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: 1391334
Sex: F
Age: 77
State:

Vax Date: 02/10/2021
Onset Date: 02/16/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Redness, pain, swelling at injection site started 5 days after injection.

Other Meds:

Current Illness:

ID: 1391335
Sex: M
Age:
State: PA

Vax Date: 02/13/2021
Onset Date: 02/17/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: NONE

Allergies:

Symptoms: Patient had swelling of the lips 4 days after the vaccine. Called his Dr. Prescribed predinisione and to take OTC Benadryl. Swelling Resolved

Other Meds: Atovastatin, Methotrexate, Carvedilol, Lisinopril, Balsalazide

Current Illness: None

ID: 1391337
Sex: M
Age: 55
State: NY

Vax Date: 02/11/2021
Onset Date: 02/13/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: none

Allergies:

Symptoms: patient states he had enlarged lymph nodes under left arm 2 days after receiving 2nd shingrix shot, swelling has improved, no treatment

Other Meds: none known

Current Illness: none stated

ID: 1392013
Sex: M
Age: 61
State:

Vax Date: 02/17/2021
Onset Date: 02/18/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Headache, Myalgia, Arthralgia, EXTREEM FATIGUE. Narrative:

Other Meds:

Current Illness:

ID: 1392014
Sex: M
Age: 54
State:

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVommiting, Chills, pain at the injection site Narrative:

Other Meds:

Current Illness:

ID: 1392016
Sex: M
Age: 58
State:

Vax Date: 02/17/2021
Onset Date: 02/18/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Headache, Myalgia, lethargy Narrative:

Other Meds:

Current Illness:

ID: 1392018
Sex: F
Age: 57
State:

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Sedation, Myalgia, Arthralgia, NauseaVomiting, Tachycardia, Chills, swollen glands Narrative:

Other Meds:

Current Illness:

ID: 1392022
Sex: M
Age: 37
State:

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Myalgia, Arthralgia Chills Narrative:

Other Meds:

Current Illness:

ID: 1392025
Sex: F
Age: 39
State:

Vax Date: 02/17/2021
Onset Date: 02/18/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Fever aux node swelling chills Narrative:

Other Meds:

Current Illness:

ID: 1392098
Sex: M
Age: 46
State:

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Headache, Sedation, Myalgia, Arthralgia, Fever, Chills, pain at the injection site Narrative: Other Relevant History:

Other Meds:

Current Illness:

ID: 1392160
Sex: M
Age: 24
State:

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Headache, Nausea Vomiting chills, malaise, pain in injection arm Narrative:

Other Meds:

Current Illness:

ID: 1392161
Sex: M
Age: 61
State:

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Headache, Sedation, Myalgia, Arthralgia, Pain at the injection site Narrative:

Other Meds:

Current Illness:

ID: 1392162
Sex: M
Age: 50
State:

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Narrative: 50 year old male with no known medical history reported having dizziness (2/10) after the first dose of COVID19 PFIZER vaccine during the 15 minutes observation period. BP 145/97, HR 86, 02 97%, temp 98.2, denies pain and shortness of breath. Patient was given water to drink and monitored for thirty minutes. Re-take BP 133/85, HR 87. Upon release, patient reported 1/10 dizziness and was ambulatory. Vaccine administered without complications. The patient denied any prior severe reaction to this vaccine or its components or a severe allergic reaction such as anaphylaxis to any vaccine or to any injectable therapy.

Other Meds:

Current Illness:

ID: 1857206
Sex: F
Age: 16
State: OH

Vax Date: 02/15/2021
Onset Date: 02/16/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: None

Allergies: None

Symptoms: Fever up to 103, Tylenol & Ibuprofen. Resolved within 24 hours. Redness & swelling at vaccine site.

Other Meds: Nymy O

Current Illness: None

ID: 1040515
Sex: F
Age: 1
State: ND

Vax Date: 01/15/2021
Onset Date: 01/25/2021
Rec V Date: 02/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: The patient had fever with a temperature maxinum of 103.5 and"Red Macular rash on her torso" that is being treated as "viral otitis media" bilateral; he patient had fever with a temperature maxinum of 103.5 and"Red Macular rash on her torso" that is being treated as "viral otitis media" bilateral; The patient had fever with a temperature maxinum of 103.5 and"Red Macular rash on her torso" that is being treated as "viral otitis media" bilateral; This spontaneous report was received from a physician and refers to a 12 month old female patient. The patient had no known medication allergies, or significant medical history. The patient's concurrent conditions were not reported. On 15-JAN-2021, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # T010651, expiration date 22-SEP-2021 in the right thigh; with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S033540, expiration date 22-OCT-2021 in the right thigh (MARRS # 2102USA007091); and with a dose of hepatitis a vaccine, inactivated(VAQTA) lot # T014836, expiration date 17-JUL-2021 in the left thigh for prophylaxis (dose and route were not reported). The vaccines were administered in the private Doctor's office with a private funds. Other suspect therapy included sterile diluent. Concomitant therapy included pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR). On 25-JAN-2021, the patient was in the clinic with a fever with a temperature maximum of 103.5 (units not reported) (pyrexia) and "red macular rash on her torso" (rash macular) that was being treated as "viral otitis media" bilateral (otitis media viral). The patient was being treated "symptomatically and conservatively" with a prescription of amoxicillin, 400 milligrams per 5 milliters, 3 milliters twice a day to begin in 2 to 3 days if symptoms persist or get worse. At the time of the report, the outcome of the events and the relationship with the vaccines were not reported. This is on of two reports regarding the same patient. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014836; expirationdate: 17-JUL-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; Sender's Comments: US-009507513-2102USA007091:Original Case : 2101USA009289

Other Meds: PREVNAR; VAQTA SYRINGE (DEVICE); STERILE DILUENT

Current Illness: Prophylaxis

ID: 1040516
Sex: U
Age:
State: TX

Vax Date: 12/18/2020
Onset Date: 12/18/2020
Rec V Date: 02/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No adverse event; incorrect product storage; This spontaneous report was received from an unspecified source via a physician, referring a patient of an unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies were not reported. On 18-DEC-2020, the patient was vaccinated with an improperly stored dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) at a dose of 0.5 mL which had a valid lot # T007790 expiration date on 03-DEC-2021) for prophylaxis, however no adverse effects reported. Administered dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) experienced the temperature excursion above 31.2 F for 430 minutes. Digital data logger was involved. There were no previous temperature excursions reported. No product to retrieve. No Product Quality Complaint reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007790; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability

Other Meds: PNEUMOVAX 23 SYRINGE

Current Illness:

ID: 1040517
Sex: U
Age: 0
State: TN

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 02/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional adverse events reported; Administration of a ROTATEQ dose to a patient / Temperature -7.9 for 53 minutes and -10.5C for 52 minutes; This spontaneous report was received from a licensed practical nurse concerning to a 8-week old patient of unknown gender. No information regarding the patient's pertinent medical history, historical drugs, drug reactions, allergies, concurrent conditions or concomitant therapies was provided. On 29-JAN-2021, a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot number reported as 1688504 and expiration date as 19-NOV-2021, had a temperature excursion of -7.9 degrees Celsius (?C) for a time frame of 53 minutes and another temperature excursion of -10.5 degrees Celsius (?C) for a time frame of 52 minutes. It was also reported there was not a previous temperature excursion and digital data logger was not involved. No additional adverse events were reported. On the same day, the patient was vaccinated with the mentioned improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) per oral route for prophylaxis, (formulation, strength, dose, vaccination scheme and anatomical site of vaccination were not provided).

Other Meds:

Current Illness:

ID: 1040518
Sex: M
Age: 1
State: LA

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

Lab Data:

Allergies:

Symptoms: Gardasil 9 was inadvertently administered to a 15 month old child; Gardasil 9 was inadvertently administered to a 15 month old child... MA was supposed to give HIB vaccine, she accidentally gave HPV (Gardasil) instead.; No adverse event experienced; This spontaneous report was been received from a healthcare professional, concerning a 15-month-old male patient. The patient's pertinent medical history, concurrent conditions, and drug reactions/allergies were not provided. On 01-FEB-2021 the patient was supposed to receive a dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (manufacturer unknown), however, the medical assistant accidentally administered to the patient the wrong vaccine and he received a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), 0.5 milliliter, intramuscularly, in the left thigh, lot # T007035 and expiration date 01-MAY-2022, for prophylaxis. On the same date, the patient also received a first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot # S039311, expiration date on 04-DEC-2021, subcutaneously, left arm; a fourth dose of diphtheria toxoid, Hib conj vaccine (tet toxoid), pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (MRC-5), tetanus toxoid (PENTACEL) (Lot # UJ1355AA, expiration date on 26-FEB-2021, intramuscularly, on right thigh; and a fourth dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (Lot # DN4219, expiration date on 31-JAN-2023, intramuscularly, left thigh. After the administration of the wrong vaccine, the family was notified. No laboratory tests were necessary. The parent was informed to monitor the patient and inform to the clinic of any side effects or adverse reaction. At the time of the report, the patient had not experienced any adverse reaction/adverse event. The medical assistant was re-educated. 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: T007035; expirationdate: 01-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability

Other Meds: M-M-R II; PENTACEL; PREVNAR; GARDASIL 9 SYRINGE (DEVICE)

Current Illness:

ID: 1040519
Sex: U
Age:
State:

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 02/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE reported; administered expired dose of M-M-R II.; This spontaneous report was received from a medical director referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies and reactions were not reported. On 04-FEB-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength and route were not provided; lot# was R030806 and expiration date was not provided but upon internal validation as 24-OCT-2020) for prophylaxis (expired product administered). No additional adverse event (AE) reported. This is one of two reports received from same reporter.; Sender's Comments: US-009507513-2102USA003583:

Other Meds:

Current Illness: Prophylaxis

ID: 1040520
Sex: F
Age: 1
State: ND

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 02/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No reaction following the vaccines; The patient was vaccinated with PROQUAD and VARlVAX at the same time; This spontaneous report was received from a physician and refers to a 12 month old female patient. The patient had no known medication allergies, or significant medical history. The patient's concurrent conditions were not reported. On 15-JAN-2021, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # T010651, expiration date 22-SEP-2021 in the right thigh for prophylaxis (dose and route were not reported). On the same date the patient also received a dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S033540, expiration date 22-OCT-2021in the right thigh for prophylaxis (dose and route were not reported). Both vaccines were administered in the private Doctor's office with a private funds. Concomitant therapies included sterile diluent. The physician also reported there was no reaction following the vaccines. On 25-JAN-2021, the patient was in the clinic with fever with a temperature maximum of 103.5 (units not reported) and "Red Macular rash on her torso" that was being treated as "viral otitis media" bilateral (MARRS# 2101USA009289) This is on of two reports regarding the same patient.; Sender's Comments: US-009507513-2101USA009289:Original Case : 2101USA009289

Other Meds: STERILE DILUENT

Current Illness:

ID: 1040521
Sex: M
Age:
State: UT

Vax Date: 07/01/2020
Onset Date: 01/28/2021
Rec V Date: 02/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Bleeding gums; This is an spontaneous report from a contactable consumer based on information received by Pfizer from license party for apixaban (ELIQUIS). This case was received via Pfizer Inc (Reference number: 2021089295) on 28-Jan-2021 and was forwarded to Company on 29-Jan-2021. This spontaneous case was reported by a patient family member or friend and describes the occurrence of gingival bleeding (Bleeding gums) in 82-year-old male patient who received Apixaban (ELIQUIS) for Cerebrovascular accident prophylaxis. Co-Suspect Products included clopidogrel bisulfate (Plavix) for an unknown indication and Covid-19 Vaccine for COVID-19 prophylaxis. Concurrent medical conditions included Diabetes (Diagnosed 40 years ago, type 2), Blood pressure high and Cardiac disorder NOS. In July 2020, the patient started ELIQUIS (unknown route), 5 milligram twice a day. On an unknown date, the patient started Plavix (unknown route) 75 milligram at an unspecified frequency. On 28-Jan-2021, the patient started Covid-19 Vaccine (unknown route). On the same day, the patient experienced gingival bleeding (Bleeding gums). The dose of ELIQUIS(Unknown) and Plavix (Unknown) was not changed. At the time of the report, gingival bleeding was resolving. For ELIQUIS(Unknown), the reporter did not provide any causality assessments. For Plavix(Unknown), the reporter did not provide any causality assessments.

Other Meds:

Current Illness: Blood pressure high; Cardiac disorder NOS; Diabetes (Diagnosed 40 years ago, type 2)

ID: 1040522
Sex: U
Age:
State:

Vax Date: 12/18/2020
Onset Date: 12/23/2020
Rec V Date: 02/19/2021
Hospital:

Lab Data: Test Date: 20201223; Test Name: Body temperature; Result Unstructured Data: (Test Result:100.2,Unit:degree F,Normal Low:,Normal High:); Test Date: 20201223; Test Name: Body temperature; Result Unstructured Data: (Test Result:97.2,Unit:degree F,Normal Low:,Normal High:)

Allergies:

Symptoms: headache; 100.2 temp / temp now 97.2; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On 18th December 2020 14:30, the patient received the 2nd dose of Shingrix. On 23rd December 2020, 5 days after receiving Shingrix, the patient experienced headache and fever. On an unknown date, the outcome of the headache and fever were not recovered/not resolved. It was unknown if the reporter considered the headache and fever to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient had headache and temperature in the morning of date of reporting. The patient had 100.2 temperature after drinking coffee and 97.2 temperature at 12:30. The reporter asked was it reaction to Shingrix.

Other Meds:

Current Illness:

ID: 1040523
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: shingles but early stages; This case was reported by a consumer and described the occurrence of shingles 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, unknown after receiving Shingrix, the patient experienced shingles. 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 reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient just had vaccine shot and unknowingly actually had the Shingles, but early stages so had no idea. The reporter asked should he or she need to be concerned.

Other Meds:

Current Illness:

ID: 1040524
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: abdominal rash; This case was reported by a pharmacist and described the occurrence of rash 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, 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 reported as follows: The patient had no history of allergic reaction. The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The reporter need to know if patient needs to avoid getting the second dose of Shingrix vaccine due to occurence of abdominal rash. The reporter asked should rechallenge occur at doctors office.

Other Meds:

Current Illness:

ID: 1040525
Sex: F
Age:
State: MN

Vax Date: 12/09/2020
Onset Date: 12/01/2020
Rec V Date: 02/19/2021
Hospital:

Lab Data: Test Date: 202012; Test Name: Nuclear antibody; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:); Test Date: 202012; Test Name: Sedimentation rate; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:); Test Date: 202012; Test Name: Sedimentation rate; Result Unstructured Data: (Test Result:21,Unit:unknown,Normal Low:,Normal High:); Test Date: 202012; Test Name: Rheum factor; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:)

Allergies:

Symptoms: Arthritis in her hands and knees; Soreness in both arms; Palpable swelling; Tenderness in the joints; Hands swollen / couldn't grip anything; Ached over; could not grip anything; Immune complex; Serum-sickness like reaction / thinking it's an immune complex; This case was reported by a physician via call center representative and described the occurrence of immune complex reaction in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included general body pain, polymyalgia (a year ago had potential polymyalgia) and colitis microscopic (had microscopic collits from duloxetine). Previously administered products included Duloxetine (received Duloxetine on an unknown date). On 9th December 2020, the patient received the 1st dose of Shingrix. In December 2020, less than a month after receiving Shingrix, the patient experienced immune complex reaction (serious criteria GSK medically significant), serum-sickness like disorder, pain in arm, swelling, joint tenderness, hand swelling, pain and grip strength decreased. On 21st December 2020, the patient experienced arthritis. The patient was treated with prednisone. On an unknown date, the outcome of the immune complex reaction, serum-sickness like disorder, arthritis, pain in arm, swelling, joint tenderness, hand swelling, pain and grip strength decreased were recovering/resolving. It was unknown if the reporter considered the immune complex reaction, serum-sickness like disorder, arthritis, pain in arm, swelling, joint tenderness, hand swelling, pain and grip strength decreased to be related to Shingrix. Additional details were provided as follows: The patient had history of general aches, a year ago worked up for potential polymyalgia and received Duloxetine as a historical drug with microscopic colitis. The age at vaccination was not reported. The reporter stated that, by 21st December 2020 after vaccination, the patient had some soreness in both arms, developed arthritis in right hand, then left hand, then knee; palpable swelling and tenderness in the joints, hands swollen, could not grip anything and ached over a fewdays time. On 28th December 2020, the patient visited physician and diagnosed with serum-sickness like disorder, arthritis and thought it was an immune complex reaction. The patient had sedimentaion rte, nuclear antibody and rheum factor negative. When the patient went to office the sedimentation rate was 21. The patient treated with prednisone and the symptoms were improving. No further details provided at this time. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1040526
Sex: M
Age: 54
State: MI

Vax Date: 12/26/2020
Onset Date: 12/29/2020
Rec V Date: 02/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: feeling like he has shingles in his whole body; severe muscle / pain; joint pain / right shoulder / aching; pain is excruciating / disabling / "jumps around a little bit," / going on for almost a month / still ongoing; his head / aching; intense pain / to both legs / right arm / aching; right kidney "feels like there is a knife in it" / new shooting pain; intense pain from the testicles; is having to wake up every couple of hours to take pills; This case was reported by a consumer and described the occurrence of shingles in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 26th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 29th December 2020, 3 days after receiving Shingrix, the patient experienced shingles, muscle pain, joint pain, general body pain, headache, leg pain, renal pain, testicular pain and poor sleep. The patient was treated with naproxen (Aleve), ibuprofen, prednisone and naproxen. On an unknown date, the outcome of the shingles, muscle pain, joint pain, general body pain, headache, leg pain, renal pain and testicular pain were not recovered/not resolved and the outcome of the poor sleep was unknown. It was unknown if the reporter considered the shingles, muscle pain, joint pain, general body pain, headache, leg pain, renal pain, testicular pain and poor sleep to be related to Shingrix. Additional details were reported as follows: The patient received the vaccine in the upper left arm. The patient experienced severe muscle and joint pain after receiving the vaccine. The pain started 2 to 3 days after getting the vaccine. He stated that the pain was excruciating and disabling. He had intense pain from the testicles down to both legs. He stated that the pain "jumps around a little bit" but reported his head, right shoulder and right arm were aching at the time of report. His right kidney "feels like there was a knife in it" and it was a new shooting pain as of yesterday that was on the right side of the body and both legs. He waked up every couple of hours to take pills. He stated he had taken more ibuprofen and naproxen in the last 20 days than he had in his whole life. He had taken 2 pills of Aleve every 8 hours and had been given prednisone to knock out the pain. He reported that the Aleve was "only knocking half of it out unlike before". He felt like he had shingles in his whole body. He reported being healthy, but the pain had been going on for almost a month and was ongoing The reporter did not consent to follow-up.

Other Meds:

Current Illness:

ID: 1040528
Sex: F
Age:
State:

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 02/19/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Adverse reaction; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed an adverse reaction. The patient's medical history was not provided. Concomitant product use was not provided. On 13 Jan 2021 prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot 041L20A) intramuscularly for prophylaxis of COVID-19 infection. After receiving the vaccine, the patient stated she experienced an adverse reaction. Treatment for the event included hospitalization. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, adverse reaction, was considered unknown.; Reporter's Comments: This case concerns a female patient of unknow age patient received their first of two planned doses of mRNA-1273 (Lot 041L20A) intramuscularly for prophylaxis of COVID-19 infection and developed a serious medically significant unlisted event of adverse reaction. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1040529
Sex: M
Age: 58
State: NY

Vax Date: 12/29/2020
Onset Date:
Rec V Date: 02/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Abscess and tissue necrosis at the injection site; Abscess and tissue necrosis at the injection site; Scarred; A spontaneous report was received from a nurse who is a 58-year-old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed an abscess and tissue necrosis at the injection site and scarred. The patient's medical history was not provided. No concomitant product use was reported. On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Approximately 6 to 7 days after the patient received the Moderna COVID-19 vaccine, the patient had an abscess and tissue necrosis at the injection site. The patient did not require hospitalization and self-treated it with polysporin. On 20 Dec 2020, the patient reported the reaction had not resolved and was now scarred. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, abscess and tissue necrosis at the injection site and scarred, were considered not resolved.; Reporter's Comments: This case concerns a 58 year-old, male patient, who experienced events of an abscess and tissue necrosis at the injection site and scarred. The events occurred 6 days after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.

Other Meds:

Current Illness:

ID: 1040530
Sex: F
Age: 28
State: CA

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 02/19/2021
Hospital:

Lab Data: Test Date: 20210115; Test Name: blood pressure; Test Result: Inconclusive ; Result Unstructured Data: at 11:15am; Test Date: 20210115; Test Name: blood pressure; Test Result: Inconclusive ; Result Unstructured Data: at 11:22am; Test Date: 20210115; Test Name: heart rate; Result Unstructured Data: 95 beats per minute at 11:15am; Test Date: 20210115; Test Name: heart rate; Result Unstructured Data: 121 beats per minute at 11:22am; Test Date: 20210115; Test Name: oxygen saturation; Test Result: 100 %; Result Unstructured Data: at 11:15am; Test Date: 20210115; Test Name: oxygen saturation; Test Result: 99 %; Result Unstructured Data: at 11:22am

Allergies:

Symptoms: Facial edema, oropharyngeal edema; Lip swelling; Throat itching; Tachycardia; A spontaneous report was received from a healthcare professional concerning a 28-year-old female, patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed lips swelling, throat itching, facial edema, and oropharyngeal edema. The patient's medical history was not provided. Concomitant product use was not reported. On 15 Jan 2021, approximately five minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection. On 15 Jan 2021, five minutes after the vaccine was administered, at 11:15am, the patient complained of lip swelling and throat itching. A healthcare provider assessed the patient and vital signs included, pressure 132/103 mmHg, heart rate 95 beats per minute, and 100 percent oxygen saturation. At 11:22am, the patient had facial edema, oropharyngeal edema and attempted to clear her throat. Vital signs reported at that time included, blood pressure 143/106 mmHg, heart rate 121 beats per minute, and oxygen saturation 99 percent. Treatment for the event included diphenhydramine 50mg and epinephrine by injection twice. Emergency services were called to transport the patient, however, the patient declined transport. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, lip swelling, throat itching, facial edema, and oropharyngeal edema, was unknown.; Reporter's Comments: This case concerns a 28 year-old, female patient, who experienced events of lips swelling, throat itching, facial edema, and oropharyngeal edema. The events occurred within minutes after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.

Other Meds:

Current Illness:

ID: 1040531
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Blacked out; Anaphylactic reaction; A spontaneous report was received from a consumer concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic reaction and blacked out. The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On unknown date, after receiving the vaccine, the patient experienced an anaphylactic reaction and blacked out. The patient was placed on a ventilator for the events. Action taken with mRNA-1273 in response to the event was not reported. The outcome for the event, anaphylactic reaction and blacked out, was unknown.; Reporter's Comments: This case concerns a patient of unknown of age and gender. The medical history is not provided. On unknown date after receiving their first of two planned doses of mRNA-1273 (Lot unknown), the patient experienced medically significant events of Anaphylactic reaction and Loss of consciousness. Treatment included placed on a ventilator for the events. Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.

Other Meds:

Current Illness:

ID: 1040532
Sex: U
Age:
State:

Vax Date: 01/28/2021
Onset Date: 01/29/2021
Rec V Date: 02/19/2021
Hospital:

Lab Data: Test Date: 20210129; Test Name: blood pressure; Result Unstructured Data: 77/40

Allergies:

Symptoms: Passed out and was unconscious for approximately 5 minutes; Nausea; Tightening or squeezing sensation of my chest; Tired; Vasovagal event; A spontaneous report was received from a healthcare professional who is the patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tightening or squeezing sensation in my chest, passed out, unconscious for approximately 5 minutes, nausea, vasovagal event and tired. The patient's medical history was not provided. No concomitant product use was reported. On 28 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection. On 29 Jan 2021, at 01:30, the patient reported they started to feel a tightening or squeezing sensation in their chest. On 29 Jan 2021 at 02:30, the patient's symptoms worsened, they reported increased chest tightening and were nauseated. The patient went into their bathroom and "I passed out and ended up on the floor". The patient reported they were unconscious for approximately 5 minutes. The patient's wife called 911 due to chest pains and to rule out a mild heart attack. The patient stated, "all tests came back negative". The patient stated they had a vasovagal event while in the hospital with a blood pressure reading of 77/40. Patient feeling better now, but still tired". Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, tightening or squeezing sensation in my chest, passed out, unconscious for approximately 5 minutes, nausea, vasovagal event and tired, were considered unknown.; Reporter's Comments: This spontaneous report from a healthcare professional of unknown gender who experienced the serious events of unconscious, passed out and tightening or squeezing sensation in my chest and non-serious events of nausea, vasovagal event and tired. The events occurred 1 day after the administration of mRNA-1273 vaccine (Lot number: unknown, expiration date: unknown). Treatment given was not provided and outcome is resolved. Based on the information provided which shows a temporal association a causal association, between the reported events and the administration of mRNA-1273 vaccine cannot be excluded. The events of nausea and fatigue are consistent with the known safety profile of mRNA -1273 vaccine.

Other Meds:

Current Illness:

ID: 1040533
Sex: M
Age:
State: CA

Vax Date: 01/24/2021
Onset Date: 01/25/2021
Rec V Date: 02/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Syncope; Diarrhea; Low pressure; Flu-like symptoms; A regulatory report was received from a consumer concerning a 72-years-old, male patient who received Moderna's COVID-19 Vaccine, and who experienced flu-like symptoms, head went back, eyes went white, jaw move left to right, made a last breath, thought he died, diarrhea and low pressure. The patient's medical history included high blood pressure. Products known to have been used by the patient, within two weeks prior to the event, included Metoprolol succinate. On 24 Jan 2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (042L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 25 Jan 2021, the patient reported flu-like symptoms. Treatment information was not provided. On 26 Jan 2021, the patient reported head went back, eyes went white, jaw move left to right, made a last breath, thought he died, diarrhea and low pressure. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The event, flu-like symptoms was considered recovered/resolved on 25 Jan 2021. The events, head went back, eyes went white, jaw move left to right, made a last breath, thought he died, and diarrhea was considered recovered/resolved on 26 Jan 2021. The outcome of the event low pressure was unknown.; Reporter's Comments: This case concerns a 72 year old male with medical history of hypertension on metoprolol, who experienced a serious unexpected event of syncope and non-serious unexpected events of flu-like symptoms, diarrhea, and low blood pressure. Event onset was 1 day after first dose of mRNA-1273. Flu-like symptoms resolved. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.

Other Meds: SELOKEN ZOK

Current Illness: Blood pressure high

ID: 1040534
Sex: M
Age: 90
State: IN

Vax Date: 12/30/2020
Onset Date: 01/02/2021
Rec V Date: 02/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Mastocytosis symptoms; flare up of Mastocytosis; A spontaneous report was received from a nurse who was also a 90 years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) experienced a flare up of mastocytosis symptoms (mastocytosis and condition aggravated). The patient's medical history included mastocytosis. Products known to have been used by the patient, within two weeks prior to the event, included cimetidine and diphenhydramine hydrochloride. The patient received their first of two planned doses of mRNA-1273 (Lot number 039K20A), intramuscularly, in the left arm on 30 Dec 2020 for prophylaxis of COVID-19 infection. On 02 Jan 2021, 48 hours after vaccination, the patient went to the emergency room (ER) with mastocytosis symptoms including low grade hives, increased heart rate, burning sensation and heat on the skin. The patient had a long history of mastocytosis and carried an ephedrine and diphenhydramine hydrochloride. The ER physician thought the vaccine caused flare up of mastocytosis. The patient was given diphenhydramine hydrochloride and methylprednisolone and sent home. A few days later, the patient had another episode of the same symptoms and went to the ER again on 15 Jan 2021. The physician recommended the patient wait and not get the second shot which was due on 28 Jan 2021. Treatment for the event included diphenhydramine hydrochloride and methylprednisolone. The second dose of mRNA-1273 was temporarily withheld in response to the event. The outcome of the event, flare up of mastocytosis symptoms, was not reported.; Reporter's Comments: This is a 90 year male patient with relevant medical history of mastocytosis which is a confounding factor that may a play contributory role providing an alternative explanation. Further information is requested.

Other Meds: CIMETIDINE; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]

Current Illness: Mastocytosis

ID: 1040535
Sex: M
Age: 65
State: CA

Vax Date: 01/10/2021
Onset Date: 01/11/2021
Rec V Date: 02/19/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Stroke (blood in the brain); heavy legs; not feeling himself; difficulty walking secondary to stroke; Bad Headache; A spontaneous report was received from a consumer concerning a 65-years-old, male patient who experienced bad headache, stroke (blood in the brain), difficulty walking secondary to stroke, heavy legs, and not feeling himself. The patient's medical history included atrial fibrillation (A-Fib) four years ago. 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 blood thinners. On 10 Jan 2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 11 Jan 2021, the patient experienced a headache. On 28 Jan 2021, he reported having a bad headache, heavy legs and was not feeling himself. On 29 Jan 2021, the patient was admitted to the hospital and was told he had a stroke (blood in the brain). Patient was discharged on 02 Feb 2021. He now has difficulty walking and is trying to walk with a walker and has to go to rehab. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The events bad headache, stroke (blood in the brain), difficulty walking secondary to stroke, heavy legs, not feeling himself and headache were resolved on 02 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. Of note, patient's medical history of atrial fibrillation and concomitant use of blood thinners may have been contributory for hemorrhagic stroke.

Other Meds:

Current Illness:

ID: 1040536
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: slight anaphylaxis reaction; difficulty swallowing; swelling at the injection; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced slight anaphylaxis, difficulty swallowing and swelling at the injection. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. Patient called to inquire about the second dose. She stated she had a slight anaphylaxis reaction. When quired for more details regarding her event she mentioned that it was sort of difficulty swallowing, which didn't last long and some swelling at the injection. No treatment information was provided. Action taken with RNA-1273 in response to the event was unknown. The event difficulty in swallowing was considered as resolved. The outcome of the event slight anaphylaxis and swelling at the injection was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1040537
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 2nd dose is overdue; A spontaneous report was received from a patient of an unknown age who received Moderna's COVID-19 Vaccine (mRNA-1273) and 2nd dose of Moderna vaccine was overdue. The patient's medical history was not provided. The patient reported recently moved to an area where they just started giving 1st dose of Moderna whereas mine 2nd dose was overdue. The date for when the patient received their first of two planned doses of mRNA-1273 (Batch number: not given) intramuscularly for prophylaxis of COVID-19 infection was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The event was considered resolved on an unknown date.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273. There were no reported adverse events associated with this case.

Other Meds:

Current Illness:

ID: 1040538
Sex: M
Age: 50
State: TN

Vax Date: 01/31/2021
Onset Date:
Rec V Date: 02/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Significant cellulitis on his left shin and foot; Anorexia/lack of appetite; Abdominal pain; Diarrhea; Fever; Chills; Fatigue/frequently had to lay in bed; A spontaneous report was received from a physician concerning a 50-year-old, White, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, chills, abdominal pain, anorexia/lack of appetite, diarrhea, fatigue/frequently had to lay in bed, and cellulitis on his left shin and foot. The patient's medical history was not provided. No concomitant medications were reported. On 31 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date, the patient experienced fever, chills, abdominal pain, anorexia/lack of appetite, diarrhea, fatigue/frequently had to lay in bed, and cellulitis on his left shin and foot. The patient took paracetamol and naproxen for the events, which somewhat helped. Action taken with mRNA-1273 in response to the events was not provided. The events, fever, chills, abdominal pain, anorexia/lack of appetite, diarrhea, fatigue/frequently had to lay in bed, were considered resolved on an unknown date. The outcome for the event, cellulitis on his left shin and foot, was reported as not resolved.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. Cellulitis of shin and foot is unlikely related to mRNA-1273.

Other Meds:

Current Illness:

ID: 1040539
Sex: U
Age:
State: MA

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 02/19/2021
Hospital:

Lab Data: Test Date: 20210122; Test Name: Bloodwork; Result Unstructured Data: confirmed Bell's Palsy; Test Date: 20210122; Test Name: Bloodwork; Result Unstructured Data: confirmed Bell's Palsy; Test Date: 20210122; Test Name: MRI; Result Unstructured Data: confirmed Bell's Palsy

Allergies:

Symptoms: Bell's Palsy; Tongue started tingling; A spontaneous report was received from a healthcare professional concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Bell's Palsy and tongue started tingling. The patient's medical history was not provided. No relevant concomitant medications were reported. On 21 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 22 Jan 2021, within two days after injection, the patient's tongue started tingling. On 23 Jan 2021, the patient spent 18 hours in the emergency room. Two MRIs (magnetic resonance imaging) and bloodwork were conducted, they confirmed the patient had Bell's Palsy on the left side of the face. On 27 Jan 2021, the patient's tongue began tingling again and had not resolved at the time of reporting. Treatment for the events was not provided. Action taken the second dose of mRNA-1273 in response to the events was not reported. The event, tongue started tingling, was reported as not resolved. The outcome for the event, Bell's Palsy, was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Based on 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: 1040540
Sex: F
Age:
State:

Vax Date: 02/03/2021
Onset Date:
Rec V Date: 02/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Major dementia type symptoms; A spontaneous report was received from a consumer concerning an elderly, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed some major dementia type symptoms/dementia. The patient's medical history was not provided. Concomitant medication history was not provided. On 03 Feb 2021, prior to the onset of the events, the patient received their dose of mRNA-1273 (lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. The reporter stated that the patient have been having some real major dementia type symptoms that were new for her (Onset date not provided). Treatment for this event was not provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, major dementia type symptoms/dementia was 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 event, a causal relationship cannot be excluded. However, the patient's age is a risk factor and confounds causality assessment.

Other Meds:

Current Illness:

ID: 1040541
Sex: F
Age: 85
State: OH

Vax Date: 01/23/2021
Onset Date: 01/25/2021
Rec V Date: 02/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Debilitating Stroke; Affecting the left side of her body; A spontaneous report was received from a consumer concerning an 85-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced debilitating stroke (cerebrovascular accident), affecting the left side of her body (hemiplegia). The patient's medical history was not provided. No concomitant medications were reported. On 23 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly for prophylaxis of COVID-19 infection. On 25 Jan 2021, the patient experienced debilitating stroke, affecting the left side of her body. Treatment information was not provided. The reporter stated that the patient was now in hospice care. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the events, debilitating stroke, affecting the left side of her body, was unknown.; Reporter's Comments: This case concerns a 85-year-old, female patient who experienced debilitating cerebrovascular accident and hemiplegia 3 days after the first dose of mRNA-1273 (Lot number: 029L20A). Very limited information regarding this event has been provided at this time. Further information regarding patient's medical history and comorbidities has been requested.

Other Meds:

Current Illness:

ID: 1040542
Sex: M
Age:
State: IL

Vax Date: 12/24/2020
Onset Date:
Rec V Date: 02/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Psychosis; Pain in the back of eyes; Weakness; Chills; Muscle pains/ Myalgia; A spontaneous report was received from a consumer concerning a male patient of an unknown age who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed psychosis, pain in the back of his eyes, chills, myalgia, and weakness. The patient's medical history included schizoaffective bipolar disorder. Products known to have been used by the patient, within two weeks prior to the event, included paliperidone. The patient received their first of two planned doses of mRNA-1273 (batch number not provided) on 24 Dec 2020. On 21 Jan 2021, an unknown amount of time prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On 27 Jan 2021, the patient received paliperidone. On an undisclosed date, the patient experienced pain in the back of his eyes, felt a chill, muscle pains, and weakness. The patient had been diagnosed with schizoaffective bipolar disorder and was missing at the time of the report. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable because the patient had received both doses. The outcome of the events psychosis, pain in the back of his eyes, chills, myalgia, and weakness, was not reported.; Reporter's Comments: This case concerns a male patient of an unknown age who experienced a medically important event of psychosis, and in addition non-serious events of pain in the back of his eyes, chills, myalgia, and weakness. Based on the current information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded, however the patient's history of schizoaffective bipolar disorder is a strong confounder for the event of psychosis. The case is lost to follow-up as Consumer did not give consent to follow-up.

Other Meds: PALIPERIDONE

Current Illness: Bipolar disorder (Schizoaffective)

ID: 1040543
Sex: U
Age:
State: NM

Vax Date:
Onset Date:
Rec V Date: 02/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: vaccine to a 16 year old patient; A spontaneous report was received from a pharmacist concerning a 16 year old patient who was administered a COVID vaccine at an inappropriate age. The pharmacist wants to know how to manage this situation. The patient's medical history was not provided. Concomitant medication details were not reported. On an unreported date, The patient received their first of two planned doses of mRNA-1273 (Batch number: 030L20A) on 05/Feb/2021 intramuscularly for prophylaxis of COVID-19 infection. On an unreported date, 16 year old patient who was administered a COVID vaccine at an inappropriate age. The pharmacist wants to know how to manage this situation. Treatment information was not provided. Action taken with mRNA-1273 in response to the event(s) was not applicable. The event was considered resolved on an unreported date.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # 030L20A with no associated AEs.

Other Meds:

Current Illness:

ID: 1040544
Sex: M
Age: 38
State: MO

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 02/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Patients arm on the injection site was red; Patients arm on the injection site was swollen; vaccinated subcutaneous and not intramuscular; A spontaneous report was received from a consumer concerning a 38-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and was vaccinated subcutaneous route, and experienced injection site red and swollen. The patient's medical history was not provided. No relevant concomitant medications were reported. On 25 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) subcutaneously in the arm for prophylaxis of COVID-19 infection. On 25 Jan 2021, the patient reported that they were vaccinated subcutaneous and not intramuscular. On 27 Jan 2021, the patient's arm on the injection site was red and swollen. No treatment information was provided. Action taken with second dose of mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated subcutaneous and not intramuscular, was considered resolved on 25 Jan 2021. The outcome of events injection site red and swollen were unknown.; Reporter's Comments: This case concerns a 38-year-old female patient (gender to be clarified) who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect route of product administration and associated non-serious adverse events of Injection site erythema and Injection site swelling. Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1040545
Sex: F
Age:
State: NY

Vax Date: 01/13/2021
Onset Date: 02/08/2021
Rec V Date: 02/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Neuropathy (tingling and burning in the feet and legs); A spontaneous report was received from a consumer, regarding herself, a female patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced neuropathy (tingling and burning in the feet and legs). The patient's medical history was not provided. Concomitant product use was not provided. On 13 Jan 2021, prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273 (lot number: unknown) for prophylaxis of COVID-19 infection. On 13 Jan 2021, after the first dose of mRNA-1273 vaccine, the patient noted neuropathy (tingling and burning in the feet and legs). Was inquiring whether this will recur after the second injection. Treatment information was not provided. Action taken with mRNA-1273 in response to event was not reported. The outcome of the event, neuropathy (tingling and burning in the feet and legs) was unknown at the time of this report.; 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. Further information has been requested.

Other Meds:

Current Illness:

ID: 1040546
Sex: M
Age:
State: IL

Vax Date: 01/12/2021
Onset Date: 02/06/2021
Rec V Date: 02/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: bell's palsy; A spontaneous report was received from a healthcare professional (HCP) concerning a 56-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's Palsy/facial paralysis. The patient's medical history was not provided. Concomitant products known to have been used by the patient, within two weeks prior to the event, included valsartan, insulin, insulin degludec, rosuvastatin, and acetylsalicylic acid. On 12 Jan 2021, prior to the onset of the events, the patient received their dose of mRNA-1273 (lot number: 06L20A) intramuscularly in his left arm for prophylaxis of COVID-19 infection. The patient experienced Bell's Palsy on 25 Jan 2021. Treatments of these events were not provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, Bell's Palsy/facial paralysis was 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 event, a causal relationship cannot be excluded. .

Other Meds: VALSARTAN; INSULIN; TRESIBA; ROSUVASTATIN; BABY ASPIRIN

Current Illness:

ID: 1040547
Sex: F
Age: 21
State: TX

Vax Date: 02/06/2021
Onset Date: 02/07/2021
Rec V Date: 02/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Mini seizures; Body chills; A spontaneous report was received from a consumer, concerning herself, a 21-year-old female patient, who received Moderna's COVID-19 vaccine and experienced mini seizures and some chills. The patient's medical history reported includes seizures. Concomitant product use was not provided by the reporter. On 06-FEB-2021, prior to the onset of events, the patient received her second of two planned doses of mRNA-1273 (lot number unknown) intramuscularly for the prophylaxis of covid-19 infection. On an unspecified date in Jan-2021, the patient received her first dose of vaccine and on 07-FEB-2021, a day after the second dose of vaccine, patient experienced some chills and mini seizures. Treatment information was not provided Action taken with mRNA-1273 in response to the events were not reported. The outcome of the events, mini seizures and some chills were considered unknown at the time of this report.; Reporter's Comments: Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded, however, patient's history of seizure is a confounding factor that may a possible contributory role. Further information has been requested.

Other Meds:

Current Illness:

ID: 1040548
Sex: F
Age: 47
State: WA

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 02/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Injection site weakness; IInjection site feeling muscles are inflamed; Shoulders got stuck, couldn't move left arm; Whole body, jaw, neck, teeth were very sore; Feeling stiff; Tendons in the gums hurt / teeth feels it's going to fall out of head; Injection site itchiness; Exacerbation of Lupus; Serum sickness; Delayed hypersensitivity; Chills; Fatigue; Injection area tenderness; A spontaneous report was received from a nurse who was also a forty-seven-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced exacerbation of Lupus, delayed hypersensitivity, serum sickness, injection site itchiness , chills, fatigue, injection site weakness, injection site feeling muscles were inflamed, shoulders got stuck/ couldn't move arm, whole body, jaw, neck, teeth were very sore , tendons in gum hurt/ teeth feels it's going to fall out of head, feeling stiff, and injection area tenderness. The patient's medical history, as provided by the reporter, included Lupus. Concomitant medications reported included hydroxychloroquine sulfate. The patient received their first of two planned doses of mRNA-1273 (Batch number 037K20A) on 07 Jan 2021 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 07 Jan 2021, the patient experienced minor injection area tenderness, chill, and fatigue. On 09 Jan 2021, the injection area tenderness, chill, and fatigue resolved. On 15 Jan 2021, the patient experienced an exacerbation of lupus, delayed hypersensitivity, and serum sickness. On an undefined date, the patient's symptoms initially started at the injection site at the left deltoid as itchiness, weakness ? feeling muscles were inflamed. Her shoulders got stuck, couldn't move left arm. Injection site was not red. Whole body, jaw, neck, teeth were very sore. The tendons in the gums hurt. The patient was now stiff but could move things and could eat. ?Teeth still felt it's going to fall out of my head.' The patient had yellow fever vaccine in 2005 and had a similar reaction; she thought it was serum sickness. She also reported that she gets annual flu shot and tetanus/ diphtheria/ pertussis vaccines and never had issues with those. No treatment information was provided. Action taken with RNA-1273 in response to the event was unknown. The outcome of the events exacerbation of lupus, delayed hypersensitivity, serum sickness, injection site itchiness, injection site weakness, injection site feeling muscles were inflamed, shoulders got stuck/ couldn't move arm, whole body, jaw, neck, teeth were very sore, tendons in gum hurt/ teeth feels it's going to fall out of head, and feeling stiff, was unknown. The outcome of the events chills, fatigue and injection site tenderness, was resolved on 09 Jan 2021.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Additional information has been requested. 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: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]

Current Illness:

ID: 1040549
Sex: M
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 02/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Bleeding in his gut; A spontaneous report was received from a consumer, male patient of unknow age, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced bleeding in his gut (gastrointestinal haemorrhage). The patient's medical history was not reported. No concomitant medications were reported. On an unknown date, prior to the onset of event, the patient received their second planned dose of mRNA-1273 (batch number: unknown), for the prophylaxis of COVID-19 infection. On an unknown date, the patient stated that he was bleeding in his gut, but he had the symptoms before receiving the vaccine. The patient got disconnected during call and was unavailable during call back. No treatment medication information was provided Action taken with second dose of mRNA-1273 in response to the event was not applicable. The outcome of the event, bleeding in his gut, was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1040550
Sex: F
Age:
State: VA

Vax Date:
Onset Date:
Rec V Date: 02/19/2021
Hospital:

Lab Data: Test Name: Body Temp; Result Unstructured Data: Test Result:102.6; Test Name: Body Temp; Result Unstructured Data: Test Result:101.6

Allergies:

Symptoms: Sore arm; fever 102.6/ 101.6; body aches; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received first dose of BNT162B2 on an unspecified date. The patient experienced sore arm, fever 102.6/ 101.6, body aches on an unspecified date after 2nd dose of COVID 19 vaccine. The event outcome was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1040551
Sex: M
Age:
State: CA

Vax Date: 01/23/2021
Onset Date:
Rec V Date: 02/19/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: nauseous; He's having some episodes of going on in his head almost like a headache, hard to explain what's going on; He's having some episodes of going on in his head almost like a headache, hard to explain what's going on; This is a spontaneous report from a contactable consumers (patient's wife and patient). An 81 year old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263), via an unspecified route of administration on 23Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included bleeding ulcer and stent put in my heart valve. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN) and acetylsalicylic acid, clopidogrel bisulfate (CLOPID-AS [ACETYLSALICYLIC ACID;CLOPIDOGREL BISULFATE]). On an unspecifed date, the patient's wife reported that her husband: He's having some episodes of going on in his head almost like a headache, hard to explain what's going on. Also nauseous, with the heart specialist told him to take probiotics with his medicine. He was hospitalized on January 7-11. He is on 81mg low dose aspirin, Clopidogrel 75mg daily medication. Prior to that week before Nov2007 he had a reaction to the aspirin and was hospitalized because it gave him a bleeding ulcer. The patient was hospitalized for the events on an unspecified date. Outcome of the events was unknown.

Other Meds: BABY ASPIRIN; CLOPID-AS [ACETYLSALICYLIC ACID;CLOPIDOGREL BISULFATE]

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm