:00 as dose 1, single for COVID-19 immunization. Medical history included samter's triad and coronary artery disease from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously took prednisone and ceclor and experienced known allergies. The patient did not receive any other vaccine in four weeks. Patient does not have covid prior vaccination and has not been tested for covid post vaccination. The facility type vaccine was reported as other while the facility type vaccine other was reported as fire house. On 07Mar2021 at 01:00, the patient experienced swollen eyelids, red eyelids, dry itchy eyes. The treatment was not received for all the events. The clinical outcome for all the events was reported as not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1725701
Sex: F
Age:
State: AL

Vax Date: 03/02/2021
Onset Date: 03/06/2021
Rec V Date: 09/23/2021
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: she had 4 bumps on her leg and 3 on her thigh; have improved, they have gotten smaller, but they are still red; This is a spontaneous report from a contactable consumer reported for herself. A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6200; Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 02Mar2021 13:30 (at the age of 65-years-old) as DOSE 1, SINGLE for covid-19 immunisation. NDC number of Covid-19 Vaccine was 02051493-0002. Vaccination Facility Type Set up clinic at a church. Medical history included autoimmune disease from 2015 and ongoing, hives, allergy to yellow jackets and wasps from an unknown date and unknown if ongoing. History: She said that she was tested for lupus, but she did not have Lupus. Caller said that she would break out in hives with her autoimmune disease and that the hives that come out sometimes. She did not know the name of the disease though. She stated that she was stung by a wasp and had to take venom shots. Concomitant medications included Venom shots (one injection in the left is for the wasp and the one in the right is for mixed Baspid) for allergy to yellow jackets and wasps from unspecified date and ongoing; montelukast sodium (SINGULAIR); cetirizine hydrochloride (ZYRTEK) taken for autoimmune disease from 2015 and ongoing. The patient experienced or had 4 bumps on her leg and 3 on her thigh, have improved, they have gotten smaller, but they were still red on 06Mar2021. The events were not serious. Patient took the first dose of the Pfizer vaccine on 02Mar2021. On Saturday (06Mar2021) noticed she had 4 bumps on her leg and 3 on her thigh. Bumps on right leg and right thigh and the shot was given on left arm. Patient asked if should proceed to get the 2nd shot on 23Mar2021. She didn't get really sick. It was not itchy. She noticed after the shower. It was going down. It was smaller but hadn't gone away. She will be getting venom shot on the 11th of March and asked if she should hold off on this. It was because she was allergic to bees, wasps, and yellow jacket. She has not seen her doctor yet and will not see her new doctor until 24Apr2021. The caller said that she had to switch doctors and has not seen the new one yet. She said that the bumps have improved, they have gotten smaller, but they were still red. The ones on her thigh were almost gone, but there was one that was small that was still there. The ones on the leg are still there and they have gotten smaller, but they were still red. The caller said that they did not hurt or anything. She said that she noticed them when she was getting out of the shower. They are just there, and they were red. She said that they were about 2-3 inches apart from each other and it was raised bump, like a pimple. History of all previous immunization with the Pfizer vaccine; immunizations; Additional Vaccines Administered on Same Date of the Pfizer Suspect; Prior Vaccinations (within 4 weeks); AE(s) following prior vaccinations; Family Medical History Relevant to AE(s) included none. AE(s) did not require a visit to Emergency Room or Physician Office. She was supposed to get her venom shots on 11Mar2021, but she does not know if she will get them now because of her symptoms. She called her doctor and they said that it would be ok to take it, but she was skeptical. Clinical outcome of events was recovering. No follow up attempts are possible. No further information is expected.

Other Meds: SINGULAIR; ZYRTEK

Current Illness: Autoimmune disorder

ID: 1725702
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
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: is a 50-50 chance that he may receive either vials.; pain on his arm; swelling; redness; anxious; This is a spontaneous report from a contactable nurse. A male patient of an unspecified age received first doe of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a 50-50 chance that he may receive either vial, pain on his arm, swelling, redness (It was about 2cm of redness. On the third day, it got bigger), anxious. It was reported that something happened during vaccination. There were 2 nurses, the first one is the one administering the Pfizer COVID-19 vaccine to him while the second nurse asked the first nurse which vaccine vial did she use on the caller. The second nurse explained that only 1 vial contained the vaccine while the other one was used for training purposes and only contained the diluent (saline). The first nurse was confused on which vial she had used. Caller is anxious since there is a 50-50 chance that he may receive either vials. He wanted Pfizer to have an opinion on whether he had he vaccine vial or the vial that only contained diluent. The outcomes of events (is a 50-50 chance that he may receive either vial, anxious) were unknown, and the outcomes of events (pain on his arm, swelling, redness) were recovered on unspecified date in 2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1725703
Sex: U
Age:
State: NY

Vax Date: 03/06/2021
Onset Date: 03/06/2021
Rec V Date: 09/23/2021
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: Rash; skin blotchiness; This is a spontaneous report from a contactable consumer. This 69-years-old consumer (patient) of an unspecified gender reported that the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration, administered in left arm on 06Mar2021 at 10:00 as dose 1, single for covid-19 immunization. Medical history included multiple allergies. The patient's concomitant medications were not reported. No Covid prior vaccination and Covid tested post vaccination. No other vaccine in four weeks product. The patient experienced rash and skin blotchiness on 06Mar2021 at 10:00. No treatment received. Ae resulted in none of the above. The outcome of event was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1725704
Sex: F
Age:
State: AL

Vax Date: 03/03/2021
Onset Date: 03/03/2021
Rec V Date: 09/23/2021
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: heartbeat; Result Unstructured Data: Test Result:fast

Allergies:

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

Symptoms: Tiredness; muscle pain; joint pain; fever; feeling unwell; fast heartbeat; This is a spontaneous report from a contactable consumer (patient). A 73-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported), via an unspecified route of administration, administered in arm left on 03Mar2021 at 09.00 (73-year-old at the time of vaccination) as dose 2, single for covid-19 immunization at doctor's office/urgent care. The patient was not pregnant at time of vaccination. The patient's medical history included allergy to Penicillin. The patient's specific concomitant medications name were not reported. It was reported that the patient had other medications in two weeks (not specified). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot number was not reported), via an unspecified route of administration administered in left arm on 10Feb2021 at 09.15 (73-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was not tested since vaccination. On 03Mar2021 at 20.00, the patient experienced tiredness, muscle pain, joint pain, fever, feeling unwell and fast heartbeat. No treatment was received for the events. The patient underwent lab tests and procedures which included heartbeat: fast, on an unspecified date. The outcome of the events was recovered on an unspecified date in Mar2021. No follow-up attempts are possible; information about batch/ lot number cannot be obtained.

Other Meds:

Current Illness:

ID: 1725705
Sex: F
Age:
State: NY

Vax Date: 02/19/2021
Onset Date: 03/07/2021
Rec V Date: 09/23/2021
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: felt weird; chills; upper shoulder pain; flu; whole body and her teeth were shaking; her shoulder where the vaccine was given was hurting her; This is a non-serious spontaneous report from a contactable consumer. This 67-year-old female consumer reported about herself. A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 2 via an unspecified route of administration, administered in Deltoid Left on 19Feb2021 (at the age of 67-years-old) as a single dose for covid-19 immunization. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date in Jan2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Caller states she received her 2nd Pfizer vaccine on 19Feb. "I didn't have a problem with the first dose and nothing with the 2nd vaccine dose for 16 days." Caller states, "Last night I had chills, upper shoulder pain, my teeth were chattering, it was like I had the flu." She says she got her first dose in January and had no reaction, then she got the second dose on 19Feb and had no reaction then, but it was very strange, yesterday her whole body and her teeth were shaking and chilling. She says she was under blankets to heat up, and the top of her shoulder where the vaccine was given was hurting her. She says she didn't relate it after almost two weeks or over two weeks since she had her second dose of vaccine. She says she had this on 07Mar, but she had flu like symptoms, chills, pain where vaccine was given in her upper left shoulder area, and she could not get warm. She says she took Tylenol and woke up feeling much better, but she still felt weird, not as cold, and her teeth were not chattering. She says that this is the weirdest thing, and she thinks it is related to the vaccine. She says she would like to know if it is an effect, if it kicks in because her body is creating its own antibodies. The patient received treatment for the adverse event with Tylenol. Outcome of the event was unknown. Description of product complaint: Consumer calling about the Pfizer COVID-19 vaccine, the two part vaccination, to report that she got both doses. She says her second dose was February 19th at (Name) after getting the first dose there three weeks prior and having no reaction on it. She says she got her first dose in January and had no reaction, then she got the second dose on February 19th and had no reaction then, but it was very strange, yesterday her whole body and her teeth were shaking and chilling. She says she was under blankets to heat up, and the top of her shoulder where the vaccine was given was hurting her. She says she didn't relate it after almost two weeks or over two weeks since she had her second dose of vaccine. She says that today she mentioned it to someone and they said it could be a delayed reaction, so she is reporting reaction. She says she had this on March 7th, but she had flu like symptoms, chills, pain where vaccine was given in her upper left shoulder area, and she could not get warm. She says she took Tylenol and woke up feeling much better, but she still felt weird, not as cold, and her teeth were not chattering. She says that this is the weirdest thing, and she thinks it is related to the vaccine. She says she would like to know if it is an effect, if it kicks in because her body is creating its own antibodies. Caller declines to complete a report. No further details captured, reported, or documented at this time. Product strength and count size dispensed: two doses. No follow up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.

Other Meds:

Current Illness:

ID: 1725706
Sex: F
Age:
State: ND

Vax Date: 03/04/2021
Onset Date: 03/05/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Red, inflamed rash to neck and portion of face; Red, inflamed rash to neck and portion of face; This is a spontaneous report from a contactable consumer (patient). A 59-year-old (non-pregnant) female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6204, Expiration date: not reported) via an unspecified route of administration in Left arm on 04Mar2021 at 16:15 (age at vaccination: 59-year-old) as dose 2, single for COVID-19 immunization. Medical history included long term diagnosis with eczema and rosacea. Concomitant medications included spironolactone 25 mg, gabapentin 500 mg and melatonin (in two weeks). The patient past drug included Tylenol 3 and codeine and the patient had known allergies with Tylenol 3 and codeine. On 05Mar2021 at 16:00, (began within 24 hours of vaccination) patient experienced red, inflamed rash to neck and portion of face. No treatment was received for the events. The events was lasted just under 48 hours. The patient did not receive other vaccine in four weeks. No covid present prior vaccination. Covid was not tested post vaccination. The outcome of events was recovered on an unspecified date in Mar2021. No follow up attempts are possible. No further information is expected.

Other Meds: SPIRONOLACTONE; GABAPENTIN; MELATONIIN

Current Illness:

ID: 1725707
Sex: F
Age:
State: TX

Vax Date: 02/26/2021
Onset Date: 02/27/2021
Rec V Date: 09/23/2021
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: a red rash appeared on my arm, which was very tender and sore.; It is still tender, although most of the rash is gone; chills; fever; nausea; headache; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: En6205 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 26Feb2021 at 01:00 PM (age at vaccination: 76 years), as unknown, a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included known allergies Penicillin. Concomitant medications included acetylsalicylic acid (ASPIRIN), paracetamol (TYLENOL ARTHRITIS), vitamin D NOS, and glucose. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 27Feb2021, the patient experienced chills, fever, nausea, and headache. Two days later on an unspecified date, a red rash appeared on my arm, which was very tender and sore. I had this rash for a week. It was still tender, although most of the rash was gone. The patient did not received any treatment for the events. Outcome of the events was recovered on an unspecified date in 2021. No follow up attempts are possible. No further information is expected.

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]; TYLENOL ARTHRITIS; VITAMIN D NOS; GLUCOSE

Current Illness:

ID: 1725708
Sex: M
Age:
State: TX

Vax Date: 03/06/2021
Onset Date: 03/07/2021
Rec V Date: 09/23/2021
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: Skin rash; Swelling; This is a spontaneous report from a contactable consumer reported for himself. A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number & Expiry date not reported) via unspecified route of administration on 06Mar2021 at 13:45 (at age of 40-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Patient medical history and concomitant medications were not reported. There were no reported allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 post vaccination. On 07Mar2021 17:00 (1 day 3 hrs 15 min after vaccination) patient experienced Skin rash, and swelling. Patient did not receive any treatment for the events. The Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1725709
Sex: M
Age:
State:

Vax Date: 03/04/2021
Onset Date: 03/05/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Achy joints; tiredness; Sore arm where injection site; This is a spontaneous report from a non-contactable consumer (patient). A 65-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: En6204, expiration date: not reported), dose 2 via an unspecified route of administration, administered in arm left on 04Mar2021 08:15 (at the age of 65-years-old) as DOSE 2, SINGLE for covid-19 immunisation at Hospital. The patient medical history was not reported. Concomitant medication included other mediation in two weeks (unspecified). Historical vaccine included that the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Em9810, expiration date: not reported) dose 1 via an unspecified route of administration, administered in arm left on 04Feb2021 08:15 (at the age of 65-years-old) as DOSE 1, SINGLE for covid-19 immunisation at Hospital. No other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination. On 05Mar2021 08:15, the patient experienced achy joints and tiredness, had sore arm where injection site. No treatment received for all the events. The outcome for all the events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1725710
Sex: F
Age:
State: CO

Vax Date: 12/30/2020
Onset Date: 01/07/2021
Rec V Date: 09/23/2021
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: having rash similar to hives; having rash similar to hives; noticed an increase in issues with my asthma; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 30Dec2020 14:45 (Lot Number: EK 9231) (at the age of 42 years old) as dose 1, single, and dose 2 via an unspecified route of administration, administered in Arm Left on 19Jan2021 (Lot Number: EL 8982) (at the age of 42 years old) as dose 2, single, both for COVID-19 immunisation at hospital. Medical history included hypothyroidism, celiacs, allergies to Sulfa meds, seasonal, latex on hands. Patient received other medications within two weeks of COVID vaccine. Patient did not received other vaccine within four weeks of COVID vaccine. Patient did not have COVID prior to vaccination. The patient experienced having rash similar to hives, noticed an increase in issues with my asthma on 07Jan2021 08:00. Adverse event reported as, patient have been having rash similar to hives that seem to show up especially in areas of friction from clothes, if something heavy rest against patient skin. Patient have also noticed an increase in Isues with his asthma. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment were received for the events with Z pack. Patient did not tested for COVID post vaccination. Outcome of all the events were recovered with sequelae on 2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1725711
Sex: M
Age:
State: TX

Vax Date: 03/04/2021
Onset Date: 03/06/2021
Rec V Date: 09/23/2021
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: Allergic reaction to both ears/Rash with bumps on both ears and they're red; Allergic reaction to both ears/Rash with bumps on both ears and they're red; Allergic reaction to both ears/Rash with bumps on both ears and they're red; Allergic reaction to both ears/Rash with bumps on both ears and they're red; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6205) via an unspecified route, administered in Left arm on 04Mar2021 at 13:00 (31-year-old at vaccination) as a Dose 1, Single for COVID-19 immunization. Facility type vaccine was reported as Pharmacy or Drug Store. Medical history was reported as none. No known allergies. There were no concomitant medications within two weeks of vaccination. The patient had not received any other vaccine in four weeks prior vaccination. The patient was not diagnosed with Covid prior vaccination. The patient was not tested for Covid post vaccination. On 06Mar2021 at 21:00, the patient experienced allergic reaction to both ears/rash with bumps on both ears and they're red. These adverse events did not result in emergency room/physician office visit. No treatment received for resulted events. The outcome of the events was not recovered. No follow-up attempts are possible. No further information was expected.

Other Meds:

Current Illness:

ID: 1725712
Sex: F
Age:
State: CA

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 09/23/2021
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: Nausea; Vomiting; Fever; headache; Pain in right shoulder and elbow; This is a spontaneous report from a contactable consumer (Patient). A 75-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN 6200) via an unspecified route of administration, administered in right arm on 19Feb2021 at 13:15 (at the age of 75-year-old) as single for COVID-19 immunization and was administered at School or Student Health Clinic. Medical history included dialysis, sleep apnea and had known allergies. The patient was not COVID prior vaccination and did not test for COVID post vaccination. Concomitant medications included varicella zoster vaccine rge (cho) (SHINGRIX) taken for an unspecified indication from 29Jan2021 to 29Jan2021, metoprolol, heparin, cetirizine hydrochloride (CETRIZINE), calcium citrate (CITRACAL [CALCIUM CITRATE]) and aloe vera, glycyrrhiza spp. root, linum usitatissimum, ulmus spp. (OMEGA FIBRE); all taken for an unspecified indication, start and stop date were not reported. On 19Feb2021, nausea and vomiting, fever and headache (slight headache continued). The patient had pain in right shoulder and elbow which started a few days after and continued for about two weeks. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received chiropractic treatment for shoulder and elbow pain. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds: METOPROLOL; HEPARIN; CETRIZINE; CITRACAL [CALCIUM CITRATE]; OMEGA FIBRE

Current Illness:

ID: 1725713
Sex: M
Age:
State: TN

Vax Date: 03/05/2021
Onset Date: 03/01/2021
Rec V Date: 09/23/2021
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: Had a reaction for three days which is a rash on his body; Rash has worsened; This is spontaneous report from a contactable consumer. This 77-years-old male consumer (patient) reported that. A 77-year-old male patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 05Mar2021 at 11:40 (at the age of 77-year-old) as dose 2, single for COVID-19 immunization. Patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in right arm on 09Feb2021 (at the age of 77-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes type 2 diabetes mellitus from an unspecified date and unknown ongoing and concomitant medications include Janumet. Past drug event includes metformin induced unknown reaction, He used to take Metformin before he took Janumet, but his HCP changed him to take Janumet. On 06Mar2021, after the vaccination, the patient experienced rash on his body. Caller states the rash has worsened and is on his back and he has to take Benadryl for it and he used the Benadryl diphenhydramine HCP 25mg for two days; states he used the Benadryl one 06Mar2021 and one on 07Mar2021. Patient received the 2nd dose of the Pfizer Vaccine three days ago which was Friday 05Mar2021 and the rash began the next day on 06Mar2021. The outcome of the events was not recovered or resolved at the time of this report. No follow-up attempts possible. No further information expected.

Other Meds: JANUMET [METFORMIN HYDROCHLORIDE;SITAGLIPTIN PHOSPHATE MONOHYDRATE]

Current Illness:

ID: 1725714
Sex: F
Age:
State: CA

Vax Date: 03/01/2021
Onset Date: 03/05/2021
Rec V Date: 09/23/2021
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: Delayed skin reaction (Covid arm) at site of injection and on upper arm; red rash; swelling; warm to touch; itchy; This is a spontaneous report received from a non-contactable consumer or other health care professional (patient). A 66-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch no: not reported /Lot number: EN6201, expiry date not reported) via an unspecified route of administration, administered in Arm left on 01Mar2021 08:00 AM as dose 2, single for covid-19 immunization. Medical history included autoimmune hepatitis and concomitant medications included other medications taken in two weeks as Azathioprine, Paracetamol (TYLENOL), Cannabidiol (CBD oil), Palmitoylethanolamide (PEA), Milk thistle all were unspecified indication and from unknown start and stop date. Patient had known Allergies which included Lactose intolerance. Historical vaccine included as patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201, Expiry date: unknown) via an unspecified route of administration and administered on in Arm left on 08Feb2021 08:00 AM as dose 1, single for COVID-19 immunization. Patient did not receive other vaccines within 4 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient has not been tested for COVID 19. No other vaccines received on the same date of vaccination. On 05Mar2021 05:00 PM, began on evening of 4th day after 2nd shot the patient experienced delayed skin reaction (Covid arm) at site of injection and on upper arm red rash, swelling, warm to touch, itchy. No treatment was received for the events caused. The outcome of the events was recovering. Follow-up attempts are completed. No follow-up attempts are possible. No further information is expected.

Other Meds: AZATHIOPRINE; TYLENOL; CBD OIL; PALMITOYLETHANOLAMIDE; MILK THISTLE

Current Illness:

ID: 1725715
Sex: F
Age:
State: MA

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: felt a rush of warmth throughout my body; Heart began racing for a minute; feeling short of breath and difficult breathing; Also felt like I couldn't swallow well; I felt weird all the way home; had a bit of tingling in lips; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself). A 60-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in arm left on 04Mar2021 at 14:00 (02:00 PM) (at the age of 60-year-old) as dose 1, single for COVID-19 immunization. Medical history included low thyroid, possibly asthma (recently got albuterol). The patient concomitant medications included levothyroxine sodium; cortisone shot a week before, both drugs taken for an unspecified indication, start and stop date were not reported. The patient previously took cipro (ciprofloxacin) and experienced drug allergy. The patient did not receive any other vaccine in four weeks. Patient was not diagnosed with COVID prior vaccination. Patient had not been COVID tested post vaccination. On 04Mar2021 at 14:00 (02:00 PM), the patient experienced felt a rush of warmth throughout my body, heart began racing for a minute, feeling short of breath and difficult breathing, also felt like I couldn't swallow well, I felt weird all the way home, had a bit of tingling in lips. Adverse event: Within 2 minutes after receiving shot, felt a rush of warmth throughout my body. Heart began racing for a minute or so but then seemed to go back to normal. Stayed the specified 15 minutes and then got in car to go home. Within a mile of the center started feeling short of breath and difficult breathing. Also felt like I couldn't swallow well. After a few more minutes it seemed to improve but I felt weird all the way home. At home got better but had a bit of tingling in lips. By 6:00 pm was totally fine. The patient did not receive treatment for the events. Outcome of all the events was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.

Other Meds: LEVOTHYROXINE SODIUM; CORTISONE

Current Illness:

ID: 1725716
Sex: F
Age:
State: AK

Vax Date: 02/27/2021
Onset Date: 02/28/2021
Rec V Date: 09/23/2021
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: injection site began to itch; injection site began to itch and the coloring of the rash turned to a purplish hue; the coloring of the rash turned to a purplish hue with smaller somewhat raised bumped within the rash area; rash area itches and feels warm; rash area itches and feels warm; Injection site feels hard; Injection site was red; This is a spontaneous report from a contactable consumer (patient) received via Regulatory Authtoirty. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 27Feb2021 at 11:30 AM (Batch/Lot number was unknown) (at the age of 29 years old) as dose 1, single for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included levothyroxine; bisacodyl (DULCOLAX); iron; unspecified prenatal vitamin, all taken for an unspecified indication, start and stop date were not reported. The patient was also taking unspecified medication reported as "b". The patient previously took amoxicillin and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Feb2021 at 11:30 AM, the patient reported that injection site was red, following injection within 24 hours. Injection site remained red and began to fade by day 7. On 08Mar2021 at 12:00 AM (also reported as day 9), the injection site began to itch and the coloring of the rash turned to a purplish hue with smaller somewhat raised bumped within the rash area. Area itched and felt warm to the touch. Injection site felt hard. The patient has not taken any treatment for the events. The outcome of events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds: LEVOTHYROXINE; DULCOLAX [BISACODYL]

Current Illness:

ID: 1725717
Sex: F
Age:
State: CA

Vax Date: 01/19/2021
Onset Date: 01/20/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data: Test Date: 20210120; Test Name: Fever; Result Unstructured Data: Test Result:100 Fahrenheit; Comments: 10:00; fever

Allergies:

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

Symptoms: 100 F fever; Chills; Fatigue; Muscle ache; Weakness; Headache; Eye pain; mild sore arm; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: ex9231) via an unspecified route of administration, administered in left arm on 19Jan2021 at 14:00 (age at vaccination was 57-year-old), as dose 1, single for COVID-19 immunization. The patient's medical history included COVID-19. Concomitant medications (medications in two weeks) were reported none. The patient did not receive any other vaccine within 4 weeks. Patient has no known allergies. Prior to vaccination, the patient has been diagnosed with COVID-19 and post vaccination, the patient has not been tested for COVID-19. The facility type where COVID-19 vaccine was administered was reported as other. On 20Jan2021 at 10:00, the patient experienced 100 F fever, chills, fatigue, muscle ache, weakness, headache, eye pain, and mild sore arm. The patient underwent lab test and procedure which included body temperature with a result of 100 Fahrenheit (fever) on 20Jan2021 at 10:00. No therapeutic measures were taken as a result of the events. Outcome of the events was recovered on an unspecified date of 2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1725718
Sex: F
Age:
State: KY

Vax Date: 02/23/2021
Onset Date: 02/25/2021
Rec V Date: 09/23/2021
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: feeling unwell; excessive fatigue; headache; joint pain; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 62-year-old female patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6198) via an unspecified route of administration, administered in arm right on 23Feb2021 15:15 (at the age of 62 years old) as dose 1, single for COVID-19 immunisation. Medical history included lung/bone cancer, and allergy to Bactrim. Concomitant medications included omeprazole, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), nebivolol hydrochloride (BYSTOLIC). On 25Feb2021 12:30, the patient experienced feeling unwell, excessive fatigue, headache, and joint pain. Patient had no other vaccines in four weeks, no COVID prior vaccination and not COVID tested post vaccination. There was no treatment received for the events. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: OMEPRAZOLE; ASPIRIN [ACETYLSALICYLIC ACID]; BYSTOLIC

Current Illness:

ID: 1725719
Sex: M
Age:
State: TN

Vax Date: 03/08/2021
Onset Date: 03/08/2021
Rec V Date: 09/23/2021
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: Sore shoulder; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6206 6121, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 08Mar2021 at 11:15 (at the age of 60-years-old) as dose 1, single for COVID-19 immunisation. Medical history included asthma and diabetes both from an unknown date. Concomitant medications included montelukast and sitagliptin phosphate (JANUVIA) both taken for an unspecified indication, start and stop date were not reported. The patient has no known allergies. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient experienced sore shoulder on 08Mar2021 at 16:00. No treatment was received for the event. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds: MONTELUKAST; JANUVIA

Current Illness:

ID: 1725720
Sex: F
Age:
State: VA

Vax Date: 03/07/2021
Onset Date: 03/07/2021
Rec V Date: 09/23/2021
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: Fever 101.3; shaky; chills; muscle aches; slight headache; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER- BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 07Mar2021 at 15:00 (Batch/Lot Number: EN6955) (at the age of 36-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 post vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. The patient previously took amoxicillin and experienced drug allergies. The patient experienced fever 101.3, shaky, chills, muscle aches and slight headache on 07Mar2021 at 20:00. The patient received no treatment for the events. The outcome of events was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1725721
Sex: F
Age:
State: OH

Vax Date: 03/05/2021
Onset Date: 03/06/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: 3 bouts of severe diarrhea; itching; few penny size hives; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EN6198) via an unspecified route of administration, administered in left arm on 05Mar2021 at 14:30 (age at vaccination was 63-year-old), as dose number unknown, single for COVID-19 immunization. The patient's medical history included IBS (irritable bowel syndrome), Penicillin allergy and intolerant to nuts. Concomitant medications (medications in two weeks) was reported as paracetamol, aspirin, and caffeine (EXCEDRIN); and Essential Enzymes. The patient did not receive any other vaccine within 4 weeks. Prior to vaccination, the patient has not been diagnosed with COVID-19 and post vaccination, the patient has not been tested for COVID-19. The facility type where COVID-19 vaccine was administered was reported as other. On 06Mar2021 at 14:30 (after 24 hours of the vaccine), the patient had 3 bouts of severe diarrhea (very suddenly), she started itching and had a few penny size hives. It was reported that she took diphenhydramine (BENADRYL) which seemed to calm it down and by the next morning the patient was fine. Therapeutic measures were taken as a result of itching and few penny size hives which included treatment with diphenhydramine while no treatment was received for 3 bouts of severe diarrhea. Outcome of the events was recovered on 07Mar2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1725722
Sex: F
Age:
State: IA

Vax Date: 03/08/2021
Onset Date: 03/08/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data: Test Date: 20210308; Test Name: body temperature; Result Unstructured Data: Test Result:100.7

Allergies:

Symptom List: Injection site pain

Symptoms: Chills; Woke up with a fever of 100.7; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN6205, Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 08Mar2021 at 17:00 (at the age of 36 years old) as dose 1, single for COVID-19 immunisation in a Pharmacy or Drug Store. Medical history included thyroid cancer from an unknown date. The patient was not pregnant at the time of vaccination and prior to vaccination was not diagnosed with COVID-19. Concomitant medications included levothyroxine; calcitriol; colecalciferol (VITAMIN D 3) and magnesium - all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Mar2021 at 23:30, the patient experienced chills and she woke up with a fever of 100.7 (as reported). No treatment was received for the adverse events. Since vaccination, the patient has not been tested for COVID-19. Outcome of all events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.

Other Meds: LEVOTHYROXINE; CALCITRIOL; VITAMIN D 3; MAGNESIUM

Current Illness:

ID: 1725723
Sex: F
Age:
State: VA

Vax Date: 02/24/2021
Onset Date: 02/28/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Severe generalized itching; painful skin on back, trunk, arms; Rash on back; This is a spontaneous report from a contactable nurse (patient). An elderly non-pregnant female patient of an unspecified age (Age: 74; Units: Unknown, as reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6200, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 24Feb2021 at 09:45 as dose 1, single for COVID-19 immunisation. Medical history included psoriasis, cancer survivor, antibiotics allergy, and shellfish allergy. The patient previously took codeine and experienced allergy. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. On 28Feb2021, the patient experienced severe generalized itching, painful skin on back, trunk, arms, and rash on back. The events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included antihistamine and anti-inflammatory. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds: SYNTHROID

Current Illness:

ID: 1725724
Sex: F
Age:
State: CO

Vax Date: 03/06/2021
Onset Date: 03/06/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data: Test Name: Mild fever; Result Unstructured Data: Test Result:100.1 Fahrenheit; Comments: 100.1F with oral thermometer

Allergies:

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

Symptoms: cold sweat/sweating and freezing at the same time; lymph nodes under left arm swollen/lymph nodes under left armpit painful; pain at injection site; mild flu like symptoms; chills; this morning in the shower left arm pit felt like possible fluid; mild fever; little headache; achy body/pretty achy; little congested; pretty tired; This is a spontaneous report from a contactable consumer (patient herself). A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN6204, Expiry Date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 06Mar2021 at 12:00 (at the age of 39-Year-old) as a DOSE 2, SINGLE for covid-19 immunisation (teacher, going back to 100% in class). The patient medical history included insomnia from an unknown date and unknown if ongoing. The patient's concomitant medications included, Insomnia medication (unspecified). The patient previously (within 4 weeks) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN6201), dose 1 via an unspecified route of administration on 13Feb2021 (at the age of 39-Year-old) as a DOSE 1, SINGLE for covid-19 immunisation. Vaccine was not administered at Military Facility. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) included first dose of the same vaccine. No additional vaccines were administered on same date with the Pfizer vaccine considered as suspect. AE(s) following prior vaccinations A vaccine when she was traveling, she received around 5 vaccines about 7 years ago. She doesn't remember the vaccine, achy body and fever that was gone in 24 hours. Thinks it was for yellow fever but can't be certain. On 06Mar2021, the patient experienced little headache, achy body, little congested and was pretty tired. On 07Mar2021, the patient had mild fever and on 08Mar2021 she had cold sweat, lymph nodes under left arm swollen, lymph nodes under left armpit painful and sweating and freezing at the same time. On an unspecified date the patient experienced, pain at injection site, mild flu like symptoms, chills and this morning in the shower left arm pit felt like possible fluid. Reporter was talking about her second Covid vaccine dose. She took it on Saturday, 06Mar2021 on Saturday 06Mar2021 she had a little headache and then Sunday 07Mar2021, she was feeling flu symptoms. She then woke up around 03:00AM on 08Mar2021 in a cold sweat and pretty achy. She went to take a shower, and her left arm where she received the vaccine, underneath where her lymph nodes in her armpit are it is significantly swollen and painful. She asked, is this a side effect or does she need to go to the doctor. She felt sweating and freezing at the same time. Reporter clarified flu symptoms as felt achy, kind of pretty tired, under the weather and a little congested. A really achy body, mild fever, 100.1F with oral thermometer. Further patient clarified that, she had her second dose of the covid-19 vaccine on 06Mar2021, the next day experienced pain at injection site, mild flu like symptoms, chills, this morning in the shower left arm pit felt like possible fluid. No relevant tests were done. The patient underwent lab tests and procedures which included body temperature that was 100.1 fahrenheit on an unspecified date reported as, 100.1F with oral thermometer. Treatment of the event included, Advil Ibuprofen 200mg gel capsules, she took 2 gel capsules. Event did not require a visit to the Emergency Room or Physician Office. Outcome of all the events were unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1725725
Sex: F
Age:
State: AZ

Vax Date: 03/07/2021
Onset Date: 03/08/2021
Rec V Date: 09/23/2021
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: lymph nodes on supraclavicular region were swollen; lymph nodes on supraclavicular region were tender; This is a spontaneous report from a contactable consumer (patient). A 32-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: EN6205; Expiration date was not reported), via an unspecified route of administration, administered in the left arm on 07Mar2021 01:00 PM (at the age of 32-years-old) as dose 2, single for COVID-19 immunisation at a Clinic/facility. Medical history included cashews allergy and nickel allergy, both from an unknown date and unknown if ongoing. Concomitant medications included testosterone cipionate, glycyrrhiza glabra (LICORICE), adrenal gland, aminobenzoic acid, calcium pantothenate, pyridoxine hydrochloride, riboflavin (ADRENOGEN); all taken for an unspecified indication, start and stop dates were not reported. The patient was previously vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: EL9267; Expiration date was not reported), via an unspecified route of administration, administered in the right arm on 13Feb2021 (at the age of 32-years-old) as dose 1, single for COVID-19 immunisation. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. On 08Mar2021, patient experienced that the lymph nodes on supraclavicular region were swollen and tender. First area was within 24 hrs, second area was within 48 hours. No treatment was taken for the events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds: TESTOSTERONE CIPIONATE; LICORICE [GLYCYRRHIZA GLABRA]; ADRENOGEN.

Current Illness:

ID: 1725726
Sex: M
Age:
State: TX

Vax Date: 03/05/2021
Onset Date: 03/05/2021
Rec V Date: 09/23/2021
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: chills; fever; sleep for 1 hour then wake up; tired; weak; feels like i have the flu; This is a spontaneous report from a non-contactable consumer (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number was not reported) via an unspecified route of administration, administered in left arm on 05Mar2021at 16:15 (age at vaccination was 54-year-old), as dose 1, single for COVID-19 immunization. The patient's medical history included high blood pressure. Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks. Prior to vaccination, the patient has not been diagnosed with COVID-19 and post vaccination, the patient has not been tested for COVID-19. The facility type where COVID-19 vaccine was administered was reported as Pharmacy or Drug Store. On 05Mar2021 at 23:15 (7 hours after vaccine), the patient experienced chills, fever and he would sleep for 1 hour then wake up. On 05Mar2021, he experienced being tired, weak, and feels like he have the flu. It was reported that it was 4 days later and the patient still felt the same. No therapeutic measures were taken as a result of the events. Outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1725727
Sex: F
Age:
State: PR

Vax Date: 03/04/2021
Onset Date: 03/01/2021
Rec V Date: 09/23/2021
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: Allergic reaction; Something like a rash; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot Number, and Expiration Date not reported) via an unspecified route of administration on 04Mar2021, as dose 1, single for COVID-19 immunisation. Medical history included allergic a while ago to all food, especially salmon. The patient's concomitant medications were not reported. The patient experienced allergic reaction and something like a rash on an unspecified date in Mar2021. Patient stated she has an "allergic reaction", all over her body she has "something like a rash", it started a day and a half after the dose, on the chest and goes down to her thighs. She stated she was allergic a while ago to all food, especially salmon but she has not eaten it. She called her doctor who sent her some prescriptions to the pharmacy but she was asking is she would have a stronger reaction to the second dose as her second dose was scheduled for 01Apr2021. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1725728
Sex: M
Age:
State: MI

Vax Date: 03/04/2021
Onset Date: 03/05/2021
Rec V Date: 09/23/2021
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: 20210305; Test Name: Body temperature; Result Unstructured Data: Test Result:101.4 degree

Allergies:

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

Symptoms: Headache; muscle soreness; 101.4 degree fever; chills; nausea; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN6199, Expiration Date: not reported), via an unspecified route of administration, administered in right arm on 04Mar2021 at 12:15 (at the age of 32 years old) as dose number unknown, single for COVID-19 immunisation in a hospital. Medical history included COVID-19 from an unknown date and unknown if ongoing. Concomitant medications included omeprazole; cetirizine hydrochloride (ZYRTEC) and fish oil - all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Mar2021, the patient experienced headache, muscle soreness, 101.4 degree fever, chills and nausea. No treatment was received for the adverse events. Since vaccination, the patient has not been tested for COVID-19. Outcome of all events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.

Other Meds: OMEPRAZOLE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FISH OIL

Current Illness:

ID: 1725729
Sex: M
Age:
State: NJ

Vax Date: 02/25/2021
Onset Date: 02/26/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data: Test Date: 20210302; Test Name: temperature; Result Unstructured Data: Test Result:over 102 degrees; Comments: over 102 degrees; Fahrenheit; Test Name: imaging of Abdomen; Result Unstructured Data: Test Result:Unknown result; Test Name: Liver Function tests; Result Unstructured Data: Test Result:Unknown result; Test Name: COVID Test; Test Result: Negative; Test Name: urinalysis; Result Unstructured Data: Test Result:Unknown result

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: No appetite; Cold when he is typically a warm person; Temperature/Fever; sweated profusely; even the sheets, pillowcase and everything was wet; Flu-like symptoms; Soreness at the Injection Site; This is a spontaneous report from a contactable consumer or other non hcp. A 49-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6203), via an unspecified route of administration, administered in Arm Left on 25Feb2021 (at the age of: 49-years-old) at 08:30 or quarter till 9:00 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications. The patient did not receive any other products. The patient did not receive any other vaccine with in 4 weeks prior to the vaccination. The reporter stated that she want to report a strange reaction, a more intense reaction, than they had anticipated. She states that they both had the vaccine on 25Feb2021. she states that they both had a mild reaction at first with soreness at the injection site and flu like feeling like she did rather go lay on the couch for 2 days than do anything else, type symptoms. reporter stated that the patient developed a more intense and had an extreme reaction, and still had a temperature. The reporter assumed that it was his left arm, since he was right handed. She was not sure if he was still had. The patient went to the hospital ER on Thursday, 04Mar2021, to be attended to and he was still not feeling well, a little better but still not well and they did a urinalysis and imaging of the abdomen, a Covid Test that was negative, Liver Function tests, and quite a few other tests, but the patient elected to go home because they did not find anything. The patient was extremely fit and works out every day and they never expected a reaction like this. He had a high fever that is going up and down, and he sweated profusely even the sheets, pillowcase and everything was wet. He had an erratic and sporadic reaction. On an unspecified date, the patient had no appetite, he did not want to eat and he was cold, when he was typically a warm person. The patient underwent lab tests and procedures which included body temperature with over 102 degrees on 02Mar2021 over 102 degrees Fahrenheit, imaging procedure with unknown result, liver function test with unknown result and sars-cov-2 test with negative on and urine analysis with unknown result. The outcome of the pyrexia, sweated profusely; even the sheets, pillowcase and everything was wet, no appetite, Cold when he is typically a warm person was recovering and Flu-like symptoms was not recovered and Soreness at the Injection Site was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1725730
Sex: F
Age:
State: MS

Vax Date: 03/08/2021
Onset Date: 03/09/2021
Rec V Date: 09/23/2021
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: Mild rash especially on upper chest and back; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on 08Mar2021 at 16:30 (at the age of 45-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. The patient received other medications in two weeks which included store bought allergy medication - brand. The patient previously took sulfur and experienced allergy. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. The patient experienced mild rash especially on upper chest and back on 09Mar2021 at 06:00. No treatment was received for the event. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1725731
Sex: F
Age:
State: FL

Vax Date: 03/09/2021
Onset Date: 03/09/2021
Rec V Date: 09/23/2021
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: painful injection; dizzy; stomach burned; tongue felt numb; glands in throat hurt; flushed; slight headache; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN9166, Expiration Date: not reported), via an unspecified route of administration, administered in right arm on 09Mar2021 at 10:45 (at the age of 70 years old) as dose 1, single for COVID-19 immunisation. The facility where the most recent COVID-19 vaccine was administered was reported to be "other". Medical history included high BP (blood pressure), high cholesterol and osteoporosis. The patient was not pregnant at the time of vaccination and prior to vaccination was not diagnosed with COVID-19. Concomitant medications included olmesartan; nifedipine; colesevelam hydrochloride (WELCHOL); ezetimibe (ZETIA) and aspirin [acetylsalicylic acid] - all taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromicin (ERYTHROMYCIN), nitrofurantoin (MACRODANTIN), oxycodone (OXYCODON) and barium Sulfate contrast (IVP dye) - all taken for an unspecified indication on an unspecified date and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Mar2021 at 10:45, the patient experienced painful injection, dizzy, stomach burned (as reported), tongue felt numb, glands in throat hurt (as reported), was flushed and slight headache. All events resulted to Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. Since vaccination, the patient has not been tested for COVID-19. Outcome of all events was recovered on an unspecified date. No follow-up attempts are needed. No further information is expected.

Other Meds: OLMESARTAN; NIFEDIPINE; WELCHOL; ZETIA; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness:

ID: 1725732
Sex: M
Age:
State: MI

Vax Date: 03/08/2021
Onset Date: 03/09/2021
Rec V Date: 09/23/2021
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: 20210309; Test Name: fever; Result Unstructured Data: Test Result:low grade fever; Comments: 11:30

Allergies:

Symptom List: Pain in extremity

Symptoms: mild body aches; low grade fever; This is a spontaneous report from a contactable consumer or non-healthcare professional (patient; Pfizer colleague). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number was not reported) via an unspecified route of administration, administered in left arm on 08Mar2021 at 13:30 (age at vaccination was 60-year-old), as dose 2, single for COVID-19 immunization. The patient's medical history included allergies to Penicillin. Concomitant medications (other medications in two weeks) were reported none. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient has not been diagnosed with COVID-19 and post vaccination, the patient has not been tested for COVID-19. The facility type where COVID-19 vaccine was administered was reported as workplace clinic. On 09Mar2021 at 11:30, the patient experienced mild body aches and low grade fever about 24 hours. The patient underwent lab test and procedure which included body temperature with a result of low grade fever on 09Mar2021 at 11:30. There was no therapeutic measures taken as a result of the events. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1725733
Sex: F
Age:
State: NC

Vax Date: 03/06/2021
Onset Date: 03/06/2021
Rec V Date: 09/23/2021
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: 20210306; Test Name: low-grade temp; Result Unstructured Data: Test Result:under 101.4 Fahrenheit; Comments: low-grade temp, off and on, 80 hours so far

Allergies:

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

Symptoms: nausea; Shakiness; Extreme fatigue; headache; low-grade temp (under 101.4); This is a spontaneous report from a contactable consumer (patient). A non-pregnant 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot Number, and Expiration Date not reported) via an unspecified route of administration, administered in the left arm on 06Mar2021 08:00 (at the age of 51-years-old), as dose 1, single for COVID-19 immunisation. Medical history included high cholesterol, and Known allergies: Penicillin, sulfa, latex, poison ivy. Concomitant medications included ascorbic acid (VIT C); ergocalciferol (VIT D); and unspecified vitamin B medication all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, shakiness, extreme fatigue, headache, and low-grade temp (under 101.4) on 06Mar2021 10:00. Events were reported as on and off for 80 hours. The patient underwent lab tests and procedures which included body temperature: under 101.4 fahrenheit (reported as low-grade temp, off and on, 80 hours so far) on 06Mar2021. No treatment was received and events did not result to either physician office or emergency room visit. The outcome of event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: VIT C; VIT D.

Current Illness:

ID: 1725734
Sex: F
Age:
State: IL

Vax Date: 03/05/2021
Onset Date: 03/01/2021
Rec V Date: 09/23/2021
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: terrible itches all over neck; neck looks like a turkey neck; could not sleep; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on 05Mar2021 (at the age of 84-years-old) as dose 1, single for COVID-19 immunisation at a hospital. The patient's medical history and concomitant medications were not reported. The patient experienced had "terrible itches" all over neck, on the outside of neck, not inside on 05Mar2021. It was reported that it started that Friday evening, very light, and continued and worsened each day until today when the patient finally took medication for it. It was also reported that her neck looks like a turkey neck and could not sleep due to the terrible itching on an unspecified date in Mar2021. The patient called her doctor on 08Mar2021 (reported as yesterday) and was advised to take fexofenadine hydrochloride (ALLEGRA). The patient took Allegra on 09Mar2021 as a result of the events "terrible itches" all over neck and neck looks like a turkey neck. Her neck was feeling better on 09Mar2021 (reported as today). The outcome of the event "terrible itches" all over neck and neck looks like a turkey neck was recovering and outcome of event could not sleep 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: 1725735
Sex: M
Age:
State:

Vax Date: 03/02/2021
Onset Date: 03/02/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: lethargic, can't walk more than a mile; soreness throughout body; soreness in shoulder, hips; soreness in buttocks; soreness in legs, thighs; burning when given/injected; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 patients. This is the first of 2 reports. A male patient of an unspecified age (reported as age: 84; unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on 02Mar2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced burning when given/injected on 02Mar2021, soreness in shoulder, buttocks, hips/legs, thighs on 03Mar2021. It was reported to went away on 04Mar2021. On 05Mar2021, the patient experienced soreness throughout body, and still sore. The patient was also "lethargic, can't walk more than a mile" on an unspecified date. It was reported that it was annoying because the patient was an active person. Patient was querying why he was sore when he get up. The outcome of the events burning when given/injected , soreness in shoulder, buttocks, hips/legs, thighs was recovered on 04Mar2021 (reported as went away), outcome of event soreness throughout body was not recovered and outcome of event "lethargic, can't walk more than a mile" was unknown. The patient was also querying if he can get COVID from the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021272981 Same reporter and product, similar events; different patients.

Other Meds:

Current Illness:

ID: 1725736
Sex: F
Age:
State:

Vax Date: 03/08/2021
Onset Date: 03/01/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: "tingling" in her face; face felt numb; having a bruise underneath her chin; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot Number, and Expiration Date not reported) via an unspecified route of administration on 08Mar2021 (at the age of 43-years-old), as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced "tingling" in her face and face felt numb on 08Mar2021, having a bruise underneath her chin on an unspecified date in Mar2021. Patient reported having a bruise underneath her chin that was not there yesterday, before the vaccination. She also stated that she did not remember hurting herself. She also reported that last night she felt a "tingling" in her face. She states that her face felt numb and "tingly" for about a half hour and then this subsided. She said she spoke with two of her colleagues who reported feeling the same thing. Patient was requesting a list of the ingredients of the vaccine, as she may be concerned she had a reaction to a certain ingredient. The outcome of "tingling" in her face and face felt numb was recovered on an unspecified date in Mar2021 while bruise underneath her chin 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: 1725737
Sex: F
Age:
State: PA

Vax Date: 02/22/2021
Onset Date: 02/28/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: red bruise like spots on the legs appeared; tiredness; feeling lethargic; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot Number, and Expiration Date not reported) via an unspecified route of administration on 22Feb2021 (at the age of 63-years-old), as dose 1, single for COVID-19 immunisation. Patient has no relevant medical history. There were no concomitant medications. Patient has no allergies to medications, food, or other products. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced red bruise like spots on the legs appeared, tiredness, and feeling lethargic on 28Feb2021. An appointment was made with patient's dermatologist and patient expressed a lot of anxiety about receiving the second dose. The outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1725738
Sex: F
Age:
State: NC

Vax Date: 02/12/2021
Onset Date: 02/22/2021
Rec V Date: 09/23/2021
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: 20210103; Test Name: Blood pressure; Result Unstructured Data: Test Result:unknown; Test Date: 20190702; Test Name: Colonoscopy; Result Unstructured Data: Test Result:unknown; Test Name: Pulse; Result Unstructured Data: Test Result:unknown; Test Date: 20161116; Test Name: Mammogram; Result Unstructured Data: Test Result:unknown; Test Name: Oxygen Saturation; Result Unstructured Data: Test Result:unknown

Allergies:

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

Symptoms: lethargy; Red face, hot face when waking up Gray spot on forehead; Red face, hot face when waking up/Feeling of warmth facial; Gray spot on forehead; was tired and wiped out; This is a spontaneous report from a contactable nurse or other health care professional. This Nurse reported on behalf of a physician for an 80-year-old female patient. A 80-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9266), via an intramuscular route of administration (at the age of 80-years), ad-ministered in deltoid right on 12Feb2021 at 09:30 as dose 2, 0.3 ml single for COVID-19 immunization. Medical history included , rotator cuff repair from 2010 to an unknown date , cataract from 16May2016 to an unknown date Surgeries, Both Eyes , total shoulder replacement from 02Jul2019 to an unknown date , adenoidectomy, vertigo, diabetes from an unknown date and unknown if ongoing. The patient had the family medical history of disorder of thyroid gland from an unknown date and unknown if on-going. The concomitant medication was not reported. The vaccination facility type was reported as other, public health department.The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient did not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL8982), via an intramuscular route of administration, administered in deltoid right on 15Jan2021 at 13:00 as dose 1, 0.3 ml single for COVID-19 immunization. On 22Feb2021 at 09:00, the patient experienced red face, hot face when waking up gray spot on fore-head, red face, hot face when waking up/feeling of warmth facial, was tired and wiped out, gray spot on forehead. On an unspecified date, experienced lethargy. It was further reported by the patient that I am 80 years old, I have been a very active person taking of my own yard and flower garden , now I am very tired ,what can I do to make the tired , no energy , feelings go away. On 22Feb2021, the patient experienced hot and red face on left side when wake up. In 2021, the hot and red face on left side when got out from shower, when wake up and warm to touch resolved. Covid-19 vaccine was also considered suspect. The patient was treated with Benadryl. The treatment was received for all the adverse events with benadryl 25mg 1/2 tab twice days for 3 days. The adverse events resulted in physician office visit. The patient was not seen in the Emergency Department. The patient was not admitted to hospitalized. The patient was not admitted to an Intensive Care Unit. No Multi organ involvement and no other symptoms/signs. The patient underwent lab tests and procedures which included blood pressure measurement: unknown on 03Jan2021, colonoscopy: unknown on 02Jul2019, heart rate and oxygen saturation: unknown on an unspecified date, mammogram: unknown on 16Nov2016. The clinical outcome for the event was tired and wiped out was reported as not recovered while for all the other events was reported as unknown. The Pfizer product had a casual effect to the adverse event. No follow-up attempts are possible. No further information is expected

Other Meds:

Current Illness:

ID: 1725739
Sex: F
Age:
State: CA

Vax Date: 03/05/2021
Onset Date: 03/06/2021
Rec V Date: 09/23/2021
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: had a rash on neck, going up cheeks and on the back of neck; redness; itchy; This is a spontaneous report from a contactable consumer or other non-HCP (Patient). A 48-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 13:00 (at the age of 48-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included Known allergies to Sulfa drugs. The concomitant medications/Other medications in two weeks included unspecified medication. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. The patient was not covid tested post vaccination. It was reported that, the patient received first immunization Friday 05Mar2021, on Saturday 06Mar2021, the patient had a rash on neck, going up cheeks, and on the back of neck, red, itchy took Benadryl and used hydrocortisone cream, started becoming less on Monday did not switch soaps, perfumes, etc. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient received the treatment for the events. The outcome of the events was recovering. No follow-up attempts are possible:information about lot/batch number cannot been obtained.

Other Meds:

Current Illness:

ID: 1725740
Sex: F
Age:
State: OK

Vax Date: 02/25/2021
Onset Date: 02/26/2021
Rec V Date: 09/23/2021
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: mild itchy rash on left forearm which stayed same x4 days, then day5 rash spread to right arm, then day 6 left arm worsened; Rash is spending to upper chest and left axilla; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in Arm Left on 25Feb2021 13:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Hx of ovarian, melanoma cancer, aortic.stenosis, asthma. Patient previously received sulfur and experienced known allergy. Patient previously received Compazine and experienced known allergy. Patient previously received proparapaine eye drops and experienced known allergy. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, from unknown start date; losartan (LOSARTAN) taken for an unspecified indication, from unknown start date; fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for an unspecified indication, from unknown start date; amlodipine (AMLODIPINE) taken for an unspecified indication, from unknown start date; montelukast sodium (SINGULAIR) taken for an unspecified indication, from unknown start date. The patient previously took sulfur for hypersensitivity, compazine spansule for hypersensitivity, proparacaine hcl for hypersensitivity. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 26Feb2021 08:00, the patient experienced mild itchy rash on left forearm which stayed same x4 days, then day5 rash spread to right arm, then day 6 left arm worsened, rash is spending to upper chest and left axilla. Doctor seen day7 given short acting cortisone and meds for itching rash improved day 8 then worsened day9 thru current date day11 is 08Mar21 rash was extremely itchy could not sleep itching only relieved with ice. Rash is spending to upper chest and left axilla. She was miserable with itching no other symptoms. Therapeutic measures were taken as a result of mild itchy rash on left forearm which stayed same x4 days, then day5 rash spread to right arm, then day 6 left arm worsened, rash is spending to upper chest and left axilla. Event resulted in Doctor or other healthcare professional office/clinic visit. The clinical outcome of events were not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: ZOLOFT; LOSARTAN; ADVAIR; AMLODIPINE; SINGULAIR.

Current Illness:

ID: 1725741
Sex: F
Age:
State: NY

Vax Date: 03/04/2021
Onset Date: 03/05/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Back pain fever headache 05Mar2021-08Mar2021 still experiencing; Back pain fever headache 05Mar2021-08Mar2021 still experiencing; Back pain fever headache 05Mar2021-08Mar2021 still experiencing; This is a spontaneous report from a Contactable Consumer (patient) reported for herself. A 20-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: Unknown), via an unspecified route in the left arm on 04Mar2021 at 19:00 (age at vaccination: 20-year-old), as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1/20). 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. Patient has not been tested for COVID-19 post vaccination. On 05Mar2021 at 13:00, patient experienced back pain, fever and headache. It was unknown if patient received any treatment for the adverse events. The clinical outcome of the events was not recovered/still experiencing as of 08Mar2021. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Other Meds: BLISOVI FE 1/20

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am