VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 0976535
Sex: F
Age:
State: FL

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: arm soreness; This case was reported by a consumer and described the occurrence of pain in arm in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with 1st dose of Shingrix and experienced arm soreness For tolerance with 2nd dose refer case US2020242307. The reporter did not consented to follow up.; Sender's Comments: US-GLAXOSMITHKLINE-US2020242307:same reporter

Other Meds:

Current Illness:

ID: 0976536
Sex: F
Age: 68
State: KY

Vax Date: 12/04/2020
Onset Date: 12/01/2020
Rec V Date: 01/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: first dose of Shingrix on 1/9/2020 / never received the second dose due to COVID-19 / / receiving first does / on 1/9/2020 and / second dose on 12/4/2020; pain and soreness at the site of injection; series of bumps along the spine / under the skin / above the skin / base of the neck / continue down below the bra strap; bumps have a pink-ish hue that varies from day to day; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 9th January 2020). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown. Additional details were provided as follows: The age at vaccination was not applicable. The patient never received the second dose due to COVID-19. The reporter consented to follow up. Follow up information was received from consumer on 5th January 2021: The patient received 2nd dose of Shingrix on 4th December 2020 and less than 2 months, the patient had pain and soreness at the site of injection. The reporter reported developing a series of bumps along the spine a day and a half after receiving 2nd dose of Shingrix. The patient stated that the bumps began under the skin and were currently above the skin. The bumps begin at the base of the neck and continue down below the bra strap and were in a straight line. The bumps were of the same or very similar size. The bumps had a pinkish hue that varies from day to day. The patient reported no pain associated with these bumps. The reporter consented to follow up.; Sender's Comments: US-GLAXOSMITHKLINE-US2021001360:same patient, 1st dose

Other Meds:

Current Illness:

ID: 0976537
Sex: F
Age: 62
State: NY

Vax Date: 12/08/2020
Onset Date: 12/09/2020
Rec V Date: 01/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: shingles; This case was reported by a pharmacist and described the occurrence of shingles in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 7Z9H3, expiry date 7th October 2022) for prophylaxis. On 8th December 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 9th December 2020, 1 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 information was provided as follows: The patient received the dose and shingles presented the next day. It was under her right breast and around her back on the right side. It was noted that the patient never had chicken pox. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 0976538
Sex: F
Age: 54
State: CA

Vax Date: 12/14/2020
Onset Date: 12/15/2020
Rec V Date: 01/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: fever; nausea; This case was reported by a consumer and described the occurrence of fever in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 14th December 2020, the patient received the 1st dose of Shingrix. On 15th December 2020, 1 days after receiving Shingrix, the patient experienced fever and nausea. On an unknown date, the outcome of the fever and nausea were not recovered/not resolved. It was unknown if the reporter considered the fever and nausea to be related to Shingrix. Additional information was provided as follows: The case was reported by patient's sister. The next day of receiving vaccine, the patient reported experiencing nausea and a fever. The reporter was asking for medical advice on how to treat the symptom and did not have time to do a report. The reporter did not consent to follow-up.

Other Meds:

Current Illness:

ID: 0976539
Sex: F
Age: 55
State: CT

Vax Date: 12/16/2020
Onset Date: 12/01/2020
Rec V Date: 01/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Headache / ongoing; Fatigue / ongoing; Arm soreness; This case was reported by a consumer and described the occurrence of pain in arm in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 16th December 2020, the patient received Shingrix (intramuscular). In December 2020, less than a week after receiving Shingrix, the patient experienced pain in arm. On 21st December 2020, the patient experienced headache and fatigue. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the headache and fatigue were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, headache and fatigue to be related to Shingrix. Additional details were reported as follows: The patient received the Shingrix dose and experienced arm soreness for a day or two after receiving the vaccine. The patient experienced headache and fatigue and ongoing till the time of report. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 0976540
Sex: F
Age: 34
State: GA

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 01/27/2021
Hospital: Y

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: Psychiatric symptoms; Talking really fast; Not being with it, acting strange; Not coherent; A spontaneous report was received from a physician who was also a 34-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and developed psychiatric symptoms, talking really fast, acting strange, and incoherent. 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: 026L20A) on 05 Jan 2021 in the left arm for prophylaxis of COVID-19 infection. On 06 Jan 2021, she experienced psychiatric symptoms. She started talking very fast, not being with it, acting strange, and incoherent. The symptoms got progressively worse by that evening and was taken to the emergency room. She was treated with an intramuscular antipsychotic and observed overnight. On 07 Jan 2021, the patient was discharged from the hospital. Since she has been released from the hospital, she has been fine. Action taken with mRNA-1273 in response to the events was not provided. The events, psychiatric symptoms, talking really fast, acting strange, and incoherent, were considered resolved on 07 Jan 2021.; Reporter's Comments: This report refers to a case of 34- year-old female patient who experienced serious unexpected events psychiatric symptoms, talking really fast, "not being with it," acting strange, and incoherent 13 hours after administration of mRNA-1273, lot # 026L20A, Exp date-unknown. Based on temporal association between the use of the product and the start date of the reported events and the absence of any other etiology factors, a causal association cannot be excluded.

Other Meds:

Current Illness:

ID: 0976541
Sex: F
Age: 72
State: FL

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Collapsed; Unable to walk on her own; Muscle pain; Nausea; Vomiting; Headache at the base of her head and neck; A spontaneous report was received from a consumer concerning a 72-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, collapsed, unable to walk on her own, muscle pain, nausea, vomiting, and headache at the base of her head and neck. The patient's medical history, as provided by the reporter, included stroke. No relevant concomitant medications were reported. On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot Number: 026L20A) in the left deltoid for prophylaxis of COVID-19 infection. On 30 Dec 2020, after vaccine administration, the patient experienced a headache at the base of her head and neck. On 03 Jan 2021, the patient collapsed and was unable to walk on her own. She was hospitalized from 04 Jan 2021 to 05 Jan 2021. She also experienced muscle pain, nausea, and vomiting. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, collapsed, unable to walk on her own, muscle pain, nausea, vomiting, and headache at the base of her head and neck, was unknown.; Reporter's Comments: This case concerns a 72 year old, female patient with a history of stroke, who experienced a serious unexpected event of fall, gait inability and non-serious expected event of myalgia, nausea, vomiting and headache. The event of headache occurred same day after first dose mRNA-1273 (Lot# 026L20A) administration. The event of fall and gait inability occurred 5 days after first dose of mRNA-1273. The event of myalgia, nausea, vomiting occurred on an unspecified date after mRNA-1273 (Lot# 026L20A) administration. The treatment medications were not provided. 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:

ID: 0976542
Sex: F
Age: 27
State: CO

Vax Date: 12/30/2020
Onset Date: 01/09/2021
Rec V Date: 01/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Cellulitis at middle arm and not on deltoid; Redness which is 3in in size; Itching; Hives; A spontaneous report was received from a nurse concerning a 27-year old, female patient who received Moderna's COVID-19 vaccine and experienced cellulitis at middle arm and not on deltoid, redness which is 3in in size, itching, and hives. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) for prophylaxis of COVID-19 infection. On 09 Jan 2021, the patient experienced redness which is 3in in size, itching, and what the patient described as hives. The patient went to urgent care where she was diagnosed with cellulitis at middle arm and not on deltoid. Treatment for the events included antibiotic and loratadine. Action taken with mRNA-1273 in response to the events was unknown. The events cellulitis at middle arm and not on deltoid, redness which is 3in in size, itching, and hives were considered not recovered/not resolved.; Reporter's Comments: This case concerns a 27 year old, female patient, who experienced a serious unexpected event of cellulitis; non-serious unexpected event of pruritus and urticaria and a non-serious expected event of erythema. The event of cellulitis, erythema, pruritus, and urticaria occurred 11 days after first dose mRNA-1273 (Lot# 025J20-2A) administration. The treatment medications included Claritin and antibiotics. 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:

ID: 0976543
Sex: F
Age: 69
State: KS

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 01/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Intermittent paralyzed left side; Hives; itching; Redness; Shortness of breath; A spontaneous report was received from a nurse who was also a 70-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed left sided paralysis, shortness of breath, hives, itching, and redness. The patient's medical history included asthma. Products known to have been used by the patient, within two weeks prior to the event, included albuterol sulfate, epinephrine and diphenhydramine. On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 075T202A) intramuscularly for prophylaxis of COVID-19 infection. On 05 Jan 2021, after receiving the vaccine the patient developed redness, itching and shortness of breath. On 06 Jan 2021, she developed hives and was paralyzed after sleeping. She experienced paralysis on the left side and her right side felt heavy. Treatment for the events included diphenhydramine, epinephrine, and albuterol. Action taken with the second dose of mRNA-1273 in response to the events was not provided. The events, paralysis on the left side and hives, was considered resolved on 07 Jan 2021. The events, redness, itching and shortness of breath, was considered resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 70 year old, female patient, with a medical history of asthma, who experienced a serious unexpected event of hemiplegia, a non-serious unexpected event of dyspnoea, urticaria, pruritus and a non-serious expected event of erythema. The event of dyspnoea, pruritus, and erythema occurred 1 day after first dose mRNA-1273 (Lot# 075T202A) administration. The event of hemiplegia and urticaria occurred 3 days after first dose mRNA-1273 (Lot# 075T202A) administration. Both concomitant and treatment medications included Benadryl, Primatene mist and albuterol. 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: ALBUTEROL SULFATE; PRIMATENE MIST; BENADRYL N

Current Illness: Asthma

ID: 0976544
Sex: F
Age: 79
State: TX

Vax Date: 01/08/2021
Onset Date: 01/11/2021
Rec V Date: 01/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Fainted; A spontaneous report was received from a consumer concerning a 79-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and fainted. The patient's medical history included diabetes, cholesterol, hypertension, and osteoporosis. Concomitant product use reported included unspecified medications for diabetes, cholesterol, high blood pressure, and osteoporosis. On 08 Jan 2021, approximately three days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: VW7392) intramuscularly in the arm for prophylaxis of COVID-19 infection. On 11 Jan 2021, the patient fainted at 3:00 am and again at 7:00 pm. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported . The outcome for the event, fainting, was not reported.; Reporter's Comments: This case concerns a 79 year old female subject, with medical history of diabetes, cholesterol and hypertension, who experienced a serious unlisted event of syncope. The event occurred 3 days after the first dose of mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However a definitive assessment is confounded by the patient's history of diabetes and hypertension.

Other Meds:

Current Illness: Blood pressure high; Cholesterol; Diabetes; Osteoporosis

ID: 0976545
Sex: F
Age: 66
State: FL

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: Lost consciousness for about 5 minutes; Couldn't move her leg; Started feeling lightheaded, dizzy; Body started feeling weak; Right arm started shaking; Left leg felt very heavy; Couldn't wiggle her toes; A spontaneous report was received from a consumer concerning a 66-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273), and who experienced feeling lightheaded, dizzy, body started feeling weak. Right arm started shaking, lost consciousness for about 5 minutes. Her left leg felt very heavy and couldn't move her leg or wiggle her toes. Concomitant product use was not provided by the reporter. On 07 Jan 2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 026L20A) intramuscularly in left arm for prophylaxis of COVID-19 infection. After patient got the vaccine, she drank some water because she was lightheaded and dizzy. She was offered crackers by the nurse. After her body started shaking, a nurse wheeled her to the emergency room. Her computerized tomogram scan on her head and magnetic resonance imaging of back came back normal. Blood tests were normal. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The event, lost consciousness was considered recovered/resolved on 07 Jan 2021. The events left leg felt very heavy and couldn't move it and couldn't wiggle her toes were considered recovered/resolved on 11 Jan 2021. The outcome of the events, lightheaded, body started feeling weak and right arm started shaking was not reported.; Reporter's Comments: This case concerns a 66-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 026L20A), and who experienced the serious unlisted events of Loss of consciousness and Monoplegia and non-serious unlisted events of Dizziness, Asthenia, Tremor, Limb discomfort, and Musculoskeletal disorder. 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.

Other Meds:

Current Illness:

ID: 0976546
Sex: M
Age: 34
State: PA

Vax Date: 12/30/2020
Onset Date: 01/05/2021
Rec V Date: 01/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Face and chin numb for two days; Stiffness; Stiffness around the collar bone; Pain on left side; Swelling around the collar bone; Pea sized lump; Black and blue on left side; Tender at collar bone and shoulder; A spontaneous report was received from a consumer concerning a 34-year old, male patient who received Moderna's COVID-19 vaccine and experienced swelling, stiffness around the collar bone, pain on the left side, a pea-sized lump, face and chin numbness, black and blue skin on the left side, and tenderness at the collar bone and shoulder. The patient's medical history was not provided. No relevant concomitant medications were reported. On 30 Dec 2020, approximately 6 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 05 Jan 2021, the patient reported that he experienced swelling and stiffness around his collar bone, a pea-sized lump, pain on his left side and face and chin numbness for 2 days. Most symptoms resided at time of report, but the patient was still black and blue on the left side and tender at his collar bone and shoulder. Treatment for the event included heating pad and paracetamol. Action taken with mRNA-1273 in response to the events was not reported. The event, face and chin numbness, was considered recovered/resolved on 07 Jan 2021. The events, swelling, stiffness around the collar bone, pain on the left side, a pea-sized lump, was considered resolved on an unknown date.The events, black and blue skin on the left side and tenderness at the collar bone and shoulder, were considered not recovered/not resolved.; Reporter's Comments: This case concerns a 34-year old, male patient, who experienced a serious unexpected event of numb chin syndrome, and non-serious unexpected event of musculoskeletal stiffness, pain, swelling, nodule, contusion, and tenderness. The events occurred 7 days after first dose of mRNA-1273, lot # 026L20A. Treatment included Tylenol and heating pad. Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and onset of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 0976547
Sex: F
Age:
State: NJ

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: body aches; temperature on 08JAN2021 was 100.2; headache; palpitations; blood pressure was 200/109; heart rate which was 130; chest and neck was red; rashes on both arm; left arm in the evening was soo stiff up to her elbow; developed a lymph node in her left armpit; A spontaneous report was received from a 62-years-old, female nurse, who was also the patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced palpitations, blood pressure was 200/109, heart rate which was 130, chest and neck was red, rashes on both arms, left arm in the evening was so stiff up to her elbow, body aches, developed a lymph node in her left armpit, temperature on 08JAN2021 was 100.2, and headache. The patient's medical history included being diabetic. Products known to have been used by the patient, within two weeks prior to the event, included sitagliptin metformin, clonidine, losartan, repaglinide, rosuvastatin, and glimepiride. On 07 Jan 2021 at 08:05, approximately 20 minutes prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection. On 07 Jan 2021, 20 minutes after receiving the vaccine, the patient felt palpitations. She checked her blood sugar due to her being diabetic, which was okay. The palpitation was going faster, her chest and neck were red, and she felt like she was choking from the palpitation. The patient returned to where the vaccine was administered where her heart rate was found to be 130 and her blood pressure was 200/109. She had small pin-point rashes on both arms. She was taken to the emergency on 07 Jan 2021 where she had blood work done, and she was given 500CC of normal saline and was released the same day. The rashes on her arms faded on Thursday (07 Jan 2021), and her left arm in the evening was so stiff up to her elbow. She also developed a lymph node in her left armpit. Her temperature was 100.2 on 08 Jan 2021 and she took a paracetamol. The patient had body aches and a headache starting on Friday (08 Jan 2021) up until Saturday (09 Jan 2021). Treatment for the events included 500CC of normal saline and paracetamol. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events palpitations, blood pressure was 200/109, heart rate which was 130, chest and neck was red, left arm in the evening was so stiff up to her elbow, developed a lymph node in her left armpit, and temperature on 08JAN2021 was 100.2 was unknown. The event rashes on both arms was considered recovered/resolved on 07 Jan 2021, and the events body aches and headache were considered recovered/resolved on 09 Jan 2021.; Reporter's Comments: This spontaneous report refers to a case of a 62-year-old female patient with medical history of diabetes, who experienced serious events of palpitations and blood pressure 200/109 and non-serious events of heart rate was 130, chest and neck was red, rashes on both arms , left arm in the evening was soo stiff up to her elbow, body aches, lymph node in her left armpit, and headache 20 minutes after the administration of the first and only dose of mRNA-127 (Lot number unknown, Exp date-unknown). Normal saline was administered, and the patient was released the same day The patient also experienced elevated temperature of 100.2, 1 day after vaccine administration. Based on temporality and the absence of any other etiology factors, a causal association between the events and vaccine administration cannot be excluded

Other Meds: SITAGLIPTIN METFORMIN; CLONIDINE; LOSARTAN; REPAGLINIDE; ROSUVASTATIN; GLIMEPIRIDE

Current Illness: Diabetic

ID: 0976548
Sex: F
Age:
State: NY

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: Tonsillitis; A spontaneous report was received from a female consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced tonsillitis. The patient's medical history was not provided. No relevant concomitant medications were reported. On 08 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection. On an undisclosed date, the patient experienced tonsillitis. Treatment for the event included antibiotics. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, tonsillitis, was considered unknown.; Reporter's Comments: event of tonsillitis occurred on an unspecified date after the first dose of mRNA-1273 (lot # unknown) administration. She was treated with antibiotics (details not provided. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 0976549
Sex: F
Age: 73
State: CO

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: Atrial Fibrillation; Tachycardia (Double heart rate); A spontaneous report was received from a 73-year-old female consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced atrial fibrillation and tachycardia. The patient's medical history was not provided No relevant concomitant medications were reported. On 09 Jan 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 10 Jan 2021, the patient reported having atrial fibrillation and tachycardia. Treatment for the events included metoprolol. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, atrial fibrillation and tachycardia, were considered not resolved.; Reporter's Comments: This case concerns a 73-year-old, female patient. The patient's medical history was not provided. The patient experienced an unexpected event of Atrial fibrillation and tachycardia. The event occurred 2 days after the first dose of mRNA-1273. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 0976550
Sex: F
Age: 56
State: CT

Vax Date: 01/05/2021
Onset Date:
Rec V Date: 01/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: Second dose scheduled 42 days later; A spontaneous report was received from a 56-year-old female consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and had second dose Moderna COVID-19 vaccine scheduled for 42 days later. The patient's medical history was not provided. No relevant concomitant medications were reported. On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection. After receiving the first vaccine on 05 Jan 2021, the second appointment was canceled so the computer system made her another appointment for her second Moderna Covid-19 vaccine on 16 Feb 2021 which is 42 days later and not within the recommended timeline. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, had second dose Moderna COVID-19 vaccine scheduled for 42 days later, was considered resolved.; Reporter's Comments: This report refers to a case of intercepted medication error for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of intercepted medication error.

Other Meds:

Current Illness:

ID: 0976551
Sex: F
Age: 25
State: VT

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

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: Looked like cellulitis; Redness had spread; Painful; Itchy; Arm became really hard and swollen; Dose above deltoid; A spontaneous report was received from a consumer concerning a 25-years-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed hard and swelling, itchiness, redness and pain at the injection site which resembled cellulitis, and she received the vaccine in the wrong anatomical location. The patient's medical history and relevant concomitant medications were not reported. On 04 Jan 2021, the same day as the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the upper shoulder joint for prophylaxis of COVID-19 infection. On 11 Jan 2021 the patient's arm became hard, swollen, itchy, and painful. On 12 Jan 2021 the patient's arm was red and resembled cellulitis. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, she received the vaccine in the wrong anatomical location, was resolved on 04 Jan 2021. The outcome of the event itchiness resolved on 12 Jan 2021. The outcome of the events swelling and pain at the injection site which resembled cellulitis were not reported..; Reporter's Comments: This case concerns a 25 years old female patient, who experienced product administration error, and a non-serious unexpected event of limb discomfort, vaccination site cellulitis, and non-serious expected event of pruritus, pain and redness. There were no reported AEs associated with this case of product administration error. The events of limb discomfort, pruritus, and pain occurred 8 days after first dose of mRNA-1273, lot # unknown. The event of erythema, and vaccination site cellulitis occurred 9 days after first dose of mRNA-1273, lot # unknown. Treatment details was not provided. Based on the current available information and temporal association between the use of the product and onset of the events (vaccination site cellulitis, pruritus, limb discomfort, pain and redness) a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 0976552
Sex: F
Age: 53
State: PA

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

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Arm soreness; vaccine was not administered in the deltoid muscle - it was 4 or 5 inches lower on arm; A spontaneous report/solicited was received from a 53-year-old female nurse who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced vaccine was not administered in the deltoid muscle, it was 4 or 5 inches lower on arm. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 09 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 in the arm for prophylaxis of COVID-19 infection. After receiving the vaccine, the patient reports that the vaccine was not administered in the deltoid muscle, it was 4 or 5 inches lower on arm. It was unknown if the vaccine was given intramuscularly. The patient also experienced arm soreness. No treatment was rendered for the event. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, vaccine was not administered in the deltoid muscle, it was 4 or 5 inches lower on arm, was considered resolved on 09 Jan 2021. The outcome of the event, sore arm, was unknown.; Reporter's Comments: This case concerns a 53-year old female patient who experienced an unexpected non-serious event of Pain in extremity after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Additionally, the patient had Product administered at inappropriate site. Based on temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.

Other Meds:

Current Illness:

ID: 0976553
Sex: F
Age: 70
State: AZ

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

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Headache; Fatigue; Nausea; When it was injected quite a bit ran down my arm; A spontaneous report was received from a 70-year-old female nurse who received Moderna's COVID-19 Vaccine (mRNA-1273) and when it was injected quite a bit ran down the arm and the patient experienced headache, fatigue and nausea. The patient's medical history was not provided. The patient current condition included autoimmune disorder. No relevant concomitant medications were reported. On 11 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 025J20-2A) intramuscularly in the arm for prophylaxis of COVID-19 infection. During the administration of the vaccine, the patient experienced when it was injected, quite a bit ran down the arm. On 12 Jan 2021, the patient woke up with a headache, fatigue and had nausea. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, when it was injected quite a bit ran down the arm, was considered resolved on 11 Jan 2021. The outcome of the events, headache, fatigue and nausea, were considered resolved on 12 Jan 2021.; Reporter's Comments: This spontaneous report refers to a case of q 70-year-old female patient who experienced non-serious events of when it was injected quite a bit ran down the arm (Incomplete dose administered) and the patient experienced headache, fatigue and nausea to hours after administration of mRNA-1273 (lot # 025J20-2A), Exp date-unknown). The events of headache, fatigue and nausea are temporally associated with vaccine administration and consistent with the known safety profile of the vaccine, hence a causal association cannot be excluded. The event of when it was injected quite a bit ran down the arm is considered not applicable.

Other Meds:

Current Illness: Autoimmune disorder

ID: 0976554
Sex: M
Age: 75
State: TX

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

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: After the vaccines lost temperature they were administered; A spontaneous report was received from a healthcare professional concerning a 75-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered. The patient's medical history was not provided. No relevant concomitant medications were reported. On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature. On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The event, after the vaccines lost temperature they were administered, was considered resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 75-year-old male patient who received their first of two planned doses of mRNA-1273 (Lot: 027L20A), reporting Out of specification product use.

Other Meds:

Current Illness:

ID: 0976555
Sex: F
Age: 74
State: TX

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: After the vaccines lost temperature they were administered; A spontaneous report was received from a healthcare professional concerning a 74-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event of the vaccine administered after the refrigerator lost power in vaccine clinic and lost temperature control. The patient's medical history was not provided. No relevant concomitant medications were reported. On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature. On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The event, the vaccine administered after the refrigerator lost power in a vaccine clinic and lost temperature control, was considered resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 74-year-old, female patient who received her first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection after a refrigerator in a vaccine clinic lost power and temperature control. There we no reported adverse events associated with the event of vaccine administered after a refrigerator in a vaccine clinic lost power and lost temperature control.

Other Meds:

Current Illness:

ID: 0976556
Sex: F
Age: 68
State: TX

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: After the vaccines lost temperature they were administered; A spontaneous report was received from a healthcare professional concerning a 68-year-old, White, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered. The patient's medical history was not provided. No relevant concomitant medications were reported. On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature. On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The event, after the vaccines lost temperature they were administered, was considered resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 68-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot: 027L20A), reporting Out of specification product use.

Other Meds:

Current Illness:

ID: 0976557
Sex: U
Age:
State: TX

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: After the vaccines lost temperature they were administered; A spontaneous report was received from a healthcare professional concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered. The patient's medical history was not provided. No relevant concomitant medications were reported. On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature. On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The event, after the vaccines lost temperature they were administered, was considered resolved on 12 Jan 2021.; Reporter's Comments: This report refers to a case of a patient who experienced non-serious event after the vaccines lost temperature they were administered (Product storage error, out of specification product use) for mRNA-1273, lot # 027L20A), Exp date-unknown. There were no reported AEs associated with the event lost temperature they were administered.

Other Meds:

Current Illness:

ID: 0976558
Sex: F
Age: 74
State: TX

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: After the vaccines lost temperature they were administered; A spontaneous report was received from a healthcare professional concerning a 74-year-old, White female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered. The patient's medical history was not provided. No relevant concomitant medications were reported. On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature. On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The event, after the vaccines lost temperature they were administered, was considered resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 74-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot: 027L20A), reporting Out of specification product use.

Other Meds:

Current Illness:

ID: 0976559
Sex: F
Age: 82
State: TX

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: After the vaccines lost temperature they were administered; A spontaneous report was received from a healthcare professional concerning a 82-year-old, Black or African American, female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered. The patient's medical history was not provided. No relevant concomitant medications were reported. On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature. On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The event, after the vaccines lost temperature they were administered, was considered resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 82-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot: 027L20A), reporting Out of specification product use.

Other Meds:

Current Illness:

ID: 0976560
Sex: F
Age: 77
State: TX

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: After the vaccines lost temperature they were administered; A spontaneous report was received from a healthcare professional concerning a 77-year-old, White female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered. The patient's medical history was not provided. No relevant concomitant medications were reported. On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature. On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The event, after the vaccines lost temperature they were administered, was considered resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 77-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot: 027L20A), reporting Out of specification product use.

Other Meds:

Current Illness:

ID: 0976561
Sex: U
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

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: 0976562
Sex: U
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

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: 0976563
Sex: U
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

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: 0976564
Sex: U
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Nausea

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: 0976565
Sex: U
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

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: 0976566
Sex: U
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

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: 0976567
Sex: U
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

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: 0976568
Sex: U
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Tremor

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: 0976569
Sex: U
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

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: 0976570
Sex: U
Age:
State: CA

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

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

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: 0976571
Sex: U
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

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: 0976572
Sex: U
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

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: 0976573
Sex: U
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

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: 0976574
Sex: U
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

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: 0976575
Sex: U
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

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: 0976576
Sex: U
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

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: 0976577
Sex: U
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

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: 0976578
Sex: U
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

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: 0976579
Sex: U
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

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: 0976580
Sex: U
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

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: 0976581
Sex: U
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

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: 0976582
Sex: U
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

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: 0976583
Sex: U
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

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: 0976584
Sex: U
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

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: 636,615

Page last modified: 03 October 2021 5:28pm