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
46,870MODERNA
532GLAXOSMITHKLINE BIOLOGICALS
353PFIZER\BIONTECH
231MERCK & CO. INC.
221UNKNOWN MANUFACTURER
62SEQIRUS, INC.
25DYNAVAX TECHNOLOGIES CORPORATION
13EMERGENT BIOSOLUTIONS
12SANOFI PASTEUR
9NOVARTIS VACCINES AND DIAGNOSTICS
5PFIZER\WYETH
5PAXVAX
2TEVA PHARMACEUTICALS
2PROTEIN SCIENCES CORPORATION
1BERNA BIOTECH, LTD.
1INTERCELL AG
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL1,906
1,575
289
IMM209286
252
236
229
s029456178
171
UT7065MA166
155
149
145
S034636133
107
U62828AA103
100
98
P10025327596
U6737AA85
UJ446AA79
78
78
59
57
4BH3254
4F47253
52
27656352
50
PP9L548
49TM346
42
40
38
MENVEO38
4F47237
R1B252M36
34
C5763AA30
93362229
25
300057A24
UNK24
22
CW311621
18
17
15
UH894AB15
3Y7NL12
R1B743M12
EJ168611
el128410
10
10
10
9
ARBA141A9
UNK9
8
UNK8
8
1F4EB8
Unknown7
7
No batch number6
5
5
UJ090AA5
5
5
4
4
4
UNK4
JEV18K95E4
UNK3
A115A3
Z127A3
3
3333324181073
2
2
2
TAR352
1
1
1
1
1
A739081
1
1
1
1
1
037K20A68,542
EL128447,700
133

Incidents per State

State Total
15,185
CA14,096
NY7,507
TX7,196
FL6,939
IN5,527
PA4,560
IL4,179
OH4,054
AZ3,856
MI3,771
NJ3,411
MA3,278
VA3,208
NC3,114
WA3,034
GA2,864
MD2,652
MN2,534
CO2,532
WI2,457
MO2,029
OR1,943
TN1,715
CT1,693
KY1,603
OK1,226
AL1,201
KS1,162
IA1,157
SC1,106
NM1,065
UT973
AR951
LA945
NE829
NV797
ME795
MT789
NH756
ID674
AK661
WV661
PR650
MS585
HI536
RI510
VT441
SD361
ND356
DE350
DC239
WY209
GU32
AS16
VI13
MP9
MH3
FM2
QM1
XB1

ID: 1045162
Sex: F
Age: 36
State: NM

Vax Date: 02/05/2021
Onset Date: 02/12/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data: Took photos

Allergies: None

Symptoms: ?COVID arm? delayed cutaneous hypersensitivity; Firmness day 1-2, a lot more painful than initial injection pain, redness that increased/spread over 3 days, painful to touch, slightly raised and swollen, started really painful ? itchy days 2-5. Took photos.

Other Meds: Topiramate, Bupropion, Montelucast, amitripytiline, omeprezole, lamotrezine, norethindone

Current Illness: No

ID: 1045164
Sex: M
Age: 25
State: NV

Vax Date: 02/19/2021
Onset Date: 02/20/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data: None

Allergies: None

Symptoms: The morning after I received both vaccine shots, I posted hearing from my right ear. The first time I received the vaccine shot, the morning after, I could barely hear out of my right ear. It almost sounded like there was a clog or earwax build-up. I didn't really think much of it and it gradually went away several days later. The worst day was the next day after the vaccine and it lasted, even though in a small amount, until 3 days after. The second dose caused the same problem. The morning after the second dose of the vaccine, I lost my hearing in the same way as before. I could barely hear out of my ear, however, I was also exhausted and ended up sleeping most of the day. When I woke up in the afternoon, I couldn't hear from my right ear, but I could hear better. (maybe 25% back to normal). The two days after the vaccine, my hearing came back way better than the previous time. It felt like 80% back to normal and later in the today, it felt like it up to 95% back to normal. The best way I can describe the feeling was as if the sound was still being received to my hear, but it sounded muffled and turned down. I was still able to hear the deeper sounds during conversations and deeper 'beats' in music, but the sharpness of everything was turned off.

Other Meds: None

Current Illness: None

ID: 1045165
Sex: M
Age: 42
State: LA

Vax Date: 01/28/2021
Onset Date: 01/29/2021
Rec V Date: 02/22/2021
Hospital: Y

Lab Data: CDC Went to allergy specialist 02/01/21 for testing that ruled out all food allergies Suspect PEG allergy

Allergies: None known

Symptoms: Severe Anaphylaxis onset at 3:00am. Epinephrine administered at home. Transported to ER. BP 80/40 at admission. 2nd Epinephrine administered at ER. IV fluids. BP recovered and discharged at 7:30am. Prescribed Prednisone 20mg, Famotidine 20mg, and Cetirizine 10mg.

Other Meds: Amlodipine 5mg 1/day Losartan 50mg 1/day Adderall 20mg 1/day Ibuprofen

Current Illness: None

ID: 1045166
Sex: F
Age: 49
State: AK

Vax Date: 02/13/2021
Onset Date: 02/21/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data: NA

Allergies: Dander allergies, possible hay and other outside allergens (minor).

Symptoms: Itchy rash near the injection site appeared 2/21/21. 2 1/2 inches long, 2 inches wide. There is still a faint pink border as to where the edges of the bandaid were (noted on the V-safe site of redness where bandaid was - no pain or itchiness symptoms at that time). The upper part of the rash touches the lower part of the pink bandaid outline. Bandaid outline still has no pain or itchiness. This symptom did not occur until after all the V-safe checking were complete. I have taken a Claritin and put anti itch cream on the site. At this point I do not have enough concern to notify a doctor. I will contact Teledoc if the rash spreads further or adversely changes in any other ways.

Other Meds: Women?s 1aday, magnesium, B12, C, D, Claritin

Current Illness: NA

ID: 1045167
Sex: M
Age: 24
State: TX

Vax Date: 02/21/2021
Onset Date: 02/22/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data:

Allergies: N/A

Symptoms: Pain in arm spreading throughout first few hours, by 14 hours post vaccination hives began appearing with increased intensity and number. By 15 hours post vaccination a mild headache and low fever of 100.8 developed. Treatment included diphenhydramine to ease antihistamine response and aspirin to lower fever and reduce severity of headache.

Other Meds: Diphenhydramine

Current Illness: N/A

ID: 1045169
Sex: M
Age: 76
State: AZ

Vax Date: 02/05/2021
Onset Date: 02/19/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data:

Allergies: None

Symptoms: Developed quite a bit of pain in the tip of left index finger. Also, have slight numbness feeling there.

Other Meds:

Current Illness: Heart

ID: 1045170
Sex: F
Age: 70
State: WA

Vax Date: 02/19/2021
Onset Date: 02/20/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data: N/a

Allergies: Prozac

Symptoms: Fever,chills,upset stomach, body aches,headache

Other Meds: Omeprazole, buspar, estrovan,multivitamin

Current Illness: None

ID: 1045171
Sex: F
Age: 44
State: AZ

Vax Date: 02/18/2021
Onset Date: 02/19/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data:

Allergies: none

Symptoms: Day 1 - pain in arm where shot was administered. Day 2 - 4 - pain down arm concentrated in left arm-pit, area surrounding arm-pit and left wrist and top of hand.

Other Meds: Vitamin D, Vitamin C, multivitamin, welbutrin, pravastatin

Current Illness: none

ID: 1045172
Sex: F
Age: 50
State: FL

Vax Date: 02/19/2021
Onset Date: 02/20/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data: I have not gone to the doctor about this yet as I?m just feeling tonight that it?s a real problem. If I still have the palpitations tomorrow I?ll go.

Allergies: Penicillin

Symptoms: There were things that I expected, like the muscle aches, fatigue, fever. But I didn?t know I was going to get such heart palpitations. I got the shot Friday afternoon, I started noticing the palpitations Saturday afternoon, and now Sunday night they?re really bothering me. They?re almost continuous. It feels like I drank a lot of caffeine, but I haven?t.

Other Meds:

Current Illness: None

ID: 1045173
Sex: F
Age: 33
State: NY

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data:

Allergies: None known

Symptoms: Pfizer-BioNTech COVID-19 Vaccine EUA

Other Meds:

Current Illness:

ID: 1045175
Sex: M
Age: 11
State: ID

Vax Date: 02/19/2021
Onset Date: 02/20/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data:

Allergies: NA

Symptoms: Arm is swollen double the normal size. Swollen from elbow to shoulder. Red and hot to the touch. Painful to move

Other Meds: NA

Current Illness: NA

ID: 1045176
Sex: F
Age: 33
State:

Vax Date: 01/09/2021
Onset Date: 01/17/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data:

Allergies: NONE

Symptoms: The patient is a 34yo female seen about 1 month ago for SOB - it developed 1 week after the COVID vaccine. She was sent to Cardiology and they diagnosed her with pericarditis and she was started on scheduled NSAIDS. - Cardiology recommended ESR, CRP and CBC and they were negative. - CXR was normal - Echocardiogram was suggestive of pericarditis. Cardiology told her to follow up in 1 month is symptoms did not improve and they have not. Also she stated she has developed mild, intermittent peripheral edema that resolves without intervention but this is new. I am also ordering the cardiac MRI which the cardiologist recommended if symptoms did not improve with NSAIDs.

Other Meds: Allegra PRN Lunesta PRN MiraLax.

Current Illness: NONE

ID: 1045177
Sex: F
Age: 37
State:

Vax Date: 02/13/2021
Onset Date: 02/16/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Arm with large area of redness, warmth and induration. Started 2-3 days after injection and lasted until day 7

Other Meds: APAP and Ibuprofen

Current Illness:

ID: 1045178
Sex: M
Age: 20
State:

Vax Date: 02/18/2021
Onset Date: 02/19/2021
Rec V Date: 02/22/2021
Hospital: Y

Lab Data: EKG; ESR; CRP; LIPASE; TROPONIN; CBC; CMP; CPK; CK-MB; CK; COVID; D-DIMER; CTA (CHEST R/O PE)

Allergies: NONE

Symptoms: CHEST PAIN; SOB; ELEVATED INFLAMATORY MARKERS; ELEVATED TROPONIN; MYOCARDITIS

Other Meds: NONE

Current Illness: NONE

ID: 1045179
Sex: F
Age: 21
State: CO

Vax Date: 02/10/2021
Onset Date: 02/11/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data: None

Allergies: Peas, pears, apricots

Symptoms: Pain at injection site began 1-2 hours after and lasted 1 week, tearing axillary pain on same side as injection began next day and lasted 1 week, chills and body aches began next day and lasted ~12 hours.

Other Meds: Zoloft, oral birth control, melatonin

Current Illness: None

ID: 1045181
Sex: F
Age: 39
State: WI

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data: Will need covid test if still symptomatic in morning of 2/22/2021 (work as nurse in NICU)

Allergies: Codeine

Symptoms: Severe body aches Chills Fever Sweats (changed clothes 4 times because wringing wet) Severe headache Fatigue (slept for 24 hours) Vomiting Nausea Light sensitivity

Other Meds: Lexapro Levothyroxine EnLyte Arnuity Ellipta

Current Illness: Runny nose, cough, congestion - tested covid negative on February 7th - ?cold? started February 3rd

ID: 1045182
Sex: M
Age: 41
State: MN

Vax Date: 02/18/2021
Onset Date: 02/19/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data: None

Allergies: None

Symptoms: Fever @ 102 degrees F Systemic Shivering Systemic Chills Systemic Muscle Aches Headache Lightheadedness

Other Meds: None

Current Illness: None

ID: 1045471
Sex: F
Age:
State: PR

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Mild discomfort; This is a spontaneous report from a contactable consumer, the patient. A 51-years-old non-pregnant female patient received the first dose of bnt162b2 (BNT162B2, lot number: EL-1283) , via an unspecified route of administration in the left arm (at 51 years of age) on 22-JAN-2021 at 13:00 as a single dose for Covid-19 Vaccination. Medical history included hypertension and Hypothyroidism. Concomitant medication included levothyroxine sodium (SYNTHROID), hydrochlorothiazide, losartan potassium (HYZAAR). The patient had no known allergies. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 22Jan2021 at 14:30, the patient experienced mild discomfort. No treatment was given for the event. The clinical outcome of the event mild discomfort was unknown.

Other Meds: SYNTHROID; HYZAAR

Current Illness:

ID: 1045472
Sex: F
Age:
State: PR

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data: Test Date: 20210120; Test Name: nasal swab (antigen); Test Result: Negative

Allergies:

Symptoms: Fever; headache; tachycardia; left arm pain; muscle pain; stomach upset; This is a spontaneous report received from a contactable nurse (patient). A 25-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and lot number: EL9282) at the age of 25 years intramuscularly to left arm on 28Jan2021 13:00 at single dose for Covid-19 immunisation in hospital. Medical history included Kyphosis. The patient had no known drug allergy (NKDA). The patient had no concomitant medications. Patient previously the first dose of BNT162B2 at the age of 25 years for Covid-19 immunisation. The patient did not receive other vaccine in four weeks. The patient was not pregnant. The patient did not have COVID prior to vaccination. The patient underwent nasal swab (antigen) test on 20Jan2021 with negative result. On 28Jan2021 16:00 the patient experienced fever, headache, tachycardia, left arm pain, muscle pain and stomach upset. Therapeutic measure was taken as a result of the events and included treatment with PANADOL 500mg. Outcome of events was recovering. No follow-up attempts are possible. No other information was reported.

Other Meds:

Current Illness:

ID: 1045507
Sex: U
Age:
State: FL

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 02/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: patient received an expired dose; No further AE; Information has been received from a pharmacist reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 01-FEB-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection for prophylaxis, lot # R011628 and expiration date 11-DEC-2020 (route of administration was not reported). No further adverse events reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R011628; expirationdate: 11-DEC-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability

Other Meds: GARDASIL 9 SYRINGE (DEVICE)

Current Illness:

ID: 1045508
Sex: U
Age:
State: UT

Vax Date: 02/15/2021
Onset Date: 02/15/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: administration of expired dose of VAQTA; This spontaneous report was received from a medical assistance and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On 15-FEB-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA), lot number S030588 with expiration date 20-OCT-2020 (dose, route and anatomical location were not reported) for prophylaxis.

Other Meds:

Current Illness:

ID: 1045509
Sex: F
Age: 51
State: VA

Vax Date: 12/15/2020
Onset Date: 12/01/2020
Rec V Date: 02/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: skin irritation on the same arm as the injection site / expanding out 5" from injection site; fever; chills; tiredness; injection site soreness; This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date). On 15th December 2020, the patient received the 2nd dose of Shingrix. In December 2020, 15 hrs after receiving Shingrix, the patient experienced injection site pain, injection site irritation, fever, chills and tiredness. On an unknown date, the outcome of the injection site pain, fever, chills and tiredness were recovered/resolved and the outcome of the injection site irritation was not recovered/not resolved. The reporter considered the injection site pain, injection site irritation, fever, chills and tiredness to be related to Shingrix. Additional details were provided as follow: After received 2nd dose of Shingrix, the patient experienced fever, chills, tiredness, injection site soreness and skin irritation on the same arm as the injection site beginning 15 hrs after injection and continuing for 24 hrs. Skin irritation expanding out 5 cm from injection site. Skin irritation had not resolved 3 days post injection. The reporter believes these symptoms were due to the injection of Shingrix. Requesting Consent to follow up.

Other Meds:

Current Illness:

ID: 1045510
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/22/2021
Hospital:

Lab Data: Test Name: Body temperature; Result Unstructured Data: 101.2; Test Name: Body temperature; Result Unstructured Data: 99.6

Allergies:

Symptoms: Heart was a little bit flippy; Been feeling very weak for several days; Arm has swelled up and went up all the way to my elbow; Arm got very red and went up all the way to my elbow; Gave me the shot at the wrong place towards the front of my arm; Fever today the highest it's been is 101.2 and is now 99.6; Very tired; Joint aches; A spontaneous report was received from a consumer, concerning a female patient of an unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart was a little bit flippy, been feeling very weak for several days, fever today the highest it's been is 101.2 and is now 99.6, very tired, arm has swelled up and went up all the way to my elbow, arm got very red and went up all the way to my elbow, gave me the shot at the wrong place towards the front of my arm. Medical history included paroxysmal supraventricular tachycardia. No concomitant medication was reported. On 23-Dec-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via an unknown route for prophylaxis of COVID-19 infection. On an unknown date, after 8 days after the first shot of vaccine, the patient's heart was a little bit flippy, been feeling very weak for several days, today's fever was the highest it's been is 101.2 and is now 99.6, very tired, arm has swelled up and went up all the way to my elbow, arm got very red and went up all the way to my elbow, gave me the shot at the wrong place towards the front of my arm. Laboratory details included body temperature: 101.2 and 99.6. Treatment medication was not reported. Action taken with mRNA-1273 in response to the events were not provided. The outcome of the events, my heart was a little bit flippy, been feeling very weak for several days, fever today the highest it's been is 101.2 and is now 99.6, very tired, my arm has swelled up and went up all the way to my elbow, my arm got very red and went up all the way to my elbow were considered unknown at the time of this report. The outcome of event gave me the shot at the wrong place towards the front of my arm was considered resolved at the time of this report.; Reporter's Comments: This case concerns a female (age unknown) with PMHx of PST had Vaccine administered at inappropriate site, NS unexpected asthenia, cardiac flutter, asthenia, NS expected fever, fatigue, arthralgia, vaccination site swelling, vaccination site erythema. Adverse events occurred 8 days after first dose of mRNA-1273 (lot # unknown). Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1045511
Sex: F
Age: 60
State: NY

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Red swelling; Red swelling; Injection in left arm but cannot assure it was intramuscular; A spontaneous report was received from a consumer who is a 60-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and got injection in left arm but cannot assure it was intramuscular, red and swelling (injection site erythema and injection site swelling). The patient's medical history was not provided. No concomitant medications were reported. On 11 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) in the left arm for prophylaxis of COVID-19 infection. On 11 Jan 2021, after the first dose of vaccine, the patient confirmed that she was fine but had a small pinhead were the vaccine was injected and was not sure if she got the injection via intramuscularly in the left arm. On 20 Jan 2021, when patient woke up, she found with red swelling that continued to grow at the time of this report. Treatment for the event included unspecified antibiotic. Action taken with mRNA-1273 in response to the events were not provided. The outcome of the events, injection in left arm but cannot assure it was intramuscular was considered resolved on 11 Jan 2021. The outcome of events red swelling was considered not resolved and was continuing at the time o this report.; Reporter's Comments: This case concerns a 60-year-old female with a NS unexpected event of Incorrect route of product administration and NS expected events of Injection site erythema and Injection site swelling. The expected events occurred 10 days after first dose mRNA-1273 (lot # unknown). Treatment included an antibiotic. Based on current available information and temporal association between the use of the product and the start date of the associated adverse events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1045512
Sex: U
Age:
State: OK

Vax Date:
Onset Date: 02/04/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 0.5 mL leaked out of patient's arm; vacination site discharge; A spontaneous report was received from a pharmacist concerning a patient of unknown age and unknown gender who received the Moderna COVID-19 vaccine and experienced incorrect dose administered and Vaccination site discharge. A different nurse administered vaccine to patient and they noticed 0.5mL leak out of patient's arm. Moderna vaccine, it was a second dose, administered to just one patient. Pharmacist wants to know if they should repeat dose. Only 1 injection was involved, and Pharmacist has no patient specific information. Ok for safety to contact. HCP wants in writing. The patient's medical history was not provided. Concomitant product use was not reported by the reporter. On 04 Feb 2021, the patient received their first of two planned doses of mRNA-1273 Batch number not provided on unknown date. Prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 Batch number not provided intramuscularly in the for prophylaxis of COVID-19 infection. On 04 Feb 2021, a different nurse administered vaccine to patient and they noticed 0.5mL leak out of patient's arm., the injection site leaked. Moderna vaccine was a second dose, administered to just one patient. Pharmacist wants to know if they should repeat dose. Only 1 injection was involved, and Pharmacist has no patient specific information. Ok for safety to contact. HCP wants in writing. Treatment information was not provided. Action taken with mRNA-1273 in response to the events incorrect dose administered and Vaccination site discharge was not applicable. The outcome of the event was considered as recovered on 04 Feb 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered and Vaccination site discharge for mRNA-1273. There were no reported adverse events associated with this case.

Other Meds:

Current Illness:

ID: 1045513
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: UTI after second dose; A spontaneous report was received from healthcare professional concerning a female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced UTI after second dose. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On 03 Feb 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On an unknown date, after receiving the second dose of vaccination, the patient developed UTI. Treatment included antibiotics. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. The outcome for the event, UTI after second dose was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1045514
Sex: F
Age: 48
State: NE

Vax Date: 01/11/2021
Onset Date: 01/28/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Appendicitis pain; A spontaneous report was received from a nurse concerning a 48-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced appendicitis pain. The patient's medical history was not provided. Concomitant medications reported included omeprazole, venlafaxine hydrochloride, trazodone and spironolactone. (batch number: 041L20A) On 11 Jan 2021, seventeen days prior to onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: 041L20A) intramuscularly in her left arm for the prophylaxis of COVID-19 infection. On 28 Jan 2021, after the vaccine administration, the patient experienced appendicitis pain, hence on 30 Jan 2021, she underwent appendicectomy. Action taken with mRNA-1273 in response to the event was not reported. The outcome of event, appendicitis pain was considered unknown at the time of his report.; Reporter's Comments: This case of appendicitis in a 48-year-old, female patient 17 days after the administration of mRNA-1273 vaccine(batch number: 041L20A) as assessed as unlikely associated with the vaccine administration based on then natural history of the disease and based on duration and outcome (appendectomy), it was most likely an ongoing inflammatory process.

Other Meds: OMEPRAZOLE; EFFEXOR; TRAZODONE; SPIRONOLACTONE

Current Illness:

ID: 1045515
Sex: F
Age:
State:

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: vaccine was injected directly into her vein/artery; bulging veins; nail beds turned blue; A spontaneous report was received from a consumer concerning a female patient, of unknown age, who developed bulging veins and nail beds turned blue after receiving a first dose of Moderna's COVID-19 vaccine administered directly into her vein/artery. The patient's medical history was not provided. No relevant concomitant medications were reported. On 07-JAN-2021 prior to the onset of the events, patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) unknown route of administration. On 03-FEB-2021, patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) unknown route of administration for prophylaxis of COVID-19 infection. The patient was administered mRNA-1273 vaccine directly into vein/artery, on 07-JAN-2021, and developed bulging veins and nail beds turned blue. Treatment for the event included ice pad. EMTs checked blood pressure and monitor the patient for several minutes. There was no change planned to the dosing schedule of mRNA-1273 in response to the event. The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The event, vaccine administered directly into vein/artery was considered resolved. The outcome for the event bulging veins and nail beds turned blue not provided. .; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. Further information is requested.

Other Meds:

Current Illness:

ID: 1045516
Sex: F
Age:
State: CA

Vax Date: 01/20/2021
Onset Date: 02/03/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Breast cancer; A spontaneous report was received on 05 Feb 2021 from a consumer concerning an unknown age, female patient who received Moderna's COVID-19 vaccine and diagnosed with breast cancer. The patient's medical history was not provided. No relevant concomitant medications were reported. On 20 Jan 2021, patient received their first of two planned doses of mRNA-1273(Lot number: unknown), for the prophylaxis of COVID-19 infection. On 03 Feb 2021, the patient was diagnosed with breast cancer. Action taken the second dose of mRNA-1273 in response to the events was not reported. The outcome of the event, breast cancer was not resolved. The assessment of the causality by reporter was, there was no relation between the vaccine and the diagnosis of cancer, but as the event occurred after the administration of the Moderna COVID-19 vaccine.; Reporter's Comments: Based on the current available information, the event was diagnosed 15 days after the administration of mRNA-1273. Due to the nature of development of breast cancer, the event was assessed as unlikely related. Further information has been requested.

Other Meds:

Current Illness:

ID: 1045517
Sex: M
Age:
State: NE

Vax Date: 02/03/2021
Onset Date: 02/04/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Sharp pains in feet (neuropathy); Bad diarrhea; Felt yucky and not feeling good at all; Arm swollen on the same side of injection; A spontaneous report was received from a consumer who was also a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced sharp pains in feet (neuropathy)/ neuropathy peripheral, arm swollen on same side of injection/ injection site swelling, bad diarrhea/ diarrhea, and feeling yucky and not good at all/ malaise. The patient's medical history was not provided. No relevant concomitant medications were reported. On 03 Feb 2021, approximately at 12:00 pm, the patient received their first of two planned doses of mRNA-1273 (Lot number: 010M20A) intramuscularly for prophylaxis of COVID-19 infection. On 04 Feb 2021, the patient started experiencing symptoms of sharp pains in his feet (neuropathy), bad diarrhea, felt yucky and not feeling good at all. On 05 Feb 2021, the patient reported that the symptoms did not abate, however they were improving. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the events, sharp pains in feet (neuropathy), arm swollen on same side of injection, bad diarrhea and felt yucky and not good at all, was resolving.; Reporter's Comments: Based on the current available information and a temporal association between the use of the product and the onset of the reported events a causal relationship cannot be excluded. Injection site swelling is consistent with the known safety profile of the vaccine.

Other Meds:

Current Illness:

ID: 1045518
Sex: F
Age:
State: NJ

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Something occurred in the syringe that not the 0.5 mL entered her arm and part spilt out; Something occurred in the syringe that not the 0.5 mL entered her arm and part spilt out; A spontaneous/solicited report was received from a consumer concerning herself, a 76 year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and reported that something occurred in the syringe so that the 0.5 mL did not enter her arm and part spilt out/device connection issue and underdose. The patient's medical history included breast cancer and cholesterol (not further specified). Products known to have been used by the patient, within two weeks prior to the event, included medicine for blood pressure (not further specified), vitamins, atorvastatin calcium and nebivolol hydrochloride. On 22 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 026L20A) intramuscularly for prophylaxis of COVID-19 infection. On 22 Jan 2021, during administration, the patient reported that something occurred in the syringe so that the 0.5 mL did not enter her arm and part spilt out. No treatment information was provided. The second dose of mRNA-1273 was scheduled for 18 Feb 2021. Action taken with mRNA-1273 in response to the events was not reported. The events, something occurred in the syringe so that the 0.5 mL did not enter her arm and part spilt out, were considered resolved on 22 Jan 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered, and underdose for mRNA-1273, lot # 026L20A with no associated AEs.

Other Meds: VITAMINS NOS; LIPITOR; BYSTOLIC

Current Illness:

ID: 1045519
Sex: F
Age: 71
State: TX

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Warm to the touch injection site; Bruise on injection site; Itching left arm injection site; Redness on the side of the injection site; Pain left arm (with movement); Urinary tract infection; Headache; A spontaneous report was received from a consumer, concerning herself, a 71-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed urinary tract infection, warm to the touch injection site, pain left arm (with movement), bruise on injection site, itching left arm injection site, headache and redness on the side of the injection site. The patient's medical history provided included cystitis. Concomitant product use was not provided by the reporter. On 27 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot # 004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 27 Jan 2021, after the first dose of vaccine administration, the patient developed headache. On 03 Feb 2021 (Wednesday) the patient experienced urinary tract infection and took one capsule of cephalexin 500mg. Later, on 04 Feb 2021, the patient's left arm of injection site had started itching and her arm was hurt on movement. When she checked in the mirror, she noticed a bruise on injection site and the side of the injection site was red and also was little warm to the touch. She thought the skin reaction might have been triggered by the cephalexin, hence she did not continue the antibiotic, but she also confirmed that she had no reactions anywhere else on the body. Action taken with mRNA-1273 in response to the events were unknown. The outcome of event, headache was considered to be resolved on 28 Jan 2021. The outcome of the events, urinary tract infection, warm to the touch injection site, pain left arm (with movement), bruise on injection site, itching left arm injection site and redness on the side of the injection site were considered unknown at the time of this report.; Reporter's Comments: Based on the current information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. Patient's medical history of cystitis is a confounder for urinary tract infection.

Other Meds:

Current Illness:

ID: 1045520
Sex: F
Age: 84
State: MI

Vax Date: 01/28/2021
Onset Date: 02/05/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Possible cellulitis; left arm stiff; itchy redness on the area of injection; itchy redness on the area of injection; A spontaneous report was received from consumer concerning a 84-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itchy redness the injection site on her left arm, her left arm is stiff, and possible cellulitis. The patient's medical history and concomitant product use were not provided. On 28-Jan-2021, the patient received the first of two planned doses of mRNA-1273, (Lot number 007M20A), intramuscularly into her left arm for prophylaxis of Covid-19 infection. On the morning of 05-Feb-2021 the patient noticed, itchy redness, 4X6 inches in size, 4 inches below the injection site on her left arm and her left arm is stiff. The patient was examined by her doctor that same day and was prescribed Doxycycline for a possible cellulitis. No relevant laboratory tests were ordered. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the events, itchy redness, 4X6 inches in size, 4 inches below the injection site on her left arm and her left arm is stiff and possible cellulitis were unknown.; Reporter's Comments: This case concerns an 84-year-old female who experienced a serious unexpected event of cellulitis along with a NS unexpected events of stiffness and injection site pruritus and NS expected event of injection site erythema. The events occurred 9 days after the first dose of mRNA-1273. Treatment included doxycycline. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1045521
Sex: F
Age: 83
State: IL

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Fainted; Diarrhea; Nausea; Warm body temperature; A spontaneous report was received from a consumer, regarding herself, a 82-year-old, female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fainted, diarrhea, nausea and warm body temperature. The patient's medical history reported included ulcerative colitis. Concomitant product use was not provided. On 04 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot Number: 038K20A) intramuscularly for prophylaxis of COVID-19 infection. On 04 Feb 2021, in the evening, after receiving the vaccine, the patient was fainted and started to experience diarrhea, nausea and warm body temperature. The event fainted was considered to be medically significant. Treatment for the events not provided. Action taken with the second dose of mRNA-1273 in response to the events were not reported. The outcome for the events, fainted, diarrhea, nausea and warm body temperature were resolved on 05 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Ulcerative colitis

ID: 1045522
Sex: F
Age: 57
State: GA

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Third of the vaccine leaked out of patients arm; A spontaneous report was received from a nurse, concerning a 57-year-old female patient, who received Moderna's COVID-19 vaccine and the third of vaccine leaked out of patient's arm. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 05 Feb 2021, prior to the onset of the event, the patient received her first of two planned doses of mRNA-1273 (Lot number: 013M20A) for prophylaxis of Covid-19 infection. On 05 Feb 2021, while nurses was administering patient's first dose of vaccine, the dose was leaked out of patient's arm (almost third of the dose leaked out). However, the nurse was not exposed to the vaccine. Treatment information was not provided. Action taken with mRNA-1273 in response to the events were not reported. The event, third of vaccine leaked out of patient's arm was considered resolved on 05-Feb-2021.; Reporter's Comments: This case report concerns a non-serious unexpected event of a 57-year-old female patient who experienced third of vaccine leaked out of patient's arm. (Incomplete dose administered) for mRNA-1273, lot # 013M20A. There were no reported AEs associated with this case of incomplete dose administered.

Other Meds:

Current Illness:

ID: 1045523
Sex: M
Age: 75
State: FL

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: AFIB; really tired; chest pain; A spontaneous report was received from a consumer concerning a himself, a 75-year-old male who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced atrial fibrillation, chest pain and really tired. The patient's medical history included atrial fibrillation with ablation 3 years ago. No relevant concomitant medications were reported. On 01 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lo038A20A) intramuscularly for prophylaxis of COVID-19 infection. On 02 Feb 2021, the patient woke up at 2:30 a.m. with chest pain, which "has" subsided (date not reported). On 03 Feb 2021, the patient was really tired. On 04 Feb 2021, the patient felt great. On 05 Feb 2021, at 6:30 a.m., the patient went into atrial fibrillation. Action taken with mRNA-1273 in response to the events was not reported. The event of chest pain was recovered/resolved. The event of really tired was recovered/resolved on 04 Feb 2021. The outcome of the event of atrial fibrillation was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient's age and history of atrial fibrillation with ablation are risk factors and confounds causality assessment.

Other Meds:

Current Illness:

ID: 1045524
Sex: M
Age: 50
State: WI

Vax Date: 12/30/2020
Onset Date: 01/07/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data: Test Date: 2021; Test Name: lumbar puncture for CSF analysis; Test Result: Inconclusive ; Result Unstructured Data: results not specified; Test Date: 2021; Test Name: MRI of brain; Test Result: Inconclusive ; Result Unstructured Data: results not specified; Test Date: 20210107; Test Name: cervical MRI; Test Result: Inconclusive ; Result Unstructured Data: no acute changes; Test Date: 20210118; Test Name: MRI thoracic and lumbar spine; Test Result: Inconclusive ; Result Unstructured Data: lesion on anterior thoracic cord. I of lumbar and thoracic spine

Allergies:

Symptoms: Tansverse myelitis; A spontaneous report was received from a physician, who was also a 50-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced transverse myelitis. The patient's medical history included cervical disc disease and low testosterone. Concomitant medications included testosterone cypionate and anastrozole. The patient reported that he had no acute illnesses at the time of vaccination and up to one month before. He had no allergies to medications, food, or other products. On 30 Dec 2020 at 12:00 pm, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On or about 07 Jan 2021, the patient began experiencing numbness in both feet. Thinking it could be related to his prior cervical disc disease causing myelopathic symptoms, hence, the patient saw a spine surgeon, who ordered a cervical magnetic resonance image (MRI) which revealed of no acute changes. On or about 18 Jan 2021, the patient began having problems with leg weakness and difficulty in standing and walking. That same day, he underwent urgent MRIs of his thoracic and lumbar spines which showed a lesion on the anterior thoracic cord. The patient was referred to a neurologist who diagnosed the patient with transverse myelitis. Subsequently, follow-up MRIs with contrast, MRI of the brain, and lumbar puncture for CSF analysis were completed but no other causes of his symptoms were identified. At the time of this report, the patient's legs were always numb (numbness propagated proximally with activity), his legs were weak, gait was unstable, he noted sexual dysfunction, and he had frequent "electrical" sensations. A follow-up thoracic MRI was completed on 05 Feb 2021 (results pending at time of this report). Treatment for the event included intravenous immunoglobulin (IVIG) infusions for five days (to start on 06 Jan 2021). The action taken with mRNA-1273 in response to the event was withdrawn (regarding dose two, the patient reported: "N/A not given"). The event, transverse myelitis, was considered not resolved at the time of this report. The physician assessed the event of transverse myelitis as related to mRNA-1273.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, it is noted that follow-up MRIs with contrast, MRI of the brain, and lumbar puncture for CSF analysis were completed and no other causes of his symptoms were identified but confirmation of the event was not reported. Also, the patient's comorbidities (cervical disc disease and low testosterone) may contribute to the patient's symptoms and confounds causality assessment. Further information has been requested.

Other Meds: TESTOSTERONE CYPIONATE; ANASTROZOLE

Current Illness: Cervical disc disease; Testosterone low

ID: 1045525
Sex: F
Age: 36
State: NY

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Possible vaccine administration via Subcutaneous Route; A spontaneous report was received from a nurse concerning a 36 year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced Subcutaneously Administered vaccine (incorrect route of product administration). The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. The patient received their second of two planned doses of mRNA-1273 LOT # 013L20A on 05-FEB-2021 for prophylaxis of COVID-19 infection. Female Nursing Practitioner called to report possible vaccine administration via Subcutaneous route. The patient had not reported any side effects. Treatment information was not provided/unknown. Action taken with mRNA-1273 in response to the event was not provided/unknown. The event, Subcutaneously Administered vaccine was considered recovered/resolved on 05 Feb 2021.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273, lot # 013L20A with no associated AEs.

Other Meds:

Current Illness:

ID: 1045526
Sex: F
Age:
State: TX

Vax Date: 01/12/2021
Onset Date: 01/13/2021
Rec V Date: 02/22/2021
Hospital: Y

Lab Data: Test Date: 20210113; Test Name: Covid-19 test positive; Result Unstructured Data: positive test

Allergies:

Symptoms: Hypoxic; Tested positive for COVID; A spontaneous report was received from a physician concerning a 79-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypoxic and tested positive for COVID-19. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 12 Jan 2021, approximately 1 day prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number not provided) intramuscularly for prophylaxis of COVID-19 infection. On 13 Jan 2021, the patient started showing symptoms of COVID and she tested positive for the virus that same day. She received Regeneron antibody infusion. On 16 Jan 2021 (day 4), the patient became hypoxic and was admitted to the hospital for 2 days. The patient was discharged not needing oxygen. She was greatly improved on Day 7. Treatment provided included Regeneron antibody infusion. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events hypoxia and COVID-19 was unknown.; Reporter's Comments: The patient had COVID symptoms one day after mRNA-1273 vaccine administration. The events were consistent with increased risk of respiratory complications associated with viral infection in pandemic set up. Based on test results the events are assessed as unlikely related to mRNA-1273.

Other Meds:

Current Illness:

ID: 1045527
Sex: M
Age:
State: NJ

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Full amount of the dose was not fully administered; Some of the vaccine leaked down the patient's arm; A spontaneous report was received from a healthcare professional concerning an 80-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the full amount of the dose was not fully administered (LLTs: vaccine underdose / syringe connection issue). The patient's medical history was not provided. No concomitant medications were reported. On 04 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. On 04 Feb 2021, a physician's assistant administered the Moderna COVID-19 vaccine to a patient and stated, that the full amount of the dose was not full administered. Some of the vaccine leaked down the patient's arm. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, full amount of the dose was not fully administered issue and some of the vaccine leaked down the patient's arm, were considered resolved on 04 Feb 2021.; Reporter's Comments: The reporter refers to a case of vaccine underdose and syringe connection issue for mRNA-1273 vaccine, batch number not provided, with no associated AEs. Causality of these events is not applicable.

Other Meds:

Current Illness:

ID: 1045528
Sex: F
Age: 28
State: NY

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccine administration via Subcutaneous Route; A spontaneous report was received from a nurse concerning a 28-year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced Subcutaneously Administered vaccine/ incorrect route of product administration. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 Batch number not provided. The patient received their second of two planned doses of mRNA-1273 (Lot number 013L20A) via subcutaneous route for prophylaxis of COVID-19 infection. Female Nursing Practitioner called to report Possible vaccine administration via Subcutaneous Route, on 05FEB2021. The patients have not reported any side effects. Treatment information was not provided. The event, Subcutaneously Administered vaccine was considered recovered/resolved on 05 Feb 2021.; Reporter's Comments: This report refers to a case of product administration error for mRNA-1273 (Lot number 013L20A). There were no associated AEs with this event of inappropriate route of vaccination.

Other Meds:

Current Illness:

ID: 1045529
Sex: U
Age:
State: FL

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: the patient received part of the dose; did not receive the full dose as part of the liquid spilled out; A spontaneous report was received from a healthcare professional concerning a patient, of unknown gender and age, who was administered Moderna's COVID-19 vaccine and received part of the dose and did not receive the full dose as part of the liquid spilled out (device connection issue). The patient's medical history was not provided. No relevant concomitant medications were reported. On 05 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) intramuscularly for prophylaxis of Covid-19 infection. It was reported that during administration of the Moderna COVID 19 vaccine on 05 Feb 2021, the patient did not receive the full dose as part of the liquid spilled out. Consent for follow up given. No treatment information was provided. Action taken with the first dose of mRNA-1273 in response to the event was not reported. The events, received part of the dose and did not receive the full dose as part of the liquid spilled out, were considered resolved on an unknown date.; Reporter's Comments: This report refers to a case of incorrect dose administered, and device connection issue for mRNA-1273, lot # 031L20A with no associated AEs.

Other Meds:

Current Illness:

ID: 1045530
Sex: M
Age: 68
State: NY

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccine ran down individual's arm; syringe which malfunctioned; A spontaneous report was received from a pharmacist concerning a 68, year old, male patient who experienced an incomplete dose administration of Moderna's COVID-19 vaccine, when the syringe malfunctioned and the vaccine ran down the patients arm. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 05 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 029L20A) intramuscularly, the injection side/site not given for prophylaxis of COVID-19 infection. The reporter, a pharmacist, called from a clinic. On 05 Feb 2021, one of the immunizers attempted to give a second dose using the agency supplied syringe which, malfunctioned and the vaccine ran down the patient's arm. Treatment information was not provided/unknown. Action taken with mRNA-1273 in response to the event(s) was not provided. The events incomplete dose administration of vaccine and syringe issue were considered recovered/resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered, and syringe issue for mRNA-1273, lot # 029L20A with no associated AEs.

Other Meds:

Current Illness:

ID: 1045531
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: developed cirrhosis; scalp infection; Headache; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed cirrhosis, scalp infection and headache. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On unknown date, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On unknown date, the patient who developed cirrhosis and scalp infection. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events who developed cirrhosis, scalp infection and headache was unknown.; Reporter's Comments: Very limited information regarding the events of cirrhosis and scalp infection have been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1045532
Sex: U
Age:
State: MN

Vax Date:
Onset Date:
Rec V Date: 02/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccine administered without waiting fifteen minutes at room temperature; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and vaccine administered without waiting fifteen minutes at room temperature. The patient's medical history was not provided. No relevant concomitant medications were reported. It was not reported when the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. It was stated from the reporter, we had vaccine that had been completely thawed, and it was administered without waiting fifteen minutes at room temperature. This was at a Mas Vaccination site and we have no knowledge of how many were vaccinated prior to the vials being at room temperature. Reporter made an estimated guess of fifteen to twenty individuals who have been vaccinated prior to the vaccine coming to room temperature. Reporter was looking for clarification on if the vaccine always needed to be brought to room temperature and why. She stated if we need to always have the vaccine at room temperature before vaccinating, that it was not clear in the instructions. No further information was provided. No treatment information was provided. Action taken with RNA-1273 in response to the event was not applicable. The outcome of the event was considered as recovered.; Reporter's Comments: This report refers to a case of product administration error for mRNA-1273 with no associated AEs.

Other Meds:

Current Illness:

ID: 1045533
Sex: F
Age: 25
State:

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: a leakage from the syringe; a leakage from the syringe; A spontaneous report was received from a consumer, concerning a 25 year-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced leakage from the syringe while it was being administered/device connection issue, underdose. The patient's medical history was not provided. No concomitant medications were reported. On 05 Feb2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 032L20A), intramuscular in the right arm for prophylaxis of COVID-19 infection. On the same day, while the vaccine was being administered, the patient reported there was leakage from the syringe and she questioned a vaccine underdose. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. The event leakage from the syringe was considered as resolved.; Reporter's Comments: This report refers to a case of device connection issue, and incorrect dose administered for mRNA-1273, lot # 032L20Awith no associated AEs.

Other Meds:

Current Illness:

ID: 1045534
Sex: M
Age:
State: TX

Vax Date: 01/14/2021
Onset Date: 01/15/2021
Rec V Date: 02/22/2021
Hospital: Y

Lab Data: Test Date: 20210126; Test Name: Tested positive for Covid; Result Unstructured Data: Positive

Allergies:

Symptoms: Tested positive for covid-19; Upset stomach; Dry cough; Feeling unwell; A spontaneous report was received from a consumer, concerning a male patient of unspecified age, who received Moderna's COVID-19 vaccine and tested positive for Covid-19 and experienced upset stomach, dry cough and did not generally feel well. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 14 Jan 2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of Covid-19 infection. On 15 Jan 2021, after the first dose of vaccine, the patient was presented with upset stomach, dry cough, and he did not generally feel well. On 26 Jan 2021, the patient tested positive for Covid-19 and was hospitalized from 29 Jan 2021 to 02 Feb 2021. No further information was provided at the time of this report. Reporter denied consent to follow-up. Treatment information was not provided. Action taken with mRNA-1273 in response to the events were not reported. The outcome for events, tested positive for Covid-19, upset stomach, dry cough, and did not generally feel well were considered to be unknown.; Reporter's Comments: This case concerns a male patient, who experienced a serious unexpected event of SARS-CoV-2 test positive after receiving mRNA-1273. Very limited information regarding this event has been provided at this time. The event of Covid test positive is assessed as unlikely related to mRNA-1273. There is no consent for follow-up, so no further information has been requested.

Other Meds:

Current Illness:

ID: 1045535
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 17-year-old received the first shot of moderna vaccine; A spontaneous report was received from a nurse concerning a 17-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced 17-year-old received the first shot of Moderna vaccine. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, approximately 0 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient received their first dose of the vaccine at 17 years old. She was turned away from getting her second dose due to her age. No treatment information was provided. Action taken with mRNA-1273 in response to the event was unknown. The event, 17-year-old received the first shot of Moderna vaccine, was considered resolved on an unknown date.; Reporter's Comments: This case report concerns a non-serious unexpected event of 17-year-old received the first shot of Moderna vaccine (inappropriate age at vaccine administration for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of inappropriate age at vaccine administration.

Other Meds:

Current Illness:

ID: 1045536
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Second dose of the Moderna vaccine was light pink color; Color of the vaccine is pink; A spontaneous report was received from a consumer, concerning a patient of unknown age and gender, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), which resulted in events, second dose of the Moderna vaccine was light pink color/poor quality product administered and color of the vaccine is pink/product colour issue. The patient's medical history was not provided. No concomitant medications were reported. On an unknown date, prior to the onset of events, the patient received their first dose of mRNA-1273 (Lot number: unknown), for prophylaxis of COVID-19 infection. The patient stated that the vaccine was supposed to be white to off-white in color. The patient received the second dose of the Moderna vaccine on an unknown date and the color of the vaccine was light pink. The patient was concerned if the vaccine was stored improperly. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events, second dose of the Moderna vaccine was light pink color and color of the vaccine is pink, were reported as resolved on an unknown date.; Reporter's Comments: This report refers to a case of poor quality product administered, and product color issue for mRNA-1273 with no associated AEs.

Other Meds:

Current Illness:

ID: 1045537
Sex: M
Age:
State: TN

Vax Date: 01/11/2021
Onset Date: 01/14/2021
Rec V Date: 02/22/2021
Hospital:

Lab Data: Test Date: 20210114; Test Name: Body temperature; Result Unstructured Data: 100.4; Test Date: 20210119; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: Positive; Test Date: 20210119; Test Name: Strep Throat; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

Symptoms: Covid-19; Strep throat; Slid down the wall and passed out; Hacky cough; Slight headache; Tired; Fever; A spontaneous report was received from a consumer concerning a 73-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced hacky cough, slight headache, tired, slight fever of 100.4, covid-19, strep throat and passed out. The patient's medical history included artificial hips. Concomitant medications reported included salbutamol, fluticasone propionate, salmeterol xinafoate, salbutamol sulfate, apixaban, mirabegron, metoprolol, cetirizine hydrochloride, colecalciferol, zinc, ascorbic acid and rutoside for unspecified indication. On 11 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection. Reporter stated that the patient was not aware of being exposed to COVID on 10 Jan 2021. They found out the following week after receiving the vaccine. The patient had COVID test on 19 Jan 2021 and tested positive. On 14 Jan 2021, the patient developed hacky cough, slight headache, tired, slight fever of 100.4 degree fahrenheit. The treatment information included fluticasone propionate, salbutamol, steroids, montelukast and azithromycin. On 17 Jan 2021, the patient got up to go to the bathroom and slid down the wall and passed out. The treatment information included fluticasone propionate, salbutamol, steroids, montelukast and azithromycin. Action taken with RNA-1273 in response to the event was not provided. The outcome of the events hacky cough, slight headache, tired, slight fever of 100.4, covid-19, strep throat and passed out was unknown.; Reporter's Comments: This case concerns a 73-year-old male with a serious expected event of loss of consciousness along with a NS unexpected COVID-19, streptococcal pharyngitis, cough and NS expected fever, headache, fatigue. Event onset 9 days after the first dose of mRNA-1273. Treatment included fluticasone, salbutamol, steroids, azithromycin. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: ALBUTEROL HFA; ADVAIR; PROVENTIL [SALBUTAMOL SULFATE]; ELIQUIS; MYRBETRIQ; METOPROLOL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; VITAMIN D [COLECALCIFEROL]; ZINC; VITAMIN C COMPLEX [ASCORBIC ACID;RUTOSIDE]

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm