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: 1571480
Sex: F
Age: 73
State: FL

Vax Date: 01/05/2021
Onset Date: 01/07/2021
Rec V Date: 08/16/2021
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: Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012C20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included MULTIVITAMINS, PROLIA, and ANTIHISTAMINE ALLERGY for an unknown indication. On 05-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 06-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE REACTION. At the time of the report, VACCINATION SITE REACTION outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication was not provided. This case was linked to US-MODERNATX, INC.-MOD-2021-089334 (E2B Linked Report). Sender's Comments: US-MODERNATX, INC.-MOD-2021-089334: dose 2.

Other Meds: MULTIVITAMINS; PROLIA; ANTIHISTAMINE ALLERGY RELIEF

Current Illness:

ID: 1571481
Sex: F
Age: 80
State: NJ

Vax Date: 03/25/2021
Onset Date: 03/25/2021
Rec V Date: 08/16/2021
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: after first shot very dizzy lasted a week; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS and NAUSEA in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The patient's past medical history included COVID-19 in March 2020. Concomitant products included TOPROL XL for Blood pressure, LISINOPRIL, LIPITOR, NORVASC, and WELLBUTRIN for an unknown indication. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced DIZZINESS and NAUSEA. The patient was treated with ADVIL at a dose of 4 pills. On 03-Apr-2021, DIZZINESS and NAUSEA had resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Other treatment medication included anti-nausea pills. This case was linked to MOD-2021-089329 (Patient Link).

Other Meds: LISINOPRIL; LIPITOR; TOPROL XL; NORVASC; WELLBUTRIN XL

Current Illness:

ID: 1571482
Sex: M
Age: 66
State: CA

Vax Date: 02/10/2021
Onset Date: 02/24/2021
Rec V Date: 08/16/2021
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: a big red patch the size of a hand around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. No Medical History information was reported. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE RASH (around the injection site). At the time of the report, VACCINATION SITE RASH (around the injection site) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to US-MODERNATX, INC MOD-2021-089236 (E2B Linked Report). This case was linked to MOD-2021-089409 (Patient Link). Sender's Comments: US-MODERNATX, INC MOD-2021-089236:

Other Meds:

Current Illness:

ID: 1571483
Sex: F
Age: 47
State: TN

Vax Date: 03/25/2021
Onset Date: 03/25/2021
Rec V Date: 08/16/2021
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: My knee pain started on after three days; felt like shooting sharp pain in my knees; I feel my knees are still sore in the muscles; I fee sore in the joint of my knees; I feel I can not bending it; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS, ARTHRALGIA, ARTHRALGIA, MYALGIA, and ARTHRALGIA in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. Concomitant products included TYLENOL for an unknown indication. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS. On 27-Mar-2021, the patient experienced ARTHRALGIA, ARTHRALGIA, MYALGIA, and ARTHRALGIA. At the time of the report, MUSCULOSKELETAL STIFFNESS, ARTHRALGIA, ARTHRALGIA , MYALGIA, and ARTHRALGIA outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No medications were taken to help with the symptoms.

Other Meds: TYLENOL

Current Illness:

ID: 1571484
Sex: F
Age:
State: MD

Vax Date: 02/15/2021
Onset Date: 03/16/2021
Rec V Date: 08/16/2021
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: Reports feeling depressed; Feels a little "out of it"; Could not sleep for a couple of days; Light chills which became stronger that night; Low grade fever (100-101F),102F fever; Severe knee pain; Neck aches that felt like her "neck was going to break if she moved it".; Did not eat much for 2 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECK PAIN (Neck aches that felt like her "neck was going to break if she moved it".), DECREASED APPETITE (Did not eat much for 2 days), DEPRESSION (Reports feeling depressed), MALAISE (Feels a little "out of it") and INSOMNIA (Could not sleep for a couple of days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Depression. Concomitant products included METOPROLOL for Heart rate. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced NECK PAIN (Neck aches that felt like her "neck was going to break if she moved it".) and PYREXIA (Low grade fever (100-101F),102F fever). 16-Mar-2021, the patient experienced DECREASED APPETITE (Did not eat much for 2 days), INSOMNIA (Could not sleep for a couple of days), CHILLS (Light chills which became stronger that night) and ARTHRALGIA (Severe knee pain). On 19-Mar-2021, the patient experienced DEPRESSION (Reports feeling depressed) and MALAISE (Feels a little "out of it"). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever and Pain, at an unspecified dose and frequency; HYDROCORTISONE at an unspecified dose and frequency and CALAMINE, DIPHENHYDRAMINE HYDROCHLORIDE (CALADRYL [CALAMINE;DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 17-Mar-2021, NECK PAIN (Neck aches that felt like her "neck was going to break if she moved it".) and ARTHRALGIA (Severe knee pain) had resolved. On 18-Mar-2021, DECREASED APPETITE (Did not eat much for 2 days), INSOMNIA (Could not sleep for a couple of days) and PYREXIA (Low grade fever (100-101F),102F fever) had resolved. At the time of the report, DEPRESSION (Reports feeling depressed), MALAISE (Feels a little "out of it") and CHILLS (Light chills which became stronger that night) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Blood pressure measurement: 122/73 (Inconclusive) BP at 122/73. On 16-Mar-2021, Body temperature: 100 (High) low grade fever (100-101F) and 102 (High) 102 F. On 16-Mar-2021, Heart rate: 85-10 (Inconclusive) Resting heart rate is now85-90 BPM. Concomitant medication include unknown antidepressant. Treatment medications include Advil, Hydrocortisone cream, Caladryl (calamine lotion) This case was linked to MOD-2021-051947 (Patient Link).

Other Meds: METOPROLOL

Current Illness: Depression

ID: 1571595
Sex: M
Age: 1
State: PA

Vax Date: 11/28/2005
Onset Date: 02/01/2006
Rec V Date: 08/16/2021
Hospital:

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: the HCP conducted "blood tests against the new born blood tests and found that it was quite different"; the consumer was "very lethargic"; "lost his speech until seven years old"; MRI done and the results showed "some brain damage"; the consumers "eye color changed from bright blue to gray"; temperature of 104 F for three days; had the exact side effects that are listed at all intervals of two, four, and six weeks; This spontaneous report was received from the patient's mother, referring to a 1-year-old male patient. It was reported that the patient had drug reaction or allergies to Augmentin. The patient did not have other pertinent medical history or concomitant medications. On 28-NOV-2005, the patient was vaccinated with his first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (human serum albumin (HSA)) (M-M-R II) at a dose of 0.5 milliliter (mL), by injection route in the left thigh as prophylaxis recommended by the doctor (exact route of administration and vaccination scheme frequency were not reported; lot number 0378R has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), expiration date reported and but upon internal validation established as 24-MAR-2007). On an unknown date in 2005, the patient had the exact side effects that are listed at all intervals of two, four, and six weeks (vaccination complication) and ending with a temperature of 104 degrees Fahrenheit (F) for three days (pyrexia). The patient was treated with Tylenol and Ibuprofen. On unknown date in February 2006 (reported as "at 18 months of age"), the patient eye color changed from bright blue to gray (eye colour change). On an unknown date in 2007 (reported as "at three years old"), the patient had an magnetic resonance imaging (MRI) done and the results showed "some brain damage" (brain injury). On an unknown date, the healthcare professional (HCP) conducted "blood tests against the new born blood tests and found that it was quite different" (blood test abnormal). After the initial event the reporter stated that the patient was "very lethargic" (lethargy) and "lost his speech until seven years old" (aphasia) only gaining it back after extensive speech therapy. It was reported that the patient sought medical attention. Under the recommendation from the HCP, the patient did not get the second shot. The outcome of the events brain injury, eye colour change, lethargy and blood test abnormal were not reported. The outcome of the events vaccination complication, pyrexia and aphasia was reported as resolved. The causal relationship between the event vaccination complication was considered to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (HSA) (M-M-R II). The causal relationship between the event brain injury, eye colour change, lethargy, blood test abnormal, pyrexia and aphasia and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (HSA) (M-M-R II). Upon internal review, the event brain injury was considered to be medically significant.

Other Meds:

Current Illness: Allergic reaction to antibiotics

ID: 1571597
Sex: F
Age:
State: MD

Vax Date: 12/31/2020
Onset Date: 01/02/2021
Rec V Date: 08/16/2021
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: Pyrexia, White blood cell count decreased

Symptoms: Eye irritation; Eye pruritus; Lip swelling; Paraesthesia oral; Pruritus; Swelling of eyelid; Urticaria; This case was received via United States FDA VAERS (Reference number: 0917887) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of EYE IRRITATION (Eye irritation), EYE PRURITUS (Eye pruritus), LIP SWELLING (Lip swelling), PARAESTHESIA ORAL (Paraesthesia oral) and PRURITUS (Pruritus) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011220A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 02-Jan-2021, the patient experienced EYE IRRITATION (Eye irritation), EYE PRURITUS (Eye pruritus), LIP SWELLING (Lip swelling), PARAESTHESIA ORAL (Paraesthesia oral), PRURITUS (Pruritus), SWELLING OF EYELID (Swelling of eyelid) and URTICARIA (Urticaria). At the time of the report, EYE IRRITATION (Eye irritation) and PARAESTHESIA ORAL (Paraesthesia oral) had resolved and EYE PRURITUS (Eye pruritus), LIP SWELLING (Lip swelling), PRURITUS (Pruritus), SWELLING OF EYELID (Swelling of eyelid) and URTICARIA (Urticaria) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1571598
Sex: F
Age:
State: GA

Vax Date: 12/24/2020
Onset Date: 12/24/2020
Rec V Date: 08/16/2021
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: Body Malaise; Aches and pain; Fever; This case was received via United States FDA VAERS (Reference number: 909064) on 18-Jan-2021 and was forwarded to Moderna on 18-Jan-2021. This spontaneous case was reported by a health care professional and describes the occurrence of MALAISE (Body Malaise), PAIN (Aches and pain) and PYREXIA (Fever) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0262201A) for COVID-19 vaccination. No Medical History information was reported. On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 24-Dec-2020, the patient experienced MALAISE (Body Malaise), PAIN (Aches and pain) and PYREXIA (Fever). At the time of the report, MALAISE (Body Malaise), PAIN (Aches and pain) and PYREXIA (Fever) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101.3 101.3. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Concomitant information was not provided.

Other Meds:

Current Illness:

ID: 1571603
Sex: U
Age:
State:

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 08/16/2021
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: now I have serious side effects / pain where the shot was injected; now I have serious side effects / Loss of arm muscle about 15 - 20 percent; now I have serious side effects / eyes are blurry / Blurry Eyes. Eyes changing daily; now I have serious side effects / shivers / Uncontrolled Shivering; now I have serious side effects / headache; vomiting; loss of taste for 1 week; This case was reported by a consumer and described the occurrence of shivers in a patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included covid-19 (in August 2020), loss of smell, taste loss, influenza-like symptoms, labored breathing (took approximately 10 to 12 weeks to be able to work again), difficulty breathing, transient ischemic attack (same exact time in the morning), transient ischemic attack (same exact time in the morning), covid-19 (in February 2020'), loss of smell, taste loss and influenza-like symptoms. Concurrent medical conditions included allergy to chemicals (severe allergy to THC, can not breath). In April 2021, the patient received the 1st dose of Shingrix. In April 2021, immediately after receiving Shingrix, the patient experienced shivers (serious criteria other: Serious as per reporter), headache (serious criteria other: Serious as per reporter), vomiting (serious criteria other: serious as per reporter), taste loss (serious criteria other: serious as per reporter) and blurred vision (serious criteria other: Serious as per reporter). On an unknown date, the patient experienced injection site pain (serious criteria other: Serious as per reporter) and muscle wasting (serious criteria other: Serious as per reporter). On an unknown date, the outcome of the shivers, headache, vomiting, blurred vision, injection site pain and muscle wasting were not recovered/not resolved and the outcome of the taste loss was recovered/resolved. The reporter considered the shivers, headache, vomiting, taste loss, blurred vision, injection site pain and muscle wasting to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient had Covid-19 symptoms in February 2020.The symptoms were loss of smell, loss of taste and flu like symptoms before Covid-19 was confirmed. The patient had Covid-19 in August 2020 and had same symptoms but much worse. Breathing was heavier and took Approx 10 to 12 weeks to be able to work again. The patient had serious side effects of Shingrix. Immediate, side effects were shivers, headache, vomiting, loss of taste for 1 week, eyes are blurry, etc. As of today, August 8 2021. The patient still had pain where the shot was injected, loss of arm muscle about 15 to 20 percent, blurry eyes and uncontrolled Shivering. The patient wrap in blankets when the patient was at home. The patient had blurry eyes. Eyes changing daily. The patient was due for the second shot in October but the patient was very scared the side effects might be much worse. The patient asked for advice.

Other Meds:

Current Illness: Allergy to chemicals (severe allergy to THC, can not breath)

ID: 1571604
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/16/2021
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: suspected vaccination failure; mild case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (before the shot). On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got mild case of shingles. The patient was glad, he/she got the Shingles shot. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirmation were not provided.

Other Meds:

Current Illness:

ID: 1571605
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/16/2021
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: suspected vaccination failure; I still get them; I have taken three shots; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. The patient received three shots of Shingles vaccine which led to extra dose administered. After receiving Shingles vaccine, the patient still got shingles. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation were not provided.

Other Meds:

Current Illness:

ID: 1571606
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/16/2021
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: Missed the window (2-6 months); This case was reported by a consumer via media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (first dose of shingrix vaccine received on 12th November 2020). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were reported as follows: The age at vaccination for this case was not applicable. The patient received first dose of shingrix and missed the window period of second dose (2 to 6 months), which led to incomplete course of vaccination. The patient enquired about to get second shot now to complete the series or must start over.

Other Meds:

Current Illness:

ID: 1571607
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/16/2021
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: Suspected vaccination failure; My Aunt / got the shingles; This case was reported by a consumer via interactive digital media (and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows The reporter had reported for her//his aunt. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.

Other Meds:

Current Illness:

ID: 1571608
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/16/2021
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: Suspected Vaccination Failure; herpes zoster; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included herpes zoster. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and herpes zoster. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the herpes zoster was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure and herpes zoster to be related to Shingrix and Shingrix. Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. The patient received both Shingrix doses last year from the date of reporting. After receiving Shingrix, the patient had herpes zoster again at the time of reporting. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation were not provided.

Other Meds:

Current Illness:

ID: 1571610
Sex: U
Age:
State:

Vax Date: 08/09/2021
Onset Date: 08/01/2021
Rec V Date: 08/16/2021
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: muscle fatigue; feeling exhausted; This case was reported by a consumer via media and described the occurrence of muscle fatigue in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 9th August 2021, the patient received the 1st dose of Shingrix. In August 2021, less than a week after receiving Shingrix, the patient experienced muscle fatigue and exhaustion. On an unknown date, the outcome of the muscle fatigue and exhaustion were unknown. It was unknown if the reporter considered the muscle fatigue and exhaustion to be related to Shingrix. Additional details were provided as follows: The patient reported the case for herself/himself. The age at vaccination was not reported. The patient received Shingrix first dose and felt exhausted and extreme muscle fatigue. The patient wanted to know how long did this last. The follow up would not be possible as no contact details were available.

Other Meds:

Current Illness:

ID: 1571611
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/16/2021
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: first dose in oct 2020 / never got my second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received in October 2020). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The patient wanted to know that did he/she start over. The patient had only few minutes and was hoping for a quick answer regarding 2nd dose and would need to try again call when he/she had more time. The follow up would not be possible as no contact details were available.

Other Meds:

Current Illness:

ID: 1571612
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/16/2021
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: "A couple" / received / first dose / 30AUG2018 / have not / received the next; This case was reported by a pharmacist via other manufacturer and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose on 30th August 2018). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter declined to provide further adverse events details or information. No additional adverse events reported. No additional information reported. This case had been linked with US2021AMR170420, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR170420:Same reporter. Patient 2/2.

Other Meds:

Current Illness:

ID: 1571613
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/16/2021
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: "A couple" / received / first dose / 30AUG2018 / have not / received the next; This case was reported by a pharmacist via other manufacturer and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose on 30th August 2018). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter declined to provide further adverse events details or information. No additional adverse events reported. No additional information reported. This case had been linked with US2021AMR170406, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR170406:Same reporter. Patient 1/2.

Other Meds:

Current Illness:

ID: 1571614
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/16/2021
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: I had the shot /still got/ Shingles/suspected vaccination failure; bad case of Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The patient reported the case for herself/himself. The age at vaccination was not reported. The patient received shingle shot and still got shingles. The patient stated that according to her/his doctor it was a bad case of Shingles. The follow up would not be possible as no contact details were available. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule and time to onset and laboratory confirmation for shingles were unknown.

Other Meds:

Current Illness:

ID: 1571615
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/16/2021
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: Suspected vaccination failure; Know someone who has Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows The age at vaccination was not reported. The reporter knew someone who had shingles at the time of reporting after receiving Shingles vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.

Other Meds:

Current Illness:

ID: 1571616
Sex: F
Age: 59
State: MA

Vax Date: 11/01/2020
Onset Date: 07/01/2021
Rec V Date: 08/16/2021
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: still with Bell's Palsy symptoms; shingles / still with / active shingles; Suspected vacination failure; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In November 2020, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. In July 2021, between 7 and 9 months after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the bell's palsy and shingles were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, bell's palsy and shingles to be related to Shingrix. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient had received both Shingrix doses and developed shingles 3 weeks before the date of reporting and she was still with Bell's Palsy symptoms and active shingles. Less than 9 months after receiving Shingrix, the patient experienced Bell's Palsy symptoms. Patient was planning to travel on November 2021. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles was unknown at the time of reporting. The reporter consented to follow up by fax.

Other Meds:

Current Illness:

ID: 1571618
Sex: F
Age: 51
State: FL

Vax Date: 08/06/2021
Onset Date: 08/06/2021
Rec V Date: 08/16/2021
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: it feels inflamed; itching / at injection site; redness / at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site inflammation in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included renal disease. On 6th August 2021, the patient received the 1st dose of Shingrix. On 6th August 2021, less than a day after receiving Shingrix, the patient experienced injection site inflammation, injection site itching and injection site erythema. On an unknown date, the outcome of the injection site inflammation and injection site itching were unknown and the outcome of the injection site erythema was not recovered/not resolved. It was unknown if the reporter considered the injection site inflammation, injection site itching and injection site erythema to be related to Shingrix. Additional details were provided as follows: This case was reported by the patient herself. The patient reported that, she received her first Shingrix shot on Friday. She experienced redness and itching at the injection site and stated that it felt inflamed. The patient did not provide a lot number or expiration date. The reporter consented to follow up.

Other Meds:

Current Illness: Renal disease

ID: 1571619
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 08/16/2021
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: LOSS OF HEARING; This case was reported by a consumer via call center representative and described the occurrence of hearing loss in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis. Concurrent medical conditions included allergy to antibiotic (amikacin allergy). On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced hearing loss (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss was unknown. It was unknown if the reporter considered the hearing loss to be related to Flu vaccine. Additional details were provided as follows: The case was reported by the mother of the patient. The age at vaccination was not reported. The patients mother stated that, the patient was allergic to amikacin. The reporter inquiring about amikacin in the flu shot currently. The reporter stated that, her daughter received the flu shot (by unknown manufacturer) previously and loss her hearing due to the daughter's allergy to amikacin. The reporter wanted to know if amikacin would be in the flu shot presently. The reporter did not provide time frame or timeline when the flu shot was administered to her daughter previously. The reporter did not provide any specific details about the flu shot such as vaccine name, dosage details, lot number, expiration date, etc. No additional patient information related to patient. The reporter abandoned the call before further details were obtained. The reporter did not provide permission to follow up with doctor.

Other Meds:

Current Illness:

ID: 1571620
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 08/16/2021
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: Suspected vaccination failure; Now has active shingles; Painful rash on back, rash on head and face; Painful rash; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (had a history of shingles for most of in her adulthood). On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and pain. On an unknown date, the outcome of the vaccination failure, shingles, rash and pain were unknown. It was unknown if the reporter considered the vaccination failure, shingles, rash and pain to be related to Shingrix and Shingrix. Additional details were provided as follows: The case was reported by the patient for herself. The age at vaccination was not reported. The patient stated that, she had received both the doses of Shingrix around 4 years before the date of reporting. The patient stated that, she now had active shingles with a painful rash on back, rash on head and face, referred her to health care professional. The reporter did not consent to follow up. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for shingles were not provided

Other Meds:

Current Illness:

ID: 1571621
Sex: M
Age: 62
State: IN

Vax Date: 03/29/2021
Onset Date: 03/29/2021
Rec V Date: 08/16/2021
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: administrated /batch recall on March 29 2021/ recall 10feb2021; administrated /batch recall on March 29 2021/ recall 10feb2021; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date 7th September 2022) for prophylaxis. On 29th March 2021, the patient received Shingrix. On 29th March 2021, unknown after receiving Shingrix, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown. Additional details were provided as follows: Health care professional reported that the patient was administered with recalled Shingrix vaccine lot, which led to recalled drug administered and drug dispensing error. The Shingrix batch was recalled on 10th February 2021. No adverse event was reported. The reporter consented to follow up. This is 1 of the six cases, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021169136:Same reporter. US-GLAXOSMITHKLINE-US2021169132:Same reporter. US-GLAXOSMITHKLINE-US2021169133:Same reporter US-GLAXOSMITHKLINE-US2021169134:Same reporter US-GLAXOSMITHKLINE-US2021169135:Same reporter

Other Meds:

Current Illness:

ID: 1571623
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/16/2021
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: Several patient were administrated with below freezing vaccines; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa-HBV-IPV (Pediarix) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) for prophylaxis, hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Havrix, Havrix Pre-Filled Syringe Device, Boostrix, Boostrix Pre-Filled Syringe Device, Engerix B and Menveo. On an unknown date, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Havrix, Havrix Pre-Filled Syringe Device, Boostrix, Boostrix Pre-Filled Syringe Device, Engerix B and Menveo, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not applicable. Several patients were administered with below freezing vaccines, which led to incorrect storage of drug. At time of report health care practitioner was unware of number of vaccines, which vaccine and when or to who it was administered no patient's identifiers provided, no batch number and expiration date provided no vaccination date provided. No adverse event was reported. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1571629
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 08/16/2021
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: never received the 2nd dose; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 5th October 2020, batch number 7SK92, expiry date 26th January 2022). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional case details were provided as follows: The age at vaccination was not applicable for this report. Health care professional reported that a patient never received the 2nd dose which led to incomplete course of vaccination. The reporter asked question if it needed repeat series. The reporter consented to follow up. VAERS details were reported for 1st dose of Shingrix.

Other Meds:

Current Illness:

ID: 1571630
Sex: F
Age:
State: NC

Vax Date:
Onset Date: 07/29/2021
Rec V Date: 08/16/2021
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: CHEST PAIN THAT HURT ALL NIGHT, ALL DAY FRIDAY AND INTO SATURDAY; SORE THROAT; BODY ACHES; CHILLS; REAL COLD ALL NIGHT; HEADACHE; This spontaneous report received from a health care professional concerned a 51 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 204B21A expiry: UNKNOWN) dose was not reported, administered on 29-JUL-2021 14:20 for prophylactic vaccination. No concomitant medications were reported. On 29-JUL-2021, the patient experienced chest pain that hurt all night, all day friday and into saturday. On 29-JUL-2021, the patient experienced sore throat. On 29-JUL-2021, the patient experienced body aches. On 29-JUL-2021, the patient experienced chills. On 29-JUL-2021, the patient experienced "real cold" all night. On 29-JUL-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore throat, headache, body aches, chills, chest pain that hurt all night, all day friday and into saturday and "real cold" all night was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1571631
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 08/16/2021
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: WETTING BED; BRAIN NOT FIRING PROPERLY, FEELS CONFUSION; WOBBLY COORDINATION; NARROWING OF THE SPINE; SWOLLEN HANDS AND FEET; INFLAMED ORGANS; LESIONS ON LIVER; JOINT FEELS SAUSAGES; PURPLE HANDS; BURNING AND SCREAMING PAIN; MULTIPLE HEMANGIOMAS ON LIVER; ARMS, HANDS, FEET GO TO SLEEP; DAILY CHILLS; LEFT ARM WEAKNESS, DEAD SHOULDER, HARD TO GET UP AND HARD TO GET UP OUT OF CAR; EXTREME PAIN IN ARM, SO SORE COULD NOT TOUCH; SPLITTING HEADACHE, DAILY HEADACHES; FACIAL DROOPING; CROHNS DISEASE; DROOLING WHEN TALK; This spontaneous report received from a patient concerned a 46 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: clostridium difficile infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total, administered on 10-MAY-2021 midday to left arm for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 10-MAY-2021, patient came home and had a headache (splitting and she still has daily headaches) and sore arm. She took Motrin (ibuprofen), slept for 10 hours and woke up in extreme pain, arm so sore could not touch it and then she took Epsom salt (magnesium sulfate) bath. Immediately after nap on unspecified date in May-2021 patient had facial drooping (which had improved but gets bad again when she was tired), drooling when talk, and vomiting violently for 5 days after the vaccination. On an unspecified date, patient's arms, hands, feet went to sleep. She had to take naps. Her joints felt like sausages. Patient experienced no appetite, diarrhea, crohns disease, wetting bed, brain was not firing properly (feeling of confusion). Coordination was wobbly. She had a new disease: narrowing of the spine. Her back felt like a piece of crackling wood. She was not able to walk. She had pain. Her organs were inflamed and experienced daily chills. Patient had swollen purple hands and swollen feet. When she leans over on the counter sometimes she had a hard time getting up and getting out of her car, she had left arm weakness and dead shoulder that made her hard to drive. Patient had screaming and burning pain. She went to the hospital on 19-JUN-2021. Whenever she had spoken to a medical doctor they told her that they do not know. On an unspecified date, Laboratory data included: CT scan (NR: not provided) resulted in multiple inflamed organs, 2.8 cm lesion on liver. Multiple hemangiomas on the liver, wrapping around liver. Cholesterol (NR: not provided) 246 ca protein (crohns was somewhere) where patient mentioned that it seems Guillain Barre reminiscent, and X-ray of lumbar spine, lumbar spine series (NR: not provided) resulted in disc degenerative disease, narrowing of the spinal column in multiple levels. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme pain in arm, so sore could not touch, had not recovered from splitting headache, daily headaches, and daily chills, and the outcome of facial drooping, left arm weakness, dead shoulder, hard to get up and hard to get up out of car, arms, hands, feet go to sleep, wetting bed, brain not firing properly, feels confusion, wobbly coordination, narrowing of the spine, inflamed organs, lesions on liver, purple hands, swollen hands and feet, burning and screaming pain, multiple hemangiomas on liver, joint feels sausages, drooling when talk and crohns disease was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210817703-COVID-19 VACCINE AD26.COV2.S -Facial drooping and Chron's disease. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.

Other Meds:

Current Illness:

ID: 1571632
Sex: U
Age:
State: CA

Vax Date:
Onset Date: 08/06/2021
Rec V Date: 08/16/2021
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: EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-AUG-2021, the patient experienced expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious. This case, from the same reporter is linked to 20210815116.

Other Meds:

Current Illness:

ID: 1571633
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 07/02/2021
Rec V Date: 08/16/2021
Hospital: Y

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: DEEP VEIN THROMBOSIS/BLOOD CLOT IN RIGHT LEG BELOW KNEE; BRUISING IN RIGHT HAND AND AREA IN LEFT HAND LIKE BRUISE; AREA OF BLEEDING UNDER SKIN IN LEFT UPPER ARM CLOSE TO VACCINATION SITE VERY DARK; 5 RED SPOTS FROM ELBOW TO HAND ON RIGHT AND LEFT ARM (BETWEEN THUMB TO INDEX FINGER); BLEEDING UNDER SKIN IN LEFT UPPER ARM CLOSE TO VACCINATION SITE; This spontaneous report received from a patient concerned an 83 year old female. The patient's weight was 130 pounds, and height was 65 inches. The patient's past medical history included ex smoker, surgery and concurrent conditions included bees allergy, insect allergy, alcohol user and non smoker and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with pregabalin, and oxycodone hydrochloride/paracetamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: unknown) dose was not reported, 1 total, administered on 18-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 02-JUL-2021, before a couple of days of hospitalization, patient had a red rash on left upper arm. The area was close to where patient received the vaccine. On the same date, at the hospital, patient was told that it was bleeding under the skin and not a rash. The area turned very dark. The area on left hand was like a bruise. On the right arm, patient had 5 red spots that run from her elbow to right hand. It was unknown as to the exact date that the bleeding rash on left arm first occurred. The issue on the right hand is recent. On both hands, the affected area on both hands between the thumb and index finger. On 04-JUL-2021, the patient had swelling in both legs, was difficult to walk. On 05-JUL-2021, the daughter of the patient took to the hospital and had blood test, ultrasound, chest x ray, EKG (electrocardiogram), the physician diagnosed from ultrasound patient with a blood clot in right leg. The blood was 9.6. On the same date, the patient was admitted in the hospital for 4 days and was put on Heparin for 4 days, then stopped Heparin and switched to Eliquis. On 08-JUL-2021, patient was discharged from the hospital. The patient was just now getting the mojo back and was using a cane for a while. They were not concerned, but patient should see a nephrologist (emergency room physician at hospital said). Patient stated that hospital did not have a nephrologist during the four days of the patient. The patient had appointment with nephrologist tomorrow. Patient was concerned and lived by own. The diet of the patient was fish and fresh vegetables and numerous fruits. Treatment medications included: heparin. Additional treatment medications (dates unspecified) included: apixaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bleeding under skin in left upper arm close to vaccination site, bruising in right hand and area in left hand like bruise, area of bleeding under skin in left upper arm close to vaccination site very dark, 5 red spots from elbow to hand on right and left arm (between thumb to index finger) and deep vein thrombosis/blood clot in right leg below knee was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0 20210820081 -Covid-19 vaccine ad26.cov2. Deep vein thrombosis, the bleeding under skin in left upper arm. This events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.

Other Meds:

Current Illness: Allergic reaction to bee sting; Insect sting allergy; Non-smoker (Patient not smoked in 35-40 years.); Social alcohol drinker (Patient drinks alcohol occasionally such as anniversary)

ID: 1571634
Sex: F
Age:
State:

Vax Date:
Onset Date: 08/06/2021
Rec V Date: 08/16/2021
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: EYES WERE HURTING; CONGESTION; EXTREMELY BAD MEMORY FOG; BODY PAIN; BACK OF MY NECK WAS HURTING; CHILLS; FEVER; FELT VERY TIRED; HEADACHE/HEAD CONTINUES HURTING/OCCIPITAL AREA HURTING; FELT THE HEAD WAS HEAVY; BLURRY VISION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 06-AUG-2021, the patient experienced felt the head was heavy. On 06-AUG-2021, the patient experienced blurry vision. On 06-AUG-2021, the patient experienced chills. On 06-AUG-2021, the patient experienced fever. On 06-AUG-2021, the patient experienced felt very tired. On 06-AUG-2021, the patient experienced headache/head continues hurting/occipital area hurting. On 07-AUG-2021, the patient experienced eyes were hurting. On 07-AUG-2021, the patient experienced congestion. On 07-AUG-2021, the patient experienced extremely bad memory fog. On 07-AUG-2021, the patient experienced body pain. On 07-AUG-2021, the patient experienced back of my neck was hurting. Laboratory data (dates unspecified) included COVID-19 virus test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt the head was heavy, blurry vision, chills, fever, felt very tired, headache/head continues hurting/occipital area hurting, eyes were hurting, congestion, body pain, and back of my neck was hurting, and had not recovered from extremely bad memory fog. This report was non-serious.

Other Meds:

Current Illness:

ID: 1571635
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/16/2021
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: PRETTY SICK; BODY ACHES; LOST WEIGHT; SHOOTING PAINS; COVID ARM (FOR A WEEK); CHILLS; NAUSEA; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: immunocompromised. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced pretty sick, body aches, lost weight, shooting pains, covid arm (for a week), chills, nausea, and fever. Laboratory data (dates unspecified) included: Lost weight (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid arm (for a week), and the outcome of pretty sick, fever, chills, body aches, nausea, lost weight and shooting pains was not reported. This report was non-serious.

Other Meds:

Current Illness: Immunocompromised

ID: 1571636
Sex: U
Age:
State:

Vax Date:
Onset Date: 08/09/2021
Rec V Date: 08/16/2021
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: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative via social media concerned a 23 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 09-AUG-2021, two months after vaccination the patient experienced symptoms of cough, headache and tested positive for covid-19 infection. The patient experienced suspected covid-19 infection and suspected clinical vaccination failure. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000189251.; Sender's Comments: V0:20210822518-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1571637
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 08/16/2021
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: PAIN IN NECK AT BASE OF SKULL ON LEFT SIDE( THE PAIN HAS GOTTEN WORSE,NOW PAIN IS MORE PRONOUNCED AND IF SHE TURNS HER HEAD A CERTAIN WAY SHE EXPERIENCES A SHARP PAIN); VACCINE EXPOSURE DURING PREGNANCY; STIFF NECK; This spontaneous pregnancy report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. It was not reported whether the patient had been pregnant before. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 09-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced stiff neck. On 09-AUG-2021, the patient experienced vaccine exposure during pregnancy. The date of the patient's last menstrual period and expected delivery date were not reported. On 11-AUG-2021, the patient experienced pain in neck at base of skull on left side ( the pain has gotten worse, now pain is more pronounced and if she turns her head a certain way she experiences a sharp pain). The pregnancy was continuing. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from pain in neck at base of skull on left side( the pain has gotten worse, now pain is more pronounced and if she turns her head a certain way she experiences a sharp pain), and stiff neck, and the outcome of vaccine exposure during pregnancy was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.

Other Meds:

Current Illness:

ID: 1571638
Sex: F
Age:
State: SC

Vax Date:
Onset Date: 06/08/2021
Rec V Date: 08/16/2021
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: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; SORENESS IN THE INJECTION ARM; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: mildly obese, and allergy to citrus. Patient had no known medical conditions. The patient experienced drug allergy when treated with macrogol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 08-JUN-2021 for prophylactic vaccination. Concomitant medications included ibuprofen. On 08-JUN-2021, the patient experienced soreness in the injection arm and tiny headache. On 06-AUG-2021, the patient experienced sinus irritation. Patient thought it could be due to seasonal allergies. Out of caution patient performed a COVID-19 test, result was positive (suspected covid-19 and suspected clinical vaccination failure). It was reported that patient received the result on 11-AUG-2021 morning at 05:00. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, soreness in the injection arm and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210822665-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds: IBUPROFEN

Current Illness: Food allergy; Obesity

ID: 1571639
Sex: U
Age:
State:

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 08/16/2021
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: BODY ACHES; PAIN IN THE AXILLARY LYMPH NODES OF THE ARM; CHILLS; FEVER; FATIGUE; PAIN AT INJECTION SITE; EXTREME TIREDNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination..The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced body aches. On AUG-2021, the patient experienced pain in the axillary lymph nodes of the arm. On AUG-2021, the patient experienced chills. On AUG-2021, the patient experienced fever. On AUG-2021, the patient experienced fatigue. On AUG-2021, the patient experienced pain at injection site. On AUG-2021, the patient experienced extreme tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, chills, fever, fatigue, pain at injection site, pain in the axillary lymph nodes of the arm and extreme tiredness was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1571640
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 06/05/2021
Rec V Date: 08/16/2021
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: EXTREMELY HUNGRY ALL DAY; RECEIVED A VACCINE THAT WAS STORED IN THE REFRIGERATOR BEYOND THE RECOMMENDED STORAGE TIME (OVER NIGHT, POTENTIALLY BETWEEN 12-24 HOURS); This spontaneous report received from a patient concerned a 46 year old male. The patient's weight was 175 pounds, and height was 69 inches. The patient's concurrent conditions included: non smoker, non alcohol user, high blood pressure, asthma, seasonal allergies, cat allergy, soap allergy, dog allergy, horses allergy, hay allergy, and fresh cut grass allergy, and other pre-existing medical conditions included: The patient have no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203AZ1A, expiry: UNKNOWN) dose was not reported, administered on 05-JUN-2021 11:00 for prophylactic vaccination. Concomitant medications included fexofenadine hydrochloride for drug used for unknown indication, glimepiride for drug used for unknown indication, losartan for drug used for unknown indication, and atenolol. On 05-JUN-2021, the patient experienced extremely hungry all day. On 05-JUN-2021, the patient experienced received a vaccine that was stored in the refrigerator beyond the recommended storage time (over night, potentially between 12-24 hours). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extremely hungry all day on 12-JUN-2021, and the outcome of received a vaccine that was stored in the refrigerator beyond the recommended storage time (over night, potentially between 12-24 hours) was not reported. This report was non-serious.

Other Meds: LOSARTAN; ATENOLOL; GLIMEPIRIDE; ALLEGRA

Current Illness: Abstains from alcohol; Allergic to cats; Allergic to dogs; Allergy to animal; Asthma; Blood pressure high; Grass allergy; Hay fever; Non-smoker; Seasonal allergy; Soap allergy

ID: 1571641
Sex: F
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 08/16/2021
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: SIDE EFFECTS (WORSE IN SEVERITY IN COMPARISON TO MILD); This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced side effects (worse in severity in comparison to mild). The action taken with covid-19 vaccine was not applicable. The outcome of side effects (worse in severity in comparison to mild) was not reported. This report was non-serious. This case, from the same reporter is linked to 20210826137.

Other Meds:

Current Illness:

ID: 1571642
Sex: U
Age:
State: WA

Vax Date:
Onset Date:
Rec V Date: 08/16/2021
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: NEGATIVE REACTION TO THE VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced negative reaction to the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of negative reaction to the vaccine was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1571643
Sex: M
Age:
State: LA

Vax Date:
Onset Date: 08/12/2021
Rec V Date: 08/16/2021
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: VACCINE WAS GIVEN TO A 16 YEAR OLD MALE; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 16 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 12-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-AUG-2021, the patient experienced vaccine was given to a 16 year old male. On 12-AUG-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine was given to a 16 year old male was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1571644
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/16/2021
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: MILDLY SORE ARM; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced mildly sore arm, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102.8 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mildly sore arm, and fever. This report was non-serious.

Other Meds:

Current Illness:

ID: 1571645
Sex: U
Age:
State:

Vax Date:
Onset Date: 06/01/2021
Rec V Date: 08/16/2021
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: This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On JUN-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on JUN-2021. This report was non-serious.

Other Meds:

Current Illness:

ID: 1571646
Sex: U
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 08/16/2021
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: SLEEPLESS NIGHTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included salicylic acid. On an unspecified date, the patient experienced sleepless nights. The action taken with covid-19 vaccine was not applicable. The outcome of sleepless nights was not reported. This report was non-serious. This case, involving the same patient is linked to 20210738895.

Other Meds: NEUTROGENA [SALICYLIC ACID]

Current Illness:

ID: 1571647
Sex: F
Age: 46
State: CA

Vax Date: 12/24/2020
Onset Date: 12/24/2020
Rec V Date: 08/16/2021
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: The firm area is now red; itching on the site, really intense like a mosquito bite; sore below the injection site; swelling below the injection site, like expanded area, kinda firm and elevated; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore below the injection site), VACCINATION SITE SWELLING (swelling below the injection site, like expanded area, kinda firm and elevated), VACCINATION SITE PRURITUS (itching on the site, really intense like a mosquito bite) and VACCINATION SITE ERYTHEMA (The firm area is now red) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No adverse event). On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Dec-2020, the patient experienced VACCINATION SITE PAIN (sore below the injection site) and VACCINATION SITE SWELLING (swelling below the injection site, like expanded area, kinda firm and elevated). On 31-Dec-2020, the patient experienced VACCINATION SITE PRURITUS (itching on the site, really intense like a mosquito bite). On 07-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (The firm area is now red). On 27-Dec-2020, VACCINATION SITE PAIN (sore below the injection site) and VACCINATION SITE SWELLING (swelling below the injection site, like expanded area, kinda firm and elevated) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itching on the site, really intense like a mosquito bite) and VACCINATION SITE ERYTHEMA (The firm area is now red) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore below the injection site), VACCINATION SITE SWELLING (swelling below the injection site, like expanded area, kinda firm and elevated), VACCINATION SITE PRURITUS (itching on the site, really intense like a mosquito bite) and VACCINATION SITE ERYTHEMA (The firm area is now red) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No adverse event). On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Dec-2020, the patient experienced VACCINATION SITE PAIN (sore below the injection site) and VACCINATION SITE SWELLING (swelling below the injection site, like expanded area, kinda firm and elevated). On 31-Dec-2020, the patient experienced VACCINATION SITE PRURITUS (itching on the site, really intense like a mosquito bite). On 07-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (The firm area is now red). On 27-Dec-2020, VACCINATION SITE PAIN (sore below the injection site) and VACCINATION SITE SWELLING (swelling below the injection site, like expanded area, kinda firm and elevated) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itching on the site, really intense like a mosquito bite) and VACCINATION SITE ERYTHEMA (The firm area is now red) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1571648
Sex: F
Age: 60
State: NY

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 08/16/2021
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: Skin felt bruised; Teeth hurt; Pain started in her arm and then spread to her body; Severe pain and body aches; Muscle aches; Joint pain; Headache; Tender at injection site; Felt tired; This spontaneous case was reported by a nurse and describes the occurrence of SKIN ABRASION (Skin felt bruised), DENTAL DISCOMFORT (Teeth hurt), PAIN IN EXTREMITY (Pain started in her arm and then spread to her body), PAIN (Severe pain and body aches) and MYALGIA (Muscle aches) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (Had COVID in July.). On 05-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced SKIN ABRASION (Skin felt bruised), DENTAL DISCOMFORT (Teeth hurt), PAIN IN EXTREMITY (Pain started in her arm and then spread to her body), PAIN (Severe pain and body aches), MYALGIA (Muscle aches), ARTHRALGIA (Joint pain), HEADACHE (Headache), VACCINATION SITE PAIN (Tender at injection site) and FATIGUE (Felt tired). At the time of the report, SKIN ABRASION (Skin felt bruised), DENTAL DISCOMFORT (Teeth hurt), PAIN IN EXTREMITY (Pain started in her arm and then spread to her body), PAIN (Severe pain and body aches), MYALGIA (Muscle aches), ARTHRALGIA (Joint pain), HEADACHE (Headache), VACCINATION SITE PAIN (Tender at injection site) and FATIGUE (Felt tired) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, SARS-CoV-2 test positive: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. For treatment of her symptoms she had a hot Epsom salt bath, ibuprofen every 4 hours and used a heating pad. This spontaneous case was reported by a nurse and describes the occurrence of SKIN ABRASION (Skin felt bruised), DENTAL DISCOMFORT (Teeth hurt), PAIN IN EXTREMITY (Pain started in her arm and then spread to her body), PAIN (Severe pain and body aches) and MYALGIA (Muscle aches) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (Had COVID in July.). On 05-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced SKIN ABRASION (Skin felt bruised), DENTAL DISCOMFORT (Teeth hurt), PAIN IN EXTREMITY (Pain started in her arm and then spread to her body), PAIN (Severe pain and body aches), MYALGIA (Muscle aches), ARTHRALGIA (Joint pain), HEADACHE (Headache), VACCINATION SITE PAIN (Tender at injection site) and FATIGUE (Felt tired). At the time of the report, SKIN ABRASION (Skin felt bruised), DENTAL DISCOMFORT (Teeth hurt), PAIN IN EXTREMITY (Pain started in her arm and then spread to her body), PAIN (Severe pain and body aches), MYALGIA (Muscle aches), ARTHRALGIA (Joint pain), HEADACHE (Headache), VACCINATION SITE PAIN (Tender at injection site) and FATIGUE (Felt tired) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, SARS-CoV-2 test positive: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. For treatment of her symptoms she had a hot Epsom salt bath, ibuprofen every 4 hours and used a heating pad. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded

Other Meds:

Current Illness:

ID: 1571649
Sex: F
Age: 51
State: NJ

Vax Date: 12/31/2020
Onset Date: 01/01/2021
Rec V Date: 08/16/2021
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: Body ache; Left arm was super sore; A spontaneous report was received from a consumer, concerning herself, a 51-year-old female patient, who received Moderna's COVID-19 vaccine and developed left arm was super sore and body ache. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 31-Dec-2020, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly in her left arm for COVID-19 infection prophylaxis. On 01-Jan-2021, the patient reported that she felt her left arm was super sore. Additionally, on 05-Jan-2021, she developed body ache. Action taken with mRNA-1273 in response to the events were not reported. The outcome of the events left arm was super sore and body ache was considered to be unknown.; Reporter's Comments: This case concerns a 51 year-old, female patient, who experienced events of left arm was super sore and body ache. The event of left arm was super sore occurred the next day after the first and last dose of mRNA-1273 vaccine administration. The event of body ache occurred 5 days after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.

Other Meds:

Current Illness:

ID: 1571650
Sex: F
Age: 29
State: KY

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 08/16/2021
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: Sweating; it's hurting; Enitre body ache; A spontaneous report was received from a consumer concerning a 29-year-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced left arm hurting(pain in extremity), entire body ache (pain) and sweating (hyperhidrosis). The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Meloxicam and Buspirone Hydrochloride. On 05 Jan 2021, the same day as the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Patient's husband reported that she received the Moderna vaccine on 05 Jan 2021. That day, he stated that her arm hurt and that she was having generalized aching. The next morning, 06 Jan 2021, he reported that she was sweating. Treatment information was not provided. Action taken with mRNA-1273 in response to the events, left arm hurting, entire body ache and sweating, was not provided. The seriousness criteria for all event was not reported. The outcome of the events, left arm hurting, entire body ache and sweating was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Other Meds: MOBIC; BUSPAR

Current Illness:

ID: 1571651
Sex: F
Age: 28
State: WI

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 08/16/2021
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: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K201A) for COVID-19 vaccination. No Medical History information was reported. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 31-Jan-2021. On 06-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 06-Jan-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This is a case of product exposure during pregnancy with no associated adverse events for this 28-year-old female. Patient will continue to be contacted for further monitoring of adverse events during the pregnancy. No concomitant medications were provided by the reporter. No treatments were provided by the reporter.; Sender's Comments: This is a case of product exposure during pregnancy with no associated adverse events for this 28-year-old female. Patient will continue to be contacted for further monitoring of adverse events during the pregnancy.

Other Meds:

Current Illness:

ID: 1571652
Sex: M
Age: 26
State: TX

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 08/16/2021
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: Cut himself; Headache; Dizziness; Weakness; Pain in the injected arm; This spontaneous case was reported by a non-health professional and describes the occurrence of WOUND (Cut himself), HEADACHE (Headache), DIZZINESS (Dizziness), ASTHENIA (Weakness) and INJECTION SITE PAIN (Pain in the injected arm) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Q27L2PA) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced WOUND (Cut himself), HEADACHE (Headache), DIZZINESS (Dizziness), ASTHENIA (Weakness) and INJECTION SITE PAIN (Pain in the injected arm). At the time of the report, WOUND (Cut himself), HEADACHE (Headache), DIZZINESS (Dizziness), ASTHENIA (Weakness) and INJECTION SITE PAIN (Pain in the injected arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm