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**
PLEASE CHECK BACK SOON
Download the files above while you wait.







Manufacturers

Total Manufacturer

Incidents per State

State Total
92,076
AK1,880
AL6,345
AR4,151
AS46
AZ14,991
CA66,887
CO12,550
CT8,943
DC1,795
DE2,009
FL42,724
FM4
GA17,031
GU124
HI2,580
IA4,919
ID2,892
IL22,128
IN24,197
KS5,047
KY9,111
LA5,500
MA15,718
MD13,434
ME3,351
MH8
MI20,971
MN13,585
MO10,747
MP30
MS3,198
MT2,477
NC18,051
ND1,501
NE3,109
NH3,218
NJ20,216
NM4,218
NV4,728
NY37,667
OH20,793
OK6,692
OR9,244
PA25,607
PR2,588
QM2
RI2,163
SC7,261
SD1,282
TN10,445
TX39,890
UT4,618
VA15,980
VI67
VT1,830
WA16,071
WI12,042
WV2,571
WY926
XB5
XL1
XV2

ID: 1290705
Sex: F
Age: 26
State: WA

Vax Date: 04/08/2021
Onset Date: 04/08/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Administered 0.5 mL of vaccine instead of 0.3 mL

Other Meds:

Current Illness:

ID: 1290706
Sex: M
Age: 69
State: ID

Vax Date: 03/10/2021
Onset Date: 03/22/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: none until this

Symptom List: Anxiety, Dyspnoea

Symptoms: None stated.

Other Meds: Metormin, insulin, blood preasure,

Current Illness: not impacting my life style

ID: 1290707
Sex: F
Age: 37
State:

Vax Date: 04/01/2021
Onset Date: 04/27/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Sinus/ear pressure and ear discomfort/pain. 2 short mild instances of tinnitus. Each lasted about 5 seconds then went away. One was in left ear, one in right. Head and ear pressure have gotten much better since first onset, but still comes and goes, not totally resolved.

Other Meds:

Current Illness:

ID: 1290709
Sex: F
Age: 40
State: FL

Vax Date: 05/04/2021
Onset Date: 05/04/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: About 5 minutes after the shot I felt pain in the area where they put the shot. About 15 minutes later I started to feel disoriented, lightheaded and felt like I was going to lose consciousness and I felt my heart racing. When they took my blood pressure it was 148/80. Then I started to have difficulty breathing. They took me to the ER in the same facility but the symptoms had resolved I believe because I drank plenty of water while I had the symptoms.

Other Meds:

Current Illness:

ID: 1290710
Sex: M
Age: 70
State: CA

Vax Date: 05/05/2021
Onset Date: 05/05/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: Patient denied allergies

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

Symptoms: The patient received the Janssen vaccine lot # 1808980 in his left deltoid muscle at 1250pm on the side of the road from our mobile foot team. He was seated on the sidewalk during vaccination and remained seated for his observation period. At 1301 the patient said he felt "fuzzy," and "light headed" but said "I do not feel like I'm going to pass out." The patient refused to lay down. He was offered a mat or the back of the car to lie down on. He was also given water by RNs and a snack by the police. He drank a few sips of water and refused the snack. His BP was 150/100, HR 76 and regular per palpation, RR 16 and unlabored. No signs of respiratory distress. The patients skin was dry and color was appropriate for ethnicity. At 1306 the patient said " I feel the same, a little light headed." RNs and asked him to describe what he meant by light headed as he still denied feeling like he was going to pass out. He said "I feel dizzy." RNs asked patient if he felt like he was spinning but he said no. BP 158/90, RR 18 and unlabored, HR 74 and regular per palpation. Pt still declined to lay down. At 1311 the patient still felt the same. RNs asked the patient to lie down again. The patient agreed to lay down in the back of the car. The patient stood up and said he felt short of breath upon standing. He has a Hx of COPD and said that he often feels SOB when he first stands. He took his own Ventolin Inhaler before laying down in the back of the car with the air conditioning on. It was 1316 when he laid down and vitals were taken again. BP 130/90, HR 70 and regular per palpation, RR 18 and unlabored. At 1321 the patient said "I feel a little better but still light headed and my head is throbbing but I get headaches every day." Vitals: 138/90, HR 70, Spo298%. At 1326 the patient tried to sit up but became flushed and said he felt "weird." Vitals were 144/90, HR 75, RR 18, Spo2 97%. RNs assisted the patient to lay back down. At 1328 RN asked the police to call 911 while RN placed a call to our lead RN. Vitals were taken again at 1331 BP 150/90, RR 18 and unlabored, HR 81, Spo2 98%. At 1337 the paramedics arrived with the ambulance and resumed care. The patient was transported to Hospital.

Other Meds: Ventolin Inhaler and Symbicort Inhaler

Current Illness: COPD

ID: 1290711
Sex: F
Age: 68
State: OR

Vax Date: 04/29/2021
Onset Date: 05/02/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: Aspertane, codeine, Demerol, metformin, contrast media (iodine-based)

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

Symptoms: Hot rash starting below the injection site, which has now spread down my arm and past me elbow to 1/2 way to my wrist.

Other Meds: Bupropion (Wellbutrin) HCL 300mg XL tabs- 1 daily. Bayer Enteric Coated Aspirin 81mg - 1 daily Clopidogrel 75 mg - 1 daily (Plavix) Levothyroxine 125mcg -1 daily Metoprolol ER 150mg - 2x daily (1 1/2 pills) Pantoprazole 40mg - 1 daily (P

Current Illness: None

ID: 1290712
Sex: M
Age: 34
State: OK

Vax Date: 05/05/2021
Onset Date: 05/05/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: None

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Around the time stated in form I began feeling slightly flushed in the face, general fatigue, as well as a slight headache.

Other Meds: None

Current Illness: None

ID: 1290713
Sex: F
Age: 37
State:

Vax Date: 05/05/2021
Onset Date: 05/05/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Patient states feeling dizzy and nauseated. Patient legs elevated and paramedics assess patient. Blood pressure checked by paramedics and was elevated. 2L oxygen was administered by paramedics via nasal cannula for 2 minutes. After 5 minutes patient states feeling better. denies any any nausea and BP rechecked was within normal limits .

Other Meds:

Current Illness:

ID: 1290714
Sex: M
Age: 51
State: OH

Vax Date: 03/10/2021
Onset Date: 03/24/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Persistent tinnitus; high-pitch frequency tone in the ears.

Other Meds:

Current Illness:

ID: 1290715
Sex: F
Age: 48
State: MD

Vax Date: 04/02/2021
Onset Date: 04/15/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: None

Symptom List: Diarrhoea, Nasal congestion

Symptoms: I am over 30 days late on my period. The only time I?ve been late is when I was pregnancy twice. I was supposed to have my period the week of 4/11 and no period to date.

Other Meds: None

Current Illness: None

ID: 1290717
Sex: M
Age: 46
State: WA

Vax Date: 04/08/2021
Onset Date: 04/08/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Administered 0.5 mL of vaccine instead of 0.3 mL

Other Meds:

Current Illness:

ID: 1290719
Sex: F
Age: 64
State: CA

Vax Date: 03/12/2021
Onset Date: 03/12/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: Lisinopril

Symptom List: Rash, Urticaria

Symptoms: I started to get Migraines the day of the shot. I was nauseous and I did have seizure which only happens twice a year. My seizures are not always triggered by migraine. I have a history of hives and I get reactions to bites. I decided to get the Johnson & Johnson because it seemed to be a better option. Ten days after the vaccine I had a Migraine that was so bad I had to go to the doctor. When I got there my blood pressure was high. I was given some migraine medicine, but it did not help. The migraine was there for four weeks after the shot. I still got a numbing headache after the shot until five weeks after the shot.

Other Meds: Topamax

Current Illness:

ID: 1290720
Sex: M
Age: 63
State: TX

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: Dilantin, some sulfa drugs

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

Symptoms: Within one hour, got very lightheaded, weak in arms and legs, almost felt like stroke coming on.

Other Meds: Bisoprolol-hctz, rosuvastatin, fenofibrate, timolol, sildenafil (not used January), triamcinolone acetone cream, aspirin, chromium picolinate, glucosamine/condroidin, citrucel, various otc allergy (Zyrtec, Allegra), prevacid

Current Illness: None

ID: 1290721
Sex: M
Age: 17
State: KY

Vax Date: 04/14/2021
Onset Date: 04/14/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: NONE

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

Symptoms: Patient was signed up to receive Pfizer vaccine when making the appointment online at ; however, our clinic had not yet started administering Pfizer, only Moderna. Father stated Moderna was ok to give. Administrating provider did not realize the patient was less than 18 years old. No known adverse symptoms occured.

Other Meds: NONE

Current Illness: NONE

ID: 1290722
Sex: F
Age: 39
State: TX

Vax Date: 04/26/2021
Onset Date: 04/27/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: Penicillin

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

Symptoms: Swollen arm and redness in the area to this day after the application of vaccination and without pain. The pain was only for the first two days.

Other Meds: Alipotec Raiz de Tejocotes

Current Illness: No

ID: 1290723
Sex: F
Age: 27
State: ME

Vax Date: 05/05/2021
Onset Date: 05/05/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: Unkown

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

Symptoms: Patient administered Janssen vaccine on 5/5/21 at 1011AM by pharmacist on duty. Patient did not admit any anxiety surrounding vaccine during counseling prior to receiving the vaccine. After administration patient mentioned she has can get anxious sometimes and has tendency to create symptoms in her head. She asked what to be on the look out for for signs of syncope and described starting to feel nauseous, clamy, and tunnel vision. Within seconds she briefly lost consciousness and started to slump in chair within immunization room. Pharmacist prevented her from falling out of chair while opening door to waiting room and asked for assistance from patients boyfriend. Together we held patient in place on chair and propped feet up on another chair. Immediately patient regained consciousness enough to explain what she was feeling but then quickly lost consciousness again and started snoring as if she immediately fell asleep. Boyfriend said no history of sleep issues/narcolepsy, together we laid patient on floor of immunization room with feet slightly elevated and boyfriend at her head and again she immediately regained consciousness. Patient explained that she was immediately starting to feel better and felt dizzy and described having very odd dream like scenarios. She laid on floor for 10 min, Alert and orientedx4, moved to seated position for another 10 min, accepted offer for apple juice, moved to waiting area to sit for another 10min before OK leaving. MOD/PDM aware....Called patient at 6pm that same evening and patient reported feeling great.

Other Meds: Unkown

Current Illness: Unkown

ID: 1290724
Sex: F
Age: 23
State: NJ

Vax Date: 04/16/2021
Onset Date: 04/18/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: 2 days after receiving dose 2 I developed hives on left and right arm, red, itchy, blotches on my legs below the knee and 4 days later my eyes swelled up

Other Meds:

Current Illness:

ID: 1290725
Sex: M
Age: 25
State: FL

Vax Date: 05/05/2021
Onset Date: 05/05/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: Diclofenac IV, pt is able to take Diclofenac PO

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Pt received vaccine and within minutes of receiving the vaccine, pt stated that he had dizziness and felt light headed. Neuro assessment was performed by reporting nurse and neuro assessment WNL. Pt started hyper ventilating and pt was advised to slow down his breathing. Pt continued to complain of feeling dizzy and lightheaded. Pt had bilateral feet elevated on a chair and bilateral arms raised. Site was called to the patient and they assessed the patient. Pt was laid down on the floor and bilateral feet elevated. Pt had a 12 lead ECG performed showed 60 with a run of SVT with rate of 182. Pt had VS taken initally 80/40, 62, 24. continued treating patient, FSBS was 79. Pt was advised to go to the ER for further assessment and treatment. provided O2 2L via , 12 lead ECG monitoring, IV access to right AC, 20g secured with opsite, 0.9% NS bolus of 200ml. Pt was transported. Ship staff aware of incident and will f/u with patient status.

Other Meds: None

Current Illness: None per pt

ID: 1290726
Sex: F
Age: 34
State: GA

Vax Date: 05/05/2021
Onset Date: 05/05/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Anaphylaxis- throat and tongue swollen and closed up

Other Meds:

Current Illness:

ID: 1290727
Sex: F
Age: 23
State: NY

Vax Date: 05/01/2021
Onset Date: 05/05/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: Dairy allergy

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

Symptoms: Extremely swollen and sore lymph node in left armpit. Began at 10:30 AM on May 5th - worsening throughout the day.

Other Meds: none

Current Illness: none

ID: 1290728
Sex: F
Age: 47
State:

Vax Date: 05/05/2021
Onset Date: 05/05/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: Aloe VeraItching Citrus FruitRash Ct Dye [Ivp Dye, Iodine Containing]Rash Penicillin V PotassiumRash Prochlorperazine Septra [Co-trimoxazole]Itching Iodine-131Rash

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

Symptoms: Pt sat down to wait and c/o itching and hives. MD immediately assessed pt and requested for 20mg of Cetrizine Hydrochloride PO to be given. Medication given as per MD orders. Pt observed for additional 20min. Pt denied any SOB, CP, or further complications. Pt cleared by MD to go home at 1700. Pt instructed to call 911 should she have a medical emergency on the way home. Pt verbalized agreement and understanding to this.

Other Meds: Metoprolol Succinate (TOPROL XL) 25 mg Oral 24hr SR Tab Furosemide (LASIX) 20 mg Oral Tab Cosentyx Pen, 2 Pens, 150 mg/mL SubQ Pen Injector Calcitriol (VecticaL) 3 mcg/gram Top Oint Clobetasol (OLUX) 0.05 % Top Foam Lidocaine (AneCream5) 5

Current Illness:

ID: 1290729
Sex: M
Age: 27
State: CA

Vax Date: 04/05/2021
Onset Date: 04/15/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: no

Symptom List: Unevaluable event

Symptoms: On day 1 (April 15) of noticing my body was very off after the vaccine I had Leg pain and severe headaches, I say severe because though I rarely get headaches and stay hydrated I could tell this headache really hurt and lasted the full day and several days after (something I have never had happen to me) Also on April 15, I had leg pain, If I took a step off a few inches curb or stair step I felt sharp pain shoot up my leg. On April 16th I still had the headaches and leg pain , but also while driving I began loosing my vision and started to pass out/faint. I Pulled over and waited at least a half hour. during that time I. noticed I couldn't type or read anything on my phone as I was trying to reach a friend to help me. eventually after time had passed I was able to drive myself to a friends where I thought the best thing would be to sleep it off. the headaches and leg pain lasted a couple more days and I thought it was going to go away, but it is now May 5th and today and last couple days the leg pain feels more like someone has been punching my left leg. five had chest pain and headaches return. I do not have medical insurance and have avoided going to the hospital or primary care because I am afraid. today the pain is so irritating and sore I wish I could escape my body.

Other Meds: Only taking Prep/Truvada.

Current Illness: none

ID: 1290730
Sex: F
Age: 42
State: PR

Vax Date: 05/05/2021
Onset Date: 05/05/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: solumedrol

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: THE PHARMACIST ADMINISTER THE VACCINE TO THE PATIENT , AFTER 10 MINUTESTHE PATIENT BECOME DIZZINES, SWETY AND WITH SHOTNESS OF BREATH. SEHE RECOVERED IN 5 MINUTES ANT THE PHARMACIST GO TO LUNCH AND TELL ME (RPH) THET THETE WERE 2 MINUTES LEFT TO COMPLETE THE 15 MINUTES WAIT. SHE BECAME SICK AGAIN WITH THE SAME SYMPTOMS. (IMZ TECH) CALL 911 AND ALERT STORE MANAGER WITH CODE WHITE. I CHECK THE PATIENT, (IMZ TECH GAVE HER AN ALCOHOL PAD TO BREATH AND I ASK IF SHE CAN MOVE AND SHE SAID SHE DIDNT, I PROCEDEED TO APPLY A COLD COMPRES S TO HER WRIST. THE AMBULANCE CAME AND TOOK HER TO THE EMERGENCY ROOM (1:10pm) HER BROTHER CALLED 5:03PM TO INDICATE THAT SHE IS FINE WITHOUT SYMPTOMS.

Other Meds: unknown

Current Illness: none

ID: 1290732
Sex: F
Age: 56
State: VA

Vax Date: 04/19/2021
Onset Date: 04/19/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: Wellbutrin Hair Dye

Symptom List: Injection site pain, Pain

Symptoms: Fever up to 102 - 24 hours; chills 12 hours; fatigue 24 hours Stayed in bed first day. Second day able to shower, eat, etc. Third day felt normal. Did not see doctor.

Other Meds: Lexapro Simvastatin Hydroxyzine Xanax Flonase

Current Illness: None

Date Died: 02/04/2021

ID: 1290733
Sex: F
Age: 94
State: MO

Vax Date: 01/11/2021
Onset Date: 01/27/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Found unresponsive but still breathing at assisted living. Sent by ambulance to the hospital

Other Meds: Levothyroxin 50mcg, metoprolol tar 25mgdiltiazem 180mg, atorvastatin 20 mg,omeprazole 20 mg, pot cl micro tab 20meq,furosemide 20 mg, tramadol 50 mg, florastor 250,

Current Illness: COVID-19 on December 24th of 2020

ID: 1290734
Sex: F
Age: 29
State: KY

Vax Date: 04/14/2021
Onset Date: 04/14/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: unknown

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: Patient came in for 2nd Pfizer covid-19 vaccination and had marked that she had an allergic reaction after getting the 1st Pfizer vaccine. Patient states that she got very red around her neck and that she was itching while in clinic after receiving the vaccination. Patient states that the NP that gave her the vaccine told her to go home and take Benadryl. Patient states that she went home and after she got home her neck started swelling and she took Benadryl and states that it improved. Patient states that the hives were behind her ears until 1 day ago. Patient was informed that she could not receive the 2nd covid-19 vaccine due to having an allergic reaction and that if she did receive it, her reaction could be much worse. Patient informed that she should have received some immunity from having only one vaccine but to continue to wear a mask and social distance.

Other Meds: unknown

Current Illness: unknown

ID: 1290735
Sex: F
Age: 25
State: TX

Vax Date: 04/06/2021
Onset Date: 04/06/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Patient got 1st dose of COVID-19 vaccine on 4/6/21 and started developing rash/hives at night on her inner thigh with severe itching and puffiness around her eyes. She took two Benadryl capsules and rashes were gone after 6-12 hours. She did not have any shortness of breath or swelling on her face, neck or tongue. Patient called to inform this at pharmacy on 5/5/21 to ask if she should still take her 2nd dose

Other Meds:

Current Illness:

ID: 1290736
Sex: F
Age: 58
State: TX

Vax Date: 05/05/2021
Onset Date: 05/05/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Patient started to felt dizzy and have hard time swallowing her water. Before this event, I counseled her on potential side effects and confirm her health status. When I came to assist her, she was not having any respiratory distress nor having any severe anaphylactic reaction so no Epipen was used. I applied ice pack on her and she started to feel better a few minutes later.

Other Meds:

Current Illness:

ID: 1290737
Sex: F
Age: 21
State: WA

Vax Date: 05/05/2021
Onset Date: 05/05/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: unknown

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Patient was given first vaccine April 16th. Second shot was due May 14th. This was a med error as she was not due for her second shot. Pt was told of the med error and agency guidelines were followed as I instructed patient not to get a second shot.

Other Meds: unknown

Current Illness: unknown

ID: 1290738
Sex: M
Age: 74
State: FL

Vax Date: 03/01/2021
Onset Date: 05/01/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: My father had a triple bypass in June of 2020 and then in October of 2020 had a stent. He had his chest wide open in June and then CAT scan in October and clean scan, after stent. Then he gets the vaccine in March of 2021 and then two days ago was diagnosed with Lymphoma. I think there is a correlation. My father also was diagnosed and treated in 2017 for STAGE 1 bladder cancer. No chemo or radiation, just surgery and clean bill of health. I think the vaccine may have "woken up" cancer cells? I don't know. But it makes no sense to me. I begged him not to get the vaccine until it was FDA approved.

Other Meds: PLAVAX

Current Illness:

ID: 1290739
Sex: F
Age: 47
State: CA

Vax Date: 05/03/2021
Onset Date: 05/04/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: Penicillin

Symptom List: Injection site pain

Symptoms: Mild fever, intense body aches (especially in calves), migraine headaches, dizziness. I was also on the fourth day of my mensuration cycle, which was very heavy. After receiving the vaccine, my flow almost completely stopped.

Other Meds: Escitalopram, Claritin, Iron w/Vitamin B

Current Illness: No other known illnesses

ID: 1290741
Sex: F
Age: 42
State: WA

Vax Date: 04/24/2021
Onset Date: 05/03/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: Erythromycin

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

Symptoms: Patient developed a painful rash to the left buttock a week after vaccine administration. Was diagnosed with herpes zoster

Other Meds: Cetirizine, Citalopram, Synthroid, Nasonex

Current Illness: History of seasonal allergies. Allergic Rhinitis

ID: 1290761
Sex: F
Age:
State:

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: more pain her her legs then before the Enbrel, especially by her right knee/thought she was having a flare; Terrible headache/Headache turned into a migraine; She got really sick; She has queasiness; Body ache; Hangover feeling; hands are also so swollen, she feels like she can see the fluid between the joints; patchy light rash on both feet that is new this week; This is a solicited report from Pfizer (marketing program name not available) from a contactable consumer, based on information received by Pfizer license party for etanercept (ENBREL). This non-serious solicited report was reported to Amgen on 15/APR/2021 by a consumer from a commercial program and involves a 41 year old female patient who experienced terrible headache/headache turned into a migraine [PT: migraine], she got really sick [PT: illness], she has queasiness [PT: nausea], body ache [PT: pain], hangover feeling [PT: hangover] while receiving Enbrel, Reusable Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. The patient's co-suspect medication included Covid-19 Vaccine. The patient began Enbrel with Reusable Autoinjector on an unknown date. On an unknown date, the patient received the Covid vaccination while on Enbrel and did well with the first one but the second one she got really sick. The patient had queasiness, body ache and terrible headache for about one and one half days. The patient stated that the headache turned into a migraine which led into a another day of not feeling well with that post migraine hangover feeling. The patient was doing much better now. No treatment information was received. The outcome of the events migraine, illness, hangover were reported as recovering/resolving. The outcome of the events nausea, pain were reported as recovered/resolved. The events nausea, pain were resolved on an unknown date. Action taken with Enbrel and Reusable Autoinjector was reported as unknown for the events migraine, illness, nausea, pain and hangover. The causal relationship between the events migraine, illness, nausea, pain, hangover and Enbrel, Reusable Autoinjector was not provided by the consumer. The patient declined to provide lot number. The reporter declined consent for follow up. Causality Assessment: Hangover, General body pain, Nausea, Sickness, Migraine Per Company (Amgen) = No. The reporter's assessment of the causal relationship of the events with the suspect product COVID vaccine was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. Follow-up (22Apr2021): This is a follow-up solicited report from a Pfizer from a contactable consumer, based on information received by Pfizer license party for etanercept (ENBREL). ADDITIONAL INFORMATION RECEIVED ON 22/APR/2021: This case was upgraded to serious. In this follow up, the patient stated. more pain her legs than before the Enbrel, especially by her right knee/thought she was having a flare [PT: rheumatoid arthritis], hands are also so swollen, she feels like she can see the fluid between the joints [PT: peripheral swelling], patchy light rash on both feet that is new this week [PT: rash] while receiving Enbrel with Reusable Autoinjector. On an unknown date, the patient stated that she was having more pain her legs than before the Enbrel, especially by her right knee. The patient called the doctor to see if they wanted to see her but thought she was having a flare and Enbrel had not kicked in after only four doses. They gave her a steroid pack prescription. The patient stated that her hands were also so swollen, she felt like she could see the fluid between the joints. On an unknown date in APR/2021, she stated she also had a diffuse patchy light rash on both feet and was not itchy or sore, will let doctor know.The outcome of the event rheumatoid arthritis was reported as not recovered/not resolved. The outcome of the events peripheral swelling, rash were reported as unknown. Action taken of Enbrel with Reusable Autoinjector was reported as unknown for the events rheumatoid arthritis, peripheral swelling and rash. The causal relationship between the events arthralgia, rheumatoid arthritis, peripheral swelling, rash and Enbrel with Reusable Autoinjector was not provided by the consumer. The reporter did not and would never have access to lot number. The reporter declined consent to contact. No follow up attempts are possible. No further information is expected. Amgen Comment:This individual case report does not change the safety profile of the product. Causality Assessments: Rash, Per Company(Amgen)=Yes Hand swelling, Rheumatoid arthritis flare up, Hangover, General body pain, Nausea, Sickness, Migraine. Per Company(Amgen)= No; Sender's Comments: Based on an implied event-vaccine chronological association the reported events were possibly related to BNT162B2 vaccine; the events were not related to etanercept. The events Rheumatoid arthritis flare, peripheral swelling and rash are attributed to underlying or intercurrent medical conditions and assessed Unrelated to suspect products BNT162B2 vaccine or etanercept.

Other Meds:

Current Illness: Rheumatoid arthritis

ID: 1290762
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 05/04/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: NUMBNESS OF TONGUE AND LIPS; TINGLING ON TONGUE AND LIPS; DIZZINESS; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and smoker, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205421A expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 04-MAY-2021, the subject experienced numbness of tongue and lips. On 04-MAY-2021, the subject experienced tingling on tongue and lips. On 04-MAY-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness of tongue and lips, dizziness, and tingling on tongue and lips. This report was non-serious.

Other Meds:

Current Illness: Alcohol use (moderately, a couple glasses of wine per week); Cigarette smoker (5-10 CIGARETTES A DAY)

ID: 1290763
Sex: F
Age: 62
State: TX

Vax Date: 03/09/2021
Onset Date: 04/06/2021
Rec V Date: 05/05/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: High Blood Pressure 200/110 mmHg; Excruciating Severe Headache (After Second Shot)/Excruciating Pain on the Right Side of Head; Pain in the Right Side of the Neck and Right Shoulder; No Energy,Not myself; Not Myself" (After Second Shot); she is not able to sleep at night from the Pain; Excruciating Pain on the Right Side of Head when CoughExcruciating Pain on the Right Side of Head when Cough; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (High Blood Pressure 200/110 mmHg), HEADACHE (Excruciating Severe Headache (After Second Shot)/Excruciating Pain on the Right Side of Head) and ARTHRALGIA (Pain in the Right Side of the Neck and Right Shoulder) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Colon cancer stage II (last chemo was 6 years ago.). Concomitant products included LOSARTAN, METOPROLOL and AMLODIPINE for an unknown indication. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced HYPERTENSION (High Blood Pressure 200/110 mmHg) (seriousness criterion hospitalization), HEADACHE (Excruciating Severe Headache (After Second Shot)/Excruciating Pain on the Right Side of Head) (seriousness criteria hospitalization and medically significant) and ARTHRALGIA (Pain in the Right Side of the Neck and Right Shoulder) (seriousness criterion hospitalization). On 27-Apr-2021, the patient experienced ASTHENIA (No Energy,Not myself), FEELING ABNORMAL (Not Myself" (After Second Shot)), INSOMNIA (she is not able to sleep at night from the Pain) and COUGH (Excruciating Pain on the Right Side of Head when CoughExcruciating Pain on the Right Side of Head when Cough). The patient was hospitalized on 06-Apr-2021 due to ARTHRALGIA, HEADACHE and HYPERTENSION. At the time of the report, HYPERTENSION (High Blood Pressure 200/110 mmHg), HEADACHE (Excruciating Severe Headache (After Second Shot)/Excruciating Pain on the Right Side of Head), ARTHRALGIA (Pain in the Right Side of the Neck and Right Shoulder), ASTHENIA (No Energy,Not myself), FEELING ABNORMAL (Not Myself" (After Second Shot)), INSOMNIA (she is not able to sleep at night from the Pain) and COUGH (Excruciating Pain on the Right Side of Head when CoughExcruciating Pain on the Right Side of Head when Cough) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 200/110 (abnormal) 200/110 mmHg. On an unknown date, Computerised tomogram: normal (normal) normal. Treatment with IV pain medications and was held in dark room in the Emergency room for several hours and discharged. This case concerns a 62-year-old female hospitalized with serious unexpected events of hypertension, headache, arthralgia, and nonserious unexpected asthenia, feeling abnormal, insomnia, and cough. Event onset the same day as second dose mRNA-1273. Event outcomes unknown. Based on 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. This case was linked to US-MODERNATX, INC.-MOD-2021-092739 (E2B Linked Report).; Sender's Comments: This case concerns a 62-year-old female hospitalized with serious unexpected events of hypertension, headache, arthralgia, and nonserious unexpected asthenia, feeling abnormal, insomnia, and cough. Event onset the same day as second dose mRNA-1273. Event outcomes unknown. Based on 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. US-MODERNATX, INC.-MOD-2021-092739:Case for dose 1

Other Meds: LOSARTAN; METOPROLOL; AMLODIPINE

Current Illness:

ID: 1290764
Sex: M
Age:
State: IL

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 05/05/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: encephalopathy with facial muscle weakness; facial muscle weakness; back pain causing inability to ambulate; dysarthria; Constipation; urinary retention; MSSA; extremity weakness; Severe refractory immune thrombocytopenia; ACUTE EPISTAXIS; DIFFUSE CUTANEOUS PURPURA; This literature-non-study case was reported in a literature article and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Severe refractory immune thrombocytopenia), EPISTAXIS (ACUTE EPISTAXIS), PURPURA (DIFFUSE CUTANEOUS PURPURA), MUSCULAR WEAKNESS (extremity weakness), ENCEPHALOPATHY (encephalopathy with facial muscle weakness), FACIAL PARESIS (facial muscle weakness), BACK PAIN (back pain causing inability to ambulate), DYSARTHRIA (dysarthria), CONSTIPATION (Constipation), URINARY RETENTION (urinary retention) and STAPHYLOCOCCAL SEPSIS (MSSA) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: Severe, Refractory Immune Thrombocytopenia Occurring After SARS-CoV-2 Vaccine. Journal of Blood Medicine. 2021;12:221-224 Previously administered products included for Influenza immunization: influenza in October 2020; for Pneumococcal immunization: pneumococcal in December 2020. Past adverse reactions to the above products included No adverse event with influenza and pneumococcal. Concurrent medical conditions included Hypertension, Gout, Hyperlipidemia and Cardiomyopathy. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced EPISTAXIS (ACUTE EPISTAXIS) (seriousness criterion hospitalization) and PURPURA (DIFFUSE CUTANEOUS PURPURA) (seriousness criterion hospitalization). On 20-Jan-2021, the patient experienced IMMUNE THROMBOCYTOPENIA (Severe refractory immune thrombocytopenia) (seriousness criterion hospitalization). On 31-Jan-2021, the patient experienced MUSCULAR WEAKNESS (extremity weakness) (seriousness criterion hospitalization), ENCEPHALOPATHY (encephalopathy with facial muscle weakness) (seriousness criterion hospitalization), FACIAL PARESIS (facial muscle weakness) (seriousness criterion hospitalization), BACK PAIN (back pain causing inability to ambulate) (seriousness criterion hospitalization), DYSARTHRIA (dysarthria) (seriousness criterion hospitalization), CONSTIPATION (Constipation) (seriousness criterion hospitalization), URINARY RETENTION (urinary retention) (seriousness criterion hospitalization) and STAPHYLOCOCCAL SEPSIS (MSSA) (seriousness criterion hospitalization). The patient was hospitalized for 5 days due to EPISTAXIS, IMMUNE THROMBOCYTOPENIA, MUSCULAR WEAKNESS and PURPURA. At the time of the report, IMMUNE THROMBOCYTOPENIA (Severe refractory immune thrombocytopenia), EPISTAXIS (ACUTE EPISTAXIS), PURPURA (DIFFUSE CUTANEOUS PURPURA), MUSCULAR WEAKNESS (extremity weakness) and FACIAL PARESIS (facial muscle weakness) was resolving and ENCEPHALOPATHY (encephalopathy with facial muscle weakness), BACK PAIN (back pain causing inability to ambulate), DYSARTHRIA (dysarthria), CONSTIPATION (Constipation), URINARY RETENTION (urinary retention) and STAPHYLOCOCCAL SEPSIS (MSSA) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Platelet count: 10 10^9/L (Inconclusive) 10. On 01-Feb-2021, Blood culture: abnormal (abnormal) blood culture grew methicillin-susceptible Staphylococcus aureus (MSSA). On 01-Feb-2021, Culture urine: abnormal (abnormal) urine culture grew methicillin-susceptible Staphylococcus aureus (MSSA). On 01-Feb-2021, Platelet count: 21 10^9/L (Inconclusive) 21. On 02-Feb-2021, Cytomegalovirus test: negative (Negative) Negative. On 02-Feb-2021, Epstein-Barr virus test: negative (Negative) Negative. On 02-Feb-2021, HIV test: negative (Negative) Negative. On 02-Feb-2021, Hepatitis B virus test: negative (Negative) Negative. On 02-Feb-2021, Hepatitis C virus test: negative (Negative) Negative. On 02-Feb-2021, Parvovirus B19 test: negative (Negative) Negative. On 04-Feb-2021, Magnetic resonance imaging: abnormal (abnormal) MRI revealed sever L1-5 stenosis with multi-level disc herniation and fluid collections within the lumbar, posterior and paraspinal musculature. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Two months prior to vaccination, the patient had a platelet count of 224 x 10^9/L. No concomitant medications were reported. Treatment for the events included high-dose dexamethasone (400mg/kg/day), five daily doses of intravenous immunoglobulin (400mg/kg/day), three daily platelet transfusions, and two weekly doses of rituximab (375mg/m^2/dose). Immune suppression with dexamethasone (20mg/day) was continued after hospital discharge. Post vaccination day ten, TPO-RA eltrombopag (50 mg/day) was initiated. On post-vaccination day 14, he received one pheresis unit of platelets and an additional dose of IVIg of 80 grams. On post-vaccination day 12, he received high dose methyl-prednisolone (1 mg/kg/day) and (5 mcg/kg). The patient was given cefazolin for MSSA infection. On post-vaccination day 19, after the third episode of plasma exchange, his facial weakness improved. On post-vaccination day 22, his platelet count was 72*10^9/L, a second dose of romiplostim 5 mcg/kg was administered, and a corticosteroid taper was begun. He was transferred to a skilled nursing facility on post-vaccination day 25 with a platelet count of 173*10^9/L. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Cardiomyopathy; Gout; Hyperlipidemia; Hypertension

ID: 1290765
Sex: F
Age: 38
State: AZ

Vax Date: 04/26/2021
Onset Date: 04/26/2021
Rec V Date: 05/05/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Body Swelling; eyes on fire; eyes completely puffy; extremely Migraine; vision went blurry; Dizzy; could not keep her balance; eyes completely red; body ache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING (Body Swelling), EYE IRRITATION (eyes on fire), PERIORBITAL SWELLING (eyes completely puffy), MIGRAINE (extremely Migraine), VISION BLURRED (vision went blurry), DIZZINESS (Dizzy), BALANCE DISORDER (could not keep her balance), OCULAR HYPERAEMIA (eyes completely red) and MYALGIA (body ache) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002c21a) for COVID-19 vaccination. No Medical History information was reported. On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced SWELLING (Body Swelling) (seriousness criterion hospitalization), EYE IRRITATION (eyes on fire) (seriousness criterion hospitalization), PERIORBITAL SWELLING (eyes completely puffy) (seriousness criterion hospitalization), MIGRAINE (extremely Migraine) (seriousness criterion hospitalization), VISION BLURRED (vision went blurry) (seriousness criterion hospitalization), DIZZINESS (Dizzy) (seriousness criterion hospitalization), BALANCE DISORDER (could not keep her balance) (seriousness criterion hospitalization), OCULAR HYPERAEMIA (eyes completely red) (seriousness criterion hospitalization) and MYALGIA (body ache) (seriousness criterion hospitalization). The patient was hospitalized from 26-Apr-2021 to 27-Apr-2021 due to BALANCE DISORDER, DIZZINESS, EYE IRRITATION, MIGRAINE, MYALGIA, OCULAR HYPERAEMIA, PERIORBITAL SWELLING, SWELLING and VISION BLURRED. At the time of the report, SWELLING (Body Swelling), EYE IRRITATION (eyes on fire), PERIORBITAL SWELLING (eyes completely puffy), MIGRAINE (extremely Migraine), VISION BLURRED (vision went blurry), DIZZINESS (Dizzy), BALANCE DISORDER (could not keep her balance), OCULAR HYPERAEMIA (eyes completely red) and MYALGIA (body ache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The treatment included Adrenaline (Epinephrine). Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

Date Died: 04/26/2021

ID: 1290766
Sex: M
Age:
State:

Vax Date:
Onset Date: 04/26/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Passed out; Abdominal pain; Trouble breathing; Sweats; Didn't feel well; Fatigue; death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (death) and LOSS OF CONSCIOUSNESS (Passed out) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Trouble breathing), HYPERHIDROSIS (Sweats), VACCINATION COMPLICATION (Didn't feel well) and FATIGUE (Fatigue). The patient died on 26-Apr-2021. The reported cause of death was Passed out. It is unknown if an autopsy was performed. At the time of death, LOSS OF CONSCIOUSNESS (Passed out), ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Trouble breathing), HYPERHIDROSIS (Sweats), VACCINATION COMPLICATION (Didn't feel well) and FATIGUE (Fatigue) outcome was unknown. No treatment information provided by the reporter and no history of concomitant medication was reported Regarding the events of loss of consciousness, malaise, abdominal pain, dyspnea, hyperhidrosis and fatigue, 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. However regarding the event of death, Very limited information regarding this event has been provided at this time. Further information has been requested; Sender's Comments: Regarding the events of loss of consciousness, malaise, abdominal pain, dyspnea, hyperhidrosis and fatigue, 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. However regarding the event of death, Very limited information regarding this event has been provided at this time. Further information has been requested; Reported Cause(s) of Death: passed out

Other Meds:

Current Illness:

ID: 1290767
Sex: F
Age: 53
State: IL

Vax Date: 04/01/2021
Onset Date: 04/04/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Forced abortion; Maternal exposure during pregnancy; Feeling unwell; Crohns flare up; Digestion issues; This spontaneous prospective pregnancy case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CROHN'S DISEASE (Crohns flare up) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease. The patient's past medical history included No adverse event (No reported medical history). On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 UNK. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On 04-Apr-2021, the patient experienced CROHN'S DISEASE (Crohns flare up) (seriousness criterion medically significant) and DYSPEPSIA (Digestion issues). On an unknown date, the patient experienced ABORTION INDUCED (Forced abortion), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and MALAISE (Feeling unwell). The delivery occurred on an unknown date. At the time of the report, CROHN'S DISEASE (Crohns flare up), DYSPEPSIA (Digestion issues), ABORTION INDUCED (Forced abortion), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and MALAISE (Feeling unwell) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The fetus was exposed to maternal use of humira in utero.Physician had given a new drug to induce labor and force abortion but she went off after five days because she did not well with it. Unspecified medication for labor and force abortion was also considered suspect. No concomitant medications were reported. No treatment information was provided. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1290768
Sex: M
Age:
State: TX

Vax Date: 03/30/2021
Onset Date: 04/27/2021
Rec V Date: 05/05/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Grand mal seizure; "extreme sluggishness; "swollen eyes, they were basically swollen shut; dark and red coloration around his eyes/his eyes were red; difficulty breathing; sore arm; fatigue; he had a high fever just by touching him, he was extremely warm to the touch.; This spontaneous case was reported by an other caregiver (subsequently medically confirmed) and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (Grand mal seizure) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included ADD. On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced SLUGGISHNESS ("extreme sluggishness), EYE SWELLING ("swollen eyes, they were basically swollen shut), OCULAR HYPERAEMIA (dark and red coloration around his eyes/his eyes were red), DYSPNOEA (difficulty breathing), PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and PYREXIA (he had a high fever just by touching him, he was extremely warm to the touch.). On 28-Apr-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (Grand mal seizure) (seriousness criteria hospitalization, medically significant and intervention required). The patient was hospitalized from 28-Apr-2021 to 28-Apr-2021 due to GENERALISED TONIC-CLONIC SEIZURE. On 28-Apr-2021, GENERALISED TONIC-CLONIC SEIZURE (Grand mal seizure) had resolved. At the time of the report, SLUGGISHNESS ("extreme sluggishness), EYE SWELLING ("swollen eyes, they were basically swollen shut), OCULAR HYPERAEMIA (dark and red coloration around his eyes/his eyes were red), DYSPNOEA (difficulty breathing), PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and PYREXIA (he had a high fever just by touching him, he was extremely warm to the touch.) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: (Inconclusive) No results were provided. On an unknown date, Chest X-ray: (Inconclusive) No results were provided. On an unknown date, Computerised tomogram: (Inconclusive) No results were provided. On an unknown date, Urine analysis normal: (Inconclusive) No results were provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. Treatment included Advil for fever, Maxipime, Keppra for seizure prevention and normal saline. Action taken with mRNA-1273 in response to the event was Not Applicable Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-098517, MODERNATX, INC.-MOD-2021-097451 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-098517:Case for dose 1 MODERNATX, INC.-MOD-2021-097451:Cross linked case

Other Meds:

Current Illness: ADD

ID: 1290769
Sex: M
Age:
State: SC

Vax Date: 04/16/2021
Onset Date: 04/17/2021
Rec V Date: 05/05/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: possible central retinal vein ablasion; left eye vision was only like 5% of his vision; severe headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RETINAL VEIN OCCLUSION (possible central retinal vein ablasion) and VISUAL IMPAIRMENT (left eye vision was only like 5% of his vision) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced HEADACHE (severe headache). On an unknown date, the patient experienced RETINAL VEIN OCCLUSION (possible central retinal vein ablasion) (seriousness criteria hospitalization and medically significant) and VISUAL IMPAIRMENT (left eye vision was only like 5% of his vision) (seriousness criterion hospitalization). At the time of the report, RETINAL VEIN OCCLUSION (possible central retinal vein ablasion) and VISUAL IMPAIRMENT (left eye vision was only like 5% of his vision) had not resolved and HEADACHE (severe headache) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Relevant concomitant medications was reported. Treatment information was not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1290770
Sex: F
Age:
State: CA

Vax Date: 03/15/2021
Onset Date: 03/15/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Blood clot; Couldn't breathe; Heart palpitations; Hives; vertigo; This spontaneous case was reported by a health care professional and describes the occurrence of THROMBOSIS (Blood clot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Medical History not reported. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion medically significant), DYSPNOEA (Couldn't breathe), PALPITATIONS (Heart palpitations), URTICARIA (Hives) and VERTIGO (vertigo). At the time of the report, THROMBOSIS (Blood clot), DYSPNOEA (Couldn't breathe), PALPITATIONS (Heart palpitations), URTICARIA (Hives) and VERTIGO (vertigo) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On 15 Mar 2021, within 1 hour of receiving first dose of the Moderna COVID-19 vaccine, the patient couldn't breathe, she had heart palpitations, hives, vertigo, and a blood clot. The patient stated that she was able to fell the blood clot. At the time of the report it was unclear if the patient had seen a physician for the events. Treatment for the event was cetirizine, and the patient stated that she has no hives when she takes cetirizine, but once she stops the cetirizine the hives return. Treatment provided with cetirizine for hives.

Other Meds:

Current Illness:

ID: 1290771
Sex: M
Age: 70
State: TN

Vax Date: 04/08/2021
Onset Date:
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: had to stop their blood pressure medications because of low blood pressure - 95/60; heart rate of 150 beats per minute/heart races as a horse/trouble keeping heart rate under 100 beats per minute with the medications; felt it a little bit pain on second and third day after the shot, but describes the pain as better than with flu vaccine; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of HYPOTENSION (had to stop their blood pressure medications because of low blood pressure - 95/60) and HEART RATE INCREASED (heart rate of 150 beats per minute/heart races as a horse/trouble keeping heart rate under 100 beats per minute with the medications) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Anxiety (severe anxiety) and Suicidal ideation. Previously administered products included for Product used for unknown indication: Flu. Past adverse reactions to the above products included Pain with Flu. Concurrent medical conditions included Smoker (decreased from 2 packs per day to about 10 cigarettes per day), Cholesterol, Diabetes and Blood pressure high. Concomitant products included LORATADINE for Allergy, LISINOPRIL and AMLODIPINE for Blood pressure high, CALCIUM for Calcium low, SIMVASTATIN and PLANTAGO OVATA (METAMUCIL CITRON) for Cholesterol, METFORMIN and GLIMEPIRIDE for Diabetes, MULTIVITAMIN IRON for Iron low, NAPROXEN SODIUM for Pain and Arthritis, VARENICLINE TARTRATE (CHANTIX) for Smoker, ACETYLSALICYLIC ACID (BABY ASPIRIN), FISH OIL, MAGNESIUM, MULTIVITAMIN [VITAMINS NOS], UBIDECARENONE, VITAMIN E NOS (COQ10 COMPLEX) and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOTENSION (had to stop their blood pressure medications because of low blood pressure - 95/60) (seriousness criterion medically significant), HEART RATE INCREASED (heart rate of 150 beats per minute/heart races as a horse/trouble keeping heart rate under 100 beats per minute with the medications) (seriousness criterion medically significant) and VACCINATION SITE PAIN (felt it a little bit pain on second and third day after the shot, but describes the pain as better than with flu vaccine). At the time of the report, HYPOTENSION (had to stop their blood pressure medications because of low blood pressure - 95/60), HEART RATE INCREASED (heart rate of 150 beats per minute/heart races as a horse/trouble keeping heart rate under 100 beats per minute with the medications) and VACCINATION SITE PAIN (felt it a little bit pain on second and third day after the shot, but describes the pain as better than with flu vaccine) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 95/60 (Low) 95/60 (low). On an unknown date, Heart rate: 150 (High) 150 beats per minute. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient received treatment with carvedilol at the dose of 3.125 milligrams increased in couple of weeks to carvedilol at a dose of 6.25 milligrams. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: LISINOPRIL; AMLODIPINE; SIMVASTATIN; METFORMIN; GLIMEPIRIDE; BABY ASPIRIN; FISH OIL; CALCIUM; MAGNESIUM; NAPROXEN SODIUM; MULTIVITAMIN IRON; MULTIVITAMIN [VITAMINS NOS]; COQ10 COMPLEX; LORATADINE; METAMUCIL CITRON; CHANTIX; ZOLOFT

Current Illness: Blood pressure high; Cholesterol; Diabetes; Smoker (decreased from 2 packs per day to about 10 cigarettes per day)

ID: 1290772
Sex: F
Age: 93
State: MI

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 05/05/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Pacemaker Surgery; patient did end up missing the date of her second vaccination and has not received it; feel itchy; feeling very funny and real strange; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of CARDIAC PACEMAKER INSERTION (Pacemaker Surgery) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included RIVAROXABAN (XARELTO), VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PRURITUS (feel itchy) and FEELING ABNORMAL (feeling very funny and real strange). On an unknown date, the patient experienced CARDIAC PACEMAKER INSERTION (Pacemaker Surgery) (seriousness criterion hospitalization) and INCOMPLETE COURSE OF VACCINATION (patient did end up missing the date of her second vaccination and has not received it). At the time of the report, CARDIAC PACEMAKER INSERTION (Pacemaker Surgery), PRURITUS (feel itchy) and FEELING ABNORMAL (feeling very funny and real strange) outcome was unknown and INCOMPLETE COURSE OF VACCINATION (patient did end up missing the date of her second vaccination and has not received it) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Electrocardiogram: normal (normal) heart was operating properly. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient was taking unspecified blood pressure medication concomitantly. Following the administration while the patient was in the clinic, she began to feel itchy, very funny and real strange. At this time the EMS on site were concerned and preformed an electrocardiogram (EKG) on the patient to make sure that the heart was operating properly. It was deemed that it was and the patient was then sent home. After that time no other side effects were present but the patient did eventually have to go into the hospital for a Pacemaker Surgery that was believed to be unrelated. The date of this surgery could not be remembered at the time of the call. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: XARELTO; VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS

Current Illness:

ID: 1290773
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/05/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Bleeding; IBD; Diarrhoea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 22-Apr-2021. Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMORRHAGE (Bleeding), INFLAMMATORY BOWEL DISEASE (IBD) and DIARRHOEA (Diarrhoea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Autoimmune disorder. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (Bleeding) (seriousness criterion hospitalization), INFLAMMATORY BOWEL DISEASE (IBD) (seriousness criterion hospitalization) and DIARRHOEA (Diarrhoea) (seriousness criterion hospitalization). At the time of the report, HAEMORRHAGE (Bleeding), INFLAMMATORY BOWEL DISEASE (IBD) and DIARRHOEA (Diarrhoea) outcome was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported.No treatment information provided. The patient received both scheduled doses of mRNA-1273 prior to the event(s), therefore action taken with the drug in response to the event(s) is not applicable Based on current available information and the temporal association between product use and start date of the events a causal relationship cannot be excluded.Based on current available information and the temporal association between product use and start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and start date of the events a causal relationship cannot be excluded.

Other Meds:

Current Illness: Autoimmune disorder

ID: 1290783
Sex: F
Age:
State: NH

Vax Date: 01/26/2021
Onset Date: 01/27/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: headache; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received BNT162B2 first dose (Pfizer-Biontech Covid19 vaccine, Batch/Lot no: EL3247) via an unspecified route of administration and administrated in left arm on 26Jan2021 at 9:30 as single dose for COVID-19 immunization at workplace clinic facility. The patient medical history included high blood pressure. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), venlafaxine hydrochloride (EFFEXOR), mirabegron (MYRBETRIC) and amlodipine besilate (NORVASC). Patient not had covid prior vaccination. On 27Jan2021 at 12:00, patient experienced headache. Patient not tested for covid post vaccination. Patient not received treatment for the event. At the time of this report event outcome was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: ADDERALL; EFFEXOR; MYRBETRIC; NORVASC

Current Illness:

ID: 1290784
Sex: F
Age:
State:

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: arm soreness; This is a spontaneous report from a contactable Other HCP (Patient) via Medical information team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown) via an unspecified route of administration on Jan2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took 1 mg of Prednisone up until 6 months ago because she had an anaphylaxis reaction to a vitamin drip. On unspecified date in Jan2021 (about 2 days after vaccination), the patient doesn't have any side effects except arm soreness. She got nervous the morning before getting her vaccine of a reaction and took a very small amount of prednisone before getting the vaccine. Her second dose was scheduled for 25 days. The seriousness of the event was reported as non-serious. The outcome of the event was unknown. Information about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1290785
Sex: M
Age:
State: FL

Vax Date: 01/14/2021
Onset Date: 01/16/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: No energy; no appetite; hot & cold; body aches; Very hoarse; coughing; This is a spontaneous report from a contactable consumer. A 77-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 14Jan2021 at 12:45 as single dose for COVID-19 immunization. Medical history was not reported. Patient had no known allergies. Concomitant medications included ezetimibe, tamsulosin, amlodipine, sumatriptan, finasteride and tadalafil. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Jan2021 at 01:00 PM, patient experienced no energy, no appetite, hot & cold, body aches. very hoarse, coughing-No fever. On 25Jan2021, the patient was tested negative for COVID-19 via nasal swab. No treatment was received for the adverse events. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Other Meds: EZETIMIBE; TAMSULOSIN; AMLODIPINE; SUMATRIPTAN; FINASTERIDE; TADALAFIL

Current Illness:

ID: 1290786
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: been 5 days and still having tiredness headaches joint pain nausea and feeling annoyed; been 5 days and still having tiredness headaches joint pain nausea and feeling annoyed; been 5 days and still having tiredness headaches joint pain nausea and feeling annoyed; been 5 days and still having tiredness headaches joint pain nausea and feeling annoyed; been 5 days and still having tiredness headaches joint pain nausea and feeling annoyed; This is a spontaneous report from a contactable consumer (patient). A 89-year-old female patient received unspecified dose number of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection) via an unspecified route of administration on an unknown date (at the age of 89-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that she received the vaccine last Friday and it had been 5 days and still having tiredness headaches joint pain nausea and feeling annoyed. The outcome of the events were not recovered. Information on Lot/Batch has been requested. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1290787
Sex: F
Age:
State: CA

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: feeling very, very dizzy/dizziness; diarrhea; This is a spontaneous report received from a contactable consumer. A 80-year-old female consumer (patient) received first dose of bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE, solution for injection), (Batch/lot number: EL3249) on 20Jan2021 at single dose for COVID-19 immunisation. The medical history of the patient included genito arthritis and asthma. The concomitant medication was not provided. On 20-JAN-2021 patient was feeling very, very dizzy and diarrhea. Patient was concerned about diarrhea as she got a shot 20Jan2021 and on 27Jan2021 she was still experiencing diarrhea. The patient took the vaccine on last Wednesday and had side effects or dizziness and 2 days later I started with diarrhea which is going on now. Patient did not received any treatment. Patient had some blood work done. The outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 704,237

Page last modified: 26 October 2021 2:21am