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: 1774590
Sex: F
Age:
State: SC

Vax Date: 04/17/2021
Onset Date: 04/17/2021
Rec V Date: 10/09/2021
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: Temperature of 99.9; Body aches; Frequent headaches; Nauseated; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, formulation: solution for injection, Lot Number: EW0151) via unknown route of administration in left arm on 17Apr2021 at 11:24 (at the age of 21 years old) as DOSE 2, SINGLE for covid-19 immunisation. Vaccine Administered At Military Facility: No, But There Were Military People And Police There. People Administering Covid Shots Were Regular Nurses. The patient medical history included severe depression with psychosis, Diagnosed a little bit over a year. Has always been a struggle since she was a child, but never knew what it was. Since taking the medications she had been feeling better and was more productive. The patient family medical history included diabetes, either high or low blood pressure and cervical cancer. Concomitant medication included hydroxyzine 25 mg thrice daily (lot number: ED6351089 and expiry date: 10Nov2021) via orally for anxiety, depression and psychosis, had been taking for a little over a year. Dose would increase to either 50mg or 100mg and quetiapine 25 mg tablet daily (two tablets for bedtime) for psychosis and sleep, doctor would up her dose to either 50mg or 100mg, had been taking a little over a year. Historical vaccine included first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, formulation: solution for injection, Lot Number: ER8727) via unknown route of administration in left arm on 27Mar2021 as DOSE 1, SINGLE for covid-19 immunization and had no reaction from the first COVID shot. The patient did not receive any other vaccine prior vaccination within 4 Weeks. On 17Apr2021, the patient had body aches, has been nauseated, and had frequent migraines. Had not actually thrown up or anything like that. Apparently she had a fever, but didn't know it. Had her temperature checked for work and it was 99.9. Her job sent her home. Had no reaction from the first COVID shot. Body aches began between 17:00-18:00. Had some last night and just thought she would try to get rest. Woke up with a headache and body pain. Was a little bit nauseated last night. Would stop for a minute and come right back on. Felt like a soreness after a workout. It was clarified she would instead classify it as headaches and not migraines, had been constant since 17Apr2021, had been turning down the TV volume and staying in quiet environments. Comes and goes, but never lasts long. had not thrown up and was not nauseated this morning. At 08:46, temperature was taken at her work and she was told it was too high and considered risky to go to work. She was sent home. On 08May2021, written on her card, she was not sure what that means or if she had to come back for another shot. The outcome of the event Frequent headaches was not recovered and other events was unknown. No follow-up attempts were needed. No further information was expected.

Other Meds: HYDROXYZINE; QUETIAPINE

Current Illness:

ID: 1774591
Sex: U
Age:
State: OH

Vax Date: 03/30/2021
Onset Date:
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Date: 202101; Test Name: Covid-19 positive; Result Unstructured Data: Test Result:positive

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: This is a spontaneous report from a contactable consumer or other non health- care professional. A 93-year-old patient of an unspecified gender received BNT162B2 (BNT162B2 Formulation: Solution for injection Batch/Lot Number: ER8732; Expiration Date: 31Jul2021) via an unspecified route of administration, administered in Left Arm on 30Mar2021 (at 92-year-old age) as dose 1, single for covid-19 immunization. Patients Medical history included Atrial fibrillation, Thyroid, anxiety, COVID-19 from Jan2021 to an unknown date. Concomitant medication(s) included apixaban (ELIQUIS) taken for atrial fibrillation, levothyroxine sodium taken for hypothyroidism, lorazepam taken for anxiety, start and stop date were not reported. The patient experienced chills, fever, nausea on an unspecified date. Patient stated he/she was afraid and worried about getting the second shot because patient was on blood thinner Eliquis, Patient asks is that going to make any difference? can patient get the second vaccine? The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on Jan2021. Outcome of events was unknown. No follow-up attempts needed or possible. No further information expected.

Other Meds: Eliquis; LEVOTHYROXINE SODIUM; LORAZEPAM

Current Illness:

ID: 1774592
Sex: F
Age:
State: NJ

Vax Date: 04/17/2021
Onset Date: 04/17/2021
Rec V Date: 10/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Itching; Skin burning sensation; red welts; About 3-4 hours afterward her 1st COVID-19 Vaccine, she had a rash start on the back of her left leg that then spread allover her body on 18Apr2021; bad back; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 49-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0153, Expiry date was not reported) via an unspecified route of administration, administered in Arm Right on 17Apr2021 16:00 (at the age of 49-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication(s) included prednisone (PREDNISONE) (60mg tablet per day) taken for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination. The reporter reported that she had her first dose of the Pfizer COVID-19 Vaccine on Saturday, 17Apr2021. She said about 3-4 hours afterwards, she had a rash start on the back of her (left) leg. She said at the time, she didn't think anything of the rash because she had received her COVID-19 Vaccine in her in right arm. She said the rash was on the back of her left leg, behind her left knee. She said by the next day (Sunday, 18Apr2021), the rash had spread all over her body. She said the rash was itching and burning with red welts. She said she went to immediate Care (an urgent care) yesterday (18Apr2021), when the rash started to spread up to her neck. She said she was concerned when the rash started to spread to her neck because she was told if she had a reaction to the COVID-19 Vaccine, the reaction could close off her breathing. As a treatment patient has received steroid injection at the urgent care, and told to start Benadryl, and to take the Benadryl 25mg tablet, every 4-5 hours. She said she was also given a steroid prescription to take for the next 5 days. The outcome for the events Rash starts on the back of her left leg that then spread all over her body, itching, skin burning sensation, red welts was not recovered. And for the event bad back was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: PREDNISONE

Current Illness:

ID: 1774593
Sex: F
Age:
State: CA

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Date: 20210415; Test Name: Blood urine; Result Unstructured Data: Test Result:Would go to urinate and she had light blood; Comments: By the night after the 2nd dose she started having light blood and it's the same color

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: was confused and tired; was confused and tired; it feels weird in her abdomen; lot of pain; would go to urinate and she had light blood; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 63-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 15Apr2021 at 14:00 pm (age of vaccination was 62 years) as dose 2, single for COVID-19 immunization. The patient's medical history included asthma that was fine, inflammation and cysts (it was reported that they had took out her uterine, it was removed for cysts and it was so many years ago, 5 years and now she didn't bleed). Concomitant medications included vitamin C [ascorbic acid], vitamin D NOS and zinc all taken for an unspecified indication. The patient took an inhaler for asthma sometimes if she had one, she took 5 mg for inflammation and asked what was inside the tube of the inhaler. She didn't have anything else. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8730, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 25Mar2021 at 14:00 pm (age of vaccination was 62 years) as dose 1, single for COVID-19 immunization and experienced lot of pain, hot flashes and it was so like burning. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient provided that with the 2nd one it was the same thing continued but more intense. She stated that she did not have a fever. On 15Apr2021, Thursday, the patient would go to urinate and she had light blood and it freaked her out, that was the 2nd day after and she thought ok 2nd day. The patient clarified that by the night after the 2nd dose she started having light blood and it was the same color and she thought it was going to go away and it didn't worry her and she didn't know what to think. On an unspecified date, the patient was very tired and very confused, airy head like go out of herself at work and just didn't want to move and she was still very tired and was feeling a lot of pain. The patient was confused and tired and woke up fine in the afternoon and had very light blood and she thought it was from taking a lot of vitamins, she always took Vitamin C, Vitamin D, and Zinc and it was not a big deal. She stated that it then continued and it felt weird in her abdomen. The patient was scared and she didn't know what to do. She wanted to know if that was a side effect.The adverse did not require a visit to Emergency Room or Physician Office. No relevant tests were done. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

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

Current Illness:

ID: 1774594
Sex: F
Age:
State: MO

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: face got swollen and got red; face got swollen and got red; I got wet nose right there swelling a little bit same time; I got wet nose right there swelling a little bit; This is a spontaneous report from a contactable consumer (patient reported for herself). A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8727 and Expiration date was unknown) via an unspecified route of administration, on 18Mar2021 (at the age of 53-years-old) as dose 1, single for COVID-19 immunization. The patient medical history included cardiovascular disease, anxiety, depression. Patient had open heart surgery, a double bypass when she was 44 and she was only 53 now though. The patient concomitant medications included acetylsalicylic acid (ASPIRIN ANALGESIC); atorvastatin; midodrine; metoprolol; clopidogrel; ronalazine; duloxetine taken for anxiety depression; meclozine hydrochloride (MECLIZINE HCL); hydrocortisone; glyceryl trinitrate (NITROGLYCERIN); zinc sulfate (ZINC SULPHATE); gabapentin; vitamin d nos; paracetamol (ACETAMINOPHEN) additional Information for acetaminophen: 1000mg each time and alprazolam (XANAX). On 18Mar2021, patient stated at the first she got the reaction, but they were gone after 30 minutes her air way did not get stopped but her face got swollen and got red and she thought she got wet nose right there swelling a little bit same time. Patient stated that was the first time she got a vaccine on March 18th and experienced face swollen but she was fine after that. When probed for the concern, Patient stated, "she may have call it one symptom she guessed adverse and adverse reaction to her second dosage of vaccine, and she need somebody about it. Patient had her first dosage on 18Mar2021 and had her second dosage on 08Apr2021 that April 8th on Tuesday really did not have reaction, did not get any nauseous, headache but her right was feeling like sinusy whatever but she do not have any sinus issues and then she was feeling little nauseas and then her right hand for some reason she got bruise on the top of her hand and then that bruise moved to left part of upper hand and gotten a big knot there and now it was black and blue and it was also like ball and her husband and she thought that could be a blood clot. she probably got headache and had a headache every single day with sickness and felt like little vomit and not having a very good appetite not at all. Patient stated she got the second reaction, it was 5 days later, it was 13Apr2021." Patient stated that she had Xanax if she was having the anxiety attack and that was alprazolam, 0.5 mg tablet. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: ASPIRIN ANALGESIC; ATORVASTATIN; MIDODRINE; METOPROLOL; CLOPIDOGREL; RANOLAZINE; DULOXETINE; MECLIZINE HCL; HYDROCORTISONE; NITROGLYCERIN; ZINC SULPHATE; GABAPENTIN; VITAMIN D NOS; XANAX; ACETAMINOPHEN

Current Illness:

ID: 1774595
Sex: F
Age:
State: CO

Vax Date: 04/18/2021
Onset Date: 04/18/2021
Rec V Date: 10/09/2021
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: tingling in face and arms; joint pain; constantly throwing up; anxiety; stomach pain; something for IBS; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and expiration date: Not reported), via an unspecified route of administration, on 18Apr2021 (at the age of 37-year-old) (at 15:00), in Arm Right, as dose 1, single for COVID-19 immunization. Medical history included, diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) obesity, ongoing chronic nausea. Concomitant medication(s) included ondansetron taken for chronic nausea, start and stop date were not reported. The patient previously took promethazine (PHENERGAN) for allergy. The patient went to the hospital last night because got so sick an hour after getting the vaccine. Reporter stated that the patient was experiencing tingling in her face and arms, severe joint pain and was constantly throwing up. The patient cannot keep anything down. The reporter took patient to the emergency room. In emergency room the patient was given with rehydration in IV fluids, something for IBS and to calm stomach pain that caller doesn't remember, as well as Zofran, Benadryl and Ativan because patient's anxiety shot through the roof. Patient's labs all came back normal so the emergency room decided to send her home, which the reporter was not very happy about, but he could not do anything about. The reporter stated that these symptoms were all ongoing and consistent. He confirmed the anxiety has not gotten any better. The reporter reported that patient had chronic nausea but it did not usually come on like this did, usually Zofran stops the nausea but it had not worked so far. Patient went to emergency room as a result of AE. Treatment was taken with rehydration in IV fluids, something for IBS, Zofran, Benadryl and Ativan. The clinical outcome of events anxiety, abdominal pain, nausea were unknown while remaining events were not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: ONDANSETRON

Current Illness: Nausea (Patient has chronic nausea)

ID: 1774596
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/09/2021
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: Full body rash; head hurts; fast heart rate; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient experienced full body rash, head hurts, fast heart rate on an unspecified date. 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: 1774597
Sex: F
Age:
State: MD

Vax Date: 01/08/2021
Onset Date: 01/13/2021
Rec V Date: 10/09/2021
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: chills; Muscle ache; supraclavicular lymphadenopaty/lymph node swell; This is a spontaneous report from a contactable other hcp. A 32-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL3246; Expiration Date: Apr2021), dose 1 intramuscular, administered in Arm Left on 08Jan2021 as SINGLE DOSE and dose 2 intramuscular, administered in Arm Left on 29Jan2021 (Batch/Lot Number: EN5318) as DOSE 2 SINGLE for covid-19 immunisation. Medical history included back pain from an unknown date and unknown if ongoing. The patient's concomitant medications were Drospirenone and ethinyl estradiol (Birth control pills). Patient did not receive other vaccine in four 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. Treatment was not received for the adverse events.The patient experienced supraclavicular lymphadenopathy on 13Jan2021, chills 02Feb2021, muscle ache on 02Feb2021. The outcome of the event supraclavicular lymphadenopathy was recovering, chills and muscle ache was recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1774598
Sex: U
Age:
State:

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 10/09/2021
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: Abdominal pain, Chills, Sleep disorder

Symptoms: 2 hours later I developed a rash on the inside of my left elbow that itched for a few days.; 2 hours later I developed a rash on the inside of my left elbow that itched for a few days.; This is a spontaneous report from a contactable consumer or other non-HCP (patient) via Pfizer sales representative. A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 01Apr2021 as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On 01Apr2021 patient took first shot in left arm. Approximately 2 hours later patient developed a rash on the inside of left elbow that itched for a few days. Event took place after use of product. 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: 1774599
Sex: U
Age:
State:

Vax Date: 04/17/2021
Onset Date: 04/19/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Date: 20210419; Test Name: Body temperature; Result Unstructured Data: Test Result:99.6

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: body aches; frequent headache; I felt nauseous; temperature was 99.6; This is a spontaneous report from a contactable consumer (patient) via from Pfizer sponsored. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on 17Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received her second shot on the 17th and had some body aches. The patient underwent lab tests and procedures which included body temperature increased: 99.6 on an unspecified date. The patient had a frequent headache and when the patient went to work today (19Apr2021) and had temperature was 99.6 so the patient could not go and felt nauseous. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1774600
Sex: F
Age:
State: MD

Vax Date: 04/19/2021
Onset Date: 04/19/2021
Rec V Date: 10/09/2021
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: my tongue feels weird/tingling above my lip; bumps all over the back of my tongue; throat swell a bit; hard to swallow; tremendous pain in my gums, like I was biting down on nails; This is a spontaneous report from a contactable consumer. A 41-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number er8735 & Expiry date not reported) via an unspecified route of administration, administered in Left arm on 19Apr2021 at 12:45 (at age of 41-years-old) as dose 2,single for COVID-19 immunisation .Patient medical history include allergic to all nuts except peanuts, seasonal allergy, allergic to bees, Oral allergy to many fruits and vegetable. Concomitant medication(s) includes epinephrine (EPIPEN) taken for an unspecified indication, start and stop date were not reported; levocetirizine dihydrochloride (XYZAL) taken for an allergy nose spray, start and stop date were not reported. Patient previously took sulfites and experienced allergic to sulfites (lip swell).Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number er8733, & Expiry date not reported) via an unspecified route of administration in left arm on Mar2021 at 12:45 as single dose for COVID-19 immunisation.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 19Apr2021 at 13:00 (15 mins after vaccination) Patient experienced events. It was reported that at the 15-minute mark my husband and I left the clinic. As we left, I remarked to him, my tongue feels weird. When I got in the car, I removed my mask and saw bumps all over the back of my tongue. A few minutes after that I felt my throat swell a bit.I am allergic to all nuts (except peanuts) and have felt my throat swell before.If I had not had this allergic reaction in the past, I would have been very scared. But I carry an EpiPen and felt that if things got worse, I'd use the EpiPen. Since this was not as severe so we did not return to the clinic.Shortly after that it was hard to swallow. I drank about 12 oz of water to help my system process everything.Within an hour these symptoms subsided.About an hour after that I felt tingling above my lip.Shortly after that I felt tremendous pain in my gums, like I was biting down on nails.(I am also allergic to sulfites and have oral food allergic reactions to most raw fruits and some vegetables.) Patient did not receive any treatment for the events. The Outcome of the events was recovered on unspecified day in Apr2021. No follow-up attempts are needed. No further information is expected.

Other Meds: EPIPEN; XYZAL

Current Illness:

ID: 1774601
Sex: F
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: This is a spontaneous report from a contactable consumer. This female consumer reported a female patient, of an unspecified age, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown, expiry date: unknown), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history not reported. There were no concomitant medications. The patient experienced dizziness, extremely weak, sore arm and chills on an unspecified date. Caller stated that the second Pfizer COVID-19 shot was due on Tuesday. With the first shot within some minutes of getting it, caller felt a little dizzy. It passed quickly. Then, 4-5 hours later experienced extreme dizziness, caller family walked her to the bed. Caller got to the bed in time was extremely weak and dizzy. The dizziness was still there the next morning, and was mildly dizzy a couple of days later. Caller also had the common side effects like pain in her arm and chills, but consumer expected that. The dizziness was listed as more of a less common side effect. It was not one of the common ones or an allergic issue. It was not a common side effect. Caller was not sure if she would get the second shot. The initial dizziness was immediately within minutes following the injection. So this worried her for the second. The outcome of events: unknown. No follow-up attempts possible. Information on lot/batch cannot be obtained.

Other Meds:

Current Illness:

ID: 1774602
Sex: F
Age:
State: NY

Vax Date: 04/09/2021
Onset Date: 04/10/2021
Rec V Date: 10/09/2021
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: tongue and throat feels puffy; extreme vertigo; Depleted energy; blurred vision; confusion; disoriented; sinuses feel inflamed; tongue and throat feels puffy; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 44-year-old-female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: ep7533, expiry date: unknown, Age at vaccination: 44-year-old) via an unspecified route of administration in arm left on 09Apr2021 05:00 PM as dose 2, single for COVID-19 immunisation. Medical history was not reported. Concomitant medications included MECLIZINE HCL, PREDNISONE. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: en6206, expiry date: unknown) via an unspecified route of administration in arm left on 12Mar2021 08:45 AM as dose 1, single for COVID-19 immunisation. On 10Apr2021 23:00, patient experienced tongue and throat feels puffy (throat swelling and swelling of tongue), extreme vertigo, Depleted energy, blurred vision, confusion, disoriented sinuses feel inflamed. Patient has been to the ER three times with in one week. Facility where the most recent COVID-19 vaccine was administered was pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse event result in doctor or other healthcare professional office/clinic visit. Adverse event result in emergency room/department or urgent care. Treatment received for the adverse event as Meclizine and prednisone. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Allergies to medications, food, or other products none. The outcome of events was recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds: MECLIZINE HCL; PREDNISONE

Current Illness:

ID: 1774603
Sex: M
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 10/09/2021
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: This is a spontaneous report from a contactable consumer or other non-HCP. A 21-year-old male patient received BNT162B2 (Comirnaty, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced rashes and welts on an unspecified date; with outcome of unknown. No follow-up attempts needed. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774604
Sex: F
Age:
State:

Vax Date: 04/19/2021
Onset Date: 04/19/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer or other non-HCP reporting for herself (patient). A 34-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiration date: unknown), via an unspecified route of administration, on Apr 19, 2021, at 10:50, single dose, for COVID-19 immunization. Patient's medical history included migraine headache. Concomitant medications not reported. Approximately 11 hours later on Apr 19, 2021, patient had a raised non-itchy rash on her upper back above her bra line about the size of an adult hand. The patient also had a headache and took Motrin around 5 pm as treatment. The rash began to resolve around 2 am on Apr 20, 2021. The outcome of event recovered on Apr 20, 2021. No follow-up attempts needed. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774605
Sex: F
Age:
State: GA

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 10/09/2021
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 Name: Covid 19; Result Unstructured Data: Test Result:negative; Comments: negative for Covid and strep throat

Allergies:

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

Symptoms: throat infection; sore throat; swelling in her eyes; fever; This is a spontaneous report from a contactable consumer (patient's mother) via Medical Information Team. A 19-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 01Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She said that her daughter had a fever and a little bit of a throat infection and was prescribed to take antibiotics, it's her 3rd day of taking it. Last week she was prescribed antibiotics for a sore throat and swelling in her eyes. She reported she was negative for Covid and strep throat. She stated her 19 y/o daughter was due to receive her second Pfizer Covid vaccine dose tomorrow 23Apr2021. She was asking if she should continue getting the 2nd dose today or should they wait a week or 2. She wanted to know if she can safely take the second dose of the vaccine while on antibiotics. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative. Therapeutic measures were taken as a result of all the events and included treatment with antibiotics. 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: 1774606
Sex: F
Age:
State: PA

Vax Date: 04/17/2021
Onset Date: 04/19/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Clarified that she is currently experiencing allergies.; This is a spontaneous report from a Pfizer Sponsored Program COVAX US Support a contactable consumer (Patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 17Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Clinical course reported as caller has taken the 1st dose on 17Apr and wants to know if she is cleared to take allergy pills. On 19Apr2021, Clarified that she is currently experiencing allergies. The outcome for the event was not recovered. No follow-up attempts are possible; Information related to batch/Lot number could not be requested.

Other Meds:

Current Illness:

ID: 1774607
Sex: F
Age:
State: TN

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Bad headache; low grade fever; bed rest for 24 hours; This is a spontaneous report from a contactable consumer reported for herself. A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL9241; Expiration date was not reported), via intramuscular on 11Feb2021 11:30 (at the age of 77-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history, concomitant medications, prior vaccination within 4 weeks included none. Historical vaccines included first dose of BNT162B2 (Lot number: EL0142) via intramuscular rout on 21Jan2021 11:30 as DOSE 1, SINGLE for covid-19 immunisation and had no problem, went well. The patient experienced bad headache, low grade fever, bed rest for 24 hours on 11Feb2021 23:30. Onset time stated as 12 hrs later. After second injection, patient was ok for first 12 hours. Then had bad headache, low grade Fever, bed rest for 24hours. Next day, felt fine. The events did not require the initiation of new medication/other treatment/procedure. Had no problems. Relevant tests included none. The events were not serious. Clinical outcome of events was recovered on 12Feb2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1774608
Sex: F
Age:
State: CA

Vax Date: 04/19/2021
Onset Date: 04/20/2021
Rec V Date: 10/09/2021
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: cough; fever; I got a tickle in my throat; This is a spontaneous report from a contactable consumer (patient). A 21-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 2 via an unspecified route of administration on 19Apr2021 as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On Tuesday, 20Apr2021, she got a tickle in her throat, and on Wednesday, 21Apr2021, cough started along with fever. The fever went away but cough was not going away. She woke up and she voice was a little worse today. She don't feel completely sick, feel like body is fighting it. She don't feel like dying or anything. Outcome of the event was unknown. Overall Safety Summary section and per attached documents and VR noting cough is not listed as a common side in our trials and listed as a possible symptom of Covid 19. Referred to HCP for further discussion/guidance, based on medical history; unfortunately, we are unable to make specific recommendations. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774609
Sex: F
Age:
State: CO

Vax Date: 03/04/2021
Onset Date:
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Diarrhea, feeling stomach sick like i was going to vomit; Diarrhea, feeling stomach sick like i was going to vomit; very tired; usual sore arm at the site; This is a spontaneous report from a contactable consumer (patient herself). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6200), via intramuscular route on 04Mar2021 09:15 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6200), via intramuscular route on 11Feb2021 09:30 as DOSE 1, SINGLE for covid-19 immunisation. On an unknown date, the patient experienced diarrhea, feeling stomach sick like she was going to vomit, very tired and usual sore arm at the site. The patient took 1 ammodium went to bed morning till noon started to feel better and was very tired for 3-4 days. Nothing but the usual sore arm at the site that night and next one then nothing. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1774610
Sex: F
Age:
State:

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Rash that break out over her body; Itching; This is a spontaneous report from a contactable consumer or other non HCP. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection in pre-filled syringe, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2 SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection in pre-filled syringe, Batch/Lot number was not reported), dose 1, via an unspecified route of administration on an unspecified date as DOSE 1 SINGLE for covid-19 immunization. On an unknown date, reporter mentioned that she got yesterday the second dose of the Pfizer covid vaccine and at night after dinner she got some rash that break out over her body and gave her itching. She would like to know if this was an adverse event of the vaccine and what could she do about it. She mentioned that she took an allergy pill. Therapeutic measures were taken as a result of rash that break out over her body, itching. The outcome of all events was unknown. No follow-up attempts are needed: information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774611
Sex: F
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 10/09/2021
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: Fatigue; Body aches; Chills; Fever; Headache; This is a spontaneous report from a contactable consumer. A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, (Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, (Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. On an unspecified date, patient experienced fatigue, body aches, chills, fever, and headache and Symptoms improving after 48 hours. Outcome of the events was recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774612
Sex: F
Age:
State: TX

Vax Date: 04/22/2021
Onset Date: 04/22/2021
Rec V Date: 10/09/2021
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: Acute diarrhea that came on suddenly about 5 hours after the vaccine was administered; This is a spontaneous report from a contactable consumer (patient). A 68-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: ER8736; Expiration date was not reported), first dose via an unspecified route of administration, administered in arm left on 22Apr2021 10:30 (at the age of 68-years-old) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. Patient was not pregnant at the time of vaccination. Medical history included hyperthyroidism from an unknown date and unknown if ongoing. Concomitant medications or other medications in two weeks included methimazole (METHIMAZOLE) taken for an unspecified indication, start and stop date were not reported. The patient previously took norco and experienced drug allergy (known allergies). No other vaccine in four weeks. No covid prior vaccination. Covid was not tested post vaccination. The patient experienced acute diarrhea that came on suddenly about 5 hours after the vaccine was administered on 22Apr2021 12:00. Therapeutic measures were taken as a result of the event or treatment was received for AE (details unspecified). AE resulted in none of the above (details unspecified). If patient recovered stated as not recovering. Clinical outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: METHIMAZOLE

Current Illness:

ID: 1774613
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/09/2021
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: neck getting inflamed; he has a little ball on top of her collar bone; This is a spontaneous report from a contactable consumer or other non hcp (patients caregiver). A 49-years-old female patient (reporters mother) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date 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 neck getting inflamed and has a little ball on top of her collar bone. The reporter reported on the behalf of her Mother (Patient). The patient received the first dose of the Pfizer-BioNTech COVID-19 Vaccine, and her neck getting inflamed, she had a little ball on top of her collar bone. The reporter asked what to do about that side effect. The outcome of all the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774614
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: she developed hives on her right arm, but received shot in theleft arm.Now she has some on her arms and face.; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 30-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot was not reported), via an unspecified route of administration, administered in left arm, on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot was not reported), via an unspecified route of administration, administered anatomical location not reported, on an unspecified date as dose 1, single for COVID-19 immunization. The patient stated she received second dose about an hour and ten minutes ago, about twenty minutes ago she developed hives on her right arm (on unspecified date). The patient stated but she received the dose in the left arm. The patient stated now she has some on her arms and face (on unspecified date). The patient stated she had no reaction with the first dose. The patient asked is this a side effect of the vaccine. The patient asked can she take a BENDADRYL. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1774615
Sex: F
Age:
State: MI

Vax Date: 04/13/2021
Onset Date: 04/13/2021
Rec V Date: 10/09/2021
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: And got a large bruise (at the COVID-19 Vaccine injection site); This is a spontaneous report from a contactable nurse. An 80-years-old female patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Strength: unknown, Batch/Lot Number: ELV0158), dose 1 in the left arm on 13Apr 2021 as Dose 1 SINGLE for covid-19 immunization (Age at vaccination was 80-year-old). The patient medical included she had COPD, Sinusitis, Bronchial infection and Doxycycline. The patient said she was a bad smoker. The patient reported that she got her first Shingles Vaccine in 2017. XARELTO was reported as concomitant medication. The patient reported that a couple years ago her Xarelto dose was upped from 15mg to 20mg. The patient had not visited emergency room or physician office due to the event and patient had not received any other vaccinations within 4 weeks. On 13-APR-2021 the patient got a large bruise (at the COVID-19 Vaccine injection site). She had her first COVID-19 shot on Tuesday (13Apr2021) and got a large bruise at the COVID-19 Vaccine injection site. She said she never had a bruise from a vaccination before. She said the bruise was over 2" in diameter, and there was no redness, or swelling. She said the bruising didn't hurt, and she did not even have to take Tylenol. She said her left arm did not hurt. She said the COVID-19 Vaccine injection site bruising was dissipating now. She said she just had a large bruise on her left arm. The outcome of the event was recovering. No follow up attempts are possible. No further information is expected.

Other Meds: XARELTO

Current Illness:

ID: 1774616
Sex: F
Age:
State: VA

Vax Date: 04/16/2021
Onset Date: 04/01/2021
Rec V Date: 10/09/2021
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: Chills; Pain in arm; arm felt hard; Headache; arm swollen; redness in arm; not feeling like getting out of bed; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Left on 16Apr2021 (Batch/Lot Number: EW0153) as dose 1, single for covid-19 immunization (at the age of 63-years-old). Medical history included medication allergy, back spasms, cramps in legs, 3 surgeries on left hand because of carpal tunnel (one on right because of carpal tunnel), had a dislocated shoulder, pain, blood cholesterol, blood iron, blood pressure, stool hard (using stool softener), hypersensitivity, heart diseases and sleep problem from an unknown date and unknown if ongoing and patient had family history of stroke, diabetic (lost sister in 2009, was diabetic and had like 4 or 5 strokes within a 10 year period) and heart attack (mama and daddy both died from heart attack) and bypass surgery (mother died in 2010 from heart attack and had had bypass surgery). The patient previously took Enapril for blood pressure and experienced swelling face and breaking out. She stated that she was breaking out and her face was swollen, went straight to the clinic and they then changed her blood pressure medication and she believes the name of the medication was Enalapril. She also stated that she Can't take Percocet because it breaks her out and she feels like a bug was crawling on her. Concomitant medication(s) included ibuprofen taken for back spasms and cramps in legs; gabapentin taken for pain; metoprolol taken for an unspecified indication; pravastatin taken for blood cholesterol; ascorbic acid, cobalt sulfate, copper sulfate, ergocalciferol, ferrous fumarate, magnesium sulfate, manganese sulfate, nicotinamide, potassium iodide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol, vitamin b12 nos, zinc gluconate (MULTIVITAMIN (16)) taken for an unspecified indication; ferrous sulfate (FEROSUL) taken for blood iron; amlodipine taken for blood pressure measurement; docusate taken for laxative supportive care; bupropion taken for pain; ketotifen fumarate (ALLEGY S MENICON) taken for hypersensitivity; pantoprazole taken for an unspecified indication; acetylsalicylic acid (ASPIRIN (E.C.)) taken for cardiac disorder; cyclobenzaprine taken for back spasms and cramps in legs; trazodone taken for sleep disorder; tramadol taken for pain, and start and stop date were not reported for all. It was reported that after receiving the first dose of vaccine on 16Apr2021 the patient experienced arm swollen and redness in arm and on 17Apr2021 experienced chills, pain in arm, arm felt hard and headache and on Apr2021 she not feeling like getting out of bed. She stated that arm swollen started later that night, in the left arm where she got the shot. She could not sleep on the left side at all. Still swollen. Arm felt hard was noticed on Saturday morning, it was red in the area. The knot there was as big as a quarter, pain in arm was not really red but hard and hurts where she got the shot and still hurts the same now, hasn't changed. She mentioned that this morning the redness in arm was gone, but it was still hard and it hurts. Yesterday, looked like redness was fading, wasn't as red as it was Friday night, when she looked at her arm. Today, she does not see much redness at all but it was still swollen and was still in pain and was still hard. For this as a treatment she had done nothing but regular medications she takes every day. Put an ice pack on yesterday and Saturday afternoon. She mentioned that chills started Saturday morning and still have now, Headache started Saturday morning and still has not gone away. Everything jumped in at the same time and her head has been hurting since Saturday morning. She had talked to her doctor about it when she went for her yearly check-up. Doctor trying to vaccinate his patients based on age. Every first of the year, she goes to the doctor for an annual check-up. If something goes wrong, they usually tell her. She knew she has to have her knees replaced. She doesn't want to do it just yet. Was trying to get stuff out of the way before she has to have the surgery. Patient was recovering from the event of erythema of extremities and outcome was unknown for the event of malaise and patient was not recovered from rest of the other events. No Follow-up attempts are needed. No further information expected.

Other Meds: IBUPROFEN; GABAPENTIN; METOPROLOL; PRAVASTATIN; MULTIVITAMIN (16); FEROSUL; AMLODIPINE; DOCUSATE; BUPROPION; ALLEGY S MENICON; PANTOPRAZOLE; ASPIRIN (E.C.); CYCLOBENZAPRINE; TRAZODONE; TRAMADOL

Current Illness:

ID: 1774617
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: I have arthritis and I take the shot; it seems to be getting louder; This is a spontaneous report from a non-contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247, Expiration date: unknown), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included arthritis.The patient's concomitant medications were not reported. The patient experienced i have arthritis and i take the shot; it seems to be getting louder (arthritis) 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: 1774618
Sex: M
Age:
State: TN

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 10/09/2021
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: Test Date: 20210419; Test Name: Covid-19; Result Unstructured Data: Test Result:Covid-19; Comments: Negative

Allergies:

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

Symptoms: Took patient down for about a week./aching all over, joints and muscles too like the flu; flu-like symptoms; Took patient down for about a week./aching all over, joints and muscles too like the flu; Took patient down for about a week./aching all over, joints and muscles too like the flu; achiness; This is a spontaneous report from a contactable consumer or other non hcp. A 74-year-old male patient received first dose bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, (Batch/Lot Number: EN6200; Expiration Date: Jun2021)), via an unspecified route of administration, administered in Arm Left on 26Feb2021(at the age of 74-year-old) as, Single for COVID-19 immunization. Medical history included arthritis from 2017 to 2018 arthritis is in his right foot only and his big toe. The patient's concomitant medications were not reported. He received the 1st dose on 26Feb2021 and the 2nd dose on 19Mar2021. She mentioned that both of them experienced achiness after the 1st dose and flu-like symptoms after both doses. Her husband however, had muscle weakness on his legs after the 2nd dose. On 13Apr2021, about 3 weeks and 4 days after the 2nd dose, her husband received a steroid shot on his right foot. They noticed that the weakness on his legs became extreme, to which he had trouble standing up and has to hold on to something to stand up as he cannot support himself. He also had a rash on his trunk, back, and down his arms. She mentioned that the rash was not itchy but was speckled like measles. They are wondering if this has been reported and if it is possibly an interaction between the vaccine and steroid. The patient experienced took patient down for about a week/aching all over, joints and muscles too like the flu on 26Feb2021 and achiness, flu-like symptoms. The patient underwent lab tests and procedures which included covid-19 was Negative on 19Apr2021. The outcome of the events pain and Influenza like illness was recovered on 03Mr2021 and unknown for other events. No follow-up attempts are needed. No further information is expected

Other Meds:

Current Illness:

ID: 1774619
Sex: M
Age:
State: IL

Vax Date: 03/23/2021
Onset Date: 03/23/2021
Rec V Date: 10/09/2021
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: 20210421; Test Name: Fever; Result Unstructured Data: Test Result:100 degrees; Test Date: 20210421; Test Name: MRI brain; Result Unstructured Data: Test Result:normal

Allergies:

Symptom List: Nausea

Symptoms: Stomach pain; Dehydrated, after first vaccine; Fever, after first vaccine; Tired, after first vaccine; Numbness in legs, from knee all the way down to the feet, after the first vaccine; Nausea, after first vaccine; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: ER8730, Expiry date: Unknown via an unspecified route of administration on 23Mar2021 10:30 (at the age of 63-year-old) as dose 1, single for COVID-19 immunization. Medical history included chronic kidney failure ongoing from an unknown date, patient stated at least 8 years ago. Reported 5 stages of kidney failure, with the most severe stage as 5, and he reported he was in Stage 4 and Covid virus in Dec2020 unknown if ongoing and had some type of infusion, clarified as a monoclonal infusion while he had Covid, because if not, he would not have had a good outcome. Patient stated he was told that he had to wait 90 days, before getting the first vaccine, in Mar2021, and he hated it. Concomitant medications were not reported. It was reported that on 23Mar2021 15:00 patient experienced Dehydrated after first vaccine, on 23Mar2021 Nausea, after first vaccine, Numbness in legs, from knee all the way down to the feet, after the first vaccine ,23Mar2021 12:00 Fever after first vaccine and Tired after first vaccine and on 23Mar2021 21:00 Stomach pain. Patient visited emergency room for the event because of concerns of his history of kidney failure. Patient stated he was glad he went, to the emergency room, and he was assured that any symptoms or side effects were normal with the covid vaccine. Patient stated the doctor in the emergency room, reclarified, that his symptoms were in keeping with the side effects of the vaccine, however, that because he has chronic kidney failure, that was the reason why he was dehydrated. Patient stated he had called his Internist, and he did not want to take the second vaccine. Lab test and procedures included on 21Apr2021 Fever100degree, MRI brain-Normal. Therapeutic measures were taken as a result of the events included saline solution, anti-nausea medication and two Tylenol on 24th.Outcome of the event Nausea, after first vaccine resolved on 24Mar2021, Fever, after first vaccine: resolved on 25Mar2021, Tired, after first vaccine resolved: 26Mar2021, Numbness in legs, from knee all the way down to the feet, after the first vaccine, Stomach pain resolved on an unspecified date in 2021. Outcome of other event was unknown. No follow up attempts are needed. No further information is expected.

Other Meds:

Current Illness: Kidney failure chronic (Verbatim: chronic kidney failure)

ID: 1774620
Sex: F
Age:
State: OH

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: really debilitated; extreme dizziness; arm pain; couldn't lift her head off the pillow; debilitating nausea; shaking chills; extreme muscle and joint pain throughout the body; extreme muscle and joint pain throughout the body; exhaustion so significant; weakness she could not get out of the bed; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EW0161) via an unspecified route of administration on 15Apr2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 on 18Mar2021, lot No. EN6207 for covid-19 immunisation. The second dose of the vaccine was so horrendous, and the reporter was considering to never get vaccines ever again. The reporter thought that this reaction correlates with premenopausal women. Upon injection of the second dose of the vaccine the patient had flushing and nausea instantaneously. The patient received the second dose on 15Apr2021 and then 12-14 hours later the patient had debilitating nausea, shaking chills, extreme muscle and joint pain throughout the body, and exhaustion so significant and weakness patient could not get out of the bed, patient couldn't unscrew the lid off her mug of tea. The patient was really debilitated and was so scared. The patient started reading that these effects were usually in women and testosterone bluttens the effects in men. The patient thinks that these reactions need to be studied in women. The nausea was debilitating. The patient didn't feel well and was able to go to a dentist appointment after the first dose of the vaccine, but after the second dose patient couldn't lift her head off the pillow. The patient has no medical conditions, was healthy and triathlete. The arm pain was much less with the second dose of the vaccine, the first time it was much worse, patient did not care about arm pain patient was just so scared because patient was so sick. The patient also had extreme dizziness, she felt like she was drunk. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1774621
Sex: M
Age:
State: PA

Vax Date: 04/15/2021
Onset Date: 04/16/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: he got the Pfizer vaccine last Thursday and on his right arm his Joint, and the Elbow the upper arm a little bit, he is having pain; he got the Pfizer vaccine last Thursday and on his right arm his Joint, and the Elbow the upper arm a little bit, he is having pain; This is a spontaneous report from consumer (patient's wife) reported for a patient (patient's husband). A 77-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0169, Expiration Date: 31Aug2021) via an unspecified route of administration, administered at an unspecified anatomical location on 15Apr2021 (age at vaccination was 77 years) as dose 1, single for COVID-19 immunization. The patient's medical history included pain. Concomitant medications included paracetamol (TYLENOL) taken for pain (he takes some 2 tablet 3 times a day) and warfarin taken for an unspecified indication. On 16Apr2021, the day after the shot, the patient experienced little bit pain in joint elbow upper arm. The patient had a side effect, he got the Pfizer vaccine last Thursday and on 16Apr2021, the patient's right arm his Joint and the elbow the upper arm a little bit, he was having pain. He was just on his regular medication, but he had been taking Tylenol. He hasn't had any medical test late or right now or lab work. He was prominent he was on Warfarin blood thinner. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: TYLENOL; WARFARIN

Current Illness:

ID: 1774622
Sex: F
Age:
State: FL

Vax Date: 04/17/2021
Onset Date:
Rec V Date: 10/09/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data: Test Date: 2021; Test Name: Fever; Result Unstructured Data: Test Result:Unknown results

Allergies:

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

Symptoms: Arm was very sore; pain on my arm was very bad where on my whole arm and my whole side, back side of that arm; very strong pain on my arm, all back side, under my arm; very strong pain around my breast, all that side; Body ache; Chills; Fever; temperature; Last night I wasn't able to sleep because of the pain; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 17Apr2021 (at the age of 60-year-old) as dose 2, single for covid-19 immunization. Medical history included blood pressure high from an unknown date and unknown if ongoing. Concomitant medications included metoprolol (METOPROLOL) taken as 50 mg once a day for hypertension, start and stop date were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8730) via an unspecified route, administered on 27Mar2021 as dose 1 single for COVID-19 immunization. The patient underwent lab test and procedure include fever result was unknown on an unspecified date in 2021. On an unspecified date in 2021, from Saturday morning and for the rest of the day the patient experienced arm was very sore, pain on her arm was very bad where on her whole arm and whole side, back side of that arm; very strong pain on her arm, all back side, under arm, very strong pain around her breast, all that side, all that side, body ache, chills, fever; temperature, last night she wasn't able to sleep because of the pain. Treatment received with 2 Tylenol 500 mg each. Consumer stated, no doctor, patient just went to get the vaccination where they were giving the vaccination. She just went herself. It was not facility but they were giving facility in big event for many people. Outcome of the event arm was very sore; pain on her arm was very bad where on her whole arm and whole side, back side of that arm; very strong pain on her arm, all back side, under her arm was not resolved, outcome of the event very strong pain around her breast, all that side, fever; temperature, last night she wasn't able to sleep because of the pain were unknown, outcome of the events body ache, chills were resolving. No follow-up attempts are needed; information about lot/batch number cannot be obtained

Other Meds: METOPROLOL

Current Illness:

ID: 1774623
Sex: M
Age:
State: WI

Vax Date: 04/14/2021
Onset Date: 04/14/2021
Rec V Date: 10/09/2021
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 Date: 20210406; Test Name: Urinalysis; Result Unstructured Data: Test Result:Leukocytes; Test Date: 20210406; Test Name: Urinalysis; Result Unstructured Data: Test Result:Blood +3

Allergies:

Symptom List: Tremor

Symptoms: couldn't sleep all night; bleeding with urination; Caller states last night, so the 4th day after, he had anxiety; He had arm pain; lightheadedness; This is a spontaneous report from a contactable consumer or other non-HCP who reported for herself. A 54-years-old male received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 14Apr2021 at 14:30 (age at the time of vaccination was 54-years-old) as a DOSE 2, single for COVID-19 immunization. Medical history included Benign prostatic hyperplasia. Additional Information for Other Conditions: Prostate Issue is BPH. Diagnosed a few years back 2016 or 2017. States he had a Uralist in 2019 and that resolved his issues. Been on no meds and back to normal since that procedure. Concomitant medications included Lipitor for Blood cholesterol. Additional Information for Concomitant Products Lipitor: Primary doctor put him on Lipitor for cholesterol. He was concerned with the dark urine so he stopped taking it, and called doc but said didn't need on it anyhow. Took within 2 weeks of first dose. The patient had received both the doses of Pfizer COVID Vaccine within 4 weeks. The patient had no reactions to medications and vaccines. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 24Mar2021 at 1:00, as a DOSE 1, single for COVID-19 immunization. On 31Mar2021, the patient experienced sweating and bleeding with urination. On 14Apr2021, the patient experienced He had arm pain and lightheadedness. On 18Apr2021, the patient experienced Caller states last night, so the 4th day after, he had anxiety. On an unspecified date, the patient experienced couldn't sleep all night. Caller was calling about the Pfizer COVID Vaccine. He stated he did not knew if he was reporting a side effect or not. He had both vaccines now and experienced the same thing both times, like clockwork on the same days. He states it was odd that it came up again. He states with the first, he had the normal arm pain and was lightheaded for a day. He states then 4-6 days after that in the evening, he couldn't sleep and had weird anxiety and half way through the night, he broke out in a sweat, but he was not feverish. He went to bathroom and was urinating blood. He was concerned because in the past he has had some issues with his prostate. Caller states with prostate infections, blood is rare it is usually cloudy. He called his urologist although it seemed to have been fixed from the surgery he had and he hadn't had a single infection since. He states for about 5 days from Thursday to a Tuesday, he pushed fluids because his doctor couldn't get him in right away. He states his urine kept getting darker and darker, and it was a brown coffee colour, then it turned bloody the day before his appointment and then it went away on the day of his appointment. States they did a urinalysis at the doctor's office and he had +3 blood and leukocytes. States the urologist said his best guess is probably an infection and he was put on a month of Cipro and he is on that still. He usually starts to feel better after antibiotics but he wasn't so he wasn't sure if the Cipro was working. He states a week or two after he noticed less abdominal discomfort. He did not knew if the antibiotics were doing that or not. He states since that he had his second COVID vaccine last Wednesday. He had arm pain and lightheadedness that went away the next day. He states last night, so the 4th day after, he had anxiety and couldn't sleep all night and sweating and today he has bleeding with urination again. States he doesn't know if it is related to the shot or not. States he was on antibiotics still, so why would he develop another infection if he is on Cipro. He doesn't know if that is normal or if it has been heard of before? States all he knows is this is the first day of the light bleeding, and he noticed it is getting dark. Right Arm Pain after First Vaccine: States it was odd because he doesn't have issues with shots. States he woke up the next day and he had deltoid pain but he also had pain like he had been hit from his right pectoral down his arm to about 4-5" above his wrist. He clarified the blood in his urine started on 31Mar2021 and it got darker 02Apr2021, 03Apr,2021, 04Apr2021, and then blood again 05Apr2O21, and then it cleared up 06Apr2021, the day of his appointment. He also clarified the sweating lasted half a hour to an hour. Caller states the first time he thought it was because of his prostate. He told the urologist he had the vaccination, but the urologist said that was probably not causing it. He called to report adverse events from the COVID vaccine. States he was on Cipro but he doesn't feel like it was doing much because he didn't feel better and he had discomfort in his abdomen. Caller states he doesn't know if it is working or not, it is not painful it was a discomfort. The patient underwent lab tests and medical procedures on 06Apr2021, which showed results as Leukocytes and Blood +3. The clinical outcome of couldn't sleep all night was recovered on an unspecified date, the clinical outcome of sweating was recovered on 01Apr2021, the clinical outcome of He had arm pain and lightheadedness was recovered on 15Apr2021, the clinical outcome of Caller states last night, so the 4th day after, he had anxiety was recovered on 19Apr2021, the clinical outcome of couldn't sleep all night was recovered on an unspecified date, while clinical outcome of bleeding with urination was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: LIPITOR

Current Illness:

ID: 1774624
Sex: U
Age:
State:

Vax Date: 04/15/2021
Onset Date:
Rec V Date: 10/09/2021
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: Joint pain; lymph node swollen; Fever; Headache; Muscular pain; where she got the second vaccine, it is swollen and red and it is still so sore; where she got the second vaccine, it is swollen and red and it is still so sore; where she got the second vaccine, it is swollen and red and it is still so sore; Not feeling good; This is a spontaneous report from a contactable consumer. This consumer reported for unknown patient. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Solution for injection. Batch/Lot Number: ER8732), dose 2 via an unspecified route of administration on 15Apr2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. Historical vaccine included: first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) as dose 1, single for COVID-19 immunization. Patient got the COVID vaccine the other day, the second shot and has several symptoms and they did not seem to be going way, lot of joint pain, lymph node swollen, fever, headache, muscular pain, redness, where got the second vaccine, it was swollen and red and it was still so sore, patient could not move it and in response to further probing, reporter stated, no, not eight to ten minutes, patient (my wife) was not feeling good for that many questions. Reporter wanted to know, recommend anything to do? Do we just have to go to a doctor to have them look at it? Further probing could not be initiated as reporter was unwilling to further answer the questions. Hence, other details were unknown and limited information was available over the call. The outcome of the events were unknown. No follow-up attempts are Possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1774625
Sex: F
Age:
State: OR

Vax Date: 03/10/2021
Onset Date: 03/01/2021
Rec V Date: 10/09/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

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

Symptoms: broke out in a rash on her arm right where the injection was given; on her arm right where the injection was given, and had a 2 inch slough; The site also itched, it was sore sore and it hurt; The site also itched, it was sore sore and it hurt; Felt hot; Tired; little sore arm; This is a spontaneous report from a contactable Consumer or other non-health professional (patient). A 65-year-old female patient bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch number: not reported/ lot number: EN6208) via an unspecified route of administration in right arm on 10Mar2021 (at the age of 65-year-old) as dose, 1 single for COVID-19 immunization. Medical history included ongoing osteoporosis (diagnosed in 2018 or 2019) and thyroid from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for thyroid from 1977 and ongoing. Patient did not receive any prior vaccinations within 4 weeks of vaccination. No Family Medical History Relevant to AE. No Additional Administered Vaccines on same day. On 11Mar2021, After the first vaccine patient broke out in a rash on her arm right where the injection was given, and she had a 2-inch slough. The site also itched, it was sore, and it hurt. It lasted for about two weeks. She still had remnants of an itch and marks when she got the second injection. On an unspecified date in Mar2021, after the first vaccine she felt hot, tired, and had a little sore arm. She needs to get Temlos injections for her osteoporosis, she was supposed to start, but she refrained from doing so because she was afraid it might affect the covid vaccine or the covid vaccine will affect these injections. AEs did not require a visit to ER or physician office. Investigation Assessment was reported as No. No relevant Tests provided. Outcome of the site also itched, it was sore sore and it hurt was recovering and outcome of the other events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: SYNTHROID

Current Illness: Osteoporosis (Diagnosed in 2018 or 2019.)

ID: 1774626
Sex: F
Age:
State: NY

Vax Date: 04/01/2021
Onset Date: 04/15/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: blood work; Result Unstructured Data: Test Result:blood work done, I don't know; Comments: 2 months ago yes, I just blood work done, I don't know

Allergies:

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

Symptoms: Very tired; Very Weak; Joints are achy; Achy; This is a spontaneous report from a contactable other hcp (nurse). A 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0153), dose 2 via an unspecified route of administration on an unspecified date in Apr2021 as dose 2, single for COVID-19 immunisation. Patient had no medical history. Concomitant medication(s) included fish oil tablets at a dose of 1000mg, oral 4 times a day taken for an unspecified indication, start and stop date were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient stated, She had reaction, not a reaction, side effect to her pfizer 2nd dose, she was good for 4 days and then 5th, 6th, 7th and 8th day after very, very weak and tired, and achy, joints are achy on 15Apr2021. Patient stated, It's covid vaccine, everybody has to get it. The place where she got it was mall. For causality, consumer stated, yes. When questioned about concomitant medication, she stated, oh my gosh, she take, I have to get my list, this is going to take a while, I take fish oil tablet, she take 4 of those a day, 1000 mg, Oral 4 times a day. Lab test included blood work on an unspecified date in 2021, she said 2 months ago yes, just blood work done, she don't know. If she was still experiencing the events, patient stated, no, not today, seem to be okay. No therapeutic measures were taken for any of the events, patient stated, no, she just rested. The outcome of all the events was recovered on an unspecified date in Apr2021. Verbatim event relatedness: Covid 19 Vaccine: Very tired - Related Covid 19 Vaccine: Very Weak - Related Covid 19 Vaccine: Joints are achy - Related No follow-up attempts are needed. No further information is expected.

Other Meds: FISH OIL

Current Illness:

ID: 1774627
Sex: F
Age:
State: PA

Vax Date: 04/15/2021
Onset Date: 04/01/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: I am coughing out a lot of mucus; Sneezing; mucus /I am coughing out a lot of mucus; Headache; My arm was hurting; My body felt hot but I didn't have temperature; Chills; Feeling lousy; Light-headed/dizzines; Ache; This is a spontaneous report from contactable consumer (patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EWASL) via unknown route of administration at left arm on 15Apr2021 (age at vaccination 56-year-old) as single dose for COVID-19 immunisation. The patient medical history included hysterectomy on 08Mar2021 and concomitant medications were reported as none. On an unspecified date in Apr2021, the patient experienced headache, dizziness/light-headed, ache, feeling lousy, chills, my arm was hurting, my body felt hot but didn't have temperature and after fourth day on 17Apr2021, sneezing, the patient coughing out a lot of mucus. The patient received treatment included Tylenol and Motrin. The second dose was scheduled at 06May2021. The outcome of the event I am coughing out a lot of mucus, sneezing was not recovered and outcome of the other events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1774628
Sex: M
Age:
State: NY

Vax Date: 04/14/2021
Onset Date: 04/01/2021
Rec V Date: 10/09/2021
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: quite a bit of muscular or joint pain in the area where he received the shot; quite a bit of muscular or joint pain in the area where he received the shot; quite a bit of muscular or joint pain in the area where he received the shot; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Co-Worker). A 29-years-old male patient 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, mid-afternoon, unsure of exact time (Batch/Lot number, Expiry Date and NDC number were not reported) as dose 2, single for covid-19 immunization. Medical history included Celiac and Irritable bowel syndrome (IBS) diagnosed about 10 years ago. The patient's dad had autoimmune stuff, Celiac and IBS as well. The patient previously received first dose of bnt162b2 via an unspecified route of administration, administered in Arm right on 29Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. There were not any additional vaccines administered on same date of the pfizer suspect, no Prior vaccinations within 4 weeks. The patient's concomitant medications were not reported. In Apr2021 the patient experienced quite a bit of muscular or joint pain in the area where he received the shot, the patient has nothing other than soreness. The reporter stated that, his employee had the Pfizer shot and had quite a bit of muscular or joint pain in the area where he received the shot and its ongoing. The patient neither visited to Emergency Room nor to Physician Office. The reporter verified that they all received the Pfizer Covid Vaccine and they had it done around the same time and around the same dates. The patient received his second dose last week, he thinks the second one was last Wednesday. The patient thinks he received his second dose on 14Apr2021, and he had his first dose exactly 3 weeks to the day from the second so that would mean his first dose was around 29Mar2021. The outcome of the events was not recovered and ongoing at time of reporting. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774629
Sex: F
Age:
State:

Vax Date: 04/05/2021
Onset Date:
Rec V Date: 10/09/2021
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: cold shivers/chills; fevers; headaches; eyes were red; This is a spontaneous report from a contactable consumer(patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 05Apr2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history were not reported and concomitant medications included patient was using Rybelsus therapy. On an unspecified date the patient experienced cold shivers/chills, fevers, headaches, eyes were red. The patient had taken 1 Tylenol as treatment. 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: 1774630
Sex: F
Age:
State: FL

Vax Date: 04/05/2021
Onset Date: 04/01/2021
Rec V Date: 10/09/2021
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: caller received the vaccine less than 3 weeks apart; Drowsiness dizziness; Drowsiness dizziness; Headache; tiredness; Pain at location; Could not move arm; Chills; Sweating; This is a spontaneous report from a contactable consumer (Patient). A 44-year-old female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID mRNA VACCINE, solution for injection, Lot Number: Unknown), via an intramuscular route of administration on 05Apr2021 at 07:30 (at the age of 44-year-old) administered in Arm Left as a single dose for COVID-19 immunisation. Medical history included fibromyalgia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unknown date Apr2021, the patient experienced Chills, Sweating, Pain at location, tiredness. On 19apr2021, the patient experienced Drowsiness dizziness, Headache. she received the COVID 19 vaccine on Monday. Caller stated she has all the symptoms that she had from the first dose so she knew it was normal but she noticed on Monday she had a little bit heart is faster and Tuesday she felt shortness of breath but it is not something horrible but something she can feel but can live with it, and also started feeling tiredness. she has never had a doctor. Caller stated she usually goes to her yearly gynecologist but her gynecologist is closing her practice and she is not working anymore. Caller stated she does not go to unwell review to see a healthcare doctor. she has not contacted Pfizer to report symptoms from either the first or second dose of the vaccine. Caller clarified the expected symptoms that she experienced that is normal is chills like goosebumps, sweating, pain at location, and nausea. Caller stated those symptoms she thought was fine and normal to experience. Caller stated she is also experiencing shortness of breath and dizziness and wants to know if this is normal? Chills started with the first dose of the vaccine and also with the second dose. it was only during the night. Caller is not sure exactly the date of when this started for either dose but sometime in April since caller stated both doses were received in April. she also had arm pain just a little bit on the spot, but she is calling just because of the shortness of breath and dizziness. She was not sure exactly the date of when event Sweating started. Pain at location: it was a huge pain just where she got the vaccine but now it is just a comfortable pain. Caller stated also she could not move her arm. Caller is unsure exactly when it started but it was sometime in Apr2021.Could not move arm was not sure exactly when it started but it was sometime in Apr2021.Nausea started on the afternoon day she took the second dose of the vaccine. Drowsiness dizziness: Caller stated she spent the day studying at home and when she woke up at 7 she felt the symptoms. Caller asked isn't drowsiness and dizziness the same thing? The symptoms were combined as caller could not differentiate between the two symptoms. she took over counter medication for the headache, Ibuprofen. Heartbeat up a little bit started in the afternoon on 19Apr2021 and it was like she had too much coffee like one can feel the heart beating differently but she did not have too much coffee. The second dose was received on 19Apr2021 in her left arm in muscle as an injection. Caller state since this is a intramuscular vaccine it cannot change since it was authorized this way. Caller stated to avoid infections and she can still get the virus but will not get so sick. Caller then clarified it is weird explaining but knowing she can still get infected but will not get so sick than supposedly if she did not have the vaccine. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines were Administered. The adverse event did result to Emergency Room and Physician Office visit. The patient did not receive any vaccine Prior Vaccinations. she is not feeling like her symptoms are life threatening and bothering her know like it is similar to one who has asthma and has shortness of breath. Caller stated the symptom is not feeling like she is going to die it just feel to be bothering her. Caller stated from her understanding someone can not receive any other vaccines until 20 days after the second dose is what the in information at pharmacy. Caller stated she is not sure if information is right or wrong. PSCC Communication: Provided caller report reference number. Provided caller USMI hours and number. Due to high call volume caller was placed in the queue for USMI. Therapeutic measures were taken as a result of headache and treatment included ibuprofen. The clinical outcome of the events was recovered for chill, sweating, Could not move arm on 21Apr2021 and recovering for vaccination site pain, dizziness drowsiness, headache and unknown for another events. No follow-up attempts are Needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774631
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 10/09/2021
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: quite a bit of muscular; joint pain in the area where she received the shot; feels like her muscle is going to tear; This is a spontaneous report from a contactable consumer or other non health care professional. A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization at Clinic. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccinations within four weeks prior to the first ad-ministration date of the suspect vaccine. It was reported that reporter states he did want to say that he thinks is very relevant, his employee had the Pfizer shot and she has quite a bit of muscular or joint pain in the area where she received the shot and its ongoing, if she goes to reach for something, she feels like her muscle is going to tear. Patient verifies she received the Pfizer Covid vaccine. Patient unsure of LOT, , Expiry date. Patient unsure of which arm she received it in. Patient unsure of date received the vaccine. Patient states she received the shot because she works in a hair salon and mostly for the compliance aspect and to resolve COVID but also to think about the community and stuff too. Reporter verifies he is unsure of dosage and it was given by injection. The adverse events did not result in emergency room and physician office. 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: 1774632
Sex: M
Age:
State: OH

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 10/09/2021
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 Date: 2021; Test Name: Blood work; Result Unstructured Data: Test Result:Normal

Allergies:

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

Symptoms: itchy when they appear; Rash; little red spots; his symptoms are worsening; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration in left arm on 10Feb2021 at 11:00 (at the age of 78-years) as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had not received any other vaccine within 4 weeks. The patient did not experience any event prior vaccination. The patient had previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EK4174), via an unspecified route of administration in left arm on 20Jan2021 (at the age of 78-years) as dose 1, single for covid-19 immunization. The patient had no additional vaccines administered on same date of the Pfizer suspect. Following second dose of vaccination, on 10Feb2021 the patient had rash; little red spots, itchy when they appear, all over body and worse on arms. The patient stated that his symptoms had worsened from 10Feb2021, spots were not that noticeable, but they looked like mosquito bites. They were mostly on his arms and looked almost like they were under the skin. Other locations on his body, like his shoulders, they looked like they were on top of the skin. Patient also stated that the bumps are not raised, just a red blotch on his skin which were maybe 1/16th of an inch or less in size. This resulted in physician office visit and the patient was advised to put lotion and hydrocortisone cream on it by this doctor. The patient underwent lab tests and procedures in between the first and second dose on an unspecified date in 2021 at his 6-month check-up and included blood test resulted normal. The outcome of the events was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1774633
Sex: F
Age:
State: NC

Vax Date: 04/13/2021
Onset Date: 04/01/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: chills returned/chills, she did not feel too hot; joint and muscle pain; joint and muscle pain; she was not eating too much; harder to swallow/ could swallow, but had some discomfort while swallowing; unconsciously clearing her throat; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0151, Expiry date: 31Jul2021) via intramuscular route of administration, administered in left arm on 13Apr2021 08:30 as DOSE 2, SINGLE for covid-19 immunization (at the age of 62-years-old). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8732, Expiry date: 31Jul2021) via intramuscular route of administration, administered in left arm on 25Mar2021 as DOSE 1, SINGLE for covid-19 immunization and experienced goose bump, chills, injection site swelling and cold feeling. Family Medical History Relevant to AE(s) was not provided. None medical history (including any illness at time of vaccination) was reported. Prior vaccinations (within 4 weeks) were none. Relevant tests were none. AE following prior vaccinations was not available. The patient did not receive other concomitant medications. She said she had her first Pfizer BioNTech COVID-19 Vaccine at about 9:00 (on 25Mar2021), and that entire evening, and throughout the night, she had chills, and goosebumps. She said that evening, she was up the entire night with goose bumps, and feeling very cold. She said the cold feeling wouldn't go away. She said the chills and goosebumps, (and cold feeling) went away the next day. She said she also had left arm injection site swelling. She said her side effects were no big deal for the first time around with vaccine. On 13Apr2021, the patient experienced chills returned. She said along with the chills, she did not feel too hot. In Apr2021, the patient had joint and muscle pain, and felt like she had ran a marathon. She said since her second dose of vaccine, In Apr2021, the patient was not eating too much. She said all she had for today was a protein drink, and it was already the late afternoon. She said as of tomorrow, it would be a week since she had her second of vaccine. In Apr2021, the patient said at times it was harder to swallow. She clarified that she could swallow but had some discomfort while swallowing. She said she felt she swallowed with some constriction. She clarified she found herself unconsciously clearing her throat, it lasts for 26-36 hours that she had swallowing difficulty. Treatment reported was self massage with heat therapy, drank tons of water, and had a professional massage. No emergency room/physician office visit was reported. The outcome of the events she was not eating too much, harder to swallow/ could swallow, but had some discomfort while swallowing and unconsciously clearing her throat was not recovered and the events chills returned/chills, she did not feel too hot and joint and muscle pain were unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1774634
Sex: F
Age:
State: AL

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 10/09/2021
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: This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date in Mar2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she was reading the whole pamphlet on Pfizer and she took the Pfizer COVID vaccine on 01Mar2021 or 08Mar2021 she believes. The patient was having some symptoms but she did not know it was from that and it still could not be from that maybe. The patient was having muscle and joint aches on an unspecified date and she always used a remedy and it would go away but with this first shot it came but then it went and came back and went again and she did not think anything else about it. 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: 1774635
Sex: F
Age:
State: AL

Vax Date: 03/29/2021
Onset Date:
Rec V Date: 10/09/2021
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: neck and shoulders hurt; neck and shoulders hurt; right side down the side hurts too; She was having muscle and joint aches; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration on 29Mar2021 as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was unknown), via an unspecified route of administration on an unspecified date (on 01Mar2021 or 08Mar2021 she believes) as DOSE 1, SINGLE for COVID-19 immunisation. The patient had some symptoms, but she didn't know it was from that, and it still couldn't be from that maybe. She was having muscle and joint aches and she always uses a remedy, and it will go away but with this first shot it came but then it went and came back and went again and she didn't though anything else about it. The patient's concomitant medications were not reported. On an unspecified date, the patient shoulder was having pain in her muscles. She put cream on the muscle ache and it will help for a while. She had no problems through the day but when she lays down and gets up in the morning, it hurts. She puts the cream on at night because her neck and shoulders hurt and her right side down the side hurts too. She had arthritis but her pain has never gone this long before. She was reading the pamphlet and it says you can have muscle and joint aches. The patient questioned that this was something she needs to be concerned with or what. She will also follow up with her doctor and wanted her question addressed at this time. She had never had anything compared to this muscle ache that she has. Now it was a little different, maybe there was something else going on. 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: 1774636
Sex: U
Age:
State: NC

Vax Date: 02/24/2021
Onset Date: 02/01/2021
Rec V Date: 10/09/2021
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: sweating; chills; felt really tired; felt feverish; This is a spontaneous report from a contactable consumer reported in response to Non-HCP letter sent. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6203), via an unspecified route of administration on 24Feb2021 as dose 2, single for covid-19 immunisation. The patient medical history was Pneumonia 5 YR booster; 15 days before Covid-19 shot. Concomitant medication(s) included levothyroxine sodium (LEVOTHYROXINE SODIUM) 50 mg ongoing taken for thyroid. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as dose 1, single on 03Feb2021Lot number EL3247 for covid-19 immunization and no side effect. The patient experienced on 24Feb2021 01:30, After 2nd dose, started having chills, took tylenol went back to bed. That morning Feb2021 just felt really tired. That evening 05:30 PM, Feb2021 felt feverish took another Tylenol just started sweating. Treatment provided after second dose tylenol extra strength for chills, Feverish. The outcome of event for chills, felt really tired, felt feverish was recovered on 2021 and rest all was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: LEVOTHYROXINE SODIUM

Current Illness:

ID: 1774637
Sex: M
Age:
State:

Vax Date: 04/20/2021
Onset Date: 04/20/2021
Rec V Date: 10/09/2021
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: Next day he got fever; started feeling itchy all over his body; This is a spontaneous report received from a contactable consumer or other non hcp. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 20Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced started feeling itchy all over his body on 20Apr2021, next day he got fever on 21Apr2021. Clinical course was reported as he got on Tuesday 20Apr2021 the first dose of the Pfizer covid vaccine and that night at approximately 8-9 pm he started feeling itchy all over his body. Next day he got fever, but the itchiness has not got away. The clinical outcome of the event fever was unknown and another event feeling itchy all over his body was not recovered. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774638
Sex: F
Age:
State: AZ

Vax Date: 03/12/2021
Onset Date: 03/15/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Name: MRI; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210409; Test Name: Nasal Swab; Test Result: Negative ; Test Name: abdominal ultrasound; Result Unstructured Data: Test Result:Unknown results

Allergies:

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

Symptoms: Stomach pains; Bloating; Diarrhea; Headache; Dry mouth; Loss of taste; This is a spontaneous report from a contactable consumer (patient). A 59-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration in left arm on 12Mar2021 at 16:15 (Batch/Lot Number: EN6206) (at the age of 59-years-old) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Patient did not receive any other vaccine in four weeks. Patient did not have covid prior to vaccination and was tested for covid post the vaccination. Medical history included high cholesterol. Concomitant medication(s) included fenofibrate, colecalciferol (VITAMIN D [COLECALCIFEROL]) and progesterone. The patient previously took tetanus and experienced drug allergy. On 15Mar2021 at 06:00 (3 days after 1st dose), the patient developed stomach pains, bloating, diarrhea, headache, dry mouth and had loss of taste. Events resulted in doctor or other healthcare professional office/clinic visit. The patient was provided with restrict diet, abdominal ultrasound & MRI as a treatment received. On an unspecified date, the patient underwent lab tests and procedures which included MRI and abdominal ultrasound with unknown results on an unspecified date and on 09Apr2021, underwent nasal swab which was found to be negative. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: FENOFIBRATE; VITAMIN D [COLECALCIFEROL]; PROGESTERONE

Current Illness:

ID: 1774639
Sex: F
Age:
State:

Vax Date: 04/17/2021
Onset Date:
Rec V Date: 10/09/2021
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: allergic reactions; Fever; chills; Headache; her left arm (vaccine arm) developed soreness and pain.; This is a spontaneous report from a contactable consumer (Patient). A 51-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: not reported), via an unspecified route of administration, administered in left arm on 17Apr2021 as Dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The concomitant medications were not reported. On an unspecified date the patient experienced allergic reaction, fever, chills, headache and pain in arm. The patient received treatment for the event her left arm (vaccine arm) developed soreness and pain with oinments and put some ice directly. The patient reported that she was advised by the pharmacist to "put some ice directly" to manage the bruise and consulted a day before with her doctor, and diagnosed the "pain in arm" as a burn- was given ointments. And added an ampule asked if it it a possible AE. The patient asked for her future health, she would like to know if she was allergic or if she should not have had the vaccine. Offered to transfer to Safety, but she declined due to work. Asked for Physician information, gave contact number but did not provide other information. E-transmitting AE for review (Response: Spoke from attached documents and as per the Pfizer-BioNTech COVID-19 EUA PI ,6 Overall Safety Summary and 6.1 Clinical Trials Experience, LAB-1457-7.0, Revised: 06 April 2021, explained to patient that Pfizer cannot assess causality, and referred to HCP for further guidance). The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am