VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1800367
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
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: Caller has received two Covid-19 AstraZeneca vaccines as well as both Pfizer Covid-19 vaccines; Caller has received two Covid-19 AstraZeneca vaccines as well as both Pfizer Covid-19 vaccines; Caller has received two Covid-19 AstraZeneca vaccines as well as both Pfizer Covid-19 vaccines; pain in her right arm; nausea; This is a spontaneous report from a contactable consumer. This female consumer(patient) reported for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 2 via an unspecified route of administration, administered in Arm left on an unspecified date as a single dose for covid-19 immunization. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included covid-19 vaccine nrvv ad (chadox1 ncov-19) (COVID-19 VACCINE ASTRAZENECA) taken for covid-19 immunisation. The patient has received two covid-19 astrazeneca vaccines as well as both pfizer covid-19 vaccines. She had pain in her right arm, nausea on an unspecified date. Caller received her second Pfizer covid-19 vaccine in her left arm, but reports pain in her right arm. Caller is interested in clinical trials for individuals in her situation and would like to report experienced side effects. Outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.

Other Meds: COVID-19 VACCINE ASTRAZENECA

Current Illness:

ID: 1800368
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
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: allergies to the pfizer covid-19 vaccine ingredients; throat closed off; lips swelled; This is a spontaneous report from a non-contactable consumer via Pfizer sponsored program (patient, reported for self). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number and expiry date were not reported), via an unspecified route of administration, on an unspecified date in year 2021, as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in year 2021, after receiving the first dose of the Pfizer covid-19 vaccine the patient had a severe allergic reaction to the ingredients in it (allergies to the Pfizer covid-19 vaccine ingredients). The patient stated that her throat closed off and lips swelled. Reportedly the patient was told not get the second dose of the Pfizer COVID-19 vaccine, but patient stated she would like to speak with Pfizer medical professionals to see their information. Outcome of the events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1800369
Sex: F
Age:
State: CA

Vax Date: 09/29/2021
Onset Date: 09/29/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: pain behind left eye; after second dose she is experiencing left arm lymph node swollen radiating to her breast causing pain in left arm and chest; after second dose she is experiencing left arm lymph node swollen radiating to her breast causing pain in left arm and chest; migraines/Migraines; behind her left eye; whole left side is affected; left arm pit is swollen and it has traveled to her breast and it is painful and it is radiating to her left arm and shoulder; after second dose she is experiencing left arm lymph node swollen radiating to her breast causing pain in left arm and chest; left arm pit is swollen and it has traveled to her breast and it is painful and it is radiating to her left arm and shoulder; the arm is more swollen, she can see the swelling.; headache; Second Dose: Felt the vaccine going in; This is a spontaneous report from a contactable consumer (Patient). A 45-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FD0809), dose 2 via an unspecified route of administration, at Arm Left on 29Sep2021 08:30 as dose 2, single for COVID-19 immunization. The patient's medical history included ongoing Severe Anaemia, ongoing migraine. There were no concomitant medications. The patient's historic vaccine included first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FD0809), for COVID-19 immunisation on 07Sep2021 at 10:30 and experienced left lymph node was swollen, Started her menstrual cycle early, taste disorder, she has migraines since both doses, Breasts are sore under arm and anaemia. No other Vaccines Administered on Same Date of the Pfizer Suspect and no Prior Vaccinations taken. She was Allergic to Morphine. On 29Sep2021, she had her second vaccination, and this time the left arm pit was swollen and it has travelled to her breast and it was painful and it is radiating to her left arm and shoulder. The patient Felt the vaccine going in on 29 sep2021; she experienced pain behind left eye, left arm pit is swollen and it has travelled to her breast and it is painful and it is radiating to her left arm and shoulder, migraines with pain behind her left eye; whole left side is affected on 30Sep2021. Caller stated she also had migraines, behind her left eye, her whole left side is affected. after the second dose, the arm was more swollen, she could see the swelling. Caller reports after second dose she is experiencing left arm lymph node swollen radiating to her breast causing pain in left arm and chest. Caller is also experiencing migraines with pain behind left eye. MI agent did not gather callers age, realized after call. she could see a difference in her arms when she extends her arms. The patient felt that with the second vaccine she felt it go in, but it was not as noticeable as the first one. she was taking Tylenol and it is not working. . Caller states her doctor checked her vaginal area and the nurse asking about taking the Tetanus shot and they offered her Provera to stop the bleeding, but she didn't want to add any more medications. The patient stated that her eyes were not that good. Events resulted in physician office visit. The outcome of pain behind left eye, Pain in arm, chest pain, migraines, swelling, Swollen lymph nodes,lymph node pain, headache was not recovered; Felt the vaccine going in was recovered on 29Sep2021 and the arm is more swollen, she can see the swelling was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness: Anemia (Verbatim: Severe Anemia); Migraine (Verbatim: Migraine)

ID: 1800370
Sex: F
Age:
State: CA

Vax Date: 09/29/2021
Onset Date:
Rec V Date: 10/20/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: she has ear problems; This is a spontaneous report from a contactable consumer (patient) reporting herself. A 71-years-old female patient BNT162B2 (COMIRNATY, Formulation: Solution for Injection, Lot Number: Unknown), via an unspecified route of administration on 29Sep2021, as dose 3 (booster), single (at the age of 71-years-old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient historical vaccine included BNT162B2 (COMIRNATY, Formulation: Solution for Injection, Lot Number: Unknown), via an unspecified route of administration on unspecified date, as dose 2, single for COVID-19 immunization and BNT162B2 (COMIRNATY, Formulation: Solution for Injection, Lot Number: Unknown), via an unspecified route of administration on unspecified date, as dose 1, single for COVID-19 immunization. On 29Sep2021 patient received the third dose of the COVID-19 vaccine from Pfizer. In 2021 the patient reported that she has ear problems. Patient wanted to know how to get the "global code" on her card with her vaccination certificate. The clinical outcome of the event was unknown. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up. .

Other Meds:

Current Illness:

ID: 1800371
Sex: F
Age:
State:

Vax Date: 10/04/2021
Onset Date: 10/01/2021
Rec V Date: 10/20/2021
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: there was a little blood at the injection site this time; patient received booster (dose 3); patient received booster (dose 3); headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine, solution for injection, Batch/Lot number was not reported; Expiration Date: 31Jan2022) via an unspecified route of administration on 04Oct2021 as dose 3 (BOOSTER), single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single and second dose of BNT162B2 (COMIRNATY, 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. On 04Oct2021, the patient experienced a little blood at the injection site and received booster (dose 3). On an unspecified date in Oct2021, the patient experienced headache. The patient wanted to know how long the vaccine could be out. The patient was concerned that it was sitting around. The patient wanted to know how old the vaccine was. The patient stated that she received her booster dose today in the same arm she got her previous doses. The patient said that there was a little blood at the injection site this time, but there wasn't any blood when she got the 1st 2 doses. The patient said she had a little headache. The patient wanted to know if injection site would more likely bleed after the booster. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1800372
Sex: F
Age:
State: ID

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 10/20/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: smallpox like scar on her chin; cold sore; throbbing, stinging pain; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non-pregnant female patient received the second dose of bnt162b2, via an unspecified route of administration, administered in Arm Left on 01Mar2021 16:30 (at the age of 68-year-old) (Lot Number: EN9266) as single dose for covid-19 immunisation. Medical history included Sjogrens, hypothyroidism, arthritis; known allergies: Augmentin, demerol, some sulfa drugs. Concomitant medications included Levothyroxine, simvastatin, Omeprazole, ibuprofen, vitamins B,C,D E, biotin, magnesium, zinc. The patient previously took the first dose of bnt162b2, via an unspecified route of administration, administered in Arm Left on 08Feb2021 16:30 (at the age of 68-year-old) (Lot: EN5318) as single dose for covid-19 immunisation. A few days after the second dose, she got what she thought was a cold sore starting on her chin. It got bigger each day until the 4th day, it was about 3/8" in diameter, and throbbing, stinging pain. She used Melaleuca oil on it, and it gradually subsided and went away, but left a smallpox like scar on her chin. The outcome of the event scar was not recovered, others was recovered in 2021. Follow-up attempts are completed. No further information is expected.

Other Meds: LEVOTHYROXINE; SIMVASTATIN; OMEPRAZOLE; IBUPROFEN; VITAMIN B [VITAMIN B NOS]; VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS; VITAMIN E [TOCOPHEROL]; BIOTIN; MAGNESIUM; ZINC

Current Illness:

ID: 1800373
Sex: F
Age:
State: MO

Vax Date: 10/01/2021
Onset Date: 10/03/2021
Rec V Date: 10/20/2021
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: I have mild bleeding and blood clots and cramps; I have mild bleeding and blood clots and cramps; I have mild bleeding and blood clots and cramps; I have vaginal bleeding; This is a spontaneous report from a non-contactable consumer. A 24-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 01Oct2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included birth control. Unspecified concomitant medication was reported. On 03Oct2021, the patient had vaginal bleeding, she was not due to start my cycle for another 2 weeks as she just got off 2 weeks ago. The patient had mild bleeding and blood clots and cramps. No treatment was received. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1800374
Sex: F
Age:
State: NJ

Vax Date: 10/02/2021
Onset Date: 10/03/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: Test Date: 20211003; Test Name: temperature; Result Unstructured Data: Test Result:103; Comments: Temperature of 103 for two days and severe diarrhea.

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Temperature of 103 for two days; severe diarrhea; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received third dose (booster dose) of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 02Oct2021 at 03:15 PM, at 72-year-old, as single dose (Lot Number: FF8839) for covid-19 immunisation. The patient was not pregnant at the time of vaccine. Known allergies was penicillin. Other medical history was none. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 19Feb2021 at 01:00 pm, as single dose (Lot number: EL9266) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 12Mar2021 at 04:00 pm, as single dose (Lot number: EN6206) for covid-19 immunisation. The patient was 71-year-old at first and second dose. No other vaccine in four weeks. There were other medications in two weeks (as reported). Prior vaccination the patient had not got covid and the patient had not been tested covid post vaccination. The patient stated she had temperature of 103 for two days and severe diarrhea on 03Oct2021 at 07:00 AM. The patient got no treatment for events fever and diarrhea. The outcome of events temperature of 103 and severe diarrhea was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1800375
Sex: F
Age:
State:

Vax Date: 09/27/2021
Onset Date: 09/28/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: Test Name: heart rate; Result Unstructured Data: Test Result:heart was beating a little fast; Comments: her heart was beating a little fast; Test Name: Sonogram; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: heart was beating a little faster; it felt like her lymph nodes and her chest were swollen; she had trouble catching her breath.; still feel that area is burning a bit; that is still hurt a lot/ hurt on both sides after firs/ chest lymph nodes started to hurt on her left side; her chest glands or lymph nodes swelled up and it felt painful; it felt like her lymph nodes and her chest were swollen; This is a spontaneous report from a contactable consumer (patient herself). A 39-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number was not reported) via an unspecified route of administration on 27Sep2021 (age at vaccination was 39 years) as dose 1, single for covid-19 immunisation. The patient's medical history was not reported. The patient received as historical vaccine as Flu shot for immunization and experienced got bad reactions with flu shots: got bad reactions with flu shots about a year ago, with a regular Flu shot given in her doctor's office. She could not provide the brand name, NDC, Lot number or expiration date of the Flu shot. The patient's concomitant medications were not reported. Other products not provided. She had a tendency to get reactions to shots. The patient stated she received the first dose of the Comirnaty vaccine on 27Sep2021 and had some reaction. On the second day after her shot, it felt like her lymph nodes and her chest were swollen and it felt painful on 28Sep2021 and said that this had been about a week or so. She wanted to know if this was normal, for how long this would last, and this had been reported. She also mentioned her heart was beating a little faster, like had trouble catching her breath but had already went away and her main concern was the feeling of lymph nodes and chest being swollen and hurt on both sides after firs. She still felt that area was burning a bit and that was still hurt a lot. Her chest lymph nodes started to hurt on her left side, and then the next day both sides hurt. She just wanted to report this because she had no idea and it had been more than week and these things still hurt every morning when she woke up. She was concerned and nervous if she should get the second dose of her Comirnaty vaccine on the scheduled time due to her side effects and that the second dose might feel worse. She also reported that these symptoms went away. She did call a nurse who told her, if the symptoms got worse to go to the emergency room. The patient underwent lab test and procedure included heart rate: heart was beating a little faster and Sonogram: unknown result. The outcome of events her chest glands or lymph nodes swelled up and it felt painful was recovered on an unspecified date of 2021 and outcome of other events was recovered on unspecified date. The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.

Other Meds:

Current Illness:

ID: 1800376
Sex: F
Age:
State:

Vax Date: 04/13/2021
Onset Date:
Rec V Date: 10/20/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Osteoarthritis knees; general body ache; fever; Itchy legs; This is a solicited report from a Pfizer sponsored based on information received by Pfizer, manufacture control number: 21K-163-3977066-00. A contactable consumer (patient) reported a 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscular on 13Apr2021 (Batch/Lot number was not reported), at the age of 60-years-old, as DOSE 2, SINGLE for Covid-19 immunisation; and adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from 2018 (Batch/Lot number was not reported) to 2018, at unspecified dose for psoriatic arthritis. Medical history included tobacco user and alcoholic, all from an unknown date and unknown if ongoing. Concomitant medication included meloxicam taken for inflammation, start and stop date were not reported. The patient received dose 1 of bnt162b2 on 15Mar2021 (batch/lot number not reported), intramuscular for Covid-19 immunisation and experienced legs itchy. In 2021, the patient experienced osteoarthritis in knees, fever, body ache, and running a temp. In Jun2021, the patient underwent knee surgery and was doing her physical therapy. She agreed to have physician contacted. In 2021, patient had second knee surgery, she was doing great but knees were tight. She was using cane. She had knee surgery and there might some arthritis left in her knees, because they were stiff, her healthcare professional was monitoring this. With the first COVID vaccine her legs itchy, and 2nd COVID vaccine she had fever and body ache, running a temp, she took paracetamol (TYLENOL). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the events for adalimumab was unknown. The outcome of the events was unknown. The reporter's causality of the events osteoarthritis knees, itchy legs, fever and body pain with Pfizer/Biontech Covid vaccine was not related. AbbVie's causality for the events was not provided for Pfizer/Biontech Covid vaccine. The reporter's causality for the events of osteoarthritis in knees and itchy legs with HUMIRA 40MG/0.4ML(ADALIMUMAB) was not related. The reporter's causality for the events fever and body pain was not provided for HUMIRA 40MG/0.4ML(ADALIMUMAB). AbbVie's opinion is that there is no reasonable possibility that the events of osteoarthritis in knees, PFIZER/BIONTECH FIRST COVID VACCINE caused legs itchy, PFIZER/BIONTECH SECOND VACCINE caused fever and body ache, running a temp unknown onset and PFIZER/BIONTECH SECOND VACCINE caused ever and body ache, running a temp unknown onset are related to HUMIRA 40MG/0.4ML(ADALIMUMAB). No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal relationship the possibility of causal association between the reported events Osteoarthritis knee, pyrexia, pain, pruritis and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: MELOXICAM

Current Illness:

ID: 1800377
Sex: F
Age:
State: NJ

Vax Date: 10/01/2021
Onset Date: 10/02/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: adverse reaction she has experienced with her third dose of the vaccine; adverse reaction she has experienced with her third dose of the vaccine; Large swelling under one arm with tenderness; Large swelling under one arm with tenderness; had a fever after the third dose of the vaccine; This is a spontaneous report from a Contactable Physician (patient). A 62-years-old female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FE3592), via an unspecified route on 01Oct2021 at 14:30 (at the age of 62-years) as dose 3 (booster), single in the left arm for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EH9899), via an unspecified route on 15Dec2020 (at the age of 62-years) as dose 1, single and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EK9231), via an unspecified route on 05Jan2021 (at the age of 62-years) as dose 2, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient Received third dose of the Pfizer Covid 19 Vaccine on 01Oct2021. The patient experienced fever on 02Oct2021, large swelling under one arm with tenderness on 03Oct2021. Patient says that with her second dose of the vaccine she had flu like symptoms. With the third one she has a large swelling with tenderness under one arm. States she got her third dose of the vaccine on Friday, 01Oct2021, the symptoms began on Sunday and have lessened today. Patient did not visit to Emergency Room/Physician Office. The outcome of the events fever was recovered on 03Oct2021 and large swelling under one arm with tenderness was recovering.

Other Meds:

Current Illness:

ID: 1800378
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: Test Name: covid-19; Result Unstructured Data: Test Result:positive

Allergies:

Symptom List: Rash, Urticaria

Symptoms: who received the booster dose of the of the Pfizer BioNtech (Comirnaty) vaccine and contracted COVID-19 infection.; who received the booster dose of the of the Pfizer BioNtech (Comirnaty) vaccine and contracted COVID-19 infection.; This is a spontaneous report from a non-contactable male consumer reported for himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 3 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient mentioned that he tested positive for COVID and wants to know more information on the reported lack of efficacy of the booster dose on an unspecified date. Patient added that he stayed at home, with no contact and has been very careful. He was in his senior and when the vaccine was authorized, he got his booster. He mentioned that he was quite shocked. He declined to speak with at first and says that he is just curious where Pfizer stands on this. He was thinking about going to the media regarding the efficacy of the third dose. He does not want to keep being transferred and if it continues, he was ready to go to a lawyer. Pfizer needs to be able to talk on behalf of this and not transfer him around everything, that was typical for a large corporate company. He was giving Pfizer a chance and he does not want to but he may have to go to a lawyer who will publicize all of that. He was informed that the transferring agent had sent him to the department regarding the medical information. He states that he wants to speak with . He was not blaming this agent he was just shocked. He thought that he has done all that he could. He has stayed inside for a year and he did not talk to anyone at all, not even for deliveries, and then he got the third shot, he is older, and then he gets COVID. He thinks that Pfizer knows more about COVID then they are disclosing is his guess. He was unable to obtain phone number because he was sick and in bed on and does not have a pen. If the call disconnects, he will have to find another way to contact them. The patient underwent lab tests and procedures which included Covid-19 test: positive on an unspecified date. Outcome of event was unknown. No follow up attempts are possible. Information about Lot/batch number cannot be obtained. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1800379
Sex: M
Age:
State:

Vax Date: 09/17/2021
Onset Date: 09/18/2021
Rec V Date: 10/20/2021
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: fainting/passing out; eyes darting around; his breathing didn't look right; shallow breathing; non responsive for about a minute to verbal commands; fell to the floor; the vaccine was administered on the left arm because she remembers sitting with him and he mentioned the extreme soreness; seizure; This is a spontaneous report from a contactable consumer (caregiver, patient's friend). A 42-year-old male patient received bnt162b2 (COMIRNATY, COVID 19 Vaccine, mRNA), dose 1 via an unspecified route of administration, administered in arm on 17Sep2021 17:00 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. Medical history included blood pressure abnormal and for years he had been regularly on a low dosage blood pressure pill. Concomitant medications were not reported. The patient experienced seizure on 18Sep2021 03:00. He was not responsive to verbal commands, eyes darting around, and he fell to the floor. No investigation assessment. Caller was not sure so she herself talked to a pharmacist and a nurse and they said it could be a seizure. She explains that her friend was collapsed in the bathroom, she heard a noise and so went to her friend and saw his mouth was ajar, his breathing didn't look right, his eyes were darting around and he was non responsive for about a minute to verbal commands. She went to other room to get phone because she wasn't sure. This happened within 12 hours of the receiving the shot, it was under 12 hours. The pharmacist said it could be directly be link to the shot, the pharmacist reported this. Caller asks should her friend get the second shot. Caller stated that she almost called an ambulance but then her friend came around after a minute and minute and a half. this was very scary to her. The seizure happened in the middle of the night on 18Sep2021 around 3AM. Caller was probed when the seizure started or if she knew how long it lasted, caller stated that her own reaction time was late because she was asleep, she then heard a thud, and it took time to realize and question what she heard, she then got to the nearby bathroom, and then discovered him, his body was limp, he was shallow breathing, eyes darting, he was on the floor non responsive to verbal command, but the time she got there it was about a minute and half longer. She was unsure how much longer he was laying in there before she saw him. She added that he has not fainted before like that, he has no history, this was an isolated event, he did not have any further side effect or adverse reaction after. Outcome: This was still unknown because maybe there would be something that cannot be seen with the eyes, she knew the shots last for 6 month after second dose. She did not know biochemically what was occurring but nothing that she can visually see and there are no changes in his behaviors. Covid Vaccine: Lot and Expiry are Unknown, as this would be with her friend. She will try to provide this information during follow up. She thinks the vaccine was administered on the left arm because she remembers sitting with him and he mentioned the extreme soreness, but she cant say 100% it's the left arm. Caller stated that she herself was worried and concerned when she saw him, he did not have a memory of the event happening. Medical conditions: She knew that for years he has been regularly on a low dosage blood pressure pill but there have never been side effects or fainting, passing out, nothing. This event is just odd. Investigation: No he doesn't have chronic health conditions. Allergies: No, even his eating habits, he eats whatever he wants, he does not show any signs of being allergic to anything, just nothing, no chronic discomfort or nothing. The seriousness of seizure and fainting/passing out was medically significant. The outcome of events was unknown. The lot number for bnt162b2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1800380
Sex: F
Age:
State:

Vax Date: 03/11/2021
Onset Date: 03/13/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: Test Name: COVID; Test Result: Positive

Allergies:

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

Symptoms: COVID-19; COVID-19; Drug effect decreased; Stress; Colitis ulcerative aggravated; Bleeding; This is a solicited report from a contactable consumer (patient) based on information received by Pfizer from Company (Mfr. Control No.: 21K-163-3988258-00). A 63-year-old female patient (same age at vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 11Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 intramuscular on 08Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for Covid-19 immunization; and adalimumab (HUMIRA), subcutaneous from Sep2016 (Batch/Lot number was not reported) to Oct2020, at 40 mg, subcutaneous from Jan2021 (Batch/Lot number was not reported) and ongoing, at 40 mg for colitis ulcerative. No relevant medical history. The patient's concomitant medications were not reported. On unknown dates, the patient experienced humira completely stopped working, COVID-19, and stressed. In 2021, the patient experienced bleeding. On 13Mar2021, the patient experienced ulcerative colitis flare ups. In May2021, the ulcerative colitis flare Ups resolved. In 2021, the bleeding resolved. Pfizer BionTech COVID-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 11Mar2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. On 08Apr2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer. The patient was treated with Prednisone. The outcome of event Colitis ulcerative aggravated was recovered in May2021; outcome of bleeding was recovered in 2021; outcome of other events was unknown. The reporter's assessment of the causal relationship of the events with BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.; Sender's Comments: The reported events are assessed as possibly related to the suspect drug BNT162B2 based on information provided in the case but consider also possible contributory effects from patient's medical history and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1800381
Sex: M
Age:
State: IN

Vax Date: 10/04/2021
Onset Date: 10/04/2021
Rec V Date: 10/20/2021
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: 20211004; Test Name: temperature; Result Unstructured Data: Test Result:99.8

Allergies:

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

Symptoms: got the Pfizer Covid vaccine/4 years old male; Went to (name withheld) yesterday for their flu shot but instead got the Pfizer Covid vaccine; fever; body aches; head ache/Head hurting; stomach ache; arm pain/Arm hurt; This is a spontaneous report from Pfizer-sponsored program from a contactable consumer (patient's father) via medical information team. This is report 3 of 4 reports. A 4-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 04Oct2021 at 16:00 (at the age of 4 years old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Patient had no medical history and there were no concomitant medications. The reporter and his wife with 2 children all went to get the flu vaccine, but were given doses of the Pfizer Covid 19 Vaccine instead. Both of the children were given full adult doses of the Pfizer Covid 19 Vaccine. On 04Oct2021, the patient started experiencing fever, body aches, head ache, stomach ache and arm pain. The reporter stated that the patient received the vaccine around 16:00. About 3 hours later the patient began to have a fever, body aches, head hurting. The patient's temperature at the time was 99.8. Reporter states they gave the patient fever reducer, Ibuprofen, and were told to take him to the hospital if the fever persisted. He states that the patient's fever lowered, he woke up at night and it was back up to 99.8 and he was complaining of a stomach ache and that his arm hurt. Reporter stated the patient's symptoms were all persisting. They were alternating Tylenol and Ibuprofen. The patient underwent lab tests and procedures which included body temperature: 99.8 on 04Oct2021. Therapeutic measures were taken as a result of fever, body aches, head ache/head hurting, stomach ache, arm pain/arm hurt. The clinical outcome of fever, body aches, head ache, stomach ache and arm pain was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1800382
Sex: F
Age:
State: NC

Vax Date: 09/13/2021
Onset Date:
Rec V Date: 10/20/2021
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: vomited for 6 straight days every time she tried to eat; This is a spontaneous report from a contactable consumer or other non-HCP (parent reported for daughter). A 14-year-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration on 13Sep2021 as dose 1, single (at the age of 14-years-old) for COVID-19 immunization. Vaccination Facility type was reported as Pharmacy or Drug Store. The patient did not receive any other vaccine in four weeks. The patient had not been tested for covid post vaccination. Medical history included COVID-19 and known allergies were reported as unknown. Concomitant medication included sertraline hydrochloride (ZOLOFT). On an unspecified date in 2021, the patient experienced vomited for 6 straight days every time she tried to eat. The patient only stopped after taking Zofran and she took it for a week. Patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration on 05Oct2021 as dose 2, single for COVID-19 immunization. The outcome of the event was resolved on an unspecified date in 2021. The lot number for the vaccine, BNT162B2, was not provided and would be requested during follow up.

Other Meds: ZOLOFT

Current Illness:

ID: 1800383
Sex: F
Age:
State: FL

Vax Date: 09/13/2021
Onset Date: 09/01/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: Test Date: 202109; Test Name: Heart; Result Unstructured Data: Test Result:beating really hard in chest; Test Date: 202109; Test Name: Breathing; Result Unstructured Data: Test Result:increased

Allergies:

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

Symptoms: First dose 07Jun2021, second dose 13Sep2021; Body went into shock; Muscles went tight and jiggled; Heart was beating really hard in chest; Breathing was going fast; Face twitched; Legs twitched hard; Hands were cold like she had them in a freezer; Feet were cold; Couldn''t make purposeful movements with face, legs, and arms; Couldn''t walk or anything; Couldn't warm up; This is a spontaneous report from a contactable consumer. A 46-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in upper right arm on 13Sep2021 11:30 (Batch/Lot Number: FC3182) at the age of 46-year old as DOSE 2, SINGLE for covid-19 immunisation. Was scared and waited a little bit to get her second dose. Medical history included epilepsy. Historical vaccine included BNT162B2 on 07Jun2021 at the age of 46-year-old for Covid-19 immunization (First dose, Lot: EW0181, EXP: Aug2021) experienced: Her body got into chills, she thought she was having a seizure; Chipped tooth; Her body got into chills, she thought she was having a seizure; shivering so hard she almost broke her teeth; typical mild fever, stomach ache, drowsy. She felt like she had the flu; heart went funny and felt like she was going into the floor; Felt like she couldn't walk, dizzy, felt like she was floating; shaking so hard she thought she would fall on the floor; eye sight has gotten blurry; Her arms were going all over the place. Her arms are tingling; Her arms were going all over the place. Her arms are tingling. Her muscles and stuff are sore because of the blood, she was shaking so hard; Chest hurt. The above symptoms happened within two weeks of the first COVID shot at night time. She held back because of what happened with the first dose, it was not cool. Then doctor told her to go ahead and get the second shot anyways because of her health problems. What happened after the first dose, happened again. The patient had first dose 07Jun2021, second dose 13sep2021 on 13sep2021. Provided details of experience after second dose: Began within 5 days of the second dose COVID shot in the middle of the day. In Sep2021, It seems like her body went into shock, Muscles went tight and jiggled, is not normal. It was bad; Has epilepsy, thought she was having a seizure, but she wasn't. She was still wide awake; Felt like she was a car engine. It was creepy; This was just like after the first dose; It hit her out of the blue within 5 days after the first shot; face twitched, legs twitching hard; hands were cold like she had them in a freezer; Feet were cold; couldn't warm up; did not have chills; It was like her body went into shock; Couldn't make purposeful movements with face, legs, and arms; Couldn't walk or anything; Was stuck on the couch; All symptoms lasted about six hours. The patient underwent lab tests and procedures in Sep2021 which included heart rate: beating really hard in chest, irregular breathing: increased. Treatment for second dose COVID shot symptoms: Unable to take anything. She was by herself and stuck on the couch. Thought she was having a seizure, but knew she was not. Her hands a feet were cold so she knew something was wrong. Outcome: Recovered completely in Sep2021. She is ok. She's worried about it. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1800384
Sex: F
Age:
State: NY

Vax Date: 06/03/2021
Onset Date: 06/05/2021
Rec V Date: 10/20/2021
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: 2021; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: I was unable to move from a sitting position without severe pain on my left side and groin; my left knee was locking up; did have a degree of osteoarthritis/after the vaccine it was exacerbated; left in a lot of pain in my knees and hip; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EWO202, Expiration date: Not reported), via an unspecified route of administration in right arm on 03Jun2021 at 12:00 (at the age of 60-years-old) as dose 2, single for COVID-19 immunization in a hospital. Medical history included osteoarthritis. The patient was allergic to penicillin and shell fish. Concomitant medications/other medications received by the patient in two weeks included duloxetine; pantoprazole and eletriptan hydrobromide (RELPAX). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EWO175, Expiration date: Not reported), via an unspecified route of administration in left arm on 12May2021 at 15:00 (at the age of 60-years-old) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination and didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Three days after her second shot on 05Jun2021, the patient was unable to move from a sitting position without severe pain on her left side and groin and also her left knee was locking up. The patient did have a degree of osteoarthritis. However, she felt that after the vaccine it was exacerbated where she was currently left in a lot of pain in her knees and hip. The patient received treatment with a steroid shot to the hip and had a series of five gel shots for the events which resulted in doctor or other healthcare professional office/clinic visit and disability or permanent damage. Post-vaccination, the patient was tested for COVID-19 by nasal swab method in 2021 with the negative result. The outcome of these events was not recovered at the time of report. No follow-up attempts are possible. No further information is expected.

Other Meds: DULOXETINE; PANTOPRAZOLE; RELPAX

Current Illness:

ID: 1800385
Sex: F
Age:
State: GA

Vax Date: 09/27/2021
Onset Date: 09/28/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: Test Date: 20211005; Test Name: blood pressure; Result Unstructured Data: Test Result:185/68; Comments: BP spiked today (05Oct) about 1:30PM, from normal to 185/68, lasting only a few minutes; Test Date: 20210928; Test Name: Body temperature; Result Unstructured Data: Test Result:102; Comments: fever (over102 for about 12 hours, 102.4 at peak; Test Date: 20210928; Test Name: Body temperature; Result Unstructured Data: Test Result:102.4; Comments: fever (over102 for about 12 hours, 102.4 at peak

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: BP spiked today(Oct 5) about 1:30PM, from normal to 185/68; headache; body aches; chills; fever (over102 for about 12 hours, 102.4 at peak); queasy stomach (no vomiting); profuse sweating; feeling woozy-headed; sensitivity to loud/sharp noise,visual sensation of flashing lights.; sensitivity to loud/sharp noise,visual sensation of flashing lights.; general fatigue; dizziness; chest discomfort; This is a spontaneous report from a contactable consumer (patient). This 72-year-old female non pregnant patient received bnt162b2 (COMIRNATY), Left arm on 27Sep2021 11:30 AM at age of 72-year-old DOSE 3 (BOOSTER), SINGLE (Lot number: FC3182) for covid-19 immunisation. Medical history: HPB, SVT, Hypothyroidism (all treated). nausea reactions to anesthesia. No covid prior vaccination. Concomitant medications included flecainide acetate, lisinopril, levothyroxine sodium (SYNTHROID). No other vaccine in four weeks. The patient previously received received bnt162b2 (COMIRNATY) Left arm on 10Feb2021 10:00 AM at age of 71-year-old as DOSE 1, single (lot number: EL9265) for covid-19 immunisation, Right arm on 03Mar2021 10:00 AM as DOSE 2, single (lot number: EN6200) for covid-19 immunisation. Only sore arm and a bit of fatigue with 1st dose, sore arm only for 2nd dose. On 28Sep2021 10:00 AM About 20 hours after 3rd dose the patient developed fever (over102 for about 12 hours, 102.4 at peak), severe headache, body aches, chills, queasy stomach (no vomiting), profuse sweating. The above continued approx 36 hrs., fever lessened after 24 hrs. Post-fever continued feeling woozy-headed, had sensitivity to loud/sharp noise, visual sensation of flashing lights in 2021. At this writing 8 days after 3rd dose the patient still have general fatigue, some dizziness, queasy stomach, some chest discomfort in 2021. Concerned about heart (have SVT). BP spiked today (05Oct2021) about 1:30PM, from normal to 185/68, lasting only a few minutes. No covid tested post vaccination. No treatments received. Outcome of the event queasy stomach (no vomiting), feeling woozy-headed, general fatigue, dizziness, chest discomfort was not recovered. Outcome of the event BP spiked today (Oct 5) about 1:30PM, from normal to 185/68 was recovered. Outcome of the event fever (over102 for about 12 hours, 102.4 at peak) was recovering. Outcome of other events was unknown.

Other Meds: FLECAINIDE ACETATE; LISINOPRIL; SYNTHROID

Current Illness:

ID: 1800386
Sex: F
Age:
State: CA

Vax Date: 10/03/2021
Onset Date: 10/04/2021
Rec V Date: 10/20/2021
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: Tunnel Vision; Pain behind eyes; blurry vision; black vision; nausea; sweating; headache; dizziness; dry heaving; vomitting; shakiness; chills; metallic taste in mouth; This is a spontaneous report from a contactable other hcp (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), vaccinated at same age, dose 1 via an unspecified route of administration, administered in Arm Left on 03Oct2021 11:00 (Batch/Lot Number: FF2587) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Non-alcoholic fatty liver disease, gallbladder removed from 2011, covid, and known allergies: penicillin and codeine. Patient is non-pregnant at time of vaccination. There were no concomitant medications. The patient experienced tunnel vision, pain behind eyes, blurry vision, black vision, nausea, sweating, headache, dizziness, dry heaving, vomitting, shakiness, chills, and metallic taste in mouth and all on 04Oct2021 06:30 with outcome of not recovered. Events resulted in Emergency room/department or urgent care. Treatment was received for all events. Sedated at ER with medication for optical migraine. No COVID tested post vaccination.; Sender's Comments: Considering a temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported event Tunnel vision cannot be completely excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate

Other Meds:

Current Illness:

ID: 1800387
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
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: partially resembling systemic capillary leak syndrome after Pfizer Covid vaccination; This is a spontaneous report from a contactable Physician. This Physician reported similar events for 2 patients. This is a 2nd of 2 reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The physician reported the patient with symptoms partially resembling systemic capillary leak syndrome after Pfizer Covid vaccination. The most recent, the physician was considering trying to get IVIG treatment. The event outcome was unknown. The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event capillary leak syndrome and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101324800 same product, reporter and event, different patients.

Other Meds:

Current Illness:

ID: 1800388
Sex: M
Age:
State: CA

Vax Date: 05/08/2021
Onset Date: 06/04/2021
Rec V Date: 10/20/2021
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: 20210926; Test Name: sars-cov-2 PCR; Test Result: Negative ; Comments: Nasal Swab

Allergies:

Symptom List: Unevaluable event

Symptoms: Diagnosed as Ptosis; This is a spontaneous report from a contactable consumer. A 48-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left at age of 48-years-old on 08May2021 (Lot Number: EW0172) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included haemochromatosis. No Covid prior vaccination. No other vaccine in four weeks. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 at age of 48-years-old on 09Apr2021 for COVID-19 immunization. The patient experienced In June started having slightly droopy left eye, which has gotten worse over time. Diagnosed as Ptosis. Left eye only. Hasn't gotten better, has slowly gotten worse over last several months. Adverse event start date: 04Jun2021. No treatment received for the event. The patient underwent lab tests and procedures which included sars-cov-2 PCR: negative on 26Sep2021 Nasal Swab. Outcome of event was not recovered. The event resulted in: [Doctor or other healthcare professional office/clinic visit, Disability or permanent damage] Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1800389
Sex: F
Age:
State: CA

Vax Date: 10/04/2021
Onset Date: 10/04/2021
Rec V Date: 10/20/2021
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: This is a spontaneous report from a contactable other HCP (patient). A 29-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2) at the age of 29-year-old, dose 3 via an unspecified route of administration, administered in Arm Right on 04Oct2021 10:45 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Facility type Vaccine: Pharmacy or Drug Store. Medical history was none. No other vaccine in four weeks; no other medications in two weeks. No covid prior vaccination. There were no concomitant medications. No Known allergies. Historical vaccine included BNT162B2 for COVID-19 immunization on an unknown date (Dose Number: 2, Prev dose product= covid 19, Prev dose brand= pfizer, Prev dose dose number=2); BNT162B2 for COVID-19 immunization on an unknown date (Dose Number: 1, Prev dose product= covid 19, Prev dose brand= pfizer, Prev dose dose number=1, Prev dose vaccine location=Right arm). The patient experienced slightly blacked out for about a second on 04Oct2021 14:15 with outcome of recovered on 04Oct2021; started to feel slightly nauseous on 04Oct2021 13:45 with outcome of recovered, felt terrible on 04Oct2021 14:15 with outcome of recovered, vomited about 4 times on 04Oct2021 14:15 with outcome of recovered on 05Oct2021 00:30, started to get terrible stomach cramps that felt like agony on 04Oct2021 14:45 with outcome of recovered on 04Oct2021 16:45 lasted for 2 hours, had some diarrhea the following day on 05Oct2021 with outcome of recovered. Detail information about adverse event includes: Shot 1 and 2 the patient had of average symptoms. She was reporting now on booster shot 3 that received at 10:45 am. About 1:45 pm she started to feel slightly nauseous. About 30 minutes later felt terrible and slightly blacked out for about a second and vomited about 4 times. About 30 minutes later started to get terrible stomach cramps that felt like agony. The cramps lasted for maybe 2 hours and then finally went away. She threw up another 4 times and then a few hours later another 4 times and then a few hours later another 4 times. The patient felt nauseous. She stopped puking at 12:30 ish am- about 14 hours after receiving the vaccine. The next month she felt nauseous but overly much better. She had some diarrhea the following day as well. By the end of the day she was able to walk around some and do household chores. The day she felt back to normal. It was unknown If treatment AE. No Covid tested post vaccination. The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: A contributory role of BNT162B2 to event blacked out cannot be excluded based on temporal association and available information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1800390
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
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: My husbands cousin had a major heart attack and is in a coma.; My husbands cousin had a major heart attack and is in a coma.; This is a spontaneous report from a non-contactable consumer. This consumer reported for a patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The medical history and concomitant medications were not reported. The consumer reported husband's cousin had a major heart attack and is in a coma. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1800391
Sex: M
Age:
State: MA

Vax Date: 09/22/2021
Onset Date: 09/25/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: Test Name: COVID-19; Test Result: Positive ; Comments: became sero positive for COVID-19

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: developed symptoms on 25Sep2021 and became sero positive for COVID-19; developed symptoms on 25Sep2021 and became sero positive for COVID-19; This is a spontaneous report from a contactable physician. This physician reported similar events for 2 patients (uncle and aunty). This is the 1st (uncle) of 2 reports. An elderly male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Sep2021 (Batch/Lot number was not reported) as dose 3 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No Covid prior vaccination. No other vaccine in four weeks. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient received the Pfizer BioNTech vaccine booster (completing the series of 3) and developed symptoms on 25Sep2021 and became sero positive for COVID-19 on an unspecified date, thus qualifying as a lack of efficacy AE (adverse event). The events did not result in emergency room visit or physician office visit. The patient underwent lab tests and procedures which included COVID-19: positive on an unspecified date. Therapeutic measures were taken as a result of the events included regeneron monoclonal antibodies. The outcome of the events was not recovered. The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Drug ineffective, Covid-19 and BNT162B2.,Linked Report(s) : US-PFIZER INC-202101326365 same reporter/drug/event, different patient

Other Meds:

Current Illness:

ID: 1800392
Sex: F
Age:
State: OH

Vax Date: 09/24/2021
Onset Date: 09/25/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: Test Name: Fever; Result Unstructured Data: Test Result:101.2; Test Name: Fever; Result Unstructured Data: Test Result:99.4; Comments: The next day after the patient got the vaccine her temperature was 101.2, the following day it was like 99.4 or something and then it was 99.5. Then there are times where the patient doesn't have a temperature, its at like 91 or something; Test Name: Fever; Result Unstructured Data: Test Result:99.5.; Comments: The next day after the patient got the vaccine her temperature was 101.2, the following day it was like 99.4 or something and then it was 99.5. Then there are times where the patient doesn't have a temperature, its at like 91 or something; Test Name: Fever; Result Unstructured Data: Test Result:91 or something.; Comments: The next day after the patient got the vaccine her temperature was 101.2, the following day it was like 99.4 or something and then it was 99.5. Then there are times where the patient doesn't have a temperature, its at like 91 or something; Test Name: Oxygen level; Result Unstructured Data: Test Result:low; Test Name: Oxygen level; Result Unstructured Data: Test Result:86; Test Name: Oxygen level; Result Unstructured Data: Test Result:97; Test Name: Covid-19; Result Unstructured Data: Test Result:Unknown result; Test Date: 202103; Test Name: Covid-19; Test Result: Positive ; Comments: She had COVID in March and has been on oxygen since then.

Allergies:

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

Symptoms: been running low oxygen levels; having a lot of drainage and that type of thing, they could hear crackling in her lungs; low grade fever here and there; This is a spontaneous report from a contactable consumer. A 82-year-old female patient (reporter's aunt) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: FC3182 and expiry date was not reported), via an unspecified route of administration, in arm right, on 24Sep2021 at afternoon (at the age of 82-year-old), as dose 2, single for COVID-19 immunization at drug store. The patient medical history included COVID-19 on an unspecified date in Mar2021 and Pulmonary fibrosis. Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), omeprazole (OMEPRAZOLE), losartan (LOSARTAN), insulin aspart (NOVOLOG), insulin degludec (TRESIBA). Patient previously received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: FD8448 and expiry date was not reported), via an unspecified route of administration on 03Sep2021 (at the age of 82-year-old), as dose 1, single for COVID-19 immunization. Reporter is calling on behalf of her 82-year-old Aunt. She had COVID in March and has been on supplemental oxygen since then. She was starting to wean off the oxygen, but then got the Pfizer COVID 19 vaccine. Her 2nd dose was on 24Sept. On an unspecified date, She has been running low oxygen levels. She cannot walk across the room without it dropping to 86. Last week she saw her pulmonary doctor and he could hear crackling in her lungs. The patient was afraid of covid again and she wouldn't make it through it. The patient has also had a low-grade fever here and there which happened after the second dose of the vaccine on 25Sep2021. The patient went to give blood and her fever was fine there but other times its not. Right now, the patient could not get her oxygen above 86. Usually, the patient oxygen runs about 97 but then when the patient walks it drops down to like 86. The next day after the patient got the vaccine her temperature was 101.2, the following day it was like 99.4 or something and then it was 99.5. Then there are times where the patient doesn't have a temperature, its at like 91 or something. The patient needs to get a covid test done because she is having a lot of drainage and that type of thing on an unspecified date. The reporter wants to know if the patient should not have gotten her 2nd dose considering she had Covid before. The patient did not receive any other vaccine in four weeks. No history of all previous immunization with the Pfizer vaccine considered as suspect and additional Vaccines Administered on Same Date of the Pfizer Suspect. The AE did not require emergency room or physician office visit. The patient underwent lab tests and procedures included fever (Body temperature) with the results of 101.2, 99.4, 99.5 and 91 or something, Oxygen saturation with the results of low, 86, 97 and SARS-CoV-2 test with unknown results on an unspecified date and positive on an unspecified date in Mar2021.Outcome of the event been running low oxygen levels was not recovered. Outcome of the event low grade fever here and there was recovering. Outcome of the events they could hear crackling in her lungs and having a lot of drainage and that type of thing were unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: BREO ELLIPTA; OMEPRAZOLE; LOSARTAN; NOVOLOG; TRESIBA

Current Illness:

ID: 1800393
Sex: F
Age:
State: FL

Vax Date: 03/30/2021
Onset Date: 03/30/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: Test Date: 20210901; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: Nasal Swab

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: it felt like a pulled muscle; couldn't hardly lift her arm/still hurts very bad; couldn't hardly lift her arm/still hurts very bad; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that a 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 58-years, via an unspecified route of administration in left arm on 30Mar2021 at 11:00 at single dose for COVID-19 immunization, at pharmacy or drug store. Medical history was none. The patient was not pregnant at time of vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT) and simvastatin. On 30Mar2021 at 11:00, after her vaccine, she went to the car and opened her door and it felt like a pulled muscle. She couldn't hardly lift her arm and it had not gotten any better. It still hurts very bad. AE resulted in disability or permanent damage. No treatment received. COVID-19 virus test (nasal swab) was negative on 01Sep2021. The patient received second single dose of BNT162B2 in left arm on 27Apr2021 at 11:00 for COVID-19 immunization. Outcome of the events was not recovered/not resolved. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds: ZOLOFT; SIMVASTATIN

Current Illness:

ID: 1800394
Sex: F
Age:
State: IL

Vax Date: 05/05/2021
Onset Date:
Rec V Date: 10/20/2021
Hospital: Y

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

Lab Data: Test Name: Weight; Result Unstructured Data: Test Result:140-145 lbs

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: UTI; Cellulitis/cellulitis in both legs which were swollen unbelievably bad; an infection of her spine; This is a spontaneous report from a contactable consumer (patient). This consumer reported for herself that a 59-year-old female patient received first dose of BNT162B2 (COMIRNATY, NDC number: 59267-1000-02, Expire Date: 17May2021) at the age of 59-years, via an unspecified route of administration by injection in her left arm on 05May2021 at 11:30 at single dose for COVID-19 immunization, at pharmacy. Medical history included Crohn's, asthma (uses inhalers daily), bronchitis (uses inhalers daily), double amputee (left leg amputation below the knee was done 13 years ago, and right leg amputation way above the knee was done about 5 years ago), immune compromised. Concomitant medications included she took a lot of medications daily. The patient had not received the second dose due to multiple hospitalizations due to infections not related to the vaccine, such as, UTI, Cellulitis, and an infection of her spine. Patient was informed by the pharmacist that she would need to start the vaccination series over. Calling to confirm if she can still only need to take the second dose, or does she need to start over. The patient inquired that she was immune compromised, how long she dose need to wait to take the booster shot. The patient reported that after receiving the 1st dose, she was hospitalized and she had been in and out of the hospital since then. She was calling because she wanted to know if she can still get the 2nd dose. Stated she hadn't been in the hospital since the end of Jul2021, so she wanted to get her 2nd dose, but when she called the pharmacy she was told that she would need to start the series all over, so she wanted to call to find out if that was true. Stated that the hospitalizations had nothing to do with the vaccine. She had a very bad urinary tract infection, cellulitis in both legs which were swollen unbelievably bad, and an infection in her spine. The infection in her spine started at the level of her bra line and instead of going down, it went up to her neck. The doctors said she got blood in her spine. The first time she was admitted was around the middle to the end of May2021 and she was in the hospital for about 1 week. Then she was back in the hospital about 1.5 to 2 weeks later and was hospitalized until 23Jun2021. The 3rd time she was admitted was in Jul2021 for about 1.5 weeks. Patient was unable to provide specific dates for her hospitalizations. She was sent home on home health care with oral and IV antibiotics. She continued to receive the IV antibiotics until about 9 weeks ago when her refrigerator went out. Her doctor had to pull her off of the IV antibiotics, and she had to throw away all the IV medication because it was warm. Stated she was so upset about it because she had to pay for all that medication out of her pocket because Medicare wouldn't pay for it. She had continued on the 2 oral antibiotics. AE(s) require a visit to emergency room and physician office, caused hospitalization. Patient's weight was 140-145lbs. Outcome of the events was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1800395
Sex: M
Age:
State: NC

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
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: broken tooth; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program Support. A 67-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient previously received first dose of bnt162b2 on an unspecified date for covid-19 immunisation. The patient experienced broken tooth in 2021 and had a dental implant today (06Oct2021). Outcome of event was unknown. The patient was prescribed with "Afrin for his right nostril because his dental implant was on the upper right side"; prescribed with Chlorhexidine mouth wash. The patient was scheduled for his booster or third dose of the Pfizer COVID-19 vaccine tomorrow and wanted to know if there would be an interaction with Afrin and Chlorhexidine mouth was with the vaccine. The patient was also prescribed with Naproxen Sodium 550mg 1 tablet every 12 hours as pain medication, and Cephalexin 500mg 1 capsule every 6 hours as antibiotic. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1800396
Sex: M
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: Test Name: covid test; Test Result: Positive

Allergies:

Symptom List: Nausea

Symptoms: Her son was diagnosed positive; Son is completely vaccinated; Her son was diagnosed positive; Son is completely vaccinated; This is a spontaneous report from a Pfizer-sponsored program Support. This is the 2nd case out of 2 cases. A contactable consumer reported for a patient (Son) that the male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced her son was diagnosed positive; son is completely vaccinated on an unspecified date with outcome of unknown. She mentioned that, she got the booster shot today, without even knowing that, her son was diagnosed positive and she was exposed to his like there is no face mask and his son is completely vaccinated(Not further confirmed which vaccine he received) as well and right now, he has the symptoms of COVID-19 virus right now. She want to know how does it matters and she added that, If any, in case they will not be infected, they will be visiting a person, who is immunocompromised, who is vaccinated as well. She wants to know and she wants to ask if there are possibility, They can carry the virus even though the immunocompromised person is already vaccinated. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1800397
Sex: F
Age:
State:

Vax Date: 08/18/2021
Onset Date: 08/18/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: Test Date: 202109; Test Name: Hearing test; Result Unstructured Data: Test Result:Confirmed sudden hearing loss; Test Date: 20210818; Test Name: Blood pressure; Result Unstructured Data: Test Result:unknown results

Allergies:

Symptom List: Injection site pain

Symptoms: upper sinus congestion/nasal congestion; upper sinus congestion/nasal congestion; sudden hearing loss; tight feeling in neck and jaw; fullness or weird feeling in her head and ears; fullness or weird feeling in her head and ears/odd feeling in ears/ears felt clogged up; fullness or weird feeling in her head and ears; nasal runny nose; This is a spontaneous report from a contactable consumer. This consumer reported for a 68-year-old female patient (family member) that who received first dose of BNT162B2 (COMIRNATY) at the age of 68-years, via an unspecified route of administration on 18Aug2021 at single dose for COVID-19 immunization. Medica history included patient was allergic to corn, spicy food, sunflower products, cumin, rye, caraway seeds. Concomitant medications were none. The patient received her first dose of the Pfizer covid vaccine. Right after she had a list of adverse reactions: on 18Aug2021, tight feeling in neck and jaw, fullness or weird feeling in her head and ears, they tested her on blood pressure and other things but no explanation on her head sensation and stated it should get better. About 5-7 days after that, on 26Aug2021, she felt were her ears were clogged up (like when you change elevation); odd feeling in her ears and that feeling didn't go away. Then went to the HCP to ENT. She had a sudden hearing loss on 26Aug2021 and regardless of treatment. She had multiple hearing tests and then get worse each time instead of better and no prior hearing issues/loss prior to the Pfizer covid vaccine. She also got side effects with upper sinus congestion/nasal congestion. She had a nasal runny nose immediately after the vaccine; within 35 minutes of the vaccine and continued with her since that time and no OTC or medicine clears up the congestion. She was at the doctor today. Consumer wanted reports about hearing loss and sinus congestion, asked about nuts in the vaccine, asked about gluten in the vaccine. They had reported the tight feeling in neck and jaw and a fullness or weird feeling in head and ears to the person that gave the vaccine and was looked at following and then they were cleared he guesses. Then a week or so later ears felt clogged up, like from an elevation change or something like that, and had since been diagnosed with sudden hearing loss. It was getting very severe and had had treatment for that and there was no other explanation other than the vaccine with having the experience with this scenario. They were still seeking treatment. Consumer said any information at this point would be helpful to them since this was something brand new. He was not entirely sure that an ENT or ear specialist were entirely familiar with what can be done to treat this other than what they may would do in for sudden hearing loss but since its quite possibly drug related this may be a totally different animal. The patient then continued having the feelings for days after the vaccine and then she also got a lot of nasal congestion that wouldn't clear and it still hadn't cleared. Consumer thought that the jaw tightness and the neck feeling may of gotten better but the ear fullness and tightness never went away. Then it worsened and went into sudden hearing loss with hearing tests confirming that. The patient had not had any type of hearing loss or issues prior to the vaccine. Consumer thought that the first sign of sudden hearing loss was within 5 to 7 days following the vaccine, and then put 26Aug2021 for when the side effects such as the fullness and the ear problems started, it was approximately a week after getting the vaccine that these occurred. Consumer confirmed that these side effects were ongoing and were getting worse very quickly, even with treatments. The patient had to see her primary care provider and then three days later was able to get an appointment and get scheduled with the ear doctor and then there was an additional 2 more days so it was probably into the first part of Sep2021 for the hearing test. The patient underwent lab tests and procedures, which included hearing test in Sep2021 confirmed sudden hearing loss. Outcome of tight feeling in their neck and jaw was recovering/resolving while of remain was not recovered/ not resolved. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1800398
Sex: F
Age:
State: MI

Vax Date: 05/01/2021
Onset Date:
Rec V Date: 10/20/2021
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: 20211005; Test Name: Blood test; Result Unstructured Data: Test Result:Unknown Results; Comments: Unknown; Test Date: 20211005; Test Name: Urine test; Result Unstructured Data: Test Result:Unknown Results; Comments: Unknown

Allergies:

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

Symptoms: I got my shot my 1st shot back in May and I ended up catching COVID a week after; This is a spontaneous report received from a contactable consumer or other non hcp. A 47-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0150; Expiration Date: 31Jul2021) via an un-specified route of administration in Arm Left on 01May2021 (age at vaccination 47years old) as single dose for covid-19 immunisation. Medical history included cerebrovascular accident from an un-known date and unknown if ongoing Verbatim: Stroke, pain from an unknown date and unknown if ongoing Verbatim: Pain disorder, depression from an unknown date and unknown if ongoing Verbatim: Depression, migraine from an unknown date and unknown if ongoing Verbatim: Migraine, hiatus hernia from an unknown date and unknown if ongoing Verbatim: Hiatal hernia, asthma from an unknown date and unknown if ongoing Verbatim: Asthma, chronic obstructive pulmonary disease from an unknown date and unknown if ongoing Verbatim: COPD, gastroesophageal reflux disease from an unknown date and unknown if ongoing Verbatim: Acid reflux, bursitis from an unknown date and unknown if ongoing Verbatim: Bursitis, osteoarthritis from an unknown date and unknown if ongoing Verbatim: Osteoarthritis. The patient experienced i got my shot my 1st shot back in May and i ended up catching covid a week on an unspecified date. Additional information she had got her first shot in May2021, and I ended up catching COVID a week later from my daughter she got it at her job but within 2 and a half month and then I was trying to find out my doctor gave me clinic yesterday to get my second shot, he told me it was okay for me to get my second shot now. The patient underwent lab tests and procedures which included blood test: unknown results on 05Oct2021 Unknown, urine analysis: unknown results on 05Oct2021 Unknown. The clinical outcome of the event was unknown. Summary of Investigation: The initial scope of the investigation was limited to the reported finished goods lot EW0150, fill lot EP8690, and the bulk formulated drug product lot EP8587. Based on the results of the investigation, the scope was not expanded. Manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history were examined for the reported complaint lot. Pfizer did not receive photographs or a complaint sample for examination. The complaint was not confirmed. No probable root cause for the complaint related to the manufacturing process of the reported lot was identified. There were no corrective or preventative actions taken as a result of this complaint investigation. No related quality issues were identified during the investigation. There were no planned or unplanned deviations recorded during the manufacture of the complaint lot and associated manufacturing lots that may have caused a complaint of this nature. A review of the manufacturing records confirmed processing steps were performed within pre established parameters. All raw materials and amounts used in the manufacture of the batch were of the correct weight and identity. The drug product is stored at controlled refrigeration throughout the manufacturing process and a log is maintained documenting the elapsed time out of refrigeration. A review of the elapsed time tracking logs indicated that the batch did exceed Time Out of Refrigeration limits. To analyse whether this impacted the quality of the batch, a assessment was conducted. The assessment concluded that the RNA integrity result from Covid-19 vaccine lot EW0150 is comparable to the standard validation limits. All release testing results from EW0150 are within product release specifications. It has been identified that the product quality attribute of RNA integrity may decline as a function of temperature, the results of this product assessment has concluded that there is no impact to the product quality attributes of the complaint lot as a result of exceeding limits. The product also requires storage in ultralow temperature freezers following the packaging of the product. A review of the freezer storage logs confirmed that all times and temperatures were within allowable limits. There is no impact to the quality of the lot. It is unknown how the product was handled, stored, or administered after it left the site. Reserve Sample Testing Result: A reserve sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months of the release date of the involved batch. The results of all analytical tests performed at the time of lot release were confirmed to be within registered specifications. All available stability results for this product were within registered specification and stability studies (including accelerated studies) are ongoing for this product. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1800399
Sex: F
Age:
State: CA

Vax Date: 03/23/2021
Onset Date: 05/21/2021
Rec V Date: 10/20/2021
Hospital: Y

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

Lab Data: Test Date: 20210521; Test Name: Heart rate; Result Unstructured Data: Test Result:210; Comments: bpm; Test Date: 20210119; Test Name: rapid test; Test Result: Negative ; Comments: Nasal Swab

Allergies:

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

Symptoms: SVT episode with a heart rate over 210 bpm; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Right on 23Mar2021 16:45 (Lot Number: ER8727) as dose 2, single (at age of 46-years-old) for covid-19 immunisation. No pregnant at time of vaccination. No other vaccine in four weeks. Medical history included allergies. No Covid prior vaccination. Concomitant medications included montelukast sodium (SINGULAIR); levocetirizine dihydrochloride (XYZAL) taken for allergies. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) on 02Mar2021 16:30 administered in Arm Right (at age of 46-years-old) for COVID-19 immunization. The patient experienced SVT episode with a heart rate over 210 bpm (hospitalization) on 21May2021 10:30. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for SVT episode with a heart rate over 210 bpm for 1 days. She never had SVT before or any heart conditions. The event treatment induced medication to slow down her heart and stop SVT. The patient underwent lab tests and procedures which included heart rate: 210 bpm on 21May2021, rapid test: negative Nasal Swab on 19Jan2021. Outcome of the event was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: SINGULAIR; XYZAL

Current Illness:

ID: 1800400
Sex: M
Age:
State: MD

Vax Date: 03/26/2021
Onset Date: 03/26/2021
Rec V Date: 10/20/2021
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: passed out and collapsed to the floor in his apartment's bathroom; passed out and collapsed to the floor in his apartment's bathroom; This is a spontaneous report from a contactable consumer (patient). A 35-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Right on 26Mar2021 12:00 (Batch/Lot number was not reported) as dose 2, single (at age of 35-years-old) for covid-19 immunisation. Medical history was none. Known allergies: none. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Mar2021 12:00 administered in Arm Right (at age of 35-years-old) for COVID-19 immunization. On 26Mar2021 23:00, later that evening on the date he got the second shot, he passed out and collapsed to the floor in his apartment's bathroom. This incident occurred as he was in the process of urinating. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment received. No Covid prior vaccination. No Covid tested post vaccination. Outcome of the events was recovered with sequelae. The lot number for BNT162B2 was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1800401
Sex: M
Age:
State: AR

Vax Date: 02/22/2021
Onset Date: 02/22/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: Test Name: test; Result Unstructured Data: Test Result:was tested for a stroke and he didn't have one; Test Date: 20210930; Test Name: covid titer; Result Unstructured Data: Test Result:0.0001; Comments: had covid titers drawn on 30Sep2021 at his PCP. The results were 0.0001 which he reported of no coverage for covid. He stated the first shot gave his zero antibodies

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: facial and throat swelling; facial and throat swelling; mental fog; fatigue; stutter; loss of balance; soreness in the arm muscle where he got BNT162B2; This is a spontaneous report from a contactable consumer (patient) from a Pfizer. A 72-years-old male patient received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration, administered in Arm Right on 22Feb2021 15:00 (Lot Number: EL9266) as dose 1, single (at age of 72-years-old) for covid-19 immunisation. Prior Vaccinations within 4 weeks was None. Medical history included Kidney cancer (Diagnosed two years ago that they snipped right off), 2 heart attacks with 3 stents, Ischemic heart disease, gout, pectoral angina, prostatitis (took a couple of other vitamins, herbs, and the T medication that is for prostatitis). Family medical history relevant to AEs was none. Concomitant medications included allopurinol taken for gout; losartan taken for pectoral angina; acetylsalicylic acid (ASPIRIN); metoprolol tartrate (METOPROLOL XL); simvastatin; ubidecarenone (COQ-10); Beyodym and rozoani. On 22Feb2021, the patient experienced mental fog, facial and throat swelling, fatigue, stutter, loss of balance, soreness in the arm muscle where he got BNT162B2. The patient experienced side effects of facial and throat swelling, fatigue, stutter, loss of balance, and mental fog. He went to the emergency room for treatment. Due to these side effects, he never got his second dose of the vaccine. Seeking information if he should get the second dose. The patient was tested for a stroke and he didn't have one. The stutter was like he couldn't get the words out or get his thoughts together, his brain and mouth couldn't get in sync. The patient didn't have a rash or nothing on his skin, he had some soreness in the arm muscle where he got it, but it didn't turn red or nothing. The patient took the shot and within the first 3-5 minutes he had face swelling and throat swelling and got epinephrine and Benadryl. The patient reported that he had covid titers drawn on 30Sep2021 at his PCP. The results were 0.0001 which he reported of no coverage for covid. He stated the first shot gave his zero antibodies. The serum that the virus suspended was contaminated and that was why he had no antibodies against the covid 19 infection. The patient asked his doctor to test the titer and its 0 so he got nothing out of that shot. He had the lot and everything and didn't know if there was a bad lot. He was afraid someone at the VA was going to infect him since he works there. Since this looks like it was contaminated lot/batch, can he start over? Or should the patient take the Moderna or the Johnson and Johnson? The patient asked if he could get a second dose, or should he restart the series due to the timing of his first dose back on 22Feb2021 and he had no antibodies against the covid virus. And asked if there had any data regarding the interchangeability between the Pfizer BioNtech covid 19 vaccines and other covid 19 vaccines. All adverse events required a visit to emergency room and physician office and received treatment. Outcome of the events mental fog, facial and throat swelling, fatigue, stutter, loss of balance was recovering; of the event soreness in the arm muscle where he got BNT162B2 was unknown. The case was reported as non-serious.

Other Meds: ALLOPURINOL; LOSARTAN; ASPIRIN [ACETYLSALICYLIC ACID]; METOPROLOL XL; SIMVASTATIN; COQ-10

Current Illness:

ID: 1800402
Sex: F
Age:
State: WI

Vax Date: 02/04/2021
Onset Date:
Rec V Date: 10/20/2021
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: had a stroke; confused; trouble hearing information; writing the wrong thing down; This is a spontaneous report from a contactable consumer (patient). A 68 years old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration at age of 67 years old on 04Feb2021 (Lot Number: EL9269) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 at age of 67 years old on 14Jan2021 (lot number: EL3249) for Covid-19 immunization and experienced horrible itching. The patient stated that after having her covid vaccination she had a stroke and had been out of work and in a nursing home. She reported that she still got caught up on little words and got confused and had trouble hearing information and writing the wrong thing down. Outcome of events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1800462
Sex: F
Age:
State: GA

Vax Date:
Onset Date: 09/09/2021
Rec V Date: 10/20/2021
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: LEFT ARM FELT HEAVY AND HARD TO LIFT ARM WITHOUT FELLING PAIN; NAUSEOUS; SORE ARM ON THE SITE OF INJECTION/PAIN IN ARM WHEN LIFTING; LOW FEVER; WEIRD TASTE IN MOUTH; CHILLS; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022 expiry: UNKNOWN) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. Concomitant medications included insulin for diabetes. On 09-SEP-2021, the patient experienced weird taste in mouth. On 09-SEP-2021, the patient experienced chills. On 09-SEP-2021, the patient experienced sore arm on the site of injection/pain in arm when lifting. On 09-SEP-2021, the patient experienced low fever. On 10-SEP-2021, the patient experienced nauseous. On 10-OCT-2021, the patient experienced left arm felt heavy and hard to lift arm without felling pain. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weird taste in mouth on 12-SEP-2021, chills, low fever, and nauseous on 10-SEP-2021, and sore arm on the site of injection/pain in arm when lifting on SEP-2021, and was recovering from left arm felt heavy and hard to lift arm without felling pain. This report was non-serious.

Other Meds: INSULIN

Current Illness: Diabetes (Diabetes diagnosed 33 and takes insulin.)

ID: 1800463
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: Test Date: 20210731; Test Name: TSH; Result Unstructured Data: 1.1; Comments: according to her doctor, it is normal

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: AFTER GETTING THE JANSSEN COVID-19 VACCINE PAIN FROM HIP DISAPPEARED AND TSH LEVEL GET NORMAL; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's past medical history included: hip surgery, and concurrent conditions included: extremely low tsh level, alcohol user, non smoker, and pain on surgical area (pain felt all day), and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with codeine for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the patient experienced after getting the janssen covid-19 vaccine pain from hip disappeared and tsh level get normal. On 31-JUL-2021, Laboratory data included: TSH (NR: not provided) 1.1. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of after getting the janssen covid-19 vaccine pain from hip disappeared and tsh level get normal was not reported. This report was non-serious.

Other Meds:

Current Illness: Alcohol use (Consume once a year at the most); Incision site pain; Non-smoker; TSH decreased (extremely low TSH ( ranging from 0.02-.04))

ID: 1800464
Sex: F
Age: 69
State:

Vax Date: 02/22/2021
Onset Date: 02/22/2021
Rec V Date: 10/20/2021
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: experienced tenderness around the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (experienced tenderness around the site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004MZ0A) for COVID-19 vaccination. NO medical history information was reported. The patient's past medical history included Hypertension since an unknown date and Diabetes since an unknown date. On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE PAIN (experienced tenderness around the site). At the time of the report, VACCINATION SITE PAIN (experienced tenderness around the site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Concomitant medications reported were Blood Pressure Medications, and Diabetes Medications. No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Feb-2021 and was forwarded to Moderna on 25-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (experienced tenderness around the site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004MZ0A) for COVID-19 vaccination. NO medical history information was reported. The patient's past medical history included Hypertension since an unknown date and Diabetes since an unknown date. On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE PAIN (experienced tenderness around the site). At the time of the report, VACCINATION SITE PAIN (experienced tenderness around the site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Concomitant medications reported were Blood Pressure Medications, and Diabetes Medications. No Treatment information for the event was provided.

Other Meds:

Current Illness: Diabetes; Hypertension

ID: 1800465
Sex: F
Age: 66
State: TX

Vax Date: 03/03/2021
Onset Date: 03/03/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Can't move her arm; nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move her arm), NAUSEA (nausea) and CHILLS (Chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move her arm), NAUSEA (nausea) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move her arm), NAUSEA (nausea) and CHILLS (Chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1800466
Sex: F
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
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: shortness of breath; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) and CHEST PAIN (Chest pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The patient's past medical history included No adverse event. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath) and CHEST PAIN (Chest pain). At the time of the report, DYSPNOEA (shortness of breath) and CHEST PAIN (Chest pain) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1800467
Sex: M
Age: 60
State: TX

Vax Date: 06/08/2021
Onset Date: 07/06/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: Test Date: 20210706; Test Name: Body temperature; Result Unstructured Data: High( 100-102 degree Fahrenheit)

Allergies:

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

Symptoms: Wicked couple of months; Diagnosed with a medical problem; Fever between 100F -102F that was fluctuating after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL BEHAVIOUR (Wicked couple of months), VACCINATION COMPLICATION (Diagnosed with a medical problem) and PYREXIA (Fever between 100F -102F that was fluctuating after 2nd dose) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 003C21A) for COVID-19 vaccination. The patient's past medical history included Colonoscopy (A medical procedure (colonoscopy) was done for an internal infection after the first dose down the throat to diagnose for the internal infection and stated that now everything is normal regarding that infection.The patient had hiccups for 10 days before the procedure hence the colonoscopy procedure was done.). Concurrent medical conditions included Blood pressure high. Concomitant products included LISINOPRIL for Blood pressure high. On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jul-2021, the patient experienced PYREXIA (Fever between 100F -102F that was fluctuating after 2nd dose). On an unknown date, the patient experienced ABNORMAL BEHAVIOUR (Wicked couple of months) and VACCINATION COMPLICATION (Diagnosed with a medical problem). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, ABNORMAL BEHAVIOUR (Wicked couple of months) and VACCINATION COMPLICATION (Diagnosed with a medical problem) outcome was unknown and PYREXIA (Fever between 100F -102F that was fluctuating after 2nd dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jul-2021, Body temperature: high (High) High( 100-102 degree Fahrenheit). For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient experienced Ran fever for 2 months (102*) and it was treated with antibiotics. This case was linked to MOD-2021-231193. Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow-up received contains significant information. The patient initials were updated. The event was updated. On 12-Oct-2021: Follow up received included Patient height, weight and race information, Start date of event Fever, outcome and Treatment was updated.

Other Meds: LISINOPRIL

Current Illness: Blood pressure high

ID: 1800468
Sex: F
Age: 87
State: NJ

Vax Date: 05/22/2021
Onset Date:
Rec V Date: 10/20/2021
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: She was in rehab for 6 weeks after twisting her ankle; Received second dose in the bone instead of the muscle; Technician who was administering the vaccine did not give her an alcohol swab, band-aid, or anything; This spontaneous case was reported by a consumer and describes the occurrence of JOINT INJURY (She was in rehab for 6 weeks after twisting her ankle), PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Received second dose in the bone instead of the muscle) and PRODUCT ADMINISTRATION ERROR (Technician who was administering the vaccine did not give her an alcohol swab, band-aid, or anything) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. Concomitant products included LEVOTHYROXINE for Hashimoto's disease. On 22-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced JOINT INJURY (She was in rehab for 6 weeks after twisting her ankle), PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Received second dose in the bone instead of the muscle) and PRODUCT ADMINISTRATION ERROR (Technician who was administering the vaccine did not give her an alcohol swab, band-aid, or anything). At the time of the report, JOINT INJURY (She was in rehab for 6 weeks after twisting her ankle) outcome was unknown and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Received second dose in the bone instead of the muscle) and PRODUCT ADMINISTRATION ERROR (Technician who was administering the vaccine did not give her an alcohol swab, band-aid, or anything) had resolved. Patient reported that she didn't get a prescription for prednisone and that her symptoms were from when she was taken off of prednisone. No treatment medication were provided. Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Follow-up received non-significant On 23-Aug-2021: Follow up document received on 23AUG2021 contains no new information.

Other Meds: LEVOTHYROXINE

Current Illness:

ID: 1800469
Sex: M
Age: 54
State: CA

Vax Date: 04/01/2021
Onset Date: 04/29/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: Test Date: 20210429; Test Name: Body temperature; Result Unstructured Data: 103 F

Allergies:

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

Symptoms: Vaccine attack every weak point in his body; Whole arm is on fire; Spinal arthritis; Burning sensation; Pain in his left shoulder; Last 2 to 3 weeks left foot has had cramps that did not go away extremely painful at times; Last 2 to 3 weeks left foot has had cramps that did not go away extremely painful at times; Diagnosed with COVID-19 after having completed Moderna COVID-19 vaccination series; Lack of drug effect; Right arm tingling 10 times a day from tip of right hand all the way up to right shoulder/Right arm is still tingly about 20 times a day; Left foot, left shoulder and entire right arm pain; Have a queasy fainting feeling, phlegm in chest and cough; phlegm in chest and cough; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Right arm tingling 10 times a day from tip of right hand all the way up to right shoulder/Right arm is still tingly about 20 times a day), COVID-19 (Diagnosed with COVID-19 after having completed Moderna COVID-19 vaccination series), MUSCLE SPASMS (Last 2 to 3 weeks left foot has had cramps that did not go away extremely painful at times), PAIN (Last 2 to 3 weeks left foot has had cramps that did not go away extremely painful at times) and VACCINATION COMPLICATION (Vaccine attack every weak point in his body) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history of the patient was reported by the reporter. Concomitant products included OMEPRAZOLE, FLUTICASONE, GABAPENTIN, TETRACYCLINE, FINASTERIDE, PSEUDOEPHEDRINE and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced PARAESTHESIA (Right arm tingling 10 times a day from tip of right hand all the way up to right shoulder/Right arm is still tingly about 20 times a day), PAIN IN EXTREMITY (Left foot, left shoulder and entire right arm pain), PRESYNCOPE (Have a queasy fainting feeling, phlegm in chest and cough) and PRODUCTIVE COUGH (phlegm in chest and cough). On 10-Jul-2021, the patient experienced COVID-19 (Diagnosed with COVID-19 after having completed Moderna COVID-19 vaccination series). 10-Jul-2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). On 12-Jul-2021, the patient experienced MUSCLE SPASMS (Last 2 to 3 weeks left foot has had cramps that did not go away extremely painful at times) and PAIN (Last 2 to 3 weeks left foot has had cramps that did not go away extremely painful at times). On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccine attack every weak point in his body), LIMB DISCOMFORT (Whole arm is on fire), SPINAL OSTEOARTHRITIS (Spinal arthritis), BURNING SENSATION (Burning sensation) and ARTHRALGIA (Pain in his left shoulder). At the time of the report, PARAESTHESIA (Right arm tingling 10 times a day from tip of right hand all the way up to right shoulder/Right arm is still tingly about 20 times a day), COVID-19 (Diagnosed with COVID-19 after having completed Moderna COVID-19 vaccination series), MUSCLE SPASMS (Last 2 to 3 weeks left foot has had cramps that did not go away extremely painful at times), VACCINATION COMPLICATION (Vaccine attack every weak point in his body), LIMB DISCOMFORT (Whole arm is on fire), SPINAL OSTEOARTHRITIS (Spinal arthritis), PAIN IN EXTREMITY (Left foot, left shoulder and entire right arm pain), PRESYNCOPE (Have a queasy fainting feeling, phlegm in chest and cough), PRODUCTIVE COUGH (phlegm in chest and cough), BURNING SENSATION (Burning sensation), DRUG INEFFECTIVE (Lack of drug effect) and ARTHRALGIA (Pain in his left shoulder) outcome was unknown and PAIN (Last 2 to 3 weeks left foot has had cramps that did not go away extremely painful at times) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Body temperature: 103 f (High) 103 F. Treatment medications were not provided. This case was linked to MOD-2021-280006 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Follow up received contains significant information and additional events are added.; Sender's Comments: This case concerns a 54-year-old, male subject with no relevant medical history reported, who experienced the unexpected, non-serious and AESI event of COVID-19. The event occurred approximately two and a half months after the second dose of Spikevax. The rechallenge was not applicable as no additional dose is expected to be given. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds: OMEPRAZOLE; FLUTICASONE; GABAPENTIN; TETRACYCLINE; FINASTERIDE; PSEUDOEPHEDRINE; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]

Current Illness:

ID: 1800470
Sex: M
Age: 58
State: FL

Vax Date: 08/10/2021
Onset Date:
Rec V Date: 10/20/2021
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: Started feeling so sick; He Is sick on the stomach/Is still sick; he could not go to work and has not gone to work; It got so bad last night; He is still sick; Nauseated/Nausea/felt like throwing up; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Started feeling so sick), ABDOMINAL DISCOMFORT (He Is sick on the stomach/Is still sick), IMPAIRED WORK ABILITY (he could not go to work and has not gone to work), FEELING ABNORMAL (It got so bad last night) and ILLNESS (He is still sick) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by reporter. Concurrent medical conditions included Diabetes. Concomitant products included INSULIN GLARGINE (LANTUS), DULAGLUTIDE (TRULICITY), INSULIN HUMAN (NOVOLIN R), MORNIFLUMATE (FLOMAX [MORNIFLUMATE]), GABAPENTIN, TIZANIDINE, OMEPRAZOLE and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication. On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Started feeling so sick), ABDOMINAL DISCOMFORT (He Is sick on the stomach/Is still sick), IMPAIRED WORK ABILITY (he could not go to work and has not gone to work), FEELING ABNORMAL (It got so bad last night), ILLNESS (He is still sick) and NAUSEA (Nauseated/Nausea/felt like throwing up). The patient was treated with ONDANSETRON (ZOFRAN MELT) for Nausea, at an unspecified dose and frequency. At the time of the report, MALAISE (Started feeling so sick), ABDOMINAL DISCOMFORT (He Is sick on the stomach/Is still sick), IMPAIRED WORK ABILITY (he could not go to work and has not gone to work), FEELING ABNORMAL (It got so bad last night), ILLNESS (He is still sick) and NAUSEA (Nauseated/Nausea/felt like throwing up) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient stated that he takes lots of medications and reported taking "sugar" medicine.

Other Meds: LANTUS; TRULICITY; NOVOLIN R; FLOMAX [MORNIFLUMATE]; GABAPENTIN; TIZANIDINE; OMEPRAZOLE; CYMBALTA

Current Illness: Diabetes

ID: 1800471
Sex: U
Age: 81
State: MI

Vax Date: 07/07/2021
Onset Date: 07/07/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: received a vaccine which was more than 30 days in the refrigerator; vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021).; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021).) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 07-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 1. On 07-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021).). On 07-Jul-2021, EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021).) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported No treatment medication was reported This case was linked to MOD21-126929 (Patient Link).

Other Meds:

Current Illness:

ID: 1800472
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: Test Name: SARS-COV-2; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

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

Symptoms: when I had my shots I was sick 3days both times; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (when I had my shots I was sick 3days both times) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (when I had my shots I was sick 3days both times). At the time of the report, ILLNESS (when I had my shots I was sick 3days both times) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. This case was linked to MOD-2021-286336 (Patient Link). Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1800473
Sex: U
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
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 know at least 3 people that got COVID even having the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I know at least 3 people that got COVID even having the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No specified medical history has been reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I know at least 3 people that got COVID even having the vaccine). At the time of the report, COVID-19 (I know at least 3 people that got COVID even having the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1800474
Sex: U
Age:
State: MA

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
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: chest pain; Med Info Agent: Staff The caller reported that saw online reports of chest pain

Other Meds:

Current Illness:

ID: 1800475
Sex: F
Age: 64
State: MS

Vax Date: 01/19/2021
Onset Date: 09/01/2021
Rec V Date: 10/20/2021
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: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A, 042L20A and 015M20A) for COVID-19 vaccination. No Medical History information was reported. On 19-Jan-2021 at 9:32 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021 at 9:16 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. No treatment medication was provided.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am