VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1767618
Sex: F
Age:
State: MI

Vax Date: 03/03/2021
Onset Date: 09/24/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Date: 20210924; Test Name: PCR; Test Result: Positive ; Comments: Nasal Swab

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: I tested positive for COVID; I tested positive for COVID; This is a spontaneous report from a contactable consumer (patient). A 50-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL3248) intramuscular, administered in Arm Right on 03Mar2021 12:45 (at the age of 50-years-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No known allergies. No other vaccine in four weeks. No other medications in two weeks. No COVID prior to the vaccination. On 24Sep2021 18:30, the patient tested positive for COVID. The patient underwent lab tests and procedures which included SARS-CoV-2 test nasal swab on 24Sep2021 which was positive. No treatment was received for the adverse events. The outcome of the event was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1767619
Sex: M
Age:
State:

Vax Date: 04/01/2021
Onset Date: 04/02/2021
Rec V Date: 10/07/2021
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: Spondylitis ankylosing aggravated; Tendonitis; Tendon thickening; Fatigue; This is a solicited report from a contactable consumer (patient) based on information received by Pfizer from Facilitating Company (manufacturer control number: 21K-163-4080256-00). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number was not reported), via an unspecified route of administration on 01Apr2021 (at the age of 53-years-old) as dose 1, single for COVID-19 immunization; and adalimumab (HUMIRA; solution for injection in pre-filled pen), subcutaneously from an unspecified date (lot number was not reported) and ongoing at unspecified dose and frequency for ankylosing spondylitis. Medical history included spinal nerve stimulator implantation from Feb2021 and ongoing ankylosing spondylitis. The patient's concomitant medications were not reported. On 02Apr2021 (1 day after vaccination), the patient experienced fatigue. On an unspecified date, the patient experienced spondylitis ankylosing aggravated, tendonitis, and tendon thickening. The action taken in response to the events for adalimumab was dose not changed. The outcome of event fatigue was unknown while the outcome of the remaining events was not recovered. The reporter's causality for adalimumab with the events spondylitis ankylosing aggravated, tendonitis, and tendon thickening was reasonable possibility, while for fatigue it was no reasonable possibility. The reporter's assessment of the causal relationship of the events with the suspect product, BNT162B2, was not provided at the time of the report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

Other Meds:

Current Illness: Ankylosing spondylitis

ID: 1767620
Sex: F
Age:
State: GA

Vax Date: 09/30/2021
Onset Date: 09/30/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Temperature; Result Unstructured Data: Test Result:103; Test Date: 2021; Test Name: Temperature; Result Unstructured Data: Test Result:105

Allergies:

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

Symptoms: My wife just had the third booster shot; My wife just had the third booster shot; She has temperature of 103 may be a temperature of 105 under her armpit; Chills; Nausea; her growing hurt back pain; Leg pain; Injection site where they injected her it feels hot, she said the fire; This is a spontaneous report from a contactable consumer (patients husband). A 53-year-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8731) via an unspecified route of administration on 30Sep2021 11:00 (at the age of 53years) as dose 3 (BOOSTER), single for COVID-19 immunization. Medical history included Diabetes, High Blood pressure, she has high blood pressure and Diabetic and Cholesterol. Concomitant medications included Lisinopril taken for Blood pressure, Metformin taken for Diabetes, Atorvastatin taken for blood cholesterol. Previously patient received first dose and second dose bnt162b2 (PFIZER-BIONTECH COVID-19, Solution for injection,), dose 1, dose 2 unspecified route of administration on unspecified date as single dose for COVID-19 immunization. On unspecified date 2021 the patient experienced she has temperature of 103 may be a temperature of 105 under her armpit, chills, nausea, her growing hurt back pain, leg pain, injection site where they injected her it feels hot, she said the fire. On 30Sep2021 my wife just had the third booster shot. Reporter stated, my wife just had the third booster shot and she is experiencing chills, nausea, she has temperature of 103 may be a temperature of 105 under her armpit, her growing hurt back pain, leg pain injection site where they injected her it feels hot, she said the fire. Patient received treatment of Tylenol Dosage: 6 tablet 500 mg once a day. The patient underwent lab tests and procedures which included body temperature: 103 body temperature: 105 in 2021. The outcome of the events was unknown.

Other Meds: LISINOPRIL; METFORMIN; ATORVASTATIN.

Current Illness:

ID: 1767621
Sex: F
Age:
State: IA

Vax Date: 09/07/2021
Onset Date: 09/08/2021
Rec V Date: 10/07/2021
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: heavy chest pain; headache; inhabilities to barely walk; Very sore; Not able to function mentally; This is a spontaneous report received from a contactable consumer (patient). This is the second of two reports with events experienced under the second dose. A 60-year-old female patient received second dose of bnt162b2 (BNT162B2), intramuscular, administered in Arm Left on 07Sep2021 16:00 (Lot Number: EW0191) as single dose for covid-19 immunisation. Medical history included blood clot in pelvis from 26Jan2015 and ongoing needing 5 stent surgery (Pertinent details: Taking warfarin blood thinners), covid-19 from Jan2021 to an unknown date (also had needed antibodies, 1 hour long infusion of Bamlavinivimad). Vaccination Facility Site: Pharmacy or Drug Store. Prior vaccinations were reported as no. Concomitant medications included warfarine (WARFARINE) taken for blood clots in pelvis, and blood thinners. First dose of bnt162b2 (BNT162B2) was administered on 18Aug2021 at 10:00 AM intramuscular in Upper left arm, Lot: EW0181, for COVID-19 immunisation and patient from 19Aug2021 to 20Aug2021 experienced walking difficulty, very sore, headache, not able to function mentally, muscle pain, pain in hip, severe leg pain and lower back pain. On 08Sep2021 patient experienced heavy chest pain, inhabilities to barely walk, very sore, headache, not able to function mentally. Events considered serious due to Persistent/significant disability/Incapacity. No treatment received for the events. Patient stated that both shots of vaccine resulted in total body inabilities to barely walk, very sore, headache, not able to function mentally, second shot has same but also included severe chest pain. Patient almost went to hospital, she had covid in Jan2021 and also has needed to antibodies 1 (hr) hour long infusion of Bamlavinivimad(?). On 09Sep2021 patient recovered from the events. No follow-up attempts are needed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075436 Same reporter, patient and product / different events and dose

Other Meds: WARFARINE

Current Illness: Clot blood (Needing 5 stent surgery Pertinent details: Taking warfarin blood thinners)

Date Died: 09/04/2021

ID: 1767622
Sex: F
Age:
State: TN

Vax Date: 08/05/2021
Onset Date:
Rec V Date: 10/07/2021
Hospital: Y

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

Lab Data: Test Name: covid test; Result Unstructured Data: Test Result:Unknown results; Comments: Postvaccination

Allergies:

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

Symptoms: covid pneumonia; covid pneumonia; covid pneumonia; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1, via an unspecified route of administration, on 05Aug2021 (age at vaccination of 54 years; Batch/Lot Number: FC3180) as single dose for COVID-19 immunization. Medical history included was diabetic and had obesity. The patient's concomitant medications were not reported. It was unknown if patient had received any other vaccine in four weeks. Patient had no COVID prior to vaccination. She developed COVID pneumonia on unspecified date in 2021. COVID was tested post vaccination on unspecified date with unspecified results. COVID pneumonia resulted in hospitalization and patient died. Patient was hospitalized for 5 days and passed away 04Sep2021. No autopsy was performed and cause of death was provided as COVID pneumonia.; Reported Cause(s) of Death: covid pneumonia; covid pneumonia; covid pneumonia

Other Meds:

Current Illness:

ID: 1767623
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: neurological issues and one a blood clot; neurological issues and one a blood clot; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received BNT162B2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated I know two patients of mine that reported neurological issues and one a blood clot on an unspecified date. Outcome of the event was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1767624
Sex: M
Age:
State: CA

Vax Date: 01/16/2021
Onset Date:
Rec V Date: 10/07/2021
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: This is a spontaneous report from a contactable consumer or other non hcp (patient). A 90-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3302) via an unspecified route of administration, Anatomical Site of injection: Left shoulder on 16Jan2021 09:00 (at the age of 90-year-old) at dose 1, single, and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, anatomical site of injection: right shoulder, on 06Feb2021 09:00 (at the age of 90-year-old) at dose 2, single, both the doses for covid-19 immunisation. Medical history was reported as none (Patient History: No). Concomitant medications were not reported. Patient did not have prior vaccinations within 4 weeks. On an unspecified date in on 2021 the patient experienced Pain in my elbow where I cannot really straighten my left arm where I got the shot. This case is made valid from invalid (Product confirm as BNT162B2, case is valid now). Additional Context: Consumer stated, I had my vaccination three days ago and I have pain in my elbow where I cannot really straighten my left arm where I got the shot and I wonder what you suggest doing about it. Will you be able to tell me what I should do to take care of it. Consumer stated, It says 06Feb.That is when my next one is scheduled. Weight: Consumer stated, I am 188. Route of administration: Consumer stated, Left arm. Other medication: Consumer stated, No, just normal things. Treatment: Consumer stated, Yes, I have taken Tylenol for pain and also a pain thing, a pain stuff that I have been rubbing in it. It is Anacort or something you need to know. Or I can go find out. Only side effect was pain and stiffness in left elbow after first vaccination. Outcome of the events was unknown. Information on the batch number has been requested. Follow-up(22Mar2021): This is a follow up-spontaneous report from a contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included the following: This case is made valid from invalid (Product confirm as BNT162B2, case is valid now). Vaccine name, vaccine 1st, 2nd doses information, vaccination dates of both doses of vaccine were added. No follow-up attempts are needed. No further information is expected. Follow-up (10May2021): Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1767625
Sex: F
Age: 43
State: LA

Vax Date: 02/11/2021
Onset Date: 02/12/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: 3/11/2021: C-reactive protein=9.4 High, Sed Rate by modified Westergren=2 Normal, ANA screen=negative. Complete metabolic panel normal with elevated AST=45 and ALT=36. 4/7/2021: 4/7/2021: C-reactive protein=9.7 high, sed rate=2 normal. 7/16/2021: ANA screen, IFA=positive, DNA (DS) Antibody=neg, SM Antibody=neg, SM/RNP Antibody=neg, Sjogren's antibody (SS-A)=neg , Sjogren's antibody (SS-B)=neg, ANA titer=1:80 high, ANA pattern=nuclear, speckled, HLA-B27=postive, creatine=0.89 normal, uric acid=5.3 normal , Hepatic function panel normal (including AST & ALT both normal), sed rate=2 normal, Cyclic citrullinated peptide=<16 neg, Rheumatoid factor=<14 neg, C-reactive protein=4.7 normal.

Allergies: Sulfa drugs

Symptom List: Pharyngeal swelling

Symptoms: At about midnight after the first dose of the covid vaccine that I received on 2/11/2021 at 8:00am, I experienced a migraine and pain in my spine, shoulders, hips and knees that kept me up trembling in excruciating pain. I was sore and fatigued 2 days after. At about 2:00pm after the second dose of the covid vaccine that I received on 3/4/2021 at 8:00am, I experienced fatigue, headaches, and the same excruciating pain in my spine, shoulders, hips, and knees. The fatigue and pain in my spine and joints after the two shots never went away. I also noticed a rapid regression in my muscle strength in my arms and legs at the gym. I went to my PCP on 3/5/2021 and he ordered labs that were completed on 3/11/2021. He noticed that my ANA screen was negative, my sed rate was negative, but my C-reactive protein was abnormal and wanted it repeated. On April 7,2021 my C-reactive protein level was even higher, to which he referred me to a Rheumotologist. After my referral finally went through, I was able to see the Rheumotologist on July 6, 2021. He ordered labs that were completed on July 16, 2021. My ANA screen came back positive with a titer of 1:80 and the pattern was Nuclear, Speckled, and my HLA-B27 was positive. On my follow up appointment on 8/12/2021 at 10:45am he told me that my labs and symptoms are consistant with Ankylosing Spondylitis. He ordered X-rays on my spine and hips to determine the damage as well as my treatment plan. On 8/26/2021 at 2:30pm, I went to my follow up appointment and was prescribed Humira shots that I will now have to take for the rest of my life.

Other Meds: armour thyroid, lo loestrin Fe, albuterol, duexis, Viibryd

Current Illness: none

ID: 1767626
Sex: M
Age: 40
State: HI

Vax Date: 10/02/2021
Onset Date: 10/03/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: N/A

Allergies: none

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: 1) headache, bodyaches, weakness, chills, and low-grade temp that started 10/3/21 ~0300 that lasted about 12hrs. 2) experienced sore arm that started about 6 hrs after the shot and lasted about 48hrs after. 3) noticed tender lymph node under L armpit ~24hrs after the shot; disappeared today ~96hrs after the shot

Other Meds: turmeric supplement

Current Illness: none

ID: 1767627
Sex: M
Age: 80
State: MI

Vax Date: 03/31/2021
Onset Date: 10/05/2021
Rec V Date: 10/07/2021
Hospital: Y

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

Lab Data: Procedure Component Value Ref Range Date/Time CT ABDOMEN AND PELVIS WITH IV CONTRAST Resulted: 10/06/21 0039 Order Status: Completed Updated: 10/06/21 0042 Narrative: EXAMINATION: CT Abdomen and Pelvis with IV Contrast EXAM DATE: 10/5/2021 11:49 PM TECHNIQUE: CT imaging of the abdomen and pelvis was performed with intravenous contrast. Coronal and sagittal images were reconstructed. CONTRAST: The amount and type of contrast are recorded in the medical record. QPP DOCUMENTATION: At least one of the following dose reduction techniques was utilized: Iterative reconstruction, and/or Automatic Exposure Control, and/or mA/kV adjustment based on body size. INDICATION: abdominal pain, intractable nausea, recent c. diff. hx of adenocarcinoma of ampulla of vater COMPARISON: CT abdomen pelvis dated September 20, 2021 FINDINGS: Lung Bases: There is dependent atelectasis at the included extent of the lung bases. Hepatobiliary: Pneumobilia remains throughout the left lobe. The liver is otherwise unremarkable. The portal and hepatic veins are patent. Pancreas: A small amount of gas is also present within the main pancreatic duct in the head of the pancreas which was seen previously. The pancreas is otherwise unremarkable. Spleen: The spleen has a normal size and there are no splenic lesions. Adrenals: The adrenal glands are normal. Kidneys, Ureters, & Bladder: Both kidneys have a normal size and there is no hydronephrosis. There is a 5 mm nonobstructing stone at the inferior pole of the right kidney. Both ureters have a normal caliber. Urinary bladder is modestly distended. Gastrointestinal: The stomach and small bowel are normal with no obstruction or inflammation. The patient had a colectomy with J-pouch and ileoanal anastomosis. There is no evidence of associated complication. Reproductive Organs: Unremarkable. Lymphatic System: There is no lymph node enlargement within the abdomen or pelvis. Vasculature: Normal caliber abdominal aorta with significant atherosclerotic disease. There is mild atherosclerotic plaque at the origins of the mesenteric vessels with no evidence for a significant narrowing. The mesenteric veins are normal. Peritoneum: No free fluid, free air, or inflammation. Abdominal Wall & Musculoskeletal: There is stable significant compression fractures of L1-L2 and a moderate compression fracture of the superior endplate of L3. Impression: 1. There is no acute abdominal or pelvic abnormality. No bowel inflammation or obstruction is identified 2. Urinary bladder is moderately distended which could be due to chronic outflow obstruction and clinical correlation is suggested 3. Stable residual 5 mm nonobstructing right renal stone. There is no hydronephrosis and no residual ureteral calculi are present DR CHEST 2 VIEWS FRONTAL AND LATERAL Resulted: 10/05/21 1440 Order Status: Completed Updated: 10/05/21 1442 Narrative: EXAMINATION: Frontal and Lateral View Chest EXAM DATE: 10/5/2021 1:53 PM TECHNIQUE: Frontal and lateral views INDICATION: cough X 1

Allergies: Penicillin G BenzathineRash Penicillins

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Patient is a 80 y.o. male with past medical history significant for type 1 diabetes mellitus, with insulin pump, dumping syndrome, prior TIA, history of ampullary cancer, who presents to the emergency department today for evaluation of generalized weakness, multiple falls at home, and intractable nausea, vomiting. He was recently admitted to the emergency department observation unit for similar symptoms, was found to have C difficile, and has since completed 10 days of oral vancomycin. Since completing antibiotics, he reports significant improvement in diarrhea, but still having some. He reports dark brown bowel movements, denies tarry black stools or hematochezia. He reports severe nausea and vomiting to the point of dry heaving. Has not been able to eat any food over the past 24 hours secondary to this. He does normally receive biweekly IV fluid infusions, but has required many increased infusions recently due to GI losses. His nausea and vomiting is worse with palpation of the abdomen and with position changes. He is tender with palpation of his abdomen. Denies fevers, chills. He does report slight cough, but no significant dyspnea. No chest pain. No urinary symptoms. The patient arrived in the emergency department hemodynamically stable, afebrile and non-hypoxic on room air. CBC was unremarkable. CMP was remarkable for Na 133, glucose 119, alk phos 153. Mag and phos were normal. hstnt baseline 16, hstnt 2hr 15 (delta - 1). The patient denies chest pain. UA was unremarkable. EKG was obtained and independently reviewed, with normal sinus rhythm, rate 83, QTC 415, no ischemic changes. Chest x-ray was independently reviewed, with persistent right upper lobe opacity, similar apical scarring to past CXRs. CT head was independently reviewed, with mild intracranial volume loss and chronic small-vessel changes. The patient was given 1 L normal saline, 4 mg IV Zofran. The patient was admitted to the hospitalist service for further workup and management.

Other Meds: Outpatient Medications acetaminophen-codeine (TYLENOL/CODEINE #3) 300-30 MG per tablet aspirin 81 MG enteric coated tablet Continuous Blood Gluc Sensor (DEXCOM G6 SENSOR) MISC Continuous Blood Gluc Transmit (DEXCOM G6 TRANSMITTER) MISC fina

Current Illness: cystoscopy, right ureteroscopy, laser lithotripsy, stone basket extraction, right ureteral stent exchange 3/25/2021 Osteoporosis with current pathological fracture, unspecified osteoporosis type, sequela 3/5/2021

ID: 1767628
Sex: F
Age: 27
State:

Vax Date: 10/03/2021
Onset Date: 10/04/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data:

Allergies: NO

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

Symptoms: headache myocarditis

Other Meds: no

Current Illness: NO

ID: 1767629
Sex: M
Age: 71
State: MI

Vax Date: 03/12/2021
Onset Date: 10/04/2021
Rec V Date: 10/07/2021
Hospital: Y

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

Lab Data: Procedure Component Value Ref Range Date/Time DR CHEST SINGLE VIEW [344856482] Resulted: 10/04/21 1950 Order Status: Completed Updated: 10/04/21 1952 Narrative: EXAMINATION: Single View Chest EXAM DATE: 10/4/2021 7:11 PM TECHNIQUE: Single view chest INDICATION: Covid COMPARISON: 7/31 2018 ENCOUNTER: Not applicable _________________________ FINDINGS: An abnormal focal area of consolidation is demonstrated in the right lower lung consistent with pneumonia. The left hemidiaphragm is not well visualized on this exam which could be due to the heart obscuring detail or airspace disease in the left lower lung. The mediastinum and pulmonary vasculature are normal. No pleural effusion is present. There is no pneumothorax. _________________________ Impression: There is abnormal infiltrate in the right lower lung consistent with pneumonia. Consider follow-up imaging to document resolution and exclude a mass. Procedure Component Value Ref Range Date/Time COVID-19 PCR - Rapid BL and Regionals [344696226] (Abnormal) Collected: 10/04/21 1618 Order Status: Completed Specimen: Swabbed Collection from Nasopharynx Updated: 10/04/21 1641 COVID-19 PCR Detected Abnormal Not Detected Comment: COVID-19 (SARS-CoV-2) test is positive. Clinical correlation with patient history and other diagnostic information is necessary to determine infection status. This test has received Emergency Use Authorization (EUA) by the FDA, but performance has not been evaluated for asymptomatic patients. Testing was performed using a nucleic acid amplification method. The specimen source may have been changed from the original order per patient situation or symptoms. Covid 19 Result Comment See Comment Comment: COVID-19 results reported as "detected" means COVID-19 positive. Positive patients should self-isolate for 10 days or 24 hours after fever resolves and other symptoms are improving, whichever is longer: - Stay home except to get medical care and wear a facemask if you must leave - Separate yourself from other people in your home, known as home isolation - Cover your coughs and sneezes - Wash your hands often - Avoid sharing household items - Clean high-touch surfaces everyday - If you have a medical emergency and need to call 911, notify dispatch personnel that you may have COVID-19 and put on a facemask before emergency medical services arrive. If the result is "inconclusive" or "invalid" and you have not been contacted by a medical professional about your result or if you have questions about COVID-19, your symptoms, or need a return to work/school note, please contact your primary care provider (PCP).

Allergies: No Known Allergies

Symptom List: Rash, Urticaria

Symptoms: History and physical obtained using telehealth technology with the assistance of the bedside nurse. a 72 y.o. male who presents to hospital. The patient states that he developed shortness of breath, coughing and fevers. The symptoms started about 10 days ago. It all started with sore throat and then symptoms progressively worsened with nasal discharge and burning feeling in his lungs. + slight fever in the first 4 days which progressively worsened. Highest was 103.7. No vomiting. + nausea but only with severe coughing spells. + diarrhea x 2 days. No black or bloody stools that he knows of recently. However, about 3 weeks ago he had some blood stools but does have hemorrhoids. He came in today because the triage nurse convinced him to come in when he was scheduling his wife for COVID testing. His SOB was not severe, he was able to walk out to the mailbox. He was vaccinated back in febrauary/march x 2 vaccinations.

Other Meds: Outpatient Medications acetaminophen (TYLENOL) 500 MG tablet atorvastatin (LIPITOR) 10 MG tablet B Complex Vitamins (VITAMIN-B COMPLEX PO) Cholecalciferol (VITAMIN D-3 PO) escitalopram (LEXAPRO) 20 MG tablet finasteride (PROSCAR) 5 MG table

Current Illness:

ID: 1767630
Sex: M
Age: 65
State: MN

Vax Date: 10/05/2021
Onset Date: 10/06/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: elevated Ddimer. Other tests stable cbc, cmp, troponin and pro bnp. CTA of the chest done - results pending

Allergies: terfenadine

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

Symptoms: SOB, bilateral hands and feet numbness.

Other Meds: losarten, Metoprolol, Viagra, glucotrol, jardiance, prilosec, lasix, asa, lipitor, glucophage,

Current Illness: No acute illness.

ID: 1767699
Sex: F
Age: 30
State: CA

Vax Date: 04/15/2021
Onset Date: 05/15/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: COVID rapid test; Test Result: Negative ; Result Unstructured Data: Negative

Allergies:

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

Symptoms: Constant discomfort makes everything difficult; Headache; Very Tired; Freak out moments, Nurse Poppy told me I prob have anxiety; Costochondritis; Had a hard time falling asleep because it hurt to breathe.; Hard to breathe in lower lungs and middle of; Evening it was rough, had a really hard time getting to sleep, heavy breathing in lower chest; pain in upper R chest at 9am started and breathing was more painful in chest; it always hurts to breathe/is more difficult to breathe around 1-2pm every day; Some sharp pains in my upper back; Heavy across all of my lungs when I breathe in; Middle of chest hurts a lot more; my lower neck hurts but unsure if there is a correlation; Lower neck hurts; Woke up and my R breast was hurting more than usual; Really not bad today, Pain in upper R chest; shallow concentrated pain up and down the middle of my chest; Pain in R upper Chest is back again; 2 hits of the inhaler between; Fungal overgrowth; When I take a breath I notice pain in my Chest; Shooting pains in R Breast; Phlegmy, spitting up stuff; Chest is sore, dry cough but better than last week; Slight pain on upper R chest; Just a slight inflammation at bottom of 1 lung; Shooting Pain in under R Armpit; Tried jumping jacks this morning, noticed it was difficult to breathe; Felt better over the weekend. symptoms appeared in daytime and in the evening.; Pain in chest. /r side below Clavicle; Cough is getting worse; Pleurisy; Feeling hot; Vertigo; Confused; Foggy brain; Dizzy; Difficulty breathing; Chest Tightness; Cough; Hard to breathe; Chills; Chills; Achy body; Flu like symptoms; slightly phlegmy coughs; lungs hurt when inhaling,hurts more when breathing deeply, constant and complete pain in lungs,; Hard to breathe, pain in upper right of my chest just below the clavicle, stabbing sensation in middle of my chest; I have had difficulty breathing for 44 days with no end in sight.; This spontaneous case was reported by a non-health professional and describes the occurrence of Pulmonary pain (lungs hurt when inhaling, more when breathing deeply, constant and complete pain in lungs), Dyspnoea (I have had difficulty breathing for 44 days with no end in sight), Chest pain (Hard to breathe, pain in upper right of my chest just below the clavicle, stabbing sensation in middle of my chest), Costochondritis, Productive cough(slightly phlegmy coughs), Pleurisy, Feeling hot, Euphoric mood (Felt better over the weekend. symptoms appeared in daytime and in the evening), Vertigo,Pneumonitis (Just a slight inflammation at bottom of 1 lung), Confusional state (Confused), Feeling abnormal (Foggy brain), Breast pain (Shooting pains in R Breast), Neck pain (Lower neck hurts), Headache, Dizziness, Influenza like illness (Flu like symptoms), Myalgia (Achy body), Chills, Fatigue, Dyspnoea, Chest discomfort (Chest Tightness), Cough, Hypopnoea (Hard to breathe), Axillary pain (Shooting Pain in under R Armpit), Chills, Chest pain (Pain in chest. /r side below Clavicle), Productive cough (Phlegmy, spitting up stuff), Chest pain (Chest is sore, dry cough but better than last week), Chest pain, Candida infection (2 hits of the inhaler between), Overgrowth fungal, Pulmonary pain(Heavy across all of my lungs when I breathe in), Chest pain(shallow concentrated pain up and down the middle of my chest), Chest pain (Really not bad today, Pain in upper R chest), Breast pain (Woke up and my R breast was hurting more than usual), Insomnia (Had a hard time falling asleep because it hurt to breathe), Chest pain (Middle of chest hurts a lot more), Neck pain (lower neck hurts but unsure if there is a correlation), Dyspnoea (to breathe/is more difficult to breathe around 1-2pm every day), Back pain(Some sharp pains in my upper back), Chest pain (pain in upper R chest at 9am started and breathing was more painful in chest), Dyspnoea (Evening it was rough, had a really hard time getting to sleep, heavy breathing in lower chest), Hypopnoea (Hard to breathe in lower lungs and middle of), Discomfort (Constant discomfort makes everything difficult), Mobility decreased (Tried jumping jacks this morning, noticed it was difficult to breathe), Fear of disease (moments, Nurse told me I prob have anxiety) in a 31-year-old female patient who received mRNA-1273 Moderna CoviD-19 Vaccine. The Concurrent medical conditions included Slight allergy to amoxicillin (Slight allergic reaction- hives (developed small spots on legs) after taking, Seasonal allergies (that go away when taking Claritin), Hives/Urticaria. The patient underwent procedure Emergency room on 25-MAY-2021. Treatment medications included IBUPROFEN 800 mg for unknown indication, from 29-AUG-2021, take at minimum 4 ibuprofen per dosage daily. PREDNISONE 20mg from 01-JUL-2021 till 05-JUL-2021. TRIMEZOL Lozenge, FROM 21-JUN-2021 to till, 1 dosage form, 5 X a day. ALEVE from 07-JUL-2021, FLONASE ALLERGY RELIEF, from 16-JUL-2021, 1 dosage form. Patients lab data included SARS-CoV-2 test 2021; Negative. On 15-APR-2021 the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) batch no unknown to unknown anatomical location 1 dosage form. On 15-MAY-2021, the patient received second dose of mRNA-1273 Moderna COVID-19 Vaccine batch no: 03C21A Intramuscular to her left arm,1 dosage form at 12pm. July. On 06-JUL-2021 Mobility decreased and after 2 days Fear of was there. On 09th JUL Fatigue and Headache was on 13th JUL. The outcomes of the events Pulmonary pain, Chest pain, Productive cough were Not Recovered/Not Resolved. Euphoric mood, Vertigo, Confusional state, feeling abnormal, Dizziness, Influenza like illness, Chills, Cough, Myalgia were Recovered/Resolved. Chest discomfort Recovered/Resolved with Sequelae, Productive cough. Breast pain, Neck pain, Headache, Cough, Hypopnoea, Axillary pain, Dyspnoea, Candida infection, Overgrowth fungal ,Pulmonary pain, Chest pain, Breast pain, Costochondritis, Feeling hot, Pleurisy, Pneumonitis, Insomnia, Neck pain,Back pain Chest pain, Hypopnoea , Fear of disease, Chills, Fatigue, Dyspnoea were unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was Not Applicable. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular). The reporter did not provide any causality assessments. Follow up received on 30-AUG-2021 is Significant include treatments and patient details provided. Also few AE was added.

Other Meds:

Current Illness: Allergy to antibiotic (Patient have slight allergy to amoxicillin (hives). Start date is 2019.Slight allergic reaction- hives (developed small spots on legs) after taking); Seasonal allergy (Patient have seasonal allergies that go away when taking Claritin.); Urticaria.

Date Died: 04/21/2021

ID: 1767722
Sex: F
Age:
State: MI

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Date: 20210921; Test Name: Autopsy; Result Unstructured Data: Hemorrhagic cerebral infarct

Allergies:

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

Symptoms: CEREBRAL VENOUS SINUS THROMBOSIS; HEMORRHAGIC CEREBRAL INFARCT; BRAIN SWELLING; This spontaneous report received from a consumer via social media (news reporter) concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in APR-2021, the patient had complications of hemorrhagic cerebral infarct and brain swelling due to cerebral venous sinus thrombosis. On 21-APR-2021, the patient died from cerebral venous sinus thrombosis, hemorrhagic cerebral infarct and brain swelling. It was reported that she was working on a story about a woman, who died on an unspecified date on 21-APR-2021. The autopsy report was completed on 21-SEP-2021. The pathologist concluded her death was caused by complications of hemorrhagic cerebral infarct and brain swelling due to cerebral venous sinus thrombosis complicating administration of human adenoviral vector vaccine for coronavirus 2019 disease. The doctor deemed the manner of death natural. It may also be considered a therapeutic complication. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211006297-covid-19 vaccine ad26.cov2.s-cerebral venous sinus thrombosis, hemorrhagic cerebral infarct, brain swelling. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: CEREBRAL VENOUS SINUS THROMBOSIS; HEMORRHAGIC CEREBRAL INFARCT; BRAIN SWELLING

Other Meds:

Current Illness:

ID: 1767723
Sex: F
Age:
State: PA

Vax Date:
Onset Date: 09/01/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Date: 202109; Test Name: COVID-19 virus test; Result Unstructured Data: Positive

Allergies:

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

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned an adult female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 01 total, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On unspecified date in SEP-2021, the patient tested positive for Covid (suspected covid-19 infection), though had vaccinated 3-4 months ago (suspected clinical vaccination failure). Patient had completed a week and a half period of isolation on 03-OCT-2021. The patient stated feeling like hit by a truck after being asked for symptoms and mentioned no hospitalization. The patient was a teacher and likely picked it up at school. The action taken with covid-19 vaccine was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000195910.; Sender's Comments: V0: 20211006359-COVID-19 VACCINE -suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1767724
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
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: CLOTS; This spontaneous report received from a consumer via social media concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch or lot number. No concomitant medications were reported. On an unspecified date, it was reported that the reporter's uncle had clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of clots was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211009238.; Sender's Comments: V0: 20211009150-Covid-19 vaccine ad26.cov2.s -Clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1767725
Sex: M
Age:
State: OR

Vax Date:
Onset Date: 10/04/2021
Rec V Date: 10/07/2021
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: SWELLING IN ARM; STABBING PAIN IN THE ARM SLIGHTLY LOWER THAN THE INJECTION SITE (MILD IN NATURE); STRESS HEADACHE AT THE TEMPLES; This spontaneous report received from a patient concerned a 22 year old male. The patient's weight was 135 pounds, and height was 72 inches. The patient's concurrent conditions included: non-alcoholic, and non-smoker, and other pre-existing medical conditions included: Patient had no pre existing medical condition and no usage of any medications. No known allergies. No illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, and batch number: 212A21A expiry: UNKNOWN) dose was not reported, administered on 04-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-OCT-2021, the patient experienced swelling in arm. On 04-OCT-2021, the patient experienced stabbing pain in the arm slightly lower than the injection site (mild in nature). On 04-OCT-2021, the patient experienced stress headache at the temples. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in arm, stabbing pain in the arm slightly lower than the injection site (mild in nature), and stress headache at the temples. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1767726
Sex: F
Age: 25
State: MO

Vax Date: 05/26/2021
Onset Date:
Rec V Date: 10/07/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: having strong menstruations lately; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (having strong menstruations lately) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 26-May-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 HEAVY MENSTRUAL BLEEDING (having strong menstruations lately). At the time of the report, HEAVY MENSTRUAL BLEEDING (having strong menstruations lately) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The concomitant medication was not reported. The treatment history was not reported. Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Non significant follow up received on 27-SEP-2021 and does not contain any new information

Other Meds:

Current Illness:

ID: 1767727
Sex: F
Age: 65
State: FL

Vax Date: 01/27/2021
Onset Date: 04/01/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Date: 20210725; Test Name: Chest X-ray; Result Unstructured Data: she had Asthma and COPD

Allergies:

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

Symptoms: SNEEZING; Chest tightness; COUGH; RUNNY NOSE; PAIN IN THE ARM; COPD; Asthma; Hypersensitivity reaction; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), ASTHMA (Asthma), COUGH (COUGH), RHINORRHOEA (RUNNY NOSE) and PAIN IN EXTREMITY (PAIN IN THE ARM) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Chronic pain and Non-smoker. On 27-Jan-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). On 29-Jul-2021, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) and ASTHMA (Asthma). On an unknown date, the patient experienced COUGH (COUGH), RHINORRHOEA (RUNNY NOSE) and PAIN IN EXTREMITY (PAIN IN THE ARM). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), ASTHMA (Asthma), COUGH (COUGH) and PAIN IN EXTREMITY (PAIN IN THE ARM) outcome was unknown and RHINORRHOEA (RUNNY NOSE) and HYPERSENSITIVITY (Hypersensitivity reaction) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jul-2021, Chest X-ray: asthma and copd (abnormal) she had Asthma and COPD. Relevant concomitant medications were not reported. This case was linked to MOD-2021-278377 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Follow-up received include ethnicity, medical history, treatment medication and newevents added.

Other Meds:

Current Illness: Chronic pain; Non-smoker

ID: 1767728
Sex: F
Age: 45
State: CA

Vax Date: 07/16/2021
Onset Date: 07/17/2021
Rec V Date: 10/07/2021
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: Test Date: 20210722; Test Name: Body temperature; Result Unstructured Data: High; Test Date: 20210722; Test Name: Echocardiogram; Result Unstructured Data: normal

Allergies:

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

Symptoms: Could barely talk; husband had to take her to the bathroom; Trouble breathing; Pressure in the chest/Pressure on chest comes and goes; Brown Urine; Could barely move; Itchy Bumps on both legs; Tiny Bumps on both legs; Rash on both legs; Fever 103 F; Vomiting; Severe Nausea; Severe Headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Trouble breathing), CHEST DISCOMFORT (Pressure in the chest/Pressure on chest comes and goes), CHROMATURIA (Brown Urine), MOBILITY DECREASED (Could barely move) and PRURITUS (Itchy Bumps on both legs) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in 2021. On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced CHROMATURIA (Brown Urine), MOBILITY DECREASED (Could barely move), PRURITUS (Itchy Bumps on both legs), SKIN MASS (Tiny Bumps on both legs), RASH (Rash on both legs), PYREXIA (Fever 103 F), VOMITING (Vomiting), NAUSEA (Severe Nausea) and HEADACHE (Severe Headache). On 22-Jul-2021, the patient experienced DYSPNOEA (Trouble breathing) and CHEST DISCOMFORT (Pressure in the chest/Pressure on chest comes and goes). On 17-Sep-2021, the patient experienced SPEECH DISORDER (Could barely talk) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (husband had to take her to the bathroom). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Trouble breathing), CHEST DISCOMFORT (Pressure in the chest/Pressure on chest comes and goes), CHROMATURIA (Brown Urine), MOBILITY DECREASED (Could barely move), PRURITUS (Itchy Bumps on both legs), SPEECH DISORDER (Could barely talk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (husband had to take her to the bathroom), SKIN MASS (Tiny Bumps on both legs), RASH (Rash on both legs), PYREXIA (Fever 103 F), VOMITING (Vomiting), NAUSEA (Severe Nausea) and HEADACHE (Severe Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jul-2021, Body temperature: 103 (High) High. On 22-Jul-2021, Echocardiogram: normal (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Lab data included ECG, cardiac test, cardiac enzymes. No relevant concomitant medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Follow up received on 30-Sep-21: DOB added and age updated.

Other Meds:

Current Illness:

ID: 1767729
Sex: U
Age: 24
State: NY

Vax Date: 08/09/2021
Onset Date:
Rec V Date: 10/07/2021
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: vaccine administered as if it had a preservative; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered as if it had a preservative) in a 24-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 006C21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered as if it had a preservative). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine administered as if it had a preservative) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided. No concomitant medication was provided. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up received on 29 SEP 2021: contains No New Information.

Other Meds:

Current Illness:

ID: 1767730
Sex: F
Age:
State: RI

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
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: Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) in a female patient of an unknown age 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 FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment information was provided by the reporter. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1767731
Sex: F
Age: 62
State: FL

Vax Date: 08/05/2021
Onset Date: 08/05/2021
Rec V Date: 10/07/2021
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: Sore left injection site arm; Was very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Was very sick) and VACCINATION SITE PAIN (Sore left injection site arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. Concurrent medical conditions included Osteoarthritis since 01-Mar-2014. Concomitant products included CELECOXIB (CELEBREX) from March 2020 to an unknown date and GABAPENTIN from March 2020 to an unknown date for Arthritis, ALENDRONATE SODIUM (ALENDRONATE) from March 2020 to an unknown date for Brittle bone disease and Osteoporosis, METHOCARBAMOL from March 2020 to an unknown date for Muscle relaxation. On 05-Aug-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced ILLNESS (Was very sick). On 05-Aug-2021, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm). On 06-Aug-2021, VACCINATION SITE PAIN (Sore left injection site arm) had resolved. At the time of the report, ILLNESS (Was very sick) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. The patient's left arm was sore for a day. This case was linked to MOD-2021-335248 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2021: Follow-up received: Patient's demography, relevant medical history, batch/lot number and concomitant medication was updated.

Other Meds: ALENDRONATE; CELEBREX; METHOCARBAMOL; GABAPENTIN.

Current Illness: Osteoarthritis.

ID: 1767732
Sex: M
Age: 56
State: NY

Vax Date: 03/08/2021
Onset Date: 04/06/2021
Rec V Date: 10/07/2021
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: Stopped needing a cane to walk/ Knee 80% better; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Stopped needing a cane to walk/ Knee 80% better) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 036A21A) for COVID-19 vaccination. The patient's past medical history included Knee arthroplasty (He had multiple problems ever since.) in 2020. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Stopped needing a cane to walk/ Knee 80% better). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Stopped needing a cane to walk/ Knee 80% better) outcome was unknown. No concomitant medications were reported. No treatment information was reported. The day after his 2nd dose he stopped needing a cane to walk and his knee was 80% better.

Other Meds:

Current Illness:

ID: 1767733
Sex: M
Age: 28
State: CA

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 10/07/2021
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: Moderna Covid-19 vaccine administered 13 hours after first puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine administered 13 hours after first puncture) in a 28-year-old male patient who received mRNA-1273 (batch no. 062E21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Sep-2021, the patient received dose of mRNA-1273 (Intramuscular) 1 dosage form. On 28-Sep-2021, after starting mRNA-1273, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine administered 13 hours after first puncture). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine administered 13 hours after first puncture) had resolved. For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments. No concomitant treatment was provided. No treatment medication was provided. Patient had not experienced any adverse reactions after vaccination.

Other Meds:

Current Illness:

ID: 1767734
Sex: F
Age: 66
State: MN

Vax Date: 08/11/2021
Onset Date: 08/11/2021
Rec V Date: 10/07/2021
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: Little bit sick; Trouble walking; Nausea; Vomiting; Little bit fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Little bit sick), GAIT DISTURBANCE (Trouble walking), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Little bit fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091021A) for COVID-19 vaccination. The patient's past medical history included Surgery. Concurrent medical conditions included Cancer (Diagnosed cancer in spring.). Concomitant products included PEMBROLIZUMAB (KEYTRUDA) for Chemotherapy, LEVOTHYROXINE and AXITINIB (INLYTA) for an unknown indication. On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced VACCINATION COMPLICATION (Little bit sick), GAIT DISTURBANCE (Trouble walking), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Little bit fatigue). At the time of the report, VACCINATION COMPLICATION (Little bit sick), GAIT DISTURBANCE (Trouble walking), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Little bit fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. It was stated that the patient has only one kidney. Treatment information was not provided. This case was linked to MOD-2021-335657 (Patient Link).

Other Meds: LEVOTHYROXINE; KEYTRUDA; INLYTA

Current Illness: Cancer (Diagnosed cancer in spring.)

ID: 1767735
Sex: U
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
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: slept for 2 days; rebound effect; fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of SOMNOLENCE (slept for 2 days), REBOUND EFFECT (rebound effect) and FATIGUE (fatigue) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (slept for 2 days), REBOUND EFFECT (rebound effect) and FATIGUE (fatigue). At the time of the report, SOMNOLENCE (slept for 2 days), REBOUND EFFECT (rebound effect) and FATIGUE (fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1767736
Sex: M
Age: 29
State:

Vax Date: 08/31/2021
Onset Date: 08/31/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Date: 20210831; Test Name: Body temperature; Result Unstructured Data: 105? F

Allergies:

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

Symptoms: High fever of 105? F; It "almost killed him"; Lost his appetite; Couldn't sleep; Sweating a lot; Hard for him to breath/difficulty breathing; "It was very painful"; Muscle ache that targeted the weakest muscles of his body (arm, neck, and lower back); Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERPYREXIA (High fever of 105? F) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A and 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19, Pneumonia and Dizziness. On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced HYPERPYREXIA (High fever of 105? F) (seriousness criterion medically significant), VACCINATION COMPLICATION (It "almost killed him"), DECREASED APPETITE (Lost his appetite), INSOMNIA (Couldn't sleep), HYPERHIDROSIS (Sweating a lot), DYSPNOEA (Hard for him to breath/difficulty breathing), PAIN ("It was very painful"), MYALGIA (Muscle ache that targeted the weakest muscles of his body (arm, neck, and lower back)) and HEADACHE (Headaches). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 02-Sep-2021, HYPERPYREXIA (High fever of 105? F) had resolved. At the time of the report, VACCINATION COMPLICATION (It "almost killed him"), DECREASED APPETITE (Lost his appetite), INSOMNIA (Couldn't sleep), HYPERHIDROSIS (Sweating a lot), DYSPNOEA (Hard for him to breath/difficulty breathing), PAIN ("It was very painful"), MYALGIA (Muscle ache that targeted the weakest muscles of his body (arm, neck, and lower back)) and HEADACHE (Headaches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Aug-2021, Body temperature: 105? f (High) 105? F. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant medication was not provided. Company Comment - This case concerns a 29-year-old male patient with medical history of COVID-19, pneumonia and dizziness, who experienced unexpected serious event of hyperpyrexia. The event occurred on the same day after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine) administration. The rechallenge was unknown as details about the second dose was not disclosed. Causality for the reported events were not provided by the reporter. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) in not affected by this report. Event assessed as serious per Regulatory Authority reporting as event was considered medically significant and is an important medical event. This case was linked to MOD-2021-335730 (Patient Link).; Sender's Comments: This case concerns a 29-year-old male patient with medical history of COVID-19, pneumonia and dizziness, who experienced unexpected serious event of hyperpyrexia. The event occurred on the same day after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine) administration. The rechallenge was unknown as details about the second dose was not disclosed. Causality for the reported events were not provided by the reporter. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) in not affected by this report. Event assessed as serious per Regulatory Authority reporting as event was considered medically significant and is an important medical event.

Other Meds:

Current Illness:

ID: 1767737
Sex: M
Age: 29
State:

Vax Date: 08/31/2021
Onset Date: 09/28/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: pain in his lower back; pain in his knee is "killing him"; fever of 103? F; if he gets up, he has extreme neck pain: "It's killing me"; pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (if he gets up, he has extreme neck pain: "It's killing me"), PAIN IN EXTREMITY (pain in the arm), BACK PAIN (pain in his lower back), ARTHRALGIA (pain in his knee is "killing him") and PYREXIA (fever of 103? F) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A and 052E21A) for COVID-19 vaccination. The patient's past medical history included COVID-19 in March 2021 and Pneumonia in March 2021. On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced NECK PAIN (if he gets up, he has extreme neck pain: "It's killing me"), PAIN IN EXTREMITY (pain in the arm), ARTHRALGIA (pain in his knee is "killing him") and PYREXIA (fever of 103? F). On an unknown date, the patient experienced BACK PAIN (pain in his lower back). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NECK PAIN (if he gets up, he has extreme neck pain: "It's killing me"), PAIN IN EXTREMITY (pain in the arm), BACK PAIN (pain in his lower back), ARTHRALGIA (pain in his knee is "killing him") and PYREXIA (fever of 103? F) outcome was unknown. No Concomitant informations were reported. This case was linked to MOD-2021-335720 (Patient Link). Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1767738
Sex: U
Age:
State:

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 10/07/2021
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: a severe allergic reaction after eating grapes; body over reacted; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (a severe allergic reaction after eating grapes) and ALLERGY TO VACCINE (body over reacted) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. not provided) for COVID-19 vaccination. No Medical History information was reported. In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced HYPERSENSITIVITY (a severe allergic reaction after eating grapes) and ALLERGY TO VACCINE (body over reacted). At the time of the report, HYPERSENSITIVITY (a severe allergic reaction after eating grapes) and ALLERGY TO VACCINE (body over reacted) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications was not provided by the reporter Treatment information was not provided To whom it may concern- I am not sure if this is beneficial to forward this information to the appropriate channels. Patient received the Maderna vaccine in March. I have never had any type of food alergy. I have always eaten grapes. The other day I ate two small bundles of grapes with seeds in them and had a severe allergic reaction where I had to go to the ER and treated for the event. I feel there is a connection with how my immune system reacted having the vaccine and this event months later. Where my body over reacted this way. I feel this is is something to start following in future research and keep statistics on soon as these concerns and improving the issues that rollout.

Other Meds:

Current Illness:

ID: 1767739
Sex: M
Age: 74
State: OH

Vax Date: 02/02/2021
Onset Date: 09/01/2021
Rec V Date: 10/07/2021
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: ultrasound scan; Result Unstructured Data: diagnosed blood clot via an ultrasound of left leg

Allergies:

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

Symptoms: blood clot in left leg/by the size of the clot it had probably been building for a while; Swelling; Severe Pain; second dose given >35 days from first dose; This spontaneous case was reported by a physician and describes the occurrence of THROMBOSIS (blood clot in left leg/by the size of the clot it had probably been building for a while) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and MORNIFLUMATE (FLOMAX [MORNIFLUMATE]) for an unknown indication. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2021, the patient experienced THROMBOSIS (blood clot in left leg/by the size of the clot it had probably been building for a while) (seriousness criterion medically significant), SWELLING (Swelling), PAIN (Severe Pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given >35 days from first dose). The patient was treated with APIXABAN (ELIQUIS) for Adverse event, at an unspecified dose and frequency. In September 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given >35 days from first dose) had resolved. At the time of the report, THROMBOSIS (blood clot in left leg/by the size of the clot it had probably been building for a while), SWELLING (Swelling) and PAIN (Severe Pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: diagnosed blood clot (abnormal) diagnosed blood clot via an ultrasound of left leg. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Company Comment: This is a case of Inappropriate schedule of product administration in a 75-year-old male patient with no relevant medical history, who experienced the unexpected event Thrombosis. The event occurred approximately 6 months after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This is a case of Inappropriate schedule of product administration in a 75-year-old male patient with no relevant medical history, who experienced the unexpected event Thrombosis. The event occurred approximately 6 months after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.

Other Meds: LIPITOR; FLOMAX [MORNIFLUMATE]

Current Illness:

ID: 1767740
Sex: F
Age: 54
State: FL

Vax Date: 08/29/2021
Onset Date:
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: between 38.7 and 38.8 degree Celsius

Allergies:

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

Symptoms: felt pressure in the head; nodules between throat and clavicle; Pain in the legs; Pain in the lower back; I was in bed; Lot of headaches; Fever between 38.7 and 38.8 C; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (felt pressure in the head), NODULE (nodules between throat and clavicle), PAIN IN EXTREMITY (Pain in the legs), BACK PAIN (Pain in the lower back) and BEDRIDDEN (I was in bed) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included VITAMINS NOS for an unknown indication. On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (felt pressure in the head), NODULE (nodules between throat and clavicle), PAIN IN EXTREMITY (Pain in the legs), BACK PAIN (Pain in the lower back), BEDRIDDEN (I was in bed), HEADACHE (Lot of headaches) and PYREXIA (Fever between 38.7 and 38.8 C). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of every 6-8 hours. At the time of the report, HEAD DISCOMFORT (felt pressure in the head), NODULE (nodules between throat and clavicle), PAIN IN EXTREMITY (Pain in the legs), BACK PAIN (Pain in the lower back), HEADACHE (Lot of headaches) and PYREXIA (Fever between 38.7 and 38.8 C) outcome was unknown and BEDRIDDEN (I was in bed) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) between 38.7 and 38.8 degree Celsius. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Patient received second dose on 26 SEP 2021. This case was linked to MOD-2021-336063 (Patient Link).

Other Meds: VITAMINS NOS

Current Illness:

ID: 1767741
Sex: F
Age: 54
State: FL

Vax Date: 08/29/2021
Onset Date: 09/01/2021
Rec V Date: 10/07/2021
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: Made sounds like she had shortness of breath at some point; Stomach ache; Very tired; Knees hurt a lot, particularly the left knee which is very painful; Stayed for 2 days in bed; Nodule on the left side next to the clavicle; Rash in the right arm and under the breasts, where it is very itchy; Lot of pressure in the head; Strong flu; Sore throat; Difficulty to walk; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Stayed for 2 days in bed), NODULE (Nodule on the left side next to the clavicle), DYSPNOEA (Made sounds like she had shortness of breath at some point), RASH PRURITIC (Rash in the right arm and under the breasts, where it is very itchy) and HEAD DISCOMFORT (Lot of pressure in the head) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included VITAMINS NOS for an unknown indication. On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced BEDRIDDEN (Stayed for 2 days in bed), NODULE (Nodule on the left side next to the clavicle), RASH PRURITIC (Rash in the right arm and under the breasts, where it is very itchy), HEAD DISCOMFORT (Lot of pressure in the head), INFLUENZA (Strong flu), OROPHARYNGEAL PAIN (Sore throat), GAIT DISTURBANCE (Difficulty to walk) and ARTHRALGIA (Knees hurt a lot, particularly the left knee which is very painful). On 29-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (Made sounds like she had shortness of breath at some point), ABDOMINAL PAIN UPPER (Stomach ache) and FATIGUE (Very tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event NOS, at a dose of Every 6-8 hours. At the time of the report, BEDRIDDEN (Stayed for 2 days in bed) had not resolved and NODULE (Nodule on the left side next to the clavicle), DYSPNOEA (Made sounds like she had shortness of breath at some point), RASH PRURITIC (Rash in the right arm and under the breasts, where it is very itchy), HEAD DISCOMFORT (Lot of pressure in the head), INFLUENZA (Strong flu), OROPHARYNGEAL PAIN (Sore throat), GAIT DISTURBANCE (Difficulty to walk), ABDOMINAL PAIN UPPER (Stomach ache), FATIGUE (Very tired) and ARTHRALGIA (Knees hurt a lot, particularly the left knee which is very painful) outcome was unknown. It was reported that the patient didn't go to work. This case was linked to MOD-2021-336022 (Patient Link).

Other Meds: VITAMINS NOS.

Current Illness:

ID: 1767742
Sex: M
Age: 22
State: TN

Vax Date: 09/03/2021
Onset Date:
Rec V Date: 10/07/2021
Hospital: Y

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

Lab Data: Test Name: CT scans; Result Unstructured Data: Normal; Test Name: Ultrasound; Result Unstructured Data: Normal ultrasound on both his legs

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Symptoms progressively got worse; right and left hand seemed to be drawing in and he could not grip anything; could not walk good, he had been crying; hurting near groin area; Hurting near hip area/Still hurting in in hip area; Patient is also hardly eating now; partial paralysis; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Symptoms progressively got worse), GRIP STRENGTH DECREASED (right and left hand seemed to be drawing in and he could not grip anything), GAIT DISTURBANCE (could not walk good, he had been crying), GROIN PAIN (hurting near groin area), ARTHRALGIA (Hurting near hip area/Still hurting in in hip area), FEEDING DISORDER (Patient is also hardly eating now) and PARALYSIS (partial paralysis) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Autism (non-verbal autistic). On 03-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONDITION AGGRAVATED (Symptoms progressively got worse) (seriousness criteria hospitalization and disability), GRIP STRENGTH DECREASED (right and left hand seemed to be drawing in and he could not grip anything) (seriousness criteria hospitalization and disability), GAIT DISTURBANCE (could not walk good, he had been crying) (seriousness criterion hospitalization), GROIN PAIN (hurting near groin area) (seriousness criterion hospitalization), ARTHRALGIA (Hurting near hip area/Still hurting in in hip area) (seriousness criterion hospitalization), FEEDING DISORDER (Patient is also hardly eating now) (seriousness criterion hospitalization) and PARALYSIS (partial paralysis) (seriousness criteria disability and medically significant). The patient was hospitalized from 20-Sep-2021 to 21-Sep-2021 due to ARTHRALGIA, CONDITION AGGRAVATED, FEEDING DISORDER, GAIT DISTURBANCE, GRIP STRENGTH DECREASED and GROIN PAIN. At the time of the report, CONDITION AGGRAVATED (Symptoms progressively got worse), GRIP STRENGTH DECREASED (right and left hand seemed to be drawing in and he could not grip anything), GAIT DISTURBANCE (could not walk good, he had been crying), GROIN PAIN (hurting near groin area), ARTHRALGIA (Hurting near hip area/Still hurting in in hip area), FEEDING DISORDER (Patient is also hardly eating now) and PARALYSIS (partial paralysis) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) Normal. On an unknown date, Ultrasound scan: normal (normal) Normal ultrasound on both his legs. Concomitant medications were not provided. The patient's father had to get a wheelchair for him on 28-Sep-2021. Treatment information was not provided. Company comment: This case concerns a 22-year-old, female patient with no previous relevant medical history, who experienced the unexpected events of Condition aggravated, grip strength decreased, gait disturbance, groin pain, arthralgia, feeding disorder, and paralysis. The events occurred 17 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report. This case was linked to MOD-2021-336017 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Follow up appended contains additional event partial paralysis.; Sender's Comments: This case concerns a 22-year-old, female patient with no previous relevant medical history, who experienced the unexpected events of Condition aggravated, grip strength decreased, gait disturbance, groin pain, arthralgia, feeding disorder, and paralysis. The events occurred 17 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.

Other Meds:

Current Illness: Autism (non-verbal autistic)

ID: 1767743
Sex: F
Age: 77
State: TX

Vax Date: 03/01/2021
Onset Date: 03/30/2021
Rec V Date: 10/07/2021
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: Felt like I had the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Felt like I had the flu) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced INFLUENZA (Felt like I had the flu). At the time of the report, INFLUENZA (Felt like I had the flu) had resolved. No concomitant medications were provided. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1767744
Sex: F
Age: 44
State: TX

Vax Date: 08/12/2021
Onset Date: 08/12/2021
Rec V Date: 10/07/2021
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: did not get her second shot; lost weight since the surgery; she had surgery; had arm pain; This spontaneous case was reported by a consumer and describes the occurrence of SURGERY (she had surgery), PAIN IN EXTREMITY (had arm pain), WEIGHT DECREASED (lost weight since the surgery) and PRODUCT DOSE OMISSION ISSUE (did not get her second shot) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. No medical history was provided by the reporter. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced PAIN IN EXTREMITY (had arm pain). On 07-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SURGERY (she had surgery) and WEIGHT DECREASED (lost weight since the surgery). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get her second shot). The patient was treated with AZITHROMYCIN (ZITHROMAX) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, SURGERY (she had surgery), PAIN IN EXTREMITY (had arm pain), WEIGHT DECREASED (lost weight since the surgery) and PRODUCT DOSE OMISSION ISSUE (did not get her second shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was unknown. Company comment: This is a case of product dose omission issue for this 44-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious events of pain in extremity, surgery and weight decreased. The event pain in extremity occurred on the same day after administration of the first dose of the Moderna COVID-19 Vaccine; the events surgery and weight decreased occurred 26 days after administration of the first dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable as the events occurred after the first dose. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This is a case of product dose omission issue for this 44-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious events of pain in extremity, surgery and weight decreased. The event pain in extremity occurred on the same day after administration of the first dose of the Moderna COVID-19 Vaccine; the events surgery and weight decreased occurred 26 days after administration of the first dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable as the events occurred after the first dose. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1767745
Sex: M
Age: 79
State: MI

Vax Date: 09/20/2021
Onset Date: 09/20/2021
Rec V Date: 10/07/2021
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: Was administered an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Was administered an expired vaccine) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Was administered an expired vaccine). On 20-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Was administered an expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications provided. No treatment medications provided.

Other Meds:

Current Illness:

ID: 1767746
Sex: F
Age: 47
State: OH

Vax Date: 02/11/2021
Onset Date: 02/01/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Ultrasound; Result Unstructured Data: complex variances on my left ovary, cyst in cervix

Allergies:

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

Symptoms: inflammation in my eyes, very dry; vision was affected; body itches; affect my menstrual periods and hormonally; complex variances on my left ovary; cyst in cervix; diagnosed Sjogren's syndrome; my tongue swells up; trouble swallowing; felt tired maybe due to the Benadryl; This spontaneous case was reported by a pharmacist and describes the occurrence of SJOGREN'S SYNDROME (diagnosed Sjogren's syndrome) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Information regarding medical history was not reported. Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), LANSOPRAZOLE (PREVACID), LINACLOTIDE (LINZESS) and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced SWOLLEN TONGUE (my tongue swells up) and DYSPHAGIA (trouble swallowing). In February 2021, the patient experienced FATIGUE (felt tired maybe due to the Benadryl). In March 2021, the patient experienced SJOGREN'S SYNDROME (diagnosed Sjogren's syndrome) (seriousness criterion medically significant), EYE INFLAMMATION (inflammation in my eyes, very dry), VISUAL IMPAIRMENT (vision was affected), PRURITUS (body itches), MENSTRUAL DISORDER (affect my menstrual periods and hormonally), OVARIAN DISORDER (complex variances on my left ovary) and CERVICAL CYST (cyst in cervix). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 11-Feb-2021 to 12-Feb-2021 for Swollen tongue and Swallowing difficult, at a dose of 2 doses and stayed on Benadryl for 24 hrs. On 12-Feb-2021, SWOLLEN TONGUE (my tongue swells up) and DYSPHAGIA (trouble swallowing) had resolved. At the time of the report, SJOGREN'S SYNDROME (diagnosed Sjogren's syndrome), EYE INFLAMMATION (inflammation in my eyes, very dry), VISUAL IMPAIRMENT (vision was affected), PRURITUS (body itches), MENSTRUAL DISORDER (affect my menstrual periods and hormonally), OVARIAN DISORDER (complex variances on my left ovary), CERVICAL CYST (cyst in cervix) and FATIGUE (felt tired maybe due to the Benadryl) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ultrasound scan: abnormal (abnormal) complex variances on my left ovary, cyst in cervix. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment was reported as rest and exercise for the fatigue and tiredness, but the patient can't do what she was doing before. It has affected her ability to do things. This case concerns a 47-year-old female patient with no relevant medical history, who experienced the unexpected serious event of Sjogren's syndrome and non-serious events of Swollen tongue, Dysphagia , Visual impairment, Menstrual disorder, Ovarian disorder and Cervical cyst. The events occurred approximately 1 days after the first dose of Spikevax. The rechallenge is unknown since there's no information about the second dose. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 47-year-old female patient with no relevant medical history, who experienced the unexpected serious event of Sjogren's syndrome and non-serious events of Swollen tongue, Dysphagia , Visual impairment, Menstrual disorder, Ovarian disorder and Cervical cyst. The events occurred approximately 1 days after the first dose of Spikevax. The rechallenge is unknown since there's no information about the second dose. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds: CYMBALTA; PREVACID; LINZESS; AMBIEN

Current Illness:

ID: 1767747
Sex: F
Age: 67
State: TX

Vax Date: 01/15/2021
Onset Date:
Rec V Date: 10/07/2021
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: my arm hurt; headache; body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (my arm hurt), HEADACHE (headache) and MYALGIA (body ache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. Concomitant products included OXYBUTYNIN, MAGNESIUM, ZINC, VITAMIN C [ASCORBIC ACID], TOCOPHEROL (VITAMIN E [TOCOPHEROL]), CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE (OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]), KRILL OIL, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN (LUTEIN [TOCOPHERYL ACETATE;XANTOFYL;ZEAXANTHIN]), FAMOTIDINE, PROGESTERONE and ESTRADIOL for an unknown indication. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (my arm hurt), HEADACHE (headache) and MYALGIA (body ache). At the time of the report, PAIN IN EXTREMITY (my arm hurt), HEADACHE (headache) and MYALGIA (body ache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information were provided. The patient had a bit of a headache and body ache but nothing severe This case was linked to MOD-2021-336727, MOD-2021-336728 (Patient Link).

Other Meds: OXYBUTYNIN; MAGNESIUM; ZINC; VITAMIN C [ASCORBIC ACID]; VITAMIN E [TOCOPHEROL]; OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]; KRILL OIL; LUTEIN [TOCOPHERYL ACETATE;XANTOFYL;ZEAXANTHIN]; FAMOTIDINE; PROGESTERONE; ESTRADIOL

Current Illness:

ID: 1767748
Sex: F
Age: 62
State:

Vax Date: 04/01/2021
Onset Date: 08/01/2021
Rec V Date: 10/07/2021
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: Her left hand start itching/right arm, then feet/itching moved all over her body, 18inch by 18inch patch on back, butt, legs.; Felt like they were on fire; Hives on steroids; Broke out in a whole body rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Her left hand start itching/right arm, then feet/itching moved all over her body, 18inch by 18inch patch on back, butt, legs.), FEELING ABNORMAL (Felt like they were on fire), URTICARIA (Hives on steroids) and RASH (Broke out in a whole body rash) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 025B21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included THYROID (ARMOUR THYROID) for an unknown indication. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced PRURITUS (Her left hand start itching/right arm, then feet/itching moved all over her body, 18inch by 18inch patch on back, butt, legs.), FEELING ABNORMAL (Felt like they were on fire), URTICARIA (Hives on steroids) and RASH (Broke out in a whole body rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency; CORTISONE ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and Manual therapy (Tried using an ice pack) for Rash. At the time of the report, PRURITUS (Her left hand start itching/right arm, then feet/itching moved all over her body, 18inch by 18inch patch on back, butt, legs.), FEELING ABNORMAL (Felt like they were on fire), URTICARIA (Hives on steroids) and RASH (Broke out in a whole body rash) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was reported that the patient started experiencing the adverse events in mid-August. Patient went to the doctor and she told her to take Benadryl which she took and she reports it helped her get to sleep. The ice pack used by the patient worked the best but the cortisone cream did not work. Benadryl helped the patient to get sleep.

Other Meds: ARMOUR THYROID.

Current Illness:

ID: 1767749
Sex: F
Age: 46
State: IA

Vax Date: 12/28/2020
Onset Date:
Rec V Date: 10/07/2021
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: headache; sore arm; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (headache) and MYALGIA (sore arm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The patient's past medical history included Hashimoto's disease and Thyroidectomy. Concurrent medical conditions included Rheumatoid arthritis. On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and MYALGIA (sore arm). The patient was treated with HYDROCORTISONE at a dose of UNK dosage form; ADALIMUMAB (HUMIRA) at a dose of UNK dosage form; ETANERCEPT (ENBREL) at a dose of UNK dosage form and HYDROCODONE at a dose of UNK dosage form. At the time of the report, HEADACHE (headache) and MYALGIA (sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. Other treatment medication included oral steroids. This case was linked to MOD-2021-336827, MOD-2021-336828 (Patient Link).; Sender's Comments: This case concerns a 47 year-old female patient with medical history of Hashimoto's disease, who experienced the unexpected serious events of headache and myalgia. The events occurred on an unknown date after the first dose of mRNA 1273 vaccine. The rechallenge is not applicable in this case as no additional dosing will be given. The medical history of Hashimoto's disease, remains a confounder. The benefit-risk relationship of the vaccine in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.

Other Meds:

Current Illness: Rheumatoid arthritis

ID: 1767750
Sex: F
Age: 67
State: TX

Vax Date: 01/15/2021
Onset Date: 02/01/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: bone pain; pain like bones were freezing; cold sweat; Patient was began to shake; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bone pain), FREEZING PHENOMENON (pain like bones were freezing), COLD SWEAT (cold sweat), TREMOR (Patient was began to shake) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history provided by the reporter. Concomitant products included OXYBUTYNIN, MAGNESIUM, ZINC, VITAMIN C [ASCORBIC ACID], VITAMIN E [VITAMIN E NOS], CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE (OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]), KRILL OIL, LUTEIN [XANTOFYL], FAMOTIDINE (FAMOTIDINE AMEL), PROGESTERONE and ESTRADIOL for an unknown indication. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced BONE PAIN (bone pain), FREEZING PHENOMENON (pain like bones were freezing), COLD SWEAT (cold sweat), TREMOR (Patient was began to shake), CHILLS (chills) and NAUSEA (nausea). At the time of the report, BONE PAIN (bone pain), FREEZING PHENOMENON (pain like bones were freezing), COLD SWEAT (cold sweat), TREMOR (Patient was began to shake), CHILLS (chills) and NAUSEA (nausea) outcome was unknown. Treatment information was not provided by the reporter. This case was linked to MOD-2021-336576, MOD-2021-336728 (Patient Link).

Other Meds: OXYBUTYNIN; MAGNESIUM; ZINC; VITAMIN C [ASCORBIC ACID]; VITAMIN E [VITAMIN E NOS]; OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]; KRILL OIL; LUTEIN [XANTOFYL]; FAMOTIDINE AMEL; PROGESTERONE; ESTRADIOL.

Current Illness:

ID: 1767751
Sex: M
Age: 66
State: MI

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 10/07/2021
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: 8 patients got expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 patients got expired vaccine) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 patients got expired vaccine). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (8 patients got expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication use was reported.

Other Meds:

Current Illness:

ID: 1767752
Sex: F
Age: 43
State: MA

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

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

Lab Data: none

Allergies: none

Symptom List: Vomiting

Symptoms: lump in neck on side of injection ( most concerning) lymphadenopathy fever, chills, extreme arm pain

Other Meds: none

Current Illness: none

ID: 1767753
Sex: F
Age: 59
State: OH

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

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Hives, shaking, sweating

Other Meds:

Current Illness:

ID: 1767754
Sex: M
Age: 71
State: OR

Vax Date: 03/16/2021
Onset Date: 03/16/2021
Rec V Date: 10/07/2021
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: Felt tired; had a sore injection site arm; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Felt tired) and VACCINATION SITE PAIN (had a sore injection site arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A, 016B21A and 050C21A) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced FATIGUE (Felt tired) and VACCINATION SITE PAIN (had a sore injection site arm). At the time of the report, FATIGUE (Felt tired) and VACCINATION SITE PAIN (had a sore injection site arm) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment information was provided by the reporter. This case was linked to MOD-2021-336849, MOD-2021-336855 (Patient Link).

Other Meds:

Current Illness: Immunocompromised.

ID: 1767755
Sex: U
Age:
State: NJ

Vax Date: 02/14/2021
Onset Date:
Rec V Date: 10/07/2021
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: Swelling on arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling on arm) 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 14-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 PERIPHERAL SWELLING (Swelling on arm). At the time of the report, PERIPHERAL SWELLING (Swelling on arm) outcome was unknown. No concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1767756
Sex: M
Age: 20
State: NY

Vax Date: 07/28/2021
Onset Date:
Rec V Date: 10/07/2021
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: 2021; Test Name: white blood cells; Result Unstructured Data: Elevated

Allergies:

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

Symptoms: Within few days of having 2nd dose, he started with muscle cramping all over the body./Cramping gets worst when he does physical activity./The muscles are extremely fatigued, cramping and locking; The muscles are extremely fatigued; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Sep-2021 and was forwarded to Moderna on 29-Sep-2021. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Sep-2021 and was forwarded to Moderna on 29-Sep-2021. This spontaneous case was reported by a nurse and describes the occurrence of MUSCLE SPASMS (Within few days of having 2nd dose, he started with muscle cramping all over the body./Cramping gets worst when he does physical activity./The muscles are extremely fatigued, cramping and locking) and MUSCLE FATIGUE (The muscles are extremely fatigued) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939893 and 017E21A) for COVID-19 vaccination. Concomitant products included CREATINE for an unknown indication. On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MUSCLE SPASMS (Within few days of having 2nd dose, he started with muscle cramping all over the body./Cramping gets worst when he does physical activity./The muscles are extremely fatigued, cramping and locking) and MUSCLE FATIGUE (The muscles are extremely fatigued). At the time of the report, MUSCLE SPASMS (Within few days of having 2nd dose, he started with muscle cramping all over the body./Cramping gets worst when he does physical activity./The muscles are extremely fatigued, cramping and locking) and MUSCLE FATIGUE (The muscles are extremely fatigued) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, White blood cell count: elevated (High) Elevated. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product included supplements. Treatment medications were given as none. Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Follow-up received on 05Oct 2021 contain no new information

Other Meds: CREATINE.

Current Illness:

ID: 1767757
Sex: M
Age:
State:

Vax Date: 03/24/2021
Onset Date:
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Date: 202105; Test Name: MRI; Result Unstructured Data: showed significant changes from 12-L1 with significant degenerative changes from L2-L3, L3-L4

Allergies:

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

Symptoms: felt worse physically; back tenderness; Nerve pain; starting having problems walking; increased weakness; degenerative disc; nerve being compressed; increased pain in the back; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt worse physically), MUSCULOSKELETAL DISCOMFORT (back tenderness), NEURALGIA (Nerve pain), GAIT DISTURBANCE (starting having problems walking) and ASTHENIA (increased weakness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt worse physically), MUSCULOSKELETAL DISCOMFORT (back tenderness), NEURALGIA (Nerve pain), GAIT DISTURBANCE (starting having problems walking), ASTHENIA (increased weakness), INTERVERTEBRAL DISC DEGENERATION (degenerative disc), NERVE COMPRESSION (nerve being compressed) and BACK PAIN (increased pain in the back). At the time of the report, FEELING ABNORMAL (felt worse physically), MUSCULOSKELETAL DISCOMFORT (back tenderness), NEURALGIA (Nerve pain), GAIT DISTURBANCE (starting having problems walking), ASTHENIA (increased weakness), INTERVERTEBRAL DISC DEGENERATION (degenerative disc), NERVE COMPRESSION (nerve being compressed) and BACK PAIN (increased pain in the back) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Magnetic resonance imaging: abnormal (abnormal) showed significant changes from 12-L1 with significant degenerative changes from L2-L3, L3-L4. Concomitant product use was not provided by the reporter. Treatment information was not provided. The test result changes of MRI scan were dramatic from previous MRI scan done on 13-Jan-2020. The patient had never felt pain from disk issues before this, and felt actual pain from being touched. MRI scan results found between 24-May-2021 to 26-May-2021 showed that the patient's ability to walk was getting worse due to increased pain in back the patient had been losing feeling in legs which increased weakness. Patient had received spinal injection on 14-Jun-2021 directly into L2/L3 facets with incredible relief for two days (felt like new) and increased pain returned but with increased intense. Patient has possible surgery of spinal fusion set for 05-Oct-2021. This case was linked to MOD-2021-335370 (Patient Link).

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am