VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1767199
Sex: F
Age:
State: MI

Vax Date: 08/07/2021
Onset Date: 08/07/2021
Rec V Date: 10/07/2021
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: Hives; itching; This is a spontaneous follow-up report from a contactable consumer or other non hcp. A 74-years-old female patient received bnt162b2, (Formulation: Solution for injection in pre-filled syringe, Batch/lot number: Unknown), dose 1 via an unspecified route of administration on 07Aug2021 (age at vaccination 74) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date, if ongoing She once had a reaction to penicillin and cannot really explain it, states started with itching and then the welts came up and started spreading. The patient's concomitant medications were not reported. On 07Aug2021 Saturday, Caller states she received the Pfizer Covid vaccine and broke out in hives and is supposed to get her second dose on Saturday, today she went to doctor because she was still having hives and itching, doctor thinks there was something in the vaccine she had a reaction to, caller wants to know should she or should she not get that second dose of the vaccine. On 07Aug2021, Caller states she got vaccine, hives appeared that day later about maybe 20 hours later. Caller states she had called to report this 10-15 days ago but no reference number was provided.Caller states she was going to be taking two different medications, doesn't want it to interfere in any way with second dose if she gets it. Going to be taking hydroxyzine and methylprednisolone, wants to know if they potentially interact with the vaccine. Caller confirms she was not yet taking these medications.Caller states she knows it was a reaction because she once had a reaction to penicillin and cannot really explain it, states started with itching and then the welts came up and started spreading. No further details provided. The Outcome of the event hives was not recovered, outcome for itching was not recovered.

Other Meds:

Current Illness:

ID: 1767200
Sex: F
Age:
State: AL

Vax Date:
Onset Date: 04/26/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Date: 20210820; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: After my 2nd dose of Covid Vaccine, I have experienced weekly flare ups of my fibromyalgia. It had been over 10 years since I had experienced any symptoms.; This is a spontaneous report from a contactable consumer (patient) and other HCP. A 57-year-old non pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported) dose 2 via an unspecified route of administration on an unspecified date (at the age of 57-year-old) as dose 2, single for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. The facility in which the vaccination was administered was other. Medical history included fibromyalgia (It had been over 10 years since I had experienced any symptoms), intervertebral disc degeneration. Patient had known allergies. Historical vaccine includes bnt162b2 (Lot number: EP7534) dose 1 via an unspecified route of administration, administered in the left arm on 01Apr2021 (at the age of 57-years-old) as dose 1, single for COVID-19 immunisation. No other vaccines were given within 4 weeks. Patient administered other medications in 2 weeks. Concomitant medication was not reported. Post vaccination, the patient was tested positive for COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 26Apr2021 the patient experienced after my 2nd dose of covid vaccine, I have experienced weekly flare ups of my fibromyalgia, it had been over 10 years since I had experienced any symptoms. No treatment was given for the events. The patient underwent lab tests and procedures which included sars-cov-2 test resulted negative on 20Aug2021. The clinical outcome of the event was reported as not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1767201
Sex: F
Age:
State: PA

Vax Date: 06/01/2021
Onset Date:
Rec V Date: 10/07/2021
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: broke out with psoriasis really bad/ had a little bit of psoriasis on the back of her neck; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient's husband). A 36-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Expiry date was not reported), via an unspecified route of administration, administered in left arm, on an unspecified date sometime in Jun2021 10:00 (at the age of 36-year-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Expiry date was not reported), via an unspecified route of administration, administered anatomical location was not reported, on an unspecified date at the end of May2021 (at the age of 36-year-old) as dose 1, single for COVID-19 immunization. The patient does not receive additional vaccines administered on same date of the Pfizer suspect. The patient visited Physician office (dermatologist) because of adverse event. The patient does not receive any vaccination aside from COVID-19 vaccine within 4 weeks. The patient never had any issues with any type of vaccine. The patient received Pfizer COVID-19 vaccine for travel purpose. On unspecified date in 2021, the patient was broke out really bad with psoriasis and is covered with it now. The patient went to the dermatologist and the dermatologist asked her if she got the vaccine. The dermatologist told her that because she had a little bit of psoriasis on the back of her neck, the vaccine is the reason that she is now covered with psoriasis. The reporter does not have her vaccination card to provide dates of doses, lot numbers, expiration date or NDC. Two weeks after her second dose she noticed the psoriasis starting to spread. It is getting a lot worse. The patient had been to the doctor and was given one type of pill and it does not work and then she was switched to another pill and that did not work either, the psoriasis is getting worse. The reporter does not have the names of the pills she took that did not work. The outcome of the event was not recovered. No follow up attempts are needed, information about batch/lot number cannot be obtained.

Other Meds:

Current Illness:

ID: 1767202
Sex: M
Age:
State: FL

Vax Date: 08/23/2021
Onset Date: 08/24/2021
Rec V Date: 10/07/2021
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: her husband is really sick; He has been nauseous; really tired; sleeping a whole lot; Shaking; had a headache; Left arm is really sore; Cold sweat; This is a spontaneous report from a contactable consumer (patient's wife) reporting for a 59-year-old male patient (reporter's husband). A 59-year-old male patient received bnt162b2 (PFIZER BIONETCH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via intramuscularly in arm left on 23Aug2021 14:00 as dose 1, single (age at vaccination: 59 years) for COVID-19 immunisation. Medical history included pain, anxiety disorder, neuropathy, all from an unknown date and unknown if ongoing. Concomitant medications included alprazolam (XANAX) 4 mg, daily taken for anxiety disorder Started taking 10 years ago, start and stop date were not reported; gabapentin (NEURONTIN) either 350mg or 400 mg three times daily started 8 years ago, taken for neuropathy, start and stop date were not reported; buprenorphine hydrochloride (SUBUTEX) taken for pain 8mg 3 times sublingual daily started taking it 18 years ago, start and stop date were not reported. Prior Vaccinations (within 4 weeks), other vaccinations within four weeks prior to the first administration date of the suspect vaccines was none. The adverse events following prior vaccinations was none. Additional vaccines administered on same date of the Pfizer suspect was none. On 24Aug2021, the patient experienced cold sweat, sleeping a whole lot, Shaking and had a headache, left arm is really sore. It was reported by the reported that her husband is really sick. She feels like someone is squeezing her throat and it hurts really bad and had a hard time swallowing and is sick. Her throat hurts so bad and feels like it is closing. He is sick from the shot too. He had cold sweats and has been sleeping a whole lot. He has been nauseous. He was shaking and had a headache. He tried to work yesterday and the boss sent him home because he was in a daze and really out of it and really tired. It all started on 24Aug2021, she does not know outcome because he is still sleeping, she would like to know if this is a normal reaction. Both received it at the same time and place, he got his after hers, they were not even going to get it and dont know about getting second one. The adverse events did not require a visit to emergency room/physician office. Treatment was received. The pharmacist told him to take Tylenol and if it is not better by the end of the day, he wants her to report back to the pharmacist. The clinical 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: XANAX; NEURONTIN; SUBUTEX

Current Illness:

ID: 1767203
Sex: F
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
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: chest pain; numbness; tingling down her arm; shortness of breath; This is a spontaneous report from Pfizer sponsored program Support. A contactable consumer (daughter) reported for a female patient (mother). A female patient of an unspecified age received bnt162b2 (bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EW0153), dose 1 via an unspecified route of administration on 2020 as DOSE 1, SINGLE for covid-19 immunisation . The patient medical history included allergies to 20 medications. Concomitant medication(s) included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. On an unknown date, she has a caller on the line who had a medical concern about the Pfizer COVID vaccine and mentioned her mother took the Pfizer COVID Vaccine last year and ended up in the emergency room with numbness and chest pain; caller states that for herself she has not had the Pfizer COVID vaccine but has had some allergic reactions to numerous medications and wanted to speak. Caller verified the information provided by the transferring agent and states for her mother, she has no idea if it was previously reported but she was two hours away from her mother and the patient called the caller at that time and was pretty sure the patient got the Pfizer shot and her stepdad also got the Pfizer covid vaccine and knows they both got both doses of the vaccine; states the patient ended up in the emergency room due to chest pain and numbness and tingling down her arm and shortness of breath which is what happened to her and with her mother's health allergy history she got some of the more severe side effects and symptoms but it was not necessarily a full on allergic reaction and they gave the patient Benadryl and watched her for four hours and did tests which came back fine and with the 2nd dose of the vaccine told the patient to contact her HCP and take Benadryl as soon as she was done with the 2nd dose as this could happen again with the 2nd dose. Caller states she has several questions and concerns about herself and talked to her own doctor and has not yet gotten vaccinated but with her health and autoimmune and allergies to 20 medications and that has caused serious allergic reactions and she was at a cross roads and was definitely afraid of catching covid because she does not have an immune system to fight it and asked if it was going to be safe for her to get the Pfizer covid vaccine. States her blood doctor and heart doctor suggested she call to speak with her primary care doctor and then speak to her hospital and insurance company to see if she can do a 23 hour admission for observation; states she has tried to go to the list of ingredients but has medications that she is allergic to and had a reaction to in the last 2 years and should not have had a reaction to the medications ingredients but she still is allergic. States with her mom she would rather either call back or call DSU with her mother on a three way call regarding a report or will give her mother the number to call as she does not have the information right now. but she still is allergic. The outcome of the all events was an unknown , Information on the lot/ batch number has been requested.

Other Meds: BENADRYL

Current Illness:

ID: 1767204
Sex: U
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
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: This is a spontaneous report from a contactable consumer (patient). A patient, of unspecified age and gender, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient received the first of the two COVID-19 vaccines and had an immediate allergic reaction. The patient mentioned a recommendation of not getting a second dose of this vaccine. The patient queried about level of protection would that they'd have long-term after just receiving one dose of this vaccine. Patient asked where would they be able to obtain samples of the ingredients in the vaccine to tell what exactly they are allergic to. The patient went to the allergist. He was at a loss for where to obtain the ingredients. The outcome of event: unknown. The lot number for the vaccine, (BNT162B2), not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1767205
Sex: F
Age:
State: VA

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
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: This is a spontaneous report from a contactable consumer. A female patient, of unspecified age, received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# and expiry date: unknown), via unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. Historical vaccine included the first dose of BNT162B2, via unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. Patient's medical history and concomitant medications not reported. Patient was going through a horrible experience since she her second dose of the Pfizer vaccine. She has seen more than 8 doctors so far. Her whole body was full of red dots that were extremely itchy. She gained over 40 pounds on prednisone. She was overly depressed. She tried all sorts of allergy medication. They even gave her ivermectin; she had no more itch for the first 9 days; then the effects came back. Taking all sort of medications was ruining her kidneys. She doesn't sleep and her mood was extremely bad. She was also getting very anxious and thus definitely affecting her daily life. The outcome of "her whole body is full of red dots that are extremely itchy:" not recovered; the rest: unknown. Follow-up attempts completed. Batch/lot number not available for BNT162B2. No further information expected.

Other Meds:

Current Illness:

ID: 1767206
Sex: F
Age:
State: NJ

Vax Date: 08/19/2021
Onset Date:
Rec V Date: 10/07/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: This is a spontaneous report from a contactable consumer (patient). A female patient, of an unspecified age, received the 1st dose of BNTBNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# and expiration date not reported), via an unspecified route of administration, on Aug 19, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient experienced dizziness on an unspecified date. Patient wanted to know more about the side effects of the Pfizer COVID-19 vaccine. Her second dose is scheduled on Sep 9, 2021. The outcome of the events: unknown. The lot number for the vaccine, (BNT162B2), not provided and will be requested during follow-up. No follow-up attempts needed. Information about lot/batch number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 1767207
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: This is a spontaneous report from a contactable consumer. A patient, of unspecified age and gender, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, on an unspecified date (Saturday), single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. On an unspecified date (Tuesday and on that day), patient broke-out in rashes on legs, thighs, buttocks and on arm; with outcome of unknown. Information on the lot/batch number requested.

Other Meds:

Current Illness:

ID: 1767208
Sex: M
Age:
State: PA

Vax Date: 07/23/2021
Onset Date: 07/23/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Name: Blood work; Result Unstructured Data: Test Result: Elevated calcium and HB; Comments: All are normal except for elevated calcium and hemoglobin conducive with dehydration; Test Name: Heart Beat; Result Unstructured Data: Test Result: Rapid; Test Date: 20210726; Test Name: Binax; Test Result: Negative; Comments: Nasal Swab.

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Extreme fatigue; Extreme thirst; Anxiety; Insomnia; Rapid heartbeat; heart palpitations; This is a spontaneous report from a contactable Consumer or other non-HCP (Patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: not reported) via an unspecified route of administration, administered on Left arm on 23Jul2021 11:00 (at the age of 46-year-old) as dose 1, single for COVID-19 immunization. The patient medical history not reported and concomitant medications (in two weeks) were none. Patient has no Known allergies. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Post vaccination, the patient has been tested for COVID-19. It was reported that on 23Jul2021 11:00 patient experienced Extreme fatigue, Extreme thirst, Anxiety, Insomnia, Rapid heartbeat and heart palpitations. The clinical course reported as follows, the patient stated that, this has been going on for nearly five weeks. The patient had two trips to the doctor's office for bloodwork. All were normal except for elevated calcium and hemoglobin conducive with dehydration. His doctor was unconcerned. A second doctor who I followed up with recommended a cardiologist. He was previously healthy. Patient underwent lab test and procedures which included on an unspecified date blood work- All are normal except for elevated calcium and haemoglobin conducive with dehydration and Heart Beat rapid whereas on 26Jul2021 Binax Nasal Swab-negative. Patient did not receive any treatment for the event. Outcome of the events was not recovered. 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:

Current Illness:

ID: 1767209
Sex: F
Age:
State: GA

Vax Date: 08/05/2021
Onset Date: 08/07/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Date: 20210818; Test Name: Binax; Result Unstructured Data: Test Result:Negative; Comments: Nasal Swab

Allergies:

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

Symptoms: Left arm is still sore primarily when I am lifting weights; This is a spontaneous report from a contactable consumer or other non hcp (Patient herself). A 51-years-old female (Non pregnant) patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection), via an unspecified route of administration, administered in Arm Left (Age at the time of vaccination 51-year-old) on 05Aug2021, at 17:30 as dose 1, single for covid-19 immunization. The patient did not receive other vaccine in four weeks. The patient medical history was not reported. Concomitant medications included in two weeks as vitamin d3 (VITAMIN D3), angelica sinensis, cimicifuga racemosa, hesperidin, oryzanol, vitex agnus-castus (MENOSENSE), turmeric [curcuma longa rhizome] (TURMERIC [CURCUMA LONGA RHIZOME]), diloxanide furoate, metronidazole (DIMET-PLUS) and ascorbic acid (VIT C). On 07Aug2021 at 09:45, in timeframe between vaccination and starting of symptoms was 2 days 9 hrs 45 min, the patient experienced left arm is still sore primarily when she lifting weights. The patient underwent lab tests and procedures which included Binax (Nasal Swab) test was negative on 18Aug2021. The patient not had covid prior vaccination; tested for covid post vaccination. The patient did not receive any treatment for AE. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: VITAMIN D3; MENOSENSE; TURMERIC [CURCUMA LONGA RHIZOME]; DIMET-PLUS; VIT C

Current Illness:

ID: 1767210
Sex: M
Age:
State: CA

Vax Date: 08/01/2021
Onset Date:
Rec V Date: 10/07/2021
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: EKG; Result Unstructured Data: Test Result:Abnormal; Comments: absolute lymphocytes were elevated. He says his Urea Nitrogen was elevated, his AST was elevated and his ALT was elevated

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Head was hot, like really hot; Dizzy; Rash; This is a spontaneous report from a Pfizer-sponsored program. This is a spontaneous report from a contactable consumer or other non hcp. A 52-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot Number: FA6780), dose 1 via an unspecified route of administration on 01Aug2021(at the age of 52-years) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included COVID-19 and concomitant medications were not reported. He says that he went through a lot of symptoms on his first dose. He also had COVID previously but with the COVID vaccine he has seen that it can cause symptoms and severe cardiac issues but he didn't know that he would get it because it said that young people were getting them and he doesn't consider himself young. Most of his coworkers got it and they did well on it. He can't get the 2nd dose of Pfizer, he thinks. He works for (Company name withheld) and they are making it impossible to not get the COVID vaccines especially since he has had COVID before and the COVID vaccine wasn't tested on those who recovered from COVID. He says that he can email his other symptoms to Pfizer if needed. He is not asking for an exemption, he just wants an extension of time to see if he can switch from Pfizer to the J&J COVID vaccine because they have no reported side effects such as this. It is unknown to him if he can tolerate the 2nd dose of the Pfizer COVID vaccine. He says that he has had a cardiac workup and he is seeing his cardiologist again on 09Sep2021 and he has until the 30th (unspecified month) to get the 2nd dose. He has worked for his company for 16 years and he is not against the COVID vaccine but he had a bad episode with it that wasn't supposed to happen on the first dose according to his research and from what he has seen people talking about on the news. Again, is there anyway that he can email his symptoms to Pfizer so that they can review and tell him what he should do? He works in the medical field as a coder and he looks for adverse events, that is his training and he had thorough training. He did research on this but it was after the fact unfortunately. He continues and says that his head was hot that night and his heart was 124 beats per minute and his blood pressure was dropping between 120 to 140 over 60. His oxygen level was 92 to 98 and he was trying to treat himself as if he had COVID again so he trying to be active to move his lymphatic system but he couldn't walk which was making it worse so he laid back down. He had reached out to the urgent health who said that there was a 2 hour wait time. He still felt dizzy and he called the nurse back at his primary care doctor's office who said to go to urgent care. Then his heartrate was 90 to 138 and his pulse rate was 100. He took a shower just in case he was admitted, and when they were driving there he had felt a lot of pressure in his heart, it was nothing substantial like the night before though. They had a long wait time again so he had decided to wait to see if his symptoms escalated throughout the night. He says it is weird that his symptoms started at night time. Then all throughout the day he was starting to have a stiff neck and a headache. Also he has chronic pain and he has Toradol so he took that but he didn't want to treat himself because he is not a medical doctor and the Toradol did alleviate the pressure in his heart from an 8 to 9 down to a 5 to 6. The nurse called him back the next morning because the doctor wanted him to get a cardiac workup and she had the results and wanted to let the caller know. He says again that he gave himself the Toradol shot the night before this. But he was told that his troponin levels were within normal range and that the only thing that was off were his Urea Nitrogen, his ALT and his ALS. Attempt was made to control caller and clarify his previously stated blood pressure was dropping between 120 to 140 over 60. He says that he checked his pulse and his blood pressure that were 147 and then it had dropped to 60 but he checked his pulse because he has an oxygen sensor so he was monitoring his oxygen saturations because he wanted to check his pulse of 124. He said his head was hot, like really hot. He was talking to a coworker who said that they had the same thing happen to them but it was with the second dose. Unable to obtain further details. His wife put cold compressions on him and then he had fallen asleep that night. He did call urgent care because he was unsure if he needed to go in or what their protocol was but they said it was a 2 hour wait so he said that he would stay at home. The next day he was dizzy and clammy and he needed to call the doctor so he messaged the doctor who said that he needed to go to urgent care so he took a shower that day and was then feeling better but his pulse was still 90 to 138 but it was not as substantial. And that's when his symptoms started, the night before. As he progressed through the day he started having stiff neck and a headache so he gave himself a Toradol shot which helped with his chest pressure and he had a minor compression type pain and his pain then dropped to a 5 to 6. The nurse called the next morning because the doctor wanted to do a cardiac workup and he said that he wanted to wait until his symptoms got worse. He went in the next day and had an EKG that was abnormal, his Troponins were within normal limits and the only thing that was off was his absolute lymphocytes were elevated. He says his Urea Nitrogen was elevated, his AST was elevated and his ALT was elevated. He did research on his ALT and the AST and he found that if one is higher than the other then his kidneys and liver were working hard to flush his system. It is weird but he recovered okay but his heart felt like it had went though hell after a few days. He went in Thursday for a work up and he didn't feel like himself until Monday, he had 2 to 10 days of not feeling like himself. On Tuesday he was taking cases with people he works with. He then on 08Aug2021 to 10Aug2021 he had a headache and was not feeling 100% so that night he did give himself another Kenalog shot. Like he already said he has chronic pain with headaches and TMJ. The Kenalog helps with the pain. Then on Friday, 13Aug2021, he didn't feel 100% and when he woke up his wife he had a blood pressure of 154/85 (documented as provided by caller) with a pulse of 82. He had then noticed his heartrate and then his pulse jumped up to 100. His coworker was asking him how he felt and he said not too bad but he felt like his heart had went through hell. He said he was checking his heartrate and it was 107 just from walking to the printer that is maybe 20 feet away from him. He noticed it has been elevated every morning anytime he did any activity. He hasn't been walking or anything like he normally does. But then back on Friday, 13Aug2021, when he woke up he had the weird chest pain again, it was a burning pain and it felt like the top of his heart was burning so he got the blood pressure machine and his wife said that it was 154/85 with a pulse of 82 and that is with the chest pain. Last week he was researching things and he said that he needed a treatment plan with a systolic that high, but everything had come back normal except his nitro's were at 24 this time which they are saying that is part of dehydration, the urea nitrogen. Then his AST stabilized which is good compared to the week before. His EKG was normal and then the only thing that he still was having is the issues with his heart. He has a cardiac follow up on 09Sep2021 and an EKG on 16Sep2021. He wanted to know what Pfizer has for symptoms, like do they still recommend the 2nd dose. He adds that his resting pulse this morning was 72. He has a smartwatch that has an EKG built in. Again, he was going to go to the urgent care but they had a 2 hour wait and his wife helped to monitor him through the night until he fell asleep, but he did sleep sitting up because he didn't want his heart to be overworked. But like he said the next morning he felt clammy

Other Meds:

Current Illness:

ID: 1767211
Sex: F
Age:
State: FL

Vax Date: 04/08/2021
Onset Date: 04/01/2021
Rec V Date: 10/07/2021
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: 2021; Test Name: Test; Test Result: Negative; Comments: Every week.

Allergies:

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

Symptoms: pains/pains all through her body; stiffness; disoriented; really sick; her shoulder still hurt; her shoulder still hurt and also her legs; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), intramuscular, administered in right arm on 08Apr2021 13:30 (Batch/Lot Number: EW0151) at the age of 75 years old as dose 1, single for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications (reported as other products: no). The patient received the first dose of the Pfizer COVID vaccine on 08Apr2021. The following morning (09Apr2021), she began experiencing pains and stiffness that has not yet improved. She spoke with her doctor and her doctor recommended that she not get her second dose until she was feeling better. The patient was fearful to get the second dose for fear it could "leave her debilitated." (as reported). Her employer was requiring her to get the second dose of the vaccine. She got her doctor to write a medical release note for her employer, but her employer rejected it, stating "these are normal side effects." She asked for advice. She added that she woke up the next morning (09Apr2021) having pains all through her body "disoriented", and a stiffness. This has not stopped since then (since 09Apr2021), now it is across her shoulders, moves throughout the body, "almost like there is a board" (as reported). She has been taking pain killers to treat it. She was afraid if she takes the second one it will leave her debilitated. She spoke to her doctor about this, and she didn't know what to do. They told her to stay on Vitamin D and magnesium. She wanted to know what to do about the second vaccine and what to tell her job that was requiring her to be fully vaccinated. The patient was really sick. The pain continued for 5 months, some stopped but her shoulder still hurt and also her legs. The patient received the second vaccine on 08Sep2021 still having pain with upset stomach. The patient had relevant tests every week (unspecified) in 2021 with result of negative. The adverse events (unspecified) were reported as serious and disabling. The patient took pain meds for the events. Outcome of disoriented was unknown, while outcome of the remaining events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1767212
Sex: F
Age:
State: TX

Vax Date: 08/28/2021
Onset Date: 08/28/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer (the patient). A 27-year-old female patient (non-pregnant) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), at the vaccination age of 27, via an unspecified route of administration, left arm, on Aug 28, 2021, at 11:45, single dose, for COVID-19 immunisation. Medical history reported as none. The patient did not have any known allergies. There were no concomitant medications. The patient had swollen eyelids and red eyes about 8 hours post injection on Aug 28, 2021, at 20:15. The patient did not take other medications in two weeks. No other vaccines were taken in four weeks. No therapeutic measures taken in response to the events. The patient did not have COVID-19 prior to the vaccination. The patient did not get COVID-19 tested post vaccination. The outcome of the events: not recovered. The lot number for the vaccine (BNT162B2), not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1767213
Sex: M
Age:
State: IL

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

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

Lab Data:

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer or other non-HCP (patient's wife), for a male patient (reporter's husband). A male patient, of an unspecified age, received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. Medical history included neuropathy from diabetes. Concomitant medications not reported. Additional Context: The report is cross referenced to report ID: 2T5JQW1M. Caller also called to report adverse reaction for herself with COVID-19 vaccine. Reporter consented to do a report for her husband. This report is for her husband. Reporter's husband was just tired after it. He also got Pfizer COVID-19 vaccine. He is always tired. He is in a walker because he fell when he was in a hurry to get to the bathroom (not related to the vaccine). He has neuropathy from diabetes. His feet are messed up. He cannot walk without the walker. Reporter stated he was sleeping, and he sleeps a lot. The outcome of the events: unknown. The lot number for the vaccine, (BNT162B2), not provided and will be requested during follow-up. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1767214
Sex: F
Age:
State: GA

Vax Date: 08/18/2021
Onset Date: 08/19/2021
Rec V Date: 10/07/2021
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: Palms and soles of feet itch, no rash, blister, or blemishes on hands or feet; This is a spontaneous report from a contactable consumer. This 34-year-old female consumer (patient) reported. A 34-years-old non-pregnant female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FD8448), via an unspecified route of administration, administered in Right arm on 18Aug2021 08:30 (34-years-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient medical history included Environmental allergies, PCOS (polycystic ovaries), Von Wille brands from an unknown date and unknown if ongoing. The patient's concomitant medications in two weeks included Multivitamin. The patient had not taken other vaccine in four weeks. The patient had not been tested for covid prior vaccination. The patient had not been tested for covid post vaccination. On 19Aug2021 at 12 pm, the patient experienced palms and soles of feet itch, no rash, blister, or blemishes on hands or feet. The patient not received any treatment. The outcome of event was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1767215
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: receiving her Covid-19 vaccine and is unfortunately having a flare from that; This is a spontaneous report from a contactable other health professional. A 21-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported), 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 and medications were not reported. Previously, the patient took XELJANZ XR (tab 11mg) and had no adverse events; and took HUMIRA and had side effects that had gone away. Reportedly, the reporter spoke with patient's mother, and it was reported that the patient reported no adverse events from XELJANZ, and she reported that her HUMIRA side effects had gone away. The patient had received her Covid-19 vaccine and was unfortunately having a flare from that on an unspecified date. The outcome of event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1767216
Sex: U
Age:
State: FL

Vax Date: 02/15/2021
Onset Date: 02/01/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Name: MRA; Result Unstructured Data: Test Result:Unspecified; Test Name: TMJ CT scan; Result Unstructured Data: Test Result:Unspecified; Test Name: MRI of neck and spine; Result Unstructured Data: Test Result:Unspecified; Test Name: MRV of Brain; Result Unstructured Data: Test Result:Unspecified; Test Date: 202101; Test Name: Covid-19; Result Unstructured Data: Test Result:Had covid; Comments: Hospitalized from 18Jan2021 to 23Jan2021. Received Remdesivir injections for 5 days, was discharged.

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Flu like symptoms that last for 3 days; headache; I wake with what feels like a hangover and typically it gets worse from there; Tension level headache; Patient could only imagine is what a migraine may feel like; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKOWN) via an unspecified route of administration on 15Feb2021 as dose 1, single for COVID-19 immunization. Patient medical history included COVID-19 in Jan2021, was hospitalized from 18Jan2021 to 23Jan2021. Received the Remdesivir injections for 5 days and was discharged on an unspecified date in Jan2021. On 15Feb2021, patient received the first of 2 Pfizer covid-19 injections (the second on 10Mar2021). The next day, 16Feb2021 developed flu like symptoms that lasted 3 days. At the end of the 3 days most symptoms had gone away but still had daily reoccurring headaches on an unspecified date in Feb2021. It was now 6 months later and still had daily headaches. Many days the headache was almost debilitating. At best wake with what felt like a hangover and typically it got worse from there on an unspecified date in Feb2021. At best many of the hours in a day it felt like a bad hangover, progressing to what may be a tension level headache and maybe finishing with what patient could only imagine is what a migraine may feel like on an unspecified date in 2021. The treatment medications included Nortriptyline at bedtime, Nurtec, Zipsor, Ubrelvy and Ajovy injections. Zipsor when Nurtec or Ubrelvy did not help. Patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKOWN) via an unspecified route of administration on 10Mar2021 as dose 2, single for COVID-19 immunization. Patient had an MRI, MRA and MRV of the brain with results as unspecified. Had MRI of the neck and spine with result as unspecified. A TMJ CT scan with result as unspecified and COVID-19 on an unspecified date in Jan2021. Seeing a neurologist but to date still had issues and did not see any light at the end of a very dark tunnel. The outcome of the events headache and feeling abnormal was not recovered, of the events tension headache and migraine was unknown, while of the event flu like symptoms was resolved on 19Feb2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Information about lot/batch number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 1767217
Sex: F
Age:
State: FL

Vax Date: 08/25/2021
Onset Date: 08/27/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Date: 20210827; Test Name: fever; Result Unstructured Data: Test Result:99.5

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Itchy; rash like hives on face, eyes, arms, back, legs, mouth; Stuffy nose; 99.5 fever; rash like hives on face, eyes, arms, back, legs, mouth; This is a spontaneous report from a contactable Consumer. A 14-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 25Aug2021 15:00 (age at vaccination 14-years-old) as dose 2, single for covid-19 immunisation. Medical history included ADHD from an unknown date and unknown if ongoing. Concomitant medication included methylphenidate hydrochloride (CONCERTA) in two weeks. The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 04Aug2021 12:00 (age at vaccination 14-years-old) as dose 1, single for covid-19 immunisation. Patient was not taken any other vaccine in four weeks. On 27Aug2021 17:00, patient experienced Itchy, rash like hives on face, eyes, arms, back, legs, mouth. Stuffy nose, 99.5 fever. Ae resulted in physician office visit. Treatment received with Benadryl, Prednisone RX. Patient has stated that she had not been diagnosed with COVID -19 prior to vaccination and not been tested since the vaccination. Outcome of the events was recovering. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: CONCERTA

Current Illness:

ID: 1767218
Sex: M
Age:
State: CA

Vax Date: 08/23/2021
Onset Date: 08/23/2021
Rec V Date: 10/07/2021
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: dull ache; had a rash 30 minutes into the infusion; got booster dose; got booster dose; This is spontaneous report from Pfizer. A contactable 78-year-old male consumer (patient) reported. A 78-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FC3183), via an unspecified route of administration in right arm on 23Aug2021 (at the age of 78-year-old) as dose 3, single for COVID-19 immunisation at pharmacy. Medical history included bronchial Asthma (the patient taking Privigen) and bronciectasis (the patient taking Privigen). Concomitant medications included immunoglobulin human normal (PRIVIGEN) taken for asthma, bronchiectasis from an unknown date in Jan2019 to an unspecified stop date; atorvastatin calcium (LIPITOR) taken for respiratory therapy, start and stop date were not reported (been on it 10 to 15 years). The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EG9261), via an unspecified route of administration in right arm on 25Jan2021 (at the age of 78-year-old) as dose 1, single for COVID-19 immunisation and experienced pain, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9809), via an unspecified route of administration in right arm on 17Feb2021 (at the age of 78-year-old) as dose 2, single for COVID-19 immunisation and experienced pain, He took a statins for respiratory therapy (There are no other medications would be relevant. No further details provided), He had been taking the IVIG for 2 years and had no problem. He asked if there was a certain timeframe recommended to wait between having the booster vaccine dose and getting an infusion of Privigen immunoglobulin. He reported that for over 2 years he had been getting Immunoglobulin infusions (10% Privigen, dose of 30 grams) a 4-hour infusion, every 28 days. 1 week ago, for antibodies for increasing your level of immune therapy, he received the Covid vaccine booster dose. He reported that during his last infusion, which he received 1 week after the booster dose, he experienced a reaction, stating, "when we get our blood tested my immunoglobulin is usually up and that's good, but this time for the first time I had a rash 30 minutes into the infusion" and reported that the doctor had to stop the infusion early and told him that "we may be taking it too soon after getting the booster" and said "we should wait around 30 days and try again. He reported that he never had a reaction from the immunoglobulin and the only variable patient checked was getting the booster, the patient even checked that the bag they were infusing into my arm was the correct thing. He reported that now, he was perfectly fine "today" and plans to go back for another infusion 30 days from that Monday. He reported that he heard from his doctor and nurse that infusion patients or cancer patients should have a time lag between the shot and their next infusion or treatment. He reported that his doctor and nurse were not aware of any timeframe required in between the two products. Now calling to obtain more information. He then asked, "Who is the manufacturer of Privigen?" He reported that he received an infusion and took a picture of the product label but was not printed on there for him to know who the manufacturer was and if the booster dose was the same as both previous doses. He stated that even before they started the nurse said that she thought there was a time lag in between shot or booster or anything. When he had the first two in January and February there was a time that he went in for his IVIG and he had no reaction. It never even came up. It was not discussed, but for some reason the nurse said that before the procedure. The only new variable was the booster. As he understood, it was the same as the first two shots he had in January and February. He did not have a clue. Maybe it did not. He felt fine before the IVIG and felt fine now, and he had recovered nicely. The reaction occurred at the hospital in "PRIVACY". Rash was occurred on 30Aug2021 at 11:00. Once they stopped the treatment the rash was gone within 12 hours. Caller clarified that he would not define it as a rash. It was reddening of skin on face and chest. He has recovered 100 percent. It was 10% Privigen. Immunoglobuin was on the label. It says route for IV (intravenous). Dose was 30gram. It was prepared that morning when he showed up. He took a picture when they hung it to put it in the arm. The picture was what he was reading to provide product information. He did not see NDC, lot, and expiry on the picture he has. He started on an unknown date in Jan2019. He skipped the dose on the 30Aug2021 and will go 28 days out into September and he will go in a repeat the treatment. At that point they will see what the reaction was. The first two were given at the "PRIVACY". The third one was done at the "PRIVACY". No test was done. He waited 24 hours and it went away. It went away after stopping IVIG. The doctor and the nurses brought up the fact there may be a time lag that should occur from the time someone gets Moderna, Pfizer, or anything before doing this kind of thing including cancer treatments at infusion center. There was no prescribed time lag from when a person gets any of the shots until the next treatment. That was the unknown. He did not know if Moderna or Pfizer should came up with something to say wait such and such amount of time. After he had the next treatment, he will be happy the next day or whenever to call back and report any reaction or any difference going forward. He has been taking the IVIG (immunoglobulin) for 2 years and had no problem. The only variable was the booster shot. All three shots were given in right upper portion of arm. Over 24-hour period he had dull ache and it went away. That happened for all three shots. He needs to have his flu shot. Does Pfizer recommend waiting a certain period of time between the booster and the flu or shingles shot? The pharmacist and doctor asked to wait to one week. He knew that Pfizer was close to this because there are three or four other variants that will show up. This virus was not going away. We were going to be doing distancing and boosters forever. We would have to work as a team. The outcome of dull ache and had a rash 30 minutes into the infusion was reported as resolved on an unknown date. Follow-up (09Sep2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported in response to HCP telephonic follow-up activity that included: physician's mailing address added. Follow-Up (17 Sep2021): Follow-up attempts are completed. No further information is expected.

Other Meds: PRIVIGEN; LIPITOR

Current Illness:

ID: 1767274
Sex: F
Age: 64
State: FL

Vax Date: 12/30/2020
Onset Date: 01/26/2021
Rec V Date: 10/07/2021
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: felt so good that she has never been more energetic in her life; she felt like she was coming down with the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (she felt like she was coming down with the flu) and THERAPEUTIC RESPONSE UNEXPECTED (felt so good that she has never been more energetic in her life) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (she felt like she was coming down with the flu). On 27-Jan-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (felt so good that she has never been more energetic in her life). On 27-Jan-2021, INFLUENZA LIKE ILLNESS (she felt like she was coming down with the flu) had resolved. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (felt so good that she has never been more energetic in her life) outcome was unknown. No concomitant medication information were provided. No treatment information were provided. This case was linked to MOD-2021-335962, MOD-2021-335982 (Patient Link).

Other Meds:

Current Illness:

ID: 1767275
Sex: U
Age:
State: FL

Vax Date: 08/24/2021
Onset Date:
Rec V Date: 10/07/2021
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: Blood glucose; Result Unstructured Data: Increased blood glucose.

Allergies:

Symptom List: Unevaluable event

Symptoms: This spontaneous case reported by a consumer, describes the occurrence of hyperglycemia (increased blood sugar levels after getting the booster) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Feb 4, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 4, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 24, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced hyperglycemia (increased blood sugar levels after getting the booster). At the time of the report, hyperglycemia (increased blood sugar levels after getting the booster) outcome: unknown. Diagnostic results: On an unknown date, blood glucose: increased (high)/increased blood glucose. No concomitant medication or treatment information provided.

Other Meds:

Current Illness:

ID: 1767276
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 10/07/2021
Hospital: Y

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: 202108; Test Name: Diagnostic ultrasound; Result Unstructured Data: low pulse in the leg

Allergies:

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

Symptoms: SEVERE BLOOD CLOT IN RIGHT FOOT; RED MARK BEHIND THE LEFT CALVE THAT MOVING UP; TERRIBLE PAIN; LOST SO MUCH WEIGHT; LEFT FOOT DOES NOT RESPOND ON TOUCH; PATIENT CANNOT MOVE; CANNOT EAT; NOT RESPONDING; DOES NOT COMMUNICATE; PATIENT SLUMPED, COULD NOT HOLD HEAD, COULD NOT SIT AND LOOKED VERY BAD; FOOT INJURY; WAS NOT BREATHING WELL, BREATHING THROUGH THE MOUTH; This spontaneous report received from a consumer concerned a 91 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: injury, and concurrent conditions included: dementia, and other pre-existing medical conditions included: the patient took Vitamins and Minerals. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 041A21A, and expiry: 19-SEP-2021) dose was not reported, one total administered on right arm on 05-APR-2021 for prophylactic vaccination. Concomitant medications included amlodipine, and sertraline hydrochloride. On APR-2021, after the vaccine for 3 or 4 days straight the patient was not breathing very well, and was breathing through mouth. On AUG-2021, the patient experienced cold dark right foot and doctor instructed the patient to warm up the leg, the patient experienced low pulse in the right leg, right foot did not look right, it was dark and swollen and the patient had never seen that before, black marks at the bottom of the toes, the patient took for examination at the hospital, and the patient had an injury to the foot (even though found no evidence of an injury). The physician told patient that the patient needed an X-Ray, made an ultrasound exam and found that patient had a low pulse in the leg. On 15-AUG-2021, the patient experienced patient slumped, could not hold head, could not sit and looked very bad. The patient was hospitalized on 08-SEP-2021 and experienced blood clot in foot, had an issue with a blood clot that causes the foot to be like that, tried to put a stent in patient's leg but it could not be done (patient had one blood vessel at the back of her knee instead of two) so they recommended amputation above the knee, family declined amputation and brought patient home on 13-SEP-2021 home. Monitored the feet, eventually the whole right foot became black. On an unspecified date the patient experienced no feelings in the right feet, left feet does not respond on touch, cannot move, red mark behind the left calve that moving up, cannot eat, does not communicate, terrible pain, lost so much weight because was not eating. The patient was not taking much but for pain management, caregiver dilutes ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from was not breathing well, breathing through the mouth, had not recovered from red mark behind the left calve that moving up, and the outcome of foot injury, patient slumped, could not hold head, could not sit and looked very bad, does not communicate, terrible pain, lost so much weight, left foot does not respond on touch, severe blood clot in right foot, patient cannot move, cannot eat and not responding was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20211002682-COVID-19 VACCINE AD26.COV2.S-severe blood clot in right foot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds: AMLODIPINE; SERTRALINE HYDROCHLORIDE

Current Illness: Dementia

ID: 1767277
Sex: U
Age:
State: MI

Vax Date:
Onset Date: 10/04/2021
Rec V Date: 10/07/2021
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: EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: 21-SEP-2021) dose was not reported, administered on 04-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-OCT-2021, the patient experienced expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious. This case, from the same reporter is linked to 20211006668, 20211006798, 20211009653 and 20211009632.

Other Meds:

Current Illness:

ID: 1767278
Sex: F
Age:
State: AL

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: PNEUMONIA; TICKLE IN THE BACK OF HER THROAT; This spontaneous report received from a consumer concerned a female of unspecified age of unknown race and ethnicity.. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient had tickle in the back of her throat and according to reporter patient was positive because patient work from home. Patient got hit hard and went to the doctor and had the start of pneumonia and almost ended up in the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pneumonia and tickle in the back of her throat was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211007273.; Sender's Comments: V0;20211007486; -covid-19 vaccine ad26.cov2.s Pneumonia. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness:

ID: 1767279
Sex: M
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 10/07/2021
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: Body temperature; Result Unstructured Data: 103; Test Name: COVID-19 virus test; Result Unstructured Data: positive

Allergies:

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

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer and concerned a male of unspecified age of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient had developed a Covid infection where he had a fever of 103 and extreme fatigue (suspected covid-19 infection and suspected clinical vaccination failure). Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103, and COVID-19 virus test (NR: not provided) positive (still testing positive). It was reported that, patient was feeling much better now. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20211008860-covid-19 vaccine ad26.cov2. s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

Date Died:

ID: 1767280
Sex: F
Age:
State: WA

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

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: BLOOD CLOT; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, frequency one total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced blood clot after receiving vaccine and died from blood clot on an unspecified date. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211009196-COVID-19 VACCINE AD26.COV2.S-Blood clot. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: BLOOD CLOT

Other Meds:

Current Illness:

ID: 1767281
Sex: M
Age:
State: MI

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

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Vaccine exposure via breast milk; This spontaneous case was reported by a physician and describes the occurrence of EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk) in a male neonate of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination. MEDICAL HISTORY (Parent): On 04-JAN-2021, parent had Normal ultrasound, on 06-JAN-2021 Glucose test Normal 107. Previously administered products included for Pregnancy: Prenatal vitamin (Daily via per oral route). Concurrent medical conditions included Exposure during breast feeding. No Medical History information was reported. On an unknown date, the mother received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The mother's last menstrual period was on an unknown date and the estimated date of delivery was 19-Aug-2021. On an unknown date, the neonate was diagnosed with EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk). The mother had a cesarean delivery which occurred on an unknown date, which was reported as Full-term. For neonate 1, with an APGAR score of 7 and 8 at (1, 5 minutes). The outcome was reported as Term Birth NOS. Head circumference 34 cm. At the time of the report, EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary), the reporter did not provide any causality assessments. Concomitant medication list was not provided. Treatment information was not provided. This report concerns a child who experienced the unexpected event of vaccine exposure via breast milk. The event occurred after an unknown duration following the mother's exposure to mRNA-1273 vaccine. The mother has no relevant past medical history. The patient was delivered by full time birth by cesarean section. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This report concerns a child who experienced the unexpected event of vaccine exposure via breast milk. The event occurred after an unknown duration following the mother's exposure to mRNA-1273 vaccine. The mother has no relevant past medical history. The patient was delivered by full time birth by cesarean section. The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds:

Current Illness:

ID: 1767282
Sex: M
Age:
State: FL

Vax Date: 03/08/2021
Onset Date: 08/17/2021
Rec V Date: 10/07/2021
Hospital: Y

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

Lab Data: Test Date: 202108; Test Name: Body temperature; Result Unstructured Data: low-grade fever spiking up to 104F.

Allergies:

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

Symptoms: potential bowel obstruction; gastric distress; low-grade fever spiking up to 104F; This spontaneous case was reported by a consumer and describes the occurrence of INTESTINAL OBSTRUCTION (potential bowel obstruction), GASTRIC DISORDER (gastric distress) and PYREXIA (low-grade fever spiking up to 104F) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 024M20A and 018B21A) for COVID-19 vaccination. Concurrent medical conditions included Crohn's disease (has Crohn's disease and Colitis for 4 years.) and Colitis. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced INTESTINAL OBSTRUCTION (potential bowel obstruction) (seriousness criteria hospitalization and medically significant), GASTRIC DISORDER (gastric distress) (seriousness criterion hospitalization) and PYREXIA (low-grade fever spiking up to 104F) (seriousness criterion hospitalization). The patient was hospitalized on 17-Aug-2021 due to GASTRIC DISORDER, INTESTINAL OBSTRUCTION and PYREXIA. At the time of the report, INTESTINAL OBSTRUCTION (potential bowel obstruction), GASTRIC DISORDER (gastric distress) and PYREXIA (low-grade fever spiking up to 104F) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Body temperature: 104 (High) low-grade fever spiking up to 104F.. No concomitant information was provided. Patient was hospitalized, and went to the ER, had CT Scan for potential bowel obstruction and gastric distress results were unknown. Then patient was discharged along with heavy maintenance medication. Company comment: This case concerns a male of unknown age with relevant medical history of Crohn's disease and colitis who experienced serious unexpected event of intestinal obstruction, gastric disorder and pyrexia one day after the third dose of the Moderna Covid 19 vaccine. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.; Sender's Comments: This case concerns a male of unknown age with relevant medical history of Crohn's disease and colitis who experienced serious unexpected event of intestinal obstruction, gastric disorder and pyrexia one day after the third dose of the Moderna Covid 19 vaccine. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.

Other Meds:

Current Illness: Colitis; Crohn's disease (has Crohn's disease and Colitis for 4 years.)

ID: 1767283
Sex: U
Age:
State: MN

Vax Date: 09/23/2021
Onset Date: 09/23/2021
Rec V Date: 10/07/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Dose administered after use by date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after use by date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after use by date). On 23-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after use by date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medication details were provided. No Treatment medication details were provided. DOSE 1 was administered on 23Sep, 8am and DOSE 2 was administered 24Sep around 1:30pm. On 24 Aug 2021,Vial went from freezer to refrigerator. At 6 am Vial from refrigerator, stored at the appropriate room temperature for 15 minutes before 1st puncture and administered to patient immediately after 1st puncture. Neither vial went through a previous temperature excursion. It was reported that the patient had no adverse events. This case was linked to US-irms-MOD21-147703 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: follow up received with no new information. On 01-Oct-2021: Follow-up information added in I narrative supplement.

Other Meds:

Current Illness:

ID: 1767284
Sex: F
Age: 35
State:

Vax Date: 09/28/2021
Onset Date:
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Name: COVID-19 test; Test Result: Negative ; Result Unstructured Data: Negative

Allergies:

Symptom List: Injection site pain

Symptoms: lost her taste; lost her smell two weeks after; She also got a sinus infection but she gets them every year; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost her taste), ANOSMIA (lost her smell two weeks after) and SINUSITIS (She also got a sinus infection but she gets them every year) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Sinus infection (patient gets them every year). Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for an unknown indication. On 28-Sep-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (lost her taste), ANOSMIA (lost her smell two weeks after) and SINUSITIS (She also got a sinus infection but she gets them every year). At the time of the report, AGEUSIA (lost her taste) and ANOSMIA (lost her smell two weeks after) had not resolved and SINUSITIS (She also got a sinus infection but she gets them every year) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. After the first shot patient lost of taste and smell two weeks after. patient was tested for COVID-19 and it came up negative. patient said people told her she might have gotten tested late though. She did not take any medications for this and still has no taste or smell. She also got a sinus infection but she gets them every year. Patient got the first and second Moderna COVID-19 vaccination at Pharmacy. No treatment was reported by the reporter.

Other Meds: CLARITIN [LORATADINE.]

Current Illness:

ID: 1767285
Sex: F
Age:
State: NY

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

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

Lab Data:

Allergies:

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

Symptoms: 16 year old got the first dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got the first dose of the Moderna vaccine) in a 16-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got the first dose of the Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got the first dose of the Moderna vaccine) outcome was unknown. no concomitant or treatment medications were provided. patient wanted to get the second dose of the vaccine. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1767286
Sex: M
Age: 84
State: PA

Vax Date: 02/13/2021
Onset Date:
Rec V Date: 10/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Slight muscular discomfort; Stomach discomfort / Abdomen discomfort; Stomach pain/ Abdomen pain; This spontaneous case was reported by a physician and describes the occurrence of MUSCLE DISCOMFORT (Slight muscular discomfort), ABDOMINAL DISCOMFORT (Stomach discomfort / Abdomen discomfort) and ABDOMINAL PAIN UPPER (Stomach pain/ Abdomen pain) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0173NA, 038K20A and 040A21A) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised (Went through a series of cancer treatments). On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE DISCOMFORT (Slight muscular discomfort), ABDOMINAL DISCOMFORT (Stomach discomfort / Abdomen discomfort) and ABDOMINAL PAIN UPPER (Stomach pain/ Abdomen pain). At the time of the report, MUSCLE DISCOMFORT (Slight muscular discomfort), ABDOMINAL DISCOMFORT (Stomach discomfort / Abdomen discomfort) and ABDOMINAL PAIN UPPER (Stomach pain/ Abdomen pain) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient is on a number of different medications (name was unspecified). No treatment information was provided. The patient received third dose of vaccine and reports slight muscular discomfort, not severe with stomach and abdomen discomfort and pain. The patient had went through series of cancer treatments and considered as immunocompromised.

Other Meds:

Current Illness: Immunocompromised (Went through a series of cancer treatments.)

ID: 1767287
Sex: U
Age: 74
State: CO

Vax Date: 01/07/2021
Onset Date: 02/01/2021
Rec V Date: 10/07/2021
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: had a reaction to the cat/symptoms started within a couple of days after it was with the cat; trouble breathing; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO ANIMAL (had a reaction to the cat/symptoms started within a couple of days after it was with the cat) and DYSPNOEA (trouble breathing) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 025L20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concurrent medical conditions included Allergic to cats. Concomitant products included METHYLPREDNISOLONE ACETATE (DEPOMEDROL) for Allergy. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced ALLERGY TO ANIMAL (had a reaction to the cat/symptoms started within a couple of days after it was with the cat) and DYSPNOEA (trouble breathing). The patient was treated with OLOPATADINE HYDROCHLORIDE (ALLERCHECK) for Adverse event, at a dose of 1 dosage form and TRIAMCINOLONE ACETONIDE (NASACORT) for Adverse event, at a dose of 1 dosage form. At the time of the report, ALLERGY TO ANIMAL (had a reaction to the cat/symptoms started within a couple of days after it was with the cat) and DYSPNOEA (trouble breathing) outcome was unknown. The Patient stated on June travelled again and took the Depometrol and that time had it one week before and could stay with the cat.The patient said it's doctor told them that possibly travelled before the Deprometrol on Feb 10th acted the patient also stated that the it was a reaction to the cat because it was on lockdown and quarantine with the cat for 5 days This case was linked to MOD-2021-335196 (Patient Link).

Other Meds: DEPOMEDROL

Current Illness: Allergic to cats

ID: 1767288
Sex: F
Age: 68
State: NY

Vax Date: 01/12/2021
Onset Date: 02/01/2021
Rec V Date: 10/07/2021
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: 202102; Test Name: body temperature; Result Unstructured Data: in the morning it is 97; Test Date: 202102; Test Name: body temperature; Result Unstructured Data: high; Test Date: 20210619; Test Name: SARS-COV-2 AB IgG; Test Result: Positive; Result Unstructured Data: Reactive positive for Anti-SARS-COV-2 IgG antibodies; Test Date: 20210908; Test Name: SARS-COV-2 AB IgG; Test Result: Positive; Result Unstructured Data: Reactive positive for Anti-SARS-COV-2 IgG antibodies; Test Date: 20210619; Test Name: COVID SARS test; Test Result: Negative ; Result Unstructured Data: first dry blood spot test Reactive # of 8.52 with <1.41 index.; Test Date: 20210908; Test Name: COVID SARS test; Test Result: Negative ; Result Unstructured Data: dry blood spot test showed a Reactive # of 2.93 with <1.41 index.

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 011L20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 97 (normal) in the morning it is 97 and 100 (High) high. On 19-Jun-2021, SARS-CoV-2 antibody test: positive (Positive) Reactive positive for Anti-SARS-COV-2 IgG antibodies. On 19-Jun-2021, SARS-CoV-2 test: negative (Negative) first dry blood spot test Reactive # of 8.52 with <1.41 index.. On 08-Sep-2021, SARS-CoV-2 antibody test: positive (Positive) Reactive positive for Anti-SARS-COV-2 IgG antibodies. On 08-Sep-2021, SARS-CoV-2 test: negative (Negative) dry blood spot test showed a Reactive # of 2.93 with <1.41 index.. Concomitant medications were not provided. Treatment information was not provided. After the second one patient had a fever, normally in the morning fever is 97. something did not remember how high was when took it but it went to 100?F and stopped taking it after that was perfectly fine. The test results show with the first dry blood spot test Reactive # of 8.52 with <1.41 index on June.19. Patient went for the 2nd antibody test and the dry blood spot test showed a Reactive # of 2.93 with <1.41 index .on Sept.8. This case was linked to MOD-2021-335496 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2021: FU received on 04-OCT-2021. Lab results updated.

Other Meds:

Current Illness:

ID: 1767289
Sex: F
Age:
State:

Vax Date:
Onset Date: 09/21/2021
Rec V Date: 10/07/2021
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: right arm is itching; it has swelling around it/shocked that it was so swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (right arm is itching) and VACCINATION SITE SWELLING (it has swelling around it/shocked that it was so swollen) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced VACCINATION SITE PRURITUS (right arm is itching) and VACCINATION SITE SWELLING (it has swelling around it/shocked that it was so swollen). At the time of the report, VACCINATION SITE PRURITUS (right arm is itching) and VACCINATION SITE SWELLING (it has swelling around it/shocked that it was so swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was mentioned. No treatment medication was mentioned.

Other Meds:

Current Illness:

ID: 1767290
Sex: F
Age: 73
State: FL

Vax Date: 02/11/2021
Onset Date:
Rec V Date: 10/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: swelling at injection site after both vaccines; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling at injection site after both vaccines) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included GABAPENTIN and PARACETAMOL (TYLENOL) for an unknown indication. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling at injection site after both vaccines). At the time of the report, VACCINATION SITE SWELLING (swelling at injection site after both vaccines) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not reported. This case was linked to MOD-2021-067360 (Patient Link).

Other Meds: GABAPENTIN; TYLENOL

Current Illness:

ID: 1767291
Sex: M
Age: 66
State: MT

Vax Date: 09/23/2021
Onset Date: 09/25/2021
Rec V Date: 10/07/2021
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: 20210925; Test Name: Body temperature; Result Unstructured Data: 101/104F fever

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Vomit; Unable to sleep; Waking up soaking wet; Out of his mind; 101/104F fever; Major chills; Body aches; All joints of the body ache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Unable to sleep), NIGHT SWEATS (Waking up soaking wet), FEELING ABNORMAL (Out of his mind), PYREXIA (101/104F fever) and CHILLS (Major chills) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes and Blood pressure abnormal. Concomitant products included MULTIVITAMIN [VITAMINS NOS], CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]), TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), TESTOSTERONE, ASPIRIN [ACETYLSALICYLIC ACID] and CLONAZEPAM for an unknown indication. On 23-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Sep-2021, the patient experienced INSOMNIA (Unable to sleep), NIGHT SWEATS (Waking up soaking wet), FEELING ABNORMAL (Out of his mind), PYREXIA (101/104F fever), CHILLS (Major chills), MYALGIA (Body aches) and ARTHRALGIA (All joints of the body ache). On an unknown date, the patient experienced VOMITING (Vomit). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, INSOMNIA (Unable to sleep), NIGHT SWEATS (Waking up soaking wet), FEELING ABNORMAL (Out of his mind), PYREXIA (101/104F fever), CHILLS (Major chills), MYALGIA (Body aches), ARTHRALGIA (All joints of the body ache) and VOMITING (Vomit) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Sep-2021, Body temperature: high (High) 101/104F fever. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitants also include turmeric, cardecentin and pain medication. No treatment medication was reported.

Other Meds: MULTIVITAMIN [VITAMINS NOS]; B12 [CYANOCOBALAMIN]; FLOMAX [TAMSULOSIN HYDROCHLORIDE]; TESTOSTERONE; ASPIRIN [ACETYLSALICYLIC ACID]; CLONAZEPAM

Current Illness: Blood pressure abnormal; Diabetes

ID: 1767292
Sex: F
Age: 43
State: TX

Vax Date: 09/28/2021
Onset Date:
Rec V Date: 10/07/2021
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: This spontaneous case reported by a consumer, describes the occurrence of sluggishness (felt really sluggish) and fatigue (felt tired) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 060E21A) for COVID-19 immunization. The patient's past medical history included COVID-19. On Sep 28, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced sluggishness (felt really sluggish) and fatigue (felt tired). At the time of the report, sluggishness (felt really sluggish) and fatigue (felt tired) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported. Reportedly, her next dose will be Oct 26, 2021.

Other Meds:

Current Illness:

ID: 1767293
Sex: F
Age: 29
State: MA

Vax Date: 09/20/2021
Onset Date: 09/20/2021
Rec V Date: 10/07/2021
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: started bleeding and has not stopped bleeding; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (started bleeding and has not stopped bleeding) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021, the patient experienced VAGINAL HAEMORRHAGE (started bleeding and has not stopped bleeding). At the time of the report, VAGINAL HAEMORRHAGE (started bleeding and has not stopped bleeding) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1767294
Sex: M
Age:
State:

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 10/07/2021
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: Patient a few months under 18 got the Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient a few months under 18 got the Moderna vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient a few months under 18 got the Moderna vaccine). On 28-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient a few months under 18 got the Moderna vaccine) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported. No treatment information reported.

Other Meds:

Current Illness:

ID: 1767295
Sex: F
Age: 52
State: MD

Vax Date: 08/27/2021
Onset Date:
Rec V Date: 10/07/2021
Hospital:

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

Lab Data: Test Name: Weight; Result Unstructured Data: increased

Allergies:

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

Symptoms: Red; Swollen face; Palpitation; Dizziness; Injection iste hard; Allergic reaction on her legs; injection site is inflamed; Injection site painfull; headaches; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red), SWELLING FACE (Swollen face), PALPITATIONS (Palpitation), DIZZINESS (Dizziness) and VACCINATION SITE INDURATION (Injection iste hard) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. The patient's past medical history included Heart murmur, Skin cancer and Brain cancer metastatic (Brenign brain cancer). Concurrent medical conditions included Depression. Concomitant products included ALPRAZOLAM (XANAX) and ZOLPIDEM for an unknown indication. On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Red), SWELLING FACE (Swollen face), PALPITATIONS (Palpitation), DIZZINESS (Dizziness), VACCINATION SITE INDURATION (Injection iste hard), HYPERSENSITIVITY (Allergic reaction on her legs), VACCINATION SITE INFLAMMATION (injection site is inflamed), VACCINATION SITE PAIN (Injection site painfull), HEADACHE (headaches), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, ERYTHEMA (Red), SWELLING FACE (Swollen face), PALPITATIONS (Palpitation), DIZZINESS (Dizziness), VACCINATION SITE INDURATION (Injection iste hard), HYPERSENSITIVITY (Allergic reaction on her legs), VACCINATION SITE INFLAMMATION (injection site is inflamed), VACCINATION SITE PAIN (Injection site painfull), HEADACHE (headaches), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: increased (High) increased. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was not reported.

Other Meds: XANAX; ZOLPIDEM

Current Illness:

ID: 1767296
Sex: M
Age: 50
State: FL

Vax Date: 08/31/2021
Onset Date: 09/28/2021
Rec V Date: 10/07/2021
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: He is feeling warm right now (today); The area of injection site started getting sore.; On same day after receiving 2nd dose, at night he started with chills.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (He is feeling warm right now (today)), VACCINATION SITE PAIN (The area of injection site started getting sore.) and CHILLS (On same day after receiving 2nd dose, at night he started with chills.) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 011F21A) for COVID-19 vaccination. No Medical History information was reported. On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced VACCINATION SITE PAIN (The area of injection site started getting sore.) and CHILLS (On same day after receiving 2nd dose, at night he started with chills.). On 29-Sep-2021, the patient experienced FEELING HOT (He is feeling warm right now (today)). At the time of the report, FEELING HOT (He is feeling warm right now (today)), VACCINATION SITE PAIN (The area of injection site started getting sore.) and CHILLS (On same day after receiving 2nd dose, at night he started with chills.) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1767297
Sex: M
Age: 22
State: TN

Vax Date: 08/03/2021
Onset Date: 08/01/2021
Rec V Date: 10/07/2021
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: 202108; Test Name: ultrasound Scan; Result Unstructured Data: ultrasound was done on both his legs. Everything appeared to be normal

Allergies:

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

Symptoms: His doctor said he had symptoms of Guillain-Barre Syndrome; Patient couldn't walk good a week after 1st dose; Father stated that patient couldn't walk good, he had been crying, is still crying; Hurting near groin area; Patient is also hardly eating now; Hurting near hip area; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GUILLAIN-BARRE SYNDROME (His doctor said he had symptoms of Guillain-Barre Syndrome) and GAIT DISTURBANCE (Patient couldn't walk good a week after 1st dose) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Autistic disorder (Non verbal Autistic.). On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced GUILLAIN-BARRE SYNDROME (His doctor said he had symptoms of Guillain-Barre Syndrome) (seriousness criteria disability and medically significant), GAIT DISTURBANCE (Patient couldn't walk good a week after 1st dose) (seriousness criterion disability), CRYING (Father stated that patient couldn't walk good, he had been crying, is still crying), GROIN PAIN (Hurting near groin area), FEEDING DISORDER (Patient is also hardly eating now) and ARTHRALGIA (Hurting near hip area). At the time of the report, GUILLAIN-BARRE SYNDROME (His doctor said he had symptoms of Guillain-Barre Syndrome), GAIT DISTURBANCE (Patient couldn't walk good a week after 1st dose), CRYING (Father stated that patient couldn't walk good, he had been crying, is still crying), GROIN PAIN (Hurting near groin area), FEEDING DISORDER (Patient is also hardly eating now) and ARTHRALGIA (Hurting near hip area) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Ultrasound scan: normal (normal) ultrasound was done on both his legs. Everything appeared to be normal. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No concomitant and treatment medication information were provided. On an unknown date in Aug-2021 (about a week after), the patient couldn't walk good, had been crying and hurting near his groin area. Thought patient might have a gout issue. Patient was also hardly eating. The patient did an ultrasound on both his legs everything appeared to be normal. The doctor said the patient had symptoms of Guillain-Barre Syndrome and suggested that should call Moderna. Father reported on follow-up, that he was taking his son to the ER. Reported he had partial paralysis and non-verbal. Reporter stated his son was progressively getting worse every day since receiving the Moderna COVID-19 vaccine and said. Caller mentioned that they would going to tell the doctors they think it was caused by the shot. Company Comment : This case concerns a 22 year old male with history of non-verbal autistic disorder who experienced serious unexpected event of GBS after the first dose of the vaccine. Medical history of non-verbal autistic disorder is a confounder. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report. This case was linked to MOD-2021-336161. Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Upon follow-up receipt: inarrative updated.; Sender's Comments: This case concerns a 22 year old male with history of non-verbal autistic disorder who experienced serious unexpected event of GBS after the first dose of the vaccine. Medical history of non-verbal autistic disorder is a confounder. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.

Other Meds:

Current Illness: Autistic disorder (Non verbal Autistic.)

ID: 1767298
Sex: M
Age: 17
State: MA

Vax Date: 09/29/2021
Onset Date:
Rec V Date: 10/07/2021
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: Unauthorized age group; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Unauthorized age group) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Unauthorized age group). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Unauthorized age group) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1767299
Sex: M
Age: 55
State: NC

Vax Date: 09/02/2021
Onset Date: 09/02/2021
Rec V Date: 10/07/2021
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: Headache; Sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and VACCINATION SITE PAIN (Sore arm at the injection site) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced HEADACHE (Headache) and VACCINATION SITE PAIN (Sore arm at the injection site). At the time of the report, HEADACHE (Headache) and VACCINATION SITE PAIN (Sore arm at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided by the reporter. Treatment information was not provided. Patient's second dose was scheduled on 29-Sep-2021 at 09:45 am.

Other Meds:

Current Illness:

ID: 1767300
Sex: M
Age: 37
State: KY

Vax Date: 08/24/2021
Onset Date:
Rec V Date: 10/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: feels like palpitation; mouth flu; sore arm; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (feels like palpitation), INFLUENZA (mouth flu), PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and CHILLS (chills) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902 and 020F21A) for COVID-19 vaccination. Concurrent medical conditions included Tourette's syndrome and Bipolar disorder. Concomitant products included QUETIAPINE FUMARATE (SEROQUEL), AMITRIPTYLINE, FLUOXETINE HYDROCHLORIDE (PROZAC) and OMEPRAZOLE for an unknown indication. On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, 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 experienced PALPITATIONS (feels like palpitation), INFLUENZA (mouth flu), PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and CHILLS (chills). At the time of the report, PALPITATIONS (feels like palpitation), INFLUENZA (mouth flu), PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and CHILLS (chills) outcome was unknown. Patient was not allergic to food or medications Treatment medication were not reported. Patient after getting the vaccine felt like palpitation, mouth flu, sore arm, fever and chills.

Other Meds: SEROQUEL; AMITRIPTYLINE; PROZAC; OMEPRAZOLE

Current Illness: Bipolar disorder; Tourette's syndrome

ID: 1767301
Sex: M
Age: 51
State: WV

Vax Date: 12/23/2020
Onset Date: 01/20/2021
Rec V Date: 10/07/2021
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: Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and CHILLS (Chills) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 039K20A) for COVID-19 vaccination. No Medical History information was reported. On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, MYALGIA (Body aches) and CHILLS (Chills) outcome was unknown. No concomitant medications were mentioned. No treatment details were reported. the patient received the third dose on 21Aug2021 This case was linked to MOD-2021-336417 (Patient Link).

Other Meds:

Current Illness:

ID: 1767302
Sex: F
Age: 78
State: KY

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

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

Lab Data: Test Date: 20210908; Test Name: Body temperature; Result Unstructured Data: low grade temperature

Allergies:

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

Symptoms: Heart felt like it was coming out of her chest all day then it went away; felt as if she was about to die; Had a fever of 99.8?F/Keeping a low grade temperature; Felt odd; little sluggish; Slept from 12:00 noon-10:30 pm; Really didn't feel well; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt odd), SLUGGISHNESS (little sluggish), SOMNOLENCE (Slept from 12:00 noon-10:30 pm), MALAISE (Really didn't feel well) and CHEST DISCOMFORT (Heart felt like it was coming out of her chest all day then it went away) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Sep-2021, the patient experienced FEELING ABNORMAL (Felt odd), SLUGGISHNESS (little sluggish), SOMNOLENCE (Slept from 12:00 noon-10:30 pm), MALAISE (Really didn't feel well) and PYREXIA (Had a fever of 99.8?F/Keeping a low grade temperature). On 10-Sep-2021, the patient experienced CHEST DISCOMFORT (Heart felt like it was coming out of her chest all day then it went away) and FEELING ABNORMAL (felt as if she was about to die). At the time of the report, FEELING ABNORMAL (Felt odd), SLUGGISHNESS (little sluggish), SOMNOLENCE (Slept from 12:00 noon-10:30 pm), MALAISE (Really didn't feel well), FEELING ABNORMAL (felt as if she was about to die) and PYREXIA (Had a fever of 99.8?F/Keeping a low grade temperature) was resolving and CHEST DISCOMFORT (Heart felt like it was coming out of her chest all day then it went away) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Sep-2021, Body temperature: 99.8?f (High) low grade temperature. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1767303
Sex: F
Age: 27
State: NY

Vax Date: 09/29/2021
Onset Date: 09/29/2021
Rec V Date: 10/07/2021
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: second dose is pfizer; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (second dose is Pfizer) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination. No Medical History information was reported. On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On 29-Sep-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (second dose is pfizer). On 29-Sep-2021, INTERCHANGE OF VACCINE PRODUCTS (second dose is pfizer) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not provided. On 29-Sep-2021, the patient received second dose of PFIZER COVID-19 VACCINE in (lot 30155BA) in left deltoid. Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Follow-up received on 01-OCT-2021 Updated reporters more details and Vaccine route of administration.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am