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: 1407251
Sex: F
Age: 47
State:

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Headache, Myalgia, Fever & NauseaVomiting Narrative:

Other Meds:

Current Illness:

ID: 1407253
Sex: F
Age: 53
State:

Vax Date: 01/22/2021
Onset Date: 01/23/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Myalgia FEVER, Left arm the night of vaccination, then body aches, feverish, lethargic and 1/24 started with left axillary pain; symptoms are slowly improving Narrative

Other Meds:

Current Illness:

ID: 1407257
Sex: M
Age: 50
State:

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: NauseaVomiting Narrative:

Other Meds:

Current Illness:

ID: 1407259
Sex: F
Age: 42
State:

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

Lab Data:

Allergies:

Symptoms: Myalgia, Fever, no appetite Narrative:

Other Meds:

Current Illness:

ID: 1407261
Sex: M
Age: 35
State:

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

Lab Data:

Allergies:

Symptoms: chills, fatigue Narrative:

Other Meds:

Current Illness:

ID: 1407270
Sex: F
Age: 52
State:

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

Lab Data:

Allergies:

Symptoms: Arthralgia severe arm pain, Narrative:

Other Meds:

Current Illness:

ID: 1407272
Sex: F
Age: 33
State:

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Myalgia, Fever, chills Narrative:

Other Meds:

Current Illness:

ID: 1417138
Sex: M
Age: 57
State:

Vax Date: 01/20/2021
Onset Date: 01/21/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: FATIGUE, HA, CHILLS, JOINT PAIN, TENDER LOCAL LYMPH NODE TO SIDE OF INJ, PAIN INJ SITE, COUGH, SOB, SORETHROAT, LOSS OF TASTE/SMELL,

Other Meds:

Current Illness:

ID: 1417141
Sex: M
Age: 27
State:

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

Lab Data:

Allergies:

Symptoms: Headache, Myalgia, Fever, cold, chills, super tired, right arm sore Narrative:

Other Meds:

Current Illness:

ID: 0980324
Sex: M
Age:
State: PR

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 01/28/2021
Hospital:

Lab Data: Test Date: 20210104; Test Name: Nasal Swab/Ag; Test Result: Negative ; Test Name: Nasal Swab/PCR; Result Unstructured Data: Test Result:unknown result; Test Date: 20210107; Test Name: Nasal Swab/PCR; Test Result: Negative

Allergies:

Symptoms: mild headache; mild rash; mild stomach upset; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration (left arm) on 15Jan2021 13:30 at single dose for Covid-19 immunization. The patient's medical history included asthma and allergic rhinitis; no known allergies. Concomitant medications included guaifenesin (ROBITUSSIN), levosalbutamol (LEVALBUTEROL), azelastine hcl, and unspecified vitamin (reported as "vit"). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 (15:45), the patient experienced mild adverse events reported as headache, mild rash within approximately 8 hours after vaccination, mild stomach upset in the morning after vaccination. The patient was treated with 10 mls Benadryl and chamomile tea on 16Jan2021 "mor". The patient has been tested for COVID-19 post vaccination (unspecified date) with unknown result. The patient had been tested for Covid with Nasal Swab on 01Jan2021 (Ag) and on 07Jan2021 (PCR) both with negative result. The outcome of events was recovered on an unspecified date in Jan2021.

Other Meds: ROBITUSSIN [GUAIFENESIN]; LEVALBUTEROL [LEVOSALBUTAMOL]; AZELASTINE HCL

Current Illness:

ID: 0980326
Sex: U
Age:
State: KS

Vax Date: 12/11/2020
Onset Date: 12/11/2020
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE details; Nurse called to report temperature excursion; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. On 11-DEC-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB), 0.5 milliliter for prophylaxis (lot # T014835 with expiration date of 17-JUL-2021 is an invalid lot Number for hepatitis b vaccine (recombinant)(RECOMBIVAX HB). Lot # T014835 with expiration date of 17-JUL-2021 is a valid lot Number for Hepatitis A Vaccine, Inactivated(VAQTA)). The vaccine experienced temperature below 2 degrees Celsius(C) (1.3 C) for 0 hours 24 minutes, time frame below 2?C (1.3 C) for 0 hours 24 minutes. Previous temperature excursi?n below 2 C (1.6C) for 24 minutes Digital data logger was involved.

Other Meds:

Current Illness:

ID: 0980327
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Transmission of drug via semen; This spontaneous report was received from the patient's and refers to a female patient of unknown age. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. On an unknown date, the patient was exposed to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) via his husband's semen(exposure via body fluid). ; Sender's Comments: US-009507513-2101USA001097: US-009507513-2012USA013606:

Other Meds:

Current Illness:

ID: 0980328
Sex: U
Age:
State: AZ

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: The patient did not have any other adverse events; The patient received a dose of GARDASIL 9 on 13-JAN-2021. The dose received had an expiration date of 12-DEC-2020; This spontaneous report has been received from a an administrator, concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant therapies were not reported. On 13-JAN-2021, the patient was vaccinated with 1 dose of an expired HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccine (exact dose, route of administration, anatomical location and vaccine scheme were not provided; lot number R011630 has been verified to be a valid lot number, expiration date was reported and established on 12-JAN-20210), as prophylaxis (expired product administered). The patient did not have any other adverse events. 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. device lotnumber: R011630; expirationdate: 12-DEC-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability

Other Meds: GARDASIL 9 SYRINGE (DEVICE)

Current Illness:

ID: 0980329
Sex: F
Age: 19
State: AZ

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

Lab Data: Test Date: 20210119; Test Name: Pregnancy test; Test Result: Positive

Allergies:

Symptoms: No additional adverse event; Caller confirmed that the consumer was found to be pregnant after the vaccine was administered; This spontaneous report was received from a nurse prescriber regarding a 19-year-old female patient. The patient's concurrent conditions, drug reactions, allergies, and concomitant therapies were not provided. Her medical history include a child birth. On 19-JAN-2021, the patient received the second dose in the three dose series of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) intramuscular (lot number S028738 has been verified to be a valid lot number, with expiration date reported and established as 03-MAR-2022) as prophylaxis. On the same day, after the vaccine administration, it was found that the patient was pregnant by a office positive pregnancy test performed (exposure during pregnancy).Moreover, it was confirmed that the patient last menstrual period was one month ago (19-DEC-2020). The patient's due date was reported as 25-SEP-2021, her gestion period was four weeks, the pregnancy outcome was pending, and the fetal outcome was unknown. Also, a gonorrhea and chlamydia test were performed but result the results were pending. 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: S028738; expirationdate: 03-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability

Other Meds: GARDASIL 9 SYRINGE

Current Illness:

ID: 0980330
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Pneumovax did not work; This spontaneous report has been received from the patient's daughter, via Pfizer (Manufacturer control #2021030235), concerning a female patient of unknown age. The patient's concurrent conditions, pertinent medical history, and concomitant medications were not reported. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot #, expiration date, dose, and route of administration were not provided) as prophylaxis. However, it was reported that it did not work (Drug ineffective). Therefore, she had to take the other one (unspecified). The causal assessment between drug ineffective and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported.

Other Meds:

Current Illness:

ID: 0980331
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 12/21/2020
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: She missed to take her fourth dose of Vivotif which was due on yesterday; Spontaneous report received on 22DEC2020. A female consumer reported that "she missed to take her fourth dose of Vivotif which was due on yesterday" (PT: Product dose omission issue). She was receiving Vivotif for immunisation. It was reported that the consumer had taken the first three doses of Vivotif as per the schedule but missed to take the fourth dose of Vivotif which was due on 21DEC2020. Action taken with Vivotif with respect to reported event was not applicable. The outcome of the reported event was unknown. Company Comment: It was reported that a consumer missed to take her fourth dose of Vivotif (missed dose). Vivotif dose should be taken every other day, and the causality of missed dose is not applicable to Vivotif considering the nature of the event.; Sender's Comments: It was reported that a consumer missed to take her fourth dose of Vivotif (missed dose). Vivotif dose should be taken every other day, and the causality of missed dose is not applicable to Vivotif considering the nature of the event.

Other Meds:

Current Illness:

ID: 0980332
Sex: F
Age: 43
State: MT

Vax Date: 12/22/2020
Onset Date: 12/26/2020
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Completed the course of Vivotif in an inappropriate schedule as she took the second dose of vivotif on day 5; Spontaneous report received on 26DEC2020. A 43-year-old adult female consumer reported that she "missed her second dose of Vivotif" (PT: Product dose omission issue). She was receiving Vivotif (lot number: 3003330 and expiry date: DEC2020) for immunisation for typhoid. On 22DEC2020, she took her first dose of Vivotif. On 26DEC2020, she reported that she missed to take her second dose of Vivotif. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown. Company Comment: A consumer missed her second dose of Vivotif (missed dose) on the scheduled date. Further details of the event is limited. Vivotif doses should be taken every other day. Considering the nature of the event, the causality of missed dose is not applicable to Vivotif. Follow up information was received on 05JAN2021. Previously reported event was updated. It was reported that the consumer "Completed the course of Vivotif in an inappropriate schedule as she took the second dose of vivotif on day 5" (PT: Inappropriate schedule of product administration). On 26DEC2020, she took her second dose of Vivotif and took her third and fourth dose of Vivotif on 28DEC2020 and 30DEC2020 respectively. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown. Company Comment: It was reported that a consumer completed the course of Vivotif in an inappropriate schedule as she took the second dose of vivotif on day 5 (Inappropriate schedule of product administration). This consumer missed her second dose of Vivotif on the scheduled date and took it on day 5 instead of day 3, and then completed the remaining course. Vivotif doses should be taken every other day, and considering the nature of the event, the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif. ; Sender's Comments: It was reported that a consumer completed the course of Vivotif in an inappropriate schedule as she took the second dose of vivotif on day 5 (Inappropriate schedule of product administration). This consumer missed her second dose of Vivotif on the scheduled date and took it on day 5 instead of day 3, and then completed the remaining course. Vivotif doses should be taken every other day, and considering the nature of the event, the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif.

Other Meds:

Current Illness:

ID: 0980333
Sex: F
Age: 31
State: MN

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

Lab Data:

Allergies:

Symptoms: Realized that the dose of Vivotif that she took yesterday had expired back in November; Spontaneous report received on 29DEC2020. A 31-year-old female pharmacist "realized that the dose of Vivotif that she took yesterday had expired back in November" (PT: Expired product administered). She was receiving Vivotif (expiry date: NOV2020) for immunisation. On 28DEC2020, she took her first dose of Vivotif. Later, she realized that the dose of Vivotif she took had been expired back in NOV2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown. Company Comment: A consumer took first dose of Vivotif and the next day, she realized it was expired about a month ago (expired product administered). Further details of the event is limited. Considering the nature of the event, the causality of expired product administered is not applicable to Vivotif.; Sender's Comments: A consumer took first dose of Vivotif and the next day, she realized it was expired about a month ago (expired product administered). Further details of the event is limited. Considering the nature of the event, the causality of expired product administered is not applicable to Vivotif.

Other Meds:

Current Illness:

ID: 0980334
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: made my son sick; regress in language; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced sickness and language disorder. On an unknown date, the outcome of the sickness and language disorder were unknown. It was unknown if the reporter considered the sickness and language disorder to be related to Meningococcal B vaccine. Additional information was provided as follows: The case was reported by patient's parent. The age at vaccination was not reported. The reporter stated that this vaccine made patient sick and regress in language for months, definitely not good for the brain.

Other Meds:

Current Illness:

ID: 0980335
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: was in severe pain; spiked a high temp; Could not walk or raise her arms; Could not walk; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced pain, high temperature, mobility decreased and unable to walk. Meningococcal B vaccine was discontinued. On an unknown date, the outcome of the pain, high temperature, mobility decreased and unable to walk were recovered/resolved. It was unknown if the reporter considered the pain, high temperature, mobility decreased and unable to walk to be related to Meningococcal B vaccine. Additional details were provided as follows: The reporter was patient's mother. The age at vaccination was not reported. The patient was vaccinated with Meningitis B vaccine and experienced severe side effects. The patient had a high temperature, severe pain, and could not walk or raise her arms for 4 days. The reporter stated the pediatrician did not seem surprised and he cancelled the second shot. No further information was provided.

Other Meds:

Current Illness:

ID: 0980336
Sex: U
Age:
State: IL

Vax Date: 02/11/2020
Onset Date:
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: low fetal heart tones; Fetal exposure during pregnancy; This prospective pregnancy case was reported by a nurse and described the occurrence of fetal heartbeat absent in a patient exposed to Men B NVS (Bexsero) (batch number ABXA14AB, expiry date 30th March 2021) in utero. The mother received the product for prophylaxis. Co-suspect product exposures included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe, Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 4MA5A, expiry date 30th June 2020), ceftriaxone (batch number JR6214, expiry date 28th February 2022) and azithromycin. The parent's medical history included Had medical history of attention deficite hyperactivity disorder in 2011 and obesity in 2017. On 11th February 2020, the 18-year-old mother received Bexsero .5 ml, Bexsero Pre-Filled Syringe Device and FluLaval Tetra 2019-2020 season (intramuscular) .5 ml. On 20th February 2020, the mother started ceftriaxone (intramuscular) 250 mg at an unknown frequency and azithromycin (oral) 1 g at an unknown frequency. The mother's last menstrual period was on 16th October 2019 and estimated date of delivery was 22nd July 2020. The patient was exposed to Bexsero at week 15 of gestation. The action taken with ceftriaxone was unknown. The action taken with azithromycin was unknown. The patient was diagnosed with fetal heartbeat absent and fetal exposure during pregnancy. On an unknown date, the outcome of the fetal heartbeat absent and fetal exposure during pregnancy were unknown. It was unknown if the reporter considered the fetal heartbeat absent to be related to Bexsero, Bexsero Pre-Filled Syringe Device and FluLaval Tetra 2019-2020 season. See case US2020AMR026586 for details regarding the mother case. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient's parent received Bexsero, Flulav tetra 2019-2020 season), ceftriaxone and azithromycin during pregnancy which led to fetal exposure during pregnancy. The patient's parent visited emergency room due to decreased fetal heart tones.

Other Meds: AZITHROMYCIN; CEFTRIAXONE

Current Illness:

ID: 0980337
Sex: U
Age: 60
State: AL

Vax Date: 12/14/2020
Onset Date: 12/01/2020
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: injection site was red; injection site / very hot to the touch; This case was reported by a consumer and described the occurrence of injection site erythema in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. On 14th December 2020, the patient received the 1st dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. The patient was treated with non-drug therapy (Ice Pack (No Medication)) and analgesic, nos (Analgesics). On an unknown date, the outcome of the injection site erythema and injection site warmth were unknown. It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix. Additional details were provided as follows: After receiving Shingrix and last night the patient's injection site was red and very hot to the touch. The patient used an ice pack for comfort.

Other Meds:

Current Illness:

ID: 0980338
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: developed shingles a couple of days later; This case was reported by a other health professional 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, several days 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 provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. Couple of days after receiving Shingrix, the patient developed shingles.

Other Meds:

Current Illness:

ID: 0980339
Sex: U
Age:
State:

Vax Date: 11/01/2020
Onset Date:
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: took the bandaid off / red; took the bandaid off / swollen; took the bandaid off / hot; Hurt when touched; This case was reported by a consumer and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site warmth and injection site tenderness. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were recovered/resolved and the outcome of the injection site tenderness was not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth and injection site tenderness to be related to Shingrix. Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. The next day after receiving Shingrix, the patient took the band aid off and it was red and swollen and amp, hot the exact length and width of the band aid. The patient stated that, it lasted a little over a week spreading out and lighter than the original area. The patient reported that, it hurt when touched but it did not inconvenience him/her in any way. The patient was concerned about his/her next injection due in May and asking if he/she should still receive the 2nd injection. The patent went back to showed it to pharmacist after about a week and a couple of days after receiving Shingrix.

Other Meds:

Current Illness:

ID: 0980340
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Arms were so sore; This case was reported by a consumer and described the occurrence of pain in arm in a adult female patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, 1 day after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be possibly related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: Age at vaccination was not reported. The patient reported that the patient rolled over the morning after receiving vaccine, the patient's arm was sore. This is 1 of 4 cases reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2020AMR252430:same reporter US-GLAXOSMITHKLINE-US2020AMR252429:same reporter US-GLAXOSMITHKLINE-US2020AMR252428:same reporter

Other Meds:

Current Illness:

ID: 0980341
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Could barely stand up; so tired; Had chills; Her whole body hurt for days; Diraheaa; This case was reported by a consumer via interactive digital media and described the occurrence of difficulty in standing in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced difficulty in standing, tiredness, chills, generalized aching and diarrhea. On an unknown date, the outcome of the difficulty in standing, tiredness, chills, generalized aching and diarrhea were unknown. It was unknown if the reporter considered the difficulty in standing, tiredness, chills, generalized aching and diarrhea to be related to Meningococcal B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient could barely stand up and was so tired, chills and her whole body hurt for days after taking this shot. No further information was provided.

Other Meds:

Current Illness:

ID: 0980342
Sex: F
Age: 65
State: NY

Vax Date: 09/18/2020
Onset Date:
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Fever; Myalgia; Not feeling very sick/sick; Needed someone to help her to the commode and take care of her; sick; . This case was reported by a physician and described the occurrence of fever in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number JC55P, expiry date unknown) for prophylaxis. On 18th September 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 fever, myalgia, feeling unwell, walking difficulty and sickness. On an unknown date, the outcome of the fever, myalgia, feeling unwell, walking difficulty and sickness were recovered/resolved. It was unknown if the reporter considered the fever, myalgia, feeling unwell, walking difficulty and sickness to be related to Shingrix. Additional details were reported as follows: The reported batch number GC55P for Shingrix did not exist and was updated to JC55P as per the sales database. The the patient did not had immediate reactions but later told the doctor that she had experienced fever, myalgia and not feeling very sick for 3 days after the vaccine was administered. She was so sick that she needed someone to help her to the commode and take care of her. Consented to follow up.

Other Meds:

Current Illness:

ID: 0980343
Sex: F
Age:
State: IL

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

Lab Data:

Allergies:

Symptoms: Felt tired; This case was reported by a consumer and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (years before reporting). Previously administered products included Zostavax (negative history for immunization with Zostavax (she never got the live shingles vaccine)). In July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved. The reporter considered the tiredness to be related to Shingrix. Additional information was provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient stated that she didn't feel much with the first shot. She said she felt tired but it resolved within 24 hours. The reporter did not want to answer any further questions. For tolerance of 2nd dose, refer case US2020AMR249357.; Sender's Comments: US-GLAXOSMITHKLINE-US2020AMR249357:Same reporter

Other Meds:

Current Illness:

ID: 0980344
Sex: F
Age: 61
State: IA

Vax Date: 09/23/2020
Onset Date: 09/23/2020
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: sometimes wakes her up at night; Localized Muscle Pain at her injection site; This case was reported by a other health professional and described the occurrence of injection site muscle pain in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 5DK5E, expiry date 31st March 2022) for prophylaxis. On 23rd September 2020, the patient received Shingrix (intramuscular). On 23rd September 2020, less than a day after receiving Shingrix, the patient experienced injection site muscle pain. On an unknown date, the patient experienced middle insomnia. On an unknown date, the outcome of the injection site muscle pain and middle insomnia were unknown. It was unknown if the reporter considered the injection site muscle pain and middle insomnia to be related to Shingrix. Additional details were reported as follows: The patient received dose of Shingrix and experienced localized muscle pain at her injection site. The patient felt pain when she does a pushup and it sometimes wakes up at night. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 0980345
Sex: F
Age:
State: NY

Vax Date: 12/15/2020
Onset Date: 12/15/2020
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: right arm weakness; right arm pain / increased pain with swimming / arm pain escalated to sharp shooting pain; arm pain and weakness has left her unable to swim; This case was reported by a nurse via call center representative and described the occurrence of weakness of arms in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB09AZ, expiry date 31st March 2022) for prophylaxis. Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis. On 15th December 2020, the patient received the 1st dose of Bexsero (intramuscular) and Bexsero Pre-Filled Syringe Device. On 15th December 2020, immediately after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain in arm and activities of daily living impaired. On 16th December 2020, the patient experienced weakness of arms. The patient was treated with ibuprofen. On an unknown date, the outcome of the weakness of arms, pain in arm and activities of daily living impaired were not recovered/not resolved. It was unknown if the reporter considered the weakness of arms, pain in arm and activities of daily living impaired to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The patient received her first dose of Bexsero in the right deltoid. Immediately following the injection the patient complained of right arm pain. On 16th December 2020, the patient began to experience right arm weakness. The patient was a competive swimmer and the arm pain and weakness had left her unable to swim due to the increased pain with swimming. The right arm pain escalated to sharp shooting pain. The patient self treated with ice, rest and ibuprofen. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 0980346
Sex: M
Age: 36
State: CO

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

Lab Data:

Allergies:

Symptoms: Administered a vaccine that has been refrozen; A spontaneous report was received from a nurse concerning a 36-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered a vaccine that has been refrozen. The patient's medical history was not provided. No relevant concomitant medications were reported. On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, administered a vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This report refers to a case of medication error for mRNA-1273 (Lot: 025J20-2A), where refrozen vaccine was administered. There were no reported AEs associated with this case of out of specification product use.

Other Meds:

Current Illness:

ID: 0980347
Sex: F
Age:
State: DE

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

Lab Data:

Allergies:

Symptoms: face was still red; swollen; feeling weak; Tired; Severe allergic reaction; Difficulty swallowing; A spontaneous report was received from a healthcare professional concerning herself, a 28 year old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced a severe allergic reaction, difficulty swallowing, face was still red, swollen, felt week and tired. The patient's medical history included anxiety and allergy to latex. Concomitant product use was not provided by the reporter. On 12-Jan-2021, 15 minutes prior to the onset of the symptoms, the patient received one of two planned doses of mRNA-1273 (026L20A) intramuscularly in an unknown injection site for prophylaxis of COVID-19 infection. 12-Jan-2021, after receiving the vaccine, the patient experienced a severe allergic reaction which made her face puffy, red, and covered with hives. She took 50 mg of diphenhydramine. She was also having trouble pronouncing words because her tongue was swelling and she couldn't swallow water, so she used epinephrine and go to the emergency room. On 14 Jan 2021 she felt weak and tired. On 13 Jan 2021follow up information was received and per source document/call - In addition one day later, on 13Jan2021 around 5:30 pm, patient reported that she went to the bathroom and noticed that her "face was still red" and "swollen" and had a "little bit of difficulty swallowing" and took another unknown dose of Benadryl and felt better. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events,severe allergic reaction, difficulty swallowing, face was still red, swollen and felt weak and tired was not reported.; Reporter's Comments: This case concerns a 28 year old female with medical history of anxiety and allergy to latex who experienced serious medically significant unlisted event of severe allergic reaction described as her face puffy, red, covered with hives, tongue swelling and difficulty swallowing within 15 minutes after the first dose of the study medication administration (LOT:026L20A). Patient also experienced additional reported events of non-serious listed events of "face was still red" and "feeling tired" and non-serious unlisted events of "face swollen", had a "little bit of difficulty swallowing", and "feeling weak". Patient was treated for the severe allergic reaction with initially Benadryl 50 mg and then with epinephrine pen and was sent to ER. Based on the temporal association between the use of the product and the start date of the events within 15 minutes of receiving the vaccine, a causal relationship cannot be excluded and the event of severe allergic reaction is possibly related to vaccine. Additional reported events of non-serious listed events of "face was still red" and "feeling tired" and non-serious unlisted events of "face swollen", had a "little bit of difficulty swallowing" and "feeling weak" are possibly related to vaccine.

Other Meds:

Current Illness: Latex allergy

ID: 0980348
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Incomplete dose; Something happened with the syringe; A spontaneous report was received from a healthcare facility staff member concerning an unspecified patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced incomplete dose and something happened with the syringe. 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 number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient was administered an incomplete dose of vaccine due to something happening with the syringe. No additional details were provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The events, incomplete dose and something happened with the syringe, were considered resolved on an unknown date.; Reporter's Comments: This report refers to a case of a patient who experienced non-serious events of incomplete dose, something happened with the syringe (Incomplete dose administered, Syringe issue) for mRNA-1273, lot # unknown), Exp date-unknown. There were no reported AEs associated with the events of incomplete dose, something happened with the syringe.

Other Meds:

Current Illness:

ID: 0980349
Sex: U
Age:
State: WV

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Accidentally given 1 mL instead of the 0.5mL dose; A spontaneous report was received from a physician concerning themselves, a patient of unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced receiving double the normal dose (1 mL instead of 0.5 mL) [Accidental overdose]. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 29-Dec-2020, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly in an unknown injection site for prophylaxis of COVID-19 infection. The patient was reported to be one of four individuals who were accidentally given 1 mL of the vaccine instead of the recommended 0.5 mL dose. The patient did not experience any adverse effects. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event was considered resolved.; Reporter's Comments: This case concerns a patient of unknown age and gender who accidentally received double the normal dose of mRNA-1273 vaccine during administration of their first dose.; Sender's Comments: :Master case - linked case numbers pending

Other Meds:

Current Illness:

ID: 0980350
Sex: U
Age:
State: NV

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Not sure how much dose the patient got; A spontaneous report was received from a healthcare professional concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was not sure how much of the dose the patient got (Incorrect dose administered). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 13 Jan 2021 the patient received their first of two planned doses of mRNA-1273 (LOT 011L20A) intramuscularly for prophylaxis of COVID-19 infection. On 13 Jan 2021, a healthcare professional was unsure of exactly how much of the vaccine the patient received as the luer-lock came off of the syringe during administration. The reporter wanted to know what the next step was in order to make sure the patient was protected. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not reported. The event, not sure how much dose the patient got, was considered resolved on 13 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown age and gender who experienced a non-serious unexpected event of Incorrect dose administered during their first injection of mRNA-1273.

Other Meds:

Current Illness:

ID: 0980351
Sex: F
Age:
State: NY

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

Lab Data:

Allergies:

Symptoms: nurse administered it, it leaked down her arm; A spontaneous report was received from a consumer concerning a female patient who was participating in the mRNA-1273 Emergency Use Program and experienced nurse administered it, it leaked down her arm. The patient's medical history was not provided. No relevant concomitant medications were reported. On 12-Jan-2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The reporter stated that the nurse had issues withdrawing the medication from the vial. She also stated that when the nurse administered the vaccine, it leaked down her arm. After that she was made to wait two hours while it was determined whether or not she could receive the second dose of vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, nurse administered it, it leaked down her arm, was considered resolved. The reporter did not provide a causality assessment of the event nurse administered it, it leaked down her arm.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273. There were no reported adverse events associated with this case.

Other Meds:

Current Illness:

ID: 0980352
Sex: M
Age: 81
State: WI

Vax Date: 01/05/2021
Onset Date: 01/08/2021
Rec V Date: 01/28/2021
Hospital: Y

Lab Data: Test Date: 20210111; Test Name: alanine transaminase; Result Unstructured Data: significantly elevated; Test Date: 20210111; Test Name: aspartate transaminase; Result Unstructured Data: significantly elevated; Test Date: 20210111; Test Name: bilirubin; Result Unstructured Data: significantly elevated; Test Date: 20210111; Test Name: blood pressure; Test Date: 20210111; Test Name: lipase; Result Unstructured Data: up to 1900; Test Date: 20210111; Test Name: troponin; Result Unstructured Data: slightly elevated

Allergies:

Symptoms: Acute pancreatitis; Acute renal failure; Low blood pressure; Weakness; Decreased appetite; Fatigue; Alanine aminotransferase increased; Aspartate aminotransferase increased; Troponin increased; Lipase increased; Blood bilirubin increased; A spontaneous report was received from a physician concerning an 81-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed an odd presentation of acute pancreatitis, acute renal failure, low blood pressure, weakness, decreased appetite and fatigue. The patient's medical history included advanced dementia, heart disease, pulmonary embolism and possible leukemia. Concomitant product use was not provided by the reporter. On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On 08 Jan 2021, three days after vaccination, the patient developed symptoms of weakness, decreased appetite, and fatigue. On 11 Jan 2021, the patient was admitted into the hospital with a diagnosis of low blood pressure,acute renal failure,acute pancreatitis,alanine aminotransferase increased,aspartate aminotransferase increased, troponin increased,lipase increased and blood bilirubin increased. Abnormal lab results included "significantly elevated" aspartate transaminase, alanine transaminase, bilirubin, lipase up to 1900, and "slightly elevated" troponin of 0.079. On 13 Jan 2021, the patient's symptoms had improved, and he was discharged. Treatment for the event included two liters of intravenous fluid and supportive care. Action taken with the second dose of mRNA-1273 in response to the event was not provided. The events, acute pancreatitis, acute renal failure, low blood pressure, weakness, decreased appetite and fatigue, were considered resolved on 13 Jan 2021. The physician assessed the events, acute pancreatitis, acute renal failure, low blood pressure, weakness, decreased appetite and fatigue, as not related to mRNA-1273. The physician's rationale was that the patient may have had a gallstone obstructing the pancreatic duct and once the stone passed, the patient got better with supportive care and slow administration of fluids.; Reporter's Comments: This case concerns a 81-year-old male patient with medical history of dementia, heart disease, pulmonary embolism, and possible leukemia, who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted events of acute pancreatitis, acute renal failure, low blood pressure, the non-serious listed event of fatigue, and the non-serious unlisted events of weakness, decreased appetite, elevated aspartate transaminase, elevated alanine transaminase, elevated bilirubin, elevated lipase, and elevated troponin. Very limited information regarding these events has been provided at this time. Based on the current available information and in agreement with the physician reporter's assessment, the events are assessed as unlikely related to mRNA-1273, noting the rapid improvement after administration of IV fluids.

Other Meds:

Current Illness: Dementia (Advanced); Heart disease, unspecified; Living in nursing home

ID: 0980353
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Some of the product leaked from where the needle was attached to the syringe; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced some of the product leaked from where the needle was attached to the syringe, patient did not receive full dose. The patient's medical history was not provided. Concomitant product use was not provided. The patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) on (date of vaccination not provided) for prophylaxis of COVID-19 infection. A nurse called to report a vaccinator was pulling a dose to give to this patient and noticed some of the product leaked from where the needle was attached to the syringe. The nurse reported, patient did not receive a full dose. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not reported. The events, some of the product leaked from where the needle was attached to the syringe, patient did not receive full dose, was considered resolved. The reporter did not provide an assessment of the events, some of the product leaked from where the needle was attached to the syringe, patient did not receive full dose.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273. There were no reported adverse events associated with this case.

Other Meds:

Current Illness:

ID: 0980354
Sex: M
Age: 58
State: GA

Vax Date: 01/13/2021
Onset Date:
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccine was given cloudy, the vial was still frozen or not thawed properly; A spontaneous report was received from a consumer concerning a 58-years-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and reported that the vaccine given was cloudy, still frozen and not properly thawed at the time of the administration. The patient's medical history was not provided. Concomitant medications were not reported. On 13 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 028L20A) intramuscularly in her left arm for prophylaxis of COVID-19 infection. On 13 JAN 2021, the patient received first dose of vaccine and reported that the vaccine given was cloudy, still frozen and not properly thawed at the time of the administration. The patient also stated that the pharmacist warmed up the new vial in his hands for couple of minutes. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, the vaccine given was cloudy, still frozen and not properly thawed at the time of the administration, were considered recovered.; Reporter's Comments: This report refers to a case of Product preparation issue for mRNA-1273, lot # 028L20A. There were no reported AEs associated with this case of Product preparation issue.

Other Meds:

Current Illness:

ID: 0980355
Sex: M
Age:
State: FL

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: The needle fell off and some of the vaccine spilled on nurse and on the patient's pants; The needle fell off and some of the vaccine spilled on nurse and on the patient's pants; A spontaneous report was received from a pharmacist, concerning a male patient of unspecified age, who received Moderna's COVID-19 vaccine and while receiving vaccine the needle fell off and some of the vaccine spilled on nurse and the patient's pants. No relevant medical history and concomitant medications were reported. On 11-Jan-2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 11-Jan-2021, while nurse was giving a patient his 1st dose of the Moderna vaccine, she had to change the needle as he was a larger man. When nurse was administering the vaccine, the needle fell off and some of the vaccine spilled on her and on patient's pants. The patient became irate that he couldn't get a replacement dose. Action taken with the first dose of mRNA-1273 in response to the event was not reported. The outcome for the event the needle fell off and some of the vaccine spilled on nurse and the patient's pants was considered to be resolved on 11-Jan-2021.; Reporter's Comments: This report refers to a case of a male patient who experienced non-serious event of the needle fell off and some vaccine spilled on nurse and the patient's pants (Incomplete dose of vaccine administered, needle issue) for mRNA-1273 (lot # 025L20A, Exp date-unknown). There were no reported AEs associated with the event of the needle fell off and some vaccine spilled.

Other Meds:

Current Illness:

ID: 0980356
Sex: F
Age:
State: OR

Vax Date: 12/28/2020
Onset Date: 12/30/2020
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Horner's Syndrome; A spontaneous report was received from a physician who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Horner's syndrome. The patient's medical history was not provided. No relevant concomitant medications were reported. On 28 Dec 2020, two days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On 30 Dec 2020 the patient developed Horner's syndrome. The specific presenting signs and symptoms experienced by the patient were not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, Horner's syndrome, was not reported.; Reporter's Comments: This spontaneous report refers to a female patient who experienced unexpected Horner's syndrome on day 3 after administration of the first dose of mRNA-1273, lot # unknown, Exp date-unknown. There is limited information to assess this case as the exact symptoms and confirmatory diagnostic test results were not provided. However, based on temporal information provided a causal association cannot be excluded.

Other Meds:

Current Illness:

ID: 0980357
Sex: M
Age: 34
State: TX

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Aching; Fatigue; Fever; Headache; Pulse was 135; A spontaneous report was received from a nurse who was also a 34-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced fatigue, aching, fever, headache, and pulse was 135. The patient's medical history was not provided. No relevant concomitant medications were reported. On 13 Jan 2021, approximately 12 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm at 09:00 for prophylaxis of COVID-19 infection. On 13 Jan 2021, around 21:00, the patient experienced fatigue, aching, fever, and headache. On 14 Jan 2021, the patient was taken to the emergency room because his pulse was 135. He hadn't been able to bring it down since 13 Jan 2021. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcomes of the events, fatigue, aching, fever, headache, and pulse was 135, were unknown.; Reporter's Comments: This case concerns a female patient, who experienced a serious unexpected events of heart race increased, a non-serious unexpected event of pain, and a non-serious expected event of fatigue, pyrexia and headache. The event of fatigue, pyrexia, pain and headache occurred 4 hours after mRNA-1273 (lot # unknown) administration. The event of heart rate increased occurred on an unknown date after mRNA-1273 (lot # unknown) administration. Treatment details were not provided. Very limited information regarding the events have 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.

Other Meds:

Current Illness:

ID: 0980358
Sex: M
Age: 31
State: NE

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Wrong needle size used; A spontaneous report was received from a pharmacist concerning 31-year-old, male patient who who received Moderna's COVID-19 vaccine (mRNA-1273) and the wrong needle size was used [Product administration error]. The patient's medical history was not provided. Concomitant medication use was not provided by the reporter. On 13-Jan-2021, the patient received the first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection. The pharmacist reported that the nurse made an administration error today by using the wrong size of needle. Treatment for the event was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event were resolved.; Reporter's Comments: This report refers to a case of a 31-year-old male patient who experienced non-serious event of the wrong needle size was used (Wrong technique in device usage process ) for administration of mRNA-1273 (lot # unknown, Exp date-unknown). There were no reported AEs associated with the event of the wrong needle size was used.

Other Meds:

Current Illness:

ID: 0980359
Sex: F
Age:
State:

Vax Date: 01/03/2021
Onset Date: 01/05/2021
Rec V Date: 01/28/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Meningitis; A spontaneous report was received from a consumer who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced serious event of meningitis. The patient's medical history was not provided. No concomitant medications were reported. On 03 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 05 Jan 2021, the patient experienced meningitis like symptoms. She was hospitalized for meningitis. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the event, meningitis was unknown.; Reporter's Comments: This case concerns a female patient, who experienced a serious unexpected event of meningitis. The event of meningitis occurred 3 days after mRNA-1273 (lot # unknown) administration. Treatment details were not provided. Very limited information regarding the events have 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.

Other Meds:

Current Illness:

ID: 0980360
Sex: M
Age: 77
State: FL

Vax Date: 01/09/2021
Onset Date: 01/09/2021
Rec V Date: 01/28/2021
Hospital:

Lab Data: Test Date: 20210109; Test Name: blood pressure; Result Unstructured Data: His blood pressure shot up to 200.; Test Date: 20210109; Test Name: tropium; Result Unstructured Data: tropium level jumped up.

Allergies:

Symptoms: Severe difficulty breathing; Blood pressure shot up to 200; Troponin level jumped up; A spontaneous report was received from a non-health professional concerning a 77-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe difficulty breathing and that his troponin level and blood pressure (BP) had shot up. The patient's medical history included chronic obstructive pulmonary disease (COPD). Concomitant product use was not provided by the reporter. On 09 Jan 2021, at approximately 14:42, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 09 Jan 2021 at 20:30, the patient experienced severe difficulty breathing and his BP shot up to 200. The patient went to the hospital and they found his troponin levels had jumped up. The patient reported no known heart issues. On 12 Jan 2021, he went to see his primary care physician (PCP). No treatment information for the event was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events, severe difficulty breathing and troponin level and blood pressure (BP) had shot up, were unknown.; Reporter's Comments: This case concerns a 77-year-old, male patient, with medical history of chronic obstructive pulmonary disease (COPD), who experienced a serious, unexpected event of dyspnoea, hypertension and raised troponin level. The event occurred 5 hours 48 min after the first dose of mRNA-1273 (Lot number: 039K20A). Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness: COPD

ID: 0980361
Sex: F
Age:
State: NY

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

Lab Data:

Allergies:

Symptoms: Fainted to the floor; Dizzy; Too dizzy, hot and sweaty; Nausea; A little vomit; sweaty; A spontaneous report was received from a non-health professional who was a 40-years-old, female patient who received Moderna's COVID-19 vaccine and fainted, was dizzy, felt hot, had nausea and vomiting, and sweaty. The patient's medical history included a propensity for fainting and low blood pressure. Concomitant product use was not provided by the reporter. On 12 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 12 Jan 2021, after receiving the vaccine, the patient got dizzy, had nausea, a little vomit, and fainted to the floor. She reported feeling dizzy, hot and sweaty. Patient did not take medication to treat her symptoms. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events, fainted, dizziness, felt hot, nausea and vomiting, and sweaty were unknown.; Reporter's Comments: This case concerns a 40-year-old female patient with medical history of propensity for fainting and low blood pressure who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the unlisted event of Syncope which was considered medically significant. Additionally, the patient experienced the non-serious listed events of Nausea and Vomiting, and the non-serious unlisted events of Feeling Hot, Dizziness and Hyperhidrosis. Based on the current available information and temporal association between the use of the product and the onset of events on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine. We would note that the patient's history of propensity for fainting and low blood pressure could be also contributory.

Other Meds:

Current Illness: Fainting (Patient has a propensity to fainting.); Low blood pressure; Penicillin allergy

ID: 0980362
Sex: F
Age: 51
State: PA

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Fainted; unconscious for 1-2 minutes; Felt dizzy; sweating; shaking; brain feels foggy; didn't sleep well; left arm started hurting from shoulder to elbow; A spontaneous report was received from a consumer who was an 51-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events of left arm started hurting from shoulder to elbow, didn't sleep well, felt dizzy, fainted, unconscious for 1-2 minutes, sweating, shaking, and brain feels foggy. The patient's medical history included asthma, hypoglycemia allergy to penicillin and tuberculin (TB) test. No concomitant medications were reported. On 13 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On the same day, the patient experienced left arm started hurting from shoulder to elbow. On 14 Jan 2021, the patient reported that she didn't sleep well, felt dizzy, and fainted. The patient was unconscious for 1-2 minutes before the ambulance arrived. It was noted that the patient's vitals were normal, so she declined to go to the hospital. The patient also experienced sweating, shaking, and brain feels foggy like she has a hangover. The patient stated that the Moderna vaccine gave her the same reaction except with penicillin and TB test she went unconscious immediately. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not provided. The events, fainted and unconscious for 1-2 minutes, was considered resolved on 14 Jan 2021. The outcome for the events, felt dizzy and brain feels foggy, was not resolved. The outcome for the events, left arm started hurting from shoulder to elbow, sweating, shaking and didn't sleep well, was unknown.; Reporter's Comments: This spontaneous report refers to a 51-year-old female patient with medical history of asthma who experienced unexpected serious events of fainted and loss of consciousness (1-2 minutes), and non-serious events of dizziness, sweating, shaking, brain feels foggy, didn't sleep well and left arm started hurting from shoulder to elbow) the next day after administration of the first dose of mRNA-1273, lot # : 012L20A, Exp date-unknown. Based on temporal information provided and with no other etiological factors, a causal association cannot be excluded. The event of left arm started hurting from shoulder to elbow is consistent with the known safety profile of the study medication.

Other Meds:

Current Illness: Allergy (TB Test); Allergy (Penicillin); Asthma; Hypoglycemia

ID: 0980363
Sex: M
Age:
State:

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: went deaf for a while; Trouble breathing; Swollen genitals; Injection site arm in severe pain; fever; A spontaneous report was received from a consumer who was also a male patient who received Moderna's COVID-19 Vaccine, and who developed trouble breathing, swollen genitals, injection site arm in severe pain, fever, and went deaf for a while. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 13 Jan 2021, approximately one hour prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT unknown) intramuscularly for prophylaxis of COVID-19 infection. On 13 Jan 2021, approximately one hour after receiving the injection, he developed trouble breathing, swollen genitals and severe pain at the injection site. He had a fever, and he went deaf for a while. On 14 Jan 2021, the pain became so overwhelming that he went to the emergency department. No diagnostic information was provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the events, trouble breathing, swollen genitals, injection site arm in severe pain, fever, and went deaf for a while, was not provided. The event, went deaf for a while, was considered recovered/resolved on an undisclosed date. The outcome of the events, trouble breathing, swollen genitals, injection site arm in severe pain and fever, was not reported.; Reporter's Comments: This spontaneous report refers to a male patient who experienced unexpected events of trouble breathing, swollen genitals, severe pain at the injection site, fever and went deaf for a while one hour after administration of the first dose of mRNA-1273, lot # unknown, Exp date-unknown. Based on temporal information provided and in the absence of any other etiological factors, a causal association cannot be excluded. Pain and fever are consistent with the known safety profile of the vaccine.

Other Meds:

Current Illness:

ID: 0980364
Sex: U
Age:
State: LA

Vax Date:
Onset Date:
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Refroze the vaccines after receiving them and administered them to patients; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's Covid-19 vaccine (mRNA-1273) with product storage error. The patient's medical history was not provided. Concomitant product use was not provided. The patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) on (date not provided) for prophylaxis of COVID-19 infection. A pharmacist called to report the vaccines were refrozen after receiving them. He stated he thought that they were frozen, but they were shipped refrigerated. He reported that he administered 108 patients with the refrozen vaccine. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The event, product storage error, was considered resolved.; Reporter's Comments: This report refers to a case of Product storage error for mRNA, where refrozen vaccine was administered. There were no reported AEs associated with this case of out of specification product use.

Other Meds:

Current Illness:

ID: 0980365
Sex: U
Age:
State: CA

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Anaphylaxis-like symptoms; A spontaneous report was received from a physician concerning a 45-year-old, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis-like symptoms. The patient's medical history included hypertension. The patient had no history of allergies or prior vaccine reactions. No concomitant medications were reported. On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 13 Jan 2021, the patient experienced anaphylaxis-like symptoms that included, anaphylaxis, angioedema, shortness of breath, itching, swelling of eyes, and sleepiness. The patient was treated with epinephrine injections and taken to the emergency department. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, anaphylaxis-like symptoms, was unknown.; Reporter's Comments: This case concerns a 45-year-old patient with medical history of hypertension, who experienced a serious, unexpected event of Anaphylactoid reaction. The event occurred the day the patient received the first dose of mRNA-1273 (Lot number: 041L20A), at an unspecified time. 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:

Current Illness: Hypertension

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm