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: 1051411
Sex: F
Age:
State: FL

Vax Date: 02/06/2021
Onset Date: 02/06/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: nausea; felt tired; Rash is red and she can feel bumps; rash is red and she can feel bumps; pain at the injection site; itching going on in my face, my left arm, in the elbow / stomach about 2 inches to the left where they made the incision for the cancer removal; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL9269), via an unspecified route of administration into left arm on 06Feb2021 (at the age of 67-years) as a single dose for COVID-19 immunization. Medical history included allergic to peanuts, allergic to Penicillin, cancer and hysterectomy. There were no concomitant medications. The patient previously took vancomycin, cefalexin (KEFLEX) and zelnorm and was allergic. On 06Feb2021, the patient had pain at the injection site, but that was gone now. She also experienced rash, which was elaborated as an itch, like a rash that started since she got the shot. She had the itching rash going on into her face, left arm, the elbow, and also 2 inches from naval on the left side where she had incision from cancer removal, hysterectomy. The rash was started in the area of the hysterectomy. The patient elaborated that the rash was red and she can feel bumps. The patient was taking diphenhydramine hydrochloride (BENADRYL) which usually stop the itching. Last night 06Feb2021, the back of her left elbow and her face started itching as well and at 23:30 the patient experienced nausea and felt tired. The patient is scheduled for second dose on 27Feb2021. The clinical outcome of event rash is red and she can feel bumps was not recovered. The outcome of pain at the injection site was recovered in Feb2021. The clinical outcome of other events was unknown.

Other Meds:

Current Illness:

ID: 1051412
Sex: F
Age:
State:

Vax Date: 01/18/2021
Onset Date: 02/04/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: they both have covid; they both have covid; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients (herself and her husband). This is first of two reports. A female patient of an unspecified age (reported as 70, unit unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. The patient's medical history included pneumonia. The patient's concomitant medications were not reported. The patient reported that she received the first dose of the Pfizer COVID vaccine on 18Jan2021, and her husband on 20Jan2021. She was diagnosed with COVID last Thursday (04Feb2021). She said she got it from her husband. They both have COVID and received antibodies (from (company name)) as it was mild case. She said she and her husband were congested, had fatigue, and the antibodies made a difference. She had pneumonia before. The patient stated so many people can only take the first dose due to side effects or some other reason. She wanted to know the time they needed to wait to get the second dose of the vaccine and asked if it was 90 days. The outcome of the event was unknown. Information about the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021171730 Same reporter, drug, and events; different patients

Other Meds:

Current Illness:

ID: 1051413
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Pain at the injection site that started about 3hrs after injection; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL3247, first dose) solution for injection intramuscular on an unknown date (at the age of 30-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced pain at the injection site that started about 3 hours after injection. No treatment was provided for the event pain at the injection site. The outcome of the event pain at the injection site was unknown. The patient was not tested for COVID post vaccination. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1051414
Sex: F
Age:
State: NJ

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: I felt like I was going to pass out; suddenly all over my body under my skin was burning everywhere; my heart was pounding so fast; dizzy; seeing blurry; tongue was stinging; eye lids were burning; I didn't feel right the whole rest of the night.; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231/212080597001), the first dose, via an unspecified route of administration on 31Dec2020 18:30 at single dose for covid-19 immunisation. Medical history included High Cholest. Type 2 Diabetes, High Blood Pressure, Fatty Liver, Overweight, and allergies to medications: Penicillin. Concomitant medication included levothyroxine sodium (UNITHROID), olmesartan medoxomil (BENICAR), rosuvastatin, empagliflozin, linagliptin (GLYXAMBI), escitalopram oxalate (LEXAPRO). After injections (on 31Dec2020) when to sit down, suddenly all over my body under my skin was burning everywhere and my heart was pounding so fast I thought it was going to come out of my chest. I got dizzy and was seeing blurry. At the end my tongue was stinging and my eye lids were burning. I felt like I was going to pass out. Then finally subsided but I didn't feel right the whole rest of the night.Therapeutic measures were taken as a result of all events. The outcome of events was recovered.Prior to vaccination, the patient did not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19. The case considered non-serious (Seriousness criteria-Results in death: No;Life threatening: No;Caused/prolonged hospitalization: No;Disabling/Incapacitating: No;Congenital anomaly/birth defect:No). Follow-up attempts are completed. No further information is expected.

Other Meds: UNITHROID; BENICAR; ROSUVASTATIN; GLYXAMBI; LEXAPRO

Current Illness:

ID: 1051415
Sex: F
Age:
State: CA

Vax Date: 02/06/2021
Onset Date: 02/06/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data: Test Name: height; Result Unstructured Data: Test Result:She used to be over 5 but she shrunk.; Test Name: Weight; Result Unstructured Data: Test Result:226 lbs; Comments: used to be at 226 lbs, it came up to 230; Test Date: 2021; Test Name: Weight; Result Unstructured Data: Test Result:went up

Allergies:

Symptoms: muscle and joint pain; wanting to faint/dizziness; blurry eyes; sweating; unable to sleep the whole night as a result of lots of pain in her wrist and hand but especially thumb/wrist on the right side; unable to sleep the whole night as a result of lots of pain in her wrist and hand but especially thumb/wrist on the right side/she was having pain on her wrist/joint pain; unable to sleep the whole night as a result of lots of pain in her wrist and hand but especially thumb/wrist on the right side; swelling in her hand and was hardly able to bend her fingers; swelling in her hand and was hardly able to bend her fingers; wrist was swollen; itchiness, numbness and tingling in her fingers on the right side; itchiness, numbness and tingling in her fingers on the right side; itchiness, numbness and tingling in her fingers on the right side; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN5318), via an unspecified route of administration on 06Feb2021 15:00 at single dose at left arm for covid-19 immunisation. Medical history included wrist had arthritis (pain). There were no concomitant medications. Patient height was a little less than 5. She used to be over 5 but she shrunk. Her weight used to be at 226 lbs, it came up to 230. This year (2021) it went up because, its her, she ate too much and she did not obey the rules. Patient received Pfizer vaccine on 06Feb2021 afternoon at 300 pm in her left arm and that night developed itchiness, numbness and tingling in her fingers on the right side. Last night (07Feb2021) she unable to sleep the whole night as a result of lots of pain in her wrist and hand but especially thumb/wrist on the right side. she also reported swelling in her hand and was hardly able to bend her fingers. She tried to bend her fingers and she can but her wrist was swollen, it was less right now but she still had the pain. She applied muscle relaxant (unclear if topical) and took paracetamol (TYLENOL) and massaged her hand with warm water and then for the second time she used the muscle relaxation. She hadn't taken paracetamol yet she was waiting 4 hours but the pain was still there, it was a little bit less. Not sure if it her arthritis or side effects from vaccine but believes it was from the vaccine. Stated she used to have the same problem with her wrist arthritis (pain). Also reported that she experienced additional side effects on 08Feb2021 which lasted about 5 minutes then went away: blurry eyes; wanting to faint; dizziness, sweating (whole body started to be like sweaty). Asking for information on muscle and joint pain after the vaccine and recommendations on what to do. So far she didn't know what it was, and if it was a side effect of the arthritis, because once in a while that happens but when it happened it went away right away but this time her wrist pain was there still there. Patient sat down and now she was stretching her leg, she sat down on the chair and its gone she had no more problems. Patient said her right hand, she was very slow writing. She said at least she can write her hand was going back to a routine but she was in a lot of pain. Outcome of event wanting to faint/dizziness, blurry eyes, sweating was recovered on 08Feb2021, and outcome of other events was unknown.

Other Meds:

Current Illness:

ID: 1051416
Sex: F
Age:
State: KS

Vax Date: 01/01/2014
Onset Date:
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: The vaccine might not have been effective on her; she received 3 different doses of the vaccine, the first one in Jan2014, the second one in Feb2016 and the last one in Sep2019.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13 solution for injection in pre-filled syringe; lot number and expiry date: unknown), via an unspecified route of administration, first dose in Jan2014, second dose in Feb2016, and third dose in Sep2019 , at single doses, for immunization. Relevant medical history included asthma, high blood pressure and allergies. Concomitant medications were not reported. The patient previously received flu vaccine for flu vaccination and experienced allergic reactions. The patient wanted to know if there was a previous version of PREVNAR 13. She wanted to know how often a patient should receive a shot. The patient stated that she received 3 different doses of the vaccine, the first one in Jan2014, the second one in Feb2016 and the last one in Sep2019. She stated during the call that her physician indicated that she should receive an additional dose because the vaccine might not have been effective on her. Outcome of the event "The vaccine might not have been effective on her" was unknown. The patient also wanted to know if she can receive the COVID-19 vaccine manufactured by Pfizer if she has medical history of allergies, asthma and high blood pressure and if she can receive a list of the risks of the vaccine. No follow up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1051417
Sex: F
Age:
State: CA

Vax Date: 06/01/2019
Onset Date: 01/30/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:165/79; Test Name: blood pressure; Result Unstructured Data: Test Result:162/79; Test Name: blood pressure; Result Unstructured Data: Test Result:150/79; Test Name: thyroid level; Result Unstructured Data: Test Result:82; Test Name: thyroid level; Result Unstructured Data: Test Result:high on the test with a result of 7.46

Allergies:

Symptoms: She thought she was going to pass out; felt like she was going to faint; chin felt funny; face was red; face was burning; This is a spontaneous report from a contactable consumer(patient). An 83-year-old female patient received first dose of BNT162B2(Covid-19 vaccine, lot number EL8982), via an unspecified route of administration on 27Jan2021 10:00 at single dose, left arm for protection from virus, vitamin D(lot number 15070802 with expiration date Jun2023, Non-Pfizer product, manufacturer: 21st Century), orally from 2019 and ongoing at 2000 iU, daily, (25 mcg/1000 IU, takes 2 by mouth daily) for bones, vitamin b complex (B COMPLEX, lot number 14704704 with expiration date Apr2023, Non-Pfizer product, manufacturer: 21st Century), orally from 2019 and ongoing at unknown dose, daily, (2 by mouth daily) for energy, digoxin(Non- Pfizer product), orally from Jun2019 and ongoing at 0.125 mg, daily to slow the heartbeat, rosuvastatin(Non- Pfizer product), orally from 2019 and ongoing at 20 mg, daily to lower cholesterol. Medical history included high blood pressure, blood thinner, low thyroid. Concomitant medication included hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ) from 2019 and ongoing for high blood pressure, rivaroxaban (XARELTO) from Nov2020 and ongoing as blood thinner, levothyroxine from an unknown date and from Nov2020 and ongoing for low thyroid(had been taking for 25 years or more). History of all previous immunization with the Pfizer vaccine considered as suspect reported as None. Prior Vaccinations (within 4 weeks) reported as None. The patient experienced felt like she was going to faint on 30Jan2021 with outcome of recovered on 30Jan2021, chin felt funny on 30Jan2021 with outcome of recovered 30Jan2021, face was red on 30Jan2021 with outcome of unknown, face was burning on 30Jan2021 with outcome of recovered on 30Jan2021. Caller was asking if she should get the second shot. She went to her doctor and was told it was ok if she got the second shot. The doctor said it was too far between the shot and the reactions for it to be the shot. She received the vaccine on 27Jan2021. On Saturday morning she took Vitamin D, B complex, Digoxin and Rosuvastatin. Twenty minutes later her chin felt funny. Her face was red and burning. She felt like she was going to faint. She got some ice and washed her face. She took 2 baby aspirin. She asked her doctor if she was allergic to the vaccine. Her doctor said the time between getting the vaccine and the events were too far between. She thought she was going to pass out. She felt better after washing her face with ice. She was her face for 30-45 minutes with ice water. She took apixaban (ELIQUIS) before and her chin felt funny. She added that her blood pressure went up and she had trembles. She felt dizzy. Clarified that she felt that way prior to taking the vaccine. At first she didn't think to take her blood pressure. When she took it the reading was 165/79. At 3:00 pm the reading was 162/79. At 6:00 pm the reading was down to 150/79. The trembles started two hours after she took her medications. When providing product details she stated she took two Vitamin D. The label indicated to take one. When asking for indication caller asked what does Vitamin D do? She was able to answer herself. Product is filled in a pharmacy bottle and does not include NDC, Lot or expiry. Prior to taking rivaroxaban (XARELTO), she was taking apixaban (ELIQUIS) 5 mg twice daily. Lot: ABL8694A, Expiry: Dec2022, It came from another country. She was sure she was allergic to it because she had a rash. That was when she was switched to rivaroxaban. She was taking levothyroxine 100 mcg until she turned 82. In Jan2021, the dose was changed to 112 mcg daily. Her last thyroid level was high on the test with a result of 7.46. The dose was changed to 112 mcg daily. Initially caller gave consent to contact her physician. She changed her mind stating she didn't want her doctor to think she was going over her head. She was worried and frightened at the time because something happened to her. She can't remember if her face was swollen. She drank some ice cold water and took two baby aspirins. She knew she needed to flush her system. She just wanted to make she was safe in getting the shot. Her doctor told her to take diphenhydramine hydrochloride (BENADRYL) if she ever felt that way. She felt fine after getting the shot and the few days after getting it. She wanted to get the shot. Events resulted in physician office visit. The action taken in response to the events for vitamin D, vitamin b complex, digoxin, rosuvastatin was dose not changed. The outcome of event "She thought she was going to pass out" was unknown.

Other Meds: TRIAMTERENE HCTZ; XARELTO; LEVOTHYROXINE; DIGOXIN; ROSUVASTATIN; B COMPLEX [VITAMIN B COMPLEX]; VITAMIN D [VITAMIN D NOS]

Current Illness:

ID: 1051418
Sex: M
Age:
State:

Vax Date: 02/08/2021
Onset Date:
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: a mild kidney infection; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (reported as 70; unit unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on 08Feb2021 at SINGLE DOSE for covid-19 imunisation. Patient's medical history and concomitant medications were not reported. It was reported that patient received first dose of the Covid vaccine yesterday (08Feb2021). Patient reported that it appears he has a mild kidney infection on an unspecified date in which his urologist has prescribed ciprofloxacin to take. Patient asked if an antibiotic will interfere with his vaccination. Outcome of the event was unknown. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1051419
Sex: M
Age:
State: IN

Vax Date: 02/08/2021
Onset Date: 02/09/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: diverticulitis, his condition flares up every once in a while; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Feb2021 at a single dose for COVID-19 immunization. Medical history included diverticulitis. Concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on an unspecified date for COVID-19 immunization. The patient was concerned about efficiency of the vaccine. He received a second dose of bnt162b2 yesterday morning and today (09Feb2021) he was experiencing bout of diverticulitis and his doctor has given him couple of antibiotics, one of them being Cipro and the other was Flagyl to treat diverticulitis and he was just concerned given he just received a vaccine if those antibiotics would affect the efficiency of the vaccine. He was concerned because he has been given antibiotics by his doctor for when his condition flares up every once in a while. The doctor gave him Cipro and Flagyl. He was wondering if he takes these, if it will have any impact on the efficacy of the vaccine. He thinks the flare up was coming on before the shot so he didn't want to do a report. The outcome of the event was unknown. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1051420
Sex: F
Age:
State: NC

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data: Test Date: 20210203; Test Name: blood pressure; Result Unstructured Data: Test Result:140/82; Test Date: 20210203; Test Name: Temperature; Result Unstructured Data: Test Result:99 - 101 Fahrenheit

Allergies:

Symptoms: Headache; Temperature 99 - 101 F; tiredness; higher blood pressure then usual (140 X 82); administration date=02Feb2021, dose number=2/administration date=20Jan2021, dose number=1; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247) on her right arm, via an unspecified route of administration on 02Feb2021 10:30 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 (first dose) for covid-19 immunization. The patient experienced Headache, Temperature 99 - 101 F, tiredness, higher blood pressure than usual (140/82); all on 03Feb2021 06:00 AM. Patient received Ibuprofen 200 as treatment for the events. The outcome of the events was recovered on unspecified dates.

Other Meds:

Current Illness:

ID: 1051421
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: green bile coming out of my behind/ having little green bowel; Bowel like a diarrhea, or bowel movement; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program Pfizer First Connect. An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient stated "I am experiencing green bile coming out of my behind. Can your covid-19 vaccine cause that?" It was clarified as seeing green bile after going to the bathroom and having a stool. It was stated that Sunday she started having little green bowel until today; bowel like a diarrhea or bowel movement. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1051422
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Fever; This is a spontaneous report from a contactable physician. A 17-year-old female patient started to received meningococcal group b rlp2086 (TRUMENBA, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, a physician mentioned that she administered the first dose of the Trumenba vaccine to a 17 year old patient last Saturday and the patient was still having fever. She would like to know if there was record of fever lasting this long. The outcome of the event was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1051423
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: viral meningitis, losing function in his legs; viral meningitis, losing function in his legs; headache; dizziness; fatigue; nausea; weak; This is a spontaneous report from a contactable consumer. A 66-year-old male patient received their first dose of 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 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient kept having very very bad headaches, dizziness, fatigue, nausea, for several days about a whole week and experienced "viral meningitis, losing function in his legs and he's still weak and having issues". The outcome of the events was unknown. information on the LOT/Batch number has been requested

Other Meds:

Current Illness:

ID: 1051424
Sex: F
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Cough; Fever; Chills; Body aches; This is a spontaneous report from a contactable consumer. A 28-year-old female patient receive the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration at left arm from an unspecified date at a single dose for COVID-19 immunisation. The patient had no medical history. The patient is not pregnant. There were no concomitant medications. On an unspecified date, after first vaccine for two weeks, the patient had a cough, couple days of fever, chills and body aches. The outcome of the events was unknown. Information on the lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 1051425
Sex: F
Age:
State: PA

Vax Date: 01/20/2021
Onset Date: 01/28/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Little bit of arm soreness; 8 days after vaccine I experienced swollen lymph nodes under arm; Swelling and pain of injection site; Swelling and pain of injection site; Fever; Chills; 3 by 5 inch red circle and swelling around injection site/arm turned red; This is a spontaneous report from a contactable other healthcare professional (medical receptionist -patient). A 47-years-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number, EL3246, expiration date unknown), via an unspecified route of administration on the left arm on 20Jan2021 at 17:30 at the age of 47 years old at a single dose for COVID- 19 immunisation in the hospital. Medical history included mitral valve prolapse, gallstones , hypertension and crab allergy. Concomitant medications included lisinopril and hydrochlorothiazide. The patient did not receive vaccines in four weeks. On 28Jan2021 at 07:00 AM, the patient had a little bit of arm soreness initially. The patient experienced swollen lymph nodes under arm, swelling and pain of injection site, fever and chills. On the 9th day after vaccine (29Jan2021), patient had a 3 by 5 inch red circle and swelling around injection site. It was also reported that the arm and lymph nodes swelled. The patient had fever and chills. Then her arm turned red. As of 05Feb2021, the swollen mark which is about 5x4 inches is swelling again. The patient's next dose is scheduled for 10Feb2021. She is really concerned about getting the second dose. The events were assessed as non-serious by the reporter. It was unknown if the patient received a treatment in response to the events. The patient was not diagnosed with COVID-19 prior t vaccination and was not tested for COVID-19 post vaccination. The outcome of the event was unknown.

Other Meds: LISINOPRIL; HYDROCHLOROTHIAZIDE

Current Illness:

ID: 1051426
Sex: F
Age:
State: FL

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

Lab Data:

Allergies:

Symptoms: anaphylactic reaction; Flush face with itching; Flush face with itching; throat became itchy; tongue tingled; sore/scratchy throat; metal taste in mouth; shakiness (like internal vibration); This is a spontaneous report from a contactable other hcp. A 42-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration arm left single dose on 03Feb2021 08:00 for covid-19 immunisation. Medical history included depression, anxiety, drug hypersensitivity to codeine, sulfa meds, influenza vaccine, food allergy to quinoa. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), colecalciferol (D3), docosahexaenoic acid, eicosapentaenoic acid, tocopherol (OMEGA 3), probiotics. The patient experienced anaphylactic reaction on 03Feb2021 08:30, flush face with itching on 03Feb2021 08:30, throat became itchy on 03Feb2021 08:30, tongue tingled on 03Feb2021 08:30, sore/scratchy throat on 03Feb2021 08:30, metal taste in mouth on 03Feb2021 08:30, shakiness (like internal vibration) on 03Feb2021 08:30. Patient went to Emergency Room and was treated with Benadryl, Pepcid C, Decadron, Epi. The outcome of the events was not recovered. Information on the lot/batch number has been requested; Sender's Comments: Based on the available information, a possible contribution of the drug to the event anaphylactic reaction cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: WELLBUTRIN; D3; OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL]

Current Illness:

ID: 1051428
Sex: F
Age:
State: MI

Vax Date: 02/09/2021
Onset Date: 02/10/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data: Test Date: 20210210; Test Name: Body temperature; Result Unstructured Data: Test Result:100.6; Comments: low grade fever

Allergies:

Symptoms: achiness; low grade fever 100.6; fatigue; This is a spontaneous report from a contactable consumer. A 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL3248), via an unspecified route of administration on the left arm at the age of 55 years, on 09Feb2021 16:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication included ibuprofen (IBUPROFEN), colecalciferol (VITAMIN D), vitamin c [ascorbic acid] (VITAMIN C) and Multi Vitamin. The patient had the first dose last 20Jan2021. The patient experienced achiness, low grade fever 100.6 and fatigue on 10Feb2021. The patient underwent lab tests and procedures which included body temperature: 100.6 on 10Feb2021. No treatment was received for the adverse events. The outcome of events was recovered on unspecified date.

Other Meds: IBUPROFEN; VITAMIN D; VITAMIN C

Current Illness:

ID: 1051429
Sex: U
Age:
State: OH

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: bad nose bleed/It's bleeding in the back of my nose; the clots are so big that I gag when I expel them; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 on 01Feb2021 at single dose for covid-19 immunization. Medical history was not reported. Concomitant medications included warfarin sodium (COUMADIN). On 02Feb2021, patient had a bad nose bleed which patient stopped. On 03Feb2021 paitent was ok and on 04Feb2021 patient got a nose bleed that patient could not stop and still have to be careful and not do anything as it starts all over again. It's bleeding in the back of nose also and the clots are so big that patient gag when patient expel them. The outcome of the event was not recovered. Information on batch/lot number was requested.

Other Meds: COUMADIN

Current Illness:

ID: 1051430
Sex: F
Age:
State: NJ

Vax Date: 02/03/2021
Onset Date: 02/01/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data: Test Name: Test; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptoms: sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes; Swollen soft palate, nose, eyes; Swollen soft palate, nose, eyes; scratchy throat on eating red meat, milk, or cheese; muscle and joint pain; earache; pain was all over; muscle and joint pain; headache; exhaustion; pain at injection site; slight fever; mild nausea; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL9264), on right arm via an unknown route of administration on 03Feb2021 13:45 for COVID-19 immunization. Medical history included VonWillebrand's and history of lyme disease. The patient had allergy to peanut and allergy to latex. Concomitant medications included unspecified vitamin supplements. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3302) on Left arm, on 13Jan2021 13:30 for COVID-19 immunization. Patient stated, "After first shot in left arm, only on her left side she had: Muscle and joint pain, earache, goopy eye, headache, exhaustion, and pain at injection site from 12 hours to 36 hours after shot administered. Second shot in right arm: Same as above (muscle and joint pain, earache, headache, exhaustion, and pain at injection site), although no eye drainage and pain was all over with slight fever, mild nausea in Feb2021. Lasted from 12 hours to 36 hours after the test. Arm remained sore longer, but not problematic. Bizarre possible response: 6 days after second shot on 09Feb2021 17:30, the patient experienced sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes, scratchy throat on eating red meat, milk, or cheese. Patient did not need epi-pen but needed double dose of benadryl. Events resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Benadryl and epi-pen on hand was received as treatment for events. The events were assessed as non-serious by the reporter. Outcome of events muscle and joint pain, earache, headache, exhaustion, pain at injection site, pain was all over, slight fever, mild nausea was recovered in Feb2021, whereas outcome for other events was reported as unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1051431
Sex: F
Age:
State: AL

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: pneumonia; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration in Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Three weeks after the first vaccination, the patient experienced pneumonia on an unspecified date. The outcome of event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1051432
Sex: F
Age:
State: NC

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

Lab Data:

Allergies:

Symptoms: Headache; Tiredness; Fever; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), via an unspecified route of administration on 09Feb2021 at 17:00 at a single dose on the right arm for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. 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. The patient was not pregnant at the time of vaccination. On 09Feb2021 at 19:00, the patient experienced headache, tiredness and fever. Patient received Acetaminophen as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events were recovered on an unspecified date. The events were considered non-serious.

Other Meds:

Current Illness:

ID: 1051433
Sex: M
Age:
State: NY

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data: Test Date: 20210211; Test Name: Heart beat; Result Unstructured Data: Test Result:Slight increased

Allergies:

Symptoms: Slight increased heartbeat for about one hour; Headache for the rest of the day; This is a spontaneous report from a contactable consumer (patient) reported that a 64-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: En-6201, expiry date unknown) in the hopsital via an unspecified route of administration on 11Feb2021 at 12:00 at a single dose on the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced slight increased heartbeat for about one hour at 12:30 then a headache for the rest of the day both on 11Feb2021. The outcome of the event slight increased heartbeat for about one hour was recovered on 11Feb2021 at 13:30 and the outcome of the event headache for the rest of the day was recovered on Feb2021. The patient did not receive treatment for the events. The events was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19.

Other Meds:

Current Illness:

ID: 1051434
Sex: F
Age:
State:

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: sore arm and headache overnight; sore arm and headache overnight; This is a spontaneous report from a non-contactable consumer (patient). A 35-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration (right arm), on 11Feb2021 10:00, at single dose, for covid-19 immunization. Medical history included celiac disease. Concomitant medication included bupropion. The patient experienced sore arm and headache overnight on 11Feb2021 18:00. The patient recovered from the events on 12Feb2021. The patient took ibuprofen (ADVIL) as treatment for the events (self-prescribed). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination. No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.

Other Meds: BUPROPION

Current Illness:

ID: 1051435
Sex: F
Age:
State: CO

Vax Date: 01/31/2021
Onset Date: 02/05/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Fatigue; Body Aches/Soreness; Chills; Swollen and Sore Tongue; Swollen and Sore Tongue; Diarrhea; Loss of Appetite; Throat swelling; Headache; Malaise; Shortness of Breath; Thick Mucus in Nose & Throat; Thick Mucus in Nose and Throat; Horseness and Sore Throat; Horseness and Sore Throat; This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on right arm on31Jan2021 08:30 at single dose for COVID-19 immunisation. Medical history included autoimmune, tachycardia, acid reflux, penicillin allergy, walnuts allergy. Concomitant medication included estradiol and levothyroxine. The patient previously took lanolin and erythromycin and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Feb2021 patient experienced fatigue, body aches/ soreness, chills, swollen and sore tongue, diarrhea, loss of appetite, throat swelling requiring 2 visits to the ER (emergency room). Culminating in Steroid injection and oral Prednisone. Headache, malaise, shortness of breath, thick mucus in nose and throat, hoarseness and sore throat. The adverse events result in Doctor or other healthcare professional office/ clinic visit and Emergency room/department or urgent care. The seriousness of the events was assessed as non-serious by the reporter. Therapeutic measurements were received for the events with steroid injection at the ER and oral Prednisone. The outcome of the events was reported as not recovered. Information on the lot/batch number has been requested.

Other Meds: ESTRADIOL; LEVOTHYROXINE

Current Illness:

ID: 1051437
Sex: F
Age:
State: TX

Vax Date: 02/14/2021
Onset Date: 02/14/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: lips swelling; This is a spontaneous report from a contactable consumer reported for herself. A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot number #EL9267on 14Feb2021 09:00 AM (at 58 year old) at single dose via unspecified route at the left arm, for COVID-19 immunization. Medical history included Anaphylactic reaction to the Capsaicin Family, thyroid and High Blood Pressure. Concomitant medications included levothyroxine sodium (SYNTHROID), lisinopril, verapamil and loratadine (CLARITIN). The patient was not pregnant. No COVID prior vaccination. The patient had not been tested for COVID since the vaccination. On 14Feb2021 09:15 AM the patient experienced lips swelling. The outcome of the event was unknown. The patient visited Emergency room for the event and treatment was received, steroid shot and prednisone for 5 days.

Other Meds: SYNTHROID; LISINOPRIL; VERAPAMIL; CLARITIN

Current Illness:

ID: 1051438
Sex: F
Age:
State: OK

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data: Test Name: temperature; Result Unstructured Data: Test Result:96 and 97 usually; Test Date: 20210203; Test Name: temperature; Result Unstructured Data: Test Result:100.4; Test Date: 20210204; Test Name: temperature; Result Unstructured Data: Test Result:99.2

Allergies:

Symptoms: feeling weak; shaky; fever, 100.4; her eyes start feeling funny and burning when she has a fever; her eyes start feeling funny and burning when she has a fever; arm was a little sore; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar event for two patients. This is the first of 2 reports. A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration at the right upper arm close to the shoulder on 02Feb2021 07:30 at single dose as she doesn't want to get COVID again or give COVID to anyone else. Medical history included metabolic syndrome from 1994 and ongoing, it all started when she was 46 and it runs in her family and it was a genetic thing; ongoing diabetes mellitus, was diagnosed when she was 65, so 7 years ago; she had COVID in Nov2020 but it was just a very mild case and she just had a cough; and cardio artery problems. She takes a lot of medications and she has metabolic syndrome which includes cardio artery problems and diabetes, but she has taken all of those medications for a long time. The patient says she was calling to report a couple little concerns she has. She received her shot on Tuesday, 02Feb2021 at about 7:30 in morning and her arm started at about 2 to 3 in the afternoon and she noticed it was getting sore, but it was no big deal, she did not think anything of it, and on the second day she thought that was it and she was over it on 03Feb2021. She states her husband also mentioned that he had soreness in his arm after his vaccination. She says at three in the afternoon on 03Feb2021, she started feeling weak and shaky, but she didn't think much of that. She says this began around 3 to 4 when yesterday afternoon, 03Feb2021, she had a fever. She says she took her temperature and it was 100.4 and that all kind of was gone by the evening but when she woke up this morning, she was weak and shaky again. Today she got up and was weak and shaky and it never left, she was still weak and shaky. The patient mentions that she was diabetic so she can get weak and shaky when she needs to eat something, but she had just eaten, and she ate yesterday so she doesn't think it was caused by that. The patient says she thinks we should know that she was diabetic. She says then she could tell that she had a fever, so she took her temperature and it was 100.4 which for her was high. She states she didn't even have a fever when she had COVID. The fever began yesterday afternoon (03Feb2021). She says her eyes start feeling funny and burning when she has a fever and they felt that way so that's why she took her temperature. This was the highest it has been in years. She says last night she took her temperature again and the fever had gone away in 30 to 40 minutes, so she thought it was over. She took her temperature again before she called this morning, 04Feb2021 and it was 99.2, which was still a little hot for her. She says for her that's a fever. She was 96 and 97 usually. The patient says she still feels like she has a little fever. She was not someone who usually has a fever and it can be just a little bit of a fever for instance like this morning when she was 99.2. Her eyes were still feeling funny and burning this morning and that was why she took her temperature this morning. The outcome of the event arm was a little sore was recovered on 03Feb2021; feeling weak and shaky was not recovered; fever and her eyes start feeling funny and burning when she has a fever was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021162089 Same reporter/drug, similar event, different patient

Other Meds:

Current Illness: Diabetes (Caller says she was diagnosed when she was 65, so 7 years ago.); Metabolic syndrome (She says it runs in her family and it is a genetic thing.)

ID: 1051439
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: swelling around left wrist and hand-same arm as vaccine injection site; "a little fever", "felt a little warm. A little unwell, not that bad"; swelling around left wrist and hand-same arm as vaccine injection site; pain/throbbing pain at the swelling location; A little unwell, not that bad; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced swelling around left wrist and hand-same arm as vaccine injection site. He also said there was pain/throbbing pain at the swelling location. He also had "a little fever", "felt a little warm. A little unwell, not that bad". He did not take his temperature but stated "I took Tylenol and iced swelling location, it helped some. It is not quit as bad today, no more throbbing pain, still swelling and sore". The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1051440
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Shot was very painful; This is a spontaneous report from a Pfizer-sponsored program. A contactable healthcare professional (patient) reported that a male patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (Diphtheria CRM 197 Protein) (PREVNAR 13; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on an unspecified date, at a single dose, for invasive pneumococcal disease (immunization). The patient's medical history and concomitant medications were not reported. The patient received pneumococcal 13-valent conjugate vaccine (Diphtheria CRM 197 Protein) and the shot was very painful on an unspecified date. The outcome of the event was unknown. No follow-up attempts are needed; information about batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1051441
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Shot was very painful; This is a spontaneous report from a Pfizer-sponsored program, 2020_2021 Strategy Research. A contactable healthcare professional (patient) reported that a male patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (Diphtheria CRM 197 Protein) (PREVNAR 13; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on an unspecified date, at a single dose, for invasive pneumococcal disease (immunization). The patient's medical history and concomitant medications were not reported. The patient received pneumococcal 13-valent conjugate vaccine (Diphtheria CRM 197 Protein) and the shot was very painful on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1051442
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Shot was very painful; This is a spontaneous report from a Pfizer-sponsored program. A contactable healthcare professional reported that a male patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (Diphtheria CRM 197 Protein) (PREVNAR 13; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on an unspecified date, at a single dose, for invasive pneumococcal disease (immunization). The patient's medical history and concomitant medications were not reported. The patient received pneumococcal 13-valent conjugate vaccine (Diphtheria CRM 197 Protein) and the shot was very painful on an unspecified date. The outcome of the event was unknown. No follow-up attempts are needed; information about batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1051443
Sex: M
Age:
State: OK

Vax Date:
Onset Date:
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: soreness in his arm after his vaccination; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for 2 patients. This is the second of two reports. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's wife received the shot and she noticed her arm was getting sore. The wife stated that the patient (her husband) also mentioned that he had soreness in his arm after his vaccination, but she does not think she wants to complete a report for her husband who had a sore arm from the COVID vaccination. She says he was not here right now, and he doesn't have anything wrong with him. She doesn't really think that he has anything else and she doesn't think it was that sore, he just commented that night that it was a little sore. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021156186 Same reporter/drug, similar event, different patient

Other Meds:

Current Illness:

ID: 1051444
Sex: F
Age:
State: MI

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Injection site bruising and pain; Injection site bruising and pain; Nausea; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL3248, vaccine location= Left arm), via an unspecified route of administration on 15Jan2021 08:00 AM at single dose for covid-19 immunisation. Patient was known allergies to penicillin. The patient's concomitant medications were not reported. Patient was not pregnant. The patient experienced nausea, injection site bruising and pain at 15Jan2021 09:00AM. No prior covid vaccination. No Covid tested post vaccination. Facility type vaccine was Workplace Clinic. No other vaccine in four weeks. Events resulted in none of the above. Patient was recovered in 2021. No treatment received for adverse events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021182443 same reporter, same patient, same product (different dose), different events

Other Meds:

Current Illness:

Date Died: 02/15/2021

ID: 1051445
Sex: F
Age:
State:

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 02/24/2021
Hospital: Y

Lab Data: Test Date: 202102; Test Name: blood cultures; Result Unstructured Data: Test Result:negative; Test Date: 202102; Test Name: chest x-ray; Result Unstructured Data: Test Result:shows numerous bilateral patchy opacities; Comments: Patient chest x-ray shows numerous bilateral patchy opacities which is significantly different from her previous chest x-ray here.; Test Date: 202102; Test Name: respiratory cultures; Result Unstructured Data: Test Result:negative; Test Date: 202102; Test Name: SARS-COV-2 test; Test Result: Negative

Allergies:

Symptoms: chest x-ray shows numerous bilateral patchy opacities; catastrophic brain bleed; Brainstem reflexes were lost; Patient died; shortness of breath; nausea; diarrhea; worsening shortness of breath/numerous bilateral patchy opacities; immunosuppressed status; This is a spontaneous report from a contactable pharmacist and a contactable other health professional. A 61-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), intramuscular at arm right on 28Jan2021 (at the age of 61 years) at single dose for COVID-19 immunization. The patient medical history included bilateral lung transplant on 23Jun2017, lymphangioleiomyomatosis, hepatocellular carcinoma, antibody mediated rejection of lung transplant , bronchiolitis obliterans syndrome, grade 0P, major depressive disorder, RLS (restless legs syndrome), chronic insomnia, long term current use of systemic steroids OSA (obstructive sleep apnea), iron deficiency anemia, bilateral sciatica, hoarseness of voice, memory change, laryngeal stridor, pure hypercholesterolemia senile nuclear cataract, bilateral myopia of both eyes, osteoporosis without current pathological fracture, alopecia, immunosuppressed status, all from an unknown date and unknown if ongoing. Concomitant medication included acyclovir (formulation: capsule, strength: 200 mg) oral at 200 mg twice daily, salbutamol (ALBUTEROL HFA) as needed (MCG/ACT inhaler take 2 puffs by inhalation every 4 hours as needed) for wheezing (shortness of breath), atorvastatin (LIPITOR, formulation: tablet) oral at 80 mg once a day, azithromycin (ZITHROMAX, formulation: tablet)oral at 250 mg (every Monday, Wednesday, Friday), bupropion hydrochloride (WELLBUTRIN XL, formulation: tablet, strength: 150 mg) oral at 150 mg once a day, calcium citrate/cholecalciferol (CALCIUM + VITAMIN D, formulation: tablet) oral at 2 dose form once a day (every morning), everolimus (ZORTRESS, formulation: tablet, strength: 1 mg) oral at 2 mg twice a day, fluticasone propionate/salmeterol xinafoate (ADVAIR, strength: 500 ug/ 20 ug) twice daily (1 puff by inhalation), gabapentin (NEURONTIN, formulation: capsule, strength:100 mg) oral at 300 mg daily (by mouth nightly), loratadine (CLARITIN, formulation: tablet, strength: 10 mg) oral at 10 mg as needed, metoprolol tartrate (LOPRESSOR, formulation: tablet, strength: 25 mg)oral at 50 mg twice daily, minoxidil (ROGAN, strength: 5%) topical apply 1 cap full every other day to affected area on scalp for alopecia, ondansetron (ZOFRAN, formulation: tablet, strength: 4 mg) oral at 4 mg as needed for nausea, pantoprazole sodium sesquihydrate (PROTONIX, formulation: tablet, strength: 40 mg) oral at 40 mg once a day, prednisone (DELTASONE, formulation: tablet, strength: 5 mg) oral at 5 mg daily (every morning), sertraline hydrochloride (ZOLOFT, formulation: tablet, strength: 100 mg) oral at 100 mg twice a day (every morning), sulfamethoxazole/trimethoprim (BACTRIM) 400-80 mg per tablet (1 tablet by mouth every Monday, Wednesday, Friday), tacrolimus (formulation: capsule) at 3 mg daily (2 mg every morning and 1 mg at night), salbutamol sulfate (PROVENTIL HFA) as needed for wheezing (shortness of breath), salbutamol sulfate (VENTOLIN HFA) as needed for wheezing (shortness of breath) , salbutamol sulfate (PROAIR HFA) as needed for wheezing (shortness of breath), ascorbic acid/ferrous fumarate/folic acid/ retinol (PRENATAL, formulation: tablet) oral daily. The patient previously took NSAIDs and voriconazole and experienced drug allergies. It was reported that the patient presented to emergency department (ED) on 04Feb2021 with chief complaint of worsening shortness of breath, nausea and diarrhea for past week since receiving since receiving COVID-19 vaccine. Full viral panel including COVID-19 was not detected. All blood cultures and respiratory cultures were negative. Patient chest x-ray shows numerous bilateral patchy opacities which is significantly different from her previous chest x-ray here. Empiric rejection treatment initiated including high dose methylprednisolone, plasmapheresis, IVIG, thymoglobulin. She continued to decline and ultimately required intubation, proning and paralyzing on 08Feb2021 and then VV ECMO cannulation on 13Feb2021. Acute pupil exam changes in the early am hours of 15Feb2021 prompted urgent head CT which revealed catastrophic brain bleed. Brainstem reflexes were lost soon after. Despite placing an EVD emergently at bedside, brain stem reflexes were not recovered. The events were all serious. The patient outcome of the events was fatal. The patient died on 15Feb2021. It was not reported if an autopsy was performed.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship. However, the reported event may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is 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.; Reported Cause(s) of Death: Chest x-ray shows numerous bilateral patchy opacities; Catastrophic brain bleed; Brainstem reflexes were lost; shortness of breath; nausea; Diarrhea; Worsening shortness of breath/numerous bilateral patchy opacities

Other Meds: ACYCLOVIR [ACICLOVIR]; ALBUTEROL HFA; LIPITOR [ATORVASTATIN]; ZITHROMAX; WELLBUTRIN XL; CALCIUM + VITAMIN D [CALCIUM CITRATE;COLECALCIFEROL]; ZORTRESS; ADVAIR; NEURONTIN; CLARITIN [LORATADINE]; LOPRESSOR; ROGAN [MINOXIDIL]; ZOFRAN [ONDANSET

Current Illness:

ID: 1051446
Sex: F
Age:
State: MA

Vax Date: 02/08/2021
Onset Date: 02/08/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data: Test Date: 20210208; Test Name: vitals; Result Unstructured Data: Test Result:stable; Comments: Physically stable, her vitals were stable and there was no angioedema

Allergies:

Symptoms: grade 2 allergic reaction; short of breathe; flushed; she was an oncology patient with large granular lymphocytic leukemia and received BNT162B2; she was an oncology patient with large granular lymphocytic leukemia and received BNT162B2; This is a spontaneous report from a contactable other healthcare professional. A 79-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9262, NDC number of COVID Vaccine: 59267-1000-1; Expiry Date of COVID Vaccine: 31May2021), intramuscularly at Left Deltoid on 08Feb2021 10:30 (either 10:30AM or within that hour or prior) at single dose for COVID-19 immunization. Medical history included anxiety, panic disorder, asthma, obstructive sleep apnea, additional Information for Other Conditions: She was oxygen Dependent, coeliac disease, allergy, Additional Information for Other Conditions: She had Medication, Environmental, and Food Allergies, central neuro hearing loss, vertigo, Allergic rhinitis, gastrooesophageal reflux disease (GERD), Additional Information for Other Conditions: Esophageal Reflux, osteopenia, impaired glucose tolerance, hypothyroidism, claustrophobia, rheumatoid arthritis (she had arthritis for which she took Orencia for), history of coronary heart disease, diabetes, she would be a targeting patient, as she was an oncology patient with large granular lymphocytic leukemia she met criteria for the pandemic, as well as they put down that she was due for immunization. She had anaphylaxis to bees. With adhesive tapes she got dermatitis. With shellfish she got hives. She had a gluten sensitivity and with mango her mouth gets fuzzy. Family Medical History Relevant to AE(s): her sisters had a few cancer. There were no concomitant medications. The patient previously received levofloxacin she had hives, with quinolones drug class she had hives, with thiopental she had hives and needed IV Decadron for it, with sertraline she has syncope, with Revatio she had an adverse event of joint and muscle pain, with ciprofloxacin she had tachycardia, with Enbrel it caused a drug induced pulmonary fibrosis granulomatosis, with Montelukast she had a headache and muscle pain, nitrofurantoin she had headache, with Symbicort it gave her hoarseness, she took Orencia for arthritis, she got the flu Vaccine in Sep2020. That was most recent. The patient had a grade 2 allergic reaction on 08Feb2021. The patient was watched after administering the vaccine on 08Feb2021 as she had background of multiple allergies and asthma. She was watched for 30 minutes in the oncology unit infusion suite. The reaction happened within 5 minutes of administration. Seriousness Criteria: Caller explained that this reaction was mild to moderate, there was a grade to intervene but at no point was she unstable, she did have a significant anxiety disorder, and so she was nervous about getting the vaccine. She was short of breathe, odd and flushed. She was physically stable, her vitals were stable and there was no angioedema. Reporter seriousness for grade 2 allergic reaction: Medically significant. The patient recovered, as a treatment they gave her IV Benadryl 50mg and IV fluids, she also had her own albuterol inhaler. In the pandemic, they are not doing nebulizers. The outcome of events allergic reaction, shortness of breath and flushed was recovered on 08Feb2021. Relatedness of drug to reaction(s)/event(s). Reaction assessed: Grade 2 allergic reaction; Source of assessment: Primary Source Reporter. Method of assessment: Global Introspection. Drug result: Related. Causality: reporter stated that she did think the patient's base line anxiety played into the reaction she experienced, the reaction was aggravated by it.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of grade 2 allergic reaction, short of breathe and flushed due to temporal relationship and current known drug safety profile. The patient's underlying allergic physique also predisposed the patient to developing the event. 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 RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1051448
Sex: M
Age:
State: IL

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

Lab Data:

Allergies:

Symptoms: angioedema - swelling of upper lip; This is a spontaneous report from a contactable physician. A 60-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via intramuscular on 03Feb2021 12:00 at single dose in left arm for COVID-19 immunization. Medical history included type 2 diabetes mellitus (DM II), hypertension (HTN). No covid prior vaccination and no covid tested post vaccination. No known allergies. Concomitant medication included lisinopril. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via intramuscular on 14Jan2021 12:00 at single dose in left arm for COVID-19 immunization. No other vaccine in four weeks. The patient experienced angioedema - swelling of upper lip on 05Feb2021 08:00. The event was resulted in doctor or other healthcare professional office/clinic visit. Treatment included prednisone/diphenhydramine/Pepcid. The outcome of the event was recovered in Feb2021.; Sender's Comments: A causal relationship between BNT162B2 and the event angioedema cannot be excluded based on 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 RAs, Ethics Committees, and Investigators, as appropriate .

Other Meds: LISINOPRIL

Current Illness:

ID: 1051449
Sex: F
Age:
State: IL

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 9-10min after getting the shot, my lungs felt like I was running a marathon; chest pain; my ears and face flushed red & hot; my ears and face flushed red & hot; coughing; choking; couldn't breathe; My throat was swelling up so fast and filling with a thick mucous; My throat was swelling up so fast and filling with a thick mucous; she was not coherent enough to remember it; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose at left arm on 17Feb2021 15:00 for Covid-19 immunisation, administered at hospital. Medical history included asthma, gastrooesophageal reflux disease (GERD), endometriosis, adenomyosis, polycystic ovaries (PCOS), anaphylactic reaction Known allergies: fried chicken/fast food unknown preservative (anaphylactic). Patient was not pregnant. The patient had not experienced Covid-19 prior vaccination. Concomitant medication in 2 weeks included: levonorgestrel (MIRENA), omeprazole (OMEPRAZOLE), paracetamol (TYLENOL). No other vaccine in 4 weeks. The patient previously took cyclobenzaprine and experienced dust allergy, metronidazole and experienced drug hypersensitivity, cephalexin and experienced drug hypersensitivity, tramadol and experienced anaphylactic reaction. On 17Feb2021 03:15 PM, 9-10 min after getting the shot, her lungs felt like she was running a marathon. She told the observer and before she finished describing her chest pain, her ears and face flushed red & hot. She called for a stretcher and she started coughing. They got her on a stretcher & ran her to the ER down the hallway. She was coughing and choking and couldn't breathe. Her throat was swelling up so fast and filling with a thick mucous. Patient received treatment with an epinephrine shot, solumedrol shot, Benadryl shot & started an iv steroid that started with a V sound (between choking/epinephrine/Benadryl, she was not coherent enough to remember it). Within a few minutes her coughing subsided and she was able to breathe normally. She received an albuterol treatment at that point. She was kept under observation for 5 hours. At about the 4 hour mark she had another albuterol treatment. She has continued albuterol treatments every 4 hrs. Oral Prednisone, oral Benadryl. It's hills immediately after meds, valleys between. Patient was not tested for covid post vaccination. AEs resulted in: doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event. Reactions were ongoing. The outcome of events was recovering.

Other Meds: MIRENA; OMEPRAZOLE; TYLENOL

Current Illness:

ID: 1051450
Sex: M
Age:
State: WI

Vax Date: 01/26/2021
Onset Date: 02/08/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: has a spot coming on that looks the same and feels the same as the MRSA he had before/red spot/little swollen on the outside/like a pimple; This is a spontaneous report from contactable consumers (patient and patient's wife) reported that a 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular on the left arm on 26Jan2021 16:15 at a single dose for Covid-19 immunization. Medical history included ongoing blood pressure high, rheumatoid arthritis and diabetes; all from an unknown date and were diagnosed many years ago. The patient had MRSA before 12 years ago (2009). Concomitant medications included prednisone. It was reported that 12 years ago, he had MRSA. He thought he has it again. The patient clarified that he had MRSA about 12 years ago and he doesn't know if there was a chance the COVID-19 triggered the MRSA. He was not positive it was even MRSA. He has a spot coming on that he noticed last night (08Feb2021). The spot he has now looks the same and feels the same as the MRSA he had before. However, it's not the in the same area. It's in the same arm he got the shot in, which he doubted it has anything to do with the COVID-19 vaccine. It just looks and feels the same as it did 12 years ago when he had MRSA. The caller explains the spot was about the size of a dime, maybe a little bit smaller. There was a red spot of course. It shows on the outside, it's a little swollen on the outside, but there was a bigger area on the inside. He explained further there was more of it on the inside. The patient's wife told him it looks like a pimple. The outcome of the event was unknown.

Other Meds: PREDNISONE

Current Illness: Blood pressure high; Diabetes; Rheumatoid arthritis

Date Died:

ID: 1051451
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: died 15 min later; This is a spontaneous report from a Pfizer Sponsored Program. A non-contactable consumer reported that a female patient (mother) of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on an unknown date for Covid-19 immunization. Medical history and concomitant drug were not provided. The reporter stated her mother took the vaccine and died 15 min later. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: died 15 min later

Other Meds:

Current Illness:

ID: 1051452
Sex: F
Age:
State: MI

Vax Date: 02/04/2021
Onset Date: 02/05/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Nausea/Mild nausea; Severe headache; Dry mouth; General Malaise; fatigue; Nighttime sweats.; Likely a low-grade fever; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3248, vaccine location=Left arm), via an unspecified route of administration on 04Feb2021 08:15 AM at single dose for covid-19 immunisation. Patient was known allergies to penicillin. The patient's concomitant medications were not reported. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL3248, vaccine location= Left arm), on 15Jan2021 08:00 AM for covid-19 immunisation and experienced nausea, injection site bruising and pain. Patient was not pregnant. The patient experienced injection site pain, severe headache, dry mouth, mild nausea, general malaise, fatigue, nighttime sweats and likely a low-grade fever all at 05Feb2021 04:00AM. No other vaccine in four weeks. No covid tested post vaccination. Events resulted in none of the above. No treatment received for adverse events. The patient was recovering; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021162107 same reporter, same patient, same product (different dose), different events.

Other Meds:

Current Illness:

ID: 1051453
Sex: F
Age:
State: AZ

Vax Date: 01/26/2021
Onset Date: 01/01/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: They were kind of itched; I was scratching and it was starts to bleed; They were kind of itched; I was scratching and it was starts to bleed; They were kind of itched; I was scratching and it was starts to bleed; They are scabbed like almost like scars; that scars on my arm; They were burning kind of and they scabbed over; I had a type of rash; little red dots on my arm, on my forearm and also my trapezius of on the same site of the injection; I had a type of rash; little red dots on my arm, on my forearm and also my trapezius of on the same site of the injection; I had a type of rash; little red dots on my arm, on my forearm and also my trapezius of on the same site of the injection; This is a spontaneous report from a contactable consumer reported for herself. A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), lot number# EL0142 via unspecified route at the arm on 26Jan2021 (at 56 year old) at single dose for COVID-19 immunization. Medical history was not reported, and concomitant medications included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patient reported as follows: "I was scratching and it was starts to bleed ,I had a type of rash; little red dots on my arm, on my forearm and also my trapezius of on the same site of the injection , they were kind of itched; they are scabbed like almost like scars; that scars on my arm , they were burning kind of and they scabbed over .Then the consumer added: I would say probably came on about I have to guess may be 3 to 5 days after I had the shot and they were kind of the itched and I was scratching and it was starts to bleed that want to I don't know about a week and a few days after I noticed on my arm, also noticed on my back of right trapezius muscle. So on top like on my in my back and behind my neck and it started all of my right side and I was awaken one night because they were burning kind of and they scabbed over so it was just look like scabbed kind of and when I scratch it scab kind of come off and it would bleeding kind of burn. "they are still there but they are having healed like on my arm have like you can see them, but they are scabbed like almost like scars. That scars on my arm, I can see they are still there, but they are not bleeding anymore." Regarding treatment she stated, "I only took Benadryl on one night because night before they woke me up because it was burning. They were hurting when I scratched them." The patient was recovered from wound bleeding while the outcome of the other events was unknown.

Other Meds: VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]

Current Illness:

ID: 1051454
Sex: F
Age:
State: MN

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 02/24/2021
Hospital:

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

Allergies:

Symptoms: She had little reaction like fever; This is a spontaneous report from a contactable consumer (patient's son/daughter) via Pfizer sponsored Program. An 84-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose in Feb2021 (9 days before this report) for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had little reaction like fever in Feb2021 and also went to the hospital. The event was considered life threatening. The outcome of event was unknown. Reporter wanted to know if her reaction was related to the vaccine even though she received it 9 days before, if it was possible that she was exposed to the virus and since she already received the vaccine if it will test false positive, and if she tested positive will she still be able to receive the 2nd dose. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1051464
Sex: M
Age: 15
State: VT

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: a patient received an expired RECOMBIVAX; This spontaneous report as received from a nurse referring to a 15 years old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided. On 21-DEC-2020, the patient was vaccinated with expired hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (dose # 2; 1 dosage form; lot # R001529, expiration date 07-NOV-2020, route was not provided) for prophylaxis. No further information was available. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: R001529; expirationdate: 07-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability

Other Meds:

Current Illness:

ID: 1051465
Sex: U
Age:
State: MD

Vax Date: 06/18/2020
Onset Date: 12/01/2020
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: reaction around the mouth / white nodule like bumps; reaction around the mouth / inflammation in area of filler injection; This case was reported by a other health professional via other manufacturer and described the occurrence of nodular rash in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included hyaluronic acid (Restylane) for product used for unknown indication. In December 2020, the patient received Shingles vaccine. On 18th June 2020, the patient started Restylane 1 ml at an unknown frequency. In December 2020, less than a month after receiving Shingles vaccine, the patient experienced nodular rash and injection site inflammation. The action taken with Restylane was unknown. On an unknown date, the outcome of the nodular rash and injection site inflammation were unknown. It was unknown if the reporter considered the nodular rash and injection site inflammation to be related to Shingles vaccine. Additional details were provided as follow: The age at vaccination was not reported. The age group was not reported but captured as adult as per vaccine indication. The patient used 1ml Restylane 1.0 on patient in lips and NLF (nasolabial folds). The patient noticed white nodule like bumps and inflammation in area of filler injection site of Restylane. The patient experienced a reaction around the mouth in December 2020 also after receiving the Shingles vaccine, which described as white nodule like bumps and inflammation in area of filler injection. The patient was injected with the COVID vaccine in January, 2021 but did not have a reaction associated with this. The patient received Moderna vaccine in January 2021. It was unknown if the reporter considered the nodular rash and injection site inflammation to be related to Restylane.

Other Meds:

Current Illness:

ID: 1051466
Sex: F
Age: 59
State: MI

Vax Date: 01/20/2020
Onset Date:
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Pain at injection site; Body aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included eczema and arthritis. On 20th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 9 months after receiving Shingrix, the patient experienced injection site pain and general body pain. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the general body pain was recovered/resolved. It was unknown if the reporter considered the injection site pain and general body pain to be related to Shingrix. Additional details were provided as follow: The case was reported by the patient herself. The patient received Shingrix in the left arm. The patient reported body aches and pain at injection site which lasted a day and then resolved. The reporter consented to follow up. For tolerance in 2nd dose refer case US2021014428.; Sender's Comments: US-GLAXOSMITHKLINE-US2021014428:Same reporter

Other Meds:

Current Illness:

ID: 1051467
Sex: F
Age: 75
State: FL

Vax Date: 11/01/2020
Onset Date:
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: arm was tender at site that night / soreness; This case was reported by a consumer via and described the occurrence of injection site tenderness in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number J454X, expiry date 4th October 2022) for prophylaxis. In November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than a day after receiving Shingrix, the patient experienced injection site tenderness. On an unknown date, the outcome of the injection site tenderness was recovered/resolved. It was unknown if the reporter considered the injection site tenderness to be related to Shingrix. Additional details were reported as follows: This case was reported by patient himself/herself. The patient did not have a history of reaction to any previous vaccines. The patient experienced that her arm was tender at site that night, and next day the soreness was lessened, and by 3rd day it was fine. The patient had not yet discussed symptoms with her physician and was referred to her physician for further evaluation and discussion. The reporter consented to follow up with her as well as with her pharmacist who administered the vaccine. For tolerance of 2nd dose, refer case US2021025175. This case had been linked with US2021025187 and US2021025175, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021025187:same reporter US-GLAXOSMITHKLINE-US2021025175:same reporter

Other Meds:

Current Illness:

ID: 1051468
Sex: U
Age:
State: UT

Vax Date:
Onset Date:
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: got some rash in my legs just like the chicken pox; This case was reported by a consumer via interactive digital media and described the occurrence of varicella-like rash in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced varicella-like rash. On an unknown date, the outcome of the varicella-like rash was unknown. It was unknown if the reporter considered the varicella-like rash to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. Patient received the 2nd dose of shingles vaccine and got some rash on legs just like the chicken pox. Patient mentioned that it was still better than having shingles. It was stated that patient had a cousin who had it twice and cousin said it was the most painful thing in the world. Patient paid insurance for himself and for his wife.

Other Meds:

Current Illness:

ID: 1051469
Sex: U
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: knocked me on my ass; This case was reported by a consumer and described the occurrence of debility in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced debility. On an unknown date, the outcome of the debility was unknown. It was unknown if the reporter considered the debility to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. Patient mentioned that shingles shot were two shot series and basically 95 percent effective,however Patient received the Shingrix and patient knocked on ass for about 1 1/2 days.

Other Meds:

Current Illness:

ID: 1051470
Sex: U
Age:
State: NE

Vax Date: 12/01/2020
Onset Date:
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: sore arm at the injection site; This case was reported by a consumer and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included Herpes zoster (Shingrix). In December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to Shingrix. Additional details were reported as follows: This case was reported by patient' friend. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient experienced sore arms at the injection site. The reporter stated that the patient was glad to receive the dose. The follow-up would not possible as no contact details were available. For tolerance of 1st dose refer case US2021AMR025887. This is 1 of 4 cases reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR025865:same reporter US-GLAXOSMITHKLINE-US2021AMR025883:same reporter US-GLAXOSMITHKLINE-US2021AMR025865:same reporter US-GLAXOSMITHKLINE-US2021AMR025883:same reporter US-GLAXOSMITHKLINE-US2021AMR025887:same reporter

Other Meds: Shingrix

Current Illness:

ID: 1051471
Sex: F
Age:
State: TX

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Pain at site of injection; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 14th January 2021, the patient received the 2nd dose of Shingrix (unknown). On 14th January 2021, less than a day after receiving Shingrix, the patient experienced injection site pain. On 15th January 2021, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. Patient received the 2nd dose of Shingrix and less than a day after the vaccination patient had injection site pain. Patient used warm compress to manage pain and stated it felt fantastic after the heat and patient could go to sleep with no issue unlike the first dose. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1051472
Sex: F
Age:
State: ND

Vax Date: 11/26/2020
Onset Date: 11/26/2020
Rec V Date: 02/24/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Allergic reaction; This case was reported by a pharmacist and described the occurrence of allergic reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) for prophylaxis and flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 26th November 2020, the patient received Shingrix, Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 26th November 2020, less than a day after receiving Shingrix, Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to Shingrix, Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not reported. Pharmacist reported patient was administrated with Fluarix QIV-Shingirx and had allergic reaction. The reporter consented to follow up.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm