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: 1711312
Sex: M
Age:
State: KS

Vax Date:
Onset Date: 04/07/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: Nasal Swab; Test Result: Negative ; Comments: he is tested regularly (he told me weekly) for Covid 19 and has been negative.

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: he had a sore arm for a couple of days after the first Pfizer Covid 19 injection.; This is a spontaneous report from a contactable consumer (other non-HCP) who reported for friend. A 62-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration, on an unspecified date (age at the time of vaccination was 62-year-old) as a single dose for COVID-19 immunization. Medical history included chronic ankle pain from a boating accident in Aug2010. Concomitant medication included Oxycodone. The patient had no known allergies. The patient had no other vaccines in 4 weeks. The patient was not tested for COVID prior to vaccination but was tested for COVID post the vaccination. On 07Apr2021, the patient experienced he had a sore arm for a couple of days after the first Pfizer COVID 19 injection. No treatment was received for the event. The patient underwent lab and medical procedure of SARS-CoV-2 test on an unspecified date, with negative result. The clinical outcome of the event was recovered on an unspecified date. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.

Other Meds: OXYCODONE

Current Illness:

ID: 1711313
Sex: F
Age:
State: NC

Vax Date: 08/17/2021
Onset Date: 08/01/2021
Rec V Date: 09/18/2021
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: 20210817; Test Name: heartbeat; Result Unstructured Data: Test Result:heartbeat that was really moving

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: joint pain; heartbeat that was really moving; she felt like a zombie; bladder incontinence; she had two days of side effects after the booster.; she had two days of side effects after the booster.; injection site was painful; chills; tiredness; This is a spontaneous report from a contactable other hcp (patient reported for herself). A 67-year-old female patient received third dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, Solution for Injection, Batch/Lot Number: FC3181), via intramuscular route of administration, administered in upper arm right on 17Aug2021 at 11:30 (at the age of 67-year-old) as dose 3, single for COVID-19 immunization. Medical history included CLL (from a couple of years), MS from 1996 to an unknown date, bladder incontinence (from a few years), hip replacement (from the last couple of years; mentions she has to take antibiotics before any dental work due to the hip), allergy to sulfa (adds sulfa gives her hives), allergic to nickel. Family medical history relevant to AE: brother said he had a reaction to the COVID second shot. The patient did not receive any other vaccines prior vaccinations within 4 weeks. The patient concomitant medications included rituximab infusion by IV twice yearly two weeks apart via intravenous route taken for CLL; fesoterodine fumarate (TOVIAZ) at a dose of 4 mg once daily via oral route taken for bladder incontinence; baclofen 5 mg at a dose of 10 mg one half twice daily taken for restless legs; bupropion 150 mg at a dose of 150 mg once daily via oral route taken for an unspecified indication (not giving a rat); vitamin c (ASCORBIC ACID) capsule 1000% daily value; take eleven capsules once daily taken for an unspecified indication (should take it); tocopherol (VITAMIN E) at a dose of 1000IU twice daily via oral route taken for helps with memory; silybum marianum (MILK THISTLE) 300 mg at a dose of 300 mg twice daily via oral route taken for liver health; urtica dioica (HILDE HEMMES HERBALS STINGING NETTLE) 480 mg at a dose of 480 mg twice daily via oral route taken for kidney health; probiotics once daily via oral route taken for an unspecified indication (good for colon), all drugs from an unspecified start date and ongoing. The patient previously took first dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, Solution for Injection, Batch/Lot Number: EL3246), via intramuscular route of administration, administered in upper arm left on 28Jan2021 at 10:00 AM (at the age of 66-year-old) as dose 1, single for COVID-19 immunization and experienced sore arm, injection site pain. Patient took second dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, Solution for Injection, Batch/Lot Number: EN6200), via intramuscular route of administration, administered in upper arm left on 18Feb2021 at 10:00 AM (at the age of 66-year-old) as dose 2, single for COVID-19 immunization and experienced chills, weakness, wonky feeling, tiredness. The patient past drugs included trospium chloride, oxybutynin, both drugs for bladder incontinence and experienced drug allergy; myrbetriq and experienced drug allergy. On an unspecified date in Aug2021, the patient experienced chills, tiredness, injection site was painful. On 17Aug2021, the patient experienced joint pain, heartbeat that was really moving, she felt like a zombie, bladder incontinence, she had two days of side effects after the booster. Licensed practical nurse calling regarding the Pfizer BionTech COVID 19 vaccine. Adds patient is calling about the booster dose. Mentioned patient previously reported after the second dose online. No report reference known to reporter. Today patient wants to report adverse effects; she had two days of side effects after the booster. Patient is the reporter; mentioned she is down to 159, she has lost on purpose. Reporter is licensed practical nurse reporting on herself. Primary/Prescriber: mentioned this is her old PCP, patient doesn't have the name of the new one. Product: Pfizer COVID 19 vaccine; treatment first dose 28Jan2021 at 10:00 in upper left arm; EL3246; administered at (withheld). Hospital; second dose 18Feb2021 at 10:00 in the upper left arm; lot EN6200; administered at (withheld); third dose booster 17Aug2021 at 11:30 in the upper Right arm; lot FC3181; administered at (withheld). Patient sees no other writing on the vaccination card, no NDC, expiration date or dose. Events: The first dose she just had a sore arm and injection site pain. The second one she had chills that night; weakness and had to hold on to things; kind of wonky feeling; didn't sleep very well and had tiredness at night. Adds she had to hold on to things as her balance was not quite there. Mentioned patient got up at 03:00 to report, she did the VAERS report and the Pfizer report. The booster went a little more, she had chills, tiredness; took a super-hot shower before she went to bed as the chills were starting in hands and feet; joint pain; injection site was painful; and then the other thing was a heartbeat that was really moving. Then she felt like a zombie; she was running errands yesterday and trying to stay focused driving. Adds she also noticed bladder incontinence that started after this dose for sure. She already has some bladder incontinence from MS and she takes a medication that helps it; controls it so she doesn't have it. But after the booster, when she gets up she just lets go; every time she peed all the way and the a little more in the toilet. She used a lot of pads, men's pads, but it is getting better now; her medication kicked in. She didn't notice it so much on the second dose. Adds staying in bed a long time this time really helped. Reporter rates all of her events as not serious. When ask for causality, she states yes, all of these events are related to the vaccine because she didn't have any of this before. Treatment: She has not gone to the emergency room or seen a doctor for any of her side effects and reported no treatment. Concomitant Products: Mentioned the Toviaz she takes for bladder control is a miracle; it made a night and day difference; she went from no control to control over her bladder. History: Mentioned for bladder incontinence she tried a few meds that she was allergic to; one was trospium chloride, she doesn't have doses; and oxybutynin. Adds sulfa gives her hives; patient is also allergic to myrbetriq; and allergic to nickel on the skin or bandages that are not latex, plastic is fine. Patient doesn't have any product or information for the products and cannot provide NDC, lot or expiration date. The patient underwent lab tests and procedures which included heartbeat was really moving on 17Aug2021. The patient did not receive treatment for the events. Outcome of the events tiredness was not recovered; she had two days of side effects after the booster was unknown; injection site was painful, bladder incontinence was recovering; chills was recovered on an unspecified date in Aug2021, heartbeat that was really moving was recovered on 17Aug2021; joint pain, she felt like a zombie was recovered on 19Aug2021. Causality: sore arm injection site pain, chills, weakness, tiredness, wonky feeling, joint pain, fast heartbeat, didn't sleep very well, felt like a zombie, bladder incontinence: Yes (Related). Causality of all these events is related to the vaccine. Follow-Up (01Sep2021): Follow-up attempts are completed. No further information is expected.

Other Meds: RITUXIMAB; TOVIAZ; BACLOFEN; BUPROPION; VITAMIN C [ASCORBIC ACID]; VITAMIN E [TOCOPHEROL]; MILK THISTLE; HILDE HEMMES' HERBALS STINGING NETTLE; PROBIOTICS

Current Illness:

ID: 1711314
Sex: M
Age:
State:

Vax Date: 08/01/2021
Onset Date: 08/01/2021
Rec V Date: 09/18/2021
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: Shortness of breath; This is a spontaneous report from a contactable consumer (Parent). An unspecified age of male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number not provided), via an unspecified route of administration on an unknown date Aug2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date Aug2021, the patient experienced Shortness of breath. It was reported that My son just had the vaccination conducted on Saturday and he is now experiencing shortness of breath and I am sure you could find out if there is any advise you can give us what can we expect in terms of the shortness of breath, what can we expect and how long it's usually last, so forth and so on. Reporter was informed about the role of Pfizer drug safety and Pfizer Medical Information and provided with the number as # and requested to dial the option 3 and informed about timings as 8 AM to 8 PM from Monday to Friday as per EST. Product details and pharmacy details could not be probed as the reporter was unwilling to complete the report. Hence limited information available over the call.The outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Follow-up activities closed. Batch/lot number not available for [vaccine/BNT162B2], F/UP closure to be managed as significant

Other Meds:

Current Illness:

ID: 1711315
Sex: F
Age:
State:

Vax Date: 08/11/2021
Onset Date: 08/11/2021
Rec V Date: 09/18/2021
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: Itchy; Trouble staying asleep; I'm breastfeeding; I'm breastfeeding; This is a spontaneous report received from a contactable consumer (Patient). A 34-year-old female patient received BNT162B2 (PIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FA7485), Solution for injection, via an unspecified route of administration, administered in Arm Left on 11Aug2021 (at the age of A 34-year-old) as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. On 11ug2021, the patient experienced itchy, trouble staying asleep and she was breastfeeding. The seriousness was reported as non-serious by the reporter. No treatment was received to treat adverse events. The event itchy, trouble staying asleep was recovered on an unspecified date in Aug2021 and outcome of other events were unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1711316
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: Body aches; Fatigue; Fever; Chills; Headache; Sweats; Coughing; This is a spontaneous report from a contactable consumer Patient reported that. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced body aches, fatigue, fever, chills, headache, sweats and coughing. The event outcome was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1711317
Sex: F
Age:
State: TX

Vax Date: 04/26/2021
Onset Date: 04/29/2021
Rec V Date: 09/18/2021
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: Get heavy flow on what would normally be my 'time of the month'; It affects my daily life to detrimental proportions.; Tired; Headache; Bloating throughout every month; My menstrual cycle is now 3 weeks+ long flow and never really stops.; Cramps, spotting, clotting; Cramps, spotting, clotting; Cramps, spotting, clotting; This is a spontaneous report from a contactable consumer. This 44-year-old female consumer (patient) reported for herself that. A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP7533), dose 2 via an unspecified route of administration, administered in Arm Left on 26Apr2021 13:45 as (At the age of 44-years) dose 2, single for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication(s) included acetaminophen taken for an unspecified indication, start and stop date were not reported. Patient was not pregnant at the time of Vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnose with COVID-19 Prior to vaccination. Patient did not test for COVID-19 Since the vaccination. The patient previously took Erythromycin, penicillin and all derivatives, Epinephrine shot (the way it is prepared) and experienced drug hypersensitivity (Allergies). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8731), dose 1 via an unspecified route of administration, administered in Arm Left on 03Apr2021 01:30 PM as (At the age of 44-years) dose 1, single for covid-19 immunisation and experienced intermenstrual bleeding. On 29Apr2021 12:00 patient experienced menstrual cycle is now 3 weeks long flow and never really stops. Cramps, spotting, clotting, the whole nine yards almost all month, every month since his second dose. First dose had made spot some between periods, too. It was reported that patient still get heavy flow on what would normally be his 'time of the month'. If patient lucky, might get up to a week after his 'time' flow-free, but never more and often less. Patient cannot go even one day without wearing a pad at least or I'll bleed through clothing. Tired, headache, cramps, even a bit of bloating throughout every month since vaccination. This suck, it affects his daily life to detrimental proportions. Patient did not receive any Treatment for events. No Prolonged Hospitalization for events. The outcome of events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: ACETAMINOPHEN

Current Illness:

ID: 1711318
Sex: M
Age:
State: NJ

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

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Shingles; This is a spontaneous report from a contactable Nurse. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown) via an unspecified route of administration as dose number unknown, single on an unspecified date for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The Nurse reported that the patient had shingles after the vaccine on an unspecified date. The reporter assessed the event as non-serious. Outcome of event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101084524 Same reporter/drug/AE, different patient

Other Meds:

Current Illness:

ID: 1711319
Sex: M
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: Shingles; This is a spontaneous report from a contactable other health care professional (registered nurse). A contactable Registered Nurse reported similar events for 3 patients. This is 2 of 3 reports. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection ,batch/Lot number was not reported, expiry date: not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Caller was listening to the radio, and they said people are reporting an uptick of shingles after getting the COVID 19 vaccine. She had shingles after the vaccine as well as 3 other people she knows. It was out of the blue. On an unspecified date, One of the people she works with was going through shingles now after the vaccine. His happened within 6 months of the shot. The person was going to be terminated if he didn't get the vaccine. She doesn't have his information to do a report. The outcome of event was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101084524 Same reporter/drug/AE, different patient

Other Meds:

Current Illness:

ID: 1711320
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: I have leg cramp, cramps in my calf.; I have swelling below my knee.; I have a bruise that after seven days is now going away; 24 hours after my vaccine I could not walk up up a hill. I barely could walk and definitely could not walk up a hill; I have red dots on my thigh; I have red spots in my thighs; I have PMS symptoms. So, like perimenopause symptoms. It is not like I had my period again but I have all those symptoms; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (at the age of 56 years), (Batch/Lot Number: FC3181) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient reported, I was going to go on Pfizer website just trying to figure out the safety one, I have had side effects from the Pfizer Covid first vaccine, and I wanted to report it, but I thought to speak to somebody verbally. I have leg cramp, cramps in my calf. I have swelling below my knee. I have a bruise that after seven days is now going away. I never bruise and I had Bruise. 24 hours after my vaccine I could not walk up a hill. I barely could walk and definitely could not walk up a hill. I had, I did not know how to put this, I had PMS symptoms. So, like perimenopause symptoms. It was not like I had my period again, but I had all those symptoms and now I had red spots in my thighs. The clinical outcome of the event I have a bruise that after seven days is now going away was recovering, and remaining all other events was unknown at the time of report. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1711321
Sex: F
Age:
State: MI

Vax Date: 04/17/2021
Onset Date:
Rec V Date: 09/18/2021
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:103.1; Test Name: blood test; Result Unstructured Data: Test Result:5.7; Comments: Her AIC is only 5.7, she thinks. She has never taken insulin

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: I would was my hair and gobs; 103.1 fever; freezing; Hair curly; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) dose 1 via unspecified route of administration on 17Apr2021 in left arm (Batch/Lot number-ER8727, Expirary date-Unknown) (Age at Time of Vaccination in Years: 77 years) as dose 1, single for COVID-19 immunisation. The patient relevant medical history included gall bladder out from unknown, Kidney stones from Feb2021, blockages (Why was the patient taking Concomitant Products rosuvastatin so her arteries don't block up), diabetic, heart attacks (why was the patient taking Concomitant Products Aspirin; for heart attacks), blood pressure from unknown date stop date were unknown. The patient had not received any other vaccine within 4 weeks before COVID vaccination. The patient concomitant medication includes Minoxidil 2.5mg (Had been taking for a year. States if she could read or spell it. She was going to have to get a magnifying glass to provide the name) tablet twice day taken for blood pressure abnormal from an unspecified start date and ongoing; Rosuvastatin 40mg (Had been taking for 15 years, maybe) once a day taken for arteries don't block up from an unspecified start date and ongoing; metoprolol (METOPROLOL) (Has been taking about the same, 15 years or more) taken for blood pressure abnormal from an unspecified start date and ongoing; Amlodipine Besilate (AMLODIPINE BESILATE) 5mg (had been taking for a year) a day both for blood pressure from an unspecified start date and ongoing; glipizide (GLIPIZIDE) 5mg one a day taken for diabetes mellitus from Feb2021 and ongoing; acetylsalicylic acid (ASPIRIN COX [ACETYLSALICYLIC ACID]) 81mg once a day taken for myocardial infarction from an unspecified start date and ongoing; quinapril (QUINAPRIL) 20mg twice a day taken for an unspecified indication from an unspecified start date and ongoing (Has been taking for a couple years, at least). Patient takes Vitamin D, 25mg for Vitamin D start date and stop date was not reported. Her AIC is only 5.7. She has never taken insulin. All she takes glipizide, which has only been since Feb2021. Patient experienced I would was my hair and gobs, hair curly, 103.1 fever and freezing on an unspecified date. Patient Experiencing hair loss since after receiving both shots of the Pfizer covid vaccine, and she has heard that this has happened to other people as well. Her hair which has never been curly was curly now. Patient stated, I sure was, but it quit now, it started after the first shot, I would was my hair and gobs would fallout, and then after the second shot and I had 103.1 fever, and my hair was falling out, I was scared to even comb it, it scared me. Then, my hair is straight, it ain't no more, it will curl up and it just curls up, my hair never did that. It has quit falling out. I spoke to the pharmacist, and to my regular doctor. Patient had a 103.1 fever the next day, after both shots. She wasn't sick or anything, just freezing but not sick, sick. It lasted only a day. Losing hair: Clarifies about 5 days after the first shot, she went to wash her hair and had handfuls of hair come out. After that, she would comb it and it and it would come right out with the comb. It stopped falling out like it did. It is not much at all and seems better. The patient underwent lab tests and procedures which included body temperature: 103.1 and blood test 5.7 (Her AIC is only 5.7, she thinks. She has never taken insulin) on an unspecified date. The patient had not taken treatment for hair loss. The outcome of events was unknown. Follow-Up (06Sep2021): Follow-up attempts are completed. No further information is expected.

Other Meds: MINOXIDIL; ROSUVASTATIN; METOPROLOL; AMLODIPINE BESILATE; GLIPIZIDE; ASPIRIN COX [ACETYLSALICYLIC ACID]; QUINAPRIL

Current Illness:

ID: 1711322
Sex: F
Age:
State: FL

Vax Date: 12/01/2020
Onset Date:
Rec V Date: 09/18/2021
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: Painful nerve issue in her neck and arm for 6 weeks; This is a spontaneous report from a contactable consumer reported for a female patient (twin sister). A female patient of unspecified age received second dose of bnt162b2 (Pfizer COVID-19 vaccine, Solution for injection), via an unspecified route on an unspecified date in Dec2020 (age at vaccination: 62-year-old), as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer COVID-19 vaccine, Solution for injection), as a single dose for covid-19 immunization. On an unknown date, after the second dose patient experienced a painful nerve issue in her neck and arm for 6 weeks. The clinical outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1711323
Sex: F
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: polycystic condition; This is a spontaneous report from a Pfizer sponsored. A contactable consumer (patient's husband) reported for a female patient (reporter's wife) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE, and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE both for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported by the reporter that before he was originally part of the original trial of Pfizer covid-19 vaccine and now his wife is part of the booster trial. He stated that he is confused in regards with Pfizer's general plan. He pointed to the 3rd dose/booster if they can get it because they were informed that after 12 months getting the 2nd dose, they will be receiving the 3rd dose but up to now they didn't receive it. Name withheld is aggravated already in regard to what happened and he stated that he wants to go to the media to inform people about Pfizer's general plan because he had diabetes and his wife had a polycystic condition. On an unspecified date, the patient experienced polycystic condition. The outcome of event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1711324
Sex: F
Age:
State: CA

Vax Date: 01/13/2021
Onset Date: 01/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: Covid-19; Result Unstructured Data: Test Result:Unknown results

Allergies:

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

Symptoms: I had bumps all over on my neck and next day it went to my face; 15 minutes after the vaccination my necks started itching, the right side of my neck; rash on the neck and her face; rash on the neck and her face; Heart palpitation; my heart just started pounding; Allergic reaction; This is a spontaneous report from a contactable consumer. This 43-year-old female consumer reported for herself that. A 43-years-old female (Non-Pregnant) patient received first dose of bnt162b2 (Pfizer vaccine, COVID 19 Vaccine, mRNA, solution for injection, Batch/Lot number: EL3302, expiry date: unknown), dose 1 via an unspecified route of administration, administered in arm right on 13Jan2021 (Age at vaccination 43 year) as dose 1, single for covid-19 immunisation. Patient medical history included don't have ovaries, don't have gallbladder. Patient concomitant medication included golden pill, echinacea for unspecified indication start from unspecified date if ongoing unknown. Patient experienced her side effects back in Jan's patient had her 1st dose on 13Jan2021, she had rash on the neck and her face, heart palpitation; my heart just started pounding, allergic reaction in Jan2021 and 15 minutes after the vaccination my necks started itching, the right side of my neck on 13Jan2021. Patient had bumps all over on my neck and next day it went to my face on 14Jan2021. Patient taken treatment of Benadryl, 50 mg, two times a day. Patient underwent lab test which included SARS-CoV-2 test which result was unknown on unspecified date. The outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: ECHINACEA

Current Illness:

ID: 1711325
Sex: M
Age:
State: FL

Vax Date: 08/02/2021
Onset Date:
Rec V Date: 09/18/2021
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: Test Name: covid-19 test; Result Unstructured Data: Test Result: negative.

Allergies:

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

Symptoms: He has been quarantined since his wife tested positive.; This case is considered as invalid as there is no indication that the patient experienced an event under BNT162b2. This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 02Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated that he and his wife both got their first Pfizer Covid 19 vaccine on 02Aug2021. The caller confirms the information provided. He was calling because it's time for him to receive his second Covid 19 vaccine tomorrow, 24Aug2021. He states he had the Covid 19 vaccine and did fine. He wants to know how long, if any time, does he have to wait to receive his second Covid 19 vaccine. He is scheduled to receive his second dose tomorrow, 24Aug2021 and he had a home Covid 19 virus test, and it was negative, and he hasn't had any other issues or symptoms in the last 12 days. He wants to get the second dose, but the pharmacist said he had to have a negative Covid 19 virus test before getting the second Covid 19 vaccine and someone else told him he had to wait until after his quarantine time and he should be ok to get the second dose. The patient underwent lab tests and procedures which included sars-cov-2 test negative on an unspecified date. The outcome of the event was unknown. Information about lot/batch number has been requested. This follow up is being submitted to amend previously reported information, Case reassessed as invalid. This case is being deleted from the database for the following reason Existence of an adverse event not confirmed at follow-up.

Other Meds:

Current Illness:

ID: 1711326
Sex: F
Age:
State: NC

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 09/18/2021
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: bladder incontinence; Joint pain; fast heart beat; Felt like a zombie; Bladder incontinence; didn't sleep very well; Chills; Weakness; Tiredness; wonky feeling; sore arm; injection site pain; This is a spontaneous report from a contactable other hcp. A 66-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection(Batch/Lot Number: EL3246), dose 1 intramuscularly, administered in Arm Left on 28Jan2021 10:00 as dose 1, single, dose 2 via an unspecified route of administration, administered in Arm Right on 18Feb2021 10:00 (Batch/Lot Number: EN6200) as dose 2, single, dose 3 via an unspecified route of administration on 17Aug2021 11:30 (Batch/Lot Number: FC3181) as DOSE 3, SINGLE for covid-19 immunisation. Medical history included chronic lymphocytic leukaemia, from a couple of years , multiple sclerosis from 1996 to an unknown date , urinary incontinence from a few years, hip arthroplasty from the last couple of years; mentions she has to take antibiotics before any dental work due to the hip, restless legs syndrome. Concomitant medication(s) included rituximab (RITUXIMAB) taken for chronic lymphocytic leukaemia; fesoterodine fumarate (TOVIAZ) taken for urinary incontinence; baclofen (BACLOFEN) taken for restless legs syndrome; bupropion (BUPROPION) ongoing; vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) ongoing; tocopherol (VITAMIN E [TOCOPHEROL]); silybum marianum (MILK THISTLE) taken for liver disorder ongoing; probiotics (PROBIOTICS) ongoing. The patient previously took tropism chloride for hypersensitivity, oxybutynin for hypersensitivity, myrbetriq for hypersensitivity, nickel for hypersensitivity. It was Reported that, The second one she had chills that night; weakness and had to hold on to things; kind of wonky feeling; didn't sleep very well and had tiredness at night. Adds she had to hold on to things as her balance was not quite there. Mentions she got up at 0300 AM to report, she did the VAERS report and the Pfizer report. The booster went a little more, she had chills, tiredness; took a super-hot shower before she went to bed as the chills were starting in hands and feet; joint pain; injection site was painful; and then the other thing was a heartbeat that was really moving. Then she felt like a zombie; she was running errands yesterday and trying to stay focused driving. Adds she also noticed bladder incontinence that started after this dose for sure. She already has some bladder incontinence from MS, and she takes a medication that helps it; controls it so she doesn't have it. But after the booster, when she gets up, she just lets go; every time she peed all the way and the a little more in the toilet. She used a lot of pads, men's pads, but it is getting better now; her medication kicked in. She didn't notice it so much on the second dose. Adds staying in bed a long time this time really helped. Caller rates all of her events as not serious. When ask for causality, she states yes, all of these events is related to the vaccine because she didn't have any of this before. The patient experienced sore arm, injection site pain on 28Jan2021 with outcome of recovered, bladder incontinence on 17Aug2021 with outcome of recovered, chills, weakness, tiredness, wonky feeling, didn't sleep very well on 18Feb2021 with outcome of recovered, joint pain, fast heartbeat, felt like a zombie, bladder incontinence on 17Aug2021 with outcome of recovered. She has not gone to the emergency room or seen a doctor for any of her side effects and reported no treatment. Follow-Up (31Aug2021): Follow-up attempts are completed. No further information is expected.

Other Meds: RITUXIMAB; TOVIAZ; BACLOFEN; BUPROPION; VITAMIN C [ASCORBIC ACID]; VITAMIN E [TOCOPHEROL]; MILK THISTLE; PROBIOTICS

Current Illness:

ID: 1711327
Sex: F
Age:
State: NC

Vax Date: 02/18/2021
Onset Date: 02/18/2021
Rec V Date: 09/18/2021
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: she had chills that night; weakness; had to hold on to things; wonky feeling; didn't sleep very well; had tiredness at night; This is a spontaneous report from a contactable nurse (patient). A 66-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6200), via intramuscular route of administration, administrated in upper left arm on 18Feb2021 10:00 (age at the time of vaccination 66-years-old), as a single dose for COVID-19 immunization. The patient's medical history included CCL (Chronic lymphocytic leukaemia) from a couple of years, MS (Multiple sclerosis) from 1996, Bladder incontinence from a few years, Hip replacement from last couple of years, mentions she has to take antibiotics before any dental work due to hip, had Allergy to trospium chloride, Oxybutynin, Nickel on the skin or bandages that are not latex, myrbetriq, and Restless legs, and Adds sulfa gives her hives. The patient's concomitant medications included Rituximab as an infusion by intravenous twice yearly two weeks apart from an unspecified date to ongoing for CLL; Toviaz as a 4mg take once daily by mouth from an unspecified date to ongoing for Indication Bladder incontinence, it made a night and day difference, she went from no control to control over her bladder; Baclofen as a 10mg take one half twice daily from an unspecified date to ongoing for Restless legs; Bupropion as a 150mg take once daily by mouth from an unspecified date to ongoing; vitamin C as a 1000 present daily value, take eleven capsules once daily from an unspecified date to ongoing; vitamin E as a 1000IU, take twice daily by mouth from an unspecified date to ongoing for helps with memory; Milk Thistle as a 300mg take twice daily by mouth from an unspecified date to ongoing for liver health (Not Coded); stinging nettles as a 480mg take one twice daily by mouth from an unspecified date to ongoing for kidney health (Not Coded); and probiotic take once daily by mouth from an unspecified date to ongoing for good for colon (Not Coded). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3246), via an unspecified route of administration, administrated in Upper Left Arm on 28Jan2021 10:00 (age at the time of vaccination 66-years-old), as a single dose for COVID-19 immunization and patient experienced sore arm, injection site pain, bladder incontinence, Chills, Weakness, Tiredness, wonky feeling, Joint pain, fast heart beat, didn't sleep very well, and Felt like a zombie. No Prior Vaccinations (within 4 weeks). On 18Feb2021, the patient experienced she had chills that night, weakness, had to hold on to things, wonky feeling, didn't sleep very well, and had tiredness at night. Patient has not gone to the emergency room or seen a doctor for any of her side effects and reported no treatment. The outcome of the event chill recovered on 17Aug2021; and event didn't sleep very well was recovered on 18Aug2021; and events weakness, had to hold on to things were unknown; and events wonky feeling, had tiredness at night were recovering. Follow-Up (31Aug2021): Follow-up attempts are completed. No further information is expected.

Other Meds: RITUXIMAB; TOVIAZ; BACLOFEN; BUPROPION; VITAMIN C [ASCORBIC ACID]; VIT E [TOCOPHEROL]; MILK THISTLE; NETTLE [URTICA DIOICA]; PROBIOTICS

Current Illness:

ID: 1711328
Sex: F
Age:
State: NC

Vax Date: 08/17/2021
Onset Date: 08/01/2021
Rec V Date: 09/18/2021
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: Side effects after the booster; Side effects after the booster; Joint pain; Heartbeat that was really moving; She felt like a zombie; Bladder incontinence; Injection site was painful; Had chills; Tiredness; This is a spontaneous report from a contactable Nurse. This contactable 66-year-old female (patient) reported for herself that. A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FC3181), (At the age of 66-years) dose 3 via an unspecified route of administration, administered in Arm Right on 17Aug2021 11:30 as dose 3, single for covid-19 immunisation. Medical history included Bladder incontinence from an unknown date (from a few years), Chronic lymphocytic leukaemia from a couple of years, Multiple sclerosis From unknown To 1996, Hip replacement from the last couple of years; mentions she has to take antibiotics before any dental work due to the hip. Concomitant medication included rituximab infusion by IV twice yearly two weeks apart taken for chronic lymphocytic leukaemia from an unspecified start date and ongoing; fesoterodine fumarate (TOVIAZ) 4mg take once daily by mouth taken for urinary incontinence bladder control is a miracle; it made a night and day difference; she went from no control to control over her bladder from an unspecified start date and ongoing; baclofen 10mg take one half twice daily taken for restless legs syndrome from an unspecified start date and ongoing; bupropion 150mg once daily by mouth taken for an unspecified indication from an unspecified start date and ongoing; ascorbic acid (VITAMIN C) 1000 % daily value; take eleven capsules once daily taken for an unspecified indication from an unspecified start date and ongoing; tocopherol (VITAMIN E [TOCOPHEROL]) 1000IU take twice daily by mouth taken for an unspecified indication from an unspecified start date and ongoing; silybum marianum (MILK THISTLE) 300mg take twice daily by mouth taken for liver health; probiotics take once daily by mouth taken for an unspecified indication from an unspecified start date and ongoing: stinging nettles 480mg take one twice daily by mouth taken for kidney health. No Additional Vaccines Administered on Same Date of the product Suspect. No Prior Vaccinations within 4 weeks. No AE(s) following prior vaccinations. It was reported that patient brother said he had a reaction to the COVID second shot. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3246) dose 1 via an unspecified route of administration, administered in Upper Left Arm for COVID-19 immunization on 28Jan2021 10:00AM and experienced Sore arm, and Injection site pain. Patient previously took Second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6200) dose 2 via an unspecified route of administration, administered in Upper Left Arm for COVID-19 immunization on 18Feb2021 1000AM and experienced chills, Weakness, Wonky feeling, didn't sleep very well, Tiredness, and Her balance was not quite there. It was reported that for bladder incontinence she tried a few meds that she was allergic to; one was trospium chloride, she doesn't have doses; and oxybutynin. Adds sulfa gives her hives; she is also allergic to myrbetriq; and allergic to nickel on the skin or bandages that are not latex, plastic is fine. She doesn't have any product or information for the products and cannot provide NDC, lot or expiration date. The patient had side effects after the booster (extra dose administered and off label use) on 17Aug2021. patient experienced had chills, tiredness, and injection site was painful on Aug2021. patient experienced joint pain, heartbeat that was really, he felt like a zombie, and bladder incontinence on 17Aug2021. Patient calling regarding the Pfizer BionTech COVID 19 vaccine. Adds she is calling about the booster dose. Mentions her computer crapped out on her and doing it on her phone is hard so she decided to call in. Mentions she previously reported after the second dose online. No report reference known to caller. Today she wants to report adverse effects; she had two days of side effects after the booster. first dose 28Jan2021 at 10:00AM in Upper Left Arm; EL3246; administered at withheld Hospital; second dose 18Feb2021 at 10:00AM in the upper left arm; lot EN6200; administered at withheld Hospital; third dose booster 17Aug2021 at 1130AM in the upper Right arm; lot FC3181; administered at #. Caller sees no other writing on the vaccination card, no NDC, expiration date or dose. The first dose she just had a sore arm and injection site pain. The second one she had chills that night; weakness and had to hold on to things; kind of wonky feeling; didn't sleep very well and had tiredness at night. Adds she had to hold on to things as her balance was not quite there. Mentions she got up at 03:00 AM to report, she did the regulatory authority report and the company report. The booster went a little more, she had chills, tiredness; took a super-hot shower before she went to bed as the chills were starting in hands and feet; joint pain; injection site was painful; and then the other thing was a heartbeat that was really moving. Then she felt like a zombie; she was running errands yesterday and trying to stay focused driving. Adds she also noticed bladder incontinence that started after this dose for sure. She already has some bladder incontinence from MS and she takes a medication that helps it; controls it so she doesn't have it. But after the booster, when she gets up, she just lets go; everytime she peed all the way and the a little more in the toilet. She used a lot of pads, men's pads, but it is getting better now; her medication kicked in. She didn't notice it so much on the second dose. Adds staying in bed a long time this time really helped. Caller rates all of her events as not serious. When ask for causality, she states yes, all of these events are related to the vaccine because she didn't have any of this before. Treatment: She has not gone to the emergency room or seen a doctor for any of her side effects and reported no treatment. Communication: Caller mentions she reported to company online after the second dose. No report reference number known. This will be follow up. Caller was provided with this report reference number. Caller mentions her brother had a reaction to the COVID second shot. A clone report is created to document the brother's experience. This is report one of two. No product complaint to report and no medical information request. The outcome of events had chills, heartbeat that was really moving was recovered on 17Aug2021, outcome of event joint pain, and she felt like a zombie was recovered on 19Aug2021, outcome of event. Outcome of events tiredness, and bladder incontinence and injection site painful was recovering The lot number for the vaccine, [BNT162B2], was not probided and will be requested during follow-up.

Other Meds: RITUXIMAB; TOVIAZ; BACLOFEN; BUPROPION; Vitamin C; VITAMIN E [TOCOPHEROL]; MILK THISTLE; PROBIOTICS

Current Illness:

ID: 1711329
Sex: U
Age:
State: TX

Vax Date: 07/25/2021
Onset Date: 07/28/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Chills; This is a spontaneous report from a contactable consumer (patient) reported in response to Non-HCP letter via follow-up letter. This case was split to capture events after first and second dose of vaccine. This is the first of two reports, reflecting events after the 2nd dose. A 62-years-old patient of an unspecified gender received BNT162b2 (PFIZER/BIONTECH COVID-19 VACCINE, Solution for injection, Lot No: FA7845), via intramuscular, administered in Arm Left on 25Jul2021, 12:08 as 2nddose, single for covid-19 immunisation (Age at vaccination was 62 years). Historical vaccine was a 62-years-old patient of an unspecified gender received BNT162b2 (PFIZER/BIONTECH COVID-19 VACCINE, Solution for injection, Lot No: EW0198), via intramuscular, administered in Arm Left on 04Jul2021, 11:40 AM as 1stdose, single for covid-19 immunisation with events of muscle pain in the raise arm, vaccine received within 4 weeks PRIOR: AstraZeneca. Medical history included hyperlipidaemia from 2005 and ongoing, hypertension from 2005 and ongoing. Concomitant medication(s) included amlodipine besilate, hydrochlorothiazide, valsartan (EXFORGE HCT) taken for hypertension from an unspecified start date and ongoing; pitavastatin (PITAVASTATIN) taken for hyperlipidaemia from an unspecified start date and ongoing. The patient experienced chills on 28Jul2021 10:00. Relevant tests where no. Treatment was received. Upon follow-Up on 01Sep2021Follow-up attempts are completed. No further information is expected. Outcome of the event was recovered on same day. Follow-Up (01Sep2021): Follow-up attempts are completed. No further information is expected.

Other Meds: EXFORGE HCT; PITAVASTATIN

Current Illness: Hyperlipidemia; Hypertension

ID: 1711330
Sex: M
Age:
State: MN

Vax Date: 03/31/2021
Onset Date: 04/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: x-rayed chest; Result Unstructured Data: Test Result:Unknown; Comments: he got an IUD or intrauterine device almost 20 years ago so they wanted to check that; Test Date: 2021; Test Name: X-ray of his groin and leg areas; Result Unstructured Data: Test Result:minor arthritis; Test Name: x-rayed heart; Result Unstructured Data: Test Result:Unknown; Comments: he got an IUD or intrauterine device almost 20 years ago so they wanted to check that

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: this morning when he got out of bed he did not think his left leg would hold him up; muscles and pain in the thigh/muscle pain/pain basically operates on the muscles of his thigh; terrific pain that came and went in his left thigh, up in his back and down in his left leg; He could hardly walk and has been taking Ibuprofen to help him walk; terrific pain that came and went in his left thigh, up in his back and down in his left leg; minor arthritis; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown, expiry date: unknown) via an unspecified route of administration at injection left shoulder (arm), up high almost where arm met body on outside on 31Mar2021 (at the age of 81-year-old) as dose 2, single as COVID-19 immunization. The patient medical history included blood clot back in 1970s (there was just normal medications that he has been on for years), coughed (1.5 years ago he had a session where he coughed for 6 weeks, he never coughed anything up), pains all over that just moved around, mainly in his side and back, short of breath, Embedded IUD, heart stopped, passed out and fallen. He was on his third IUD (lot number and expiry date: unknown). The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unknown date in 2021 (might be 2 weeks before second dose) as dose 1, single for covid-19 immunisation. Past drug included Pradaxa for 35 months (then he got done with that and then got a device that looks like a toy parachute in his right aorta flap in there to prevent blood clots for him to get off of Coumadin) and Coumadin for blood clots (Lots number and Expiry dates were unknown). His first device was put in in the state of withheld There were two ladies that went up there to the hospital and they backed out and it was a study. They later called patient's wife to know. how he was doing and then one of them had it done afterwards. They said he actually died in the woods before he got the IUD or Device; that his heart stopped completely, not a heart attack, his heart just stopped. A guy picked him up because he had fallen into a campfire. The guy picked him up, lifted him about as high as a table to get him out of the fire and dropped him to the ground and they thought that was what started his heart back. When he came out of that he had passed out and it sounded like someone was calling his name from way far away where he could barely hear he until it got louder and louder and he came around thinking what the he was doing down there. On an unknown date approximately in Apr2021, maybe 4 to 5 days or almost a week after he was administered second dose of Pfizer Covid-19 Vaccination could had been 04Apr2021 or 05Apr2021, the patient experienced terrific pain that came and went in his left thigh, up in his back and down in his left leg, this morning when he got out of bed he did not think his left leg would hold him up, muscles and pain in the thigh/muscle pain/pain basically operates on the muscles of his thigh and he can hardly walk. It was reported that his right leg was not bothered. It felt like the pain basically operated on the muscles of his thigh, but he did not really know what was in there. He mentioned the shots themselves were nothing. 10 minutes after he had the shots of Pfizer Covid-19 Vaccination doses he did not even know he had them. Outcome was unknown, some days side effects were better than other days but the severity he did not think has changed even over several weeks. This morning when he got out of bed he did not think his left leg would hold him up. He was not sure if he had not had the bed stand to put his hand on when he stood up for a second he was not sure his left leg would have held. He has not been hospitalized or been to the emergency room relative to this event. He has been to his healthcare provider's office multiple times relative to this event. The first two times he told the provider about it and she just hoo-hooed it off. Then he went in to see the provider again and she felt his leg and sent him packing. He could hardly walk and has been taking Ibuprofen to help him walk. Regarding relevant testing/investigations/x-rays/scans/cultures/bloodwork/lab: he has had X-rays might be about a month ago of his groin and leg areas; where they had him lay on his back, pulled his parts up, dropped his legs out like a chicken to see his bones and everything but they only thing they found was something like minor arthritis, not due to Pfizer Covid-19 Vaccination or the side effects; but just minimal everything, minimal wear for his age, like wear and tear; that everything looked good in there. The patient underwent lab tests and procedures which included x-rayed chest and heart: unknown, he got an IUD or intrauterine device almost 20 years ago so they wanted to check that and X-ray: minor arthritis unspecified date in 2021. The outcome of the event this morning when he got out of bed he did not think his left leg would hold him up was unknown and the outcome of rest of the events was not recovered. reinforced and referenced: "Because these reactions are reported voluntarily, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure." The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1711331
Sex: F
Age:
State: NY

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 20200331; Test Name: Covid-19 test; Result Unstructured Data: Test Result:positive

Allergies:

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

Symptoms: did not take second dose; swollen lymph node under her right arm; fever; She had huge nodules; chills; rapid heartbeat; chest pain; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored. A 61-years-old female patient received bnt162b2 (Pfizer COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 14Jan2021 (Batch/Lot Number: EL3248, Age at Vaccination: 61-years) as DOSE 1, SINGLE for Covid prevention. The patient had Covid on 31Mar2020. She has a lot of food allergies such as soy, eggs avocado, you name it. She is also allergic to nuts. No additional vaccines were administered on same date of the Pfizer suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). No AE(s) following prior vaccinations. Concomitant medications included olmesartan medoxomil (BENICAR) at a dose of 25/12.50mg daily taken for hypertension (has been taking for over 10 years), from an unknown start date and ongoing; rosuvastatin calcium (CRESTOR) taken for Cholesterol (Low dose of either 5mg or 10mg. Has been taking it for the last year), from an unknown start date and ongoing. Patient took the first dose of the Covid 19 vaccine on 14Jan2021. She did not take the second dose. The patient experienced chills on 14Jan2021, rapid heartbeat on 14Jan2021, chest pain on 14Jan2021, swollen lymph node under her right arm on 15Jan2021, fever on 14Jan2021, she had huge nodules on 14Jan2021. She took an Aspirin. The rapid heart beat lasted for 4 hours. She had huge nodules. It lasted longer than the chest pain. The nodules started small the following day and they got bigger for a few days. The patient underwent lab tests and procedures which included Covid-19 test: positive on 31Mar2020. Therapeutic measures were taken as a result of chills, rapid heartbeat, chest pain, swollen lymph node under her right arm, fever, she had huge nodules. AE(s) did not require a visit to: Emergency Room, Physician Office. She was supposed to have the 2nd dose on 03Feb2021 and did not take it due to the reactions - She will go to (Name withheld) 2 weeks from now and wants to know if she can still have the 2nd dose. The outcome of the event rapid heartbeat was recovered on 14Jan2021, chest pain was recovered on 16Jan2021, swollen lymph node under her right arm was recovered on 15Jan2021, fever, chills, she had huge nodules was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: BENICAR; CRESTOR

Current Illness:

ID: 1711332
Sex: F
Age:
State: OK

Vax Date: 06/27/2021
Onset Date: 06/27/2021
Rec V Date: 09/18/2021
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 Date: 20210823; Test Name: Nasal swab; Test Result: Negative

Allergies:

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

Symptoms: After 5 minutes of injection, nasal passages congested and throat tightening and swelling.; After 5 minutes of injection, nasal passages congested and throat tightening and swelling.; After 5 minutes of injection, nasal passages congested and throat tightening and swelling.; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 27Jun2021 12:30 (Lot number and Expiration Date was not reported) as dose 1, single for covid-19 immunisation. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing, known allergies included Wheat, gluten, wasp, yellow jacket and bee venom. Concomitant medication included gabapentin taken for an unspecified indication, start and stop date were not reported; adalimumab (HUMIRA) taken for an unspecified indication, start and stop date were not reported; cefixime (FLEXERIL [CEFIXIME]) taken for an unspecified indication, start and stop date were not reported; bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported; lisinopril taken for an unspecified indication, start and stop date were not reported. The patient previously took high doses of prednisone and experienced drug allergy. The patient did not receive other vaccine in four weeks. The patient did not receive covid prior vaccination. The patient experienced after 5 minutes of injection, nasal passages congested and throat tightening and swelling. on 27Jun2021 12:35. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 23Aug2021. Therapeutic measures were taken as a result of after 5 minutes of injection, nasal passages congested and throat tightening and swelling and treatment included benadryl, claritin, albuterol inhaler, water. The events resulted in Doctor's office/urgent care. The outcome of the events was reported as resolved on an unspecified date in 2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: GABAPENTIN; HUMIRA; FLEXERIL [CEFIXIME]; WELLBUTRIN; LISINOPRIL

Current Illness:

ID: 1711333
Sex: F
Age:
State: ME

Vax Date: 08/19/2021
Onset Date: 08/19/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Insomnia; Chills; Fever; Joint pain; Intense headache; Nausea; Diarrhea; Fatigue; Sore arm; Intense body aches; Chest tightness; Abdominal cramping; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 27-year-old non pregnant female patient received bnt162b2 (BNT162B2 Formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 19Aug2021 at 16:30 (Batch/Lot Number: EW0180) as DOSE 2, SINGLE (at the age of 27-year-old) for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included asthma and generalised anxiety disorder from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on 28Jul2021 at 16.00 (Batch/lot number: EW0191, left arm) for covid-19 immunisation. The patient did not receive any other vaccine in four weeks. The patient experienced Insomnia, chills, fever, joint pain, intense headache, nausea, diarrhea, fatigue, sore arm, intense body aches, chest tightness and abdominal cramping on 19Aug2021 at 16:30. The patient was not tested for COVID post vaccination. No treatment received for the event. The outcome of the events reported as recovered on an unknown date of Aug2021. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1711334
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: allergy to PEG in Covid vaccine/ experienced 3 weeks of severe allergic reaction after each dose of the covid vaccine; This is a spontaneous report from a contactable consumer (patient) via medical information team . This consumer reported similar events for two patients (including self). This is first of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified dates as dose 1, single and dose 2, single (Lot number and Expiry date was not reported) for covid-19 immunization. This vaccine contains Polyethylene Glycol (PEG). The patient medical history and concomitant medications were not reported. The patient experienced allergy to PEG in covid vaccine/ experienced 3 weeks of severe allergic reaction after each dose of the covid vaccine on an unspecified dates. It was reported, patient was since been diagnosed with PEG allergy. Treatment for the event was not reported. The outcome for the event was unknown. The lot number for the BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101137872 same reporter, drug, event/ different patient

Other Meds:

Current Illness:

ID: 1711335
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: there are a lot of days I have to push myself through the day; I just very weak; This is a spontaneous report from a contactable consumer (patient) via medical information team. A male patient of an unspecified age received bnt162b2 (COMIRNATY, Solution for injection) via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient asked about the data on the long-term side effects to the vaccine. He is asking because he stated that was a very active person and after the vaccine there are some days, he felt good and there are "a lot" of days I have to push myself through the day. He had advised to take iron pills, which he confirms he took. He says today he woke up feeling "fine" and "a few hours ago I just very weak." His symptoms began back in Mar after he received the vaccines a few weeks later. The patient stated he wanted to know if there is any data on an effect it will have on a person who has had postpartum depression. He also stated that he has 2 other daughters that have not received the vaccine and he is trying to convince them to get vaccinated. He stated that they have seen on TV/news or told by a friend that after the vaccine they are losing their hair, and this is a big thing for his daughter, and she will not get the vaccine because of this. He stated that the daughters have also been told, despite the short 7-8 months the vaccine has been out he states, that teenagers are saying from the 12+ age group that they are not able to have children after the vaccine. He also stated that he is fully vaccinated since Mar. He questions why they want "us to get the booster vaccine. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1711336
Sex: M
Age:
State:

Vax Date:
Onset Date: 08/20/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Had some joint pain; This is a spontaneous report from a contactable consumer or other non hcp. A 80-years-old male patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), dose 3 (Lot number was not reported expiry dae was unknown) via an unspecified route of administration on an unspecified date (at the age of 80-years-old) as a single for covid-19 immunisation. Reporter stated that he was called about the Covid 19 Booster. He said thinks this will be of interest because people are not reporting their good results. Reporter stated he was a lawyer with over 30 years' experience with medical cases, so he was not some crazy person. Stated that he got the booster shot because the county he resides in had some that were about to expire, and he was told he could get one. States he is not immune deficient. Reporter stated that about 5 days before the shot he twisted his knee. Said he has had this happen to him before and it's like a meniscus tear and takes about a month to get better. Said that he went and got the booster shot on this past Friday. He woke up that night around 0100, his knee was killing him. He also had joint pains that he knew were just side effects. Stated that he finally got to sleep, the next day it was a little less uncomfortable and the next day it did not hurt at all. Reporter stated he has had no pain in his knee since. Reporter stated that he was convinced. Said he doesn't know what in the vaccine could affect inflammation, but he has never heard of anyone reporting a positive side effect. Reporter states that this is a positive side effect. Said he has hurt his knee a couple of times and knows how long it normally takes to get well. Reporter stated that if enough people take the time to report their positive side effects it would be good. Reporter stated that he called health safety orginization about this as well, but they acted like they didn't understand him. Reporter stated that's when he decided he would call Pfizer. Reporter stated if Pfizer was interested in contacting him that would be fine. He would be willing to be of any further help. Full details not obtained as caller declines to complete report. Declines to provide mailing address, alternative phone number, or email address. Reporter stated that he called the health safety organization about this as well, but they acted like they didn't understand him. Reporter stated that's when he decided he would call Pfizer. Reporter stated if Pfizer is interested in contacting him that would be fine. He would be willing to be of any further help. Full details not obtained as caller declines to complete report. Declines to provide mailing address, alternative phone number, or email address. Outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1711337
Sex: F
Age:
State:

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: She had some allergic reaction with shrimp; had hard time breathing; throat was swollen; missed the second dose scheduled; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) reported for herself. A female patient of unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date 2021, after the vaccination, the patient experienced allergic reaction with shrimp, and she had hard time breathing, and the throat was swollen and she missed the second dose scheduled, which was supposed to be on 20Apr2021. And now she wanted to take the second dose and her doctor advised her to take the second dose but just safety medication of Benadryl, if in case she will take the second dose. she just needs a record, something that shows that she had the first shot, the patient misplaced the card, she cannot find it. she wants to get the second shot in the morning. but she can't, she does not have the record for the first shot. The outcome of the events was unknown. No follow-up attempts possible. No further information expected. Follow-up (08Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1711338
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: did that some type of vaccination of Pfizer; gotten so sick; smelling like some chemicals all kinds of crazy stuff; This is a spontaneous report from a contactable consumer (parent). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient mentioned that did some type of vaccination of pfizer; gotten so sick; smelling like some chemicals all kinds of crazy stuff on an unspecified date. Everybody else in the house had been started to experience like some type of sickness. And very funny that after she got this vaccine then people in house have gotten sick you know one of other daughter says that everyone has gotten sick very bad. Consumer stated will be having COVID test tomorrow. Consumer stated never got really, really sick and got so sick. That was ridiculous but better now but still feeling like I was smelling like some chemicals all kinds of crazy stuff and I liked this thing we part of a regular flu unless we could part of COVID this feel like some kind of mainly or whatever what was going on. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1711339
Sex: F
Age:
State: FL

Vax Date: 08/10/2021
Onset Date: 08/19/2021
Rec V Date: 09/18/2021
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: Pustular rash, painful. Only on right side of leg and abdomen; Pustular rash, painful. Only on right side of leg and abdomen; This is a spontaneous report from a contactable consumer or other non hcp. A 34-years-old female Non-Pregnant patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 10Aug2021 12:00 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant was not reported. The patient previously took cipro [ciprofloxacin] and experienced hypersensitivity. No other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was Reported that, the patient experienced pustular rash, painful, only on right side of leg and abdomen on 19Aug2021 with outcome of not recovered Therapeutic measures were taken as a result of pustular rash, painful. only on right side of leg and abdomen (rash pustular), pustular rash, painful. only on right side of leg and abdomen (rash). The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up

Other Meds:

Current Illness:

ID: 1711340
Sex: F
Age:
State:

Vax Date: 08/01/2021
Onset Date: 08/01/2021
Rec V Date: 09/18/2021
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: throat feeling clogged or stuffed; This is a spontaneous report from a non-contactable consumer or other non hcp. 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 an unspecified date in Aug2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Aug2021 as dose 1, single for covid-19 immunisation. On an unspecified date in Aug2021, the patient experienced throat feeling clogged or stuffed. Reporter stated that "I was wondering if that one of the side effects that you all have been hearing about children because I don't have any side effects with myself and not the family members have any side effects". The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1711341
Sex: F
Age:
State:

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

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

Lab Data: Test Name: blood tests; Result Unstructured Data: Test Result:normal (liver, pancreas, sonogram); Test Name: thyroid; Result Unstructured Data: Test Result:2.3; Test Name: weight; Result Unstructured Data: Test Result:about 10 lbs; Comments: knows others that have gained as well after receiving the Pfizer vaccine, one about 30 pounds, one about 10; Test Name: weight; Result Unstructured Data: Test Result:30 lbs; Comments: someone she orders clothes from has also gained 30 pounds

Allergies:

Symptom List: Nausea

Symptoms: knows others that have gained as well after receiving the Pfizer vaccine, one about 30 pounds, one about 10; shut down my metabolism; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is second of two reports. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient medical history included Hashimoto's thyroiditis from an unknown date and unknown if ongoing. Concomitant medications were not provided. On an unknown date, the patient experienced have gained as well after receiving the Pfizer vaccine, one about 30 pounds, one about 10, shut down metabolism. she can't eat anything anymore, because every time she eats or drinks anything, she gains weight. Sometimes has a glass of wine to go to sleep at night, and that's like, 120 calories, then mentioned something else she ate yesterday. States repeatedly that most people don't care, and just buy bigger clothes, but this is "really annoying". States her weight does fluctuate, but this is extreme and she cannot take it off. Reports that she has gained 15 pounds and nothing is going to fit her this fall, knows others that have gained as well after receiving the Pfizer vaccine, one about 30 pounds, one about 10. She asked them both if they had underlying thyroid condition, and they said yes. She reports that she has Hashimoto's thyroiditis, and has high antibodies, thyroid is 2.3. This vaccine has completely shut down my metabolism and there's nothing else she can do. States tape measure went down because of exercise, but the scales continue to go up. She states that she wishes more people will report it, as well as that most of them are men. Says repeatedly that none of her clothes fit, but that it is "only 10Aug, so I have some time before fall". Caller reports that she had blood tests a month ago and they were normal (liver, pancreas, sonogram) and comprehensive aside from gynecologist. States the bloating is not in her hips or waist and is up to ribs. States that she looks healthy at 5'5" and 130#. Has been exercising and eating better. Is ready to "just never eat again". Did not have exact dates of vaccinations, but said they were 2 months ago. Attempted to gather additional demographic and PCP information, but caller hung up before providing that. Mentions her doctor may increase her water pill. Tried Synthroid, but she could not tolerate that, because TSH is already normal, per patient report. she is not the only one experiencing this side effect and knows of people who have had the same side effect of weight gain. She has an underlying thyroid condition and this Covid vaccine makes her put on so much weight, severe weight. She doesn't even eat and keeps gaining weight. Knows of a pizza guy who gained 30 pounds and someone she orders clothes from has also gained 30 pounds and she has gained 15 pounds. She has to watch every morsel of food and is just frustrated. Does not eat more than 500 calories a day or anything like that and it is so frustrated. Attempts made to slow caller to clarify other people with same side effect. Wanted to know how long report would take and if anyone has reported any of this and what kind of doctor she should see about this. Declines to provide an address or email. Declines to provide any further report details and would like someone to answer her questions. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Follow-up activities closed. Batch/lot number not available for [vaccine/BNT162B2], F/UP closure to be managed as significant.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101099307 same reporter/product, different patient / event.;US-PFIZER INC-202101097977 same reporter/product, different patient / event.

Other Meds:

Current Illness:

ID: 1711342
Sex: F
Age:
State:

Vax Date: 08/15/2021
Onset Date: 08/21/2021
Rec V Date: 09/18/2021
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: Feeling unwell; Nausea; Vomiting; Itching head to toe; Joint pain head to toe; Rash/ on her feet/ on her tummy/She also had the same rash on her armpits, and intermittent spasms in her armpits. /rash on her feet that subsided, and a rash that reappeared on her abdomen last night; Rash/ on her feet/ on her tummy/She also had the same rash on her armpits, and intermittent spasms in her armpits. /rash on her feet that subsided, and a rash that reappeared on her abdomen last night; Sensation of being severely dehydrated even though I drink plenty of water; It hurts to walk; Colon issues; I am miserable right now; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0198, Expiration Date: not reported), via an unspecified route of administration on 15Aug2021 as dose 2, single for COVID-19 immunization (at the age of 68-year-old). Previously patient took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0176, Expiration Date: not reported), via an unspecified route of administration in left shoulder on 24Jul2021 as dose 1, single for COVID-19 immunization and subsequently experienced severe joint pain, dizziness and nausea. Medical history and family medical history relevant to AE(s) was none. There were no concomitant medications. Additional Vaccines Administered on same date of the Pfizer Suspect was none. Prior Vaccinations within 4 weeks and AE(s) following prior vaccinations was none. Patient stated that, she got through it, but by the time she did it was time for the second dose. She received her second dose of the vaccine on 15Aug2021 and on Saturday, 21Aug2021, she began feeling unwell, experienced nausea/vomiting, itching head to toe, joint pain head to toe, a rash that appeared on her feet and went away, a rash on her tummy that was itching rash on her feet that subsided and a rash that reappeared on her abdomen last night. She also had the same rash on her armpits and intermittent spasms in her armpits. She also had some colon issues and a sensation of being severely dehydrated even though she drink plenty of water/fluids. She was miserable right now. She had constant itching head to toe. She woke up in the middle of the night scratching. All it took is a sharp U-turn and se was nauseated and vomiting. It hurts to walk. This was making her nuts. It felt like someone had severely beat her to a pulp. She never had a temperature. Patient called her doctor earlier in the afternoon but she had not heard back from them yet. Hopefully she would hear from them tomorrow. She could not hardly deal with this anymore and could hardly get anything done. She was fortunate enough not to had work. This reaction had been really bad, but then again she was knocking on the door of 70 years old, and nobody would know it. Patient was very active and a very healthy person and took no medications. Patient wanted to know recommendations for how to get over this. AE(s) did not require a visit to emergency room or physician office. Patient received time frames for negative reactions to go away and she enquired if there any other recommendations or did she just had to ride this out. Patient was suggested that, these might not be all the possible side effects of the Pfizer-BioNTech COVID-19 Vaccine. Serious and unexpected side effects might occur. Pfizer-BioNTech COVID-19 Vaccine was still being studied in clinical trials. The safety evaluation of participants was still ongoing. Participants were asked about local and systemic events and use of fever reducing medication after each vaccination. Participants continued to be monitored for non-requested adverse events, including serious adverse events up to 6 months after the last vaccine dose. Among the Pfizer-BioNTech COVID-19 Vaccine recipients, mild-to-moderate pain at the injection site within 7 days after an injection was the most commonly reported local reaction, with less than 1% of participants across all age groups reporting severe pain. In general, local side effects; the ones patient got on the arm where patient got the shot (such as injection site redness and injection site swelling) were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Side effects that patient might experience throughout the rest of body; (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days, is likely to have resulted from a robust vaccine-elicited immune response. The Centers for Disease Control and Prevention (CDC) provided information regarding Possible Side Effects After Getting a COVID-19 Vaccine. The response below was copied on 23Apr2021. COVID-19 vaccination will help protect patient from getting COVID-19. Patient might have some side effects, which are normal signs that body is building protection. These side effects might affect ability to do daily activities, but they should go away in a few days. Some people had no side effects. If patient received a second shot Side effects after second shot might be more intense than the ones patient experienced after first shot. These side effects were normal signs that patient body was building protection and should go away within a few days. And it was suggested to call the vaccination provider or healthcare provider if had any side effects that bother patient or did not go away. Patient called to ask for recommendations for treating everything. This was ongoing and she was miserable. Patient received treatment with Tylenol, ibuprofen, rubbed asper cream and bengay, nothing made it go away. Relevant tests was none. The outcome of the events it hurts to walk and joint pain head to toe was not recovered and for rest of the events it was unknown.

Other Meds:

Current Illness:

ID: 1711343
Sex: F
Age:
State: FL

Vax Date: 08/19/2021
Onset Date: 08/21/2021
Rec V Date: 09/18/2021
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: Never had panic attacks or anxiety untill received first dose. With nausea. Now won't go away. Life is hell.; Never had panic attacks or anxiety untill received first dose. With nausea. Now won't go away. Life is hell.; Never had panic attacks or anxiety untill received first dose. With nausea. Now won't go away. Life is hell.; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 68-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm (reported as left shoulder) on 19Aug2021 12:00 as dose number unknown, single (at the age of 68-years-old) for COVID-19 immunization. Vaccination facility type was reported as Pharmacy or Drug Store. Patient was not pregnant at the time of vaccination. Patient did not have COVID-19, prior to vaccination and was not tested for COVID-19 post vaccination. Patient did not receive any other vaccine in four weeks. Patient medical history included known allergies with Lopressor, effient and statins. The concomitant medications were not reported. Patient never had panic attacks or anxiety until received first dose, with nausea on 21Aug2021. Now would not go away. Life was hell. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The therapeutic measures taken as a result of the events included Anxiety medication. The outcome of the event was not resolved. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1711344
Sex: F
Age:
State: FL

Vax Date: 03/04/2021
Onset Date: 03/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Caller states that the man who gave her the first shot gave it too high she thinks; and that's why it hurt more.; sore arm; Caller states that the man who gave her the first shot gave it too high she thinks; and that's why it hurt more.; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: GN6199) via an unspecified route of administration, administered in left arm on 04Mar2021 (at the age of 67-year-old) as dose 1, single for covid-19 immunization. Medical history included COPD (chronic obstructive pulmonary disease) from 2009 and ongoing, h1n1 from 2009 to an unknown date and was on a ventilator because it attacked her lungs, ongoing diabetes and had Covid on an unspecified date in Nov2020 and she had lost of taste and smell with Covid. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. Family history not provided. On an unspecified date in Mar2021 the patient stated that the man who gave her the first shot gave it too high she thinks and that's why it hurt more, had a sore arm. It was reported that Sore arm after the first dose of the vaccine. Caller states that she had her first dose of the vaccine on 04Mar2021. Her arm was sore for maybe 4 days. Sore arm after the second dose of the vaccine. Her arm was not as bad with the second one. Says it was sore for maybe half of a day. Caller states that the man who gave her the first shot gave it too high she thinks; and that's why it hurt more. The AEs does not required a visit to emergency room and physician office. The patient wanted to know if the vaccine that she got was a placebo as she has COPD, so she needs the real vaccine, not a placebo. caller stated that sometimes a sore arm was to be expected if you have a shot that goes in a muscle. Outcome of the event sore arm was resolved on an unspecified date in Mar2021 and outcome of rest of events were unknown.

Other Meds:

Current Illness: COPD; Diabetes

ID: 1711345
Sex: M
Age:
State:

Vax Date: 04/09/2021
Onset Date: 04/11/2021
Rec V Date: 09/18/2021
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: Tachycardia; frequent palpitations (severe at times); sternal inflammation and very frequent cracking and popping (never experienced before); sternal inflammation and very frequent cracking and popping (never experienced before); other chest pains; upper neck and left back/left shoulder also very painful; upper neck and left back/left shoulder also very painful; Increased fatige; Increased need to urinate; insatiable thirst/ "dry mouth" sensation; insatiable thirst/ "dry mouth" sensation; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 23-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 (at the age of 23 years) (Batch/Lot Number: EP7533) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, irritable bowel syndrome from an unknown date and unknown if ongoing. Concomitant medications included Omeprazole taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient reported, he experienced, following vaccination (11Apr). Symptoms persisting for 4 plus months to current date (date not specified) Tachycardia, frequent palpitations (severe at times), sternal inflammation, and very frequent cracking and popping (never experienced before), other chest pains, upper neck and left back/left shoulder also very painful. Increased fatigue, pain when breathing in fully. Increased need to urinate and insatiable thirst, dry mouth sensation. The events resulted in visit to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received the treatment as Colchicine 0.6mg Once daily for 30 days. The clinical outcome of the event Increased need to urinate, insatiable thirst, dry mouth sensation, was recovered on an unspecified date in 2021 and remaining all other events was not recovered at the time of report. Follow-up attempts are completed. No further information is expected.

Other Meds: OMEPRAZOLE

Current Illness:

ID: 1711346
Sex: F
Age:
State:

Vax Date: 08/01/2021
Onset Date: 08/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: This is a spontaneous report received from a contactable consumer (mother) reported for a daughter. A 17-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not provided), dose 1 via an unspecified route of administration on an unspecified date in Aug2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that caller states her daughter had her yearly immunizations on Monday and has been running a fever/temperature on Aug2021 and her paediatrician said to wait a week to get her COVID vaccine. Caller states her daughter already had her first dose, and the family doctor told them to wait a week to initiate the second dose. Caller asks what vaccination provider to call to speak to Referred to call local health department for the information. Outcome of event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1711347
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: Test Name: temp; Result Unstructured Data: Test Result:104.0

Allergies:

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

Symptoms: temp of 104.0 after the vaccine/has a fever of 104; This is a spontaneous report received from a contactable consumer (Patient's friend). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on an unspecified date as unknown single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced temp of 104.0 after the vaccine/has a fever of 104. The patient underwent lab tests and procedures which included body temperature: 104.0. The outcome of event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up

Other Meds:

Current Illness:

ID: 1711348
Sex: M
Age:
State:

Vax Date: 08/24/2021
Onset Date: 08/24/2021
Rec V Date: 09/18/2021
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: red bumps on his skin and it is itching; red bumps on his skin and it is itching; he does not feel comfort; This is a spontaneous report from a contactable consumer (patient). A 23-year-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 24Aug2021 as dose 1, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller reported that he got his first shot yesterday (24Aug2021) and explained he did not feel comfort. He experienced red bumps on his skin, and it was itching. Caller wanted to know if this was an allergy to the product. The outcome of events was unknown. Information about lot/batch number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 1711349
Sex: F
Age:
State: FL

Vax Date: 07/27/2021
Onset Date: 07/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: Covid; Test Result: Negative ; Test Date: 20210806; Test Name: Covid rapid test; Test Result: Negative

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: ear ache; bad headache, couldn't open her eyes; hurting under her armpits where the lymph nodes are; had chills the whole time; her throat was almost swollen shut, her ears and face were also swollen; her throat was almost swollen shut, her ears and face were also swollen; her throat was almost swollen shut, her ears and face were also swollen; I had hives all over my body and itching really bad; I had hives all over my body and itching really bad; her chest hurt since she had the shot; the inside of her nose was infected; her throat was blood red, very bad; tired; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ew0180) via an unspecified route of administration on 27Jul2021 14:15 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was asthmatic. The patient's concomitant medications were not reported. On 27Jul2021 at 19:00 that evening "I had hives all over my body and itching really bad". She reports that the hives began within 3 hours of getting the shot. Patient reported "I didn't go to the hospital, I put ice packs on my whole body, took my antihistamines and inhalers." Patient reported that she has an epi-pen but didn't have to use it. Patient reported that the next morning on 28Jul2021 when she woke up her throat was almost swollen shut, her ears and face were also swollen. She called her PCP and they didn't call back so she stayed home from work, and continued taking her antihistamines and using her emergency inhaler. She reports then calling her allergy doctor and when she told them what was happening they said to come in, or if it gets worse to go to the hospital or go to a walk in clinic because the hospitals are busy. Patient reported that on Saturday 31Jul2021 she had a really bad headache, couldn't open her eyes and was hurting under her armpits where the lymph nodes are and also had chills the whole time. Patient reported that on unspecified date Jul2021 her chest hurt since she had the shot. On unspecified date 2021 She reported that she was told that the inside of her nose was infected, her throat was blood red, very bad, so he called in a prednisone prescription and advised her to stay home for 10 days. Patient reported that in the meantime she took the Prednisone (reports that the pharmacy ordered it Tuesday and told her it wouldn't be in till later Thursday) So she and her husband went to get Covid tested on unspecified date. She was told that the rapid test was negative and she began her Prednisone Friday at noon. They also advised her not to get the 2nd dose of the vaccine. Patient reported that she is still home on and off, only going in to work to do payroll, because she has been really tired on unspecified date 2021. I even went to my ear Dr. last week Aug2021, because I had an earache, ears were clean, he checked my throat because it was swollen and said there was no infection there and it must still be from the shot. Lab test included Covid Negative on unspecified date, Covid rapid test Negative on 06Aug2021. The outcome of event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1711350
Sex: M
Age:
State: NV

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: heartbeat; Result Unstructured Data: Test Result:irregular

Allergies:

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

Symptoms: irregular heartbeat; This is a spontaneous report from a contactable consumer or other non-hcp (patient himself). A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date in Mar2021 (Lot number and Expiry date was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Patient previously received bnt162b2 dose 1 via an unspecified route of administration on unspecified date in Feb2021. The patient's concomitant medications were not reported. The patient experienced irregular heartbeat on an unspecified date. The patient underwent lab tests and procedures which included heart rate: irregular. The outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1711351
Sex: F
Age:
State: NC

Vax Date: 08/12/2021
Onset Date: 08/20/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: With in a week of my first shot I developed shingles on my left side. On my back ribcage.; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 43-year-old adult female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: FA7485), dose 1 via an unspecified route of administration, administered in Arm Right on 12Aug2021 at 18:30 (at the age of 43-year-old), as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included chicken pox as a child and lactose intolerance from an unknown date and unknown if ongoing. The patient had no covid prior vaccination. Concomitant medication(s) included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), kachava meal replacement, ion gut health, taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient had not been covid tested post vaccination. On 20Aug2021 at 13:00, the patient experienced shingles on her left side and on her back ribcage. The clinical details of the event as follows: within a week of her first shot, she developed shingles on her left side, on her back ribcage. She had chicken pox as a child and am usually very healthy and well. Thought this was strange. The patient received treatment with Antiviral valacyclovir and Gabapentin 100MG to treat the events. The patient outcome of the event was Resolving at the time of this report. Follow-up attempts are completed. No further information is expected.

Other Meds: ADDERALL

Current Illness:

ID: 1711352
Sex: M
Age:
State:

Vax Date: 08/01/2021
Onset Date: 08/01/2021
Rec V Date: 09/18/2021
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: he is scared; numbness in his fingers; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age reported for himself that he received BNT162B2 (Comirnaty, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on an unspecified date in Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Aug2021, five days later, the patient experienced numbness in his fingers. The patient was scared and asked what he should do and if he should receive the second vaccine. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1711353
Sex: F
Age:
State:

Vax Date: 07/15/2021
Onset Date:
Rec V Date: 09/18/2021
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: Arm pain, unspecified, has been increasing since the shot was administered; arm is sore/ feel worse; arm is sore; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported, NDC number was not reported) dose 2 via an unspecified route of administration on 15Jul2021 as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. Historical vaccine reported bnt162b2 on an unspecified date as dose 1, single for COVID-19 immunisation. The patient concomitant medication was not reported. Investigation assessment was not provided. On unspecified date of 2021 the patient experienced arm pain/unspecified has been increasing since the shot was administered, arm was sore/ feel worse, arm was sore. Caller stated that it seemed unusual to have the pain, lasting six weeks after injection. The clinical outcome of the events was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1711354
Sex: F
Age:
State: AR

Vax Date: 08/05/2021
Onset Date: 08/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 202108; Test Name: Temperature; Result Unstructured Data: Test Result:102

Allergies:

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

Symptoms: began to have chest pain on the right side; back under right shoulder blade; slight pain still in chest and back; sweating; temperature was 102; chills; felt weak; feeling very bad; slept a lot; very achy; This is a spontaneous report from a contactable consumer. This 63-Year-Old female consumer(patient) reported that: A 63-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 05Aug2021 11:00 (at the age of 63-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history included migraines, asthma, allergies, cancer survivor, cholecystectomy. The patient had food allergy (Allergy to preservatives, com, mushrooms and citrus)-all from an unknown date and unknown if ongoing. The patient was not received treatment for the adverse events. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. 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. The patient had previously received flu vaccine VII for immunization. Codeine and experienced drug allergy codeine. The patient had previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 15Jul2021 14:00 (at the age of 63-years-old) as DOSE 1, SINGLE for COVID-19 immunization. On 05Aug2021 21:30 after the second dose of vaccination, the patient experienced began to have chest pain on the right side. Back under right shoulder blade on 05Aug2021 09:30. Slight pain still in chest and back on 05Aug2021. On an unspecified date in Aug2021, the patient experienced sweating, temperature was 102, chills, felt weak, feeling very bad, slept a lot and very achy. It was reported that during the late evening after second dose, patient began to have chest pain on the right side. The level of this pain rose during the night and the pain began to go through to back under right shoulder blade. This pain was about an 8 on a scale from 0 to 10. The next day the pain was better but patient was feeling very bad and slept and was very achy, with slight pain still in chest and back. Patient woke up sweating and temperature was 102 but felt like it had been higher because patient been having chills but couldn't get up to take it. patient ran fever for two days and had chills. For the next three days patient felt weak and slept a lot but did not have any fever. Patient doctor said, she needed to report this to you, particularly the chest and back pain and fever. On an unspecified date in Aug2021, the patient underwent lab tests and procedures which included body temperature: 102. The patient was not received any treatment for the adverse events. The seriousness of events was reported as non-serious. The outcome of events was recovered on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1711355
Sex: F
Age:
State: WA

Vax Date: 07/27/2021
Onset Date: 07/27/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 20210727; Test Name: Blood; Result Unstructured Data: Test Result:Unknown; Comments: Blood and proteins in urine; Test Date: 20210727; Test Name: Fever; Result Unstructured Data: Test Result:101.9 to 103 Fahrenheit; Test Date: 20210727; Test Name: mono test; Test Result: Negative ; Test Date: 20210727; Test Name: pregnancy test; Test Result: Negative ; Test Date: 20210727; Test Name: proteins in urine; Result Unstructured Data: Test Result:Unknown; Comments: Blood and proteins in urine; Test Date: 20210729; Test Name: COVID test; Test Result: Negative ; Comments: Nasal Swab; Test Date: 20210801; Test Name: COVID test; Test Result: Negative ; Comments: Nasal Swab; Test Date: 20210820; Test Name: COVID test; Test Result: Negative ; Comments: Nasal Swab; Test Date: 20210727; Test Name: 4 negative strep tests; Test Result: Negative

Allergies:

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

Symptoms: Trouble walking; back pain; stiffness; severe sore throat; inflammation; sores and swollen glands in mouth; swollen lymph nodes/swollen glands in mouth; white reaction in throat; fever x3 days 101.9 to 103.; Difficulty and pain swallowing; talking and opening mouth.; loss of appetite; decreased and dark urine output; decreased and dark urine output; constipation; nausea; vomiting; Light headedness/Dizziness; trembles; weakness; heart palpitations; fatigue; low blood pressure; Losing hearing; muscle twitches; jaw and sinus pain; jaw and sinus pain; chemical taste when eating/drinking; heightened sense of smell; Body aches; This is a spontaneous report from a contactable consumer. A 27-year-old non-pregnant female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0172) via an unspecified route of administration on 27Jul2021 at 12:15 PM (at 27-year-old) on right arm as dose 1, single for COVID-19 immunization. The medical history of the patient included mental illness and scoliosis. No other vaccines were received within 4 weeks prior to the COVID vaccine. The concomitant medications included venlafaxine taken for an unspecified indication, start and stop date were not reported and methylphenidate taken for an unspecified indication, start and stop date were not reported. The patient was diagnosed with COVID-19 prior to vaccination and was tested for covid-19 since the vaccination. The device date was 25Aug2021. The patient did not receive any past drug and had no allergies. On 27May2021 at 12:15 PM the patient experienced trouble walking, back pain and stiffness, severe sore throat, inflammation, sores and swollen glands in mouth, swollen lymph nodes, white reaction in throat, fever x3 days 101.9 to 103. Difficulty and pain swallowing, talking and opening mouth. Body aches, loss of appetite, decreased and dark urine output, constipation, nausea, vomiting. Light headedness, dizziness, trembles, weakness, fatigue. heart palpitations, low blood pressure. Losing hearing when dizzy upon standing. Left thigh muscle twitches. Jaw and sinus pain, chemical taste when eating/drinking, heightened sense of smell. No prolonged hospitalization was required. The patient went to emergency room, Walk-in, PCP-Decadron etc as treatment. On 27Jul2021 the patient underwent lab tests and procedures which included blood test for which results were unknown, blood and proteins in urine, body temperature was 101.9 to 103 fahrenheit, infectious mononucleosis were negative, pregnancy test was negative, protein urine was unknown. On 29Jul2021 blood and proteins in urine, sars-cov-2 test was negative, Nasal Swab, sars-cov-2 test: negative. On 01Aug2021 nasal Swab, sars-cov-2 test was negative. On 20Aug2021 Nasal Swab, streptococcus test was negative. The patient was recovering. Follow-up attempts were completed. No further information was expected.

Other Meds: VENLAFAXINE; METHYLPHENIDATE

Current Illness:

ID: 1711356
Sex: M
Age:
State: TX

Vax Date: 04/09/2021
Onset Date: 04/12/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 20210412; Test Name: Pain; Result Unstructured Data: Test Result:5; Comments: average severity about 5/10.

Allergies:

Symptom List: Vomiting

Symptoms: shoulder/upper arm pain.; shoulder/upper arm pain.; Adhesive Capsulitis; This is a spontaneous report from a contactable consumer (patient). A 68-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: EW0150, Expiration date were not provided), via an unspecified route of administration on administered in Arm Left on 09-APR-2021 at 11:30 (at the age of 68-years-old) AM as DOSE 2 SINGLE for covid-19 immunisation. Medical history included, BPH, cataracts, basal & squamous cell carcinomas. The patient had known allergies penicillin. Concomitant medications included calcium citrate (CALCIUM CITRATE) taken for an unspecified indication, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number=EN6202), via an unspecified route of administration on administered in Arm Left dose 1, on 09MAR2021 at 01:00 for covid-19 immunization. On an 12Apr2021, the patient experienced shoulder/upper arm pain, the pain is dull, but can be sharp, difficult to localize (no specific area), average severity about 5/10, and aggravated by almost any movement of the upper arm. I thought it was just covid arm, and that it would go away in a few days or weeks, but it's still hurting and unchanged over 4 months later. My PCP was stumped so sent me to an orthopedist who diagnosed me with Adhesive Capsulitis. I've never had my arm immobilized, nor have I had any recent trauma, so the mechanism of onset doesn't fit the diagnosis; therefore, he could not rule out that the injection may have caused it. Just thought this reaction should be reported and wondering if others have reported anything similar. I'm a bit apprehensive about getting the booster. The patient underwent lab tests and procedures which included pain assessment: 5 on 12Apr2021 (average severity about 5/10). The patient visits to physician office. The patient not received treatment. The outcome of the events was not recovered. No Follow-up attempts are possible. No information is expected further.

Other Meds: CALCIUM CITRATE; VITAMIN D3

Current Illness:

ID: 1711357
Sex: U
Age:
State:

Vax Date: 08/23/2021
Onset Date: 08/24/2021
Rec V Date: 09/18/2021
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: red at the injection site and it was about the size of finger nail; This is a spontaneous report from a contactable consumer or other non-health care professional. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration on 23Aug2021 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced red at the injection site and it was about the size of finger nail on 24Aug2021. The outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1711358
Sex: M
Age:
State:

Vax Date: 08/22/2021
Onset Date: 08/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 202108; Test Name: fever; Result Unstructured Data: Test Result:101.5

Allergies:

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

Symptoms: fever/His fever is 101.5; shaking; This is a spontaneous report from a contactable consumer or other non hcp from a Pfizer sponsored program Pfizer RxPathways (patient's mother). A male 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 22Aug2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced fever/his fever is 101.5, shaking. The patient underwent lab tests and procedures which included body temperature: 101.5 on Aug2021. Therapeutic measures were taken as a result of fever/his fever is 101.5, shaking included Tylenol. Reporter stated that fever went up after Tylenol and was asking if patient can take advil. The outcome of the events was unknown. Information about lot/batch number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 1711359
Sex: F
Age:
State: MI

Vax Date: 03/25/2021
Onset Date: 03/01/2021
Rec V Date: 09/18/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: sore arm; TThis is a spontaneous report from a contactable consumer (Patient herself) via Pfizer sponsored program. A 67-year-old female received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number ER8732), dose 2 via an unspecified route of administration on 25Mar2021 on left arm as SINGLE DOSE for covid-19 immunization. The patient's medical history includes COPD from 2009 and ongoing, H1N1 from 2009, Diabetes ongoing from an unknown date. The patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number GN6199), dose 1 via an unspecified route of administration on 04Mar2021 on Left Arm as SINGLE DOSE for covid-19 immunisation and experienced sore arm, Thinks first shot was given too high and that's why it hurt more. Concomitant medication are none. Patient experienced sore arm. Patient was not in emergency room. Patient was not in physicians office. There were no Prior Vaccinations (within 4 weeks) vaccine. No relevant test performed. The outcome of event was recovered.

Other Meds:

Current Illness: COPD; Diabetes (States she was diagnosed in 2010 or 2011.)

ID: 1711360
Sex: U
Age:
State:

Vax Date: 08/24/2021
Onset Date: 08/24/2021
Rec V Date: 09/18/2021
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: 20210824; Test Name: Blood pressure; Result Unstructured Data: Test Result:High; Comments: Going high; Test Date: 20210824; Test Name: Heart rate; Result Unstructured Data: Test Result:90 and 91

Allergies:

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

Symptoms: My blood pressure is going high; my wrist and heart is 90 and 91; This is a spontaneous report from a contactable consumer or other non health care professional (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Aug2021 14:30 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 24Aug2021 at 14:30, the patient's blood pressure was going high and wrist and heart was 90 and 91. The patient got the Pfizer Vaccine like 14:30 today and now patient's blood pressure was really high like patient's wrist and heart was 90 and 91. The patient underwent lab tests and procedures which included blood pressure measurement: high on 24Aug2021 going high, heart rate: 90 and 91 on 24Aug2021. The outcome of the event "My blood pressure is going high" was not recovered and outcome of "my wrist and heart is 90 and 91" was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1711361
Sex: F
Age:
State: CA

Vax Date: 08/24/2021
Onset Date: 08/24/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: The whole area feels warm and is more sore than the other areas; her arm is uncomfortable and a little scary; It was very swollen in the center of her injection site last night; It is sore all the way under her arm and around her shoulder; It is more sore at the sight of the injection though; she had the 3rd dose yesterday; she had the 3rd dose yesterday; it really hurt; wound had a considerable amount of blood; arm developed a bruise the size of a silver dollar; This is a spontaneous report from contactable consumer (patient) via a Pfizer sponsored program. A 68-year-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: FD8448), via an unspecified route of administration, administered in arm right on 24Aug2021 14:45 (at the age of 68-years-old) as dose 3, single for covid-19 immunisation at pharmacy or drug store. Medical history included mycobacterium avium complex infection and primary immune deficiency disease from 2017 to ongoing. She was immunocompromised and has a primary immune deficiency disease. Also diagnosed with something else that was related to her being immunocompromised. She said that she gets Subcutaneous IG every 2 weeks. The patient mom died of cancer. Investigation Assessment was no. Prior Vaccinations, patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient's concomitant medication included immunoglobulin human normal (CUVITRU) from Jun2017 and subcutaneous IG every 2 weeks. Historical vaccines included Prevnar 13 and Pneumovax vaccine and had no problems with either of them. Additional vaccines administered on same date of the Pfizer suspect was none. The patient previously second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration, administered in arm left on 26Feb2021 as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EB5313), via an unspecified route of administration, administered in right arm on 05Feb2021 (at the age of 68-years-old) as dose 1, single for covid-19 immunisation. She did not feel the first injection and the second injection did sting a little. List of any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none and no prior vaccinations within 4 weeks. Patient reported that on 24Aug2021, she had the 3rd dose and had an unusual reaction. While being vaccinated the dose it really hurt and it was like the vaccine was thick, unlike the previous doses. The wound had a considerable amount of blood. The arm developed a bruise the size of a silver dollar. Caller reported that her arm was uncomfortable and a little scary. It was very swollen in the center of her injection site last night, it had kind of spread out now, it was sore and kind of swollen, but not lumped up then. It was sore all the way under her arm and around her shoulder. It was more sore at the sight of the injection though. The whole area felt warm and was more sore than the other areas. It definitely hurt. She did not feel the lump anymore, it was just a bulging all over then like swelling. She said that there was almost a hard feeling in the centre of its last night. She said that she kept rubbing the front of her chest, was massaging the shoulder and back, and gently rubbing the injection site area. Caller said that she had soreness before with the other 2 vaccines. He did not visit emergency room or physician office. She said that she took some Tylenol and put ice on it for uncomfortable arm. The outcome of events wound had a considerable amount of blood was recovered on 24Aug2021, event arm developed a bruise the size of a silver dollar was recovering, and outcome of other events was unknown, event arm developed a bruise the size of a silver dollar was not resolved. No follow-up attempts were possible. No further information was expected.

Other Meds: CUVITRU

Current Illness: Mycobacterium avium complex infection (She has been fighting it for 4 years.); Primary immunodeficiency syndrome (Diagnosed in Spring of 2017.)

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am