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: 1554786
Sex: F
Age: 14
State: NY

Vax Date: 08/01/2021
Onset Date: 08/12/2021
Rec V Date: 08/13/2021
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: None

Symptom List: Dysphagia, Epiglottitis

Symptoms: Headache, nausea, insomnia, hot flashes

Other Meds: None

Current Illness: None

ID: 1554787
Sex: F
Age: 67
State: CA

Vax Date: 08/11/2021
Onset Date: 08/12/2021
Rec V Date: 08/13/2021
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: Celebrex, Sulfa,Sulfites,certain perfumes n lotions

Symptom List: Anxiety, Dyspnoea

Symptoms: 8/12/21 Induration 3 inches by 3inches, pain, redness, swelling upon awakening, by 8pm I had chills n fever. On 8/13/21 I continued with all of the above plus, nausea, diarrhea, weakness, body aches. I felt like I was getting COVID all over again. I was Positive for COVID 6/2020 and was still donating convalecent plasma until July 2021, I stop donating because my vein was disappearing. I still had antibodies to COVID

Other Meds: None

Current Illness: No

ID: 1554789
Sex: F
Age: 36
State: FL

Vax Date: 03/13/2021
Onset Date: 03/13/2021
Rec V Date: 08/13/2021
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: None

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

Symptoms: Burning in arm right after injection. Lip swelling (lower lip) about 30-45 minutes after injection. Experienced high fevers (103), intense chills, body aches, and exhaustion for two days. My husband called the ER and they said to take Tylenol and Ibuprofen and cold baths to reduce fever.

Other Meds: Pau D?Arco

Current Illness: None

ID: 1554790
Sex: F
Age: 32
State: CA

Vax Date: 08/12/2021
Onset Date: 08/12/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies: N/a

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Dizziness, joint pain, severe headache

Other Meds: Birth control pills

Current Illness: N/a

Date Died: 06/05/2021

ID: 1554791
Sex: M
Age: 83
State: WV

Vax Date: 03/18/2021
Onset Date: 05/28/2021
Rec V Date: 08/13/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Pneumonia or Pneumonitis Weakness Severe hypoxia Cough Atrial fibrillation Dyspnea Death Progressed from ambulatory to death in 8 days

Other Meds: Synthroid Norvasc Metoprolol Omeprazole Keytruda Mirtazepine Benadryl Loratadine Metamucil

Current Illness: Metastatic melanoma (substantially improving)

ID: 1554792
Sex: F
Age: 54
State: FL

Vax Date: 07/21/2021
Onset Date: 07/21/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies: Seafood Cashews Poultry Eggs Latex

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

Symptoms: First vaccination Large melasma patches on back ( 6 inches in diameter) 2nd vaccination swelling tenderness & warm to touch still on day 3

Other Meds: Propranolol ER 80mg azelastine nasal spray montelucast 10mg

Current Illness: None

ID: 1554793
Sex: M
Age: 65
State: MA

Vax Date: 08/11/2021
Onset Date: 08/11/2021
Rec V Date: 08/13/2021
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: ADMINISTERED SECOND DOSE OF COVID 19 PFIZER VACCINE FROM A BATCH 6 DAYS OUT OF DATE. NO ADVERSE EVENT.

Other Meds: UNKNOWN

Current Illness: NONE

ID: 1554794
Sex: M
Age: 80
State: CA

Vax Date: 08/13/2021
Onset Date: 08/13/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies: n/a

Symptom List: Pharyngeal swelling

Symptoms: patient lied on intake form and said he had never received any moderna doses. after administration and checking cairs it shows he received in jan and feb 2021. no reaction at this time.

Other Meds: n/a

Current Illness: n/a

ID: 1554795
Sex: F
Age: 40
State: KS

Vax Date: 08/09/2021
Onset Date: 08/12/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies: Soy, Feraheme infusion

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: This was about four days after my emergency room visit for an allergic reaction to the vaccine. On early Thur 8/12 morning between about 4-4:30 am I woke up shaking extremely bad, uncontrollable, similiar to a seizure. I was also notabley hot, I think the hottest I've ever been. The extreme shaking only lasted a couple minutes, I think. I still had tremors and jumping legs. I stood up and my lower legs were very weak. It was very hard to walk, my legs were shaking. It was hard to bend my toes. And it was hard to use my hands, I could not make fists. The hot feeling lasted a short time, about 15 minutes. The tremors and jumping nerves lasted about an hour to hour and a half. My leg, feet, and hand weakness continued longer. I had regained my strength and movement by about Noon-1:00. I also still had a burning sensation in my chest, back, and underarms off and on throughout the day. The burning at night lasted about a half hour to hour before I fell asleep.

Other Meds: None at time of vaccination

Current Illness:

ID: 1554797
Sex: F
Age: 35
State: IL

Vax Date: 07/20/2021
Onset Date: 07/30/2021
Rec V Date: 08/13/2021
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: None

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Severe jaw pain/symptoms of TMJ, brain fog, excessive fatigue and tiredness

Other Meds: Mirena, Metformin, Seroquel, Lamictal

Current Illness:

ID: 1554798
Sex: M
Age: 62
State: AR

Vax Date: 08/06/2021
Onset Date: 08/10/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Patient reports tachycardia randomly occurring. This is occurring when patient is idle and not being active (ie while sleeping at night). Reports several instances of this. Patient has had this issue in the past but has been common since the vaccine. Patient is on heart medication since he has had stents/previous heart attacks.

Other Meds:

Current Illness:

ID: 1554799
Sex: M
Age: 40
State: LA

Vax Date: 08/13/2021
Onset Date: 08/13/2021
Rec V Date: 08/13/2021
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: bleeding and swelling outside of normal reaction to vaccine

Other Meds:

Current Illness:

ID: 1554800
Sex: F
Age: 70
State: CA

Vax Date: 08/13/2021
Onset Date: 08/13/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies: na

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

Symptoms: patient lied on intake form and said he had never received any moderna doses. after administration and checking cairs it shows she received in jan and feb 2021. no reaction at this time and wasn't eligible for 3rd dose when administered.

Other Meds: na

Current Illness: na

ID: 1554801
Sex: F
Age: 16
State: MA

Vax Date: 08/11/2021
Onset Date: 08/11/2021
Rec V Date: 08/13/2021
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: NONE LISTED

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

Symptoms: DOSE 2 OF COVID 19 PFIZER VACCINE ADMINISTERED WAS 6 DAYS EXPIRED, NO ADVERSE EVENTS AS A RESULT

Other Meds: NONE LISTED

Current Illness: NONE LISTED

ID: 1554802
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/13/2021
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: PENICILLIN

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

Symptoms: Allergy around the vaccine point, inflammation on the zone, fever, the flue.

Other Meds: NO

Current Illness: NO

ID: 1554810
Sex: F
Age: 31
State: WA

Vax Date: 02/26/2021
Onset Date: 01/22/2021
Rec V Date: 08/13/2021
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: pregnant patient received teh first dose of Moderna vaccine; sore arm; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant patient received teh first dose of Moderna vaccine) and VACCINATION SITE PAIN (sore arm) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The patient's past medical history included Alcohol use (2 drinks/month) from 25-Feb-2006 to 06-Sep-2020 and Caesarean section (Cephalopelvic disproportion -significant blood loss (Emergency C-section)) on 19-Sep-2018. Previously administered products included for an unreported indication: TDAP (Upper left Arm) on 19-Mar-2021. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from 04-Jan-2021 to an unknown date and PRONASE from 04-Jan-2021 to an unknown date for Allergy, PROMETHAZINE from 10-May-2020 to 11-May-2020 for Nausea, MINERALS NOS, VITAMINS NOS (PRENATAL PLUS) from 08-Jan-2020 to an unknown date for Pregnancy. On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 09-Aug-2020 and the estimated date of delivery was 16-May-2021. On 22-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant patient received teh first dose of Moderna vaccine) and VACCINATION SITE PAIN (sore arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the twenty-eighth week of the pregnancy. The cesarean delivery occurred on 12-May-2021, which was reported as Full-term. For neonate 1, the birth weight was 3100 grams (6lbs 13oz) with an APGAR score of 9 and 9 at (1, 5 minutes). The outcome was reported as Term Birth w/o Complications. thrombocytopenia Blood transfusion after delivery Male Fetus length-49cm. On 22-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant patient received teh first dose of Moderna vaccine) had resolved. On 23-Jan-2021, VACCINATION SITE PAIN (sore arm) had resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2020, Prenatal screening test: low risk (Inconclusive) low risk. On 06-Sep-2020, Pregnancy test: positive (Positive) positive. On 05-Nov-2020, Prenatal screening test: negative (Negative) Nothing abnormal, everything was negative. On 23-Dec-2020, Ultrasound abdomen: baby was little bit small (Inconclusive) Baby was a little bit small and normal (normal) normal. On 02-Feb-2021, Ultrasound abdomen: normal (normal) Everything was normal and normal (normal) normal. On 21-Apr-2021, Streptococcus test: negative (Negative) Negative. On 03-May-2021, Blood glucose: 91 (normal) normal. On 18-Sep-2021, Sexually transmitted disease test: negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information was not provided. The Estimated date of conception was 15Aug2020 This case was linked to MOD-2021-032146 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: followup received on 07-may 2021 had included second dosage information and concomitant drugs and second dosage events and Completed Pregnancy Reporting Form after 1st dosage On 23-Jun-2021: Follow-up received on 23-Jun-2021 and does not contain any new information

Other Meds: PRENATAL PLUS; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; PRONASE; PROMETHAZINE

Current Illness:

ID: 1554811
Sex: M
Age: 65
State: MO

Vax Date: 03/01/2021
Onset Date: 03/30/2021
Rec V Date: 08/13/2021
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: Achy Neck; Stiff neck; Headache; Shoulders sore; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Achy Neck), MUSCULOSKELETAL STIFFNESS (Stiff neck), HEADACHE (Headache) and ARTHRALGIA (Shoulders sore) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 00B21A) for COVID-19 vaccination. No medical history was reported. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced NECK PAIN (Achy Neck), MUSCULOSKELETAL STIFFNESS (Stiff neck), HEADACHE (Headache) and ARTHRALGIA (Shoulders sore). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 1 dosage form. On 31-Mar-2021, NECK PAIN (Achy Neck), MUSCULOSKELETAL STIFFNESS (Stiff neck), HEADACHE (Headache) and ARTHRALGIA (Shoulders sore) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant includes high blood pressure medication. Action taken with mRNA-1273 with the events was considered as not applicable. Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow-up received on 28-jun-2021 which is updated with the information of Concomitant medication and expiry dates for the 1st and 2nd doses.

Other Meds:

Current Illness:

ID: 1554812
Sex: F
Age: 74
State: FL

Vax Date: 01/06/2021
Onset Date: 02/04/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Heart rate was rising; headache; tiredness; shingles; fever; sore arm; swelling; red blotches all over her arm; itchy rash; flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY, SWELLING, RASH MACULAR, RASH PRURITIC, and INFLUENZA LIKE ILLNESS in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. Concomitant products included WARFARIN for Anticoagulant therapy, FAMOTIDINE for Gastroesophageal reflux disease, PROBIOTICS for Stomach upset. On 06-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) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY, SWELLING, RASH MACULAR, and RASH PRURITIC. 04-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS and PYREXIA. On 13-Feb-2021, the patient experienced HERPES ZOSTER (shingles). On 04-May-2021, the patient experienced FATIGUE. On an unknown date, the patient experienced HEART RATE INCREASED and HEADACHE. On 05-Feb-2021, INFLUENZA LIKE ILLNESS and PYREXIA had resolved. At the time of the report, PAIN IN EXTREMITY, SWELLING, RASH MACULAR, and RASH PRURITIC had not resolved, HEART RATE INCREASED, HEADACHE, and FATIGUE outcome was unknown and HERPES ZOSTER had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 90 above (High) pulse rate never dropped under 90. Patient took Tylenol and Benadryl for her treatment. Concomitant medications taken were Vitamin D 5000 units 3 tablets a day, Vitamin B-12 1000mg 1 tablet daily, Vitamin C 750mg Chew 2 a day. On 28Jul2021, patient will have an appointment with the lung specialist to check up on the ground glass cancer 10 years ago. Action taken with mRNA-1273 in response to the events were Not Applicable Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Patient email id was updated. Drug start date was updated. New adverse event was updated. Lab data was updated. Concomitant medication was updated

Other Meds: FAMOTIDINE; WARFARIN; PROBIOTICS

Current Illness:

ID: 1554889
Sex: M
Age:
State: PR

Vax Date:
Onset Date: 07/07/2021
Rec V Date: 08/13/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: fever; headache; trouble speaking; unable to walk; unable to breath; crooked fingers/ twisted fingers; This is a spontaneous report from a contactable consumer (patient). A 15-years-old male patient received first dose of bnt162b2 (BNT162B2, BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EW0178) via an unspecified route of administration, administered in arm left on 15Jun2021 09:00 as dose 1, single and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EW0186) as dose 2, single for COVID-19 immunization (Age at vaccination 15 years). Medical history included asthma; food allergy Known allergies to the shrimp, sinus disorder. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. On 07Jul2021 01:00 patient experienced fever, headache, trouble speaking, unable to walk, unable to breath and crooked fingers/ twisted fingers. Therapeutic measures were taken as a result of all AE includes treatment with vein treatment solumedrol and Panadol, vendria. AE resulted in Emergency room / department or emergencies. The outcome for all events was recovered on an unspecified date in 2021 Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1554935
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/13/2021
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: a golf-ball sized ball in arm; This spontaneous report has been received from a consumer in courtesy from Pfizer, referring to a 40 years old (estimated as DOB and AE onset date) female patient. The patient had familial Mediterranean fever (FMF/) but do not present active symptoms (Genetic asymptomatic carrier for Familial Mediterranean Fever) and also frequently suffered from migraines. Also reported that patient's immune system generally reacts strongly to all vaccines. Patient also had ongoing allergy to etodolac (LODINE). Past medical treatment(s) medical treatment(s), vaccination(s) and concomitant was not provided. In 2019, the patient received a dose of suspect yellow fever vaccine produced by unknown manufacturer, a dose of suspect hepatitis a vaccine (manufacturer unknown), a dose of suspect hepatitis b vaccine (manufacturer unknown) and a dose of suspect measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), all for prophylactic vaccination. Strength, lot number and expiration date for all suspect vaccines were not reported. Route and administration site for all suspect product were unknown. In 2019, the patient developed a non-serious strong reaction including a golf-ball sized ball in arm (limb mass), in the same year following the vaccinations and on the third Hepatitis A/ Hepatitis B dose. It was unknown if the patient experienced any additional symptoms/events. No laboratory data reported. Steroids as a corrective treatment was received by the patient to bring down the limb mass. At time of reporting, the outcome was unknown for the reported event. There would be no information on the batch number for this case. The causality assessment between all suspect vaccines and the event was not reported. It was also reported that on 10- MAR-2021 07: 15 AM, the patient, who was 42 years old currently (pregnancy: no), received the most recent coronavirus disease 2019 (COVID-19) (coronavirus disease, two doses) vaccine in Hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and also no any other medications was received within 2 weeks of vaccination. Reported event: for both doses: chills for about an hour (began exactly 3 hours after the shot was administered in both doses). First dose had a hangover-type headache the day after the shot. Second dose the hangover-type headache started the same day as the shot and with much greater intensity. It was day 2 and the headache was still present but with less intensity. Some chills in the morning sporadically. Patient thanked and said let's get rid of this COVID pandemic. She did not received treatment for the adverse event, Prior to vaccination, the patient was not diagnosed with COVID- 19 and since the vaccination, she had not been tested for COVID-19; Vaccine facility information available. Ethnicity information was available. Race information was available (race also reported as unknown).

Other Meds:

Current Illness: Drug hypersensitivity; Familial mediterranean fever (Familial Mediterranean Fever (FMF) but do not present active symptoms (Genetic asymptomatic carrier for Familial mediterranean fever)); Migraine; Prophylactic vaccination

ID: 1554938
Sex: F
Age:
State: NY

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 08/13/2021
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: Pain; Chills; Injection site pain; Pyrexia; This case was received via VAERS (Reference number: 0931176) on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021. This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Pain), CHILLS (Chills), VACCINATION SITE PAIN (Injection site pain) and PYREXIA (Pyrexia) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included High cholesterol and Hypertension. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PAIN (Pain), CHILLS (Chills), VACCINATION SITE PAIN (Injection site pain) and PYREXIA (Pyrexia). At the time of the report, PAIN (Pain), CHILLS (Chills), VACCINATION SITE PAIN (Injection site pain) and PYREXIA (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. Other Meds : calcium, biotin, aspirin, Norvasc, Atorvastatin Symptom Text : fever, soreness at injection site, body aches and chills. These began approximately 6:30pm night of injection, continued into the next day. Taking advil every 4 hours and this has helped to stop the fever but the rest of the symptoms continue Reporter did not allow further contact

Other Meds: CALCIUM; BIOTIN; ASPIRIN (E.C.); NORVASC; ATORVASTATIN

Current Illness:

ID: 1554939
Sex: F
Age:
State: VA

Vax Date: 12/29/2020
Onset Date: 12/30/2020
Rec V Date: 08/13/2021
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: Abdominal pain upper; Back pain; Chest discomfort; Injection site reaction; Musculoskeletal stiffness; Neck pain; Pain in extremity; Injection site pruritus; Injection site erythema; Injection site swelling; Injection site pain; Fatigue; This case was received via VAERS (Reference number: 0933587) on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021. This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN UPPER (Abdominal pain upper), BACK PAIN (Back pain), CHEST DISCOMFORT (Chest discomfort), INJECTION SITE REACTION (Injection site reaction) and MUSCULOSKELETAL STIFFNESS (Musculoskeletal stiffness) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy (Penicillin). Concomitant products included MAGNESIUM, LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), SERTRALINE HYDROCHLORIDE (ZOLOFT) and PROBIOTICS NOS for an unknown indication. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced ABDOMINAL PAIN UPPER (Abdominal pain upper), BACK PAIN (Back pain), CHEST DISCOMFORT (Chest discomfort), INJECTION SITE REACTION (Injection site reaction), MUSCULOSKELETAL STIFFNESS (Musculoskeletal stiffness), NECK PAIN (Neck pain), PAIN IN EXTREMITY (Pain in extremity), INJECTION SITE PRURITUS (Injection site pruritus), INJECTION SITE ERYTHEMA (Injection site erythema), INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE PAIN (Injection site pain) and FATIGUE (Fatigue). At the time of the report, ABDOMINAL PAIN UPPER (Abdominal pain upper), BACK PAIN (Back pain), CHEST DISCOMFORT (Chest discomfort), INJECTION SITE REACTION (Injection site reaction), MUSCULOSKELETAL STIFFNESS (Musculoskeletal stiffness), NECK PAIN (Neck pain), PAIN IN EXTREMITY (Pain in extremity), INJECTION SITE PRURITUS (Injection site pruritus), INJECTION SITE ERYTHEMA (Injection site erythema), INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE PAIN (Injection site pain) and FATIGUE (Fatigue) had not 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 information were not provided.

Other Meds: MAGNESIUM; XYZAL; ZOLOFT; PROBIOTICS NOS

Current Illness:

ID: 1554942
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/13/2021
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: Suspected Vaccination failure; had a case of them; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. The patient was told that, there was a new vaccine out there at the time of reporting, so he/she would try that one too. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.

Other Meds:

Current Illness:

ID: 1554943
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: suspected vaccination failure; I had internal shingles; nerve pain/awful pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingles vaccine (original vaccine). On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix and Shingrix. Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. The patient had the original vaccine and then both the doses of Shingrix, years ago from the date of reporting. After receiving Shingrix, the patient got shingles. The patient reported that, he/she had internal shingles, too. The patient had most awful pain in his/her entire life. The patient did not even know there was such a thing. At the time of reporting, the patient was still having nerve pain but tolerable. The patient's doctor said, he/she might have this pain for the rest of his/her life. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation of shingles were not provided.

Other Meds:

Current Illness:

ID: 1554945
Sex: M
Age:
State: TX

Vax Date: 12/01/2020
Onset Date:
Rec V Date: 08/13/2021
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: Redness /at injection site; Swelling at injection site; Fever; Chills; Weakness; Flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. In December 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, fever, chills, weakness and influenza-like symptoms. On an unknown date, the outcome of the injection site erythema, injection site swelling, fever, chills, weakness and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling, fever, chills, weakness and influenza-like symptoms to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient reported that he received first dose of Shingrix. The patient experienced redness and swelling at injection site, fever, chills, weakness and flu like symptoms. The patient stated that the symptoms went away after a few days. The reporter was referred to health care professional. The reporter did not consent to follow-up. Limited information was obtained. All these symptoms also experienced post second dose. For second dose refer linked case US2021168407 (same reporter).; Sender's Comments: US-GLAXOSMITHKLINE-US2021168407:Same reporter

Other Meds:

Current Illness:

ID: 1554946
Sex: U
Age:
State:

Vax Date: 04/20/2019
Onset Date:
Rec V Date: 08/13/2021
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: Suspected vaccnation failure; shingles /suffering terribly/ nasty; 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. On 20th April 2019, the patient received the 2nd dose of Shingles vaccine. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. The patient received 1 shot version in 2018. The vaccine only lasted about 5 years and they did not give another vaccination or booster. The patient had 2nd dose on 20th April 2019. After receiving 2 doses of Shingles vaccine, the patient had shingles at the time of reporting. The patient stated that, it was 97 percent effective and he/she fell into the exception 3 percent. This case was considered as suspected vaccination failure, since the details regarding laboratory test confirmation was not provided.

Other Meds:

Current Illness:

ID: 1554949
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/13/2021
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: Had permanent nerve pain; This case was reported by a consumer via other manufacturer and described the occurrence of nerve pain in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced nerve pain. On an unknown date, the outcome of the nerve pain was not recovered/not resolved. The reporter considered the nerve pain to be related to Shingrix. Additional details were provided as follows: Age at vaccination was not reported. The patient experienced permanent nerve pain from a Shingrix shot. No further information was reported. The reporter did not consented to follow up.

Other Meds:

Current Illness:

ID: 1554953
Sex: F
Age:
State: WA

Vax Date:
Onset Date:
Rec V Date: 08/13/2021
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: problem with arm she had the shot in; muscle weakness; This case was reported by a consumer via call center representative and described the occurrence of muscle weakness in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle weakness and arm discomfort. On an unknown date, the outcome of the muscle weakness and arm discomfort were not recovered/not resolved. It was unknown if the reporter considered the muscle weakness and arm discomfort to be related to Shingrix. Additional details were provided as follows: Age at vaccination was not provided. The patient received Shingrix and experienced muscle weakness, problem with arm she had the shot in and still having some side effects. No further information reported.

Other Meds:

Current Illness:

ID: 1554954
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 08/13/2021
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: had her complete vaccination of SHINGRIX got Shingles/suspected vaccination failure; got Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and COVID-19 VACCINE (COVID-19 VACCINE UNKNOWN) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and COVID-19 VACCINE UNKNOWN. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. Additional case details were provided as follows: The age at vaccination was not reported. Pharmacist reported that female patient who had completed her vaccination of Shingrix got Shingles. Patient's physician told her that it might be due to the COVID vaccination. The pharmacist called to see if Glaxosmithkline had information regarding that topic. The reporter did not have any vaccine information at the time of the call (lot number, expiration date of the doses). This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation were unknown at the time of reporting. No further events were reported at the time of the call. The reporter consented to follow up by email.

Other Meds:

Current Illness:

ID: 1554955
Sex: F
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 08/13/2021
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: Delayed receiving second dose because of COVID-19 pandemic; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 29th October 2019). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, the patient was delayed receiving second dose because of COVID-19 pandemic and pharmacy delays in receiving Shingrix vaccines and had not yet been administered. The pharmacist was not able to provide lot number and expiration date of first Shingrix vaccine. The VAERS details were reported for 1st dose of Shingrix. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1554956
Sex: M
Age:
State: AL

Vax Date:
Onset Date:
Rec V Date: 08/13/2021
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: first dose /04-Jan-2019 /not received dose two.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 4th January 2019). 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. The patient received 1st dose of Shingrix and did not receive dose two. Till the time of reporting, the patient did not receive the 2nd dose of the vaccine, which led to incomplete course of vaccination. The reporter consented to follow up. This case has been linked to the case US2021168351, US2020079556 and US2019096333 reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021168351:Same reporter US-GLAXOSMITHKLINE-US2020079556:Same reporter US-GLAXOSMITHKLINE-US2019096333:Same reporter

Other Meds:

Current Illness:

ID: 1554957
Sex: M
Age: 66
State: IL

Vax Date: 05/01/2018
Onset Date: 08/04/2021
Rec V Date: 08/13/2021
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: shingles outbreak / after the complete vaccination/ suspected vaccination failure; shingles outbreak; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number ZG47A, expiry date 12th February 2021) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) (batch number B5EK2, expiry date 28th April 2020) for prophylaxis. On 27th July 2018, the patient received the 2nd dose of Shingrix. On 1st May 2018, the patient received the 1st dose of Shingrix. On 4th August 2021, 1104 days after receiving Shingrix and 1191 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. Additional details were provided as follows: The patient had a shingles outbreak after the complete vaccination of Shingrix. The shingles outbreak was not confirmed by the pharmacist, the patient stated having shingles. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory test confirmation for shingles were unknown. No further events were reported at the time of the call. The pharmacist called to know if they had to revaccinate the patient or not. The health care professional could not clearly see the last letter of the lot number of the 2nd dose of Shingrix. The reporter consented to follow up by phone.

Other Meds:

Current Illness:

ID: 1554961
Sex: M
Age:
State: TX

Vax Date: 08/06/2021
Onset Date: 08/06/2021
Rec V Date: 08/13/2021
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: redness /at injection site; swelling at injection site; fever; chills; weakness; flu-like symptoms; first dose /December 2020/ second dose August 6, 2021.; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (had swelling, fever, chills, weakness after receiving 1st dose in December 2020, for tolerance refer case US2021AMR169451). On 6th August 2021, the patient received the 2nd dose of Shingrix. On 6th August 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced injection site erythema, injection site swelling, fever, chills, weakness and influenza-like symptoms. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema, injection site swelling, fever, chills, weakness and influenza-like symptoms were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, fever, chills, weakness and influenza-like symptoms to be related to Shingrix. Additional details provided were as follows: Age at vaccination was not reported. The patient received the second dose of Shingrix on left deltoid and after 12 hours experienced redness and swelling at injection site, fever, chills, weakness and flu like symptoms. He had not recovered yet from those symptoms and stated his fever comes and went for the last four days. He also mentioned that he had the same symptoms with the first dose but the symptoms went away after a few days. The reporter referred him to health care professional. Limited information was obtained. The reporter did not consented to follow-up.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR169451:1st dose, Same reporter

Other Meds:

Current Illness:

ID: 1554962
Sex: F
Age:
State: CA

Vax Date: 04/06/2021
Onset Date:
Rec V Date: 08/13/2021
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: case of shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 53l2z, expiry date 15th May 2022) for prophylaxis. On 6th April 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingrix. Additional details were provide are as follows: The age at vaccination was not reported but it could be 65 or 66 years old. The patient received 1st dose of Shingrix and experienced a case of shingles. The Health care professional did not clarify how much time had past after the administration of 1st dose and the begging of the shingles episode. The patient had not yet received the 2nd dose. No further events were reported. The reporter consented to follow-up. The case was linked with case US2021007444 and US2020185477 reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021007444:same reporter US-GLAXOSMITHKLINE-US2020185477:same reporter

Other Meds:

Current Illness:

ID: 1554963
Sex: F
Age: 30
State: VA

Vax Date: 08/09/2021
Onset Date: 08/09/2021
Rec V Date: 08/13/2021
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: NKA

Symptom List: Erythema, Pruritus

Symptoms: Menstrual cycle started 7 days early Heavy bleeding (more than normal for myself)

Other Meds: None

Current Illness: None

ID: 1554964
Sex: F
Age: 67
State: IL

Vax Date: 08/10/2021
Onset Date: 08/12/2021
Rec V Date: 08/13/2021
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: Tetracycline Environmental allergies - dust mites, ragweed, trees, grasses, dogs, horses

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

Symptoms: I woke up and the hemangioma on my left cheek had a larger bump - size of pea - and was painful (Thursday Aug 12). Next day I got up and it was normal.

Other Meds: Chlorothalidone 25mg Calcium 600 mg w Vit D 20 mcg Prednisolone Acetate 1% Magnesium 400 mg Zinc 15mg B12 1000mcg Vitamin C 500mg

Current Illness: None

ID: 1554965
Sex: M
Age: 13
State: MA

Vax Date: 08/11/2021
Onset Date: 08/11/2021
Rec V Date: 08/13/2021
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 LISTED

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

Symptoms: DOSE ONE OF THE COVID 19 PFIZER VACCINE ADMINISTERED WAS 6 DAYS EXPIRED

Other Meds: NONE LISTED

Current Illness: NONE LISTED

ID: 1554966
Sex: F
Age: 44
State: MN

Vax Date: 03/12/2021
Onset Date: 03/27/2021
Rec V Date: 08/13/2021
Hospital: Y

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

Lab Data:

Allergies: Nickel

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: I developed ITP. My blood was tested two weeks after getting the vaccine and my platelets were at zero. I was treated for two months with numerous treatments including: rituximab, promacta, platelet transfusions, prednisone, nplate, IVGG. I started having better platelet numbers around May 4th.

Other Meds: Vitamin c, vitamin d, probiotic, fish oil, multivitamin

Current Illness: None

ID: 1554967
Sex: F
Age: 49
State: CA

Vax Date: 08/13/2021
Onset Date: 08/13/2021
Rec V Date: 08/13/2021
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: na

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

Symptoms: patient falsified immunization paperwork to say she had never received any doses of moderna but had received in early 2021. at the time of administration she was not eligible for 3 rd booster and wasn't caught on cairs until after.

Other Meds: na

Current Illness: na

ID: 1554968
Sex: F
Age: 25
State: MI

Vax Date: 08/13/2021
Onset Date: 08/13/2021
Rec V Date: 08/13/2021
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: None

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

Symptoms: Patient received 1st dose pfizer vaccine. About 10 minutes later, patient said she was feeling unwell. Pharmacist went over to check her vitals. Pulse oximeter showed her to be at 151bpm. She complained that she was not feeling well. Looked distressed. She complained that her left arm where she received the injection, was feeling numb/heavy and tingling. Patient also complained that she was feeling very thirsty and asked for water, which we refused to give her in the fear of her choking if she was to pass out. Paramedics were called to the scene and she was taken to hospital by ambulance.

Other Meds: Patient mentioned after she received the vaccine, that she takes blood pressure, and thryroid medications.

Current Illness: Patient has sinus tachycardia and wears a monitor for this.

ID: 1554969
Sex: F
Age: 31
State: PA

Vax Date: 05/14/2021
Onset Date: 05/30/2021
Rec V Date: 08/13/2021
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: Pain in extremity

Symptoms: Patient was about 3-4 weeks pregnant at the time of second vaccine dose. She subsequently had a miscarriage which started with vaginal bleeding on May 30th in the evening. Prior to this miscarriage, she had 2 gestations which resulted in 2 full term uncomplicated deliveries.

Other Meds: Prenatal vitamins

Current Illness:

ID: 1554970
Sex: F
Age: 23
State: MA

Vax Date: 08/11/2021
Onset Date: 08/11/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies: NONE LISTED

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

Symptoms: DOSE ONE OF THE VACCINE ADMINISTERED WAS 6 DAYS OUT OF DATE, NO ADVERSE EVENT

Other Meds: NONE LISTED

Current Illness: NONE LISTED

ID: 1554971
Sex: F
Age: 53
State: MA

Vax Date: 08/09/2021
Onset Date: 08/10/2021
Rec V Date: 08/13/2021
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: shrimp

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

Symptoms: Shingles. Nerve Pain. Swelling of right side of nose, mouth, cheek and lower eyelid.

Other Meds: Zoloft. Finished anti-biotics for strep the Friday before.

Current Illness: Strep

ID: 1554972
Sex: F
Age: 51
State: SC

Vax Date: 06/08/2021
Onset Date: 06/16/2021
Rec V Date: 08/13/2021
Hospital: Y

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

Lab Data:

Allergies: None

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

Symptoms: Onset of symptoms on June 15, 2021, shortness of breath, tightness in lungs, swelling and pain in right calf . Symptoms grew progressively worse over following week. June 24 ? extreme difficulty breathing, loss of consciousness. Ambulance to emergency room. CT Scan at ER revealed dual branch pulmonary embolisms. Emergency Thrombectomy. Multiple blood clots between 1 and 6 inches long removed from both branches. Anticoagulants prescribed for one year and assisted oxygen.

Other Meds: Eliquis, Sertraline, Busparine, Topirimate, Quetiapine, Levothyroxine, Gabapentin

Current Illness: None

ID: 1554973
Sex: F
Age: 25
State: TX

Vax Date: 08/13/2021
Onset Date: 08/13/2021
Rec V Date: 08/13/2021
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: none

Symptom List: Vomiting

Symptoms: come on for a Pfizer Covid 19 IMZ. I gave the IMZ at roughly 9:30 am in her right Deltoid. She was ask along with her husband to stay for 15 minutes to observer and make sure there was no reaction before leaving. In a few minutes waiting she rushed to the restroom feeling hot/cold and nauseated. She returned from the restroom and sat in one of the waiting area chairs. I immediately came out and ask her to come back into the IMZ room and lay down on the floor and I propped up her feet on a ABC plastic container and put a few sacs underneath her head. She complained about feeling hot/cold and woozy. I ask if she had any breathing difficulties and she said no and that she could breath fine. I began taking her blood pressure at around roughly 9:40. It was 123/82 and HR 63. I continued to monitor her BP and HR every few minutes. At roughly 9:50 I ask and then gave her 15ml of diphenhydramine oral solution 12.5mg\5ml to help with any allergic reaction and nausea the might have. She was sleepy but alert and talking. At 10:10 she was talking on the phone to someone while still lying down. She ask at one point if she could sit in the chair but I said for her safety for her to continue to lie on the floor until she felt very stable and she agreed. In roughly another 15 minutes I ask her if she felt like she was improving and she said not really and still felt hot/cold and woozy. I spoke to both of them and suggested calling 911 just to be on the safe side and they agreed. I called 911 and was transferred to the medical center where I gave my name, reason for calling, our address and patient's condition, IMZ received and was requesting EMS to come. While continuing to check BP and HR we waited for EMS to arrive. After 15 to 20 minutes, I believe roughly, they arrived and took over care of patient. They told her that the symptoms she was experiencing were not too unusual with the Pfizer Covid IMZ and that she might have had some anxiety that contributed to her symptoms. The assisted her into a chair at her request and again took her vitals and BS. They ask all routine questions while filling out computer visit questions. After discussing with her the options she had as to go to the hospital for observation or just monitoring herself and calling them back if needed. She decided to not go to the hospital. She signed the computer AMA about going to the hospital. She was still a little woozy and sleepy but as I had told her the EMS techs did also that the generic Benadryl might maker her feel sleepy and sluggish also. She and her husband left on there own power walking out of the clinical service room next to the pharmacy . BP and HR readings 9:40 - 123/82 HR 63 9:50 - 120/86 HR 63 9:54 - 121-82 HR 59 9:56 - 124-86 HR 62 10:00 - 127/83 HR 60 10:07 - 126/89 HR 68 10:11 - 127/94 HR 64 10:16 - 129/92 HR 67 10:21 - 127/93 HR 67 10:28 - 126/90 HR 65

Other Meds: none known

Current Illness: none known

ID: 1554974
Sex: F
Age: 52
State:

Vax Date: 08/07/2021
Onset Date: 08/08/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: pt reports nausea that occurred for 3 days post 2nd dose. pt also reports fever, chills and hot flashes that have still not gone away 7 days post 2nd dose. told pt this is not normal and that she got go to MD, ER, URGENT CARE ASAP. pt said that she might have possible UTI as she also had blood in her urine prior to 2nd dose that was being treated with abx. TOLD PT NOT NORMAL AND TO SEE MD ASAP.

Other Meds:

Current Illness:

ID: 1554975
Sex: F
Age: 69
State: MI

Vax Date: 08/10/2021
Onset Date: 08/11/2021
Rec V Date: 08/13/2021
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: pennicillan, sulfa drugs. Grass,trees,especially pine. Dust, mold Glipiside

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

Symptoms: Came on gradually. I felt like it was an additional symptom of Covid 19 about once every hour. Started with headache, then a neck ache. Then my eye balls felt swollen and hot in the back . Next was total body aching and fatigue. The fever started and within about 1.5 hours it was up to 102.6. after about 103 I had chills really bad. Of course in that time I took Tylenol.I laid under 3 blankets until morning. By the next morning the fever broke. And little by little the symptoms started to go away Today is the third day and I don't feel symptomatic any more. But I feel like I'm coming down with a terrible head cold and cough. And the injection sit itches something awful

Other Meds: Lisinopril HCL 20mg, Atorvstatin, cetalopram,flonase

Current Illness: No illnesses. I am having an aortic valve replacement in a few weeks. i only use the Glipiside if my blood sugar is over 145. My latest A1c was 6.2

ID: 1554976
Sex: F
Age: 36
State: NJ

Vax Date: 08/09/2021
Onset Date: 08/11/2021
Rec V Date: 08/13/2021
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: Vincomycin

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Heavy menstral bleeding 5 days before period was due. Heavy clots passed

Other Meds: Zoloft Xanax Multi vitamin Lipitor Seasonique

Current Illness: Anxiety

ID: 1554977
Sex: F
Age: 28
State: CA

Vax Date: 08/12/2021
Onset Date: 08/12/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies: na

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

Symptoms: patient received 1st dose of Pfizer vaccine. About 5-10 minutes she became light headed, flushed, dizzy, and nauseous. she ended up throwing up and her bp was 95/81. emt was called but she was not transported as she began to feel better.

Other Meds: na

Current Illness: na

ID: 1554978
Sex: F
Age: 35
State: MN

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 08/13/2021
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: Pcn, erythromycin

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

Symptoms: The evening following my vaccination I started heavily menstrating lasting 6 full days. Prior to this vaccine I have not experienced a period for 8 months as I have an IUD. I have experienced a monthly period every month since the vaccination.

Other Meds: Lexapro

Current Illness: No

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm