VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
199,106MODERNA
36,710JANSSEN
5,381PFIZER\BIONTECH
2,555GLAXOSMITHKLINE BIOLOGICALS
1,469UNKNOWN MANUFACTURER
897MERCK & CO. INC.
627SEQIRUS, INC.
112DYNAVAX TECHNOLOGIES CORPORATION
91SANOFI PASTEUR
75NOVARTIS VACCINES AND DIAGNOSTICS
40EMERGENT BIOSOLUTIONS
14PAXVAX
12TEVA PHARMACEUTICALS
12PROTEIN SCIENCES CORPORATION
9PFIZER\WYETH
4BERNA BIOTECH, LTD.
4SMITHKLINE BEECHAM
3INTERCELL AG
1MEDIMMUNE VACCINES, INC.
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL7,949
7,473
2,547
1,506
1,187
1,051
1,049
s0294561,043
866
IMM209861
816
UT7065MA766
657
579
U62828AA563
557
538
U6737AA516
515
S034636506
4F472471
458
P100253275449
444
276563436
429
418
4BH32414
MENVEO404
PP9L5362
UJ446AA337
319
306
290
271
49TM3270
R1B252M253
4F472179
933622147
C5763AA144
CW3116134
3Y7NL126
UNK114
113
ARBA141A105
104
103
96
300057A90
79
1F4EB73
R1B743M62
56
UJ090AA55
51
UH894AB46
45
UNK44
UNK42
42
EJ168638
Unknown36
35
34
32
32
26
el128424
24
A115A22
22
EN620222
21
UNK20
20
19
Z127A19
19
17
JEV18K95E15
12
111798PI12
10
A739088
No batch number8
3333324181078
6
6
TAR356
5
5
U6935AA5
UNK5
4
unknown4
3
2
55RB72
2
2
2
2
2
U7124AA2
JEV18A68E2
2
ABYB05BA1
1
1
1
1
AMVA436A1
1
1
TJ3521
A130A; VIS give1
1
U7140BB1
1
1
SP UP016AA1
1
1808P08802/ESV01
037K20A300,947
EL1284288,578
57,766
1,432

Incidents per State

State Total
82,750
CA62,821
FL38,209
TX36,512
NY34,921
PA23,646
IN23,622
IL20,597
MI19,590
OH19,426
NJ18,413
NC16,769
GA15,932
WA15,351
VA15,234
MA14,876
AZ14,206
MN12,940
MD12,656
CO11,908
WI11,425
MO10,240
TN9,685
OR8,768
KY8,437
CT8,300
SC6,700
OK6,293
AL5,692
LA5,025
IA4,825
KS4,821
UT4,637
NV4,374
NM3,967
AR3,807
ME3,161
NH3,096
NE2,918
MS2,859
ID2,785
WV2,469
HI2,459
PR2,417
MT2,414
RI2,076
DE1,868
AK1,830
VT1,734
DC1,715
ND1,388
SD1,269
WY866
GU118
VI69
AS47
MP29
MH8
XB6
FM4
QM3
XV2
XL1

ID: 1744138
Sex: F
Age: 28
State: IL

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium

Other Meds:

Current Illness:

ID: 1744139
Sex: F
Age: 18
State: CA

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Systemic: Dizziness / Lightheadness-Mild, Additional Details: patient passed out momentarly after receiving vaccination in her chair, patient quickly awakened and responded that she is ok. Instructed patient to lay down and elevate legs and had gatorafe. Asked if she wants an ambluance, patient indicated that this is normal when she seees needles, happened before when she gave blood. patient fully recovered and felt no symptoms, asked family members to pick her just incase. Pharmacy will follow up with patient before closing, will follow in the morning

Other Meds:

Current Illness:

ID: 1744140
Sex: F
Age: 36
State: VA

Vax Date: 09/01/2021
Onset Date: 09/12/2021
Rec V Date: 09/29/2021
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: No

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

Symptoms: Shingles on right trunk near bra line

Other Meds: No

Current Illness: No

ID: 1744141
Sex: M
Age: 32
State: CA

Vax Date: 09/07/2021
Onset Date: 09/07/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Systemic: palpitations-Severe, Systemic: Tachycardia-Severe, Additional Details: patient came in seeking 2nd vaccine on 9/28/21. Discussed with patients of risk and advised patient to see doctor prior to recieving 2nd shot

Other Meds:

Current Illness:

ID: 1744142
Sex: M
Age: 34
State:

Vax Date: 08/27/2021
Onset Date: 09/17/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: 19/09/2021 - Eye Vessel scans - Clotting discovered 20/09/2021 - Full Cardiological exam - Normal 21/09/2021 - Further Eye scans - New hemorrhage discovered. Condition deteriorating. 22/09/2021 - COVID19 PCR (for travel) - Negative 23/09/2021 - Blood Tests - Normal 27/09/2021 - Eye Scans - Condition unchanged 27/09/2021 - Full thrombotic screening (Blood tests) - All normal 29/09/2021 - Further Blood Tests - Normal

Allergies: None

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

Symptoms: On Morning of 17th September, found to be partially blinded in left eye. Clotting in retinal vein discovered by ophthalmologist, as well as macular hemorrhage.

Other Meds: Ibuprofen for mild tension headache

Current Illness: None

ID: 1744143
Sex: F
Age:
State: NE

Vax Date: 04/07/2021
Onset Date:
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: I had some severe allergies, I start feeling like my usual allergy; An external itch; feels like little ants are crawling all over you head to toe; the external itch from my head to my toe; I then got sick; My throat sore; Swollen tongue; Its persisting may be worsened; Sleepy; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0150 via an unspecified route of administration, administered in Deltoid Right on 07Apr2021 (at the age of 50-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced I had some severe allergies, I start feeling like my usual allergy, an external itch; feels like little ants are crawling all over you head to toe; the external itch from my head to my toe, I then got sick, my throat sore, swollen tongue, its persisting may be worsened and sleepy. Therapeutic measures were taken as a result of I had some severe allergies, I start feeling like my usual allergy. The patient reported that, I understand my allergies and I took Benadryl (treatment) right away, I woke up this morning and I feel the same way. I have been to the emergency room enough to know the test what they gave me because of my allergy. The patient was scheduled for second shot of vaccine on 28Apr2021. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1744144
Sex: F
Age: 50
State: NC

Vax Date: 09/24/2021
Onset Date: 09/25/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Systemic: Abdominal Pain-Medium, Systemic: Diarrhea-Medium, Systemic: Weakness-Medium, Additional Details: Pt has fully recovered. talked to patient about general reactions/ ae from vaccine. No major reaction

Other Meds:

Current Illness:

ID: 1744145
Sex: M
Age: 52
State: NC

Vax Date: 09/24/2021
Onset Date: 09/25/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Systemic: Abdominal Pain-Medium, Systemic: Diarrhea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: Talked to patient over the phone. Has fully recovered.

Other Meds:

Current Illness:

ID: 1744146
Sex: M
Age: 40
State: GA

Vax Date: 09/29/2021
Onset Date: 09/29/2021
Rec V Date: 09/29/2021
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: Headache, fever, some body aches , lack of energy

Other Meds: Metformin, lisnopril, allopurinol

Current Illness: None

ID: 1744147
Sex: F
Age: 36
State: CA

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Error: Wrong Vaccine Formulation (ex. different manufact. initial and booster)-

Other Meds:

Current Illness:

ID: 1744148
Sex: F
Age: 32
State: NC

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 09/29/2021
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: Error: Wrong Patient (documentation in EMR)-

Other Meds:

Current Illness:

ID: 1744149
Sex: F
Age: 44
State: PA

Vax Date: 09/27/2021
Onset Date: 09/27/2021
Rec V Date: 09/29/2021
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: Penicillin

Symptom List: Rash, Urticaria

Symptoms: Chills, fever, arm pain, ear pain, headache, tiredness, body aches

Other Meds: Nuvaring Metformin

Current Illness: N/A

ID: 1744150
Sex: M
Age: 59
State: OH

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Error: Wrong Vaccine Formulation (ex. different manufact. initial and booster)-

Other Meds:

Current Illness:

ID: 1744151
Sex: F
Age: 84
State: MA

Vax Date: 09/15/2021
Onset Date: 09/15/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Error: Wrong Vaccine Formulation (ex. different manufact. initial and booster)-

Other Meds:

Current Illness:

ID: 1744152
Sex: M
Age: 60
State: MI

Vax Date: 03/31/2021
Onset Date: 09/09/2021
Rec V Date: 09/29/2021
Hospital: Y

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

Lab Data: SARS-COV-2 (COVID-19) by NAA, Micro Status: Final result Visible to patient: Yes (seen) Next appt: 10/01/2021 at 02:20 PM in Internal Medicine Specimen Information: Nasopharyngeal; Swab 0 Result Notes Ref Range & Units SARS-CoV-2 (COVID-19) by NAA, Micro Not Detected Detected Abnormal Narrative The SARS-CoV-2 (COVID-19) by NAA test is for in vitro diagnostic use under the FDA Emergency Use Authorization (EUA) for laboratories certified to perform high complexity testing. This test has not been FDA cleared or approved. Methodology: Nucleic Acid Amplification (NAA)/Polymerase Chain Reaction (PCR). Specimen Collected: 09/12/21 5:55 PM Last Resulted: 09/12/21 6:56 PM

Allergies: No Known Allergies

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

Symptoms: This is a 60-year-old male thats presents to the ED complaining of back pain as well as abdominal pain. Onset of symptoms within the past 3 days. States that he drove up to his cottage 3 days prior & developed symptoms on arrival. He has not been able to eat for the past 3 days. There is associated nausea but no vomiting or diarrhea. He has recurrent bouts of pancreatitis, but is unsure of the cause. He denies alcohol use. He states he is vaccinated for COVID with Pfizer. Review of Systems Constitutional: Negative for chills, fatigue and fever. HENT: Negative for facial swelling and trouble swallowing. Respiratory: Negative for cough, shortness of breath and wheezing. Cardiovascular: Negative for chest pain and palpitations. Gastrointestinal: Positive for abdominal pain. Negative for diarrhea, nausea and vomiting. Genitourinary: Negative for dysuria and frequency. Musculoskeletal: Positive for back pain (right paraspinal thoracic). Negative for neck pain. Skin: Negative for rash and wound. Neurological: Negative for weakness, light-headedness and headaches. Psychiatric/Behavioral: Negative for confusion. The patient is not nervous/anxious.

Other Meds: APIXABAN (ELIQUIS) 5 MG PO TAB take 1 Tablet by mouth twice daily. ASPIRIN 81 MG PO CHEW TAB take 81 mg by mouth once daily. ATORVASTATIN (LIPITOR) 80 MG PO TAB take 1 Tablet by mouth once every night at bedtime. GLIPIZIDE (

Current Illness: Acute pancreatitis 05/15/2018 ? Bilateral pulmonary embolism 01/09/2018 ? GERD (gastroesophageal reflux disease) ? Hypercholesterolemia ? Hypertension ? Leg DVT (deep venous thromboembolism), acute, left 01/09/2018 ? Renal stone Feb 2004 ? Type 2 diabetes mellitus

ID: 1744154
Sex: F
Age: 91
State: CA

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 09/29/2021
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: Error: Wrong Vaccine Formulation (ex. different manufact. initial and booster)-

Other Meds:

Current Illness:

ID: 1744155
Sex: F
Age: 22
State: SD

Vax Date: 09/08/2021
Onset Date: 09/09/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: none

Allergies: no

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

Symptoms: Fever of 104. Chills and shaking throughout the night. Fever went down after a day and a half. Body weakness and headache took three days to go away.

Other Meds: Birth control, anxiety meds

Current Illness: Strep throat prior to vaccine

ID: 1744156
Sex: M
Age: 76
State: NY

Vax Date: 09/25/2021
Onset Date: 09/26/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: none

Allergies: none

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Bilateral knee pain

Other Meds: 80mg aspirin; flaxseed oil; vitamin D; fish oil

Current Illness: none

ID: 1744157
Sex: F
Age: 39
State: PA

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 09/29/2021
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: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-

Other Meds:

Current Illness:

ID: 1744158
Sex: F
Age: 36
State: VA

Vax Date: 09/21/2021
Onset Date: 09/22/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies: n/a

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

Symptoms: 3 inches below and to the left of the injection site (near armpit) have a hard, hot swelling lump that is spreading. Stabbing pain from site, up to armpit and down to elbow/fingers. GI upset that does not seem normal. Started day after second injection. Also had typical side effects (fever, chills etc) but the arm pain and area of redness seem abnormal. Will be seeing a provider to ensure it is not a blood clot or cellulitis. (Please note always have been up to date on immunizations and flu shots) Last year similar reaction to flu shot. No allergies

Other Meds: Vitamin D, C, Echinacea

Current Illness: n/a Quadrivalent flu vaccine given 9/16/2021

ID: 1744159
Sex: F
Age:
State: WI

Vax Date: 04/09/2021
Onset Date: 04/09/2021
Rec V Date: 09/29/2021
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: Test Name: bloodwork; Result Unstructured Data: Test Result:glucose going up a notch, almost a prediabetic

Allergies:

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

Symptoms: arm feels like it is going to sleep at times; huge welt starting on her right breast; Headache; her right breast started itching; inflammation of lymph nodes; right armpit feels like about half the size of tennis ball sticking out; feels tight like it is cutting something off; pressure; fatigued; down and out, no ambition at all, tired;; injection shot higher than where she gets any other injections like the flu shot; pain where shot was administered; radiating pain going from right shoulder to neck to ear/sticking out right side of neck and shoulder ear area fills the palm of left hand; trouble sleeping because of pain in armpit area; This is a spontaneous report from a contactable HCP and consumer (patient herself). A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0162, expiry date: unknown) via unspecified route of administration, in right arm on 09Apr2021 09:00 (age at vaccination: 59-years) as dose 1, single for covid-19 immunisation. Medical history included allergic to Vioxx, allergic to Celebrex, cold urticaria, hypoglycemia, Covid-19 from an unspecified date and unknown if ongoing. Past drug included Nexium for acid reflux and Escitalopram for hot flushes. Concomitant medications were not reported. Caller stated when she pulled her band aid off of the injection site, she noticed that the site was higher than what she normally gets her other immunizations like her flu shot. She also noticed injection site pain, but stated that she does always get this pain with any other immunization like the flu shot or shingles shot. No further information provided for flu shot or shingles shot. Later that night, on 09Apr2021 about 2200 or 2300, while laying in bed she had radiating pain going from shoulder up to her neck all the way to her ear on her right side. It seemed like it was building up. She only got about 2 hours of sleep that night and she still had trouble sleeping because of the armpit pain that feels like pressure or something is getting cut off in her right arm. She did get some relief by laying on the other side and putting a pillow between her right arm and her body. Patient also stated it feels like her arm is going to sleep at times. The next day, Saturday 10Apr2021, the pain was gone but the swelling had started. It was that morning on 10Apr2021, she was experiencing inflammation of lymph nodes. There was swelling in her right armpit feels like about half the size of tennis ball and on the right side, sticking out in between neck shoulder and ear and it fills in her palm of her left hand. The pain in her arm where the shot was administered has improved, but if she presses on the spot she can feel it, but if she doesn't press on it, it doesn't bother her. Patient stated that she had been taking Tylenol for these events. She stated this was first shot and gets second one in three weeks and was wondering if she should reschedule it or even get it at all and if so should she get it in the other arm? Caller also asked how long will it take for swelling to go down and should she take something else in addition or instead of the Tylenol that may help more. Patient was sitting home yesterday and noticed her right breast started itching on 12Apr2021. When it really started itching more, she lifted up her shirt and noticed a huge welt starting on her right breast. States that it grew from about 3 and a half by 2 and grew larger. It was very concerning. Does not want any allergic reactions. Last night it grew to 3 and a half by 4, was long and oval. She then finally took an allergy pill. Took one of these and it helped the itching. Welt on right breast was so big, can't even put her arm down on side, it was so uncomfortable, where the lymphadenopathy was. Today, it looked the same. It was not very red and was smooth. It feels lumpy to the touch. It was more pink than red. Itching started around 3:00pm. Was outside and didn't notice right away. Had vaccine Friday morning 9:00 am. It was 78 hours later that this occurred. Is a little less itchy because she took an allergy pill. Treatment was taken with generic allergy pill, took one time, was a once a day medication. Last night took acetaminophen, one 500mg pill. This was the first dose. Worried about the second one. Personally does not want to break out worse. She didn't want to get Covid again. She was still working on taste and smell. Is not back 100 percent. She had COVID in October and her symptoms were not that bad just congestion and she did lose taste and smell about a week later and still to this day was affected everything smells and tastes burnt; didn't want to get it again. Around May2020 she weaned herself off of Nexium for acid reflux and escitalopram for hot flashes. Other than a sleeping pill every now and then, she took no prescription medications. She does some over the counter supplements like take vitamin C, vitamin D, and Airborne. Patient underwent lab tests which included bloodwork which showed her glucose going up a notch, almost a prediabetic on an unspecified date. There was no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) and no additional vaccines administered on same date of the Pfizer Suspect. No other vaccines was administered to patient in four weeks. There was no visit to physicians office or emergency room due to the adverse events. The outcome of event was not recovered for inflammation of lymph nodes, armpit pain, sleep difficult, feeling abnormal, recovering for vaccination site pain, pruritus breast, breast lump recovered for pain on 10Apr2021, fatigue on 11Apr2021, and rest it was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1744160
Sex: M
Age: 91
State: FL

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 09/29/2021
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: Error: Wrong Vaccine Formulation (ex. different manufact. initial and booster)-

Other Meds:

Current Illness:

ID: 1744161
Sex: F
Age: 56
State: MA

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 09/29/2021
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: Error: Booster Given Too Early-

Other Meds:

Current Illness:

ID: 1744162
Sex: F
Age: 73
State: FL

Vax Date: 09/25/2021
Onset Date: 09/26/2021
Rec V Date: 09/29/2021
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: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium

Other Meds:

Current Illness:

ID: 1744163
Sex: F
Age: 66
State: TX

Vax Date: 09/25/2021
Onset Date: 09/26/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: None thus far

Allergies: Medications: Penicillin, Clindamycin Food: Spices, onions, garlic, peppers, processed foods with additives

Symptom List: Injection site pain, Menorrhagia

Symptoms: When I received my first two vaccines I was given a weblink where I was to check in regularly to report symptoms. I was given no such instruction for the booster shot I received at pharmacy. Therefore, I thought I should report the following symptoms I have been experiencing since I have had my booster on Saturday 9/25 at 4:30 pm. CST. 9/25 - some minor pain at injection site and a slight headache 9/26 - minor pain at injection site, fatigue, migraine like headache, general body aches, nausea 9/27 - redness and swelling around injection site, slight fatigue, minor headache 9/28 - redness, swelling and hardness in muscle around injection site, slight fatigue 9/29 - continued redness, itching, swelling and hardness in muscle around injection site While I don?t think any of these side affects to be major or long lasting at this point, I do want to point out that the migraine headache, nausea and injection site reactions (aka COVID Arm) are not symptoms I had from my first two Pfizer shots and I think this may be significant to follow in case there is the potential for multiplying side effects occurring in future booster shot recommendations (like a 2nd, 3rd or more booster).

Other Meds: Pepcid AC, Claritin

Current Illness: Seasonal allergies

ID: 1744164
Sex: M
Age: 88
State: NY

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 09/29/2021
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: Error: Wrong Vaccine Formulation (ex. different manufact. initial and booster)-

Other Meds:

Current Illness:

ID: 1744165
Sex: F
Age: 56
State: PA

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 09/29/2021
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: Error: Booster Given Too Early-

Other Meds:

Current Illness:

ID: 1744166
Sex: M
Age: 26
State:

Vax Date: 12/28/2020
Onset Date: 02/17/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies: nka

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: 1 month after my second dose, I was experiencing chest pain. Went to the ER and my systolic blood pressure was in the high 180's and diasystolic was 110's. They did a liver ultrasound and lab work. Found that i have elevated liver enzymes and a fatty liver.

Other Meds: loratadine

Current Illness: prehypertension

ID: 1744167
Sex: M
Age: 59
State: PA

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 09/29/2021
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: Error: Booster Given Too Early-

Other Meds:

Current Illness:

ID: 1744168
Sex: F
Age: 72
State: NC

Vax Date: 09/27/2021
Onset Date: 09/28/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: None

Allergies: Penicillin

Symptom List: Nausea

Symptoms: Pain and a heavy feel to left arm. A headache came on around 12 PM. I am usually an energetic individual. But around the same time as the headache, I felt fatigued and stayed home and rested.

Other Meds: Vitamin C, fish oil

Current Illness: Head cold

ID: 1744169
Sex: F
Age: 57
State: OH

Vax Date: 03/26/2021
Onset Date: 05/20/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: For my eyes the doctor gave me drops to clear up. As for my Spine, I underwent Spinal surgery of my lower Thoracic because of the issues mentioned previously. I did see on the Moderna vaccine analysis print, Synovial cysts are mentioned as well as other musculoskeletal issues

Allergies:

Symptom List: Injection site pain

Symptoms: Starting In May 2021, I had a very strange red inflammation in my eyes that I went to the doctor 2 times for. It was nothing like red allergy eyes at all and not pink eye. Then End of June 2021, I ended up going to the ER because I had excruciating back pain that radiated around my sides to stomach. I was given a CAT scan and some pain meds and sent home told to rest. I was fine for about a week and then it started back up on July 9th and eventually got worse causing serious issues with walking, sleeping and sitting. It took. me almost a month to get to a spinal surgeon to get an MRI to find out that I had Myeomalacia or Spinal Stenosis, with Cysts that were compromising my spine. I had not had any falls over the last year that could have caused this and it literally came out of nowhere

Other Meds:

Current Illness:

ID: 1744170
Sex: F
Age: 46
State: KY

Vax Date: 09/15/2021
Onset Date: 09/22/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: No labs done.

Allergies: NKDA

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

Symptoms: 1 week after receiving the Moderna injection I started with pain under my left arm and left breast. The pain in my breast is a severe sharp stinging pain that goes through out my breast. The pain has not resolved as of today and I was told to report the adverse reaction per employee health. I had a normal mammogram 2 weeks prior to having the injection.

Other Meds: Ibuprofen. Phentermine 37.5 mg.

Current Illness: None

ID: 1744171
Sex: M
Age: 28
State: CA

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 09/29/2021
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: Error: Improper Storage (temperature)-

Other Meds:

Current Illness:

ID: 1744172
Sex: M
Age: 69
State: FL

Vax Date: 02/22/2021
Onset Date: 02/22/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: NA

Allergies: Penicillin

Symptom List: Tremor

Symptoms: Immediate pain at site of injection. Pain increased over next 24-72 hours. Could barely lift my arm above shoulder height. Continued to have soreness at spot of injection and then on 9/22/21 pain increased and now having problem raising my arm without pain. Difficult to sleep without taking Alieve.

Other Meds: Gabapentin DHEA (Micro) Chorionic (HCG) Vitamin D Vitamin B12 L-Lysine Centrum Silver Tumeric

Current Illness: NA

ID: 1744173
Sex: F
Age: 73
State: IL

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Error: Booster Given Too Early-

Other Meds:

Current Illness:

ID: 1744174
Sex: F
Age: 89
State: MI

Vax Date: 05/06/2021
Onset Date: 08/31/2021
Rec V Date: 09/29/2021
Hospital: Y

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: COVID-19 test positive on 8/30/2021.

Allergies: Xanax (delirium)

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

Symptoms: Patient presented to emergency room on 8/30/2021 with shortness of breath, cough, and bilateral lower extremity edema. She was admitted for further management and found to be COVID-19 positive. On 9/1/2021, her condition worsened and she was transferred to ICU and was intubated on 9/4/2021. She was extubated on 9/5/2021 and transferred out of the ICU on 9/6/2021. Patient underwent a pulseless respirator arrest on 9/8/2021 and returned to the ICU. Patient was intubated and underwent tracheostomy. Patient was discharged to LTAC facility on 9/27/2021.

Other Meds: acetaminophen (TYLENOL) 325 MG tablet atorvastatin (LIPITOR) 10 MG tablet cephALEXin (KEFLEX) 500 MG capsule diltiazem (DILACOR-XR) 240 MG XR capsule ferrous sulfate (FEOSOL, 65 FE,) 325 (65 FE) MG tablet metoprolol tartrate (LOPRESSOR) 25

Current Illness: None known

ID: 1744175
Sex: F
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: broken out in a rash on her neck and chin; broken out in a rash on her neck and chin; This is a spontaneous report from a contactable consumer (patient) received through Regulatory Agency. A female patient of an unspecified age received BNT162B2 (, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2 SINGLE, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1 SINGLE for covid-19 immunizations. The patient medical history and concomitant medications were not reported. The patient experienced broken out in a rash on her neck and chin on an unspecified date with outcome of unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained

Other Meds:

Current Illness:

ID: 1744176
Sex: F
Age:
State: KY

Vax Date: 03/27/2021
Onset Date: 03/28/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Name: Electrocardiography; Result Unstructured Data: Test Result:Normal; Test Date: 20210402; Test Name: RT-PCR; Result Unstructured Data: Test Result:Negative; Test Date: 20210406; Test Name: RT-PCR; Result Unstructured Data: Test Result:Negative

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: heart palpitations; SOB; nausea; intermittent dry cough; headache; runny nose; extreme fatigue; Joint tenderness; malaise; muscle aches; This is a spontaneous report from a contactable other hcp. A 33-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8732), dose 2 via an unspecified route of administration, administered in Arm Left on 27Mar2021 15:30 as SINGLE DOSE, dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 (Batch/Lot Number: EN6202) as an unspecified dose for covid-19 immunisation. Patient received dose for CETIRIZINE HCL via an unspecified route of administration, administered in unspecified location of administration as an unspecified dose for unspecified indication. List of any other medications the patient received within 2 weeks of vaccination: Cetirizine HCl, Olly Multi-vitamin, joint supplements. Medical history included hypersensitivity from an unknown date and unknown if ongoing known allergies: Codeine. Information was available for Vaccine Facility, Ethnicity and Race. Patient was not pregnant at the time of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive other medications in two weeks of vaccination. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. On 28Mar2021 the patient experienced joint tenderness, malaise, muscle aches, extreme fatigue on 30Mar2021, heart palpitations on 03Apr2021, sob on 03Apr2021, on 01Apr2021 intermittent dry cough, headache, runny nose, nausea on 02Apr2021. The patient underwent lab tests and procedures which included echocardiogram: normal, sars-cov-2 test: negative on 02Apr2021, sars-cov-2 test: negative on 06Apr2021. He said was probably a neurological response to vaccine and prescribed a beta blocker (propanolol) to help with heart palpitations. Extreme fatigue and muscle aches lasted through 4/10, still experiencing slight SOB and heart palpitations upon exertion. Therapeutic measures were taken as Covid test, EKG, zofran, propanolol as a result of the events. The outcome of the events were recovering. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1744177
Sex: F
Age:
State:

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 09/29/2021
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: Rashes over her body; maybe she was having an allergic reaction; This is a spontaneous report received from a contactable consumer. This consumer (patient) reported for herself. A female patient of unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on Apr2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, after the vaccination, the patient experienced rashes over on her body. She just thought maybe she was having an allergic reaction. She brought it up to someone who told her that is a side effect of the Pfizer-BioNTech Covid-19 Vaccine. She asked for information on rashes, if that is a side effect of the Pfizer-BioNTech Covid-19 Vaccine, and if the rashes over her body get worse. The outcome of the event was unknown. No follow-up attempts possible. No further information expected.

Other Meds:

Current Illness:

ID: 1744178
Sex: M
Age:
State: NJ

Vax Date: 03/23/2021
Onset Date: 04/13/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: temperature was 99 when the ambulance was there and went to 101.5 degrees Fahrenheit; sick; hot; sweating; cheeks were red; throwing up; nauseous; chills and was freezing; had palpitations in his chest; he couldn't breathe and was having a hard time breathing; had a headache that began last night and had this morning; had shakes last night; This is a spontaneous report received from a contactable other Reporter. This Reporter has reported for a 83-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: ER8727; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 13Apr2021 10:30 (at the age of 83-years-old) as DOSE 2, SINGLE and patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6208; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 23Mar2021 10:30 (at the age of 83-years-old) as DOSE 1, SINGLE both for COVID-19 immunization. Medical history included diabetes mellitus, cardiac operation, pneumonia; he had the COVID on 24Nov2020 and had double covid pneumonia, illness, arthritis, gout from an unknown date and unknown if ongoing. Concomitant medications included paracetamol (TYLENOL) and prednisone (PREDNISONE) taken for an unspecified indication. Family medical history relevant to AE(s) was none. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Apr2021 the patient experienced had shakes last night, chills and was freezing, had palpitations in his chest, he couldn't breathe and was having a hard time breathing, had a headache that began last night and had this morning while on an unspecified date patient experienced temperature was 99 when the ambulance was there and went to 101.5 degrees Fahrenheit, sick, hot, sweating, cheeks were red, throwing up and nauseous. AE(s) did not require a visit to ER or MD office. Stated the patient had the shingles shot in Dec2020 or Jan2021 and it was his 2nd shingles shot but she has no name or lot number or further information and it was given to him at the drug store.Stated the patient did take Tylenol in the morning and does not know why he took the Tylenol 500mg extra strength and took one last night when he had the temperature; Stated he took Tylenol right before the 2nd dose of his Pfizer Vaccine yesterday and took it about a half hour before the vaccine; stated she has no lot number to provide for the Tylenol and does not know from which of the two bottles she has that he took it from; no further details provided. Stated for the patient, he sees pulmonary and gets arthritis, gets gout a lot; states he was diagnosed with arthritis and gout about 10 years ago; states he was on Prednisone 5mg once per day by mouth and started the Prednisone on and off about about 8 months ago. Caller states the patient was weak and she does not want him to get up alone; stated the HCP took care of him in the hospital and clarified that the patient was in the hospital before the Pfizer Vaccines and he was in the hospital in November. This report was not serious. Relevant tests were reported as none. Outcome of event had shakes last night was resolving. Outcome of events temperature was 99 when the ambulance was there and went to 101.5 degrees Fahrenheit, sick, hot, sweating, cheeks were red, throwing up, nauseous was unknown. Outcome of events chills and was freezing, had palpitations in his chest, he couldn't breathe and was having a hard time breathing was resolved on an unspecified date in 2021 while had a headache that began last night and had this morning was resolved on 14Apr2021. No follow-up attempts are needed. No further information is expected.

Other Meds: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034

Current Illness:

ID: 1744179
Sex: U
Age:
State: KY

Vax Date: 03/16/2021
Onset Date:
Rec V Date: 09/29/2021
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: Joint pain; Muscle pain; Nauseated; pain of lower abdominal; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported) via an unspecified route of administration on 16Mar2021 as dose 1, single for COVID-19 immunization, and patient had received medication include paracetamol (TYLENOL), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced joint pain, muscle pain, nauseated and pain of lower abdominal. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1744180
Sex: M
Age:
State: NE

Vax Date: 03/16/2021
Onset Date: 04/08/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer. A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6207, Expiry date: unknown), via intramuscular route of administration, administered in Arm Left on 16Mar2021 as dose 1, single for COVID-19 immunisation (Age at Vaccination was 68 years) for Covid-19 immunisation. Patient received mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE, Batch/Lot number and Expiry date: unknown), via an unspecified route of administration on 08Apr2021 as dose 2, single for COVID-19 immunisation. The patient medical history included ongoing high blood pressure. Concomitant medications included ongoing Metformin, Apixaban (ELIQUIS), Lisinopril, Finasteride (PROPECIA), Saxagliptin hydrochloride (ONGLYZA), Tamsulosin hydrochloride (FLOMAX RELIEF), and Atorvastatin (LIPITOR (ATORVASTATIN)). Patient did not visit the emergency room or physician office as a result of events. On 08Apr2021, the patient experienced received Moderna COVID-19 vaccine after receiving the first dose of the Pfizer COVID-19 vaccine. On an unspecified date, the patient experienced headache and fever. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034

Current Illness: Blood pressure high (Verbatim: high blood pressure)

ID: 1744181
Sex: F
Age:
State: SC

Vax Date: 04/08/2021
Onset Date: 04/01/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: bumpers and blister at injection and wrist; bumpers and blister at injection and wrist/got blisters today near the injection site; red whelps on the hip with; left thigh that has big old welts and itches real bad; started breaking out in three big hard bumps and they were on the same arm as her shot between her elbow and wrist and the bumps were big and she still has a tiny knot that will not go away; itching big knots on arm and legs/left thigh that has big old welts and itches real bad; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 54-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0150, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 08Apr2021 11:30 as dose 1, single for COVID-19 immunization (age at vaccination:54-years-old); formoterol fumarate, mometasone furoate (DULERA) via an unspecified route of administration from an unspecified date (Batch/Lot Number: T000895; Expiration Date: 11Jul2021) to an unspecified date, at two puffs per day twice per day. Medical history included chronic obstructive pulmonary disease from 21Jan2021 and ongoing, hypersensitivity and asthma. She is allergic to a lot of things. The patient concomitant medications were not reported. She did not took any other vaccine prior to covid vaccination (4 week). On 13Apr2021 the patient experienced bumpers and blister at injection and wrist/ got blisters today near the injection site. On unspecific date in Apr2021 the patient experienced itching big knots on arm and legs/left thigh that has big old welts and itches real bad, bumpers and blister at injection and wrist/got blisters today near the injection site , red whelps on the hip with , left thigh that has big old welts and itches real bad , started breaking out in three big hard bumps and they were on the same arm as her shot between her elbow and wrist and the bumps were big and she still has a tiny knot that will not go away. She has not had the 2nd dose of the pfizer biontech covid vaccine and does not think she will get it. States she had no treatment, no visit to the HCP and no visit to the emergency room but she is thinking about going to the HCP though. States her asthma doctor also with Hospital recommended her to get the Pfizer BioNTech COVID vaccine due to her lungs and stuff and the asthma doctor thought it would help her lungs that are so bad and she does not know what to do. States the reason she did not go to the HCP is that she was trying to see what this thing would do regarding the reported event; states she knows she needed the Pfizer BioNTech Covid vaccine because of all that is going on but the HCP can't give her the steroid shot or pills and she went to the HCP and they did not give her the steroid shot. States she went to her asthma doctor a week before the 1st dose of the Pfizer BioNTech COVID Vaccine and he said she needed a steroid shot but he couldn't give the steroid shot to her because she was going to get the Pfizer BioNTech COVID shot. States two months before the Pfizer BioNTech COVID shot, her COPD doctor gave her a steroid shot for her lungs but she does not know the name of the steroid shot or lot number to provide but the steroid shot was given to her on 21Jan2021. States she does not want to waste time by going if they will not do anything for her; no further details provided. The outcome of the events was unknown. Follow-up activities closed: No follow-up attempts are possible.

Other Meds:

Current Illness: Asthma; COPD

ID: 1744182
Sex: F
Age:
State: GA

Vax Date: 04/07/2021
Onset Date: 04/08/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Date: 20210413; Test Name: Nasal Swab; Test Result: Negative

Allergies:

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

Symptoms: dizziness; Severe shortness of breath; fever; body aches; This is a spontaneous report from a contactable consumer or other non hcp. A 38-year-old non-pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: Ep 7533), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 17:30 (at the age of 38-year-old) as dose 1, single for COVID-19 immunisation. Medical history included none. There were no concomitant medications. Patient did not receive other vaccine in four weeks. Patient did not receive other medications in two weeks. Patient not experienced COVID prior vaccination. On 08Apr2021, the patient experienced dizziness, severe shortness of breath, fever and body aches. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 13Apr2021. The outcome of the events was not Recovered. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1744183
Sex: F
Age:
State: FL

Vax Date: 04/14/2021
Onset Date: 04/14/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: She's been having side effects and can't get out of bed; dizziness; Couldn't walk straight; headache; joint pain/hips really hurting her; nausea; hot/cold flashes; tiredness; muscle pain; can't get out of bed to sit up; This is a spontaneous report received from a contactable consumer (son) reporting for his old mother (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 14Apr2021 at the age of 48-years-old as dose 1, single for covid-19 immunisation. Medical history included breast cancer from an unknown date, ongoing MS (multiple sclerosis) from an unknown date, hernia repair on an unknown date and she recently had a vasectomy on an unknown date. she has a history of different immunocompromised things. Concomitant medications included gabapentin (GABAPENTIN) taken 400mg a day for an unspecified indication from an unspecified start date and ongoing, unspecified Allergy Pills on a daily basis from an unspecified date and there are more, but he can't remember what they are. The reporter was calling on behalf of his mother, who got the first vaccine, the previous day. On 14Apr2021, the patient experienced, she's been having side effects and can't get out of bed. She's been experiencing dizziness, couldn't walk straight, headache, joint pain, hips really hurting her, nausea, hot/cold flashes, tiredness and muscle pain. The reporter asked, what should she do? Should she see a doctor? He states his mom had the vaccine, the previous day and later yesterday on 14Apr2021, she started having really bad side effects and she can't get out of bed to sit up. States he wants to know if this is a normal reaction or he doesn't know if needs to take her somewhere? Caller handler asked for clarification on what the caller stated after hernia repair, and he stated again, vasectomy. He clarified this was his mom's first dose of the vaccine. Treatment included Ibuprofen, Acetaminophen. Reporter seriousness for Dizziness, couldn't walk straight, Headache, Joint Pain, hips really hurting her, Nausea, Hot/Cold Flashes, Tiredness, Muscle pain and can't get out of bed to sit up was unspecified. The outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness: Multiple sclerosis

ID: 1744184
Sex: F
Age:
State: NC

Vax Date: 04/14/2021
Onset Date: 04/14/2021
Rec V Date: 09/29/2021
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: I could hardly swallow again; my jaw bone sore going through my ear/under my jaw starts hurting; my jaw bone sore going through my ear; Right side cheek face swelled/right side of my face, right cheek bone where my jaw where my cheek is, is swelled up like a baseball/sort of swollen today under my jaw bone, top of my neck; it hurt sort of swelling and everything.; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 63-years-old non pregnant female patient (not pregnant at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 14Apr2021 11:00 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization (at the age of 61-year-old). The patient medical history was reported as no. the patient concomitant medications included tazarotene (TAZORAC) taken for an unspecified indication, used as a face cream at nighttime, start and stop dates were not reported; vitamins nos (MULTIVITAMINUM) taken for an unspecified indication, start and stop date were not reported; bcg vaccine (BCG) taken for bladder cancer from 09Apr2021 to an unspecified stop date. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug Store. The patient did not received any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient received BCG drug on 09Apr2021 for bladder cancer and multivitamins within 2 weeks of vaccination. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient had an allergic to aspirin and anti-inflammatories from an unspecified date since 30-40 years, she do not take aspirin. The patient had previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 24Mar2021 15:00 (Batch/Lot Number: unknown) as dose 1, single for covid-19 immunization. On 14Apr2021 17:30, after the vaccination, evening at about 5, the patient experienced, right side of my face, right cheek bone where her jaw where her cheek was swelled up like a baseball and it hurt sort of swelling and everything. So, the patient called the pharmacist and she recommended Tylenol and ice and she did Tylenol and ice and started going down. So, she took the Benadryl before she went to bed and she was okay. But yesterday evening, the second day after her shot. She was eating dinner and it was still sore yesterday like her jaw bone sore going through her ear and when she started getting after day down some. But she went to ear and it went down a little bit more and she took a Benadryl before she went to bed and she was okay. But yesterday evening after the second day after her shot. She was eating dinner yesterday and it started hurting so bad. The patient could hardly swallow again and she took the Tylenol and she did some more icing on it and today it is so sore that it started hurting, it is like something connected to her jaw, between her jawbone and ear. Patient was not sure. It is a little bit swollen, not much. Today but when she like if she open her mouth like under her jaw starts hurting happen last night. It just hurts and the more she eat the worst it hurts and then before she finished it starts hurting really bad. This is sort of swollen today under her jaw bone, top of her neck, not much but a little bit. She does not know if that was the reaction other people have had. Patient did not have any reaction to the first shot. The patient received Tylenol and children's Benadryl for the treatment of events. The outcome of the events was unknown at the time of report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1744185
Sex: F
Age:
State:

Vax Date: 04/09/2021
Onset Date: 04/01/2021
Rec V Date: 09/29/2021
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: She has a lot of allergies; Dermographia of the skin, commented she gets issues with getting hives and things like that.; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration on 09Apr2021 as dose 1, single for covid-19 immunisation and fexofenadine hydrochloride (ALLEGRA), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history included Dermographia of the skin from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. On an unspecified date on Apr2021, the patient had a lot of allergies and dermographia of the skin (she got issues with getting hives and things like that). She has a lot of allergies and needs to take Allegra everyday. She already had the first dose, but she didn't take her medicine the day of the vaccine. However, she had to start taking it a day or two later. She confirmed she has not had a reaction as far as she knows. She has Dermographia of the skin, commented she gets issues with getting hives and things like that. The reporter asked will it interfere with the potency with vaccine, She also wanted to know if it will cause masking of symptoms if she should have an reaction or if anything to worry about. The outcome of events was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1744186
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 03/18/2021
Rec V Date: 09/29/2021
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: body aches; period (two weeks early) and heavy; period (two weeks early) and heavy; lethargic; fever; chills; headache; nausea; extremely tired; This is a spontaneous report from a contactable consumer (patient). A 33-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported), dose 1 via an unspecified route of administration, administered in arm left on an unspecified date (administration time: 09:00 AM) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Known allergies to codeine, DURICEFF; other medical history was none. The patient's concomitant medications were not reported. No covid prior vaccination, no covid tested post vaccination. On 18Mar2021, 18:00, the patient experienced fever, chills, body aches, headache, nausea, lethargic, extremely tired, period (two weeks early) and heavy after 1st shot. No treatment received for events. Outcome for all events was recovering. No follow-up attempts are possible; information about lot/batch cannot be obtained.

Other Meds:

Current Illness:

ID: 1744187
Sex: M
Age:
State: CA

Vax Date: 04/09/2021
Onset Date: 04/10/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Nasal Swab; Test Result: Negative

Allergies:

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

Symptoms: Severe pain in right side of neck.; Fluid build up in right side of neck.; Swelling in right side of neck; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 56-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 13:00 (at the age of 56-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient had no known allergies. Concomitant medication(s) included lisinopril, and metformin. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 13:00 (at the age of 56-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 01:15 AM (at the age of 56-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no other vaccine in four weeks. On 10Apr2021 at 12:00 PM, the patient had fluid build-up in right side of neck. Severe pain in right side of neck. Swelling in right side of neck. All behind right ear. Started day after vaccine on 10Apr2021. The patient had emergency room (ER)/department or urgent care visit on 12Apr2021. The patient not required treatment for the events. Symptoms resolved 13Apr2021. On an unspecified date in 2021, post vaccination, the patient was covid tested, nasal swab taken, and the result was negative. The outcome of the events was resolved on 13Apr2021. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: Pfizer, EUA 027034; Pfizer, EUA 027034

Current Illness:

ID: 1744188
Sex: F
Age:
State: CA

Vax Date: 04/16/2021
Onset Date: 04/01/2021
Rec V Date: 09/29/2021
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: muscle aches; pain; fatigue; severe headache; lethargy; swollen and painful lymph node in left armpit the size of a golf ball; swollen and painful lymph node in left armpit the size of a golf ball; This is a spontaneous report from a contactable consumer. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8729), dose 2 via an unspecified route of administration, administered in Arm Left on 16Apr2021 at 10:15 (at the age of 45 year) as dose 2, single for COVID-19 immunisation at Pharmacy or Drug Store. Medical history included Hashimoto's syndrome. The patient had no known allergies. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. Concomitant medication(s) included thyroid (ARMOUR THYROID), acetylsalicylic acid (BABY ASPIRIN) and Vitamins. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER8727), dose 1 via an unspecified route of administration in Left arm on 26Mar2021 at 16:00 (at the age of 45 year) for COVID-19 immunisation. On 16Apr2021 at 19:00 within 10 hours patient experienced muscle aches, pain, fatigue. On an unspecified date in Apr2021, in 24 hours severe headache, muscle pain, and lethargy. In 36 hours, swollen and painful lymph node in left armpit the size of a golf ball. It was reported that no therapeutic measures were taken for the events experienced. The outcome of events was not recovered No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am