VAERS 2021 Database www.vaers.hhs.gov

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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: 1062306
Sex: F
Age:
State: AL

Vax Date:
Onset Date:
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: severe allergic reaction/very ill and having a fever; shingles type rash; This spontaneous report was received from a currently 61-year-old female patient referring to herself. The patient's pertinent medical history included low thyroid. Concomitant medication included levothyroxine sodium (reported as levothyroxine). The patient had a lot of allergies. On an unknown date in 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, strength, lot# and expiration date was not provided; route reported as injection) for shingles. On an unknown date in 2014, the patient experienced a "severe allergic reaction", felt very ill and had a fever (hypersensitivity) and shingles type rash (herpes zoster). There was no lab diagnostics/studies performed. The patient did not seek medical attention. The outcome of hypersensitivity and herpes zoster was reported as recovered on an unknown date in 2014. The causality assessment between the events and zoster vaccine live (ZOSTAVAX) was not provided.

Other Meds: levothyroxine sodium

Current Illness: Hypothyroidism; Shingles

ID: 1062307
Sex: F
Age: 18
State: KS

Vax Date: 02/10/2021
Onset Date:
Rec V Date: 03/01/2021
Hospital:

Lab Data: Test Date: 20210210; Test Name: pregnancy test; Test Result: Positive

Allergies:

Symptoms: After administration of the vaccine, the patient was found to be pregnant; no adverse event; This spontaneous pregnancy report was received from a medical assistant referring to an 18 year old female patient. The patient had no pertinent medical history or drug reactions/allergies. Concomitant therapies included ibuprofen and loratadine. On 10-FEB-2021, the patient went to the medical center for birth control management, and it was noticed that she was due for the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccine. The medical assistant administered the dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) pre-filled syringe, lot # 1621929, expiring on 06-DEC-2021, intramuscularly. Then a pregnancy test was taken and the patient was found to be pregnant. The last menstrual period and estimated due date were unknown. The pregnacy was ongoing at the time of reporting. No additional adverse event or product quality issues were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621929; expirationdate: 06-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent

Other Meds: ibuprofen; CLARITIN; GARDASIL 9 SYRINGE (DEVICE)

Current Illness: Routine immunisation

ID: 1062308
Sex: M
Age:
State: KS

Vax Date:
Onset Date:
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: That same test suggested he use BCG VACCINE as a treatment for fibromyalgia; patients wife states she knows the HCP will write the prescription for him.; unable to find BCG VACCINE anywhere; This spontaneous report was received from a patient's wife and refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient had a test done (name of test was not provided) for fibromyalgia and he was "unequivocally positive for fibromyalgia". That same test suggested that he use bcg live (BCG VACCINE USP) (dose, route of administration, anatomical location, lot # and expiration date were not reported) as a treatment for fibromyalgia (product use in unapproved indication). The reporter stated she knew the healthcare professional (HCP) would write the prescription for him (circumstance or information capable of leading to medication error). It was also reported that the patient was unable to find bcg live (BCG VACCINE USP) anywhere (product availability issue). combinationproductreport: Yes; brandname: BCG VACCINE USP PUNCTURE DEVICE (DEVICE); commondevicename: BCG live; productcode: LDH; devicetype: SYSTEM, DELIVERY, ALLERGEN AND VACCINE (LDH); manufacturername: Organon Teknika Corporation LLC; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent

Other Meds: BCG VACCINE USP PUNCTURE DEVICE (DEVICE)

Current Illness: Fibromyalgia

ID: 1062309
Sex: F
Age:
State: WA

Vax Date: 07/11/2014
Onset Date:
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: varicella type rashes under her breast and spread throughout her body; Information was received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. Information regarding concomitant medication, current condition or historical condition was unknown. On or around 11-JUL-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose number, 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, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered varicella type rashes under her breast and spread throughout her body. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not presented prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her 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 of the company's conduct, 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 event was considered as not recovered. The reporter considered varicella type rashes to be related to zoster vaccine live (ZOSTAVAX). The event of varicella type rashes was considered as disabling.

Other Meds:

Current Illness: Routine health maintenance

ID: 1062310
Sex: F
Age:
State: CT

Vax Date:
Onset Date:
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: the patient's mother claimed that the patient had 2 doses of the "HPV vaccine", 1st dose at 13 years of age and 2nd dose at 15 years of age.; HCP provided patient history of abnormal Pap smear in 2019 that was positive for HPV and "ASCUS./HCP reported the patient came back to their office in July 2020 for another Pap smear which was again positive for HPV; in July 2020 for another Pap smear which was again positive for HPV and "ASCUS"/in September 2020 and results showed a "low grade squamous intra-epithelial lesion CIN 1 on all 3 biopsies."; This spontaneous report was received from a medical assistant, referring to a 26-year-old female patient. The patient's pertinent medical history and concomitant medications were not reported. Her current conditions included "heavy smoker, 20-39 cigarettes per day", and the patient has no known drug allergies. On unknown dates, at the age of 13 and 14-year-old the patient was vaccinated with the first and second dose, respectively of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), both vaccines were administered as prophylaxis (formulations, strengths, doses, routes of administration, anatomical sites of vaccination, lot numbers and expiration dates were not reported) (inappropriate schedule of product administration). The reporter stated that, the patient had history of abnormal Papanicolaou (PAP) smear in 2019, it was positive for human papilloma virus infection (HPV) and atypical squamous cells of undetermined significance (ASCUS) (papilloma viral infection and cervical dysplasia), and negative for 16, 18 and 45 genotype. The medical assistant reported that, the patent did not return for further testing as recommended after this result. In July 2020, the patient came back to their office for another PAP smear, which was again positive for HPV and ASCUS (papilloma viral infection and cervical dysplasia), and negative for 16, 18 and 45 genotype. In September 2020, the patient was underwent a colposcopy and the results showed "a "low grade squamous intra-epithelial lesion CIN 1 on all 3 biopsies." The outcome of papilloma viral infection and cervical dysplasia, was not recovered. The causality assessment between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) with the aforementioned events were not reported.

Other Meds:

Current Illness: Heavy smoker

ID: 1062311
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: headache; sore arm; fatigue; This case was reported by a consumer via other manufacturer and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, pain in arm and fatigue. On an unknown date, the outcome of the headache, pain in arm and fatigue were recovered/resolved. It was unknown if the reporter considered the headache, pain in arm and fatigue to be related to Shingrix. Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient had issue with the vaccine and experienced sore arm, fatigue and headache. This case has been linked with US2021AMR001169 reported by same reporter, same patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR001169:Tdap vaccine, same patient

Other Meds:

Current Illness:

ID: 1062312
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: rash following Shingrix shot; This case was reported by a consumer and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had rash. The reporter looking for information on rash following Shingrix shot.

Other Meds:

Current Illness:

ID: 1062313
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Dizziness; Nausea; This case was reported by a consumer and described the occurrence of dizziness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced dizziness and nausea. On an unknown date, the outcome of the dizziness and nausea were unknown. It was unknown if the reporter considered the dizziness and nausea to be related to Shingles vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient received shingles vacckine and experinced dizziness and nausea. The patient asked how long the side effects last and can do anything to minimize the side effects.

Other Meds:

Current Illness:

ID: 1062314
Sex: U
Age:
State: MI

Vax Date: 12/18/2020
Onset Date:
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: ringing in my ears; This case was reported by a consumer and described the occurrence of ringing in ears in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 18th December 2020, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced ringing in ears. On an unknown date, the outcome of the ringing in ears was unknown. It was unknown if the reporter considered the ringing in ears to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient had constant ringing in ears since getting the first dose of Shingrix vaccine. The information provided to patient suggested that if this occurred to contact doctor, which patient did. Unfortunately, there was nothing posted on the CDC web site regarding this particular side effect other than it was rare. The patient looking for any information on this particular adverse reaction, especially any indication if this would now be a permanent occurrence life. The patient concerned about getting second dose.

Other Meds:

Current Illness:

ID: 1062315
Sex: F
Age:
State: WA

Vax Date:
Onset Date:
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: experienced some slight itching; This case was reported by a consumer and described the occurrence of injection site itching in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site pruritus (received 1st dose on unknown date, refer case US2021026215). Concurrent medical conditions included drug hypersensitivity (to Depo-Medrol). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site itching. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site itching was recovered/resolved. The reporter considered the injection site itching to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient could not remember the exact dates of when she received the vaccine but believed it to be last year or possibly 2019. The patient experienced some slight itching the following day that lasted several weeks and experienced no other reactions. Did not consent to follow up.; Sender's Comments: US-GLAXOSMITHKLINE-US2021026215:same reporter

Other Meds:

Current Illness: Drug hypersensitivity (to Depo-Medrol)

ID: 1062316
Sex: F
Age:
State: VA

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Shingles after getting Shingrix vaccine two weeks ago; This case was reported by a consumer and described the occurrence of shingles in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. In January 2021, the patient received Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient had shingles after getting Shingrix vaccine two weeks ago. The primary care physician said that it rare and prescribed me Valacyclovir 1000 mg every 8 hours for 7 days.

Other Meds:

Current Illness:

ID: 1062317
Sex: U
Age:
State: NC

Vax Date:
Onset Date:
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: arm hurt in cold weather; This case was reported by a consumer and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. In 2019, the patient received Shingrix and had pain arm. The patient took cough medicine later right arm hurt in cold weather.

Other Meds:

Current Illness:

ID: 1062318
Sex: F
Age:
State: CO

Vax Date: 01/25/2021
Onset Date:
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Has had sharp back / pain / not resolved; Right leg pain / not resolved; This case was reported by a consumer and described the occurrence of back pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 6th November 2020, refer case US2021032748). On 25th January 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced back pain and leg pain. On an unknown date, the outcome of the back pain and leg pain were not recovered/not resolved. It was unknown if the reporter considered the back pain and leg pain to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix and had sharp back and right leg pain. It had not resolved and would follow up with HCP. The reporter could not find HCP contact information during call, it was not obtained for that reason. The reporter did not consent to followup.; Sender's Comments: US-GLAXOSMITHKLINE-US2021032748:Same reporter.

Other Meds:

Current Illness:

ID: 1062319
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Headaches; Ear pain; Lots of other nerve pain in my hands and legs; Inappropriate age at vaccine administration; My face started drooping / diagnosed me with Bell's palsy; Numbness in my face; This case was reported by a consumer and described the occurrence of bell's palsy in a 35-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. In November 2020, not applicable after receiving Shingrix and 3 weeks after receiving Shingrix, the patient experienced numbness facial. On an unknown date, the patient experienced bell's palsy (serious criteria GSK medically significant), headache, ear pain, nerve pain and inappropriate age at vaccine administration. The patient was treated with antivirals nos and steroids nos (Steroids). On an unknown date, the outcome of the bell's palsy, numbness facial, headache, ear pain and nerve pain were not recovered/not resolved and the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the bell's palsy, numbness facial, headache, ear pain and nerve pain to be related to Shingrix. Additional details were provided as follows: The patient had reported the case for herself. The age at vaccination was not reported for the 1st dose and it could be 34 or 35 year for 2nd dose of Shingrix. The patient received 1st and 2nd dose of Shingrix before 50 years of age, which led to inappropriate age at vaccine administration. The patient started having numbness in her face about 3 weeks November 2020 after 2nd dose of shingrix, a couple weeks later her face started drooping and she had headaches and ear pain. The patient was diagnosed me with Bell's palsy 2 months after 2nd dose. At the time of reporting, the patient was at 3 months post 2nd dose and have gone through two rounds of steroids and antivirals and symptoms were came back with lots of other nerve pain in her hands and legs. The consent to follow-up was requested.

Other Meds:

Current Illness:

ID: 1062320
Sex: F
Age:
State: IL

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

Lab Data:

Allergies:

Symptoms: unexpected benefit alleviation of chronic all over body pain, especially in the hands; swollen glands; fatigue; chills; fever; This case was reported by a consumer and described the occurrence of swollen glands in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included genital herpes (25 year history) and chronic pain (chronic all over body). Concomitant products included valaciclovir hydrochloride (Valacyclovir). On 2nd January 2021, the patient received the 2nd dose of Shingrix. On 3rd January 2021, 1 days after receiving Shingrix, the patient experienced swollen glands, fatigue, chills and fever. On 4th January 2021, the patient experienced unexpected therapeutic effect. The patient was treated with paracetamol (Tylenol). In January 2021, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the swollen glands, fatigue, chills and unexpected therapeutic effect were unknown. It was unknown if the reporter considered the swollen glands, fatigue, chills, fever and unexpected therapeutic effect to be related to Shingrix. Additional details were provided as follows: The patient was using valacyclovir as treatment for genital herpes. The patient developed fever, chills, swollen glands and fatigue and self treated with Tylenol and bed rest. Two days later the patient experienced the unexpected benefit alleviation of chronic all over body pain, especially in the hands. The reporter consented to follow up.

Other Meds: Valacyclovir

Current Illness: Chronic pain (chronic all over body); Genital herpes (25 year history)

ID: 1062321
Sex: M
Age: 78
State: MI

Vax Date: 11/17/2020
Onset Date:
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: itchy bothersome rash/hives; itchy bothersome rash/hives; little red bumps all over his back, legs, arm, and chest.; This case was reported by a consumer and described the occurrence of itchy rash in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included dry skin (every winter gets dry skin from taking hot showers) and pruritus (had some itching on his back before he got the shingles shot, but no rash). On 17th November 2020, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced itchy rash, hives and erythropapular rash. The patient was treated with prednisone. On an unknown date, the outcome of the itchy rash and erythropapular rash were not recovered/not resolved and the outcome of the hives was unknown. It was unknown if the reporter considered the itchy rash, hives and erythropapular rash to be related to Shingrix. Additional information was provided as follows: The patient received of Shingrix and developed an itchy bothersome rash and hives, little red bumps all over his back, legs, arm, and chest. The rash was not on his neck or head. The patient visited his regular doctor and was prescribed Prednisone 5 mg one tablet per day for 7 days. The patient mentioned that, this prescription did not do much. Around 7th December 2020, the patient visited a dermatologist and was prescribed with Prednisone 10 mg which eliminated the rash after 3 weeks. About 4 days after discontinuing the tablets, the rash reappeared. The patient had called the dermatologist and asked for more prednisone and was told that another prescription for prednisone had been phoned in for him. The patient was planning on picking up the prescription on the day of reporting. The reporter went online to see what the possible side effects were of Shingrix and that he didn't get any of them except rash or hives. The reporter stated that every winter he gets dry skin from taking hot showers and he stated that he did have some itching on his back before he got the shingles shot, but no rash. The reporter did not consent to follow up.

Other Meds:

Current Illness: Dry skin (every winter gets dry skin from taking hot showers); Pruritus (had some itching on his back before he got the shingles shot, but no rash)

ID: 1062322
Sex: F
Age:
State: AR

Vax Date:
Onset Date:
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Got sick; Got / feverish; This case was reported by a consumer and described the occurrence of sickness in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness and fever. On an unknown date, the outcome of the sickness and fever were unknown. It was unknown if the reporter considered the sickness and fever to be related to Shingrix. Additional details were provided as follows: The patient's daughter called and reported the case. The age at vaccination was not reported. The patient received Shingrix and got sick and feverish. The lot number unknown to caller. The reporter did not consent to follow up. This case linked with US2021004404 and US2021AMR005804, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021004404:Same reporter US-GLAXOSMITHKLINE-US2021AMR005804:Same reporter

Other Meds:

Current Illness:

ID: 1062323
Sex: U
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: fatigue; swelling; vomiting; pain; chilis; fever; This case was reported by a physician and described the occurrence of fatigue in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced fatigue, swelling, vomiting, pain, chills and fever. On an unknown date, the outcome of the fatigue, swelling, vomiting, pain, chills and fever were recovered/resolved. It was unknown if the reporter considered the fatigue, swelling, vomiting, pain, chills and fever to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient received 2 months ago the first dose of Shingirx and had fever, pain, chilis, swelling, fatigue and vomiting. The reporter did not provided patient's identifiers, no lot number nor expiration date provided, no vaccination date provided no date when the adverse events appeared and recovered provided. The reporter consented to follow up. This case has been linked with the case US2021010469 reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021010469:same reporter

Other Meds:

Current Illness:

ID: 1062324
Sex: U
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: fever; This case was reported by a physician and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient received 1st dose of Shingrix and experienced fever. The reporter consented to follow up. The case was linked with the case US2021010470, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021010470:same reporter

Other Meds:

Current Illness:

ID: 1062325
Sex: M
Age:
State: MO

Vax Date:
Onset Date:
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: diarrhea; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced diarrhea and influenza-like symptoms. On an unknown date, the outcome of the diarrhea and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the diarrhea and influenza-like symptoms to be related to Shingrix. Additional details were provided as follows: The patient was reporter's pharmacist. The age at vaccination was not reported. The patient had to cancel a fishing trip because the day after getting Shingrix, he had diarrhea and flu like symptoms that lasted 3 days. The reporter did not consent to follow-up. The reporter thought that the pharmacist would welcome a call and gave his number for follow-up.; Sender's Comments: US-GLAXOSMITHKLINE-US2021010485:same reporter

Other Meds:

Current Illness:

ID: 1062326
Sex: F
Age: 65
State: MO

Vax Date: 01/08/2021
Onset Date:
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: half dollar size redness around injection site; itching; blisters at site of injection; This case was reported by a pharmacist and described the occurrence of injection site erythema in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 744AH, expiry date 3rd October 2022) for prophylaxis. On 8th January 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced injection site erythema, injection site itching and injection site blisters. On an unknown date, the outcome of the injection site erythema, injection site itching and injection site blisters were unknown. It was unknown if the reporter considered the injection site erythema, injection site itching and injection site blisters to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient had Shingrix had redness around injection site which has increased in size to half-dollar size, the area was itching and has blisters. Did not consent to follow-up.

Other Meds:

Current Illness:

ID: 1062327
Sex: F
Age:
State: SC

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: hives / itchy; hot in the injection site; pain / in the injection site; redness / in the injection site; Injection site itchy; This case was reported by a pharmacist via call center representative and described the occurrence of hives in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 4th January 2021, the patient received Shingrix. On 4th January 2021, several hours after receiving Shingrix, the patient experienced hives, injection site warmth, injection site pain, injection site erythema and injection site itching. On an unknown date, the outcome of the hives was not recovered/not resolved and the outcome of the injection site warmth, injection site pain, injection site erythema and injection site itching were unknown. It was unknown if the reporter considered the hives, injection site warmth, injection site pain, injection site erythema and injection site itching to be related to Shingrix. Additional details were provided as follows: Age at vaccination was not reported. The Shingrix was administrated to the patient and some hours after the vaccination the patient had redness, itchy, pain, hot in the injection site and hives. At the time of reporting, the patient still had hive in her chest. The reporter consented to follow up. This case was linked with the case US2021015571 reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021015571:same reporter

Other Meds:

Current Illness:

ID: 1062328
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Experienced redness at the injection site, that turned purple; Experienced redness at the injection site, that turned purple; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema and injection site discoloration. On an unknown date, the outcome of the injection site erythema and injection site discoloration were recovered/resolved. It was unknown if the reporter considered the injection site erythema and injection site discoloration to be related to Shingrix. Additional details were provided as follows: The patient had reported the case for herself. The age at vaccination was not reported, however it could be 62 or 63 years. The patient received 2nd dose sometime in 2018 specific date unknown and experienced redness at the injection site, that turned purple. The reporter did not consent to follow-up.

Other Meds:

Current Illness:

ID: 1062329
Sex: F
Age:
State: NC

Vax Date: 01/24/2021
Onset Date: 01/01/2021
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: redness / inch and a half below the injections site.; This case was reported by a consumer via call center representative and described the occurrence of erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 24th January 2021, the patient received the 2nd dose of Shingrix. In January 2021, less than a week after receiving Shingrix, the patient experienced erythema. On an unknown date, the outcome of the erythema was unknown. It was unknown if the reporter considered the erythema to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. Patient received the dose of Shingrix and presented redness an inch and a half below the injections site and redness was presented in a 3 inches radius. Patient refused to answer any additional questions. The reporter did not consent to follow up

Other Meds:

Current Illness:

ID: 1062330
Sex: F
Age:
State: NY

Vax Date: 10/01/2020
Onset Date:
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: had a sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis. In October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were reported as follows: The patient received Shingrix at the end of October and had a sore arm that resolved quickly. No lot number or expiration date for either vaccine was known. The reporter consented to follow up. For tolerances of 2nd dose, refer case US2021AMR022113, reported by same reporter for the same patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR022113:same reporter

Other Meds:

Current Illness:

ID: 1062331
Sex: F
Age: 58
State: MI

Vax Date: 10/27/2020
Onset Date: 01/26/2021
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Dose 1 / on October 27, 2020 / Patient is experiencing a shingles outbreak; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 27th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 26th January 2021, 91 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix and experiencing a shingles outbreak. The patient had not yet received the second dose. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1062332
Sex: F
Age:
State: WI

Vax Date:
Onset Date:
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: injection site pain; Headache / severe headache; Difficulty Breathing; Pain / body aches /; could not use her right arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site pain, headache, difficulty breathing, pain and injected limb mobility decreased. Shingrix was interrupted. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the headache, difficulty breathing, pain and injected limb mobility decreased were recovered/resolved. It was unknown if the reporter considered the injection site pain, headache, difficulty breathing, pain and injected limb mobility decreased to be related to Shingrix. Additional information were provided as follows: The age at vaccination was not reported. The patient received 1st dose of shingrix and she developed pain, difficulty breathing, body aches throughout,a severe headache,injection site pain and injected limb mobility decreased. The reporter stated that the headache did not resolve for more than a week, and she could not use her right arm for 3 days, with the soreness lasting more than 3 weeks,and her difficulty breathing resolved the night she received the vaccination. The reporter informed that her HCP advised her not to get the second dose. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1062333
Sex: M
Age:
State:

Vax Date: 02/04/2021
Onset Date:
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: injection site pain; headache, head pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On 4th February 2021, the patient received the 2nd dose of Shingrix. In February 2021, less than a week after receiving Shingrix, the patient experienced injection site pain and headache. In February 2021, the outcome of the injection site pain and headache were recovered/resolved. It was unknown if the reporter considered the injection site pain and headache to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient had a headache, head pain, and injection site pain. The headache and injection site pain resolved 4 days later. The patient did not want to provide any additional details for adverse event or give Health Care Professional information. The reporter did not consented to follow up.

Other Meds:

Current Illness:

ID: 1062334
Sex: F
Age:
State:

Vax Date:
Onset Date: 01/05/2021
Rec V Date: 03/01/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: tingling in arms; tingling in lips; pain that went down her whole arm; arm feels painful and she can't move it; has been hurting all day; red ring around injection site; A spontaneous report from was received from a Reporter concerning a unknown year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like Paraesthesia, Oral Paraesthesia, Limb discomfort, injection site erythema. The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, after receiving the dose of Moderna COVID vaccine (mRNA-1273) (lot/batch: unknown) intramuscularly in the arm for prophylaxis of COVID-19 infection. On date or an unknown date, The patient experienced tingling in the arms, tingling in lips, pain that went down her whole arm, arm hurting, red ring around her injection site, and painful arm which can't be moved. Treatment included diphenhydramine hydrochloride and two steroids for her symptoms, which subsided. Action taken with mRNA-1273 in response to the events was reported. On date 5 January 2021 the outcome of the events like pain in extremity, limb discomfort, injection site erythema are unkown.; Reporter's Comments: This case concerns a female of unknown age who had serious unexpected events of tingling of extremity, oral paraesthesia, and pain in extremity, NS unexpected arm discomfort, and NS expected injection site erythema. Event onset 15 minutes after first dose of mRNA-1273. Treated with Benadryl and steroids. Events subsided. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1062335
Sex: F
Age: 53
State: ID

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 03/01/2021
Hospital: Y

Lab Data: Test Date: 20210116; Test Name: Temperature; Result Unstructured Data: Fahrenheit (F); Test Date: 20210117; Test Name: Temperature; Result Unstructured Data: Fahrenheit (F); Test Date: 20210117; Test Name: Temperature; Result Unstructured Data: Fahrenheit (F); Test Date: 20210119; Test Name: Temperature; Result Unstructured Data: Fahrenheit (F)

Allergies:

Symptoms: Lymph nodes swelled up; Couldn't breathe; Diarrhea; Stomach hurt; Profusely sweat; Arm was sore; Fatigue; Chills; Fever; Headache; Teeth chattering; Joints hurt; Coughing; Chest tightness; Back hurt; Got so sick; A spontaneous report (United States) was received from a consumer, a 53-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273), and who experienced lymph nodes swelled up (lymphadenopathy), couldn't breathe (dyspnoea), chest tightness (chest discomfort), got so sick (illness), arm was sore (pain in extremity), headache, fever (pyrexia), chills, fatigue, teeth chattering (chills), coughing (cough), joints hurt (arthralgia), profusely sweat (hyperhidrosis), back hurt (back pain), diarrhea (diarrhoea), and stomach hurt (stomach pain). The patient's medical history was not reported. Concomitant product use was not provided by the reporter. On 16 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 027L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Around 6:30 pm on the same day, the patient's arm was sore. She also started getting a headache, fever up to 103 Fahrenheit (F), and chills. She got "so sick, she couldn't breathe", so she used her continuous positive airway pressure machine (CPAP), but it didn't help. She felt fatigued and was coughing. Her joints hurt that night until the next day. Her teeth were chattering until the next day. She had a fever and started to profusely sweat for a couple of hours. She had chest tightness and her back hurt. On 17 Jan 2021, her temperature was 95 F. On 18 Jan 2021, the patient's stomach hurt and stopped later that day. The she had diarrhea. On 19 Jan 2021, she reported that she still had a temperature of 95 F, coughing, fatigue, arm soreness, diarrhea, chest tightness, and back pain. On 20 Jan 2021, the patient's lymph nodes swelled up and she was having difficulty breathing. She went to an urgent care and from there she was "sent/admitted" to the hospital. No treatment information was provided. The events, teeth chattering and arthralgia, profusely sweat, were considered resolved on 17 Jan 2021. The event, stomach hurt, resolved on 18 Jan 2021. The events, chest tightness, arm was sore, fever, fatigue, coughing, diarrhea, back hurt, were considered not resolved. The events, lymph nodes swelled up, couldn't breathe, headache, chills, got so sick, were considered unknown.; Reporter's Comments: This case concerns a 53-year-old female with serious unexpected lymphadenopathy and dyspnea and NS unexpected cough, chest tightness, arm pain, back pain, stomach pain, sickness, diarrhea, hyperhidrosis and NS expected headache, fatigue, fever, chills, teeth chattering, arthralgia. Event onset the same day as first dose mRNA-1273. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1062336
Sex: F
Age: 31
State: FL

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 200/100 high blood pressure; stammering problems; uncontrolled shaking at my right hand; cold feet; dry mouth; Headaches; body aches; A spontaneous report was received from a 31-year old, female patient who experienced headaches, body aches, dry mouth, cold feet, uncontrolled shaking in right hand, stammering problems, and 200/100 high blood pressure. 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 (Batch number not provided). On 21 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 028L20A) for prophylaxis of COVID-19 infection. On 21 Jan 2021, the patient was taken to the emergency room (ER) approximately four hours after receiving the second dose of the Moderna COVID vaccine. She was experiencing headaches, body aches, dry mouth, cold feet, uncontrollable shaking in her right hand, speech impairment, and her blood pressure was 200/100. The patient tested negative for all stroke tests performed in the ER.. The patient reported she received a medication that "knocked me out" and relieved the symptoms. Treatment information was not provided. On 23 Jan 2021, the patient still had shaking and stammering problems. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The outcome of the events headaches, body aches, dry mouth, cold feet, and 200/100 high blood pressure were unknown. The outcome of events uncontrolled shaking in right hand and stammering problems were not recovered/ not resolved. Follow up: Follow-up received on 29 Jan 2021 included the patient's report that her adverse events have been sustained and not improved. On 27 Jan 2021, the patient received an MRI that showed brain lesions existed as diagnosed by a neurologist.; Reporter's Comments: The follow-up received reports that on 27Jan 2021, the patient received an MRI that showed brain lesions existed as diagnosed by a neurologist. Based on this information, the event of hypertensive crisis, dysphemia, tremors, is assessed as unlikely related to mRNA-1273.

Other Meds:

Current Illness:

ID: 1062337
Sex: U
Age:
State: OH

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Allowed 4 patients to be vaccinated with the vaccines that experienced a temperature excursion; A spontaneous report was received from a physician regarding product storage error. On 05 FEB 2021, a physician contacted the safety team regarding five (5) vials of Moderna's COVID-19 vaccine (mRNA-1273) that had a temperature excursion of less than 12 hours at maximum of 50 degrees Fahrenheit. It was moved to a refrigerator that was within the acceptable range immediately. She stated that she exercised clinical judgement and allowed 4 patients to be vaccinated with those vials.; Reporter's Comments: This report refers to a case of product storage error regarding five (5) vials of Moderna's COVID-19 vaccine (mRNA-1273) (Lot # unknown) with no reported adverse events. No further information is expected.

Other Meds:

Current Illness:

ID: 1062338
Sex: M
Age: 39
State: NY

Vax Date: 01/19/2021
Onset Date: 01/21/2021
Rec V Date: 03/01/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Not able to walk; A spontaneous report was received from a [consumer/physician/nurse/pharmacist/healthcare facility staff member/regulatory authority report] concerning a [age/gender] patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and became unable to walk/gait disturbance. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included unspecified psychiatric medications. On 19 Jan 2021, approximately two days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. The patient lost the ability to walk on 21 Jan 2021 and was hospitalized. He was entered into a rehabilitation facility where he was to start treatment with a physical therapist to walk again. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events fatigue, body aches, loss of taste, chills, and temperature of 99 degrees were not reported. Reporter causality for the events was not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. Company assessed the event to be unlikely related to company product.

Other Meds:

Current Illness:

ID: 1062339
Sex: F
Age:
State: TX

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: had some bleedings this week; Pregnant; A spontaneous report was received from a nurse concerning a female patient who experienced had some bleedings this week (haemorrhage in pregnancy) and pregnant. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 11 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection. On 11 Jan 2021, the patient found out she was pregnant after the vaccination. Patient also reported that she had some bleedings this week. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events had some bleedings this week and pregnant were unknown.; Reporter's Comments: This is a case of product exposure during pregnancy with an adverse event of bleeding during pregnancy for this female of an unknown age. Patient will continue to be contacted for further monitoring of the AE during the pregnancy. Very limited information regarding the event of Bleeding during Pregnancy has been provided at this time and further information has been requested.

Other Meds:

Current Illness:

ID: 1062340
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Heart attack; A spontaneous report was received from a consumer, who was also a female patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a heart attack (myocardial infarction). The patient's medical history was not provided. No relevant concomitant medications were reported. On an undisclosed date, the patient received their first of two planned doses of mRNA-1273 (lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an undisclosed date after receiving mRNA-1273, the patient had a heart attack. The patient stated that Moderna should have told her "about the montelukast allergy". No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, heart attack, was unknown.; Reporter's Comments: Very limited information regarding this event of heart attack has been provided at this time. Patient's age, medical history, list of concomitant medications, onset date and clinical details of the event is lacking. Further information has been requested.

Other Meds:

Current Illness:

ID: 1062341
Sex: F
Age:
State: AL

Vax Date:
Onset Date:
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: felt temporary black out; loss of memory; A spontaneous report was received from a pharmacist concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt temporary black out and temporary loss of memory. 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 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, it was reported that the patient experienced a possible adverse event after the first dose of the vaccine. It was reported that on the night of receiving the vaccine the patient felt temporary blackout and temporary loss of memory. She mentioned that "she wake up fine the next morning". No treatment information provided. The outcome of the events felt temporary black out and temporary loss of memory were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Other Meds:

Current Illness:

ID: 1062342
Sex: F
Age: 67
State: DE

Vax Date: 01/24/2021
Onset Date: 01/24/2021
Rec V Date: 03/01/2021
Hospital: Y

Lab Data: Test Date: 202101; Test Name: Pulse meter; Test Result: Inconclusive ; Result Unstructured Data: 128 beats per minute

Allergies:

Symptoms: Racing heart; Fever; Pain at injection site; cough; A spontaneous report was received from a consumer concerning a ? 67 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like racing heart, cough, fever and pain at injection site. The patient had a history of heart disease. On 24-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch: 028L20A ) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection. On 24-JAN-2021, The patient experienced the events like racing heart, cough, fever and pain at injection site with hospitalization as seriousness criteria. The Patient is taking atenolol ? every other day. The patient was also advised to take Tylenol. Action taken with mRNA-1273 in response to the events was not reported. On 24- JAN-2021, the outcome of the events like tachycardia, cough, pyrexia, pain at injection site was not resolved. At the time of this report, the outcome of the event tachycardia was resolved and cough, pyrexia , pain at injection site was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The patient medical history of heart disease remains a confounder for causality.

Other Meds:

Current Illness: Heart disease, unspecified

ID: 1062343
Sex: M
Age:
State: OK

Vax Date: 02/13/2021
Onset Date: 02/13/2021
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: inadvertently given vaccine from a vial that was punctured a day before; A spontaneous report was received from a health care professional (HCP) concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) inadvertently from a vial that was punctured a day before/expired vaccine used. The patients' medical history was not provided. Concomitant medication history was not provided. On 13 FEB 2021, the patient received his dose of mRNA-1273 (Lot number 016M20A) intramuscularly for prophylaxis of COVID-19 infection. The HCP stated that this patient was inadvertently given the vaccine from a vial that was punctured a day before. A single dose was taken out of that vial and put back outside the six-hour window. Treatment for this event was not provided. The outcome of the event, expired vaccine used, was recovered on 13 Feb 2021.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273, Lot number 016M20A with no associated adverse events.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-013964:same reorter, different patient

Other Meds:

Current Illness:

ID: 1062344
Sex: F
Age: 71
State: CA

Vax Date: 02/05/2021
Onset Date: 02/01/2021
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Spot on forearm where vaccine dripped turned red; facility chose to administer another dose; the syringe wasn't screwed in tight enough and the vaccine leaked down her arm; the syringe wasn't screwed in tight enough and the vaccine leaked down her arm; the syringe wasn't screwed in tight enough and the vaccine leaked down her arm; (spot) blistered; A spontaneous report was received from a consumer concerning a 71-year-old, female who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the syringe not tightly screwed on and the vaccine leaked down the patient's arm, received another dose of the vaccine, a red spot developed on her forearm where the vaccine dripped, and later blistered. The patient's medical history was not provided. No relevant concomitant medications were reported. On 05-Feb-2021, during vaccine administration the syringe was not tightly screwed on, and the vaccine leaked down the patient's arm. The facility chose to administer another dose and the patient received two doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID -19 infection. On 07-Feb-2021, two days later, a spot developed on her forearm where the vaccine dripped, turned red, and later blistered. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The events, the syringe was not screwed tightly on and the vaccine leaked down her arm was considered resolved. The events of a spot developed on her forearm where vaccine dripped, turned red, and later blistered were reported as unknown.; Reporter's Comments: This report refers to a case of syringe that was not tightly screwed on and the vaccine leaked down the patient's arm, and the facility chose to administer another dose for mRNA-1273, lot # unknown, with associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1062345
Sex: M
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: some solution leaked out of the syringe; the patient may not have received the recommended .5ml; A spontaneous report was received from a pharmacist concerning a 31-year old, male patient who was scheduled to receive Moderna's COVID-19 vaccine but during the administration the patient may have received an invalid first dose as some solution leaked out of the syringe (syringe leak and underdose). The patient's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date, the patient presented to the clinic for their first of two planned doses of mRNA-1273 (Lot number not provided) intramuscularly for prophylaxis of COVID-19 infection. The pharmacist stated that, during attempted administration, the consumer may have received an invalid first dose as some solution leaked out of the syringe and the patient may not have received the recommended 0.5ml. No treatment information was provided. Action taken with mRNA-1273 in response to the event(s) was not reported. The outcome of the events, syringe leak and underdose were considered recovered.; Reporter's Comments: This report refers to a case of syringe issue and underdose for mRNA-1273 (lot # unknown) with no associated AEs reported.

Other Meds:

Current Illness:

ID: 1062346
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: gave the last two doses after the six hours of vaccine viability time; A spontaneous report was received from a healthcare professional concerning a patient of unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and the person that was giving the doses gave the last two doses after the six hours of vaccine viability time (expired product administered). The patients' medical history was not provided. Concomitant product use was not provided. On an undisclosed date, the patient received a dose of mRNA-1273 (batch number unknown) for prophylaxis of COVID-19 infection. The reporter stated that they punctured the vial but the person that was giving the doses gave the last two doses after the six hours of vaccine viability time. Treatment information was not provided. The action taken with mRNA-1273 in response to the event was unknown. The event, gave the last two doses after the six hours of vaccine viability time, was considered recovered/resolved on an unknown date.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 (batch number unknown) with no associated AEs.

Other Meds:

Current Illness:

ID: 1062347
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Gave the last 2 doses after the 6hs punctured vial lifespan; A spontaneous report was received from a consumer concerning a patient of unknown age and gender who received Moderna's COVID-19 vaccine who received (mRNA-1273) and the person that was administering the doses gave the last two doses after the six hour of vaccine viability time (expired product administered). The patient's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date, the patient received a dose of mRNA-1273 (lot number not provided) for prophylaxis of COVID-19 infection. It was reported that the person that was administering the doses gave the last two doses after the six hour of vaccine viability time. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event gave the last two doses after the six hour of vaccine viability time was considered resolved.; Reporter's Comments: This case concerns a patient of unknown age and gender who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Expired product administered without any associated adverse events.

Other Meds:

Current Illness:

ID: 1062348
Sex: U
Age:
State: AL

Vax Date: 02/14/2021
Onset Date: 02/14/2021
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 1 dose given to a patient 6 hours and 15 minutes after the first puncture; A spontaneous report was received from a pharmacist concerning a patient, age and gender unknown, who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, dose given to a patient 6 hours and 15 minutes after the first puncture. The patient's medical history was not provided. No relevant concomitant medications were reported. On 14 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection. On 14 Feb 2021, a dose of Moderna's vaccine was administered to the patient 6 hours and 15 minutes after the first puncture of vial. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, dose given to a patient 6 hours and 15 minutes after the first puncture, was considered resolved on 14 Feb 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Expired product administered without any associated adverse events.

Other Meds:

Current Illness:

ID: 1062349
Sex: F
Age: 55
State: NY

Vax Date: 01/06/2021
Onset Date: 01/18/2021
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Anaphylactic reaction; rash 3.5 x 5 inches below the injection site; A spontaneous report was received from a consumer concerning a 65-year-old female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylactic reaction and a vaccination site rash. The patient's medical history included diabetes since an unknown date. Relevant concomitant medications included an unspecified diabetes medication. On 06-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 18-Jan-2021, the patient experienced the event anaphylactic reaction and a vaccination site rash 3.5 x 5 inches. Laboratory details were not provided. Treatment information included fexofenadine and diphenhydramine. Action taken with mRNA-1273 in response to the events was not reported. On 23-Jan-2021, the outcome of the events, anaphylactic reaction and vaccination site rash, was considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Allergy (Allergic to hairs.); Sulfonamide allergy (allergic to sulfa drugs)

Date Died: 01/25/2021

ID: 1062350
Sex: M
Age:
State:

Vax Date: 01/23/2021
Onset Date: 01/25/2021
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Death; A spontaneous was received from a consumer concerning a male patient, who received Moderna's COVID-19 vaccine and who died. The patient's medical history was not provided. No relevant concomitant medications were reported. On 23-Jan-2021, prior to the onset of the event, patient received their first of two planned doses of mRNA-1273 (Lot number:013620A) intramuscularly for prophylaxis of COVID-19 infection. On 25-Jan-2021, approximately 2 days after injection, patient Died. On 26-Jan-2021, neighbor Reporter called in to report a potential AE death. She shared that she lives in a condo building with other elderly. She shared that she and 2 other neighbors went to a vaccination site in Miami at a fire department. She shared that she is fine but that her neighbor died two days after shot. She shared that she didn't know if he had symptoms and that she knows that he had a lot of medical issues and was on about 15 medicines. She shared that she didn't know his age but guessed 70. She said we can contact his wife, but it must be a Spanish speaking agent because she speaks little English. She is concerned because they all received the vaccine at the same time. She wanted to reiterate that she was fine but believed we should know about the neighbor's death. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event death is not applicable. The patient died on 26-Jan-2021. The cause of death was not provided. Plans for an autopsy were not provided.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested. The cause of death was not provided.; Reported Cause(s) of Death: Unknown

Other Meds:

Current Illness:

ID: 1062351
Sex: F
Age: 31
State: NC

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Not Administered in the Deltoid; Itchy Sensation - Near Elbow; Rash - Near Elbow; Redness - Near Elbow; Swelling - Near Elbow; A spontaneous report was received from a consumer concerning a 31-year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) at the incorrect injection site and experienced rash, redness, swelling, and an Itchy sensation near her elbow. The patient's medical history, is not provided by the reporter. Concomitant medications were not reported. On 21 Jan 2021, the patient received their first of two planned dose of mRNA-1273 in the left arm for prophylaxis of COVID-19 infection. On 21 Jan 2021, the patient began to experienced rash, redness, a lot of swelling, and an Itchy sensation near her elbow where the vaccine was administered. Treatment for the events included ibuprofen Action taken with mRNA-1273 in response to the events was unknown. The outcome of event, incorrect injection site, was considered recovered/resolved on 21 Jan 2021. The outcome of the events, rash, redness, swelling, and an Itchy sensation, was unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The causality of the event of vaccine administered at inappropriate site is assessed as not applicable.

Other Meds:

Current Illness:

ID: 1062352
Sex: F
Age:
State: NC

Vax Date:
Onset Date: 01/01/2021
Rec V Date: 03/01/2021
Hospital:

Lab Data: Test Name: body temperature; Result Unstructured Data: abnormal

Allergies:

Symptoms: Face and neck all hot; rash had spread throughout her body; Face was really flushed; tachycardia; fever 99.9-102F; A spontaneous report was received from a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced face and neck all hot, rash had spread throughout her body, face was really flushed, tachycardia and fever 99.9-102f. Medical history was not reported. Concomitant medication was not reported. On 01 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) in left arm for prophylaxis of COVID-19 infection. On 01 Feb 2021, the patient experienced face and neck all hot, rash had spread throughout her body, face was really flushed, tachycardia with seriousness criteria life threatening and fever 99.9-102f. Treatment medication included Benadryl at a dose of 50 milligram. Action taken with mRNA-1273 in response to the face and neck all hot, rash had spread throughout her body, face was really flushed, tachycardia and fever 99.9-102f was not provided. The outcome of the events face and neck all hot, rash had spread throughout her body, face was really flushed, tachycardia and fever 99.9-102f was unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced serious unexpected events of severe allergic reaction, tachycardia, rash, flushing, and skin warm, and NS expected event of fever. The events occurred the same day as the first dose of mRNA-1273. Treatment included Benadryl. Event outcome not reported. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1062353
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: had COVID (double Covid pneumonia); A spontaneous report (United States) was received from an Other Health Care Professional concerning a female patient age not provided who developed COVID (double Covid pneumonia) The patient's medical history was not provided. Concomitant product use was not provided. On 22-Jan-2021, prior to the onset of events, the patient had the first of two planned doses of mRNA-1273, (Batch number was not provided) (route and site was not provided) for prophylaxis of Covid-19 infection. The patient left a voicemail message reporting adverse reactions to the Moderna mRNA-1273 vaccine. The patient reported having "Covid". She reported being hospitalized with, " double Covid pneumonia". No treatment information or hospitalization details were provided. Agent called the patient back on 26-Jan-2021 and was unable to reach her for more information. Action taken with mRNA-2021 in response to the events was not reported. Outcome of the event had COVID (double Covid pneumonia) was unknown.; Reporter's Comments: This case concerns a female of unknown age who was hospitalized with a serious unexpected event of COVID-19 pneumonia. The event occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1062354
Sex: M
Age: 36
State: CT

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

Lab Data:

Allergies:

Symptoms: Syringe and/or needle broke; Did not receive intended dosage volume; A spontaneous report was received from a consumer concerning a 36 year old, white, male patient who received Moderna's Covid 19 vaccine (mRNA1273) and experienced a syringe issue and incorrect dose administration. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. ON 29-JAN-2021, the patient received first of two planned dose of mRNA-1273 (Batch Number 012M20A) intramuscularly for prophylaxis of COVID-19 infection. On 29 Jan 2021, during administration of the vaccine, the syringe plastic broke and patient did not receive the intended dosing volume of 0.5 mL. Treatment information was not provided/unknown. Action taken with mRNA-1273 in response to the events was not provided/unknown. The outcome of the events, syringe issue and incorrect dose administration, were considered recovered/resolved on 29 Jan 2021.; Reporter's Comments: This report refers to a case of Vaccine underdose and Device connection issue for mRNA-1273 (Batch Number 012M20A) with no associated AEs.

Other Meds:

Current Illness:

ID: 1062355
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Part of the dose leaked out through the connection of the needle to the syringe; Part of the dose leaked out through the connection of the needle to the syringe; A spontaneous report was received from a healthcare professional (pharmacist) concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) experienced the event part of the dose leaked out through the connection of the needle to the syringe (syringe issue) (underdose). The patient's medical history was not provided. No Relevant concomitant medications was provided. On unknown date, patient received their second of two planned dose of mRNA-1273 (Lot/Batch: unknown) vaccine for prophylaxis of COVID-19 infection. On an undisclosed date, patient experienced the event part of the dose leaked out through the connection of the needle to the syringe. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was unknown. The outcome of events experienced for event part of the dose leaked out through the connection of the needle to the syringe was resolved.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273 (lot # unknown) with no associated AEs reported.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm