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: 0927427
Sex: F
Age: 55
State: VT

Vax Date: 12/27/2020
Onset Date: 12/28/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: none

Allergies: severe tree nut allergy with h/o anaphylaxis

Symptoms: Sudden onset severe diarrhea, accompanied by nausea (no vomiting), chills, severe fatigue, and diffuse rash over LE initially, then to UE. No rash on trunk. Diarrhea resoled in 4 hours after 3 doses of Imodium. Remained afebrile. Benadryl 25mg taken that night, and the next night as rash continued to be itchy.

Other Meds: Took 1 ibuprofen directly after having vaccine

Current Illness: none

ID: 0927428
Sex: F
Age: 78
State: GA

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

Lab Data: None

Allergies: Chocolate

Symptoms: Nausea, chills, constipation

Other Meds: Clarinet,Synthroid, Rouvasstatin,Singulair, Trokendi, all daily. Prolix twice a year.

Current Illness: Covid, diagnosed 12 December, light case.

ID: 0927429
Sex: F
Age: 70
State: FL

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

Lab Data: None

Allergies: to eye drops

Symptoms: She verbalize she develop headache, nausea, dizziness. She was evaluated onsite by Rescue and released home feeling better at 10:25 am.

Other Meds: None

Current Illness: None

ID: 0927430
Sex: F
Age: 40
State: MN

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: None

Allergies: Morphine: hallucinations

Symptoms: Headache started at 1pm and was gone by 7:30pm Very sore arm Then the nausea and diarrhea started and lasted until 5am Then chills started from 3:00am until 7:00am Then fatigue continued throughout the day- I slept for 15hours

Other Meds: None

Current Illness: Rash on face

ID: 0927431
Sex: M
Age: 37
State:

Vax Date: 12/18/2020
Onset Date: 12/18/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 7 hours after first COVID-19 dose he experienced dysosmia x 1 hour which spontaneously resolved (not a/w dyspnea, cough, fever, lost of taste, nausea, or vomiting). He did not seek medical attention.

Other Meds:

Current Illness:

ID: 0927446
Sex: F
Age:
State: HI

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

Lab Data:

Allergies:

Symptoms: Date of vaccination: annually; This spontaneous report as received from a laywer refers to a currently might be 69 years old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates (reported as annually), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (route, strength, dose, batch/lot # and expiration date were not reported) for prophylaxis (Inappropriate schedule of vaccine administered). This case was split from a case in litigation (link#2003USA008689).; Sender's Comments: US-009507513-2003USA008689:

Other Meds:

Current Illness:

ID: 0927447
Sex: U
Age:
State: PA

Vax Date: 12/04/2020
Onset Date: 12/04/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: PROQUAD stored at -5?C for 20 hours was administered to the patient; This spontaneous report was received from a register nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapies were not reported. On 04-DEC-2020, the patient was vaccinated with an incorrect storage dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # T021302 (also reported as T0l 1302 which is non-valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) is valid for sitagliptin phosphate (XELEVIA)) , expiration date 19-DEC-2021, 0.5 milliliter for prophylaxis (route not reported). The temperature excursion occurred on 2 separate dates at -5 Celsius degrees (?C) for 20 hours. There was no previous temperature excursion. The call was made due to "data logger". The register nurse also reported that varicella virus vaccine live (manufacturer unknown) had temperature excursion (temperature and time were not reported). It was unknown if this vaccine was administered. This is one of two reports from the same reporter.; Sender's Comments: US-009507513-2101USA003511:

Other Meds:

Current Illness:

ID: 0927448
Sex: U
Age:
State: PA

Vax Date: 12/08/2020
Onset Date: 12/08/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Temperature excursion incolving PROQUAD and VARICELLA; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapies were not provided. On an unknown date, the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) vaccine underwent a temperature excursion; the storage temperature of the vaccine was -5 degrees Celsius (?C) for a time frame of 20 hours. There was no previous temperature excursion. Digital logger was involved On 08-DEC-2020, the patient was vaccinated with the improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 milliliter, (frequency, route and anatomical location were not provided, lot # T021302 (also reported as T011302) has been verified to be a valid lot number, expiration date 19-DEC-2020) for prophylaxis.

Other Meds:

Current Illness:

ID: 0927449
Sex: U
Age:
State: CA

Vax Date: 10/05/2020
Onset Date: 10/05/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE/PQCs reported; Caller informed Agent of the administration of improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On 05-OCT-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rha) (PROQUAD) (lot # T015598 and expiration date reported 02-NOV-2021) (dose, route, and anatomical location were not reported) for prophylaxis. According to the reporter, the temperature was 20.5 degrees Fahrenheit for a time frame of 1 hour 54 minutes. The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rha) (PROQUAD) vaccine had a previous temperature of excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (12.3 degrees Fahrenheit) for 23 hours, which was detected by a digital data logger. No additional adverse event (AE) was reported.

Other Meds:

Current Illness:

ID: 0927450
Sex: U
Age: 0
State: IL

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: no adverse event; fist dose administered at 15 weeks 0 days, 1 day too late; This spontaneous report was received from a other health professional refers to a 15-week-old patient. 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 the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliters, administered orally, lot # 1684166, expiration date 27-JUN-2021 (strength, was not reported) for prophylaxis. At the time of vaccination, the patient was 15 weeks old (was past 14 weeks 6 days, so the patient received the first dose 1 day too late).

Other Meds:

Current Illness:

ID: 0927451
Sex: M
Age:
State: PA

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

Lab Data:

Allergies:

Symptoms: first GARDASIL 9 vaccine 2 years ago; This spontaneous report was received from a pharmacist who was reporting on 26-year-old male patient. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided. On an unknown date in 2018, also reported as 2 years ago, the patient was vaccinated with his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml (exact dose , lot number, expiration date, route of administration, anatomical location and strength were not provided) for prophylaxis. He did not receive consecutive doses yet (inappropriate schedule of vaccine administered), reported wanted to know if the patient needs to restart the series.

Other Meds:

Current Illness:

ID: 0927452
Sex: U
Age:
State: FL

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

Lab Data:

Allergies:

Symptoms: hearing loss; other zoster-related conditions; other zoster-related conditions; Information has been received on 04-JAN-2021 from a lawyer regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On an unknown date in 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. On unknown dates, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by healthcare providers at hearing aid centers for hearing loss and other zoster-related conditions. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events of hearing loss and other zoster-related conditions to be related to zoster vaccine live (ZOSTAVAX). Upon internal evaluation, the event of hearing loss was determined to be medically significant.

Other Meds:

Current Illness:

ID: 0927453
Sex: U
Age:
State: TX

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

Lab Data:

Allergies:

Symptoms: vision loss; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a currently 74-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about an unknown date in 2014, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) by a pharmacist at the pharmacy, for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the patient was treated by a healthcare provider for the following injury resulting from the patient's zoster vaccine live (ZOSTAVAX) use: vision loss. The outcome of vision loss was not provided. The reporter considered the event of vision loss to be related to zoster vaccine live (ZOSTAVAX). Upon internal review, the event of vision loss was considered to be medically significant.

Other Meds:

Current Illness:

Date Died: 06/07/2016

ID: 0927454
Sex: M
Age:
State: NC

Vax Date:
Onset Date: 06/07/2016
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: shingles; death; This spontaneous report was received from a lawyer concerning a case in litigation and refers to a 80 year old male patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On or about 2014, 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 "subsequent to vaccination"), the patient experienced shingles and was treated with unspecified medications. On 07-JUN-2016, the patient died. The caused of death and if an autopsy was performed were not reported. The outcome of shingles was unknown. The reporter considered death and herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).

Other Meds:

Current Illness:

ID: 0927455
Sex: U
Age:
State: VA

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: a ROT ATEQ vaccine which had been improperly stored was administered to a patient; This spontaneous report was received from a medical assistant referring to a patient of unknown gender and age. The patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant therapies were unknown. On 28-DEC-2020, the patient was vaccinated with a improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, strength and route were not reported, lot # 1684157 has been verified as valid, expiration date 26-JUN-2021) for prophylaxis (product storage error). The excursion was supported as below 36 Fahrenheit (32.1 F) for 5 hours and 40 minutes. There were no previous temperature excursions. The vaccines were back in range at the reporting time. The digital data logger was involved.

Other Meds:

Current Illness:

ID: 0927456
Sex: M
Age:
State: NY

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

Lab Data:

Allergies:

Symptoms: the child had a reaction to the product after the first dose; fever; rash; This spontaneous report as received from a nurse refers to a 5 years old male patient. The patient's concomitant medication, pertinent medical history, drug reactions/allergies were unknown. On an unknown date in 2016, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength, site of administration, lot number and expiration date were not provided) subcutaneously (SQ) for prevention of measles, mumps, and rubella. On an unknown day in 2016 (reported as 5 years ago), the patient had a reaction to the product (adverse reaction) at one year of age after first dose and also experienced fever and rash. It was unknown if treatment was given, lab diagnostics/studies was performed, medical attention was sought or not. The outcome of adverse reaction, fever and rash was unknown. The action taken was not applicable. The causal relationship between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not provided.

Other Meds:

Current Illness:

ID: 0927457
Sex: U
Age: 73
State: OR

Vax Date: 11/30/2020
Onset Date: 12/02/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: While still in bed, the room started to spin; This case was reported by a consumer via call center representative and described the occurrence of spinning sensation in a 73-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. On 30th November 2020, the patient received the 2nd dose of Shingrix. On 2nd December 2020, 2 days after receiving Shingrix, the patient experienced spinning sensation. On 2nd December 2020, the outcome of the spinning sensation was recovered/resolved. It was unknown if the reporter considered the spinning sensation to be related to Shingrix. Additional details were provided as follows: The patient reported for himself/herself. On 2nd December 2020 morning, while patient was still in bed, the room started to spin. The patient felt ok at the time of reporting.

Other Meds:

Current Illness:

ID: 0927458
Sex: F
Age:
State: CO

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

Lab Data:

Allergies:

Symptoms: Anaphylactic reaction; This case was reported by a consumer via call center representative and described the occurrence of anaphylactic reaction in a adult female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season and PNEUMONIA VACCINE. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was unknown. The reporter considered the anaphylactic reaction to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The reporter did not have Lot number or expiry date or brand name of flu shot. The patient had anaphylactic reactions to flu and pneumonia shots. The reporter considered the anaphylactic reaction to be related to PNEUMONIA VACCINE. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 0927459
Sex: U
Age:
State: VA

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Syringe leaked of suspension: less than 0.5 given to patient; Syringe leaked of suspension: less than 0.5 given to patient; A report was received from a nurse concerning a patient of unreported age who was participating in the mRNA-1273 Emergency Use Program and experienced syringe leaked of suspension: less than 0.5 given to patient. The patient's medical history was not provided. No concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 on 22 Dec 2020. On 22 Dec 2020, while administering the first of the two planned doses of mRNA-1273 to the patient, some of the suspension dripped out of the syringe. The nurse was not aware of how much leaked out. She stated it was a dribble. Action taken with mRNA-1273 in response to the event was not applicable. The outcome for the event, experienced syringe leaked of suspension: less than 0.5 given to patient, was considered resolved on 22 Dec 2020. The reporter did not provide an assessment for the event, experienced syringe leaked of suspension: less than 0.5 given to patient.; Reporter's Comments: This case concerns a patient of unreported age and sex, experienced an unexpected event of suspension leaked from the syringe: less than 0.5 given to patient. The event occurred on 22 Dec 2020 during administration of the first dose of the study medication. The sponsor considered the event as related to mRNA-1273.

Other Meds:

Current Illness:

ID: 0927460
Sex: U
Age:
State: NY

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Not all of the dose was administered; A report was received from a pharmacist concerning a patient who was participating in the mRNA-1273 Emergency Use Program and who experienced incorrect 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 22 Dec 2020 intramuscularly for prophylaxis of COVID-19 infection. On 22 Dec 2020, the pharmacist administered the mRNA-1273 vaccine to a patient. During the administration, the needle fell off the syringe, and not all of the dose was administered. The pharmacist stated that about three-quarters of the dose was received by the patient. 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 22 Dec 2020. The reporter did not provide an assessment for the event, incorrect dose administered.; Reporter's Comments: This case concerns a patient of unreported age and sex. The patient's medical history is not provided. The patient experienced an unexpected event of incorrect dose administration. The event occurred on 22 Dec 2020 during the administration of the first dose of mRNA-1273. The sponsor assessed the event as unrelated to the mRNA-1273 vaccine.

Other Meds:

Current Illness:

ID: 0927461
Sex: U
Age:
State: NY

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: The needle came off syringe and the patient did not receive a full dose; A spontaneous report was received from a pharmacist concerning a patient who was participating in the mRNA-1273 Emergency Use Program and who experienced the non-serious event the needle came off syringe and the patient did not receive a full dose. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 22 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot # 011J20A) intramuscularly for prophylaxis of COVID-19 infection. On 22 Dec 2020, the pharmacist reported that while administering the vaccine to the patient, the needle came off the syringe, and the patient did not receive a full dose. The patient had already left the office, and the pharmacist currently had no patient identifiers at the time. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, the needle came off syringe and the patient did not receive a full dose, was considered resolved on 22 Dec 2020. The reporter did not provide an assessment for the event, the needle came off syringe and the patient did not receive a full dose.; Reporter's Comments: This case concerns a patient of unreported age and sex, who experienced an unexpected event of the needle coming off syringe and the patient did not receive a full dose. The event occurred on 22 Dec 2020 during the administration of the first dose of the study medication. The sponsor considered the event as related to the mRNA-1273.

Other Meds:

Current Illness:

ID: 0927462
Sex: U
Age:
State: AZ

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Syringe malfunctioned and leaking during administration; A spontaneous report was received from a pharmacist concerning a patient who was participating in the mRNA-1273 Emergency Use Program and who experienced syringe malfunctioned and leaking during administration. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 22 Dec 2020, a health care provider administered the mRNA-1273 vaccine to a patient. During the administration, the syringe malfunctioned and leaked during administration. The health care provider was uncertain if the patient received the full dose of the vaccine or how much of the vaccine was spilled. The patient had no observable symptoms and did not receive any treatment for the event. Action taken with mRNA-1273 in response to the event was not reported. The event, syringe malfunctioned and leaking during administration, was considered resolved on 22 Dec 2020. The reporter did not provide an assessment for the event, syringe malfunctioned and leaking during administration, to study drug.; Reporter's Comments: This case concerns a patient of unreported age and sex. The patient's medical history is not provided. The patient experienced an unexpected event of syringe malfunctioned and leaking during administration. The event occurred on 22 Dec 2020 during administration of the first dose of the study medication. The sponsor assessed the event as unrelated to the mRNA-1273 vaccine.

Other Meds:

Current Illness:

ID: 0927463
Sex: U
Age: 48
State: DE

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 48-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature. 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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown. The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 48-year-old subject who experienced the unlisted event of administered vaccine that was not stored in recommended temperature. The sponsor considers the event as Unassessable, because the event is a storage error.

Other Meds:

Current Illness:

ID: 0927464
Sex: U
Age:
State: AZ

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Syringe malfunctioned and leaking during administration; A spontaneous report was received from a pharmacist concerning a patient who was participating in the mRNA-1273 Emergency Use Program and who experienced syringe malfunctioned and leaking during administration. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 22 Dec 2020, a health care provider administered the mRNA-1273 vaccine to a patient. During the administration, the syringe malfunctioned and leaked during administration. The health care provider was uncertain if the patient received the full dose of the vaccine or how much of the vaccine was spilled. The patient had no observable symptoms and did not receive any treatment for the event. Action taken with mRNA-1273 in response to the event was not reported. The event, syringe malfunctioned and leaking during administration, was considered resolved on 22 Dec 2020. The reporter did not provide an assessment for the event, syringe malfunctioned and leaking during administration, to study drug.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect dose administered without any associated adverse events.; Sender's Comments: No adverse event

Other Meds:

Current Illness:

ID: 0927465
Sex: F
Age:
State: OH

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Did not think vaccination was given in her deltoid muscle in upper left arm; A report was received from a consumer, who is also a nurse and a 29-year-old, female patient participating in the mRNA-1273 Emergency Use Program and who did not think vaccination was given in her deltoid muscle in upper left arm. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 on 22 Dec 2020. On 22 Dec 2020, at the same time as the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly in her left arm for prophylaxis of COVID-19 infection. The patient, a nurse practitioner working on the front line, stated that she did not think the health care provider injected the vaccine in her actual deltoid muscle because she is skinny. To her, the injection seemed further back. She was not having any side effects from the injection. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event, does not think vaccination was given in her deltoid muscle in upper left arm, was considered unknown. The reporter did not provide an assessment for the event, does not think vaccination was given in her deltoid muscle in upper left arm.; Reporter's Comments: This case concerns a 29-year-old, female patient who experienced the unlisted event of product administration error- did not think vaccination was given in her deltoid muscle in upper left arm. The event occurred the same day after the first dose of Moderna COVID-19 Vaccine administration. The reporter causality assessment for the event was not provided. The reported event is more of a human error and noting the subject's thin built, the event was unlikely related to Moderna COVID-19 Vaccine.

Other Meds:

Current Illness:

ID: 0927466
Sex: U
Age: 31
State: DE

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 31-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature. 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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown. The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 31-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.

Other Meds:

Current Illness:

ID: 0927467
Sex: U
Age: 46
State: DE

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 46-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature. 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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown. The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 46-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.

Other Meds:

Current Illness:

ID: 0927468
Sex: U
Age: 28
State: DE

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 28-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature. 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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown. The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 28-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.

Other Meds:

Current Illness:

ID: 0927469
Sex: U
Age: 29
State: DE

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 29-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature. 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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown. The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 29-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.

Other Meds:

Current Illness:

ID: 0927470
Sex: U
Age: 48
State: DE

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 48-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature. 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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown. The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 48-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.

Other Meds:

Current Illness:

ID: 0927471
Sex: U
Age: 23
State: DE

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 23-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature. 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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown. The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 23-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.

Other Meds:

Current Illness:

ID: 0927472
Sex: U
Age: 61
State: DE

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 61-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature. 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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown. The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 61-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated AE.

Other Meds:

Current Illness:

ID: 0927473
Sex: U
Age: 46
State: DE

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 46-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature. 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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown. The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 46-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.

Other Meds:

Current Illness: No adverse event (No reported medical history)

ID: 0927474
Sex: U
Age: 30
State: DE

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 30-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature. 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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown. The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 30-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.

Other Meds:

Current Illness:

ID: 0927475
Sex: U
Age: 46
State: DE

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 46-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature. 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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown. The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 46-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.

Other Meds:

Current Illness:

ID: 0927476
Sex: U
Age: 47
State: DE

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 47-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature. 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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown. The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 47-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.

Other Meds:

Current Illness:

ID: 0927477
Sex: U
Age: 73
State: DE

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 73-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature. 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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown. The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 73-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.

Other Meds:

Current Illness:

ID: 0927478
Sex: U
Age: 79
State: DE

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 79-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature. 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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown. The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 79-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.

Other Meds:

Current Illness:

ID: 0927479
Sex: U
Age: 49
State: DE

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 49-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature. 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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown. The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 49-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.

Other Meds:

Current Illness:

ID: 0927480
Sex: U
Age: 43
State: DE

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 43-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature. 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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown. The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 43-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.

Other Meds:

Current Illness:

ID: 0927481
Sex: U
Age: 56
State: DE

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 56-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature. 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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown. The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 56-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.

Other Meds:

Current Illness:

ID: 0927482
Sex: U
Age: 57
State: DE

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 57-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature. 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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown. The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 57-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.

Other Meds:

Current Illness:

ID: 0927483
Sex: U
Age: 39
State: DE

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 39-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature. 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 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown. The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 39-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.

Other Meds:

Current Illness:

ID: 0927484
Sex: M
Age:
State: MA

Vax Date: 12/24/2020
Onset Date: 12/24/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Date: 20201226; Test Name: Blood pressure; Test Result: 150 {DF}; Result Unstructured Data: systolic; Test Date: 20201224; Test Name: Heart Rate; Test Date: 20201226; Test Name: Heart Rate

Allergies:

Symptoms: Severe allergic reaction; anaphylactic reaction; A spontaneous report was received from a physician, who was also a male patient who received Moderna's COVID-19 Vaccine and developed a severe/anaphylactic allergic reaction. The patient's medical history, as provided by the reporter, included a shellfish allergy and elevated Immunoglobulin E. He reported no history of adverse events following other immunizations, that all his immunizations were up to date, and that he gets the flu shot annually. Products known to have been used by the patient, within two weeks prior to the event, included pantoprazole, vitamin D, and vitamin B12. On 24 Dec 2020, minutes prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273 intramuscularly for COVID-19 infection prophylaxis. Within minutes, the patient felt dizzy and his heart was racing. His throat felt swollen and he experienced shortness of breath ("heavy breathing") with no wheezing or stridor, but with chest tightness that he felt was possibly related to anxiety about receiving the vaccine and the potential for allergic reaction. No supplemental oxygen was required. Vital signs showed a heart rate of 145, with normal blood pressure (BP) and oxygen saturation. After a few more minutes, he started to feel numbness and tingling in his mouth and tongue. He experienced diaphoresis ("drenched in a cold sweat"), skin pallor ("skin was severely pale"), felt faint, and reported that his blood pressure was undetectable by a monitor. He did not lose consciousness and denied any skin rash. The patient felt he was developing an allergic reaction and self-administered his personal epinephrine auto-injector. He felt better within five to six minutes after self-administration of epinephrine and was taken by stretcher to the Emergency Department for further evaluation and treatment of shortness of breath, dizziness, palpitations, and numbness. The patient was evaluated, treated, observed, and discharged four hours later. Treatment provided for the events while in the Emergency Department included diphenhydramine hydrochloride, intravenous (IV) fluids, IV steroids, and famotidine. On 25 Dec 2020, the patient felt fully recovered. On 26 Dec 2020, the patient felt dizzy and reported experiencing a "rapid heart rate" of 70-120 with a systolic BP that was abnormal for him at 150 mmHg. He also reported that he felt premature atrial contractions, for which he took his wife's propranolol. His heart rate came down, but he still felt flushing and dizziness for a few more hours. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, severe/anaphylactic allergic reaction, was considered resolved on 26 Dec 2020. The reporter assessed the event of severe/anaphylactic allergic reaction as related to Moderna's COVID-19 Vaccine due to the temporal association and the similarity of symptoms previously experienced with severe/anaphylactic allergic reactions to shellfish.; Reporter's Comments: Company Comment: This case concerns a male patient with medical history of shellfish allergy , who experienced an unexpected events of severe allergic reaction; anaphylactic reaction, dizzy, faint, heart racing, tongue prickled and went numb, cold sweat, blood pressure plummeted, shortness of breath, numbness and skin was pale..The onset of event occurred 15 hrs the first dose of vaccine administration . The events are assessed as possibly related to vaccine.

Other Meds: PANTOPRAZOLE; VITAMIN D NOS; VITAMIN B12 NOS

Current Illness:

ID: 0927485
Sex: U
Age:
State: IA

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Patient bleeding was more than usual; Needle of the syrine inadvertently came out of arm and drip; A report was received from a pharmacist concerning a 34-year-old patient who was participating in mRNA-1273 Emergency Use Program and experienced the events, product administration error and bleeding more than usual. The patients' medical history was not provided. No relevant concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 on 23 Dec 2020. On 23 Dec 2020, at the same time as the events, the patient received their first of two planned doses of mRNA-1273 (lot 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 23 Dec 2020, when the patient was receiving the vaccine, the needle of the syringe inadvertently came out of the patient's arm and two drips of the dose dripped out of the syringe. The needle was replaced and the remaining dose in the syringe was administered to the patient at a close site of the original injection site on left arm. The patient bleeding was more than usual and is under post vaccination protocol. Treatment for the events was not provided. The outcome of the events, product administration error and bleeding more than usual, was not reported. Action taken with mRNA-1273 in response to the events was not provided. The reporter assessment of causality of events, product administration error, bleeding more than usual, was not provided.; Reporter's Comments: This case concerns a 34-year-old, patient who experienced the unlisted events of injection site bleeding and product administration error. The events of injection site bleeding and product administration error occurred on the same day after the first dose of Moderna COVID-19 Vaccine administration. The reporter causality assessment for the events was not provided. Due to the temporal association between onset of injection site bleeding and the administration of the vaccine, a causal relationship cannot be excluded. Additional information regarding the reason for the bleeding, patient's medical history and concomitant medication details are required for further assessment. However, the needle of the syringe slipping out of the arm is more of a human error. The event of product administration error was unlikely related to Moderna COVID-19 Vaccine.

Other Meds:

Current Illness:

ID: 0927486
Sex: F
Age: 57
State: KY

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Employee did not receive full dose because needle broke and some of the vaccine liquid ran down their arm; A spontaneous report (United States) was received from a pharmacist's assistant concerning a 57-year-old, female, 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 23 Dec 2020 the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left arm deltoid for prophylaxis of COVID-19 infection. On 23 Dec 2020, during vaccine administration, the patient experienced incorrect dose administered. During the patient's vaccination, the needle came off the syringe and some of the vaccine liquid leaked down the patient's arm. The reporter felt that the needle was not tightened enough prior to administering the vaccine. No treatment was administered for the event. Action taken with mRNA-1273 in response to the event was not reported. The event, incorrect dose administered, was considered resolved on 23 Dec 2020.; Reporter's Comments: This case concerns a 57 year old, female, patient. The patient's medical history is not provided. The patient experienced an unexpected event of incomplete dose administered. The event occurred on 23 Dec 2020 during administration of the first dose of mRNA-1273 (Lot number: 039K20A). The sponsor considered the event as not related to mRNA-1273.

Other Meds:

Current Illness:

ID: 0927487
Sex: U
Age:
State: KY

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: The vaccine ran down from the injection site to the elbow; A spontaneous report was received from a healthcare facility staff member concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, vaccine ran down from the injection site to the elbow. 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 intramuscularly for prophylaxis of COVID-19 infection. During vaccine administration, the syringe that comes with the vaccine popped off and the vaccine ran down from the injection site to the elbow. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event, vaccine ran down from the injection site to the elbow, was considered resolved on 23 Dec 2020.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot-# and expiration date -unknown), reporting an unexpected event of incomplete dose administered. This event occurred the same day of vaccine administration. The reporter did not provide the causality assessment for the events. The event is more of a mechanical error and was assessed as not related to Moderna COVID-19 Vaccine.

Other Meds:

Current Illness:

ID: 0927488
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: had an occurrence on Monday of an outbreak of herpes; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 04Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse reporting for herself. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number not reported), via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously took valaciclovir hydrochloride (VALTREX). Patient stated "I stopped taking my Valtrex a week before getting the vaccine. I got the vaccine on Friday. I started having symptoms again and started taking it again". Patient also stated "I've been told that effectiveness of flu vaccine might not be as good for people taking this medication". Patient was inquiring about taking Valtrex medication before/during her 2 dose vaccine. She stated that she is a nurse in healthcare and she received an email. She received her first dose of the Covid vaccine on a Friday and had an occurrence on Monday of an outbreak of herpes. She stated she was taking Valtrex to suppress her symptoms for a year and stopped taking her medication a week before receiving the vaccine. She stated that she tested for Covid a week before receiving the vaccine as well due to exposure at work. She stopped the medication and panicked thinking it would have an interaction since reading information regarding flu vaccine. Patient states she could not get up with HCP regarding stopping her Valtrex so she called Pfizer. She spoke to someone at Pfizer that asked her if it would be okay to relay her information to someone else and she said yes. Then she received a weird email from [Company name] that said they were made aware a person that was under your care received the flu vaccine. Patient states she does not administer vaccines, she works at the hospital. Patient states she called the company and they did not have any information. She also called her HCP who told her to contact Pfizer to see what the email is all about. Her HCP told her to restart her medication and there is no interaction with Valtrex. Her HCP informed her that the only time she should stop taking her Valtrex is if she was receiving the shingles vaccine or a live vaccine. The outcome of the event was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0927489
Sex: F
Age:
State: OH

Vax Date: 12/17/2020
Onset Date: 12/01/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Name: muscle joints pain; Result Unstructured Data: Test Result:20; Comments: She said on a scale of 1-10 it is 20.

Allergies:

Symptoms: Experiencing sever cramps in her legs and thighs/cramps in my legs are horrendous they hurt so bad that I'm screaming they hurt so bad; Experiencing sever cramps in her legs and thighs/cramps in my legs are horrendous they hurt so bad that I'm screaming they hurt so bad; caused her to go into the flare; Muscle joints pain; Extremely tired; Muscle joints pain; Experiencing flu like symptoms; Body ache; Headache; sick; feeling bad; The initial case was missing the following minimum criteria: specific product. Upon receipt of follow-up information on 01Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (BNT162B2 also reported as Covid 19 vaccine; unknown lot number and expiration date), via an unspecified route of administration on 17Dec2020 at a single dose for covid-19 vaccination. Medical history included having something called Adult Still's which is bad Rheumatoid Arthritis. The patient's concomitant medications were not reported. The patient reported that she got the vaccine and was experiencing sever cramps in her legs and thighs, and muscle joints pain. She mentioned on a scale of 1-10 it is 20. The patient also experienced flu like symptoms which were body ache and extremely tired. The patient reported that she called because she received her first Covid shot on 17Dec2020 and she was really sick from then, she was talking like super sick. In Dec2020, she had muscle cramps, headache, no fever but like she had the flu. She has something called Adult Still's which is bad Rheumatoid Arthritis, so it caused her to go into the flare but she was still sick. She was still feeling bad. She was still having muscle pains in her leg. The patient mentioned that she had to go to the emergency room because she could barely move her leg. They told her that it was a combination of Adult still's and her Covid 19 shot, so they gave her some medications. They gave her Lyrica 75 mg, twice a day and it messed me up that she couldn't even function. So, now she had to come home from work and now she was still having the leg cramps and just not feeling well so what can she do to feel myself better. The outcome of the event cramps in legs was not recovered while the outcome of the other events was unknown. Information on the batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 0927490
Sex: M
Age:
State: PA

Vax Date: 12/24/2020
Onset Date:
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: sore throat, cough, and headache; sore throat, cough, and headache; sore throat, cough, and headache; This is a spontaneous report from a contactable nurse. A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1685), via an unspecified route of administration on 24Dec2020 as single dose for COVID-19 immunization. There was no medical history and no concomitant medications. The patient experienced sore throat, cough, and headache on an unspecified date. No treatment was given for the events. The outcome of sore throat, cough, and headache was not recovered.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm