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: 0978309
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0978310
Sex: F
Age:
State: CA

Vax Date: 01/11/2021
Onset Date: 01/12/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: I have had severe lymph node swelling on the right side where I got the vaccine; 24hrs post 2nd vaccination I have had a sudden onset of an extremely violent cough; My sputum is greenish/yellow brown with blood flecks; My sputum is greenish/yellow brown with blood flecks; chest tightness; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular in the right arm on 11Jan2021 15:45 at single dose for COVID-19 immunisation. Medical history included hypothyroidism, asthma, polycystic ovarian syndrome (PCOS), endometriosis, chronic allergies, gastritis, and walnut allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), metformin, loratadine (CLARITINE), spironolactone, and calcium carbonate, colecalciferol (VITAMIN D 2000). The patient previously took first dose of bnt162b2 (lot number and expiry date not reported), intramuscular in the right arm on 21Dec2020 15:15 at single dose for COVID-19 immunisation. The patient verbalized, "I don't know if it's related but I figured I should report just in case. I have had severe lymph node swelling on the right side where I got the vaccine. 24hrs post 2nd vaccination I have had a sudden onset of an extremely violent cough. By sudden onset, I mean I had no desire to cough and over about 30 min I developed the severe need to cough. My sputum is greenish/yellow brown with blood flecks. I've never experienced such a violent cough with so much sudden sputum production. I am using an Albuterol inhalor to help chest tightness." Clinical outcome of chest discomfort was unknown while for the other events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on a close chronological association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: SYNTHROID; METFORMIN; CLARITINE; SPIRONOLACTONE; VITAMIN D 2000

Current Illness:

ID: 0978311
Sex: F
Age:
State: FL

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: isolated hives/generalized hives; generalized itching/itchy from head to toe; contact Dermatitis had worsened/reactivations of contact dermatitis that flared up on her right knee; contact Dermatitis had worsened/reactivations of contact dermatitis that flared up on her right knee; This is a spontaneous report from a contactable physician. A 64-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular on deltoid left from 30Dec2020 to 30Dec2020 at SINGLE DOSE for covid-19 immunisation. Medical history included contact dermatitis. There were no concomitant medications. The reporter stated that the patient had mentioned that she had contact dermatitis for several months now and before taking the COVID-19 vaccine, it has settled within a month. 6-12 hours after getting the COVID-19 vaccine, her contact dermatitis had worsened dramatically on 30Dec2020. She was prescribed high dose topical steroids by her doctor. She also developed generalized itching and isolated hives on 12Jan2021. She is trying to avoid systemic corticosteroids because it might affect the vaccine. She is also taking antihistamines but she said these interventions don't seem to be working. Stated that it has not responded to anything. The patient also stated stated that she has not taken steroids because her second dose is due in a week. Stated that the doctors do not think that it is due to the vaccine but due to reactivation (immune system reactivity) of something that had happened. Stated that they are treating it with high dose topical steroids, pepcid and hydroxyzine. Wanted to see if there was information on this sort of reaction and if they had guidance on the second shot. Had the Pfizer BioNTech Covid 19 vaccine. Outcome of the events urticaria and pruritus was not recovered while outcome of the remaining events was recovering.; Sender's Comments: The reported generalized itching and isolated hives occurred 13 days after the first dose of COVID 19 vaccine, BNT162B2. Based on the reasonable temporal association, the Company cannot completely exclude the possible causality between the reported events and the administration of the suspect. However, the pre-existing contact dermatitis might have provided alternative explanation towards the onset of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

Other Meds:

Current Illness:

ID: 0978312
Sex: F
Age:
State: CA

Vax Date: 12/18/2020
Onset Date: 12/21/2020
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 20210102; Test Name: blood work; Test Result: Negative ; Comments: essentially negative; Test Date: 20210102; Test Name: CRP; Test Result: 4 mg/dl; Test Date: 20210112; Test Name: PET scan; Test Result: Negative ; Test Date: 20210102; Test Name: ESR; Result Unstructured Data: Test Result:124; Comments: mm/hr; Test Date: 20210102; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptoms: unable to work; ESR of 124 mm/hr; CRP of 4 mg/dl; difficulty with ADLs; neck and leg muscle stiffness and pain; neck and leg muscle stiffness and pain; difficulty ambulating; neck and leg muscle stiffness and pain; fatigue; body aches; chills; sweats; This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at left arm on 18Dec2020 at single dose for COVID-19 immunization. No medical history. The patient's concomitant medications were not reported. Patient had been otherwise well prior to receiving the bnt162b2 on 18Dec2020. Within 72 hours, she experienced fatigue, body aches, chills and sweats since 21Dec2020, though she was able to work Xmas week. On 31Dec2020, she contacted her PCP to report neck and leg muscle stiffness and pain, difficulty ambulating, fatigue, chills and sweats. She had a negative COVID test on 02Jan2021 and essentially negative blood work, other than an ESR of 124 mm/hr and CRP of 4 mg/dl. I had a negative PET scan on 12Jan2021. Currently, she had pain/stiffness in her neck and legs, and progressive difficulty w/ ambulation (both of which are worst in the early hours of the AM), and difficulty with ADLs since 31Dec2020. She had been unable to work since 03Jan2021. Her physician had not indicated or endorsed any relationship between her symptoms and the vax. She forewent dose 2 out of an abundance of caution. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: The events muscle stiffness , neck pain and gait disturbance appeared 13 days after administration of single dose BNT162B2. The Company considers that the events are less likely related to suspect BNT162B2 injection given the weak time association. The detailed clinical course and cause of the events would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0978313
Sex: F
Age:
State: FL

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:normal

Allergies:

Symptoms: Tiredness; A sore arm/Arm was a little sore; Dizziness; Passed out; Chills; Tremor in fingers; A headache; This is a spontaneous report from a contactable Nurse (patient). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EH9899, expiry date: unknown), via an unspecified route of administration on 06Jan2021 10:30 at single dose (Right upper arm) for COVID-19 immunization. Medical history included Blood pressure (takes blood pressure medication). The patient's concomitant medications included blood pressure medication. The patient experienced a sore arm, chills, tremor in fingers and a headache when she came home from being vaccinated. The morning after, she experienced dizziness, tiredness and passed out. She then checked her blood pressure and it was fine and then she went to bed and slept all day. She got up around 7 pm and was fine. It was further reports that the patient received first COVID Vaccine on 06Jan2021. She came home and was fine. Arm was a little sore. During night had chills and noticed fingers had tremors. Had a bad headache. Woke up in morning and went to do usual things. Was dizzy and passed out. Woke up on floor. Husband helped her back into bed and she slept the whole day. After that she was absolutely fine. They were curious, but a little bit concerned about taking the second dose. Advised patient to follow up with primary care physician. She went to primary care physician yesterday. Primary care physician advised her to take the second dose of COVID Vaccine stating he didn't see why she couldn't take it. HCP Details: Address and email address are unknown Received first dose of COVID Vaccine on 06Jan2021 around 10:30. Chills: began at 23:00 Fingers had tremors: began 23:00 Bad headache: did not provide time of onset Dizzy and passed out: 08:00 Woke up absolutely fine on 07Jan2021 around 19:00 Indication: 66 years old and it was available to her Causality: Yes, because she was fine before then History and Investigations: Takes blood pressure medication, but blood pressure has been normal. Product name not provided by caller. Vaccination facility type was at a skilled nursing facility. The outcome of the events was unknown. Chills, Tremor in fingers, headache, Dizziness, and Passed out were reported as Medically significant events. Reaction assessed for Chills, Fingers had tremors, Had a bad headache, Dizzy, and Passed out. Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events including chills, tremor in fingers, headache, dizziness, and passed out, and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

Other Meds:

Current Illness:

ID: 0978314
Sex: F
Age:
State: PA

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 20210114; Test Name: temperature; Result Unstructured Data: Test Result:100.2

Allergies:

Symptoms: feeling cold/coldness; increased temperature/she took her temperature and it was 100.2/fever; body numbness/body started to feel numb; This is a spontaneous report from a contactable nurse reported for herself. A 44-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular at left deltoid on 13Jan2021 16:00 at single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient historic vaccine included the first dose of BNT162B2 on 22Dec2020 for covid-19 immunization. The patient body started to feel numb on 13Jan2021, she was feeling cold/coldness on 14Jan2021, increased temperature on 14Jan2021 and she took her temperature and it was 100.2, stated that she knew that a fever is a side effect. She was only concerned with the body numbness and wanted to know if body numbness was anything to be concerned about. The reporter assessed events was related to Pfizer Covid vaccine and as serious due to medically significant. The outcome of the events was not recovered.; Sender's Comments: Based on the compatible temporal association, the Company considers the reported events of hypoesthesia, pyrexia and feeling cold are possibly related to suspect vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0978315
Sex: F
Age:
State: VA

Vax Date: 12/18/2020
Onset Date: 12/21/2020
Rec V Date: 01/27/2021
Hospital: Y

Lab Data: Test Date: 20201223; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptoms: Severe proximal myositis of upper and lower extremities/ proximal upper and lower muscle weakness/ vaccine related myositis; dysautonomia; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899), intramuscular in the left arm on 18Dec2020 at 05:00 PM at a single dose for COVID-19 immunization. Medical history included premature ventricular contractions (PVCs) with heart ablation. Patient was not pregnant at the time of vaccination. Patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient also did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced severe proximal myositis of upper and lower extremities also reported as proximal upper and lower muscle weakness on 21Dec2020 at 09:00. The patient also experienced dysautonomia on 21Dec2020. The patient was admitted to hospital for 4 days due to the reported events and was then released. Follow up evaluations and testing showed and confirmed vaccine related myositis. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department visit or urgent care and hospitalization. No treatment for the adverse events. The patient underwent lab test which included nasal Swab: negative on 23Dec2020. The outcome of the events was not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported myositis, dysautonomia and the administration of the COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

Other Meds:

Current Illness:

ID: 0978316
Sex: M
Age:
State: NY

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: medication error with Pentacel described as receiving only the liquid DTAP-IPV portion and not the powder HIB component with no adverse event; Initial information regarding an unsolicited valid non-serious case received from a nurse via phone at a call center as a Medication Inquiry on 11-Jan-2021. This case involved a 4 month old male patient for whom medication error was reported with Pentacel described as receiving only the liquid DTaP-IPV portion and not the powder HiB component with no adverse event (Product preparation issue), after receiving DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (PENTACEL). Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included pneumococcal vaccine 13V for prophylactic vaccination. On 11-Jan-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE 0.5 mL (lot number: UJ317AAA, expiry date: 04-Jun-2021) via intramuscular route in the left thigh for prophylactic vaccination. On 11-Jan-2021, medication error was reported with Pentacel described as receiving only the liquid DTaP-IPV portion and not the powder HiB component with no adverse event (Product preparation issue). At the time of reporting, the patient did not involve any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001-83-EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds: PNEUMOCOCCAL VACCINE 13V

Current Illness:

ID: 0978317
Sex: M
Age: 67
State: TX

Vax Date: 09/01/2020
Onset Date: 09/01/2020
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: very red eyes with mucus; nasal discharge; tighening of throat; very red eyes with mucus; Initial information regarding an unsolicited valid non-serious case was received from a consumer via The Agency (Reference number- 00418470) and transmitted to Sanofi on 06-Jan-2021. The case involved a 67 year old male patient who had allergic reactions, nasal discharge (rhinorrhoea), very red eyes with mucus (ocular hyperaemia and eye discharge) and tightening of throat (throat tightness), while he received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided. Concomitant medications included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL). On 01-Sep-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site prophylactic vaccination. On 01-Sep-2020, the patient developed non-serious allergic reactions, nasal discharge (rhinorrhoea), very red eyes with mucus (ocular hyperaemia and eye discharge) and tightening of throat (throat tightness), 2 hours following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. Relevant laboratory test was not reported. Around 6pm, he called his doctor, who prescribed Benadryl. He took the antihistamine about 7PM and went to bed. He stated that he had never taken a flu vaccine before. On 01-Sep-2020, the patient had recovered from all the reported events within 3 or 4 hours of taking the Benadryl. There would be no information available on batch number for this case.

Other Meds: BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]

Current Illness:

ID: 0978318
Sex: M
Age:
State: VA

Vax Date: 10/14/2020
Onset Date: 11/09/2020
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: His first dose was on 10/14/2020 and the second (booster) was given on 11/9/2020, 26 days later. 0.5 ml was given each time. First use of Fluzone Quad with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health professional and transmitted to Sanofi on 08-Jan-2021. This case involved a 1 year old male patient who received his first dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] on 14-Oct-2020 and the second (booster) on 09-Nov-2020, 0.5 ml each time, 26 days later instead of 28 days (inappropriate schedule of product administration). It was the first use of FLUZONE QUAD. Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided. It was a case actual medication error due to inappropriate schedule of product administration (latency 26 days post the prior dose). At the time of reporting, no adverse event was reported. This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error was in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party had contributed to or was to be held liable for the occurrence of this medication error. There would be no information available on batch number for this case.

Other Meds:

Current Illness:

ID: 0978319
Sex: M
Age: 0
State: DE

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: dose of PENTACEL was administered last week, only the Dtap/Ipv portion was administered with no AE; Initial information received on 11-Jan-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 months old male patient who received an dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: UJ319AA, expiry date: 04-Jun-2021) via intramuscular route in the left thigh on 04-Jan-2021 for prophylactic vaccination (Product preparation issue). The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ). It was an actual medication error due to Product preparation issue(latency same day). At the time of report, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds: PREVNAR; ROTATEQ

Current Illness:

ID: 0978320
Sex: M
Age:
State: RI

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

Lab Data:

Allergies:

Symptoms: Memory issue; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via The Agency (Reference number- 00428032) and transmitted to Sanofi on 13-Jan-2021 via call-center. This case involves an 81-year-old male patient who experienced memory issue (memory impairment), while he received vaccines influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent]. The patient's medical history, past vaccination(s), past medical treatment, concomitant medication and family history were not provided. On an unknown date, the patient received a (one dosage form) dose of suspect influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent] (lot number UJ567AA) (0.7 mg) via unknown route at an unknown administration site for prophylactic vaccination. On 12-Jan-2021, the patient developed a non-serious memory issue (memory impairment), following the administration of influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent]. Laboratory details were not reported. It was not reported if the patient received a corrective treatment. Outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 0978485
Sex: F
Age: 28
State:

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

Lab Data:

Allergies:

Symptoms: sore arm, headache, muscle aches, fatigue. Also breastfeeding and baby seems slightly more fussy than usual unsure if related.

Other Meds:

Current Illness:

ID: 0978489
Sex: F
Age: 59
State: MA

Vax Date: 01/14/2021
Onset Date: 01/27/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Hives

Other Meds:

Current Illness:

ID: 0978494
Sex: F
Age: 27
State: IN

Vax Date: 01/25/2021
Onset Date: 01/26/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies: Nka

Symptoms: Mild headache. Took 600mg ibuprofen after an hour, and pain quickly subsided. Has not returned. No other effects.

Other Meds: Birth control Lexapro

Current Illness: None

ID: 0978496
Sex: F
Age: 35
State: IA

Vax Date: 01/20/2021
Onset Date: 01/24/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: None at this time.

Allergies: NA

Symptoms: Began with an itchy top left hand (same side as injection site). Raised bumps began appearing on both hands and up to the right wrist. Looks similar to heat rash. Extremely itchy. Irritation and itch continues on both hands and wrist and continue on to the lower back and abdomen three days later. Topical anti-itch creams have been applied- very little relief.

Other Meds: Birth Control

Current Illness: NA

ID: 0978499
Sex: F
Age: 30
State: NY

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: None

Allergies: Amoxicillin

Symptoms: Day of shot later in the afternoon: Pain in right arm at injection site Day after shot: 2:00 pm- fever. 7:30 pm severe fatigue 2 Days after shot: 9:00am-11:00pm- nausea, fatigue, headache, low grade fever

Other Meds: None

Current Illness: None

ID: 0978501
Sex: M
Age: 49
State:

Vax Date: 01/08/2021
Onset Date: 01/14/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Rash on Back and on sides wrapping around to the front of chest, primarily on the back. Associated with urticaria. The patient developed headache, lack of taste, fatigue as well as the aforementioned rash on 1/14/2021(6 days after receiving first dose of covid vaccine. A rapid covid test was positive on 1/14/2021 also. The patient was prescribed claritin, methylprednisolone for the rash after seeing his family physician virtually and the family physician recommended he contact where he was vaccinated to report these symptoms. I have reached out to the patient for additional information and he has declined, so I do not have any access to details on his positive covid test or records from that virtual encounter.

Other Meds:

Current Illness:

ID: 0978505
Sex: M
Age: 31
State: WA

Vax Date: 01/25/2021
Onset Date: 01/26/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies: None

Symptoms: Fatigue - Severe Headache - Moderate Chills/Fever - Mild Local (injection site) Muscle Pain - Moderate

Other Meds: None

Current Illness: None

ID: 0978511
Sex: F
Age: 27
State: IN

Vax Date: 01/25/2021
Onset Date: 01/26/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Chest X-ray- normal EKG- normal both tests performed 1/26/21

Allergies: Penicillin, Keflex

Symptoms: I received the shot a 5:30 pm and just had arm pain. At 3am, I woke up with fever, chills, a migraine, dizziness and lightheadedness that prevented me from walking without assistance. I began feeling pain while breathing and was very weak when standing. My fever reached 102.9 while taking Tylenol. The body aches and Migraine were a 10/10. I went to hospital where they treated my migraine and the benedryl seemed to ease much of my pain and dizziness related to the vaccine. I was told I was having a vaccine reaction.

Other Meds: Citalopram, 30 mg.

Current Illness: None

ID: 0978515
Sex: F
Age: 73
State: WI

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

Lab Data: none

Allergies: penicillin and tetanus toxoid

Symptoms: Dizziness and equilibrium issues upon waking on 01/27/2021. Chills onset between 11 AM and 11:20 AM.

Other Meds: Omeprazole, amlodipine, lisinopril, lisinopril-hydrochlorothiazide, pravastatin, vitamin C, vitamin D, vitamin E, multivitamin, Zyrtec-D

Current Illness: none

ID: 0978517
Sex: F
Age: 28
State: AL

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

Lab Data: Jan 21 - EKG and Chest X-ray - all normal Jan 26- EKG , CT Scan , Bloodwork , Chest X-Rays , UTI Specimen taken - all normal

Allergies: None

Symptoms: My arm started to hurt , tingled and then turned into feeling very heavy as soon as injection was admitted. I suddenly became light headed and felt very abnormal. Broke out in hives on my neck and face . They took me to the ER department and by the time they wheeled me down the hall I was white , very disoriented. Couldn?t open my eyes and went from slurred speech to I couldn?t speak at all and couldn?t swallow. My throat and closed and I was having a anaphylactic reaction . They administered epi pen , pepcide and steroids. Since then I have been very weak , running a fever , tired , dizzy . Can hardly walk and I get out of breath from standing or walking .My muscles are very sore and have spams . Almost last night I went to the ER due to theses symptoms lingering. I have been unable to work since the vaccine was administered to me .

Other Meds: Acutane

Current Illness: None

ID: 0978518
Sex: F
Age: 47
State: NY

Vax Date: 01/18/2021
Onset Date: 01/26/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: none

Allergies: penicillin

Symptoms: 7 days after the first dose patient developed redness and swelling of about 5 cm in diameter, indurated and itchy.

Other Meds: spironolactone

Current Illness: none

ID: 0978521
Sex: F
Age: 82
State: OK

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

Lab Data: CBC, CMP, Lactic Acid, PT, PTT, TSH TROPONIN, CT BRAIN, CHEST 1 VIEW, BMP, BNP,

Allergies: NKDA

Symptoms: This is an 82-year-old female with history of cerebellar degeneration, who had her first COVID vaccine today around 11 a.m. she was in her usual state of health prior to that time. About two and half hours afterwards she became nauseated. She had several bouts of emesis and then had a fall. She was found to be hypotensive and bradycardic. The ambulance crew actually gave her atropine at the same because she had a pulse in the 30s, improved her quickly and she presented to the ER. She is to remain very orthostatic, received several liters of IV fluid as now symptomatically better. She remains a little nauseated. She denies any headache, diarrhea, fatigue, or myalgias. She does not feel quite right. She is still dizzy with sitting up.

Other Meds: Cardizem CD 180 mg a day., CeleXA 20 mg a day., Chlorpheniramine as needed., Allegra 180 mg a day as needed., Flomax 0.4 mg b.i.d., Lipitor 10 mg at bedtime., Losartan 50 mg at bedtime., Meclizine 25 mg t.i.d. p.r.n. dizziness., Naprosyn 3

Current Illness: she was in her usual state of health prior to that time

ID: 0978523
Sex: U
Age:
State:

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

Lab Data: None

Allergies:

Symptoms: Fatigue, chills, body aches, brain fog, soreness at injection site.

Other Meds:

Current Illness:

ID: 0978524
Sex: F
Age: 48
State: PA

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

Lab Data: Next appointment at the respiratory clinic 2/ 29/21 3:50pm.

Allergies: Erythromycin

Symptoms: First inject lot # ej1685 in right arm. had itchy rash with open wounds all over right breast with burning pain. Was told is was shingles but wasn?t treated. Was told to get the second vaccine in the opposite arm to see if the same thing happens. Received 2nd injection in left arm and ended up with full blown symptoms of COVID. Uncontrollable shakes, cold, fever, severe body aches, cough, diarrhea and the rash still remains. As of today, I have an upper respiratory infection as well as the open rash, which the PCP listed has taken control of and deemed the cause side effects of the second injection.

Other Meds: Zyrtec

Current Illness: N/a

ID: 0978525
Sex: F
Age: 36
State: MA

Vax Date: 01/24/2021
Onset Date: 01/27/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies: Gaolinium, Seasonal Allergies

Symptoms: Macular type rash that developed later in the evening after her initial vaccine

Other Meds: Levoxyl, Metoprolol, Folic Acid, Remicaid, Gamunex, methotrexate, Magnesium, Vitamin D

Current Illness: None

ID: 0978526
Sex: F
Age: 51
State: OR

Vax Date: 01/15/2021
Onset Date: 01/20/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies: Neosporin

Symptoms: 5 days after the shot I started getting a rash/itching on my face. Under my right arm (armpit) was sore. I also had a sore throat. 8 days after the shot my arm (where the shot was) starting turning red. It ended up growing about 5 inches wide and was very warm and tender for a few days.

Other Meds: Spiriva, Escitalopram, Doxycycline and daily vitamin.

Current Illness: None

ID: 0978527
Sex: F
Age: 35
State:

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

Lab Data:

Allergies:

Symptoms: fatigue,muscle and joint pain, headache, chills

Other Meds:

Current Illness:

ID: 0978528
Sex: F
Age: 64
State: NY

Vax Date: 01/15/2021
Onset Date: 01/25/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: N/A

Allergies: Penicillin,sulfa,ibuprofen ,cipro

Symptoms: 11 days after 1 st dose a red 4x6 in re area appeared on left arm slightly swollen and itchy

Other Meds: Vitamin D

Current Illness: None

Date Died: 01/15/2021

ID: 0978529
Sex: F
Age: 88
State: WV

Vax Date: 12/31/2020
Onset Date: 01/15/2021
Rec V Date: 01/27/2021
Hospital: Y

Lab Data: Chest XR 1/15/21 CT chest/abdomen 1/15/21

Allergies: Bee Stings, Statins, Flecinide

Symptoms: Patient developed Covid pneumonia dx 1/15/21, patient expired

Other Meds: Lasix 20 mg daily, KCL ER 20 MEQ daily, Eliquis 2.5 mg twice daily, allopurinol 300 mg daily, Lyrica 50 mg daily, Metoprolol Succinate ER 50 mg daily, Amlodipine 5 mg daily, Pravstatin 20mg daily, Vit d3 25mcg daily

Current Illness: None

ID: 0978530
Sex: M
Age: 0
State: AZ

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

Lab Data:

Allergies: nono

Symptoms: None stated.

Other Meds: eliquis carvedilol

Current Illness: no

ID: 0978531
Sex: M
Age:
State:

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

Lab Data:

Allergies:

Symptoms: his son was born and has "delayed speech and learning abilities, asthma, and his legs hurt."; his son was born and has "delayed speech and learning abilities, asthma, and his legs hurt."; his son was born and has "delayed speech and learning abilities, asthma, and his legs hurt."; his son was born and has "delayed speech and learning abilities, asthma, and his legs hurt."; Exposure via father; Fetal Exposure During Pregnancy; This spontaneous report was received from the patient's father and refers to his son a male patient of unknown age. Information regarding the patient's medical history, drug reactions and allergies were not provided. In 2008-2009, the patient's father was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) and his son was exposure via transplacental. The father reported that his son had delayed speech and learning hablities, asthma and his legs hurt The outcome of speech disorder, asthma, learning disorder and pain in extremity was unknown. The reporter did not provide the causality assessment.; Sender's Comments: US-009507513-2012USA013606: US-009507513-2101USA001098:

Other Meds:

Current Illness:

ID: 0978532
Sex: F
Age: 22
State: NY

Vax Date: 12/22/2020
Onset Date:
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: pregnant patient received the GARDASIL 9 injection; No other AE was given; This spontaneous report was received from a Licensed Practical Nurse who was reporting on currently 22-year-old female patient. She was pregnant, and hers last menstruation period was on 07-APR-2020 and estimated delivery date was 05-FEB-2021. There was no information about the patient's medical history, drug reactions or allergies and concomitant therapies provided. On 22-DEC-2020, the patient was intramuscularly vaccinated with dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringe (dose, anatomical location and strength were not provided; lot number 1602284 was confirmed to be valid, expiration date was not reported but upon internal validation process, it was established as 26-SEP-2021) for prophylaxis (patient experienced exposure during pregnancy). Initial exposure to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was at 37 week. At the time of the report the patient did not delivered yet. She did not experienced 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.; devicelotnumber: 1602284; expirationdate: 26-SEP-2021; 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: 0978533
Sex: F
Age: 43
State: IN

Vax Date: 01/25/2021
Onset Date: 01/26/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: none

Allergies: Penicillan - Hives Levofloxacin - Hives

Symptoms: I had severe body aches the day after my injection. They lasted throughout the day and required 3 doses of 800mg Ibuprofen and 2 doses of 1000mg Tylenol. I felt fine the morning of 1/27/2021 (48 hours after injection), but I took 1000mg Tylenol just to make sure. Not symptoms since.

Other Meds: Diazide, Zyrtec, Fish oil, Centrum Multivitamin, Biotin, Calcium, Vit D, Vit E, Tumeric/Curcumin

Current Illness: None

ID: 0978534
Sex: U
Age:
State: IN

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

Lab Data:

Allergies:

Symptoms: Received their third dose of ROT ATEQ at 9 months of age instead of 6 months of age; This spontaneous report as received from a nurse prescriber refers to a 9 month old patient of unknown gender. Medical history, concurrent conditions, and concomitant medications were not reported. On unknown date in 2020, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) orally; and approximately in April 2020, the patient received second dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ)orally (Dose, Lot number, and expiration date were not provided) prophylaxis.

Other Meds:

Current Illness:

ID: 0978535
Sex: F
Age: 34
State: WA

Vax Date: 12/30/2020
Onset Date: 01/01/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Troponin I, High Sensitivity - Result <3 ng/L Standard <=45 ng/L hCG Screen, Serum - Negative ECG 12 LEAD - Normal sinus rhythm with sinus arrhythmia Na 138 mmol/L 136 - 145 mmol/L K 3.7 mmol/L 3.5 - 5.1 mmol/L Cl 106 mmol/L 98 - 107 mmol/L CO2 28 mmol/L 20 - 31 mmol/L Calcium 9.4 mg/dL 8.7 - 10.4 mg/dL Anion Gap 4 mmol/L 5 - 16 mmol/L Albumin 4.9 g/dL 3.2 - 4.8 g/dL BUN 9 mg/dL 9 - 23 mg/dL Creatinine 0.79 mg/dL 0.55 - 1.02 mg/dL Glucose 76 mg/dL 65 - 140 mg/dL Total Protein 7.1 g/dL 5.7 - 8.2 g/dL Globulin 2.2 g/dL 2.0 - 4.0 g/dL Albumin/Globulin Ratio 2.2 Ratio 0.7 - 2.2 Ratio Alkaline Phosphatase 81 U/L 46 - 116 U/L ALT 15 U/L 10 - 49 U/L AST 19 U/L <=33 U/L Bilirubin Total 0.3 mg/dL 0.3 - 1.2 mg/dL Estimated GFR >60 mL/min/1.73m2 >=61 mL/min/1.73m2 Adult GFR Result Intervals measured in mL/min/1.73 m squared: GT 60: Normal renal function. LT or equal to 60: Chronic kidney disease, if confirmed over a 3 month period. A single determination is not considered diagnostic. 30-60 eGFR (Stage 3 CKD): Chronic renal disease. 15-29 eGFR (Stage 4 CKD): Chronic renal disease, consider nephrology consult. LT 15 eGFR (Stage 5 CKD): Renal failure. White Blood Cells 4.7 K/uL 3.8 - 11.0 K/uL Red Blood Cells 4.19 M/uL 3.70 - 5.10 M/uL Hemoglobin 12.5 g/dL 11.3 - 15.5 g/dL Hct 37.6 % 34.0 - 46.0 % MCV 89.7 fL 80.0 - 100.0 fL MCH 29.8 pg 27.0 - 34.0 pg MCHC 33.2 g/dL 32.0 - 35.5 g/dL RDW-CV 13.7 % 11.0 - 15.5 % Platelet Count 245 K/uL 150 - 400 K/uL % Neutrophils 52.9 % % % Lymphocytes 24.3 % % % Monocytes 20.7 % % % Eosinophils 1.1 % % % Basophils 0.8 % % % Immature Granulocytes 0.2 % 0.0 - 1.0 % Absolute Neutrophils 2.5 K/uL 1.9 - 7.4 K/uL Absolute Lymphocytes 1.1 K/uL 1.0 - 3.9 K/uL Absolute Monocytes 1.0 K/uL 0.0 - 0.8 K/uL Absolute Eosinophils 0.1 K/uL 0.0 - 0.2 K/uL Absolute Basophils 0.0 K/uL 0.0 - 0.2 K/uL Absolute Immature Granulocytes 0.01 K/uL 0.00 - 0.03 K/uL

Allergies: None

Symptoms: Trachycardia, syncope, dizziness, facial swelling, full body numbness, rash over arms

Other Meds: Women's multivitamin

Current Illness: None

ID: 0978536
Sex: U
Age:
State:

Vax Date: 12/02/2020
Onset Date: 12/02/2020
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On 2nd December 2020, the patient received the 2nd dose of Shingrix. On 2nd December 2020, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved. It was unknown if the reporter considered the fever to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but selected as adult as per vaccine indication. The patient received the 2nd dose of Shingrix and experienced fever. The patient inquired that how long fever would last. The information regarding consent to follow up was not reported. No further information was available.

Other Meds:

Current Illness:

ID: 0978537
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Was never so sick in my life; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved. It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season. Additional information was provided as follows: The age at vaccination was not reported. The doctor said the patient was old and need to get a flu shot. The vaccine was received 3 years before reporting and the patient was never so sick in his/her life. The patient did get one after that dose and been just fine.

Other Meds:

Current Illness:

ID: 0978538
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0978539
Sex: F
Age: 0
State: AK

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

Lab Data: None

Allergies: PCN, Septra, Sulfa

Symptoms: Monday 1-25-2021 #2 vacination COVID--Onset 4pm body aching then at 9pm fever 101 and felt tired, achy. Following day tired and less aching.

Other Meds: Tylenol

Current Illness: None

ID: 0978540
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0978541
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0978542
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0978543
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0978544
Sex: F
Age: 60
State: CA

Vax Date: 01/19/2021
Onset Date: 01/20/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: First vaccine small bruise at her left knee and extreme pain in her neck, shoulder and left arm and missed work. Second vaccine she has 4 bruises and clots on her inner leg from ankle to thigh. So painful she can't sleep and she is having a hard time walking. Her left shoulder is limited due to extreme pain. She sought care from her physician and he is sending her for scans that the facility is requiring a deposit.

Other Meds:

Current Illness:

ID: 0978545
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0978546
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0978547
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0978548
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm