VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1744038
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: itchy; skin rash; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 49-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date was not reported) (at the age of 49-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced itchy and skin rash. Events took place after use of product. It was reported that following first Covid vaccination dose, patient felt itchy and experienced a skin rash and after the second dose, felt symptoms similar to pneumonia for one day. The clinical outcome of the events was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : -PFIZER INC-2021377013

Other Meds:

Current Illness:

ID: 1744039
Sex: F
Age:
State: MN

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

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: pain and inflammation in the joints of the ankles, knees and her jaw; pain and inflammation in the joints of the ankles, knees and her jaw; pain and inflammation in the joints of the ankles, knees and her jaw; pain and inflammation in the joints of the ankles, knees and her jaw; This is a spontaneous report from a contactable consumer (patient) received via medical information team. An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included COVID-19 (she was infected with the COVID-19 virus on January). The patient's concomitant medications were not reported. The patient experienced pain and inflammation in the joints of the ankles, knees, and her jaw on an unspecified date. The patient reported that the inflammation in the jaw was making difficult to eat and chew. The patient reported that she was managing these symptoms with Tylenol and she has not visited her Physician for more information and management. Outcome of events was unknown. The patient reported that she has an appointment for the administration of the second dose of the COVID-19 vaccine on 22Apr2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021372685 Same reporter/drug/event, different patient.

Other Meds:

Current Illness:

ID: 1744040
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: not feel quite good.; does not feel comfortable; sunburn on face and neck; Confusion; tiredness/desire to take a rest; felt off balance; felt dizzy; forgetful; spaciness;not precise; she is just sensitive; her face and neck are beet red. It occurred to the parts of her body that were exposed; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8734 and expiry date was not reported), dose 2 via an unspecified route of administration, in Arm Left, on 03Apr2021 at 13:50, as dose 2, single for COVID-19 immunization (Age at vaccination: 65years). The patient's medical history and concomitant medications was not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6206 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 03Mar2021 at 13:30, as dose 1, single for COVID-19 immunization at Hospital's conference center. Medical conditions: liver condition in the past associated with a divorce and it actually healed itself. Patient declined to list any medications, but does mention she takes something to prevent osteoporosis to prevent it for her age. for five years you take it once per week and if it hasnt worked to prevent osteoporosis it wont. No History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available. No Additional Vaccines Administered on Same Date of the Pfizer Suspect Additional Administered Vaccines If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect. The patient did not received any other vaccine in four weeks. The patient stated that she expected all of the other events and that she was only calling to report the sunburn as it was not expected and explained when had wisdom teeth taken out and took Tetracycline they explained could have sensitivity to light in her 20s. Stated this reaction was somewhat similar, but back then it was not as severe, she barely even noticed it. Also mentioned yesterday she felt off balance and normally she does not feel this way. When she got home she realized she was really tired. She took a nap and when she woke up she felt dizzy and She confirmed she no longer feels dizziness or off balanced, it was just 04Apr2021 and She does not feel comfortable to go out and like gas up her car. She commented she does not feel quite good. She asked if anyone else has reported these events. While providing details she commented she must sound like a confused individual, but she understands that will ago away. She also added, she talked to the person who gave her the first shot and she asked him what did he think when he got the second shot and he said he was wicked tired, so she expected that. The events did not require Emergency Room and Physician Office. Outcome of the events was unknown. Description of complaint: Caller reporting on the Covid Vaccine. Caller states that she is calling to report sunburn on face and neck. Caller states she looked in the literature because she was expecting to read something that says the vaccine may make you sensitive to light, in the same way that Tetracycline would, but the literature that she received does not say that. She just wanted to point that out. Caller also mentioned if the vaccine has any type of Tetracycline or Penicillin type thing in it we should warn people that they could have a sensitivity to sunlight, especially since going into the summer. She also added, it could also be that she is just sensitive, but she thinks she is pretty normal. Caller states she remembers taking Tetracycline when she had her wisdom teeth removed when she was in her 20s and remembers learning that sensitivity to sunlight and will cause sun damage is a side effect of Tetracycline. She saw that warning listed, but we do not have that warning listed. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1744041
Sex: F
Age:
State: MD

Vax Date: 03/06/2021
Onset Date: 03/06/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Date: 20210306; Test Name: Blood pressure; Result Unstructured Data: Test Result:167/106; Test Date: 20210306; Test Name: body temperature; Result Unstructured Data: Test Result:felt heat rising up my body

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: I wasn't able to work or do much of anything; I started to shiver; feel weird; I felt heat rising up my body; got an intense top of my head headache; I got flushed; felt extremely lightheaded; Severely nauseous; Then I got cold; my gums in my mouth started to hurt; She took my blood pressure which was 167/106; My right arm hurt severely for 10 days; muscle aches; fatigue; This is a spontaneous report from A 62-year-old non-pregnant female consumer (patient) reported for herself that the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6198, Expiry Date: not reported), intramuscular, administered in left arm on 06Mar2021 at 15:45 (at the age of 62 years) as dose 1, single for covid-19 immunisation. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8732, Expiry Date: not reported), via an unspecified route of administration, administered in right arm on 27Mar2021 (at the age of 62 years) as dose 2, single for covid-19 immunisation. Patient's medical history included migraine and had vertigo. Patient allergy to most seafood, alcohol and have had reactions to medications. Concomitant medication(s) in two weeks included magnesium and vitamin. No Covid tested post vaccination. No other vaccine in four weeks. Prior vaccination was none. On 06Mar2021 at 15:50 (within 5 minutes of 1st vaccine), she started to feel weird. She felt heat rising up her body and going up into her head and got an intense top of her head headache. She got flushed and hot and felt extremely lightheaded and severely nauseous. Then she got cold and her gums in her mouth started to hurt which she got when she got sick with flu. She started to shiver. The nurse called for the on call physician and she brought her to the medical building. On same day, she took her blood pressure which was 167/106. She gave her oxygen. It took about an hour for her symptoms to calm so that she could drive home. Her right arm hurt severely for 10 days. The pain moved into her shoulder and elbow. She applied heat. She had a headache, lightheadedness, muscle aches, nausea and severe fatigue for 10 days. The adverse event result in doctor or other healthcare professional office/clinic visit. She received treatment for the adverse events and she was seen by physician. On an unknown date, she wasn't able to work or do much of anything. It was suggested that she get her second dose but in hospital. She worked for 3 weeks to get her second dose moved which proved impossible. Her primary physician agreed but couldn't help her. The patient underwent lab tests and procedures which included body temperature: felt heat rising up my body on 06Mar2021, blood pressure measurement: 167/106 on 06Mar2021. The outcome of events Weird feeling, Temperature elevation, Flushed, Cold, Gum pain, Shivers, recovered on 06Mar2021 at 16:50; event Blood pressure increased recovered on 06Mar2021 and event Fatigue recovered on 16Mar2021; event Headache, Lightheadedness, Nauseous, Pain in extremity, Muscle ache recovered with sequel on 16Mar2021. The outcome of event General physical health deterioration was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1744042
Sex: F
Age:
State: NY

Vax Date: 04/01/2021
Onset Date: 04/02/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Swollen lymph node in left armpit; pain in armpit; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL3247 and expiry date not reported), via an unspecified route of administration, administered in Arm Left, on 01Apr2021 11:15 (at the age of 52-year-old), as dose 2, single, for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Patient had no allergies to medications, food, or other products. Medical history included lupus. Concomitant medications included hydroxychloroquine phosphate (PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]); sumatriptan and acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL3247 and expiry date not reported), via an unspecified route of administration, administered in Arm Left, on 09Mar2021 13:15 (at the age of 52-year-old), as dose 1, single, for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced pain in armpit on 02Apr2021 and swollen lymph node in left armpit on 02Apr2021 at 20:00. Patient received no treatment for swollen lymph nodes. The outcome of swollen lymph node in left armpit was not recovered and the outcome of pain in armpit was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1744043
Sex: M
Age:
State: SC

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

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

Lab Data: Test Date: 2021; Test Name: ANA; Result Unstructured Data: Test Result:inconclusive; Test Date: 2021; Test Name: Bursitis; Test Result: Negative ; Test Date: 2021; Test Name: Lab test; Test Result: Negative ; Test Date: 2021; Test Name: Lab test; Test Result: Negative ; Test Date: 2021; Test Name: Lab test; Test Result: Negative ; Test Date: 2021; Test Name: Lab test; Result Unstructured Data: Test Result:unknown; Comments: doctor gave him more lab tests; Test Date: 2021; Test Name: pain scale; Result Unstructured Data: Test Result:3 or 4; Test Date: 2021; Test Name: ESR; Test Result: Negative ; Test Date: 2021; Test Name: Rheumatoid Arthritis; Test Result: Negative

Allergies:

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

Symptoms: swelling in both of his hands/the first shot, the thumb swelled and then with the second shot; he had pain/Pain of the hands on the scale of 1 to 10 is a 3 or 4; half of his face is swollen; This is a spontaneous report received from a contactable consumer (patient wife). A 71-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9266 and expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 12Feb2021 (age at vaccination 70-years-old) as dose 2, single for covid-19 immunization and colchicine taken for arthritis on an unspecified date. The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9262and expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 22Jan2021 (age at vaccination 70-year-old) as dose 1, single for covid-19 immunization. The patient medical history included kidney problem. Concomitant medications were not reported. Reported and her husband, name, took his last COVID-19 Vaccine dose on 12Feb2021. She said the next week her husband had swelling in both of his hands. Following week, his hand swelling got worse, and he had pain with the hand swelling. The third week, her husband went to a doctor at a place where he could get an appointment the same day. She said that doctor did tests on her husband for Rheumatoid Arthritis and Bursitis, and both tests were negative. She said that doctor gave her husband Prednisone to take. She said when her husband took the Prednisone, his hand swelling went down for 3-4 days. She said when her husband stopped the Prednisone, the swelling in his hands came back. She said her husband then went to his primary care doctor. She said her husband's primary care doctor gave him more lab tests, and did another Rheumatoid Arthritis test, which was negative. She said her husband's primary care doctor gave her husband some Rheumatoid Arthritis medicine to take, but her husband stopped taking the medicine after 2 days. She said her husband had a history of kidney problems. She said her husband continued to have hand swelling, so she took her husband to the Emergency Room. She said the Emergency Room doctor did an ANA test that was inconclusive, and an ESR test that was negative. Emergency Room doctor gave her husband more Prednisone to take. She said when her husband took the Prednisone, and his hand swelling went down, again. She said when her husband finished taking he Prednisone, his hand swelling came back. She said her husband had more tests done with his primary care doctor, and all the tests were negative. Her husband's arms started to be effected by the swelling, so she took her husband back to the Emergency Room. She said now her husband had to go to a Rheumatoid Arthritis specialist. This morning her husband woke up, and half of his face was swollen. Her husband is having, she believed a reaction to the vaccine (confirmed as Pfizer COVID Vaccine). Over the past few weeks, he is having hands, both hands swollen. He's had test for rheumatoid arthritis and ANA and several other things coming out negative for the first week, 2 week, 3 week, last week one of the test came up inconclusive, they are giving him Prednisone that's taken the swelling down and referring him to rheumatoid specialist but they are saying also that it could be reaction to vaccine. Now today half of his face is swollen. He has not gotten to the rheumatoid specialist but half of the face is swollen now and so we are wondering what we should do at this point. He was in a lot of pain, the pain of the hands on the scale of 1 to 10 is a 3 or 4 and when he took the Prednisone (treatment), it goes down and just a little or no pain. Then with the swelling of the face right now there is no pain. When probed for other treatment, reporter stated, He did took, he only took it twice because they told him not to take it anymore. So, they repeated that (Colchicine) if it was arthritis then it would help and it would go down but it did not and they told him to stop taking it. The patient underwent lab tests and procedures which included antinuclear antibody and result was inconclusive, laboratory test result was negative, doctor gave him more lab tests, pain assessment: 3 or 4 on 2021, red blood cell sedimentation rate result was negative, rheumatoid arthritis and bursitis result was negative in 2021. Outcome of the events was recovered with sequel. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1744044
Sex: F
Age:
State: FL

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

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: arm got really sore this time, just hanging down walking across the room it hurt, it was sore if someone touched the injection site; some odd red spots on her arm about 4 inches down from the injection site/2 red spots about the size of a quarter; arm is visibly swollen and painful/left arm is swollen and visibly larger than her right arm; has a bruise in between the red spots and the injection site as well; has a bruise in between the red spots and the injection site as well; the spots as feeling a little hard and raised but not a fully formed bump; red spots are tender and swollen, kind of like a lump but they are sore; red spots are tender and swollen, kind of like a lump but they are sore; arm got really sore this time, just hanging down walking across the room it hurt, it was sore if someone touched the injection site; tired and fatigued; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7534), via an unspecified route of administration in left arm on 01Apr2021 (at the age of 56-years-old) as dose 2, single for COVID-19 immunization. Medical history included type 2 diabetes mellitus, overweight and pneumonia (She was hospitalized in Jan2020 with double pneumonia). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 11Mar2021 (at the age of 56-years-old) as dose 1, single for COVID-19 immunization and experienced extreme fatigue and sore arm. The patient also received flu shot for influenza immunization and it bubbled up under her skin. Concomitant medications included dulaglutide (TRULICITY) taken for diabetes from an unspecified start date and ongoing at 1.5ml once weekly, taken for a year; metformin taken for diabetes from an unspecified start date and ongoing at 500 mg, 2x/day, taken over a year, maybe 2 years; atorvastatin taken for cholesterol from an unspecified start date and ongoing as 20 mg, 1x/day taken about a year to guard her heart; dapagliflozin propanediol monohydrate (FARXIGA) taken for diabetes from an unspecified start date and ongoing as 10 mg, 1x/day taken 6 or 7 months; acetylsalicylic acid (BABY ASPIRIN) taken from an unspecified start date and ongoing; chondroitin sulfate, glucosamine hydrochloride (OSTEO BI-FLEX) taken from an unspecified start date and ongoing and vitaprime: (Contains Vitamins A,C,D,E,K, thiamine, riboflavin, niacin). Prior to vaccination, the patient did not receive any vaccines within four weeks. The patient experienced arm got really sore this time, just hanging down walking across the room it hurt, it was sore if someone touched the injection site and tired and fatigued on 01Apr2021, arm got really sore this time, just hanging down walking across the room it hurt, it was sore if someone touched the injection site, some odd red spots on her arm about 4 inches down from the injection site/2 red spots about the size of a quarter, arm is visibly swollen and painful/left arm is swollen and visibly larger than her right arm, has a bruise in between the red spots and the injection site as well, the spots as feeling a little hard and raised but not a fully formed bump, red spots are tender and swollen, kind of like a lump but they are sore on 06Apr2021. On 06Apr2021 she noticed about 4 inches down from the injection site on her left arm, she has 2 red spots about the size of a quarter. Her left arm is swollen and visibly larger than her right arm. She has a bruise in the middle of those 2 red spots. She hasn't been anywhere else in the past week that she can think of where she would have gotten these 2 red spots and a bruise. Patient tried to call her doctor, but he has recently left his practice and the doctor's office didn't have any openings. The doctor office told her to go to urgent care. She doesn't think this is an urgent care situation. She's asking if it's a normal reaction or an occurring reaction. Patient reported that she noticed her arm last night, 06Apr2021, while she was getting ready for bed and she looked in the mirror. Those red spots are tender and swollen, kind of like a lump, but they are sore. She reported she has been tired and fatigued. She feels better every day. With the first Covid 19 vaccine she had extreme fatigue and her arm got sore the next day after receiving the Covid 19 vaccine. Her left arm with the second vaccine got sore later the same day that she received the vaccine. Even walking with her arm hanging down it was sore. Her arm had started being less sore, more soreness isolated at the injection site, just sore to touch. But then yesterday, 06Apr2021 when she was getting ready to take a shower before bed, she noticed she had those 2 red spots on her arm, and she saw the bruise. She thought that's strange for those red spots to appear almost a week after she received the vaccine. Patient didn't know what to do. She thought she would wait another 24 hours and then report it. She did call her sister who is a retired health medical professor, and her sister hadn't heard of that side effect. As far as her fatigue, she reports yesterday she was feeling pretty good and not napping as much. She reports she slept pretty much all-day Saturday, 03Apr2021 and Sunday, 04Apr2021. She is more alert and doesn't have much fatigue today. She thinks she's at about 98% now. She reported that she qualified to receive the Covid 19 vaccine because she's a high risk because she has type 2 diabetes, and she is overweight. She has also had multiple rounds of pneumonia in the past. She thinks she had the Covid 19 virus in Jan2020. She was hospitalized in Jan2020 with double pneumonia. The emergency room doctor told her lungs sounded like a washing machine. The chest x-ray did not show the pneumonia, so she had to have a CT scan of her chest. She was at a New Year's Evening party with about 40 people and all 40 people got sick. She's the only one who had to be hospitalized. All 40 people had various symptoms. She wasn't coughing anything up and she thinks she had more Covid 19 virus symptoms. Hospitals were not testing for Covid 19 at that time. The Covid 19 antibody test was available in May2020 so she had that done and it showed negative Covid 19 antibodies. She doesn't think those early antibody tests were accurate. Outcome of event tired and fatigued was resolving. Outcome of remaining events was not resolved. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1744045
Sex: F
Age:
State: OH

Vax Date: 03/25/2021
Onset Date: 03/01/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Dizzy; Tingling around my mouth and tongue, specially lips; Tingling around mouth and the roof of the mouth, specially the face; she was starting to have an allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: ER8733), via an unspecified route of administration administered in left arm on 25Mar2021 around 14:00 (60-year-old at the time of vaccination) as single for covid-19 immunisation. The patient medical history was reported as none. The patient's concomitant medications were not reported. The patient had no additional vaccines administered on same date of BNT162B2. The patient usually does not even get the flu shot. The patient had not received any vaccine within four weeks. The patient had no adverse event prior to vaccination. On an unspecified date in Mar2021, the patient experienced starting to have an allergic reaction. On 25Mar2021, the patient got really dizzy and had tingling around her mouth and tongue, around mouth and the roof of the mouth, specially the face and lips. These were not listed as one of the side effects. The dizziness calmed down fairly quickly, it lasted maybe 45 minutes. The patient would say the tingling lasted about 24 hours. The patient asked who she would talk to if she was concerned about getting the second dose. The patient has also seen online where it said even if it was not life threatening that she may not want to get the second dose. The patient had not visited emergency room and stated she had gotten worse she would have gone to the ER. The outcome of the event dizzy was recovered on 25Mar2021, while events tingling around my mouth and tongue, around mouth and the roof of the mouth, specially lips and face were recovered on 26Mar2021 and event starting to have an allergic reaction was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1744046
Sex: F
Age:
State:

Vax Date: 02/24/2021
Onset Date: 03/05/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Date: 20210305; Test Name: Body temperature; Result Unstructured Data: Test Result:100.9 Fahrenheit; Test Date: 20210211; Test Name: Cardiac function test; Result Unstructured Data: Test Result:Elevated; Comments: Elevated

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: right upper quadrant pain; upper quadrant discomfort; Broke out in a rash; she developed a rash; Cardiac numbers are elevated; After she did her injection she started feeling bad; nausea; vomited; feeling sweaty; chest discomfort; diarrhea; gas; burping; She feels feverish; achy; Her temperature is 100.9?F; chest pain; Numbness around mouth; Difficulty swallowing; This is a spontaneous report from a non-contactable consumer (patient). A 58-years-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch no/Lot number: not reported) via an unspecified route of administration on 24Feb2021 as dose 2, single for COVID-19 immunization. Patient also received Inotersen sodium (TEGSEDI, injection) ongoing via subcutaneously on 29Aug2019 for hereditary neuropathic amyloidosis and diphenhydramine hydrochloride (BENADRYL ALLERGY) on an unspecified date for right upper quadrant pain and upper quadrant pain. ISSD (Integrated Syringe Safety Device) for unknown Indication from unknown therapy dates. Patient's medical history included as hereditary neuropathic amyloidosis. Concomitant medications were not reported. On 05Mar2021, patient experienced right upper quadrant pain, upper quadrant discomfort, broke out in a rash; she developed a rash, cardiac numbers are elevated, after she did her injection and she started feeling bad, had nausea, vomited, feeling sweaty, chest discomfort, developed diarrhea, gas, was also burping, she feels feverish, achy, her temperature is 100.9 F, chest pain, numbness around mouth and difficulty swallowing. Patient under lab tests and procedures which included cardiac function test and results noted elevated on 11Feb2021 and on 05Mar2021, body temperature increased results 100.9F. Outcome of the events Abdominal pain upper and Rash was not recovered, and other events was unknown. No follow-up attempts are needed; Information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: INOTERSEN SODIUM

Current Illness:

ID: 1744047
Sex: F
Age:
State: NY

Vax Date: 02/10/2021
Onset Date: 02/01/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Date: 202102; Test Name: fever; Result Unstructured Data: Test Result:fever

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Chills and fever started from 15 hours after administration; Chills and fever started from 15 hours after administration; This is a spontaneous report received from a contactable other- health professional (in response to HCP letter sent in cross referenced case). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration on 10Feb2021 (at the age of 47-year-old) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. In Feb2021, the patient experienced chills and fever started from 15 hours after administration. The patient took 1 extra strength TYLENOL as therapeutic measure for both. Fever went away and did not repeat any other symptom. It was reported that the patient did not receive re-vaccination. Outcome for chills was unknown and for fever was recovered in 2021. Do you consider the Pfizer product had a causal effect to the adverse event: Yes. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1744048
Sex: F
Age:
State: OH

Vax Date: 03/30/2021
Onset Date: 04/04/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Date: 20210405; Test Name: blood work; Result Unstructured Data: Test Result:Normal

Allergies:

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

Symptoms: her ear had a sunburn-like pain and was red/she had a redness and heat feeling in her ears; joint pain on her knee, lower back, and wrist areas; her ear had a sunburn-like pain and was red; her ear had a sunburn-like pain and was red/she had a redness and heat feeling in her ears; allover body rash without itchiness; This is a spontaneous report received from a contactable consumer or other non hcp. A 41-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: ER8733; Expiration Date: 31Jul2021) via an unspecified route of administration in Arm Left on 30Mar2021 16:45 (age at vaccination 41years old) as single dose for covid-19 immunisation. Medical history included covid-19 from 25Dec2020 to an unknown date. Concomitant medication(s) included sucralfate (SUCRALFATE) taken for an unspecified indication from Mar2021 to 05Apr2021. The patient experienced all over body rash without itchiness on 04Apr2021, and joint pain on her knee, lower back, and wrist areas, her ear had a sun-burn-like pain and was red/she had a redness and heat feeling in her ears on 05Apr2021. She received her first COVID-19 Vaccine dose on 30Mar2021. She did have the COVID-19 Virus and was diagnosed on 25Dec2021. She wanted to talk to someone about the COVID-19 Vaccine. She said about 6 days after she received the COVID-19 Vaccine she broke out in a rash. She said the rash wasn't itchy. She clarified the rash started on her arms and then spread to her legs. She said both her calves were most effected by the rash. She said she also had the rash on her stomach, and the rash was all over the bottom half of her body. She said the rash was not contagious, and she didn't spread the rash to anyone else. She said she took herself to her doctor to have her doctor check out the rash. She said her doctor did blood work, and her blood work was pretty normal. She clarified she went to her doctor on Monday, 05Apr2021. She said she had a redness and heat feeling in her ears that started on 05Apr2021, and the redness and heat feeling in her ears stopped after she started the prescription her doctor gave her. She said her joints were hurting, especially her knees. She clarified she noticed her lower back and both wrists hurt along with her knees. She said she was currently taking an arthritis medication that her doctor had prescribed on Monday, 05Apr2021. She said she wasn't sure if anyone else had reported a rash or joint pain after getting their first COVID-19 Vaccine and wanted to know if that was a normal COVID-19 Vaccine side effect. She was on a different medication that she had started about 3-1/2 weeks prior to having her symptoms. She said it was the only medication she was taking at the time. She said her doctor told her to stop taking the medication, when she saw him on Monday, 05Apr2021. She clarified the medication as: Sucralfate 1gm tablet by Greenstone. She said her Sucralfate 1gm tablet was dispensed in a pharmacy bottle and had no NDC, Lot, and Expiration Date listed. She said she started the Sucralfate 1gm tablet in early Mar2021, and was taking a Sucralfate 1gm tablet by mouth, twice a day. She said she discontinued the Sucralfate 1gm tablet on 05Apr2021, after she saw her doctor. She said she didn't think she was going to continue to take the Sucralfate 1gm tablet because she didn't think she needed it anymore. No further details provided. Treatment Stated on Monday, 05Apr2021, her doctor prescribed Meloxicam 15mg tablet. She started taking the Meloxicam 15mg tablet on Tuesday, 06Apr2021. She said she was prescribed 10 Meloxicam 15mg tablets, and she was to take 1 Meloxicam 15mg tablet every day. The patient underwent lab tests and procedures which included blood test normal: normal on 05Apr2021. The clinical outcome of the event her ear had a sunburn-like pain and was red/she had a redness and heat feeling in her ears was recovered on 06Apr2021 and other events was recovering. Therapeutic measures were taken as a result of joint pain on her knee, lower back, and wrist areas, her ear had a sunburn-like pain and was red/she had a redness and heat feeling in her ears. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1744049
Sex: F
Age:
State: OR

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

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: tinnitus on the left side; felt swollen on the left side of her face; gives me anxiety; my ear clogged and swell up; my ear clogged and swell up; This is a spontaneous report from a contactable consumer (patient). A 24-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported; Expiry Date: Not Provided), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, she was calling to report some side effects that she had from the first dose of the Pfizer vaccine. She was scheduled for second dose on this coming Saturday, but she was hesitant to go. It only gives her anxiety that's how bad the reaction was. Almost immediately after receiving the vaccine her ear clogged and swell up. She has tinnitus on the left side and it started within an hour after the vaccine and it's been like that for 3 weeks. She spoke to three different doctor they keep saying it's not associated with the vaccine. She don't know why everyone keep denying it. She felt helpless. She know tinnitus was correlated with vaccine. She follow a group on social media which was called tinnitus from the vaccine. There's 500 people on the page who have reported this side effects. She got a bad tinnitus from the vaccine. The doctor just gave me anxiety pills and didn't do anything else. The patient also felt swollen on the left side of her face, it was the same side she got her shot in. The caller is almost 100% sure this was from the vaccine because she has never had tinnitus before in her life. The caller doesn't know what to do and she didn't know if this was reported from other patients. Response received form medical information team, stating that however these may not be all the possible side effects of the Pfizer BioNTech COVID-19 Vaccine. Serious and unexpected side effects may occur. Pfizer BioNTech COVID-19 Vaccine was still being studied in clinical trials. You should always talk with a vaccination provider, doctor, or other qualified health care professional about whether a specific treatment. They were in the best position to advise you about the suitability of a particular treatment as they have access to the details of your medical history, as well as to information on all medical products. The outcome of events was unknown at the time of reporting. The relatedness for the event of tinnitus on the left side was related with Covid vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1744050
Sex: M
Age:
State: MN

Vax Date: 02/17/2021
Onset Date: 02/01/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Aggressiveness; soreness; Headache; fatigue; chills; This is a spontaneous report from a contactable consumer or other non hcp. A 74-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9263) via intramuscular route of the administration in Arm Left on 17Feb2021 11:30 (age at vaccination: 74-Years-old) as DOSE 2, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks prior to vaccination, patient didn't receive other medications within 2 weeks to post vaccination. The patient medical history and concomitant medications were not reported. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EK 9231) via unspecified route of administration on 27Jan2021 11:30 in left shoulder as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced soreness on 28Jan2021, headache on 28Jan2021, fatigue on 28Jan2021, chills on 28Jan2021, aggressiveness on 17Feb2021. No Therapeutic measures were taken for the events. The outcome of the event aggression was recovered on Feb2021, the outcome of the event arthralgia, headache, fatigue, chills was recovered on 30Jan2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1744051
Sex: M
Age:
State: KS

Vax Date: 04/06/2021
Onset Date:
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: pain in his arm, neck, shoulder, and back; pain in his arm, neck, shoulder, and back; pain in his arm, neck, shoulder, and back; pain in his arm, neck, shoulder, and back; headache; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 60 year old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 06Apr2021 09:45 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included acetylsalicylic acid, butalbital, caffeine (FIORINAL [ACETYLSALICYLIC ACID;BUTALBITAL;CAFFEINE]) taken for an unspecified indication, start and stop date were not reported. The patient experienced pain in his arm, neck, shoulder, and back causing pain in extremity on an unspecified date with outcome of unknown , arthralgia on an unspecified date with outcome of unknown, headache on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of this with Fiorinal and Tylenol. Follow-up (07pr2021): This is a follow up spontaneous report received from a contactable consumer (patient) reported that: Caller received first vaccine last week Tuesday. Caller took pain killers before for a headache and then after for his arm which was sore. Wants to know if that will decrease the efficacy of the vaccine. Follow-up (17May2021): Follow-up attempts completed. No further information expected.

Other Meds: Pfizer, Inc. EUA 027034

Current Illness:

ID: 1744052
Sex: M
Age:
State: IL

Vax Date: 03/08/2021
Onset Date: 03/01/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Date: 20210403; Test Name: Punch biopsy; Test Result: Positive

Allergies:

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

Symptoms: patient ended up having a little bit of a rash on his stomach; patient's testicles are so red, and that the patient's testicles are inflamed.; This is a spontaneous report from a contactable consumer or other non hcp. A 71-year-old male patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EM9810), via an unspecified route of administration, administered in Arm Left on 08Mar2021 09:45 (at the age of 71-year-old) as dose 1, single for COVID-19 immunisation. Medical history included patient has had ongoing arthritis for years. Caller reported that she just thought the patient was not a rash person. Caller reported that the patient has experienced skin issues here and there all his life, but that the rash and red, inflamed testicles are unusual. Concomitant medication(s) included Meloxicam on and off for about a month when he has issues with arthritis in his hands. Additional Information for Concomitant Products Unspecified supplements: Caller reported that the patient takes supplements but stated that they were unrelated to the AEs he experienced. The patient experienced rash and inflammation. Caller reported that she was happy to say that she and her husband got their first dose of the Covid-19 vaccine on 08Mar2021 and the second dose of the Covid-19 vaccine on 29Mar2021. Caller reported that she is calling for husband, the patient, stating that they always say if there's anything weird that might have happened to call and report it. Caller reported that the patient is seeing a dermatologist after the patient ended up having a little bit of a rash on his stomach. Caller reported that the patient thinks the rash kind of started before the first dose of the Covid-19 vaccine but is not 100 percent sure. Caller reported that the patient's testicles are so red, and that the patient's testicles are inflamed. Caller reported that the patient's dermatologist took a punch biopsy of the rash on the patient's stomach and testicles. Caller reported that she was unsure if the rash and the red, inflamed testicles were something that Pfizer needs to know as it might be coincidental. Caller reported that she didn't know if the rash and the red, inflamed testicles were a concern but stated that everyone was telling the caller and patient to call Pfizer to report. Caller reported that she just had the normal side effects following the Covid-19 vaccine. Caller reported that she had a little headache and an achy arm. Caller reported that she experienced just what she expected following the Covid-19 vaccine, that she was just tired. Caller reported that the testicle thing is the patient's concern more than the rash. Rash: Caller reported that the patient thinks the rash started before the first dose of the Covid-19 vaccine on 08Mar2021. Caller reported that she thought that the rash developed after the first dose of the Covid-19 vaccine on 08Mar2021. Caller reported that the rash comes and goes. Caller reported that she can see that the rash is raised a little bit, and then the rash will get red. Caller reported that the patient is dealing with his dermatologist and doesn't want to jump the gun. Caller reported that the rash has stayed the same and that the rash is not any worse. Caller reported that she believes the rash is getting better. Testicles: Caller reported that the patient's testicles became red and inflamed after the first dose of the Covid-19 vaccine on 08Mar2021, towards the end, just before the second dose of the vaccine on 29Mar2021. Caller reported the redness and inflammation of the patient's testicles comes and goes. Caller reported that the patient's testicles will be fine one day and the next day it's like whoa. Caller reported that the patient is concerned about his red and inflamed testicles because he has never experienced any of this stuff before. Investigations: Skin punch biopsy results from the patient's testicles and the rash on the patient's stomach are not in yet. Caller reported that the dermatologist's office stated yesterday, 05Apr2021, that it would take a week to two weeks before results are known. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness: Arthritis (the patient has had arthritis for years.)

ID: 1744053
Sex: F
Age:
State:

Vax Date: 03/09/2021
Onset Date: 03/01/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: I only had a slightly sore arm after dose; This is a spontaneous report from a two contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, administered in Arm Right, on 09Mar2021 (at the age of 60-year-old), as dose 1, single, for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. 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. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced slightly sore arm after first dose in Mar2021 and it was reported that it did not last long. No treatment received for the event. The patient recovered from the event in Mar2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1744054
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Tingling in lips and they were slightly swollen; Tingling in lips and they were slightly swollen; Little hard to swallow for a while; Face and whole body was itchy; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2) formulation solution for injection, dose 1 (Lot number and expiry date was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included diphenhydramine hydrochloride taken for pruritus, start and stop date were not reported. Consumer stated, " patient had the Pfizer COVID-19 Vaccine the first dose this (reported date) morning and after a few minutes, patient just had like a tingling in patient lips, and they were slightly swollen. And then, it was just a little hard to swallow for a while and then patient was fine after 20 minutes. And then after a few hours, it kind of came back again and then patient whole body itched like patient was (incomplete sentence), patient face and whole body was itchy and then patient took a Benadryl and then seem to ease a little bit. Patient was just wondering, if patient should continue taking Benadryl and then, patient was just wondering if that was an allergic reaction to it." Consumer was informed about the role of Pfizer Drug Safety and Pfizer Medical Information. When offered the contact# for Pfizer Medical Information, consumer stated, waited for few minutes on hold for this call, consumer can't do that again. When requested for permission to probe questions, consumer stated, "What is this for?. When informed about the need to probe questions for a safety report, consumer stated, "patient need to find out if patient having an allergic reaction or not. Patient don't care about that. This was not helping to patient at all. Patient just going to call patient hospital. Consumer hung up abruptly. Hence further probing could not be done. Hence, limited information was available over the call. Reason for no lot number: of COVID-19 Vaccine: Complainant hung up abruptly/transfer incomplete No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: Pfizer, Inc. EUA 027034

Current Illness:

ID: 1744055
Sex: M
Age:
State: FL

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

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

Lab Data: Test Date: 202109; Test Name: Blood Work; Test Result: Negative ; Test Date: 202003; Test Name: Influenza type A; Test Result: Positive ; Test Date: 202008; Test Name: Antibody Test; Test Result: Negative ; Test Date: 202005; Test Name: COVID-19; Test Result: Negative

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: a lot more pain in left arm; dizzy; rashes on his neck, chest lower jaw, face and on the back of neck, head and ears and everywhere. He has black marked rashes; itching/ A rash like bubbles, small, leaking, and itching in night; skin irritation; This is a spontaneous report from a contactable other healthcare professional (patient). A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL1284, Expiry date: not reported), via intramuscular route of administration in left arm on 08Jan2021 (at age of 63-years-old) as dose 2, single for covid-19 immunization. Medical history included ongoing perforated ulcer, he had a history of asthma (He was wheezing), severely sick in Mar2020, short term disability, influenza A in Mar2020. Concomitant medications included pantoprazole sodium sesquihydrate (PANTOPRAZOLE); famotidine (PEPCID), both taken for perforated ulcer, start and stop date were not reported. The patient previously received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: EH9899, Expiration Date: Not reported), via an unspecified route of administration in left upper arm on 20Dec2020 as dose 1, single (at age of 63-years-old) for covid-19 immunisation and he had minor swelling and soreness in his arm following the 1st dose. The patient previously took Singulair, azithromycin, Tamiflu, prednisone, Levaquin, all drugs taken for asthma; Celebrex as needed for arthritis, but was not taking it 1 month prior to getting rash. History of all previous immunization with the bnt162b2 vaccine considered as suspect was none. Additional vaccines administered on same date of the bnt162b2 suspect was none. The HCP received his 2nd vaccine dose on 08Jan2021. Following the 2nd vaccine dose he experienced a lot more pain in left arm, he was dizzy for 3-4 days then started to develop rashes on his neck, chest lower jaw, face and on the back of neck, head and ears and everywhere. He has black marked rashes. A rash like bubbles, small, leaking, and itching in night. Onset of rash reported as in Jan2021, 3-4 days after 2nd dose on 8Jan2021. He used aloe-Vera and 1% steroid cream for the rash. The itching and the skin irritation has been very difficult to deal with in Jan2021. He spent 30 years as a Respiratory Therapist in Emergency Room care and a front line worker and had to take early retirement at 63 y/o. He also has a realtor license. He has been unable to work since Mar2020 at which time he tested positive for Influenza type A. He was too sick to work with patients, His Covid-19 test was negative in May2020 and his Covid antibodies were also negative in Aug2020. Since his 2nd Pfizer vaccine, 3 months ago, he has seen his doctor multiple times. His symptoms get a little better with taking 5 different medications, although this was not what he wants to do. He was asking if Pfizer knows of any other patients that have had these same symptoms and if so what medications or treatments helped with the symptoms?. He really wants to return to work, but cannot due to the extent of his side effects. It's been 3 months since I have these symptoms. It has become a financial and an emotional hardship for him. He was currently, and has for months now, been taking oral prednisone, Allegra, Advil, Flexeril and also corticosteroid cream, and various antibiotics. The HCP states, "I still get SOB when I wear a face mask." He saw his primary doctor for the rash and she prescribed him 1% steroid cream: Prednisone 20mg, before he was only taking this one time a day, but then she prescribed the Prednisone 20mg twice a day and allergy medicine and the rash was not going away. The rash outcome verified with caller as worsened-further described as rash was still itching, maintaining and not going away. He was taking too much Prednisone now and has so much concern about that because of his history of perforated ulcer and he was taking Pantoprazole and Pepcid. He was afraid to go to the hospital. He has worked at the hospital for 30 years. He sees his doctor there. He added he has a history of arthritis, which he takes Celebrex as needed, but was not taking it 1 month prior to getting rash. Caller added in Mar2020, he got severely sick while working in the ICU. He went to the Emergency Room and requested a Covid test, but they did not have them. He was tested and resulted with a positive Influenza A. He went a couple times more to the Emergency Department for the Influenza A. He suffered for 2 months on and off. He has a history of asthma. He was wheezing and received azithromycin, tamiflu, prednisone, Levaquin or something. They thought it was pneumonia but did not know that, so were being over cautious. In May2020 he had a Covid negative test. He had an antibody test in Aug2020 negative result. In Sep2020 his blood work was negative. When he came to Florida and got the Pfizer Covid-19 Vaccine shot, that was when he took early retirement. He had been on short term disability and not working when he was diagnosed with influenza A in Mar2020. He also did not contract Covid in that time-no exposure to known covid patients. Before Mar2020, his own patient, not himself, was not able to wean off the ventilator and was being tested for Covid with nose swabs, but never known to be positive for covid-so caller not exposed as far as he knows. He has an appointment with a pulmonologist in the next 3 weeks. The adverse events did not result in visit to emergency room or physician office. The outcome of the events Rash and Rash pruritic was not recovered while the outcome of rest of the events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness: Perforated ulcer

ID: 1744056
Sex: F
Age:
State: NY

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: pain in right arm where she had the injection for about 5 days; really, really bad pain in both arms; pain in joints; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on an unspecified date in Mar2021 as dose 1, single for covid-19 immunisation. Medical history included fibromyalgia. The patient's concomitant medications and other Products were not provided were not reported. On an unspecified date, the patient experienced pain in right arm where she had the injection for about 5 days, really, really bad pain in both arms, pain in joints. It was reported that the patient got her first Pfizer Covid-19 vaccine around 11Mar2021 and they gave her all these papers and she experienced pain in right arm where she had the injection for about 5 days. She stated she has fibromyalgia and after about 11 days she had pain in joints. She stated she had really, really bad pain in both arms, right and left. She went to the doctor and they said because she has fibromyalgia that could have given her the reaction. They gave her anti inflammatory to take. Reportedly, it felt better but then it would come back again. The anti inflammatory they told her to take it once a day because it is not really that great to take. She was only taking one a day and then she would take the Tylenol. She stated the pain would get better but then it would come back. She was going for her second one on Thursday. She stated she wanted to know if it was okay to get the second dose, her doctor wanted her to take it but she wanted to get in touch with her rheumatologist but was unable to get in touch with him so she called Pfizer to ask if it is okay. She stated her doctor told her to get the second dose, she experienced more pain than other people and just wanted to make sure it was safe. This report is not related to a study or programme. Investigation Assessment was not provided. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1744057
Sex: F
Age:
State: GA

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

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

Lab Data:

Allergies:

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

Symptoms: a nurse at the doctor's office said her grandmother had this with her first vaccine in the same area of her chest; This is a spontaneous report from a contactable consumer or other non-Health Care Professional.A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization.The patient medical history was not reported.The patient's concomitant medications were not reported. Reporter states a week after the vaccine the patient started feeling bad. On an unspecified date the patient experienced a nurse at the doctor's office said her grandmother had this with her first vaccine in the same area of her chest . States the doctor ordered a chest x-ray today because he heard wheezing, she has no energy and all that. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1744058
Sex: U
Age:
State: MO

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

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

Lab Data:

Allergies:

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

Symptoms: I have red bumps popping up on arms, torso and legs; typical redness by the injection site; started to have these itchy bumps on the arms and progressing down from there; It is like it is progressing through my body from head to toe; This is a spontaneous report from a contactable consumer (patient) via Pfizer. A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had red bumps popping up on arms, torso and legs. Predominantly legs and arms. This started after 2nd Covid shot. Initially typical redness by the injection site, then started to had these itchy bumps on the arms and progressing down from there, it was like it was progressing through body from head to toe (condition aggravated). It was reported that now 17 days out and was still getting more annoying. Patient did not have this reaction after the first injection. Outcome of all events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1744059
Sex: F
Age:
State: AZ

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

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: injection site sore; rashes; Light headache; dizziness; This is a Spontaneous report from Pfizer Support program. A contactable female consumer (reported for herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 27Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. on an unspecified date in 2021, the patient experienced injection site sore, rashes, light headache and dizziness. The second dose was scheduled on 18Apr2021. The outcome of the events was unknown. No follow-up attempts are possible; Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1744060
Sex: M
Age:
State: FL

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

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

Lab Data:

Allergies:

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

Symptoms: flu-like symptoms: fever, chills, and body aches; flu-like symptoms: fever, chills, and body aches; flu-like symptoms: fever, chills, and body aches; flu-like symptoms: fever, chills, and body aches; felt horrible; This is a spontaneous report from a contactable consumer (patient's mother) via a Pfizer Sponsored Program Support. A 50-years-old male patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: ER8730 and Expiration date was not reported), via an unspecified route of administration on 03Apr2021 as dose 1, single (at the age of 50-years-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 04Apr2021 (from last 2 days), patient had flu-like symptoms, fever, chills, and body aches and felt horrible. Patient's mother asked how long patient flu-like symptoms will continue, and should patient think about getting the second COVID-19 Vaccine shot. The outcome of all the events was unknown. No follow-up attempts are needed. No further information is expected

Other Meds:

Current Illness:

ID: 1744061
Sex: M
Age:
State: HI

Vax Date: 03/18/2021
Onset Date: 03/01/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: He got a rash a week after getting his COVID-19 Vaccine. He said the rash was along his waist and upper thigh area.; he was noticeably more tired for the first couple days after he got the COVID-19 Vaccine; jock itch around his upper thigh area; This is a spontaneous report from a contactable male consumer (patient). A 41-years-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot Number: ER2613, Expiration Date: Jul2021), via an unspecified route of administration, administered in Arm Right on 18Mar2021 15:00 (age at the time of vaccination: 41 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included when he was a kid, he had an allergic reaction to Penicillin. He said he was not sure if his reaction to the Penicillin was a medical condition or an allergy to Penicillin. Family Medical History Relevant to AE was not provided. The patient's concomitant medications included patient had been only taking vitamins and a probiotic prior to the COVID-19 Vaccine, clarifying he had been taking the vitamins and probiotic for a while. There was no vaccine administered at military facility. There was no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). There was no prior Vaccinations (within 4 weeks). There was no additional Vaccines Administered on Same Date of the Pfizer Suspect. It was reported that the patient got his first COVID-19 Vaccine on 18Mar2021. He said his only symptom after getting his first COVID-19 Vaccine was he was tired. He clarified he was tired before he got his first COVID-19 Vaccine shot. He said he was noticeably more tired for the first couple days after he got the COVID-19 Vaccine, and now he was no more tired than he was before he got the COVID-19 Vaccine. He said he got a rash a week after getting his COVID-19 Vaccine. He said he didn't think his rash was caused by the COVID-19 Vaccine, but he wasn't sure. He said the rash was along his waist and upper thigh area. He said the rash was like a jock itch around his upper thigh area. He said he never had a rash before when he was growing up and was not sure what caused this rash. He said he was swimming more and seemed to have more of a reaction when he swims. He said he wanted to get the second COVID-19 Vaccine shot, which he was scheduled to get in 2 days, but he didn't know if he should move forward with the it. He said he sent his doctor an email to ask if he should get the second COVID-19 Vaccine, and he hadn't received a response from his doctor yet. Caller asked if a rash was a side effect of the COVID-19 Vaccine. Reported he contacted his doctor through email today (06Apr2021), and his doctor had prescribed a topical lotion for his rash. He said he was going to pickup the lotion today. He said his doctor didn't give him any information about the lotion she prescribed, only that she was calling in the prescription to his pharmacy. No further details provided. There was no AE require a visit to emergency Room. Not visited to Physician Office. There was no relevant test. The outcome of event rash were not recovered, for pruritis it was unknown and for fatigue it was recovered in 2021. No follow-up attempts are needed. No further information was expected.

Other Meds:

Current Illness:

ID: 1744062
Sex: U
Age:
State:

Vax Date: 03/29/2021
Onset Date: 03/01/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: dominant hand and wrist swollen up with extreme pain; dominant hand and wrist swollen up with extreme pain; Extreme pain; can't use that; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 29Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first of the vaccine on 29March2021 and during a night her dominant hand and wrist swollen up with extreme pain and the patient still have it and it has been 8 days now. The patient just wants to know that was that common. Oh there was my question. Was that patient's conditional side effect on receiving a shot. When consumer informed about Medical Information Department, consumer stated, "Well it was my right hand. The patient can't use the patient can't use that. The patient would not be able to write it down, could you help someone call me. Oh that was a person giving you my phone number, you can give that. The patient can't right with my hand. The patient wouldn't be able to report it. Can you send me message with the number. The outcome of the events was unknown. No follow up attempts are needed. Information about Lot/Batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1744063
Sex: U
Age:
State: TX

Vax Date: 03/22/2021
Onset Date: 03/26/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: my 6 month old, whom I am breastfeeding, became sick with a moderate fever for 3 days and then a rash about a week about 10 days later; sick; moderate fever for 3 days; then a rash about a week about 10 days after; This is spontaneous stimulated report received from a contactable HCP. This contactable Female reported for her 6 months old baby (patient). A 6-month-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: ER8727) via transmammary route of administration on 22Mar2021 at 10:00 AM as dose 2, single for COVID-19 immunization. Medical history included allergies to medications, food, or other products: penicillin, from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (lot number: EN6202) administered on 01Mar2021 at 10:00 AM for COVIID-19 immunization. Reported facility where the most recent COVID-19 vaccine was administered was Hospital. The patient's mother did not receive any other vaccines within 4 weeks prior to the COVID vaccine, not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient's mother was not diagnosed with COVID-19. Since the vaccination, the patient's mother has not been tested for COVID-19. On 26Mar2021 at 12:00 the patient experienced sick, moderate fever for 3 days; On an unspecified date in 2021 the patient experienced a rash about a week about 10 days after. It was reported that her baby, whom she was breastfeeding, became sick with a moderate fever for 3 days and then a rash about a week about 10 days later." The mother received no treatment for the adverse events. The clinical outcome of the events was not resolved. No follow up attempts are needed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021388307 same reporter/drug, different patient/event(mother case)

Other Meds:

Current Illness:

ID: 1744064
Sex: F
Age:
State:

Vax Date: 04/02/2021
Onset Date: 04/05/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Neck pain; low back pain; loss sense of taste 5 days after; extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 42-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration in left arm on 02Apr2021 at 03:30 PM (at the age of 42-years-old) as dose 1, single for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and patient has not been tested for COVID-19 since the vaccination. On 05Apr2021, patient experienced Neck pain, low back pain, loss sense of taste 5 days after and extreme fatigue. No treatment was received in response to events. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1744065
Sex: F
Age:
State: GA

Vax Date: 03/09/2021
Onset Date: 03/10/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: painful ankle and knee, joints painful,; right hand pain; This has messed with her brain, she couldn't think straight; Numbness in hand up to wrist; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 91-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration, administered in Arm Right on 09Mar2021 between 12:30 and 13:30 (Batch/Lot Number: EN6203) as dose 1, single for covid-19 immunization Age at vaccination was 91 years old). Medical history included transient ischaemic attack for years, has a growth on her left shoulder, stroke and affected her speech all were from an unknown date and unknown if ongoing. The patient did not have COVID-19 prior to vaccination (within 4 weeks). The concomitant medication was not reported. The patient was not a pill person, she only takes her usual blood thinner and heart medicine. It was reported that on 09Mar2021 patient received her 1st dose of vaccine and the next day on 10Mar2021 she experienced painful ankle and knee, joints painful, right hand pain, this has messed with her brain, she couldn't think straight and numbness in hand up to wrist. The patient further stated that in the early morning when she tried to get out of bed, it knocked her on her rear end, she could not go. She did not lose consciousness. She lost use of her ankle and knee. Her right hand was her greatest problem. It has been painful for a long time and she was still having problems with the hand up to the wrist. It has impacted everything she does. She could not use her cane to walk with. She stated that she had a little improvement, but her fingers don't wake up. She had been to several doctors and has no one to turn to. This has messed with her brain and she couldn't think straight. She feels handicapped trying to wait on herself. she had a growth on her left shoulder and they decided not to tackle it. She described it as a big wad on her left shoulder. She stated that she was not much to go to the doctor, she has had it since the 1970s. That was why she got it in her right shoulder. At first, she has severe pain. It's manageable now and limited to her hand and fingers. When she rubs them, it doesn't feel real. It is limited to certain fingers. The pain was sharp, but manageable. If she gets to hurting, she uses ice, but not yesterday or today. She would have waited to get it, but when she had a stroke around Halloween time, her body had an overload of problems. Caller added the 1st encounter she had an emotional day before it happened this happened in 2019, then stated it was 2020, but was unable to clarify event. On same day patient also experienced right hand pain numbness in hand up to wrist. The events resulted into the physician office visit. The patient did not perform any relevant test. Treatment was received for the events. Outcome of all the events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1744066
Sex: F
Age:
State: TX

Vax Date: 04/02/2021
Onset Date: 04/06/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: redness in the itchy areas; itching all over my body with a rash; itching all over my body with a rash; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8733, Expiration date: not reported), via an unspecified route of administration in arm right on 02Apr2021 at 14:15 (at the age of 51-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history was not reported. Allergies to medications, food, or other products was reported as no. The patient's concomitant medication received within 2 weeks of vaccination included amoxicillin 500 mg, taken for an unspecified indication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6206, Expiration date: not reported), via an unspecified route of administration in arm right on 07Mar2021 at 14:15 (at the age of 51-year-old) as a dose 1, single for COVID-19 immunization. It was reported that, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. On 06Apr2021, the patient experienced itching all over her body with a rash and redness in the itchy areas. Treatment was not received for the events. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1744067
Sex: F
Age:
State: NC

Vax Date: 03/19/2021
Onset Date:
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: feel something different in her neck; pain in her neck; she can actually feel the injection go into the right of her neck, the middle of the back of her neck into her right breast and then into her right leg; feeling as discomfort and thinks it might be inflammation; This is a spontaneous report from a contactable consumer (patient). A 80-year-old female received (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Batch/Lot Number: EN6207) dose 1 via an unspecified route of administration, administered in Deltoid Right on 19Mar2021 (at the age of 60 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced feel something different in her neck , pain in her neck, she can actually feel the injection go into the right of her neck, the middle of the back of her neck into her right breast and then into her right leg feeling as discomfort and thinks it might be inflammation. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1744068
Sex: F
Age:
State: NJ

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: cold like symptoms; exposed to covid; This is a spontaneous report from a contactable consumer or other non-HCP communicated to a Regulatory Authority. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration on 27Mar2021 (Lot number was not reported), as DOSE1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced cold like symptoms and exposed to covid. Patient received first dose 27Mar2021 and due for second 15Apr2021, had cold like symptoms and has been exposed to covid and currently waiting on results from Covid test. Patient would like to know what the protocol is if she tested positive. No unaddressed medical questions referred or forwarded to Medical Information. The patient outcome of the events was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1744069
Sex: F
Age:
State:

Vax Date: 03/06/2021
Onset Date: 03/06/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This is a spontaneous report received from a contactable consumer (patient's friend). A 40-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via an unknown route of administration, on Mar 6, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medication not reported. On Mar 6 ,2021, patient experienced hives and rashes. The patient will be getting her second dose. The outcome of events unknown. No follow-up attempts needed. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1744070
Sex: F
Age:
State: CA

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

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

Lab Data:

Allergies:

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

Symptoms: pain in my arm and left arm aching; before midnight I had a fever/Had what she thought was a fever; fatigue; headache; loose stool; achy joints; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0158), via an unspecified route of administration on 08Apr2021 at 11:00 in left arm (at the age of 56-year-old) as single dose of for COVID-19 immunisation. The patient's medical history included covid-19 since Nov2020. Concomitant medication was reported as none. Patient was not received any other vaccine four weeks prior vaccination. History of all previous immunization with the Pfizer vaccine considered as suspect reported as none. Additional vaccines administered on same date of the Pfizer suspect reported as none. Patient reported she took the first dose of Pfizer Covid-19 vaccine yesterday on 08Apr2021 at 11:00. She felt fine and about 3 hours after on 08Apr2021 at 14:00 her injection, her arm began to ache, and she took one Tylenol. Last night, she had what she thought was a fever, fatigue, headache, and loose stool she added not like diarrhoea she also reported her joints ache and it all started last night and is still happening. The case assessed as non-serious by the reporter. No relevant tests were performed. Patient was not visited to emergency room or physician's office for the events. The patient received treatment with Tylenol for event pain in my arm and left arm aching. The clinical outcome of the events was not recovered. No follow-up attempts are needed. No further information expected.

Other Meds:

Current Illness:

ID: 1744071
Sex: F
Age:
State: AZ

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

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: This is a spontaneous report received from contactable consumer (patient). A 20-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EW0150), at the age of 20, via an unspecified route, left arm, on Apr 8, 2021, at 12:30, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 8, 2021, at 15:00, patient had a full body rash (red dots covering her whole body). Patient stated the rash and itching was worse today. Patient did not go to emergency room/physician office. The outcome of itching: unknown; full body rash (red dots covering her whole body): not recovered. No follow-up attempts needed. No further information expected.

Other Meds:

Current Illness:

ID: 1744072
Sex: M
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: This is a spontaneous report from a contactable consumer (patient) or other non-HCP. A male patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Mar 31, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unspecified date, he had a sore right arm/shoulder and a sore shoulder the next day. The skin on his forearm between his wrist and elbow went numb. He felt a spot on his hand, right above his thumb. He had another spot on his left arm and felt tingling there or like it was going to become numb. He felt something going on too where he wears his mask (cheek and an area of his jaw under his eyes). He reported he just got the Pfizer COVID-19 shot and his skin was numb on his arm, but he felt it on his other arm. He clarified it was not muscle pain, it is skin. He felt tingling on his face. The patient went to his doctor. Reportedly, it was not a stroke or a heart attack, but he didn't know what to think. He was offered an MRI and other tests. The patient reported the tingling started 4 or 5 days after the shot. He still felt the tingling after 3 or 4 days, and still has numbness on his arm where he got the shot. He added the feeling was down on the forearm and not at injection site. The outcome of the events: unknown. No follow-up attempts needed. No further information expected.

Other Meds:

Current Illness:

ID: 1744073
Sex: F
Age:
State: MI

Vax Date: 04/05/2021
Onset Date: 04/05/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: nausea; Bleeding gum; acne like on her face and her back.; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported) via an unknown route of administration on 05Apr2021 at 15:45 (at the age of 38-year-old) in left arm as dose 1, single for COVID-19 immunization. Medical history included penicillin allergy. The patient had no known allergies. The patient's concomitant medications were not reported. The most recent COVID-19 vaccine was administered at pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 05Apr2021 at 15:35, the patient experienced bleeding gum. On 05Apr2021 at 15:45, the patient experienced nausea immediately after getting vaccination. On an unknown date, the patient had acne like on her face and her back and Patient was asked that if needs to report these or is this something related to the vaccine and if needs to follow-up with patient's doctor. No treatment was received for the adverse events. The clinical outcome of nausea was recovered on 05Apr2021 at 16:45 while bleeding gum was not recovered, and acne like on her face and her back was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1744074
Sex: M
Age:
State: CA

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

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

Lab Data:

Allergies:

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

Symptoms: the back of his neck felt itchy/ the itchiness spread all over his body; red welts, and red marks around his ankles that eventually spread all over his body as well; her husband has sensitive skin; dry skin itch; not feeling well; he experienced red blotches; Dates for his legs were peeling and he was just itching all over; This is a spontaneous report from a contactable consumer or other non hcp. A 83-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 04Mar2021 (at the age of 83-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced the back of his neck felt itchy/ the itchiness spread all over his body, red welts, and red marks around his ankles that eventually spread all over his body as well, her husband has sensitive skin, dry skin itch, not feeling well, he experienced red blotches, his legs were peeling and he was just itching all over. Reporter wanted to know when her husband will receive his 2nd dose of the vaccine. Patient went to the allergist dermatologist. The outcome of the events was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1744075
Sex: F
Age:
State: IL

Vax Date: 03/29/2021
Onset Date: 03/01/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: she had vaginal bleed after getting the first dose of the Pfizer-BioNTech COVID-19 vaccine; This is a spontaneous case received from a contactable female consumer (Patient). A 39-year-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8733, expiration date: unknown), via an unspecified route of administration in arm left on 29Mar2021 14:00 (age at vaccination 39-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included thyroid and celiac. Concomitant medication included Synthroid 50 mcg, once a day by mouth. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none. Additional administered vaccines and prior vaccinations (within 4 weeks) was reported as none. Family medical history relevant to adverse events was reported as none. On an unspecified date in Mar2021, the patient had vaginal bleed after getting the first dose of the Pfizer-BioNTech COVID-19 vaccine. The patient did not undergo any relevant tests. Adverse event required a Physician office visit. the outcome of the event was not recovered. No follow-up attempts were needed. No further information was expected.

Other Meds: Pfizer, Inc. EUA 027034

Current Illness:

ID: 1744076
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: she then felt like her "face was a little bit swollen" along with her "neck"; she then felt like her "face was a little bit swollen" along with her "neck"; Dry mouth; also had very little arm pain; face felt weird/little weird when she was trying to swallow; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on 03Apr2021 16:00 as single dose for COVID-19 immunisation. Medical history included contrast dye allergy, pistachio allergy and concomitant medications were not reported. The patient previously took amoxicillin and experienced allergy and took cephalosporin and experienced allergy. On 04Apr2021, she felt like her face was a little bit swollen along with her neck, dry mouth, face felt weird/little weird when she was trying to swallow and also had very little arm pain. It was reported that, she received the first dose of the Pfizer-BioNTech COVID-19 vaccine on 3 April 2021. She explained she had listed the following allergies to the vaccination provider: contrast dye, amoxicillin, pistachio, and cephalosporin; then was monitored for 30 minutes after the injection. She specified she develops hives in reaction to the contrast dye but takes Benadryl before it to prevent the reaction. She explained that, she was scheduled at 4pm for the 1st shot, she left the facility at 4:30pm. At night, she woke up from sleep at 12:45 AM which is 8 hours later after receiving her 1st shot. She said her face felt weird, both sides of her neck were swollen. She stated it was a little weird when she was trying to swallow. She had a very dry mouth but her tongue was not swollen. She took two Benadryl 25 mg each total of 50mg. The next morning, she felt kind of the same thing: a little bit swollen, puffy in the face, her mouth was really dry and about 10 am until 11am in the morning she was fine until the rest of the week. She was scheduled to take the 2nd dose on 24Apr2021 at 10:30 am. Concerned what will happen next for the 2nd dose of covid vaccine. Therapeutic measures were taken as a result of events. The outcome of the events was Recovering/Resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1744077
Sex: F
Age:
State:

Vax Date: 03/11/2021
Onset Date: 03/01/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Name: Chest Xray; Result Unstructured Data: Test Result:Normal; Test Name: blood clot work up; Result Unstructured Data: Test Result:normal; Test Name: ECG; Result Unstructured Data: Test Result:Normal; Test Name: Covid test; Result Unstructured Data: Test Result:Negative

Allergies:

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

Symptoms: Fatigue; Trouble breathing; Brain fog; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 11Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. On an unspecified date in Mar2021, the patient experienced fatigue, trouble breathing and had brain fog. It was reported that patient received her second dose of Pfizer 11Mar2021. She felt fatigue, trouble breathing with mask and a brain fog. Her doctor ran all kind of test because they saw she was short of breath with the mask. She never had that before. She only had these symptoms after she got the vaccine. It had been 31 or 32 days since she had these symptoms. The patient underwent lab tests and procedures which included blood clot work up, ECG and chest Xray which were found to be normal and had covid test which resulted in negative. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1744078
Sex: F
Age:
State: IN

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

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Feeling ill; Dizzy; nauseous; fatigued; Taste and smell off; Taste and smell off; Feel loopy and drugged; Feel loopy and drugged; This is a spontaneous report received from a contactable consumer (patient) reported herself. A 38-year-old non-pregnant female patient 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 at left arm on 07Apr2021 12:00 (at the age of 38-year-old) as dose 1, single for COVID-19 immunisation at Pharmacy or Drug Store. The patient medical history and concomitant medications were not reported. Patient relevant medical history None. Patient do not have any allergic to medications, food or other products. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination,patient was the patient diagnosed with COVID-19. It was none patient received any other medications the patient received within 2 weeks of vaccination. Patient did not diagnose with COVID-19 prior to vaccination and since the vaccination the patient has not been tested for COVID-19. The patient experienced feeling ill, dizzy, nauseous, fatigued, taste and smell off, feel loopy and drugged on 07Apr2021 12:30. Patient did not receive any treatment for the events. Since the vaccination, patient has the patient been tested for COVID-19Outcome of events was not resolved. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1744079
Sex: F
Age:
State: MO

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

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

Lab Data:

Allergies:

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

Symptoms: chills; fever; This is spontaneous report from a contactable consumer (patient) from Medical information Team. A female patient of an unspecified age received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, it was reported that the patient received the second dose of the Pfizer covid shot, yesterday, she was experiencing chills, and fever and wants to know how long will symptoms last. There was given the response which included side effects after your second shot may be more intense than the ones you experienced after your first shot. These side effects are normal signs that your body was building protection and should go away within a few days These side effects usually start within a day or two of getting the vaccine. Side effects might affect your ability to do daily activities, but they should go away in a few days. The outcome of the events was unknown. No Follow-up attempts are needed. No further information was expected. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1744080
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: my left arm all of the sudden showed up as a bruise; left arm now is hurting me and it's tingling; left arm now is hurting me and it's tingling; my left arm is throbbing to the point that is shaking; my left arm is throbbing to the point that is shaking; My left arm goes numb it's tingling right now; going to sleep all the time; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation (age at the time of vaccination was 56 years). The patient's medical history and concomitant medications was not reported. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date dose 1, single for COVID-19 immunisation. On an unspecified date patient reported, the second shot which was like a week and a half ago, well around Monday her left arm all of the sudden showed up as a bruise, where the vaccine went in, and her left arm was hurting her and it's tingling (per caller: symptoms started a week after second vaccine). She never had a problem with her left hand, four weeks into this her left arm was throbbing to the point that was shaking. Her left arm goes numb it's tingling right now, I have to change hands with my left arm, that's a problem. She never had tingling in left arm and going to sleep all the time. She would never had this pain unless they did not inject her. Her left arm goes numb it's tingling, she had to change hands with her left arm. The clinical outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1744081
Sex: F
Age:
State: NY

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

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

Lab Data:

Allergies:

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

Symptoms: tightness in the chest; Lethargic; slight labored breathing/shortness of Breath; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number : EN6206, Expiry Date: 30Jun2021), via an unspecified route of administration, administered in Left arm on 20Mar2021 11:00 (at the age of 49 year old) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications reported as none. No history of previous immunisations. Prior vaccination, patient did not receive any other vaccines within four weeks. After receiving the vaccine on 20Mar2021, patient had a little bit of slight labored breathing. Then on 02Apr2021, friday, she had tightness in the chest, and was kind of lethargic and had a little more labored breathing than usual. Also on the days, 3rd, and 4th of April, she experienced all these events. At the time of report, she still kind of feels it, where It is so slight, but not usual for her at all. She confirms that her side effects have been stable, but out of the ordinary. They are noticeable, but slight, not enough for her to go to the doctor or hospital. The outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1744082
Sex: F
Age:
State: MD

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

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: bumps; dry cough; hoarseness; slight headache; chills; sweating; had no energy; Her bed was soaking, she was soaking, her chair was soaking, and she couldn't stop shaking and couldn't stay warm; fever; arm like was really swollen, really red, and really itchy; arm like was really swollen, really red, and really itchy; arm like was really swollen, really red, and really itchy; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8729; Expiration Date: Jul2021), via an unspecified route of administration in right arm on 03Apr2021 11:30 (at the age of 72-years-old) as dose 2, single for COVID-19 immunization. Medical history included ongoing High blood pressure (Over 20 years ago she was diagnosed), ongoing Blood cholesterol increased (Over 20 years ago she was diagnosed). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198; Expiration Date: Jun2021), via an unspecified route of administration in right arm on 11Mar2021 1:15 p.m. (at the age of 72-years-old) as dose 1, single for COVID-19 immunization and experienced sore arm, redness, itchiness and shoulder and her neck interrupted her sleep. Patient also received Shingrix vaccine on 07Jan2021 (the dose was 50 MCG; lot number: 3PD3E; expiration date: 08Oct2022). Patient did not receive any vaccines within four weeks of receiving the COVID vaccine. Concomitant medications included metoprolol taken 50 mg tablet once day by mouth from 2012; losartan potassium taken 50 mg tablet on in the morning and night by mouth from 2012; doxazosin mesylate taken 2 mg tablets once daily by mouth from 2012; hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ) taken 37.5-25 mg one tablet on MWF from 2012; atorvastatin taken as 10 mgs daily by mouth for blood cholesterol increased from 2008. The patient experienced arm like was really swollen, really red, and really itchy on 03Apr2021, chills, sweating, had no energy, her bed was soaking, she was soaking, her chair was soaking, and she couldn't stop shaking and couldn't stay warm and fever on 04Apr2021. Patient experienced dry cough, hoarseness, and slight headache on 05Apr2021 and bumps on 06Apr2021. It was reported that her arm like was really swollen, really red, and really itchy. It started the evening, she got the shot at 11:30, by like late in the day early evening it was like, oh yeah, she knows she got her shot. While it was itching Saturday, Sunday, and Monday, it was really itchy and she even put anti-itching cream, maybe cortisone, and ice on her arm trying to get rid of the itching. It has subsided and is not painful or noticeable on 06Apr2021, but she still could feel bumps but that's it. Her arm was the least of it. Sunday about midday 4Apr2021 she had chills, was sweating and had no energy. It became really excessive into the night and the next day and the next day till yesterday morning, 5Apr2021. She thought she was all better than about 3 to 4 hours she again had chills and loss of energy. She doesn't know if she is over it or not. She will see at 3pm today to see how this works. The worst symptoms were the chills and no energy. Her bed was soaking, she was soaking, her chair was soaking, and she couldn't stop shaking and couldn't stay warm. Started Sunday, she was slightly sweaty sleeping last night, but she would say it's a marked improvement. She doesn't own a thermometer, so she doesn't know if she had a fever, but she is assuming now that she had a fever and that it broke overnight. Yesterday it picked up again at 3 in the afternoon until 7 in the evening just with the chills and no energy. The redness and swelling in the arm, that dissipated by now. Since Monday, 05Apr2021, she has had a dry cough and her voice since Monday was hoarse. She states like this is not how she normally sounds. On the day of this report, she was on her fifth day, and she was hoping nothing reburps itself up this afternoon and will be the end of it. She was aware of side effects and this was way worse and not what she expected. Outcome of events arm like was really swollen, really red, and really itchy was resolved on 06Apr2021, sweating was resolving. Events dry cough, hoarseness, slight headache, and bumps were not resolved. Outcome of events chills, had no energy, Her bed was soaking, she was soaking, her chair was soaking, and she couldn't stop shaking and couldn't stay warm and fever were unknown. Her concern is that she needs to go and get her second Shingrix shot at the end of this month, and the reaction she got with COVID isn't going to happen with the Shingrix. She will talk to her pharmacist about it. She states the first time she got chills and shaking and sweating.

Other Meds:

Current Illness: Blood pressure high (Over 20 years ago she was diagnosed.); High cholesterol (Over 20 years ago she was diagnosed.)

ID: 1744083
Sex: F
Age:
State: TX

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

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

Lab Data: Test Name: fever; Result Unstructured Data: Test Result:102 Centigrade

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Fever; Chills; Sleepy; feels so so bad; pain in your arm; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTEHC COVID-19 VACCINE, Batch/Lot Number: ER8733), Solution for injection, via an unspecified route of administration, administered in Arm Left on 31Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were reported as none. On 31Mar2021, patient experienced pain in arm, on 07Apr2021, she had fever, chills, felt so bad and sleepy. It was reported that, patient got her vaccine last Wednesday, 31 MAR 2021, stated she felt so good and only a pain in her arm, stated last night, one week after the vaccine, around 2 or 3 in the morning she had a fever of 102 degrees and a lot of chills and felt so bad. Treatment took Tylenol and felt a little better. Wanted to also know if the second dosage safe for her. Therapeutic measures were taken as a result adverse events, Tylenol. The outcome of event sleepy was not recovered and outcome of all other events was recovering.

Other Meds:

Current Illness:

ID: 1744084
Sex: F
Age:
State: PA

Vax Date: 04/06/2021
Onset Date:
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: flu-like symptoms; runny nose; sore throat; coughing after 15 mins from getting the dose which got worse; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown) dose 1 via an unspecified route of administration on 06Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced flu-like symptoms, runny nose, sore throat and coughing after 15 mins from getting the dose which got worse. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1744085
Sex: U
Age:
State: IL

Vax Date: 03/21/2021
Onset Date: 03/01/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: I had a huge wave of fatigue and a slight fever.; Really bad sore arm.; throbbing headache; I got warm again with a slight fever; I had a huge wave of fatigue and a slight fever/really tired/tiredness came on; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose and experienced just sore arm and slight warmth. On an unspecified date in Mar2021, the patient had a huge wave of fatigue and a slight fever/really tired/tiredness came on, really bad sore arm, throbbing headache and got warm again with a slight fever. Patient stated, I just got my second shot of Pfizer Vaccine on 21Mar2021. Will there be any clinical trials of tring out a third dosage? I heard the company is looking into trying out a third shot of it seeing how it would react of an immune response I might be interested in doing it possibly. Patient stated my second dose I noticed side effects more than first. My second shot about 16-18 hours in (unspecified date in Mar2021), I had a huge wave of fatigue and a slight fever. Really bad sore arm. Then the next day had to call off of work had a throbbing headache when I woke up and just really tired and out of it for about 36 hours. I took a Aleve 12 hour relief that helped some after I woke up the day after shot but then I got warm again with a slight fever and tiredness came on. But after this went away, I felt fine on Tuesday March 23rd and returned back to work. Therapeutic measures were taken as a result of adverse events, Aleve 12-hour relief. The outcome of all the events was recovered on 23Mar2021. No follow-ups are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1744086
Sex: F
Age:
State: NJ

Vax Date: 03/29/2021
Onset Date: 04/01/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: My big toe is like really painful and like swollen; My big toe is like really painful and like swollen; It's a little red and it's painful; joint of my big toe is really red and very painful; This is a spontaneous report from a contactable consumer (patient reported for herself). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EP6955 and Expiration date: 30Jun2021) via intramuscularly, in left arm on 29Mar2021 (at the age of 61-years-old) as dose 1, single for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had 1st COVID shot on Monday the 29th (29Mar2021). On 01Apr2021, the patient experienced big toe that was like really painful and like swollen. Big toe was like red, and that was not really swollen. It was a little red and painful. Patient stated the joint of his big toe was really red, very painful. The patient was still experiencing the adverse event and it had worsened than it was on last day (09Apr2021). The patient enquired if that was a normal reaction from the COVID shot. Patient just wanted to know if other people had that reaction. Patient received no treatment for the events. Patient stated due date of her second shot was on 19Apr2021. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1744087
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: developed a rash after receiving second dose a week ago; This is a spontaneous report from a Pfizer-sponsored program from a Contactable consumer, the patient. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient developed a rash after receiving second dose a week ago on an unspecified date (around 30Mar2021). The outcome of the event was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am