VAERS 2021 Database www.vaers.hhs.gov

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

Total Manufacturer
46,870MODERNA
532GLAXOSMITHKLINE BIOLOGICALS
353PFIZER\BIONTECH
231MERCK & CO. INC.
221UNKNOWN MANUFACTURER
62SEQIRUS, INC.
25DYNAVAX TECHNOLOGIES CORPORATION
13EMERGENT BIOSOLUTIONS
12SANOFI PASTEUR
9NOVARTIS VACCINES AND DIAGNOSTICS
5PFIZER\WYETH
5PAXVAX
2TEVA PHARMACEUTICALS
2PROTEIN SCIENCES CORPORATION
1BERNA BIOTECH, LTD.
1INTERCELL AG
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL1,906
1,575
289
IMM209286
252
236
229
s029456178
171
UT7065MA166
155
149
145
S034636133
107
U62828AA103
100
98
P10025327596
U6737AA85
UJ446AA79
78
78
59
57
4BH3254
4F47253
52
27656352
50
PP9L548
49TM346
42
40
38
MENVEO38
4F47237
R1B252M36
34
C5763AA30
93362229
25
300057A24
UNK24
22
CW311621
18
17
15
UH894AB15
3Y7NL12
R1B743M12
EJ168611
el128410
10
10
10
9
ARBA141A9
UNK9
8
UNK8
8
1F4EB8
Unknown7
7
No batch number6
5
5
UJ090AA5
5
5
4
4
4
UNK4
JEV18K95E4
UNK3
A115A3
Z127A3
3
3333324181073
2
2
2
TAR352
1
1
1
1
1
A739081
1
1
1
1
1
037K20A68,542
EL128447,700
133

Incidents per State

State Total
15,185
CA14,096
NY7,507
TX7,196
FL6,939
IN5,527
PA4,560
IL4,179
OH4,054
AZ3,856
MI3,771
NJ3,411
MA3,278
VA3,208
NC3,114
WA3,034
GA2,864
MD2,652
MN2,534
CO2,532
WI2,457
MO2,029
OR1,943
TN1,715
CT1,693
KY1,603
OK1,226
AL1,201
KS1,162
IA1,157
SC1,106
NM1,065
UT973
AR951
LA945
NE829
NV797
ME795
MT789
NH756
ID674
AK661
WV661
PR650
MS585
HI536
RI510
VT441
SD361
ND356
DE350
DC239
WY209
GU32
AS16
VI13
MP9
MH3
FM2
QM1
XB1

ID: 0970135
Sex: F
Age:
State: KS

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: her spot on chest is now hives on chest, back, arms, and at injection site.; her spot on chest is now hives on chest, back, arms, and at injection site.; her chest had a red spot; vivid dreams; restlessness; This is a spontaneous report from a contactable Nurse. A 36-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot# EK9231) vaccine , intramuscular in the left arm on 11Jan2021 08:00 at single dose for Covid-19 immunisation . Medical history included drug hypersensitivity to azithromycin, morphine and sulfa. Concomitant medication included levothyroxine (LEVOTHYROXINE), liothyronine (LIOTHYRONINE), abaloparatide (TYMLOS). The patient received the first dose of bnt162b2 vaccine on 21Dec2020 . The patient experienced her chest had a red spot on 11Jan2021 10:00 with outcome of unknown , vivid dreams on 11Jan2021 with outcome of unknown , restlessness on 11Jan2021 with outcome of unknown , her spot on chest is now hives on chest, back, arms, and at injection site on 12Jan2021 14:00 with outcome of unknown. The patient received cetirizine (ZYRTEC) and acetaminophen (TYLENOL) as treatment of rash. Further information has been requested.

Other Meds: ; ; TYMLOS

Current Illness:

ID: 0970136
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Site tenderness; Feeling light headed; Flu-like symptoms; This is a spontaneous report from a contactable Nurse (patient). A 36-year-old male patient received the second dose of BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization and experienced site tenderness, arm felt sore and heavy. The patient stated apart from site tenderness which was pretty much the same from the first dose, he was feeling light headed, flu-like symptoms. He had not checked his temperature though, maybe he should do that when he got back from break. He heard a lot of terrible stories from their second dose so yeah, be cautious about it. The outcome of the events was unknown. No follow up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 0970137
Sex: F
Age:
State: MI

Vax Date: 01/11/2021
Onset Date: 01/01/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: dose of the COVID vaccine she was just given on 11Jan2021 was given too high; She was experiencing shoulder and joint pain; She was experiencing shoulder and joint pain; This is a spontaneous report from a Pfizer sponsored call center, by a contactable consumer (patient). This female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose in the left deltoid on 11Jan2021 for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was experiencing shoulder and joint pain on an unspecified date in Jan2021 with outcome of unknown. The patient stated that she was concerned that dose of the COVID vaccine she was just given on 11Jan2021 was given too high, underneath the shoulder bone. She had questions on the efficacy of the product given. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0970138
Sex: U
Age:
State: VA

Vax Date:
Onset Date:
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: fever; chills; body aches; headache; This is a spontaneous report from a contactable Physician via a sales srepresentative. This Physician reported similar events for 3 patients. This is report 2 of 3. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fever, chills, body aches and headache for about 24 hours. Events took place after receiving BNT162B2. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021034918 Same drug and event, Different patient;US-PFIZER INC-2021034920 Same drug, Different patient and event

Other Meds:

Current Illness:

ID: 0970140
Sex: F
Age:
State: TN

Vax Date: 01/05/2021
Onset Date: 01/01/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data: Test Name: BP; Result Unstructured Data: Test Result:148/92; Comments: High BP; Test Name: temperature; Result Unstructured Data: Test Result:102.3; Test Name: O2; Result Unstructured Data: Test Result:91

Allergies:

Symptoms: fever/102.3 temperature; headache; achy all over; Within 3 minutes had tingling pins in mouth tongue and throat; Within 3 minutes had tingling pins in mouth tongue and throat; had hard time breathing; O2 sat were at 91; i had High BP 148/92; severe fatigue; This is a spontaneous report from a contactable Other HCP (patient). This 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number=EJ1686), via an unspecified route of administration on 05Jan2021 07:00 at single dose on the left arm for COVID-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD), asthma, depression, irritable bowel syndrome (IBS), known allergies included bacitracin, penicillin, levofloxacin (LEVAQUIN), metronidazole (FLAGYL), oseltamivir phosphate (TAMIFLU), Bees, Hornets. Patient took other medications in two weeks. No other vaccine received in four weeks. Patient was not pregnant. Facility type vaccine was hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 05Jan2021 07:03, within 3 minutes patient had tingling pins in mouth tongue and throat, had hard time breathing. The nurses gave her 50 mg of diphenhydramine hydrochloride (BENADRYL). The doctors checked her O2 sat were at 91, and she had High BP 148/92. After 40 minutes (05Jan2021 07:43) after the medication her symptoms seem to go away and she could breath better. She went home and went to bed because she work night shift. She got the vaccine when she got off work, then about six hours later (05Jan2021 13:00) she had bad headache and achy all over, 12 hours later (05Jan2021 19:00) she had 102.3 temperature and took paracetamol (TYLENOL) every 4 hours and fever finally broke 26 hours later (06Jan2021 21:00). She continued to have a headache for about 5 days and severe fatigue. Adverse event resulted in life threatening illness (immediate risk of death from the event). Patient was recovered with lasting effects.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported life threatening events including tingling pins in mouth tongue and throat, had hard time breathing, PO2 decreased, blood pressure increased, bad headache, achy all over, fever, and severe fatigue, and the administration of the COVID 19 vaccine, BNT162B2, considering the plausible temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

Other Meds:

Current Illness:

ID: 0970141
Sex: F
Age:
State: PA

Vax Date: 01/12/2021
Onset Date: 01/01/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: runny nose; sneezing; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for herself that a female patient of an unspecified age received first dose BNT162B2, via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient got the first dose of the covid-19 vaccine yesterday on 12Jan2021 and she was currently experiencing runny nose and she continuously sneezing in Jan2021. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0970142
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/25/2021
Hospital:

Lab Data: Test Name: platelets; Result Unstructured Data: Test Result:unknown

Allergies:

Symptoms: middle finger turned purple, it felt pins and needles, felt like there was like a tourniquet around the base of my finger/it turned red/swelled; middle finger turned purple, it felt pins and needles, felt like there was like a tourniquet around the base of my finger/it turned red/swelled; middle finger turned purple, it felt pins and needles, felt like there was like a tourniquet around the base of my finger/it turned red/swelled; middle finger turned purple, it felt pins and needles, felt like there was like a tourniquet around the base of my finger/it turned red/swelled; This is a spontaneous report from a contactable nurse (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiry date were unknown), via an unspecified route of administration from an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced, "My middle finger turned purple, it felt pins and needles, felt like there was like a tourniquet around the base of my finger and then it turned red, then it swelled and then it turned purple and it stayed purple for two days. Then it went away for the most part and then yesterday it came back as a blue circle in the middle of my finger. " The patient went to the doctor, "I asked them to check my platelets or whatever and I haven't gotten the results yet and then which I am assuming they are okay I hope so that. And then I also I have called back this morning to just say it turned blue in the middle last night it was like in a circle of my finger in the middle segments between the two joints on the middle finger on the right hand it just turned blue like in a circle I don't know how to describe it just a small circle, way smaller than a dime like almost like I would say a quarter of a dime. So, I was just wondering has anyone had any vascular issues after getting the vaccine." Outcome of all the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0970143
Sex: F
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 01/25/2021
Hospital:

Lab Data: Test Name: bloodwork; Result Unstructured Data: Test Result:Unknown result; Comments: done in order to clarify that there were no underlying conditions, but patient stated pain was still severe a couple days later.; Test Name: pain; Result Unstructured Data: Test Result:10 out of 10; Comments: Knee and elbow pain

Allergies:

Symptoms: Severe joint pain; Wrist pain; Knee and elbow pain; Knee and elbow pain; Raised rash on hands and shin; Raised rash on hands and shin; Raised rash on hands and shin; condition has not improved and seems to be getting worse; Patient is currently breastfeeding; Patient is currently breastfeeding; This is a spontaneous report from a contactable Health Care Professional. A 30-year-old female patient who is currently breastfeeding received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on an unspecified date, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, 3 weeks after the vaccination, the patient experienced severe joint pain, wrist pain, knee and elbow pain (10 out of 10 knee and elbow pain), raised rash on hands and shin. Bloodwork were done in order to clarify that there were no underlying conditions, but patient stated pain was still severe a couple days later. Patient initially went to the emergency room thinking it was bladder infection and mastitis and that was not the case since her condition did not improve and seem to be getting worse. The patient did not recover from the events at time of this report. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021037719 Parent/fetus cases

Other Meds:

Current Illness:

ID: 0970144
Sex: M
Age:
State: GA

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 01/25/2021
Hospital:

Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:97; Test Name: body temperature; Result Unstructured Data: Test Result:98

Allergies:

Symptoms: sick; With the first dose he got tired and had malaise, and body aches for two days; With the first dose he got tired and had malaise, and body aches for two days; With the first dose he got tired and had malaise, and body aches for two days; felt warmth in the arm; hot flash; just got really hot; This is a spontaneous report from a contactable consumer (patient himself). This 52-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ELO140), via an unknown route, on 23Dec2020 (at 06:00 AM), at single dose in the left upper arm on 23Dec2020 for COVID-19 immunization, administered at hospital. The patient had COVID-19 from 17Jul2020 to 14Aug2020 for which he was not hospitalized but he was pretty sick and had circulations issues; he had a little of numbing and tingling in his left three fingers after COVID virus. The patient clarified left three fingers as his middle finger, index finger, and ring finger. He had numbing and tingling in his toes as well. Relevant concomitant medications included ubidecarenone (COQ-10), rosuvastatin calcium (CRESTOR OD), monascus purpureus (RED YEAST RICE PLUS), and acetylsalicylic acid (BABY ASPIRIN). With the first dose he got tired and had malaise, and body aches for two days: He got the vaccine after working that night (He works in the intensive care unit). He got it at 6:00 AM. He felt warmth in the arm. It went all the way down the left arm. He got a hot flash. He stayed there for 15 minutes and was fine, but just got really hot. He finished his shift and didn't have any other reactions. He went to sleep and woke up in the afternoon on the 23Dec2020 and went to work. He didn't feel anything at that time. He was working six or seven days in a row. When he was working that night was when he started feeling body aches and fatigue. He didn't even put two and two together that it was from the vaccine. He felt like he needed to take something. His body temp was normally 97 and when he checked it was 98. He took a little ibuprofen (MOTRIN) and felt a lot better after taking it. He slept when he got home and had body aches and fatigue for a couple of days. He cancelled going away for a couple of days. By noon on 25Dec2020 he was feeling like he was getting back to normal. He continued to lay around all day and didn't do much. He was sick with the first and was expecting to be more sick with this one. He wanted to give himself an extra day before he had to go back to work. The patient had recovered from the event 'with the first dose he got tired and had malaise, and body aches for two days' on 25Dec2020 while the outcome of the remaining events was unknown.

Other Meds: COQ-10; CRESTOR OD; RED YEAST RICE PLUS; BABY ASPIRIN

Current Illness:

ID: 0970145
Sex: F
Age:
State:

Vax Date: 12/22/2020
Onset Date:
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Arm pain at injection site; Runny nose; Lightheaded; This is a spontaneous report from a non-contactable physician, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 22Dec2020 (at the age of 36-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced arm pain at injection site, runny nose, and lightheaded. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of arm pain at injection site, runny nose, and lightheaded were unknown. No follow-up attempts are possible; information about lot number cannot be obtained.

Other Meds:

Current Illness:

ID: 0970146
Sex: U
Age:
State: WA

Vax Date:
Onset Date: 01/14/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Red, swollen and warm face, left side; Red, swollen and warm face, left side; Red, swollen and warm face, left side; This is a spontaneous report from a contactable nurse and a contactable physician. A 39-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on an unspecified date at single dose for COVID-19 immunization. The patient medical history included anxiety, depression, cough, pain, paranasal sinus congestion, infection, hypertension, diarrhea, nausea and vomiting, constipation, type 2 diabetes mellitus, skin rash, erythema of skin, anemia, muscle spasm, asthma, hypercholesterolemia, allergy disorder, acute otitis media, gastroesophageal reflux disease, intellectual disability, acne vulgaris, otitis media, hypersensitivity condition, bacterial infection, dental disease, infective otitis externa, generalized ache or pain, allergies to cotton and thistle, each from an unknown date and unknown if ongoing. The patient's concomitant medications included paracetamol (TYLENOL), atorvastatin, cetirizine, cyclobenzaprine, esomeprazole magnesium (ESOMEPRA), ferrous sulfate, lisinopril, loperamide, metformin, venlafaxine, all from an unknown date and unknown if ongoing. On 14Jan2021 at 10:15, the patient experienced red, swollen and warm face, left side. Therapeutic measures were taken as a result of the events and included treatment with BENADRYL. The patient outcome of the events was recovering. The information on the batch number has been requested.

Other Meds: TYLENOL; ; ; ; ESOMEPRA; ; ; ; ;

Current Illness:

ID: 0970147
Sex: F
Age:
State: MN

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: rash all over her stomach; a little pain at injection site; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at 15:00 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 13Jan2021, the patient experienced rash all over her stomach (7 hours after vaccination) and a little pain at injection site. The patient outcome of the events was unknown. The information on the batch number has been requested.

Other Meds:

Current Illness:

ID: 0970148
Sex: F
Age:
State: NC

Vax Date: 01/13/2021
Onset Date: 01/14/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Headache; myalgia; nausea; diarrhea; second dose received on 14Jan2021; This is a spontaneous report from a contactable Physician. A 31-year-old female Physician (patient) reported that received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), intramuscular at single dose into the left arm on 13Jan2021 at 01:15 PM for COVID-19 immunization. The patient had received the first dose on 13Dec2020 at 01:15 PM Intramuscular in Left arm. Medical history included migraines. On 14Jan2021 at 12:00 PM, the patient experienced headache, myalgia, nausea and diarrhea. The patient was not Covid tested post vaccination. At the time of reporting the patient was recovering Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 0970149
Sex: F
Age:
State: CO

Vax Date: 12/01/2020
Onset Date: 12/01/2020
Rec V Date: 01/25/2021
Hospital:

Lab Data: Test Date: 20200813; Test Name: IgG; Test Result: Positive ; Test Name: BMI; Result Unstructured Data: Test Result:34; Test Name: fever; Result Unstructured Data: Test Result:101 Fahrenheit; Test Date: 20200813; Test Name: PCR; Test Result: Positive

Allergies:

Symptoms: headache; fever to 101F; chills; body aches; congestion; This is a spontaneous report from a contactable physician. This physician reported for a 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Dec2020 at single dose for COVID-19 immunization. The patient's medical history included diagnosed with COVID on 10Jul2020 and 11 weeks of prolonged illness. The patient's concomitant medications were not reported. Patient with no significant risk factors except for a BMI of 34. On day 33 (13Aug2020) post diagnosis she was PCR and IgG positive. On 01Dec2020, patient had the first Pfizer Covid vaccine dose. The first 2-5 days (Dec2020) were described as very bad, fever to 101F, chills, headache, body aches, congestion. The week after she was somewhat better but didn't feel better until day 9 post vaccination. Outcome of the events was unknown. Information on the Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0970150
Sex: F
Age:
State: CA

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data: Test Date: 20210111; Test Name: Covid-19; Result Unstructured Data: Test Result:Positive

Allergies:

Symptoms: got a shot of vaccine today but after that she tested positive; got a shot of vaccine today but after that she tested positive; This is a spontaneous report from a contactable nurse reported for self via Pfizer-sponsored program Pfizer First Connect. A 29-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunisation. Medical history was not reported. The patient's concomitant medications were not reported. The patient already got a shot of vaccine today but after that she tested positive on 11Jan2021. Outcome of events was unknown.; Sender's Comments: No effect of the suspect vaccine BNT162B2 could be reasonably achieved to protect from the targeted infection/ disease due to the very short time lag. Instead, the positive test represents the pre-existing infection prior to vaccine use. Further information like confirmative COVID 19 nucleic acid/ PCR test together with any associated symptoms are needed for full medical assessment.

Other Meds:

Current Illness:

ID: 0970151
Sex: M
Age:
State: FL

Vax Date: 12/31/2020
Onset Date: 01/09/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data: Test Date: 20210109; Test Name: Covid 19; Test Result: Positive

Allergies:

Symptoms: I tested positive yesterday for Covid 19; I tested positive yesterday for Covid 19; This is a spontaneous report from a contactable Other-HCP (patient). A 32-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899) , via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunisation. Medical history reported as none. There were no concomitant medications. The patient tested positive for covid 19 on 09Jan2021. No treatment for the events. The outcome of events was unknown.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be completely excluded for reported "tested positive for Covid 19".

Other Meds:

Current Illness:

ID: 0970152
Sex: U
Age:
State: PA

Vax Date: 01/11/2021
Onset Date: 01/01/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Nausea; Fever; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant mediations were not reported. This patient experienced fever and nausea on unspecified date in Jan2021. The outcome of events was not provided. Information on the Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0970153
Sex: F
Age:
State: MA

Vax Date: 01/05/2021
Onset Date: 01/01/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Pain through whole body and tremoring; Pain through whole body and tremoring/ whole body was sore; Things started looking funny/ Funny feeling in her ears; Deaf and couldn't hear; Leg cramps in both legs and toes curled out/ muscle spasming; Dizzy; nauseous; Threw up twice; Bruise at injection site; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL3246) via an unspecified route of administration on the arm left on 05Jan2021 around 12:00 PM at single dose for COVID-19 immunization. The patient used to get legs cramps when she was pregnant with her twins, but it was only one leg. The patient stated she delivered six children, was in car accidents, and had surgeries. And the patient stated the pain from the COVID-19 Vaccine was beyond any other pain she has experienced. The patient needed glasses to read patient card. And stated her eyesight was going. The patient was pretty healthy. There were no concomitant medications. The patient had no prior vaccinations within 4 weeks. And the patient did not receive additional vaccines on same date that administered BNT162B2. The patient experienced deaf and couldn't hear on 06Jan2021 09:00, leg cramps in both legs and toes curled out on 05Jan2021 19:00, dizzy on 05Jan2021, nauseous on 05Jan2021, threw up twice on 05Jan2021, things started looking funny on 06Jan2021 09:00, pain through whole body and tremoring on 06Jan2021 10:00, bruise at injection site on Jan2021. All the events (except for event bruise at injection site) were reported as seriousness as life threatening. Clinical course: the patient worked nightshift. Laid down that afternoon to take a nap and got up around 10:00. Around 05Jan2021 19:00 PM had sever leg cramps in both legs where her toes were curled out. Leg cramps after vaccine wouldn't go away and it was in both legs. Just wouldn't go away. Around 05Jan2021 21:00 PM it went away. The patient was dizzy, nauseous, and threw up twice on the night of 05Jan2021, and going into 06Jan2021. The patient went to the couch in the hotel room and started going deaf. She couldn't hear anything on 06Jan2021 around 09: 00 AM. Things started looking funny on 06Jan2021 around 09: 00 AM. Woke up at 09:35. Hour after that there was pain through her whole body and everything was hurting at 10:00 AM on 06Jan2021. The patient was tremoring at 10:00 AM on 06Jan2021. Couldn't reach the phone to dial 9-11. Thought she was going to die. Last until about noon and then started to go away. Doesn't know if it is safe to take the second vaccine. Doesn't know if these are thing that should have happened to her. She started to get real concerned. Went into hotel room and started feeling dizzy again. Stopped haring things. Funny feeling in her ears. Was seeing things, got dizzy, and everything got dark. Everything lasted until 12:00 PM on 06Jan2021. Everything was good now. The patient had a bruise where injection was in Jan2021. Stated it was nothing compared to what she went through. Woke up around 10:00 AM. Then went back to sleep and got up around 18:00 PM. She felt fine. Her whole body was sore from the muscle spasming. The outcome of the event bruise at injection site was unknown, of the event leg cramps in both legs and toes curled out was recovered around 05Jan2021 21:00, the outcome of other remain events was recovered on 06Jan2021 12:00. The reporter considered (method of assessment: Global Introspection) that all the events were related to BNT162B2.; Sender's Comments: All the reported events were possibly related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. However, it is worth noting that the 60-year-old female patient had car accidents history and had surgeries. All the events started when she worked nightshift, including leg cramps in both legs and toes curled out, nauseous, threw up twice, pain through whole body, tremoring and transient deafness. Patient did not get rest after vaccination may a risk factor to the onset of the events. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0970154
Sex: F
Age:
State: LA

Vax Date: 01/05/2021
Onset Date: 01/01/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data: Test Date: 202101; Test Name: COVID; Test Result: Positive

Allergies:

Symptoms: Felt bad; Not feeling well; tested positive for COVID; Diagnosed with Covid; This is a spontaneous report from a contactable consumer (Patient) from a Pfizer-sponsored program Pfizer First Connect. This female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient took the COVID-19 vaccine last Tuesday on the 05Jan2021, after she took it she felt bad in that evening, she was not feeling well. Patient tested COVID positive and diagnosed with COVID on an unspecified date in Jan2021. Patient inquired that can she still get the second dose that was supposed to have on 26th. The outcome of event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0970155
Sex: F
Age:
State: TX

Vax Date: 12/23/2020
Onset Date:
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: my first covid vaccine caused tingly lips; This is a spontaneous report from a contactable Health Professional reporting for herself. A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number not provided, expiry date unknown) via an unspecified route of administration in the left arm at single dose on 23Dec2020 at 15:30 for COVID-19 immunization. The patient had allergy to codeine. Concomitant medications included metformin, atorvastatin, vortioxetine hydrobromide (TRINTELLIX), insulin glargine/lixisenatide (SOLIQUA). The patient reported that her first dose of the vaccine caused tingly lips. Onset date and outcome of the event were not reported. Information about lot/batch number has been requested.

Other Meds: ; ; TRINTELLIX; SOLIQUA

Current Illness:

ID: 0970156
Sex: F
Age:
State: IL

Vax Date: 01/07/2021
Onset Date: 01/01/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:high; Test Date: 20210108; Test Name: temperature; Result Unstructured Data: Test Result:102; Test Date: 20210109; Test Name: temperature; Result Unstructured Data: Test Result:101; Test Date: 20210110; Test Name: temperature; Result Unstructured Data: Test Result:temperature was gone

Allergies:

Symptoms: Developed hives on my face, on my head, on top of my back and they also itch in addition to the all over itching; headaches; Pain around my face, my left arm; Developed severe itching from head to toe; I was running a temperature of 102; I could not even sit on the side of bed without falling to one side or the other or falling backwards so very weak and unable to move; I could not even sit on the side of bed without falling to one side or the other or falling backwards so very weak and unable to move; Appetite lost; Chills; soreness more than usual from the shot; Soreness in my arm, my neck; Soreness in my arm, my neck/ pain around her face, her left arm; I got stiff neck, my back, my lower back; Massive weakness; Confusion; terrible sleepiness; Diarrhea; I still don't feel good; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received her second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot EL3248, expiration Apr2021) at 6:00AM on 07Jan2021 for Covid-19 immunization. The patient had her first dose on 19Dec2020 and had side effects from it but very few. The patient was worked at COVID rooms to clean rooms in hospital as a housekeeper and so her exposer to the hospital made her in first group to get the vaccine. Medical history included allergies (had anaphylactic shock from Amoxicillin and from Tylenol, she cannot take Tylenol), anxiety, and high blood pressure. Concomitant medications included acetylsalicylic acid (ASPIRIN) on regular basis, bisoprolol fumarate, loratadine (CLARITIN) for allergies, escitalopram for anxiety, mometasone furoate (FLONASE) for allergies, losartan, magnesium, omeprazole, and triamterene. On the first day (07Jan2021) she had soreness more than usual from the shot, soreness in her arm, her neck. She got stiff neck, back, lower back. She had gotten the shot at 6 am, then worked at that time and by the time she got home at noon, she had massive weakness, some confusion, terrible sleepiness and by evening, she developed diarrhea. On the second day (08Jan2021) the pain increased the weakness increased, and she was running a temperature of 102. She could not even sit on the side of bed without falling to one side or the other or falling backwards so very weak and unable to move pretty much. She could not eat and lost appetite, and she developed the chills on that evening. On the third day (09Jan2021) she was running a temperature of 101 so it had gone down. She still had headaches, and pain around her face, her left arm and developed severe itching from head to toe, and on the next day (10Jan2021) she developed hives on her face, on her head, on top of her back and they also itch in addition to the all over itching. The temperature was gone, she had no temperature when she developed the hives. At the report day, she stated that she had not gone back to work as she broke out in the horrible hives and she still did not feel good. Only cold ice packs on the hives/ itching and no more treatment received for the events. The fever and itching resolved on 10Jan2021, and outcome of all other events was unknown.

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]; ; CLARITIN [LORATADINE]; ; FLONASE [MOMETASONE FUROATE]; ; ; ;

Current Illness:

ID: 0970157
Sex: F
Age:
State: TX

Vax Date: 01/11/2021
Onset Date:
Rec V Date: 01/25/2021
Hospital:

Lab Data: Test Name: Temperature; Result Unstructured Data: Test Result:101; Test Name: blood work; Result Unstructured Data: Test Result:unknown results

Allergies:

Symptoms: Body aches; Chills; temperature was up to a 101; pains/she said she can't even move because it hurt; Fatigue; Felt horrible/felt very bad; This is a spontaneous report from a contactable Physician. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Jan2021 at single dose for COVID prevention. Medical history included breast cancer, rheumatoid arthritis. The patient's concomitant medications were not reported. The patient said that she felt horrible, she had body ache, pains and chills and that was just horrible. she felt very bad you know body aches and chills. She was a doctor, she wasn't even able to go to the work. She was not going to go to work tomorrow and her temperature was up to a 101 and she said she can't even move because it hurt when she move. Body aches, chills, fever, fatigue, she just said she just felt horrible. She did have some blood work done about three weeks ago from her oncologist. The outcome of events was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021044872 Same reporter, same drug, different patient

Other Meds:

Current Illness:

ID: 0970158
Sex: F
Age:
State: MO

Vax Date: 01/11/2021
Onset Date: 01/01/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: temperature was up to a 101 / fever; she could not even move because it hurt when she moved; felt very bad / Feels horrible; Body ache; Chills; fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 55-year-old female patient of an unspecified age received the 2nd dose of bnt162b2 (BNT162B2) at single dose on 11Jan2021 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 11Jan2021 night she felt very bad with body aches and chills but then on 12Jan2021 she was not even able to go to the work. She was not going to go to work on 13Jan2021 and her temperature was up to a 101 and she could not even move because it hurt when she moved. Body aches, chills, fever, fatigue, she just said she just feels horrible. She took two Ibuprofen maybe 200 mg, so probably total of 400 mg of Ibuprofen. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 0970159
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Fever; body ache; Miserable; Tired; This is a spontaneous report from a contactable consumer. This consumer reported same events for 2 patients. This is 2nd of 2 report. A patient of unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had fever, body ache, couldn't even lay in bed, the patient was miserable. The patient was tired. The outcome of all the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021044957 same reporter/drug/event, different patient.

Other Meds:

Current Illness:

ID: 0970160
Sex: F
Age:
State: MO

Vax Date:
Onset Date:
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Systemic rash all over the back, chest, stomach and thighs; Some spots on arms and legs; This is a spontaneous report from a contactable Nurse (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL3248), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient stated, "I got my first dose yesterday at 4:30 and then everything was fine and then at about 10:30 that night, I got a systemic rash all over my back, my chest, my stomach and my thighs and there were some spots on my arms and my legs. So, I went ahead and had took some Benadryl and I just monitored the rash and made sure it wasn't going to my face, or my eyes or my throat. I never had any difficulty in breathing or anything but it definitely was a reaction to something that was in the vaccine." Treatment: Consumer stated, "I took Benadryl last night. It was a capsule, 25 mg. Indication: Consumer stated, "I work at a hospital and right now the hospital that I work at is not requiring that we get it but they just advised that we should. But they left it to us if we want to get it or not and they said that they just have the first doses available." The outcome of the events was unknown.

Other Meds:

Current Illness:

Date Died:

ID: 0970162
Sex: M
Age:
State: MD

Vax Date:
Onset Date:
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: received the vaccine on Tuesday and was found dead at his kitchen table Wednesday afternoon; This is a spontaneous report from a contactable consumer. An 89 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the vaccine on Tuesday (unspecified date) and was found dead at his kitchen table on Wednesday afternoon (unspecified date). Cause of death was unknown. It was unknown if an autopsy was performed. Information about batch/lot number has been requested.; Reported Cause(s) of Death: received the vaccine on Tuesday and was found dead at his kitchen table Wednesday afternoon

Other Meds:

Current Illness:

ID: 0970164
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: sore arm; This is a spontaneous report from a non-contactable nurse (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at singled dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date with outcome of unknown. The patient took ibuprofen after the first dose. She took 800mg of ibuprofen right before the second dose since her arm was sore. No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 0970165
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/25/2021
Hospital:

Lab Data: Test Name: BP; Result Unstructured Data: Test Result:shot up high

Allergies:

Symptoms: Felt dizzy; Her BP shot up high; This is a spontaneous report from a Pfizer-sponsored program from a contactable Nurse. A female patient of an unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient felt dizzy and her BP shot up high. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0970166
Sex: F
Age:
State: NC

Vax Date: 12/17/2020
Onset Date: 12/28/2020
Rec V Date: 01/25/2021
Hospital: Y

Lab Data: Test Date: 20201229; Test Name: Nasal Swab for COVID-19; Test Result: Negative ; Test Date: 20201231; Test Name: Nasal Swab for COVID-19; Test Result: Negative

Allergies:

Symptoms: Acute pancreatitis with sepsis; Acute pancreatitis with sepsis; This is a spontaneous report from a contactable pharmacist, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 17Dec2020 at 15:00 (at the age of 48-years-old) as a single dose for COVID-19 immunization. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fexofenadine (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Dec2020, the patient experienced acute pancreatitis with sepsis, which were reported as serious for hospitalization and being life threatening. The patient had gone to the emergency room due to the event and was hospitalized for a total of 6 days. On 29Dec2020 and 31Dec2020, the patient had COVID-19 nasal swabs performed and both results were negative. Therapeutic measures were taken as a result of acute pancreatitis with sepsis and included gall bladder removal. The clinical outcome of acute pancreatitis with sepsis was recovering.; Sender's Comments: Based on the temporal relationship, the association between the events pancreatitis with sepsis with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0970167
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: severe pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (pharmacy intern) reported similar events for 2 patients. This is 1st of 2 reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2) at single dose on an unspecified date for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced severe pain (not specified) on an unspecified date. The action outcome of event was unknown. Information on lot/batch has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021057811 same reporter, different patient

Other Meds:

Current Illness:

ID: 0970168
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: flu symptoms; vomited for 4 straight hours; Initial and additional information was received on 14-Dec-2020 regarding an unsolicited valid non-serious case from the non-healthcare professional via social media. This case involved an unknown demographic patient who vomited (vomiting) and had flu symptoms (influenza), after the patient received INFLUENZA VACCINE. The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported. On an unknown date (last year), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination. On an unknown date, the patient vomited (vomiting) and had flu symptoms (influenza), (unknown latency) following the administration of INFLUENZA VACCINE. Physician had advised the patient to avoid flu shot also the patient had suspected that he/she had reaction to something in that solution. It was reported that, the flu can be life-threatening for people above 65year old with heart disease and preventive care could make a difference and these events labeled as type 1-B adverse event. Details of laboratory data were not reported. It was not reported if the patient received any corrective treatment. At the time of reporting, the outcome was not reported for influenza and after 4 hours duration (on an unknown date), the patient had recovered from vomiting. There will be no information available on batch number for this case.

Other Meds:

Current Illness:

ID: 0970169
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: patient got sick; Initial information was received on 16-Jan-2021 regarding an unsolicited valid serious from a consumer/ non-heath care professional. This case involves a patient of unknown age who got sick (illness), while being received vaccine INFLUENZA VACCINE. Medical history, past medical treatment, vaccination, family history and concomitant medication were not reported. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (batch number and other dosing details were not reported) at an unknown dose via unknown route and unknown administration site for prophylactic vaccination. On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient got sick (illness). No laboratory data was reported. It was not reported if the patient received any corrective treatment. Outcome of the event was reported as unknown. There will be no information available regarding batch number in this case.

Other Meds:

Current Illness:

ID: 0970170
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/25/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: still ill after the double dose flu shot; ill; Initial information was received on 16-Jan-2021 regarding an unsolicited valid serious case received from a consumer This case involved adult male patient who was still ill after the double dose flu shot (illness) and ill (malaise), while he received INFLUENZA VACCINE. The patient's medical history, medical treatment(s), vaccination(s), concomitant medication (s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiration date not reported via unknown route at unknown administration site for prophylactic vaccination. On an unknown date, the patient was still ill after the double dose flu shot (illness) and ill (malaise), unknown latency following the administration of INFLUENZA VACCINE. The patient was hospitalized (caused or prolonged) for this event. No relevant laboratory data was reported. It was not reported if the patient received a corrective treatment. The event outcome was reported as unknown for both the events. There will be no information available on the batch number for this case.; Sender's Comments: This case concerns adult male patient who was still ill after the double dose flu shot and ill after vaccination with INFLUENZA VACCINE. It was unknown if the time to onset was compatible. However, concomitant medications, patient's medical condition and laboratory tests ruling out alternate etiologies. Moreover, vaccination preceded the events. Based upon the reported information, the role of vaccine cannot be assessed.

Other Meds:

Current Illness:

ID: 0970171
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: he was out sick for 2 weeks; Initial information was received on 15-Jan-2021 regarding an unsolicited valid serious from a consumer/ non-heath care professional. This case involves a patient of unknown age who was out sick for 2 weeks (illness), while being received vaccine INFLUENZA VACCINE. Medical history, past medical treatment, vaccination, family history and concomitant medication were not reported. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (batch number and other dosing details were not reported) at an unknown dose via unknown route and unknown administration site for prophylactic vaccination. On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient was out sick for 2 weeks (illness). No laboratory data was reported. It was not reported if the patient received any corrective treatment. Outcome of the event was reported as unknown. There will be no information available regarding batch number in this case.

Other Meds:

Current Illness:

ID: 0970172
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Last flu shot patinet got made me sick; Initial information was received on 18-Jan-2021 regarding an unsolicited valid serious from a consumer/ non-heath care professional. This case involves a patient of unknown age who got sick (illness), while being received vaccine INFLUENZA VACCINE. Past vaccination(s) included INFLUENZA VACCINE. Medical history, past medical treatment, family history and concomitant medication were not reported. Concomitant medications were not reported. On an unknown date in 1980, the patient received a dose of suspect INFLUENZA VACCINE (batch number and other dosing details were not reported) at an unknown dose via unknown route and unknown administration site for prophylactic vaccination. On an unknown date in 1980, (latency: unknown) after starting the suspect vaccine therapy, patient who last flu shot an became sick (illness). No laboratory data was reported. It was not reported if the patient received any corrective treatment. Outcome of the event was reported as unknown. There will be no information available regarding batch number in this case.

Other Meds:

Current Illness:

ID: 0970173
Sex: M
Age:
State: ID

Vax Date:
Onset Date:
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: patient received a dose of Menactra after the vaccine was exposed to a temperature excursion of 22.7?F with no AE; Initial information regarding this unsolicited valid non-serious case was received from Other Healthcare Professional via Medical Information (Reference number- 00418272) and transmitted to Sanofi on 06-Jan-2021. This case is linked with 2021SA005526, 2021SA006661(same reporter). This case involves an 18 year old male patient who received a 0.5 ml second dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot: U6827BA, expiration date: 18-Feb-2022) once via unknown route at right deltoid for prophylactic vaccination on an unknown date which was exposed to a temperature excursion of 22.7 degree Fahrenheit (product storage error). The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant therapies were not asked. It was an actual medication error due to product storage error temperature too low. The reporter stated that the facility initially reported temperature excursion of 32.5 degree Fahrenheit and were cleared to immunize based on that temperature. However, on further review, it was discovered facility made a mistake and the actual temperature the vaccines were exposed to was 22.7 degree Fahrenheit. During that time period, three patients received vaccines that were actually unsuitable for use. The reporter wanted to know how they should proceed and if they should revaccinate the patient. No adverse event reported to the patient at the time of reporting. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 0970174
Sex: M
Age:
State: FL

Vax Date: 01/07/2021
Onset Date:
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: gave a Menactra instead of an MMR yesterday with no AE; Initial information regarding this unsolicited valid non-serious case from Regulatory Authority (Reference number- 00421820) was received from Pharmacist and transmitted to Sanofi on 08-Jan-2021. This case involved a 7 months old male patient who received a 0.5 ml dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] instead of MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE [MMR] (lot: U6575AA, expiration date: 08-May-2021), gave a Menactra instead of an MMR yesterday with no AE (Wrong vaccine administered). The dose was given in the left deltoid via intramuscular route. Past vaccination included meningococcal vaccine(unknown brand) 2 years ago. The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided. It was a actual medication error due to wrong vaccine administered (Wrong product administered). At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 0970175
Sex: F
Age:
State: GA

Vax Date:
Onset Date: 01/07/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: tired; sleeping; 18 year old who received 2 doses of MENACTRA within minutes of each other; Initial information regarding this unsolicited valid non-serious case via Medical Information (Reference number-00422339) was received from a Other Healthcare Professional and transmitted to Sanofi on 08-Jan-2021. This case involved a 18 year old female patient who was tired (fatigue), sleeping (somnolence) and for whom 18 year old who received 2 doses of menactra within minutes of each other (extra dose administered) was, while she received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]. The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication included HPV VACCINE; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE). On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number and expiration date not reported via intramuscular route at the left arm for prophylactic vaccination. On 07-Jan-2021, the patient was tired (fatigue), sleeping (somnolence) and for whom 18 year old who received 2 doses of menactra within minutes of each other (extra dose administered) was reported, unknown latency following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. No relevant laboratory data was reported. It was not reported if the patient received a corrective treatment. The event outcome was reported as unknown for tired and somnolence. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Disclaimer: Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on the batch number for this case.

Other Meds: HPV VACCINE; VARICELLA VACCINE

Current Illness:

ID: 0970180
Sex: M
Age:
State: WI

Vax Date: 11/15/2016
Onset Date:
Rec V Date: 01/25/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: acute respiratory distress syndrome/ acute respiratory failure with hypoxia; pneumonia of the lower lobe; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a male patient of unknown age. His concurrent conditions, medical history and concomitant medications were not reported. On or about 15-NOV-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered acute respiratory distress syndrome, requiring hospitalization and intubation. He remained hospitalized for 16 days and was diagnosed with acute respiratory failure with hypoxia and pneumonia of the lower lobe. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not present prior to vaccination. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, he suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX). The events of pneumonia of the lower lobe and acute respiratory distress syndrome/ acute respiratory failure with hypoxia were determined to be disabling. Upon internal review, the events of pneumonia of lower lobe and acute respiratory distress syndrome/ acute respiratory failure with hypoxia were considered to be medically significant.

Other Meds:

Current Illness: Routine health maintenance

ID: 0970181
Sex: M
Age:
State: MI

Vax Date: 10/18/2017
Onset Date:
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: bilateral hearing loss; postherpetic neuralgia; intrinsic eczema; herpes zoster; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or around 18-OCT-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown, date shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered shingles rashes on his lower back and mid left back, muscular lower back pain and loss of hearing. He was diagnosed with herpes zoster, postherpetic neuralgia, intrinsic eczema and bilateral hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not present prior to using the vaccine. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, he suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment, and injury. As a direct and proximate result, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX). The events were determined to be disabling. Upon internal review, the event of bilateral hearing loss was considered to be medically significant.

Other Meds:

Current Illness: Routine health maintenance

ID: 0970182
Sex: F
Age: 53
State: CO

Vax Date: 12/22/2020
Onset Date: 12/23/2020
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Tingling of the arms / Intermittent tingling in the leg opposite of the left arm; Vomiting; Cold/shivers; Cold/shivers; This case was reported by a pharmacist via call center representative and described the occurrence of tingling of extremity in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 5C29J, expiry date 25th March 2022) for prophylaxis. Previously administered products included Shingrix with an associated reaction of chills (1st dose was received on an unknown date, refer linked case US2020AMR255397). On 22nd December 2020 16:15, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 23rd December 2020, 1 days after receiving Shingrix, the patient experienced tingling of extremity, vomiting, cold and shivers. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the tingling of extremity, vomiting, cold and shivers were not recovered/not resolved. It was unknown if the reporter considered the tingling of extremity, vomiting, cold and shivers to be related to Shingrix. Additional details were provided as follows: The second dose of vaccine was administered day before the reporting date at 4:15pm at the pharmacy; which was given intramuscularly in the left deltoid. The patient had experienced tingling of the arms, vomiting, and intermittent tingling in the leg opposite of the left arm (where the injection was given) from the 2nd dose of the Shingrix vaccine. The patient had also experienced colds/shivers. The reporter also stated that the patient did not experience swelling, shortness of breath, paralysis, or anything like that. The reporter consented to follow-up and provided contact information.; Sender's Comments: US-GLAXOSMITHKLINE-US2020AMR255397:Same reporter, same suspect, same patient, diferent dose (1st dose)

Other Meds:

Current Illness:

ID: 0970183
Sex: F
Age: 67
State: PA

Vax Date: 11/27/2020
Onset Date: 11/27/2020
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: left side of her face is red since waking up; itching around the injection site; pain in left arm; swelling in the left arm; redness around the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number J79G7, expiry date 27th August 2022) for prophylaxis. Concurrent medical conditions included penicillin allergy (allergic to Amoxicillin) and allergic reaction to drug (allergic to isoamylalcohol). On 27th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 27th November 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, swelling arm and injection site erythema. On 28th November 2020, the patient experienced injection site itching. On 2nd December 2020, the patient experienced red face. The patient was treated with loratadine (Claritine). On an unknown date, the outcome of the injection site itching, swelling arm and injection site erythema were not recovered/not resolved and the outcome of the pain in arm was recovered/resolved and the outcome of the red face was unknown. It was unknown if the reporter considered the injection site itching, pain in arm, swelling arm, injection site erythema and red face to be related to Shingrix. Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The patient received the 1st dose of the Shingrix vaccine in the left arm. The patient reported that same day after receiving the vaccine she had pain in the left arm, redness around the injection site that was a 4 to 5 inch area going down from the injection site, and swelling in the left arm. The Patient reported the pain has resolved. The patient reported the redness around the injection site and the swollen arm is still ongoing. The patient reported itching around the injection site began and was not resolved.

Other Meds:

Current Illness: Drug allergy (allergic to isoamylalcohol); Penicillin allergy (allergic to Amoxicillin)

ID: 0970184
Sex: U
Age:
State: FL

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccine got on the nurse who administered vaccine; A spontaneous report was received from a nurse concerning a 58-year-old nurse, who administered the Moderna's COVID-19 vaccine (mRNA-1273) and the vaccine got on the nurse who administered the vaccine. The patient's medical history was not provided. No relevant concomitant medications were reported. On 11 Jan 2021, the nurse administered the vaccine to a patient who received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) for prophylaxis of COVID-19 infection. On 11 Jan 2021, as the nurse was administering the vaccine to a patient, the hub of the syringe came off while in the patient's arm and some of the vaccine got on the nurse. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, vaccine got on the nurse who administered vaccine, was resolved on 11 Jan 2021.; Reporter's Comments: This report refers to a case of Accidental exposure to product for COVID -19 vaccine( mRNA-1273), lot # 011L20A. There were no reported AEs associated with this case of Accidental exposure to product COVID -19 vaccine( mRNA-1273).

Other Meds:

Current Illness:

ID: 0970185
Sex: M
Age: 60
State: FL

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Needle came out of the syringe whlie applying vaccine; A spontaneous report was received from a healthcare professional concerning a 59 year old male patient who was participating in the mRNA-1273 Emergency Use Program and experienced the needle came out of the syringe while applying vaccine. The patient's medical history, as provided by the reporter, included diabetes. Concomitant medications reported included two diabetes medications and HMG COA reductase inhibitor. On 11-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot 011L02A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 11-Jan-2021, the needle came out of the syringe while applying vaccine and it came off in the patient's arm. It is unknown how much of the vaccine the patient received but reports there was a lot of liquid on his pants and arm. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The event, needle came out of the syringe while applying vaccine was considered recovered on 11-Jan-2021. The reporter did not provide a causality assessment of the event needle came out of the syringe while applying vaccine.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of Incorrect dose administered. Reported event is unlisted for mRNA-1273 and causality was assessed as not applicable.

Other Meds: HMG COA REDUCTASE INHIBITORS; ANTI DIABETES; ANTI DIABETES

Current Illness: Diabetes

ID: 0970186
Sex: U
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vial was punctured more than 6 hours before administration; A spontaneous report was received from a consumer concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) from a vial that was punctured more than 6 hours before administration. The patient's medical history was not provided. Concomitant medication use was not provided by the reporter. On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On the unknown date, the vial used for the patient's vaccine had been punctured for more than 6 hours before administration. No treatments were administered for the event. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event, vial was punctured more than 6 hours before administration, was considered resolved.; Reporter's Comments: This report refers to a case of patient of unknown age who received the first dose of the vaccine from a vial that had been punctured for more than 6 hours before administration of mRNA-1273 (Lot# unknown). There were no reported AEs associated with this event of "the vial used for the patient's vaccine was punctured more than 6 hours before administration."

Other Meds:

Current Illness:

ID: 0970187
Sex: U
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 1 ml of vaccine administered; A spontaneous report was received from a health care professional concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 1 ml of vaccine was administered. The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) intramuscularly for prophylaxis of COVID-19 infection. The patient received a 1 ml dose of the Moderna COVID-19 vaccine, instead of 0.5 ml, during their first dose. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, 1 ml of vaccine was administered, was considered resolved on unknown date.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of incorrect dose administered.

Other Meds:

Current Illness:

ID: 0970188
Sex: F
Age: 66
State:

Vax Date: 01/02/2021
Onset Date: 01/02/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Redness at injection site; Tenderness at injection site; Might have gotten the vaccine subcutaneously; Itching at the injection site; Hard injection site; A spontaneous report w was received from a nurse concerning herself, a 66-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and might have received the vaccine subcutaneously and experienced itching at the injection site itching, redness, a hard injection site and tenderness at the injection site. The patient's medical history included an allergy (unknown) and high blood pressure. Concomitant medications included cetirizine, famotidine, losartan, folic acid, calcium, ascorbic acid, and cyanocobalamin. On 02-Jan-2021, a few hours prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Lot 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. A few hours after receiving the vaccine, the patient started to feel itching at the injection site. Later that same night, she developed redness and the injection site became hard and a little tender. The following day the reaction was worse and lasted for four days By 06-Jan-2021 the reaction was gone but appeared again and lasted until 11-Jan-2021. She also mentioned that the needle used for the injection was 25-gauge needle so she believed she may have received the vaccine subcutaneously. Treatment for the events included hydrocortisone cream. Action taken with mRNA-1273 in response to the event was not provided. The outcomes of the event, might have received the vaccine subcutaneously, was resolved on 02 Jan 2021. The events, itching at the injection site itching, redness, a hard injection site and tenderness at the injection site, were considered resolved on 11 Jan 2021.; Reporter's Comments: This case concerns a 66-year-old, female patient, with history of allergy and hypertension, who experienced a non-serious unexpected event of incorrect route of product administration, injection site pruritus, injection site induration, non-serious expected events of, injection site erythema and injection site pain. There was no AEs associated with incorrect route of product administration. The events of, injection site pruritus, injection site induration, injection site erythema, and injection site pain, occurred 1 day (same day) after first dose of mRNA-1273, lot # 025L20A. Treatment included cortisone cream. Based on the current available information and temporal association between the use of the product and onset of the events (injection site pruritus, injection site induration, injection site erythema, injection site pain), a causal relationship cannot be excluded.

Other Meds: CETIRIZINE; PEPCID AC; LOSARTAN; FOLIC ACID; CALCIUM; VITAMIN C [ASCORBIC ACID] VITAMIN B12 [CYANOCOBALAMIN]

Current Illness: Allergy (Not specific); Hypertension

ID: 0970189
Sex: F
Age: 31
State: VA

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vial punctured 24 hours or even 48 hours prior to being adminstered; A spontaneous report was received from a nurse who was also a 31-years-old, female patient who received Moderna's COVID-19 Vaccine and who experienced the event, vial punctured 24 or even 48 hours prior to being administered. The patient's medical history was not provided. Concomitant medication use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 vaccine (Lot 039K20A) intramuscularly for prophylaxis of COVID-19 infection on 06 Jan 2021. The patient noted that the vial was punctured for 24-48 hours before the vaccine content was administered to her. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event, vial punctured 24 or even 48 hours prior to being administered, was considered resolved on 06 Jan 2021.; Reporter's Comments: This case concerns a 31-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 039K20A), reporting Out of specification product use without any associated adverse events.

Other Meds:

Current Illness:

ID: 0970190
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/25/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: flu; pneumonia; chronic sinus infection; Initial information received on 16-Jan-2021 regarding an unsolicited valid serious social media case received from a consumer. This case involves male patient who experienced flu (influenza), Pneumonia, chronic sinus infection (chronic sinusitis), while he received vaccine INFLUENZA VACCINE. The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were unknown. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a serious flu (influenza), Pneumonia, chronic sinus infection (chronic sinusitis) (Unknown latency) following the administration of INFLUENZA VACCINE. Pneumonia was assessed as medically significant as per important medical event list. The patient was hospitalized for these events. Relevant laboratory data was not reported. It was not reported if the patient received a corrective treatment. The outcome was reported as Unknown for all events. There will be no information available on the batch number for this case.; Sender's Comments: This case involves male patient of unknown age who experienced flu (influenza), Pneumonia, chronic sinus infection (chronic sinusitis), while he received vaccine INFLUENZA VACCINE from unknown manufacturer. The time to onset is also unknown. There is, moreover, no information regarding patient's medical history, condition at time of vaccination and lab tests ruling out alternate etiologies. Based upon the reported information, the role of suspect vaccine cannot be assessed.

Other Meds:

Current Illness:

ID: 0970191
Sex: F
Age: 3
State: MI

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Flublok had been administered to 3 year old patient with no AE; Initial information received on 04-Jan-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 3 years old patient who received a 0.5 ml dose of vaccine QUADRIVALENT RECOMBINANT INFLUENZA VACCINE [FLUBLOK QIV] prefilled syringe (lot: UJ509AA, expiry date: 10-May-2021), via intramuscular route at the left deltoid, on 29-Dec-2020 (Product administered to patient of inappropriate age) The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided. It was an actual medication error due to Inappropriate age at vaccine administration. (Latency same day). It was reported nurse with question regarding administration of FLUBLOK to patients under 18 years of age. Caller reported FLUBLOK had been administered to 11 patients and would like to know if they are "covered" for influenza vaccination for the season At the time of reporting, the patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm