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: 1024936
Sex: F
Age: 32
State: CA

Vax Date: 02/03/2021
Onset Date: 02/09/2021
Rec V Date: 02/12/2021
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: Minor Bell's Palsy- Increase in numbness/tingling of the tongue over the past two days. Lips started to numb today. Pain is increasing in left ear. No noticeable drooping of facial muscles yet, but symptoms may increase in the next 24 hours.

Other Meds: Women's daily vitamin Effexor Remeron

Current Illness: n/a

ID: 1024937
Sex: M
Age: 28
State: HI

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 02/12/2021
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: Just after being seated in the post vaccination area, reported a headache. Describes it as a throbbing feeling over forehead area. Rates pain 3-4 on 0-10 pain scale. Patient typically only gets headache around cigar or cigarette smoke. Offered water to drink, patient accepted. By 1300, reports headache getting smaller. By 1306, headache pain 1/10 on 0-10 pain scale. Reports feeling well. Released from post vaccination area at 1306.

Other Meds: None

Current Illness: None

ID: 1024938
Sex: F
Age: 73
State: NJ

Vax Date: 01/27/2021
Onset Date: 02/10/2021
Rec V Date: 02/12/2021
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: woke with uncontrollable itching, hives or welts, from ankles to head, knees, inside thighs, outside thighs, buttocks, fingers, by underarm pits, chin, eyes, top of legs between knees and torso, urgent care at urgent care, Dr. concluded it was from vaccine, gave me 3 pills of some type of cortisone , and 4 day course of cortisone tablets next four days, also OTC benedryl, to allow me to sleep

Other Meds: simvstatin, propranalol, fluvoxamine, lamotragine, magnesium citrate, melatonin, vit.D, toviaz, melatonin

Current Illness: none

ID: 1024939
Sex: F
Age: 39
State: IL

Vax Date: 02/02/2021
Onset Date: 02/09/2021
Rec V Date: 02/12/2021
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: 1 week After My 2nd dose , I feel abdominal cramps like My stomach is full of air and I have the urge to move My bowel like I?m having diarrhea. I can?t Control it. I?m honestly not sure if this was a side effect of the Vaccine but I didnt have this issue before I got the Vaccine.

Other Meds: Montelukast, vitamin C, zinc, acai berry, vitamin D, black seed oil, mx3 (mangosteen tablet)

Current Illness: Asthma

ID: 1024940
Sex: F
Age: 42
State: WA

Vax Date: 02/09/2021
Onset Date: 02/10/2021
Rec V Date: 02/12/2021
Hospital:

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

Lab Data:

Allergies: Cats, rats, grass, lychee, artificial citrus

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

Symptoms: Chills and fever along with dizziness, weakness, and joint pain started ~12 hours post vaccination lasting about 4-5 hours. Persistent pain was treated with 200 mg ibuprofen 28 hours post vaccination. 48 hours post vaccination had mild nausea and fatigue. All symptoms appeared resolved by 60 hours post vaccination.

Other Meds: Multivitamin, Vitamin D 1000 IU supplement, fish oil supplement 720 mg, tretinoin Cream 0.1%, tacrimus ointment 0.1%

Current Illness:

ID: 1024941
Sex: M
Age: 55
State:

Vax Date: 02/10/2021
Onset Date: 02/11/2021
Rec V Date: 02/12/2021
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: none

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

Symptoms: headache (4 of 10) chills muscle aches fever

Other Meds: none

Current Illness: none

ID: 1024942
Sex: M
Age: 37
State:

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 02/12/2021
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: N/a

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Sore arm at injection site, fever of 102?, chills, aches and headache

Other Meds: N/a

Current Illness: N/a

ID: 1024943
Sex: F
Age: 24
State: FL

Vax Date: 02/11/2021
Onset Date: 02/12/2021
Rec V Date: 02/12/2021
Hospital:

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

Lab Data:

Allergies: None

Symptom List: Pharyngeal swelling

Symptoms: Woke up at 2:00am after falling asleep around 12:00am. Experiencing feverish feelings with no fever (98.0). Nausea also began around this time. Took a zofran 8mg at 2:30am, didn?t really experience any relief. Then suddenly had to vomit (mostly bile) at 3:00am. Feeling slightly nauseous after vomiting but better than before.

Other Meds: Blisovi birth control Zofran 8mg

Current Illness: None

ID: 1024944
Sex: M
Age: 54
State: HI

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 02/12/2021
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: 1420 recieved vaccination. When arrived at post vaccination area, reported a very mild pins and needles sensation from L shoulder down to hand and pinky and ring finger. 1426: BP 128/90 HR 62. 1420: Reports upper arm has returned to normal feeling; sensation of pins and needles to hand, pinky, ring finger. Reports that sensation remains at same intensity. Over time, reports that the pins and needles sensation leaves his lower arm until at 1440 when tingling has resolved and everything feels "back to normal." Released from post vaccination area.

Other Meds: Vitamins

Current Illness: None

ID: 1024945
Sex: F
Age: 34
State: PA

Vax Date: 02/11/2021
Onset Date: 02/12/2021
Rec V Date: 02/12/2021
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: N/A

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Started menstruating 14 hours after both 1st and 2nd shot

Other Meds: Zoloft

Current Illness:

ID: 1024946
Sex: F
Age: 74
State: WI

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 02/12/2021
Hospital:

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

Lab Data:

Allergies: latex, seasonal allergies

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

Symptoms: angioedema, lip paresthesia, tongue swelling, dry eyes, chest tightness

Other Meds: Albuterol, ASA, biotin, Wellbutrin, klonopin, Vit B -12 injections, Lasix, amaryl, insulin, lisinopril, Prilosec, potassium, fish oil, multivitamin, metoprolol, metformin, Claritin, relafen

Current Illness: none

ID: 1024947
Sex: F
Age: 44
State:

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 02/12/2021
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: On 04 February 2021 during our COVID-19 Vaccine Drive we vaccinated one of the clinic?s staff with a dose of Moderna COVID-19 vaccine. This is her 2nd mRNA COVID-19 Vaccine dose. She is a new Clinic employee who received the first dose of Pfizer/BioNTech COVID-19 vaccine in December prior to moving. Referencing the CDC guidance and consulting with our provider on site, the team determined that this situation falls under exceptional situation due to the following reasons: ? The Pfizer/BioNTech COVID-19 vaccine is not available in our footprint. ? The vaccine recipient belongs to the Phase 1a population, an essential healthcare worker. ? The vaccine recipient was in the window to receive her 2nd dose. There has been no adverse reaction from the patient receiving the second dose. Submitting report for awareness.

Other Meds:

Current Illness:

ID: 1024948
Sex: M
Age: 62
State: HI

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 02/12/2021
Hospital:

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

Lab Data:

Allergies: Scallops, typically gets hives.

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

Symptoms: 1420 recieved vaccination. When arrived at post vaccination area, reported a very mild pins and needles sensation from L shoulder down to hand and pinky and ring finger. 1426: BP 128/90 HR 62. 1420: Reports upper arm has returned to normal feeling; senstaion of pins and needles to hand, pinky, ring finger. Reports that sensation remains at same intensity. Over time, reports that the pins and needles sensation leaves his lower arm until at 1440 when tingling has resolved and everything feels "back to normal." Released from post vaccination area.

Other Meds: Bioastin, Tylenol 600mg

Current Illness: none

ID: 1024949
Sex: M
Age: 71
State: AK

Vax Date: 02/10/2021
Onset Date: 02/11/2021
Rec V Date: 02/12/2021
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: sulfites, peanuts, some ground nuts, gluten intolerance

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

Symptoms: Asthma became unpleasant about 30 hour following inoculation. Noticeable improvement with an oral Montelukast pill, about 40% better.

Other Meds:

Current Illness: none

ID: 1024997
Sex: F
Age:
State: HI

Vax Date: 12/29/2020
Onset Date: 01/01/2021
Rec V Date: 02/12/2021
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: enlarged lymph node in armpit of the side the injection was on; uncomfortable; uneasy to keep her arm down; This is a spontaneous report from a contactable other healthcare professional (hcp). A 30-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number ELI284, expiry date not reported), intramuscular on 29Dec2020 07:30 at a single dose in the left arm for COVID-19 immunization. The patient had no medical history. Patient had no COVID prior vaccination and had no known allergies. The patient was not pregnant at the time of the vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks and no other medications in two weeks. Patient was just reporting symptoms experienced outside of normal symptoms that she was aware of: enlarged lymph node in armpit of the side the injection was on that began swelling about 7-10 days post vaccine and subsided after two days (Jan2021). Swelling of armpit lymph node was very uncomfortable and uneasy to keep her arm down. Again, went away after two consecutive days. No treatments received in response to the events reported. The patient was not tested for COVID post vaccination. The outcome of the event "enlarged lymph node in armpit of the side the injection", uneasy to keep her arm down, and uncomfortable was recovered in Jan2021.

Other Meds:

Current Illness:

ID: 1024999
Sex: F
Age:
State:

Vax Date: 01/21/2021
Onset Date: 01/27/2021
Rec V Date: 02/12/2021
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:

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

Symptoms: Admitted to the hospital with multiple small strokes; Feeling fatigue; Headache; A spontaneous report was received from a consumer concerning a 79-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced being admitted to the hospital for multiple small strokes, fatigue and headache. The patient's medical history was not included. Products known to have been used by the patient were not provided. On 21 Jan 2021, prior to the onset of the events, the patient received the first of planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. On an unknown date, Shortly after the mRNA-1273 vaccine was given, the patient experienced fatigue and headache which was attributed to vaccine side effect. On 27 Jan 2021, the patient was admitted to the hospital with multiple small strokes. No other treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, fatigue, headache and being hospitalized with multiple small strokes, is unknown.; Reporter's Comments: This case concerns a 79 year-old, female patient, who experienced events of multiple small strokes, fatigue and headache. The events of fatigue and headache occurred on an unknown date after the first and last dose of mRNA-1273 vaccine administration. The event of stroke occurred approximately 6 days after the first and last dose of mRNA-1273 vaccine administration. Based on the current available limited information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.

Other Meds:

Current Illness:

ID: 1025000
Sex: M
Age: 92
State: IL

Vax Date: 12/29/2020
Onset Date: 01/26/2021
Rec V Date: 02/12/2021
Hospital: Y

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: right sided pneumonia; having difficulty breathing; cyanotic; coughing; sounded congested; A spontaneous report was received from a nurse concerning a 92-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced right sided pneumonia, difficulty breathing, cyanotic, cough and sounded congested. The patient's medical history, as provided by the reporter included Alzheimer's, hypertension, arteriosclerotic heart disease, hyperlipidemia, benign prostatic hyperplasia, prostate cancer, covid-19, allergy to aricept and exelon. The concomitant medications reported included atorvastatin, tamsulosin hydrochloride, paracetamol, macrogol 3350, furosemide and ipratropium bromide/salbutamol sulfate for unspecified indications. On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 26 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 039k208) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 08 Jan 2021, the patient was on droplet isolation due to possible exposure of Covid 19 and received duoneb treatments for chronic nonproductive cough. The patient also received honey consistency fluids. On 19 Jan 2021, the patient's droplet precautions were discontinued. On 26 Jan 2021, after receiving the vaccine, the patient experienced difficulty breathing, cyanotic, cough and sounded congested following which the patient was repositioned. The lab findings included oxygen saturation at 78 percent on room air, so oxygen was applied at 2L which increased oxygen saturation at 88 percent, so oxygen was increased to 4L and oxygen saturation increased to 95percent, body temperature at 103.1 degree Fahrenheit, blood pressure 188/110 mmHg, respiratory rate at 28 breaths per minute, pulse rate at 128 heartbeat per minute. The patient was then sent to the Hospital emergency room (ER) where he was diagnosed with right sided pneumonia. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the events, right sided pneumonia, difficulty breathing, cyanotic, cough and sounded congested was unknown.; Reporter's Comments: This case concerns a 92-year-old, male patient. The patient's medical history od Alzheimer's, hypertension, arteriosclerotic heart disease, prostate cancer, covid-19, on duoneb treatments for chronic nonproductive cough remains as contributing factors. Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds: ATORVASTATIN; FLOMAX [TAMSULOSIN HYDROCHLORIDE]; TYLENOL; MIRALAX; LASIX [FUROSEMIDE]; DUONEB

Current Illness: Alzheimer's disease; Arteriosclerotic heart disease; BPH; Drug allergy (Aricept, Exelon); Hyperlipidemia; Hypertension

ID: 1025001
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/12/2021
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: Bell's palsy after 7 days first dose; A regulatory report was received from a physician, concerning an unknown patient of unknown age and gender, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced "Bell's palsy after 7 days first dose". The patient's medical history was not provided. Concomitant medication reported included metformin. On an unknown date, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown), for COVID-19 infection. On an unknown date, after 7 days from first dose, the patient developed Bell's palsy. No treatment information was reported for the event. Action taken with second dose of mRNA-1273 in response to the event was not reported. The outcome of the event " Bell's palsy", was unknown.; Reporter's Comments: This case concerns a patient of unknown age and gender, who experienced a serious event of Facial paralysis approximately 7 days after first dose of mRNA-1273, lot # unknown. Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1025002
Sex: F
Age: 81
State: VA

Vax Date: 01/23/2021
Onset Date: 01/26/2021
Rec V Date: 02/12/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Wobbly; Sees double; BP dropped; Fluid behind ears; Lower back pain; Ear infection; Severe Vertigo; Dizziness; A spontaneous report was received from a consumer who was also a 81-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe vertigo (vertigo), dizziness, ear infection, fluid behind her ears (middle ear efflusion), being wobbly (gait disturbance), seeing double (diplopia), lower back pain (back pain), and blood pressure dropped (blood pressure decreased). The patient's medical history included arthritis and migraine. Products known to have been used by the patient included fluticasone propionate/ salmeterol xinafoate, botulinum type A, duloxetine hydrochloride, hydrochlorothiazide (HCTZ), umeclidinium bromide, atorvastatin calcium, gabapentin, raloxifene, sumatriptan, telmisartan, cetirizine hydrochloride, cholecalciferol, calcium, zinc, probiotics, apoaequorin, and galcanezumab-gnlm. On 14 Jan 2021, the patient saw an ear doctor for ear pain. Treatment included steroids and eardrops that were antibiotics. On 23 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 26 Jan 2021, approximately 3 days after the mRNA-1273 vaccine was given, the patient noted she started getting severe vertigo or dizziness. On 28 Jan 2021, she saw her physician who attributed the dizziness to an ear infection that went undiagnosed. She also had fluid behind her ears. On 28 Jan 2021, a different doctor informed her that her eardrops were not going to touch the ear infection she had and prescribed amoxicillin. She reported that she still has dizziness. She stated that she was still wobbly and sees double. She then saw an ophthalmologist for her double vision and his concern was that it was not an eye issue more of a head issue and should be checked for a transient ischemic attack (TIA) or stroke. She then went to the emergency room (ER) to get it checked out and left the ER after waiting over 2 hours. The triage nurse at the ER told her that she was beyond any help since it was after 90 minute window if she had a stroke. She was attempting to get a CT scan of her head done. She was given pain medication as well for lower back pain. She was taken off the HCTZ because blood pressure dropped after getting the vaccine. Consent to contact was obtained. Treatment information included amoxicillin, meclizine and pain medication. Action taken with mRNA-1273 was not reported. The outcome of the events, severe vertigo, and/or dizziness, ear infection, fluid behind her ears, being wobbly and seeing double, lower back pain and blood pressure dropped, was not resolved.; Reporter's Comments: Based on the information provided the event of ear infection is unlikely related to the vaccine administration as event was pre-existing , Although a temporal association exist between the other events and mRNA-1273, critical details is lacking as patient is of an advanced age and has an undisclosed cardiac condition (on treatment with HCTZ ). . Hence, there is not enough information to adequately assess association with mRNA-1273 at this time.

Other Meds: ADVAIR; BOTOX; CYMBALTA; HCTZ; INCRUSE; LIPITOR; NEURONTIN; RALOXIFENE; SUMATRIPTAN; TELMISARTAN; ZYRTEC ALLERGY; VITAMIN D3; CALCIUM; ZINC; PROBIOTICS NOS; PREVAGEN [APOAEQUORIN]

Current Illness: Arthritis

ID: 1025003
Sex: F
Age: 58
State: WA

Vax Date: 01/04/2021
Onset Date:
Rec V Date: 02/12/2021
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: Pneumonia; Partial left lung collapsed; Injection site cellulitis, red rash around injection site which was tender and itchy; A spontaneous report was received from a consumer, who was a 58-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced injection site cellulitis, red rash around injection site which was tender and itchy (injection site cellulitis), cough, pneumonia, and partial left lung collapse (pneumothorax). The patient's medical history was not provided. Concomitant medications were not reported. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for COVID-19 infection. On an unspecified date, a few days after vaccination administration, the patient experienced red rash around the injection site which was tender and itchy and was diagnosed by a nurse as cellulitis, which later resolved. On 14 Jan 2021, the patient began coughing. On 18 Jan 2021, the patient went to urgent care for a COVID-19 test and the results came back negative. The patient was prescribed dexamethasone for three days, but symptoms did not improve. She again went to urgent care where X-rays was performed which showed pneumonia and partial left lung collapse, she was prescribed erythromycin. On 24 Jan 2021, patient went to emergency room and was given amoxicillin and advised to see their doctor. On 27 Jan 2021, her doctor prescribed prednisone and the symptoms started to get better. Action taken with mRNA-1273 in response to the events was not reported, although the patient expressed concern about getting the second injection. The outcome of events, cough, pneumonia, and partial left lung collapse (pneumothorax), was reported and resolving. The event, injection site cellulitis, red rash around injection site which was tender and itchy, was reported as resolved.; Reporter's Comments: Although a temporal association exist, the report lacks critical details such as the patient's medical history and concomitant medications. Noting that cellulitis and pneumonia are usually caused by an infectious agent, both events are considered unlikely associated with mRNA-1273. Pneumothorax is confounded by the pneumonia.

Other Meds:

Current Illness:

ID: 1025004
Sex: F
Age: 84
State: FL

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 02/12/2021
Hospital: Y

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: Respiratory distress; Difficulty breathing; A spontaneous report was received from a pharmacist concerning an 84-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced respiratory distress and difficulty breathing. The patient's medical history, as provided by the reporter, included heart disease, osteoporosis, osteoarthritis, gastroesophageal reflux disease, hypothyroidism, hypertension and history of anemia. No relevant concomitant medications were reported. On 26 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot Number:029K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 26 Jan 2021, within an hour of vaccination, patient had respiratory distress and difficulty breathing. The patient was treated with diphenhydramine and epinephrine, the patient was intubated and was taken to the hospital. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events, respiratory distress and difficulty breathing unknown.; Reporter's Comments: This case concerns an 84-year-old female patient with medical history of heart disease, who received their first of two planned doses of mRNA-1273 (Lot 029K20A), and who experienced the serious unlisted events of Respiratory distress and Dyspnoea. The events occurred within one hour of vaccination. Based on the current available information and temporal association between vaccine administration and the onset of events on the day of vaccination, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1025005
Sex: F
Age:
State:

Vax Date: 01/27/2021
Onset Date: 01/28/2021
Rec V Date: 02/12/2021
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: Fainted during the night; I had chills with a high fever; A spontaneous report was received from a female consumer, age not reported who experienced "chills with a high fever", and "fainted during the night" after receiving the second dose of mRNA-1273. The patient's medical history was not reported. Concomitant product use was not reported. On 27-Jan-2021 prior to the onset of symptoms, the patient received her second dose of mRNA-1273, route, site and Batch number not reported, for prophylaxis of Covid-19 infection. The patient reported a bad reaction approximately after ten or eleven hours after her immunization, she had chills with a high fever and then fainted during the night. She reported that she did come to a moment later. On 29-Jan-2021 she reported that she is feeling fine that day. The patient stated that she felt it was an unusual reaction that should be reported. Treatment for the event was not reported. Action taken with the study drug due to the events "chills with a high fever", and "fainted during the night was not reported. The events "chills with a high fever", and "fainted during the night", were considered recovered/resolved on 29-Jan-2021.; Reporter's Comments: This case concerns a female patient, who experienced events of chills with a high fever, and fainted during the night. The events occurred 10-11 hours after the second and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.

Other Meds:

Current Illness:

ID: 1025006
Sex: F
Age: 89
State: CA

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 02/12/2021
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: began seeing hallucinations; A spontaneous report was received from a consumer concerning a 89-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and began seeing hallucinations. The patient's medical history was not provided. No relevant concomitant medications were reported. On 01 Feb 2021, about 4 hours prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 01 Feb 2021, about 4 hours after receiving the vaccine, the patient began seeing hallucinations. She was seeing moss grow on the walls and real bright turquoise colors that turn pink. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event began seeing hallucinations was unknown.; Reporter's Comments: This case concerns a 89 year-old, female patient, who experienced event of hallucinations. The event occurred 4 hours after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded and the event is assessed as possibly related.

Other Meds:

Current Illness:

ID: 1025007
Sex: F
Age: 21
State: NJ

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 02/12/2021
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: Rapid eye movement like "having a mini-seizure"; Fainted; Feeling warm; A spontaneous report (United States) was received from a pharmacist concerning a 21-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and fainted and experienced to have rapid eye movement like "having a mini-seizure" and feeling of warmth. The patient's medical history included historical seizures. Concomitant product use was not provided by the reporter. On 02 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number:026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 02 Feb 2021, a few minutes after the injection, the patient fainted then recovered but again fainted and was noted to have rapid eye movement like "having a mini-seizure". HCP managed her with ice pack as patient complained of feeling warm and she recovered in less than 30 minutes. Treatment information was not provided. The outcome for events fainted, rapid eye movement like "having a mini-seizure"" and feeling warm were resolved.; Reporter's Comments: This spontaneous report concerns a 21-year-old, female patient with historical seizures. who received experienced the patient fainted then recovered but again fainted and was noted to have rapid eye movement like "having a mini-seizure." The event occurred a few minutes after the administration of mRNA-1273 vaccine (Batch number: 026L20A, expiration date: unknown). Treatment administered include Icepack and outcome is resolved. Based on the information provided which includes a strong temporal onset between the vaccine administration and the event, a causal association cannot be excluded. However, event is confounded by the subject's history of seizures. Feeling warm is consistent with the safety profile of the product.

Other Meds:

Current Illness:

ID: 1025008
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/12/2021
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: Allergic to the following: influenza shot, pneumonia shot, Solu-Medrol, tetanus shot, and penicillin; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received methylprednisolone sodium succinate (SOLUMEDROL) via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication, pneumococcal 13-val conj vac (dipht crm197 protein) lot/expiry: unknown, via an unspecified route of administration on an unspecified date at single dose for immunization, influenza vaccine (INFLUENZA), via an unspecified route of administration on an unspecified date at unknown dose for an unspecified indication, tetanus vaccine, via an unspecified route of administration on an unspecified date at unknown dose for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient has many allergies. She said that she is allergic to the following: influenza shot, pneumonia shot, Solu-Medrol, tetanus shot, and penicillin. She asked if it would be safe to take the COVID-19 vaccine. The action taken in response to the event for methylprednisolone sodium succinate was unknown. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.

Other Meds: SOLU-MEDROL

Current Illness:

ID: 1025009
Sex: F
Age:
State: NY

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 02/12/2021
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: meniere's ringing in right ear; head felt fuzzy; unable to concentrate; Nausea; Vomiting; Vertigo; This is a spontaneous report from a contactable healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982 and expiry date: unknown), via an unspecified route of administration on the right arm, on 25Jan2021 08:30 at a single dose for COVID-19 immunization. Medical history included HTN and Meniere's disease. Patient was not pregnant at the time of vaccination. Concomitant medication included amlodipine and hydrochlorothiazide. No other vaccine was received in the four weeks. The patient experienced head felt fuzzy, unable to concentrate, Meniere's ringing in right ear, nausea and vomiting, vertigo on 25Jan2021 10:30. Events resulted in emergency room/department or urgent care. Meclizine, IV Fluids, Maalox and Zofran were given as treatment for the adverse events. Outcome of the events was recovered. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.; Sender's Comments: The patient had medical history of Meniere's disease. The reported event was more likely due to underlying disease, and less likely causally related to the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

Other Meds: AMLODIPINE; HYDROCHLOROTHIAZIDE

Current Illness:

ID: 1025010
Sex: M
Age:
State: WA

Vax Date: 01/25/2021
Onset Date: 01/26/2021
Rec V Date: 02/12/2021
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: Throwing up foamy stuff; Oxygen saturation was in the 80%s; confused; This is a spontaneous report from a contactable nurse. An 88-year-old male patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL3302), intramuscular at the right arm on 25Jan2021 02:30 at a single dose for COVID-19 immunization. The vaccine was administered in a Nursing Home. No other vaccine was given to the patient in four weeks. Medical history included Parkinsons, dementia, diastolic heart failure and known allergies: Iodine, Propranolol. Concomitant medication included paracetamol (TYLENOL), melatonin, quetiapine fumarate (SEROQUEL), ropinirole and sertraline hydrochloride (ZOLOFT). On 26Jan2021 11:30 AM, the patient was throwing up foamy stuff and his oxygen saturation was in the 80%s and was confused. The events led to Emergency room/department or urgent care visit. Treatment was given for the events. The patient has no COVID-19 prior to vaccination. He was tested for COVID-19 on 26Jan2021 with Nasal Swab, Rapid Test and the result was negative. The outcome of the events was unknown.; Sender's Comments: Based on the information provided and temporal relationship, a causal association between BNT162B2 and the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds: TYLENOL; MELATONIN; SEROQUEL; ROPINIROLE; ZOLOFT

Current Illness:

ID: 1025011
Sex: M
Age:
State: MN

Vax Date: 01/22/2021
Onset Date: 01/26/2021
Rec V Date: 02/12/2021
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: This morning at 6 am his blood pressure was 156/74, with 65 beats. Then, at 7am, it was 167/76, with 65 beats. Then at 8:40 am, his blood pressure was 137/64, with 65 beats. So it is fluctuating; This morning at 6 am his blood pressure was 156/74, with 65 beats. Then, at 7am, it was 167/76, with 65 beats. Then at 8:40 am, his blood pressure was 137/64, with 65 beats. So it is fluctuating; feel light headed and it's been coming on and off/feeling dizzy and light headed; This is a spontaneous report from a contactable consumer (patient). An 85-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: EK4176, via an unspecified route of administration in his left upper arm, on 22Jan2021 at single dose for COVID-19 immunization. Medical history included surgery on aorta to put a stent in Nov2020. There were no concomitant medications. On 26Jan2021 at mid day the patient started to feel dizzy and light headed and this feeling has been coming on and off, so he decided to take his blood pressure. He didn't have his values from 26Jan2021. In the morning of 27Jan2021 at 6 am his blood pressure was 156/74, with 65 beats, then, at 7am, it was 167/76, with 65 beats and at 8:40 am, his blood pressure was 137/64, with 65 beats, so it was fluctuating. At the time of the report the events had not resolved yet.

Other Meds:

Current Illness:

ID: 1025012
Sex: M
Age:
State: NJ

Vax Date: 01/05/2021
Onset Date:
Rec V Date: 02/12/2021
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: Erectile Dysfunction; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (Age: 62; Unit: Unknown) received bnt162b2 (BNT162B2), first dose (lot: EL0142) via an unspecified route of administration on 05Jan2021 at single dose, second dose (lot: EN5318) via an unspecified route of administration on 26Jan2021 (administered between 1:00-2:30PM) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced erectile dysfunction on an unspecified date. The patient asked What is the mRNA half life. He stated that he received the Pfizer vaccine on the 5th and the second on the 26th. He was asking if there were any reports of erectile dysfunction after receiving the vaccine. He also asked if the ingredient Hexane was a poison, if this is safe. The patient had some questions, he is really worried because he has seemed to be experiencing something. He is wondering if Erectile Dysfunction has been reported as a problem from the COVID vaccine. He seemed to be experiencing worsening of his sexual function, and the only thing that is new that he can think, is that he got the vaccination. He received the second dose of the product on 26Jan2021. He asked how long the MRNA last in your system, how many people were involved in the study, When did it start, if the hexane solvent in the vaccine affect your testes. It was further reported that he was having a bad reaction he believe to the vaccination (Covid Vaccine) and asked if there were any reports of erectile dysfunction or sexual dysfunction regarding males from the vaccine. The patient had an article here it says your system mounts a response against the new protein, because they are seen as foreign invaders, developing antibodies that are specific to SARS-CoV-2 in the process. These infection fighters tick around to help your body fight a future case of Covid-19 but it's not yet understood for how long and this is the sense he wanted to talk to about that body will do its thing and eventually will get rid of the protein or mRNA on its own? The patient said since he had taken the COVID-19 Vaccine injections he has experienced worsening erective dysfunction. He asked if anyone else has reported having that issue since receiving the COVID-19 Vaccine. He was advised he would be transferred to Medical Information for further assistance. He stated he is so sad, and started crying while speaking with the agent. He declined to answer any further questions and asked to be transferred to Medical Information to have his question addressed. He asked the agent if she knew that Hexane is in the Pfizer COVID- 19 Vaccine. He said he did not realize Hexane was in the COVID-19 Vaccine before he got the vaccine. The outcome of the event was unknown. No follow-up attempts are possible. No further information expected.

Other Meds:

Current Illness:

ID: 1025013
Sex: F
Age:
State: CA

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 02/12/2021
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: blood pumping to my head and became very hot; face turned red and was hot to the touch; blood pumping to my head and became very hot; face turned red and was hot to the touch; blood pumping to my head and became very hot; face turned red and was hot to the touch; facial muscles became weak on both; difficult to make facial expressions; my mouth began to tremble; chills; facial muscles became weak on both; difficult to make facial expressions; This is a spontaneous report from contactable consumers. An 70-year-old female non-pregnant patient received her first dose bnt162b2 (BNT162B2; Solution for injection; lot number: EL9283) via an unspecified route of administration at Left arm on 28Jan2021 12:30 at single dose for COVID-19 immunisation at Clinic. Medical history included high blood pressure, high cholesterol. Concomitant medication included rosuvastatin calcium (CRESTOR), amlodipine, calcium carbonate simethicone. There was no other vaccines in four weeks. The patient previously took iodine had contrast, procaine hydrochloride (NOVOCAIN) had drug allergy, omeprazole (PRILOSEC) and had drug allergy, olmesartan medoxomil (BENICAR) had drug allergy. Five minutes after the injection 28Jan2021 12:35, patient felt blood pumping to her head and became very hot. Her face turned red and was hot to the touch. Then, facial muscles became weak on both sides and made it difficult to make facial expressions. Lastly, her mouth began to tremble and had chills. Symptoms subsided about 30 minutes after the injection. she worried about getting the second injection. The patient received treatment with Liquids/electrolytes. The events result in doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered in 2021.

Other Meds: CRESTOR; AMLODIPINE; CALCIUM CARBONATE;SIMETICONE

Current Illness:

ID: 1025015
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/12/2021
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: a bit of warmth at site; Initial information received on 30-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer or non-health care professional via social media. This case involves a patient of unknown age and gender who experienced bit of warmth at site (vaccination site warmth), while he/she received vaccine INFLUENZA VACCINE. It was reported that it was shot doing it was worked so no pain. Just tough it out . It beats hell. Alternative: would probably ask about Pneumonia shot too. The patient's vaccination(s) included COVID-19 VACCINE and had side effects from it (felt like crap & got bumps in armpit). The patient's past medical history, concomitant therapy, medical treatment(s) and family history were not provided. At the time of the event, the patient had COVID-19 (Coronavirus disease) (he was recovering from COVID). On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed non-serious a bit of warmth at site (vaccination site warmth) (Unknown latency) following the administration of INFLUENZA VACCINE. Patient stated that "he/she was stupid for decades because his folks got sick when they got shots. So he/she just got Flu & almost died twice. He/She got Flu shot between COVID shots. Did not feel Flu shot. It sucked his/her strength like a Vampire. Patient also mentioned "It was up to individuals to decide if they can Live with Guilt if they do not get shots & give these sickness to somebody who never recovers. Details of laboratory data were not reported. It was not reported if the patient received any corrective treatment. At the time of reporting, outcome of the event was unknown. There will be no information available on batch number for this case.

Other Meds:

Current Illness: COVID-19 (he/she was recovering from COVID.)

ID: 1025016
Sex: M
Age:
State:

Vax Date: 10/08/2017
Onset Date: 10/10/2017
Rec V Date: 02/12/2021
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: Whites of eyes was completely red; swollen under eyes; face swelling; swollen glands in neck; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via agecy (Reference number- 00448535) and transmitted to Sanofi on 27-Jan-2021. This case involves a male patient (age unspecified) whose whites of eyes were completely red (ocular hyperaemia), swollen under eyes (periorbital swelling), face swelling (swelling face) and swollen glands in neck (lymphadenopathy)while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE]. Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 08-Oct-2017 (on Sunday), the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UI840AA, expiry: 06-Apr-2018) via unknown route in unknown administration site for prophylactic vaccination. On 09-Oct-2017 (on Monday), she had fish On 10-Oct-2017 (Tuesday afternoon), the patient's whites of eyes were completely red (ocular hyperaemia), swollen under eyes (periorbital swelling), face swelling (swelling face) and swollen glands in neck (lymphadenopathy) 2 days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. These non-serious reactions were severe. The consumer was trying to get ingredients from the FLUZONE High Dose vaccine she got on 08-Oct-2017, so that she could determine if she is able to get the coronavirus disease (COVID-19) vaccine and why she had the reaction to the high dose (HD) flu vaccine. She had a severe reaction to Sanofi's High dose Flu vaccine. In Oct-2017 she had Sanofi (HD) flu shot for the 1st time and she had a severe reaction. The patient stated that she never had a reaction to the regular dose of Flu vaccine before and is not sure why she reacted to the high dose flu vaccine. Patient had a picture of how her face looked with the reaction. She did not recall having a fever. She went to Urgent Care. Relevant laboratory test results included: Allergy test showed that nothing else was involved It was not reported if the patient received a corrective treatment. At the time of report, the outcome of event was unknown.

Other Meds:

Current Illness:

ID: 1025017
Sex: F
Age: 52
State: CA

Vax Date: 01/15/2021
Onset Date: 01/16/2021
Rec V Date: 02/12/2021
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: Codeine-syncope Dilaudid- clonus

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

Symptoms: Pain level 8/10 arm throbbing pain woke me up. Felt like my upper arm was throbbing like a heart and was going to burst open. My fingers were swollen and I couldn?t get my ring off. I was unable to extend my arm fully. This lasted 40 hours . Then it subsided to a 2/10 ache in my arm that felt like I had been punched hard and felt like I had a salad plate size bruise on my arm. This lasted 2 more days.

Other Meds:

Current Illness:

ID: 1025018
Sex: M
Age: 48
State:

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/12/2021
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: None

Symptom List: Tremor

Symptoms: 6 days of severe headaches, body aches, cold sweats, swollen lymph nodes; 2 days of on and off fevers (started on 3rd day), over 100 Fahrenheit; 2 days of ears swollen up, red, ringing, and pain.

Other Meds: None

Current Illness: None

ID: 1025019
Sex: F
Age: 25
State:

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 02/12/2021
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: N/A

Symptom List: Erythema, Pruritus

Symptoms: Pain at injection site, full body aches and headache, fatigue

Other Meds: Mirena IUD, Depo-Testosterone

Current Illness: N/A

ID: 1025020
Sex: F
Age: 24
State: IN

Vax Date: 02/08/2021
Onset Date: 02/09/2021
Rec V Date: 02/12/2021
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: Redness and swelling for 2 days at the place of injection. Fatigue and dizzyness

Other Meds:

Current Illness:

ID: 1025021
Sex: F
Age: 37
State:

Vax Date: 01/22/2021
Onset Date: 02/03/2021
Rec V Date: 02/12/2021
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: Cirprofloxacin Milk Gluten

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

Symptoms: Pt is a 37y F with previous history of pericarditis diagnosed after an initial COVID infection SEP20 with a second occurrence NOV20. Pt subsequently received her first COVID Vaccine shot on 22JAN21 and reported to medical on 3FEB21 with mild chest pain and an EKG with changes demonstrating pericarditis and a US demonstrating trace effusion. Pt was minimally symptomatic but given her previous episodes was sent to the Role 3 for further evaluation. Her work up on 10FEB21 demonstrated resolution of EKG changes and effusion with normal cardiopulmonary work up. Given her history it has been recommended that she does not receive the second dose of the vaccination.

Other Meds: MVI Probiotic

Current Illness: None

ID: 1025022
Sex: F
Age: 22
State: VA

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 02/12/2021
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: Seasonal Allergies

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: -Soreness around injection site ( Started right after and the severity is the same as the flu shot) - Warm feeling around injection site for the first 15-30 minutes after receiving the injection - 6 hours later around 8:00/30 I began having bloating, stomach cramps and diarrhea

Other Meds: Lexapro Birth Control Vitamin D Women?s Multi Vitamin Allegra

Current Illness: None

ID: 1025024
Sex: F
Age: 40
State: CA

Vax Date: 02/09/2021
Onset Date: 02/11/2021
Rec V Date: 02/12/2021
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: I felt stupid

Other Meds:

Current Illness:

ID: 1025025
Sex: F
Age: 39
State: CO

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 02/12/2021
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: Very very hight energy. Can't sleep much as I have an overload of energy. Don't feel tired or exhausted. Everyone seems to have different symptoms after vaccine I seem to be doing the opposite. Is this normal?

Other Meds: None

Current Illness: None

ID: 1025026
Sex: F
Age: 42
State: TX

Vax Date: 01/16/2021
Onset Date: 01/23/2021
Rec V Date: 02/12/2021
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: One week after receiving the vaccine I started experiencing a mild allergic reaction on the skin surrounding the injection site, about 3 inches by 3 inches. The area was red, itchy, hard, and felt warm. It was uncomfortable, but not painful and it went away on its own after 2 days.

Other Meds:

Current Illness:

ID: 1025027
Sex: M
Age: 51
State: KS

Vax Date: 01/28/2021
Onset Date: 01/30/2021
Rec V Date: 02/12/2021
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

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

Symptoms: Injection site pain within 24 hours, lasting 48 additional hours. Nausea onset 30 hours after first dose injection. SEVERE vomiting 33 hours after first dose injection which came in frequent waves over the following 3 hours, but then subsided.

Other Meds: Omega 3 1400mg Daily multi-vitamin Men?s vitality supplement (testofen)

Current Illness: None

ID: 1025028
Sex: M
Age: 56
State: VA

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 02/12/2021
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: Cloraquin

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

Symptoms: Shortly after - brain fog Two days of headache, extreem fatigue, chills Symptoms ended - Feb. 12th around 3am I was too weak to report this earlier.

Other Meds: Just vitamins

Current Illness: None

ID: 1025029
Sex: F
Age: 68
State: FL

Vax Date: 02/10/2021
Onset Date: 02/11/2021
Rec V Date: 02/12/2021
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: NONE

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

Symptoms: I was fine except for soreness in the arm and a mild headache from the time I got the vaccine (Wednesday 1:20 p.m.) through the evening, but woke up (Thursday morning about 6:00) very sick . I had a worse headache, extreme tiredness, nausea , vomiting (dry heaves as I couldn?t eat or drink the whole time), fever and chills. The bouts of vomiting fever and chills came in three through the day. I felt extremely unwell the whole time and just kept reminding myself that it would be over soon, but it lasted throughout Thursday. I fell asleep around 5:00 p..m. Thursday afternoon and woke up around midnight feeling that the symptoms had passed. Now it?s Friday morning (5:30 a.m.) and I feel completely well again.

Other Meds: Glucosamine, multi-vitamin,

Current Illness: NONE

ID: 1025030
Sex: F
Age: 37
State: NY

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 02/12/2021
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: "Patient reports that just after she was administered the Pfizer COVID-19 vaccine (first dose) on 1/16/21, she developed redness around the area that resolved in "two to three days". However, she then developed a wheal-like lesion around the injection site in the last day after the initial redness resolved. She noted diffuse warmth around the proximal left upper arm/left deltoid region. She denies tenderness on palpation. She reported feeling a "knot" underneath skin where lesion occurs. She did not complain of SOB/wheezing, swelling."

Other Meds: None

Current Illness:

ID: 1025035
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/12/2021
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: pretty much like having the flu; fever; aches; weakness; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms, fever, pain and weakness. On an unknown date, the outcome of the influenza-like symptoms, fever, pain and weakness were unknown. It was unknown if the reporter considered the influenza-like symptoms, fever, pain and weakness to be related to Shingrix. Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingrix, the patient had a pronounced reaction which included fever, aches, weakness pretty much like having the flu.

Other Meds:

Current Illness:

ID: 1025036
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/12/2021
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: flare ups of herpes simplex; This case was reported by a nurse and described the occurrence of herpes simplex aggravated in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included herpes simplex. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced herpes simplex aggravated. On an unknown date, the outcome of the herpes simplex aggravated was unknown. It was unknown if the reporter considered the herpes simplex aggravated to be related to Shingrix. Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. The patient asked if the Shingrix could ever cause flare ups of herpes simplex. Was this a possible side effect.

Other Meds:

Current Illness: Herpes simplex

ID: 1025037
Sex: F
Age: 59
State: MN

Vax Date: 10/23/2020
Onset Date: 10/01/2020
Rec V Date: 02/12/2021
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: Had itching; perspiration; rash on her back / also at the base of her neck to her waist; This case was reported by a pharmacist and described the occurrence of rash in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number XG52X, expiry date 28th November 2021) for prophylaxis. On 23rd October 2020, the patient received the 1st dose of Shingrix. In October 2020, 24 hrs after receiving Shingrix, the patient experienced rash and sweating. On 26th October 2020, the patient experienced pruritus. On 26th October 2020, the outcome of the rash and sweating were recovered/resolved. On 28th October 2020, the outcome of the pruritus was recovered/resolved. It was unknown if the reporter considered the rash and pruritus to be related to Shingrix. The reporter considered the sweating to be unrelated to Shingrix. Additional details were provided as follows: The patient received 1st dose of Shingrix and 24 hours later developed a rash on her back after perspiring from physical activity. The pharmacist stated that the perspiration was not from Shingrix but from physical activity of the patient working in her home. The patient was wearing a sports bra and the rash was near the bra band and was also at the base of her neck to her waist, the rash was 2 inches wide on each side of her spine, the rash stayed there for 2 days then resolved. The pharmacist stated that after the rash resolved, 3 days after receiving Shingrix, she had itching that lasted for 2 days then it was gone. All events resolved, no further symptoms reported. The reporter consented to follow-up.

Other Meds:

Current Illness:

ID: 1025038
Sex: M
Age: 74
State: WA

Vax Date: 12/01/2020
Onset Date: 12/01/2020
Rec V Date: 02/12/2021
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: Shoulder muscle is sore; Soreness is restricting his movement; Soreness keeps him up at night; it hurts / soreness has worsened; This case was reported by a consumer and described the occurrence of muscle pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included PNEUMONIA VACCINE. On 1st December 2020, the patient received the 1st dose of Shingrix (intramuscular). In December 2020, several days after receiving Shingrix, the patient experienced muscle pain, mobility decreased, nocturnal awakening and pain. On an unknown date, the outcome of the muscle pain, mobility decreased, nocturnal awakening and pain were not recovered/not resolved. The reporter considered the muscle pain, mobility decreased, nocturnal awakening and pain to be related to Shingrix. Additional details were provided as follows: The patient reported for himself. The patient received 1st dose of Shingrix in his right arm and a Pneumonia shot and within a couple of days he had a problem with his shoulder, he claimed that his shoulder muscle was sore, and the soreness was restricting his movement. The patient reported that the soreness keeps him up at night and it hurts, and he felt that the soreness had worsened. The patient stated that the pharmacist was careful while injecting the pneumonia shot in his left arm, but he was not careful when injecting the Shingrix in his right arm. The patient related his symptoms to the Shingrix vaccine. The reporter consented to follow-up.

Other Meds: PNEUMONIA VACCINE

Current Illness:

ID: 1025039
Sex: F
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 02/12/2021
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: the patient having a shingles outbreak.; incomplete course of vaccination; This case was reported by a pharmacist and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the shingles to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patiernt received 1st dose in 2018 and experienced shingles outbreak. The reporter stated that, the patient was came back for the second dose but the second dose was denied due to the patient having a shingles outbreak. Till the time of reportingf, the patient did not receive dose 2 of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm