VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
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: 1770762
Sex: M
Age:
State: TX

Vax Date: 03/20/2021
Onset Date: 03/01/2021
Rec V Date: 10/08/2021
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: Can't open mouth wide; throat felt like it was closing up; pain in the back of his head and neck; headaches/pain in the back of his head; really sleepy; tiredness; flu like symptoms; the neck pain is weird, it goes from the back of his skull down to between his shoulders/he turns he can feel the muscles tightening up in his shoulders; the neck pain is weird, it goes from the back of his skull down to between his shoulders/he turns he can feel the muscles tightening up in his shoulders; throat felt like it was swelling; pain in his jaw; super tired and out of energy; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, /Lot number was not reported, Expiry date: unknown, at the age of 54 years), dose 1 via an unspecified route of administration on 20Mar2021 as dose 1, single for covid-19 immunisation. Medical history included diabetes mellitus and car accident (he has never experienced neck pain like this, even after car accident he was in many years ago). The concomitant medications were not reported. The patient experienced pain in the back of his head and neck and reported that his head was locked and could not turn it either way. He described it as having a crick in the neck. He would like to know if this could be from the vaccine. He also reported that he had headaches since the vaccination, felt really sleepy and tiredness, and flu like symptoms. He developed neck pain on 21Mar2021. On Monday, 22Mar2021, he could not move his head. He was told that the Pfizer has joint type pain. He did not have pain anywhere else, no joint pain anywhere but his neck. He could not turn his head. He went to his primary care physician again. He was still experiencing neck pain, that he hadn't done anything to cause the neck pain, and that he could not do much. The neck pain was weird, it went from the back of his skull down to between his shoulders. When he turns, he felt the muscles tightening up in his shoulders. He could open his mouth only so far and he could not open his mouth wide. He had pain in his jaw back to the back of his head. Monday night he got scared because it felt like his throat was closing. He became very tired and sleepy the same day that he received the Covid-19 vaccine, 20Mar2021. The sleepiness began almost immediately after receiving the Covid-19 vaccine, before leaving the parking lot. He had headaches galore since Saturday night, 20Mar2021. The neck pain came in hard, and it was keeping his head locked up. He did not sleep funny, did not even use a pillow. Terrible pain could not take it. Mentioned he was kind of confused when providing dates for this report. When he tried to open his mouth wide, it hurt his jaw by his ears. His throat felt like it was swelling. Monday night, the throat swelling was not as bad Tuesday, 23Mar2021, that it was like it was alleviated. It seemed like at night the throat swelling acted different. He felt the throat swelling when he layed down and was experiencing the throat swelling slightly now. He was super tired and out of energy or something. He still felt a little drained at time of call on 24Mar2021 and that he tried to keep active. On Saturday, 20Mar2021, he had a headache pretty good Saturday night. On Sunday, 21Mar2021 the headache was kind of bad. He thinks the headache was from neck pain, that the headache was in the side of his temples and head. When he bended over, he felt a lot of pain in his neck, and it was hard to hold his head up. The outcome of the events pain in the back of his head and neck, headaches and could not open mouth wide was not recovered, for events really sleepy, tiredness and throat felt like it was closing up was recovering and for rest of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness: Diabetes

ID: 1770763
Sex: M
Age:
State:

Vax Date: 02/23/2021
Onset Date:
Rec V Date: 10/08/2021
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: 2021; Test Name: Heart rate; Result Unstructured Data: Test Result:Increased

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Muscle pain; muscle soreness; Shortness of breath; Increased heart rate; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on 23Feb2021, as dose 1, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received his first dose of Pfizer-BioNTech COVID-19 vaccine on 23Feb2021 and was originally scheduled for his second dose 23Mar2021. In 2021, the patient has been experiencing symptoms such as muscle pain, shortness of breath, and increased heart rate. Lots of muscle soreness comes. The patient asked if it was okay to take it. The patient has already rescheduled his second dose for 41 days after the first. The patient wanted to know what he should do about receiving the second dose. The outcome of the events was unknown. No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1770764
Sex: F
Age:
State: GA

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 10/08/2021
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: pain above left hip but in the center of her body; felt like a bruise/ states it was a dull bruise feeling; Left Arm Hurting; shoulder to fingertip; Body Aches; Brain Fog/ does not feel good feeling; left arm hurt from shoulder to fingertip/ arm soreness; had flashes of headaches accompanied by chest tightness and heaviness with a little shortness of breath; had flashes of headaches accompanied by chest tightness and heaviness with a little shortness of breath; had flashes of headaches accompanied by chest tightness and heaviness with a little shortness of breath; feeling like forgot how to swallow/ front of her mouth would move but the back was not swallowing; injection site pain; fever; This is a Follow-up spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 40-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot Number: EL9267), via an unspecified route of administration, administered in left arm on 01Mar2021 18:30 (at the age of 40-year-old) as dose 1, single for covid-19 immunisation. The patient's medical history included in the last year or two she developed an anaphylactic allergy to a weird spice in Indian food; scary 2 years for creepy allergies. Concomitant medications were not reported. On 01Mar2021, the patient had a strange side effect to the vaccine: She states she had body aches, she does not feel good feeling, her left arm hurt from shoulder to fingertip, and she had flashes of headaches accompanied by chest tightness and heaviness with a little shortness of breath as well as feeling like forgot how to swallow, nothing in her throat was swollen. States the front of her mouth would move but the back was not swallowing, states it was odder than anything. The patient had injection site pain. States she thought she should check if reactions are worse with the second dose of the vaccine. The next day on 02Mar2021 she reports pain above left hip but in the center of her body. The area was about the size of a golf ball that expanded and covered a larger area over the next few days and it felt like a bruise. states it was a dull bruise feeling. She also reports the following side effects: arm soreness, and brain fog. States her symptoms were mostly in the afternoon. The injection site pain lasted until the 04Mar2021. The patient experienced fever on an unknown date in 2021. Should I have any concerns about proceeding with a second vaccination?. The patient clarified that forgot how to swallow: it happen 2 times very close to one another. States that it took 15-20 seconds of telling her body how to swallow and it happened once more where it took another 15-20 sec to figure out how to make her body work then it was gone. The patient also states that someone she knows just died from it. She verified from the coronavirus, not the vaccine. States they lost someone close to them. States that is what pushed her to get the vaccine. States she is supposed to go there [withheld] again today for second vaccine. Caller states that in the last year or two she developed an anaphylactic allergy to a weird spice in Indian food. She states it is one of reasons why she wanted to call. She states this has been a scary 2 years for creepy allergies. Discovering an allergy with an anaphylactic reaction is not fun. Prior Vaccinations (within 4 weeks): None. AE(s) following prior vaccinations: None. Family Medical History Relevant to AE: None. No AEs require a visit to Emergency Room and Physician Office. The outcome of the event fever was unknown. The outcome of forgot how to swallow was recovered on 01Mar2021. The outcome of Vaccination site pain, body aches, Pain in arm and bruise was recovered on 04Mar2021. The outcome of the event Dysphagia was recovered on 01Mar2021. The outcome of all the other events was recovered on 05Mar2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1770765
Sex: F
Age:
State:

Vax Date: 03/07/2021
Onset Date: 03/09/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: breaking out with a rash under her breasts, back, side of the arm, thighs, stomach; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age (Age: 68; Units: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 07Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that two days later on the 09Mar2021, she began breaking out with a rash under her breasts, back, side of the arm, thighs, stomach. She spoke with her doctor virtually yesterday (on an unspecified date) and was prescribed Presdnisone and clotrimazole/betamethsone cream. The doctor said to wait until these side effects subside until she received the second dose which was scheduled for 07Apr2021, and the patient asked should she receive the second dose. The event outcome was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1770766
Sex: F
Age:
State:

Vax Date: 03/12/2021
Onset Date: 03/18/2021
Rec V Date: 10/08/2021
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: My tongue was swelling; my mouth was tingly; my face was swelling; lips were swelling; my glands under my chin was swollen; I had a rash on my neck; eyes were pretty swollen; I had a spider bite; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported, Expiry date: Unknown) via an unspecified route of administration on 12Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 18Mar2021, the patient experienced my tongue was swelling, my mouth was tingly, my face was swelling, lips were swelling, my glands under my chin were swollen, patient had a rash on her neck, eyes were pretty swollen, patient thought she had a spider bite. Therapeutic measures were taken which include Benadryl for every 4 hours. The next day patient cut down Benadryl the next day, but still have to take during certain times a day. This went over the weekend. Yesterday, patient took just one dose. But patient tongue was swollen and fingers were tingly. The patient received treatment for the events. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Other Meds:

Current Illness:

ID: 1770767
Sex: F
Age:
State:

Vax Date: 03/09/2021
Onset Date: 03/09/2021
Rec V Date: 10/08/2021
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: head started to itch; hives all over her scalp that travelled to her chin, neck, and back down to shoulder blades; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered anatomical location not reported, on 09Mar2021 16:00 (at the age of 45-year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. On 09Mar2021 19:00, the patient head started to itch, patient had hives all over her scalp that travelled to her chin, neck, and back down to shoulder blades. The patient stated she took BENADRYL to treat with no relief and then took another BENADRYL 20 minutes later and the symptoms finally began to subside. The patient wanted to know if she should get the second dose. The patient asked if it is okay to delay the second dose of the vaccine and what if she waits a whole year to get the second dose. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1770768
Sex: F
Age:
State: NE

Vax Date: 03/14/2021
Onset Date: 03/14/2021
Rec V Date: 10/08/2021
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 Name: Blood pressure; Result Unstructured Data: Test Result:170/120; Test Name: Blood pressure; Result Unstructured Data: Test Result:128/103; Test Name: Bloodwork; Result Unstructured Data: Test Result:Normal; Test Name: EKG; Result Unstructured Data: Test Result:Normal; Test Name: Urine sample; Result Unstructured Data: Test Result:Normal

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Occipital neuralgia; neck pain and Inflammation of front of neck; Soreness of upper back on right side; neck pain and Inflammation of front of neck; Tender right ear; Headache; This is a spontaneous report from a contactable consumer (patient). A 36-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EN6207, Expiry date: unknown) (age at the time of vaccination was 36 years) via intramuscular route, administered in arm left on 14Mar2021 13:15 DOSE NUMBER UNKNOWN, SINGLE DOSE for COVID 19 immunization. The patient's medical history included slightly elevated blood pressure on Jul2020, heart health, familial risk factor of high blood pressure, historical vaccine included MMR for immunization on an unknown date in 2018. She may have had slightly elevated blood pressure due to stress last year, but she exercises regularly and is a pretty healthy person. She does not typically get a flu shot because she has been so healthy. She really has not has a lot of vaccines put in her body, so that was why they were wondering if this was a bad reaction to this one. The patient's medical History (including any illness at time of vaccination) was none. Concomitant medications included Amlodipine, lisinopril, B12 (cyanocobalamin) at a dosage of 1000 ug once a day from 2019, Fish oil at a dosage of 1290 mg twice a day orally for heart health, Juice plus vitamin twice daily orally from 2019, calcium magnesium blend 1000mg/500mg, 2 per day, by mouth. The patient did not take any other vaccine in four weeks prior COVID -19 vaccine. She was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. She did not take any other vaccine in four weeks prior COVID -19 vaccine. In Jul on an unspecified year, the patient had vitality check for an insurance discount, the patient's blood pressure increased during blood draw. Maybe it was slightly elevated before. The physician suggested to stop taking all supplements until her blood pressure leveled out and to start vegan diet. Caller says she thinks she may have had an adverse reaction to the Pfizer vaccine. She received the shot on Sunday at 1:15 and by 3:00 she had a headache on the right side of her head. She took ibuprofen for that and it seemed to help, but then Monday the headache returned and lasted all day. She started to get severe pain at a specific point near her right ear, and it was exceptionally tender. She waited to see what was happening, then Tuesday it was even more severe, she started to have neck pain and inflammation in front of the neck. She began to take Tylenol because her sister in law suggested she switch but that did not help. Wednesday at the end of her workday she went to the doctor and her blood pressure was 170/120. She had a stressful work week prior to getting the shot. With the mask this year she hasn't been staying as hydrated. She is a teacher, so at work it has been really stressful this year. She said her blood pressure may have been slightly elevated prior to receiving the shot, she doesn't know. It had been so long since her last physical she did not know. She was treated for occipital neuralgia that might be a possible side effect she experienced in addition to the huge spike in blood pressure. She did not know if someone else might have an increase in blood pressure because this was relatively new, so someone else may have experienced the same thing. Again of note, her blood pressure could have been high prior to the shot. She has been under a lot of stress, but that 90 percent of America right now. She received the shot at 1:15 and the headache started about 3:15. She said it was ongoing. The doctor said it was probably a result of the blood pressure and occipital neuralgia she is experiencing. The headache is getting a little better as her blood pressure is going down. The doctor put her on blood pressure lowering medication to bring it down, and as it was going down it was improving slightly but the headache was still persistent. Near her right ear, that's the occipital neuralgia, it was like a spot on the back right kind of where the neck and the base of the skull is, there was a spot that is so tender if you press on it. The inflammation on the front of her neck started on Wednesday, that's when everything was happening. The headache, the spot on the back of her head, and the inflammation in the neck. She started having soreness of the upper back on the right side. The inflammation of the neck has slowed down some after she saw the doctor and he put her on Gabapentin which was a nerve pain medication. She thinks it would have been yesterday it started to calm down a little bit. The entire right side was inflamed so it's not entirely better. On her Gabapentin she sees an Rx number, she says it is in an amber colored pharmacy bottle. It says standard white capsule, 100mg, there is a 5 digit number but she does not think that was a lot number. She does not see an NDC, lot, or expiration date on the pharmacy vial. He also put her on blood pressure medication, Amlodipine, and that did not help. He went one step forward and added Lisinopril. It was still elevated, last time she checked it was 128/103. That blood pressure number after increasing the dosage of the blood pressure medication and taking her blood pressure every hour on the hour. It was a slow process to bring it back down. Her Amlodipine and Lisinopril are also in amber colored pharmacy bottles. She does not have NDC, lot, or expiration to provide from the label. She did have to go for additional lab work. EKG, bloodwork, and urine sample. All of those came back normal. She doesn't have those results, her doctor certainly would. The outcome of the events headache, occipital neuralgia, tender right ear, neck pain and Inflammation of front of neck was not resolved and unknown for other events. No follow up attempts are possible. No further information was expected.

Other Meds: B12 [CYANOCOBALAMIN]; FISH OIL; AMLODIPINE; LISINOPRIL

Current Illness: Elevated BP; Heart disorder

ID: 1770769
Sex: F
Age:
State: AZ

Vax Date: 02/27/2021
Onset Date: 02/27/2021
Rec V Date: 10/08/2021
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: She could not swallow; throat swelled up; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program Support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 27Feb2021, the patient experienced throat swelled up/swollen throat. She could not swallow. She took her second dose of the vaccine on 22Mar2021 as scheduled. She experienced throat swelling after second dose as well as first dose. She had difficulty swallowing after first dose, but not second dose. The reporter added that the throat swelling was not visually verified by HCP. She was monitored at vaccination site both times by HCP and throat swelling resolved on its own within 30 minutes without need for intervention. The outcome of the event she could not swallow was unknown. The outcome of the event was throat swelling was recovered. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1770770
Sex: F
Age:
State: CA

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 10/08/2021
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: pain that went down to her legs; headaches; earaches; fever; chills; arm pain that migrated to her hand and causing her not to be able to work the equipment at her physical therapy job; body aches; left leg nerve pain; weakness in the patient's hand; arm pain that migrated to her hand and causing her not to be able to work the equipment at her physical therapy job; Caller states his daughter was suppose to receive 0.3 ml of the vaccine but she received 0.8 ml of the vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A 22-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6205, expiration date: not reported) via an unspecified route of administration, administered in Left arm on 26Feb2021 at around noon, 11:45 (at the age of 22-years-old) as dose 1, 0.8 ml single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. No family medical history relevant to AE. History of all previous immunization with the Pfizer vaccine considered as suspect was not reported. Neither received Prior Vaccinations (within 4 weeks) nor AE(s) following prior vaccinations. On 26Feb2021, patient stated that his daughter was suppose to receive 0.3 ml of the vaccine but she received 0.8 ml of the vaccine (Overdose), On an unspecified date, patient experienced pain that went down to her legs, headaches, earaches, fever, chills, arm pain that migrated to her hand and causing her not to be able to work the equipment at her physical therapy job, body aches, left leg nerve pain, weakness in the patient's hand. Patient took treatment of prednisone for 5 days. The outcome of event for arm pain that migrated to her hand and causing her not to be able to work the equipment at her physical therapy job was not recovered. outcome of his daughter was suppose to receive 0.3 ml of the vaccine but she received 0.8 ml of the vaccine was unknown and rest all events outcome was recovered in an unspecified date of 2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1770771
Sex: F
Age:
State: NY

Vax Date: 03/12/2021
Onset Date: 03/13/2021
Rec V Date: 10/08/2021
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 Name: fever; Result Unstructured Data: Test Result:102; Test Name: fever; Result Unstructured Data: Test Result:100

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: white noise/ white noise in her head; threw up; neck hurt; headache/ wicked headache; Nausea; scared; chills; tremors; shaking; high fever continued fever went up and down Saturday night; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6207 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 12Mar2021 (age at vaccination: 60 years), as a single dose for COVID-19 immunization at Clinic. The patient taking Covid vaccine due to build up her immunity for covid. Vaccine was not administered at Military Facility. The patient's medical history included kidney transplant. Concomitant medications included mycophenolate mofetil (MYCOPHENOLATE), tacrolimus (PROGRAF), sirolimus, famotidine, metoprolol succinate, rosuvastatin calcium, sulfamethoxazole, trimethoprim, furosemide, and acetylsalicylic acid (BABY ASPIRIN). The patient did not receive any vaccine prior vaccinations within 4 weeks. The patient reported that she was immunosuppressed because she had a kidney transplant. She had a severe reaction which scared her on 13Mar2021; not sure she wanted to get the 2nd one and asked was it a normal reaction. She received the shot on Friday morning around 10:30 and not much happened. Probably about 1pm on Saturday, she started feeling a little off, nothing major, just off. When she got home from work around 3 she ate and went to bed, slept for 3 or 4 hours. On 13Mar2021, by 7pm Saturday night she had chills/tremors/ shaking thing for a while went into a high fever continued fever went up and down Saturday night. Sunday morning on 14Mar2021, she had threw up a little bit, tremors again really bad. Her fitbit recorded it as a bicycle ride. Tremors stopped then fever again. She was good early Sunday afternoon and fever again Sunday night until 11:00-12:00. Monday when she woke up the fever was gone, but had a headache and white noise, weird in her head. Tuesday morning, she still had a slight headache. Going through it; it was scary. There was no report related to a study or programme. She thinks on Saturday, her temperature was just over 100 degrees and then when that stopped, she fell asleep and woke back up with another fever. She stated then when she woke up Sunday morning, she felt a little nauseous, not awful nausea, but a little nausea and she had a wicked headache. She could tell the fever was back but was not as high. She got up, took a Tylenol, and immediately threw that up, so she laid down a little bit longer and she could tell her fever was going up so did get up and took another Tylenol which stayed down and it was fine. About 7:00ish, she started getting tremors again but this time she didn't hold herself really tight, and her arms were flopping, her head, her whole body was flopping around. Then, after that, she got a fever again that went up to 102 and that lasted for a while and then she came off of that. At that point, she was okay, her head still hurt and neck hurt but she thought it was done. About 5pm, she got hungry and had something to eat, and she was fine. She went back to bed and then probably around 10:00pm that night, she started getting the fever again and this lasted until 1-2 and again it was pretty high so she took Tylenol again and iced herself. The next morning when she woke up the fever was gone and the shakes were gone, but her head was really weird and her neck hurt, she had a headache. She also had a white noise in her head all day long, which was kind of weird. Tuesday when she woke up, she still just had a slight headache, she took a Tylenol and then it was gone, and that was the end of it. She clarified on Sunday, the tremors lasted for at least 15 minutes. She stated she did have the tremors on both days in two sessions, and the fever also. The patient mentioned with the nausea, she had a little bit later on Saturday, but it was more on Sunday. The nausea ended about mid-day 14Mar2021. The adverse events did not require a visit to emergency room and physician office. There was a Product Complaint and description of Product Complaint included Tylenol: Caller was reporting adverse events with COVID vaccine. While providing information, caller stated she felt a little nauseous, she had a wicked headache and she could tell the fever was back but was not as high. She got up, took a Tylenol, she immediately threw that up, laid down, could tell her fever was going up and took another one. She states she got a fever again, that went up to 102 and that lasted for a while and then she came off of that. Caller stated she went back to bed and then 10:00pm that night she started getting the fever again and lasted until 1-2am and again it was pretty high and took Tylenol again. Tylenol: She clarified it is not Tylenol, it was the cheaper brand, Equate, she thinks that was the(Name) brand. LOT: P118837 EXP: Jan2022, Product strength and count size dispensed: 250mg tablets. Caller states she probably took just one on Saturday and she took two on Sunday. Additional lot numbers: N/A, Is a sample of the product available to be returned, if requested (Y/N)? Not provided Packaging sealed and intact? Not provided. Sulfamethoxazole TMP DS: Caller states she takes it every other day. She stated it was some kind of antibiotic, something that normal people have that she does not have. She states it was a single dose, no mg listed, so she has no idea the dose. NDC, Lot number and expiry date not provided. The patient underwent lab test and procedure included fever with 100 and 102 on an unspecified date. Outcome of the event neck hurt was resolved on 15Mar2021, high fever continued fever went up and down Saturday night, headache/ wicked headache, white noise/ white noise in her head was resolved on 16Mar2021, and for all other events, it was resolved on 14Mar2021. No follow-up attempts are possible. No further information is expected.

Other Meds: MYCOPHENOLATE; PROGRAF; SIROLIMUS; FAMOTIDINE; METOPROLOL SUCCINATE; ROSUVASTATIN CALCIUM; SULFAMETHOXAZOLE+TRIMETHOPRIM; FUROSEMIDE; BABY ASPIRIN

Current Illness:

ID: 1770772
Sex: F
Age:
State: CT

Vax Date: 03/14/2021
Onset Date: 03/18/2021
Rec V Date: 10/08/2021
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: This is a spontaneous report from a contactable consumer (patient). A female patient, of unspecified age, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, on Mar 14, 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. She received the 1st dose on Mar 14, 2021. On Thursday, Mar 18, 2021, there was swelling and a weltering rash on the outside of her neck. She had an extreme sore throat on Mar 2021. She asked how she can treat these. She was still experiencing these side effects. The outcome of events: not recovered. No follow-up attempts possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1770773
Sex: F
Age:
State: MI

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 10/08/2021
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: coughing; scratchy sore throat; scratchy sore throat/painful in her throat and chest; stuffed up and congested; Runny eyes; painful in her throat and chest; when she touches the injection site, it is warm feeling and is still painful; when she touches the injection site, it is warm feeling and is still painful; extreme tiredness; Chills; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EN6207, Expiry date: unknown) (age at the time of vaccination was 60 years) via intramuscular, on 18Mar2021 at 12:15 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included type 2 diabetes, low immune system, asthma, allergies, covid around the middle of Dec2019 to the middle of Mar2020, patient lost 80 pounds, depression, migraine, arthritis, low thyroid and hiatal hernia, brother had triple heart bypass surgery in 2019. Concomitant medications included Elavil (amitriptyline hydrochloride) tablet 30 mg, 1x/day [10 mg by mouth, tablets, 3 at bedtime] for depression, Hydroxychloroquine 200 mg, 1 in the morning 1 in the evening, by mouth, tablet for arthritis, Zanaflex at a dosage of 4 mg, one in the morning, by mouth, Synthroid 88 mcg one in the morning by mouth for low thyroid, Celexa at a dosage of 40 mg one in the evening, Protonix at a dosage of 40 mg one in the morning and one in the evening by mouth for hiatal hernia, Keppra at a dosage of one in the morning, one in the evening with dinner by mouth, Potassium chloride at a dosage of 20meq ER one in the morning by mouth, Myrbetriq at a dosage of 25 mg one at bedtime by mouth, Singulair at a dosage of 10 mg one at bedtime by mouth, Petadolex at a dosage of 50 mg one in the morning and two at dinner time by mouth, Metformin ER at a dosage of 500mg one in the morning by mouth, Nature's way black cohosh at a dosage of two with dinner by mouth as vitamin supplement, Probiotic at a dosage of two at lunchtime by mouth, Osteo bi-flex at a dosage of one in the morning, and one at bedtime. No dosage written on the paper, Calcium with vitamin d3 at a dosage of 600mg, takes one in the morning and one at dinner, by mouth, Iron at a dosage of 27 mg one at dinner time, Frova at a dosage of 2.5mg every two hours for diarrhea. The patient did not take any other vaccine in four weeks prior COVID -19 vaccine. She was diagnosed with COVID prior vaccination and not tested with COVID post vaccination. On 19Mar2021 at around 09:00 AM, the patient coughs hard, so that it was painful in her throat it comes and goes and when it does come. The patient had scratchy sore throat and chills. The patient was coughing hard, so that it was painful in her throat and chest. It remained for three months that she was so sick with the coughing except this time. The patient does not have the diarrhea or throwing up. The patient had injection site, it was warm feeling and was still painful to the touch. The patient felt tired last night. The patient was not coughing or having a sore throat and congested. The patient was having runny eyes that started this morning. Stuffed up and congested/congestion started this morning. The patient's brother got the first vaccine and never got sick but his wife. The patient does not know the symptoms of his brother's wife. The outcome of the events was not resolved. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds: ELAVIL [AMITRIPTYLINE HYDROCHLORIDE]; HYDROXYCHLOROQUINE; ZANAFLEX; SYNTHROID; CELEXA [CELECOXIB]; PROTONIX [OMEPRAZOLE]; KEPPRA; POTASSIUM CHLORIDE; MYRBETRIQ; SINGULAIR; PETADOLEX; METFORMIN ER; NATURE'S WAY BLACK COHOSH; PROBIOTIC [BIFI

Current Illness: Allergy; Arthritis; Asthma; Depression; Hiatal hernia; Hypothyroidism; Immune system disorder; Migraine; Type 2 diabetes mellitus

ID: 1770774
Sex: F
Age:
State:

Vax Date: 03/04/2021
Onset Date:
Rec V Date: 10/08/2021
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: the shot "felt warm" when injected; metallic taste in her mouth; itchiness in her nose, ears, and throat; rash at the injection site; severe headache; hands and feet swelled; she doesn't feel comfortable; inflammation; I had delayed allergic reaction; I have chronic issue with inflammation and respiratory to begin with; I'm a little bit nervous; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Strength: unknown, Batch/Lot Number: unknown), dose 1 in the left arm on 04Mar2021 as Dose 1 SINGLE for covid-19 immunization (Age at vaccination was 65-Years-old). The patient medical history included she had sinuses and inflammation. On an unspecified date the patient had Injection site warmth, metallic taste in her mouth, itchiness in her nose, ears, and throat, rash at the injection site, severe headache, hands and feet swelled, discomfort, inflammation, allergic reaction. The reporter reported that she talked to her doctor's office this morning, so she had this first injection of Pfizer one almost 3 weeks ago and she was scheduled to have the second one on Thursday. she had delayed allergic reaction about 5 hours later. It had been what she considered she had allergies on her life and primarily medication (Captured as Unspecified medication) but she was considered moderate. she didn't have breathing issues, but she had the nose and the itchy eyes, ears and throat then she got the mouth reaction like on the warm parts on her arm you know like. So they didn't affect her breathing. Then the next day she had swelling in my left side in my arm, the whole way end to her back, even her hands were swollen for 2 days. The patient reported that for 3 days she had got inflammation. She worked for agency. she was responders. So she had lot more sensitivities from work you know at a site (Intent: History). So she had chronic issue with inflammation and respiratory to begin with. So she called her doctor today to see if maybe she should do some Benadryl or something before, she went. she was nervous about taking the second shot because she had such a moderate reaction to the first shot (Further not confirmed hence captured as unspecified shot). The outcome of the events was unknown. Follow-up attempts are completed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1770775
Sex: M
Age:
State:

Vax Date: 03/19/2021
Onset Date: 03/22/2021
Rec V Date: 10/08/2021
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 repot from a contactable consumer (patient's wife). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), on 19Mar2021 as DOSE 1, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was vomiting black substance, having a black stool, fever, feeling dizzy and weak. Symptoms started on 22Mar2021. Asking if black stool and vomiting black substance was part of side effects of the vaccine and if he will be eligible for the 2nd dose. The outcome of the events was unknown. No follow-up attempts are Possible. Information about lot/batch number cannot been obtained.

Other Meds:

Current Illness:

ID: 1770776
Sex: M
Age:
State:

Vax Date: 03/08/2021
Onset Date:
Rec V Date: 10/08/2021
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: arm pain at the injection site; The injection site itched; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 69-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 08Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 08Mar2021, patient received the first dose of the Pfizer COVID 19 vaccine and still having arm pain at the injection site. How long does the pain usually last. The injection site itched for a couple days after the shot. Patient was 69 years old. And asking Should he get the 2nd dose. The outcome of the event the injection site itched was unknown. The outcome of the event arm pain at the injection site was not recovered. No follow-up attempts are possible; No further information is expected.

Other Meds:

Current Illness:

ID: 1770777
Sex: F
Age:
State: WV

Vax Date: 03/17/2021
Onset Date: 03/17/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: diarrhea; cramping; joint pain; nausea; achy all over; flu-like symptoms; headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient (Age 72; units: Unspecified) received first dose of bnt162b2(PFIZER-BIONTECH COVID -19 VACCINE, Solution for injection, Lot Number and Expiry date was not reported) via an unspecified route of administration on 17Mar2021 as dose 1, single for COVID-19 immunization. Medical history included asthma and diabetes mellitus. The patient concomitant medications were not reported. On 17Mar2021, patient had a slight headache, the next day (18Mar2021) she had a terrible headache, joint pain and nausea, she felt achy all over (flu-like symptoms) and she took Tylenol. On Friday she was fine but from Saturday until today (3 days) she had diarrhea and cramping. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1770778
Sex: M
Age:
State: MO

Vax Date: 03/20/2021
Onset Date: 03/21/2021
Rec V Date: 10/08/2021
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: sore right arm by the injection site/sore arm; He woke up on Sunday morning with an expected sore right arm by the injection site.; pain under his right armpit/dull pain under his right arm, in the armpit area, that progressively got worse as the day went on; pain under his right armpit/It became swollen; He went to sleep but woke up at 4am this morning; it was inflamed.; This is a spontaneous report from a contactable consumer (patient). A 61-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injec-tion, Batch/Lot Number: ER8727; Expiration Date: was not reported), via an unspecified route of administration, administered in Arm Right on 20Mar2021 15:15 (age at vaccination 61-years-old)) as dose 1, single for COVID-19 immunization. Medical history included di-verticulum from an unknown date and unknown if ongoing , hypertension (high blood pressure ) from an unknown date and unknown if ongoing , food allergy (seafood)from an un-known date and unknown if ongoing. The patient's concomitant medications included maintenance pills for his high blood pressure. Previously patient received Shingles/SHINGRIX on Dec2021 for an unspecified indication and he takes the Flu shot each year with no adverse events. The patient previously took hydrocodone and experienced hypersensitivity. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID- 19. It was re-ported that he received the 1st dose of the Pfizer Covid19 Vaccine Last Saturday afternoon (20Mar2021 at 15:15). Staff where he received it explained some common symptoms and told him that a sore arm is the biggest complaint that they have. He woke up on 21Mar2021 (Sunday) morning with an expected sore right arm by the injection site. Later that day, he noticed a dull pain under his right armpit which progressively got worse and really getting sore. It became swollen and it would be aggravated once he moved a certain way. He went to sleep but woke up at 4am this morning and he noticed that it was really sore so he took some Tylenol and was able to sleep. Today it was still noticeable and sore but it was not quite as bad as it was yesterday. He mentioned that he was fine until about 24 hours after his shot when it started to really bother him. He was concerned because nobody else he knows who get the vaccine experienced this side effect other than him. They experienced other side effects but nothing like him. He mentioned that he saw on the fact sheet that there was swollen lymph nodes and would like to confirm if this is a common side effect. He will be consulting with his doctor this Wednesday. He slept last night and didn't take any Tylenol, but he took Tylenol this morning for pain in the arm pit and that really seemed to lessen it up. Treatment received: Tylenol helped his pain this morning. Clarified he took Tylenol 500mg Extra Strength and he took 2 tablets one time at 0600. He mentions he doesn't like to take Acetaminophen more than he has to. He should have taken it last night before he went to bed, but whatever. Since the vaccination, patient was not tested for COVID-19. The outcome of the events he went to sleep but woke up at 4am this morning and it was inflamed was unknown and rest all events was recovering. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1770779
Sex: M
Age:
State: CA

Vax Date: 02/24/2021
Onset Date: 03/01/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data: Test Name: X-ray left foot; Result Unstructured Data: Test Result:no result

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Left foot joint pain (gout) several days after receiving 1st vaccine shot; Left foot joint pain (gout) several days after receiving 1st vaccine shot; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN 5318), via an unspecified route of administration, administered in Arm Left on 24Feb2021 15:30 (at the age of 48-year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient had no allergies to medications, food, or other products. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced left foot joint pain (gout) several days after receiving 1st vaccine shot. The patient had started to notice the adverse event on left foot on Monday, 01Mar2021. Monday, 01Mar2021 was when he had first noticed the adverse event (joint pain) on his left foot after he had received the 1st dose of Pfizer vaccine on Wednesday, 24Feb2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and received treatment. The patient was prescribed Colchicine. The patient underwent lab test an procedure X-ray left foot on an unspecified date. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1770780
Sex: F
Age:
State: NY

Vax Date: 03/20/2021
Onset Date: 03/20/2021
Rec V Date: 10/08/2021
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: itch/itching after receiving the vaccine; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient). A female patient of age 63 (units unknown) received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 20Mar2021 12:00 as dose 1, single for covid-19 immunization. Medical history and concomitant medications were not reported. Patient known allergies included as included penicillin allergy from an unknown date and unknown if ongoing. It is reported that, patient got Pfizer's covid vaccine on 20Mar2021 at noon and sat for the half hour to be monitored after the vaccine. On the same date 20Mar2021 at 5 pm, about 5 hours later, she had a slight itch and it was very mild. Outside of the itch, she has had no other symptoms and also stated it was now 48 hours after her first vaccination and the itching was very mild but she still has it. She does not know if the itch was related to the vaccine, it was not a side effect from what she understands. She did not have itching before the vaccine but has it after. Patient was asking that if she get the second one, as she heard the side effects could be worse with the second shot. She was not seeking medical advise but wanted to know if itching was a side effect of the vaccine. No Investigation Assessment was provided. The outcome of the event was not recovered. No follow up attempts are possible. Information about Lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1770781
Sex: M
Age:
State: PA

Vax Date: 03/19/2021
Onset Date: 03/20/2021
Rec V Date: 10/08/2021
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: face was all swollen up; This is a spontaneous report received from a contactable consumer. A 52-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number and expiry date was not reported) via intramuscular, administered in Arm Right on 19Mar2021 11:45 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medication was not reported. On 20Mar2021 10:00, patient experienced Face swelled up. Patient wanted to know if facial swelling be an allergic reaction to the vaccine or is it something else. Patient went back to work and worked that night and went to bed and woke up the next day with his face totally swollen. He read the literature and it said facial swelling could be an effect. He is not on any other medications. Vaccination facility type was Hospital. NO ER or physician's office required. Patient did not received any vaccine Prior Vaccinations.. Outcome of the event was recovering. Information about batch/lot number has been requested. Follow-up (22Mar2021): This is a Follow-up spontaneous report from a contactable consumer. This male consumer (patient) reported that: Route of administration, Time of vaccination and time of AE was added. Case summary added. No follow-up attempts are needed; information about lot/batch number cannot be obtained. No information expected.

Other Meds:

Current Illness:

ID: 1770782
Sex: M
Age:
State: MI

Vax Date: 03/04/2021
Onset Date: 03/05/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data: Test Name: he tested positive; Result Unstructured Data: Test Result:Positive; Comments: he tested positive last year Apr of Covid

Allergies:

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

Symptoms: Scheduled for the second Pfizer Covid vaccine on 25March2021, caller canceled the appointment due to traveling; Body aches; Fever; Chills; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 04Mar2021 as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 05Mar2021 the patient experienced body aches, fever, chills. scheduled for the second pfizer covid vaccine on 25march2021, patient canceled the appointment due to traveling. The following morning caller experienced body aches, fever & chills. Caller voiced that he previous spoke with someone about the symptoms, he needed to know about scheduling. Per caller he noticed in New York Times that if you have tested positive for Covid in the past you only need one vaccine. Asking if he only needs the one Pfizer Covid vaccine or both. The caller got the first dose last 04Mar and second dose was on 25Mar, however he wants to move his second dose to later date because he needs to be somewhere, more so he tested positive last year April of Covid and after his first shot he experienced the same symptoms of Covid like fever chills and body ache for 24 hours .The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on he tested positive last year Apr of Covid. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1770783
Sex: M
Age:
State: OH

Vax Date: 03/19/2021
Onset Date: 03/01/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data: Test Date: 20210102; Test Name: COVID test; Result Unstructured Data: Test Result:Positive

Allergies:

Symptom List: Unevaluable event

Symptoms: Loss of taste and smell; Loss of taste and smell; Brain fog; Problems breathing/had some difficulty breathing that was not labored but it was hard to catch a deep breath; injection site pain; Strong fatigue/had tiredness and fatigue; had a minor headache; Muscle and joint pain; Chills; Muscle and joint pain; Fever; feeling unwell; Loss of appetite; later on had swollen lymph nodes under his left armpit; was sweating and sweating off heat; had soreness; definitely had weakness and if he had dizziness it was minimal or non-existent; definitely had weakness and if he had dizziness it was minimal or non-existent; injection site swelling; he is at a loss for words; This is a spontaneous report from a contactable consumer or other non health care professional. A 60-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6207) via an unspecified route of administration in arm left on 19Mar2021 13:00 as dose 1, single (at the age of vaccination of 60-year-old) for COVID-19 immunization. Historical vaccine included shingrix shingles shot, dose 1 administered on 07Nov2020 and dose 2 administered on 20Feb2021. Patient's medical history was none. Patient's COVID test was positive on 02Jan2021. On an unspecified date in Mar2021, experienced loss of of taste and smell, problems breathing and injection site pain. Patient stated that was part of the problem with his brain fog and he figured it was a bunch of things. Patient stated he had possible injection site pain which he was sure everyone had, stated he had tiredness and fatigue, had a minor headache, had minor muscle pain, chills definitely, had minor joint pain and certainly had a fever after receiving the bnt162b2 vaccine. Patient also stated he was sweating and sweating off heat and his girlfriend felt heat coming off of him; states he might have had injection site swelling but nothing that was unexpected; had soreness of course. Patient had nausea but was feeling unwell and absolutely loss of appetite and later on had swollen lymph nodes under his left armpit which was the side he had his bnt162b2 vaccine. Patient had some difficulty breathing that was not labored but it was hard to catch a deep breath; states he had no swelling of the face or throat, did not have a fast heartbeat and did not have a rash. Patient stated he definitely had weakness and if he had dizziness, it was minimal or non-existent and also clarified to state he had a lot of fatigue and overwhelming means he was in a coma and he was not in a coma. Patient stated his side effects were a bit more mental and he was at a loss for words which is more like the brain fog and honestly what he experienced after the bnt162b2 vaccine was like a mini COVID infection for like 30 hours and everything he experienced after the vaccine was like before when he had covid plus a few more things and then the side effects disappeared very suddenly and he would say in the morning (also reported as 06:00 am) on 22Mar2021. He was his old self and knew this was a possibility with the bnt162b2 vaccine. Events did not require emergency room or physician office visit. The patient underwent lab tests and procedure: patient's COVID test was positive on 02Jan2021. Outcome of all the events was recovered on 22Mar2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1770784
Sex: U
Age:
State: DE

Vax Date:
Onset Date:
Rec V Date: 10/08/2021
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: joint pain; chilling; This is a spontaneous report from a contactable consumer (patient's friend). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose number unknown, single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced joint pain and chilling on an unspecified date. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1770785
Sex: F
Age:
State: MA

Vax Date: 03/06/2021
Onset Date: 03/06/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data: Test Date: 20210313; Test Name: Nasal Swab; Test Result: Negative ; Comments: Rapid test

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: dry itchy eyes; dry itchy eyes; swollen red irritated eyes; swollen red irritated eyes; This is a spontaneous report from a contactable consumer (patient herself). A 59-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EN6199), via an unspecified route of administration, administered in Arm Left on 06Mar2021 13:00 (at the age of 59 years old )as dose 1, single for COVID-19 immunization. Medical history included ongoing hypertension (It's been 4 to 5 years), asthma (It's been 4 to 5 years), gastroesophageal reflux disease (I do not think that is an issue but I just thought to bring it out but I might have GERD). Concomitant medication(s) included HYDROCHLOROTHIAZIDE taken for hypertension daily once, ALBUTEROL SULFATE. Last year she had a bunch of vaccine, she usually do not do vaccine but with the COVID she thought do her vaccine. So, she did the flu vaccine, shingles vaccine and pneumonia vaccine and she was fine with all those vaccine, at the end of the year. No pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She had the 1st vaccine shot on March 6th and she did had a reaction and just wanted to know if she was okay to get the second shot. The patient reaction was like three hours after this shot on 06Mar2021 at 16:00 dry itchy eyes and swollen red irritated eyes. It was reported that her eyes started bothering her, very irritated and dry. The patient did not think anything about it till the next morning when her eyes were swollen, red and very irritating. She kind of like searched online it in the afternoon. The patient know this is a reaction, she do not have eye issues like she do not have dry eye issue. So that day she had put her cold compresses on and in the afternoon she ended up taking an anti-histamine and said on Saturday she got the shot and Saturday late afternoon and started having some issues, Sunday morning it definitely 'flared off' and then Monday morning she was totally fine so, a day and half of the irritation but just wanted to make sure that is not going to be worse with the second shot. She did go online that day and filled out information on the website and today she just saw that the same information on the Pfizer website. The patient reported that the patient only take the inhaler before exercising and she do not do it all the time and just do it when she feel like she having trouble breathing or it is not very consistent. She do not take it a lot. On 06Mar2021 16:00 the patient experienced dry itchy eyes and swollen red irritated eyes. The patient underwent lab tests and procedures which included sars-cov-2 test (rapid test) COVID test type-Nasal Swab and result was negative on 13Mar2021. Therapeutic measures were taken as a result for all the events. The outcome of the events was recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: HYDROCHLOROTHIAZIDE; ALBUTEROL SULFATE

Current Illness: Asthma (Asthma It's been 4 to 5 years. ); Blood pressure high (Blood pressure high "It's been 4 to 5 years." daily once tablet)

ID: 1770786
Sex: F
Age:
State: CA

Vax Date: 03/05/2021
Onset Date: 03/01/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data: Test Date: 20210312; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: I was so congested I thought I was getting a very bad cold or Flu.; I was so congested I thought I was getting a very bad cold or Flu.; I was so congested I thought I was getting a very bad cold or Flu.; And then for the next 9-days I had a very high fever; chills, body aches and So tired; chills, body aches and So tired; chills, body aches and So tired; my arm was sore; but was too sick to go to the doctors; I still do not feel back to my normal self; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female patient received BNT162B29 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration in left arm on 05Mar2021 02:00 PM (at the age of 64-years-old) as dose 1, single for covid-19 immunization. The patients medical history include High Blood Pressure, Sinuses constantly, Chronic Pain. The patient concomitant medications (medications in two weeks) include buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE), methylphenidate hydrochloride (RITALIN), Lisinopril, Hydrochloride, drospirenone, ethinylestradiol (DIVA). Patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine and was tested to COVID post vaccination. On 12Mar2021 patient had undergone with Nasal Swab test which resulted as negative. Patient had the 1st shot on Friday 05Mar2021, she was fine, Saturday 06Mar2021, her arm was sore, then Sunday 07Mar2021 09:30 AM when she woke up she could barely talk and she was so congested she thought she was getting a very bad cold or Flu. And then for the next 9-days she had a very high fever, chills, body aches and so tired she would have to sit down on the stairs in her house, and it just kept going on with no relief. she made a doctor appointment for 18Mar2021 but was too sick to go to the doctors. Patient still do not feel back to her normal self. She was afraid to get the 2nd shot on 26Mar2021, she called the health department in which where she received her 1st shot and was told to go to the appointment and let them know. And made a decision then, but she already know that she can't go through the side effects. Patient had not received any treatment for the events I was so congested I thought I was getting a very bad cold or Flu, chills, body aches and So tired, And then for the next 9-days I had a very high fever, my arm was sore. Outcome of events I was so congested I thought I was getting a very bad cold or Flu, chills, body aches and So tired, And then for the next 9-days I had a very high fever, my arm was sore recovering and for the events I still do not feel back to my normal self was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

Other Meds: SUBOXONE; RITALIN; LISINOPRIL; DIVA [DROSPIRENONE;ETHINYLESTRADIOL]

Current Illness:

ID: 1770787
Sex: M
Age:
State: VA

Vax Date: 03/17/2021
Onset Date: 03/01/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data: Test Date: 202103; Test Name: body temprature; Result Unstructured Data: Test Result:102; Comments: it came down to 98

Allergies:

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

Symptoms: dizziness; tiredness; headaches; body pains; muscle aches and pain; chills; fever; nausea; some vomiting; rapid heart beats; breathing problems; Soreness in arm; This is a spontaneous report from a contactable consumer or other non hcp (patient himself) via medical information team and Pfizer- sponsored program Support. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported, Expiry date: Unknown) via an unspecified route of administration on 17Mar2021 16:30, as dose 1, single for COVID-19 immunization. Medical history included Seasonal asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 19Mar2021, the patient experienced tiredness, headaches, body pains, muscle aches and pain, chills, fever, nausea, some vomiting, rapid heartbeats, breathing problems, on an unspecified date in Mar2021, experienced soreness in arm and on an unspecified date, experienced dizziness. The caller went to work Thursday and Friday and there were no problems. Friday night it started going downhill. The patient underwent lab tests and procedures which included body temperature: 102 on unspecified date in Mar2021 and it came down to 98. The outcome for tiredness, body pains, chills, fever, nausea, some vomiting, rapid heartbeats, breathing problems, soreness in arm and dizziness was unknown. The outcome of events headaches, muscle aches and pain were not recovered. The outcome for fever was recovered on unspecified date in Mar2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : -PFIZER INC-2021316682 same reporter/drug/event, diff patients

Other Meds:

Current Illness:

ID: 1770788
Sex: M
Age:
State: TX

Vax Date: 02/02/2021
Onset Date: 02/01/2021
Rec V Date: 10/08/2021
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: Test Name: SARS-CoV-2 test; Test Result: Negative

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: This is a spontaneous report from a contactable other health care professional (patient). This case is of first dose. A 70-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EN5318), via intramuscular route of administration, administered in left deltoid, on 02Feb2021 16:00 (at the age of 70-year-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing Lymphocytosis (diagnosed after colonoscopy, has gas and diarrhea every day for over a year and a half), ongoing klinefelter's syndrome (diagnosed 40 years ago), ongoing sleep apnoea syndrome (diagnosed about 13 years ago), allergic to peas, beans, and that type of thing and peanut butter from an unknown date and unknown if ongoing, arthritis from an unknown date and unknown if ongoing. Concomitant medications included testosterone cipionate (DEPO-TESTOSTERONE) taken for klinefelter's syndrome, started taking 40 years ago, last shot was 3 weeks ago, delayed getting another shot so patient does not mess up the bloodwork; buspirone hydrochloride (BUSPAR) taken for anxiety, started taking 7 years ago; bupropion hydrochloride (WELLBUTRIN) taken for depression, takes generic of Wellbutrin, taken for 7 years; C-PAP Machine, taken 13 years ago. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EL9266, Expiry date May2021), via an unspecified route of administration, administered in left deltoid, on 23Feb2021 11:00 (at the age of 70-year-old) as dose 2, single for COVID-19 immunization. The patient does not receive additional vaccines administered on same date of the Pfizer Suspect. The event resulted in Physician Office visit. The patient does not receive vaccination within 4 weeks and no adverse event following prior vaccination. The patient had a severe reaction when he was stung by a wasp on the lip 8 years ago and almost ended up in Emergency Room. The patient stated the first dose hit him like a Mack truck. The patient felt like he had flu without the fever and had joint pains. The patient stated the second dose hit him like an 18-wheeler that ran over him and backed up and ran over me again. The patient contacted his doctor who works at the university where they teach medical students, and he does not know. The patient asked are these symptoms common and have they been reported. The patient stated exhausted all the time, arms legs feel heavy, joints are sore. The patient asked will it go away, is it temporary, what can he do to get better, will he hurt him if he tries to rehabilitation, can this be a cardiac condition. The patient stated first dose knocked him through a loop. The patient stated he felt very tired all week but got over it after a week. The patient stated he received the second dose, and he was completely exhausted with extreme fatigue. The patient stated he felt like he had the flu. The patient stated his joints and muscles are sore and he feels like he got ran over by about three 18-wheelers. The patient stated that everyone says the symptoms go away within a couple days, but he is still experiencing symptoms. The patient wanted to know if the extreme fatigue is normal and if it is not, will it go away, what can he do for relief, how long will it last, is it permanent, what will happen if he tries to strengthen himself and push himself, will exercise help him or hurt him. The patient stated he took his grandchildren, who are 5 and 9 years old, to the zoo. The patient stated he could keep up with the 9-year-old, but he does not had energy to chase the 5-year-old. The patient stated he came home and practically collapsed. The patient stated if these symptoms last for a long time, he had to change his lifestyle. The patient reported the doctor is ordering additional bloodwork and he needs to find out would Pfizer want him to do additional bloodwork. The patient asked what bloodwork Pfizer would recommend he has done, is this exhaustion that's lasting for four weeks a typical or atypical reaction. The patient stated he looked online, and he is hearing that normally the reactions go away within three to five days. The patient stated the reaction to first went away in 3 to 5 days, the second is 4 weeks in and he is still exhausted. The patient stated he also heard if you have a reaction to the first one that the reaction to the second one is much worse, which it is, that is concerning. The patient asked what the ramifications of this, is this something that has gone away, can he do something about this to return to normal. The patient stated he is having trouble concentrating, he thinks that is related to not having enough energy. The patient stated his symptoms are messing up his capacity to work and he will have to scale back if this is permanent. The patient stated that Pfizer can also contact his wife who is a nurse. The patient stated he had the same symptoms with the first dose. He was exhaustion, fatigue, arms, and legs felt heavy, joints were sore, but it went away after a week. The patient stated he is feeling like he has the flu as exhaustion, fatigue, arms, and legs heavy and sore. The patient stated he did not have fever. The patient stated he has minor arthritis, but it feels like he has major arthritis. The patient stated he is grunting and groaning all the time. The patient stated he does not remember when he started feeling very tired after the first dose, but the next day he went home and did not do much. The patient stated the following weekend he was okay and back to normal. The patient stated he feels 400% worse with the second dose. The patient stated if he takes his grandson for a walk, he had to rest afterwards. He used to be able to take him for a mile walk with no problems. The patient stated on Friday (26Feb2021) after the second dose, he took a two-day Interactive CE course on chronic pain, and he fell asleep eight times over the two days. He could not get credit for the course and will have to take it again. He fell asleep even after drinking two mugs of very strong French heavy dark roast coffee. The coffee couldn't keep him awake and he was sitting up in his office chair and fell asleep. The patient stated with the first dose, he went back to his normal routine and was able to function, he was tired and never got back to functioning fully. The patient stated his arms and legs feel like they weigh a thousand pounds, and this has severely aggravated arthritis. The patient mentioned that because he has been so exhausted, he has given up trying to do things. The patient stated he has a new client tomorrow at 14:00 and he does not know how it will be going to be. The patient explained he tries not to think about how he feels because it is depressing. The patient stated his arthritis was in his hands and now maybe one elbow, now it is in his hands, elbows, shoulders, hips, legs, and everything. The patient asked is its possible vaccine affected arthritis, if his responses are normal, could it affect his heart, does he now have cardiac problems because of the COVID-19 vaccine, what should he have checked in cardiac. The patient asked his wife how she felt his symptoms were doing and she replied maybe slightly improving, but not much. The patient stated he had to radically cut back on his lifestyle. The patient stated his daughter, and two grandchildren live with him, and his wife and he take his grandchildren on walks to the park. He is not doing things he used to do. The patient stated he is exhausted even walking around the house. The patient stated he told the nurse at the doctor's office; he may have picked up COVID-19 on top of it because of how he was feeling, and they checked him for COVID-19 on Friday and he did not have COVID-19. The outcome of the events after the first dose was recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: DEPO-TESTOSTERONE; BUSPAR; WELLBUTRIN

Current Illness: Klinefelter's syndrome (Diagnosed 40 years ago.); Lymphocytosis (Diagnose after colonoscopy,has gas, diarrhea every day for over a year and a half); Sleep apnea (Diagnosed about 13 years ago)

ID: 1770789
Sex: M
Age:
State: TX

Vax Date: 01/13/2021
Onset Date: 01/01/2021
Rec V Date: 10/08/2021
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: joint pains; metallic flavor in mouth; his joints, knees, and elbows were hurting; headache; discomfort; injection site soreness; slight flushness; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 47-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL1283, Expiration Date: 30Apr2021) via an unspecified route of administration, administered in Arm Left on 13Jan2021 13:30 (at the age of 47-years-old) as dose 1, single for COVID-19 immunization. Medical history included shin splints (1991-1995 is when this started, that was more because of shoe cushioning wearing out ) and migraine (started 1992 or 1993 while in the military) from an unknown date and unknown if ongoing. Concomitant medication included unspecified vitamins and bifidobacterium bifidum, bifidobacterium lactis, lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lactobacillus casei, lactobacillus paracasei, lactobacillus plantarum, lactobacillus rhamnosus, lactobacillus salivarius (PROBIOTIC 10) taken for an unspecified indication, has been taking for about 7 or 8 months. No investigation assessment was performed. No prior vaccinations within 4 weeks. On an unspecified date in Jan2021, the patient experienced injection site soreness, this happened and hour or two after receiving the vaccines. This didn't go away until the following day. Most of the other symptoms besides the injection site soreness happened when he woke up the following day after receiving the first vaccine. He had slight flushness, discomfort, his joints, knees, and elbows were hurting and headache. He mentioned that he had migraines and sinus infections before, but this was just a strong headache. The headache lasted about a day and a half. He had no fever but felt flushed- he felt warm. On 14Jan2021, the patient had joint pain and metallic flavor in mouth. He compared it to when a person was receiving a CAT scan or something and they give an injection, and the person gets a flavor in their mouth. He was drinking water and juice and the metallic flavor was still there. He thought this was just normal since COVID makes people lose their sense of taste, so maybe the metallic flavor was a reaction. With the first vaccine, symptoms were pretty mild. He stated that most events happened on the 14Jan2021, he was back to normal on 15Jan2021. No visit to ER or Physician. Therapeutic measures were taken as a result of joint pain. The outcome of the events was recovered on 15Jan2021. No follow-up attempts are needed. No further information is expected.

Other Meds: PROBIOTIC 10

Current Illness:

ID: 1770790
Sex: F
Age:
State:

Vax Date: 03/17/2021
Onset Date: 03/01/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: problem with her leg after receiving the covid vaccine; inflammation; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program [ Support]. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on 17Mar2021 as dose 1, single for covid-19 immunization. Medical history included neuralgia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On Mar2021, patient experienced problem with her leg after receiving the covid vaccine, inflammation. second dose will be (07Apr2021) she's not experiencing any symptoms and hasn't taken any medicines yet, just wanted to know. She will take Advil for nerve pain, or should she wait after having the 2nd dose before taking. At the time of reporting, the outcome of the events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1770791
Sex: F
Age:
State: AL

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: body soreness; swelling; Fatigue; headache; fever; chills; itchy; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6203 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 01Mar2021 at 10:00 AM (age at vaccination: 53 years), as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included diabetes type 2 and thyroid. Concomitant medications were not reported. It was unknown if the patient had known allergies. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient did not receive any other vaccine in four weeks. On 01Mar2021 at 11:30 AM, the patient experienced fatigue, headache, body soreness, fever, chills and a week later COVID arm at injection site, soreness and itchy with swelling. The patient did not receive any treatment for the events. Outcome of the events was resolved on an unspecified date in Mar2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1770792
Sex: M
Age:
State: WA

Vax Date: 03/15/2021
Onset Date: 03/16/2021
Rec V Date: 10/08/2021
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: hives on the back of his neck that swelled up; He said he had a rash on his scalp; hives inside of his hands, wrists and around his body/he had hives on the rest of his body (arms, chest, and stuff); This is a spontaneous report from a contactable consumer. A 61-years-old male patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Strength: unknown, Batch/Lot Number: EN6199), dose 1 in the left arm on 15Mar2021 as Dose 1 SINGLE for covid-19 immunization (Age at vaccination was 61years). The patient medical included difficulty sleeping, and Itch and concomitant medication included MELATONIN 5mg. He said his kids had some Melatonin and thought he should try the Melatonin to help him sleep. He said the Melatonin didn't help too much with sleep, so he stopped taking the Melatonin after that. Stated he started the Melatonin 5mg tablet either on 10Mar2021 or 11Mar2021, providing: Natrol Brand Melatonin 5mg tablet. The patient had not received any prior vaccination within 4 weeks. On 16Mar2021 the patient had hives inside of his hands, wrists and around his body. On an unspecified date the patient had rash and his neck swelled up. The patient reported that he had a rash on his scalp, clarified as hives. He said the hives went through to the rest of his body, his chest, where his skin hits against his clothes, almost anywhere on his body. Reported his scalp hives had lasted a couple days, and then he went camping, and then his scalp hives got worse, and the hives started to progress. He clarified he had hives on the back of his neck that swelled up, and he had hives on the rest of his body (arms, chest, and stuff). He said his scalp was better. He said he was hoping the hives were going to get getting better on the rest of his body once he started the spray on lotion (that he had to pick up at the pharmacy). He said the hives were persisting and moving around on his body. He said the hives had gone down a little to his chest, and behind his knees, too. He said he wanted to report his side effect to Pfizer and ask if he should get the second COVID-19 Vaccine shot. He said his doctor said he probably should not get the second COVID-19 Vaccine. Reporter was advised he would be transferred to Pfizer Medical Information for further assistance with his ketoconazole Shampoo 2% every 3 days, and he was hoping his hives would go quickly. He said the doctor prescribed 2 2 bottles of Ketoconazole Shampoo 2% with the same NDC Number: 45802-465-64, Lot Number: 146931 and expiration date was Apr2022. Reported he did not know the name of the spray-on medication that he had to pick up at the pharmacy. He said the pharmacist told him the doctor had ordered quite a bit of the spray-on medication because the doctor had never seen hives as bad as what he had before. He said his spray-on medication was supposed to be in at the pharmacy today. The outcome of the event Hives was not recovered. The outcome of the event swelling and rash were unknown. No follow up attempts are possible. No further information is expected.

Other Meds: MELATONIN

Current Illness:

ID: 1770793
Sex: M
Age:
State: NY

Vax Date: 03/17/2021
Onset Date: 03/17/2021
Rec V Date: 10/08/2021
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: This is a spontaneous report from a contactable consumer or other non hcp. A 59-years-old male patient received bnt162b2 (bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: 6207; Expiration Date: Jun2021), dose 1 via an unspecified route of administration, administered in Arm Left on 17Mar2021 12:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included type 2 diabetes mellitus for about 10 years ago, Back surgery in 2021. Past drug included Lidocaine. Concomitant medication(s) included cefalexin (CEPHALEXINE) taken for an unspecified indication from 11Mar2021 and ongoing. On 17Mar2021, it was reported he had received his first COVID-19 Vaccine, and had an allergic reaction. He said he had a rash all over his body. He clarified his rash had started about 7-8 hours after he had received his COVID-19 Vaccine on 17Mar2021. He said the rash started on the inside of his arms and around his upper thighs and waist last night (17Mar2021). He said today (18Mar2021) in the morning and throughout the day, his rash got worse. He said his rash went down both of his arms and legs, and on his chest and back. Reported approximately 2 weeks ago he had minor back surgery with a local anesthesia. He said he believed the anesthesia was something like Lidocaine for pain. He said he had just started an antibiotic (Cephalexin 500mg capsule) about a week ago (Thursday, 11Mar2021). He stated he had a 14-day prescription for the Cephalexin 500mg capsule with instructions to take 1 500mg capsule by mouth, twice a day. He said he was about halfway through his prescription with 6 more days to go. He said the Cephalexin 500mg was dispensed in a pharmacy bottle with no NDC, Lot, and Expiration Date. It was reported that his saw his doctor today, and his doctor prescribed over-the-counter medications for his rash. He said he was told to take one tablet a day of the Zyrtec and Pepcid AC. He said he was already feeling better since he had taken a dose of the Zyrtec and Pepcid AC. He said he needed to use an eye loop and put the Zyrtec bottle under light, so he could see the product label information better. He said it wasn't that the Zyrtec product label information was really, really, tiny, but that he wanted to make sure he provided the information correctly to the Pfizer agent. His doctor recommended he not get the second Pfizer COVID-19 Vaccine. He said his doctor told him to wait three months and then get the Johnson & Johnson COVID-19 Vaccine shot. Therapeutic measures were taken as a result of rash all over (rash), his rash got worse (condition aggravated). The outcome of the event allergic reaction was unknown, rash all over was recovering , his rash got worse was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: CEPHALEXINE

Current Illness:

ID: 1770794
Sex: F
Age:
State: NY

Vax Date: 03/19/2021
Onset Date: 03/19/2021
Rec V Date: 10/08/2021
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 Name: PCR Covid Test; Test Result: Negative

Allergies:

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

Symptoms: Sick; Arms ached; Extreme Fatigue; low grade temperature; Severe chills; dull headache; 2nd Day. Feeling lethargic no energy; 2nd Day. Feeling lethargic no energy better at night; nauseated; body and muscle aches/severe body aches; body and muscle aches; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EP7534, expiry date: unknown) (age at the time of vaccination was 61 years, patient was non-pregnant at the time of vaccination), administered in arm left on 19Mar2021 at 10:30 as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included asthma, Lichen's sclerosis. The patient known allergies to penicillin, amoxicillin, erythromycin, clindamycin. It was reported that the patient was really sick for a week but that was after the second dose of the measles, mumps, and rubella shot at the age of 42 years in 2012. Concomitant medications included Livalo, Synthroid, Flovent, Vitamin D, Vitamin C and Probiotics. The patient did not take any other vaccine in four weeks prior COVID -19 vaccine. She was not diagnosed with COVID prior vaccination and tested negative with COVID post vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6202), via an unspecified route of administration, administered in arm left on 26Feb2021 10:30 as DOSE 1, SINGLE for COVID-19 immunisation. On 19Mar2021 at 13:00, after the second shot, patient had dull headache, feeling lethargic no energy better at night 3rd day fine most of day then body and muscle aches at 8 pm 4th day done most of day until 1 pm nauseated better in 3 hours 8pm that night body and muscle aches. No post COVID test was performed after the second dose. On 28Apr2021, patient had second occurrence of headache. The caller stated after the second vaccine she had side effects 2 and 3 days but now it was six weeks later and she lives very carefully and she has come down with severe body aches, chills, low grade temperature, nausea and she was sick for about a week and there were still some residual symptoms but she was much better. It was reported that the patient had severe chills and could not get warm. The patient stated that yesterday morning her arms ached but that went away after taking Tylenol. Arms ached stopped within a 4 hours period. The patient also experienced fatigue. The patient underwent lab tests and procedures, which included PCR COVID test: negative. Therapeutic measures were taken as a result of arms ached and included treatment with Tylenol and no treatment received for other events. The patient did not visit emergency room/physician office. The outcome of the events dull headache and low grade temperature resolved on 30 Apr2021, nauseated resolved on 02May2021, severe chills and arms ached resolved on 05May2021, The outcome of the event sick was unknown and for other events outcome was resolving. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds: LIVALO; SYNTHROID; FLOVENT; VITAMIN D [ERGOCALCIFEROL]; VITAMIN C [ASCORBIC ACID]; PROBIOTICS NOS;VITAMINS NOS

Current Illness:

ID: 1770795
Sex: F
Age:
State: MA

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: It wasn't like everywhere just one spot; it is only in middle of my torso; It's not like it's red or anything, it just itches; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6200 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 01Mar2021 (age at vaccination: 76 years), as a single dose for COVID-19 immunization. The patient's medical history included blood pressure measurement and slight depression. Concomitant medications included colecalciferol (VITAMIN D), lisinopril, pravastatin and chlorothiazide. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9264 and expiry date was not reported), via an unspecified route of administration, on 01Feb2021 (age at vaccination: 76 years), as a single dose for COVID-19 immunization. On an unspecified date in Mar2021, the patient had it wasn't like everywhere just one spot; it was only in middle of her torso; It's not like it's red or anything, it just itches. The patient reported that she really did not have right immediately follow but couple days ago she started itching and she did not know if it's from that or what, but it's been 15 days since she had the shot. But she did not know if, because she could not think of anything else different that she has done to make her body itchy. The patient stated that she did not know if it's from that, she just wondered of it that was one of the side effects. She thought it was one of the side effects, because she did not do anything different. So, she was just calling to ask if that was possible. She used some anti-itch creams that she had and it's for anything that itches. It helped because she could sleep last night but then she got to put some more on. She was going to call her doctor to find out what to do for it but then she figured out to call you guys first. The patient used anti-itch creams some a couple of days ago and then she used it last night. It's not like it's read or anything, it just itches. It's little bit red when she itch it. Outcome of the event was not recovered. No follow-up attempts are possible; No further information is expected

Other Meds: VITAMIN D [COLECALCIFEROL]; LISINOPRIL; PRAVASTATIN; CHLOROTHIAZIDE

Current Illness:

ID: 1770796
Sex: F
Age:
State: VA

Vax Date: 02/27/2021
Onset Date: 02/27/2021
Rec V Date: 10/08/2021
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: CBC; Result Unstructured Data: Test Result:Normal; Test Name: platelets; Result Unstructured Data: Test Result:43,000

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: I felt an abdominal pain, Strong abdominal pain; My face had a little rash, a butterfly rash; not really bad and it didn't feel hot; I didn't have any other itches; I started feeling, my body itching on the inside; It spreading through the day; oozing blood from the injection site; The bandage was soaked in blood; there was oozing blood from the injection site; the bruise was forming; My arm started hurting like a regular after flu-shot; maybe a little more than a regular flu-shot; The bruise was getting bigger; the swelling was about the same and the pain, the discomfort was there but nothing out; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6200 and expiration date: not reported), via an unspecified route of administration, in Right Arm on 27Feb2021, as DOSE 1, SINGLE for covid-19 immunization and prednisone via an unspecified route of administration, on an unspecified date, 5mg, for immune thrombocytopenic purpura. Medical history included thrombocytopenic purpura, the patient had ITP, low platelets and the day before shot, platelets were 43,000. The patient had thrombocytopenia prophylaxis, for 30 years, In Oct2020, patient got very bad case of shingles and platelets dropped after few weeks of being on prednisone and was being taken off the prednisone they dropped to the 20,000 and then they increased the prednisone. The patient had blood pressure. Concomitant medications included cholecalciferol (VITAMIN D3) and metoprolol taken for hypertension. On 27Feb2021,20 minutes after patient got the shot, patient looked in the mirror and her face had a little rash, a butterfly rash. Not really bad and it didn't feel hot, patient didn't have any other itches. The patient came home and within about 2 hours, the patient started feeling, body itching on the inside. It is spreading through the day. On 27feb2021, 6 hours after the shot, patient's husband took the bandage off and the bandage was soaked in blood and there was oozing blood from the injection site and the bruise was forming and that night patient arm started hurting like a regular after flu-shot, maybe a little more than a regular flu-shot and then by the next day, the bruise was getting bigger, and the swelling was about the same and the pain. The patient felt an abdominal pain, Strong abdominal pain on an unspecified date. The patient underwent lab tests and procedures which included full blood count: normal on an unknown date, platelet count: 43,000 on day before shot. Therapeutic measures were taken as a result of butterfly rash included Benadryl and hydrocortisone cream. The outcome of the event Butterfly rash was not recovered, while that of all other events was unknown at time of report. No follow-up attempts are possible. No further information is expected.

Other Meds: VITAMIN D3; METOPROLOL

Current Illness:

ID: 1770797
Sex: M
Age:
State: FL

Vax Date: 03/03/2021
Onset Date: 03/03/2021
Rec V Date: 10/08/2021
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: Pins and Needles Feeling in Both Lips; Upper Body Itching All Over; This is a spontaneous report from a contactable Consumer or other non-health care professional (Patient). An 85-years-old male patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; (Batch no: not reported/Lot Number: EN6198) via an unspecified route of administration, administered in Arm Right on 03Mar2021 08:30 (at the age of 85 years) dose 1, single for covid-19 immunization at Hospital Main Building. Medical history and concomitant medications were not reported. Known allergies reported as he was severely allergic to all crustaceans, shrimp, crab, lobster and first time he had an anaphylactic reaction was when he was 16-years-old, also highly allergic to penicillin (was 20 years ago), cipro (was given once as prophylactic during a medical procedure of Colonoscopy and he reacted within 10 sec), sulfa drugs (he experienced that reaction while getting x rays) and allergic to grass, dust, pollen, perfume, and flowers. No Family Medical History Relevant to AE. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior vaccinations taken within 4 weeks. On 03Mar2021, Patient had the injection at 8:30 AM and the reaction started at 10:30 AM within two hours after the first injection, he experienced with reactions of pins and needles in both lips and his upper body was itching all over. He immediately took 50mg of Benadryl and a half an hour later his symptoms went away and he stated that he was not sure if the Benadryl stopped the reaction because it stopped quickly. AEs did not require to visit Emergency Room or Physician's office. No Investigation Assessment was provided. No relevant tests reported. Therapeutic measures included 50mg of Benadryl. Patient reported that he was scheduled for his second shot tomorrow and was very concerned about getting the next injection. The outcome of the events was recovered on 03Mar2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1770798
Sex: F
Age:
State: MI

Vax Date: 03/16/2021
Onset Date: 03/17/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: swelling on the side of her neck; pain on the left side of her neck that went to her shoulder; Sore throat; Hoarseness; This is a spontaneous report from a contactable consumer(Patient). A 66-year-old female patient had received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number EN6207) via an unspecified route of administration into arm left on 16Mar2021 as DOSE 1, SINGLE for covid-19 immunization (at the age of 66 year). The patient medical history had included Diabetes mellitus( from unknown to Ongoing and spasmatic fibrosis(from unknown To Ongoing). The patient concomitant medication included Rosuvastatin (20 mg) for the indication of High cholesterol and it has been used since 15 years.It was reported that the patient did not take any vaccination within four weeks of the vaccination and also reported that She saw her doctor 3-4 days before she received the vaccine. The patient did not received any prior vaccination within 4 weeks. No additional vaccine was administered on Same Date of the Pfizer Suspect. The doctor said since she was getting the vaccine he was going to hold off giving her a pneumonia shot. She switched doctors. The last time she had her cholesterol checked her doctor said it was fine. Since she has had two T strokes the doctor wanted her to stay on her cholesterol medication. The last stroke was 12 years ago. The first one was 25 years ago. She didn't know that she had a stroke until she fell and had an X-ray of her head. The X-ray indicated that she had the two strokes She was in her twenties when she had the first stroke. She remembers that her arm was numb and she had pain. She dropped the cup that she was holding. The numbness and pain went away after 1-2 minutes.On 17 Mar2021, the patient had experienced sore throat and Hoarseness. On 18Mar2021 the patient had experienced pain on the left side of her neck that went to her shoulder and swelling on the side of her neck. Patient applied alcohol twice for the event pain on the left side of her neck that went to her shoulder and swelling on the side of her neck and it went down. The outcome of the events were recovering . No follow-up attempts are possible. No further information is expected.

Other Meds: ROSUVASTATIN

Current Illness: Diabetes (Verbatim: Diabetes); Fibrosis (Verbatim: spasmatic fibrosis); High cholesterol (Verbatim: High cholesterol)

ID: 1770799
Sex: F
Age:
State: NJ

Vax Date: 03/10/2021
Onset Date: 03/10/2021
Rec V Date: 10/08/2021
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: Two steps feels like a mile; feeling kind of cold; she was 5ft 2in but that might have decreased a little bit; nausea; lack of appetite/she has no appetite; itching, rash all over her body; itching, rash all over her body; feels like low grade fever; chills, woke up shivering; light has been bothering her; body ache; muscle pain; headache; weakness; no energy/lack of energy; tiredness/feeling tired; This is a spontaneous report from a contactable consumer (patient). This report is not related to a study or programme. A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6205; Expiration date: 30Jun2021), via an unspecified route of administration in left arm on 10Mar2021 15:00 (at the age of 69-years-old) as DOSE 2, SINGLE for covid-19 immunisation or to prevent the COVID-19 virus. Vaccination facility type was Expo Center, place where they have concerts and conferences. The patient medical history and concomitant medications included none. Had flu vaccine was in October. Historical vaccine included first dose of BNT162B2 (Lot Number: EL9266) on 17Feb2021 as DOSE 1, SINGLE for covid-19 immunisation and experienced muscle aches, headache and some lingering weakness. Additional vaccines administered on same date with the Pfizer vaccine considered as suspect; prior Vaccinations (within 4 weeks); AE(s) following prior vaccinations; relevant tests included none. The patient experienced tiredness/feeling tired on 10Mar2021, body ache, muscle pain, headache, weakness, no energy/lack of energy on 11Mar2021, feels like low grade fever, chills, woke up shivering, light has been bothering her on 16Mar2021, itching, rash all over her body on 17Mar2021, nausea, lack of appetite/she has no appetite on 18Mar2021, two steps felt like a mile, feeling kind of cold on an unspecified date. Therapeutic measures were taken as a result of reported events. Patient was calling about the Covid vaccine. Her second shot was last week on Wednesday, 10Mar2021. On 11 Mar 2021, she felt body aches, tiredness, muscle pain and headache. It was expected. The next day, she basically was tired and had weakness and then that was gone. Now on Tuesday of this week on 16Mar2021 she started feeling tired again and lack of energy and muscle and body aches all over again like she has the flu. Then, yesterday she woke up with a rash and itching all over her body. She still had the rash and itching. Today, she had no energy. Two steps felt like a mile. And she had no appetite. She didn't know if the rash or itching could be because of the vaccine. She had no idea. She just expected to be tired and had muscle aches and all that like everybody else had. The day before she also had chills, she woke up shivering on 16Mar2021. Tiredness, no energy, weakness, itching, rash all over her body was reported as worsened. Investigation assessment included none. She thought this was important for Pfizer to know. She hadn't gone out since 10Mar2021 when she received her second Covid 19 vaccine. She was not exposed to anything or anyone else. Nothing has bitten her, and the rash was all over her body and she thought at first, she had shingles. She's had the shingles shots and her doctor said shingles was only on one side of her body and nerves would be shot, but that was not the case. Her rash was in her ears and hair, and it was itching, and the rash was all over her body- arms, legs, torso. When probing height caller reports she was 5ft 2in but that might have decreased a little bit. She said it was a shame that nothing could be done. She spoke to her doctor yesterday and he said to take Benadryl, but she didn't like to take Benadryl in the daytime, and she didn't have Benadryl at her house, and she didn't feel well enough to go get it. He told her if the rash was really bad then he would prescribe something. He mentioned steroids but she didn't want that. She mentioned her rash was expanding and was getting worse still. The tiredness and weakness were worse on the day of this report than any other day she's had it. She reported she was really sapped she didn't even want to take a shower today, but she made herself. She never falls asleep in the daytime and today she did. She confirmed she had a headache on 11 Mar 2021 and 12 Mar 2021. She had another headache on 16Mar2021. Since then, she hasn't had a headache. She mentioned she has been taking Tylenol all 3 days. She had to take Tylenol at least twice because the muscle aches come back. She clarified she was taking Tylenol in the morning and by the late evening, she had to take it again because the aches come back. Sometimes, she was taking Aleve so it will be even longer lasting. Right then she didn't have a headache. The worse thing right now was she had no energy. On the day of this report, the worst day for no energy. And in between those days she felt ok. On the weekend she felt ok. She cleaned the bathroom and the floor, and she was ok. It was just this Tuesday, 16Mar2021 that all this came back. And she couldn't figure out why she had the rash. She hadn't been outside since Wednesday, 10Mar2021 when she got her vaccine. She hadn't been exposed to anything or anyone or been bitten by anything. She was asking if there are any suggestions for getting her energy or if any suggestions for the rash. She reported she couldn't finish her lunch. She had been feeling like she had a low-grade fever, she had not taken her temperature. It was not 99 or something like that. It goes away after she takes something, but at times she was waking up feeling like she had a low-grade fever. Also, mentioned light has been bothering her as well since 16 Mar 2021. She hadn't had chills yesterday or this morning. However, she had been feeling kind of cold all these days and she was turning the heat up. Patient received treatment with Tylenol 500mg tablets 1-2 tablets every 8-10 hours (NDC/Lot unknown; Expiration Mar2022), Aleve 220mg she took one tablet every 12 hours (NDC/Lot unknown; expiration Nov2021). Advised caller to follow up with her primary health care doctor for treatment options and persisting side effects. AE(s) did not require a visit to Emergency Room or Physician Office. No further details were provided or obtained.Clinical outcome of event body height decreased was unknown and outcome of other events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1770800
Sex: M
Age:
State: MI

Vax Date: 03/11/2021
Onset Date: 03/18/2021
Rec V Date: 10/08/2021
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: Swollen big toe and joint; Big toe, right foot, that joint has just got so swollen and tender and there has been real bad pain; Swollen big toe and joint; Big toe, right foot, that joint has just got so swollen and tender and there has been real bad pain; Swollen big toe and joint; Big toe, right foot, that joint has just got so swollen and tender and there has been real bad pain; Swollen big toe and joint; Big toe, right foot, that joint has just got so swollen and tender and there has been real bad pain; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 11Mar2021 (at the age of 58-years-old) as dose 1, single for covid 19 immunization. The patients medical history and concomitant medications were not reported. Reporter stated that he received a Pfizer vaccine shot on 11Mar2021. The only thing he had with the actual shot was stuck with the needle in it and he didn't feel any fever, no chills, no headache, nothing in the whole week. But exactly one weeks later, patient guessed and stated that on 18Mar2021, he did get a swollen big toe and joint and he looked it up, it looks like a gout. Patient had big toe, right foot, that joint had just got so swollen and tender and there had been real bad pain. Patient received aleve which was Naproxen and also, he had been taking Ibuprofen, over the counter for the treatment of events reported. Reporter further stated that he never had this before and queried for what should he be doing to alleviate his pain. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1770801
Sex: M
Age:
State: PA

Vax Date: 01/20/2021
Onset Date: 01/01/2021
Rec V Date: 10/08/2021
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: Test Date: 202101; Test Name: MRI; Result Unstructured Data: Test Result:showed bulging disc; Comments: showed bulging disc

Allergies:

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

Symptoms: This is a spontaneous report from a contactable other health care professional (patient himself). A 37-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3246) via an unspecified route of administration on left arm on 20Jan2021 06:30 (at the age of vaccination of 37-year-old) as dose 2, single for COVID-19 immunization. Historical vaccine included, bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL0140) via an unspecified route of administration on left arm on 30Dec2020 06:30 as dose 1, single for COVID-19 immunization. On an unspecified date, after dose 1 patient experienced his arm completely cramped up. Prior to vaccination patient was not diagnosed with COVID-19 and since the vaccination, patient had not been tested for COVID-19. Patient's relevant medical history included, arthritis in hips and allergy to sulfur drugs from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 20Jan2021, patient experienced entire body became full blown itchy an hour after. Day after patient's arthritis flared up and had lower back pain since. MRI (magnetic resonance imaging) showed bulging disc and was given steroid shot. Patient still had pain. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment as steroid shot. The patient underwent lab tests and procedures which included magnetic resonance imaging: showed bulging disc on an unspecified date in Jan2021. Outcome of the all events was recovering. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1770802
Sex: F
Age:
State: LA

Vax Date: 03/16/2021
Onset Date: 03/19/2021
Rec V Date: 10/08/2021
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: doesn't know if she has a fever as one minute it is saying one thing, she has a fever, and one saying another, she is low; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6207, expiration date was not reported), via an unspecified route of administration on 16Mar2021 (at the age of 58-years-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that on 19Mar2021 the patient doesn't know if she has a fever as one minute it is saying one thing, she has a fever, and one saying another, she is low. Patient, reporting on the Pfizer COVID vaccine, who explains she has a monitor to check her temperature and this morning when she woke up and checked it, it says she has a fever but she doesn't feel like she has a fever. Patient has a physical therapy appointment today and wants to know if she should go to the appointment. Patient got her first shot on 16Mar2021. This morning when she checked, the device she uses said she had temperature. She doesn't feel like she does though. It is noted that the information she was given says that a person could get a fever after the first shot. She is not going to go to the appointment, she doesn't want to take any chances. When asked the reading the device provided for her temperature she says it said 90-91 but then says she isn't sure, it said she had a fever. When asked to clarify the patient offers to recheck her temperature and then explains that it says low now, she remarks she doesn't know as the device is acting a fool. Consumer clarifies this statement saying she doesn't know if she has a fever as one minute it is saying one thing, she has a fever, and one saying another, she is reading a low temperature. Treatment: she just woke up to this, she hasn't done anything. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1770803
Sex: F
Age:
State: OH

Vax Date: 03/19/2021
Onset Date: 03/20/2021
Rec V Date: 10/08/2021
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: itching starting at the injection site going up the left shoulder; itching starting at the injection site going up the left shoulder; feel a slight rough texture to the skin on her arm at the area of the itching; this has spread across the back of her neck to her other shoulder; itchy, red, bumpy, hot rash; itchy, red, bumpy, hot rash; itchy, red, bumpy, hot rash; itchy, red, bumpy, hot rash; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 54-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EP7534, expiration date: not reported) via an unspecified route of administration, administered in left arm on 19Mar2021 at 17:00 (at the age of 54-years-old) as dose 1, single for covid-19 immunization. Medical history included Gastric Sleeve Surgery from an unknown date and unknown if ongoing Verbatim: Gastric Sleeve Surgery, sinus, allergies, AV Node reentry and tachycardia, nerve pain fibromyalgia, COPD and Depression, start and stop date unknown. Patient had no family history. Concomitant medication(s) included gabapentin (GABAPENTIN) taken ongoing, 400mg; take one four times a day by mouth taking 8 years for nerve pain fibromyalgia; montelukast (MONTELUKAST) taken ongoing 10mg; take once daily by mouth, taking 4 years for allergies; diltiazem hydrochloride (CARTIA XT) taken ongoing, 120mg; take once daily by mouth, taking 4 years for AV Node reentry and tachycardia; fluticasone propionate (FLUTICASONE PROPIONATE) taken ongoing, two sprays each nostril once daily, using four years for allergies; bupropion hydrochloride (BUPROPION HCL XL) taken ongoing, 150mg; take one twice daily by mouth, taking for 2 years for Depression; cetirizine hydrochloride (CETIRIZINE HYDROCHLORIDE) taken ongoing, 10mg; take once daily by mouth, taking for 6 months for sinus; tiotropium bromide (SPIRIVA) taken ongoing, 18mcg; take once daily by mouth, taking for 8 years for COPD; salbutamol sulfate (PROAIR HFA) taken ongoing, inhaler use as needed, taking for 8 years for COPD and Multivitamin taken ongoing taking for three years. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No Prior Vaccinations (within 4 weeks). On 20Mar2021, patient experienced itching starting at the injection site going up the left shoulder, feel a slight rough texture to the skin on her arm at the area of the itching; this has spread across the back of her neck to her other shoulder, itchy, red, bumpy, hot rash. The outcome of all events were not recovered. No follow up attempts are possible. Information about lot/batch number cannot been obtained.

Other Meds: GABAPENTIN; MONTELUKAST; CARTIA XT; FLUTICASONE PROPIONATE; BUPROPION HCL XL; CETIRIZINE HYDROCHLORIDE; SPIRIVA; PROAIR HFA

Current Illness:

ID: 1770804
Sex: F
Age:
State: IA

Vax Date: 03/18/2021
Onset Date: 03/19/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: A little more than 24 hours after the shot, I experienced severe back pain and severe pain in what I called my adenoids; A little more than 24 hours after the shot, I experienced severe back pain and severe pain in what I called my adenoids; Get a bad cold; Stuffed head for two days; Last night I experienced trouble Breathing.; Asthma; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 59-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, Solution for injection, Lot Number: EN6208, Expiry date: unknown) via an unspecified route of administration, administered in arm right on 18Mar2021 12:00 (age at vaccination: 59-years-old) as dose 1, single for COVID-19 immunization (facility). Medical history included asthma and hypertension from an unknown date and unknown if ongoing. Concomitant medication included hydrocodone taken for limb injury. On 19Mar2021 13:00, patient experienced severe back pain and severe pain in what she called her adenoids which was the first sign that she was going to get a bad cold. Stuffed head for two days then last night she experienced trouble breathing. She had diagnosed with asthma and she had asthma medicines there which she took. Patient had no Covid prior and after the vaccine and no allergies to medications, food, or other products. 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 had not been tested for COVID-19 and not tested for covid post vaccination. Patient received prednisone, symbicort and albuterol prevented a trip to the hospital for the treatment of the event asthma. Patient did not take any treatment for the events severe back pain, severe pain, bad cold, stuffed head and trouble breathing. The outcome of the events was reported as resolving.

Other Meds: HYDROCODONE

Current Illness:

ID: 1770805
Sex: F
Age:
State: NY

Vax Date: 03/07/2021
Onset Date: 03/01/2021
Rec V Date: 10/08/2021
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; Joint pain; Muscle pain; Nausea; Headache; Tired all the time; got really sick the day after she got the shot; whole body was hurting; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6206; Expiration Date: Jun2021) via an unspecified route of administration, administered in Arm on 07Mar2021 10:00 (at the age of 70 years old) as dose 1, single for COVID-19 immunisation at school. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced nausea, headache on 08Mar2021, joint pain, muscle pain on 09Mar2021, chills on 11Mar2021, tired all the time, got really sick the day after she got the shot, whole body was hurting on Mar2021. Reported as, the patient got really sick the day after she got the shot and it was being a week and a half now. Patient started with nausea, then it went to joint pain, then muscle pain, then chills, then a really bad headache, then really tired all the time. Patient whole body was hurting. Patient has recovered from the joint pain and muscle pain. The chills, headache, and nausea all come and go. Patient was given nausea medicine. Adverse event resulted in Physician office: Primary Care Provider. Therapeutic measures were taken as a result of nausea (nausea). Outcome of the event joint pain, muscle pain was recovered on Mar2021, recovering for nausea, headache, chills, not recovered for got really sick the day after she got the shot, and unknown for tired all the time, whole body was hurting. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1770806
Sex: F
Age:
State: CT

Vax Date: 03/19/2021
Onset Date: 03/19/2021
Rec V Date: 10/08/2021
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: Mostly Reactogenicity post Vax2; Burning eyes; Moderate pain at IP site; Pyrexia; Moderate muscle pain; Moderate headache; Runny Nose; Moderate Chills; first dose on 02Mar2021 and 2nd dose on 19Mar2021; This is a spontaneous report from a contactable consumer (parent). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: ER2613 and expiration date: not reported), via an unspecified route of administration, on 19Mar2021 (at the age of 56-year-old) as DOSE 2, SINGLE for covid-19 immunization. Medical history included type 2 diabetes mellitus, hypertension, and deep vein thrombosis. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6205 and expiration date: not reported), on 02Mar2021 (at the age of 56-year-old) as DOSE 1, SINGLE for covid-19 immunization. The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. The Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 19Mar2021, the patient was mostly reactogenicity post vax2, experienced Moderate pain at IP site, Pyrexia, Moderate muscle pain, Moderate headache, Runny Nose and Moderate Chills. No treatment was received for the adverse events. The outcome of the events was not recovered at time of report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1770807
Sex: F
Age:
State:

Vax Date: 03/11/2021
Onset Date: 03/01/2021
Rec V Date: 10/08/2021
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: Exhaustion; Pain in arm; very sleepy; Coughing; This is a spontaneous report from a contactable consumer (patient). The consumer reported events for 2 patients. This is report 1 of 2. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 11Mar2021 (at the age of 60-year-old) as single dose for COVID-19 immunization. Medical history included chronic fatigue syndrome, a lot of times the patient got ill with bacterial infections. Concomitant medication included sleep aid (unspecified). The patient had her first dose of the covid vaccine on 11Mar2021. The patient had underlying conditions and had chronic fatigue syndrome. The patient had been exhausted, had pain in her arm and coughing in Mar2021. The patient wanted to know if this was normal because her reaction, it made her very sleepy, like she was falling asleep and couldn't get up. The patient would fall asleep watching TV, she felt very tired but had sleep aid so its hard to tell if it was an attack on that or what. It's been 5 or 6 days, almost a week since they had the vaccine. The patient just had the first vaccine, they felt kind of bad. Just in case there's bacteria, in case the doctor prescribes an antibiotic, if they needed it, for say and for an upper respiratory infection. If you need antibiotics for pneumonia or sinus infection or respiratory infection, the patient wanted to make sure its okay to take antibiotics in-between the two doses of the vaccine. The patient got very sick very easily. Its a week later and the patient husband was concerned because of the mechanism of the vaccine and the immune system being challenged. It was not an underactive immune system, and a lot of times the patient and her husband get ill with bacterial infections. They wanted to know if they should avoid antibiotics. The husband knows one could not avoid them if one need them but enquired if there are any contraindications for that. The outcome of all the events were unknown. No follow-up attempts are possible: Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1770808
Sex: F
Age:
State: PA

Vax Date: 03/11/2021
Onset Date: 03/11/2021
Rec V Date: 10/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: She still has lingering red spots; super hot feeling; Hives to the face, neck, chest, arms, everywhere; Lightheaded; Allergic Reaction; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown, Expiry Date: unknown), via an unspecified route of administration on arm left on 11Mar2021 (age at vaccination: 43 years) as dose 1, single for COVID-19 immunization. The patient medical history included Entire arm swelled up and was red(Vaccine/Brand Name: Pneumonia Vaccine.States was like 12 years ago), very hot like fever for 24 hours. History of all previous immunizations with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) and Additional Vaccines Administered on Same Date of the Pfizer Suspect and Prior Vaccinations (within 4 weeks) was reported as none. Patient's Medical History (Including any illness at time of vaccination) and Family Medical History Relevant to adverse events was reported as none. The patient Concomitant medications were not reported. On 11Mar2021, 30 minutes after the vaccine, the patient experienced Hives to the face, neck, chest, arms, everywhere, Lightheaded, Allergic Reaction. On an unspecified date, the patient experienced She still has lingering red spots and experienced super hot feeling. It was reported that Hives face, neck, and chest, arms, everywhere: States that the super-hot feeling and swelling of the hives lasted for about 24 hours, but the hives are still ongoing at this time, she still has lingering red spots but they are not itchy. Feels she had an allergic reaction. Lightheaded feeling after vaccination lasted for 6 hours then caller was recovered completely. Therapeutic measures were taken as a result of events and treatment included Took Benadryl and Tylenol. she two 50 mg Benadryl pills every 4 hours on 11Mar2021 following the start of the event. Caller too two 500 mg Tylenol pills at the onset of the events on 11Mar2021, and then took another unspecified amount of Tylenol twice throughout that night. The outcome of Lightheaded was resolved on 11Mar2021. The outcome of Hives to the face, neck, chest, arms, everywhere was resolving. The outcome of Allergic Reaction, super hot feeling was unknown. The outcome of She still has lingering red spots was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1770809
Sex: F
Age:
State: AZ

Vax Date: 03/09/2021
Onset Date: 03/14/2021
Rec V Date: 10/08/2021
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: Test Date: 20210322; Test Name: Physical Examination; Result Unstructured Data: Test Result:3.25; Comments: About 3.25-inch diameter.; Test Name: Temperature; Result Unstructured Data: Test Result:100.6; Test Date: 20210314; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: I have a large bruise on my left arm at injection site; There were still a slight discoloration at the injection site; I had a normal reaction of chills, 100.6 temp, tired and achy starting 18 hours after 2nd dose, lasting 1.5 days, and a sore arm at the injection site for over a week.I have a large bruise on my left; I had a normal reaction of chills, 100.6 temp, tired and achy starting 18 hours after 2nd dose, lasting 1.5 days, and a sore arm at the injection site for over a week.I have a large bruise on my left; I had a normal reaction of chills, 100.6 temp, tired and achy starting 18 hours after 2nd dose, lasting 1.5 days, and a sore arm at the injection site for over a week.I have a large bruise on my left; I had a normal reaction of chills, 100.6 temp, tired and achy starting 18 hours after 2nd dose, lasting 1.5 days, and a sore arm at the injection site for over a week.I have a large bruise on my left; I had a normal reaction of chills, 100.6 temp, tired and achy starting 18 hours after 2nd dose, lasting 1.5 days, and a sore arm at the injection site for over a week.I have a large bruise on my left; Rash/localized rash at injection site; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 69-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6205) via an unspecified route of administration in left arm on 09Mar2021 18:45 as dose 2, single (at the age of 69-years-old) for COVID-19 immunization. Patient did not have Covid prior to vaccination. Patient was tested for COVID-19 post vaccination. Patient was not pregnant at the time of vaccination. Patient medical history included cardiovascular disease. Patient had not known allergies. The concomitant medications included Spironolactone tablet, levothyroxine sodium, rosuvatstain. The reported seriousness of the report was non-serious. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL1283) via an unspecified route of administration in right arm on 16Feb2021 11:30 as dose 1, single for COVID-19 immunization. Patient did not receive any other vaccine in last four weeks. Patient had a normal reaction of chills, 100.6 temp, tired and achy starting 18 hours after second dose, lasting 1.5 days, and a sore arm at the injection site for over a week on 17Mar2021 12:00. She had a large bruise on her left arm at injection site, about 3.25-inch diameter on 22Mar2021. Today at thirteenth day post second shot, there were still a slight discoloration at the injection site, but greatly faded on 22Mar2021. An urgent care P.A. on 14Mar2021 said the rash was cellulitis, prescribed Cephalexin 500mg and said to go to a hospital ER if the arm got worse, fever or streaking as it could be systemic and very serious. She almost had to reschedule a 17Mar2021 heart procedure due to uncertainty of the rash. A doctor called her later in the day of 14Mar2021 and thought it was not cellulitis based on her responses to her questions, and no need for antibiotics, so she did not take them. She asked was her 2 week localized rash at injection site normal. Why was this rash not seen as a normal side effect, and why leap to call it cellulitis, and maybe hospitalization. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care visit. Patient received treatment for vaccination site rash at hospital while for the other events did not receive any treatment. Patient lab tests and procedures included SARS-COV-2RNA (nasal swab) test with result as negative on 14Mar2021. The outcome of the events vaccination site bruising, vaccination site rash and vaccination site discolouration was unknown while for the other events was recovering. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds: SPIRONOLACTONE; LEVOTHYROXINE SODIUM; ROSUVASTATIN

Current Illness:

ID: 1770810
Sex: F
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 10/08/2021
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: 20210309; Test Name: Nasal Swab; Test Result: Negative

Allergies:

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

Symptoms: First shot I got a giant red rash 7 days after on my arm.; This is a spontaneous report from a contactable consumer (patient herself ). A 36-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on unspecified date as dose 1, single for COVID-19 immunization. Medical history included fibromyalgia, asthma. The patient's concomitant medications were not reported. The patient was not pregnant at time of vaccination. The patient is not allergic to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. After the First shot she got a giant red rash 7 days after on my arm. The patient underwent lab tests and procedures which included sars-cov-2 test which was negative on 09Mar2021. The patient visited physician office. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1770811
Sex: F
Age:
State: CT

Vax Date: 03/12/2021
Onset Date: 03/12/2021
Rec V Date: 10/08/2021
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: Severe muscle aches and pains; exhaustion; severe headache; fever; nausea; chills; This is a spontaneous report from a contactable consumer. A 37-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 12Mar2021 14:00 (at the age of 37-year-old) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if other vaccine in four weeks. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 19Feb2021 04:00 PM (at the age of 37-year-old) covid-19 immunization. The patient had no covid prior vaccination. On 12Mar2021 17.00, the patient experienced severe muscle aches and pains, exhaustion, severe headache, fever, nausea, and chills that prevented the person from carrying on daily activities for about 24 hours. The patient received treatment with Advil. It was unknown if covid tested post vaccination. Outcome of the events was recovered in Mar2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am