VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1645447
Sex: M
Age:
State: CA

Vax Date: 07/15/2021
Onset Date: 07/15/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: Fever; Result Unstructured Data: Test Result:Unknown results; Test Name: SARS-CoV-2; Test Result: Positive

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: fever; felt hot all over his body; his stomach felt really hot; he is still not hungry; stomach feels like when you get diarrhea; even when I urinate I feel hot, like it burns. Is this normal?; flu-like symptoms; flu-like symptoms including throat pain; I felt light-headed; This is a spontaneous report from a contactable consumer (patient). A 54-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0169), via an unspecified route of administration, administered in Deltoid Right on 15Jul2021 (at the age of 54 years) as dose 2, single for covid-19 immunization at Clinic. Medical history included Covid-19, gastritis (Start date: Like 8-9 years ago), High Blood Pressure (Start date: Like 8-9 years ago), blood cholesterol abnormal. Concomitant medications included omeprazole taken for gastritis from an unspecified start date and ongoing; lisinopril taken for hypertension from an unspecified start date and ongoing; pravastatin taken for blood cholesterol abnormal from an unspecified start date and ongoing. The patient historical vaccine included bnt162b2 for Covid-19 immunisation (Lot: FA6780, vaccinated at the age of 54 years) administered in right hand shoulder, and previously took Alka Seltzer Aspirin for urticaria (Feels like had hives when drank Alka Seltzer Aspirin this occurred like 4-5 years ago). Patient reported that on 15Jul2021 after second dose, that night about 9:00PM he felt a little lightheaded, not a light headache so he took Tylenol and went to bed. Patient stated that on 16Jul2021 he woke up and he had mild sensation of flu-like symptoms including throat pain. On 17Jul2021 he went to work, and everything started like at 16:00: his stomach felt really hot, and he did not want to eat, did not have an appetite but he had to eat either way because he had to work because he was a driver. He got to work at like 14:00 and at 21:00 took Tylenol. On 18Jul2021, he went back home at 02:00AM he got a fever and felt hot all over his body. He again took some Tylenol and right now he feels hot all over his body, and his stomach feels like when you get diarrhea, that sensation in his stomach, which he initially reported as persistent, but later clarified had improved stomach still feels bad, was not comfortable but not as bad, he was still not hungry but knows he had to eat. He clarified that when he urinates or pees it was hot, burning, feels painful, it was weird which was still ongoing but improved, not as much as in the beginning. He still feels fever, hot all over his body and his stomach, but it was better right now; it was not as strong as it was in the beginning. During call reported treatment for those adverse events as Tylenol. Mild sensation of flu-like symptoms including throat pain. After taking Tylenol he got a fever, and his stomach feels like when you get diarrhea, that sensation in his stomach. The events did not result in visit to Emergency Room or Physician Office. The patient underwent lab tests and procedures which included body temperature: unknown results on an unspecified date, sars-cov-2 test: positive on an unspecified date. Therapeutic measures were taken as a result of I felt light-headed, fever, felt hot all over his body with Tylenol (Lot: S190394, Expiry: Aug2022). The clinical outcome of the event I felt light-headed, even when I urinate, I feel hot like it burns, flu-like symptoms, his stomach felt really hot, flu-like symptoms including throat pain, he is still not hungry was resolving, stomach feels like when you get diarrhea, fever, felt hot all over his body was not resolved. Information on the Lot/batch number has been requested.

Other Meds: OMEPRAZOLE; LISINOPRIL; PRAVASTATIN

Current Illness:

ID: 1645448
Sex: F
Age:
State: TX

Vax Date: 04/08/2021
Onset Date: 04/09/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Fever; Nausea; Dizzy; Full body numbness; Achy; Headache; Stomach ache; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8733) via an unspecified route of administration in the right arm on 08Apr2021 at 14:00 (at the age of 54 year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine, liothyronine (NP THYROID) from an unknown date for unknown indication and unknown if ongoing. The patient previously took local anesthesia (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6202) via an unspecified route of administration in the left arm on 11Mar2021 at 16:00 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. On 09Apr2021 at 15:00, the patient experienced fever, nausea, dizzy, full body numbness, achy, headache and stomach ache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, nausea, dizzy, full body numbness and achy were recovered with sequelae on an unknown date in 2021 while, the clinical outcome of the events headache and stomach ache were not recovered at the time of this report.

Other Meds: NP THYROID

Current Illness:

ID: 1645449
Sex: F
Age:
State:

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 08/28/2021
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: heart rate; Result Unstructured Data: Test Result:130 or higher

Allergies:

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

Symptoms: rapid heart rate; an allergic reaction; This is a spontaneous report from a contactable consumer (patient herself) and via Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number: Unknown, Expiry Date: Unknown), dose 1 via an unspecified route of administration on an unspecified date of Jan2021 as dose 1, single for COVID-19 immunisation. Medical history reported as none. There were no concomitant medications. Consumer stated that she took the Pfizer COVID-19 vaccine in January. She was experienced a rapid heart rate, immediately. The heart rate was 130 or higher. That was deemed an allergic reaction. She was then advised to not take the second dose. She was called today for more information after having had a reaction and getting the 2nd dose. She states Pfizer advised her not to take it. Also advised not to take Moderna as well. She stated that she knows there was something in the Pfizer product she may be allergic to but unsure if the ingredients are different in the "J&J" vaccine. She had an AE of a very rapid Heartbeat and was told not to take the second dose as a result; she could not take the second dose of the vaccine. Consumer stated for the reason of no lot number, she had no idea. She did not think she was going to be able to get that because she did not even know that they even gave her a vaccination card, so she was not even sure what information, she did not have that with her. On an unspecified date, the patient experienced rapid heart rate and an allergic reaction. The patient underwent lab tests and procedures which included heart rate: 130 or higher on an unspecified date. The outcome of the events was unknown. Information on the lot/batch number has been requested. Follow up (03Aug2021) This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1645450
Sex: F
Age:
State: WI

Vax Date: 07/16/2021
Onset Date: 07/17/2021
Rec V Date: 08/28/2021
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: Headache; Chills; Muscle/body aches; Muscle/body aches; Fatigue; Cough; Congestion; This is a spontaneous report from a contactable nurse, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the arm left on 16Jul2021 at 15:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included ergocalciferol (VITAMIN D) and multi-vitamin (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient previously received codeine (MANUFACTURER UNKNOWN) and epinephrine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the arm left on 18Jun2021 at 15:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Jul2021 at 04:00 the patient experienced headache, chills, muscle/body aches, fatigue, cough and congestion. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event headache, chills, muscle/body aches, fatigue, cough and congestion were recovered on unknown date in Jul2017.

Other Meds: VITAMIN D [ERGOCALCIFEROL]

Current Illness:

ID: 1645451
Sex: F
Age:
State: NV

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: pain in the arm; This is a spontaneous report received from a contactable consumer. A female patient of unspecified age (reporter's friend) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number and Expiration date: not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pain in the arm which lasted for about a month. The reporter wanted to know if the patient was "supposed to sit in pain or get an X-ray to see what was going on with the muscle or tendon in her arm". The outcome of the reported event was unknown. The lot number for BNT162B2 was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1645452
Sex: F
Age:
State: NC

Vax Date: 03/17/2021
Onset Date: 06/21/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210409; Test Name: COVID-19 test; Test Result: Negative ; Comments: Blood test

Allergies:

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

Symptoms: Missing partial smell, no longer smell perfume; Missing partial taste, everything tastes different; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6208) via an unspecified route of administration in the left arm on 17Mar2021 at 14:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, neuromyelitis optica spectrum disorder (misdiagnosed NMOSD). The patient had known allergies to penicillin, keflex, ceclor, synthroid, gluten and latex. Concomitant medications included thyroid (ARMOUR THYROID) and amantadine (MANUFACTURER UNKNOWN) all from unknown dates for unknown medication and unknown if ongoing. eculizumab (SOLIRIS) for unknown indication, from unknown start date and since May2021 have stopped soliris. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6208) via an unspecified route of administration in the left arm on 24Feb2021 at 15:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures, which included COVID-19 test (blood test) on 09Apr2021 and result was negative. On 21Jun2021 the patient experienced missing partial smell (she could no longer smell perfume) and taste (everything tasted different). The patient was training to be a sommelier. Loss of taste, smell did not start until june2021. The clinical outcome of the events missing partial smell (she could no longer smell perfume) and taste (everything tasted different) was not recovered at the time of this report.

Other Meds: SOLIRIS; ARMOUR THYROID; AMANTADINE

Current Illness:

ID: 1645453
Sex: F
Age:
State: IN

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: started sore (vaccinated arm) right after the 1st dose; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer sponsored program. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in arm, on an unspecified date (Batch/Lot number was unknown) (at the age of 69 years old) as dose 1, single for COVID-19 immunisation. Medical history included shaking/ shakes; allergic to hornets and yellow jackets. Concomitant medications included primidone; spironolactone. The patient started sore (vaccinated arm) right after the 1st dose on an unspecified date (reported as Tuesday). The patient reported that by the night of vaccination day, if not earlier, her arm wasn't hurting anymore. The patient recovered from the event on an unspecified date. The lot number for BNT162B2, was not provided and will be requested during follow-up.

Other Meds: PRIMIDONE; SPIRONOLACTONE

Current Illness:

ID: 1645454
Sex: F
Age:
State:

Vax Date: 06/11/2021
Onset Date: 06/11/2021
Rec V Date: 08/28/2021
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: Elevated heart rate; chest pounding following first dose.; This is a spontaneous report from a non-contactable consumer or other non-health care professional (Patient). A 45-year-old Non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0176 and expiration date was not reported), first dose via an unspecified route of administration, administered in arm right on 11Jun2021 17:00 (at the age of 45 years) as single for covid-19 immunisation. Patient also received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0176 and expiration date was not reported), second dose via an unspecified route of administration, administered in arm right on 02Jul2021 17:00 (at the age of 45 years) as single for covid-19 immunisation. Patient medical history and concomitant medications were not reported. Patient had no known allergies. Patient did not receive any other vaccines within 2 or 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. On 11Jun2021 18:00 the patient experienced Elevated heart rate, mild sensation of chest pounding following first dose. This persisted for the three weeks until 2nd dose and continues to date. The outcome of the events was not recovered. Follow-up attempts are needed. No further information is Expected.

Other Meds:

Current Illness:

ID: 1645455
Sex: M
Age:
State: CT

Vax Date: 07/06/2021
Onset Date: 07/08/2021
Rec V Date: 08/28/2021
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: really bad hives; still has some/feels a little bit, but they are not as bad; Chills; Headache; a little bit of dizziness; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in arm left on 06Jul2021 16:00 (at the age of 55 years old) as dose 1, single for COVID-19 immunisation. No known medical history and concomitant medications. On 08Jul2021, the patient experienced really bad hives and still has some/feels a little bit, but they are not as bad, chills, headache, a little bit of dizziness. The patient stated that they have all improved and didn't notice these reactions until 2 days after getting the vaccine. The patient other products were reported as no. The patient history was reported as no, and the investigation assessment was reported as no. It was reported that the patient had no other vaccines given the same day or 4 weeks prior and no problems with vaccines in past. The Vaccination Facility Type was Pharmacy/Drug Store and was not administered in a military facility. The history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none. The Additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was reported as none. The patient adverse events did not require a visit to the emergency room or physician office. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was reported as none. There were no adverse events following prior vaccinations. The Family Medical History Relevant to adverse event and relevant tests were reported as none. The outcome of the event hives was not recovered; outcome of the events chills, headache and dizziness was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1645456
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: have arthritis; This is a spontaneous report from a contactable consumer (patient). A male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications adalimumab (Humira) daily form an unknown date. The 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 an unknown date as single dose for COVID-19 immunization. On an unspecified date, the patient experienced arthritis. Patient was interested in a Covid booster trial. He has had both Pfizer Covid vaccines. He adds, he does have arthritis and takes Humira daily. The patient received treatment for event. The outcome of the event was unknown. No other additional information provided. Information on lot/batch number has been requested

Other Meds: HUMIRA

Current Illness:

ID: 1645457
Sex: F
Age:
State: NV

Vax Date: 05/24/2021
Onset Date: 05/25/2021
Rec V Date: 08/28/2021
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: lost strength right arm and she cannot hold up a skillet; soreness to right arm extends between elbow and wrist worsened /pain to entire right arm 24/7/she has pain from where the shot was given past her elbow to mid arm; Stated that her arm is tender to touch; numbness to right arm; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318) via an unspecified route of administration, administered in Deltoid Right on 24May2021 13:00 (age at vaccination 56-year-old) at dose 2 0.3 mL single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318) in right deltoid on 03May2021 (age at vaccination 56-year-old) for COVID-19 immunisation and she had no side effects. Patient stated that she had her last dosage of Pfizer on 24May and had numbness to right arm on 25May2021 08:00 and soreness for a week that continued and got worst. Stated that she lost strength in her arm, cannot hold up a skillet on 28May2021 12:00, that if she lifts her arm up to reach that she has pain from where the shot was given past her elbow to mid arm on 28May2021 08:00. Stated that her arm was tender to touch and she has pain throughout her entire arm 24/7 on 28May2021 08:00. Stated that it has been going on into two months and not subsiding. Wanted to know if she was supposed to sit in pain or get an X-ray to see what was going on with the muscle or tendon in her arm. Later clarified that it was her right arm. Stated that she had no side effects from the first dose. Stated that the soreness to her right arm that has worsened to where it extends between the elbow and the wrist. Stated that her friend told her to try an anti-inflammatory. Stated that she had Ibuprofen did not work. Stated that her friends gave her balm oil, Avoniki balm, that did not work. Stated that the Motrin did not work. Stated that was about three weeks ago. Later clarified that it was Motrin and not Ibuprofen that did not work. Patient did not require a visit to emergency Room or physician Office. Prior Vaccinations (within 4 weeks) were none. The outcome of the events was not recovered. Follow-Up (03Aug2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1645458
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Discomfort in his arm at injection site; arm was swelling; discomfort in his arm; His arm was sore, where he got injected was sore.; This is a spontaneous report from a contactable consumer. This consumer reported for two patients. This is the 2nd of two reports (father). 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. The patient experienced discomfort in his arm at injection site; arm was swelling; discomfort in his arm; his arm was sore, where he got injected was sore; on an unspecified date. The outcome of events was unknown. The lot number for BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1645459
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Head was hurting; fever; stomach really hurts; heartburn; This is a spontaneous report from a non-contactable consumer. A male 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 an unspecified date (reported as on the 15th) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced head was hurting on an unspecified date. The patient took paracetamol (TYLENOL) as treatment for the event head was hurting. On an unspecified date, after taking Tylenol, the patient experienced fever, stomach really hurts and heartburn. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1645460
Sex: F
Age:
State: NH

Vax Date: 07/17/2021
Onset Date: 07/17/2021
Rec V Date: 08/28/2021
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: Metallic taste in mouth; constant urine smell; arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the right arm on 17Jul2021 at 15:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia and allergy to latex and coffee. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously took lidocaine hydrochloride (LIDOCAINE), benzocaine (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the right arm on an unknown date in 2021 as a single dose for COVID-19 immunisation. On 17Jul2021 at 16:00, the patient experienced metallic taste in mouth, constant urine smell and arm soreness. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events metallic taste in mouth, constant urine smell and arm soreness was not resolved at the time of this report.

Other Meds:

Current Illness:

ID: 1645461
Sex: F
Age:
State: PA

Vax Date: 06/01/2021
Onset Date: 06/01/2021
Rec V Date: 08/28/2021
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: Shortness of breath; migraine headache; caused extremely high blood pressure; elevated veins in hands and arms; swollen hands; pain in body and legs; pain in body and legs; also extreme anxiety due to side effects; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 60-year-old female patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on Jun2021 14:30 (at the age of 60 years old) as dose 1, single for COVID-19 immunisation. Medical history included none, and concomitant medications were not reported. The patient had no known allergies. The patient also received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on Jul2021 15:00 as dose 2, single for COVID-19 immunisation. On Jun2021, the patient experienced shortness of breath, migraine headache, caused extremely high blood pressure, elevated veins in hands and arms, swollen hands, pain in body and legs, extreme anxiety due to side effects. Symptoms became worst after the second vaccine dose. It was reported that the patient does not have high blood pressure, except resulting from vaccine side effects. The facility type vaccine was reported as pharmacy or drug store. The reported adverse event start date was Jun2021. The adverse event resulted in Doctor or other healthcare, professional office/clinic visit, Emergency room/department or urgent care. The patient had no COVID prior vaccination and did not test for COVID post vaccination. The patient was recovering from the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1645462
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: sore arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported (patient wife) for a male patient (husband). A 73-years old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date caller reported that she and her husband had both doses of the Pfizer BCOVID19 vaccine and he had only experienced sore arm as side effect of the vaccine. The clinical outcome of event was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1645463
Sex: F
Age:
State: MI

Vax Date: 04/10/2021
Onset Date: 05/29/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20200420; Test Name: Nasal Swab; Test Result: Negative

Allergies:

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

Symptoms: Really tired; stomach bubbling; This is a spontaneous report from a contactable consumer (patient) via COVAES. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm, on 10Apr2021 at 01:15 PM (Batch/Lot number was unknown) (at the age of 49 years old) as dose 2, single for COVID-19 immunisation. Medical history included chronic pelvic pain and other unspecified medical conditions. The patient has no known allergies. The patient was taking unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was really tired and experienced stomach bubbling on 29May2021. The events resulted to physician office visit. The patient did not receive treatment for the events. The patient underwent lab tests and procedures on 20Apr2020 which included a negative nasal swab result. The patient did not recover from the events on the time of the report. The lot number for BNT162B2 was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1645464
Sex: M
Age:
State: AR

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: onset shingles within 5 days of first dose of vaccine; This is a spontaneous report from a non-contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunisation at workplace clinic. The patient's medical history was not reported. Concomitant medications within 2 weeks of vaccination was reported as unknown. Patient did not receive other vaccine within 4 weeks of COVID vaccine. On an unspecified date, the patient experienced an onset of shingles within 5 days of first dose of vaccine. Adverse event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if treatment was received for the event. The patient had no COVID prior vaccination and unknown if patient tested COVID post vaccination. The clinical outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1645465
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: caused her back problems to go away.; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single; and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced after receiving both of her doses all her symptoms have gone away (also reported she wanted to know what was in the vaccine that might have caused her back problems go away). The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1645466
Sex: M
Age:
State: FL

Vax Date: 06/19/2021
Onset Date: 06/21/2021
Rec V Date: 08/28/2021
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: Caller reported that she thinks the side effect is affecting all of the patient's muscles, sometimes he can't get off the bed and can't walk; Caller reported that the patient has such pain and they thought it would go away by now; Caller reported that she thinks the side effect is affecting all of the patient's muscles, sometimes he can't get off the bed and can't walk; Muscle ache; This is a spontaneous report from a contactable consumer (reported for her husband). A 66-years-old male patient received first dose ofBNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN0180, Expiration date: UNKNOWN), dose 1 via an unspecified route of administration, administered in arm right on 19Jun2021 10:00 as (At the age of 66-years) dose 1, single for COVID-19 immunization (precaution not to get the Covid). The patient's medical history included ongoing cataract, ongoing glaucoma Caller reported that the patient has had problems with cataracts and glaucoma for a very long time, probably over 10 years, eye disorder from an unknown date and unknown if ongoing patient only has 1 eye, patient eye was removed probably 20 years ago. Concomitant medications included unspecified eye drop, caller reported that the patient has been using the eye drop forever, probably over 5 years, for 6-7 years for Cataracts and glaucoma. No Investigation Assessment were reported. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. It was reported that patient took his flu vaccine in 2020. The patient experienced muscle ache on 21Jun2021, patient experienced caller reported that she thinks the side effect is affecting all of the patient's muscles, sometimes he can't get off the bed and can't walk (bedridden, pain, and gait disturbance) on an unspecified date. Caller reported that the patient still has side effect of muscle aches. Caller reported that the patient has such pain and they thought it would go away by now, pain is still not going away. She thinks the side effect was affecting all of the patient muscles, sometimes he can't get off the bed and can't walk. Caller reported that the patient was afraid to get the second dose of the Covid-19 vaccine, couple days after the first dose of the Covid-19 vaccine, the patient has this pain until now. The adverse events required a visit Physician Office It was reported that the patient's physician just did some labs and said everything was fine or something like that. Caller reported that the patient went to see the doctor and they gave him Motrin and Tylenol. Patient was prescribed Motrin by his physician for muscle aches following the Covid-19 vaccine and reported that the Motrin didn't do anything and didn't work. Caller reported that she didn't know what to do with the pain that the patient was having. No emergency room visit. The outcome of event muscle ache was not recovered, and outcome of all other events was unknown.

Other Meds:

Current Illness: Cataracts (for a very long time, probably over 10 years); Glaucoma (for a very long time, probably over 10 years)

ID: 1645467
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Little headache; This is a spontaneous report received from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number and Expiration date: not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, after receiving the second dose, the patient experienced a little headache. The outcome of the reported event was unknown. The lot number for BNT162B2 was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1645468
Sex: F
Age:
State:

Vax Date: 07/17/2021
Onset Date:
Rec V Date: 08/28/2021
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: lymph nodes were enlarged and still are; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: was not reported/ Caller unwilling to complete the report, Expiry date: Not provided) via an unspecified route of administration on 17Jul2021 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On unspecified date patient lymph nodes were enlarged and still are. Additional Context: Caller just received her first dose on Saturday afternoon and by sunday afternoon her lymph nodes were enlarged and still are. She wanted to know, she has been reading different things that swollen lymph nodes aren't in the category of severe allergic reaction. Should she take the second dose vaccine or should she wait until her lymph nodes go down. Patient declined to provide- address, alternative telephone, email address. The clinical outcome of lymph node was unknown. Information about Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1645469
Sex: F
Age:
State:

Vax Date: 07/18/2021
Onset Date: 07/19/2021
Rec V Date: 08/28/2021
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: Swollen lymph node under left armpit; Swollen lymph node under left armpit causing soreness; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on 18Jul2021 at 10:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patients' medical history was not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within two weeks of the COVID-19 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on 27Jun2021 at 10:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 19Jul2021 at 04:00, the patient experienced swollen lymph node under left armpit which caused soreness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen lymph node under left armpit which caused soreness was unknown at the time of this report.

Other Meds:

Current Illness:

ID: 1645470
Sex: F
Age:
State: MI

Vax Date: 06/30/2021
Onset Date: 06/30/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210630; Test Name: scan temperature; Result Unstructured Data: Test Result:99.9

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: high fever of 99.9; arm pain; nausea; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) report that a 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 30Jun2021 (at the age of 66 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 30Jun2021, the patient stated that in about five to ten minutes, she experienced a high fever of 99.9 and also had arm pain and she also experienced nausea after the first dose. She stated the arm pain and nausea came after, that the fever spiked right away and she didn't think it was 10 minutes, stated she may have had it before. The patient came in after the vaccine and it was 99.9, they gave her the vaccine, walked out and came in a little later and gave her the scan temperature to her head. She was wondering if she should get the second one. She stated that her doctor didn't really know he has other ways of dealing with the virus and she didn't know who to ask. The patient was asking how protected is she after the first dose. The outcome of the events was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1645471
Sex: F
Age:
State: MO

Vax Date: 07/19/2021
Onset Date: 07/20/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Headache and nausea on first dose; Headache and nausea on first dose; Thigh is painfully sore; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 19Jul2021 at 17:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The medical history were reported as no. It was unknown whether the patient was allergic to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. On 20Jul2021 at 07:00, the patient experienced headache and nausea on first dose, thigh was painfully sore. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, nausea and thigh painfully sore was not recovered at the time of this report. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1645472
Sex: F
Age:
State:

Vax Date: 07/17/2021
Onset Date: 07/17/2021
Rec V Date: 08/28/2021
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: Sore throatChillsNauseaTirednessInjection site itchy and swollen; chills; nausea; Tiredness; Injection site itchy; Injection site swollen; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 17Jul2021(at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication was not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. On 17Jul2021, the patient experienced sore throat, chills, nausea, tiredness, injection site itchy and injection site swollen. The patient did not receive any treatment for the event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore throat, chills, nausea, tiredness, injection site itchy and injection site swollen was recovering at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1645473
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: a friend of mine had inflammation on her lungs after receiving the 2nd Pfizer vaccine dose; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received Bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine information included bnt162b2 (COMIRNATY) 1st dose on an unknown date for COVID-19 immunisation. The patient reported that a friend of mine had inflammation on her lungs after receiving the 2nd pfizer vaccine dose on an unspecified date. It was reported that HCP states a friend of mine had inflammation on her lungs after receiving the 2nd Pfizer vaccine dose and HCP states these AEs have already been reported. The outcome for event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1645474
Sex: M
Age:
State:

Vax Date: 07/17/2021
Onset Date: 07/18/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210718; Test Name: Body temperature; Result Unstructured Data: Test Result:102

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Fever 102 for 24 hours; Nausea; This is a spontaneous report from a non-contactable consumer. A male patient of 15-year-old received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 17Jul2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Jun2021 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient had received any other vaccines within four weeks prior to the vaccination. On 18Jul2021, the patient experienced fever 102 for 24 hours and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of these events. On 18Jul2021, the patient underwent body temperature and the result was 102(Units unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever and nausea was recovering 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:

ID: 1645475
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: 2 people developed alopecia after getting the vaccination; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), second dose via an unspecified route of administration on an unspecified date single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), first dose via an unspecified route of administration on an unspecified date single for covid-19 immunisation. The HCP states on unspecified date of 2021 two people developed alopecia after getting the vaccination. The outcome of the event was unknown. The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1645476
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: 2 people developed alopecia after getting the vaccination; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot number: Not reported), via an unspecified route of administration on an unspecified date as dose 2,single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot number: Not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. It was reported that on an unspecified date the patient developed alopecia after getting the vaccination. At the time of the report the outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1645477
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Another one of my friend 's eczema become full body eczema after her 2nd dose; This is a spontaneous report from a contactable pharmacist reported for a patient (friend). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA 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 immunisation. Patient previously received first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter reported stating "another one of my friend 's eczema become full body eczema after her 2nd dose and she had to take steroids for 2 weeks". The outcome of the event was unknown. Follow-up attempts have been made. Information about Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1645478
Sex: F
Age:
State: CA

Vax Date: 06/14/2021
Onset Date: 06/23/2021
Rec V Date: 08/28/2021
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: Tingling sensation on entire right side of face; Muscle weakness in cheeks/ right side feels very weak; Muscle weakness in tongue; Slight drooling; Impairing speech ability; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 14Jun2021 at 10:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included morphea. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bupropion (MANUFACTURER UNKNOWN); for an unknown indication from an unknown date and unknown if ongoing. The patient previously received codeine (MANUFACTURER UNKNOWN) and experienced a drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 23May2021 at 12:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 23Jun2021, the patient experienced tingling sensation on entire right side of face, muscle weakness in cheeks and tongue which resulted in drooling. The patient reported that she was able to smile but the right side felt very weak. The patient also experienced impaired speech ability. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tingling sensation on entire right side of face, muscle weakness in cheeks and tongue which resulted in drooling, right side felt very weak and impaired speech ability was not resolved at the time of this report. The batch/lot numbers for BNT162b2 were not provided and will be requested during follow up.

Other Meds: BUPROPION

Current Illness:

ID: 1645479
Sex: M
Age:
State: OH

Vax Date: 07/18/2021
Onset Date: 07/19/2021
Rec V Date: 08/28/2021
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: headache/ a slight headache; knot in his stomach/ a little bit of an upset stomach; threw up/ Vomited; chills; tired; not hungry for anything; he was really sick/ he's still not feeling good/ sickness; This is a spontaneous report from a contactable consumer (wife) reported for her husband that a 63-years-old male patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: FA6780, expiry date: 30Sep2021, code number: 59267100002), via an unknown route of administration in right arm on 18Jul2021 (at the age of 63-years-old) at 11:30 as single dose for COVID-19 immunisation at pharmacy. The patient's medical history and concomitant medications were none. History of all previous immunization with the Pfizer vaccine considered as suspect and additional vaccines administered on same day of the Pfizer Suspect were none. No additional vaccines administered on same date of the Pfizer Suspect. On 19Jul2021 at 00:30, the patient experienced headache/ a slight headache, knot in his stomach/ a little bit of an upset stomach, threw up/ Vomited, chills, tired, not hungry for anything, he was really sick/ he's still not feeling good/ sickness. The reporter explained that the patient received his first dose of the Pfizer COVID vaccine on Sunday 18Jul2021 then really late Sunday early Monday morning woke up with a bad reaction: headaches, knot in his stomach, threw up and had chills, he was really sick, he's still not feeling good. Caller confirms all symptoms started Sunday night at 11:30 AM, so technically on 19Jul2021 and all symptoms were still having have gotten a little better, they have improved. No adverse event required a visit to emergency Room and physician office. Prior vaccinations within 4 weeks, adverse event and relevant test were none. The outcome of the events threw up/vomiting and chills was recovered on 19Jul2021 at 21:00, while the outcome of the remaining events was recovering. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1645480
Sex: F
Age:
State: UT

Vax Date: 06/11/2021
Onset Date: 06/11/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: joint pain; Nausea; Massive headaches; Bouts of chronic and sudden diarrhea; Chronic outbreaks of cluster cold sores more severe and frequent than at any other time of my life; 11Jun2021=Dose 1, 11Jun2021= Dose 2; This is a spontaneous report from a contactable consumer (patient). A 60-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0179), via an unspecified route of administration, administered in right arm on 11Jun2021 as dose 1, single; and received second dose of BNT162B2 (Lot Number: EW0177) via an unspecified route of administration, administered in right arm on 11Jun2021 as dose 1, single; both (at the age of 60-years-old) for covid-19 immunization at pharmacy or drug Store. Medical history included thyroidectomy, stomach ulcer, cold sores on occasion; all from an unknown date and unknown if ongoing. Concomitant medications in two weeks included omeprazole magnesium (PRILOSEC), levothyroxine, celecoxib (CELEXA); all taken for an unspecified indication, start and stop date were not reported. The patient had known allergies to Codeine. No other vaccine in four weeks. Patient had no COVID-19 prior vaccination and no COVID-19 tested post vaccination. On 07Jul2021, the patient experienced extreme joint pain throughout body, massive headaches, bouts of chronic and sudden diarrhea, nausea, chronic outbreaks of cluster cold sores more severe and frequent than at any other time of patient's life. No treatment received for events. Patient was not recovered from the events at the time of report. Follow-up attempts are completed. No further information is expected.

Other Meds: PRILOSEC [OMEPRAZOLE MAGNESIUM]; CELEXA [CELECOXIB]; LEVOTHYROXINE

Current Illness:

ID: 1645481
Sex: F
Age:
State: OH

Vax Date: 02/13/2021
Onset Date: 02/13/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: blood work; Result Unstructured Data: Test Result:Unknown results; Test Date: 2018; Test Name: body temperature; Result Unstructured Data: Test Result:103 Fahrenheit; Test Date: 202107; Test Name: Chest X-Ray; Result Unstructured Data: Test Result:Unknown results; Test Date: 202107; Test Name: MRI of spine; Result Unstructured Data: Test Result:Unknown results; Test Name: sedimentation rate; Result Unstructured Data: Test Result:60; Test Date: 20210510; Test Name: Knee X-Ray; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210510; Test Name: Hip X-Ray; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: extreme tiredness; trouble walking; legs are sore but not related to muscle or bone/legs are sore in her inner thigh area; Things like bending over, putting her shoes and socks on and going up steps are hard for her to do.; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 57-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9267; Expiration Date: 31May2021), via an intramuscular route of administration (at the age of 57-years), on 13Feb2021 at 08:30 as dose 1,.single for COVID-19 immunisation and co-suspect as adalimumab (HUMIRA, Batch/Lot number was not reported), via an subcutaneous route of administration an unspecified date at unspecified dose for an unspecified indication and received apremilast (OTEZLA, Batch/Lot number was not reported), via an unspecified route of administration from Mar2021 to Jul2021, at unspecified dose for an unspecified indication. Medical history included ongoing asthma had maybe 15 years , allergy to vaccine from 2018 to an unknown date. The patient concomitant medications were not reported. The patient previously took pneumococcal vaccine and experienced cellulitis, Arm swelled up, pneumococcal vaccine and experienced fever. On 13Feb2021, the patient experienced extreme tiredness, trouble walking, legs are sore but not related to muscle or bone/legs are sore in her inner thigh area and things like bending over, putting her shoes and socks on and going up steps are hard for her to do. The adverse events resulted in physician office visit. After her first dose she experienced that same day, extreme tiredness, trouble walking, and leg soreness in her inner thigh area. He doctors told her it is not related to her muscle or bones. After her second dose the doctor did a lab test and tested her SED rate. It resulted at 60 and is supposed to be 5. Her inflammatory response is very high. She saw a rheumatologist and that doctor repeated the SED rate and it resulted an even higher number. The rheumatologist believes she has autoimmune disease. As of today, no one medically knows what to do with her. Caller asking do you know of any physicians that are dealing with symptoms of Covid-19 for example, has lower back pain and unable to do daily activities been reported after receiving the Pfizer Covid-19 Vaccine? Still having trouble putting shoes on going up steps. She was calling about the Covid 19 vaccine. She received the first dose on 13Feb2021 and that same day, later in the evening she was extremely tired and had trouble walking. Her legs are sore but not related to muscle or bone. Her legs are sore in her inner thigh area. Things like bending over, putting her shoes and socks on and going up steps are hard for her to do. She went to her doctor in Mar2021 and her sedimentation rate was 60 and it's normally supposed to be 5 so her inflammatory numbers were really high. Her doctor prescribed a steroid and referred her to a rheumatologist. The rheumatologist repeated the blood work and her sedimentation rate kept going up higher. The rheumatologist believed the caller has an autoimmune disease. The rheumatologist prescribed another steroid because the caller's legs were hurting again. The caller was signed up for Otezla but that medication takes a long time for approval from insurance so she was finally approved and took the Otezla. It was supposed to be in her system for 40 days to know if it's going to work. The Otezla did not work. She was prescribed another round of steroids and is now trying to get Humira. Her blood work now shows she is anemic. She has pain in her lower back. She does not think that her doctor know what to do with her. She has a full time job working with special education kids and she was very concerned over how can she go back to work. Her doctor wanted to prescribe an opioid but she does not want to take that and to become addicted to something like that. She was asking for some kind of direction or guidance. She is hoping to find a doctor that deals with adverse events from the Covid 19 vaccine. She wascalled the (name)and the CDC but no one can help her. She reports she used to work in housekeeping at Hospital. She had to quit because of the Covid 19 pandemic because she was immune compromised. She quit prior to receiving her Covid 19 vaccines. She received her second Covid 19 vaccine on 06Mar2021 in the right arm but was not 100% certain. Lot# EN6205, Expiry 30Jun2021, NDC not known. First Covid 19 vaccine information is in the suspect product field. When probing anatomical location of her first Covid 19 vaccine she wants to say she received it in the left arm but was not 100% sure. She received the second vaccine in the other arm thinking maybe that would cure her. After receiving her second Covid 19 vaccine she reports her symptoms and side effects stayed about the same. When probing for medical history and concomitant medications she reports she does not think her medications are relevant, she has been on her medications for years. She reports the rheumatologist did an X-ray of her hips and her knees and her chest. She had an MRI done of her spine. The MRI was about 2 weeks ago. The chest X-ray was sometime last week. Her hips and knees were X-rayed on 10May2021. When probing for adverse events following other vaccines she reports she had an allergic reaction to the pneumonia vaccine. She states one doctor called it an allergic reaction but the emergency room doctor called it cellulitis. She reports her arm swelled up and she had a fever of 103 degrees Fahrenheit. That happened in 2018. NDC/Lot/Expiry not known. When probing for information regarding the Otezla, she reports she tried it maybe in Mar2021. She had to take it for 40 days before she could see results. She has been off of it for maybe 2 or 3 weeks now. Description of Product Complaint: Description of complaint: The caller was signed up for Otezla but that medication takes a long time for approval from insurance so she was finally approved and took the Otezla. It was supposed to be in her system for 40 days to know if it was going to work. The Otezla did not work. Caller stated that she would just like to add additional information to her previous encounter in case her Rheumatologists calls she would like her blood work information included in the file. Patient was speaking about the Pfizer COVID-19 Vaccine she had her first dose on 13Feb2021 and her second on 06Mar2021. She stated they are thinking that her pain that she was having is being cause by her blood being out of wack. Spontaneous report by a consumer of a 57-year-old female with events of non-serious trouble walking, things like bending over, putting shoes and socks on and going up steps were hard to do, allergic reaction to pneumonia vaccine/cellulitis, autoimmune disease, sedimentation rate kept going up higher, inflammatory numbers were really high, Otezla did not work, anemic, pain in lower back, arm swelled up, fever and legs hurting/legs were sore but not related to muscle or bone/legs were sore in inner thigh area with Humira (Adalimumab). On unknown dates, the patient experienced autoimmune disease, sedimentation rate kept going up higher, inflammatory numbers were really high, anemic, pain in lower back, arm swelled up, fever and allergic reaction to pneumonia vaccine/cellulitis. in 2018, the patient experienced allergic reaction to pneumonia vaccine/cellulitis. in 2021, the patient experienced Otezla did not work. on 13Feb2021, the patient experienced trouble walking, things like bending over, putting shoes and socks on and going up steps were hard to do and legs hurting/legs were sore but not related to muscle or bone/legs were sore in inner thigh area. Pfizer BioNTech covid-19 vaccine (Tozinameran) and Otezla (Apremilast) were also considered suspect. The patient underwent lab tests and procedures which included blood work: unknown results, sedimentation rate: 60 on unspecified date, body temperature: 103 fahrenheit on unspecified date in 2018, chest x-ray: unknown results on Jul2021, MRI

Other Meds:

Current Illness: Asthma (Had maybe 15 years)

ID: 1645482
Sex: M
Age:
State:

Vax Date: 07/19/2021
Onset Date:
Rec V Date: 08/28/2021
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: muscle ache in his arm and muscle pain; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FA6780, NDC and UPC number: Unknown, Expiry Date: Unknown), via an unspecified route of administration on 19Jul2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced muscle ache in his arm and muscle pain. Reporter stated, just have a question. My son was 19 (not clarified) he took Pfizer earlier today and he was experienced the muscle, you know the muscle ache in his arm. If he allowed to take Tylenol. Reporter was informed about Pfizer Medical Information Department. It was reported when asked for further probing, reporter stated, No, just called to ask, patient had muscle pain so reporter need to find out if he could take the Tylenol. Reporter think that's the priority right now. If you could call me back at another time reporter will be happy to answer any questions but right now the priority was to figure out if he can take something to alleviate the muscle ache. The outcome was unknown of adverse event. Reporter was unwilling to provide further information hence limited information available over call.

Other Meds:

Current Illness:

ID: 1645483
Sex: F
Age:
State: CA

Vax Date: 07/18/2021
Onset Date: 07/19/2021
Rec V Date: 08/28/2021
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: whole chin is swelling and the rest of the face as well; Lower back pain; feel horrible; Chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the left arm on 18Jul2021 at 15:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the left arm on 20Jun2021 at 15:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation and had hyaluronic acid (MANUFACTURER UNKNOWN) filler on chin from unknown date for unspecified indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had hyaluronic acid filler on chin and believed there was reaction. On 19Jul2021 at 08:00, the patient's whole chin was swelling and the rest of face as well and also had never felt lower back pain like after the second dose of Pfizer vaccine. The patient felt horrible and had chills and fever. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events whole chin was swelling and the rest of face as well, lower back pain, chills, fever and feel horrible was not recovered at the time of this report.

Other Meds:

Current Illness:

ID: 1645484
Sex: F
Age:
State: OH

Vax Date: 07/14/2021
Onset Date: 07/15/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210715; Test Name: Body temperature; Result Unstructured Data: Test Result:102.6 Units:[degF]

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Lymph node swelling on the lower left side of neck that's increasing in size; Lethargic; Nauseated; Fever of 102.6F; couldn't stay awake and didn't even have the energy to sit up; couldn't stay awake and didn't even have the energy to sit up; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Jul2021 at 17:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety and post-traumatic stress disorder; both from unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included raloxifene hydrochloride (RALOXIFENE HCL), citalopram (MANUFACTURER UNKNOWN) and cetirizine (MANUFACTURER UNKNOWN); all from an unknown date for unspecified indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 25Jun2021 (at the age of 44-year-old) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Jul2021 at 11:15, approximately 18 hours after receiving the second dose, the patient was lethargic, nauseated, and had a fever of 102.6F. Once this started, the patient couldn't stay awake and didn't even have the energy to sit up for almost 24 hours. The fever lasted approximately 21 hours before finally breaking. On 16Jul2021, two days after receiving this dose, the patient experienced Lymph node swelling on the lower left side of neck that's increasing in size. Reported to PCP who suggested the patient to report the reaction. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever of 102.6F, couldn't stay awake and didn't even have the energy to sit up was recovered with sequelae on 16Jul2021 and of the events lethargic, nauseated and experienced Lymph node swelling on the lower left side of neck that's increasing in size was recovered with sequelae on unknown date in Jul2021. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds: RALOXIFENE HCL; CITALOPRAM; CETIRIZINE

Current Illness:

ID: 1645485
Sex: M
Age:
State: AZ

Vax Date: 07/19/2021
Onset Date: 07/20/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210720; Test Name: Temperature; Result Unstructured Data: Test Result:101 degrees

Allergies:

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

Symptoms: cough; nose feels stuffed; fever; body aches; Slight headache; This is a spontaneous report from a contactable other healthcare professional (nurse, patient). A 67-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FA6780), via an unspecified route of administration, in left arm (left upper arm) on 19Jul2021 at 11:00 (at the age of 67-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history included ongoing blood cholesterol increased (had since mid 20s, had this condition for about 40 years, it runs in his family, his father has it), COVID-19 from Aug2020 to an unknown date (in the beginning of Aug2020 and was in the hospital until Nov2020. He was in the hospital for 100 days. He was on a ventilator for 30 days. He was really bad. He was out. He did not know what was going on. He knows what it is like when patients don't know what is going on- he states they have to put patients in a semi-induced coma because the vent makes people shake and thrash in the bed and the patient have to be put under. He had not had any COVID tests since Nov202. He used to have weekly COVID tests when he was in the hospital to see if he was carrying COVID. He was always negative for all of the tests. He went to (center name) for the COVID tests. He was in the (center name) every month, they were the ones who did the COVID testing every week. He saw his doctor and had blood work in Jan2021. His doctor did not recommend a COVID test), blood triglycerides increased from an unknown date and unknown if ongoing and bad allergies (takes Singulair for this). The patient previously received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0217, Expiration date: Unknown), via an unspecified route of administration in left arm (left upper arm) on 28Jun2021 at 11:30 as dose 1, single for COVID-19 immunisation. The patient concomitant medications included atorvastatin (LIPITOR) 40 mg taken for blood cholesterol from an unspecified start date and ongoing (been on it for about 40 years); fenofibrate (TRICOR [FENOFIBRATE]) 160 mg taken for blood triglycerides increased from an unspecified start date and ongoing (been on it for about 20 years). He got the flu shot every year and had the pneumonia shot and had no reactions. He did not do the shingles shot, he might. The patient did not receive other vaccines the same day or within 4 weeks prior to COVID vaccination. On 20Jul2021, the patient experienced fever, body aches, slight headache, and cough, nasal stuffiness on an unspecified date. Patient reported that he received his second dose yesterday on 19Jul2021 and is having the same symptoms as first dose now but thinks they may be already improving. Caller stated his nose feels stuffed and when he takes his medication it usually keeps it clear, but it is still there and he thinks maybe it is allergies. The patient received treatment as Tylenol for all events taken every 4 hours. The patient was afraid to give Pfizer's drugs because he has had so many bad experiences with Pfizer. He stated that Pfizer was doing bad things and was getting all this money and doing all this crap to people and Pfizer cannot even answer a question. He took Tylenol for fever and it got rid of it. He knows these symptoms are normal because he had a neighbour that had the vaccine and he was tired from it. Caller also states he knows people that have had this and supposedly the vaccine was doing its job. He clarified further his fever was not that high, it was only 101, and it was not like its escalating. The following day it went away, just like that. He confirms by the 16Jun2021, he was fine. He had fever, chills and headache with the first dose. With the second dose he had the same thing except no chills. What has happened is that he has allergies and he is getting a cough every couple of hours. Caller confirms he got the second COVID shot yesterday and the first shot 3 weeks ago. He figured if he got a fever and all, it was normal and goes away in a day and half, and he is usually fine. He is just concerned about the cough. He is not coughing every hour, its just like every 4 or 5 hours, he does not know if that a concern or not. With the second dose, Caller confirms he has a fever. His fever started in the middle of the night at 03:00AM with the body aches and slight headache. He confirms he had no chills. The body aches woke him up. He didnt know he had a fever, he was not sweaty, but he figured he might as well check his temperature and it was only 101 degrees, its not like it was high. He clarifies he checked his temperature at 03:00. He states his back was so bad from the body aches. He states the body aches are better now because the Tylenol is probably helping. His current fever after having the second dose is staying the same at 101 degrees, its not getting any higher or going down. He is sure by tomorrow it will be gone. He would be more concerned if his temperature was at 103 or 104, he is not really concerned at 101 degrees. He confirms the headache is improving with the Tylenol. He is not currently working but since he had COVID so bad to where he almost died, he was afraid he might get it again. He confirmed with the second dose, his headache was not as bad as it was with the first dose. He confirmed the date of his second dose was 19Jul2021. The patient underwent lab tests and procedures which included body temperature 101 101 degrees on 20Jul2021. The outcome of the events headache was resolved in 2021. Outcome of event fever was not recovered. Outcome of events body ache, slight headaches was recovering and outcome of other events cough, nose feels stuffed was unknown. The reporter assessed the fever, and headache to be related to bnt162b2 (Method of assessment: Global introspection). Information about lot/batch number requested. Follow-up (20Jul2021): New information received from a contactable nurse included: patient details (height, weight and ethnicity was added), vaccine facility info updated and best HCP info updated, event (cough, nasal stuffiness) added and narrative updated. Follow-up attempts are completed. No further information is expected.

Other Meds: ATORVASTATIN; TRICOR [FENOFIBRATE]; SINGULAIR

Current Illness: High cholesterol (Had since mid 20s. Had this condition for about 40 years.)

ID: 1645486
Sex: M
Age:
State: FL

Vax Date: 07/17/2021
Onset Date: 07/17/2021
Rec V Date: 08/28/2021
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: Throat was sore; Allergies have been more frequently than before the vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the left arm on 17Jul2021 at 09:30 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 17Jul2021 at 12:00, the patient experienced "allergies have been more frequently than before the vaccine" and the day of vaccination the throat was sore. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events allergies have been more frequently than before the vaccine and throat was sore were resolving at the time of reporting.

Other Meds:

Current Illness:

ID: 1645487
Sex: F
Age:
State: OH

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:dropped; Test Name: hemoglobin; Result Unstructured Data: Test Result:lowered

Allergies:

Symptom List: Pain in extremity

Symptoms: Her bleeding is also very different, it is blood like she cut her wrist.; anemic; blood pressure dropped; dizzy; tightness in chest; lowered her hemoglobin.; tired; two weeks later she started a period and has not stopped since then; This is a spontaneous report from a contactable consumer or other non hcp. A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported; Expiry Date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Left on Mar2021 (at the age of 51-years-old) as dose 2, single for covid-19 immunisation. Medical history included ongoing anaemia. There were no concomitant medications. Historical vaccine included bnt162b2 in left arm in mid Feb2021 for covid-19 immunization as 1st dose. In Mar2021, the patient experienced "two weeks later she started a period and has not stopped since then, on an unspecified date her bleeding is also very different, it is blood like she cut her wrist, anemic, blood pressure dropped, dizzy, tightness in chest, lowered her hemoglobin, tired. The patient underwent lab tests and procedures which included blood pressure measurement: dropped, haemoglobin: lowered. Therapeutic measures were taken as a result of blood pressure dropped, dizzy and tightness in chest. It was reported the patient had a period close to 3 months now since she had the second dose. She asked if other people have had this experience. She wanted to know if this has been reported and how long it lasts. She had second dose in early-mid Mar2021 and 2 weeks later she started her period and it has yet to stop. She explained it has gotten less but it is still going and going. She talked to doctor about this but didn't relate it to the vaccine but then she heard other people have had this experience. It is explained she is pretty regular so she wanted to call and report this in case there are others who have the same experience. She had the shot done through (facility name) at 2 different locations. She explained that she tends to be anemic anyway and so this has lowered her hemoglobin. The caller stated she did not want to do a full report and only want this call handler to get the essential as she is very tired and has a lot to do. She started her period on 26 or 27Mar2021, it wasn't due till the second week of Apr2021. She said she thinks it is a little less; it will get less and she will think it's almost over but then 12 hours later she is back to bleeding again. Her bleeding is also very different, it is blood like she cut her wrist. The patient was at that age of early menopause and so at first she chalked it up to that. Then the caller explained she had another friend that reported the same experience and that she had the Pfizer vaccine also. She reported she would see someone the next day to get blood work and then she would be referred to a gynecologist. When asked if she had gone to the emergency room related to the event, she stated no but did have an episode this morning and thought about. She reported she felt like her blood pressure dropped, she was dizzy and had tightness in chest. She treated this by having orange juice, took a nap and got herself together. It is explained that she has felt similar to this before and it was that her hemoglobin was low. She said she thinks it was related to the bleeding and losing a lot of iron. She then called the doctor and has an appointment for the next day at 1:30. She has done nothing else other than just home treatment of the symptoms. Both doses were given in the left arm. She doesn't have her card with her right now and therefore has no NDC, Lot, or Expiry. She asked if anyone has reported this before. She would also like to know how long this would last if it is related. She has had no other vaccines on the same day of the COVID vaccine. Outcome of the event Menstruation prolonged was recovering and outcome of other events were unknown. Follow-up (20Jul2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported for herself included outcome of the event and clinical information. Information about lot/batch number has been requested.

Other Meds:

Current Illness: Anemic (Verbatim: Anemic)

ID: 1645488
Sex: M
Age:
State:

Vax Date: 07/16/2021
Onset Date:
Rec V Date: 08/28/2021
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: feel very different; This is a spontaneous report from a contactable consumer reporting for himself. A 33-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 16Jul2021 16:00 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced feel very different on an unspecified date. Patient wanted to know the symptoms that one can get after the vaccine. Patient was 33 years old but feel like a very different man from what he was, and afraid to get the last vaccine. Patient was told that on 06Aug he had to get the Pfizer Covid-19 vaccine. Asked whether the vaccine kill hormones. Upon probing, caller stated he received the Johnson & Johnson vaccine, but later said he was not sure what vaccine he received. Patient asked why if he got Johnson's vaccine then, they were wanting him to get other vaccines. Clinical outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1645489
Sex: F
Age:
State:

Vax Date: 06/23/2021
Onset Date:
Rec V Date: 08/28/2021
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: arm pain for about 24 hours on her right arm; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 23Jun2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter would like to know the possible side effects of taking the Pfizer?s COVID-19 vaccine, and how long would the side effects last after receiving the second dose of the vaccine. She already received both doses of the Pfizer's COVID-19 vaccine and developed several side effects, she received the first dose on 23Jun2021, and she developed arm pain for about 24 hours on her right arm. The outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1645490
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: rash; This is a spontaneous report from a non-contactable consumer (patient). 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 in 2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified for COVID-19 immunisation. The patient experienced rash on an unspecified date in 2021. The outcome of event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1645491
Sex: F
Age:
State: MI

Vax Date: 07/20/2021
Onset Date: 07/20/2021
Rec V Date: 08/28/2021
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: Pain at injection site; Nausea; Body aches; Fever; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 20Jul2021 at 12:15 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. The medical history was not reported. The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT), diphenhydramine hydrochloride (BENADRYL) and valproate semisodium (DEPAKOTE), all from unknown dates and for unknown indications. On 20Jul2021 at 14:00, the patient experienced pain at injection site, nausea, body aches and fever. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain at injection site, nausea, body aches and fever were resolving 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: ZOLOFT; BENADRYL; DEPAKOTE

Current Illness:

ID: 1645492
Sex: M
Age:
State: CO

Vax Date: 07/09/2021
Onset Date: 07/11/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210715; Test Name: SARS-CoV-2 test; Test Result: Negative ; Comments: nasal swab

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Full body aches; Chills; Fever; Weakness; Headache; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Jul2021 at 21:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Jun2021 at 20:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 11Jul2021, the patient experienced full body aches, chills, fever, weakness, headache and nausea. The patient stated that, he had no issues first two days and each day after the first two it progressively became worse for over a week. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 15Jul2021, the patient gave nasal swab for SARS-CoV-2 test and the result was negative. The clinical outcome of the events full body aches, chills, fever, weakness, headache and nausea were resolving at the time of this report. The batch/lot numbers for BNT162b2, were not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1645493
Sex: F
Age:
State:

Vax Date: 07/17/2021
Onset Date: 07/19/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Large swollen, itchy, red splotch at injection site; Large swollen, itchy, red splotch at injection site; Large swollen, itchy, red splotch at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Jul2021 at 08:15 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient and concomitant medication were not reported. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient also received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26Jun2021 at 08:15 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jul2021, at 09:00, the patient experienced large swollen, itchy, red splotch at injection site. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19.The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event large swollen, itchy, red splotch at injection site was ongoing 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:

ID: 1645494
Sex: M
Age:
State: MD

Vax Date: 04/28/2021
Onset Date: 05/01/2021
Rec V Date: 08/28/2021
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: feels tingling or different; feels tingling or different; skin on shoulders has peeled; skin on shoulders has peeled; It has improved his skin. It has improved his immune system greatly.; itching; improved immune system greatly; all of the skin on head has peeled; This is a spontaneous report from a contactable consumer reported for himself from a Pfizer-sponsored program. This is First of two reports. A 51-years-old male patient received single dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EW0173, Expiration date was not reported), via an unspecified route of administration in arm right on 28Apr2021 (at the age of 51-years-old) as single dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EW0186, Expiration date was not reported), via an unspecified route of administration in arm right on 09May2021 (at the age of 51-years-old) as single dose for COVID-19 immunisation. Medical history included patient had skin cancer few years ago, pancreatitis in past, sickness from an unknown date and unknown if ongoing. There were no concomitant medications. History of all previous immunization with the Pfizer vaccine considered as suspect; additional vaccines administered on same date of the Pfizer suspect; prior Vaccinations (within 4 weeks); AE(s) following prior vaccinations; relevant tests and investigation assessment included none. The patient was taking Covid vaccine for Covid prevention. The patient experienced all of the skin on head has peeled, improved immune system greatly on May2021, skin on shoulders has peeled, it has improved his skin, it has improved his immune system greatly, itching on 19May2021, skin on shoulders has peeled on Jul2021, feels tingling or different on an unspecified date. Since getting the vaccine all of the skin on his head has peeled. The skin on his shoulders have peeled. It has improved his skin. It has improved his immune system greatly. He had a great response to the Covid vaccine. Caller was unsure of the name of his physician. There were 4-5 people in the group that he sees. Caller stated his skin started peeling after getting the first shot. There were two occasions where he picked his skin because of itching. He thought it was liver spots that they wanted to cut off. It started a couple of times. It was like the spots were itching. He didn't notice at first. The area was scabbed and then it fell off. Caller was unable to provide outcome of event. It was cyclic every 3 to 5 to 7 days he feels tingling or different and it was receptive to being to be scratched. It didn't feel the same every day. In shoulders, he started scratching and it was receptive. The same thing started like his head. In the last two weeks it has happened three different times. When asking about his immune system improving caller added that he has had trouble with pancreatitis in the past. His immune system has improved greatly since getting the vaccine. He has not had any problems. Before the vaccine one week he was sick then better then sick again. It was also cyclic. He had to go the hospital. He went to the emergency room twice. He confirms that he was not admitted. He was sent home. Patient did not go to physician office. Clinical outcome of the event all of the skin on head has peeled (onset May2021) was recovered on 15Jun2021, of improved immune system greatly (onset May2021) was not recovered, skin on shoulders has peeled (onset 19May2021), it has improved his skin, it has improved his immune system greatly (onset 19May2021), skin on shoulders has peeled (onset Jul2021) was recovering, while the other events outcome was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100924246 same reporter/drug/event, different patient.

Other Meds:

Current Illness:

ID: 1645495
Sex: M
Age:
State: MI

Vax Date: 07/08/2021
Onset Date: 07/08/2021
Rec V Date: 08/28/2021
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: FIRST DOSE: Patient received a COVID-19 Vaccine dose involved in a temperature excursion; FIRST DOSE: Patient received a COVID-19 Vaccine dose involved in a temperature excursion; This is a spontaneous report from a contactable Consumer or other health care professional. A 13-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0196; Expiration Date: 30Sep2021), via an unspecified route of administration in left arm on 08Jul2021 (at the age of 13-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Investigation assessment was not provided. The reporter was an office manager who reported invalid COVID-19 vaccine doses were administered to 4 patients. "PRIVACY" clarified that the office manager reported their practice had kept the COVID-19 vaccine in the freezer since 08Jun2021, past the allowed extended freezer time, and then the COVID-19 vaccine was then given to 4 patients. "PRIVACY" said the COVID-19 vaccine can only be kept in the freezer for 3 weeks. "PRIVACY" said a temperature excursion had occurred on the practices COVID-19 vaccine, and the practices office manager was being transferred to report on the 4 patients that received the COVID-19 vaccine involved in the temperature excursion. Caller stated that the patients was vaccinated with expired use by date including on 08Jul2021 and later. Caller was looked for guidance on how to proceed. Reported the patient was unaware the COVID-19 vaccine was involved in a temperature excursion, and the patient had not reported any adverse events to their office since the COVID-19 vaccine was administered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1645496
Sex: U
Age:
State: MD

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: It has improved his skin. It has improved his immune system greatly.; itching; all of the skin on head has peeled/ The skin on his shoulders have peeled.; This is a spontaneous report from a contactable consumer or other non hcp received from Pfizer sponsored Program. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced all of the skin on head has peeled/ the skin on his shoulders have peeled, it has improved his skin. it has improved his immune system greatly and itching on an unspecified date. It was reported: Caller adds that he spoke with a woman at the bank and it happened to a friend of hers. Caller does not have any details to provide. The outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100924204 same reporter/drug/event, different patient

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am