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: 1003743
Sex: F
Age: 26
State: AZ

Vax Date: 02/02/2021
Onset Date: 02/03/2021
Rec V Date: 02/05/2021
Hospital:

Lab Data: I didn't see a doctor since all of these symptoms were listed as common in the pamphlet.

Allergies: Macrobid -causes intense itching Avocado - mild anaphylaxis

Symptoms: Approximately 20 hours after injection (about 7pm) I had some common symptoms. I began to develop a mild fever of 100.3, body aches, headache, swollen arm. These persisted throughout the night. I treated with Tylenol as recommended. I got a LOT of sleep and fever and headache persisted until about noon the next day. By 4pm I was feeling good again except my lymph nodes under my left arm are swollen and are tender and painful. I am treating the swollen lymph node pain with Tylenol. Over all the fever only lasted less than 24 hours with plenty of sleep. It also is worth noting that my first dose I had zero side effects. These side effects from the second dose seem harmless enough and tolerable as they don't last long.

Other Meds: Low hormone birth control pill- Lissina. Melatonin

Current Illness: None

ID: 1003744
Sex: F
Age: 25
State: AK

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 02/05/2021
Hospital:

Lab Data: N/A

Allergies: No

Symptoms: Fever, nausea, vomiting, hallucinations and headache for nearly 24 hours.

Other Meds: Aspirin, sleeping medication

Current Illness: Birth control problems

ID: 1003745
Sex: M
Age: 34
State:

Vax Date: 02/03/2021
Onset Date: 02/04/2021
Rec V Date: 02/05/2021
Hospital:

Lab Data: PAST MEDICAL HISTORY: Denies MEDICATIONS: See medication reconciliation note. ALLERGIES: See nursing note. FAMILY HISTORY: Noncontributory SOCIAL HISTORY: See above note. REVIE

Allergies: NKDA

Symptoms: Pt reports receiving 2nd COVID vaccine yesterday at 1030. Pt reports HA, fatigue, subjective fever yesterday evening. Pt reports feeling some relief with Motrin at 0930. Pt in NAD. HISTORY OF PRESENT ILLNESS: 34-year-old male presents with headache, body aches, subjective fever and nausea after second COVID vaccine yesterday. Acute onset of generalized body aches, mild, constant. Denies objective fever, chills, vomiting, vision changes, chest pain, dyspnea, cough, abdominal pain, back pain, weakness or numbness. Patient took Motrin with some improvement this morning.

Other Meds: UNK

Current Illness: N/A

ID: 1003746
Sex: F
Age: 51
State: IN

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

Lab Data: None ...

Allergies: Shellfish anaphylactic: cat dander anaphylactic; soy allergy

Symptoms: 02/02/2021 at 11:30am breathing uneasy; I took Benadryl at home and slept for 10 hours. Pain to injection site upon waking; I took Tylenol 8 hrs and drank 20 oz water. 02/03/2021 at 130am running nose and nausea started. At 9am I took some alka seltzer cold tabs. At 5pm I realized pain to right arm was worsening after full inspection I recognize swollen axillary lymph nodes; entire arm pit is swollen. I applied moist heat compress throughout the night and took more Tylenol. I hydrated with water and just layed around resting my body. 02/04/20 swelling continues with some decreased visible; pain to right arm pit continues and nausea continues.

Other Meds: Norvasc 10 mg daily HCTZ 25mg daily

Current Illness: None

ID: 1003747
Sex: F
Age: 39
State: HI

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 02/05/2021
Hospital:

Lab Data: None

Allergies: Unknown

Symptoms: At about 12:25pm, client noted to place her head in between her legs. When assessed, client complained of feeling dizzy. Water was offered but she continued to place her head between her legs. She began to cry and appeared weak. Pt assisted to the floor, where she laid down and legs were elevated. VS taken. Care transferred to EMS at 12:34pm. At time of hand-off, client appeared to have some resolution of symptoms. Allowed to rest in rig. 12:50pm per EMS, symptoms resolved and client released and picked up by husband.

Other Meds: Unknown

Current Illness: Unknown

ID: 1003748
Sex: M
Age: 21
State:

Vax Date: 02/03/2021
Onset Date: 02/04/2021
Rec V Date: 02/05/2021
Hospital:

Lab Data: 21 yo M with viral syndrome symptoms s/p 2nd covid vaccine. Pt relatively well appearing in no acute distress. vss/nml. no fever. no CP/SOB. No rash/meningismus. HA not sudden/f

Allergies: NKDA

Symptoms: Pt c/o Headache, dizziness, body aches, weakness starting last night, and symptoms got worse this morning. Pt received 1st vaccine dose 05 Jan, 2nd dose 3 Feb. Pt denies sob/v. No Known Drug Allergies CHIEF COMPLAINT & HPI: 21 yo M with Headache, dizziness, body aches, weakness starting last night, and symptoms got worse this morning. Pt received 1st vaccine dose 05 Jan, 2nd dose 3 Feb. Pt denies sob/v.

Other Meds: UNK

Current Illness: pnuemothorax 2019

ID: 1003749
Sex: M
Age: 34
State:

Vax Date: 02/03/2021
Onset Date: 02/04/2021
Rec V Date: 02/05/2021
Hospital:

Lab Data: PAST MEDICAL HISTORY: Denies MEDICATIONS: See medication reconciliation note. ALLERGIES: See nursing note. FAMILY HISTORY: Noncontributory SOCIAL HISTORY: See above note. REVIE

Allergies: NKDA

Symptoms: Pt reports receiving 2nd COVID vaccine yesterday at 1030. Pt reports HA, fatigue, subjective fever yesterday evening. Pt reports feeling some relief with Motrin at 0930. Pt in NAD. HISTORY OF PRESENT ILLNESS: 34-year-old male presents with headache, body aches, subjective fever and nausea after second COVID vaccine yesterday. Acute onset of generalized body aches, mild, constant. Denies objective fever, chills, vomiting, vision changes, chest pain, dyspnea, cough, abdominal pain, back pain, weakness or numbness. Patient took Motrin with some improvement this morning.

Other Meds: UNK

Current Illness: N/A

ID: 1003750
Sex: F
Age: 41
State: HI

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

Lab Data: None

Allergies: None known

Symptoms: Patient left clinic at 2:46pm and went to office then car. Returned to post vaccination area after feeling nauseous and "a little cold." Dr. completed assessment. VSS while sitting in chair. Allowed to rest, provided water. Monitored for symptoms. Symptoms resolved at 4:28pm. Pt picked up by family members in good condition.

Other Meds: Unknown

Current Illness: Unknown

ID: 1003751
Sex: F
Age: 71
State: WA

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Nausea, vomiting, fever, chills, fatigue, body ache, stomache upset

Other Meds: Metformin, levothyroxine, vitamin d, vitamin c

Current Illness:

ID: 1003752
Sex: M
Age: 34
State: HI

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

Lab Data: None

Allergies: None known. States previous similar reaction after flu vaccine.

Symptoms: Client states he felt dizzy and fell off chair. He had head cradled in hands but did not hit his head. Incident was witnessed by staff. He regained consciousness within 10 seconds. Laid him on back and feet elevated. BP 138/82, P92, RR24. EMS on site. He was able to stand with minimal assist to walk to gurney. No distress. A&Ox3. Transported via ambulance to Medical Center at 2:37pm.

Other Meds: Unknown

Current Illness: None

ID: 1003753
Sex: M
Age: 39
State:

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 02/05/2021
Hospital:

Lab Data: none

Allergies: none

Symptoms: fatigue, malaise, headache, nausea, body aches

Other Meds: Omeprazole

Current Illness: none

ID: 1003754
Sex: M
Age: 55
State:

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 02/05/2021
Hospital:

Lab Data: none

Allergies: none

Symptoms: severe fever, chills ,body ache , head ache all night took Tylenol a every 4 hr all night and the next day. the 2nd day day feel much better and able to go back to work.

Other Meds: multi vitamins, probiotic, fish oil .

Current Illness: none

ID: 1003755
Sex: F
Age: 42
State:

Vax Date: 01/26/2021
Onset Date: 02/02/2021
Rec V Date: 02/05/2021
Hospital:

Lab Data:

Allergies: lisinopril, processed beef

Symptoms: exacerbation of cough, arm pain, vasovagal syncope (suspected to be from cough)

Other Meds: Metformin, losartan, crestor, Wellbutrin, trazodone, lorazepam

Current Illness:

ID: 1003756
Sex: F
Age: 56
State: WA

Vax Date: 01/31/2021
Onset Date: 01/31/2021
Rec V Date: 02/05/2021
Hospital:

Lab Data:

Allergies: Codeine

Symptoms: Moderna COVID-19 Vaccine EUA. I was diagnosed Dec. 23, 2020. First injection caused medium swelling and was about an 8 on the pain scale... The next day I had a red VERY ITCHY rash about 2 inches in diameter from the site. I didn't put anything on it. Scared to. Calmed down 3days later. Pain was better after 48ish hrs. HURTS LIKE A BITCH!!! Thanks for all yall's hard work!

Other Meds: Ibuprofen

Current Illness: None

ID: 1003757
Sex: F
Age: 57
State:

Vax Date: 02/03/2021
Onset Date: 02/05/2021
Rec V Date: 02/05/2021
Hospital:

Lab Data: None

Allergies: Morphine, Codeine, Valium,

Symptoms: Nausea, dizziness, headache, neck and shoulder pain. No treatment, was told to report these symptoms.

Other Meds: HCTZ 25 mg, Methimazole 2.5 mg, Omeprazole 40mg, Losartan 40mg, Cranberry-D-monose OTC, Metformin 1000mg

Current Illness: no

ID: 1003758
Sex: M
Age: 64
State: CA

Vax Date: 01/29/2021
Onset Date: 01/30/2021
Rec V Date: 02/05/2021
Hospital:

Lab Data: I had no tests performed.

Allergies: Penicillin

Symptoms: 36 hours following the vaccine I was having a bad headache, moderate to severe pain at injection site, and severe diarrhea. The diarrhea lasted about 12 hours. I also felt general discomfort over entire body as if I had flu. This discomfort lasted for approximately 2 to 3 days. I was unable to perform normal activities during this time.

Other Meds: Percocet 10/325 prescribed by my dr for severe back pain Tizandine 4 mg Atorvastatin 40 mg, Tricor 48 mg, Norvasc 10 mg, Duloxetin 60 mg, Tadalafil 5 mg

Current Illness: None

ID: 1003759
Sex: F
Age: 31
State: GA

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

Lab Data: None

Allergies: None

Symptoms: Started with headache and fever. Fever spike from 99.4 to 101.3 in 1.5 hours. Vomited one time. Chills, sweating, hot-then-cold, and terrible body aches persisted for the next 24 hours.

Other Meds: None

Current Illness: None

ID: 1003760
Sex: F
Age: 39
State: CO

Vax Date: 02/03/2021
Onset Date: 02/04/2021
Rec V Date: 02/05/2021
Hospital:

Lab Data: N/a

Allergies: Sulfa Codeine Grapes Melons

Symptoms: Redness at injection site. Itchy and painful injection site. Extremely sore muscles throughout the body. Lethargy.

Other Meds: Sertraline 100mg daily Omeprazole 40mg daily

Current Illness: N/a

ID: 1003761
Sex: F
Age: 16
State:

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 02/05/2021
Hospital:

Lab Data: N/A

Allergies: NKA

Symptoms: There were no complications following vaccination. Pt was monitored for 30 minutes following vaccination. Pt was not at approved age to receive COVID19 Moderna vaccination.

Other Meds:

Current Illness:

ID: 1003762
Sex: F
Age: 52
State: MN

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

Lab Data: None

Allergies: Morphine

Symptoms: Fever of 102.4* F, chills, body aches & headache until 10:00am, headache continued off & on for 2 days

Other Meds: Duloxetine, Metformin, Glipizide, Lisinopril, Trulicity, Aspirin, Vitamin D, Vitamin B complex

Current Illness: None

ID: 1003763
Sex: M
Age:
State: AZ

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

Lab Data:

Allergies: No

Symptoms: None stated.

Other Meds: None

Current Illness: No

ID: 1003764
Sex: F
Age: 39
State:

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

Lab Data:

Allergies: Xifaxin and Prilosec

Symptoms: Woke up with severe urticaria on day 3. Hives all over my body

Other Meds: Advil, claritin, ambien adderal

Current Illness:

ID: 1003765
Sex: F
Age: 62
State: CA

Vax Date: 02/02/2021
Onset Date: 02/03/2021
Rec V Date: 02/05/2021
Hospital:

Lab Data:

Allergies: Ampicillin -total body rash; gentamycin (?)

Symptoms: Chills x about 2 hrs; fever (100.2 F) x 1/2 day; moderate headache, mild nausea, mild dizziness for 1 day; as of now, still have mild headache.

Other Meds: LIsinopril 1.25 mg (1/4 of 5 mg tablet); Calcium 600 mg with Vitamin D 400 IU; Vitamin C 500 mg.

Current Illness:

ID: 1003931
Sex: M
Age: 30
State:

Vax Date: 01/31/2021
Onset Date: 02/01/2021
Rec V Date: 02/05/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: New onset complex migraine headaches requiring admission to hospital for intractable pain for 1 week along with focal neurological symptoms with right sided weakness of upper and lower extremity that resolved.

Other Meds:

Current Illness:

ID: 1003934
Sex: F
Age: 25
State:

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 02/05/2021
Hospital:

Lab Data: N/A

Allergies: NKA

Symptoms: I received the second dose of the Moderna COVID Vaccine 3 FEB 21. Within 2-3 hours I was incredibly tired. I was hit with intense nausea and vomiting that has been persistent since the night of 3 FEB. I can?t keep much down. 4 Feb I had a fever of 102.3 starting around 4am, I brought it down with a 600 Mg dose of Ibuprofen but it came back off and on throughout the day alongside sweats and chills. All of my lymph nodes were swollen and my entire body hurt. I was unable to sleep last night 4feb/5feb due to muscle pain. As of today I feel a little better and am without a fever, but I am still incredibly nauseous and have developed a sore throat.

Other Meds: Vitamin D, Vitamin B12 Injections, Sertaline

Current Illness: Anemia

ID: 1004159
Sex: F
Age:
State: PR

Vax Date: 12/16/2020
Onset Date: 12/16/2020
Rec V Date: 02/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: moderate intensity myalgias and arthralgias; moderate intensity myalgias and arthralgias; fatigue; headache; This is a spontaneous report from a contactable physician. A 41-year-old female patient received the first does of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EH9899), via an unspecified route of administration on the left arm on 16Dec2020 09:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included rhinitis allergic from an unknown date and unknown if ongoing, eczema from an unknown date and unknown if ongoing. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and ethinylestradiol, norgestimate (TRINESSA). The patient previously took septra and experienced drug hypersensitivity. After the first dose of the COVID 19 vaccine, on 16Dec2020 20:00 the patient developed moderate intensity myalgias and arthralgias, also significant fatigue and headache. She waited the 2-3 days after vaccination to see if adverse reaction improved and for the first dose it improved at the third day but unfortunately the same symptoms started again one week after second dose of vaccine and have no improved. No treatment was received for the events. The outcome of the event was not recovered.

Other Meds: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; TRINESSA

Current Illness:

ID: 1004160
Sex: F
Age:
State: PR

Vax Date: 01/18/2021
Onset Date: 01/19/2021
Rec V Date: 02/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: left axillary swelling; This is a spontaneous report from a contactable other HCP (patient). A 46-year-old female patient received second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL9261), intramuscular at Arm Left on 18Jan2021 11:15 at the 46 years old at single dose for COVID-19 immunization. The medical history was none. The concomitant medication was ascorbic acid, biotin, folic acid, iodine, pantothenic acid, pyridoxine hydrochloride, retinol, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc(CENTRUM MULTIGUMMIES). The Historical Vaccine was fist dose BNT162B2 for COVID-19 immunization. The patient previously took Iodine and experienced allergy. There was no other vaccine in four weeks. The patient experienced left axillary swelling on 19Jan2021 22:00. There was no treatment received for the event. There was no COVID prior vaccination. There was no COVID tested post vaccination. The outcome of the event was not recovered.

Other Meds: CENTRUM MULTIGUMMIES

Current Illness:

ID: 1004161
Sex: F
Age:
State: PR

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

Lab Data: Test Name: ANA; Result Unstructured Data: Test Result:negative; Test Date: 202101; Test Name: ANA; Test Result: Positive ; Test Date: 202101; Test Name: Creatine kinase; Result Unstructured Data: Test Result:WNL; Test Date: 202101; Test Name: TSH; Result Unstructured Data: Test Result:WNL; Test Date: 202101; Test Name: CBC; Result Unstructured Data: Test Result:WNL; Test Date: 202101; Test Name: CMP; Result Unstructured Data: Test Result:WNL; Test Date: 202101; Test Name: ESR; Result Unstructured Data: Test Result:borderline elevated for age; Test Date: 202101; Test Name: RF; Result Unstructured Data: Test Result:WNL

Allergies:

Symptoms: moderate intensity myalgias and arthralgias; moderate intensity myalgias and arthralgias; fatigue; headache; I have been having difficulty with routine activities due to pain; I have been having difficulty with routine activities due to pain; pain at the lumbosacral area; ESR elevated; ANA is positive; This is a spontaneous report from a contactable physician (patient). A 41-years-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number EL1283), on 05Jan2021 at single dose in left arm for COVID-19 immunisation at hospital. Medical history included rhinitis allergic and eczema. Concomitant medication included cetirizine hydrochloride (ZYRTEC) and ethinylestradiol, norgestimate (TRINESSA). The patient previously took ciprofloxacin hydrochloride (SPECTRA) and experienced drug hypersensitivity. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number EH9899) on 16Dec2020 at 09:00 for COVID-19 immunisation in the left arm and experienced myalgia, arthralgia, fatigue and headache. After the second dose on unspecified date in Jan2021 the patient developed moderate intensity myalgias and arthralgias, also significant fatigue and headache. The patient waited the 2-3 days after vaccination to see if adverse reaction improved, and it improved at the third day, but unfortunately the same symptoms started again one week after second dose of vaccine and have no improved. The patient had symmetric polyarthralgias affecting her hands, wrist, knees, ankles. She had been having difficulty with routine activities due to pain. Also pain at the lumbosacral area. Also have myalgias and fatigue affecting her work and routine activities. The patient also had a mild HA. The patient underwent laboratories after symptoms began again and CBC, CMP, CK, RF, Anti-CCP and TSH are WNL. But, ANA was positive which in the past was negative and have a ESR borderline elevated for her age. The patient was going to see a rheumatologist, but all this that she was feeling coincides with the vaccination for COVID 19. The outcome of the events was not recovered, no treatment was performed.

Other Meds: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; TRINESSA

Current Illness:

ID: 1004189
Sex: U
Age: 0
State: OK

Vax Date: 02/06/2015
Onset Date: 02/06/2015
Rec V Date: 02/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: no adverse event; expired vaccine administered; This spontaneous report was received from a Registered Nurse, and refers to a 5 year old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 06-FEB-2015, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # S032358 with expiration date on 11-JAN-2021 (discrepant information) (formulation, strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported) for prophylaxis. At the reporting time, the nurse was wondering if the patient needed to be revaccinated. No adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032358; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability

Other Meds: VAQTA SYRINGE (DEVICE)

Current Illness:

ID: 1004190
Sex: U
Age:
State: SD

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 02/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No further AE; administration of an improperly stored vaccine; This spontaneous report as received from a Registered Nurse regarding to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided. On 15-JAN-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # T013537, expiration date 17-OCT-2021, 1 dosage form for prophylaxis. The improperly stored suspect vaccine experienced a temperature of 9 degrees Celsius (?C) for 2 hours. There was no previous temperature excursion reported. The call was made due to a digital data logger. No additional adverse effect reported.

Other Meds:

Current Illness:

ID: 1004191
Sex: U
Age:
State: VA

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 02/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: administration of ROTATEQ after temperature excursion; This spontaneous report as received from other reporter regarding to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided. On 11-JAN-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1742457, expiration date 06-JAN-2022, 2 milliliter, orally for prophylaxis. The improperly stored suspect vaccine experienced a temperature of 13 degrees Celsius (?C) for 19 minutes. There was no previous temperature excursion reported. The call was made due to a digital data logger.

Other Meds:

Current Illness:

ID: 1004192
Sex: F
Age: 42
State: SD

Vax Date: 02/01/2011
Onset Date: 02/01/2011
Rec V Date: 02/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: anxiety; bronchitis; influenza; knee problems; sinusitis; hypoglycemia; high cholesterol; hormones; irritable bowel syndrome (IBS); heartburn; attention deficit disorder (ADD); insomnia; skin problems; varicella type rash; shingles and other zoster related injuries/herpes zoster/rash/painful; zoster vaccine live (ZOSTAVAX) administered to a 32-year-old patient; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. In 2012, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) by a healthcare provider at a family medicine laboratory for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by a healthcare provider at the family medicine laboratory for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: shingles and other zoster related conditions. The outcome of the events was not provided. The reporter considered shingles and other zoster related conditions to be related to zoster vaccine live (ZOSTAVAX). Follow up (FU) information has been received on 26-JAN-2021 from a lawyer via a Plaintiff Fact Sheet, regarding a case in litigation, and refers to a 42-year-old female pt. The pt smoked cigarettes from 1993 to 2007, 1 once a day on average. She was diagnosed with chickenpox in or about 1974, at the approx. age of 6 years old. The pt had never received a chickenpox vaccine. The pt was disabled (reported as "disable" in the employment history, with no dates provided). The pt filed for social security benefits for mental health problems in 2003; granted. In the 7 years preceding her zoster vaccine live (ZOSTAVAX)-vaccination to the present, the pt received inpatient or outpatient care for the following reasons (approx. dates of care/treatment given): primary care, from 2001 to present; bronchitis (onset date, treatment, outcome and causality unknown), 24-MAR-2013 - just one time; influenza (onset date, treatment, outcome and causality unknown), 13-JAN-2014 - just one time; hypothyroidism, from 11-NOV-2015 to 09-FEB-2017; knee problems (onset date, treatment, outcome and causality unknown), from 29-NOV-2017 to present; sinusitis (onset date, treatment, outcome and causality unknown), from 29-DEC-2017 to present; skin problems (onset date, treatment, outcome and causality unknown), from 21-MAR-2015 to present; psychiatric medical conditions, from 2001 to present. Medical conditions other than those alleged to be caused by zoster vaccine live (ZOSTAVAX), for which the pt required hospitalization or recurrent medical care and treatment or medication at any time during the 7 years preceding her zoster vaccine live (ZOSTAVAX) vaccination to present, included (approx. dates of care/treatment given): bronchitis, 24-MAR-2013 - just one time; influenza, 13-JAN-2014 - just one time; hypothyroidism, from 2010 to present; knee problems, from 29-NOV-2017 to present; sinusitis, from 29-DEC-2017 to present; skin problems, from 21-MAR-2015 to present; psychiatric medical conditions, from 2001 to present; hypoglycemia (onset date, outcome and causality unknown), from 2016 to present; high cholesterol (onset date, outcome and causality unknown), from October 2019 to present; hormones (onset date, outcome and causality unknown), from 2012 to present; shingles, from 2006 to present (hence, the event of herpes zoster considered to be a progression of disease); irritable bowel syndrome (IBS) (onset date, outcome and causality unknown), from 01-AUG-2020 to present; heartburn (onset date, outcome and causality unknown) and anxiety, both from January 2012 to present. Prescription medications that the pt had taken on a regular basis in the 7 years preceding her zoster vaccine live (ZOSTAVAX) vaccination to the present included (approximate dates of use given): linaclotide (LINZESS), from 01-AUG-2020 to present, for IBS; omeprazole (reported as "ameprazole"), from January 2012 to present, for heartburn; clonazepam (KLONOPIN), from January 2012 to present, for anxiety; methylphenidate hydrochloride (RITALIN), from 02-OCT-2019 to present, for attention deficit disorder (ADD) (onset date, outcome and causality unknown); vortioxetine hydrobromide (TRINTELLIX), from 2016 to present, for bipolar depression; metformin (reported as "Medphormine"), from 2016 to present, for hypoglycemia; trazodone, from July 2020 to present, for insomnia (onset date, outcome and causality unknown); rosuvastatin calcium (CRESTOR), from October 2019 to present, for high cholesterol; ethinyl estradiol (+) levonorgestrel (AMETHYST), from 2012 to present, for hormones; valacyclovir hydrochloride (VALTREX), from 2017 to present, for shingles; valacyclovir (reported as "Valazyclovir"), from March 2006 to 2017, for shingles; prazosin, from 2010 to present, for post-traumatic stress disorder (PTSD) and nightmares; naltrexone hydrochloride (REVIA), from 2015 to present, for bipolar disorder; lamotrigine (LAMICTAL) and bupropion hydrochloride (WELLBUTRIN), both from 2006 to present, both for bipolar disorder; levothyroxine, from 2010 to present, for hypothyroidism. Before receiving zoster vaccine live (ZOSTAVAX), the pt experienced shingles, diagnosed on 06-MAR-2006 by a physician at a family medicine facility, treatment received: ointments (unspecified) and oral oils (unspecified) for pain (reported as "acyclovir"). At any time in the 7 years preceding her alleged zoster vaccine live (ZOSTAVAX)-related injury to the present, the pt used or took the following medications: steroids or corticosteroids, for sinus infection, taken in or about 2008. On 01-FEB-2011, the pt was administered zoster vaccine live (ZOSTAVAX) in the left arm by a physician at a family medicine facility. The pt received a written prescription for zoster vaccine live (ZOSTAVAX) from the physician. The pt did not recall if she had received any written or oral instruction or information about zoster vaccine live (ZOSTAVAX) before receiving it. The pt claimed that she suffered the following physical injuries related to her zoster vaccine live (ZOSTAVAX) administration: shingles (herpes zoster), and varicella type rash. She experienced shingles all around her body. The pt first became aware of these injuries on 01-MAR-2011, and of varicella type rash in or about November 2011, because she noticed some kind of rash all around her body, it was very painful, so she went to see her doctor and he said she had shingles. The pt was diagnosed by the physician with shingles on or about 01-JUN-2011. In connection with the injuries alleged to be have been caused by zoster vaccine live (ZOSTAVAX), the pt was prescribed the following medications/received the following treatments (approx. dates of treatment given): creams (unspecified) and oral pills (unspecified) for pain, on or about 01-JUN-2011. In or about November 2011, a test ordered and performed by the physician at the family medicine facility to determine if the rash was wild type or vaccine strain varicella zoster virus. The result of the test was vaccine strain varicella zoster virus. In or about November 2011, the physician at the family medicine facility told the pt that she had vaccine strain varicella zoster virus. The pt claimed that her receipt of zoster vaccine live (ZOSTAVAX) caused or aggravated the following psychiatric and/or psychological conditions (other than pain and suffering and emotional distress): anxiety, diagnosed in or about October 2014 by a physician. The outcome of the events of shingles (herpes zoster) and varicella type rash was not provided. The reporter considered the events of shingles (herpes zoster) and varicella type rash to be related to zoster vaccine live (ZOSTAVAX).

Other Meds: valacyclovir hydrochloride; prazosin; LAMICTAL; WELLBUTRIN; levothyroxine sodium

Current Illness: Bipolar disorder (bipolar disorder treated from 2006 to present); Disability; Hypothyroidism (treated from 2010 to present); Mental disorder (mental health problems - applied for social security benefits in 2003; granted psychiatric medical conditions - dates of care/treatment (approx.): 2001 to present); Nightmare (treated from 2010 to present); Post-traumatic stress disorder (treated from 2010 to present); Shingles (dates of care/treatment (approx.): 2006 to present shingles treated from March 2006 to 2017 and from 2017 to present diagnosed by a physician on 06-MAR-2006; treatment received: ointments (unspecified) and oral oils for pain (reported as acyclovir) hence, the claimed event of shingles (herpes zoster) with the onset date of 01-MAR-2011 considered a progression of disease)

ID: 1004193
Sex: F
Age:
State: NY

Vax Date: 01/27/2020
Onset Date: 01/27/2020
Rec V Date: 02/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE reported; PROQUAD administered in a 53-year-old patient; Nurse reported that PROQUAD was administered to a patient accidently via IM route; This spontaneous report has been received from a nurse concerning a 53-year-old female patient. Her relevant medical history, drug reactions/allergies, concurrent conditions and concomitant therapies were not reported. According to the reporter, on 27-JAN-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, strength, dose number, anatomical location, lot number, therapy type, and expiration date were not provided), which was administered accidently via intramuscular (IM) instead of subcutaneous (SC) route for prophylaxis (incorrect route of product administration) (product administered to patient of inappropriate age). There was no additional adverse event (AE) reported.

Other Meds:

Current Illness:

ID: 1004194
Sex: U
Age:
State: LA

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

Lab Data:

Allergies:

Symptoms: No additional AE reported.; GARDASIL 9 was inadvertently administered to a 15 month old; This spontaneous report was received referring to a 15 months old patient of unknown gender. The patient's pertinent medical history, drug reactions/ allergies and concomitant medication were not reported. On 01-FEB-2021, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml, route, lot# and expiration date were not reported) for prophylaxis (inappropriate age at vaccine administration). No other adverse event was reported. The outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1004195
Sex: U
Age:
State: TX

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

Lab Data:

Allergies:

Symptoms: no additioanl AE reported; Caller states the vaccine was administered after a temperature excursion; This spontaneous report as received from a Medical Assistance, referring to a patient (gender and age not reported). No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 28-JAN-2021, the patinet was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) with a valid lot # T012551, at a dose of 0.5 mL (dose number, route and anatomical location not provided) for prophylaxis, however no additional adverse effects reported. Administered dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) experienced the temperature excursion above -13.8 degrees Celsius for 41 minutes. Digital data logger was involved. There were no previous temperature excursions reported.

Other Meds:

Current Illness:

ID: 1004196
Sex: U
Age: 60
State: CA

Vax Date: 09/01/2020
Onset Date: 10/01/2020
Rec V Date: 02/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Bell's Palsy; Initial Report Received on 02-Dec-2020 A patient who is registered nurse reported that she, a 60 year-old female (race and ethnicity not provided), had received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and developed Bell's Palsy. The patient declined to share her medical history and shared that she was not sick. No concomitant medications were reported. At the end of Sep-2020, the patient received her first and only dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) from a medical office. About 30 days later, the patient began having ear pain and facial paralysis to the left side of her face. She previously had the ENGERIX-B series but did not show immunity when tested. The patient was working and taking care of her parents prior to developing Bell's palsy. The patient received medication but did not share what medications that she had since completed. At the time of report, she was receiving acupuncture treatments to tone her facial muscle. No additional information was reported. An attempt was made by Medical Information to obtain the lot number, expiration and serial number from the medical office clinic but was referred to medical records instead. No information was received regarding the company's request to follow-up with the medical records department. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.

Other Meds:

Current Illness:

ID: 1004197
Sex: U
Age:
State: NY

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

Lab Data:

Allergies:

Symptoms: Pain, / in the arm (site of injection); Swollen / in the arm (site of injection); Redness in the arm (site of injection); General discomfort; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received Men B NVS (Bexsero) for prophylaxis. On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site pain, injection site swelling, injection site erythema and general discomfort. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and general discomfort were unknown. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and general discomfort to be related to Bexsero. Additional details were reported as follows: The age at vaccination was not reported. Nurse informed that after the vaccination of patient with Bexsero, the patient experienced pain, swollen, redness in the arm (site of injection) and general discomfort. The reporter consented to follow up. This case is 1 of the 12 cases, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2020AMR209822:same reporter US-GLAXOSMITHKLINE-US2020AMR210158:same reporter US-GLAXOSMITHKLINE-US2020AMR210159:same reporter US-GLAXOSMITHKLINE-US2020AMR210164:same reporter US-GLAXOSMITHKLINE-US2020AMR210162:same reporter US-GLAXOSMITHKLINE-US2020AMR210165:same reporter US-GLAXOSMITHKLINE-US2020AMR210160: US-GLAXOSMITHKLINE-US2020AMR210163:same reporter US-GLAXOSMITHKLINE-US2020AMR210161:same reporter US-GLAXOSMITHKLINE-US2020AMR210157:same reporter US-GLAXOSMITHKLINE-US2020AMR210166: US-GLAXOSMITHKLINE-US2020208660:same reporter

Other Meds:

Current Illness:

ID: 1004198
Sex: F
Age: 62
State: OR

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 02/05/2021
Hospital:

Lab Data: Test Date: 20201225; Test Name: CT of lower abdomen; Result Unstructured Data: Earlier diagnosis of diverticulitis on 27/NOV/2020 inflation had gotten better

Allergies:

Symptoms: hemorrhoid pain; bloody diarrhea; severe diarrhea; Nausea; abdominal pain; shaking chills; Severe leg cramps; A spontaneous report was received from a 62 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe leg cramps, severe diarrhea, nausea, abdominal pain, shaking chills, hemorrhoid pain and the serious event of bloody diarrhea. The patient's medical history included diverticulitis. No relevant concomitant medications were reported. On 22 Dec 2020, about 4pm, the patient received their first of two planned doses of mRNA-1273 (Lot #011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 22 Dec 2020, around 7pm, the patient experienced severe leg cramps. On 23 Dec 2020, she experienced severe diarrhea, nausea, abdominal pain, shaking chills and bloody diarrhea. Treatment for nausea was ondansetron. On 24 Dec 2020, the patient experienced terrible hemorrhoid pain and abdominal pain. On 25 Dec 2020, the patient went to the emergency room where she received a computed tomography scan. The computed tomography scan of the lower abdomen showed that earlier diagnosis of diverticulitis 27 Nov 2020 "inflammation" had gotten better. Action taken with mRNA-1273 in response to the events were not reported. The outcome for events, severe leg cramps, severe diarrhea, nausea, abdominal pain, shaking chills, bloody diarrhea and hemorrhoid pain, were unknown.; Reporter's Comments: This case concerns a 62-year-old female patient with medical history of diverticulitis, who received their first of two planned doses of mRNA-1273 (Lot 011J20A), and who experienced the serious unlisted event of bloody diarrhea, the non-serious listed events of nausea and chills, and the non-serious unlisted events of severe leg cramps, severe diarrhea, abdominal pain, and hemorrhoid pain. Based on the current available information and temporal association between the use of the product and the onset of events after vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine. The patient's history of diverticulitis is noted.

Other Meds:

Current Illness: Diverticulitis

ID: 1004199
Sex: F
Age: 66
State: GA

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 02/05/2021
Hospital:

Lab Data: Test Date: 20210108; Test Name: Blood Pressure; Result Unstructured Data: 149/89; Comments: typically between 120-110/80-70; Test Date: 20210109; Test Name: Body temperature; Result Unstructured Data: 103 ?F; Test Date: 20210110; Test Name: Body temperature; Result Unstructured Data: 99 ?F; Test Date: 20210108; Test Name: heart rate; Result Unstructured Data: 110 heart beats per minute

Allergies:

Symptoms: possible stroke; face is drooping a little; had numbness and tingling on the left side of my face; had numbness and tingling on the left side of my face; red splotches about the size of a small leaf from injection site to elbow; had a rash opposite the injection site; a vein protruded out; bone chilling chills; deep pain in my arm that feel like someone was beating me; arm sore to touch; my arm was sore to touch from injection site to elbow; had a fever of 103 F/low grade (~99 F); I was shaking; blood pressure went up to 149/89; my heart rate was elevated to over 110; dull headache off and on since receiving the vaccine; A spontaneous report was received from a nurse who was also a 66-years old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced possible stroke, face is drooping a little, a vein protruded out, blood pressure went up to 149/89, my heart rate was elevated to over 110, deep pain in my arm that feel like someone was beating me; arm sore to touch; my arm was sore to touch from injection site to elbow, I was shaking, had numbness and tingling on the left side of my face, red splotches about the size of a small leaf from injection site to elbow, dull headache off and on since receiving the vaccine, had a rash opposite the injection site, my arm was sore to touch from injection site to elbow, bone chilling chills, and had a fever of 103 degrees Fahrenheit (F)/low grade (~99 F). The patient's medical history was not provided. There were no concomitant medications provided. On 08 Jan 2021 the patient received the first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly, in her right arm, for prophylaxis of COVID-19 infection. On 08 Jan 2021 at 3:00 pm, the patient received her first injection. Right after the injection, her blood pressure went up to 149/89 and her heart rate was elevated to over 110 and both came down to normal by 4 pm. A dull headache started on the same day. About midnight on 09 Jan 2021, the patient was awakened by deep vein in her arm that felt like someone was beating her. About 11 am the same day she had a fever of 103 degrees Fahrenheit, bone chilling chills., and she was shaking. Treatment included a hot shower, ibuprofen, paracetamol, and acetylsalicylic acid. The chills and shaking stopped after treatment. It was noted that fever lowered to about 99 degrees. On 11 Jan 2021, the patient had red splotches about the size of a small leaf and her arm was sore to touch from injection site to elbow. A vein protruded out and she had a rash opposite the injection site. On 12 Jan 2021, the fever had resolved. The patient noted that all right arm reaction lasted until Saturday, 16 Jan 2021. On 19 Jan 2021 in the evening, the patient had numbness on the left side of her face. It appeared as if her face was drooping a little, but there was nothing wrong with her smile or her speech. She noted she called the clinic and they wanted her to come in to determine if she had a possible stroke. Additionally, she reported she had a dull headache off and on since she got the vaccine. Action taken with mRNA-1273 in response to the event was not provided. The event of dull headache off and on since receiving the vaccine was not recovered/not resolved. The outcome for the events, possible stroke, face is drooping a little, had numbness and tingling on the left side of my face, was unknown. The outcome of the events, a vein protruded out, blood pressure went up to 149/89, my heart rate was elevated to over 110, deep pain in my arm that feel like someone was beating me; arm sore to touch; my arm was sore to touch from injection site to elbow, I was shaking, red splotches about the size of a small leaf from injection site to elbow, had a rash opposite the injection site, bone chilling chills, and had a fever of 103 F/low grade (~99 F) were resolved at the time of this report.; Reporter's Comments: This spontaneous report concerns a 66-years old female patient who experienced possible stroke, face is drooping a little, a vein protruded out, blood pressure went up to 149/89, my heart rate was elevated to over 110, deep pain in my arm that feel like someone was beating me; arm sore to touch; my arm was sore to touch from injection site to elbow, I was shaking, had numbness and tingling on the left side of my face, red splotches about the size of a small leaf from injection site to elbow, dull headache off and on since receiving the vaccine, had a rash opposite the injection site, my arm was sore to touch from injection site to elbow, bone chilling chills, and had a fever of 103 degrees Fahrenheit (F)/low grade (~99 F). The events of blood pressure went up, heart rate elevated and dull headache occurred on the same day after the administration of the first dose of mRNA-1273 ((lot number unknown) and events of deep vein in her arm that felt like someone was beating her, fever of 103 degrees Fahrenheit, bone chilling chills., shaking occurred 1 day after. The events of red splotches, arm was sore to touch from injection site to elbow, a vein protruded out, rash opposite the injection site developed 3 days after the vaccine dose and numbness on the left side of her face and possible stroke occurred 11 days after the vaccine dose. Treatment provided, fever and dull headache are resolved, and outcome of other events are unknown. He events of injection site redness and pain, fever, rash chills and headaches are consistent with the safety profile of the vaccine. Based on the current available information and temporal association between the use of the product and onset of the reported events a causal relationship cannot be excluded

Other Meds:

Current Illness:

ID: 1004200
Sex: F
Age: 28
State: NY

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 02/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: UTI; A spontaneous report was received from a 28 year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced a urinary tract infection (UTI). The patient's medical history was not provided. No relevant concomitant medications were reported. On 21 Jan 2021, a day prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (batch number 02AL20A) intramuscularly in the left arm for COVID-19 infection prophylaxis. On 22 Jan 2021, the patient reported that she had experienced a UTI. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, UTI was unknown.; Reporter's Comments: This case concerns a 28 year-old female patient, who experienced a serious unexpected event of urinary tract infection. The event of urinary tract infection occurred 2 days after first dose of mRNA-1273, lot # 02AL20A. Treatment was not reported. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1004201
Sex: F
Age: 74
State: ME

Vax Date: 01/11/2021
Onset Date: 01/14/2021
Rec V Date: 02/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Experienced symptoms of Benign Paroxysimal Postural Vertigo or BPPD; Malaise; Felt like mild flu; Swelling; Joint Pain; Fatigue; Feeling feverish; A spontaneous report was received from a consumer concerning a 74-years-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced joint pain, malaise, swelling, fatigue, felt like mild flu, feeling feverish and experienced symptoms of benign paroxysmal, postural vertigo or BPPD. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Acetaminophen, Losartan, Hydrochlorothiazide, and Trazadone. On 11 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 026I20A) intramuscularly in the right arm deltoid for prophylaxis of COVID-19 infection. On 14 Jan 2021, the patient experienced joint pain, malaise, swelling, fatigue, felt like mild flu, feeling feverish and experienced symptoms of benign paroxysimal, postural vertigo or BPPD. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events joint pain, malaise, swelling, fatigue, felt like mild flu, feeling feverish, and experienced symptoms of benign paroxysmal, postural vertigo or BPPD was not reported; Reporter's Comments: This spontaneous report concerns a 74-years-old, female patient who experienced joint pain, malaise, swelling, fatigue, felt like mild flu, feeling feverish and experienced symptoms of benign paroxysmal, postural vertigo or BPPD. The events occurred 3 days after the administration of the first dose of mRNA 1273 (lot number 026l20A, expiration date unknown). No treatment information was provided, and outcome is Unknown. Fever, fatigue and joint pain are consistent with the known safety profile of the mRNA-1273 vaccine and based on the current available information and temporal association between the use of the mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.

Other Meds: ACETAMINOPHEN; LOSARTAN; HYDROCHLOROTHIAZIDE; TRAZODONE

Current Illness:

ID: 1004202
Sex: F
Age: 31
State: PA

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 02/05/2021
Hospital:

Lab Data: Test Name: hCG; Result Unstructured Data: 0; Test Date: 20210119; Test Name: hCG; Test Result: Inconclusive ; Result Unstructured Data: Started to climb back up again; Test Date: 20201227; Test Name: USG; Result Unstructured Data: Got it done, but it was too early so it didn't show anything.

Allergies:

Symptoms: Presumed miscarriage; human chorionic gonadotropin decreased; Vaccine exposure during pregnancy; A spontaneous report was received from a consumer who was also a 31-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) who experienced vaccine exposure during pregnancy, human chorionic gonadotropin decreased and presumed miscarriage. The patient's medical history was not provided. The patient's prior history of pregnancies were two miscarriages (2013 and 2015) and two full term births (2017 and 2019) were reported. The patient's last menstrual period was 25 Nov 2021. The estimated due date was 1 Sep 2021. Concomitant medications included sertraline hydrochloride and vitamins. On 27 Dec 2020, the patient found out she was pregnant, but she already had some bleeding. On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On undisclosed date, after receiving the vaccine her human chorionic gonadotropin (hCG) levels went down to 0. Her health care professional presumed it was a miscarriage. Treatment for the event was not reported. On 19th Jan 2021, her hCG levels started to climb back up again. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the event, presumed miscarriage, and human chorionic gonadotropin decreased was unknown. The outcome of the event, vaccine exposure during pregnancy, was resolved on 28 Dec 2020.; Reporter's Comments: This spontaneous report concerns a 31-years-old, G5P2 female patient who experienced vaccine exposure during pregnancy and presumed miscarriage. The patient's last menstrual period was 25-Nov-2020 with estimated date of delivery as 01-Sep-2021. One day after the patient discovered she was pregnant; she received the first dose of mRNA-1273 vaccine (lot # 026L20A expiration date unknown). The event of presumed miscarriage (human chorionic gonadotropin (hCG) levels went down to 0) was diagnosed on an unknown date after vaccine administration. The HCG level began to climb up again 22 days after the vaccine administration. Based on the information provided which includes, the patient's obstetric history, vaginal bleeding the day prior to mRNA-1273 vaccination and without definitive confirmation of pregnancy loss, there is not enough evidence to assess that that there was a miscarriage and is also unlikely to be associated with mRNA-1273 administration. The event of vaccine exposure during pregnancy is considered not applicable

Other Meds: ZOLOFT; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS

Current Illness:

ID: 1004203
Sex: F
Age: 71
State: FL

Vax Date: 01/14/2021
Onset Date: 01/15/2021
Rec V Date: 02/05/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: AFIB; A spontaneous report was received from a nurse concerning a 71-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced AFIB (Atrial fibrillation). The patient's medical history including COVID-19. Concomitant product use was not provided. On 14 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in for prophylaxis of COVID-19 infection. On 15 Jan 2021, the patient was hospitalized for two days with atrial fibrillation. The patient received Cardizem IV, converted back to sinus rhythm and discharged home two days later on Lopressor PO. Treatment for the event included Cardizem IV and Lopressor PO. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event AFIB was unknown.; Reporter's Comments: This case concerns a female patient, who experienced a serious unexpected event of atrial fibrillation. This event occurred 1 days after first dose of mRNA-1273, lot # 013L20A. Treatment included Cardizem iv and Lopressor po. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1004204
Sex: F
Age: 72
State: NY

Vax Date: 01/18/2021
Onset Date: 01/19/2021
Rec V Date: 02/05/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Thrombocytopenia/lowplatelet; A spontaneous report was received from a caregiver concerning a 72-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced thrombocytopenia/low platelet count. The patient's medical history was not provided. No relevant concomitant medications were reported. On 18 Jan 2021 at 04:00 pm, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 19 Jan 2021, the patient was hospitalized for thrombocytopenia/low platelet count, the patient was in emergency room and was given a strong dose of steroid. Her body did not react to it and she was then given a platelet transfusion. The doctors have given her steroids, immunoglobulin and aminocaproic acid during the hospitalization. They were discussing the next steps of therapy and plan to try rituximab. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event thrombocytopenia/low platelet count was unknown.; Reporter's Comments: This case concerns a 72-year-old, female patient, who experienced a serious unexpected event of thrombocytopenia. This event occurred 2 days after first dose of mRNA-1273, lot # unknown. Treatment included steroids, platelet transfusion, immunoglobulin, Amicar and pending treatment with Rituximab. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1004205
Sex: F
Age: 74
State: NC

Vax Date: 01/20/2021
Onset Date: 01/21/2021
Rec V Date: 02/05/2021
Hospital:

Lab Data: Test Date: 20210122; Test Name: blood pressure; Result Unstructured Data: 120/75 mm Hg

Allergies:

Symptoms: Passed out-was totally out for a couple of second; UTI; PVCs; very very dizzy; Vasovagal reaction; Arm was sore-not hurting much; A spontaneous report was received from a 74-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced dizziness, passed out, vasovagal reaction, urinary tract infection, premature ventricular contractions and arm pain. The patient's medical history included back problems with osteoarthritis in the spinal column neck and lower back. Products known to have been used by the patient, within two weeks prior to the event, included celecoxib and nortriptyline. On 20 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 21 Jan 2021, the patient reported she got very dizzy and passed out. Her husband relays that she was totally out for a couple of seconds. She went to the emergency room and was diagnosed with a vasovagal reaction and urinary tract infection. Premature ventricular contractions were also discovered and was not known prior to this event. Patient reports a normal blood pressure of 114-120/75. Patient also stated her arm was sore the day after vaccine but not hurting much during her usual four mile walk. Treatment for the event included intravenous medications in the emergency room, cephalexin, and a heart monitor. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events passed out, dizziness, vasovagal reaction and arm pain were resolved. The outcome of the events, urinary tract infection and premature ventricular contractions were unknown.; Reporter's Comments: This case concerns a 74 year-old, female patient, who experienced events of dizziness, passed out, vasovagal reaction, urinary tract infection, premature ventricular contractions and arm pain. The events occurred the next day after the first and last dose of mRNA-1273 vaccine administration. Based on the current limited available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related. Further information have been requested.

Other Meds: CELEBREX; NORTRIPTYLINE

Current Illness: Osteoarthritis (on spinal column, neck and lower back and had lost 2 inches in height)

Date Died: 01/23/2021

ID: 1004206
Sex: F
Age: 91
State: MN

Vax Date: 01/21/2021
Onset Date: 01/23/2021
Rec V Date: 02/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Death; A spontaneous report was received from a nurse concerning a 91-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and died two days later. The patient's medical history included dementia. Concomitant medications reported included paracetamol. On 21 Jan 2021, approximately two days prior to her death, the patient received the first of two planned doses of mRNA-1273, intramuscularly for prophylaxis of COVID-19 infection. On 23 Jan 2021, the patient died. The nurse reporting the event stated that the patient's death was considered as due to "natural causes" and that she was not aware of any new-onset symptoms of illness prior to the patient's death. The patient was described as "fragile" and was under hospice care at the time of her death. An autopsy was not performed. Action taken with the drug in response to the event is not applicable. The patient died on 23 Jan 2021. The cause of death was natural cause of death related to dementia. Autopsy was not performed.; Reporter's Comments: This case concerns a 91-years-old female patient, with medical history of dementia, who experienced a serious unexpected event of death. This event occurred 2 days after first dose of mRNA-1273, lot # unknown. At the time of death, the subject was very fragile and was in hospice care. Concomitant medication included Tylenol. Treatment details were not provided. The doctor considered that the death was due to natural causes. However, autopsy was not performed. Very limited information regarding this event has been provided at this time. Based on the limited information available, it is difficult to assess a cause and effect relationship. The benefit-risk relationship of Moderna's COVID-19 vaccine is not affected by this report.; Reported Cause(s) of Death: Natural cause of death related to dementia

Other Meds: TYLENOL

Current Illness:

ID: 1004207
Sex: F
Age: 31
State: CA

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/05/2021
Hospital: Y

Lab Data: Test Date: 20210121; Test Name: Pulse rate; Result Unstructured Data: Dropped

Allergies:

Symptoms: Anaphylactic reaction; Stomach hurt; Tired; Headache; Body ache; GI issues; Shortness of breath while talking; A spontaneous report was received from a 31-year-old, female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic reaction, stomach hurt, GI issues, shortness of breath while talking, fatigue, headache and body aches. The patient's medical history includes allergy to Tylenol, Imitrex, mango, pineapple, oranges, nuts, seafood and cinnamon. No relevant concomitant medications were reported. On 21 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 21 Jan 2021, 5 minutes after receiving the vaccine, the patient experienced an anaphylactic reaction. She experienced shortness of breath, coughing, vomiting, pulse rate dropped to 40 and she showed signs of anaphylactic reactions. She was administered Benadryl 50 mg IM at the 5-minute mark and 1 dose of the EpiPen at the 20 minute mark. This helped relieve some of the tightness around the throat. She experienced a secondary anaphylactic reaction 5 hours later and was rushed to the emergency room. She was hospitalized from 21 Jan 2021 to 24 Jan 2021. While in the hospital, she experienced two more anaphylactic reactions reported as similar to the previous reactions except that for the last two reactions, she could feel them coming on before her coughing and tightness started. She states "I felt very hot, clammy, and could feel the allergic reaction coming on for the last two reactions." During the hospitalization, she was administered Benadryl, Solumedrol, and EpiPen. On 26 Jan 2021, she has recovered from her anaphylactic reaction but she was tired, has shortness of breath while talking, headache, body aches, her stomach hurts, and its hard for her to eat without having some GI issues. She has never felt like this before and it is very unusual for her. Action taken with the second dose of mRNA-1273 in response to the events were not reported. The outcome for the event, anaphylactic reaction was considered Resolved/Recovered On 26 Jan 2021. The outcome for the events, stomach hurt, GI issues,shortness of breath while talking, fatigue, headache and body aches was unknown.; Reporter's Comments: This case concerns a 31-year-old female patient with medical history of multiple food and drug allergies, who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted event of anaphylactic reaction, the non-serious listed events of Fatigue, Headache, and Myalgia, and the non-serious unlisted events of stomach ache, gastrointestinal issues, and shortness of breath while talking. The event of anaphylactic reaction started within minutes after vaccination. Based on the current available information and temporal association between the use of the product and the onset of events on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.

Other Meds:

Current Illness: Allergy to nuts; Drug allergy (Tylenol); Drug allergy (Imitrex); Fruit allergy (Pineapple); Fruit allergy (Oranges); Fruit allergy (Mango); Seafood allergy; Spice allergy (Cinnamon)

ID: 1004208
Sex: F
Age: 73
State: TX

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 02/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Neuropathy in the finger / Neuropathy in the right arm; chills; Nausea; Headache; A spontaneous report received from a consumer concerning a 73-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced chills, nausea, headache, neuropathy in the finger and right arm. The patient's medical history was not provided. Concomitant medications reported included rosuvastatin and eye drop. On 16 Jan 2021, approximately 0 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number 041L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 16 Jan 2021, the patient experienced chills, nausea and headache, all of which resolved within 36 hours on 18 Jan 2021. She took 3 Tylenol, and a Zomig to help with the symptoms. On 24 Jan 2021, the patient began to experience neuropathy in her finger and right arm, which she reported as it was getting worse. Action taken with mRNA-1273 in response to the events was not reported. The events, chills, nausea and headache, were considered resolved on 18 Jan 2021. The outcomes of the events, neuropathy in the finger / neuropathy in the right arm were unknown.; Reporter's Comments: This spontaneous report concerns a 73-year-old female patient who experienced a serious event of neuropathy in the right finger and non-serious events of chills, nausea and headache. The events of chills, nausea and headache occurred on the same day after the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: Unknown, expiration date-Unknown). Neuropathy occurred 8 days after the administration of mRNA-1273 vaccine. Treatment administered included Tylenol and Zomig for chills, nausea and headache with resolution. The events of chills, nausea and headache are consistent with the safety profile for mRNA-1273 vaccine. Based on the information provided, including temporal association and in the absence of any other etiology, a causal association cannot be excluded for all reported events. Causality for the event of neuropathy is also confounded by the patient's advanced age. Main field defaults to ?possibly related'

Other Meds: ROSUVASTATIN; eye drop

Current Illness:

ID: 1004209
Sex: F
Age: 79
State: OK

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 02/05/2021
Hospital: Y

Lab Data: Test Date: 202101; Test Name: CT; Test Result: Negative ; Result Unstructured Data: No acute findings.; Test Date: 202101; Test Name: EKG; Result Unstructured Data: Within normal limits; Test Date: 202101; Test Name: CBC; Result Unstructured Data: Within normal limits; Test Date: 202101; Test Name: Chem lab; Result Unstructured Data: Within normal limits; Test Date: 202101; Test Name: MRI; Test Result: Negative ; Result Unstructured Data: No acute findings.; Test Date: 202101; Test Name: XRay; Result Unstructured Data: Normal

Allergies:

Symptoms: Stroke like symptoms; Couldn't speak; Shortness of breath; Legs and arm weakness; Dizziness with Nystagmus; Throat swelling; Dizziness with vertigo; Dizziness with vertigo; A spontaneous report was received from a nurse concerning a 79-year-old, white, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stroke like symptoms, dizziness with nystagmus, legs and arm weakness, couldn't speak, shortness of breath, throat swelling and dizziness with vertigo. The patient's medical history, as provided by the reporter included anemia, overactive bladder, fibroid cystic disease, allergy to fluoroquinolone, ciprofloxacin, povidone iodine, morphine and adhesive tape. The concomitant medications reported included atorvastatin, calcium, colecalciferol, metoprolol succinate, pramipexole hcl and prasugrel hcl for unspecified indications. On 07 Jan 2021, 11 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient experienced stroke like symptoms, couldn't speak, shortness of breath and throat swelling. It was reported that the patient was hospitalized for acute stroke. On an unknown date, while still being hospitalized, the patient developed, dizziness with nystagmus and dizziness with vertigo. The lab findings included, magnetic resonance imaging (MRI) and computed tomography (CT) scans as negative for acute findings, electrocardiography (EKG), complete blood count (CBC), X-ray and chemistries were reported as within normal limits. The patient remained hospitalized for 2.5 days while the symptoms improved. On 09 Jan 2021, the patient was discharged. On 20 Jan 2021, the reporter stated that the patient felt weak and tired without other symptoms. It was also noted that the patient's discharge summary stated the patient's symptoms may be worse following a second dose of mRNA-1273 vaccine. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, stroke like symptoms, dizziness with nystagmus, legs and arm weakness, couldn't speak, shortness of breath, throat swelling and dizziness with vertigo. were considered as resolved on an unknown date.; Reporter's Comments: This case concerns a 79-year-old, white, female patient with medical history of anemia, overactive bladder, fibroid cystic disease, who experienced the serious, unexpected event of stroke, Aphasia, dyspnea and non-serious, unexpected events of , dizziness, vertigo, pharyngeal swelling, nystagmus and muscular weakness. The events of stroke, Aphasia, Dyspnea and pharyngeal swelling occurred 11 hours after the first dose of mRNA-1273 (Lot number: 025J20-2A) administration and the events of dizziness, vertigo, pharyngeal swelling, nystagmus and muscular weakness occurred on an unknown date while the patient was still hospitalized. 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: ATORVASTATIN; CALCIUM; VITAMIN D 3; METOPROLOL SUCCINATE; PRAMIPEXOLE HCL; PRASUGREL HCL

Current Illness: Adhesive tape allergy; Allergy to antibiotic; Drug allergy (Morphine); Iodine allergy; Overactive bladder; Uterine fibroid cyst

ID: 1004210
Sex: F
Age: 62
State:

Vax Date: 01/24/2021
Onset Date: 01/24/2021
Rec V Date: 02/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Anaphylactic reaction; A spontaneous report was received from a 62-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylactic reaction. The patient's medical history, as reported, included 4 previous anaphylactic reactions since she was 9 years old, history of throat problems and swelling, bronchitis, and her brother died in 1997 due to an anaphylactic reaction to poison ivy and bee stings. Concomitant medications reported included thyroid medication (not specified), blood pressure medication (not specified), gabapentin, sleep medicine (not specified) and curcuma longa rhizome. On 24 Jan 2021, about 15 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 24 Jan 2021, 30 minutes prior to receiving the vaccine, the patient took prednisone (dose unknown), per instructions from her doctor due to her history of anaphylactic reactions. She did notify the vaccinators of her history and there was an ambulance present. About 15 minutes after receiving the vaccine, the patient started coughing, had heavy chest pain, trouble breathing, and felt like her throat was constricting more than usual. No rash developed. She approached the ambulance and asked if she could take diphenhydramine. She took one dose, followed by 3 other doses, and felt a bit better. Consent given for Safety to follow up with patient. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event, anaphylactic reaction was resolving at the time of this report.; Reporter's Comments: This case concerns a 62 year old female patient with medical history of included 4 previous anaphylactic reactions since she was 9 years old, history of throat problems and swelling, bronchitis, and her brother died in 1997 due to an anaphylactic reaction to poison ivy and bee stings. Concomitant medications reported included thyroid medication (not specified), blood pressure medication (not specified), gabapentin, sleep medicine (not specified) and curcuma longa rhizome. She experienced a serious unexpected event of Anaphylactic reaction that needed treatment diphenhydramine. The event occurred approximately 15 minutes after first dose of the study medication administration even thought the patient took prednisone prior to receiving the vaccine. 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: THYROID; GABAPENIN; TURMERIC [CURCUMA LONGA RHIZOME]

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm