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: 1537808
Sex: M
Age: 0
State: LA

Vax Date: 02/01/2004
Onset Date: 02/01/2004
Rec V Date: 08/10/2021
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: N/A

Symptom List: Dysphagia, Epiglottitis

Symptoms: Autism

Other Meds: N/a

Current Illness: N/a

ID: 1537809
Sex: F
Age: 44
State: MO

Vax Date: 06/30/2021
Onset Date: 08/02/2021
Rec V Date: 08/10/2021
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: none

Symptom List: Anxiety, Dyspnoea

Symptoms: Although I felt super tired the day I got the shot, I experienced few other side effects until a month later. I've just had one of the worst periods of my life - the headache was unbearable and the cramps were near crippling. My period was a week late. Although these are not life-threatening side effects, they did handicap me for an entire day to the point where all I could do was sit on the couch; this is highly unusual for my menstrual cycle, so I thought I'd report it. I realize that women's cycles are hard to analyze because of stress, diet, and other irregularities that make it difficult to pinpoint sudden changes; but my cycles have been mostly predictable to the point where this is memorable in a long line of unmemorable periods. I was not going through any extra stress (physical or emotional) in the weeks before my period, had not eaten anything strange, met new people, or even had sex in the month prior to my period. The first three days of my 7-day cycle (which is now complete) were utterly devastating. The headache started as a migraine, which is not unusual for me, but it progressed to my ENTIRE HEAD and down to the top of my shoulders (double-sided migraine, which I've never had before). My cramps were powerful, relentless, and left me gasping for breath. My flow was extra heavy and lasted. much longer than normal.

Other Meds: none

Current Illness: none

ID: 1537810
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/10/2021
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: Lymp nobe under left arm pit was enlarged and painful for 4 days

Other Meds:

Current Illness:

ID: 1537811
Sex: M
Age: 46
State: HI

Vax Date: 08/07/2021
Onset Date: 08/07/2021
Rec V Date: 08/10/2021
Hospital:

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

Lab Data:

Allergies: none

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: severe depression, gloom, anxiety, including unsafe thoughts

Other Meds: none

Current Illness: none

ID: 1537812
Sex: F
Age: 25
State: MI

Vax Date: 03/29/2021
Onset Date: 04/30/2021
Rec V Date: 08/10/2021
Hospital:

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

Lab Data:

Allergies: No

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

Symptoms: Daily nose bleeds, generalized bruising, and heavy menstrual cycle

Other Meds: Yaz

Current Illness: No

ID: 1537813
Sex: M
Age: 28
State: KY

Vax Date: 08/06/2021
Onset Date: 08/07/2021
Rec V Date: 08/10/2021
Hospital: Y

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

Lab Data:

Allergies: NKDA.

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

Symptoms: chest pain, shortness of breath, elevated troponin and BNP values

Other Meds: None.

Current Illness: None.

ID: 1537814
Sex: F
Age: 32
State: CA

Vax Date: 08/07/2021
Onset Date: 08/09/2021
Rec V Date: 08/10/2021
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: None

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Swollen lymph node in armpit

Other Meds: None

Current Illness: None

ID: 1537815
Sex: M
Age: 15
State: CA

Vax Date: 08/06/2021
Onset Date: 08/06/2021
Rec V Date: 08/10/2021
Hospital:

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

Lab Data:

Allergies: Pfizer mRNA vaccine

Symptom List: Pharyngeal swelling

Symptoms: While at a UVAX event, a client was scheduled to have his second dose of the Pfizer vaccine. While interviewing the client, he reported experiencing a linear rash on the abdominal area and slight difficulty breathing during the first dose of the Pfizer vaccine on 7/16/21. We edited our records, gave the 2nd dose of the vaccine, and monitored the patient for 30 minutes for any anaphylactic reactions. The patient did not report having any allergic signs and symptoms during and after the 30 minute monitor time. The patient mother verbalized understanding instructions.

Other Meds: None

Current Illness: None

ID: 1538377
Sex: F
Age: 29
State: TX

Vax Date: 07/29/2021
Onset Date: 08/05/2021
Rec V Date: 08/10/2021
Hospital:

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

Lab Data:

Allergies: None

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Pt had first Moderna covid vaccine on 7/29/2021 with no initial reaction. Since 8/5/2021 with the beginning of symptoms., pt has noticed a erythematous rash around possible vaccine site of left deltoid region. Not pruritic. Little more than 2 cm in height and width. It can feel warm at times. Never had a reaction to any vaccine prior COVID ARM

Other Meds: None

Current Illness: None

ID: 1538378
Sex: F
Age: 40
State: KS

Vax Date: 08/09/2021
Onset Date: 08/09/2021
Rec V Date: 08/10/2021
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: Confirmed: Soy, Feraheme iron infusion

Symptom List: Diarrhoea, Nasal congestion

Symptoms: As soon as vaccine given by the nurse I had a strong smell of aluminum in my nose (masked) and my face, chest, hands, and underarms felt very flushed. My heart rate jumped to 150 then dropped into 80s-110s, accompanied by a sense of panic, dizziness, and blurry vision. My chest, underarms, and forehead burned exceptionally bad like on fire, alternating between hot fire and cold fire. My pulse rate stabilized within a half hour. I had a meeting with the doctor before leaving. I was told to go home, take Benadryl, relax, and to go to the ER if I had throat issues. I returned to feeling very sick on my short five to ten minutes ride home. At home the burning intensified, the dizziness increased, my pulse rate was spiking to the 140s then dropping to 70s-80s. My throat started to hurt. I took Benadryl and swallowing was hard and painful. That combined with the other symptoms I decided to go to the ER. In triage I had a very hard time sitting still for an EKG because my nerves were jumping so bad, especially in my legs. As I understand my oxygen rate was okay and my pulse was fast. I was told the Benadryl probably had kicked in to help. I had about a two to three hour wait at the ER before I was taken back. As long as I stayed very still I felt mostly okay except being very hot. If I tried to walk such as a short distance to the restroom I has very dizzy and had bad balance. At one point in the waiting, having been sitting still, I thought I was okay to go home. But as soon as I got outside I was very dizzy and had to sit down on the ground. The ER intake staff came and got me with a wheelchair. One I was taken to a room in the ER I was feeling better than I did two-three hours before, but was still yo-yoing with dizziness, burning pain in my chest and back. It still felt like my heart was racing some. The doctor prescribed a steroid allergy medicine to treat allergies. After about one hour I started feeling a lot better. The burning sensation went away and I was able to walk without being dizzy. I still felt sick and my chest felt like it was very severely bruised. After about five hours in the ER I started getting very anxious, overhearing the covid and trauma patients. I was treated for that then discharged. Once home by about 9:00 pm I felt very achy and bruised in some places, but overall better. At about midnight the chest pain and burning returned and I had a small headache. I took more Benadryl. It is now after 2:30 am and my chest is still cold and burning and the nerves in my legs are very jumpy. I have low to moderate pain in my muscles and joints, especially jaw, wrists, and hips.

Other Meds: No medicine the day of vaccine before vaccine

Current Illness: Mild allergy attack to soy

ID: 1538379
Sex: F
Age: 76
State: GA

Vax Date: 02/18/2021
Onset Date: 02/21/2021
Rec V Date: 08/10/2021
Hospital: Y

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: Dementia symptoms became aggressively worse within 48 hours of the 2nd shot. She went from being a little confused on her bad days to not knowing anyone including me(her daughter/caregiver) on her bad day even sometimes on her good days. Now she doesn't even have good days even more. She has had stomach and body pain that has gotten so progressively bad that she has been to the emergency room numerous times, she has been to to emergency room numerous times due to her mental state and confusion, all of this has started 48 hours after she got the 2nd shot. It has all gotten so bad that I had to put her into hospice care at home just to get her help for her pain. I regret getting her the shot. I thought I was helping my mom, that I was protecting but it ruined her mind, it has caused her so much physical pain. It has destroyed her

Other Meds:

Current Illness:

ID: 1539066
Sex: F
Age: 90
State: WY

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 08/10/2021
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: Hardness; Warm to touch; Redness on top and underneath her arm the size of grapefruit; Itching at the injection site; Soreness from the elbow to shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION, VACCINATION SITE WARMTH, ERYTHEMA (Redness on top and underneath her arm the size of grapefruit), INJECTION SITE PRURITUS (Itching) and ARTHRALGIA (Soreness from the elbow to shoulder) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE INDURATION, VACCINATION SITE WARMTH, ERYTHEMA (Redness on top and underneath her arm the size of grapefruit), INJECTION SITE PRURITUS (Itching), and ARTHRALGIA (Soreness from the elbow to shoulder). At the time of the report, VACCINATION SITE INDURATION, VACCINATION SITE WARMTH, ERYTHEMA (Redness on top and underneath her arm the size of grapefruit), INJECTION SITE PRURITUS (Itching) and ARTHRALGIA (Soreness from the elbow to shoulder) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1539067
Sex: M
Age: 35
State: MA

Vax Date: 01/14/2021
Onset Date: 01/19/2021
Rec V Date: 08/10/2021
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: swollen lymph node on his left arm and left armpit; This spontaneous case was reported by a consumer and describes the occurrence of in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included paracetamol.

Other Meds:

Current Illness:

ID: 1539068
Sex: F
Age: 43
State: CT

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 08/10/2021
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: a welt on the injection site that is warm to the touch; a welt on the injection site that is about the size of a half dollar; a welt on the injection site that is itchy; a welt on the injection site that is red; sore at the sight of injection for 3-4 days; chills; low grade temperature of 99.1; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH, VACCINATION SITE URTICARIA, VACCINATION SITE PRURITUS, VACCINATION SITE ERYTHEMA (a welt on the injection site that is red) and VACCINATION SITE PAIN (sore at the sight of injection for 3-4 days) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No reported medical history. Concomitant products included ACIPHEX, MULTIVITAMINS, VITAMIN D3, PROBIOTICS, VITAMIN B12, ELDERBERRY, and FLONASE ALLERGY RELIEF for an unknown indication. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN, CHILLS, and PYREXIA. On 19-Jan-2021, the patient experienced VACCINATION SITE WARMTH, VACCINATION SITE URTICARIA, VACCINATION SITE PRURITUS, and VACCINATION SITE ERYTHEMA. At the time of the report, VACCINATION SITE WARMTH, VACCINATION SITE URTICARIA, VACCINATION SITE PRURITUS, and VACCINATION SITE ERYTHEMA outcome was unknown and VACCINATION SITE PAIN, CHILLS, and PYREXIA 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. Treatment details were not reported by the reporter.

Other Meds: ACIPHEX; MULTIVITAMIN; VITAMIN D3; PROBIOTICS; VITAMIN B12; ELDERBERRY; FLONASE ALLERGY RELIEF

Current Illness:

ID: 1539069
Sex: U
Age:
State: CA

Vax Date: 01/08/2021
Onset Date:
Rec V Date: 08/10/2021
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: swelling around injection site; redness around injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE SWELLING and INJECTION SITE ERYTHEMA (redness around injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE SWELLING and INJECTION SITE ERYTHEMA (redness around injection site). At the time of the report, INJECTION SITE SWELLING and INJECTION SITE ERYTHEMA (redness around injection site) outcome was unknown. 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. Concomitant product use was not provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1539071
Sex: F
Age: 66
State: AL

Vax Date: 01/20/2021
Onset Date: 01/21/2021
Rec V Date: 08/10/2021
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: felt like acid reflux; nausea; vomiting; felt pain between shoulder blades; A Spontaneous report was received from consumer concerning a 66-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced acid reflux nausea then vomited, felt pain between shoulder blades. The patient's medical history and concomitant medical history reported unknown. On 20 Jan 2021 at 01:30 PM, the patient received their one dose of the two planned doses of COVID-19 Vaccine (mRNA-1273) intramuscularly in the right arm for prophylaxis of COVID-19 infection and experienced acid reflux and on 21 Jan 2021 felt nausea then vomited and pain Between Shoulder Blades. No laboratory tests were provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event is unknown. Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.

Other Meds:

Current Illness:

ID: 1539072
Sex: F
Age: 67
State: NJ

Vax Date: 01/18/2021
Onset Date: 01/18/2021
Rec V Date: 08/10/2021
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: Didn't feel good; started running fever, its spiking up to 101 deg F; Headache; Shooting pain above ears; Felt achy; Didn't sleep well; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA, MALAISE, PYREXIA (started running fever, its spiking up to 101 deg F), POOR QUALITY SLEEP, and HEADACHE in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. NO medical history information was reported. Concomitant products included LEVOTHYROXINE and SIMVASTATIN for an unknown indication. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced POOR QUALITY SLEEP. On 19-Jan-2021, the patient experienced MYALGIA. On 20-Jan-2021, the patient experienced MALAISE, PYREXIA, HEADACHE, and PAIN (Shooting pain above ears). The patient was treated with TYLENOL at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, MYALGIA (Felt achy), MALAISE, PYREXIA, POOR QUALITY SLEEP (Didn't sleep well), HEADACHE, and PAIN (Shooting pain above ears) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Pyrexia: 101 Degree F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was received via an unknown source (no reference has been entered for a health authority) on 22-Jan-2021 and was forwarded to Moderna on 22-Jan-2021. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA, MALAISE, PYREXIA, POOR QUALITY SLEEP, and HEADACHE in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. NO medical history information was reported. Concomitant products included LEVOTHYROXINE and SIMVASTATIN for an unknown indication. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced POOR QUALITY SLEEP (Didn't sleep well). On 19-Jan-2021, the patient experienced MYALGIA (Felt achy). On 20-Jan-2021, the patient experienced MALAISE, PYREXIA (started running fever, its spiking up to 101 deg F), HEADACHE and PAIN (Shooting pain above ears). The patient was treated with TYLENOL at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, MYALGIA, MALAISE, PYREXIA, POOR QUALITY SLEEP, HEADACHE, and PAIN (Shooting pain above ears) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Pyrexia: 101 Degree F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds: LEVOTHYROXINE; SIMVASTATIN

Current Illness:

ID: 1539073
Sex: F
Age: 43
State: NC

Vax Date: 08/06/2021
Onset Date: 08/07/2021
Rec V Date: 08/10/2021
Hospital:

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

Lab Data:

Allergies: Surgical glue, Penicillin, Sulfur

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Stomach cramps and loose stool, fatigue. Still cramps and gassiness continue

Other Meds: Synthroid, Paxil, Xanax, Metoprolol, Vitamin D and C, and multi-vitamin, Ibuprofen

Current Illness: None

ID: 1539074
Sex: F
Age: 63
State: CA

Vax Date: 05/28/2021
Onset Date: 06/17/2021
Rec V Date: 08/10/2021
Hospital:

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

Lab Data:

Allergies: None

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: 18 days after 2nd shot- Polymyalgia rbeumatica attack, extreme muscle weakness, dizziness 2 trips to the ER, in bed for 30 days, too weak to get off of the sofa or eat much for 30 days. I was very "unwell" had to hire someone to stay in my home with me in the mornings 8am until 12 noon. I lost 20 lbs, both arms feel very heavy with a very stiff neck, trembling hands and anxiety due to immobility.

Other Meds: Vit D no other oral meds Topical DHS zinc SHAMPOO

Current Illness: Diarrhea, I was getting blood & stool samples tested to see what was causing it a week before the ER visit. All of those tests came back in normal range, even had a colonoscopy biopsies were benign.

ID: 1539075
Sex: F
Age:
State: IN

Vax Date: 01/15/2021
Onset Date: 01/22/2021
Rec V Date: 08/10/2021
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: injection site redness 4-5 inches; itchiness; feels warm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (injection site redness 4-5 inches), PRURITUS (itchiness) and FEELING HOT in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. The patient's past medical history included Pain since an unknown date. Concomitant products included MINERALS, VITAMINS, CALCIUM, CRANBERRY, and TYLENOL for an unknown indication. On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site redness 4-5 inches), PRURITUS (itchiness) and FEELING HOT. At the time of the report, INJECTION SITE ERYTHEMA (injection site redness 4-5 inches), PRURITUS (itchiness) and FEELING HOT outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jan-2021 and was forwarded to Moderna on 23-Jan-2021. This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (injection site redness 4-5 inches), PRURITUS (itchiness) and FEELING HOT in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. The patient's past medical history included Pain since an unknown date. Concomitant products included MINERALS, VITAMINS, CALCIUM, CRANBERRY, and TYLENOL for an unknown indication. On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site redness 4-5 inches), PRURITUS (itchiness) and FEELING HOT. At the time of the report, INJECTION SITE ERYTHEMA (injection site redness 4-5 inches), PRURITUS (itchiness) and FEELING HOT outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment details were reported.

Other Meds: MINERSALS; VITAMINS; CALCIUM; CRANBERRY; TYLENOL

Current Illness: Pain

ID: 1539077
Sex: F
Age: 69
State: GA

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 08/10/2021
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: Platelets dropped; Could not get out of bed; Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT DECREASED, FATIGUE (Could not get out of bed), and VACCINATION SITE PAIN in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The patient's past medical history included Platelets increased since an unknown date. Concurrent medical conditions included Platelets decreased. Concomitant products included HYDROXYUREA for Platelet count low, VITAMIN D, VITAMIN B COMPLEX, PRESERVISION AREDS 2, BABY ASPIRIN, and ATORVASTATIN for an unknown indication. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PLATELET COUNT DECREASED, FATIGUE (Could not get out of bed), and VACCINATION SITE PAIN. At the time of the report, PLATELET COUNT DECREASED, FATIGUE (Could not get out of bed), and VACCINATION SITE PAIN outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: 406. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided.

Other Meds: HYDROXYUREA; VITAMIN D [VITAMIN D NOS]; SUPER B COMPLEX [VITAMIN B COMPLEX]; PRESERVISION AREDS 2; BABY ASPIRIN; ATORVASTATIN

Current Illness: Platelets increased

ID: 1539078
Sex: F
Age: 34
State: CA

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 08/10/2021
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: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. Concurrent medical conditions included Anxiety depression. Concomitant products included PRENATAL MULTIVITAMIN + DHA for Pregnancy, ZOLOFT for an unknown indication. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in August 2020 and the estimated date of delivery was 10-May-2021. On 01-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY. The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the ninth month of the pregnancy. On 01-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY had resolved. Not Provided 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. Concomitant medications also included Iron supplement. No treatment information was provided. Previous pregnancy end date was on 28 Apr 2021 resulted into live birth. Most recent FOLLOW-UP information incorporated above includes: On 11-Feb-2021: Follow up received and added concomitant medications.

Other Meds: ZOLOFT; PRENATAL MULTIVITAMIN + DHA

Current Illness:

ID: 1539080
Sex: M
Age: 72
State: CO

Vax Date: 01/05/2021
Onset Date: 02/03/2021
Rec V Date: 08/10/2021
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: Low Grade Fever/ 100F and lower; Bad Headache/ Intense headache varying in intensity; Chills off and on throughout day; Lack of appetite; weakness; Nausea/ Intense nausea. One instance of vomit; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE, ASTHENIA (weakness), NAUSEA, PYREXIA (Low Grade Fever / 100F and lower), and HEADACHE (Intense headache varying in intensity) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history information was reported. Concomitant products included B-12 and VITAMIN D 2000 for an unknown indication. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced DECREASED APPETITE, ASTHENIA (weakness), NAUSEA, HEADACHE (Intense headache varying in intensity), and CHILLS. On an unknown date, the patient experienced PYREXIA (Low Grade Fever/ 100F and lower). At the time of the report, DECREASED APPETITE, ASTHENIA (weakness), NAUSEA, PYREXIA (Low Grade Fever/ 100F and lower), HEADACHE (Intense headache varying in intensity), and CHILLS outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 100f (normal) 100F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was considered to be not applicable. No treatment medications were provided. Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Patient demographics, lab data, and concomitant medications were updated. Two events were added (chills and loss of appetite). On 19-Apr-2021: additional information received on 19-APR-2021 and does not contain any new information

Other Meds: B-12; VITAMIN D 2000

Current Illness:

ID: 1539081
Sex: F
Age: 34
State: NJ

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 08/10/2021
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: pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. No Medical History information was reported. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 22-May-2021. On 22-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY had resolved. 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 and treatment medications were not reported. Patient was 25 weeks pregnant at the time of vaccination.

Other Meds:

Current Illness:

ID: 1539082
Sex: F
Age: 38
State: FL

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 08/10/2021
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: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination. No medical history information reported. Concomitant products included PRENATAL VITAMIN for an unknown indication. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 08-Oct-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY had not resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. Treatment information was not provided.

Other Meds: PRENATAL VITAMIN

Current Illness:

ID: 1539083
Sex: M
Age: 51
State: TX

Vax Date: 01/22/2021
Onset Date:
Rec V Date: 08/10/2021
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: from top of ankle to all the way down to toe, I touch it and it hurts; tender; both ankles are extremely tender; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (from top of ankle to all the way down to toe), TENDERNESS, and ARTHRALGIA in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. Concurrent medical conditions included Guillain-Barre syndrome and Paralyzed (At young age). On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (from top of ankle to all the way down to toe), TENDERNESS, and ARTHRALGIA. The patient was treated with TYLENOL at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (from top of ankle to all the way down to toe), TENDERNESS, and ARTHRALGIA had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient received Tylenol but it did not help.

Other Meds:

Current Illness: Guillain-Barre syndrome; Paralyzed (At young age)

ID: 1539084
Sex: M
Age:
State: NY

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 08/10/2021
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: Dehydration; extremely dizzy; felt violently nauseous; threw up profusely for hours; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION, DIZZINESS, FATIGUE, NAUSEA, and VOMITING in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 029L20A) for an unknown indication. No Medical History information was reported. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced FATIGUE. On 07-Feb-2021, the patient experienced DEHYDRATION, DIZZINESS, NAUSEA, and VOMITING. On 08-Feb-2021, DEHYDRATION, DIZZINESS, NAUSEA, and VOMITING had resolved. At the time of the report, FATIGUE had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication were not provided. At the ER he received treatment for vomiting and dehydration, they put him on a drip and gave him meds for nausea and dizziness

Other Meds:

Current Illness:

ID: 1539085
Sex: F
Age: 27
State: NY

Vax Date: 01/14/2021
Onset Date:
Rec V Date: 08/10/2021
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: Pregnant; This case was received via an unknown source (no reference has been entered for a health authority) on 11-Feb-2021 and was forwarded to Moderna on 12-Feb-2021. This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 004M20A) for COVID-19 vaccination. Patient medication history was not provided by the reporter. Concomitant products included PRENATAL + DHA for an unknown indication. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 06-Sep-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound abdomen: ultrasound done two times as a part of pregnancy.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds: PRENATAL + DHA

Current Illness:

ID: 1539086
Sex: F
Age: 41
State: NC

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 08/10/2021
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: sore left arm; LOW fever; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (sore left arm), MATERNAL EXPOSURE DURING PREGNANCY, and PYREXIA (LOW fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The patient's past medical history included Pregnancy (40 weeks 4 days) in October 2014, In vitro fertilization and Miscarriage in October 2020. Concomitant products included PRENATAL VITAMIN and BABY ASPIRIN for an unknown indication. On 13-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 18-Nov-2020 and the estimated date of delivery was 05-Sep-2021. On 13-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore left arm) and PYREXIA (LOW fever). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the eighth week of the pregnancy. On 13-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY had resolved. At the time of the report, PAIN IN EXTREMITY (sore left arm) had not resolved and PYREXIA (LOW fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2020, Pregnancy test: positive. 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 medications were not provided. Estimated Date of conception was 18-Dec-2020

Other Meds: PRENATAL VITAMIN; BABY ASPIRIN

Current Illness:

ID: 1539087
Sex: F
Age: 32
State: NJ

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 08/10/2021
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: Pregnancy and vaccinated; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy and vaccinated) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Crohn's disease and Asthma. Concurrent medical conditions included Shellfish allergy and Drug allergy (Patient have allergy towards aspirin and ibuprofen.). Concomitant products included ASPIRINETAS for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 14-May-2021. On 10-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy and vaccinated). On 10-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy and vaccinated) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications Aspirinetas Treatment medications were not provided.

Other Meds: ASPIRINETAS

Current Illness: Drug allergy; Shellfish allergy

ID: 1539088
Sex: F
Age: 32
State: MI

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 08/10/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Got the vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Got the vaccine while pregnant) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. Concurrent medical conditions included Gestational diabetes. Concomitant products included INSULIN, LEVOTHYROXINE, VITAMIN D, PRENATAL VITAMINS for an unknown indication. On 15-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 15-Aug-2020 and the estimated date of delivery was 22-May-2021. On 15-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Got the vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the twenty-sixth week of the pregnancy. On 15-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Got the vaccine while pregnant) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Reporter details and patient demographic details were updated.

Other Meds: INSULIN; LEVOTHYROXINE; VITAMIN D; PROBIOTICS NOS; PRENATAL VITAMIN

Current Illness: Gestational diabetes

ID: 1539089
Sex: M
Age:
State: MA

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 08/10/2021
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: pain fierce for almost a month in arm - sharp pain up and down; pinky and finer next to pink are numb; looks like a spasm sporadically from elbow to hand; A spontaneous report was received from a consumer concerning male patient of unknown age who was administered Moderna's COVID-19 vaccine for prophylaxis of COVID-19 infection experienced pain fierce for almost a month in arm, sharp pain up and down, looks like a spasm sporadically from elbow to hand. The patient's medical history was not provided. No relevant concomitant medications were reported. On 12/Jan/2021, the patient received their first of two planned doses of mRNA-1273 (Lot number:026L20A) intramuscularly for prophylaxis of COVID-19 infection. On 12/Jan/2021 the patient reported adverse events such as pain fierce for almost a month in arm, sharp pain up and down pinky and finger next to pinky are numb, also a spasm felt sporadically from elbow to hand. The treatment information for the events were calcium and vitamin D intake provided. Action taken with the first dose of mRNA-1273 vaccine was not reported. Th e outcome for the events pain fierce for alomst a month in arm, sharp pain up and down, looks like a spasm sporadically from elbow to hand was unknown. Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1539200
Sex: F
Age:
State: PR

Vax Date:
Onset Date:
Rec V Date: 08/10/2021
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: BLEEDING; SPITTING BLOOD; This spontaneous report received from a consumer concerned a female of unspecified age of an unknown ethnic origin and race. Initial information processed with additional information received from reporter on 04-AUG-2021. 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: Unkown expiry:unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the reporter stated that her friend was spitting blood and bleeding after receiving her Janssen covid vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bleeding and spitting blood was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; 20210812102-Covid-19 vaccine ad26.cov2. s, Bleeding and spitting blood - 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 event.

Other Meds:

Current Illness:

ID: 1539201
Sex: F
Age:
State: PR

Vax Date: 03/19/2021
Onset Date:
Rec V Date: 08/10/2021
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: Pain in the armpit area of the left arm.; Low grade fever 98.8F; Light headache; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207), via an unspecified route of administration in the left arm on 19Mar2021 at 09:30 (at the age of 59-year-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151), via an unspecified route of administration in the left arm on 09Apr2021 at 10:00 (at the age of 59-year-old), as a single dose for COVID-19 immunisation. Medical history included Hashimoto's and the patient had a history of beets allergy. Concomitant medications included levothyroxine sodium (SYNTHROID) 25 milligrams and vitamins (MANUFACTURER UNKNOWN) for an unknown indication form an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in 2021, 14 hours after vaccination the patient experienced low grade fever 98.8 degrees Fahrenheit, light headache, pain in the armpit area of the left arm. These started at approximately 14 hours after vaccination. The pain in the armpit got worse, extending to arm by 48 hrs. and still feeling the pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the events. The clinical outcome of low-grade fever 98.8 degrees Fahrenheit, light headache, pain in the armpit area of the left arm was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: SYNTHROID

Current Illness:

ID: 1539319
Sex: U
Age:
State: PA

Vax Date: 07/19/2021
Onset Date: 07/19/2021
Rec V Date: 08/10/2021
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: No additional AE reported; a dose of Gardasil 9 was administered following a temperature excursion; This spontaneous report has been received from a licensed practical nurse concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not provided. On 19-JUL-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) syringe as prophylaxis (vaccine scheme, route of administration, and anatomical site of vaccination were not reported; lot number T030746 has been verified to be a valid lot number, expiration date reported and established as 16-MAR-2023). The vaccine was improperly stored at 49.69 degrees Fahrenheit for 1 hour, 24 minutes (product storage error), which was detected by a digital data logger; with no previous temperature excursion. No additional adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T030746; expirationdate: 16-MAR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability

Other Meds: GARDASIL 9 SYRINGE (DEVICE)

Current Illness:

ID: 1539320
Sex: M
Age: 0
State: DE

Vax Date: 07/15/2021
Onset Date: 07/01/2021
Rec V Date: 08/10/2021
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: Caller stated after her son received his vaccinations on 7/15/2021, he appeared to be "more clingy, unsettled, and developed a low fever of 99 .1 ?F."; Caller stated after her son received his vaccinations on 7/15/2021, he appeared to be "more clingy, unsettled, and developed a low fever of 99 .1 F."; fussiness; Caller stated after her son received his vaccinations on 7/15/2021, he appeared to be "more clingy, unsettled, and developed a low fever of 99 .1 ?F."; Caller reported her son (age: 2 months old) was mistakenly administered GARDASIL 9 instead of PNEUMOVAX 23 on 7/15/2021; Caller reported her son (age: 2 months old) was mistakenly administered GARDASIL 9 instead of PNEUMOVAX 23 on 7/15/2021.; seeming tired/poor feeding; seeming tired/poor feeding; family reported local swelling at vaccine site; This spontaneous report has been received from the physician and also from the patient's mother, referring to a 2-months-old male patient. It was stated that the patient had none pertinent medical history, concomitant medications, and past drug reactions or allergies. It was reported by the physician that patient was a well child. On 15-JUL-2021, the patient was mistakenly vaccinated with once dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) intramuscular injection as part of his routine vaccinations (prophylaxis) (lot number S028737, has been verified to be valid lot number, expiration date reported and established as 03-APR-2022) (dose, vaccination scheme frequency, dose number and anatomical site of administration were not provided) instead of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (wrong product administered). It was reported that on that same date, the patient also received two additional vaccines Rotavirus Vaccine, Live, Oral, Pentavalent (reported as "Rotavirus") (manufacturer unknown) and Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (reported as "HIv") (manufacturer unknown) also as part of his routine vaccinations (prophylaxis) (doses, vaccination scheme frequencies, dose numbers, anatomical sites , lot numbers and expiration dates of administration were not provided). It was reported by the physician, that they realized of the error on the dispensing process, less than an hour (reported as "less than an hour") after vaccination and immediately alerted the patient's family and monitoring precautions were discussed (product dispensing issue). On the same date (15-JUL-2021), after the patient vaccination, the patient appeared to be more clingy (dependent personality disorder), unsettled (restlessness) and developed a low fever of 99.1 degrees Fahrenheit (99.1 F )(pyrexia) for which he received acetaminophen (TYLENOL). Additionally, he experienced fussiness that night (irritability). On an unspecified date in July 2021, he also experienced local swelling at vaccine site (vaccination site swelling), seemed tired (fatigue) and had poor feeding (feeding disorder) for seven days. It was reported by the physician that no drug treatment was prescribed for the events of vaccination site swelling, irritability, fatigue and feeding disorder. On 19-JUL-2021, the patient recovered from the pyrexia, dependent personality disorder and restlessness events. On an unknown date in July 2021, the physician stated all events (also reported as "symptoms") were resolved. The patient was doing well without symptoms (events). The causality assessment between the events and the suspect vaccines was not provided. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S028737; expirationdate: 03-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability

Other Meds: GARDASIL 9 SYRINGE (DEVICE)

Current Illness:

ID: 1539321
Sex: U
Age:
State: OH

Vax Date: 07/27/2021
Onset Date: 07/27/2021
Rec V Date: 08/10/2021
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: No further AE reported; Gardasil 9 underwent a temperature excursion and was administered to a patient.; This spontaneous report has been received from a Registered Nurse and refers to a patient of unspecified age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions, or allergies. On 27-JUL-2021, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliters (mL) (dose number, vaccination scheme frequency, route and anatomical site of administration were not provided; lot number 1687290, that was verified to be valid, expiration date reported and established as 06-SEP-2022) as prophylaxis. It was reported that the administered vaccine had experienced a temperature excursion of 59 degrees Fahrenheit (F) with a time frame of 15 minutes, which was detected by data logger (product storage error). No previous temperatures excursions were reported. No additional adverse events (AEs) were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability

Other Meds: GARDASIL 9 SYRINGE (DEVICE)

Current Illness:

ID: 1539322
Sex: F
Age:
State: MO

Vax Date:
Onset Date: 07/19/2021
Rec V Date: 08/10/2021
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: Puncture wound to right index finger; the flange was bronken/ the circular flange around the syringe was broken in 2 pieces - one was a chip and the other was the sice of about half the flange; This spontaneous report has been received from a nurse referring to herself, as a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not provided. On 19-JUL-2021, the patient went to remove HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot number T028583 has been verified to be a valid lot number, expiration date reported and established as 04-MAR-2023) from the package and noticed something stocked in her finger, then she realized that the circular flange around the syringe was broken in 2 pieces, one was a chip and the other was the size of about half the flange (syringe issue). The patient experienced a puncture wound (injury associated with device) in her right index finger. At the time of this report, the patient had healed, and she was not sure which finger was injured (conflicting information). The syringe had been disposed; therefore, it was not possible to be returned. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T028583; expirationdate: 04-MAR-2023; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability

Other Meds: GARDASIL 9 SYRINGE (DEVICE)

Current Illness:

ID: 1539323
Sex: U
Age:
State: TX

Vax Date: 08/08/2020
Onset Date: 07/20/2021
Rec V Date: 08/10/2021
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: No additional AE reported; an 11 year old patient was administered his first dose of GARDASIL 9 on 8AUG2020/ the patient has come into the pharmacy today, 20JUL2021, to receive the second dose; This spontaneous report was received from a pharmacist and refers to a 11 years old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 08-AUG-2020, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter for prophylaxis (anatomical location, route of administration, lot # and expiration date were not reported). On 20-JUL-2021, the patient has come into the pharmacy to receive the second dose. No additional adverse event reported.

Other Meds:

Current Illness: Prophylaxis

ID: 1539326
Sex: M
Age:
State: KY

Vax Date:
Onset Date:
Rec V Date: 08/10/2021
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: The doctor informed her that his son had modified measles after an MMR 2 shot; This spontaneous report was received from consumer referring to a male patient of unknown age. Information regarding the patient's pertinent medical history, concomitant therapies, previous drug reactions, or allergies was not reported. On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, route of administration, vaccination scheme frequency, anatomical location, lot number and expiration date were not reported) as prophylaxis On an unknown date, during the reporter's daughter's doctor visit, the physician informed to the reporter, that his son had modified measles after the vaccination with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (measles post vaccine) It was unknown by the reporter if treatment was given, or if lab diagnostics were performed due to event, and the outcome of the event. The consumer's causal relationship between Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II ) and measles post vaccine was not reported. Upon internal review, the event measles post vaccine was considered to be medically significant.

Other Meds:

Current Illness:

ID: 1539332
Sex: M
Age:
State:

Vax Date: 10/20/2020
Onset Date: 10/20/2020
Rec V Date: 08/10/2021
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: Loss of consciousness; Syncope; Face injury; Tooth loss; Immediate post-injection reaction; Somnolence; This spontaneous report was received from the agency, referring to a 16-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported. On 20-OCT-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered intramuscularly in the right arm (lot number S004578, expiration date 29-SEP-2021) as prophylaxis, the third dose of Japanese encephalitis vaccine inact (IXIARO), administered intramuscularly in the left arm (lot number reported as JEV18L97E, expiration date was not reported), and the second dose of meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), administered intramuscularly in the left arm (lot number reported as U6691AB, expiration date was not reported). On the same date, immediately after receiving final vaccine, patient fainted from treatment bed (loss of consciousness, syncope, and immediate post-injection reaction). Patient lost consciousness and hit face (face injury) on the floor knocking out two front right teeth (tooth loss). Patient took approximately 30 seconds to rouse but was still somnolent (somnolence). Patient oriented to person, place, and time. Vital signs taken BP 130/76 HR 81 PaO2 100% on room air and 14 breathes/min. Rapid response called, ER arrived to evaluate patient. Pt escorted onto gurney and brought to ER to be further evaluated. The outcome of loss of consciousness, somnolence, immediate post-injection reaction, tooth loss, face injury and syncope, and the causal relationship between the events and the suspect therapies was not reported were not reported. Upon internal review, the events loss of consciousness and syncope were determined to be medically significant. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: S004578; expirationdate: 29-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent

Other Meds: GARDASIL 9 SYRINGE (DEVICE)

Current Illness:

ID: 1539333
Sex: F
Age: 55
State: VA

Vax Date: 10/19/2015
Onset Date: 10/19/2015
Rec V Date: 08/10/2021
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: 102 Fever; head to toe rash; This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2015-2016 season) (batch number 33FF2, expiry date 30th June 2016) for prophylaxis. The patient's past medical history included allergic reaction. On 19th October 2015, the patient received Fluarix Quadrivalent 2015-2016 season (intramuscular). On 19th October 2015, less than a day after receiving Fluarix Quadrivalent 2015-2016 season, the patient experienced fever and rash. On an unknown date, the outcome of the fever and rash were recovered/resolved. It was unknown if the reporter considered the fever and rash to be related to Fluarix Quadrivalent 2015-2016 season. Additional details provided were as follows: Patient was called to enquired about Fluarix description. Patient stated that she wanted to get a Covid-19 vaccine, but her allergist was concerned because of an allergic reactions she had from Fluarix in the past. The patient received the Shingrix vaccine at her job site and experienced head to toe rash with a 102 fever. Consumer stated that she came back to work the next day and her supervisor sent her back. VAERS details were captured. Reporter reported that emergency room visit is required. The reporter consented to follow-up.

Other Meds:

Current Illness:

ID: 1539334
Sex: U
Age:
State:

Vax Date: 04/01/2021
Onset Date: 05/01/2021
Rec V Date: 08/10/2021
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: Second vaccine in april of 2021 / got very sick; Second / shot hurt; Feels like raw flesh and alot of burning!; Feels like raw flesh / pain is in the skin; Buttocks! / started hurting in may / a lot of pain / Still having pain this is aug; Cant sit on one side; suspected vaccination failure; 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. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. In April 2021, the patient received the 2nd dose of Shingles vaccine. On an unknown date, the patient received the 1st dose of Shingles vaccine. In May 2021, less than 2 months after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, buttock pain and mobility decreased. On an unknown date, the patient experienced sickness, pain, burning sensation and skin pain. On an unknown date, the outcome of the vaccination failure, shingles, sickness, mobility decreased, burning sensation and skin pain were unknown and the outcome of the buttock pain and pain were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles, sickness, buttock pain, mobility decreased, pain, burning sensation and skin pain to be related to Shingles vaccine. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received both Shingles vaccines but with the 2nd dose he/she got very sick and shot hurt. The reporter stated, if could get shingles on one side of the buttocks, started hurting in May 2021 with a lot of pain could not sit on one side but physician said did not thought its shingles. The patient knows it had something with Shingles. At the time of reporting, less than 5 months after vaccination, the patient had pain, felts like raw flesh and a lot of burning. The pain was in the skin, the patient knows the shingles shot did something. The patient stated that like the Covid vaccine no one told him/her about the adverse events. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation was not provided.

Other Meds:

Current Illness:

ID: 1539335
Sex: F
Age:
State: TX

Vax Date: 09/01/2020
Onset Date:
Rec V Date: 08/10/2021
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: Corneal Allograft Rejection; blurring of vision in the left eye; conjunctiva had trace injection; cornea had temporal stromal and epithelial edema; 1+ cells in the anterior chamber; Eye inflammation; This case was reported in a literature article and described the occurrence of transplant rejection in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis. The patient's past medical history included fuchs' endothelial dystrophy (undergone Descemet stripping endothelial keratoplasty in 2010 in OD and in 2009 in OS). Previously administered products included influenza vaccine. Concomitant products included Herpes zoster (Shingrix) and Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season). In September 2020, the patient received the 2nd dose of Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, 6 weeks after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced transplant rejection (serious criteria GSK medically significant), blurred vision, conjunctival injection, corneal edema, anterior chamber cell and eye inflammation. The patient was treated with loteprednol and prednisolone acetate. On an unknown date, the outcome of the transplant rejection, blurred vision, conjunctival injection and anterior chamber cell were unknown and the outcome of the corneal edema was recovered/resolved and the outcome of the eye inflammation was recovering/resolving. The reporter considered the transplant rejection, blurred vision, conjunctival injection, corneal edema, anterior chamber cell and eye inflammation to be possibly related to Shingrix. It was unknown if the reporter considered the transplant rejection, blurred vision, conjunctival injection, corneal edema, anterior chamber cell and eye inflammation to be related to Influenza vaccine Quadrivalent 2020-2021 season. Additional details were reported as follows: This case was reported in a literature article and described the occurrence of Zoster subunit vaccine (RZV)-associated corneal allograft rejection, in a female patient of unspecified age, who was vaccinated with Shingrix (GlaxoSmithKline) and Unspecified Infleunza vaccine (manufacturer unknown) for prophylaxis. This case corresponds to Table 1 reported in this literature article. This case corresponds to a case reported in this literature article. The patient was a healthy woman. The patient had undergone Descemet stripping endothelial keratoplasty in 2010 in the OD and in 2009 in the OS for Fuchs endothelial dystrophy. In 2019 (one year prior to presentation), the grafts were clear and best corrected visual acuity was 20/20 OD and 20/25 OS. The patient did not have previous history of viral keratitis or an episode of herpes zoster of any dermatome. No information on patient family history or concurrent condition or concomitant medication was reported. In August 2020, the patient was vaccinated with first dose of Shingrix (administration route and site unknown; batch number not provided), and the second dose of Shingrix in September 2020, along with the influenza vaccine (administration route and site unknown; batch number not provided for both). The age at vaccination was not reported but it could be between 68 or 69 years at the time of vaccination. In previous years, the patient had received the influenza vaccine each fall without incident. On an unknown date in 2020, 6 weeks after the second dose of Shingrix vaccination, the patient had blurring of vision in the left eye. At the time of onset of symptoms, the patient had been using topical loteprednol 0.5%, 1 drop 1 to 2 times per week in both eyes. At the age of 69 years, in October 2020, the patient presented with a 1-week history of blurring of vision in the left eye. At the time of the visit, visual acuity OS was 20/70. The conjunctiva had trace injection. The cornea had temporal stromal and epithelial edema, with 1+ cells in the anterior chamber. Intraocular pressure was 13 mm Hg. The patient denied systemic or local infection or trauma. The patient was diagnosed with allograft rejection. The patient was treated with prednisolone acetate 1% 8 times per day. Within 3 weeks, the anterior chamber was quiet, and after 8 weeks, the corneal edema had resolved. Vision at 3 months was 20/25 with no residual edema. Improvement of inflammation occurred quickly after intense topical steroid therapy. The author commented "It elicits a robust immune response, with both humoral and cell-mediated responses detectable 1 month after the first dose. RZV is more immunogenic than the older ZVL. It is likely that RZV may pose a greater risk for associated immune-mediated reactions, such as reactivation of zoster keratitis and corneal allograft rejection than ZVL. Identifiable potential risk factors other than the RZV were as follows: One patient had a history of a second Descemet stripping endothelial keratoplasty in the fellow eye 10 years previously. One patient had a history of 1 previous PKP that failed because of allograft rejection. The same patient also underwent removal of 1 suture before the onset of blurred vision. One drop of topical loteprednol 0.5% was administered at the time of the suture removal, and the patient was instructed to continue his previous regimen of prednisolone acetate 1% 4 per day. The third patient had 1 episode of rejection in a previous transplant. Original indications for keratoplasty were corneal endothelial dystrophy, past trauma, and keratoconus. In 2 of the 3 cases, rejection occurred despite relatively high level of topical corticosteroid therapy: difluprednate emulsion 0.05% 3 per day (for the treatment of cystoid macular edema), in 1 patient, and prednisolone acetate 1% 4 per day, in a second patient. Improvement of inflammation occurred quickly after intense topical steroid therapy in all 3 cases. Onset of symptoms of allograft rejection occurred 5 weeks after the first RZV dose in 1 patient. In the other 2 patients, blurred vision was noted 1 and 6 weeks after the second dose. It has been reported that "overall, 30% of transplanted corneas experience at least 1 episode of immune reaction."10 Therefore, observation of a chance temporal association with RZV is possible. However, with 3 cases identified within a 3-month period, it is reasonable to consider the possibility that RZV may increase the risk for corneal allograft rejection.". The author concluded "RZV, which elicits a more robust immune reaction than the zoster live-attenuated vaccine, ZVL, may increase the risk of allograft rejection in immunocompetent patients with preexisting corneal endothelial or penetrating transplants. Based on the available data, it may be reasonable to increase the topical corticosteroid regimen before the first dose, until approximately 3 months after the second dose of ZVL". This is 1 of the 3 valid cases reported in this literature article.; Sender's Comments: US-GLAXOSMITHKLINE-US2021GSK167260:Same reporter

Other Meds: Shingrix; Influenza vaccine Quadrivalent 2019-2020 season

Current Illness:

ID: 1539336
Sex: U
Age:
State: IN

Vax Date:
Onset Date:
Rec V Date: 08/10/2021
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: first dose /on Dec-10-2020; This case was reported by a pharmacist 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 on 10th December 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 as follows: The age at vaccination was not applicable for this report. Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. No other information about the patient was provided. Pharmacist declined to give adverse event information because he was busy. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1539337
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 08/10/2021
Hospital: Y

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: COVID-19 TEST POSITIVE; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnicity. 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) dose was not reported, 1 total, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient's husband reported that, the patient was tested positive for Covid-19 virus and was hospitalized (date and duration not specified). Laboratory data (dates unspecified) 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 covid-19 test positive was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210807871 and 20210808196.; Sender's Comments: V0: 20210807550-Covid-19 vaccine ad26.cov2.s -Covid-19 test positive . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1539338
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 03/26/2021
Rec V Date: 08/10/2021
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: ELEVATED BLOOD PRESSURE; SINUS INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; JOINT PAIN; FEVER; FEELING BAD; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, non smoker and high blood pressure (currently on high blood pressure medication for 10 years), and other pre-existing medical conditions included the patient had no known allergies and no 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: 1808609, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 26-MAR-2021 into right deltoid for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the patient experienced an hour or two of slightly elevated fever (did not get temperature) and just felt bad. On 02-AUG-2021, the patient experienced bad headache, fever, coughing, general weakness, he was not eating, could not get out of bed (for 2 and half days), low level of oxygen (suspected covid-19 infection and suspected clinical vaccination failure) . On 02-AUG-2021, the patient experienced sinus infection and joint pain. On 04-AUG-2021, at 11:00, the patient went to the emergency room and tested positive for covid-19. As per the patient, he has received regeneron infusion and his blood pressure was elevated. Laboratory data included: Oxygen saturation (NR: not provided) low. The patient stated that he wants to talk to someone from JNJ and because the fact that he trusted JNJ and now here he was sick even after getting the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sinus infection, joint pain, elevated blood pressure, suspected covid-19 infection, fever and the outcome of feeling bad and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210807550 and 20210808196.; Sender's Comments: V0: 20210807871-COVID-19 VACCINE AD26.COV2.S- suspected clinical vaccination failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS. 20210807871--Suspected COVID-19 infection, elevated blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness: Abstains from alcohol; Blood pressure high (taking blood pressure medication for 10 years.); Non-smoker

ID: 1539339
Sex: F
Age:
State: AZ

Vax Date:
Onset Date: 06/01/2021
Rec V Date: 08/10/2021
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: LOSS OF BLOOD; LEGS STARTED BUCKLING; PALE OR YELLOW; This spontaneous report received from a consumer concerned a 73 year old female with unspecified race. The patient's height, and weight were not reported. The patient's concurrent conditions included anemia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 202A21A expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 10-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced loss blood. On JUN-2021, the patient was pale or yellow. On JUL-2021, the patient experienced legs started buckling. Patient went to see her PCP, from there patient went to emergency room and had 2 pints of blood administered. Patient had a repeat transfusion with 2 pints and now patient was on the way to the emergency room as doctor recommended for patient to have another 2 pints. Patient was getting treated for anemia in every 6 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pale or yellow, and loss of blood, and the outcome of legs started buckling was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210810877-covid-19 vaccine ad26.cov2.s -loss of blood . 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: MEDICAL HISTORY, UNDERLYING DISEASE

Other Meds:

Current Illness: Anemia (Treated every 6 months.)

ID: 1539340
Sex: F
Age:
State:

Vax Date:
Onset Date: 08/04/2021
Rec V Date: 08/10/2021
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: SPOON STUCK TO HER LIKE A MAGNET ON SITE THE OF INJECTION; This spontaneous report received from a consumer concerned an adult 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, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-AUG-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 04-AUG-2021, the patient experienced spoon stuck to her like a magnet on the site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of spoon stuck to her like a magnet on the site of injection was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1539341
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/10/2021
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: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative (social media) concerned a patient of unspecified age, sex and unknown race and ethnic origin. 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) frequency 1 total, dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced suspected clinical vaccination failure, and suspected covid-19 infection. Patient symptoms included 103.5 fever, body aches, headache, loss of smell and taste which lasted pretty bad for 3 and more days. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103.5 C. 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).; Sender's Comments: V0: 20210812347-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has an unknown/unclear 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:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm