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: 1756309
Sex: F
Age:
State: MD

Vax Date: 03/23/2021
Onset Date: 03/23/2021
Rec V Date: 10/02/2021
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: very uncomfortable; her legs were clearer; where she had hives on her legs, there was a small area with marks on her skin, but no longer hives. She said the marks on her skin may have been from her scratching; her lip was swollen; a strange thing happened on 26Mar2021, she said she noticed on the way to the store, her voice sounded strange; She said she took 2 Benadryl 25mg tablets on 24Mar2021, and the Benadryl 25mg made her sleepy; her ears started itching and were red; her ears started itching and were red; the hives were itchy and she had a little itching; She said the back of her neck & shoulders were covered with hives. She said the hives were on her arms & elbows, & parts of her back. She said the hives were on the side of her legs, & down her ankles; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection with Lot Number: EN6207 Expiration Date: Sep2022), via an unspecified route of administration, administered in Arm Right on 23Mar2021 16:30(at the age of 58-year) as DOSE 1, SINGLE for COVID-19 immunisation and diphenhydramine hydrochloride (BENADRYL, Batch/Lot Number: SSF051), oral from 24Mar2021 to an unspecified date, at 25mg tablet by mouth, 2 tablets initially, and then 1 tablet in morning and at night, as needed for pruritus. Medical history included blood cholesterol increased (cholesterol was 184, and her LDL was a little elevated). She said both her parents had high cholesterol. Concomitant medication(s) included vitamin c, aspirin [acetylsalicylic acid] and vitamins nos (MULTIVITAMIN [VITAMINS NOS]). Clinical course: She said everything was fine, and she did not think she had an allergy to the COVID-19 Vaccine. She said for 3-4 hours she was fine after getting the COVID-19 Vaccine, but then her ears started itching and were red. She said the back of her neck and shoulders were covered with hives. She said the hives were on her arms and elbows, and parts of her back. She said the hives were on the side of her legs, and down to her ankles. She said she was scratching and very uncomfortable. She clarified the hives were itchy. She said the next day (24Mar2021) she bought Benadryl 25mg tablets and took 2 Benadryl 25mg tablets. She said the Benadryl 25mg tablets made her sleepy. She said the hives and itching went down. She said she took another Benadryl 25mg tablet, clarifying she continued to take 1 Benadryl 25mg tablet (on 24Mar2021, 25Mar2021, and 26Mar2021) in the morning and 1 at night. She said she did not want to take too many of the Benadryl 25mg tablets, but just enough to manage her itching and hives. She said then a strange thing happened on 26Mar2021. She said she noticed on the way to the store, her voice sounded strange. She said when she got home from the store and looked in the mirror, her lip was swollen. She said she showered and then went to sleep. She said she woke up in the middle of the night and her lip looked fatter, so she took a Benadryl 25mg tablet, and then went back to sleep. She said when she had woke up the next morning, the swelling had gone down in her lip. She said the itching gradually stopped, and she did not have much left, only a little itching around her belly button, and on the back of her neck. She clarified her skin was not very raised in the areas that still itched a little. She said she was not concerned so much about the hives and itching. She added she had a little itching and hives on her forehead area, but it was not a big thing. She said the thing that concerned her was that she had a big fear of getting the second COVID-19 Vaccine and having a worse reaction than the first COVID-19 Vaccine dose. She said she wanted to make sure if she got the second COVID-19 Vaccine, her reaction would be nothing worse than what she had after the first COVID-19 Vaccine dose. The events outcome for pruritus and urticaria was reported as recovering, ear pruritus and erythema was reported as recovered, lip swelling recovered on 27Mar2021, the event outcome for limb discomfort, voice sounded strange, made her sleepy and scratching were reported as unknown. The events were assessed as non-serious No follow-up attempts are needed. No further information is expected.

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

Current Illness:

ID: 1756310
Sex: F
Age:
State: OK

Vax Date:
Onset Date:
Rec V Date: 10/02/2021
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: Fever; chills; aching; sweating; headache; This is a spontaneous report received from a contactable pharmacist via Pfizer sales representative. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fever, chills, aching, sweating, headache. The reporter clarified that the adverse event took place after Pfizer product use. The outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1756311
Sex: F
Age:
State: IL

Vax Date: 03/06/2021
Onset Date: 03/01/2021
Rec V Date: 10/02/2021
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: extreme itching on my neck; extreme itching on my neck; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EM9809), via an unspecified route of administration on 06Mar2021 (at the age of 34-year-old), dose 1, single for COVID-19 immunisation. Medical history included depression, asthma, irritable bowel syndrome (IBS), gastrooesophageal reflux disease (GERD), polycystic ovarian syndrome (PCOS), extreme itching on neck (this was how she discovered that she was allergic to other medications) and had allergies to kiwi, pineapple, oranges, bananas, latex, dogs, cats. Concomitant medications included prescribed medications, multi-vitamins, and birth control medications. The patient previously took acetaminophen; ondansetron (ZOFRAN); hydromorphone hydrochloride (DILAUDID); hydrocodone bitartrate paracetamol (NORCO) and had allergy to these medications. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. The vaccine was administered at hospital. On an unspecified date in Mar2021, the patient had extreme itching on her neck. The patient stated that she became concerned because this was how she discovered that she was allergic to other medications. The patient spoke with the emergency room (ER) and then had a telehealth visit with her primary doctor. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was unknown. No follow-up attempts are possible; No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021347541 same reporter/patient/product, different dose and similar events

Other Meds:

Current Illness:

ID: 1756312
Sex: M
Age:
State:

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

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

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

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: fever; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (son). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications. The patient experienced fever on an unspecified. The reporter reported that her son who was fine yesterday but woke up this morning with a little fever. She added his COVID-19 test came back "inconclusive" and they are waiting for the PCR. She said his doctor specified that her son wouldn't have been contagious yesterday, since his symptoms began today. She asked if her mother could get her second dose as scheduled given this potential exposure to COIVD-19date with. She asked if she can be around her son who may have COVID-19, since she has received both doses of the COVID-19 vaccine around 3 weeks ago. The patient underwent lab tests and procedures which included sars-cov-2 test: inconclusive. Outcome of the event was unknown. No Follow-up attempts are possible: information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1756313
Sex: F
Age:
State: VA

Vax Date: 03/24/2021
Onset Date: 03/25/2021
Rec V Date: 10/02/2021
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: Sore arm; headache; low grade fever; tired; Achy; This is a spontaneous report from a contactable consumer. An 18-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via an unspecified route of administration in the left arm on 24Mar2021 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as unknown. Allergies to medications, food, or other products was reported as unknown. It was unknown if the patient had received any other medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) on an unspecified date as a single dose for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not tested for COVID-19, since the vaccination. On 25Mar2021, the patient had experienced sore arm, headache, low grade fever, tired, and achy. The patient did not receive treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events sore arm, headache, low grade fever, tired, and achy was resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: added vaccine administration information. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1756314
Sex: U
Age:
State:

Vax Date: 03/24/2021
Onset Date: 03/25/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Name: fever; Result Unstructured Data: Test Result:101.8; Comments: developed a fever of 101.8 about 24 hours later.

Allergies:

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

Symptoms: fever of 101.8; This is a spontaneous report from a contactable consumer. This consumer (Patient)of unknown age and gender reported that he/she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 24Mar2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunization. On 25Mar2021, about 24 hours later the patient developed a fever of 101.8. The event outcome was unknown. No follow-up attempts were possible. information about lot/batch number could not be obtained.

Other Meds:

Current Illness:

ID: 1756315
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: fever; body aches; nausea; fatigue; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sales Representative. A female patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced fever, body aches, nausea, fatigue. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1756316
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/02/2021
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: high Fever; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: L3247) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: unknown) via unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced high fever on an unspecified date. The outcome of the event pyrexia was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1756317
Sex: U
Age:
State:

Vax Date: 03/24/2021
Onset Date:
Rec V Date: 10/02/2021
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: Fever; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 24Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated, patient received the first dose of the Pfizer COVID Vaccine yesterday, 24March2021 (later confirmed). And it said you might have as a side effect have a fever on an unknown date. How high a fever should I be concerned about. The outcome of the event was reported as unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1756318
Sex: M
Age:
State: TN

Vax Date: 03/22/2021
Onset Date: 03/23/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Name: fever low grade; Result Unstructured Data: Test Result:99-100

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: just didn't feel good; had a little bit of swelling at site; fever; tenderness; This is a spontaneous report received from a contactable consumer or other non hcp. A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EP7534) dose number unknown via an unspecified route of administration in Arm Right on 22Mar2021 (age at vaccination 59years old) as single dose for covid-19 immunisation. Medical history included diabetes mellitus from Jan2021 and ongoing Verbatim: diabetes, myocardial infarction from 2018 to an unknown date Verbatim: heart attack, asthma from 2000 and ongoing Verbatim: asthma, hypersensitivity from an unknown date and unknown if ongoing Verbatim: bad allergies, deafness from an unknown date and unknown if ongoing, hepatic steatosis from an unknown date and unknown if ongoing, liver disorder from an unknown date and unknown if ongoing , covid-19 from Jun2020 to an unknown date. The patient's concomitant medications were not reported. The patient experienced fever, tenderness, had a little bit of swelling at site on 23Mar2021, and just didn't feel good on 24Mar2021. Clinical course was reported as patient started having a fever, he had a little bit of swelling at site, that's called just having a shot. Patient's swelling has actually gone down, still there, but getting better. site still tender to the touch but getting better and it never turned red. Patient received COVID shot 23Mar2021 and that's when the swelling and tenderness/pain began, very mild, a small knot, a little knot, but it started going on probably late Tuesday on 23Mar2021. Patient was still running fever and the swelling didn't get any worse but by that afternoon, swelling went down, a little bit of swelling still and still tenderness and fever broke on 24Mar2021. Fever recovered completely. Medical History: Patient had a heart attack in 2018 and was just diagnosed with diabetes about a month ago end of Jan2021/early Feb2021. Patient has had asthma since 2000, has bad allergies too, he has always had allergies. They have been married for 30 years, has had allergies since way back when. Patient having hearing loss that occurred about six months ago. Patient was diagnosed with a fatty liver, liver problems, about six months ago. Next morning the reporter and patient got up, she went to work. Her husband, the patient, he stayed at home. Her husband called the reporter and said he just didn't feel good. Fever: her husband said he's been running a fever low grade of 99-100 and they watched the fever all afternoon, both kept taking Tylenol, every so often to keep it under control. They both woke up soaking wet, she guesses their fever had broken in the middle of the night and they were just sweating big time and that was the only day of that. Pfizer Covid Vaccine: she got the shot was because her husband, the patient, has asthma, and they got COVID before, and he had a whole month of breathing issues. he struggles even now with his breathing, a lot of long-term problems after the COVID, so they can't get it again. when she took him to get the shot, they offered her the shot. She had some major medical problems, she got sickly with hers, when she had COVID, and they don't want to do that again. They got COVID in Jun2020. The patient underwent lab tests and procedures which included body temperature: 99-100 on unspecified date. Medications: Tylenol when she ran a fever, they took it every 4 hours. she guesses it's just as needed. They have taken it here recently for fever. (Tylenol: LOT: 0LV2167, EXP: Sep2022 ,250 tab-lets, 500 mg each). The clinical outcome of the event fever was recovered on 24Mar2021 and other events tenderness, had a little bit of swelling at site was recovering, and just didn't feel good event was unknown. Therapeutic measures were taken as a result of fever. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness: Asthma (Verbatim: asthma); Diabetes (Verbatim: diabetes)

ID: 1756319
Sex: F
Age:
State: NY

Vax Date: 03/23/2021
Onset Date: 03/24/2021
Rec V Date: 10/02/2021
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: This is a spontaneous report from a contactable consumer (patient). A 37-year-old (non-pregnant female) patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; solution for injection, batch/lot# EL3247), at the age of 37, via an unspecified route of administration, left arm, on Mar 23, 2021, at 13:15, single dose, for COVID-19 immunization. Patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; solution for injection, batch/lot# EL3247) via an unspecified route of administration, left arm, on Mar 2, 2021, at 13:15, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient did not have any allergies. The patient had no other vaccine within four weeks and no other medications received within 2 weeks of vaccination. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. On Mar 24, 2021, at 12:00, patient experienced chills and body aches. The patient did not receive any treatment. Outcome of the event recovered (at the time of this report). The awareness date: Feb 24, 2021. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1756320
Sex: F
Age:
State: OH

Vax Date: 02/27/2021
Onset Date: 02/28/2021
Rec V Date: 10/02/2021
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 on chest; blood blister on nose; This is a spontaneous report from a contactable consumer (patient). A 77-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 27Feb2021 12:00 (Lot Number: EN6202) as dose 1, single for covid-19 immunisation. Medical history included pollen allergies and had antigen test for 25 years, 25 years ago, cataract surgery, hip replacements. Concomitant medications within 2 weeks of vaccination included paracetamol (TYLENOL); fluticasone propionate nasal spray; ibuprofen (ADVIL); loratadine (CLARITIN); 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. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had been tested for COVID-19. On 28Feb2021, 12hrs after 1st dose, patient had blood blister on nose and after 36 hours on 01Mar2021, she had rash on chest. The rash went away about 12hrs later. The nose blister flattened and the came back on day 2. The patient received Eucerin as treatment on nose and rash. The outcome of rash was recovered on 01Mar2021 12:00; and outcome of blood blister was recovered in Mar2021. No follow-up attempts are needed. No further information is expected.

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

Current Illness:

ID: 1756321
Sex: F
Age:
State: CA

Vax Date: 03/26/2021
Onset Date: 03/26/2021
Rec V Date: 10/02/2021
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: 20210326; Test Name: body temperature; Result Unstructured Data: Test Result:Fever; Comments: Fever

Allergies:

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

Symptoms: feeling dizzy; Fever; sore arm; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 62-years-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8732), via an unspecified route of administration, administered in Arm Left on 26Mar2021 11:30 (Age at vaccination: 62-years-old) as single dose for covid-19 immunization. Medical history included Esophagitus, allergies to Percocet, Bactrim, Seasonal allergies all from an unknown date and unknown if ongoing. Patient was not diagnosed with covid prior to vaccination. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient did not receive any other medications within 2 weeks of vaccination. The patient concomitant medications were not reported. It was reported that on 26Mar2021 14:00 patient experienced Fever sore arm and feeling dizzy. Patient did not receive any treatment for the events. Patient was not hospitalized for the events. Patient was not tested covid post vaccination. patient underwent lab tests and procedures which included body temperature: fever on 26Mar2021. The outcome for the events was reported as unknown at the time of this report. Information on Lot/Batch number was available. No further information is expected.

Other Meds:

Current Illness:

ID: 1756322
Sex: F
Age:
State: NY

Vax Date: 02/23/2021
Onset Date: 02/01/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Name: Complete blood test; Result Unstructured Data: Test Result:25-MAR-2021; Test Date: 202103; Test Name: Blood test for Rheumatoid arthritis; Result Unstructured Data: Test Result:25-MAR-2021; Test Date: 202103; Test Name: Temperature elevation; Result Unstructured Data: Test Result:23-FEB-2021; Test Name: MRI; Result Unstructured Data: Test Result:??-DEC-2020; Test Date: 202103; Test Name: MRI; Result Unstructured Data: Test Result:??-DEC-2020; Test Name: Nasal swab test; Result Unstructured Data: Test Result:??-MAR-2021; Test Date: 202103; Test Name: Nasal swab test; Result Unstructured Data: Test Result:??-MAR-2021; Test Date: 202103; Test Name: COVID-19 antibody test; Result Unstructured Data: Test Result:??-MAR-2021; Test Date: 202103; Test Name: Body weight; Result Unstructured Data: Test Result:??-MAR-2021

Allergies:

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

Symptoms: headache; I felt like I was getting a cold; she did not go for the second dose of the Covid-19 vaccine because she was worried that the second dose would make it worse; she went for an antibody blood test/the blood test showed no antibodies at all for Covid-19; Appetitle lost; Hyperaesthesia; Muscle pain; Lost weight; Then I felt heat in my thighs that turned to burning moving down my legs/the heat in her thighs is now a burning/she is experiencing the burning in her thighs, the bottom of her legs, and her arm; tingling/very little tingling in her hands and here and there in her body; I felt numbness one night on the left side of my face/feel a kind of numbness on one side of her face; weird sensation; My face felt a little warm/she continued to feel some warmth in her face that felt like she was coming down with a cold; she felt a weird kind of weakness; Faint taste of metal in mouth; a little bit of a fever/her temperature went up; Nasal burning; her nose was dry and drippy; Burning in abdomen; This is a spontaneous report from a contactable consumer or other non hcp. A 69-years-old female patient received first dose of bnt162b2 (BNT162B2, Batch/Lot Number: EM9810), intramuscular, administered in Arm Right on 23Feb2021 11:30 (at the age of 69 years) as single for covid-19 immunisation and Synthroid, oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 0.1 mg, 1x/day for thyroid cancer. Medical history included thyroid cancer from 1975, breast cancer from 2015, Thyroid removed, neuropathy peripheral from 2021, feeling hot from 2016, hypoaesthesia from 2016 and disturbance of skin sensation from 2016. Concomitant medication included Arimidex, 1 mg, 1x/day for breast cancer, Calcium taken for supplementation, Vitamin D NOS for supplementation. The Patient after receiving the Covid-19 vaccine on 23Feb2021 her temperature went up and she felt a weird kind of weakness that kind of went away after a couple days. She continued to feel some warmth in her face that felt like she was coming down with a cold and thought maybe it was normal part of receiving the Covid-19 vaccine. About 3 weeks after receiving the Covid-19 vaccine, she started to feel a kind of numbness on one side of her face and some kind of heat in her thighs. The patient reported that the heat in her thighs is now a burning. She was experiencing the burning in her thighs, the bottom of her legs, and her arm. She was also experiencing tingling in her hands. The burning and tingling sensations were not a constant, that the burning and tingling comes and goes, but sometimes it gets very intense. She did not go for the second dose of the Covid-19 vaccine because she was worried that the second dose would make it worse. She went for an antibody blood test about 4 weeks after the first dose of the Covid-19 vaccine. The blood test showed no antibodies at all for Covid-19. She previously had the same feelings of warmth and numbness in her face 5 years ago from chemotherapy. The patient reported the burning started in her thighs, traveled down to her lower legs, and her left arm. She was also experiencing very little tingling in her hands and here and there in her body, but she was still experiencing the burning sensation her temperature went up the same day that she received the Covid-19 vaccine. The elevated temperature resolved the same night, 23Feb2021 or the next day 24Feb2021. The Patient reported that it was hard to describe the feeling she had but that she felt better a couple days after the weakness began on 23Feb2021. The weird kind of weakness resolved by the third day following the first dose of the Covid-19 vaccine on 23Feb2021.The weakness wasn't a constant, and that when it got really strange it wasn't constant. The warmth in her face felt like when she is coming down with cold, her nose got really dry, but she knew she was not really getting sick. She did not feel the warmth in her face all the time. She began experiencing the numbness on her face about 3 weeks after her Covid-19 vaccine on 23Feb2021. The numbness on her face occurred just the one night approximately 3 weeks following her Covid-19 vaccine on 23Feb2021. She could feel the numbness on her face and it was bothering her. The numbness has resolved. The numbness was like the general weird skin sensation that she experienced 5 years ago after chemotherapy. She began experiencing the heat in her thighs on the same night that she experienced the numbness in her face, approximately 3 weeks after receiving the vaccine on 23Feb2021. She could feel the warmth in her thighs and that the next day it became a burning sensation. The Patient reported that the burning sensation went from her thighs and moved to the bottom her of legs and her arm. The burning sensation was still ongoing and that it kind of comes and goes. It was reported that the symptom had worsened in the sense that it had moved to different parts of her body, but she did not know if the burning sensation is occurring as often. The burning sensation spread day by day from her thighs to other affected areas. She had been experiencing a burning on a very slight lower part of her abdomen. Her abdomen was not burning as much as her thighs or legs. The patient experienced tingling in her hands began about the same time as the numbness in her face and all that, about 3 weeks after the Covid-19 vaccine. she was having very little tingling and that it is not really still ongoing. Patient stated if she sits down, when she gets up, she feels a little bit of tingling. Patient reported that the tingling seems like pressure and is not as bad as the burning in her thighs. Patient reported that the postnasal drip began about 3-4 days after receiving the Covid-19 vaccine. There was very little, and that her nose was dry and drippy. Patient reported that the drip in her nose has resolved and that it lasted at least 3 weeks. Patient reported that she had recovered completely from the drip in her nose. She reported that she had labs drawn to check for antibodies about 4 weeks after she got the vaccine on 23Feb2021. she was not sure if the test was specific, that she just took a regular antibody test. she had 2 MRIs at one week distance a few months before the Covid-19 vaccine. She reported that right after the Covid-19 vaccine injection, she experienced a faint taste of metal in her mouth. She reported that the metal taste was just the one instance on 23Feb2021 and that it resolved. The outcome of the events a little bit of a fever/her temperature went up, My face felt a little warm/she continued to feel some warmth in her face that felt like she was coming down with a cold, I felt numbness one night on the left side of my face/feel a kind of numbness on one side of her face, weird sensation, tingling/very little tingling in her hands and here and there in her body, she felt a weird kind of weakness, her nose was dry and drippy, Faint taste of metal in mouth and Nasal burning were Recovered. The outcome of the events headache, I felt like I was getting a cold, Then she felt heat in her thighs that turned to burning moving down my legs/the heat in her thighs is now a burning/she is experiencing the burning in her thighs, the bottom of her legs, and her arm, she did not go for the second dose of the Covid-19 vaccine because she was worried that the second dose would make it worse, she went for an antibody blood test/the blood test showed no antibodies at all for Covid-19, Burning in abdomen were Unknown. The outcome of the events Muscle pain, appetitle lost, Lost weight were Not recovered/Not resolved. Follow-up attempts were completed. No further information was expected.

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

Current Illness:

ID: 1756323
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/02/2021
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: her friend took the vaccine and reported sneezing; This is a spontaneous report from a contactable consumer (patient's friend). This consumer reported two reports. This is second of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter reported that her friend took the vaccine and reported sneezing on an unspecified date, the outcome was unknown. 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-2021304315 same reporter/drug, different patient/event

Other Meds:

Current Illness:

ID: 1756324
Sex: M
Age:
State: SC

Vax Date: 03/08/2021
Onset Date: 03/01/2021
Rec V Date: 10/02/2021
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: shortness of breath; congestion and slight cough; chills; sore muscle; fatigue; congestion and slight cough; when I raise my arm above my shoulder a sharp pain strikes down my upper arm from injection site to now; intestinal trauma; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN 6205) via an unspecified route of administration, in left arm, on 08Mar2021 11:45 (at the age of 68-year-old), at dose 1, single for covid-19 immunization. The patient had no medical history. There were no concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021 at 05:30 the patient experienced shortness of breath, congestion and slight cough with some chills, sore muscle, and fatigue. It was also reported that the injection site also caused problems on the 4th day (Mar2021), when he raised the arm above the shoulder a sharp pain strikes down the upper arm from injection site until the time of report. The patient also had intestinal trauma on an unspecified date in 2021, lasted about 6 to 8 days and a little longer with some issues. The events did not result in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1756325
Sex: F
Age:
State: TX

Vax Date: 03/23/2021
Onset Date: 03/23/2021
Rec V Date: 10/02/2021
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: Horrible itching at the vaccine site; Horrible itching at the vaccine site with swelling that has not gone away and redness with a rash; Horrible itching at the vaccine site with swelling that has not gone away and redness with a rash; Horrible itching at the vaccine site with swelling that has not gone away and redness with a rash; Eye bludging; Cross eye; Chest pain; Headache; Extremely exhausted.; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6202; Expiration date was not reported) on the left arm on 23Mar2021 (16:15) (age at vaccination: 37 years) as dose 1, single, with route of administration unspecified, for COVID-19 immunization at the hospital; and medroxyprogesterone acetate (DEPO-PROVERA, Lot number and expiration date were not reported) on the right arm on 23Mar2021 as dose 1, single, with route of administration unspecified, for sickle cell anaemia. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Prior to and since the vaccination, the patient was not diagnosed with COVID-19. Medical history included sickle cell anaemia (taking hydroxycarbamide and medroxyprogesterone acetate); and was allergic to IV contrast, pineapples, green apples, kiwi and adhesives. Concomitant medication included hydroxycarbamide (HYDROXYUREA MEDAC) for sickle cell anaemia. The patient previously took morphine, and had hypersensitivity. On 23Mar2021 (16:30), the patient had a cross eye; eye was "bludging"; chest pain; headache; and was extremely exhausted. On 01Apr2021 (03:00), the patient woke up at 3 AM with horrible itching at the vaccine site with swelling that had not gone away and redness with a rash. The itching continued through the day. The patient did not receive treatment for the reported events. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1756326
Sex: M
Age:
State: CA

Vax Date: 03/31/2021
Onset Date: 03/31/2021
Rec V Date: 10/02/2021
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: Lost his taste and smell; Lost his taste and smell; Vaccinated arm was sore after receiving the vaccine; This is a spontaneous report from a contactable consumer (patient). A 21-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 31Mar2021 as dose 1, single for COVID-19 immunization (at the age of 21-years-old). Medical history included nasal congestion, runny nose and allergy from Mar2021 to an unknown date. The patient's concomitant medications were not reported. The patient stated that, yesterday (31Mar2021) he got his first dose of COVID but he had been having a congested runny nose and he thought it was allergy, then today the next day (01Apr2021) he lost his taste and smell completely. So he was just worried because he was not sure if that was part of the symptoms or side effects of COVID of the first COVID dose and he was just worried thinking because he had job or work the next day and wanted a make sure that like if he had to call, because he might had it so he had to call off. Patient also added that his vaccinated arm was sore after receiving the vaccine (31Mar2021). He will be getting tested later that day (02Apr2021) for COVID-19. It was also reported that he had been having a congested nose for 2 weeks then (by 02Apr2021). That day (02Apr2021), his taste and smell came back. He said the congested nose was not as bad as the previous days. The patient did not receive any treatment, patient was just resting his body. The clinical outcome for the events was recovered on 02Apr2021 except unknown for vaccinated arm was sore after receiving the vaccine. No follow-up attempts are possible, information about lot/batch number cannot be obtained.

Other Meds:

Current Illness: Nasal congestion

ID: 1756327
Sex: U
Age:
State: NY

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

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

Lab Data: Test Date: 20210303; Test Name: fever; Result Unstructured Data: Test Result:100 - 100.4; Test Date: 20210305; Test Name: SARS-CoV-2 Rapid ag Covid-19; Test Result: Negative

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Fever of 100-100.4; tired; headache; achey; loss of appetite; This is a spontaneous report from a non-contactable consumer (patient) in response to non-HCP letter sent in cross-reference case. A 72-years-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: SN6205, patient was 72-yeear-oldat the time of vaccination), via intramuscular route of administration, administered in Arm Left on 03Mar2021 at 09:30 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included migraine and Hashimoto. Concomitant medication(s) included diclofenac (DICLOFENAC) taken for migraine from an unspecified start date and ongoing 2 days prior; levothyroxine sodium (SYNTHROID) taken for autoimmune thyroiditis from an unspecified start date and ongoing; liothyronine sodium (CYTOMEL) taken for autoimmune thyroiditis from an unspecified start date and ongoing. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL9624), via intramuscular route of administration, administered in Arm Left on 10Feb2021 at 08:22 AM as DOSE 1, SINGLE for covid-19 immunisation and experienced hot/cold, achy, tired, headache, fever all on 11Feb2021 for 4 days with outcomes of events were recovered without any treatment. No prior Vaccinations received. On 03Mar2021, the patient experienced fever of 100-100.4, tired, headache, achey, loss of appetite for 5 days (Outcome unknown for events). The patient underwent lab tests and procedures which included body temperature: 100 - 100.4 on 03Mar2021, sars-cov-2 test: negative on 05Mar2021. No treatment received for Fever and required urgent care on 05Mar2021. The outcome of event (fever of 100-100.4) was recovered on an unspecified date in 2021 and the outcomes of events (tired, headache, achey, loss of appetite) were unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.

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

Current Illness:

ID: 1756328
Sex: F
Age:
State: CA

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 10/02/2021
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: fatigue resulting in sleeping 14 hrs+/day for 3 days; fatigue resulting in sleeping 14 hrs+/day for 3 days; muscle and joint pain; muscle and joint pain; Underarm swelling; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9266 and expiration date was not reported), via an unspecified route of administration, administered in Arm Right on 17Feb2021 09:30 (at the age of 72-years-old) at dose 1, single for covid-19 immunization. Medical history included hypothyroidism, high cholesterol, depression and sulfonamide allergy. Concomitant medications included rabeprazole sodium (ACIPHEX); rosuvastatin calcium (CRESTOR); desvenlafaxine; levothyroxine. The patient had allergies to xanax and azithromycin. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Feb2021, the patient experienced underarm swelling and on 25Feb2021, the patient experienced fatigue resulting in sleeping for 14 hours+ per day for three days, muscle and joint pain for several days that appeared day 10 out. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events underarm swelling, fatigue, muscle pain and joint pain was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

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

Current Illness:

ID: 1756329
Sex: F
Age:
State: NY

Vax Date: 03/26/2021
Onset Date: 03/26/2021
Rec V Date: 10/02/2021
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: Felt tired; developed a low grade fever and just felt crummy; developed a low grade fever and just felt crummy; My arm got sore at the injection site; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: not reported) via an unspecified route of administration in the arm right on 26Mar2021 at 13:00 (at the age of 62-years-old) as dose 1, single for COVID-19 immunization. The patient had no medical history and concomitant medication. The patient had no known allergies. Prior to vaccination, the patient was not pregnant, not diagnosed with COVID-19, did not receive any other vaccines within 4 weeks and no other medications within 2 weeks. Since the vaccination, has the patient has not been tested for COVID-19. On 26Mar2021 at 20:00 (later that Friday evening), the patient experienced arm sore at the injection site. On 27Mar2021 (the next day Saturday), the patient felt tired and developed a low-grade fever and just felt crummy. On 28Mar2021 (Sunday), she felt better but on 29Mar2021 (Monday) the patient felt like old self again. Arm soreness lasted till 31Mar2021 (Wednesday). The patient did not receive any treatment for these events. The outcome of the events tiredness and fever was resolved on 29Mar2021 and for sore arm was resolved on 31Mar2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1756330
Sex: F
Age:
State: NC

Vax Date: 01/12/2021
Onset Date: 01/01/2021
Rec V Date: 10/02/2021
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: EMG; Result Unstructured Data: Test Result:Normal; Comments: EMG due to concern over ulnar neuropathy. EMG/NCS were completely normal.; Test Date: 20210202; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: Nasal Swab

Allergies:

Symptom List: Unevaluable event

Symptoms: Extreme pain in both wrists and pain in elbows bilaterally; Pain in 4th and 5th fingers; bilateral knee swelling as well as left ankle swelling; Knee stiffness and Left ankle stffness; This is a spontaneous report from a contactable nurse (patient). A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL1283 and expiry date not reported) via an unspecified route of administration, administered in left arm on 12Jan2021 (at the age of 39-year-old) as dose 2, single, for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no known allergies. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX), lamotrigine (manufacturer unknown) and levothyroxine sodium (SYNTHROID) all for unknown indication from an unknown date. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number EJ1685 and expiry date not reported) via an unspecified route of administration, administered in left arm, on 22Dec2020 (at the age of 39-year-old) as dose 1, single, for COVID-19 immunisation and experienced tingling down the arm in the 4th and 5th fingers, aching in the left wrists more than the right. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 13Jan2021, the morning after receiving second dose, patient woke up in the early morning hours with extreme pain in both wrists. This progressed to include 4th and 5th fingers and elbows bilaterally. The patient was seen by the doctor a week later and scheduled for EMG due to concern over ulnar neuropathy. EMG/NCS were completely normal. In between that time on an unknown date in Jan2021, the patient developed bilateral knee swelling and stiffness, as well as left ankle swelling and stiffness. The patient finally saw a rheumatologist who is working up the patient for inflammatory arthritis. The adverse events were reported retrospectively as, the patient didn't make the connection of the timing of symptoms corresponding with dates of vaccination until consulted the rheumatologist. The patient received prednisone (manufacturer unknown) as a therapeutic measure for the joint inflammation. The patient underwent lab tests and procedures, which included EMG/NCS: completely normal; COVID-19 virus test (nasal swab) on 02Feb2021 and the result was negative. The outcome of the events was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1756331
Sex: F
Age:
State:

Vax Date:
Onset Date: 03/31/2021
Rec V Date: 10/02/2021
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: Not feeling very good; Diarrhea; Sore throat; Nausea; Headache; Fever; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included apremilast (OTEZLA) taken for psoriatic arthritis, start and stop date were not reported. On 31Mar2021, the patient developed diarrhea, sore throat, nausea, headache and fever. The patient stated that she went to her HCP and had tests done on Friday 02Apr2021. The patient was not feeling very well on 05Apr2021. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected

Other Meds: Pfizer, Inc. EUA 027034

Current Illness:

ID: 1756332
Sex: F
Age:
State:

Vax Date: 03/09/2021
Onset Date: 03/01/2021
Rec V Date: 10/02/2021
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: the fever at the first vaccine was very livable, was not uncomfortable, and did not last long; This is a spontaneous report from a contactable consumer or other non-hcp (patient herself). A 65-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration in Arm Left on 09Mar2021 (Lot Number: EN6199, Expiry date: Unknown) as dose 1, single for COVID-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing, allergic to penicillin, since around 1996, corrected to 1995, she has been diagnosed with this, nodule from 2020 to an unknown date, nodules in throat, diagnosed early last year, diverticulitis from an unknown date and unknown if ongoing caller had three episodes three different times, one way back in May2010 that was the first time, then Apr2016 and the 3rd time was Sep2019, osteoporosis from an unknown date and unknown if ongoing, diagnosed when she was at 35. The patient previously received Flu vaccine and she states in 2012 the flu vaccine really hurt pain in her arm, it had not been like the other times. Concomitant medication included raloxifene hydrochloride (EVISTA) taken for osteoporosis, start and stop date were not reported, has been on for 2 or 3 years or 3.5 or longer maybe and regular vitamins but she did not take yesterday. On an unspecified date in Mar2021, the patient experienced the fever at the first vaccine was very livable, was not uncomfortable, and did not last long. Caller adds fever with first vaccine was very low grade at night in bed, she started perspiring and that woke her up and she knows that mean by then the fever was going down. Caller adds that at the first vaccine, she may have also had this fever a couple of hours. She took notice of it because she thought it was interesting that she was not expecting any reactions. Caller adds that the fever at the first vaccine was very livable, was not uncomfortable, and did not last long. The outcome of the event was recovered on an unspecified date in Mar2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1756333
Sex: M
Age:
State: FL

Vax Date: 04/02/2021
Onset Date: 04/01/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Date: 20210404; Test Name: body temperature; Result Unstructured Data: Test Result:102

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: fever of 102; Nausea; Threw Up Once; Gurgling in chest; Gurgling with deep breaths and sleep; Very Pale; Dizzy; Couldn't hardly get out of bed; Weak; Coughing up phlegm in the morning; This is a spontaneous report from a contactable consumer (patient's wife). A 70-years-old male patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EN6208 and Expiration date was not reported), via an unspecified route of administration, administered in left upper arm on 02Apr2021 as dose 2, single (at the age of 70-years-old) for COVID-19 immunization. Medical history included ongoing high blood pressure, thyroid cancer (three types of cancer in the tumor) from Apr2001 to an unknown date, ongoing radiation damage (radiation damage to spine) and pneumonia from an unknown date and unknown if ongoing. Historical vaccine included patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EN6206 and Expiration date was not reported), via an unspecified route of administration, administered in left upper arm on 10Mar2021 as dose 1, single (at the age of 70-years-old) for COVID-19 immunization. Concomitant medications included gabapentin taken for pain (radiation damage to spine), oxycodone hydrochloride, paracetamol (Oxycodone and Acetaminophen) taken for pain (radiation damage to spine), tizanidine taken for pain, muscle relaxant (radiation damage to spine), oxycodone (Xtampza ER) taken for pain (radiation damage to spine), lisinopril taken for high blood pressure and amlodipine taken for high blood pressure. Patient was always tested negative for covid. Patient was doing so well lately then he had this shot and was back in bad shape. Patient was experienced some hard side effects from the second COVID vaccine. On 03Apr2021 (the next following day), patient had soreness in his arm, very pale, weak and was having terrible dizzy spells and could hardly get up of bed when he was about to go to the rest room. On 04Apr2021, patient experienced one time vomiting/threw up once, because he had nausea and he had fever of 102, his fever subsided but he was freezing last night and now he was totally in his chair. On04Apr2021, patient breathing was still pretty bad, gurgling when he breathes deep or when he was sleeping/gurgling in chest, stayed about the same since it started. On Apr2021, when patient wakes up in the morning, he had phlegm that he needs to cough up. Patient can be heard coughing in the background. Patient symptoms resolved, and the patient says that he feels a lot better. Now, patient's wife was not so sure that it was all from the COVID vaccine, patient had been experiencing health problems. But patient's wife called his doctor and his doctor said that she should call Pfizer because it was a possible side effect from the vaccine, and it was the Pfizer. The outcome of gurgling in chest and gurgling with deep breaths and sleep was not recovered, unknown for coughing up phlegm in the morning, threw up once was recovered on 04Apr2021, and recovered for rest of the events on Apr2021. No follow-up attempts are needed. No further information is expected

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

Current Illness: Blood pressure high; Injury radiation (Radiation damage to spine)

ID: 1756334
Sex: F
Age:
State: IN

Vax Date: 04/06/2021
Onset Date: 04/06/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Allergic reaction; everything was swelling up, my feet, my toes, my hands, my stomach everything; profuse sweating; everything was swelling up, my feet, my toes, my hands; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8732), via an unspecified route of administration in the upper right arm on 06Apr2021 as dose 1, single for COVID-19 immunization (at the age of 57-years-old). Medical history included cholesterol problem from an unknown date and unknown if ongoing. Concomitant medication(s) included simvastatin and omeprazole, it was a 20mg tablet but she always took half of it so it was 10mg, taken for an unspecified indication, start and stop date were not reported. Patient initially stated she was wondering if she had an allergic reaction. She was much better that day (07Apr2021) than she was yesterday (06Apr2021). She was on Simvastatin and omeprazole and took them the night before she got her shot. Later she clarified that she had an allergic reaction to her first vaccine shot. Well, it was an allergic reaction it started out within 20 minutes (on 06Apr2021, date of vaccination) profuse sweating and she kind of brushed that off because it lasted for about she did not know off and on about an hour. And then she noticed everything was swelling up, her feet her toes her hands her stomach everything and that was when she realized she was having an allergic reaction. So, she went ahead and chewed up some Benadryl lied down took a nap slept most of the night. She was seeing signs of relief then, she meant her feet had gone down her hands had gone down her stomach had gone down. So, but she thought it was just an allergic reaction. Patient also stated that she tended to be sensitive to drugs (unspecified medications) anyway so she did not think that was anything unusual for her body because it just hated anything, it just does not like to take drugs. Patient further added that she had just a little bit of a cholesterol problem that she was on medication for. And she also wanted to ask, she was not told, not to take her usual meds the day before so she went ahead and took that statin the night before like she always did. And she wondered if that (Simvastatin) did not have something to do with it too and she also had acid reducers (Unspecified Medications, patient might be referring to Omeprazole) so she took that yesterday morning as well. Treatment was that she took Benadryl once she realized what she was going through, she went ahead and took some Benadryl. She believed it was 24 mg because she just chewed up a kitty sized one. The clinical outcome for the events was recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1756335
Sex: F
Age:
State: MI

Vax Date: 04/05/2021
Onset Date: 04/06/2021
Rec V Date: 10/02/2021
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: Quarter size bruise that's swollen on right leg; Quarter size bruise that's swollen on right leg; This is a spontaneous report from a contactable consumer (patient's husband) or other non-health care professional. A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration in left arm on 05Apr2021 at 10:05 (at the age of 33-years-old) as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 06Apr2021, the patient experienced quarter size bruise that was swollen on the right leg. Reporter reported that they both had the vaccine yesterday, but he was concerned because it was swollen. He stated it had been a full 24 hours since the vaccine. Reporter reported that the vaccine was given yesterday, but the bruise appeared today. They have only noticed it within the last hour. Reporter mentioned that the second vaccine is scheduled on 26Apr2021. Reporter was unsure if the symptom was improved, persisting, or worsening. Outcome of the events was unknown. Information about lot/batch number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 1756336
Sex: F
Age:
State: FL

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 10/02/2021
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: entire mouth swelled up to the point where my gums all cracked open, along with the roof of my mouth splitting open in several places; lymph nodes in my throat are swollen; pain; gums all cracked open; feeling like everything was going black; chest pains; pounding headache; intense pain in my right arm; nausea; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Right on 01Apr2021 at 17:00 (Batch/Lot number was not reported) and dose 1 via an unspecified route of administration, administered in Arm Left on Mar2021 at 14:00 (Batch/Lot number was not reported) both as single dose (at the age of 63-year-old) for covid-19 immunisation. Patient was non pregnant at the time of vaccination. Medical history included allergies to codeine, adhesive glues/chemicals. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 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 Since the vaccination. On 01Apr2021 21:00, the patient experienced chest pains, pounding headache, intense pain in my right arm, nausea, entire mouth swelled up to the point where my gums all cracked open, along with the roof of my mouth splitting open in several places, lymph nodes in my throat are swollen, pain, feeling like everything was going black and gums all cracked open. It was reported that, patient initially had chest pains and a pounding headache within about five minutes after receiving the vaccine, along with feeling like everything was going black. After being stabilized, she went home and was okay for about 4-5 hours. When she went to bed, she became incapacitated for the next 40 hours with intense pain in her right arm and nausea. The following day, her entire mouth swelled up to the point where her gums all cracked open, along with the roof of my mouth splitting open in several places. The lymph nodes in her throat were swollen as well. It had now been 6 days and she was still in pain. No treatment was received to treat adverse events. The outcome of the events was not recovered. No follow-up attempts possible. No further information expected.

Other Meds:

Current Illness:

ID: 1756337
Sex: M
Age:
State: MN

Vax Date: 03/20/2021
Onset Date: 03/21/2021
Rec V Date: 10/02/2021
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: lips tingling; fingertips/fingers tingling; This is a spontaneous report from a contactable consumer (patient's wife). A 58-years-old male patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot Number: EP7534, Expiration date and NDC number was unknown) via an unspecified route of administration, administered in upper left arm on 20Mar2021 at 10:00 hours as dose 1, single (at the age of 58-years) for COVID-19 immunisation. The patient had no relevant medical history or family history, and concomitant medications. Patient had no prior vaccinations (within 4 weeks). Patient had no history of previous immunization with the Pfizer vaccine considered as suspect and did not received any additional vaccine. On 21Mar2021 around 08:00 hours, the day after he got the shot, patient had lips tingling, fingertips/fingers tingling, and events lasted for about 30 minutes. Reporter asked were these an allergic reaction to the shot, side effects of the vaccine. Patient did not treat any symptoms or received any treatment for the events. Patient had no physician office or emergency room visits. No relevant tests were performed. Patient was scheduled for tomorrow (10Apr2021) for the second dose. The outcome of all the events was recovered on 21Mar2021 at 08:30 hours. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1756338
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/02/2021
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: Hands became swollen; Precursor to hives; This is a spontaneous report from a contactable consumer(patient) via Medical Information Team. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that 5hours after taking the Pfizer covid 19 vaccine her hands became swollen which she recognize as the precursor to hives (on an unspecified date), she took some Zyrtec (treatment) and when she woke up this morning (on an unspecified date) the swelling was gone. The patient asked was it okay for to take the second dose to which she was replied yes, the Pfizer-BioNTech COVID-19 Vaccine vaccination series is 2 doses given 3 weeks apart, if she receive one dose of the Pfizer-BioNTech COVID-19 Vaccine, she should receive a second dose of this same vaccine 3 weeks later to complete the vaccination series, these may not be all the possible side effects of the Pfizer-BioNTech COVID-19 Vaccine. Serious and unexpected side effects might occur. Pfizer-BioNTech COVID-19, Vaccine was still being studied in clinical trials. The patient further stated that her doctor told to take Tylenol and Benadryl before the second dose will that be okay, in the Pfizer-BioNTech COVID-19 vaccine study, people were allowed to take fever-reducing medications and pain relievers. The patient considered that antipyretics and pain medications (like acetaminophen and non-steroidal anti-inflammatory drugs, like ibuprofen) may be taken after vaccination for treating symptoms, if medically appropriate. But, ACIP also states that these medications should not be routinely given before the vaccine to prevent these symptoms because the effects of the medications on mRNA vaccines (like the Pfizer-BioNTech COVID-19 Vaccine) were not available at that time. Outcome of events was recovered on an unspecified date. No follow-up attempts are needed. information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1756339
Sex: F
Age:
State: TN

Vax Date: 03/31/2021
Onset Date: 04/01/2021
Rec V Date: 10/02/2021
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: 20210409; Test Name: COVID TEST; Result Unstructured Data: Test Result:waiting for result; Test Date: 202104; Test Name: did some test; Result Unstructured Data: Test Result:unknown

Allergies:

Symptom List: Injection site pain

Symptoms: sore throat; allergic symptoms; headache; sneezing; sore throat that's burning; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received BNT162B2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration on 31Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Medical history included bit by a tick (but did not realize she had a tick until a few days after and it was attached for a few days and then she had the vaccine and stated that she realized it the same day or the day before and was fine and got the vaccine and was fine for several days) from 2021 to an unknown date. The patient's concomitant medications were not reported. Patient never was sick and never got COVID. On Apr2021, (symptoms did not appear right away, started earlier this week), had sore throat and allergic symptoms and she never had allergies to spring or anything at all before and stated that she had a headache and sneezing and no fever. Patient does have a sore throat that was burning. Patient was surprised and asked was it the vaccine or not. Patient is getting worse. Patient talked to her doctor and he doesn't know and did some tests just in case. Patient wanted to know if symptoms she was having could be from the vaccine even 4-5 days after the vaccine and with symptoms or if have a reaction or symptoms was it that same day or 2 days later or can it be later. Patient was also wondering if the tick like gave problems would that interact with the vaccine, was there consequences with that if it was only the tick or only the vaccine. Patient stated it was a mess. Patient does not know what to do and patient had no fever, and the doctor won't give her antibiotics. Patient stated that a few days after the vaccine she feels like this and was testing it is a little ridiculous and also concerning. On 09Apr2021, patient was tested for Covid and waiting for the results. The outcome of all the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1756340
Sex: F
Age:
State:

Vax Date: 04/02/2021
Onset Date: 04/03/2021
Rec V Date: 10/02/2021
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: Left arm very swollen; Very hot to touch; Red and rashy on entire upper arm; This is a spontaneous report from a non- contactable consumer (patient). A 29-year-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8733) (age at the time of vaccination was 29 years) via an UNKNOWN route of administration on 02Apr2021 in left arm as dose 1, single for COVID-19 immunisation. The patient's medical history included drug hypersensitivity, allergies to Sulfa. Concomitant medications included Junel (ETHINYLESTRADIOL, NORETHISTERONE ACETATE). There were no other vaccine in four weeks. There was no Covid tested prior to vaccination and not tested for COVID post vaccination. Patient most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. On 03Apr2021, the patient experienced left arm very swollen, very hot to touch and red and rashy on entire upper arm. No treatment was received for the events. It was reported that the events were started day after vaccination and lasted about 5 days. The clinical outcome of the event left arm very swollen was recovered in 2021. The clinical outcome of the events very hot to touch and red and rashy on entire upper arm was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1756342
Sex: F
Age:
State:

Vax Date: 03/31/2021
Onset Date:
Rec V Date: 10/02/2021
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: fever; Result Unstructured Data: Test Result:high fever as high as 101.9 degree; Test Date: 202102; Test Name: antibody test; Result Unstructured Data: Test Result:39.10

Allergies:

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

Symptoms: Sick; High fever as high as 101.9 degree; Vomiting; Diarrhea; Sweating and feels very cold and it has been four days; Sweating and feels very cold and it has been four days; This is a spontaneous report from a contactable consumer or other non-hcp (patient herself). A 51-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration in Arm Left on 31Mar2021 (Lot Number: ER8733, Expiry date: Unknown) as dose number unknown, single for COVID-19 immunisation. Medical history included COVID-19 from Feb2021 to an unknown date, patient had COVID before in February. The patient's concomitant medications were none. On an unspecified date, the patient experienced sick, high fever as high as 101.9 degree, vomiting, diarrhea, sweating and feels very cold and it has been four days. The patient had the Pfizer vaccine (COVID Vaccine) on Wednesday and patient had been sick ever since. The patient underwent lab tests and procedures which included body temperature: high fever as high as 101.9 degree on an unspecified date and sars-cov-2 antibody test: 39.10 on an unspecified date in Feb2021. Therapeutic measures were not taken as a result of the events. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1756343
Sex: M
Age:
State: OH

Vax Date: 01/27/2021
Onset Date: 02/01/2021
Rec V Date: 10/02/2021
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: Red itchy rash - Chest, Shoulders, legs; Generalized urticaria - Chest, legs; Generalized pruritus with skin rash - Chest, legs; Difficulty breathing; This is a spontaneous report from a contactable pharmacist (patient). An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number ZL3249 and expiry date not reported), via an unspecified route of administration, administered in Arm Left, on 27Jan2021 13:00, as dose 1, single, for COVID-19 immunisation. Medical history included Sulfa allergy and tree nuts allergy. The patient's concomitant medications were not reported. The patient previously took cipro [ciprofloxacin] and keflex [cefalexin monohydrate] and experienced allergy. Patient was not taking any medications prior to the event being reported. Patient did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. On morning of 02Feb2021, red rash appeared in chest, had red itchy rash in chest, shoulders, legs. The patient also experienced generalized urticaria in chest and legs and generalized pruritus with skin rash in chest and legs on 02Feb2021. On an unspeciifedd ate in Feb2021, the patient had breathing difficulty. The patient was treated with corticosteroids. On 06Feb2021 with Solumedrol injection and prednisone for 6 days and then was treated with Medrol injection and Medrol on an unspecified date. Patient was not seen in emergency department and was not hospitalized. The outcome for the events was recovering. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on plausible dose-event temporal relationship the causal role of bnt162b2 vaccine cannot be excluded for reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

Other Meds:

Current Illness:

ID: 1756344
Sex: F
Age:
State: TX

Vax Date: 04/01/2021
Onset Date: 04/02/2021
Rec V Date: 10/02/2021
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: bruise the size of a quarter with lump underneath on arm at injection site/the bruise has started to turn colors so she would say, yes, it is improving; bruise the size of a quarter with lump underneath on arm at injection site/the bruise has started to turn colors so she would say, yes, it is improving; This is a spontaneous report from a contactable consumer, the patient. A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: ER8733) via an unspecified route of administration, administered in arm right on 01Apr2021 at 14:00 as dose 2, single (at the age of 48-years-old) for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EN6204) via an unspecified route of administration, administered in arm left on 11Mar2021 as dose 1, single for covid-19 immunization at the age of 48-years-old). It was reported that after receiving the second dose of vaccine on 02Apr2021 in the afternoon the patient experienced the bruise the size of a quarter with lump underneath on arm at injection site. She reported that the bruise has started to turn colors so she would say, yes, it was improving. After the patient first dose she had no side effects, it was fantastic. The patient had not underlain health conditions. The patient did not visit emergency room and physician office for the adverse events. The outcome of the events was recovering at the time of report. No follow-up attempts were needed. No further information was expected.

Other Meds:

Current Illness:

ID: 1756345
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/02/2021
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: little flare up of her asthma; get sicker; respiratory illness; This is a spontaneous report from a non-contactable consumer or other non hcp. A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced little flare up of her asthma, get sicker and respiratory illness. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1756346
Sex: M
Age:
State: IN

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

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

Lab Data:

Allergies:

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

Symptoms: This is a spontaneous report received from a contactable consumer (patient/himself). A 72-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EN6201, expiration date: unknown), at the age of 72, via unspecified route, left arm, on Apr 10, 2021, at 12:50, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. On Apr 10, 2021 (after the vaccination), patient experienced a little swelling of his bottom lip. He took 2 Benadryl but didn't think it helped any. He also wanted to know if he should get the second dose in 3 weeks. No vaccines taken 4 weeks prior vaccinations, The outcome of the events: not recovered (at the time of this report). No follow-up attempts possible. No further information expected.

Other Meds:

Current Illness:

ID: 1756347
Sex: M
Age:
State: TN

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

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Joint pain; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients (reporter's son and grandson). This is the first of two reports. A male patient (grandson) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The grandson was healthy and fine. The consumer stated that his grandson had the PFIZER Covid vaccine and had joint pain. The outcome of the event was unknown. 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-2021402538 same reporter/drug/event, different patient

Other Meds:

Current Illness:

ID: 1756348
Sex: U
Age:
State:

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 10/02/2021
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: significant swelling without pain; This is a spontaneous report from a non-contactable other-HCP. A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on an unspecified date in Jan2021 as dose 2, single for COVID-19 immunization and received lidocaine HCL strength 180 mg via an unspecified route of administration for an unknown indication. Patient medical history and concomitant medications were not reported. Patient was injected with Juv?derm VOLIFT Lidocaine in the lips a few months ago. Patient received the second Pfizer vaccine in Jan. 3 days after the vaccination, patient presented significant swelling without pain on an unspecified date in 2021. Treatment included hydrochloride 180 mg for one day without improvement, therefore the day after patient started steroids as Prednisone 20mg BID. The patient was getting better and continued with the medications. The outcome of the event was unknown. No Follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1756349
Sex: U
Age:
State:

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 10/02/2021
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: Test Name: blood tests; Result Unstructured Data: Test Result:Unknown

Allergies:

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

Symptoms: 2 days later the patient complained of major swelling of all cheeks and lips area; 2 days later the patient complained of major swelling of all cheeks and lips area; all the face [was] with big lumps on NL, Lip1 upper lower and C8; A day later, patient presented swelling on all mid lower face mostly on lips, NL and C6. Patient did not attend the clinic and a day later, patient presented worsening.; This is spontaneous report from a Non-contactable HCP. This HCP reported for a patient that: A patient of unspecified age and gender received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: Unknown), via an unspecified route of administration as dose number unknown, single on Jan2021 for covid-19 immunisation. Medical history included mass, lip swelling, hypoaesthesia, injection site mass and injection site swelling all from an unknown date and unknown if ongoing. Concomitant medications included lidocaine hydrochloride (LIDOCAINE HYDROCHLORIDE); hyaluronic acid (HYALURONIC ACID); hyaluronic acid (JUVEDERM; prednisone (PREDNISONE) at 40mg; ciprofloxacin (CIPROFLOXACIN) at 750mg per day and azithromycin (AZITHROMYCIN) at 500mg a day all taken for an unspecified indication, start and stop date were not reported. As per reporter, the patient injected with 1ml of Juvederm (VOLIFT) with Lidocaine in the NL23, Lip1 and C6, 2ml of Juvederm (VOLUX) in JW1, JW4/5 and C2 and 1ml of Juvederm (VOLITE) in Lip8 and CK5. The result was excellent, satisfaction level high. Two months later, patient started to feel a lump in JW4 left side. Two weeks later patient attended the clinic for a review and HCP injected HAYALSE 200U to the area. Reporter felt mild degradation and prescribed Prednisone 40mg for 5 days and Ciprofloxacin 750mg per day for 14 days. Healthcare professional (HCP) advised, the lump got smaller but was still prominent 48 hours after injection. Two days later, patient felt better and continued with the prescribed medication Prednisone for 3 days. One week later, patient presented swelling all around the lips and NL area and numbness at the NL area and nose area. Two days later, patient presented, worsening on swelling and lumps on injection areas mainly NL and lips. Patient took 40mg of Prednisone and felt better after 6 hours. After consultation HCP decided to stop with Ciprofloxacin and start Azithromycin at 500mg a day for 2 days and then 250mg for 3 more days till the next consultation. In early Jan2021, the patient received the first COVID-19 PFIZER vaccination. A day later, patient presented with swelling on all mid lower face - mostly on lips, NL and C6 (On unspecified date in 2021). Patient did not attend the clinic and a day later, patient presented got worsened. Patient attended ER for blood tests and treatment and received IV of Hydrocort 250mg. A day later, the patient showed no recovery and started to take Fexofenadine 180mg twice a day. Patient attended clinic the following day and HCP noted, all the face was with big lumps on NL, Lip1 upper lower and C8. HCP injected HAYALASE 1000U and felt a small improvement while massaging the areas. The patient started Augmentin 875mg twice a day, along with Fexofenadine. A few days later, patient received another injection of HAYALASE 1000U to the remaining stubborn lumps on same areas. HCP noted, improvement on swelling, but prominent lumps. Patient received another injection of HAYALASE 500U. HCP noted, improvement with smaller lumps remnant -no major degradation. HCP advised, the patient satisfaction rate for 2 months after the treatment was extremely high. Patient was frustrated obviously and want to get rid of the lumps. HCP further advised, the feeling in the tissue was a hard capsulation of the filler with minimum ability to degrade with HAYALASE. The patient improved dramatically but still with small lumps on all C8, Lips -focused and NL3. This record captures events relating to the Juvederm (Volite) injection. The patient underwent lab tests and procedures which included blood test: unknown on unspecified date. Therapeutic measures were taken as a result of the events. The outcome of event condition worsened was unknown and rest all were recovering. No follow-up attempts are possible. No further information.

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

Current Illness:

ID: 1756350
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: major swelling of all cheeks and lips area; major swelling of all cheeks and lips area; This is a spontaneous report from a non-contactable other healthcare professional. A patient of unspecified age and gender received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. On an unknown date, it was reported that the patient had 1ml of VOLUMA T1. 4 months later patient had COVID-19 2nd vaccination. 2 days later the patient complained of major swelling of all cheeks and lips area. Patient started 40 mg prednisone for 5 days and fexofenadine for 7 days. Patient symptoms have improved. Update that HCP feels event was not device related. Symptoms on going. Outcome of event was not recovered. No follow-up attempts are possible. No further information was expected.

Other Meds:

Current Illness:

ID: 1756351
Sex: F
Age:
State: MA

Vax Date: 04/01/2021
Onset Date: 04/06/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: very swollen face; eye brow was hanging over eye, very swollen, like a baseball cap shield hanging over her eye and the whole eye was swollen, like her eye vision was a little slit on both sides; her eye vision was a little slit on both sides; nose was swollen; rash over her entire face, a scaly rash. States it was more so on the left side of her face than the right; could feel the top of her forehead into her scalp was very hot; face was extremely itchy and rashy, she didn't even recognize herself, itching felt very deep, her fingers sunk in when she scratched her face; left side of her neck, she has swollen glands on the lateral side of head; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8737), via an unspecified route of administration (at the age of 60-years), administered in right arm, on 01Apr2021 11:45 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. Historical vaccines include, in 1990, patient received series of 3 Hep B vaccines (Hepatitis B vaccine, NDC was not reported, Lot/Batch number was not reported, Expiration date was not reported) for working in a hospital, and on the third shot, she was paralyzed from the waist down for 8.5 hours. Patient states at the time she was young, and she doesn't panic. Patient states she worked in PT and so she sat there, and they kept checking on her and within 30 minutes, she couldn't move, and they said with vaccines sometimes these things happen and kept checking on her. Patient states it started wearing off and she got up and went home. Patient states she has never had anything after that, no residuals. The patient did not receive other additional vaccines administered on same date of the Pfizer Suspect. The adverse events did not result in visit to emergency room or physician office. Patient states she had her first vaccination on 01APR2021 and 6 days later, so 3 days ago she had an adverse reaction. Patient stated she tried to call the number and the recording kept cutting off. Patient states so she went online and was filling out the information and everything said it was incorrect, it was all red flags saying the information was wrong. Call handler clarified which reporting site and she states VAERS. Informed caller thanks for letting us know; however, that site is not operated by Pfizer and call handler would be happy to complete a safety report with her now. Patient states on 06Apr2021 at 10:00, she woke up to a very swollen face. Patient states it felt like the sheet was on her eye. Patient states she looked in the mirror and her eyebrow were hanging over her eye, and it was very swollen. Patient states it was like a baseball cap shield hanging over her eye and the whole eye was swollen, like her eye vision was a little slit on both sides. Patient states her nose was swollen. Patient states she had a rash over her entire face, a scaly rash. Patient states it was more so on the left side of her face than the right. Patient states she could feel the top of her forehead into her scalp was very hot. Patient states she is not a person to panic but she hears about blood clots and so she got out of bed and made sure to get times for reference. Patient states her face was extremely itchy and rashy, she didn't even recognize herself and then after she put Aloe Vera on and it calmed down a bit, she used Neosporin every hour or so because it was so inflamed, hot, and itchy and the itching felt very deep. Patient states that are what woke her up, when she scratched her face and it felt like her fingers went down in. Patient said she is not in scary movie, what is going on. Patient states that lasted through till yesterday and it started to calm down last night at 23:00 and when she woke up this morning the inflammation had went down but it is still itchy, but not severe. Patient states she does not want to go outside because she does not want people to see her and say they aren't getting the vaccine now. Patient states the rash is still there but not as intense. Patient states on the left side of her neck, she has swollen glands on the lateral side of her neck and under her chin, so from her clavicles to the top of her head, but it is no big deal. Patient states she warned of possible side effects. States it is nothing to be concerned about. Patient states she does have a question, when they gave us the paperwork, it lists the possible risks, and under non severe allergic reaction, it lists swelling of the face. Patient states it also says swelling of the face as severe, so which is it. Patient stated she was assuming it depends on if there is a little bit or a lot. Patient enquired is she okay to have the second one. The patient was provided with report reference. The patient was provided with the website and phone number for and hour of operation. The outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1756352
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/02/2021
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: abnormal bruising; swelling started at night; This is a spontaneous report from a non-contactable other health care professional. An unspecified age and gender patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation and received hyaluronic acid, lidocaine hydrochloride (Juvederm Volbella with lidocaine injection, Batch/Lot number and Expiration date was not reported), via unspecified route of administration, on an unspecified date for an unspecified indication. Patient took COVID-19 vaccine 3 weeks before the Juvederm Volbella with lidocaine injection. The patient's medical history was not reported. Patient received pre-treatment of numbing cream as concomitant medication. On an unspecified date, patient was injected with Juvederm Volbella with lidocaine injection under eye and voluma in checks jawline temples nasolabial and patient had abnormal bruising immediately after injection and swelling started at night. On an unspecified date, after 10 days, patient developed product aggregation in jaw angle and cheeks and under eye. Therapeutic measures were taken as a result of abnormal bruising and swelling started at night and treatment included post treatment of vitamin K. Record related to Juvederm Volbella with lidocaine injection. The outcome of both the events was not recovered. No follow-up attempts were possible, information about lot/batch number could not be obtained

Other Meds:

Current Illness:

ID: 1756353
Sex: F
Age:
State: OH

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

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

Lab Data: Test Date: 20210411; Test Name: Fever 100.8 degrees; Result Unstructured Data: Test Result:100.8; Comments: Degrees; Test Name: Covid test; Result Unstructured Data: Test Result:Negative

Allergies:

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

Symptoms: Fever like 100.8; Pain to chest/says it felt like a rubber band was wrapped around her chest and back; Sick on your stomach; Dizzy; felt like a rubber band was wrapped around her chest and back; throat and tongue swelling like an allergy; Throat and tongue swelling; Throat and tongue swelling; Sore Throat; Headache; Pain in Arm; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EW0162, Expiration date: 31Jul2021, NDC number was unknown), via an unspecified route of administration on 10Apr2021 at 08:15 hours as dose 1, single (at the age of 72-years-old) for COVID-19 immunisation. The patient medical history included ongoing pacemaker (implanted 2 years ago), ongoing high blood pressure diagnosed 2 years ago, cholesterol, (diagnosed about 2 years ago), 2 stomach surgeries (many years ago), Back Surgery (many years ago), Diverticulitis (many years ago), removal of part of intestines (about 3 and a half years ago), several allergies (patient cannot take pain medications or most antibiotics, stated they made her sick, patient cannot eat red meat, lactose, cannot digest some meats, chest pain that felt like a rubber band around her chest and back before, unrelated to the vaccine, regulate heart rate, cannot take any pain medications, as they make her throw up and feel sick, had issues when taking almost all antibiotics, sick for about 7 weeks from Nov 2020 to unknown if ongoing, in about Nov 2020 for about 7 weeks, patient had horrible, horrible symptoms, patient was sick to the stomach, throwing up, same chest pain with feeling like a rubber band was around her body, losing weight, difficulty breathing, and fever, called her doctor and got antibiotics, antibiotics were hard for her to take. Patient took two rounds of antibiotics and was still sick. Patient went to Emergency Room and tested negative for COVID. Doctor thought false negative because of her symptoms. Patient stated that there was lot of health issues in her family such as heart disease and cancer. Historical vaccine included flu vaccine every year with no issues for immunisation. Patient had no history of all previous immunizations with the Pfizer vaccine considered as suspect. Patient had no prior vaccinations (within 4 weeks). Concomitant medications included unknown medications for high blood pressure and unknown medication to regulate heart rate. Patient was worried about getting the vaccine at first; she did not want to do it because she gets sick from everything. On 10Apr2021, about an hour after the vaccination, patient throat and tongue began swelling a little; like an allergy, sore throat, also had a slight headache and pain in her arm. Patient stated that throat and tongue swelling lasted for about 8 hours. On 11Apr2021, patient had a fever 100.8 degrees, had pain across her chest and stated that it felt like a rubber band was wrapped around her chest and back, was sick on her stomach and dizzy, had a headache, and the fever. Patient asked if it was normal to have side effects after the first shot. Patient heard from everybody not to worry about the first dose, it does not have side effects. They said the side effects come with the second dose. Patient does not know if it was safe for her to get the second dose. Patient had no emergency room and physician office visit for all the events. No relevant tests were performed. The outcome of throat and tongue swelling and throat and tongue swelling like an allergy was recovered on 10Apr2021, Headache, fever like 100.8, pain to chest/says it felt like a rubber band was wrapped around her chest and back, Sick on your stomach, Dizzy was recovered on 12Apr2021, pain in arm was recovering, unknown for felt like a rubber band was wrapped around her chest and back and not recovered for sore throat. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness: Artificial cardiac pacemaker user (implanted 2 years ago.); Blood cholesterol abnormal (Diagnosed about 2 years ago.); Blood pressure high (Diagnosed about 2 years ago)

ID: 1756354
Sex: F
Age:
State: DC

Vax Date: 02/01/2021
Onset Date: 03/17/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Date: 20210329; Test Name: Blood creatinine; Result Unstructured Data: Test Result:Normal; Test Date: 20210329; Test Name: Blood urea; Result Unstructured Data: Test Result:normal; Test Date: 202101; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:No results reported; Test Date: 202101; Test Name: Hepatic enzyme; Result Unstructured Data: Test Result:Elevated; Comments: Liver enzymes are borderline elevated, but they aren't concerned about it. Her providers not worried about results.; Test Date: 202101; Test Name: Renal function test; Result Unstructured Data: Test Result:no results reported

Allergies:

Symptom List: Vomiting

Symptoms: patient had a rash all over her trunk, legs, buttocks, and back; red, raised, itcpatient experienced hy, burning "dots" on her thighs, back, buttocks, abdomen, trunk, and face.; patient experienced red, raised, itchy, burning "dots" on her thighs, back, buttocks, abdomen, trunk, and face.; This is a spontaneous report based on the information received by Pfizer from (manufacturer report number 2021CAT00031). A contactable consumer reported that a 69-year-old female patient received bnt162b2 (BNT162B2, solution for injection), dose unknown via an unspecified route of administration on 10Mar2021 (Batch/Lot number was not reported) as dose number, unknown single for covid-19 immunisation; amifampridine phosphate (FIRDAPSE), oral from Jan2021 (Batch/Lot Number: 3185427; Expiration Date: 28Feb2021) to Jan2021, at 5 mg, 3x/day, oral from Jan2021 (Batch/Lot Number: 3185427; Expiration Date: 28Feb2021) to Jan2021, at 20 mg, daily, oral from Jan2021 (Batch/Lot Number: 3185427; Expiration Date: 28Feb2021) to Jan2021, at 15 mg, 1x/day, oral from Jan2021 (Batch/Lot Number: 3185427; Expiration Date: 28Feb2021) to Jan2021, at 10 mg, 2x/day, oral from 2021 (Batch/Lot Number: 3185427; Expiration Date: 28Feb2021) to 2021, at 15 mg, 2x/day, oral from 2021 (Batch/Lot Number: 3185427; Expiration Date: 28Feb2021) to Feb2021, at 10 mg, 1x/day, oral from Feb2021 (Batch/Lot Number: 3185427; Expiration Date: 28Feb2021) to 22Feb2021, at 15 mg, 3x/day, oral from 23Feb2021 (Batch/Lot Number: 3185427; Expiration Date: 28Feb2021) to 2021, at 20 mg, 3x/day, oral from 2021 (Batch/Lot Number: 3185425; Expiration Date: 28Feb2021) and ongoing, at 20 mg, 3x/day for myasthenic syndrome. Medical history included diverticulitis from Sep2020, endoscopy from Sep2020 All Clear, colonoscopy from Sep2020 All Clear, hospitalisation from 11Jan2021 to an unknown date, Having muscle weakness prior to hospitalization and couldn't swallow but was related to LEMS, Ongoing myasthenic syndrome, muscular weakness, dysphagia, constipation, gastrooesophageal reflux disease, abdominal pain upper, Hypertension, Meniere's disease, Blood cholesterol increased, ongoing dry mouth, Anxiety, Depression. Concomitant medication included pantoprazole sodium sesquihydrate (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) taken for an unspecified indication, start and stop date were not reported; docusate sodium (COLACE) taken for an unspecified indication, start and stop date were not reported; olmesartan medoxomil (BENICAR) taken for an unspecified indication, start and stop date were not reported; lansoprazole (LANSOPRAZOLE) taken for an unspecified indication, start and stop date were not reported; fluoxetine hydrochloride (PROZAC) taken for an unspecified indication, start and stop date were not reported; senna glycosides (SENNA GLYCOSIDES) taken for an unspecified indication, start and stop date were not reported. The patient previously took iviglob-ex for drug therapy and experienced no adverse event. On 16Jan2021, the patient started treatment with FIRDAPSE 10 MG. On unspecified dates in 2021, after starting FIRDAPSE, the patient experienced headache, nausea, muscle spasms, weight loss, and hip and back pain. On 23Feb2021 (previously reported as an unspecified date in Feb2021), the patient's FIRDAPSE dose was increased to 20 mg, taken orally, 3x/day for LEMS. After increasing the dose, the patient's nausea (previously reported) became more pronounced. As of 10Mar2021, treatment with FIRDAPSE was ongoing. The statuses of the headache, muscle spasms, nausea, weight loss, and hip and back pain were not reported. No additional information was reported. On 26Mar2021, it was learned that on 10Mar2021, the patient received an unspecified COVID vaccine. On an unspecified date in Mar2021, about one week after the vaccine, the patient had a rash all over her trunk, legs, buttocks, and back. As treatment, she used Benadryl (diphenhydramine hydrochloride) at night, some nights. As of 26Mar2021, treatment with FIRDAPSE continued, and the rash all over her trunk, legs, buttocks, and back was ongoing. She had a doctor appointment scheduled for 29Mar2021. No additional information was provided. On 05Apr2021, it was learned that the COVID vaccine was manufactured by Pfizer. On 17Mar2021, the patient experienced red, raised, itchy, burning "dots" on her thighs, back, buttocks, abdomen, trunk, and face. On 29Mar2021, the patient went to her doctor who diagnosed it as a rash and didn't provide much more than that. He did not want to prescribe oral steroids due to the patient receiving the COVID vaccine. The doctor did not say whether or not he thought it was related to the vaccine. A BUN (blood urea nitrogen) and creatinine level were drawn and the results were normal. The patient treated the rash with unspecified topical steroids and cold showers. As of 05Apr2021, the rash was improved, as it was still present, but faint and it no longer burned or itched. No additional information was provided. The patient underwent lab tests and procedures which included blood creatinine: normal on 29Mar2021, blood urea: normal on 29Mar2021, electrocardiogram: no results reported on Jan2021, hepatic enzyme: elevated on Jan2021 Liver enzymes are borderline elevated, but they aren't concerned about it. Her providers not worried about results, renal function test: no results reported on Jan2021. The action taken in response to the event for amifampridine phosphate was dose not changed. Therapeutic measures were taken as a result of patient had a rash all over her trunk, legs, buttocks, and back (rash), red, raised, itcpatient experienced hy, burning "dots" on her thighs, back, buttocks, abdomen, trunk, and face. (rash pruritic), patient experienced red, raised, itchy, burning "dots" on her thighs, back, buttocks, abdomen, trunk, and face. (skin burning sensation). Outcome of the events was not recovered. No follow-up attempts are needed. Information about lot/batch number cannot be requested. No further information is expected.

Other Meds:

Current Illness: Dry mouth; Myasthenic syndrome

ID: 1756355
Sex: F
Age:
State: GA

Vax Date: 04/07/2021
Onset Date: 04/10/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:Unknown; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Unknown

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Severe migraines for weeks; Fatigue; Nausea; Rash on both sides of my neck; strange dreams; Night sweats; Extreme sore arm; Burning in the back of my head; Muscles soar in the back and lower rib cage; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 46-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 07Apr2021 09:45 (Lot Number: ER8734, Expiration date was not reported) (at the age of 46-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included covid-19. The patient received other medications in 2 weeks (details were not reported). The patient had known allergies (details were not reported). The patient had covid prior to vaccination and was tested for covid post vaccination (blood test and nasal swab). Historical vaccine included bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 10Mar2021 09:30 (Lot Number and Expiration date was not reported) for covid-19 immunisation. The patient did not receive any other vaccine within 4 weeks of covid vaccine. On 10Apr2021 19:00, the patient experienced patient experienced severe migraines for weeks, fatigue, nausea, rash on both sides of my neck, strange dreams, night sweats, extreme sore arm, burning in the back of my head and muscles soar in the back and lower rib cage. Laboratory tests on an unspecified date included sars-cov-2 test (blood test) unknown result and sars-cov-2 test (nasal swab) unknown result. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with Shot of Zofran and tramadol, Benadryl & Cortizone. The clinical outcome of the events was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1756356
Sex: M
Age:
State: CA

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 10/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Had gotten rash and sore body; Had gotten rash and sore body; This is a spontaneous report from a Pfizer-sponsored program via non-contactable consumer (son) for a male patient (father). A male patient of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported) via an unknown route of administration on 01Apr2021 as dose 1, single for COVID-19 immunisation; infliximab (REMICADE), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included Still disease. The patient's concomitant medications were not reported. The patient had infusion close to vaccine. On an unknown date, the patient had gotten rash and sore body. The patient's healthcare professional (HCP) kept patient back on Prednisone 06Apr2021. The patient had not taken Remicade in 4 or 5 months. The patient's son was wondering when the patient can get 2nd dose of covid vaccine. It was not clarified if after 1st dose of vaccine, patient had to get treatment of Remicade. Therapeutic measures were taken for the events. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1756357
Sex: M
Age:
State: AZ

Vax Date: 03/11/2021
Onset Date: 03/16/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Date: 20210316; Test Name: Fever; Result Unstructured Data: Test Result:101.8 F

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: his fever today is 101.8 F; This is a spontaneous report received from a other health care professional. A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 11Mar2021 (at the age of 57-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated, "My husband and I both had a Covid vaccine shot on the 11Mar2021, and he was having a reaction, but she was okay, and he has like underlying conditions so she just wondering if she should be concerned because his fever today was 101.8 F". Height and weight for the patient, reporter stated, he was about 5'9, 5'10 and 230 pounds probably. For further probing, reporter mentioned, "I did tell you my story after I get my questions answered about the vaccine that if I need to worry or take him to the doctor or what?". The patient underwent lab tests and procedures which included fever was 101.8 Fahrenheit on an unknown date. The outcome of the event was unknown. No follow up activities are needed; No further information is expected.

Other Meds:

Current Illness:

ID: 1756358
Sex: F
Age:
State: CA

Vax Date: 02/14/2021
Onset Date: 02/14/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Date: 20210303; Test Name: complete blood count; Result Unstructured Data: Test Result:Normal; Comments: Normal; Test Date: 20210303; Test Name: Urine test; Result Unstructured Data: Test Result:Normal; Comments: Normal

Allergies:

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

Symptoms: Real strong appetite change; Episode of nausea; Achy; Fatigue; Itchy hive on my arm about 2 inches from the injection site and it itched and grew for a couple of days and then it flattened; Hives that itched on my arm; Itchy hive on my arm about 2 inches from the injection site and it itched and grew for a couple of days and then it flattened; Hives that itched on my arm; she thought she had a non-severe allergic reaction; Rash; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received BNT162B2 (Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 14Feb2021 (at the age of 67 year old) as dose 2, single for COVID-19 immunisation. Medical history included, High cholesterol, nerve disorders like chronic migraine both started 20 years ago. She is not a smoker. Concomitant medications included pravastatin for high cholesterol and nortriptyline hydrochloride (PAMELOR) for migraine and an unspecified statin for high cholesterol. Historical vaccine included first dose of BNT162B2, lot number unknown, via an unspecified route of administration on 24Jan2021 (at the age of 67 year old), as single dose for COVID-19 immunization. After the second COVID vaccine, the patient had an unusual reaction. On 14Feb2021, a couple of hours after getting the vaccine, she got a very itchy hive on her arm about 2 inches from the injection site and it itched and grew for a couple of days and then it got flattened. And by day 3 or 4, that is on 17Feb2021/18Feb2021, the hives was gone, where she thought she had a non-severe allergic reaction. After the rash went away, on 18Feb2021, she got very nauseous, achy and very fatigued for about 4 days, till 22Feb2021. She reported that she rested for 4 weeks. By 27Feb2021, she got better, where achiness gone. She also had a real strong appetite change, that she could not stand to eat flavory food or much cooked food. It was reported that, between 22Feb2021 and at the time of report, she had about 4-5 episodes of nausea. At the time of report, it's been 4 and a half weeks, where about every 3 days (as like episode of nausea on last Friday and then on Monday) she would get very nauseous, she took Compazine or Zofran for it. Compazine was of dose 10 mg and she would take either 5 or 10 depending on how she feel. And after a day or so it goes away. She did doctor's visit on Friday and had all her laboratory test 03Mar2021, including blood test, complete blood count, urine test and all they were normal. The outcome of the event nauseous was not recovered and of Real strong appetite change was unknown and of very fatigued was recovering and of other events was recovered on an unspecified date in Feb2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

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

Current Illness:

ID: 1756359
Sex: U
Age:
State: CA

Vax Date: 03/16/2021
Onset Date:
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Name: Fever; Result Unstructured Data: Test Result:101.1; Test Date: 202008; Test Name: COVID-19 test; Test Result: Positive

Allergies:

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

Symptoms: Feeling bad; The fever was a 101.1; Dizzy/Started feeling like kind of lightheaded like we have a little joint or something; I was not able to sleep last night; Felt very weak; Nauseated; Whole body had joint pain; Vaccine site is hurting where they gave the injection; Exhaustion; Muscle pain; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in Left arm on 16Mar2021 as dose 1, single for covid-19 immunization. Medical history included osteoporosis and irritable bowel syndrome. Prior to vaccination patient previously had covid-19 in Aug2020. Patient concomitant medication included vitamins. The patient was feeling bad after the vaccination, she had the fever with temperature a 101.1 and was dizzy ,started feeling like kind of lightheaded like we have a little joint or something, she was not able to sleep last night. The patient felt very weak and was nauseated. The whole body had joint pain and vaccine site is hurting where they gave the injection exhaustion. She had muscle pain. The patient underwent lab tests and procedures which included body temperature: 101.1 (units unspecified) and COVID-19 test with positive result in Aug2020. The outcome of the events was unknown. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am