VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1810913
Sex: F
Age:
State:

Vax Date: 03/15/2021
Onset Date: 03/15/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Date: 20210318; Test Name: Walking distance test; Result Unstructured Data: Test Result:Worse on her 6 minute walk

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: patient experienced the event of did worse on her 6 minute walk; Increased to 11 breaths of Tyvaso; not been feeling well; This is a spontaneous report from a contactable consumer or other non hcp (patient) received via Pfizer from regulatory authority (Manufacturer Report No: UNT-2021-005040).A 81-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 15Mar2021 (Batch/Lot number was not reported)(at the age of 81-year-old) as dose number unknown, single for COVID-19 immunization, treprostinil sodium (TYVASO, concentration of 0.6 mg/ml) delivered by Tyvaso inhalation device (TD-300/A) (device only) via an inhalation route of administration from 04Jan2021 (Batch/Lot number was not reported) to an unspecified date, at unspecified dose, via inhalation route of administration from an unspecified date (Batch/Lot Number: 2101910; Expiration Date: 31Oct2021) to an unspecified date, at 18-54 microgram, four times a day and via inhalation route of administration from 15Mar2021 (Batch/Lot number was not reported) to an unspecified date, at 66 microgram for pulmonary arterial hypertension. Medical history included ongoing pulmonary arterial hypertension. Concomitant medications included sildenafil citrate and diltiazem hydrochloride. On 15Mar2021, patient experienced increased to 11 breaths of tyvaso and not been feeling well. On 18Mar2021, patient experienced the event of did worse on her 6-minute walk. It was reported that on 15Mar2021, 2 months 12 days after initiating IH Tyvaso the patient had not been feeling well and the patient got her Covid-19 vaccine and she increased to 66 microgram (11 breaths) of IH Tyvaso (off label use) on the same day. On 18Mar2021 (Yesterday), 2 months 15 days after initiating IH Tyvaso, the patient did worse on her 6-minute walk test at physician visit. The patient underwent lab tests and procedures which included walking distance test: worse on her 6-minute walk on 18Mar2021. The action taken in response to the events for treprostinil sodium was unknown. The outcome of the events was unknown. The reporter's causality for the event malaise with IH Tyvaso was considered to be possibly related. The reporter did not provide causality for the event of walking distance test. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds: SILDENAFIL CITRATE; DILTIAZEM HYDROCHLORIDE

Current Illness: Pulmonary arterial hypertension

ID: 1810914
Sex: U
Age:
State: MN

Vax Date: 03/25/2021
Onset Date:
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: I am receiving some sure pain in my foot; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A patient of unspecified age and gender received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection with Lot Number: ER8732; Expiration Date: 31Jul2021), via an unspecified route of administration on 25Mar2021 as dose 1, single for COVID-19 immunisation. Co-suspect product included clopidogrel bisulfate (PLAVIX) taken for anticoagulant therapy. Medical history included foot amputation surgery that he had month and half ago before vaccination. The patient experienced some sure pain in his foot on an unspecified date and wanted to know if that was because of the dose or not. The event outcome was reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1810915
Sex: M
Age:
State: MN

Vax Date: 03/15/2021
Onset Date:
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Name: INR level; Result Unstructured Data: Test Result:lower

Allergies:

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

Symptoms: his INR level during the Prothrombin time test became lower; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number, expiry date: unknown), via an unspecified route of administration, on 15Mar2021 as dose 2, single for Covid-19 immunization and Warfarin from an unspecified date as an anticoagulant. First dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number, expiry date: unknown) via an unspecified route of administration, unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient wanted to know the reason why his international normalized ratio (INR) level during the Prothrombin time test became lower. Caller was unable to provide the date he received the 1st dose. The patient underwent lab tests and procedures which included prothrombin time: lower on an unspecified date. The action taken in response to the event for warfarin was unknown. Outcome of the event was unknown. No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1810916
Sex: F
Age:
State:

Vax Date: 02/18/2021
Onset Date: 03/11/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: bad as well; fatigue; injection site pain; pain; This is a spontaneous report based on the information received by Pfizer from Merck & Co., Inc (Case Number: 01893875). A female patient of an unspecified age received BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 18Feb2021 as dose 2, single for covid-19 immunization; pembrolizumab (KEYTRUDA, Batch/Lot number was not reported) via an unspecified route of administration from 10Mar2021 to an unspecified date, at unspecified dose and frequency for an unspecified indication. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on an unknown date as dose 1, single for covid-19 immunization. The patient experienced fatigue on 11Mar2021 with, bad as well on 22Mar2021, injection site pain and pain on an unspecified date in 2021. It was reported that patient had her 2nd Pfizer COVID vaccine on 18Feb2021 "she did well", and on 10Mar2021 she received her "4th or 5th" treatment with keytruda. Patient has not had any problems with keytruda however, experienced fatigue on 11Mar2021, extreme fatigue on Friday 19Mar2021 and yesterday 21Mar2021, and today 22Mar2021, was bad as well. she has experienced injection site pain and intense pain all over however, could not recall when these symptoms started. since the Keytruda therapy on 10Mar2021 patient "has gone downhill" and was unsure which medication caused these side effects. The action taken in response to the event for pembrolizumab was unknown. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Other Meds: KEYTRUDA

Current Illness:

ID: 1810917
Sex: F
Age:
State:

Vax Date: 03/13/2021
Onset Date: 03/13/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Date: 20210313; Test Name: blood pressure; Result Unstructured Data: Test Result:Dropped; Comments: She had a blood pressure reaction drop at the site whenever she received the first dose of the covid vaccine. She was fine after that.

Allergies:

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

Symptoms: low grade temperature; experienced headache before receiving the vaccine and then the headache worsened afterwards; body aches; the vaccination site her blood pressure dropped; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP7534) via an unspecified route of administration on 13Mar2021 (at the age of 51 year old) as dose 1, single for COVID-19 immunisation. Medical history included allergies. No reported family history. There were no concomitant medications. She had a headache two days before receiving the vaccine. On 13Mar2021, when she received the vaccine, she had a blood pressure reaction drop at the site. She was fine after a couple of minutes. Then on Sunday, 14Mar2021, her headache got worsened, where it was an intense bad headache. Her headache got went up and down. Also she had body aches that started from 14Mar2021, for 2 weeks straight (full on for the first two weeks), then it became intermittent. On 18Mar2021, she experienced a low grade temperature. It was reported that, she was confused on how to move forward. Patient clarified that she knows some of her symptoms were from the vaccine. At the time of report, she is on week three, and is still having symptoms. Patient has intermittent body aches, but they got little better, but her headache has not left her at all, it got much worse she has ever had, and now it is weaning, and her low-grade temperature was reported as intermittently ongoing. She was trying to find out the best path to take. She was asking should she delay her second dose of the COVID vaccine, and if she can delay then, how long can she delay it for it to still be effective. The outcome of the event Blood pressure dropped was recovered on 13Mar2021, and of body aches was recovering and of other events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness: Headache (Caller experienced headache before receiving the vaccine)

ID: 1810918
Sex: F
Age:
State: MA

Vax Date: 03/30/2021
Onset Date: 03/31/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Mucus on the stool in the day following the vaccine. Multiple instances (5+); This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number and expiry date: not reported) via an unspecified route of administration on 30Mar2021 at 16:30 (Age at vaccination: 46-year-old) on left arm as dose 1, single for Covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was neither diagnosed with Covid-19 prior to vaccination, neither been tested for Covid-19 since the vaccination. Medication history included: Penicillin allergy. Concomitant medications included: semaglutide (OZEMPIC), Levothyroxine, and Atorvastatin (within 2 weeks of vaccination). On 31Mar2021 at 10: 00 Am, the patient had Mucus on the stool in the day following the vaccine. Multiple instances (5+). The patient did not receive any treatment for adverse event. Outcome of event was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: OZEMPIC; LEVOTHYROXINE SODIUM; ATORVASTATIN

Current Illness:

ID: 1810919
Sex: F
Age:
State: NJ

Vax Date: 03/25/2021
Onset Date: 03/26/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: tired; body was sore; nipples have been sore/nipples on my breast are tender; breast is still sore; arm was sore; This is a spontaneous report from a contactable consumer (herself). A 54-years-old non pregnant female patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number: EP6955), dose 2 via an unspecified route of administration, administered on Arm Left on 25Mar2021 10:45 as DOSE 2, SINGLE for covid-19 immunisation (at an age of 54 years). Medical history included lung neoplasm malignant from an unknown date and unknown if ongoing and contrast media allergy (Iodine with contrast) from an unknown date and unknown if ongoing. Concomitant medication included drospirenone (SLYND) and patient had green pills after dose 2 of vaccination. The patient previously took bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL3247), dose 1 via an unspecified route of administration, administered on Arm Left on 03Mar2021 14:15 as DOSE 1, SINGLE for covid-19 immunisation received other vaccines within 4 weeks prior to this COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. No medications received within 2 weeks of vaccination. The patient took her second vaccine on Thursday. The next day about 23 hours later on 26Mar2021 at 11:00 she felt very tired and her body was sore. Her concern is that her nipples have been sore since Friday. She took Slynd 4mg everyday. She was concerned because her breast has not been sore in the past. Today is Monday, March 29, 2021 and her breast is still sore if she touch it. Note: on 26Mar2021 her arm was sore with both shots which she know is a normal side effect. Also, she aware that being tired and her body being sore is another side effect. Her concern is that her nipples on her breast are tender. This is something new that she have not experienced in years. No treatment measures were taken in response to events. The clinical outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: SLYND

Current Illness:

ID: 1810920
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Chills; Staggering at times; Could not get out of bed for some time; Lack of sex drive; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization; leuprorelin acetate (ELIGARD), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 7.5 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. On unspecified date the patient experienced chills, staggering at times, could not get out of bed for some time, and also stated, the patient had all of the side effects (including lack of sex drive). The patient did not feel the vaccine was related to side effects. The outcome of all events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1810921
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Patient had pre-existing tinnitus but it was very slight. After receiving the COVID vaccine, he told her the tinnitus (ringing in ears) got much more severe; This is a spontaneous report from a non-contactable consumer. A male patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history included tinnitus from an unknown date and ongoing. Concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Any other vaccines taken within four weeks prior to the vaccination was not reported. On an unknown date, the patient experienced tinnitus but it was very slight. After receiving the COVID vaccine, the tinnitus (ringing in ears) got much more severe. The patient had a pre-existing tinnitus but it was very slight. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event tinnitus (ringing in ears) got much more severe was unknown at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness: Tinnitus (pre-existing tinnitus but it was very slight)

ID: 1810922
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Pain; Head was hurting; I thought was like cold coming up; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified gender and age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/lot number: Unknown, Expiry Date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization: Paracetamol (TYLENOL, Lot number: unknown, Expiry date: Not reported) via an unspecified route of administration on an unknown date unknown dose and frequency for pain killer and unknown if ongoing. The patient medical history and concomitant medications were not reported. It was reported that on an unspecified date patient experienced Pain. Patient stated "I had a (Pfizer, Covid-19) Vaccine shot 2 days ago, I took a Tylenol pain killer (might have pain after shot) yesterday (24Mar2021). Reporter queried that would that effect. "I took some, my head was hurting, so I took Robitussin and I thought was like cold coming up" on an unspecified date. Therapeutic measures were taken as a result of the events Pain, Head was hurting. 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: 1810924
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: diagnosed with Mono today; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on an unspecified date (at the age of 18-year-old), as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had first dose and due for the second dose next Wednesday. On unspecified date patient was diagnosed with Mono (today). The Urgent Care doctor said it would be fine to go get it. Her Primary said to wait a couple of weeks. Reporter asking can she got the second dose of vaccine and would the second dose be less effective if patient waited for second dose. The clinical 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: 1810925
Sex: F
Age:
State: NJ

Vax Date: 03/05/2021
Onset Date: 03/06/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: nausea; insomnia; once again slightly irritated; dehydrated; chills; headache; extremely drowsy; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EN6203) via intramuscularly in arm on 05Mar2021 at 15:40 (age at the time of the vaccination 69 year) as dose 2, single for COVID-19 immunization, levocetirizine dihydrochloride (XYZAL ALLERGY 24HR, Lot number was not reported) via an unspecified route of administration from 05Mar2021 16:40 to 05Mar2021, at 5 mg, via an unspecified route of administration from 06Mar2021 to 10Mar2021, at 2.5 mg for an unspecified indication and fexofenadine hydrochloride (ALLEGRA, Lot number was not reported) via an unspecified route of administration from 10Mar2021 to 11Mar2021, at unspecified dose for an unspecified indication. Medical history included hepatitis A from 1975 to 1976 (contracted from food (Recovered)), benign ovarian cysts endometriosis (Laparoscopy (Recovered)), brucellosis from 1987 to 1993 (cured with Doxycycline), shinglesfrom 2005 to 2005 (very mild case), benign uterine polyp from 2007 to 2007 (D+C), blood pressure, osteoporosis, vaginal atrophy and vitamins. Prior vaccinations (within 4 weeks) were none. Concomitant medications included olmesartan medoxomil (BENICAR) for blood pressure, raloxifene hydrochloride (EVISTA) for osteoporosis, estradiol (ESTRACE) for vaginal atrophy, magnesium oxide for vitamins, tocopheryl acetate (VITAMIN E-400) for vitamins, vitamin d3 (VITAtaken for supplementation therapy from an unspecified start date and ongoing. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EN6201) via intramuscularly in arm on 11Feb2021 (age at the time of the vaccination 69 year) as dose 1, single for COVID-19 immunization and experienced rash developed on my inner thigh, headache and fatigue. On 03Mar2021, she consulted with an allergy/Immunology Specialist. To (Hopefully) prevent a rash from the second shot, he advised to take levocetirizine Dihydrochloride after the second shot and for an additional 6 nights. She had the 2nd shot at 4pm on 5Mar. She took 5mg of Xyzal 24 hour (Levocetirizine) one hour after the shot. No rash appeared. On 06Mar2021, the patient was extremely dehydrated in the morning, experienced chills, slight headache and extremely drowsy from the xyzal and cut the dose down to 2.5 mg for the next 4 nights (06Mar through 09Mar). She remained extremely drowsy from the antihistamine, even with the lower dose. On 09Mar2021, the patient once again slightly irritated. Although no rash visually appeared, on 09Mar the area on her inner thighs, where the rash previously appeared from the first shot, was once again slightly irritated. On the night of 10Mar, the doctor switched her to Allegra, a non-sedating antihistamine. On 10Mar2021, the patient experienced nausea and insomnia. She saw the doctor again on 11Mar. All antihistamines were discontinued due to their side effects. The doctor prescribed Mometasone Cream which she used on her inner thighs on the evenings of 11,12 and 13 Mar. So far, So good. She discontinued the use of the mometasone cream on 14Mar. although the skin remained visually clear, the skin was still slightly irritated. (more so at night, she was able to sleep). Because a hot bath or shower would worsen the irritated, she took only tepid showers. She consulted with a dermatologist on 15Apr. He confirmed that the patient should avoid hot showers and he thought that the irritation would eventually subside. By the end of April the skin was no longer irritated. In summary, the skin irritation lasted 2 half months after the rash that was caused by the first dose of the vaccine. Therapeutic measures were taken as a result of once again slightly irritated (irritability). The action taken in response to the events for levocetirizine dihydrochloride was permanently withdrawn on 10Mar2021 and for fexofenadine hydrochloride was permanently withdrawn on 11Mar2021. The outcome of the event dehydration, extremely drowsy and nausea was unknown. On 06Mar2021, the outcome of the event chills and headache recovered. On an unspecified date in Apr2021, the event once again slightly irritated recovered. The outcome of the event insomnia was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds: BENICAR; EVISTA; ESTRACE; MAGNESIUM OXIDE; VITAMIN E-400; VITAMIN D3; XYZAL ALLERGY 24HR; ALLEGRA

Current Illness:

ID: 1810926
Sex: F
Age:
State:

Vax Date: 03/29/2021
Onset Date: 03/01/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: taken Ibuprofen and done everything, she is ready to do something that call handler was not able to clarify, and fight, and it is now cramping up; arm is really numb; arm is painful; This is a spontaneous report from a non-contactable consumer or other non-Health-care professional (Patient herself). A female patient of an unspecified age received BNT162B2 (BNT162B2 Formulation: Solution for injection Batch/Lot number: Unknown Expiration Date: Unknown) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history was not reported. The patients concomitant medications includes ibuprofen for Pain in arm on an unspecified date. Patient says she got the Pfizer shot on the 29th, and her arm is numb, it was really painful, she has taken Ibuprofen and done everything, she was ready to do something that call handler was not able to clarify, and fight, and it is now cramping up, so she was seeking recommendations on an unspecified date in Mar2021. Outcome of all events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained

Other Meds: IBUPROFEN

Current Illness:

ID: 1810927
Sex: M
Age:
State: PA

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

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

Lab Data:

Allergies:

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

Symptoms: having a bad reaction/ He is really miserable; red blotches/Got red blotches in arm; little blisters; Burning and sore; they are very uncomfortable; Burning and sore; they are very uncomfortable; Blood pressure high; Upset stomach; Throwing up; This is a spontaneous report received from a contactable consumer or other non hcp. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 22Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 on an unspecified date for covid-19 immunisation. The patient experienced having a bad reaction/ he is really miserable, red blotches/got red blotches in arm, little blisters, burning and sore; they are very uncomfortable, blood pressure high, upset stomach, throwing up on an un-specified date. Additional context reported as Patient wife said my husband had his 2nd Covid shot on the 22Mar2021, my husband is having a bad reaction. He got red blotches down in his arm, it's a little blister on it, he did have red blotches. He got it and he is having really right now; he is really miserable. They are burning and sore, they are very uncomfortable, he got his blood pressure got high (high blood pressure). The patient received treatment for the adverse events. The clinical outcome of the events was unknown. Therapeutic measures were taken as a result of having a bad reaction/ he is really miserable, red blotches/got red blotches in arm, little blisters, burning and sore; they are very uncomfortable, blood pressure high, upset stomach, throwing up. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1810928
Sex: F
Age:
State: OH

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: if she was possibly having an allergic reaction to the vaccine because of the slow swelling in her stomach; she was being paranoid; the upper part of her stomach felt like it was expanding/she had a slow swelling feeling in her stomach after she had her second covid-19 vaccine; she threw up a few times, and then the vomiting; she has a tin taste in her mouth still; she still felt a little nauseous today; Stomach pain; she felt like her inside was going to explode; This is a Spontaneous report received from a 61-year-old contactable female. This female patient reported for herself. A 61-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/lot number: ER8733) via unknown rote of administration in right arm on 01Apr2021 at 14:40 (at the age of 61 years old) as DOSE 2, SINGLE for COVID-19 immunisation and also received acetylsalicylic acid (ALKA-SELTZER) via unknown route of administration on 01Apr2021 for an unknown indication. The patient medical history included allergy to Penicillin for approximately 30 to 40 years and gastric bypass 20 years ago, she was very much overweight, and had heartburn and indigestion issues. The concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/lot number: EN6199) via unknown rote of administration in right arm on 11Mar2021 as DOSE 1, SINGLE for COVID-19 immunisation and had no problems. It was reported that patient had the second dose of the vaccine yesterday, on 01Apr2021, within 30 to 45 minutes, from leaving the convention center where she got her second COVID-19 Vaccine, she and her husband went to a restaurant to eat. She said she had 1 bite of soup, and 1 bite of salad, and then the upper part of her stomach felt like it was expanding and bloating. She said she felt she was going to throw up, and her inside was going to explode. She said she had her husband pack up her food, and they went home. She said when she got home, she threw up a few times, and then the vomiting subsided. She said her husband suggested she take an Alka Seltzer to settle her stomach. She said she took 1 Alka Seltzer with a 1/2 cup water, and threw up, again. She said she didn't throw up anymore after that and felt fine today (02Apr2021). She stated she was allergic to Penicillin and thought maybe she was having an allergic reaction to the COVID-19 Vaccine. She clarified with Penicillin her neck swelled up. She said she had a slow swelling feeling after she had the COVID-19 Vaccine, but the slow swelling feeling was in a different spot than her neck. She clarified the slow swelling feeling as in her stomach, describing it as stomach bloating and pain. she also had a tin taste in her mouth right away after she received her second COVID-19 Vaccine. She said the tin taste was no big deal. She clarified she noticed after drinking water this morning that she still had a slight tin taste in her mouth. She said there was another person at the COVID-19 Vaccination facility (at the same time as her) that had told her he had the same experience with the tin taste after getting the COVID-19 Vaccine. She said clarified the person was someone her husband knew. She said she didn't really know anything about that person except he was a male around her age. She said clarified he mentioned a "tinny" taste after getting the COVID-19 Vaccine. It was reported she took only 1 Alka Seltzer in a 1/2 cup of water. She said immediately upon taking a swallow of the Alka Seltzer, her stomach started expanding, and the Alka Seltzer made her feel bad. She said her stomach felt all closed up, and the Alka Seltzer couldn't go anywhere. She said she immediately threw up again. She said she didn't throw up again after that. She stated she had taken the last Alka Seltzer and had thrown away any product packaging. It was reported the stomach bloating and pain went away 1 to 1-1/2 hours after she took the Alka Seltzer. Reported she still felt a little nauseous today and was being cautious. She said she had coffee this morning, and the coffee didn't bother her. No further details provided. She stated she was allergic to Penicillin and thought maybe she was having an allergic reaction to the COVID-19 Vaccine. She clarified with Penicillin her neck swelled up. She said she had a slow swelling feeling after she had the COVID-19 Vaccine, but the slow swelling feeling was in a different spot than her neck. She clarified the slow swelling feeling as in her stomach, describing it as stomach bloating and pain. She said the stomach bloating and pain went away 1 to 1-1/2 hours after she took Alka Seltzer. Reported she also had a tin taste in her mouth right away after she received her second COVID-19 Vaccine. She said the tin taste was no big deal. She said she noticed after drinking water this morning (02Apr2021) that she still had a slight tin taste in her mouth. The patient did not visit emergency room and Physician Office due to the events. No other vaccines Prior Vaccinations (within 4 weeks). The outcome of the events she was being paranoid and if she was possibly having an allergic reaction to the vaccine because of the slow swelling in her stomach were unknown, she has a tin taste in her mouth still and she still felt a little nauseous today were recovering and other was recovered on 01Apr2021. No follow-up attempts were needed. No further information was expected.

Other Meds: ALKA-SELTZER

Current Illness:

ID: 1810929
Sex: F
Age:
State: TN

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

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

Lab Data:

Allergies:

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

Symptoms: Weak; Dizzy; Nauseous; This is a spontaneous report from a contactable Nurse. A contactable Nurse reported for a female patient. A 53-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Mar2021 (52-year-old at the time of vaccination) as Dose 1, single for covid-19 immunisation. Medical history included acquired absence of kidney, asthma, allergic rhinitis, disorder of brain, hypertension, hyperglycemia pruritus vulvae, type 2 diabetes mellitus unknown if ongoing. The patient pregnancy at the time of event was reported as N/A. Concomitant medication(s) included axitinib (INLYTA, Batch/Lot number was not reported; Expiration Date: 31Jul2023), 5 mg, twice a day for mal neoplasm of rt kidney except renal pelvis 1 tab by mouth from 29Jan2021 to an unspecified date. rosuvastatin calcium (ROSUVASTATIN CALCIUM) taken for an unspecified indication, start and stop date were not reported; medroxyprogesterone (MEDROXYPROGESTERONE) taken for contraception, start and stop date were not reported; diphenhydramine hydrochloride (BANOPHEN) taken for an unspecified indication, start and stop date were not reported; prednisone (PREDNISONE) taken for an unspecified indication, start and stop date were not reported; potassium chloride (KLOR-CON) taken for an unspecified indication, start and stop date were not reported; ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI 24 FE) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported; famotidine (FAMOTIDINE) taken for an unspecified indication, start and stop date were not reported; metoprolol succinate (METOPROLOL SUCCINATE) taken for an unspecified indication, start and stop date were not reported; diltiazem (DILTIAZEM) taken for an unspecified indication, start and stop date were not reported; montelukast sodium (MONTELUKAST SODIUM) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for an unspecified indication, start and stop date were not reported; lidocaine hydrochloride (LIDOCAINE VISCOUS) taken for an unspecified indication, start and stop date were not reported; prochlorperazine (PROCHLORPERAZINE) taken for an unspecified indication, start and stop date were not reported; levetiracetam (LEVETIRACETAM) taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin (AMOXICILLIN) and penicillin (PENICILLIN NOS) experienced allergy. On an unspecified date on Mar2021, the patient experienced nausea, weak and dizzy. The patient reported that she mentioned she took 1st dose of covid vaccine last weekend and notes she feels weak, dizzy and nauseous. The outcome of the events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: INLYTA; ROSUVASTATIN CALCIUM; MEDROXYPROGESTERONE; BANOPHEN; PREDNISONE; KLOR-CON; BLISOVI 24 FE; HYDROCHLOROTHIAZIDE; FAMOTIDINE; METOPROLOL SUCCINATE; DILTIAZEM; MONTELUKAST SODIUM; LEVOTHYROXINE SODIUM; LIDOCAINE VISCOUS; PROCHLORPERAZIN

Current Illness:

ID: 1810930
Sex: F
Age:
State: WV

Vax Date: 03/11/2021
Onset Date: 03/23/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Sinus infection; sore throat; ears that felt full; mucus drainage; pressure headache around the eyes and forehead; generally not feeling good; This is a spontaneous report from a contactable consumer (patient) via from a Pfizer sponsored Program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not reported), via an unspecified route of administration on 11Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 23Mar2021, patient began to have sinus infection, manifested by having a sore throat, ears that felt full, mucus drainage, pressure headache around the eyes and forehead, and generally not feeling good. Patient took antibiotics called Cefdinir 300mg twice a day for these symptoms. She reported that, 2nd vaccination was scheduled for tomorrow 01Apr2021. Patient wanted to know whether it is alright to push through her 2nd vaccination because she took antibiotics for her sinus infection. Therapeutic measures were taken as a result of events. The outcome of all the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1810932
Sex: F
Age:
State: TX

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

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

Lab Data: Test Name: laboratory test; Result Unstructured Data: Test Result:Unknown Result; Comments: When probed to specify the laboratory test: Consumer stated, " I don't, may be in January. I don't know maybe the doctor has all the information."

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Dizzy; rapid heartbeat; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6206), via an unspecified route of administration in left arm on 10Mar2021, as dose 1, single for COVID-19 immunization (age at vaccination: 67 years) and LISINOPRIL (LISINOPRIL, route of administration, lot number and expiry date was not reported) on an unspecified date for high blood pressure (hypertension) once a day (it is 20/12.5). Medical history included high blood pressure. Concomitant medications were not reported. The patient experienced dizzy and rapid heartbeat on an unspecified date in 2021. The patient stated the concern that she took this 1st vaccine like 3 weeks ago and scheduled to get another one Thursday 01Apr2021. She was wondering that one point she had like dizzy, rapid heartbeat. She did not know that she used to take the blood pressure medicine when you do it, she takes it in the morning, but then she took it the other day, she did not know if it was the blood pressure medicine or not. Two or three days after she get the rapid heartbeat and dizziness. She got the dizziness when she first got it, so all of those typical symptoms and she wanted to know if it was the typical symptom. Therapeutic measures were taken as a result of event dizzy. The patient stated that she did lab test recently may be in January, but she did not know, and her doctor has all the information. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1810933
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Patient states after she got the Pfizer Covid vaccine first dose, she felt some tenderness in her hands; She has been very tired; Sleeping more from it; This is a spontaneous report from a contactable physician. A 46-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Mar2021 (46-year-old) as a single dose for COVID-19 immunisation. Medical history included long qt syndrome (reported as I45.81). It was unknown if the patient had known allergies to medications, food or other products. It was unknown if the patient was diagnosed with COVID-19 prior to the vaccination. Concomitant medications included diclofenamide (KEVEYIS) taken for unspecified indication, from an unknown date and unknown if ongoing. It was unknown if the patient received any other vaccine within four weeks prior to the COVID vaccine. On an unknown date in Mar2021 after first dose of vaccination, the patient stated, she felt some tenderness in her hands and she had been very tired and sleeping more from it. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. It was unknown since the vaccination, if the patient had been tested for COVID-19. It was unknown if therapeutic measures were taken as a result of the reported events. The clinical outcome of the events she felt some tenderness in her hands, she had been very tired and sleeping more from it was unknown at the time of report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: KEVEYIS

Current Illness:

ID: 1810935
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Fillers were nodular and hard; This is a spontaneous report from a contactable other hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2,PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injec-tion, Batch/Lot number: not reported)), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE for covid-19 immunisation. botulinum toxin type a (BOTOX), route of administration, start and stop date, batch/lot number and dose were not reported for an un-specified indication. The patient medical history was not reported. The concomitant medication(s) include voluma in cheek on 25Jun2020 of last year no fillers since that date, volbella in different area V15LA80728 EXP Sep2020 treatment was in June 2020 did not use fillers when AE happened patient saw last week. The patient experienced fillers were nodular and hard. botox has voluma in cheek (25Jun2020 of last year no fillers since that date) last week was supposed to have another procedure that is when nodukar was seen and said she had vaccine 2 weeks told her Pfizer they did not do Botox no info on that last week Mar2021no labs no meds no previous surgerys Voluma lot VB20B00020 Expiration Jun2021 did volbella in different area V15LA80728 EXP Sep2020 treatment was in June 2020 did not use fillers when AE happened patient saw last week coming in for botox she had filler in the check when she came in it was very nodular and hard had covid vaccine 2weeks prior.The action taken in response to the event(s) for botulinum toxin type a was un-known. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: BOTOX

Current Illness:

ID: 1810936
Sex: F
Age:
State:

Vax Date: 04/02/2021
Onset Date: 04/03/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: exacerbation of MS nerve pain; exacerbation of MS nerve pain; Headache; fever; chills; injection site pain; arm soreness; itching; rash; This is a spontaneous report from a non-contactable consumer (patient). A 37-year-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8730), dose 2 via an unspecified route of administration, administered in Arm Left on 02Apr2021 16:00 (at the age of 37-year-old), as Dose 2, Single for COVID-19 immunization. Medical history included multiple sclerosis (ms) on an unknown date. Concomitant medication included gabapentin and ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) for unspecified indication. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's historical vaccine included first dose of bnt162b2 (BNT162B2, Solution for injection, lot no: EN6205), dose1 at arm left on 12Mar2021,16:00 for COVID-19 immunization. The patient was not diagnosed with COVID-19, Prior to vaccination and since the vaccination. No allergies to medications, food, or other products. On 03Apr2021 10:30, the patient experienced exacerbation of MS nerve pain, headache, fever, chills, injection site pain, arm soreness, itching, rash. The events were not treated. The outcome of all the events was Recovering at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: GABAPENTIN; LO LOESTRIN FE.

Current Illness:

ID: 1810937
Sex: M
Age:
State: NV

Vax Date: 01/25/2021
Onset Date: 01/28/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Loss of appetite; weight loss; weariness; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Er5218), via an unspecified route of administration, administered in left arm on 25Jan2021 (at the age of 78-year-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history includes asthma, hip replacement, arthritis and high cholesterol from an unknown dare and unknown if ongoing. The patient previously took clindamycin and experienced known drug allergies. Concomitant medications included ibuprofen 400 mg (MOTRIN [IBUPROFEN]), simvastatin 20 mg (SIMVASTATIN) and vitamin D NOS (VITAMIN D NOS) all were from an unspecified date. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Jan2021, the patient experienced loss of appetite, weight loss and weariness. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for adverse events and the treating medication was ferrous sulfate 325 mg twice daily. The clinical outcome of the events loss of appetite, weight loss and weariness were not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: SIMVASTATIN; VIT D [VITAMIN D NOS]; MOTRIN [IBUPROFEN]

Current Illness:

ID: 1810938
Sex: F
Age:
State: OH

Vax Date: 03/24/2021
Onset Date: 03/27/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: 3 days after the shot I woke up in the morning and the left side of my face was all swollen.; This is a spontaneous report from a contactable consumer. A 44-years-old non-pregnant female patient received bnt162b2 (BNT162B2,Formulation:Solution for injection, Lot Number: EN6204), via an unspecified route of administration, administered in Arm Left on 24Mar2021 09:15 (at the age of 44-year-old) as Dose 1, Single for covid-19 immunization. Medical history included allergy. It was reported that patient was not received any vaccine in four weeks and had other medications in two weeks. The patient had not covid prior vaccination nor tested post vaccination. On 27Mar2021 (at 06:00), the patient experienced 3 days after the shot i woke up in the morning and the left side of my face was all swollen. The patient received steroids and antibiotics in a shot and pills as treatment for the events. On an unspecified date in Apr2021,the patient had recovered from the event. No follow-up attempts were needed. No further information was expected.

Other Meds:

Current Illness:

ID: 1810939
Sex: F
Age:
State: CO

Vax Date: 04/02/2021
Onset Date: 04/02/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: I was hit hard by chills; Fever; Extreme shivering; Hot flashes; I was achy; I was achy with a pounding headache; This is a spontaneous report from a contactable consumer (patient). This is the first of two reports. A 34-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number: ER8729 and expiry date was not reported), via an unspecified route of administration in the left arm, on 02Apr2021 at 10:00 (at the age of 34-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history included known allergies to penicillin and sulfas from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient was not tested for COVID-19 post vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number: EN6208 and expiry date was not reported), via an unspecified route of administration in the left arm, on an unspecified date in Mar2021 (at the age of 34-years-old) as DOSE 1, SINGLE for COVID-19 immunisation and experienced tingly, felt overcaffeinated, was extremely thirsty. On 02Apr2021 at 20:00 PM, after about 10 hours of vaccination, the patient was hit hard by chills, fever, extreme shivering and hot flashes. The patient was achy with a pounding headache. Symptoms dissipated after 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The outcome of the events were recovered on an unspecified date in Apr2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1810940
Sex: M
Age:
State:

Vax Date: 12/12/2020
Onset Date:
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:high; Test Date: 202103; Test Name: Scan; Result Unstructured Data: Test Result:Lenvima improving his cancer

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: fatigue, tiredness; achy; sore arm; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient) based on information received by Pfizer (manufacturer control number: EC-2020-085416), for bnt162b2. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), second dose via intramuscular on 26Mar2021 (Batch/Lot number was not reported) as dose 2, single, first dose via intramuscular on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation; lenvatinib mesilate (LENVIMA), oral from 12Dec2020 (Batch/Lot number was not reported) and ongoing, at 18 mg for renal cell carcinoma; everolimus (EVEROLIMUS), oral from an unspecified date (Batch/Lot number was not reported) and ongoing, at 5 mg daily for renal cell carcinoma. Medical history included ongoing blood pressure measurement (per patient this was present prior to start of therapy and is unchanged since starting Lenvima), MD aware, diarrhoea from an unknown date and unknown if ongoing uncontrollable diarrhea, dehydration from an unknown date and unknown if ongoing period of dehydration. The patient's concomitant medications were not reported. The patient experienced fatigue, tiredness, achy, sore arm on an unspecified date. It was reported that, patient reported that a couple of weeks ago there was a "handful of days" that patient was experiencing "uncontrollable diarrhea" which led to a period of dehydration. Patient stated that he stopped Lenvima for two days and the aforementioned side effects resolved. MD not aware. Patient reported that after start of therapy he had both his Covid-19 vaccines and stated after the vaccines he experienced fatigue, tiredness and was achy (these symptoms have resolved). As per patient, he was currently experiencing a sore arm, but he had his second COVID-19 vaccine on 03/26/2021 and the soreness was starting to improve. Unknown if MD aware. Patient stated scans done on an unspecified date in March 2021 showed "remarkable" results with the Lenvima improving his cancer. MD aware. The patient underwent lab tests and procedures which included blood pressure measurement: high. The action taken in response to the events for lenvatinib mesilate was dose not changed. The outcome of the events fatigue, tiredness, achy was reported as recovered on an unspecified date and outcome of event sore arm was reported as resolving.

Other Meds:

Current Illness: Blood pressure

ID: 1810941
Sex: F
Age:
State:

Vax Date: 03/26/2021
Onset Date:
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: awful; hoarseness; This is a spontaneous report received from a contactable consumer (patient), based on information received by Pfizer. (manufacturer control number: EC-2021-090533) for BNT162B2. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: not reported) via an unspecified route of administration on an unspecified date at dose number unknown, single for COVID-19 immunization; lenvatinib mesylate (LENVIMA, lot number: not reported) via an unspecified route of administration on 26Mar2021 at 20 mg and pembrolizumab (KEYTRUDA) via an unspecified route of administration on an unspecified date at an unspecified dose both for an unspecified indication. Medical history included C54.1 endometrial cancer. Concomitant medications were not reported. Patient previously took fluoxetine. She stated that she got her first COVID shot (unsure which one) and her first Keytruda infusion as well. She felt "awful" for a day or two after all three were on board but feels much better today. Patient also reported hoarseness. Outcome of events was unknown. Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1810942
Sex: M
Age:
State: MI

Vax Date: 03/17/2021
Onset Date: 03/01/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Date: 20210305; Test Name: stress test; Result Unstructured Data: Test Result:Fine; Comments: did a stress test on 05Mar, and it was fine.

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Shortness of breath; Dizzy; didn't feel good; has problems with his heart; lungs he has problems; Tiredness; arm soreness; This is a spontaneous report from a contactable consumer or other non-HCP (patient reported for self). A 53-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6207, Expiry Date: UNKNOWN), via an unspecified route of administration, administered in left arm on 17Mar2021 03:00 as dose 1, single (at the age of 53-years-old) for COVID-19 immunization. Medical history included lung carcinoma cell type unspecified stage IV from Mar2018 as Verbatim: Lung cancer stage IV, cancer surgery from 31May2018 to an unknown date Verbatim: lung cancer surgery, neoplasm as have a small tumor on his bladder the size of a BB, prostate(Prostate infection). Concomitant medication(s) included alfuzosin hydrochloride (10mg once a day by mouth), taken for prostate infection from 12Feb2021. On an unspecified date of Mar2021 the patient experienced tiredness and arm soreness. On an unspecified date the patient experienced shortness of breath, dizzy, didn't feel good, has problems with his heart. Reporter stated after his first shot the first couple days he had soreness and was tired, and now he has other different things going on. He says he ws not gonna get second shot, he doesn't need any more health problems, he just wants to make sure this is what is causing those. Now they think he has problems with his heart, he is also having more problems breathing than he was before with the cancer, which he has had 3 years. He says he never had these problems before he got the shot. Reporter stated a week after that, those wore off, and he felt kinda dizzy, he didn't feel good, he had shortness of breath. The patient underwent lab tests and procedures which included stress test (Cardiac stress test): fine on 05Mar2021 did a stress test on 05Mar, and it was fine. Other Medical Conditions mentioned as he might have a small tumor on his bladder the size of a BB, and now they think he has heart problems also. Investigations mentioned as his stress test came back fine, but his heart and lungs he has problems now he doesn't know if it is related to the vaccine but that is why he doesn't want to get a second dose. Reporter stated he started a medication for his prostate a month and a half ago, but he didn't have any side effects before getting the Pfizer COVID-19 vaccine. The outcome of event tiredness and arm soreness was recovered on an unspecified date. The outcome of rest all events was unknown No follow-up attempts are possible. No further information is expected.

Other Meds: ALFUZOSIN HYDROCHLORIDE

Current Illness:

ID: 1810943
Sex: M
Age:
State:

Vax Date: 04/05/2021
Onset Date:
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: dizzy; chills; joint pain; This is a spontaneous report from a Contactable Consumer. This consumer reporter This consumer reporter for a Unknown male: The Unknown male patient (husband) who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 05Apr2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date the patient experienced chills, joint pain, and was feeling dizzy. The consumer asked if these were normal side effects of the vaccine. The event outcome was unknown. The consumer asked if patient could take motrin for pain. No follow-up attempts were possible; Information about lot/batch number could not be obtained

Other Meds:

Current Illness:

ID: 1810944
Sex: F
Age:
State: FL

Vax Date: 03/10/2021
Onset Date: 03/18/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: redness and a rash on the left arm; redness and a rash on the left arm; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, lot number: EN6206), dose1, single at Arm Left on 10Mar2021 08:00 and 2nd dose (BNT162B2, Solution for injection, lot number ER8730) on 31Mar2021 08:00 in left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included famotidine and ethinylestradiol, norethisterone acetate (LOESTRIN). Prior to vaccination, the patient was not diagnosed with COVID-19. After 1st dose, patient developed redness and a rash on the left arm that was injected 10 days after vaccine (onset date 18Mar2021 08:00 PM) and it lasted 1 day. After 2nd vaccine, patient developed redness and a rash on the left arm that was injected 1 day after vaccine and it lasted 4 days. The adverse event result in Emergency room/department or urgent care. No treatment received for the adverse event Since the vaccination, the patient had not been tested for COVID-19. At the time of report, outcome of the events was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: FAMOTIDINE; LOESTRIN.

Current Illness:

ID: 1810945
Sex: F
Age:
State: TX

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

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: My face got tight; Got very hot; Sharp pain down spine; Hard to breath; Racing heart lasting about 3-4 minutes; pain throughout the body; teeth chattering chills (over 2 hours); This is a spontaneous report from a contactable consumer, the patient. A 52-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6199) via an unspecified route of administration in the left arm on 04Mar2021 at 11:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis on an unknown date. The patient did not have any allergies to food, medications or other products. Concomitant medications included glatiramer acetate (COPAXONE) at a dose of 40 mg from an unknown date for an unknown indication, other items not listed due 2 space. 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 04Mar2021 at 19:30 the patient experienced face got tight, got very hot, sharp pain down spine, hard to breath, racing heart lasting about 3-4 minutes, pain throughout the body and teeth chattering chills (over 2 hours). The events were right after giving copaxone shot (over 24 hours from COVID). The patient did contact MS doctor but they felt it was a blood vessel. No therapeutic measures were taken as a result of reported events. The 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 face got tight, got very hot, sharp pain down spine, hard to breath, racing heart lasting about 3-4 minutes, pain throughout the body and teeth chattering chills (over 2 hours) was recovered on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.

Other Meds: COPAXONE

Current Illness:

ID: 1810946
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: fever; red eyes like conjunctivitis; rash on her body, rash on both arms; hives from her head to toe; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: 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 medical history and concomitant medications were not reported. On an unknown date, started 8 days after 2nd dose, the patient experienced fever, red eyes like conjunctivitis, rash on her body, rash on both arms and hives from her head to toe. It was reported that rash lasted several days and fever lasted 1 week. The outcome of all the events was reported as unknown. No follow-up attempts were possible; information about lot/batch number could not be obtained.

Other Meds:

Current Illness:

ID: 1810947
Sex: F
Age:
State: NJ

Vax Date: 04/06/2021
Onset Date: 04/06/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: tongue started feeling itchy; asthma was triggered; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number was not reported), dose 1 via an unspecified route of administration on 06Apr2021 at approximately 8:45am (at the age of 65-Year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included allergies to Penicillin and Shrimp. The patient's concomitant medications were not reported. The patient previously took avelox and lisinopril and experienced allergy. On 06Apr2021, patient reported that she didn't have a reaction until about 9:45 am but about an hour after her tongue started feeling itchy and asthma was triggered. She took 25mg Benadryl at 9:10, but when it started to wear off this afternoon, tongue started itching again, she took another Benadryl at 4:45pm. She further enquired can this be a reaction to the vaccine. If so, how long was it expected to last and how can she treat her reaction. Therapeutic measures were taken as a result of tongue started feeling itchy and asthma was triggered. At the time of this report, 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: 1810948
Sex: F
Age:
State: TX

Vax Date: 04/02/2021
Onset Date: 04/02/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: feverish; slight headache; left arm where the injection was given, felt hot and very sore (felt like heat was radiating); left arm where the injection was given, felt hot and very sore (felt like heat was radiating); This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 02Apr2021 (at the age of 62 years old) (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included AFIB (atrial fibrillation) from Dec2018 to an unknown date, mitral valve replacement, known allergies to milk, lactose allergy, and allergies. The patient was not pregnant at the time of the events. Concomitant medications included metoprolol tartrate taken for an unspecified indication, start and stop date were not reported, rivaroxaban (XARELTO) taken for an unspecified indication, start and stop date were not reported; loratadine (CLARITIN) taken for hypersensitivity, start and stop date were not reported; and acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were not reported. The patient did not have COVID prior to vaccination and had not been tested for COVID post-vaccination. The patient previously took the first dose of BNT162B2 on 09Mar2021 for COVID-19 immunisation and experienced metal taste in mouth, soreness at injection, tired, and on the outside of my left arm a pain shot down my arm all the way down my pinky finger. On 02Apr2021, the patient experienced left arm where the injection was given, felt hot and very sore (felt like heat was radiating). On 03Apr2021, the patient experienced feverish and slight headache. No treatment was received for the events. The outcome of the event vaccination site pain was not recovered, and outcome of other events was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: METOPROLOL TARTRATE; XARELTO; CLARITIN [LORATADINE]; BABY ASPIRIN

Current Illness:

ID: 1810949
Sex: U
Age:
State:

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

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

Lab Data: Test Name: BP; Result Unstructured Data: Test Result:131/74; Comments: BP: 131/74; Test Name: HR; Result Unstructured Data: Test Result:67; Comments: HR: 67; Test Name: O2 SAT; Result Unstructured Data: Test Result:Transmit too long; Comments: O2 SAT: Transmit too long; Test Name: RESP; Result Unstructured Data: Test Result:18; Comments: RESP: 18.

Allergies:

Symptom List: Tremor

Symptoms: itching/head, back, arms and feet itching; Hives or rash present; This is a spontaneous report from a non-contactable other HCP (Nurse). A 74-years-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0150), via an unspecified route of administration on an unspecified date at 17:14 as dose 2, single (Age at vaccination: Unknown) for COVID-19 immunization. Patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection, Lot number/Expiration date: Unknown) on an unspecified date for covid-19 immunization. Medical history included asthma, tachycardia, hypertension, diabetes mellitus. Concomitant medications includes Vitamins. Patient Allergies (food/drugs/etc.) includes Penicillin, Acrylic allergy. Patient denies Illness at time of vaccination or up to 1-month prior. On an unspecified date the patient experienced itching/head, back, arms and feet itching and hives or rash present. The patient underwent lab tests and procedures which included BP (blood pressure measurement): 131/74, HR (heart rate): 67, O2 SAT (oxygen saturation): transmit too long, RESP (respiratory rate): 18. Therapeutic measures were taken as a result of itching/head, back, arms and feet itching, hives or rash present which includes Diphenhydramine (Dose: 25mg; Route: PO). Stated relief of itching at 17:50 (10 mins after taking PO Diphenhydramine). No CPR indicated. The outcome of event itching/head, back, arms and feet itching was recovering while outcome of event hives or rash present was unknown. No follow-up attempts are possible; no further information expected.

Other Meds:

Current Illness:

ID: 1810951
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: low grade fever; body aches; This is a spontaneous report from a contactable consumer (patients friend). A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, Solution for injection, (Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history included unspecified autoimmune disorder. The patient's historical vaccine included first dose of bnt162b2 (BNT162B2, Solution for injection, (Batch/Lot number was not reported), dose 1 for COVID-19 immunisation on unspecified date. Patient was not on Keytruda. Patient reported that she heard more reaction occur with the second dose of the Covid vaccine. The patient experienced low grade fever and body aches on an unspecified date. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1810952
Sex: F
Age:
State: CA

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

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

Lab Data:

Allergies:

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

Symptoms: shake/shaking, but very mild; I had a wave of chill; I had fatigue after first and second shot; ears were red; mild allergic response; my cheeks were beat red; This is a spontaneous report from a contactable Physician. This female Physician reported for herself that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation; Solution for Injection,Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as Dose 2, Single for Covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included Diphenhydramine Hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. Historical vaccination included the patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation; Solution for Injection, Batch/Lot number was not provided) via unspecified route of administration on an unspecified date as Dose 1 Single for COVID-19 immunisation and experienced Fatigue. On an unspecified date,the patient experienced Shake/Shaking, But Very Mild and I had a wave of chill, I had fatigue after first and second shot, Ears Were Red, Mild Allergic Response and My cheeks were beat red on an unspecified date. The events were assessed as non serious. The outcome of events for Shake/Shaking, But Very Mild and I had a wave of chill was recovered on an unspecified date while the outcome of the rest of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: BENADRYL

Current Illness:

ID: 1810953
Sex: M
Age:
State: MN

Vax Date: 04/03/2021
Onset Date: 04/01/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: previously received Vaxzevria as dose 1 / received bnt162b2 dose 2; previously received Vaxzevria as dose 1 / received bnt162b2 dose 2; blood in my urine; This is a spontaneous report from a contactable consumer (patient reported for self). A 59-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation; Solution for Injection), dose 2 via an unspecified route of administration, administered in arm left on 03Apr2021 11:00 (Age at Vaccination is 59 years) (Batch/Lot Number: EN 6206 and Expiry date was not provided) as dose 2 (initial Pfizer dose), single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included Rivaroxaban (XARELTO) taken for an unspecified indication, start and stop date were not reported. The patient previously received Vaxzevria, Formulation; Solution for Injection, Batch/Lot number; EP7534b, and Expiry date was not provided) via unspecified route of administration as DOSE 1 on Left arm on 13Mar2021, 11:00 AM for COVID-19 immunisation and reported stating 3 days after the first dose patient developed a blood clot in right calf, never had one before, no trauma, patient was very active on 16Mar2021, 07:00 AM. The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced blood in my urine on Apr2021. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: XARELTO

Current Illness:

ID: 1810954
Sex: M
Age:
State: WI

Vax Date:
Onset Date: 03/07/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Swelling in the whole body; Especially the throat area, making it discomfort to swallow.; Stomach sick; pain in arm; brain fog.; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (son) that: A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation; Solution for Injection, Batch/Lot Number: ER2613), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date at 10:00 AM as dose 1, single for COVID-19 Immunization. Medical history included Wolff-Parkinson-White syndrome and essential tremor from an unknown date and unknown if ongoing and autism. Concomitant medication(s) included Ibuprofen (IBUPROFEN) 400 mg (each 200mgs x2 pills) taken for an unspecified indication, start and stop date were not reported. The patient previously received Morphine Batch/Lot number, and Expiry date was not provided) and experienced hives, Cefdinir Batch/Lot number, and Expiry date was not provided and experienced Pharyngeal swelling and Dysphagia. There was no other vaccine in four weeks. Patient did not have Covid prior vaccination. Patient did not Covid tested post vaccination. The patient experienced Swelling in the whole body, Especially the throat area, making it discomfort to swallow, Stomach sick, Pain in arm and Brain fog on 07Mar2021 12:00. No treatment was received for the events. The events were assessed as Non serious. The outcome of events recovered on an unspecified date in 2021. No follow up attempts are possible; Information about lot/batch number cannot be requested. No further information is expected.

Other Meds: IBUPROFEN

Current Illness:

ID: 1810955
Sex: M
Age:
State: WI

Vax Date:
Onset Date: 03/07/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: not have any effects to the vaccine, other than a sore arm.; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 07Mar2021, the patient experienced not have any effects to the vaccine, other than a sore arm. The outcome of the event was recovered on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1810956
Sex: F
Age:
State: IL

Vax Date: 02/27/2021
Onset Date: 02/28/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Dose 2 -14 hours after shot: Severe Vertigo; dizziness; fever; headache; body aches; nausea; vomiting; diarrhea; loss of balance; dehydration; debilitating; This is a spontaneous report from a contactable consumer(patient reported for herself). A 69-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Formulation:Solution for Injection, Batch/Lot Number: EN6205 and Expiry date was not provided),via an unspecified route of administration, administered in Arm Left on 27Feb2021 (at the age of 69-year-old) as Dose 2, Single for Covid-19 immunization. Medical history included Hypothyroidism, Hypertension, Sleep Apnoea syndrome, Malignant melanoma and Endometrial cancer from an unknown date and unknown if ongoing. Concomitant medication(s) included Levothyroxine Sodium (SYNTHROID) 125 ug; hydrochlorothiazide (HYDROCHLOROTHIAZIDE) 25 mg and Ergocalciferol (VIT D [ERGOCALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE; Formulation; Solution for Injection, Batch/Lot Number: EN6201 and Expiry date was not provided) via unspecified route of administration as Dose 1 Single on Left arm on 06Feb2021, (at 13:15) for COVID-19 immunization and experienced diarrhoea. The patient did not receive no other vaccine in four weeks and not have Covid prior vaccination. The patient was not tested Covid post vaccination. The patient experienced Dose 2 -14 hours after shot: Severe vertigo, Dizziness, Fever, Headache, Body Aches, Nausea, Vomiting, Diarrhea, Loss of balance, Dehydration and Debilitating on 28Feb2021 03:15. No treatment was received for the events. The events were assessed as Non serious. The outcome of all the events was recovering. No follow up attempts are possible. No further information is expected

Other Meds: HYDROCHLOROTHIAZIDE; SYNTHROID; VIT D [ERGOCALCIFEROL]

Current Illness:

ID: 1810957
Sex: F
Age:
State: IL

Vax Date: 03/02/2021
Onset Date: 03/04/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: sleep a lot; Blister; This is a spontaneous Other company report from a contactable physician (patient). A 91-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EL12184 and expiration date was not reported), via intramuscular on 02Mar2021 as dose number unknown, single for covid-19 immunization (at the age of 91-years-old ), hydrocodone bitartrate, paracetamol (VICODIN), via oral route from an unspecified date (Lot number was not reported) and ongoing, at 325 mg, 2x/day for an unspecified indication. Medical history included psychotic disorder. Concomitant medications included atorvastatin calcium (10 mg, 1x/day ), solifenacin (10 mg, 1x/day), colecalciferol (1 tablet twice a week), docusate sodium (3 in 1 week) taken for diarrhoea. On 04Mar2021 the patient experienced blister on left knee after sitting in the sun. On an unspecified date patient experienced sleep a lot. Relevant tests were none. The patient was recovered from blister in March2021 and outcome of sleep a lot was unknown. The reporter's causality for the event of makes sleep a lot and Blisters on. Left knee after sitting in the sun was provided. No follow-up information needed. Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.

Other Meds: ATORVASTATIN CALCIUM; SOLIFENACIN; VITAMIN D 3; DOCUSATE SODIUM; VICODIN

Current Illness:

ID: 1810958
Sex: F
Age:
State: FL

Vax Date: 02/24/2021
Onset Date: 02/25/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Injection site pain; Slight fever; muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6198, Expiration Date was not reported), an unspecified route of administration in left arm on 24Feb2021 at 10:15 (at the age of 74-years-old), as dose 1, single for COVID-19 immunisation. Medical history included dry eye, migraines, scoliosis, thyroid, osteoporosis and arthritis. The patient had allergies to food, medications, or other products. Concomitant medications included levothyroxine sodium (SYNTHROID), liothyronine (MANUFACTURER UNKNOWN), vitamin D2 (ergocalciferol) (MANUFACTURER UNKNOWN) and Ciclosporin (RESTASIS) all taken for unspecified indication with stop and start dates not reported. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. 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 25Feb2021, next day of vaccination, the patient experienced injection site pain, slight fever, and muscle pain. The patient did not receive any treatment for the events. The 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 injection site pain, slight fever, and muscle pain was resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.

Other Meds: SYNTHROID; LIOTHYRONINE; VITAMIN D2; RESTASIS

Current Illness:

ID: 1810959
Sex: F
Age:
State: TX

Vax Date: 03/26/2021
Onset Date: 03/26/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: exhausted; rash on upper chest, thighs and the edges of the face; face felt tight in a pre-swelling phase; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GN6204), via an unspecified route of administration, administered in arm left on 26Mar2021 at 17:45 (at the age of 27-year-old), as dose 2, single for COVID-19 immunization. The patient medical history included mood disorder, asthma, migraine, arthritis and ADD, allergic to mosquitos, fire ants, sun. The patient concomitant medications included lithium; verapamil; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR), topiramate and fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), all drugs taken for an unknown indication from unknown date to unknown date and unknown if ongoing. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: gn6206), via an unspecified route of administration, administered in arm left on 04Mar2021 at 17:30 as dose 1 single for COVID-19 immunization and experienced bruising at the injection site for a week and a half with minor soreness. The patient past drug event included lamictal, imitrex, neosporin and experienced allergy. 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 26Mar2021 at 21:45, about 4 hours after the second dose, the patient experienced rash on upper chest, thighs and the edges of the face. The right side of face felt tight in a pre-swelling phase. The patient had prior allergic reactions to meds and insects, and this had the same early precursors because of the time elapsed, what read in the patient guide and no breathing issues. The next day, the patient's left arm felt like a bat hit it and the patient was more exhausted than normal for about 24 hours on 27Mar2021. The patient received treatment for the events rash, swelling face which included benadryl and tylenol regiment for reactions which worked within one to two hours. Outcome of all the events was recovered on an unspecified date in 2021. No follow-up attempts are needed. No further information is expected.

Other Meds: LITHIUM; VERAPAMIL; ADDERALL; TOPIRAMATE; BREO ELLIPTA

Current Illness:

ID: 1810960
Sex: F
Age:
State: TX

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

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

Lab Data:

Allergies:

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

Symptoms: After the first dose I had bruising at the injection site for a week; a half with minor soreness; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for self). A 27-years-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation; Solution for Injection, Batch/Lot Number: gn6206 and Expiry date was not provided), dose 1 via an unspecified route of administration, administered in arm left on 04Mar2021 17:30 as dose 1, single for COVID-19 immunisation. Medical history included mood disorder, Asthma, Migraines, Arthritis, Attention deficit hyperactivity disorder (ADD), Known allergies to mosquitos, fire ants, sun from an unknown date and unknown if ongoing. Patient was not pregnant at time of vaccination. Concomitant medications included Amfetamine Aspartate, Amfetamine Sulfate, Dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); Fluticasone Furoate, Vilanterol trifenatate (BREO ELLIPTA); Lithium; Topiramate and Verapamil taken for an unspecified indication, start and stop date were not reported. The patient experienced drug hypersensitivity with Lamictal, Neosporine, Imitrex on unspecified date(s). The patient did not have covid prior vaccination, Patient did not test covid post vaccination. There were no other vaccine in four weeks. The patient experienced after the first dose patient had bruising at the injection site for a week and a half with minor soreness on an unspecified date. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: ADDERALL; BREO ELLIPTA; LITHIUM; TOPIRAMATE; VERAPAMIL.

Current Illness:

ID: 1810961
Sex: F
Age:
State: IL

Vax Date: 04/02/2021
Onset Date: 04/02/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Chest tightness and pressure since the day of vaccination. Going on 6 full days of constant dull pressure and tightness in the chest/Almost as if someone is sitting on my chest.; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0151) via an unspecified route of administration, administered in Arm Left on 02Apr2021 16:15 (at the age of 30-year-old) as dose 1, single for covid-19 immunization. Medical history included anxiety. The patient had no allergies to medications, food, or other products. The patient was not received other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. It was Unknown that Prior to vaccination, the patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient had chest tightness and pressure since the day of vaccination 02Apr2021 at 16:30. Going on 6 full days of constant dull pressure and tightness in the chest. Does not hurt to take a deep breath, but feels like she can't make it all the way to the top. Almost as if someone is sitting on her chest. The adverse event result in Doctor or other healthcare professional office/clinic visit. It was unknown that the treatment received for the adverse event. The case was considered as non-Serious. The outcome of the event of not recovered No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1810962
Sex: F
Age:
State: CA

Vax Date: 03/31/2021
Onset Date:
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Headache; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program Support. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number was not reported) single dose via an unspecified route of administration on 31Mar2021 for COVID-19 immunization and acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. After first dose patient experienced headache, on an unspecified date in 2021. She wanted to know the medication Excedrin migraine is allowed. The outcome of the event was unknown. No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1810963
Sex: F
Age:
State: PA

Vax Date: 03/02/2021
Onset Date: 04/01/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Name: X-ray; Result Unstructured Data: Test Result:Unknown result

Allergies:

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

Symptoms: Coughing up a little blood; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on 02Mar2021 as dose 1, single for COVID-19 immunization. Medical history included emphysema from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced that she was coughing up a little blood since the beginning of Apr2021. The patient underwent lab tests and procedures which included xray: unknown result on an unspecified date. The outcome of the event was unknown. It was reported that the patient was scheduled supposedly on 30Mar2021 for the second dose, but it was cancelled because she underwent X-ray procedure prior to 2nd dose schedule. The patient was querying if she could get the second dose despite of the event. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1810964
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Feeling asthmatic; not feeling well; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a Female Patient that: A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation; Solution for Injection, Batch/Lot Number and Expiry date was not provided), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 Immunization. The patient's medical history and patient's concomitant medications were not reported. It was unknown that Reporter was a Healthcare Professional or prescribing HCP. The unaddressed medical questions were referred or forwarded to Medical Information. The patient experienced Feeling Asthmatic and Not feeling well on an unspecified date. Caller's mom got her 1st dose at their local hospital and she's supposed to get her 2nd dose but she's not feeling well and is feeling asthmatic. The events were assessed as Non serious. The outcome of events was unknown. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1810965
Sex: U
Age:
State:

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Having persistent allergic reactions; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The medical history and concomitant medications were not reported. On an unknown date the patient experienced persistent allergic reactions. It was reported that the patient received first dose 01Apr and having persistent allergic reactions. The outcome of the event was not resolved. No follow-up attempts are possible; information about lot/batch cannot be obtained.

Other Meds:

Current Illness:

ID: 1810966
Sex: M
Age:
State: GA

Vax Date: 04/06/2021
Onset Date: 04/06/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: The right eye swelled up 45 mins after the shot and feels sore to the touch; The right eye swelled up 45 mins after the shot and feels sore to the touch; eyeball is bloodshot; This is a spontaneous report received from a contactable consumer. This 44-year-old male consumer (patient) reported that he received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6207) via an unspecified route of administration into the right arm on 06Apr2021 at 09:15 AM (at the age of 44-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history included reflux/reflux gastritis from an unknown date and unknown if ongoing. Concomitant medications included cyanocobalamin (B12-VITAMIIN) and atenolol (ATENOLOL) taken for unspecified indications, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6207) via an unspecified route of administration into the left arm on 16Mar2021 at 02:30 PM (at the age of 44-year-old) as dose 1, single for COVID-19 immunisation. On 06Apr2021 at around 10:00 AM, the patient experienced the right eye swelled up 45 minutes after the shot and feels sore to the touch and eyeball was bloodshot. It was unknown if treatment was received for the adverse event. Outcome was unknown for all the events. No follow-up attempts are needed. No further information is expected.

Other Meds: B12-VITAMIIN; ATENOLOL

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am