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: 0933201
Sex: M
Age: 41
State: CA

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: None

Allergies: No

Symptoms: On the date of injection. My right arm was fine. Waited 15 mins. Everything was ok. Until 130 am at night. Woke up due to the heart palpitations and nausea that lasted 10-20 mins. Monitor the symptoms and it went away after 20 mins. Symptoms was mild.

Other Meds: Famotidine

Current Illness: Gerd

ID: 0933202
Sex: F
Age: 78
State: VA

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

Lab Data: None

Allergies:

Symptoms: 8 days after the first vaccine dose, I had itching, swelling, redness, and warmth at injection site on my right upper arm when I woke up in the morning. This is the first day I have had these symptoms. The swelling and redness is about 4 inches in diameter and is very firm. The symptoms have stayed the same all day and the swelling has not gone down yet. I haven?t taken any medication for it or gone to a doctor yet.

Other Meds: Serevent, Asmanex, levothyroxine,

Current Illness: None

ID: 0933203
Sex: F
Age: 60
State: CA

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: RN administered 1.0 ml delivering 200 mcg, patient was monitored for 30 minutes, no complaints or symptoms reported at time of administration and no symptoms or complaints as of today.

Other Meds:

Current Illness:

ID: 0933204
Sex: M
Age: 17
State: WA

Vax Date: 01/08/2021
Onset Date: 01/09/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies: None

Symptoms: 3? Hard, painful, swollen lump at injection site.

Other Meds: None

Current Illness: None

ID: 0933205
Sex: F
Age:
State: AZ

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

Lab Data:

Allergies: none aware of

Symptoms: None stated.

Other Meds: 1) Levothyroxine 50mg, 2) Lisinopril HCTZ 20mg, 3)Alendronate Sodium 70mg, 4) Vitamin E-D2 25mcg

Current Illness: none

ID: 0933206
Sex: M
Age: 49
State: CO

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Moderna COVID?19 Vaccine EUA - RN administered 1.0 ml delivering 200 mcg, patient was monitored for 30 minutes, no complaints or symptoms reported at time of administration, day 2-3 complaint of severe headache and arm heaviness w/ pain, and no symptoms or complaints days 4-5.

Other Meds:

Current Illness:

ID: 0933207
Sex: F
Age: 37
State: WA

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

Lab Data: none

Allergies: none

Symptoms: patient c/o feeling anxious, jittery and worried about vaccine. given H2), 120/80, 84, 98% stayed on site 30 mins. no symptoms or sob. called next day 01/08 1042 am c/o of nausea, chills and fatigue. eating and drinking fluids instructed to call provider if symptoms get worse or 911

Other Meds: c/o feeling anxious, jittery, and no sob 120/80,84 98%, given H2O. pt explained she often has this reaction with vaccines. no hx of adverse reactions/anaphylaxis. stayed fro 30 mins and felt better. called patient 01/08 stated feeling be

Current Illness: none

ID: 0933208
Sex: F
Age: 80
State: CA

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Moderna COVID?19 Vaccine EUA - RN administered 1.0 ml delivering 200 mcg, patient was monitored for 30 minutes, no complaints or symptoms reported at time of administration and no symptoms or complaints as of today.

Other Meds:

Current Illness:

ID: 0933209
Sex: F
Age: 36
State: CA

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Moderna COVID?19 Vaccine EUA - RN administered 1.0 ml delivering 200 mcg, patient was monitored for 30 minutes, no complaints or symptoms reported at time of administration and no symptoms or complaints as of today.

Other Meds:

Current Illness:

ID: 0933210
Sex: F
Age: 24
State: TX

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies: NA

Symptoms: Immediately after receiving the vaccine I felt fine. Around 7 pm that night I began having body aches that continually worsened throughout the night. At 2 am on Saturday I took my temperature and it was 101.6 F, at 3 am it was 102 F. The body aches, joint pain, fever, and headache continued through the next day until about 6 pm on Saturday. Also on Saturday around 12 pm I began experiencing severe nausea, abdominal pain, and dizziness. At one point it felt as if I was going to pass out. All the major symptoms finally subsided Saturday night around 6 pm. Saturday till Sunday I have felt fatigued and sore but otherwise fine.

Other Meds: Estarylla Probiotic

Current Illness: NA

ID: 0933211
Sex: M
Age: 62
State: CA

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Moderna COVID?19 Vaccine EUA - RN administered 1.0 ml delivering 200 mcg, patient was monitored for 30 minutes, no complaints or symptoms reported at time of administration and no symptoms or complaints as of today.

Other Meds:

Current Illness:

ID: 0933212
Sex: M
Age: 50
State: IA

Vax Date: 01/04/2021
Onset Date: 01/05/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: N/A

Allergies: E-mycin, rash; Kelflex, nausia

Symptoms: Body aches, chills, nausea lasting through January 5th and 6th. Missed work both of these days. Previously had Covid-19 in July 2020.

Other Meds: Omeprazole, 40mg/day; Vitamin D3, 100mcg/day; Fluoxetine, 80mg/day; Multivitamin, 1/day; Metformin, 2000mg/day; Fish Oil 4000mg/day; Tamsulosin, 0.8mg/day; Atorvastatin, 40mg/day

Current Illness: N/A

ID: 0933213
Sex: F
Age: 25
State: CA

Vax Date: 12/30/2020
Onset Date: 01/02/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies: Most seafood, kiwi

Symptoms: Bad sore arm for 24 hours Possible migraine/headaches began 2-3 days later unsure if related to the vaccine. I normally don?t get migraines and it?s been lasting ever since, all day and has progressively slowly gotten worse, some very minor nausea at night from the headache. Not even Tylenol extra strength helps the pain.

Other Meds: None

Current Illness:

ID: 0933214
Sex: F
Age: 65
State: WA

Vax Date: 12/31/2020
Onset Date: 01/05/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies: NKDA

Symptoms: About five days after vaccine administration I noticed an inflammation of the area of the achilles tendon of left foot. Since I am not prone to inflammation of any sort nor did I have any strain or trauma, I took notice. I do not CHF (causing swelling of the ankles). The area of inflammation is tender, a bit red and a bit swollen. It is worrisome since I have never had anything like this in the past. I WILL NEED FOLLOW UP ON THIS. I AM UNSURE IF I SHOULD RECEIVE THE SECOND VACCINE. AND I WOULD LIKE TO KNOW IF SIMILAR INFLAMMATORY RESPONSES HAVE BEEN REPORTED, WHETHER IN ANKLE OR SOMEWHERE ELSE IN THE BODY. I realize that this may not be a typical vaccine reaction BUT this is a brand new vaccine, has not been time-tested, is only permitted by the FDA to be administered under these emergency circumstances. SO all possible reactions must be taken seriously and recorded. We are the guinea pigs. Also. I was handed a packet of papers when I received the vaccine. To register for v-safe the only two options given for registration were smart phone browser or QR code. I do not have a cell phone. So this leaves me out of the loop, which I think is unfair and unwise. Why can computer registration not be made available, and if it can then why doesn't the instruction sheet tell of this? In rural areas not everyone has a cell phone nor is cell service available to all areas.

Other Meds: Levothyroxine 75 mcg, multiple vitamins, vitamin D, Glucosamine, calcium.

Current Illness: none

ID: 0933215
Sex: F
Age: 54
State:

Vax Date: 12/30/2020
Onset Date: 01/01/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: None

Allergies: e-mycin, narcotics (nausea/vomiting), anesthesia

Symptoms: I had a normal lump, red (lemon-sized), warm area surrounding the injection site. This occurred within 2-3 days. Within 2-3 more days, the area became more dusky and appeared to be resolving. However, 9 days after the injection, the red area reappeared and was warm to the touch. I called the nurse advice line for the base and they had me get it checked out. (The only open location was the ER at a specific location.) The ER doc advised it was an adverse reaction because it came back after resolving. In addition, he advised to report it to the location that administered the vaccine. I tried to do that, and they advised me to report it here. Note: I have no health insurance and will be financially responsible for that ER visit.

Other Meds: prednisone; Cytomel; levothyroxine; Prilosec; Breo ellipta; Flonase; Azelastine spray; Singulair; Zyrtec; Vit D; Iron

Current Illness: GERD, hypothyroid, asthma

ID: 0933216
Sex: M
Age: 55
State: NV

Vax Date: 12/17/2020
Onset Date: 12/22/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data: None to date

Allergies: NKDA

Symptoms: A few days after first shot, noticed numbness in left little toe which progressed to 3,4,5 digits. After second dose (1-2days later) numbness extended to both feet, all digits, soles, and outside foot

Other Meds: Climdamycin

Current Illness: Prostatitis

ID: 0933217
Sex: F
Age: 35
State: MP

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

Lab Data: N/A

Allergies: N/A

Symptoms: 30 minutes of blurred vision with flashes of light.

Other Meds: Acetaminophen

Current Illness: Fever

ID: 0933218
Sex: M
Age: 41
State:

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Tenderness and swelling at site of injection time 2 days.

Other Meds:

Current Illness:

ID: 0933219
Sex: F
Age: 36
State: MD

Vax Date: 01/08/2021
Onset Date: 01/09/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: N/a

Allergies: None

Symptoms: At 4:30pm on Saturday January 9, 2021 I experience a slight fever with chills and back and neck pain. Nothing alarming. I was still able to carry out my normal day activities that included cleaning, tidying, cooking. I did not check my temperature because there was no need, as I said, I could carry on with my day. My arm hurt a lot that day and there was a rectangular red rash around the injection site. That was about the weirdest part at 5:15pm today (Jan 10th, 2021). I noticed this gnarly rash on my chest and back and both shoulders. Red and a little itchy, warm to the touch. It is now 11:50pm same day and the relish has spread to under both of my breasts and down to the bottom of my back. I have pictures of the rash. No fever today. Also, I am both the patient and a member of the vaccination team at my company. My coworker and I are in charge of all admin associated with the vaccine. We are currently vaccinating all our staff. I was the first to get vaccinated in our company. And here it looks like I have an allergic reaction! I have never had an allergic reaction in the past to an injection. I just took some BENADRYL. I'll show a nurse at my clinic tomorrow. Hoping it doesn't spread anymore.

Other Meds: Adderall 10mg BID

Current Illness:

ID: 0933220
Sex: F
Age: 44
State: CA

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data: Covid swab PCR X 3, 24 hrs apart, took Tylenol

Allergies: Mucomyst, bactrim

Symptoms: Flushing, lump in throat, body aches , fatigue, sore arm, increase BP , increase heart rate after 10-20 mins post vaccine, then mild headache , nausea, metallic taste, dizziness for 3 days , then developed swollen lymph nodes on left supra clavicular area , fever, chills , extreme fatigue on day 4. Increase BP for a week, my BP runs low -my baseline.

Other Meds: Tylenol and Benadryl

Current Illness: Migraine

ID: 0933221
Sex: F
Age: 30
State: CO

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

Lab Data:

Allergies:

Symptoms: About 12hrs after the vaccine was administered, I was at work and wearing nitrile gloves. After 10 minutes, the gloves began burning my hands so badly that I couldn't wear them any longer. I have never had an allergy or an adverse reaction to the gloves I was using. I washed my hands and attempted a different pair of nitrile gloves by a different manufacturer and had the same reaction. I then put on latex gloves, which still caused a burning sensation, but not to the same degree as the nitrile.

Other Meds: Vitamin C, Biotin, Zinc. 150mg Modafinil was taken 36hrs before vaccine

Current Illness:

ID: 0933222
Sex: F
Age: 33
State: HI

Vax Date: 01/07/2021
Onset Date: 01/08/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data: None

Allergies: Keflex

Symptoms: Body Aches, Chills, tiredness

Other Meds: None

Current Illness: End Stage Renal Disease

ID: 0933223
Sex: F
Age: 25
State: KS

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

Lab Data:

Allergies: NKDA

Symptoms: headache, lightheadedness, vertigo, fever, chills, nausea, stomach cramps, tachycardia. All lasting 18 hours.

Other Meds: N/A

Current Illness: N/A

ID: 0933224
Sex: M
Age:
State: AZ

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

Lab Data:

Allergies: None

Symptoms: None stated.

Other Meds: Trulicity-76MG, Thyroxine-75MG, Losartan -50MG. Vitamin D3, Primidone 50MG, Atorvastation 10MG, Januvia-100MG Tamsulosin-4 MG,

Current Illness: None

ID: 0933225
Sex: M
Age: 34
State: OR

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

Lab Data: N/A

Allergies:

Symptoms: Fatigue with localized soreness at site of injection.

Other Meds:

Current Illness:

ID: 0933241
Sex: F
Age:
State: PR

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Numbness of the left side of the face and headache on the left side and part of the tongue; Numbness of the left side of the face and headache on the left side and part of the tongue; The left side of my body, like burning (ankle, elbow); The left side of my body, like burning (ankle, elbow); This is a spontaneous report from a contactable healthcare professional (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular at left arm on 30Dec2020 11:30 at SINGLE DOSE for COVID-19 immunization. Medical history included known allergies to Uva roja. The patient is not pregnant. No COVID prior vaccination. Facility where the most recent COVID-19 vaccine was administered was in the Doctor's office/urgent care. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications (received within 2 weeks of vaccination) included atorvastatin (LIPITOR) and fexofenadine hydrochloride (ALLEGRA). The patient previously took titanium and experienced allergies. On 30Dec2020 , the patient experienced numbness of the left side of the face and headache on the left side and part of the tongue. The left side of patient's body, like burning (ankle, elbow). No treatment received for the events. The events were assessed as non-serious. The patient had not been tested for COVID post vaccination. The outcome of the events was recovered on unspecified date. Information on lot/batch number has been requested.

Other Meds: LIPITOR [ATORVASTATIN]; ALLEGRA

Current Illness:

ID: 0933244
Sex: U
Age:
State: OH

Vax Date: 12/09/2020
Onset Date: 12/09/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Patient should have come back 8 weeks later; This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 17-NOV-2020 the patient was vaccinated with a dose of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13). Patient should have come back 8 weeks later in approximately middle January 2021 for the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) but on 09-DEC-2020, the patient was received the dose (0.5 milliliter (unspecified route) lot # T028093 expiration date 24-APR-2022 for prophylaxis). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T028093; expirationdate: 24-APR-2022; 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: PNEUMOVAX23 SYRINGE (DEVICE)

Current Illness:

ID: 0933245
Sex: M
Age: 65
State: TN

Vax Date: 11/15/2010
Onset Date:
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Infection in hand; This spontaneous report has been received from a licensed practical nurse via a lawyer, concerning a 65-year-old male patient. The patient's medical history included chicken pox. The concurrent conditions included arthritis and degeneration of intervertebral disc. Concomitant medications were not reported. On 15-NOV-2010 and 02-APR-2015, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (reported as "pneumonia") by a license practical nurse at a physician's office (strength, lot #, expiration date, dosage, anatomical location and route of administration were not provided) for prophylaxis. On an unspecified date, the patient experienced infection in hand which was considered an adverse reaction or side effect of Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). The outcome of the event was unknown. The patient subsequently experienced Ophthalmic herpes zoster, blindness, sudden hearing loss, major depression, vaccination failure, skin infection, back pain, post herpetic neuralgia, chronic, obstructive coronary disease, colonoscopy, auditory disorder, benign, prostatic hyperplasia, restless legs syndrome, and herpes zoster while on therapy with Zoster Vaccine Live (ZOSTAVAX) (litigation case # 1706USA007417).; Sender's Comments: US-009507513-1706USA007417:

Other Meds:

Current Illness: Arthritis (Dates of care/treatment: 2005 to present); Intervertebral disc degeneration (Dates of care/treatment: birth to present)

ID: 0933246
Sex: U
Age:
State: NJ

Vax Date:
Onset Date: 12/16/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: A unproperly vaccine was administered; This spontaneous report was received from a nurse referring to a 9-week-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) with a valid lot # S013439, expiration date reported as 03-MAR-2021, 2 mL, orally for prophylaxis. On 16-DEC-2020, the vaccine experienced a temperature excursion of 0.38 ?C for 4 hours and 45 minutes and 11.09 ?C for 1 hour and 30 mins. Previous temperature excursion of 17.52?C for 2 hours and 42 minutes. There was data logger involved.

Other Meds:

Current Illness:

ID: 0933247
Sex: U
Age: 1
State: IL

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Excursion - vaccine; Information has been received from a registered nurse concerning to a 12 month old patient (gender not reported). No medical history, concurrent conditions nor concomitant medications were reported. On 21-DEC-2020, the patient was vaccinated with excursion temperature (product storage error) dose of varicella virus vaccine live (oka/merck) (VARIVAX) (Lot No. T017688, exp. date 21-MAY-2022), 0.5 milliliter for prophylaxis. Temperature: -13.3C Timeframe: 4 hours and 15 minutes Previous temperature excursion: No Call because of data logger

Other Meds:

Current Illness:

ID: 0933248
Sex: U
Age: 4
State: IL

Vax Date: 12/17/2020
Onset Date: 12/17/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No other AE details available at this time; Caller reported temperature excursion. / Temperature -1 3.3C; This spontaneous report was received from a registered nurse concerning to a 4-year-old patient of unknown gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided. On 17-DEC-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), 0.5 milliliter (ml) for prophylaxis, lot number reported as T021638 and expiration date as 21-DEC-2021 (vaccination scheme, route of administration and anatomical site of vaccination were not provided). No additional adverse events were reported. The administered vaccine had a temperature excursion of -13.3 degrees Celsius (?C) for a time frame of 4 hours and 15 minutes on an unspecified date, and the data was recorded by a digital data logger. It was also reported there was not a previous temperature excursion. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2012USA013095: US-009507513-2012USA013584: US-009507513-2012USA013603: US-009507513-2012USA013093:

Other Meds:

Current Illness:

ID: 0933249
Sex: U
Age: 4
State: IL

Vax Date: 12/24/2020
Onset Date: 12/24/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No other AE details available at this time; Caller reported temperature excursion. / Temperature -1 3.3C; This spontaneous report was received from a registered nurse concerning to a 4-year-old patient of unknown gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided. On 24-DEC-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), 0.5 milliliter (ml) for prophylaxis, lot number reported as T021638 and expiration date reported as 21-FEB-2021, but upon internal validation established as 21-DEC-2021 (vaccination scheme, route of administration and anatomical site of vaccination were not provided). No additional adverse events were reported. The administered vaccine had a temperature excursion of -13.3 degrees Celsius (?C) for a time frame of 4 hours and 15 minutes on an unspecified date, and the data was recorded by a digital data logger. It was also reported there was not a previous temperature excursion. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2012USA013095: US-009507513-2012USA013596: US-009507513-2012USA013584: US-009507513-2012USA013095:

Other Meds:

Current Illness:

ID: 0933250
Sex: U
Age: 4
State: IL

Vax Date: 12/04/2020
Onset Date:
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Improperly stored vaccine administered; No other AE details available; This spontaneous report was received from a registered nurse referring to a 4 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug allergies and reactions were not reported. On 04-DEC-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status recombinant human albumin (rHA) (strength and route of administration were not reported; lot# was T021638 and expiration date was reported as 21-FEB-2021, but upon internal validation established as 21-DEC-2021) 0.5 milliliter for prophylaxis, which experienced temperature excursion (product storage error). No other adverse event (AE) details available at this time. The vaccine underwent temperature excursion of -13.3 degree Celsius for 4 hours 15 minutes. There were no previous temperature excursions. The digital data logger was involved.

Other Meds:

Current Illness:

ID: 0933251
Sex: F
Age:
State:

Vax Date: 01/14/2018
Onset Date: 12/03/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: The product gave the patient shingles, on the right side all the way down, including her groin, front, and back of the legs. Then it travelled to the left side of her body; Her eye was twitching; This spontaneous information has been received from a female patient of unknown age, concerning herself via Agency. The patient's pertinent medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided. On 14-JAN-2018, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date were not reported). On an unknown date, the patient experienced shingles, on the right side all the way down, including her groin, front and back of the legs, then it travelled to the left side of her body (herpes zoster). On 03-DEC-2020, her eye was twitching (eye movement disorder) and the shingles travelled down her arm and shoulders. It was reported that it had been a severe thing and they would try a new technique in the center of her nervous system. They wanted to put six rods in her body and she would received tapentadol hydrochloride (NUCYNTA) in the emergency room (ER) until she could get the procedure done for the nerve pain she had. At the time of this report, the patient had not recovered from the adverse events. The reporter considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX). The causal relationship between eye movement disorder and zoster vaccine live (ZOSTAVAX) was not provided.

Other Meds:

Current Illness:

ID: 0933252
Sex: M
Age:
State: TX

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

Lab Data:

Allergies:

Symptoms: Bell's Palsy; This spontaneous report was received from a lawyer concerning a case in litigation and refers to currently 70 year old male patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On or about 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported) for long-term prevention of shingles and zoster-related conditions. On an unknown date (reported as "subsequently"), the patient experienced bell's palsy (facial paralysis), and was treated with unspecified medications. The outcome of facial paralysis was unknown. The reporter considered facial paralysis to be related to Zoster Vaccine Live (ZOSTAVAX). Upon internal review, the event of bell's palsy was considred medically significant.

Other Meds:

Current Illness:

ID: 0933253
Sex: U
Age: 74
State: TX

Vax Date: 06/10/2015
Onset Date:
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Herpes zoster; Information has been received from a lawyer regarding a case in litigation, concerning a currently 79-year-old patient (pt) of unknown gender. The pt's medical history, concurrent conditions, and concomitant medications were not reported. On or about 10-JUN-2015, the pt was administered zoster vaccine live (ZOSTAVAX) by a pharmacist, for the long-term prevention of shingles and herpes zoster-related conditions (dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unspecified date (reported as "subsequently"), the pt was treated by a health care provider for the following injuries resulting from zoster vaccine live (ZOSTAVAX) vaccine: herpes zoster. The pt claimed damages as a result of injury to themselves, loss of consortium, loss of services and economic losses. The outcome of the event was unknown. The reporter considered herpes zoster to be related to the suspect vaccine.

Other Meds:

Current Illness:

ID: 0933254
Sex: F
Age:
State: AZ

Vax Date: 01/01/2011
Onset Date: 01/01/2011
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: She stated that she had a cyst develop on her arm from the pneumonia vaccine that had to be surgically remove; anaphylactic reaction to Pneumovax; This spontaneous report as received from a 68 years old female retired medic via Pfizer referring to herself. The patient had a significant allergies to food related, nitrate plants and medications. The patient was allergic to tomato, potato, eggplant, cayenne, chili pepper, paprika, whole wheat, egg albumin, aluminum, baclofen, diphenhydramine hydrochloride (BENADRYL), benzene (BENZOL), clindamycin, and so on. The patient had an allergic reaction to egg component of influenza virus vaccine (unspecified). The patient was immunocompromised and had multiple sclerosis. The patient was taking immunosuppressants and interferon beta-1a (AVONEX). In approximately January 2011 (reported as 10 years ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route, lot# and expiration date were unknown) for prophylaxis. In approximately January 2011 (reported as 10 years ago), the patient had an anaphylactic reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The patient received self medicating with an antihistamine. On an unknown date, the patient had a cyst develop on her arm from the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine that had to be surgically removed. The outcome of anaphylactic reaction and cyst was unknown. The reporter considered the causal relationship between anaphylactic reaction and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was related. The causality assessment between cyst and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported. Upon internal review, anaphylactic reaction was determined to be medically significant.

Other Meds: AVONEX

Current Illness: Allergy to aluminium; Allergy to plants (nitrate plants); Allergy to vaccine; Drug hypersensitivity; Food allergy (allergic to tomato, potato, eggplant, cayenne, chili pepper, paprika, whole wheat, egg albumin); Hypersensitivity; Immunocompromised; Multiple sclerosis

ID: 0933255
Sex: U
Age:
State: PA

Vax Date: 07/27/2016
Onset Date:
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: meningitis; pneumonia; cardiovascular event; congestive heart failure; postherpetic neuralgia; multiple outbreaks of herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or about 27-JUL-2016, the patient was inoculated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date after the vaccination, the patient suffered multiple outbreaks of herpes zoster, postherpetic neuralgia, meningitis, pneumonia, cardiovascular event and congestive heart failure. As a result of these symptoms, patient was seen and treated by medical providers and was still under their care. As a result of vaccine live(ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient also had incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of above events was considered as not recovered. The reporter considered the events to be disable and related to Zoster Vaccine Live(ZOSTAVAX). Upon internal review, meningitis, pneumonia and congestive heart failure were determined to be medically significant.

Other Meds:

Current Illness:

ID: 0933256
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Received "23 pneumonia vaccine" with an underlying autoimmune condition resulted in frozen shoulder; This spontaneous report was received from a health care professional via Pfizer regarding a female patient of unknown age. The patient's current conditions included an autoimmune disorder. Her medical history included facial paralysis. The patient's drugs reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose, frequency, route of administration, anatomical injection site, lot number, and expiration date were not reported) as prophylaxis. At the vaccination time, the patient had an underlying autoimmune condition resulted in frozen shoulder (periarthritis). The outcome of the event was unknown. The causal relationship between periarthritis and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not provided

Other Meds:

Current Illness: Autoimmune disorder

ID: 0933257
Sex: U
Age:
State: NY

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: no additional adverse event reported; temperature excursion for PROQUAD/doses were administered following the excursion; This spontaneous report was received from a physician referring to a 4 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 29-DEC-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 milliliter for prophylaxis, lot number reported as T021642 and expiration date as 21-DEC-2020 (vaccination scheme, anatomical location, and route of administration were not provided) (product storage error). No additional adverse event reported. The administered dose of the vaccine experienced a temperature excursion of max. 16.2 Fahrenheit (F) for a timeframe of 2 hours and 28 minutes, as recorded by a digital data logger. It was also reported there was not a previous temperature excursion.

Other Meds:

Current Illness:

ID: 0933258
Sex: U
Age: 11
State: MI

Vax Date: 12/18/2020
Onset Date: 12/18/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional adverse events reported.; GARDASIL9 was administered during a temperature excursion; Information has been received from a medical assistant, referring to a 11 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-DEC-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # S033308, expiration date on 08-APR-2022, 0.5 milliliter (administration route and anatomical location were not reported)for prophylaxis. The reporting medical assistant stated that the dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was administered during a temperature excursion that was later found supported. No additional adverse events reported. The temperature excursion was 8.5 Celsius degrees (C), during a time frame of 3 minutes. It was confirmed that no previous temperature excursions occurred and no digital data logger was involved. 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: S033308; expirationdate: 08-APR-2022; 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 suggest a causal association with the device or device constituent

Other Meds: GARDASIL 9 SYRINGE (DEVICE)

Current Illness:

ID: 0933259
Sex: U
Age:
State: TX

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

Lab Data:

Allergies:

Symptoms: bullous pemphigoid; This case was reported by a physician via sales rep and described the occurrence of bullous pemphigoid in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced bullous pemphigoid (serious criteria GSK medically significant). On an unknown date, the outcome of the bullous pemphigoid was unknown. It was unknown if the reporter considered the bullous pemphigoid to be related to Shingrix. Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected adult as per vaccine indication. The patient developed bullous pemphigoid after receiving the Shingrix vaccine. The permission to follow up was denied. This case has been linked with US2021AMR001850, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR001850:same reporter

Other Meds:

Current Illness:

ID: 0933260
Sex: U
Age:
State: TX

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

Lab Data:

Allergies:

Symptoms: bullous pemphigoid; This case was reported by a physician via sales rep and described the occurrence of bullous pemphigoid in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced bullous pemphigoid (serious criteria GSK medically significant). On an unknown date, the outcome of the bullous pemphigoid was unknown. It was unknown if the reporter considered the bullous pemphigoid to be related to Shingrix. Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected adult as per vaccine indication. The patient developed bullous pemphigoid after receiving the Shingrix vaccine. The permission to follow up was denied. This case has been linked with US2021AMR001842, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR001842:same reporter

Other Meds:

Current Illness:

ID: 0933261
Sex: M
Age: 31
State: CT

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Chills; Fever; Loss of consciousness x 2; GI upset; Diarrhea; Difficulty sleeping; Pallor; Stomach flu; A spontaneous report was received from a nurse concerning a 31-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced loss of consciousness (LOC) x 2, gastrointestinal (GI) upset, diarrhea, difficulty sleeping, pallor, stomach flu, chills and fever. The patient's medical history, as provided by the reporter, included allergy to cefaclor and hereditary hemorrhagic telangiectasia. Concomitant medications reported included desvenlafaxine succinate, gabapentin and dexlansoprazole. On 23 Dec 2020 at 11:30 am, approximately six hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On the morning of 23 Dec 2020, prior to receiving mRNA-1273, the patient felt "achy". At 5:30 pm, the patient experienced chills, fever to 102, GI upset and diarrhea. At 11:00 pm, the patient reported difficulty sleeping, GI upset, LOC x 2 and pallor. The patient was transported to the emergency room via ambulance. A COVID-19 polymerase chain reaction test and routine labs were collected; however, results were not provided. Treatment for the events included paracetamol, unspecified intravenous (IV) medications, ondansetron and ketorolac tromethamine. The emergency room discharge diagnosis was stomach flu. Action taken with mRNA-1273 in response to the events was not reported. The events, loss of consciousness (LOC) x 2, GI upset, diarrhea, difficulty sleeping, pallor, stomach flu, chills and fever, were considered resolved on 24 Dec 2020.; Reporter's Comments: This case concerns a 31-year-old, male subject with a medical history of hereditary hemorrhagic telangiectasia, who experienced the unexpected events of loss of consciousness (LOC) x 2, gastrointestinal (GI) upset, diarrhea, difficulty sleeping, pallor, and stomach flu, and the expected events of chills and fever. The events of chills, fever occurred approximately 6 hrs. and the events of GI upset, loss of consciousness, difficulty sleeping occurred after 12 hrs. after the first dose of Moderna COVID-19 Vaccine. The time to onset for the events of GI upset and diarrhea were unknown. The reporter did not provide the causality assessment for the events. Due to the temporal association between the LOC and the administration of the vaccine, a causal relationship cannot be excluded, however, the subject's medical history of hereditary hemorrhagic telangiectasia and other concurrent conditions of GI upset, diarrhea, and stomach flu remain as confounders.

Other Meds: PRISTIQ; GABAPENTIN; DEXILANT

Current Illness: Drug allergy (Ceclor)

ID: 0933262
Sex: F
Age:
State: VA

Vax Date: 12/26/2020
Onset Date: 12/26/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Sharp shooting pain up my arm, upper chest, the shoulder, above my brest; Trouble swallowing, slurred speech, red across the chest and hoarse/raspy voice; A report was received from a consumer concerning a patient who was participating in the mRNA-1273 Emergency Use Program and who experienced sharp shooting pain up my arm, upper chest, the shoulder, above my brest, trouble swallowing - could not swallow my saliva, slurry speech, red across my chest, and hoarse/raspy voice. The patient's medical history included diphenhydramine hydrochloride allergy, shellfish allergy, and latex allergy. Concomitant medications included salbutamol sulfate. The patient received their first dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection in their right arm on 26 Dec 2020. Five minutes following administration of the vaccine, the patient felt sharp shooting pains up her arm, upper chest, the shoulder, above the breast. Five to 10 minutes after, the patient had trouble swallowing and began to have slurred speech. The patient was administered epinephrine in her right thigh. Following this, she began to experience redness across the chest and was administered another dose of epinephrine. She also experienced hoarse/raspy voice. The patient was then transported to the emergency room in an ambulance, where she received intravenous fluids and solumedrol after which she began feeling better. The patient was observed in the hospital for several hours and discharged on the same day. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, sharp shooting pain up my arm, upper chest, the shoulder, above my brest, was unknown. The event, trouble swallowing - could not swallow my saliva, was considered resolved on 26 Dec 2020. The outcome of the event, slurry speech, was unknown. The outcome of the event, red across my chest, was unknown. The outcome of the event, hoarse/raspy voice, was unknown. The reporter did not provide an assessment for the events, sharp shooting pain up my arm, upper chest, the shoulder, above my brest, trouble swallowing - could not swallow my saliva, slurry speech, red across my chest, or hoarse/raspy voice.; Reporter's Comments: This case concerns a female patient with a medical history of diphenhydramine hydrochloride allergy, shellfish allergy, and latex allergy who experienced the events of pains up her arm, upper chest, the shoulder, hypersensitivity reaction with symptoms of trouble swallowing, slurred speech, erythema of the chest and hoarse/raspy voice, occurring between five and ten minutes following administration of the first dose of mRNA-1273 vaccine. The patient was treated with 2 shots of epinephrine, was transported to the hospital and received and IV solumedrol, after which symptoms improved. Based on the information provided and temporal association, the event is assessed as possibly related to mRNA-1273. The patient's medical history of multiple allergies could have contributed to the event. Further information has been requested.

Other Meds: VENTOLIN [SALBUTAMOL SULFATE]

Current Illness: Drug allergy (Benadryl); Latex allergy; Shellfish allergy

ID: 0933263
Sex: U
Age:
State: AZ

Vax Date: 12/24/2020
Onset Date: 12/24/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: patient received half of dose from vaccine due to making movement; A spontaneous report was received from a physician concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced incorrect dose administered. The patient's medical history was not provided. No relevant concomitant medications were reported. On 24 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011j20a)intramuscularly for prophylaxis of COVID-19 infection. On 24 Dec 2020, during vaccine administration, the patient experienced incorrect dose administered. The physician reported the patient moved while being given the vaccine and about half of the dose was injected and the other half was not. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The event, incorrect dose administered, was considered resolved on 24 Dec 2020.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot 011j20A), reporting Incorrect dosage administered without any associated adverse events.

Other Meds:

Current Illness:

ID: 0933264
Sex: U
Age:
State: LA

Vax Date: 12/01/2020
Onset Date: 12/01/2019
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Received a subcutaneous injection; A spontaneous report was received from a healthcare professional concerning a patient who was who received Moderna's COVID-19 vaccine and received a subcutaneous injection. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unreported date in Dec 2020, the patient received their first of two planned doses of mRNA-1273 subcutaneously for prophylaxis of COVID-19 infection. On an unreported date in Dec 02020, the patient received a subcutaneous injection. No treatment information was provided. Action taken with mRNA-1273 in response to the event, received a subcutaneous injection, was not reported. The event, received a subcutaneous injection, was considered resolved on an unreported date in Dec 2020. The reporter did not provide an assessment for the event, received a subcutaneous injection.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot-# and expiration date not provided), who experienced an unexpected event of wrong route of administration. The patient details and time to onset for the events was unknown. The reporter did not provide the causality assessment for the events. However, wrong route of administration is more of a human error and it was unlikely related to Moderna COVID-19 Vaccine.

Other Meds:

Current Illness:

ID: 0933265
Sex: F
Age: 26
State: CA

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: generalized itchiness; woke up with headache; feeling fatigued; anaphylactic reaction; right arm started going numb; right arm was tingling; A spontaneous report was received from a 26-year-old, female consumer who received Moderna's COVID-19 vaccine and experienced anaphylactic reaction, right arm numbness and tingling, headache, fatigue, and generalized itchiness. The patient's medical history was not provided. No relevant concomitant medications were 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 number: OU520A/011520A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 23 Dec 2020, within minutes of receiving the vaccine, the patient experienced an anaphylactic reaction and was rushed to the emergency room (ER). When transported to the ER she began to experience throat swelling, redness of arms and chest, trouble breathing with lower chest pain shooting into lungs, and numbness with tingling in her right arm. Treatment for the event included epinephrine, steroids, and diphenhydramine. She was released from the ER on 23 Dec 2020. On 24 Dec 2020 patient awoke with a headache, fatigue, and generalized itchiness. Treatment for the event included ibuprofen and diphenhydramine. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events, anaphylactic reaction, right arm numbness and tingling, were reported as resolved on 23 December 2020. The events of headache, fatigue, and generalized itchiness were considered resolving.; Reporter's Comments: This case concerns a 26-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot OU520A/011520A), and who experienced the unlisted events of anaphylactic reaction, right arm numbness and tingling, and generalized itchiness, and the listed events of headache and fatigue. The events were considered to be possibly related to the vaccine due to the temporal relationship with onset on the day of vaccination.

Other Meds:

Current Illness:

ID: 0933266
Sex: F
Age: 49
State: CA

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data: Test Date: 20201222; Test Name: Potassium; Result Unstructured Data: units not reported; Test Date: 20201222; Test Name: Troponin; Test Result: Negative ; Result Unstructured Data: units not reported

Allergies:

Symptoms: Anaphylactic reaction; Chest pressure; Rash (on neck,belly and arm); Metallic taste in mouth; Hot flashes; Headaches; A spontaneous report was received from a 49-year-old female nurse, who was also a patient, who received Moderna's COVID-19 vaccine and experienced anaphylactic reaction, chest pressure, rash (on neck, belly and arm), metallic taste in mouth, hot flashes and headaches. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, at 7:00 pm, approximately 15 minutes prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 intramuscularly, for prophylaxis of COVID-19 infection. On 22 Dec 2020, approximately 15 minutes after the mRNA-1273 vaccination, the patient experienced anaphylactic reaction, chest pressure, rash (on neck, belly and arm), metallic taste in mouth, hot flashes and headaches. She was taken immediately to the emergency room. Laboratory values included a negative troponin level and low potassium at 3.3. All other laboratory results were normal. Treatment included prednisone for five days, diphenhydramine hydrochloride, famotidine and paracetamol. Action taken with mRNA-1273 in response to the events was not reported. The outcome for the events, anaphylactic reaction, chest pressure, rash (on neck, belly and arm), metallic taste in mouth, hot flashes and headaches was not reported The causality assessment for the events, anaphylactic reaction, chest pressure, rash (on neck, belly and arm), metallic taste in mouth, hot flashes and headache was not reported.; Reporter's Comments: This case concerns a 49-year-old, female patient who received their first of two planned doses of mRNA-1273 (Lot-# and expiration date -unknown), reporting an unexpected event of anaphylactic reaction, chest pressure, rash, metallic taste in mouth, hot flush and an expected event of headache. The events occurred the same day, 15 minutes after vaccine administration. The reporter did not provide the causality assessment for the events. Due to the temporal association between the events and administration of the vaccine, a causal relationship cannot be excluded, and the events are assessed as possibly related to vaccine.

Other Meds:

Current Illness:

ID: 0933267
Sex: U
Age:
State: MO

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Did not receive the full dose; Vaccine leaked on arm; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and did not receive the full dose and vaccine leaked on arm. The patient's medical history was not provided. No relevant concomitant medications were reported. On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot #025J20-2A) intramuscularly for prophylaxis of COVID-19 infection. On 23 Dec 2020, during vaccine administration, the pharmacist reported that the vaccine leaked on the patient's arm and that the patient did not receive the full dose. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The events, did not receive the full dose and vaccine leaked on arm, were considered resolved on 23 Dec 2020.; Reporter's Comments: This case concerns a patient of unreported age and sex. The subject medical history is not provided. The patient experienced an unexpected event of not receiving the full dose and vaccine leaked on arm. The event occurred on 23 Dec 2020 during administration of the first dose of the mRNA-1273 (Lot #025J20-2A). The event is considered not related to mRNA-1273.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm