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: 1035189
Sex: M
Age: 51
State: GA

Vax Date: 02/15/2021
Onset Date: 02/16/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies: none

Symptoms: chills and muscle aches about 16 hours after injection continued chills and myalgia along with headaches about 24 hours after injection at 30 hours after injection symptoms persist

Other Meds: none

Current Illness: none

ID: 1035191
Sex: F
Age: 71
State: IN

Vax Date: 02/02/2021
Onset Date: 02/14/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Started with slight itching Sunday afternoon. By Monday evening swelling and warm to touch at injection site. Tuesday morning,swelling area hard to touch and some pain around swelling.

Other Meds: TRULICITY, VALTASSA, CARVEDILOL, SIMVISTATIN, XARELTO, ENTRESTO, B COMPLEX, D3, MAGNESIUM

Current Illness:

ID: 1035192
Sex: F
Age: 37
State:

Vax Date: 01/29/2021
Onset Date: 01/30/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: A red bump about 2 inches long and 1 inch wide. Hot to the touch. Its been over two weeks and I still have a bruise

Other Meds: Motrin in the morning

Current Illness:

ID: 1035193
Sex: F
Age: 78
State: CT

Vax Date: 02/12/2021
Onset Date: 02/13/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies: sulfa drugs

Symptoms: Received shot on Friday, February 12 around 1PM. Saturday, February 13:Approximately 30 hours after receiving shot, 8:00 pm, Saturday, Feb 13, developed stomach cramps. Over the next 4/5 hours, diarrhea, vomiting, cramps, chills. Felt very hot at times, but never ran a fever. Sunday, February 14, felt tired and weak, periodic cramps. No nausea or diarrhea. Monday, February 15, more energy, some cramps, By

Other Meds: amlodipine besylate 10mg atorvastatin calcium 40 mg valsartan & hydrochlorithiazide 160/25 mg calcium 600 mg + D3

Current Illness: none

ID: 1035194
Sex: M
Age: 53
State: FL

Vax Date: 02/12/2021
Onset Date: 02/16/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data: none

Allergies: None

Symptoms: Chills, fever, fatigue

Other Meds: Vitamins C, D, E

Current Illness: None

ID: 1035495
Sex: F
Age:
State: TN

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

Lab Data:

Allergies:

Symptoms: she had terrible hives; This spontaneous report was received from a female adult consumer of unknown age refering to herself. The patient'sconcurrent conditions included osteoporosis. The patient's concomitant therapies included metoprolol. Information regarding the patient's pertinent medical history, historical drugs and previous drug reactions or allergies was not reported. On an unknown date (reported as "about 5 or 6 years ago"), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (dose, vaccination scheme frequency, route of administration, anatomical site of vaccination, lot number and expiration date were not reported). The patient stated that after the vaccine she had terrible hives (urticaria), had to go to the emergency room (ER), and got steroids to treat it. The outcome of urticaria was reported as recovered. The causal relationship between urticaria and zoster vaccine live (ZOSTAVAX) was unknown.

Other Meds: metoprolol

Current Illness: Osteoporosis

ID: 1035496
Sex: U
Age:
State: PA

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No other AE/PQC identified; expired dose of MMR administered; This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drug and concomitant therapies were not provided. On 20-JAN-2021, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 milliliters intramuscular route, Lot number S001322 and expiration date 14-JAN-2021 as prophylaxis. Lot number S001322 is an invalid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) does not match any company product as confirmed by lot verification team.

Other Meds:

Current Illness:

ID: 1035497
Sex: U
Age:
State: CO

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE/PQC reported; VARlVAX had been administered via the IM route to a patient; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions or allergies were not reported. On 28-JAN-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (strength and dose were not reported, lot # S031494, expiration date was 07-OCT-2021) intramuscularly (IM) for prophylaxis and sterile diluent (strength and dose were not reported, lot # T006500, expiration date was 16-SEP-2022) intramuscularly for prophylaxis (incorrect route of product administration).

Other Meds:

Current Illness: Prophylaxis

ID: 1035498
Sex: F
Age: 75
State: DE

Vax Date: 10/19/2020
Onset Date: 10/19/2020
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: she experienced Flu-like symptoms; and had a mild reaction; headache; tiredness; chills; mild fever of 99; she felt out of sorts; This spontaneous report was received from a 54-year-old female patient regarding herself. The patient's concurrent conditions included seasonal allergies, antifungal drug and allergy to iron infusion. The patient's medical history included heart attack. Concomitant therapy included unspecified blood pression (BP) medicine, clopidogrel bisulfate(PLAVIX) and alprazolam (reported as generic for alprazolam(XANAX)). On 19-OCT-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) in the arm, lot number T020639, expiration date not reported but upon internal validation established as 13-MAR-2022 (dose, route, and anatomical location were not reported) to prevent pneumonia. On the same day six hours after vaccination with of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), the patient experienced a mild reaction to the vaccine, flu-like symptoms, headache, tiredness, chills, and a mild fever of 99 (units not reported), she felt out of sorts for four days (influenza like illness, mood altered, pyrexia, chills, fatigue, vaccination complication and headache). The patient enquired for the ingredients of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) because she had pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) the year before (19-OCT-2019) and she did not have any symptoms. The patient sought medical attention by informing the doctor's office and no treatment was given for the events. At the time of the report, on 23-OCT-2020, the patient had recovered from mood altered and on an unspecified date, she had recovered from the events. The relatedness between the events of influenza like illness, mood altered, pyrexia, chills, fatigue, vaccination complication and headache and therapy with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T020639; expirationdate: 13-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent

Other Meds: PLAVIX; alprazolam; PNEUMOVAX23 SYRINGE (DEVICE)

Current Illness: Allergy to metals; Drug hypersensitivity; Seasonal allergy

ID: 1035499
Sex: U
Age:
State: MA

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: no other issues were reported; The patient received his 3rd dose of RECOMBIVAX HB on 03-FEB-2021 and it expired on 24-JAN-2021; This spontaneous report was received from a pharmacy student and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On 03-FEB-2021, the patient was vaccinated with the third dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) with expiration date of 24-JAN-2021 (dose, route, anatomical location and lot number were not reported) for prophylaxis. No other issues were reported.

Other Meds:

Current Illness:

ID: 1035500
Sex: U
Age:
State: FL

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: a dose of expired Pneumovax 23 was administered to a patient; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies, and concomitant therapies were not reported. On 11-FEB-2021, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml, administered intramuscularly, as prophylaxis, lot number S012245, expiration date 09-FEB-2021 (expired product administered) (frequency and anatomical vaccination site were not provided). The reporter confirmed there were no previous temperature excursions. It was also reported that vaccine was "supported 1 month post expiration date per post expiry memo". Any decision for re-vaccination, would be up to the healthcare provider. The outcome of expired product administered was unknown. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S012245; expirationdate: 09-FEB-2021; 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: PNEUMOVAX23 SYRINGE (DEVICE)

Current Illness:

ID: 1035501
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: syncope; This spontaneous report as received from a nurse refers to her sister of unknown age.There was no information about the patient's medical history, concurrent conditions or concomitant medication. On an unknown date, the patient was vaccinated with 2 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) for prophylaxis (dose, route of administration, lot number and expiration date were not reported), unidentified Merck hpv vaccine administered (name not provided). On an unknown date, the patient experienced syncope. No treatment was given for the adverse event. The patient did not seek medical attention. The outcome of syncope was reported as recovered, on an unknown date. The causal relationship between the aforementioned event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), unidentified Merck hpv vaccine administered (name not provided) was not reported.No further information was provided Upon internal review the event syncope was considered to be medically significant.

Other Meds:

Current Illness:

ID: 1035502
Sex: M
Age:
State: WA

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

Lab Data:

Allergies:

Symptoms: Took last dose of Viviotif a day late; Spontaneous report received on 10JAN2020. A male consumer "took last dose of Vivotif a day late" (PT: Inappropriate schedule of product administration), while being on Viviotif for immunization. The consumer took the final dose of Vivotif a day late. Action taken with Vivotif with respect to reported event was not applicable. The clinical outcome of the reported event was unknown. Company Comment: A consumer took his last dose of Vivotif a day late (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took his last dose of Vivotif a day late (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not applicable to Vivotif.

Other Meds:

Current Illness:

ID: 1035503
Sex: M
Age: 49
State: GA

Vax Date: 01/10/2020
Onset Date: 01/14/2020
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Drank coffee within an hour after taking third dose of Vivotif; Spontaneous report received on 14JAN2020. A nurse reported that a 49-year-old male consumer "drank coffee within an hour after taking third dose of Vivotif" (PT: Product administration error). He was receiving Vivotif for immunisation. The consumer took first two doses of Vivotif on an empty stomach on 10JAN2020 and 12JAN2020 respectively. On 14JAN2020 he drank coffee less than an hour after taking the third dose. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown. Company Comment: A consumer drank coffee within an hour of taking his third dose of Vivotif (drug administration error). Vivotif should be taken on an empty stomach with cold or luke warm water and the person should not have a meal for at least one hour after taking Vivotif dose. Considering the nature of the event, the causality of drug administration error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer drank coffee within an hour of taking his third dose of Vivotif (drug administration error). Vivotif should be taken on an empty stomach with cold or luke warm water and the person should not have a meal for at least one hour after taking Vivotif dose. Considering the nature of the event, the causality of drug administration error is assessed as not applicable to Vivotif.

Other Meds:

Current Illness:

ID: 1035504
Sex: M
Age:
State: MD

Vax Date: 01/16/2020
Onset Date:
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Ate food immediately after first dose and took some doses with coffee; Spontaneous report received on 16JAN2020. A male consumer reported that he "ate food immediately after first dose and took some doses with coffee" (PT: Product administration error) while being on Vivotif capsule for immunisation. The consumer stated that, he took the first dose of Vivotif and ate food immediately afterwards. He also took some doses of Vivotif with coffee. He had completed the course of Vivotif on 16JAN2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown. Company Comment: A consumer ate food immediately after taking first Vivotif dose and also took some Vivotif doses with coffee (drug administration error). Vivotif dose should be taken one hour before a meal with cold or luke-warm water. Considering the nature of the event, the causality of drug administration error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer ate food immediately after taking first Vivotif dose and also took some Vivotif doses with coffee (drug administration error). Vivotif dose should be taken one hour before a meal with cold or luke-warm water. Considering the nature of the event, the causality of drug administration error is assessed as not applicable to Vivotif.

Other Meds:

Current Illness:

Date Died:

ID: 1035505
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Passed away with an hour to hour and 1/2 of receiving vaccine; A spontaneous report was received from a consumer concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and passed away with an hour to hour and 1/2 of receiving vaccine. The patient's medical history, as provided by the reporter, included COVID-19. No relevant concomitant medications were reported. On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient passed away within an hour and a 1/2 of receiving the vaccine. Per the nursing home staff, they did not expect the patient to make it many more days. The patient was unresponsive in the room when the shot was given. The patient was 14+ days post COVID. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. The patient died on an unknown date. The cause of death was unknown.; Reporter's Comments: This case concerns a patient, who experienced event of death (unknown cause). The event occurred an hour to hour and 1/2 after the first and last dose of mRNA-1273 vaccine administration. Based on the current limited available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded and the event is assessed as possibly related. However, Per the nursing home staff, the patient was 14+ days post COVID and they did not expect the patient to make it many more days. The patient was unresponsive in the room when the shot was given.; Reported Cause(s) of Death: unknown cause of death

Other Meds:

Current Illness:

ID: 1035506
Sex: F
Age: 37
State: ID

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data: Test Date: 20210129; Test Name: body temperature; Result Unstructured Data: 102.0 F Done at 12:00 am; Test Date: 20210129; Test Name: body temperature; Result Unstructured Data: 99.0 F Done at 5:00 am; Test Date: 20210128; Test Name: heart rate; Result Unstructured Data: 105-112 Beats per minute; Comments: 80 is normal

Allergies:

Symptoms: Temperature was 102 F; Lips turned blue; Wheezing; Heart rate was elevated to 105-112 bpm; A spontaneous report was received from a dentist, a 37-year old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced heart rate was elevated to 105-112 bpm, wheezing, lips turned blue, and temperature was 102 F. The patient's medical history, as provided by the reporter, included monk fruit allergy and high blood pressure. Concomitant medications reported included hydrochlorothiazide. On an unknown date, the patient received their first of two planned doses of mRNA-1273. On 28 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 030L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 28 Jan 2021, following vaccination, the patient experienced an elevated heart rate of 105-112 beats per minute (bpm). The patient stated that 80 bpm was normal for her. At 7:30 pm, she began wheezing and her lips turned blue, both of which resolved within 2 hours. The patient took ibuprofen, naproxen, and diphenhydramine and sat in a warm tub for an hour and felt better after she covered up in bed. On 29 Jan 2021, the patient's temperature was 102 degrees Fahrenheit (F) at midnight and 99 degrees F at 5:00 am. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. The events, wheezing and lips turned blue, were considered resolved on 28 Jan 2021. The outcome of the events, heart rate was elevated to 105-112 bpm and temperature was 102, was unknown.; Reporter's Comments: This case concerns a 37-year-old, female patient, with medical history of high blood pressure and allergies to monk fruit, who experienced serious unexpected event of cyanosis, non-serious unexpected event of wheezing, heart rate increased, and non-serious expected event of pyrexia. The event of cyanosis, wheezing, heart rate increased occurred 1 day (same day) and fever occurred 2 days after mRNA-1273 (Lot# 030L20A). Treatment included Ibuprofen, Benadryl and Naprosyn. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.

Other Meds: HYDROCHLOROTHIAZIDE

Current Illness: Fruit allergy (Monk fruit); Hypertension

ID: 1035507
Sex: F
Age: 45
State: WA

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 3 episodes of fainting; Flu like symptoms; Chest tightness; Sore and tender upon swallowing food; Muscle aches on right arm; fever; fatigue; A spontaneous report was received from a consumer concerning a 45-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced fatigue, fever, fainting, muscle aches, flu-like symptoms, chest tightness, and sore throat. The patient's medical history, as provided by the reporter, included childhood asthma and seasonal allergies. No relevant concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 on an unknown date. On 28 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (042L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 28 Jan 2021, the patient had fatigue by the end of the day following vaccination. On 29 Jan 2021, the patient presented fever and 3 episodes of fainting. She had muscles aches on her right arm, flu-like symptoms, chest tightness, and sore/tender throat area upon swallowing food. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events is not applicable. The outcome of the events was not reported.; Reporter's Comments: Further information has been requested as there is limited information regarding the events, particularly the event of syncope and chest discomfort. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Seasonal allergy

ID: 1035508
Sex: F
Age: 64
State: FL

Vax Date: 12/31/2020
Onset Date:
Rec V Date: 02/17/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Platelet count of 28,000; Generalized body pain all over; Weakness; On and off Chills; Low grade fever; Injection site soreness; A spontaneous report was received from a consumer who was a 64-year-old, female patient who developed a platelet count of 28,000 (thrombocytopenia), generalized body pain all over (general body pain), weakness (asthenia), on and off chills (chills), low grade fever (pyrexia), and vaccination site soreness (injection site pain). The patient's medical history was not provided. Concomitant product use was not provided. The patient received their first of two planned doses of mRNA-1273 (lot number 039K20A) on 31 Dec 2020. On 28 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (lot number 209K20A) in the left arm for prophylaxis of COVID-19 infection. On an undisclosed date the patient experienced injection site soreness, generalized body pain all over, chills, low grade fever and weakness. She also went to the hospital because she had a platelet count of 28,000. Treatment of these events was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable. The outcome of the events, platelet count of 28,000, generalized body pain all over, weakness, on and off chills, low grade fever, and vaccination site soreness, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1035509
Sex: F
Age: 38
State: AR

Vax Date: 01/11/2021
Onset Date: 01/12/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Throat closing; Swelling of throat; Lip swollen; Shortness of breath; Tachycardia; Swelling of face; A spontaneous report was received from a healthcare professional concerning a 38-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced throat closing, swelling of the face and throat, shortness of breath, tachycardia and lip swollen. The patient's medical history was not provided. Concomitant product use was not reported. On 11 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 12 Jan 2021, one day after vaccine administration, the patient was sent to the hospital by ambulance after her throat closed. She had swelling of face and throat, shortness of breath and tachycardia. In the ambulance, diphenhydramine, methylprednisolone, and famotidine were administered. She was discharged four hours later with prednisone, diphenhydramine, epinephrine, famotidine, and loratadine. On 15 Jan 2021, the patient was still having daily flare ups of a swollen lip and throat closing. Action taken with mRNA-1273 in response to the events was not reported. The events, throat closing and lip swollen, were considered not resolved. The outcome of the events, swelling of the face and throat, shortness of breath, and tachycardia, was unknown.; Reporter's Comments: This spontaneous report concerns a 38-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced throat closing, swelling of the face, shortness of breath, tachycardia and lip swollen. The events occurred 1 day after the administration of mRNA-1273 vaccine (Lot number: 041L20A, expiration date: unknown). Treatment provided include diphenhydramine, methylprednisolone and famotidine and outcome is unknown for swelling of the face, shortness of breath and tachycardia. Throat closing and lip swollen are not resolved. Based on the information provided which shows a temporal association, a causal association between the reported events and the administration of mRNA-1273 vaccine cannot be excluded.

Other Meds:

Current Illness:

ID: 1035510
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Administering the 2nd dose of the moderna vaccine to patient, needling splattering occured; Needle splattering occurred; A spontaneous report was received from a heath care professional in the concerning a patient who and had administering the 2nd dose of the Moderna vaccine to patient, needling splattering occurred. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. On an unknown date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On an unknown date, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection Physician stated that in the course of administering the 2nd dose of the Moderna vaccine to a patient, needle splattering occurred. She did not know how much of the vaccine went into the recipient's arm. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The event administering the 2nd dose of the Moderna vaccine to patient, needling splattering occurred was considered resolved on an unknown date.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their second of two planned doses of mRNA-1273 (Lot unknown), reporting Underdose and Device connection issue without any associated adverse events.

Other Meds:

Current Illness:

ID: 1035511
Sex: F
Age:
State: FL

Vax Date: 01/17/2021
Onset Date: 01/17/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data: Test Name: Weight; Result Unstructured Data: Test Result:Around 128 pounds

Allergies:

Symptoms: lower back pain; nerve pain; excruciating pain/getting pain; muscle pain; couldn't sleep with the pain; Her husband had to pull her out of the bed because she felt she had no muscle activity; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #: EL8982), via an unspecified route of administration in the left arm on 17Jan2021 at 15:00 (at the age of 68-years-old) as a single dose for COVID-19 vaccination. Medical history included benign spinal cord tumor from 1987 and unspecified if ongoing (a lot of bone had to get cut), lot of scar tissue (wonders if it is a weak spot) from an unspecified date and unspecified if ongoing, thyroid removed in 2015, neurosurgery (to remove the benign spinal cord tumor) on an unspecified date, thyroid on an unspecified date and unspecified if ongoing and cholesterol from an unspecified date and unspecified if ongoing. Concomitant medications included ongoing levothyroxine (strength: 125 ug) taken for an unspecified indication at 125 ug, 1x/day, ongoing pravastatin (strength: 40mg) taken for cholesterol from an unspecified date at 40mg, 1x/day and ongoing multivitamin. The patient did not receive any other vaccinations within four weeks prior to the first administration of the COVID-19 vaccine. The patient experienced lower back pain, nerve pain, excruciating pain/getting pain, muscle pain, couldn't sleep with the pain and her husband had to pull her out of the bed because she felt she had no muscle activity, all on 17Jan2021. The patient called and stated "she had a very extreme reaction from the first dose of the vaccine, which she had last Sunday the 17th. It began with lower back pain, which did not alarm her too much but then it went in to nerve pain. By the end of the evening, by about midnight, she was in what she considered to be excruciating pain. She changed positions and it was hitting the nerve and she was getting pain and having muscle pain. She was up all night because she could not sleep with the pain. Monday and Tuesday were very excruciating, and she took Tramadol Monday after consulting with her doctor. She did not get any relief until Wednesday, 3 days after the shot. Even today she had some lower back pain, but it is way better than it was. It was improving from Wednesday to today but Sunday to Wednesday was excruciating since it was giving her nerve pain. Her husband had to pull her out of the bed because she felt she had no muscle activity. In 1987 she had a spinal cord tumor and a lot of bone had to get cut and she stated she was sure she had a lot of scar tissue and wondered if it was a weak spot. She stated this could be an isolated incident, but she really thought she had another tumor at first until it started dissipating on its own. She stated she did not know anyone who has had this reaction and asked if it was safe/advisable to get the second shot? She stated she was afraid of the permanent nerve damage but as long as it cannot do anything permanent, she wanted to get it. Was this a reported symptom? Has anyone ever gotten paralyzed? After verbal response she stated she will talk with her doctor and maybe see a neurologist." Upon follow-up the patient called and stated "I had two questions actually. I received the Pfizer Vaccine yesterday and last night I started with the excruciating back pain, my lower back. I do not know if it was coincidence or not because I have back trouble before. I did not do anything to throw my back out. However, I was told it would be okay to take Extra Strength Tylenol. I took 4 Tylenol within like 3 hours period because it was not working. I took another two this morning. Tylenol was not doing anything at all for the pain relief. My question was, I have a prescription of Tramadol which I took for pain for different reason, but I have it. First of all, I hope by taking the Tylenol yesterday that it did not interfere with the efficiency of the vaccine. My other question is can I take the Tramadol now? Since the vaccine was 24 hours ago would it interfere with efficiency?" Upon follow-up the patient called to report that "she went to her chiropractor late Wednesday afternoon, and he did some stretching, but her spine was not out of alignment, so he felt her pain was due to the vaccine. Stated that it was not until her back started getting better on Wednesday without treatment that she first started to attribute it to the vaccine, because her back just did not get better on its own. Stated that the first day she did not take anything for the pain because she was worried that it might interact with the vaccine or its effectiveness, but the next day she began taking Tramadol pain meds that she already had in the house for her knee. Stated that the pain in her back was so bad, that even a strong medication like the Tramadol did not take away the pain. It did not help all that much, she had to take a 2nd 50mg tablet 3 hours later. Should she get the second dose of the vaccine? Could it possibly do more nerve damage; could she be jeopardizing her nervous system? Have there been any other reports about this? Stated that other people had minor things like, one person reported being tired for a couple days, and another person reported body aches like with the flu, but after 3 days they both were fine. Her husband was 74 and had the vaccine and he had no side effects." The events prompted a visit to her physician. The patient stated that "this was the first day since Sunday that she was feeling almost 100%. She had the pain from Sunday evening all the way until noon on Wednesday; at that point it improved about 50% and she had some mobility." The outcomes of the events lower back pain, nerve pain, excruciating pain/getting pain, muscle pain, couldn't sleep with the pain and her husband had to pull her out of the bed because she felt she had no muscle activity were all recovering/resolving.

Other Meds: LEVOTHYROXINE; PRAVASTATIN

Current Illness:

ID: 1035513
Sex: F
Age:
State: MI

Vax Date: 01/12/2021
Onset Date: 01/01/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data: Test Name: blood work; Result Unstructured Data: Test Result:within normal limits, including platelets

Allergies:

Symptoms: kidney stones; blood in her urine; sore arm; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer, reporting for herself. A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took glipizide for diabetes and experienced bruising and bleeding. About three years ago, the patient took Glipizide ER for about 3 months (dose unknown but she was splitting the tablets and taking small amount) and noted an increased incidence of bruising which was worsening over time and longer bleeding because of it. She had blood work done and results came back within normal limits, including platelets. She discontinued the glipizide ER. The patient currently has kidney stones that can shift around and cause blood in her urine which occurred on an unspecified date in Jan2021, about 3 days after the first Pfizer COVID vaccine. After receiving this first vaccine, she had a sore arm, but no bleeding or bruising. The patient underwent lab tests and procedures which included blood work: within normal limits, including platelets on an unspecified date. The outcome of the events was unknown. Information on the batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1035514
Sex: U
Age:
State:

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

Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:high; Comments: high blood pressure (in the 160s, normally <120s systolic)

Allergies:

Symptoms: feelings of fainting; high blood pressure in the 160s, normally <120s systolic); severe headaches; dizziness; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received first dose of BNT162B2 (Lot number and expiry date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history concomitant medications were not reported. On an unspecified date, the patient developed severe headaches, dizziness, high blood pressure (in the 160s, normally <120s systolic), and feelings of fainting 5-10 minutes after receiving the first dose of the vaccine. This adverse event was reported already, but the pharmacist was wondering if it is still recommended to get the second dose after a reaction like this. Stated "This reaction doesn't meet your definition of anaphylaxis or allergic reaction which is why I am reaching out to see if you have any recommendations on this". The patient underwent lab tests and procedures which included blood pressure: high blood pressure (in the 160s, normally <120s systolic). The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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: 1035515
Sex: F
Age:
State: MD

Vax Date: 01/13/2021
Onset Date: 01/01/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: almost like she also had some mild hearing loss; nausea; exacerbation of migraine with paresthesia and tinnitus/ headaches/migraines; exacerbation of migraine with paresthesia and tinnitus; exacerbation of migraine with paresthesia and tinnitus/ increased tinnitus; some abdominal tightness; This is a spontaneous report from a contactable pharmacist (patient herself) via Medical Information team. A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3302, NDC number/expiration date was unknown), via an unspecified route of administration on the left arm (also reported as upper left arm) on 13Jan2021 at 09:00 at a single dose for COVID-19 immunization; the patient was a healthcare worker and was trying to protect herself. The vaccination facility type was reported as a drive thru site. Relevant medical history included previous neurological problems, which included history of underlying migraine with paresthesia/chronic paresthesia (ongoing) and tinnitus. The patient had no family medical history relevant to the adverse events (AEs). There were no concomitant medications. The patient had no other vaccine received on the same day of the Pfizer suspect or 4 weeks prior. She never had any problems with vaccines in the past. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Initially, the patient was asking if there were any reports of paresthesia, serious neurologic adverse events, tinnitus, hearing loss, or abdominal tightness in the studies for the Pfizer-Biontech Covid-19 vaccine. After the patient received the first dose of the Pfizer-BioNTech COVID-19 vaccine on 13Jan2021, she experienced an exacerbation of migraine with paresthesia and tinnitus. She also reported experiencing some abdominal tightness on an unspecified date in Jan2021. The patient reported she was scheduled for her second dose of the Pfizer COVID-19 vaccine, but had concerns because she was still experiencing tinnitus and it was "almost like she also had some mild hearing loss" on an unspecified date. The patient further reported that she was due for the next dose the following day at the time of the report (03Feb2021). She had previous neurological problems and did not know if this did exacerbate things or not. She had migraines, tinnitus, and paresthesia and was wondering how many other patients with neurological problems reported this and was this a common side effect or adverse event reported. One doctor told her not to get the second dose and another one told her to get it and she wanted to know what she should do. The patient had headaches/migraines on the evening of vaccination on 13Jan2021 that were fairly mild and 3 days after that on 16Jan2021, they got bad and was accompanied with nausea with increased tinnitus. The migraines and nausea had gone, and the chronic paresthesia was the same as she always had, but the tinnitus was a lot louder and worse. The patient also mentioned that her migraines usually go away, but this one had lingered. The AEs did not require any visit to an emergency room or a physician office. There were no investigation assessment. The patient recovered from the event "nausea" on an unspecified date, she was recovering from the event "exacerbation of migraine/ headaches/migraines," she was not recovered from the events "exacerbation of paresthesia and tinnitus/increased tinnitus, while the outcome of the events "almost like she also had some mild hearing loss and some abdominal tightness" was unknown. The reporter assessed the events "migraine, tinnitus, paresthesia, and nausea" as serious, other medically important conditions. The relatedness of drug to the reactions/events "migraine, tinnitus, paresthesia, and nausea" was unknown as per the reporting pharmacist (Method of assessment: Global Introspection).; Sender's Comments: The 61-year-old female had relevant medical history included previous neurological problems. The reported neurological events and partial hearing loss were more likely due to pre-existing conditions, and less likely related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). Event nausea was likely due to the first dose of bnt162b2. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

Other Meds:

Current Illness: Paresthesia (history of underlying migraine with paresthesia/chronic paresthesia and tinnitus)

ID: 1035516
Sex: F
Age:
State: NC

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data: Test Date: 20210106; Test Name: exam; Result Unstructured Data: Test Result:unknown result

Allergies:

Symptoms: Dysgeusia; Left hemicranial numbness/ Mild residual numbness left face; This is a spontaneous report from a contactable physician. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK9231, expiry: unknown), intramuscular in the left arm on 06Jan2021 14:30 at a single dose for covid-19 immunization at a clinic. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and had no other medications received within 2 weeks of vaccination. On 06Jan2021 at 15:00, the patient experienced dysgeusia 20 min after exam lasting 1 min and left hemicranial numbness times 24 hrs. The patient still has mild residual numbness on left face. The events resulted in doctor or other healthcare professional office/clinic visit. The events were not treated. Prior to vaccination, the was not patient diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the events dysgeusia and numbness with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1035517
Sex: F
Age:
State: VA

Vax Date: 01/30/2021
Onset Date: 01/30/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data: Test Name: COVID; Result Unstructured Data: Test Result:Unknown; Test Date: 202003; Test Name: COVID; Result Unstructured Data: Test Result:Unknown; Test Name: nasal swab; Result Unstructured Data: Test Result:Negative

Allergies:

Symptoms: psychedelic feeling; horrible palsy, as if her muscle was being pulled like a rubber band; horrible palsy, as if her muscle was being pulled like a rubber band; the worse bowel movement. She had to go the bathroom a lot; Her right arm was the worse with the pain and then her hands would kind of move in a kind of crazy way where it was tightening; muscle cramping and pulling; Her toes would contort and go backwards.; she feels like the left arm is going to do something, its like the last to be pulled; shingles; muscles became tight/contort; minor nausea; Stomach cramps; Gas; Indigestion; became weird in her head, almost like a lightheadedness; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), intramuscular on 30Jan2021 at 10:00 at a single dose on right arm for COVID-19 immunisation. Medical history included fever, being ill (deathly ill and it lasted for three weeks) and bug bites from an unknown date and unknown if ongoing. There were no concomitant medications. The patient is the type of person that takes a lot for her to take medications. She is allergic to a lot of things; she always has crazy reactions. She can't take morphine. It took her 7 pills to get the right one for high blood pressure. She has the craziest one-day reactions. She received the COVID-19 vaccine on Saturday much against her will, knowing she had COVID but not diagnosed in March. She had a fever, she was deathly ill and it lasted for three weeks. She had a nasal swab done and it came back negative. She doesn't think that was right, she believes she had COVID-19 in Mar2020. Her daughter is younger, and she had the same thing, she couldn't breathe good for 3 weeks. She had pneumonia. She knows she had COVID-19. She was trying to lose weight. She was given her first COVID-19 vaccine by a doctor. Everything was going okay at first. About an hour and a half later, she became weird in her head, almost like a lightheadedness. She can't describe it. She has never taken drugs. She doesn't drink alcohol at all. She has like a virgin body. She states plus she is red headed, which it is known red heads have a harder time with medication. As the day goes on, she just felt lightheaded all the rest of the day. The next day (Sunday, 31Jan2021), she wakes up and it hits her like a ton of bricks. She woke in the morning and seemed to be okay and then it was like she was pregnant and blew up. She started cramping really bad and had gas. Everybody has gas. She was a little nauseated as well. She experienced lots of indigestion, cramping in her stomach like she was going to have a baby or the worse bowel movement. She had to go the bathroom a lot. She had a little bit of nausea. She had nausea pills because she had a gallbladder taken out and she took nausea pills for 2-3 days. She didn't take any medication for any of these symptoms she started to experience on Sunday. However, she did start popping Gas-X. She was taking two Gas-X every 3 or 4 hours. The caller states it helped. She had lots of gas; gas was just coming out of her bottom. She had the gas, cramps, her stomach hurt. She was able to get through it, which that is good. Then Monday, 01Feb2021 was the day she had weird things happen to her that she was kind of concerned about. Her muscles started to draw, that is the best way she can describe it. Her feet would just draw up weird. Her arms and hands would do crazy things and contort or draw up. This hurts because the muscles are like a rubber band pulling. It was weird, and she didn't like it. It wasn't like when she has a horse and has to get up and stand, it wasn't like that at all. Her muscles were tightening up like a rubber band. Her right arm was the worse with the pain and then her hands would kind of move in a kind of crazy way where it was tightening. She thought to herself, "what is this Parkinson's?". She doesn't even know. She still has some stomach issues, but it is easing up. The gas is still coming out. It wasn't debilitating or anything. She has some minor nausea. What scared her more was the muscle cramping and pulling. Her toes would contort and go backwards. The muscle tightness occurred yesterday, 01Feb2021. It happened all day and was sporadic. Her toes moved in a different way like a rubber band pulling on muscle. Nothing has happened today. Everything was yesterday. Her whole body basically was affected, just different sections at different times. Today, she feels like the left arm is going to do something, it's like the last to be pulled. Her hands and fingers stayed the same. She explains like the upper arm area from her elbow to her shoulder part. She can't even think of what that area is, but it's the part between her elbow and shoulder. She has been doing lots of exercises and moving, hoping the part of her elbow to her should don't atrophy or won't pull. She hasn't told anybody about it. She doesn't like it. It was very frightening. She is scheduled for her second shot and she is scared to death to go back. She mentions her nerves are shot. From stress, she had previously broken out instantly. She thought it was a bug biting her. She never had gone to the doctor but after about 4 weeks, she thought she had these horrible bug bites. She was shaking her clothes and she almost wanted to strip it was so bad. She thought it was severe bug bites. She couldn't figure it out. She finally went to the doctor after a week. It was a Saturday. The doctor told her it was shingles. Explained that it itches a lot. She went on medication. She clarifies she went on acyclovir 800mg, three pills a day. She called her doctor knowing that she had shingles and how scared she is with medicine, the doctor assured her she could get the COVID-19 shot as scheduled. The medicine for shingles (acyclovir) was finished up the Friday before she received the COVID-19 vaccine. She got the shingles shot at 60 but everybody is now saying to get the new shot for shingles which she has never done obviously since she got the shingles. She plans to get the shingles shot in the summer. She is not worried about it. She took 3 pills a day and that was fine. She is fine, meaning every day she did normal things going through the whole process. She states she plans to go to the bank. She asked if anybody has reported the reaction she experienced after receiving the first dose of the Covid vaccine. She received the first dose of the vaccine last Saturday, in which within an hour and a half her "brain got weird, like a psychedelic feeling and it felt like I was getting an injection in the operating room to go to sleep." On Monday she experienced, "horrible palsy, as if her muscle was being pulled like a rubber band." Stated that it wasn't a horse feeling. Her hands and fingers would pull and contort in different positions, in which they would remain tight and stay in that position, and then she would be able to make a closed fist. On Monday night, her left arm contorted (which is not administration arm) and her muscle became really tight from her elbow to her wrist leading to her hand contorting as well. She describes the muscle tension as if a rubber band was being pulled, it would have burst. This muscle pulling hurt, in which she took 3 ibuprofen (ADVIL). She has crazy reactions with almost anything that she takes. She has never smoked or drank. The patient underwent lab tests and procedures which included COVID-19: unknown on an unspecified date and unknown on Mar2020, SARS-COV-2 test: negative on an unspecified date. Therapeutic measures were taken as a result of gas (flatulence), muscles became tight/contort, minor nausea, horrible palsy, as if her muscle was being pulled like a rubber band and shingles. The outcome of the event 'the worse bowel movement. She had to go the bathroom a lot' was not recovered while of the rest of the events was unknown.

Other Meds:

Current Illness:

ID: 1035518
Sex: M
Age:
State: PA

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

Lab Data: Test Date: 20210202; Test Name: Fever; Result Unstructured Data: Test Result:99.5; Comments: low grade fever

Allergies:

Symptoms: passed out; terrible headache; still some body aches; general bad feeling all over; nausea/tremendous chills and nausea; tremendous chills and nausea; low grade fever 99.5; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm (at age of 48-year-old) on 02Feb2021 at 10:30 AM as a single dose for COVID-19 immunisation, lot number: EL9262. Medical history included high cholesterol and allergies to some seaweeds. Patient received first vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Jan2021 via an unspecified route of administration in Left arm (at age of 48-year-old) for COVID-19 immunisation, lot number: EL3246. Concomitant medications in two weeks prior to the vaccination included atorvastatin and multi- vitamin. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Patient started about 12 hours after getting vaccinated (reported as 02Feb2021 at 10:00 PM) with a general bad feeling all over, 15 hours after (03Feb2021 at 01:00 AM) patient got out of bed because of nausea and passed out, his wife found he on the floor. Patient had tremendous chills and nausea with a low grade fever 99.5 for several more hours, maybe 6 hours, (onset date 02Feb2021) the next morning patient had a terrible headache and still some body aches. Patient was treated with extra strength paracetamol (TYLENOL) and ondansetron (ZOFRAN). Since the vaccination patient had not been tested for COVID-19. Patient was recovering from the events, at the time of the report.

Other Meds: ATORVASTATIN

Current Illness:

ID: 1035519
Sex: F
Age:
State: TN

Vax Date: 02/01/2021
Onset Date: 02/02/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data: Test Date: 20210202; Test Name: blood pressure; Result Unstructured Data: Test Result:227/153

Allergies:

Symptoms: At 4 Am the morning after my second vaccine I had a seizure.; I was found non responsive; blood pressure of 227/153; This is a spontaneous report from a contactable Other Health Professional (patient). A 37-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 01Feb2021 10:00 at single dose on right arm for COVID-19 immunisation. Medical history included high blood pressure. Historical vaccine included 1st dose of BNT162B2 on 11Jan2021 08:00 am via intramuscular on right arm for COVID-19 immunisation. Patient was not pregnant. Concomitant medication included labetalol and HCTZ. At 04:00 am of 02Feb2021, after second vaccine patient had a seizure. Patient was found non-responsive with a blood pressure of 227/153. Emergency room was visited. Patient have no history of seizures and it was concluded by PCP that this was an adverse response to the vaccine. Treatment was received. Outcome of the events was recovered/resolved with sequel. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events seizure, loss of consciousness and hypertension cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: LABETALOL; HCTZ

Current Illness:

ID: 1035520
Sex: F
Age:
State: PA

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data: Test Date: 20200129; Test Name: Hearing exam; Result Unstructured Data: Test Result:revealed slightly hearing loss consistent with age; Comments: revealed slightly hearing loss consistent with age. It was pretty normal; Test Date: 20200129; Test Name: Ear exam; Result Unstructured Data: Test Result:perfect

Allergies:

Symptoms: tinnitus/she had 2 seconds of a very high pitch and then the following morning, she began having a low level, not high pitched, background low level type hum that was unresolved; This is a spontaneous report from a contactable pharmacist (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), via intramuscular on 12Jan2021 17:30 at single dose on left arm for prevention. Medical history included hashimoto's hypothyroidism. Concomitant medication included levothyroxine sodium (SYNTHROID) and liothyronine sodium (CYTOMEL), both for Hashimoto's Hypothyroidism; cyanocobalamin (VIT B12), selenium, VITAMIN D3, ascorbic acid (VITAMIN C), calcium + magnesium, all for many years for vitamin supplementation. She also had a hormone replacement therapy patch that she had been taking for 5 years. She had experienced some tinnitus on 12Jan2021 21:00 and it had not resolved. She went to ENT (ear, nose and throat) for an ear exam. They were fine. They did not think it was the vaccine but did not know. After she received the vaccine, she had 2 seconds of a very high pitch and then the following morning, she began having a low level, not high pitched, background low level type hum that was unresolved. It started the evening of around 9pm. She went after work at 17:30 to get the vaccine. It was further reported that tinnitus started at 21:00 for just 2 seconds and then hearing was normal. However, the following morning, she woke up with this low level like if you leave TV on the like a hum. Very mild. This started at 06:00. No ER (Emergency Room) or physician's office required. On 29Jan2020, patient did an ear exam and hearing exam. Ear exam was perfect. Hearing exam revealed slightly hearing loss consistent with age. It was pretty normal. The part of the hearing that goes first as the age. Outcome of the event was not resolved. This case was reported as serious with seriousness criteria: medically significant.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event tinnitus cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: SYNTHROID; CYTOMEL; VIT B12; SELENIUM; VITAMIN D3; VITAMIN C [ASCORBIC ACID]; CALCIUM + MAGNESIUM

Current Illness:

ID: 1035521
Sex: M
Age:
State: TX

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: hallucinations; drowsiness; Insomnia; extremely vivid and realistic dreams; metallic taste in mouth; muscle soreness; joint pain; headache; nausea; This is a spontaneous report from a contactable consumer reporting for self. A 43-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265), via an unspecified route of administration on 01Feb2021 08:15 at single dose for covid-19 immunisation. Medical history included allergies to azithromycin, erythromycin, amoxicillin, penicillin. Concomitant medication included influenza vaccine inact split 4v (FLUZONE), diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL), hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ). The patient experienced Insomnia, extremely vivid and realistic dreams, hallucinations 16-20 hours after injection (that night), metallic taste in mouth, muscle soreness, joint pain, headache, nausea, drowsiness for approximately 36 hours on 01Feb2021 11:00. Outcome of events was recovering.

Other Meds: LISINOPRIL HCTZ

Current Illness:

ID: 1035522
Sex: M
Age:
State: DE

Vax Date: 01/30/2021
Onset Date: 01/31/2021
Rec V Date: 02/17/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: First time seizure occurred 12 hr after injection; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9265), via an unspecified route of administration on left arm on 30Jan2021 13:30 at single dose for COVID-19 immunization. Medical history reported as none. There were no concomitant medications. First time seizure occurred 12 hr after injection (AE resulted in: Emergency room/department or urgent care, Hospitalization for 3 days) on 31Jan2021 02:00. Therapeutic measures (LEVETIRACETAM TABLETS - (KEPPRA)) were taken as a result of event. The outcome of event was recovering.

Other Meds:

Current Illness:

ID: 1035523
Sex: F
Age:
State:

Vax Date: 02/02/2021
Onset Date: 02/03/2021
Rec V Date: 02/17/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: vertigo; This is a report from an interventional study sponsored by BioNTech, managed and reported by Pfizer on the sponsor's behalf. The subject was in open-label phase of the study when the event occurred. A 72-year-old female subject received first and second dose of blinded therapy vaccine (BNT162; PLACEBO) on 31Aug2020 and 21Sep2020 respectively. She then received third dose of study vaccine (BNT162B2) on 13Jan2021 at 15:48 and fourth dose of study vaccine (BNT162B2) on 02Feb2021 at 11:50, both intramuscularly on left deltoid as single doses, all for COVID-19 immunization. Medical history included insomnia from 2010 and ongoing, sleep apnea from 2010 and ongoing, left knee osteoarthritis from 2014 to 2017 (with left total knee arthroplasty), osteoporosis from 2016 and ongoing and basal cell carcinoma on nose in 2018. No concomitant vaccines or prior vaccinations (within 4 weeks) were received. Family medical history relevant to the adverse event (AE) was unknown. Ongoing concomitant medications included estradiol (ESTROGEL) as hormone replacement from 2019, denosumab (PROLIA) for osteoporosis from 2017, zolpidem tartrate (AMBIEN) for insomnia from 2010; and ascorbic acid (VITAMIN C), zinc, vitamin B6, quercetin and glucosamine, all as health supplement from Mar2020. On 03Feb2021, the subject experienced vertigo with serious criteria of medically significant and hospitalization. The event required a visit to emergency room. The clinical course was as follows: Around midnight on 03Feb2021, the subject did not feel well with severe chills. She got up out of bed and went to the bathroom. She experienced vertigo, fell and hit her head. She was found bleeding by her husband who called the ambulance. She was taken to the hospital and had 7 stitches placed. She was still in the hospital at the time of the report. The action taken in response to the event for study vaccine BNT162B2 was not applicable. The outcome of event was not recovered. The investigator considered there was a reasonable possibility that the event vertigo was related to the study vaccine but not related to concomitant drugs or clinical trial procedure.; Sender's Comments: The event "Vertigo" is unlisted in the Single Reference Safety Document (SRSD) of the Investigational Product therapy vaccine (BNT162B2). The information provided is very limited and mainly anecdotal. Results of the diagnostic workup during hospitalization are not available. The company considers there is not a reasonable possibility that the event, vertigo, is related to vaccine administration based on the latency, the circumstances and a possible role of concomitant medication zolpidem. Pfizer's safety database was reviewed for cases reporting PF-07302048 or blinded therapy through 15-JAN-2021 for adverse events encoding to MedDRA (v.23.1J) Preferred Term(s) of Vertigo. Review of the database for the PT Vertigo had the following results: 2 serious clinical trial cases (0 of which were attributed to therapy) and 109 non clinical trial cases. The impacts of this report on the benefit/risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committee and Investigators, as appropriate.

Other Meds: ESTROGEL; PROLIA; AMBIEN; VITAMIN C [ASCORBIC ACID]; ZINC; VITAMIN B6; QUERCETIN; GLUCOSAMINE

Current Illness: Insomnia; Osteoporosis; Sleep apnea

ID: 1035524
Sex: F
Age:
State: TX

Vax Date: 01/15/2021
Onset Date: 01/21/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data: Test Date: 20210121; Test Name: Colonoscopy; Result Unstructured Data: Test Result:found bacteria on her stomach

Allergies:

Symptoms: bacteria on her stomach; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer (patient) reported that a 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly into the right arm on 15Jan2021 at a single dose for covid-19 immunisation. Medical history included ongoing cholesterol and ongoing high blood pressure. Concomitant medication included losartan (LOSARTAN) for high blood pressure and atorvastatin (ATORVASTATIN) for cholesterol. It was reported that the patient had colonoscopy on 21Jan2021 and had found bacteria on her stomach. The patient was treated with 10 days antibiotic regimen of amoxicillin and clarithromycin. The patient's second dose was scheduled on 04Feb2021 and she was inquiring if she could still have the shot and if the antibiotic will affect the effectiveness of that shot. Outcome of event was unknown. Information about lot/batch number has been requested.

Other Meds: LOSARTAN; ATORVASTATIN

Current Illness: Blood cholesterol abnormal; Blood pressure high

ID: 1035525
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: kidney or urinary tract excused here; infection in urinary tract; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (30th) at single dose for covid-19 immunization. Medical history included wear hearing aids in both ears. The patient's concomitant medications were not reported. Patient found out here evidently had either a kidney or urinary tract excused here. Patient had either an infection in urinary tract. Outcome of events was unknown. Information on the Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1035527
Sex: F
Age:
State: NV

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

Lab Data:

Allergies:

Symptoms: dementia; This is a spontaneous report from a Pfizer Sponsored program. A contactable consumer reported that a female patient (wife) of unspecified age was received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Calling on behalf of her wife that has dementia, she already received the 1st dose of the vaccine and was prescribed a new drug Nuplazid. Husband wanted to know the drug interaction between the two. outcome of the event was unknown. Information on batch/lot number was requested.

Other Meds:

Current Illness:

ID: 1035528
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: stroke; couldn't speak; feeling tired; diarrhea; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a female patient of an unspecified age received the 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 a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a stroke (medically significant) after the first shot and couldn't speak, was feeling tired as well and diarrhea. She wanted to know if she could still take the second shot. Patient does not want to give any information. The outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number could not be requested.

Other Meds:

Current Illness:

ID: 1035529
Sex: F
Age:
State:

Vax Date: 01/28/2021
Onset Date: 02/01/2021
Rec V Date: 02/17/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: ischemic stroke; This is a spontaneous report from a contactable consumer. A 9-decade-old (reported as: "in her 80's") female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration, first dose on 28Jan2021 at single dose for COVID-19 vaccination. Recent medical history included GI complications. The patient's concomitant medications were not reported. On 01Feb2021, the patient experienced ischemic stroke requiring hospitalization. Event took place after use of product. The outcome of the event was recovering. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1035530
Sex: F
Age:
State: GA

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Fatigue; fever; vomiting; pain and swelling at injection site; pain and swelling at injection site; bone and muscle aches throughout body; bone and muscle aches throughout body; headaches; nausea; painful lump on under arm of the arm that the shot was given; trouble breathing; chest heaviness; This is a spontaneous report from a contactable other health professional (patient). A 41-year-old female patient (pregnant: unknown) received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, , Formulation: Solution for injection, Lot number: unknown, expiration date unknown), via intramuscular on the left arm on 04Feb2021 at 11:30 at a single dose for COVID-19 immunization in the hospital. Medical history included diverticulosis and COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19). The patient concomitant medications were not reported. The patient experienced fatigue, fever, vomiting, pain and swelling at injection site, bone and muscle aches throughout body, headaches, nausea, painful lump on under arm of the arm that the shot was given, trouble breathing, chest heaviness all on 04Feb2021 at 19:00 PM. Patient visited emergency room/department or urgent care in response to the events. Patient received Zofran, dexamethasone and espi. The reporter assessed the events as non-serious. The patient was recovering from the events. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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: 1035531
Sex: F
Age:
State: NC

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

Lab Data:

Allergies:

Symptoms: mild stroke; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose as vaccine. Medical history and concomitant medications were not reported. On an unspecified date, the patient had a mild stroke after the 1st vaccine and she's asking if she could go early to facility for the second dose. The outcome of the event was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1035532
Sex: F
Age:
State: FL

Vax Date: 01/07/2021
Onset Date: 01/01/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Sty on my right eye; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number: EL3246, via an unspecified route of administration on 07Jan2021 11:00 at a single dose for COVID-19 immunization. Medical history included multiple sclerosis (MS) and environmental allergies. Concomitant medication included ascorbic acid (VIT C), colecalciferol (VIT D3), zinc, acetylcysteine (NAC) and montelukast. In Jan2021, after 1 dose the patient formed a sty on her right eye, and it was still there three weeks later. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior vaccination the patient was not diagnosed with COVID-19 and has not been tested for COVID-19. The outcome of the event was unknown. The event was assessed as serious-medically significant.

Other Meds: VIT C; VIT D3; ZINC; NAC [ACETYLCYSTEINE]; MONTELUKAST

Current Illness:

ID: 1035533
Sex: F
Age:
State: AR

Vax Date: 01/28/2021
Onset Date: 01/30/2021
Rec V Date: 02/17/2021
Hospital:

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

Allergies:

Symptoms: she lost total hearing in one ear inside of five minutes/went totally deaf in her right ear; This is a spontaneous report from a contactable consumer reported for herself. A 74-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247 and expiry date: May2021), via an unspecified route of administration on left arm on 28Jan2021 16:00 at SINGLE DOSE for covid-19 immunisation. Medical history included chronic lymphocytic leukaemia, anaemia. The patient's concomitant medications were not reported. The patient previously took morphine and experienced drug hypersensitivity. The patient received the first dose of the Pfizer COVID 19 vaccine on 28Jan2021. On the 30Jan2021 04:00 PM, she lost total hearing in one ear inside of five minutes/she went totally deaf in her right ear. She has had tests done including a CT and MRI but she is still waiting for the results, which reported as under treatment. Adds she doesn't have an appointment yet, but she is supposed to get the next dose 18Feb2021. The event reported as serious with disability, result emergency room/department or urgent care. Outcome of the event was not recovered. Patient is not pregnant at the time of vaccination. No Covid prior vaccination. No covid tested post vaccination.

Other Meds:

Current Illness:

ID: 1035534
Sex: M
Age:
State: AZ

Vax Date:
Onset Date: 02/04/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data: Test Date: 20210206; Test Name: blood sugars; Result Unstructured Data: Test Result:very high; Comments: very high blood sugars; Test Date: 20210206; Test Name: ketones; Result Unstructured Data: Test Result:high; Test Date: 20210204; Test Name: fever (101.9); Result Unstructured Data: Test Result:101.9; Comments: fever 101.9

Allergies:

Symptoms: stomach pain; vomiting; high ketones; high blood sugars and headache; my body could no longer absorb insulin; 12 hours after vaccine experienced a fever (101.9), aches, chills, and a very bad headache; 12 hours after vaccine experienced a fever (101.9), aches, chills, and a very bad headache; chills; 12 hours after vaccine experienced a fever (101.9), aches, chills, and a very bad headache; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 38-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration second dose (lot number: EL0142) on 03Feb2021 14:45 at a single dose in left arm for COVID-19 immunization. Medical history included type 1 diabetes. Concomitant medication included insulin lispro (HUMALOG), celecoxib (CELEXA) within 2 weeks of vaccination. The patient previously took first dose of bnt162b2 (lot number: EL0142) on 13Jan2021 14:45 at age of 38 years old in left arm for COVID-19 immunization. On 04Feb2021 06:00, the patient experienced 12 hours after vaccine experienced a fever (101.9), aches, chills, and a very bad headache, the body could no longer absorb insulin. On 06Feb2021, the patient experienced stomach pain, vomiting, high ketones, high blood sugars. The worst occurred the day after when the body could no longer absorb insulin. The patient increased basal rate by almost 400% and could not bring sugars down. Saturday afternoon, the patient began experiencing symptoms of diabetic ketoacidosis: stomach pain, vomiting, high ketones and very high blood sugars. The patient was able to eventually take in enough water to lower the ketones and sugar and narrowly avoided going to the emergency room (ER), but high blood sugars and headache persisted, and the patient were still experiencing these symptoms. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in doctor or other healthcare professional office/clinic visit. The treatment (Insulin and hydration) was received for the adverse event. The seriousness of all the events were life threatening. Therapeutic measures were taken as a result of adverse events. The outcome of all the events was not recovered.

Other Meds: Pfizer, Inc. EUA 027034; HUMALOG; CELEXA [CELECOXIB]

Current Illness:

ID: 1035535
Sex: M
Age:
State: OK

Vax Date: 01/29/2021
Onset Date: 01/31/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Bloody stool; Blood in urine; This is a spontaneous report from a contactable consumer reported for himself. A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL8982 (reported as looks like EL8982 or 1982), on 29Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient got his COVID shot on Friday and he have no problem with the shot as far as the shot itself. On Sunday which is two days later, he had first blood in his stool when he went to the bathroom, no fever and then this morning went he urinated, at the end of the urination he has some blood there too, like that. The only adverse effect he have was bloody stool and blood in his urine. Yesterday (31Jan2021), he had no temperature, no fever stuff like that, only blood in his stool and urine, then this morning, next day, three days, blood in his urine. No Investigation Assessment. no treatment for the events. Outcome of the event was unknown. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1035536
Sex: F
Age:
State: KY

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 02/17/2021
Hospital: Y

Lab Data: Test Date: 20210108; Test Name: BP; Result Unstructured Data: Test Result:144/86; Comments: Date/Time: 08Jan2021 14:11; Test Date: 20210108; Test Name: BP; Result Unstructured Data: Test Result:147/98; Comments: Date/Time: 08Jan2021 12:54; Test Date: 20210108; Test Name: Height; Result Unstructured Data: Test Result:157.5 cm (62"); Test Date: 20210108; Test Name: Temp; Result Unstructured Data: Test Result:97.6 F (36.4 C) Fahrenheit; Comments: 1229; Test Date: 20210108; Test Name: ECG; Result Unstructured Data: Test Result:ECG result: None; Test Date: 20210108; Test Name: Pulse; Result Unstructured Data: Test Result:79; Comments: Date/Time: 08Jan2021 14:11; Test Date: 20210108; Test Name: Pulse; Result Unstructured Data: Test Result:90; Comments: Date/Time: 08Jan2021 12:54; Test Date: 20210108; Test Name: Pulse; Result Unstructured Data: Test Result:121; Test Date: 20210108; Test Name: Pulse; Result Unstructured Data: Test Result:121; Comments: 12:29; Test Date: 20210108; Test Name: Result of current screen is; Test Result: Negative ; Test Date: 20210108; Test Name: Who; Result Unstructured Data: Test Result:; Comments: Date/Time: 08Jan2021 14:11; Test Date: 20210108; Test Name: Who; Result Unstructured Data: Test Result:; Comments: 08Jan2021 12:54; Test Date: 20210108; Test Name: Who; Result Unstructured Data: Test Result:; Test Date: 20210108; Test Name: SpO2; Test Result: 998 %; Test Date: 20210108; Test Name: SpO2; Test Result: 96 %; Comments: Date/Time: 08Jan2021 14:11; Test Date: 20210108; Test Name: SpO2; Test Result: 96 %; Comments: Date/Time: 08Jan2021 12:54; Test Date: 20210108; Test Name: SpO2; Test Result: 97 %; Test Date: 20210108; Test Name: SpO2; Test Result: 97 %; Comments: 12:29; Test Date: 20210108; Test Name: Resp.; Result Unstructured Data: Test Result:18; Comments: Date/Time: 08Jan2021 14:11; Test Date: 20210108; Test Name: Resp.; Result Unstructured Data: Test Result:16; Comments: Date/Time: 08Jan2021 12:54; Test Date: 20210108; Test Name: Resp.; Result Unstructured Data: Test Result:16; Test Date: 20210108; Test Name: Resp.; Result Unstructured Data: Test Result:16; Comments: 12:29; Test Date: 20210108; Test Name: Imaging; Result Unstructured Data: Test Result:None; Test Date: 20210108; Test Name: Weight; Test Result: 72.06 kg; Comments: (160 lb)

Allergies:

Symptoms: Hives and it progressed to an anaphylactic reaction; Hives and it progressed to an anaphylactic reaction; hives itch; slight swelling around her eyes; This is a spontaneous report from a contactable nurse (patient) via Pfizer Sales Representative. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 at single dose for COVID-19 immunization. Medical history included anaphylaxis (Patient does have a history of anaphylaxis to bee stings), Hysterectomy, Gallbladder surgery, Mastectomy partial/ lumpectomy, Alcohol use: Yes (Comment: socially rare, Drug use: Never), Shellfish-derived products, Seasonal allergies (J30.21), HX: breast cancer (Z85.31), smoker stopped on 01Jan2000 (Former Smoker, Years since quitting: 21, Smokeless tobacco: Never Used), Hot flashes, Axillary Node Dissection. Allergie to Bee venom, Shellfish-derived products, Coconut, Codeine, and Other The patient's allergies have been reviewed. Family History included Cancer oral of Mother; Lung cancer of Father and Maternal Grandfather and Paternal Grandmother; Uterine cancer of Paternal Grandmother. Concomitant medication included ongoing cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ongoing dexmethylphenidate hydrochloride (FOCALIN [DEXMETHYLPHENIDATE HYDROCHLORIDE]), epinephrine (EPIPEN), ongoing lisinopril dihydrate (PRINIVIL), lisinopril (ZESTRIL), ongoing metoprolol succinate (TOPROL XL), valaciclovir hydrochloride (VALTREX), zolpidem tartrate (AMBIEN) from 30Apr2020 and ongoing, promethazine (PHENERGAN [PROMETHAZINE]) from 13Sep2019. Patient previously took Codeine and had vomiting and allergy to it. Patient had an anaphylactic reaction to our vaccine. it started as hives and it progressed to an anaphylactic reaction on 08Jan2021. they gave patient Benadryl afterwards for her anaphylactic reaction because they do not want to interfere with the efficacy of the vaccine that she was able to breathe so she did not have to have any Epipen or anything. She was sent to an ER within hospital to get that. She was in the hospital getting the shot and then they sent her to the ER and she started having the reaction. Emergency department summary of care: Chief complaint: Allergic reaction. ED Diagnosis: Diagnosis Final diagnosis. Allergic reaction to vaccine: Allergic reaction to vaccine. ED Vitals: Date/Time: 08Jan2021 14:00. Pulse: 79. Resp.: 18. BP: 144/86. SpO2: 96%. Date/Time: 08Jan2021 12:54. Pulse: 90. Resp.: 16. BP: 147/98. SpO2: 96%. Weight: 72. 06 kg (160 lb). Date/Time: 08Jan2021. Temp.: 97.6 F (36.4 C). Pulse: 121. Resp.: 16. SpO2: 97%. Result: None. Imaging result: None. ECG result: None. Emergency Department Encounter: Patient was placed in face mask in first look and the following protective measures were taken unless additional measures were taken and documented below in the ED course. Patient was wearing facemask when nurse entered the room and throughout our encounter. nurse wore full protective equipment throughout this patient encounter including a face mask, and gloves. Hand hygiene was performed before donning protective equipment and after removal when leaving the room. Date of encounter: 08Jan2021. Last ED provide Note: patient is a 49 y.o. female who presents to the ED c/o chief complaint of allergic reaction. Patient reports that she just received her first Covid immunization approximately 30 minutes ago, immediately broke out into hives. Patient reports she had hives on bilateral arms as well as her back, hives itch. Patient complains of slight swelling around her eyes. No swelling of her tongue slipped or throat, no difficulty swallowing, no difficulty breathing, no nausea or vomiting. Patient reports that prior to the vaccination she was at baseline without complaint. Patient does have a history of anaphylaxis to bee stings, no other history of anaphylactic reactions, does have history of allergic reactions with hives. Patient received 50 mg oral Benadryl prior to arrival. Patient reports that the hives on her arm have since resolved, continues complain of itching on her back. No active ambulatory problem. No resolved ambulatory problem. All systems reviewed and negative except for those discussed in HPI. PHYSICAL EXAM nurse have reviewed the triage vital signs and nursing notes. ED Triage Vitals (08Jan2021 1229): Temp: 97.6 F (36.4 C), Heart Rate: 121, Resp.: 16, SpO2: 97%. General: No acute distress. HENT: NCAT, PERRL, Nares patent, no swelling of the lips tongue, no posterior oropharyngeal swelling, Voice is normal, no difficulty handling secretions Eyes: no scleral icterus. Neck: trachea midline, no ROM limitations, no stridor. CV: regular rhythm, regular rate. Respiratory: normal effort, CTAB, no wheezing rales or rhonchi Abdomen: soft, nondistended, nontender to palpation, no rebound tenderness, no guarding or rigidity. GU: deferred. Musculoskeletal; no deformity. Neuro: alert, moves all extremities, follows commands. Skin: warm, dry, bilateral arms are normal in appearance, no hives, No rash. Patient has several scattered Hives on her back. Lab Results: No results found for this or any previous visit (from the past 24 hour(s)). Nurse ordered the above labs and reviewed the results. Radiology: No Radiology Exams Resulted Within Past 24 Hours. Nurse ordered the above noted radiological studies. Nurse reviewed the images and results. Nurse agree with the radiologist interpretation. Procedures: Medications - No data to display. PROGRESS DATA. A complete history and physical exam have been performed. All available laboratory and imaging results have been reviewed by nurseself prior to disposition. After the initial H&P, Nurse discussed pertinent information from history and physical exam with patient/family. Discussed differential diagnosis. Discussed plan for ED evaluation/work up treatment. All questions answered. Patient/family is agreeable with plan. ED Course: Patient complaining of allergic reaction, hives seems to be resolving, no symptoms consistent with anaphylaxis. Symptoms seem to be improving after oral Benadryl, no further medication at this time, will monitor closely. Patient reassessed, reports rash has resolved, itchiness has resolved. Patient continues to deny any swelling of lips tongue or throat, no difficulty breathing, no nausea or vomiting. Discussed at length with the patient that Nurse do not advise her to get the second dose of the vaccination as it can cause repeat allergic reaction, possibly worse allergic reaction. Discussed possibility of obtaining the mother no vaccine once it becomes available. Patient understands. Discussed need for close follow- up with primary care physician, Extensive discussion return precautions. Discharging. The patient was reexamined. They have had symptomatic improvement during their ED stay. nurse discussed today's findings with the patient, explaining the pertinent positives and negatives from today's visit, and the plan of used plan for discharge as there is care. No emergent indication for admission. Discussed limitation of the ED work-up and that this is to rule out life-threatening emergencies but that they could require further testing as determined by their primary care and or any referred specialist patient is agreeable and understands need for follow-up and repeat exam/testing. Patient is aware that discharge does not mean there is nothing wrong. Indicates no emergency is present, and that they must continue their care with their primary care physician and/or any referred specialist. They were given appropriate follow-up with their primary care physician and/or specialist. nurse had an extensive discussion on the expected clinical course and return precautions. Patient understands to return to the emergency department for continuation, worsening, or new symptoms. Nurse answered any of the patient's questions. Patient was discharged home in a stable condition. As of 14:11 EST Vitals: BP - 144/86, HR -79, Temp - 97.6 OF (36.4 (Tympanic) 02 SATS - 96%. DISPOSITION: DISCHARGE: Patient discharged in stable condition. Reviewed implications of results, diagnosis, meds, responsibility to follow up, warnin

Other Meds: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FOCALIN [DEXMETHYLPHENIDATE HYDROCHLORIDE]; EPIPEN; PRINIVIL; ZESTRIL; TOPROL XL; VALTREX; AMBIEN; PHENERGAN [PROMETHAZINE]

Current Illness:

ID: 1035537
Sex: F
Age:
State:

Vax Date: 02/02/2021
Onset Date: 02/01/2021
Rec V Date: 02/17/2021
Hospital:

Lab Data:

Allergies:

Symptoms: developed paralysis in the opposite part of the body; Her hand, fingers and knee all became swollen; Her hand, fingers and knee all became swollen; This is a spontaneous report from a contactable consumer via Pfizer Sponsored program Pfizer First Connect. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Feb2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient took the first dose of the vaccine on an unknown date for COVID-19 immunization. In Feb2021, about 12 hours after getting the vaccine, the patient developed paralysis in the opposite part of the body where she didn't get the vaccine. Her hand, fingers and knee all became swollen. She had the symptoms on her right and was given the vaccine in her left. The final outcome of the events was unknown.Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1035538
Sex: F
Age:
State: GA

Vax Date: 01/28/2021
Onset Date:
Rec V Date: 02/17/2021
Hospital:

Lab Data: Test Name: eye examination; Result Unstructured Data: Test Result:inflammation to her retina

Allergies:

Symptoms: the reaction is inflammation to her retina; dose given 11Jan2021, and second dose LOT: EK9231 for dose given on 28Jan; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), via an unspecified route of administration on 28Jan2021 at sngle dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 (lot: EH9899) received on 11Jan2021 for COVID-19 immunisation. Patient went to her ophthalmologist and they examined her eye. The ophthalmologist said that the reaction was inflammation to her retina. Outcome of the event was unknown.

Other Meds:

Current Illness:

Date Died: 02/07/2021

ID: 1035539
Sex: F
Age:
State: OH

Vax Date: 01/19/2021
Onset Date: 01/01/2021
Rec V Date: 02/17/2021
Hospital: Y

Lab Data: Test Date: 202102; Test Name: cell lines; Result Unstructured Data: Test Result:down

Allergies:

Symptoms: Fall; fatigued; arm pain; AML; Sepsis secondary to AML; This is a spontaneous report from a contactable consumer. An 88-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3249), via an unspecified route of administration on 19Jan2021 17:30 in right arm at single dose for covid-19 immunization. Medical history included hypertension, hyperlipidemia, OA (osteoarthritis), cognitive impairment. No other vaccine in four weeks was administrated. Concomitant medication in two weeks included atorvastatin, aspirin, calcium, gabapentin, losartan and memantine hydrochloride (NAMENDA). The patient previously took lisinopril and tetracycline and both experienced allergies. The patient had no covid prior vaccination. The patient initially had no symptoms but arm pain in Jan2021, no bleeding or bruising from injection. On 31Jan2021 19:00, patient felt fatigued. Patient suffered fall on 01Feb2021. She was admitted to hospital. All cell lines were down in Feb2021. She was diagnosed with AML (acute myeloid leukemia) in 2021. She expired 07Feb2021. Events resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event) and patient died. The patient received the treatment of blood and platelet transfusions, bone marrow biopsy, cytogenetic testing, antibiotics, intubation for events. The patient died on 07Feb2021 due to sepsis secondary to AML. An autopsy was not performed. Outcome of events were fatal.; Reported Cause(s) of Death: arm pain; fatigued; fall; Sepsis secondary to AML; Sepsis secondary to AML

Other Meds: ATORVASTATIN; ASPIRIN [ACETYLSALICYLIC ACID]; CALCIUM; GABAPENTIN; LOSARTAN; NAMENDA

Current Illness:

ID: 1035540
Sex: M
Age:
State: NY

Vax Date: 01/28/2021
Onset Date: 01/31/2021
Rec V Date: 02/17/2021
Hospital: Y

Lab Data: Test Date: 20210209; Test Name: CT scan; Result Unstructured Data: Test Result:an aneurysm was discovered; Comments: an aneurysm was discovered that was actively bleedings

Allergies:

Symptoms: loss of feeling in legs as well as incoherent behavior; loss of feeling in legs as well as incoherent behavior; Upon a CT scan an aneurysm was discovered that was actively bleedings.; extreme headache/severe headaches; went to ER via ambulance in 31Jan2021 for extreme headache and body lameness; This is a spontaneous report from a contactable Consumer. A 44-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jan2021 at single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medication included allergy pills. Patient went to emergency room (ER) via ambulance on 31Jan2021 for extreme headache and body lameness, which started on 31Jan2021 22:00. Patient was discharged from ER on 01Feb2021. Patient returned to ER via ambulance on 09Feb2021 due to severe headaches and loss of feeling in legs as well as incoherent behavior. Upon a Computerised tomogram (CT) scan an aneurysm was discovered that was actively bleedings. Patient was transferred to medical center and is currently waiting surgical procedure. Adverse events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1035541
Sex: F
Age:
State: MO

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 02/17/2021
Hospital: Y

Lab Data: Test Date: 20210119; Test Name: Blood pressure; Result Unstructured Data: Test Result:70/40; Test Date: 20210119; Test Name: P; Result Unstructured Data: Test Result:40-30

Allergies:

Symptoms: syncope within 10 min. of injection, episode; BP 70/40 P 40-30 admitted to ICU; BP 70/40 P 40-30 admitted to ICU; Adrenal Crisis; patient with a medical history CVID (Immunodeficiency common variable) received bnt162b2; patient with a medical history CVID (Immunodeficiency common variable) received bnt162b2; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date unknown), via an unspecified route of administration in Left arm on 19Jan2021 at single dose for COVID-19 immunization in hospital; antilymphocyte immunoglobulins (reported as immunoglobulin infusion, concentrate for solution for infusion, lot/batch number and expiration date not provided) via an unspecified route of administration from an unspecified date at unknown dosage for an unspecified indication. Medical history included CVID (Immunodeficiency common variable), Addison Dx (diagnosis) and Pituitary Tumor. Prior to vaccination, patient was not diagnosed with COVID-19. No known allergies. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had syncope within 10 minutes of injection on 19Jan2021, episode, BP (blood pressure) 70/40, P (pulse) 40-30, admitted to ICU in Jan2021, determined adverse event maybe 2nd to immunoglobulin infusion received previous day leading to Adrenal Crisis, 2nd to Addison dx / Pituitary tumor which was unknown at time of vaccination. Events were resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Patient had been hospitalized for 6 days in Jan2021. Since the vaccination, patient had not been tested for COVID-19. The action taken in response to the events for antilymphocyte immunoglobulins was unknown. Therapeutic measures were taken as result of the events syncope, BP 70/40, P 40-30 and Adrenal Crisis. The outcome of the events "syncope, BP 70/40, P 40-30, Adrenal Crisis" was recovered in 2021. Patient then received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Feb2021. Pfizer is a marketing authorization holder of antilymphocyte immunoglobulins in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of antilymphocyte immunoglobulins has submitted the same report to the regulatory authorities. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect vaccine BNT152B2 and antilymphocyte immunoglobulins to the events syncope, low BP and heart rate, adrenal crisis, cannot be excluded. The underlying Addison disease and Pituitary Tumor are major cofounders for the events. 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: antilymphocyte immunoglobulins

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm