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: 0976939
Sex: F
Age:
State: NJ

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 202012; Test Name: covid 19 PCR test; Test Result: Negative

Allergies:

Symptoms: involuntary muscle contractions in her diaphragm; chills; cold; severe body aches; Involuntary muscle cramping; chest pain; Feels bad; severe joint aches; tremor; nausea; severe body pain in her back and knees; severe body pain in her back and knees; Weakness; Headache; This is a spontaneous report from a contactable Other HCP reported for self. This 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 07:00 on Deltoid Left at single dose (Lot # EK9231) for covid-19 immunisation. Concomitant medications were none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 via Intramuscular at age of 50 years old on Deltoid, Left at single dose (Lot # EH9899) for covid-19 immunisation, experienced Tingling lips, Swollen lips, and the Benadryl took away the lip tingling and swelling, Tachypnea, Myalgia, Joint pain, severe headache, Weakness generalized, Nausea, she said she was really pale, so much so, that her husband was scared for her. She said the symptoms lasted for about 3 days, but the weakness lasted longer. Reported she took some Zofran disintegrating tablets for her nausea. Clarified she did have a PCR COVID-19 Virus test after she developed symptoms from receiving the first COVID-19 Vaccine dose. She said she had the PCR COVID-19 Virus test about 3 weeks ago and the test was negative. She said she thought she had the COVID-19 Virus after receiving the first COVID19 Vaccine dose because no one else she knew who had the COVID-19 Vaccine had any issues. Reported she received the second COVID-19 Vaccine dose on 12Jan2021 at 7:00AM in the left Deltoid. She said the adverse reaction she experienced after the second vaccine dose was slightly different from what she experienced with the first dose. She said about 10 hours after the COVID-19 Vaccine was administered, clarifying at around 17:00PM 12Jan2021, she started having severe body aches(disability), and involuntary muscle cramping (disability), like tetanus. She said even her diaphragm was cramping. She said she had chest pain on 12Jan2021(disability), tremors on 12Jan2021 (medically significant), and body aches, but doesn't think she had fever. She said the symptoms are still going on like with the first COVID-19 Vaccine dose, but she has more severe joint aching on 12Jan2021 (disability), weakness on 12Jan2021 (disability), and nausea on 12Jan2021 (medically significant). She said her knees feel like she was beaten severely. She said she aches so bad, it hurts having pants on. She said she does not have a headache or tremors now, but did have a headache on 12Jan2021 (medically significant) and tremors in the beginning. She said she feels the most pain in her back and knees. She said she feels really bad on 12Jan2021(disability). After the second dose on 12Jan2021, she reports severe body pain in her back and knees (disability). She reports almost feeling like she has tetanus- involuntary muscle contractions in her diaphragm on unknown date(disability), tremor, cold, chills, nausea, muscle cramps/chest pain. 'Felt like a heart attack. It was out of this world'. She still has nausea, severe pain all over my body, she can't be touched, and even wearing pants hurts. She said she is a healthy person with no chronic disease. She said she had nothing wrong with her prior to getting the COVID-19 Vaccine. Reported she hurts so bad, she can't even lift her arm. She completed a covid 19 PCR test after the first dose in Dec2020, which was negative. Treatment were received for the events severe body pain in her back and knees, involuntary muscle contractions in her diaphragm, tremor, nausea, muscle cramping, chest pain, Feels bad, more severe joint aching, severe body aches, Weakness, headache, chills, cold. Reported she has taken 1500mg of Motrin. Outcome of the severe body aches, Involuntary muscle cramping, Chest pain, severe joint aches, weakness, Nausea, Back pain, Knee pain, Feels bad was not recovered. Outcome of the event Tremor was recovered in Jan2021, Headache was recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the reported events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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: 0976940
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Not sleeping well; Throwing up; Hot and cold flashes; Can't eat; Hot and cold flashes; This is a spontaneous report from a contactable consumer reported for patient (father). A male patient of an unspecified age received BNT162B2 via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient has got the shot whatever it is, the vaccine. And he has got it on Sunday. And since Sunday night he has been not sleeping well, throwing up, hot and cold flashes, can't eat. Events outcome was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0976941
Sex: F
Age:
State: CA

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Sore throat; nasal congestion; chills; headache; nausea; feels like the flu; This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored Program Pfizer First Connect. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, in Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sore throat, nasal congestion, chills, headache, nausea, and feels like the flu in Jan2021. The clinical outcome of sore throat, nasal congestion, chills, headache, nausea, and feels like the flu was not recovered. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.

Other Meds:

Current Illness:

ID: 0976942
Sex: M
Age:
State:

Vax Date: 01/15/2021
Onset Date: 01/16/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Large nodule on left side of neck; Lymphadenopathy; Some pain occurs when straining neck, but mostly just very uncomfortable; Some pain occurs when straining neck, but mostly just very uncomfortable; Some pain occurs when straining neck, but mostly just very uncomfortable; This is a spontaneous report from a contactable pharmacist (patient). A 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 at 13:00 (at the age of 32-years-old) at a single dose for COVID-19 immunization. Medical history included penicillin allergy and sulfa allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included ibuprofen (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced large nodule on left side of neck, lymphadenopathy, and some pain occurs when straining neck, but mostly just very uncomfortable on 16Jan2021. The clinical course was reported as: The patient woke up the morning after being vaccinated and had a large nodule on left side of neck, which appeared to be lymphadenopathy. There was some pain that occurred when straining neck, but patient was mostly just very uncomfortable. The patient did not receive any treatment for the events. The clinical outcome of large nodule on left side of neck, lymphadenopathy, and some pain occurs when straining neck, but mostly just very uncomfortable was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.

Other Meds: IBUPROFEN

Current Illness:

ID: 0976943
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: sore arm the day after; This is a spontaneous report from a non-contactable consumer (patient). A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 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 sore arm the day after on an unspecified date. The clinical outcome of sore arm the day after was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 0976944
Sex: M
Age:
State: CA

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Back pain in the muscle; Back was swelled up; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at single dose (lot number: EL3249) for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced back pain in the muscle and back was swelled up started yesterday 12Jan2021 in the evening. Treatment included Advil. Outcome of events was recovering.

Other Meds:

Current Illness:

ID: 0976945
Sex: F
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: pain on the side; This is a spontaneous report from a contactable nurse (reported for herself). A 73-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein, lot/batch number and expiration date not reported) (reported as pneumonia vaccination) via an unspecified route of administration on an unspecified date at single dose for Pneumonia; influenza vaccine via an unspecified route of administration on an unspecified date at an unspecified dose for Flu. The patient's medical history and concomitant medications were not reported. Got the vaccine for Pneumonia and Flu. The patient did not get adverse reactions, but stated she only had pain on the side. The outcome of the event was unknown. Pfizer is a marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 0976946
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/27/2021
Hospital:

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

Allergies:

Symptoms: Covid positive; Covid positive; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect via a contactable consumer reported for patient (husband). This reporter reported similar events for 2 patients (reporter and reporter's husband). This is 2nd of 2 reports reported for reporter's husband. A male patient of an unspecified age received BNT162B2 via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter and her husband both had vaccine on Friday and they discovered that they both are Covid positive on Monday. Reporter does not have symptoms but her husband (patient) does, the question is wants to know whether they should still get the second shot? Events outcome was unknown. Information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021049653 Same reporter, same drug/event, different patient

Other Meds:

Current Illness:

ID: 0976947
Sex: M
Age:
State: RI

Vax Date:
Onset Date:
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Allergic to the vaccine; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient's wife). A 76-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (unknown manufacturer), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history was not reported. Concomitant medications were none. The patient was allergic to the vaccine on an unspecified date with outcome of unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. Pfizer is a Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the reporter's country. This may be a duplicate report if another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.

Other Meds:

Current Illness:

ID: 0976948
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:99.8; Comments: low grade fever

Allergies:

Symptoms: Low grade fever; Chills; This is a spontaneous report from a contactable consumer reported for self. This female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose (Reason for no lot number: don't know if it is F179899) for covid-19 immunisation. She had low grade fever she mentioned 99.8, and she had chills. Outcome of the events was unknown. Information on Lot/Batch has been requested.

Other Meds:

Current Illness:

ID: 0976949
Sex: M
Age:
State:

Vax Date: 01/08/2021
Onset Date: 01/13/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Nauseous; Throwing up; Severe stomach pains; This is a spontaneous report from a contactable consumer. A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced nauseous, throwing up, severe stomach pains on 13Jan2021. The reporter described that the patient received the vaccine on 08Jan2021 and on 13Jan2021 he was nauseous, throwing up and had severe stomach pains. The reporter wondered if 5 days is too long to consider a side effect or not. The outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0976950
Sex: F
Age:
State: NY

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: some severe nausea to the point started on the 11Jan2021 that was very hard for her to talk to people; Soreness in my arm; Headache; This is a spontaneous report from a contactable consumer reported for self. This 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were none. And right after the vaccine the patient was okay. Into the next day (07Jan2021) the patient had soreness in her arm, and headache which was known as a common side effect of the vaccination. But as of Monday, had been experiencing some severe nausea to the point started on the 11Jan2021 that was very hard for her to talk to people. Because she was almost gag in. Every time she talked she felt like she was going to throw up just if she was upright she felt like she had to throw up. So, she reached out to her employee health services and they asked her to reach out to you guys. She just wanted to add that she didn't experience this portion right away, it took some days for her to feel this. No treatments received for the event nausea. Outcome of the event nausea was not recovered. Outcome of other events was unknown. information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0976951
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: fatigue; This is a spontaneous report from a contactable nurse(patient) via a sales representative. A patient of unspecified age and gender received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization . The patient medical history and concomitant medications were not reported. Patient previously first dose BNT162B2 for COVID-19 immunization and experienced headache and arm pain. The patient experienced fatigue after use of product, it was reported that it "laid me out for one day" described as fatigue as well. Outcome was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0976952
Sex: F
Age:
State: NC

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

Lab Data:

Allergies:

Symptoms: I am blurry and it's sort of a vision thing where I can't see everything quite right, it's blurry; A little bit of brain fog not quite thinking everything correctly; Sometimes it feels like my legs aren't quite there; My senses aren't quite right; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3246), on 07Jan2021 at SINGLE DOSE on upper left arm for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient was blurry and it's sort of a vision thing where she can't see everything quite right, it's blurry and a little bit of brain fog not quite thinking everything correctly and sometimes it feels like her legs aren't quite there like her senses aren't quite right. Treatment was no.

Other Meds:

Current Illness:

ID: 0976953
Sex: U
Age:
State:

Vax Date: 01/12/2021
Onset Date: 01/01/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Headache; Muscle pain; Tiredness; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown), via an unspecified route of administration on 12Jan2021 14:00 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache, muscle pain and tiredness in Jan2021. The outcome of events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0976954
Sex: F
Age:
State: VA

Vax Date: 01/08/2021
Onset Date: 01/01/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Nausea; vomiting; Metallic taste; Headache; migraine; didn't have an appetite; lost taste, lost the sense of taste; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient) reported a 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176) via unspecified route single dose for COVID-19 immunization on 08Jan2021, 10 am, at 38-year-old. Medical history was not reported. Concomitant medication included: celecoxib (CELEXA) 10 mg for an anti-depressant; alprazolam (XANAX) 0.25mg three times a day. Once the patient took that second vaccine, she had the metallic taste and had some headache and migraine at that time (08Jan2021). When the patient got the vaccine, within one minute, she started getting her usual migraine on the right side of head (08Jan2021), that was pretty much instantly. She didn't have an appetite (Jan2021), she only vomited when she ate. She had nausea and vomiting, it was about 2 o'clock that afternoon (08Jan2021, 2 pm). Every time she ate, she vomited and lost taste, lost the sense of taste. The patient was still nauseated (Hence, ongoing checked for nausea) and she hadn't tasted anything. She hadn't drink or ate anything yet this morning but last night her taste was starting to come back. But she still couldn't identify something. No treatment received. Action taken for BNT162B2 was not applicable. Outcome of the event nausea was not resolved, outcome of the other events was unknown.

Other Meds: CELEXA [CELECOXIB]; XANAX

Current Illness:

ID: 0976955
Sex: F
Age:
State: SC

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 20210114; Test Name: temperature; Result Unstructured Data: Test Result:up to 101.7

Allergies:

Symptoms: body pain/ Soreness; Headache; Fever up to 101.7; Shivers; This is a spontaneous report from a contactable consumer (patient's husband). A 62-year-old female patient received first dose BNT162B2 of (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246, expiration date: Apr2021), via an unspecified route of administration on left arm on 14Jan2021 10:00 at SINGLE DOSE for COVID-19 immunization (patient is a medical worker). There were no medical history and concomitant medication. The patient noticed about 21:00 on 14Jan2021, she was having body pain and a headache. The patient's husband took her upstairs and took her temperature and she had a fever and then she got the shivers which went on for quite a while. The hot bath seemed to help. She has had no other treatment. The patient's husband stated that his wife and he both got inoculated at the local hospital. He was fine but his wife has a fever up to 101.7 and he was asking if she take ibuprofen as she has a roaring headache and she was sore. The patient has been taking baths to relieve the soreness. No prior vaccinations (within 4 weeks). No additional vaccines administered on same date of the Pfizer vaccine. No event required a visit to physician or emergency room. There were currently no vaccines available for the second dose, but she is planning to get the second dose 31Jan2021. The outcome of the event Shivers was recovered on 14Jan2021 and the outcome of the other events were not recovered.

Other Meds:

Current Illness:

ID: 0976956
Sex: F
Age:
State: TN

Vax Date: 01/11/2021
Onset Date: 01/12/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: joint pains; headaches; This is a spontaneous report from a contactable other health professional. A 66-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3246), intramuscularly on 11Jan2021 at 10:00 at a single dose for COVID-19 immunization. Medical history included pre-diabetic from an unknown date and unknown if ongoing, high cholesterol from an unknown date and unknown if ongoing; known allergies: no. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; first dose-lot number: EJ1685, intramuscularly, in the left arm at 19:30) for COVID-19 immunization on 22Dec2020. Concomitant medications included calcium (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), vitamin d (MANUFACTURER UNKNOWN), simvastatin (ZOCOR); all taken for an unspecified indication from an unspecified date to an unspecified date. On 12Jan2021 at 03:00, the patient experienced: joint pains and headaches; no treatment was reached. The clinical outcome of the events was recovered in Jan2021. There were no other vaccines within four weeks of the suspected vaccine. The patient did not have COVID prior to the vaccination. The patient was not tested for COVID post vaccination.

Other Meds: CALCIUM; METFORMIN; VITAMIN D [VITAMIN D NOS]; ZOCOR

Current Illness:

ID: 0976957
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: numb tongue; This is a spontaneous report from a contactable nurse. 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 medical history and concomitant medications were not reported. The patient experienced numb tongue on an unspecified date. Event took place after use of product. The outcome of event was unknown. Information on the Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 0976958
Sex: F
Age:
State: TX

Vax Date: 01/07/2021
Onset Date: 01/08/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: dizziness (intermittent); This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 07Jan2021 at 16:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took ciprofloxacin (CIPRO) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 08Jan2021 at 07:00, the patient experienced dizziness (reported as intermittent for 5 days). Patient was given an unspecified treatment for the event. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the event was recovering. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0976959
Sex: F
Age:
State:

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 20210113; Test Name: fever; Result Unstructured Data: Test Result:101.7; Comments: 03:45 pm (15:45)

Allergies:

Symptoms: Nausea; vomiting; Fever of 101.7; Body aches all over; Headache; Fatigue; Swelling and bruising at injection site; Swelling and bruising at injection site; dose number 1 on 27Dec2020/dose number 2 on 13Jan2021; This is a spontaneous report from a contactable consumer (patient herself). A 23-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3302, expiry date May2021), via an unspecified route of administration, on 13Jan2021 08:45 am, at single dose, on the left arm, for covid-19 immunization. Medical history included GERD, asthma, and allergies: kiwi fruit. The patient's concomitant medications were not reported. The patient previously took hyoscyamine and experienced allergies; and previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EJ1685, expiry date May2021) on 27Dec2020 09:15 am, for covid-19 immunization at the age of 23-years-old with vaccination location on the left arm. The patient experienced nausea with vomiting, fever of 101.7, body aches all over, headache, fatigue, swelling and bruising at injection site - all on 13Jan2021 at 15:45 (reported as 03:45 pm). No treatment was received for these events except for fever (with acetometaphine and ibuprofen in system). The patient had no COVID prior vaccination, had no other vaccines received in four weeks and, had not been COVID tested post-vaccination. The outcome of event dose number 1 on 27Dec2020/dose number 2 on 13Jan2021 was unknown; while the outcome of all the other remaining events was recovering.

Other Meds:

Current Illness:

ID: 0976960
Sex: F
Age:
State: MO

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

Lab Data:

Allergies:

Symptoms: a bunch of swollen lymph nodes/lymph node was now larger/ a really big bulge like above the collar bone and going towards her neck and then another larger bulge under her right axillary; a bunch of swollen lymph nodes/lymph node was now larger/ a really big bulge like above the collar bone and going towards her neck and then another larger bulge under her right axillary; feelings of like disconnection; Feelings of like of being drunk; another larger bulge under her right axillary and that one was causing off and on under the armpit, she was getting some shooting pain; Fatigue; This is a spontaneous report from a contactable Nurse. This 48-year-old female Nurse (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686), via unspecified route at left upper arm on 11Jan2021 at single dose for COVID-19 immunization. Medical history included hypertension. Concomitant drugs included lisinopril for blood pressure/hypertension, omeprazole and vitamin supplements. Historical vaccine included the first dose of BNT162B2 (lot# EK5730) on 21Dec2020 for COVID-19 immunization and having a swollen lymph node along her collar bone on the left side which was on the side where she got the shot and it didn't really change much, it just kind of stayed the same size and it remained there for whole three weeks. Nurse stated then she got the second dose of the vaccine and thought that what she was having were a bunch of swollen lymph nodes, and that lymph node was now larger and she had a really big bulge like above the collar bone and going towards her neck and then another larger bulge under her right axillary (12Jan2021) and that one was causing off and on under the armpit, she was getting some shooting pain and her lymph node was larger now as well, the lymph node along her collar bone. Nurse further stated she also had some intermittent fatigue that she expected and also off and on feelings of like disconnection or feelings of like of being drunk. But that's not very bothersome, that's just once in a while since 11Jan2021. But she was concerned about the swelling of lymph nodes. No treatment was received for events. Outcome of events was not recovered. Nurse believed that swollen lymph nodes, fatigue and feeling drunk were due to the Covid 19 Vaccine.

Other Meds: LISINOPRIL; OMEPRAZOLE

Current Illness:

ID: 0976961
Sex: F
Age:
State: MO

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: When I got my first half of vaccine I did have a swollen lymph node along my collar bone on the left side; This is a spontaneous report from a contactable nurse. This 47-year-old female nurse reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#: EK5730) at single dose in the left upper arm for vaccination on 21Dec2020. Relevant history included Hypertension. Relevant concomitant drug included Lisinopril 10 mg daily for blood pressure, Omeprazole 20 mg daily, Vitamin Supplements. The nurse stated, " When I got my first dose of vaccine I did have a swollen lymph node along my collar bone on the left side which is on the side where I got the shot and it didn't really change much. It just kind of stayed the same size and it remained there for whole three weeks. This small one along my collar bone that started right after the first vaccine and that has stayed the whole time. But got bigger after my second." No treatment was received. The outcome of event was not resolved. The patient believed the swollen lymph nodes were due to the Covid 19 Vaccine.

Other Meds: LISINOPRIL; OMEPRAZOLE

Current Illness:

ID: 0976962
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Nausea; chills; fever; tiredness; sore throat; body aches; This is a spontaneous report from a non-contactable healthcare professional. A 25-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications were not reported. On an unspecified date, the patient experienced nausea, chills, fever, tiredness, sore throat, and body aches. No treatment was received for the adverse events. Clinical outcome of the events was recovering. No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 0976963
Sex: F
Age:
State: MA

Vax Date:
Onset Date:
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Received the first vaccination and they put into the subcutaneous tissue instead of into the muscle.; I don't think I got the full vaccination; Hearing impaired; Made a blister and it burst and little fluid also came; This is a spontaneous report from a contactable nurse (patient). A 70-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1686) on an unspecified date at SINGLE DOSE for COVID-19 immunisation. Medical history was none. Concomitant medication included omeprazole. The patient received the first vaccination and they put into the subcutaneous tissue instead of into the muscle. It made a blister and it burst and little fluid also came. The patient did not think she got the full vaccination. The patient needed to know as she was going to go ahead and get the second dose which for her is really the first dose but she need to know how to proceed with and she wanted to make sure that she get her second one, her real second one. Nurse stated, "I need you to talk a little slower, I am hearing impaired and I can't understand you, just a little bit slower." No Treatment received. The outcome was unknown.

Other Meds: OMEPRAZOLE

Current Illness:

ID: 0976964
Sex: F
Age:
State: AR

Vax Date: 12/22/2020
Onset Date:
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Headache with the first COVID-19 Vaccine; A little bit of chest pain; Heart Troubles; This is a spontaneous report from a contactable consumer. This 56-year-old female consumer reported that she the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) at single dose for vaccination on 22Dec2020. Relevant medical history included Rheumatoid, Asthma, Artery disease, Gastroparesis. Relevant concomitant drugs were unknown. The patient had a headache with the first COVID-19 Vaccine and a little bit of chest pain. Stated she has heart troubles. Outcome of events was unknown.

Other Meds:

Current Illness:

ID: 0976965
Sex: M
Age:
State: AZ

Vax Date: 01/13/2021
Onset Date: 01/14/2021
Rec V Date: 01/27/2021
Hospital: Y

Lab Data: Test Date: 20210114; Test Name: temp; Result Unstructured Data: Test Result:101 to 101.7; Test Date: 20210118; Test Name: Echocardiogram; Result Unstructured Data: Test Result:normal EF; Test Date: 20210118; Test Name: ECG; Result Unstructured Data: Test Result:ST elevation inferior lead; Test Date: 20210114; Test Name: heart rate; Result Unstructured Data: Test Result:110 to 130; Test Date: 20210114; Test Name: pain; Result Unstructured Data: Test Result:1-2/10; Test Date: 20210115; Test Name: pain; Result Unstructured Data: Test Result:7-8/10; Test Date: 20210118; Test Name: pain; Result Unstructured Data: Test Result:10/10; Test Date: 20210118; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Negative; Test Date: 20210118; Test Name: Trop; Result Unstructured Data: Test Result:16.28 ng/ml

Allergies:

Symptoms: coronary spasm; STEMI COVID vaccine induced; slight 1-2/10 substernal chest pain on/off; fever of 101 to 101.7; diffuse severe muscle aches; tachycardia of 110 to 130; painful lymphadenopathy of the ipsilateral axilla and clavicular lymph node (LN); This is a spontaneous report from a contactable physician (patient). A 45-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142), via an unspecified route of administration in the left arm on 13Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included benign prostatic hyperplasia (BPH). Concomitant medication included alfuzosin. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) in the left arm on 23Dec2020 16:00 at the age of 44 years old for COVID-19 immunization. On 14Jan2021, the patient started having fever of 101 to 101.7, diffuse severe muscle aches, and tachycardia of 110 to 130. Thursday evening (14Jan2021) through Sunday (17Jan2021), the patient also had painful lymphadenopathy of the ipsilateral axilla and clavicular lymph node (LN). Thursday evening (14Jan2021), the patient had slight 1-2/10 substernal chest pain on/off. Friday evening around 23:30 (15Jan2021), the patient had chest pain substernal 7-8/10 that lasted for one hour. The burning sensation was worse with cold air. It resolved with paracetamol (TYLENOL) and ibuprofen. Monday early morning at 04:00 (18Jan2021), the patient experienced STEMI COVID vaccine induced wherein the patient woke up with 10/10 chest pain and shoulder pain which lasted for 30 to 40 minutes and resolved with paracetamol and ibuprofen. The patient also decided to check blood work Monday morning (18Jan2021) while in the hospital. Trop came back 16.28 ng/ml. This is the old trop not high sensitivity. Normal high is 0.30 ng/ml. The patient went to the hospital. ECG showed ST elevation inferior lead. Left heart catheterization was done. The patient have clean coronaries. No evidence of any atherosclerosis. Echocardiogram showed normal EF. No wall motion abnormality. It was concluded that the patient also had coronary spasm. The patient underwent other lab test and procedure which included nasal swab COVID test showed negative on 18Jan2021. Outcome of the lymphadenopathy was recovered on 17Jan2021, of the chest pain was recovered on Jan2021, of the coronary spasm and STEMI was recovering, while of the remaining events was unknown. The events coronary spasm and STEMI resulted in hospitalization and life threatening illness.; Sender's Comments: The reported coronary spasm with chest pain and suspected STEMI were likely related to the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) due to plausible temporal relationship, and no evidence of any atherosclerosis during left heart catheterization. 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: ALFUZOSIN

Current Illness:

ID: 0976966
Sex: F
Age:
State: TX

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Name: Weight; Result Unstructured Data: Test Result:like 200 lbs

Allergies:

Symptoms: She is now feeling little congestion like sinus; Tightness in chest; This is a spontaneous report from a Pfizer-sponsored program. A contactable 47-year-old female Consumer (patient) reported that she received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported she is now feeling little congestion like sinus and tightness in chest in Jan2021 with outcome of unknown. She was not sure if it's from the vaccine. No treatment was received. The patient underwent lab tests and procedures which included weight: was like 200 pounds lbs on an unknown date. information on the batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 0976967
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 01/12/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 20210112; Test Name: nose swab; Test Result: Positive

Allergies:

Symptoms: Felt tired; Headache; Arm sore; patient tested positive and had the second dose of the vaccine; patient didn't have any chills or anything; patient tested positive and had the second dose of the vaccine; patient didn't have any chills or anything; This is a spontaneous report from a contactable consumer reported for self. This 57-year-old female patient received the first dose of BNT162B2 (Lot number ELD140, Expiry Date Mar2021) via unspecified route of administration on an unspecified date at single dose, and second dose of BNT162B2 (maybe the same Lot/ Expiry date as the first dose) via unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient tested positive and had the second dose of the vaccine; patient didn't have any chills or anything. The patient clarified that she was tested positive at work. The patient had the nose swab 12Jan2021 at job and the patient had the second dose of the shot (vaccine). The patient stated that she felt tired in the morning and had headache and arm was sore, other than that the patient felt she was fine. The patient didn't have any chills or anything. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 0976968
Sex: U
Age:
State:

Vax Date: 01/12/2021
Onset Date: 01/13/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Chills; Body ache; Fever; Headache; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (batch/lot number was EL1284, expiration date was unknown) via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 12Jan2021, patient was fine and then today (on 13Jan2021), this morning, patient had the symptoms of having the chills, body ache, fever and headache. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 0976969
Sex: U
Age:
State: LA

Vax Date: 01/10/2021
Onset Date: 01/10/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: spit up a slime which was a yellow color/spit up another blob of slime; cough; burning in the back of my throat; burning all the way down my esophagus; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age (Age: 74; Unit: Unknown) and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 10Jan2021 at single dose for COVID-19 immunization. Medical history included cold and extremely ill from 1981 to an unknown date. The patient's concomitant medications were not reported. The patient stated, "I was reading the fact sheet that was given to me after I received my Vaccine on the 10Jan2021 and I developed a strange thing which was the cough. I don't cough. I never had a cold since 1981 that is not being exaggerated that is the truth because I was extremely ill. So I know it was 1981. About 6 hours after I came home from getting the injection. I do not know, there was the burning in the back of my throat. So I gargled some salt water but it did not go away. By the evening I had a horrible cough and burning all the way down my esophagus and I was coughing. I don't cough it's not that. I am well, my lungs are well I never cough. Next morning again I was coughing. If I sat still and didn't move it stopped and then it would started again when I get up and move around. The coughing was like a raspy cough that was strange. I have never experienced anything like it. However, on the morning of the 13th of Jan2021, 3 days after the injection I began to spit up a slime which was a yellow color. Now I don't do that, it is not a part of my healthcare, my lungs are fine, I have never smoked, not one sign of lung problems ever. So I spit up the big thing of this slime. The next morning which was yesterday, I spit up another blob of slime and today the cough is gone like I never had it. Now I know this is not the normal for me, this has never happened to me before and so it is either a coincidence. I had the injection which I requested and the symptoms began slowly in the evening after I got the injection on the 10Jan and stopped last night, it just stopped, the last bit of slime came out of mouth, out of my lungs and the coughing stuff and that what happened. I don't know what that is but I have a feeling that the two are related in some manner. I am not a sickly person, I had nothing going on in my body, I am very lucky, I am 74 and I had nothing. So this was surprise and shock. This may be an interest to your survey. I have been in this house for eleven months. I have not left. I have had food brought to me and I have had medicines (Unspecified Medications) brought to me and no one has come into my home since eleven months. So if I have somehow contracted this virus. God only knows because this little known and no one comes in my home and I am isolated for 11 months. That is how hard I have trying not to get the virus. I have not, have I been taking medication and been to a doctor no, I have not. I have just been in my house." The outcome of the event "spit up a slime which was a yellow color/spit up another blob of slime" was recovered on 13Jan2021. The outcome of the rest of the events was recovered on 12Jan2021. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0976970
Sex: F
Age:
State: TN

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 01/27/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Rash; Hives; Throat started to close up; Voice changed/ Functional dysphonia; This is a spontaneous report from a contactable other health professional reporting for herself. A 43-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL1284), intramuscular in the right arm, on 29Dec2020 at 16:42, at single dose, for COVID-19 immunisation. Medical history included diabetes from an unknown date and unknown if ongoing, blood pressure high from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing, migraine from an unknown date and unknown if ongoing, drug allergy to triptans from an unknown date and unknown if ongoing. Past drug event included drug allergy to Topamax and Rocephin both from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced rash on 29Dec2020 at 16:45 with outcome of not recovered, hives on 29Dec2020 at 16:45 with outcome of not recovered, throat started to close up on 29Dec2020 at 16:45 with outcome of not recovered. The patient was given Benadryl and EpiPen and was rushed to the emergency room (ER). The events needed emergency room visit and physician office visit. She was admitted into the hospital for 3 days and received Solu-Medrol and intravenous Benadryl every 6 hours until discharge. The reporter stated that after the reaction her voice changed. She was visited by an otorhinolaryngology (ENT) doctor on 19Jan2021 and she had functional dysphonia. Therapeutic measure included speech therapy. Outcome was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination the patient has not been tested for COVID-19.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events rash, hives and throat tightness. 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: 0976972
Sex: U
Age:
State: IA

Vax Date: 01/12/2021
Onset Date: 01/14/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: red warm welt at injection site; red warm welt at injection site; welt at injection site; This is a spontaneous report from a contactable nurse via a Pfizer sponsored program. This contactable nurse reported same event for two patients. This is the second of two reports. A 15-month-old patient of an unspecified gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe, 0.5 ml, lot number: DL2971, expiry date: 30Nov2022, NDC number of Prevnar 13: 0000519-71-02) via intramuscular route in right thigh on 12Jan2021 at 0.5 mL, single for immunization. Patient had no medical history. Concomitant medications were not reported. It was reported that, she is calling about Prevnar 13, states she just opened a new Lot of the Prevnar and the first two doses administered, both patients had adverse reactions. States that she was no longer going to use that Lot number at this time for fear that it may continue. Agent state the product information is: Patient was 27lb 8 ounces at time of injection. Gender not provided, Patient received vaccine on 12Jan2021, on 14Jan2021 a warm red welt at the injection site was reported. Reporter considered events as non-serious. Treatment was a cool compress to the site and the welt resolved in a couple of days. Outcome of events was recovered on 16Jan2021. The relatedness of event red warm welt at injection site was unknown. Relatedness of drug to reaction(s)/event(s) for Red warm welt at injection site at Source of assessment was Primary Source Reporter and Method of assessment was Global Introspection. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021058499 same reporter/drug/event, different patient

Other Meds:

Current Illness:

ID: 0976973
Sex: M
Age:
State: NJ

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 20210120; Test Name: blood pressure; Result Unstructured Data: Test Result:180/116; Comments: Elevated, highest recorded

Allergies:

Symptoms: Elevated blood pressure (180/116 highest recorded); dizziness; weakness lasting several hours; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 20Jan2021 14:15 at single dose for COVID-19 immunisation at Public Health Clinic/Veterans Administration facility. The patient medical history was not reported. Concomitant medication included atorvastatin (LIPITOR), 40 mg daily, butalbital, caffeine, paracetamol (FIORICET). The patient experienced elevated blood pressure (180/116 highest recorded), dizziness and weakness lasting several hours on 20Jan2021 14:30 with outcome of recovering. The events were considered life-threating (immediate risk of death from the event) and resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit. No treatment was performed. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.

Other Meds: LIPITOR [ATORVASTATIN]; FIORICET

Current Illness:

ID: 0976974
Sex: M
Age:
State: CO

Vax Date: 11/17/2020
Onset Date: 12/27/2020
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 20201227; Test Name: Nasal swab; Test Result: Positive

Allergies:

Symptoms: tested positive for COVID via nasal swab; tested positive for COVID via nasal swab; This is a spontaneous report from a contactable healthcare professional. A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ165), via an unspecified route of administration at left arm on 17Nov2020 18:45 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID via nasal swab on 27Dec2020. The outcome of the events was unknown.; Sender's Comments: The 51-year-old male received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ165), on 17Nov2020 and tested positive for COVID via nasal swab on 27Dec2020. It was unknown whether he received second dose. Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information is needed for full meaningful medical assessment.

Other Meds:

Current Illness:

ID: 0976975
Sex: F
Age:
State: CT

Vax Date:
Onset Date:
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Every year has an allergic reaction to the flu vaccine; Initial information regarding this unsolicited valid non-serious case received from a consumer via other company and transmitted to Sanofi on 30-Dec-2020. The case involves a 36 year old female patient who had allergic reaction (hypersensitivity) every year, while she received INFLUENZA VACCINE (flu vaccine). The patient's past vaccination included Pertussis vaccine for prophylactic vaccination as a kid and she had a severe allergic reaction which was described as almost anaphylactic (anaphylactic reaction). Medical history, concomitant medication, past medical treatment 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 expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, it was reported that, the patient developed a non-serious allergic reaction (hypersensitivity), every year, unknown latency following the administration of INFLUENZA VACCINE. Relevant laboratory test was not reported. DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL) was given as a corrective treatment. It was reported that recently the patient had already been diagnosed twice with COVID-19, she has not received the vaccine yet. At the time of reporting, the outcome was unknown for the reported event. There would be no information available on batch number for this case.

Other Meds:

Current Illness:

ID: 0976976
Sex: F
Age:
State: WA

Vax Date: 01/05/2021
Onset Date: 01/05/2020
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: products were exposed to a temperature of 9.4 degrees Celsius and were out of range for a total of 76 hours due to malfunction of refrigerator with no adverse event; Initial information regarding an unsolicited valid non-serious case received from a nurse via phone at a call center from The Agency on 06-Jan-2021. This case involved a 86-year old female patient who was vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] which was exposed to a temperature of 9.4 degrees Celsius and were out of range for a total of 76 hours due to malfunction of refrigerator with no adverse event (Product storage error). Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 05-Jan-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE 0.7 mL pre-filled syringe (lot number: UJ469AA, expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination. On 05-Jan-2021, it was reported that the patient was vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] which was exposed to a temperature of 9.4 degrees Celsius and were out of range for a total of 76 hours due to malfunction of refrigerator with no adverse event (Product storage error). It was an actual medication error due to product storage error. 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 holders 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: 0976977
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: allergic reaction; Initial information was received on 11-Jan-2021 regarding an unsolicited valid non-serious from other health care professional. This case involves a patient of unknown age who experienced allergic reaction (hypersensitivity), 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 experienced allergic reaction (hypersensitivity). No laboratory data was reported. Outcome of the events was reported as unknown. There will be no information available regarding batch number in this case.

Other Meds:

Current Illness:

ID: 0976978
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: gets the flu; 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 experienced flu, while being received 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 experienced flu. No laboratory data was reported. It was not reported if the patient received any corrective treatment. Outcome of the events was reported as unknown. There will be no information available regarding batch number in this case.

Other Meds:

Current Illness:

ID: 0976979
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: sick in bed; Initial information was received on 20-Jan-2021 regarding an unsolicited valid non-serious from a consumer/ non-heath care professional. This case involves a 76-year old patient who got sick (illness), while being received vaccine INFLUENZA VACCINE. Past medical history, medical treatment(s), past vaccination(s) and family history were not provided. 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 sick in bed (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: 0976980
Sex: M
Age:
State: CA

Vax Date: 11/09/2020
Onset Date: 11/09/2020
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: given a double dose of the Fluzone Quadrivalent, first dose given on 09Nov2020 and second dose given 06Jan2021 with no adverse event; Initial information regarding an unsolicited valid non-serious case received on 06-Jan-2021 from other health professional (Nurse) via call center. This case involved a 71 year old male patient who received a 0.5 ml first dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number- UJ476AA and expiry date- 30-Jun-2021), via unknown route at unknown administration site, on 09-Nov-2020 and second dose given 06-Jan-2021 (Extra dose administered). The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided. It was an actual medication error given a double dose of the Fluzone Quadrivalent, first dose given on 09-Nov-2020 and second dose given 06-Jan-2021 (Extra dose administered).. 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:

ID: 0976981
Sex: M
Age:
State: ID

Vax Date:
Onset Date:
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: received a dose of Pentacel after it 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- 00418447) and transmitted to Sanofi on 06-Jan-2021. This case is linked with 2021SA005526, 2021SA006645 (same reporter). This case involved a 2 months old male patient who received a 0.5 ml first dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot: UJ382AA, expiration date: 01-Oct-2021) once via unknown route at left vastus lateral 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 reason documented in that case for the temperature excursion was a technical malfunction of the refrigerator. The reporter wanted to know how they should proceed and if they should revaccinate the patient. Doctor/emergency room visit on 05-Jan-2021. 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: 0976982
Sex: F
Age: 0
State: ID

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: a patient received a Pentacel vaccine which was exposed at the actual temperature of 22.7 degrees Fahrenheit, which rendered it unsuitable for use with no Adverse event; Initial information regarding an unsolicited valid non-serious case received on 06-Jan-2021 from the other health care professional. This case involves a 4 months old female patient who received a 0.5 ml second dose of QUADRIVALENT INFLUENZA VACCINE [FLUZONE] which was exposed at the actual temperature of 22.7 degrees Fahrenheit (lot number: UJ559AB, expiry date: 14-May-2021), via an unknown route at left vastus lateral on 29-DEC-2020 (Product storage error). The patient's medical history, medical treatments, vaccinations and family history were not provided. List concomitant or no other vaccines not asked. It was an actual medication error due to product storage error temperature too low (latency: same day). At the time of reporting, the patient had no adverse event. Description: Caller advised previously reported temperatures on inquiry: 00408503 were incorrect. The lowest temperature reached was 22.7 degrees F. Also advised PENTACEL was given to patient, wants to know how they should proceed. Should we re-vaccinate the patient who received Pentacel. He provides Adverse Event (AE) information: It is noted that 408503 did not contain AE information, as the reason documented in that case for the temperature excursion was a technical malfunction of the refrigerator. Additional Description of event: The facility initially reported a temperature excursion of 32.5 degrees Fahrenheit and were cleared to immunize based on that temperature. However, on further review, it was discovered they made a mistake and the actual temperature the vaccines were exposed to was 22.7 degrees Fahrenheit. During that time period, three patients received vaccines that were actually unsuitable for use. The patient received a dose of Pentacel after the vaccine was exposed to a temperature excursion of 22.7 degrees Fahrenheit, which rendered it unsuitable for use. Emergency Room/Doctor visit and date 29-Dec-2020. Administering physician Vaccine was administered by a nurse. Product used: Used. First time product used: No and Still using product: No. 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: 0976983
Sex: F
Age: 57
State: TX

Vax Date: 10/02/2020
Onset Date: 01/07/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: patient that had received two Fluzone Quad vaccinations during this flu season. The first one was administered on 10/2/2020 and the second one on 01/17/2021/no AE; Initial information received on 08-Jan-2021 regarding an unsolicited valid non-serious case received from an other health professional. This case involved a 57 year old female patient who received 0.5 ml of two INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number: UJ506AB and expiry date: 30-Jun-2021) via unknown route in right deltoid for prophylactic vaccination during this flu season. The first one was administered on 02-Oct-2020 and the second one on 07- Jan-2021 (Extra dose administered). Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. It was an actual medication error case due to extra dose administered (latency 3 months 5 days post the first dose). 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 holders 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: 0976984
Sex: M
Age:
State: MN

Vax Date: 11/24/2020
Onset Date: 11/24/2020
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: an infant was administered Quadracel instead of Pentacel with no AE; Initial information regarding this unsolicited valid non-serious case from the via Global Medical Information (GMI) (Reference number- 00418272) was received from nurse 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 DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] instead of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot: C5755AB, expiration date: 10-Jul-2022), an infant was administered Quadracel instead of Pentacel (Wrong vaccine administered). The dose was given in the right thigh via intramuscular route. The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant medication included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) for Immunisation; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and INFLUENZA VACCINE (INFLUENZA VACCINE). It was a potential medication error due to wrong vaccine administered (Wrong product administered). At the time of reporting, the vaccine was administered. 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: PREVENAR 13; ROTAVIRUS VACCINE; INFLUENZA VACCINE

Current Illness:

ID: 0976985
Sex: F
Age: 65
State: FL

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: inadvertently administered Fluzone Quadrivalent instead of Prevnar with no AE; inadvertently administered Fluzone Quadrivalent High-Dose vaccine and Fluzone Quadrivalent instead on same day with no AE; Initial information regarding this unsolicited valid non-serious case was received from Pharmacist via The Agency (Reference number- 00422121) and transmitted to Sanofi on 08-Jan-2021. This case involves a 65 years old female patient who received a dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (prefilled syringe, lot UJ565AB, expiration date 30-Jun-2021) via intramuscular route in the left deltoid and then inadvertently received a 0.5ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (prefilled syringe, lot UJ442AA, expiration 30 June 2021) via intramuscular route in the right deltoid both for prophylactic vaccination (extra dose administered) instead of PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) [PREVENAR] on 08-Jan-2021 (wrong product administered). The patient's medical history, medical treatments, vaccinations and family history were not provided. Patient received no other concomitant vaccines. It was a actual medication error due to wrong vaccine administered and extra dose administered (latency-same day). At the time of reporting, no adverse event was reported. The reporter stated that she grabbed the Fluzone Quadrivalent prefilled syringe box instead of the Prevnar box because the boxes for the two vaccines look very similar. Prevnar was not administered. Repoert stated that doctor information not available since the vaccines were administered at a retail pharmacy. The reporter had been trying to reach the patient, but not spoken to the patient since the error. 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: 0976986
Sex: U
Age:
State: MO

Vax Date:
Onset Date:
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Ipol that was not suitable for use due to being involved in the temperature excursion with no AE; Initial information regarding this unsolicited valid non-serious case from the via Global Medical Information (GMI) (Reference number- 00422264) was received from Other Healthcare Professional on 08-Jan-2021. This case involved seven patients (unknown demographic) who received dose of IPV (VERO) [IPOL] (lot number and expiration date not reported), that was not suitable for use due to being involved in the temperature excursion (product storage error). [caller did not have patient information or had the vaccine information] The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided. It was a case of actual medication error due to incorrect product storage error. It was reported, nurse advised punctured IPOL was given to patients after temperature excursion in which they had gone out of range wanted to know if they should re-vaccinate those patients. 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. There will be no information available on batch number for this case.

Other Meds:

Current Illness:

ID: 0976987
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: patient inadvertently received 2 doses of Menacta 1 year apart from 2 different providers with no AE; Initial information was received on 14-Jan-2021 regarding an unsolicited non-valid non-serious case from a physician. This case involves a 13 years old patient who inadvertently received 2 doses of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] 1 year apart on unknown dates from 2 different providers (extra dose administered) (lot number: unknown and expiry date: unknown] via an unknown route at an unknown administration site for prophylactic vaccination. Medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was an actual medication error due to extra dose administered (latency: unknown). Reporter wanted to know if there were any concerns after this error. At the time of report, no adverse event was reported. Disclaimer: 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. There will be no information available regarding batch number in this case.

Other Meds:

Current Illness:

ID: 0976988
Sex: U
Age:
State: MA

Vax Date:
Onset Date:
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: A patient received a partial dose of PENTACEL, whereby DTaP and IPV were administered, but the HIB was not, no AE; Initial information was received on 14-Jan-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional. This case involves a patient (demographics unknown) who received a partial dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] whereby DTAP and IPV were administered, but the HIB was not, (batch number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination on an unknown date (Product preparation issue). Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. It was a case of an actual medication error due to Inappropriate reconstitution technique (latency same day). The reporter asked if the HIB could be given separately At the time of report, 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. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 0976994
Sex: F
Age: 80
State: NY

Vax Date: 08/01/2018
Onset Date:
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Become ill; 1st dose of Shingrix on August 2018 and has not completed the schedule/because of the pandemic, the patient did not receive the 2nd dose; This case was reported by a pharmacist and described the occurrence of illness in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In August 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced illness and social problem. On an unknown date, the outcome of the illness and social problem were unknown. The reporter considered the illness to be unrelated to Shingrix. Additional information was provided as follows: The age at vaccination was not applicable for 2nd dose. The patient did not complete the schedule. The patient become ill a time later after receiving the 1st dose (he said it was not related to the vaccine, did not specify which illness) and then because of the pandemic, the patient did not receive the 2nd dose. The reporter did not have vaccination details but agreed to follow up.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm