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: 0957887
Sex: F
Age: 32
State: TX

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 01/19/2021
Hospital:

Lab Data: Labs/X-rays Normal

Allergies: None

Symptoms: 1135 - (L) ear ringing it migrate to (L) neck. V/S BP-116/70, HR-76, O2Sat-97% on RA, R-18 1142 - Diziness and middle back pain start hurting. V/S BP-110/68, HR-75, O2Sat-96%, R-15 1150 - pt. continue to have symptoms, escort to ER.

Other Meds:

Current Illness: None

ID: 0957888
Sex: F
Age: 41
State: WV

Vax Date: 12/29/2020
Onset Date:
Rec V Date: 01/19/2021
Hospital:

Lab Data: None

Allergies: None

Symptoms: no adverse reaction to much vaccine given felt tired next day.

Other Meds: None

Current Illness: None

ID: 0958065
Sex: F
Age: 37
State: WV

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 01/19/2021
Hospital:

Lab Data: none

Allergies: none

Symptoms: - Severe pain, swelling & redness at the injection site (RA) - Chills, headaches, dizziness, tiredness, hunger.

Other Meds: none

Current Illness: none

ID: 0958102
Sex: F
Age: 70
State: WV

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 01/19/2021
Hospital:

Lab Data: N/A

Allergies: PCN/Sulfa

Symptoms: Headache Sore Arm received 1ml instead of 0.5ml

Other Meds: Synthroid

Current Illness: N/A

ID: 0958124
Sex: F
Age: 45
State: WV

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies: IV Contrast Dye

Symptoms: I was given 1ml,Correct Dose is 0.5ml.Headache, Tiredness, cough and slight nasal Discharge. Symptoms lasted 24 hours.

Other Meds: N/A

Current Illness: N/A

ID: 0958150
Sex: F
Age: 53
State: WV

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 01/19/2021
Hospital:

Lab Data: none

Allergies: Aspirin

Symptoms: Patient no adverse symptoms Patient was given too much vaccine 1mL instead of 0.5 mL

Other Meds: 0

Current Illness: 0

ID: 0958154
Sex: F
Age: 35
State: WV

Vax Date: 12/29/2020
Onset Date: 01/03/2021
Rec V Date: 01/19/2021
Hospital:

Lab Data: none

Allergies: NKDA or NKA

Symptoms: headache sore axillary nodes pressure in chest

Other Meds: birth control pill - orthomicronor

Current Illness: none

ID: 0958163
Sex: M
Age: 70
State: WV

Vax Date: 12/29/2020
Onset Date: 12/30/2020
Rec V Date: 01/19/2021
Hospital:

Lab Data: N/A

Allergies: None NKDA

Symptoms: Mild soreness injection site Slight swelling of 3-4 cm diameter at injection site with little or no redness. Lasted 48-72 hour as it tapered off

Other Meds: Preservision - Areds 2, Osteo Biflex, Centrum Silver

Current Illness: None

ID: 0958183
Sex: F
Age: 49
State: WV

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies: Statol Oxycodone

Symptoms: I was given 1mL of the vaccine instead of the 0.5mL. No adverse reactioNs.

Other Meds:

Current Illness:

ID: 0958197
Sex: F
Age: 48
State: TX

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: ear congestion Bilateral hand swelling, redness BP 132/92 HR 107 P 70 99% RA

Other Meds:

Current Illness:

ID: 0958203
Sex: F
Age: 52
State: WV

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 01/19/2021
Hospital:

Lab Data: N/A

Allergies: Pineapple

Symptoms: Pain at the site of the injection and fatigue. Tylenol 1g taken on 12/29/2020 at night *** Given 1ml of the vaccine instead of the recommended 0.5ml

Other Meds: OTC multivitamins

Current Illness: N/A

ID: 0958210
Sex: F
Age: 48
State: WV

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 01/19/2021
Hospital:

Lab Data: Was given a shot of Prednisone & antibiotics

Allergies: Cipro, Levaquin, Cleocin, Bactrim

Symptoms: Was given a double dose of vaccine by accident. Severe headache Asthma flare up pain, redness, swelling @ injection site. Earache/infection but don't know if its related.

Other Meds: Zoloft, Wellbutrin, Abilify, Protonix, Famotidine, Trazodone, Xyzal, Pro-Air

Current Illness:

ID: 0958215
Sex: M
Age: 58
State: TX

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies: none

Symptoms: feeling light headed & legs feels heavy which makes it difficult to walk. dizziness

Other Meds:

Current Illness: none

ID: 0958222
Sex: F
Age: 48
State: WV

Vax Date: 12/29/2020
Onset Date: 12/30/2020
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies: pineapple, peicillins

Symptoms: Woke at 4:30 AM on 12/30/21 with headache, fever, body aches, sore arm, redness and swelling at site, vomiting. Took tylenol for fever and stayed in bed. The next morning I felt fine just tired. I was given full dose on 12/29/20.

Other Meds: Atorvastatin vit D3, vit B12, ezetimibe, lamotrigine, losartan, metoprolol, venlfaxine

Current Illness:

ID: 0958231
Sex: M
Age: 58
State: TX

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies: none

Symptoms: feeling light headed & legs feels heavy which makes it difficult to walk. dizziness

Other Meds:

Current Illness: none

ID: 0958240
Sex: F
Age: 51
State: TX

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/19/2021
Hospital:

Lab Data: EKG / Lab normal

Allergies:

Symptoms: 10 min after recieving vaccine: - increased HR - itchy over entire body - Benadryl given - ER for further eveluas

Other Meds:

Current Illness:

ID: 0958244
Sex: F
Age: 49
State: TX

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 10 mins after first dose - Flushed, heart racing and head pressure. BP 139/89 - HR 115 Took Benedryl 25 mg P.O. Denied ER visit Released home.

Other Meds:

Current Illness:

ID: 0958257
Sex: F
Age: 56
State: CA

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: received covid vaccine at 1100. Informed writer of flushed Feeling and heart pounding at 1105. Manual pulse done. 95bpm. O2 sat monitor to be delivered. 11:10 vital signs done. BP 122/80 P-72 O2 sat 97%. By 11:15 symptoms passed. Patient stayed by cart. No further feeling of flushing or increased heart rate. Left clinic at 11:35, vital signs stable feeling well

Other Meds: Metformin, HCTZ, Losartan, Rosuvastatin, Vitamin D

Current Illness:

ID: 0958799
Sex: F
Age: 47
State: OH

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 01/19/2021
Hospital:

Lab Data: None

Allergies: None

Symptoms: Client stated she had participated in a trial for Regeneron, last therapy was 12/31/2020 (received 3 of 6 injections). Stated she had a negative COVID-19 antibody test the week before holiday. She assumed that she was a placebo recipient. She contacted the study and asked about getting the COVID-19 vaccine. She stated that she was not advised either way to get vaccine or not. She will no longer participate in the Regeneron study, but will do follow up appointment. Discussed CDC guidance "Person who previously received passive antibody therapy or COVID-19" and client to try to find out if she was receiving a placebo, if so, she will schedule 2nd immunization at recommended time. No adverse reaction at at this time.

Other Meds: Vit. D3, Multivitamin.

Current Illness: None

ID: 0958801
Sex: F
Age: 55
State: CA

Vax Date: 01/06/2021
Onset Date:
Rec V Date: 01/19/2021
Hospital:

Lab Data: Lab test done on 1/11/21 - PTT 39.6+ High PT ratio 1.3 H. Na 137. Taking Tyelnol 650 Q 8 hr, (Motrin makes symptoms worse)

Allergies: NKA

Symptoms: I received the vaccine and approx 1min I developed chest pressure, head pressure, Dizzy + lightheaded - Had a hard time waking to gurney due to dizzy. BP +180s Back burning pain traveling mid back to lower back, joint pain, general weakness, throat scratchy, itichess on legs + Think I was monitored for 2 1/2 hrs and sent home after Benadry + Tylenol given. I have continued to have extreme fatigue. general weakness, lightheaded, dizzy and burning back pain lasted 11 days. Today is 12th day and still have lightheaded, dizzy intermittent and general weakness, fatigue, "no energy."

Other Meds: Losartan, Clonidine, multivitamin, folic acid, vit B 12

Current Illness: Newly Dx Diabetic 10/2020, HTN, Obese,

ID: 0959927
Sex: M
Age: 77
State:

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

Lab Data:

Allergies:

Symptoms: short of breath Narrative: patient complained of shortness of breath prior to getting covid vaccine, patient and wife stating it was his norm. After vaccine he complained of increasing shortness of breath, and hypoxic with bluish nail beds, lips, and greyish in color. Applied O2 via mask, and nail beds, lips, and facial color returned, sent patient to local ER for treatment and evaluation.

Other Meds:

Current Illness:

ID: 1279627
Sex: F
Age: 65
State: CA

Vax Date: 01/14/2021
Onset Date: 01/15/2021
Rec V Date: 01/19/2021
Hospital:

Lab Data: none

Allergies: sulfa, doxycycline, codeine

Symptoms: 1/15/21 severe sore lt deltoid x 3 days. PM of 1/15, nausea and fatigue. AM 1/16 awoke with severe chills and nausea. Thru 1/16 & 1/17 severe fatigue, dizziness, GI sx, w/ severe diarrhea. No fever, but chills and hot flashes persisted. I kept falling asleep. My typical activity was severely affected. Family had to care for me. I am a registered nurse, which helped prevent an ER visit. Benadryl and Advil were minimal help. These symptoms were not mild. Moderate to severe

Other Meds: norvasc. lipitor, ketotifen, ceclor, metformin, epi-pen

Current Illness: none

ID: 1279628
Sex: F
Age: 63
State: ME

Vax Date: 01/08/2021
Onset Date: 01/16/2021
Rec V Date: 01/19/2021
Hospital:

Lab Data: see above

Allergies: None

Symptoms: EE reports she received the Covid 19 Modera vaccine lot number 039K20A on 01/08/2021 at 0600 in her left deltoid. EE reports she noted a rash the next day but then it resolved the next day. EE reports she noted redness and itching on her left upper arm on 1/16/21. EE reports the rash and itching has mostly resolved today 1/19/2021.

Other Meds: Magnesium, Ginko supplement

Current Illness: denies

ID: 1353830
Sex: F
Age: 35
State:

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

Lab Data:

Allergies:

Symptoms: Headache fatigue, site tenderness, red and swollen glands, mild neck pain

Other Meds:

Current Illness:

ID: 1385075
Sex: M
Age: 55
State:

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Myalgia & Fever Narrative:

Other Meds:

Current Illness:

ID: 0957333
Sex: F
Age:
State: NC

Vax Date: 12/18/2020
Onset Date: 12/01/2020
Rec V Date: 01/20/2021
Hospital:

Lab Data: Test Date: 20201230; Test Name: Covid test; Test Result: Positive

Allergies:

Symptoms: received first dose of COVID vaccine on 18Dec2020 and tested positive on 30Dec2020; received first dose of COVID vaccine on 18Dec2020 and tested positive on 30Dec2020; she had a 5 day migraine after the first dose; This is a spontaneous report from a contactable other healthcare professional (patient). A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date were unknown), via an unspecified route of administration on 18Dec2020 at first single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of COVID vaccine on 18Dec2020 and tested positive on 30Dec2020. The patient stated her isolation will be over the day that she was to receive her second dose. The patient stated that she had a 5-day migraine after the first dose. Outcome of the events was unknown. Information on the lot/batch number has been requested. Follow-up (06Jan2021): New information received in response to query via mail includes confirmation of the primary reporter's last name. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection needed for meaningful medical assessment.

Other Meds:

Current Illness:

ID: 0957334
Sex: M
Age:
State: MD

Vax Date:
Onset Date: 01/06/2021
Rec V Date: 01/20/2021
Hospital:

Lab Data:

Allergies:

Symptoms: revaccination of a second dose of GARDASIL 9 which was given at a 30 day interval after the first dose; This spontaneous report has been received from an unspecified source referring to a 26 year old male patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis. On 06-JAN-2021, the patient experienced inappropriate schedule of product administration.

Other Meds:

Current Illness:

ID: 0957335
Sex: U
Age:
State: KY

Vax Date: 12/07/2015
Onset Date:
Rec V Date: 01/20/2021
Hospital:

Lab Data:

Allergies:

Symptoms: hearing problems; vision problems; balance problems; Information has been received regarding a case in litigation from a lawyer referring to a currently 63 years old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 07-DEC-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) in a clinic for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a provider for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: hearing, vision and balance problems. The outcome of the events was unknown.

Other Meds:

Current Illness: Prophylaxis

ID: 0957336
Sex: M
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Two days after vaccination, the baby persistently refused a bottle.; Over a 24-hour period, he only ate 4.5 oz of formula and 6 ounces of Pedialyte, versus the typical 6 oz of formula ever 4 hours.; This spontaneous report as received from an unknown reporter and refers to a 6 month old male patient. The baby had no underlying medical conditions. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, as part of routine vaccinations (lot/batch # and expiration date were not reported), the patient also received hib conj vaccine (unspecified carrier), diphtheria toxoid, pertussis acellular vaccine (unspecified), poliovirus vaccine inactivated (unspecified), tetanus toxoid, influenza virus vaccine (unspecified) and pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) as part of routine vaccinations. Two days after vaccination, on an unknown date, the baby persistently refused a bottle (food refusal). Over a 24-hour period, he only ate 4.5 oz of formula and 6 ounces of Pedialyte, versus the typical 6 oz of formula ever 4 hours (decreased appetite). The patient recovered 3 days after vaccination, on an unknown date. The causal relationship between the events and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided.

Other Meds:

Current Illness: Prophylaxis

ID: 0957337
Sex: U
Age:
State: ME

Vax Date:
Onset Date: 01/11/2021
Rec V Date: 01/20/2021
Hospital:

Lab Data:

Allergies:

Symptoms: A dose of PROQU AD was administered this morning 1/11/2021 and expired yesterday, 1/10/2021. The PROQUAD had never undergone a temperature excursion. No additional AE/no PQC.; A dose of PROQUAD was administered this morning 1/11/2021 and expired yesterday, 1/10/2021. The PROQUAD had never undergone a temperature excursion. No additional AE/no PQC.; This spontaneous report as received from a licensed practical nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided. On 11-JAN-2021, in the morning, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter once, for prophylaxis, lot # S021732, with expiration date of 10-JAN-2021 (expired product administered). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) had never undergone a temperature excursion. The patient did not experienced an adverse event.

Other Meds:

Current Illness:

ID: 0957338
Sex: U
Age:
State: NC

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 01/20/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AEs; Expired vaccine VAQTA administered; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's pertinent medical history, drug allergies and reactions and concomitant medications were not provided. On 11-JAN-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe (lot # S036494 which has been verified to be a valid lot number, expiration date 09-JAN-2021) at a dose of 1.0 milliliter, intramuscularly as prophylaxis. No additional adverse events. No product quality complaint was filed. There were no previous temperature excursions. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036494; expirationdate: 09-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: 0957339
Sex: M
Age:
State: MA

Vax Date: 08/19/2014
Onset Date:
Rec V Date: 01/20/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Patient suffered many black occasional flash dots, flashes and floaters in his left eye and went for an urgent eye exam. Plaintiff was diagnosed with posterior vitreous detachment, vitreous hemorrhage, and retinal tear of the left eye.; Patient suffered many black occasional flash dots, flashes and floaters in his left eye and went for an urgent eye exam. Plaintiff was diagnosed with posterior vitreous detachment, vitreous hemorrhage, and retinal tear of the left eye.; Patient suffered many black occasional flash dots, flashes and floaters in his left eye and went for an urgent eye exam. Plaintiff was diagnosed with posterior vitreous detachment, vitreous hemorrhage, and retinal tear of the left eye.|1; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or around 19-AUG-2014, the patient was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) (anatomical location, administration route, lot number 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, shortly after receiving the vaccine, the patient suffered many black occasional flash dots, flashes and floaters in his left eye and went for an urgent eye exam. Later, the patient was diagnosed with posterior vitreous detachment, vitreous hemorrhage, and retinal tear of the left eye. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX) vaccine, mental an emotional distress due to resulting physical limitations and seriousness of his condition; the patient sustained severe and permanent personal injuries. 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. At the time of the report, the outcome of posterior vitreous detachment, vitreous hemorrhage, and retinal tear of the left eye was not recovered. The reporter considered the posterior vitreous detachment, vitreous hemorrhage, and retinal tear of the left eye to be related to Zoster Vaccine Live (ZOSTAVAX). The events of posterior vitreous detachment, vitreous hemorrhage, and retinal tear of the left eye were considered to be disabling. Upon internal review, the posterior vitreous detachment, vitreous hemorrhage, and retinal tear of the left eye were considered as medically significant event.

Other Meds:

Current Illness:

ID: 0957340
Sex: M
Age:
State: AL

Vax Date: 02/01/2016
Onset Date:
Rec V Date: 01/20/2021
Hospital:

Lab Data:

Allergies:

Symptoms: post-herpetic neuralgia; skin lesions developed on his head and forehead; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. Information regarding current condition, historical condition or concomitant medication was not reported. In or around February 2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, batch/lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) being administered, the pt developed skin lesions on his head and forehead, and this resulted in post-herpetic neuralgia in his upper body, particularly the shoulders, that also persisted to the present. The pt first learned of the link between zoster vaccine live (ZOSTAVAX) and injuries such those from which he (also reported as she, conflicting information) suffered, on or about 22-DEC-2018, when a friend shared information found on website. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not presented prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt 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. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered as not recovered. The causality between the events and zoster vaccine live (ZOSTAVAX) was considered as related. Skin lesions and post-herpetic neuralgia were considered as disabling.

Other Meds:

Current Illness: Routine health maintenance

ID: 0957341
Sex: U
Age:
State: IA

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

Lab Data:

Allergies:

Symptoms: Some of the fluids squirted out and the individual did not receive the full dose of the vaccine; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and some of the fluids squirted out and the individual did not receive the full dose of the vaccine. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the pharmacist administered the Moderna COVID-19 vaccine to her coworker and during vaccine administration, some of the fluids squirted out and the individual did not received the full dose. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The event, some of the fluids squirted out and the individual did not receive the full dose of the vaccine, was considered resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of incorrect dose administered.

Other Meds:

Current Illness:

ID: 0957342
Sex: M
Age:
State:

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/20/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccine leaked out at injection site; A spontaneous report was received from a pharmacy intern concerning a 29 year-old, male patient who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced the events, vaccine leaked out at injection site and possible error in administration of the vaccine. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 04 Jan 2021, the patient removed the bandage placed over the injection site and reported clear liquid underneath the bandage. The reporter states that the vaccine leaked out at the injection site and a lot of the vaccine got out. The reporter states this may be due to error in the administration of the vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The events, vaccine leaked out at injection site and possible error in administration of the vaccine, were considered resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a 29 year old, male patient. The patient's medical history is not provided. The patient experienced the unexpected event of administration of incomplete dose (vaccine leaked out at injection site) after the administration of the first dose of mRNA-1273 on 4 Jan 2021.

Other Meds:

Current Illness:

ID: 0957343
Sex: F
Age: 66
State: OK

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

Lab Data:

Allergies:

Symptoms: Administered with less than optimal dose (0.45 mL); A spontaneous report was received from pharmacist concerning a 66-years old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273), and who experienced incomplete dose administered. The patient's medical history was not provided. No relevant concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 on 5 Jan 2021 (Lot number 039K20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. During the administration, the pharmacist did not push the plunger correctly all the way, and the patient did not receive the full dose. After measuring what was left in the barrel of the syringe, they estimated that the patient received only 0.45 mL of the vaccine instead of 0.5 ml. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, incomplete dose administered, was considered resolved on 5 Jan 2021.; Reporter's Comments: This is a report of 66-year-old female patient, who was administered less than optimal dose (0.45 mL) (incomplete dose administered) mRNA-1273, lot # 039K20-2A. There were no reported adverse events associated with this case of incomplete dose administered

Other Meds:

Current Illness:

ID: 0957344
Sex: F
Age: 70
State: OK

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

Lab Data:

Allergies:

Symptoms: O.45ml of Vaccine Was Administered; A spontaneous report was received from pharmacist concerning a 70-years old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273), and who experienced incomplete dose administered. The patient's medical history was not provided. No relevant concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 on 5 Jan 2021 (Lot number 039K20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. During the administration, the pharmacist did not push the plunger correctly all the way, and the patient did not receive the full dose. After measuring what was left in the barrel of the syringe, they estimated that the patient received only 0.45 mL of the vaccine instead of 0.5 mL. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, incomplete dose administered, was considered resolved on 5 Jan 2021.; Reporter's Comments: This case concerns a 70 year old, female patient. The patient's medical history is not provided. The patient experienced the unexpected event of administration of incorrect dose (0.45 mL of the vaccine instead of 0.5 mL) of the first dose of the mRNA-1273 (Lot number 039K20-2A) on 5 Jan 2021. There was no reported adverse reaction associated with this case.

Other Meds:

Current Illness:

ID: 0957345
Sex: F
Age:
State: OR

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/20/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Anaphylactic reaction; A spontaneous report was received from a physician, who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic reaction. The patient's medical history was not provided. No concomitant medications were reported. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 04 Jan 2021, after vaccination, the patient experienced anaphylactic reaction. No treatment information for the event was reported. The Action taken with mRNA-1273 in response to the event was not provided. The outcome for the event, anaphylactic reaction, was not reported.; Reporter's Comments: This case concerns a female patient with unknown medical history, who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced a serious event of anaphylactic reaction. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the onset of the event on the day of vaccination, a causal relationship cannot be excluded and the event was considered possibly related to the vaccine.

Other Meds:

Current Illness:

ID: 0957346
Sex: U
Age:
State: NE

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

Lab Data:

Allergies:

Symptoms: Vaccine administed to a 17 year old; A spontaneous report was received from a Certified in Public Health (CPH) concerning a 17-years old patient who was received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced the event, product administered to patient of inappropriate age. The patient's medical history was not provided. No relevant concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 on an unknown date, intramuscularly for prophylaxis of COVID-19 infection. On 05 Jan 2021, the CPH reported that one of their local hospitals administered a dose of Moderna vaccine in error to the 17-years old patient. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, product administered to patient of inappropriate age, was resolved on unknown date.; Reporter's Comments: This case concerns a 17-year-old patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events.

Other Meds:

Current Illness:

ID: 0957347
Sex: U
Age:
State: GA

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

Lab Data:

Allergies:

Symptoms: Administered dose from punctured vial left out at room temperature for over 9 hours; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273), and who was administered dose from punctured vial left out at room temperature for over 9 hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received a dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 05 Jan 2021, a pharmacist reported that the facility's clinic administered a dose of the vaccine to a patient from a punctured vial that was left out at room temperature for 9 hours. The pharmacist was unable to provide any information about the patient or vial. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered dose from punctured vial left out at room temperature for over 9 hours, was considered resolved on an unknown date. The reporter did not provide an assessment for the event, administered dose from punctured vial left out at room temperature for over 9 hours.; Reporter's Comments: This report refers to a case of a patient administered dose from punctured vial left out at room temperature for over 9 hours (Expired product administered) for mRNA-1273. Lot # was not provided. There were no reported adverse events associated with this case of administered dose from punctured vial left out at room temperature for over 9 hours

Other Meds:

Current Illness:

ID: 0957348
Sex: M
Age:
State: GA

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

Lab Data:

Allergies:

Symptoms: Administered Vaccine that was a punctured vial and stored at room temperature for more than 6 hours; A spontaneous report was received from a pharmacist concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered a vaccine from a punctured vial stored at room temperature for more than 6 hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026020A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection. On 05 Jan 2021, a pharmacist administered the vaccine to the patient from a vial that had been previously punctured and stored at room temperature for a total of 18 hours. The patient reported no adverse reactions. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered a vaccine from a punctured vial stored at room temperature for more than 6 hours, was considered resolved on 05 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use for mRNA-1273. There were no reported adverse events associated with this case.

Other Meds:

Current Illness:

ID: 0957349
Sex: U
Age:
State: NY

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

Lab Data:

Allergies:

Symptoms: Syringe leaked and not sure how much Vaccine was administered; A spontaneous report was received from a pharmacist concerning a patient of unknown age who received Moderna's COVID-19 vaccine and experienced syringe leaked and not sure how much vaccine was administered. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 05 Jan 2021, a pharmacist reported that liquid leaked out of a syringe while the nurse was injecting and is not sure how much of the vaccine was applied to the patient. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The event, syringe leaked and not sure how much vaccine was administered, was considered resolved.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown, reporting syringe leaked and not sure how much vaccine was administered without any associated adverse events.

Other Meds:

Current Illness:

ID: 0957350
Sex: M
Age: 49
State: NH

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

Lab Data:

Allergies:

Symptoms: Vaccine leaked out of the deltoid muscle; A spontaneous report was received from a healthcare professional concerning a 49-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and vaccine leaked out of the deltoid muscle. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly for prophylaxis of COVID-19 infection. On 05 Jan 2021, the patient received the mRNA-1273 vaccine using a one inch needle. Right after administration, the vaccine leaked out of the deltoid muscle of the patient's arm. The patient's vaccinator thought the patient received half the dose. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The event, vaccine leaked out of the deltoid muscle, was considered resolved on 05 Jan 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273, lot # 039K20A. There were no reported AEs associated with this case of incorrect dose administered.

Other Meds:

Current Illness:

ID: 0957351
Sex: F
Age:
State: KY

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

Lab Data:

Allergies:

Symptoms: Vaccine injected subcutaneously; A spontaneous report was received from a healthcare professional concerning a female consumer who received Moderna's COVID-19 vaccine subcutaneously, instead of intramuscularly (IM) on her arm. The patient's medical history was not provided. No relevant concomitant medications were reported. On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On 05 Jan 2021, a patient was administered mRNA-1273 subcutaneously in her arm, instead of IM. There was no report of adverse event experienced by the patient. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The event, vaccine given to a patient subcutaneously instead of IM, was considered resolved on 05 Jan 2021.; Reporter's Comments: This report refers to a case of a female consumer who received Moderna's COVID 19 vaccine subcutaneously, instead of intramuscularly (IM) on her arm for mRNA-1273. The vaccine lot number was not provided. There were no reported AEs associated with this case of female consumer who received Moderna's COVID-19 vaccine subcutaneously, instead of intramuscularly on her arm.

Other Meds:

Current Illness:

ID: 0957352
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/20/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0957353
Sex: U
Age:
State: NY

Vax Date: 12/01/2020
Onset Date: 12/01/2020
Rec V Date: 01/20/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 17 year old administered vaccine; A spontaneous report was received from a pharmacist concerning a 17-year-old consumer who received Moderna's COVID-19 vaccine and was at an inappropriate age at vaccine administration. The patient's medical history was not provided. No relevant concomitant medications were reported. On 29 or 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On 29 or 30 Dec 2020, a 17-year-old patient was given the vaccine and is outside the lower age limit for Moderna's mRNA-1273 vaccine. No adverse events were reported. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The event, inappropriate age at vaccine administration, was considered resolved.; Reporter's Comments: This report refers to a case of 17- year-old patient who was administered vaccine outside the lower age limit for Moderna's mRNA-1273 vaccine, lot # unknown, Exp. unknown. There were no reported AEs associated with this case of vaccine and is outside the lower age limit for Moderna's mRNA-1273 vaccine.

Other Meds:

Current Illness:

ID: 0957354
Sex: U
Age:
State: KY

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

Lab Data:

Allergies:

Symptoms: Freezer dropped down to -16.8 degree Fahrenheit; Freezer dropped down to -16.8 degree F and the vaccine was administered.; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 Vaccine) mRNA-1273 and experienced product storage error and product administration error. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 28-Dec-2020, the supply of vaccine was received by the nurse's facility. Following receipt, the freezer the vaccine was stored in dropped down to -16.8 degrees Fahrenheit for an unknown amount of time. On an unknown date, prior to the medical error, the patients received one of two planned doses of mRNA-1273 (Lot number 039K20A, expiration date 20 Jun 2021) intramuscularly in an unknown injection site for prophylaxis of COVID-19 infection. The patient was administered with the improperly stored product and experienced product administration error. No adverse events were reported. Treatment information was not provided. Action taken in response to the event was not provided. The outcome of the event was resolved.; Reporter's Comments: This report refers to a case of Product storage error for mRNA-1273, lot # 039K20A. There were no reported adverse events associated with this case of Product storage error.

Other Meds:

Current Illness:

ID: 0957355
Sex: F
Age: 61
State: GA

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/20/2021
Hospital: Y

Lab Data: Test Date: 20201230; Test Name: BP; Test Date: 20201230; Test Name: HR; Result Unstructured Data: heart beats per minute; Test Date: 20201230; Test Name: O2; Test Result: 100 %

Allergies:

Symptoms: Trouble breathing; Nauseated; Heart Palpitations; Hot, felt flush; A spontaneous report was received from a nurse concerning a 61 year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, hot, felt flushed, heart palpitations, nauseated and trouble breathing. The patient's medical history, as provided by the reporter, included myocardial infarction. Concomitant medications reported included sertraline hydrochloride. On 30 Dec 2020, approximately 20 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 30 Dec 2020, the patient was walked to the waiting room to wait 15-20 minutes following vaccination. At 3:50 pm the patient began to feel hot and flushed. The patient started having heart palpitations and felt nauseated. The patient was assisted by a nurse and approximately 20 minutes later, patient reported feeling better. The patient was instructed to wait another 30 minutes before leaving the clinic. At 4:30 pm, the patient stated that she was not feeling well, reporting heart palpitations, flushing and trouble breathing. Patient was taken to the hospital via emergency medical services at 4:43pm. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, hot, felt flushed, heart palpitations, nauseated, and trouble breathing, was unknown..; Reporter's Comments: This case concerns a 61 year old, female patient, with medical history of Myocardial Infarction, who experienced a serious, unexpected events of hot flush, heart palpitations, nausea and trouble breathing. The event occurred 20 minutes after administration of the first dose of mRNA-1273 (Lot number: 011J20A). Very limited information regarding this event has been provided at this time. Based on temporal association between the use of mRNA-1273 and the onset of the event, a causal relationship cannot be excluded.

Other Meds: ZOLOFT

Current Illness:

ID: 0957356
Sex: U
Age:
State: PA

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 01/20/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Dose was adminstered outside of the 6 hour timeframe from the first puncture of the vial; A spontaneous report was received from a healthcare facility administrator concerning a patient who received Moderna's COVID-19 (mRNA-1273) Vaccine and experienced expired product administered. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 30 Dec 2020, a vial containing Moderna's COVID-19 Vaccine was thawed, and the vial was punctured. Afterwards, the vial was placed back into refrigeration overnight. On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection from the same vial. The dose given was outside of the six-hour timeframe from the first puncture of the vial. Treatment information was not provided. Action taken with mRNA-1273 in response to the event, expired product administered, was not provided. The event, expired product administered, was considered recovered/resolved on 31 Dec 2020.; Reporter's Comments: This case concerns a patient of unknown age and gender. The patient's medical history is not provided. The event occurred 31 Dec 2020 during administration of the first dose of mRNA-1273. This report refers to a case of out of specification product use where, mRNA-1273 was given outside of the 6 hour timeframe from the first puncture of the vial.

Other Meds:

Current Illness:

ID: 0957357
Sex: F
Age: 93
State: TN

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

Lab Data: Test Date: 20210105; Test Name: pulse; Test Result: Inconclusive ; Result Unstructured Data: heart beats per minute; Comments: 20 mins after vaccination; Test Date: 20210105; Test Name: pulse; Test Result: Inconclusive ; Result Unstructured Data: heart beats per minute; Comments: after EMS arrived; Test Date: 20210105; Test Name: Osats; Test Result: Inconclusive ; Comments: 20 mins after vaccination; Test Date: 20210105; Test Name: Osats; Test Result: Inconclusive ; Comments: after EMS arrived

Allergies:

Symptoms: Osats down to 80; Pulse upwards of 130; A spontaneous report was received from a health care professional, concerning a 93-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Osats down to 80 and pulse upwards of 130. The patient's medical history, as provided by the reporter, included hypertension and heart disease. Concomitant product use was not provided. On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 05 Jan 2021, around 20 minutes after vaccination, the patient's oxygen saturation was down to 80 and she had a pulse upwards of 130. The patient was given 3-4 L of oxygen, but did not respond, so, epinephrine was administered. Emergency medical services (EMS) was called. The patient's oxygen saturation was around 90 with pulse ranging from 80-120 after EMS arrived. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, Osats down to 80 and pulse upwards of 130, was unknown.; Reporter's Comments: This case concerns a 93 year-old, female patient with medical history of hypertension and heart disease, who experienced events of oxygen saturation decreased and heart rate increased. The events occurred approximately 20 minutes after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.

Other Meds:

Current Illness: Heart disease, unspecified; Hypertension (No reported medical history)

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm