VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1817508
Sex: F
Age:
State: NV

Vax Date: 10/15/2021
Onset Date: 10/15/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: received dose from expired vial; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Oct-2021 and was forwarded to Moderna on 18-Oct-2021. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication. No Medical History information was reported. On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and INFLUENZA VACCINE (FLU VACCINE VII) (Intramuscular) at an unspecified dose. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from expired vial). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant drugs were provided. No treatment drugs are provided. Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Follow up received and updated patient demographics and flu vaccine were added.

Other Meds:

Current Illness:

ID: 1817509
Sex: F
Age:
State: AR

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 10/26/2021
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: Soreness at the injection site; Sore muscle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) and MYALGIA (Sore muscle) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. No Medical History information was reported. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site) and MYALGIA (Sore muscle). On 22-Jan-2021, VACCINATION SITE PAIN (Soreness at the injection site) and MYALGIA (Sore muscle) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Second dose was taken by the patient on 23-Feb-2021. No concomitant medications was reported. No treatment drug details was reported. patient didn't report any adverse reaction to the shots. There was only mild sorness in her left arm at the injection site that went away after a couple of days. No other side effects were noted. she will now waiting to qualify for the booster. This case was linked to MOD-2021-355997 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Follow up received on 21-Oct-2021 contains no new information.

Other Meds:

Current Illness:

ID: 1817510
Sex: F
Age: 38
State: FL

Vax Date: 10/18/2021
Onset Date: 09/18/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Pfizer COVID19 Vaccine was administered; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer COVID19 Vaccine was administered) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination. Previously administered products included for COVID-19 vaccination: Pfizer COVID-19 Vaccine on 18-Sep-2021. On 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer COVID19 Vaccine was administered). On 18-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer COVID19 Vaccine was administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant drugs were not reported. Treatment medications were not provided. Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: Reporter information, contact details were Updated.

Other Meds:

Current Illness:

ID: 1817511
Sex: M
Age: 61
State: PA

Vax Date: 03/25/2021
Onset Date:
Rec V Date: 10/26/2021
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: after he had the first dose, he had like a burst of energy/He came home and had tons of energy; little itchy on his stomach; the next day he just crashed/was tired/exhausted/Felt completely exhausted; This spontaneous case was reported by a consumer and describes the occurrence of ENERGY INCREASED (after he had the first dose, he had like a burst of energy/He came home and had tons of energy), PRURITUS (little itchy on his stomach) and FATIGUE (the next day he just crashed/was tired/exhausted/Felt completely exhausted) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The patient's past medical history included Cancer. Concurrent medical conditions included Hypertension, Migraine, Hypokalemic periodic paralysis (it's a condition that causes extreme muscle weakness, he probably had it since a kid, sometimes they call it dead sleep,he has liquid potassium and liquid magnesium in his hand, and when he feels it coming, he can feel his muscles weak, and he would mix that with juice and then feel better, and then take it again after an hour) and Asthma. Concomitant products included BECLOMETASONE DIPROPIONATE (QVAR REDIHALER) for Asthma, EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE (SYNJARDY XR) for Diabetes, LOSARTAN for Hypertension, ROSUVASTATIN CALCIUM (CRESTOR) for Lipids, ALPRAZOLAM, TADALAFIL (CIALIS), LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN D 12 HOUR), DULAGLUTIDE (TRULICITY), OMEPRAZOLE, METOPROLOL TARTRATE, FINASTERIDE, ZOPICLONE and VITAMINS NOS for an unknown indication. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ENERGY INCREASED (after he had the first dose, he had like a burst of energy/He came home and had tons of energy), PRURITUS (little itchy on his stomach) and FATIGUE (the next day he just crashed/was tired/exhausted/Felt completely exhausted). At the time of the report, ENERGY INCREASED (after he had the first dose, he had like a burst of energy/He came home and had tons of energy), PRURITUS (little itchy on his stomach) and FATIGUE (the next day he just crashed/was tired/exhausted/Felt completely exhausted) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medications were provided. Reporter provided concomitant Metoprolol tartrate indication for Heart. As the patient is suffering from hypokalemic periodic paralysis, he states that is the reason why he can't take certain medications anymore: azythromycin , prednisone triggers the condition This case was linked to MOD-2021-356037 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Non-significant Follow-up

Other Meds: ALPRAZOLAM; CIALIS; CLARITIN D 12 HOUR; SYNJARDY XR; TRULICITY; LOSARTAN; OMEPRAZOLE; QVAR REDIHALER; CRESTOR; METOPROLOL TARTRATE; FINASTERIDE; ZOPICLONE; VITAMINS NOS

Current Illness: Asthma; Hypertension; Hypokalemic periodic paralysis (it's a condition that causes extreme muscle weakness, he probably had it since a kid, sometimes they call it dead sleep,he has liquid potassium and liquid magnesium in his hand, and when he feels it coming, he can feel his muscles weak, and he would mix that with juice and then feel better, and then take it again after an hour); Migraine

ID: 1817512
Sex: M
Age:
State: MN

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
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: SAlb; Result Unstructured Data: Laboratories during presentation 3.7 g/dl; Test Name: SAlb; Result Unstructured Data: Laboratories during last follow-up 3.8 g/dl; Test Name: SCr; Result Unstructured Data: 1.1 mg/dl baseline; Test Name: SCr; Result Unstructured Data: during presentation 2.5 g/dl; Test Name: SCr; Result Unstructured Data: Laboratories during last follow-up 3.6 g/dl; Test Name: urine protien; Result Unstructured Data: Laboratories during presentation 14 g/d; Test Name: urine protien; Result Unstructured Data: Laboratories during last follow-up 5.6 g/d; Test Name: urine RBC; Result Unstructured Data: Laboratories during presentation 21 ? 30 HPF; Test Name: urine RBC; Result Unstructured Data: Laboratories during last follow-up 3-10 HPF

Allergies:

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

Symptoms: IgA nephropathy; Acute interstitial nephritis; Acute kidney injury; This literature-non-study case was reported in a literature article and describes the occurrence of IGA NEPHROPATHY (IgA nephropathy), TUBULOINTERSTITIAL NEPHRITIS (Acute interstitial nephritis) and ACUTE KIDNEY INJURY (Acute kidney injury) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IGA NEPHROPATHY (IgA nephropathy) (seriousness criterion medically significant), TUBULOINTERSTITIAL NEPHRITIS (Acute interstitial nephritis) (seriousness criterion medically significant) and ACUTE KIDNEY INJURY (Acute kidney injury) (seriousness criterion medically significant). At the time of the report, IGA NEPHROPATHY (IgA nephropathy), TUBULOINTERSTITIAL NEPHRITIS (Acute interstitial nephritis) and ACUTE KIDNEY INJURY (Acute kidney injury) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood albumin: 3.7 g/dl Laboratories during presentation 3.7 g/dl and 3.8 g/dl Laboratories during last follow-up 3.8 g/dl. On an unknown date, Blood creatinine: 1.1 mg/dl 1.1 mg/dl baseline, 2.5 g/dl during presentation 2.5 g/dl and 3.6 g/dl Laboratories during last follow-up 3.6 g/dl. On an unknown date, Protein urine: 14 g/d Laboratories during presentation 14 g/d and 5.6 g/d Laboratories during last follow-up 5.6 g/d. On an unknown date, Red blood cells urine: 21 ? 30 high power field (hpf) Laboratories during presentation 21 ? 30 HPF and 3-10 hpf Laboratories during last follow-up 3-10 HPF. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered IGA NEPHROPATHY (IgA nephropathy), TUBULOINTERSTITIAL NEPHRITIS (Acute interstitial nephritis) and ACUTE KIDNEY INJURY (Acute kidney injury) to be possibly related. Patient was presented with Acute kidney injury and in follow up it was reported that patient was treated with high dose High-dose steroid. About 69% of patients in our case series developed AKI but majority of them developed AKI stage 1. This is a literature case concerning a 44-year-old, male patient with no relevant history reported, who experienced the ,unexpected serious events of IGA NEPHROPATHY, TUBULOINTERSTITIAL NEPHRITIS and ACUTE KIDNEY INJURY . The event occurred approximately 2 weeks after the 1st dose of mRNA-1273 Moderna vaccine. The rechallenge was N/A (no information about 2nd dose was provided) This case was linked to MOD-2021-357609, MOD-2021-357610, MOD-2021-357611, MOD-2021-357612, MOD-2021-357613, MOD-2021-357614 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Follow up received by safety 22-Oct-2021 included an Email with FTA received from team and does not contain any new information.; Sender's Comments: This is a literature case concerning a 44-year-old, male patient with no relevant history reported, who experienced the ,unexpected serious events of IGA NEPHROPATHY, TUBULOINTERSTITIAL NEPHRITIS and ACUTE KIDNEY INJURY . The event occurred approximately 2 weeks after the 1st dose of mRNA-1273 Moderna vaccine. The rechallenge was N/A (no information about 2nd dose was provided) The benefit-risk relationship of COVID19 MODERNA is not affected by this report.

Other Meds:

Current Illness:

ID: 1817513
Sex: F
Age:
State: MN

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

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

Lab Data: Test Name: kidney biopsy; Result Unstructured Data: kidney biopsy was done which revealed pauci-immune crescentic GN.; Test Name: SCr; Result Unstructured Data: Baseline SCr 0.8 mg/dl; Test Name: SCr; Result Unstructured Data: Laboratories during presentation 2.5 Serum creatinine peaked at 3.1 mg/dL; Test Name: SCr; Result Unstructured Data: Laboratories during last follow-up 2.3 mg/dl; Test Name: urine protein; Result Unstructured Data: Laboratories during presentation 1.2 g/d; Test Name: urine RBC; Result Unstructured Data: Laboratories during presentation 3-10 HPF

Allergies:

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

Symptoms: MPO-ANCA associated vasculitis; Pauci-immune crescentic GN; This literature-non-study case was reported in a literature article and describes the occurrence of ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS (MPO-ANCA associated vasculitis) and GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (Pauci-immune crescentic GN) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS (MPO-ANCA associated vasculitis) (seriousness criterion medically significant) and GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (Pauci-immune crescentic GN) (seriousness criterion medically significant). The patient was treated with RITUXIMAB for Vasculitis, at an unspecified dose and frequency and PREDNISONE for Vasculitis, at an unspecified dose and frequency. At the time of the report, ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS (MPO-ANCA associated vasculitis) and GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (Pauci-immune crescentic GN) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy kidney: abnormal kidney biopsy was done which revealed pauci-immune crescentic GN.. On an unknown date, Blood creatinine: 0.8 mg/dl Baseline SCr 0.8 mg/dl, 2.5 mg/dl Laboratories during presentation 2.5 Serum creatinine peaked at 3.1 mg/dL and 2..3 mg/dl Laboratories during last follow-up 2.3 mg/dl. On an unknown date, Protein urine: 1.2 g/d Laboratories during presentation 1.2 g/d. On an unknown date, Red blood cells urine: 3-10 high power field(hpf) Laboratories during presentation 3-10 HPF. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS (MPO-ANCA associated vasculitis) and GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (Pauci-immune crescentic GN) to be possibly related. Our patient presented with shortness of breath and fatigue 4 weeks after the 2nd dose. The patient was found to have Acute kidney injury, hematuria and proteinuria. Patient was diagnosed with myeloperoxidase-antineutrophilic cytoplasmic antibody (MPO-ANC) associated vasculitis. Patient was treated with High-dose steroid. This case concerns a 82-year-old female patient with no previous relevant medical history, who experienced the unexpected serious event of Anti-neutrophil cytoplasmic antibody positive vasculitis and Pauci-immune glomerulonephritis after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The events occurred approximately 4 weeks after the second dose of Spikevax. Clinical manifestations included dyspnoea and fatigue. Laboratory results showed acute kidney injury with rapid increase of creatinine up to 3.1mg/dl, microscopic haematuria and subnephrotic range proteinuria. Kidney biopsy showed pauci-immune crescentic glomerulonephritis. Treatment with rituximab and high dose prednisone was given. At the time of the report, creatinine was improving (2.3mg/dl) The rechallenge is not applicable, since the event was reported exclusively after the second dose. The benefit-risk relationship of Spikevax vaccine is not affected by this report. This case was linked to MOD-2021-357261, MOD-2021-357609, MOD-2021-357610, MOD-2021-357612, MOD-2021-357613, MOD-2021-357614 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Follow up received by safety 22-Oct-2021 included an Email with received from team and does not contain any new information; Sender's Comments: This case concerns a 82-year-old female patient with no previous relevant medical history, who experienced the unexpected serious event of Anti-neutrophil cytoplasmic antibody positive vasculitis and Pauci-immune glomerulonephritis after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The events occurred approximately 4 weeks after the second dose of Spikevax. Clinical manifestations included dyspnoea and fatigue. Laboratory results showed acute kidney injury with rapid increase of creatinine up to 3.1mg/dl, microscopic haematuria and subnephrotic range proteinuria. Kidney biopsy showed pauci-immune crescentic glomerulonephritis. Treatment with rituximab and high dose prednisone was given. At the time of the report, creatinine was improving (2.3mg/dl) The rechallenge is not applicable, since the event was reported exclusively after the second dose. The benefit-risk relationship of Spikevax vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1817514
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
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: vaccinated on day 46 with second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccinated on day 46 with second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccinated on day 46 with second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccinated on day 46 with second dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1817515
Sex: M
Age: 42
State: TX

Vax Date: 10/18/2021
Onset Date: 10/18/2021
Rec V Date: 10/26/2021
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: Expired Vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Oct-2021 at 4:09 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitants and treatment drugs were provided.

Other Meds:

Current Illness:

ID: 1817516
Sex: M
Age:
State: CA

Vax Date: 02/21/2021
Onset Date: 02/22/2021
Rec V Date: 10/26/2021
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: left shoulder where the vaccine was put in his shoulder has been sore; Patient was in bed; This is a spontaneous report from a contactable consumer. A 90-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ; Lot Number: EN6200; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in Arm Left on 21Feb2021 13:30 (at the age of 90-years-old) at dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously got the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ; EL9265, expiration date was 31May2021), via an unspecified route of administration, in Arm Left on 31Jan2021 at dose 1, single for covid-19 immunization. The patient probably had a little sensation on the vaccination day but left shoulder pain started the next day after the second shot and has not gotten better, has not gotten worse on 22Feb2021. Patient was in bed. Caller stated the left shoulder where the vaccine was put in patient's shoulder has been sore and tried a hot water bottle, it did not help. The most recent vaccine was administered at the Forum, it was a big round building. Patient got no other vaccines the same day. The events not resulted in Emergency Room and Physician Office visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. They do not have a primary care physician. Patient goes to a heart specialist and if they have a certain thing they go to a specialist for that. Caller asked if shoulder pain after the vaccine has been reported by other people. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1817517
Sex: F
Age:
State: TX

Vax Date: 03/17/2021
Onset Date: 03/18/2021
Rec V Date: 10/26/2021
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: Hives on stomach and legs; This is a spontaneous report from a contactable consumer, the patient. A 37-years-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 arm left on 17Mar2021, (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic idiopathic urticaria. The patient had known allergies to penicillin. Concomitant medication included Omalizumab (XOLAIR) (MANUFACTURER UNKNOWN) injection on 25Mar2021 for an unknown indication. 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 right arm on 24Feb2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 06:00 the patient experienced hives on stomach and legs which started 18 hours after 2nd shot and still currently have the hives 2 weeks later. The patient took unspecified medications as a therapeutic measure for adverse event. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event hives on stomach and legs was not recovered. No follow-up attempts are needed. Information about lot/batch number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: deleted second dosage regimen for Xolair, updated vaccine administration anatomical site in narrative.

Other Meds: XOLAIR

Current Illness:

ID: 1817518
Sex: F
Age:
State: PA

Vax Date: 03/09/2021
Onset Date: 03/01/2021
Rec V Date: 10/26/2021
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: says it is spotting like period blood; first dose, there was blood in the urine/second dose, there was blood in her urine again; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Mar2021 (lot number: EN6208), dose 1, single and on 30Mar2021 (lot number: ER8734), dose 2, single; both via an unspecified route of administration at the age of 79-year-old for COVID-19 immunisation. Medical history included menopause. The patient's concomitant medications were not reported. In Mar2021, 3 days later the vaccination, the patient went to pee and there was blood in the urine. The patient went to the doctor and they checked her urine and there was blood and they said they did not know where the blood was coming from. The patient took an anti-biotic cephalexin (Keflex) 500 mg for 10 days. The bleeding stopped 3 days later after she started the treatment medication. The patient stated there was no more bleeding when she peed for 10 days. Then the patient took the second vaccine around 10:00 in the morning and a couple hours later (about 02:00) she went to pee and there was blood in the urine again. It was kind of suspicious she has never bled since menopause at like 40, she has never bled all these years it was kind of strange she just wanted to tell about her experience. The patient stated she called her gynecologist on 31Mar2021 and she was going to go take a test at 01:45 and see what they say at the hospital. She said it was spotting like period blood and she said it was persisting on 31Mar2021 about the same as on 30Mar2021. The patient further stated, when she peed this morning, a lot of blood came out. The outcome of the events was not recovered. No follow-up attempts are possible; No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021366596 Pfizer

Other Meds:

Current Illness:

ID: 1817519
Sex: M
Age:
State:

Vax Date: 03/25/2021
Onset Date: 03/29/2021
Rec V Date: 10/26/2021
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: Pain in arm; Chills; Fever; Not feeling well; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955), via an unspecified route of administration in the right arm on 25Mar2021 at 00:30 (at the age of 52-year-old), as DOSE 1, single for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. Medical history included thyroid Thyroid cancer but had no allergies to any medicines, food or other products. Concomitant medications included influenza virus vaccine(flu). On unknown date, the patient experienced pain in the arm. On day 4, 29Mar2021, the patient experienced chills, fever and was not feeling well in the whole body. The patient had received no treatment for the clinical events. The clinical outcome of the events pain in arm was recovered on an unknown date; chills, fever and not feeling well was recovered on an unknown date in 2021. No follow-up attempts are possible. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: Updated country added in patient tab; updated relevant Med History and narrative tab per source provided; updated vaccination Facility Type and Vaccination Facility Country; updated Onset Date/Time for events updated Leading and final sentence.

Other Meds: FLU

Current Illness:

ID: 1817520
Sex: F
Age:
State:

Vax Date: 03/22/2021
Onset Date: 03/28/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: Test Name: fever; Result Unstructured Data: Test Result:101; Test Name: COVID test; Test Result: Negative

Allergies:

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

Symptoms: extreme pelvic pain; 101 fever; felt mentally disoriented; This is a spontaneous report from a non-contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 22Mar2021 as dose 1, single for covid-19 immunization. The patient medical history included shoulder replacement (I'm 70 and I've had shoulder replacement about a year ago and still recovering from that). Concomitant medications were not reported. It was reported that patient received her first dose of Pfizer's COVID vaccine on 22Mar2021. She was fine until 6 days later on 28Mar2021, she stated she had 101 fever, and felt mentally disoriented but she managed to get in for a COVID test the next day on Monday, and it was negative. By Easter Sunday, she had extreme pelvic pain, so she went into a walk-in clinic and got treated for that. Just today, my symptoms are letting up. She is 70 and she have had shoulder replacement about a year ago and still recovering from that. Patient is concerned if she should get the second dose. Patient was asking if there may be more symptoms on the second dose. Patient also asking if surgery causes you to be immunocompromised. The patient underwent lab tests and procedures which included fever (body temperature): 101 on an unspecified date, COVID test (sars-cov-2 test): negative on an unspecified date. Therapeutic measures were taken as a result of extreme pelvic pain. The outcome of the events was unknown. No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1817521
Sex: F
Age:
State: FL

Vax Date: 03/24/2021
Onset Date: 03/25/2021
Rec V Date: 10/26/2021
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: usual chills; Swollen lymph nodes same side as vaccine in neck and throat; feeling of lump in throat; dull pain from lower throat all along up to inner ear/dull ache up to inner ear; dull pain from lower throat all along up to inner ear/dull ache up to inner ear; strep throat.; This is a spontaneous report from a non-contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ED753Y) via an unspecified route of administration, administered in the right arm on 24Mar2021(age at the time of vaccination was 59-year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history included Osteoarthritis, gastritis, coiled and stented aneurysm and Tetracycline allergy. The patient's concomitant medications were not reported. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not having covid prior vaccination and has not been covid tested post vaccination. On 25Mar2021 besides the usual chills 24 hours later. Swollen lymph nodes same side as vaccine in neck and throat. Constant feeling of lump in throat and dull pain from lower throat all along up to inner ear. Lymph node under neck reduced but still lump in throat feeling and dull ache up to inner ear at end of week 2. Getting next shot in 5 days. Doctor prescribed antibiotics to rule out strep throat. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Adverse event resulted in treatment with antibiotics. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected

Other Meds:

Current Illness:

ID: 1817522
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
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: Developed generalized pruritic uricaritc rash; Developed generalized pruritic uricaritc rash; This is a spontaneous report from a contactable consumer (patient). A male patient (Age: 80; Unit: unknown) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE , solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE; dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced developed generalized pruritic uricaritc rash on an unspecified date. The patient received two doses of vaccine. Developed generalized pruritic uricaritc rash and dermatologist put him on prednisone- relived the itching temporality. Once off prednisone the rash has returned. The patient has another dermatologist appointment today. The patient wanted to know if this side effects has been reported. Therapeutic measures were taken because of developed generalized pruritic uricaritc rash with prednisone. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1817523
Sex: M
Age:
State: TX

Vax Date: 03/29/2021
Onset Date: 04/02/2021
Rec V Date: 10/26/2021
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: I began experiencing pain in both hips (approximately a 6 on 10 point scale)/as well as both shoulders; Making it difficult to rise from a chair and sleep without knees elevated; This is a spontaneous report from a contactable consumer (patient). A 72-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 29Mar2021 09:30 (Batch/Lot Number: ER8733) (age at vaccination) as DOSE 2, SINGLE for covid-19 immunisation in hospital. Relevant medical history and concurrent conditions included high cholesterol, acute sleep apnea (using CPAP), Continuous positive airway pressure and allergies to Penicillin. Historical vaccine included BNT162B2 at 08Mar2021 10:00 AM as dose number 1 (Batch/Lot number: EN6206 and Anatomical Location: Arm Left) for covid-19 immunisation and experienced yellow bruise the size of a $.50 piece manifested at injection site (vaccination site bruising). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took minocin and bactrim and experienced drug hypersensitivity. The patient received other medications within 2 weeks of vaccination. On 02Apr2021, the patient experienced i began experiencing pain in both hips (approximately a 6 on 10-point scale)/as well as both shoulders and making it difficult to rise from a chair and sleep without knees elevated. The patient received the initial Pfizer COVID-19 vaccination, LOT #EN6206, on 08Mar2021 at 09:55 am. About three days later a yellow bruise the size of a withheld piece manifested at injection site in upper left arm. Disappeared within one week. No other manifestations. On 29Mar2021 at 09:30 am, I received the second COVID-19 vaccine LOT #ER8733 injection in upper left arm. Approximately 72 hours later I began experiencing pain in both hips (approximately a 6 on 10-point scale), making it difficult to rise from a chair and sleep without knees elevated, as well as both shoulders. Pain has reduced to Level 2-3 in hips, and Level 1 in shoulders. Pain has persisted thru this writing on 07Apr2021 at 2:30 pm. The patient did not received treatment for the events. The outcome of the event Mobility decreased was resolving whereas another event was not resolved. No follow up attempts needed. No further information expected.

Other Meds:

Current Illness:

ID: 1817524
Sex: M
Age:
State: NC

Vax Date: 04/06/2021
Onset Date: 04/06/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Headache; Chills; had a temperature; Weakness; body aches; Joint pain; feeling miserable; This is a spontaneous report from a contactable consumer. A 57-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm on 06Apr2021 (Batch/Lot Number: ER8733; Expiration Date: 31Jul2021) (age at vaccination 57 years) as 0.3 mg, single for covid-19 immunisation. Medical history included allergies and covid-19. Historical vaccine included BNT162B2 as first dose received on 15Mar2021 (lot EN6206, expiration date 30Jun2021). Concomitant medication included sinus pills for allergies. On 06Apr2021 20:00, the patient experienced headache, chills, had a temperature, weakness, body aches, joint pain and feeling miserable. The patient had covid before and he wanted to make sure he didn't get it anymore. The patient had the second dose of his vaccine yesterday 06Apr2021 and he has been feeling some side effects from the vaccination. Early in the day after the vaccine the patient was feeling fine. At 8:00 pm that night the patient had a headache, chills, a temperature, weakness in his body, joint pain, and feeling miserable. The patient wanted to know what he can take for these symptoms. The outcome of the events was resolving and feeling miserable was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1817525
Sex: M
Age:
State: IL

Vax Date: 03/31/2021
Onset Date: 03/31/2021
Rec V Date: 10/26/2021
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: less smell; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as Dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced less smell and taste after receiving the first dose of the COVID vaccine on 31Mar2021. The 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: 1817526
Sex: U
Age:
State:

Vax Date: 04/03/2021
Onset Date:
Rec V Date: 10/26/2021
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: Dizziness; Can hardly raise my arm where the shot was given; First dose which I received was Moderna and on April 3rd I received the Pfizer; Dosage was mixed; I got two different shots, I got, the first one was the Moderna and second one wat the Pfizer one; This is a spontaneous report received from a contactable consumer (patient reported for himself/herself). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), first dose via an unspecified route of administration on 03Apr2021 as dose 2 (initial Pfizer dose), single for COVID-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration from an unspecified date to an unspecified date, at dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced dizziness can hardly raise my arm where the shot was given, first dose which i received was moderna and on April 3rd i received the Pfizer; dosage was mixed; i got two different shots, i got, the first one was the moderna and second one wat the Pfizer one on an unspecified date. Consumer stated, "I am calling because Saturday I received the second dosage, the first dose which I received was March the 6th which was Moderna (further clarified hence captured as COVID shot). And Saturday on April 3rd I received the Pfizer (further clarified hence captured as COVID shot), not realizing that it was the Pfizer. So, I am calling about, I am having the side effects as in the dizziness and can hardly raise my arm where the shot was given. And I am concerned because the dosage was mixed, so I wanted to know, they did a report on place where they gave the shot, but I did not receive the report and I want to know if they had reported it to you or not.' Consumer stated, 'Yes, because the First shot it was the Moderna, so I got two different shots, I got, the first one was the Moderna and second one wat the Pfizer one. So, I want to know, I just got off the phone with my primary care doctor and they said to go to emergency room, but I wanted to know what other side effects will happen to me taking the first dose of each one and do I need to take the second dose of the Moderna or the second dose of the Pfizer". The outcome of the events was reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1817527
Sex: U
Age:
State:

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

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

Lab Data: Test Name: fever; Result Unstructured Data: Test Result:101+ Fahrenheit

Allergies:

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

Symptoms: headaches; nausea; fever; This is a spontaneous report from contactable consumer (patient) via Pfizer Sales Representative. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (Lot number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. On an unspecified date, post COVID 19 vaccine dose 2, the patient experienced headaches, nausea, fever (101 degrees F+). It was reported that event took place after use of product. The patient underwent lab tests and procedures which included fever: 101+ Fahrenheit on an unspecified date. The outcome of events was unknown. No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1817528
Sex: U
Age:
State:

Vax Date: 03/11/2021
Onset Date:
Rec V Date: 10/26/2021
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: an allergic reaction it was not a severe; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, on 11Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had an allergic reaction it was not a severe but when the patient returned on 01Apr2021 to get the second vaccine, the patient was told that could not receive it as the patient had a reaction to the first vaccine. The patient explained to them that it was not severe, they said that did not matter and the patient need to take the second vaccine in a hospital setting so they would not give second vaccine. They referred this to doctor's office, the patient's doctor's office did agree, they said it probably good to administer it in hospital setting, however they referred the patient to the local health department. The patient contacted the health department they said we won't approve that you need to be in a hospital setting so now I am here back and forth. The patient asked that do I really need to a hospital to have the second vaccine done, I am running out of time right now. 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: 1817529
Sex: M
Age:
State: NC

Vax Date: 04/06/2021
Onset Date: 04/06/2021
Rec V Date: 10/26/2021
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: It made me drowsy; I itch all over; itchy; This is a spontaneous report from a contactable consumer or other non hcp (Patient).A 45-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7533, Expiration date: not reported) via an unspecified route of administration on 06Apr2021 (at the age of 45-years-old) as dose 1, single for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included naproxen sodium (NAPROXEN SODIUM) taken 220 mg twice a day. On 06Apr2021, patient experienced i itch all over, on an unspecified date, it made me drowsy. Patient did not receive any treatment. It was reported that second shot of vaccine was scheduled on 27Apr2021. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: NAPROXEN SODIUM

Current Illness:

ID: 1817530
Sex: M
Age:
State: NC

Vax Date: 02/26/2021
Onset Date:
Rec V Date: 10/26/2021
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: after I got the Second injection the first injection was in the first of the month last month and the last injection was on the 26th and I got injected in the opposite arm and that broke up in rash; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EN6202), via an unspecified route of administration, administered in Arm Right on 26Feb2021 (at the age of 77-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included metoprolol (METOPROLOL) one tablet a day, 50mg, orally taken for hypertension from (for 5 years) an unspecified start date and ongoing; amlodipine (AMLODIPINE) 2.5mg, one tablet a day, orally taken for hypertension, start and stop date were not reported. On an unspecified date the patient experienced after i got the second injection the first injection was in the first of the month last month and the last injection was on the 26th and i got injected in the opposite arm and that broke up in rash. The outcome of event unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: METOPROLOL; AMLODIPINE

Current Illness:

ID: 1817531
Sex: U
Age:
State: IL

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: I had a kind of an allergic reaction to it; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were 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. On an unspecified date, the patient had a kind of an allergic reaction to it. Outcome of the event was unknown. No follow-up attempts are needed. Information about Lot/Batch number cannot be requested.

Other Meds:

Current Illness:

ID: 1817532
Sex: U
Age:
State:

Vax Date: 03/30/2021
Onset Date: 04/02/2021
Rec V Date: 10/26/2021
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: Lot of swelling; Large red patch; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 30Mar2021 (Lot Number: EP7534, expiry date: unknown) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 02Apr2021, the patient experienced lot of swelling and large red patch. Patient Stated had the Pfizer vaccine first dose last week and still having the side effects that was not noted on your, any of your material. It's related to a lot of swelling and large red patch after three days of vaccine which apparently is sometimes seen with the Moderna vaccine. But was just trying to find if there is anything need to do and if it's okay for me to still have my second shot in which due date is 20Apr2020. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1817533
Sex: F
Age:
State: MA

Vax Date: 03/03/2021
Onset Date: 03/04/2021
Rec V Date: 10/26/2021
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: headaches/sometimes the pain feels intense; feel like a squeezing sensation; neck muscles also sometimes feel very stiff; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EN6205) via an unspecified route of administration, administered in Arm Left on 03Mar2021 13:00 (at the age of 76-years-old) as DOSE 2, SINGLE for covid-19 immunization. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EL9262) via an unspecified route of administration, administered in arm left on 10Feb2021 at 2PM as DOSE 1, SINGLE for covid-19 immunization. No vaccine was administered within 4 weeks. The patient's medical history included left elbow surgery after traumatic fall in May2018 from an unknown date, physical therapy for neck stiffness from an unknown date and unknown if ongoing, skin allergy to nickel and allergic to ceclor from an unknown date and unknown if ongoing and covid was tested prior vaccination on an unknown date and covid was not tested post vaccination. Concomitant medications included levothyroxine, atorvastatin, hydrochlorothiazide taken for an unspecified indication, start and stop date were not reported. On 04Mar2021 at 03:00 AM the patient reported that for the past six weeks after her second vaccine, she was experiencing daily headaches (which began 12-24 hours after her vaccine) on both the top and back of her head, varying in intensity and duration. She feels like a squeezing sensation, sometimes the pain feels intense. Neither Tylenol nor Ibuprofen really help. Her neck muscles also sometimes feel very stiff when the headache is coming on. No treatment was received for the events. The outcome of the events was reported as not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: LEVOTHYROXINE; ATORVASTATIN; HYDROCHLOROTHIAZIDE.

Current Illness:

ID: 1817534
Sex: M
Age:
State: MA

Vax Date: 03/29/2021
Onset Date: 03/29/2021
Rec V Date: 10/26/2021
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: Strange Anxiety; problem is that the anxiety is feeling since I have diagnosed is different since I took vaccination; felt like it's making me sicker; This is a spontaneous report from a contactable consumer (patient). A 70-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: ER8732, expiry date: unknown) via an unspecified route of administration, administered in deltoid left on 29Mar2021 (70-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation and the patient also received atenolol via an unspecified route of administration at dose of 25 mg a day, atorvastatin via an unspecified route of administration at dose of 40 mg a day; clonazepam via an unspecified route of administration at dose of 3 or 4 mg a day; sertraline via an unspecified route of administration at dose of 150 mg a day; retigabine 500 mg a day; for all unknown indications from unknown dates and ongoing. Medical history included hypertension from an unknown date and unknown if ongoing, hypocholesterolaemia from an unknown date and unknown if ongoing, sciatica from an unknown date and unknown if ongoing, ongoing severe anxiety disorder from an unknown date. All medical history was chronic and it was really not being treated. Concomitant medication was not reported. On 29Mar2021, the patient experienced strange anxiety; problem was that the anxiety was feeling since she had diagnosed was different since she took vaccination and felt like it was making sicker. The patient started strange anxiety that was the day he got the vaccine that was on 29Mar2021. He had anxiety before he received her first inoculation of the COVID-19 but again since he received it his anxiety was different and it was noticeably different and it was little difficult to explain it how. He tried but the main effect was different. It did not go up and down, it was just a state of flat one, but it was still there. The patient stated that he got first Pfizer injection and was due for the second one and he believed on 21Apr2021. The patient just wanted to report the side effects, that was the strange side effects which was involved with other medicine which he was on and he took two medicine or 3 medical psychiatric medications and he found that and he had superior anxiety disorder and the patient found that what seemed to be happening and he did not think it was his imagination, was that anxiety has taken different forms since he was inoculated and when he said that he meant was that it did not mean anxiety. The patient just labile the anxiety did not go up and down which was why the anxiety was a state of flat mind, plane but was still anxiety and it was not changing and the other times it just felt different. The patient did not know how to explain it that the problem was that the anxiety was feeling since he have diagnosed was different since he took vaccination. It was really difficult to explain that was why that was what the problem, that was why he was calling because it did not have definite effect on his anxiety. The patient guessed it was safe to say but it made it different but still problematic but that was his story basically he thought he did not know if you heard about that. The patient just wanted to report that. The patient stated that actually he sees psychiatrist for psychotherapy purposes and for other conditions basically taking medications for hypertension, hypercholesterolemia, that was chronic and it was really not being treated. The patient had not gone through any Laboratory tests. The patient stated that he received no treatment, not beyond that which he normally just taken. The patient stated that actually he went psychiatrist for psychotherapy purposes and for other conditions basically taking medications for hypertension, hypercholesterolemia, that was chronic and it was really not being treated. The name for the medications was atenolol, atorvastatin, calcium and then he had clonazepam, Sertraline, Retigabine. Action taken of all co suspect was unknown. The outcome of the event strange anxiety; problem was that the anxiety was feeling since she had diagnosed was different since she took vaccination was not recovered and felt like it was making me sicker was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness: Anxiety disorder (Still anxiety & it is not changing.)

ID: 1817535
Sex: F
Age:
State: NY

Vax Date: 03/07/2021
Onset Date: 03/08/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: She states she did take something before the last one, and it's usually a combination of Tylenol and Naproxen; Malaise; This is a spontaneous report from a contactable consumer or other non-HCP (patient himself). A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6206, Expiry Date: Unknown) via an unspecified route of administration on 07Mar2021 at 15:49 (at the age of 48 years-old) as dose 1, single for COVID-19 immunization, naproxen (NAPROXEN, batch/lot number: Unknown) via unspecified route of administration on an unspecified start and stop date and dose were not reported taken for an unspecified indication and paracetamol (TYLENOL, batch/lot number: Unknown) via unspecified route of administration on an unspecified start and stop date, and dose were not reported and taken for an unspecified indication. Patient medical history and concurrent conditions included depression, headaches, nausea, ongoing systemic lupus erythematosus (Verbatim: lupus), She states she had a reaction (hypersensitivity) to contrast dye, throat closed. The concomitant medications included hydroxychloroquine (HYDROXYCHLOROQUINE) taken for systemic lupus erythematosus started taking it from 3.5 years ago and ongoing, colecalciferol (VITAMIN D 3) taken as a dose of 50000 units once a week for an unspecified indication, start and stop date were not reported. The patient previously took flu and experienced hypersensitivity, and she had a reaction to the flu shot, got depressed and not feeling well. No additional vaccines administered on same date of the pfizer suspect and vaccine was not administered at military facility. No prior vaccinations (within 4 weeks) and adverse events following prior vaccinations. Patient medical history (including any illness at time of vaccination) reported as no. No family medical history relevant to adverse events. The patient experienced malaise on 08Mar2021 and she states she did take something before the last one, and it's usually a combination of tylenol and naproxen on an unspecified date. The duration of the malaise was reported as 5 days. Additional Information for Concomitant Products Vitamin D and she states her vitamin D last lab was insanely off the charts, and she suffers from depression. She states she was diagnosed a few years ago, well the titer showed up in her blood 5 years ago, but she didn't have enough elements for a diagnosis. She stated that the doctor is an idiot. She says it's slow, so they state you have a connective tissue disease. She had a rash, then her hand started to be paralyzed. They were fish-netting to figure out what it was. She is with a new rheumatologist, and they said lupus, no way diseases evolve, the more they can step back and look at them the better. It was reported that She was scheduled to get part two of the vaccine she states that at the beginning of March she got sick, and it had nothing to do with the vaccine. She states she is supposed to go today to get the vaccine, but her doctor said she needs to hold off. States she has been having really bad migraines and nausea. Adds it has nothing to do with COVID it is just my cycle that happens in my body. Adds it is hard for her to exist without taking Naproxen and Tylenol. She is asking what's the real harm; she states that she won't take anything before if my trade-off is getting there. She states that she has been hearing conflicting things, oh it's totally fine to take medication before the vaccine and then reading online, no you shouldn't do it. She states that because of her Lupus she was afraid it would knock her off her terrain. No events result in emergency and physician office visit. No investigation assessment and relevant tests are performed. The action taken in response to the events for naproxen was unknown, for paracetamol was unknown. Therapeutic measures were taken as a result of malaise. The clinical outcome of the event malaise recovered on 13Mar2021 No follow-up attempts are possible. No further information is expected.

Other Meds: HYDROXYCHLOROQUINE; VITAMIN D 3.

Current Illness: Lupus syndrome (Verbatim: lupus.)

ID: 1817536
Sex: F
Age:
State: OH

Vax Date: 04/23/2021
Onset Date:
Rec V Date: 10/26/2021
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: Killer headaches; Dizziness; Nausea; Has been experiencing "killer" headaches. She states that this morning it is "really bad"; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 50-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot Number: EW0162) via an unspecified route of administration, administered in right arm on 23Apr2021 morning at 9:30 (at the age of 50-years-old) as dose 1, single dose for covid-19 immunization. The patient medical history included high blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported but patient stated took small dose of medication for high blood pressure. On an unspecified date, the patient experienced killer headaches, this morning it is really bad and stated that she is also having dizziness and nausea. Patient received the first dose yesterday but she is experiencing a severe headache. She already took Ibuprofen orally one last night and one this morning, took one 800 mg tablet it's the prescription that she had last year for something else but it helped little but today it got worse. Patient concerned that she had a headache yesterday and this morning it's getting worse, and she took Ibuprofen last night but today it's not helping. She would like to know if it is safe to take Excedrin to treat her symptoms, as she is worried about a potential interaction between it and the vaccine. Response received as there is no information regarding a potential interaction between the vaccine and Excedrin. Spoke from the attached document to let caller know about CDCs considerations that medications used to reduce pain can be taken after vaccination to treat symptoms, but let caller know that it does not specify Excedrin. Referred caller to HCP for further guidance. Unaddressed medical questions referred or forwarded to medical Information. Therapeutic measures were taken as a result of all the events. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1817537
Sex: F
Age:
State:

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

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

Lab Data: Test Name: Cholesterol; Result Unstructured Data: Test Result:Normal; Test Name: sedimentation rate; Result Unstructured Data: Test Result:High; Test Name: x ray; Result Unstructured Data: Test Result:No details

Allergies:

Symptom List: Nausea

Symptoms: having hand pain; sedimentation rate is high; knees being bad; Product use error; This is a spontaneous report from a Specialty Pharmacy reported on behalf of a 55-years-old female (patient) reported that: A 55-Year-old female patient of an age received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration (at the age of 56-year-old) on an unspecified date at for COVID-19 immunisation; tofacitinib citrate (XELJANZ XR), at 11 mg, orally, daily from an unspecified date (Batch/Lot number was not reported) to an unspecified date for rheumatoid arthritis. Medical history included overweight from an unknown date and unknown if ongoing. The patient reported that her cholesterol levels are normal. The patient's concomitant medications were not reported. The patient experienced having hand pain, sedimentation rate is high and knees being bad. The Patient reported that she had been off of xeljanz for over a month due to taking the COVID vaccine Pfizer and being on antibiotics (previously reported adverse event 20Jan2021). The patient reported having hand pain while off of xeljanz, but was not in complete pain (patient did not clarify complete pain). The patient reported that the sedimentation rate is high, knees being bad (patient did not clarify knees being bad), and took knees x-ray. No exact dates or further details were reported. The patient re started the xeljanz on 21Apr2021. The patient reported before xeljanz being upset and cried, was in too much pain, had to take prednisone. The action taken in response to the events for tofacitinib citrate was unknown. No follow-up attempts are needed. Information of lot/batch number can not be obtained.

Other Meds:

Current Illness:

ID: 1817538
Sex: M
Age:
State: FL

Vax Date: 04/11/2021
Onset Date: 04/27/2021
Rec V Date: 10/26/2021
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: has a dental problem and he thinks it was after his 1st dose/root canal; This is a spontaneous report received from a contactable consumer (Patient) or other non-HCP. A 70-year-old male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was ER8735) via an unspecified route of administration on 11Apr2021 12:00 administered in left arm as a DOSE 1, SINGLE dose for COVID-19 immunization. Co-suspect AMOXICILLIN 3 tablets a day, each tablet was 500 mg from 20Apr2021, taken for infection. Medical history and concomitant medications was not reported. The patient had no relevant family history related to adverse events. included. The caller stated that he was taking amoxicillin till his second dose 04May2021. No Additional Vaccines were Administered (on same date as Pfizer vaccine considered as suspect). The patient had no Prior Vaccination within 4 weeks. On 27Apr2021, the patient experienced has a dental problem and he thinks it was after his 1st dose/root canal. Additional Information included the caller said that he actually had a question regarding the COVID-19 vaccine. He was taking antibiotics right now because of a dental surgery and he had his 1st dose on 11Apr2021 and his 2nd dose appointment is 02MAR2021 and he will be taking antibiotics for this whole week so he is just wondering if this will affect the vaccination. He clarified antibiotic he was taking to amoxicillin. He had a dental problem and he thought it was after his 1st dose. He had one surgery right after the 1st dose but now he needs to have a second dental surgery. The surgery he has had and was having was a root canal. Again, actually he already had the root canal but it was not working very well so he needs to revisit to the clinic to fill it again because he had some infection going on so they did the root canal but they did not complete it. caller says he does not have those to provide since it is in an orange pharmacy bottle. He started taking the amoxicillin on 20Apr2021 and will take until 04May2021. The investigation assessment was not provided. No relevant tests were done. The clinical outcome of event was unknown. No follow-up attempts are needed; No further information is expected.

Other Meds:

Current Illness:

ID: 1817539
Sex: F
Age: 68
State: NE

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

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

Lab Data:

Allergies: Coke soda pop.

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

Symptoms: Was asleep and was awakened by severe dizziness and nausea. Went to bathroom and had numerous sessions of vomiting along with dizziness so bad I couldn?t keep my eyes open and could not sit down or walk. The vomiting was so severe in nature it caused blood vessels to break under the skin of my face.

Other Meds: Generic Tylenol PM.

Current Illness: None.

ID: 1817540
Sex: F
Age: 25
State: PA

Vax Date: 10/25/2021
Onset Date: 10/25/2021
Rec V Date: 10/26/2021
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: none

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

Symptoms: fever, chills, joint pain, injection site swelling

Other Meds: birth control spranolactone

Current Illness: none

ID: 1817541
Sex: F
Age: 33
State:

Vax Date: 10/24/2021
Onset Date: 10/25/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Lymph node pain under arm

Other Meds:

Current Illness:

ID: 1817542
Sex: F
Age: 45
State: MO

Vax Date: 08/06/2021
Onset Date: 08/07/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: None

Allergies: None

Symptom List: Erythema, Pruritus

Symptoms: Swelling occurred particularly in my extremities but very bad I?m my legs. Dissipated after about two weeks. Was several pounds of water gain I believe. Also had a headache that was pretty intense a couple of days.

Other Meds: Levothyroxine, Bupropion

Current Illness: None

ID: 1817543
Sex: F
Age: 37
State: VA

Vax Date: 10/25/2021
Onset Date: 10/25/2021
Rec V Date: 10/26/2021
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: Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium

Other Meds:

Current Illness:

ID: 1817544
Sex: F
Age: 25
State: NJ

Vax Date: 10/16/2021
Onset Date: 10/16/2021
Rec V Date: 10/26/2021
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: Error: Improper Storage (temperature)-

Other Meds:

Current Illness:

ID: 1817545
Sex: M
Age: 28
State: NJ

Vax Date: 10/16/2021
Onset Date: 10/16/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Error: Improper Storage (temperature)-

Other Meds:

Current Illness:

ID: 1817546
Sex: F
Age: 33
State: NJ

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

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

Lab Data:

Allergies: Penicillin (rash), bee stings (local swelling), flu shot (local swelling)

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

Symptoms: Moderna COVID-19 Vaccine EUA administered. Observed at facility for 30mins, with nly soreness at injection site present. Itchiness, Urticaria, tachycardia, and shortness of breath/wheezing developed approximately 45min-1hr after administration of vaccination and slowly got progressively worse. Minimal relief of symptoms after taking 50mg liquid Benedryl PO and prescribed rescue Albuterol Inhaler. Epi pen administered and symptoms improved, other than minor itching. Medical evaluation obtained at urgent care center for anaphylactic reaction.

Other Meds:

Current Illness: None

ID: 1817547
Sex: F
Age: 66
State: NJ

Vax Date: 10/16/2021
Onset Date: 10/16/2021
Rec V Date: 10/26/2021
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: Error: Improper Storage (temperature)-

Other Meds:

Current Illness:

ID: 1817548
Sex: F
Age: 76
State: TX

Vax Date: 10/08/2021
Onset Date: 10/20/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Flushed / Sweating-Severe

Other Meds:

Current Illness:

ID: 1817549
Sex: F
Age:
State: TX

Vax Date: 03/07/2021
Onset Date: 03/22/2021
Rec V Date: 10/26/2021
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: And this month I start to spotting couple of days and now stopped again; I suppose to have period on march 20th after first shot. After my first and 2nd shot, I totally missed my period.; This is a spontaneous report from a contactable consumer, the patient. A 44-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 on 07Mar2021 at 10:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation and 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 28Mar2021 at 10:00 (at the age of 44-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 medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 22Mar2021, the patient reported that she was suppose to have period on March 20th. After her first and 2nd shot, she totally missed her period and on an unknown date in Apr2021, she start to spotting couple of days and now stopped again. 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 event suppose to have period on march 20th, after her first and 2nd shot, she totally missed her period and she start to spotting couple of days and now stopped again was not resolved at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1817550
Sex: F
Age:
State: AL

Vax Date: 04/05/2021
Onset Date: 04/05/2021
Rec V Date: 10/26/2021
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: 202104; Test Name: Pregnancy Test; Test Result: Negative.

Allergies:

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

Symptoms: Patient not had a menstrual period since receiving the first dose of the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 30-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 left arm on 05Apr2021, at 10:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity and hypertension. Patient had no known allergies. 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. Concomitant medication taken within two weeks of vaccination was not reported. On 05Apr2021, the patient did not have a menstrual period since receiving the first dose of the vaccine and patient feel perfectly fine with no other side effects. In Apr2021, over the last 3 weeks (as reported), the patient underwent pregnancy tests and the result was negative. Therapeutic measures were not taken as a result of the event. The events did not result in doctor 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 patient not had a menstrual period since receiving the first dose of the vaccine was not resolved at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1817551
Sex: F
Age:
State: IN

Vax Date: 04/20/2021
Onset Date: 04/20/2021
Rec V Date: 10/26/2021
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: Was extremely dizzy immediately after in first 10 minutes; Headache; Bad fatigue lasted a week; Bruised at injection site; Had some itching on back and base of skull; This is a spontaneous report from a contactable consumer, the patient. A 50-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 left arm on 20Apr2021 at 12:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included PIDDS (primary immune deficiency syndrome), allergy to oranges (fruit allergy), allergy to milk and a lot of environmental allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. Concomitant medications included clonazepam (MANUFACTURER UNKNOWN); for unknown indication from unknown date and unknown if ongoing. On 20Apr2021 at 12:15, immediately after in first 10 minutes the patient was extremely dizzy, had headache, bad fatigue that lasted a week. The patient experienced bruise at injection site, had some itching on back and base of skull. 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 extremely dizzy, headache and bad fatigue lasted a week were recovered on an unknown date in Apr2021; while that of the events bruised at injection site, some itching on back and base of skull were recovering at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: CLONAZEPAM.

Current Illness:

ID: 1817552
Sex: F
Age:
State: CA

Vax Date: 04/28/2021
Onset Date: 04/30/2021
Rec V Date: 10/26/2021
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: Heavy menstrual bleeding despite that previous period ended just a week before; Heavy menstrual bleeding despite that previous period ended just a week before; Fatigue; Pain in left arm; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 28Apr2021 at 12:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. It was unknown if the patient was pregnant at vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within 4 weeks prior to the vaccination. Concomitant medications included unspecified vitamins, taken for an unknown indication from an unknown date and unknown if ongoing. On 30Apr2021 at 16:00, the patient experienced heavy menstrual bleeding despite that previous period ended just a week before, fatigue and pain in left arm. The events did not result in a visit to the doctors or other healthcare professional office/clinic, 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 heavy menstrual bleeding despite that previous period ended just a week before, fatigue and pain in left arm was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1817553
Sex: M
Age:
State: FL

Vax Date: 04/30/2021
Onset Date: 04/30/2021
Rec V Date: 10/26/2021
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: 20210430; Test Name: Blood pressure; Result Unstructured Data: Test Result:114/68; Test Date: 20210430; Test Name: Heart rate; Result Unstructured Data: Test Result:125; Comments: Heart rates staying between 93 and 117 bpm

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Heart rate was 125; Feeling fatigue; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Apr2021 at 15:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. 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-19 vaccine. Concomitant medications included amoxicillin (MANUFACTURER UNKNOWN) and doxycycline (MANUFACTURER UNKNOWN); both for unknown indications from unknown dates 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 on an unknown date (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 30Apr2021 at 15:15, after injection, the patient's heart rate was 125 (unit unspecified) and blood pressure was 114/68 (unit unspecified). The patient's heart rates were staying between 93 and117 bpm. The patient was also feeling fatigue. The patient was very healthy before second shot. It was reported that no health issues. 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 heart rate was 125 and feeling fatigue was not resolved at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: AMOXICILLIN; DOXYCYCLINE.

Current Illness:

ID: 1817554
Sex: F
Age:
State: MT

Vax Date: 04/30/2021
Onset Date: 04/30/2021
Rec V Date: 10/26/2021
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: I have had a headache; my joint are killing me; numbness occurred right away in my arms and hands; Very lethargic; weak; Starting at 11pm I have had severe diarrhea and vomiting; Starting at 11pm I have had severe diarrhea and vomiting that hasnt stopped; This is a spontaneous report from a contactable consumer, the patient. A 48-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 left arm on 30Apr2021 at 11:45 (at the age of 48-year-old), as a single dose for COVID-19 immunisation. Medical history included known allergies to latex and abs whole wheat. 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 included sertraline (MANUFACTURER UNKNOWN) and estradiol (MANUFACTURER UNKNOWN); both for unspecified indication from unknown date and unknown if ongoing. On 30Apr2021 at 23:00, the patient experienced severe diarrhea and vomiting that had not stopped. On same day at 23:45, the patient experienced headache and patient's joints were killing her, numbness occurred right away in her arms and hands, felt very lethargic and weak. 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 severe diarrhea and vomiting that had not stopped, headache, joints were killing her, numbness occurred right away in her arms and hands, very lethargic and weak was not resolved at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: SERTRALINE; ESTRADIOL.

Current Illness:

ID: 1817555
Sex: M
Age:
State: MN

Vax Date: 04/28/2021
Onset Date: 04/29/2021
Rec V Date: 10/26/2021
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: Dehydration; incredibly irritating dryness, dry mouth; incredibly irritating dryness, dry mouth, dry skin; Bloody nose; Gastrointestinal issues; Stomach pains; Difficulty breathing; Congestion; Muscle pains/ Sore muscles; Feet pain; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient 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 28Apr2021 at 15:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The medical history included aspergers syndrome(ASD), attention-deficit hyperactivity disorder (ADHD), depression and anxiety. It was unknown whether the patient had any allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The concomitant medications included citalopram (MANUFACTURER UNKNOWN), lisdexamfetamine (MANUFACTURER UNKNOWN) and bupropion (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates and unknown if on going. On 29Apr2021, the patient experienced dehydration, incredibly irritating dryness, dry mouth, dry skin, bloody nose, gastrointestinal issues, stomach pains, difficulty breathing, congestion, muscle pains, sore muscles and feet pain. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dehydration, incredibly irritating dryness, dry mouth, dry skin, bloody nose, gastrointestinal issues, stomach pains, difficulty breathing, congestion, muscle pains, sore muscles and feet pain were not resolved at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: CITALOPRAM; LISDEXAMFETAMINE; BUPROPION

Current Illness:

ID: 1817556
Sex: F
Age:
State: NY

Vax Date: 04/11/2021
Onset Date: 04/13/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: Test Date: 20210413; Test Name: Blood sugar; Result Unstructured Data: Test Result:high blood sugar/insulin resistance; Comments: at 12:00; Test Date: 20210425; Test Name: Nasal Swab; Test Result: Negative.

Allergies:

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

Symptoms: Swollen glands below the jaw; Extreme sensitivity of the teeth in the back or the mouth on top and bottom of both sides; Severe acne on lower half of the face; High blood sugar/insulin resistance; High blood sugar/insulin resistance; painful soreness in the throat on the upper right side; This is a spontaneous report from a contactable consumer, the patient. A 48-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 left arm on 11Apr2021 at 12:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes and celiac disease. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included insulin lispro (HUMALOG), pramlintide acetate (SYMLIN), bupropion (MANUFACTURER UNKNOWN) and escitalopram (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 12:00, the patient experienced swollen glands below the jaw, extreme sensitivity of the teeth in the back or the mouth on top and bottom of both sides, severe acne on lower half of the face, high blood sugar and insulin resistance, painful soreness in the throat on the upper right side. 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 events. Since the vaccination, the patient had been tested for COVID-19. On 25Apr2021, the patient underwent test for COVID-19 via nasal swab and the result was negative. The clinical outcome of the events swollen glands below the jaw, extreme sensitivity of the teeth in the back or the mouth on top and bottom of both sides, severe acne on lower half of the face, high blood sugar and insulin resistance, painful soreness in the throat on the upper right side was resolving at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: HUMALOG; SYMLIN; BUPROPION; ESCITALOPRAM.

Current Illness:

ID: 1817557
Sex: F
Age:
State: TN

Vax Date: 04/24/2021
Onset Date: 04/28/2021
Rec V Date: 10/26/2021
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: My right arm pit area is throbbing/ It even goes into my back & under my arm a little too.; My right arm pit area is throbbing. Its like my lymph nodes are being applied pressure to them; My right arm pit area is throbbing/ It even goes into my back & under my arm a little too.; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the right arm on 24Apr2021 at 10:00 (at the age of 45-year-old), as a single dose for COVID-19 immunisation. Medical history included lyme disease. The patient had no known allergies. 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-19 vaccine. Concomitant medications included estradiol (MANUFACTURER UNKNOWN) and montelukast sodium (SINGULAIR); both for unknown indication from an unknown date and unknown if ongoing. On 28Apr2021, the patient's arm pit area was throbbing and felt like lymph nodes were being applied pressure to them. It even went into the back and under arm a little too. 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 arm pit area is throbbing, lymph nodes were being applied pressure to them, even went into back and under arm a little too was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: ESTRADIOL; SINGULAIR

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am