VAERS 2021 Database www.vaers.hhs.gov

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

Total Manufacturer
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: 0990344
Sex: M
Age:
State: MA

Vax Date: 12/07/2020
Onset Date: 12/07/2020
Rec V Date: 02/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: injection site pain almost immediately; headache; fever; This case was reported by a consumer and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On 7th December 2020, the patient received the 2nd dose of Shingrix. On 7th December 2020, immediately after receiving Shingrix, the patient experienced injection site pain, headache and fever. On an unknown date, the outcome of the injection site pain, headache and fever were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, headache and fever to be related to Shingrix. Additional details were provided as follows: The case was reported by the wife of the patient. The age at the vaccination was not reported. The patient received Shingrix and had injection site arm pain almost immediately. The patient developed headache and fever as well and that these symptoms persist. The reporter did not had vaccine information for this adverse event and declined follow up. The reporter did not consent to follow up. This case linked with US2020243295, reporter by same reporter for patient wife.; Sender's Comments: US-GLAXOSMITHKLINE-US2020243295:Same Reporter

Other Meds:

Current Illness:

ID: 0990345
Sex: F
Age: 1
State: KS

Vax Date: 12/10/2020
Onset Date:
Rec V Date: 02/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: vaccinated with Kinrix a 1.5 years old girl.; Inappropriate vaccination schedule; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a infant female patient who received DTPa-IPV (Kinrix) (batch number H9Y52, expiry date 31st January 2022) for prophylaxis. Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 10th December 2020, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The reporter stated that they vaccinated with Kinrix a 1.5 years old girl, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. The nurse did not realize that the prescribing Information states that Kinrix is indicated for kids aged 4 through 6 years. This was the 3rd dose for DTaP and 3rd dose for IPV series. The reporter consented to follow up. No other information was available.

Other Meds:

Current Illness:

ID: 0990346
Sex: F
Age: 74
State: CA

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

Lab Data:

Allergies:

Symptoms: pain around injection site; pain in left side of body to waist; pain in the muscle of the left underarm; red and blotchy upper arm; blotchy upper arm; This case was reported by a consumer and described the occurrence of injection site pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 1st December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 2nd December 2020, 1 days after receiving Shingrix, the patient experienced injection site pain, generalized aching, axillary pain, erythema of extremities and blotchy. On an unknown date, the outcome of the injection site pain, generalized aching, axillary pain, erythema of extremities and blotchy were recovered/resolved. It was unknown if the reporter considered the injection site pain, generalized aching, axillary pain, erythema of extremities and blotchy to be related to Shingrix. Additional details were provided as follows: The patient reported herself. The patient reported the day after receiving the vaccine she had pain around the injection site, her left arm was red and blotchy around the whole upper arm, pain in the muscle of the left underarm, and pain in the left side almost down to the waist area. The patient reported these events lasted about 10 days and have resolved. The reporter did not have batch number and expiry date information. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 0990347
Sex: U
Age:
State: WV

Vax Date: 12/02/2020
Onset Date: 12/03/2020
Rec V Date: 02/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: redness at injection site; pain; This case was reported by a pharmacist and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On 2nd December 2020, the patient received the 1st dose of Shingrix. On 3rd December 2020, 1 days after receiving Shingrix, the patient experienced injection site erythema and pain. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the injection site erythema and pain to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but selected as adult as per vaccine indication. The patient received the 1st dose of Shingrix and experienced redness at injection site and pain. A week later the symptoms appeared again. The reporter did not not provided patient identity. The reporter did not provided lot number and expiry date. No further information was available.

Other Meds:

Current Illness:

ID: 0990348
Sex: M
Age:
State: NJ

Vax Date: 12/18/2020
Onset Date: 12/20/2020
Rec V Date: 02/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: red, itchy, and a rash at the injection site; rash at the injection site; itchy, and a rash at the injection site.; fever; sweats; This case was reported by a consumer and described the occurrence of injection site erythema in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On 18th December 2020, the patient received the 1st dose of Shingrix. On 20th December 2020, 2 days after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced fever and sweating. On 22nd December 2020, the patient experienced injection site erythema, injection site rash and injection site itching. The patient was treated with ibuprofen. On 21st December 2020, the outcome of the fever and sweating were recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site rash and injection site itching were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site rash, injection site itching, fever and sweating to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient states he received 1st dose of Shingrix and developed fever and sweats. The patient was treated with ibuprofen for fever and sweats. On 22nd December 2020,4 days after vaccination the patient stated that he had red, itchy, and a rash at the injection site. The reporter declined for any other information for Adverse event. The reporter did not consented to follow up.

Other Meds:

Current Illness:

ID: 0990349
Sex: F
Age: 71
State: IN

Vax Date: 09/24/2020
Onset Date: 09/24/2020
Rec V Date: 02/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: dizzy; disoriented; sore muscles; chills; shaking all over; This case was reported by a consumer and described the occurrence of dizziness in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 24th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 24th September 2020, 1 hr after receiving Shingrix, the patient experienced dizziness, disorientation, muscle soreness, chills and tremor. On an unknown date, the outcome of the dizziness, disorientation, muscle soreness, chills and tremor were recovered/resolved. It was unknown if the reporter considered the dizziness, disorientation, muscle soreness, chills and tremor to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. One hour after receiving 1st dose of Shingrix, patient experienced chills, shaking all over, sore muscle, disoriented and dizziness. The reporter stated that the events were resolved. The reporter consented to follow up.; Sender's Comments: US-GLAXOSMITHKLINE-US2020AMR254620:same reporter

Other Meds:

Current Illness:

ID: 0990350
Sex: M
Age:
State: CA

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

Lab Data:

Allergies:

Symptoms: Mild case of Shingles; This case was reported by a consumer and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 months after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced shingles. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced shingles. The patient was treated with acyclovir. The reporter did not consen to follow up.

Other Meds:

Current Illness:

ID: 0990351
Sex: M
Age: 65
State: IL

Vax Date: 10/17/2011
Onset Date: 10/24/2011
Rec V Date: 02/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: pneumonia; blood clot in lung; kidney stone; neurological injury (occipital neuralgia); Postherpetic neuralgia (PHN); nauseated; passed out; The vaccine did not prevent shingles as intended; severely debilitating case of shingles/herpes zoster/herpes viral infection/"awful, awful" case of shingles. She further described them as all over his chest and too painful to touch./ persistent strain of herpes zoster / shingles; postoccipital headache; codeine allergy; A week prior to that Zostavax vaccination the patient received his Pneumovax vaccination; This spontaneous report as received from a physician via company representative (field employee) refers to a male patient of unknown age with hypertension and hypercholesterolemia. In 2011 (exact day unspecified) the patient was vaccinated with zoster vaccine live(ZOSTAVAX), one time, subcutaneously (dose and lot number not reported). Other suspect therapies included pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, lot number and route not reported), given about the same time (in 2011) as receiving zoster vaccine live(ZOSTAVAX) vaccine. On an unknown date, the patient developed a severely debilitating case of shingles. The physician reported that it was the worst case of shingles that they had ever seen in 30 years. The patient had also been travelling and it was upon his return that he developed shingles. There was unspecified treatment given for the event. The patient sought medical attention (doctor visit). There was no intervention required to prevent the seriousness criteria. There was no hospitalization. There was no PQC involved. The event was not life-threatening. The outcome of the event was unknown. Relatedness between the therapies and the event was unknown. Reporting physician considered shingles to be disabling. Follow up information received with updates: this spontaneous report as received from a physician regarding a 69 year old male patient via Program. On 24-OCT-2011 the patient was vaccinated with zoster vaccine live (ZOSTAVAX), lot# 670542/0619AA expire date 26-JUL-2012 in left arm. Prior to this vaccine, on 17-OCT-2011 the patient was vaccinated pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). It was reported that on 22-APR-2014, a program sample of the vesicle from the skin was obtained. The clinical data obtained was about differentiating rash unspecified or shingles. The specimen was obtained from the back superior lateral upper. It was described as received information is an 8x7x1 mm shave specimen of skin. Blanched and submitted in one cassette(s). It was confirmed to be herpes viral infections which consist with herpes zoster. It was noted that on an unknown date, the patient experienced herpes zoster. The patient was already on treatment (unspecified). On an unknown date the patient recovered from the above experience. It was also reported that the patient not had chickenpox or shingles on VZV exposure recently. Follow up information was received from Registered Nurse. She reported that on unspecified date in 2011, the patient received a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and one week later in October 2011, the patient received a dose of zoster vaccine live (ZOSTAVAX). She stated also that on unspecified date, the patient developed "awful, awful" case of shingles. She further described them as all over his chest and too painful to touch. Nurse reported shingles were actually hardened. Patient had biopsy completed by a Dermatologist. The outcome of painful skin was unknown. Relatedness between the therapies and painful skin was unknown. Follow up information has been received on 13-MAY-2014, The registered nurse stated that she had faxed over the information on the program questionnaire. The RN stated the patient received the zoster vaccine live (ZOSTAVAX) vaccine in 2011 (unspscified date). A week prior to that zoster vaccine live (ZOSTAVAX) the patient received his pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccination. The R.N was concerneed about "that in 2013, the company all of a sudden told them there needs to be at least 2 weeks between vaccinations of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and zoster vaccine live (ZOSTAVAX)". Follow-up information was received from a lawyer on 04-FEB-2020, regarding a case in litigation and refers to a 69-year-old male patient. In 2013 (conflicting with information received previously from program), the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 23-APR-2014, patient was treated by a healthcare provider for a blistering vesicular outbreak, which was diagnosed as shingles. Patient was prescribed gabapentin and acyclovir for management of his painful symptoms and chronic pain. On or about 21-FEB-2017, patient sought subsequent treatment from a healthcare provider for a blistering vesicular outbreak, which was diagnosed as herpes zoster. Patient was again prescribed gabapentin and acyclovir for management of his painful symptoms and chronic pain. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter considered herpes zoster and vaccination failure to be related to Zoster Vaccine Live (ZOSTAVAX). Follow-up information was received on 22-JAN-2021 from a lawyer via a Plaintiff Fact Sheet, concerning the 69-year-old male patient (pt). Pt's medical history included chicken pox. He had never received varicella vaccine. He was a non-smoker. On 01-DEC-2013 (conflicting with information received previously from program), the pt was vaccinated with zoster vaccine live (ZOSTAVAX) in the left arm. The pt claimed that as a result of zoster vaccine live (ZOSTAVAX), he experienced shingles (herpes zoster), postherpetic neuralgia (PHN) and neurological injury (occipital neuralgia). Pt experienced severe pain on his left arm with temporary loss of movement of this arm for approximately 4 months. He first became aware of the injury on approximately 20-APR-2014. Pt saw the blisters, went to the doctor and asked him about it because he thought it was sun poisoning. Doctor did a biopsy and called 2 days later to let pt know it was shingles. Diagnosis of shingles was made by a physician on 20-APR-2020 and 24-APR-2020 and "shingles" gel (not specified), acyclovir and gabapentin were prescribed; diagnosis of PHN was made on 23-MAY-2014; and with occipital neuralgia on 21-FEB-2017. No test was performed by a Health Care Provider to determine if the rash was wild type or vaccine strain varicella zoster virus. No Health Care Provider ever told the pt that he had vaccine strain varicella zoster virus. Pt claimed that his receipt of zoster vaccine live (ZOSTAVAX) did not cause or aggravate any psychiatric and/or psychological condition(s) (other than pain and suffering and emotional distress). In the 7 years preceding zoster vaccine live (ZOSTAVAX) vaccination to the present, the pt received inpatient or outpatient care from health care providers for the following conditions: prostate problems (dates of care/treatment: 2007-2015), urology/prostate problems (dates of care/treatment: 2015-present), pneumonia (dates of care/treatment: 25-AUG-2019-December 2019), blood clot in lung (dates of care/treatment: 25-AUG-2019-December 2019). The pt was diagnosed with the following medical conditions for which she required hospitalization or recurrent medical care and treatment or medication in the 7 years preceding zoster vaccine live (ZOSTAVAX) vaccination to the present: high blood pressure (dates of care/treatment: 2000

Other Meds: CIALIS; DIOVAN; ascorbic acid; codeine

Current Illness: Alcohol use; Blood pressure high; Family history of cancer; Family history of diabetes; Hypercholesterolaemia; Hypertension (dates of care/treatment: 2000-present); Prostatic disorder NOS (dates of care/treatment: 2007-present); Routine health maintenance; Urinary tract disorder NOS

ID: 0990352
Sex: F
Age:
State:

Vax Date: 01/14/2021
Onset Date: 01/15/2021
Rec V Date: 02/01/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: New onset Afib; A spontaneous report was received from a female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced new onset Afib. The patient's medical history was not provided. No relevant concomitant medications were reported. On 14 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On the evening of 15 Jan 2021, the patient was hospitalized for new onset Afib. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, new onset Afib, was not reported.; Reporter's Comments: This spontaneous report refers to a case of female patient who experienced a serious event of new onset Afib on the same day after administration of the first dose of mRNA-127 (lot unknown, Exp date-unknown). Based on temporal the information provided and the absence of any other etiology factors, a causal association cannot be excluded

Other Meds:

Current Illness:

ID: 0990353
Sex: F
Age: 58
State: PA

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

Lab Data: Test Date: 20210115; Test Name: Temperature; Result Unstructured Data: 100.5 - 101.1 degrees; Test Date: 20210118; Test Name: Pulse rate; Result Unstructured Data: over 100 at rest

Allergies:

Symptoms: High pulse rate at rest - over a 100; I feel it in my right ear-Swishing sound; Couldn't sleep; Afraid to go to sleep, and afraid to not wake up; Felt delirious; High fever 100.5? - 101.1?; Chills; A spontaneous report was received from a 58-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) felt delirious and experienced high fever 100.5 - 101.1, chills, high pulse rate at rest - over a 100, I feel it in my right ear - swishing sound, couldn't sleep until 3 am, afraid to go to sleep, and afraid to not wake up. The patient's medical history, as provided by the reporter, included menopause and high blood pressure. Concomitant product use included valsartan and bumetanide. On 15 Jan 2021 between 7:15 ? 7:30 AM, the patient received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 15 Jan 202 between 4:30 - 5 PM, the patient experienced symptoms of high fever 100.5 - 101.1 degrees Fahrenheit, chills, and felt delirious. On 18 Jan 2021, the patient reported a high pulse rate at rest, in her right ear she felt a swishing sound. Additionally, the patient, could not sleep, she was afraid to go to sleep and afraid to not wake up. Treatment for the events included a cold compress and paracetamol. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, high fever 100.5 ? 101.1, was considered resolved. The outcome for the events, high pulse rate at rest - over a 100, in her right ear she felt ? swishing sound, couldn't sleep, afraid to go to sleep, and afraid to not wake up was considered not resolved. The outcome for the events, chills and felt delirious, was unknown.; Reporter's Comments: This spontaneous report refers to a case of a male patient with medical history of high blood pressure, who experienced a serious event of felt delirious and non-serious events of high fever 100.5 - 101.1, chills, high pulse rate at rest - over a 100. "I feel it in my right ear" ? swishing sound, couldn't sleep until 3 am, afraid to go to sleep, and afraid to not wake up. The events of fever, chills and delirium developed on the same day after the administration of the mRNA-1273 vaccine (lot # unknown, expiration date-unknown). The other couldn't sleep, felt swishing sound in ear, afraid to go to sleep and afraid to not wake up and high pulse rate occurred 3 days after the vaccine administration. Treatment administered include cold compress and paracetamol. The events of fever and chills are listed in safety profile of the vaccine and based on the information provided which includes a temporal association, a causal association between the reported events and the administration of the vaccine cannot be excluded.

Other Meds: VALSARTAN; BUMEX

Current Illness: Blood pressure high; Menopause

ID: 0990354
Sex: U
Age:
State: MD

Vax Date: 01/04/2021
Onset Date: 01/06/2021
Rec V Date: 02/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Facial paralysis; A spontaneous report was received from a pharmacist concerning a patient between 51 to 55 years of age, who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed facial paralysis. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, approximately two days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 06 Jan 2021, the patient began having symptoms of facial paralysis and the symptoms got progressively worse. On 08 Jan 2021, the patient sought medical attention where they received an official diagnosis of facial paralysis. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, facial paralysis, was unknown.; Reporter's Comments: This case concerns a patient between 51 to 55 years of age of unknown gender. The medical history is not provided. The patient experienced a medically significant and unexpected event of Facial paralysis approximately two days after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.

Other Meds:

Current Illness:

ID: 0990355
Sex: M
Age: 60
State: NY

Vax Date: 01/07/2021
Onset Date: 01/11/2021
Rec V Date: 02/01/2021
Hospital:

Lab Data: Test Date: 202101; Test Name: Doppler exam; Result Unstructured Data: lower extremity blood clot, top of calf to mid thigh

Allergies:

Symptoms: DVT blood clot; A spontaneous report was received from a 60-year-old male consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and developed deep vein thrombosis (DVT) blood clot. The patient's medical history, as provided by the reporter, included factor V Leiden, enlarged prostate, DVT, pulmonary embolism and hypertension. Concomitant medications reported included valsartan, alfuzosin, and acetylsalicylic acid. On 07 Jan 2021, approximately four days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 11 Jan 2021, the patient developed DVT blood clot and experienced leg pain so intense that he could not walk. A doppler exam showed the DVT was from the top of the calf to mid-thigh. Treatment for the event included a rivaroxaban starter pack with dose tapering. Action taken with mRNA-1273 in response to the event deep vein thrombosis (DVT) blood clot was not reported. The outcome of the event, DVT blood clot, was unknown.; Reporter's Comments: This case concerns a 60-year-old male patient with a relevant medical history of factor V Leiden, DVT, pulmonary embolism and hypertension who received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. Patient experienced the medically significant unlisted event of Deep vein thrombosis approximately four days after administration of vaccine. Treatment for the event included rivaroxaban. Based on the temporal association between the use of the product and the event occurring after receiving the vaccine, a causal relationship cannot be excluded and the event of Deep vein thrombosis is possibly related to the product. Of note, the patient's underlying Factor V Leiden which predispose to developing abnormal blood clots, and prior medical history of DVT with pulmonary embolism are considered risk factors to the occurrence of the event.

Other Meds: VALSARTAN; ALFUZOSIN; BABY ASPIRIN

Current Illness: Enlarged prostate; Factor V Leiden thrombophilia; Hypertension

ID: 0990356
Sex: F
Age: 75
State: FL

Vax Date: 01/13/2021
Onset Date: 01/15/2021
Rec V Date: 02/01/2021
Hospital: Y

Lab Data: Test Date: 202101; Test Name: Heart rate; Result Unstructured Data: Decreased, 3 different times.; Test Date: 202101; Test Name: Heart rate; Result Unstructured Data: Decreased, couple of times.; Test Date: 202101; Test Name: Platelet count; Result Unstructured Data: Dropped

Allergies:

Symptoms: Passed out from cardiac arrest (her head feeling really full and really hot, and felt as if she was going to pass out, then she passed out).; Passed out; fractured her face; Head really hot; Head full; Diarrhea; heart rate dropped; platelets dropped; A spontaneous report was received from a consumer concerning a 75-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced head feeling really full and really hot, passed out from cardiac arrest, heart rate dropped, platelets dropped, fractured her face and diarrhea. The patient's medical history was not provided. Concomitant medication included atenolol. On 13 Jan 2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: Unknown) in her arm for prophylaxis of COVID-19 infection. On 15 Jan 2021, the patient complained her head was feeling full and hot. Felt as she was going to pass out, then she passed out from cardiac arrest and fractured her face. After passing out she got diarrhea. On 15 Jan 2021, the patient was hospitalized. The patient's heart rate decreased to 22 beats/minute three times and to 15 beats/minutes twice, and her platelet count dropped. The second dose of mRNA-1273 was discontinued in response to the events. The outcome for the events, head feeling really full and really hot, passed out from cardiac arrest, heart rate dropped, platelets dropped, fractured her face and diarrhea, and diarrhea, was unknown.; Reporter's Comments: This spontaneous report concerning a 75-year-old, female subject who experienced unexpected events of passed out from cardiac arrest and fractured her face, head feeling really full and really hot, and felt as if she was going to pass out, then she passed out, and got diarrhea, heart rate dropped down to 22, platelets also dropped, after the first dose of the Vaccine (mRNA-1273) (Lot number: unknown, expiration date: unknown). The events developed 2 days after vaccine administration. The patient was hospitalized. Treatment and outcome are unknown.' Based on the information which includes a temporal association and the absence of any other etiology, a causal association cannot be excluded. However, there is inadequate information in that the patient's medical history is lacking and event is also confounded by patient's advanced age.

Other Meds: ATENOLOL

Current Illness:

ID: 0990357
Sex: F
Age:
State: VA

Vax Date: 12/23/2020
Onset Date: 12/25/2020
Rec V Date: 02/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Bell's palsy stage 4/partial face paralysis; A spontaneous report was received from a female consumer who received Moderna's COVID-19 vaccine and diagnosed with Bell's palsy stage 4. The patient's medical history was not provided. No relevant concomitant medications were reported. On 23 Dec 2020 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 25 Dec 2020, after receiving the vaccine the patient was diagnosed with stage 4 Bell's palsy. She has a partial face paralysis. Treatment for the event was not provided. Action taken with the mRNA-1273 in response to the event was not reported. The outcome for the event was Not recovered/Not resolved.; Reporter's Comments: This case concerns a female patient of unknown age. The medical history is not provided. The patient experienced a medically significant and unexpected event of Facial paralysis approximately two days after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Very limited information regarding this event has been provided at this time. However, based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.

Other Meds:

Current Illness:

ID: 0990358
Sex: F
Age:
State: CA

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

Lab Data:

Allergies:

Symptoms: Face feels like a dry mud mask on it; Tongue tingling; Inconsistent chills; Red hot flushed skin; Anaphylactic response; Pin pricks all over her body; A report was received from a consumer who was a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced the serious adverse event of an anaphylactic reaction, body paresthesia, facial rigidity, tingling tongue, chills, and red, hot flushed skin. The patient's medical history was not provided. No relevant concomitant medications were reported. On 16 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number 042L20A) intramuscularly for prophylaxis of COVID-19 infection. On 16 Jan 2021 the patient reported that she received the Moderna vaccine . It took 35 minutes to have a systemic reaction of anaphylactic response which started with tightness in the throat, swelling tongue, itching, that became tighter and tighter along with body paresthesia. The paresthesia continued and felt like pin pricks all over her body except for her face which felt like it had a dry mud mask on it. She reported that she had no temperature but did have red, hot flushed skin. Her tongue was tingling and irritated, and she had inconsistent chills. The paresthesia and tingling tongue were "driving her nuts." Treatment for the event included diphenhydramine hydrochloride. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, anaphylactic reaction, body paresthesia, facial rigidity, tingling tongue, chills, and red, hot flushed skin, was unknown/not reported.; Reporter's Comments: Company Comment: This case concerns a patient who experienced unexpected serious systemic reaction of anaphylactic response and non-serious reactions of body paresthesia, facial rigidity, tingling tongue, chills, and red, hot flushed skin. The events occurred 35 minutes after the first dose and only dose of the vaccine mRNA-1273 vaccine (lot # 042L20A, expiration date-unknown). Based on the information provided which includes a strong temporal association, for all reported events, a causal association cannot be excluded.

Other Meds:

Current Illness:

ID: 0990359
Sex: F
Age:
State: IL

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

Lab Data:

Allergies:

Symptoms: The vaccine was administered to the patient with a subq needle; A spontaneous report was received from a pharmacist concerning 65-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) administered with a 5/8-inch (subcutaneous) needle. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot#026L20A) for prophylaxis of COVID-19 infection. On an unknown date, the patient was administered a vaccine using a 5/8-inch (subcutaneous) needle. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, vaccine administered with a 5/8-inch (subcutaneous) needle, was considered recovered/resolved.; Reporter's Comments: This report refers to a case of Product administration error (administered with a 5/8-inch needle) for mRNA-1273, lot # 026L20A. There were no reported AEs associated with this case of Product administration error. The reported event is unlisted and company causality was assessed s not applicable.

Other Meds:

Current Illness:

ID: 0990360
Sex: U
Age:
State: CA

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

Lab Data:

Allergies:

Symptoms: fever; vaccinated after the 6 hour mark; A spontaneous report was received from a hospital office manager concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a fever and was vaccinated after the 6 hour mark. The patient's medical history was not provided. No relevant concomitant medications were reported. On 06 Jan 2021, it was reported that the facility was delivered 3 vials of the vaccine, with no documentation, from the Department of Public Health. Some vaccines were left out more than 6 hours punctured but were refrigerated. The vaccines were used to vaccinate staff and patients, approximately 20 people. Of the 20 people vaccinated at least 10 were vaccinated after the 6 hours mark. On 06 Jan 2021, 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 and received vaccine that from a vial that had been punctured more than 6 hours previously. On an undisclosed date, the patient also experienced a fever after receiving the vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, fever, was not reported. The outcome of the event, was vaccinated after the 6 hour mark, was considered resolved on 06 Jan 2021.; Reporter's Comments: This report refers to a case of product administration error for mRNA, where the vaccine was administered from a vial punctured more than 6 hours. The event of pyrexia was associated with this case of out of specification product use.

Other Meds:

Current Illness:

ID: 0990361
Sex: F
Age: 83
State: IN

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

Lab Data:

Allergies:

Symptoms: blindness in left eye; stroke in back of the eye; blood clot; A spontaneous report was received from a consumer concerning an 83-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced blindness in left eye, blood clot, and stroke in back of the eye. The patient's medical history was not provided. Concomitant medications reported included comerdol, losartan, hydrocortisone, meloxicam, and unspecified stomach pills. On 14 Jan 2021 at 10:15 am, approximately 3 hours and 45 minutes prior to the onset of the events, the patient received a dose of mRNA-1273 (Lot number: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 14 Jan 2021 around 2:00 pm, the patient lost sight in her left eye as a result of a blood clot and stroke in the back of her eye. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, blindness in left eye, blood clot, and stroke in back of eye, was unknown.; Reporter's Comments: This case concerns an 83-years-old female patient, who experienced a serious unexpected event of blindness unilateral, retinal artery occlusion, and thrombosis. The event of blindness unilateral and retinal artery occlusion occurred 3 hrs. after first dose of mRNA-1273, lot # 013L20A. The event of thrombosis occurred on an unspecified date after first dose of mRNA-1273, lot # 013L20A. Treatment included details were not provided. Concomitant medications included Comerdol, Losartan for blood pressure, Hydrocortisone, Meloxicam and stomach pills. Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.

Other Meds: Comerdol; LOSARTAN; HYDROCORTISONE; MELOXICAM; stomach pills

Current Illness:

ID: 0990362
Sex: F
Age:
State: MD

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

Lab Data:

Allergies:

Symptoms: Needle slipped and some of the content was lost on her arm; needle slipped and some of the content was lost on her arm; A spontaneous report was received from a nurse concerning a female patient who received Moderna's COVID-19 vaccine and received less than a full dose due to the needle slipping and some of the content was lost on the patient's arm. The patient's medical history was not included. Products known to have been used by the patient, were not provided. On 26 Jan 2021, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. On 26 Jan 2021, after she received the mRNA-1273 vaccination, the nurse notes that the patient did not receive the full dose as the needle slipped and some of the content was lost on her arm. Treatment information was not provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the event, not receiving a full dose due to the needle slipping and some of the content was lost on her arm, was considered resolved.; Reporter's Comments: This case concerns a female patient of unknown age who received one of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection and after she received the vaccination, the nurse notes that the patient did not receive the full dose as the needle slipped and some of the content was lost on her arm. There were no reported adverse events associated with this case of device connection issue and incorrect dose administered

Other Meds:

Current Illness:

ID: 0990363
Sex: F
Age: 22
State: NJ

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

Lab Data:

Allergies:

Symptoms: Vaccine dripping down her arm; Vaccine dripping down her arm; A spontaneous report was received from a consumer who was a 22-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine dripping down her arm. The patient's medical history was not reported. Concomitant product use reported included unspecified birth control. On 15 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013Z20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 15 Jan 2021, the patient experienced vaccine dripping down her arm during vaccine administration. The nurse administering the vaccine did not have the needle pushed in all the way into the patient's arm. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The event, vaccine dripping down arm, was considered resolved on 15 Jan 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered and exposure through skin contact for COVID-19 vaccine mRNA-1273, lot # 013Z20A. There were no reported AEs associated with this case of incorrect dose administered and exposure through skin contact .

Other Meds:

Current Illness:

ID: 0990364
Sex: M
Age: 73
State: FL

Vax Date: 01/12/2021
Onset Date: 01/14/2021
Rec V Date: 02/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Loss of hearing in his right ear; A spontaneous report was received from a 73-year-old, male, patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced hearing loss in right ear. The patient's medical history, as provided by the reporter, included ventriculoperitoneal (VP) shunt in his head. Concomitant product use was not provided by the reporter. On 12 Jan 2021, approximately two days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 14 Jan 2021, the patient had dental work done where four crowns were prepped and temporaries were put in, he then lost hearing in his right ear. Treatment information was not provided. He thinks that the loss of hearing might be due to this dental procedure as they were drilling for hours. He states that he has a VP shunt in this head which needs readjustments occasionally. He is seeing his neurosurgeon for the readjustment. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, hearing loss in right ear, was unknown.; Reporter's Comments: This case concerns a 73 year-old, male patient with history of ventriculoperitoneal (VP) shunt in his head, who experienced event of hearing loss in right ear. The event occurred 2 days after the first and last dose of mRNA-1273 vaccine administration. 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 and the event is assessed as possibly related. However, on the same day and prior to the onset of the event, the patient had extensive dental procedures done which may provide an alternative explanation for the event.

Other Meds:

Current Illness: Ventriculo-peritoneal shunt

ID: 0990366
Sex: M
Age:
State: SC

Vax Date: 01/13/2021
Onset Date: 01/14/2021
Rec V Date: 02/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: injection site swelling (size of dime); TThe one at the injection site itself, was an injection site swelling about the size of a dime, "a red area"/at the site where the shot was administered he has some red streaks; red streaks running from the site up to his neck and shoulder. It is very small. It looks like if he took a ball point pin and drew some lines; This is a spontaneous report from the Medical Information Team. A contactable consumer reported that a 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/lot number: ELO142, via an unspecified route of administration from 13Jan2021 11:00 at SINGLE DOSE for COVID-19 immunization. Medical history included haemochromatosis diagnosed in the mid 90's and wa reported as hereditary it was too much iron in the blood, he goes once a month for therapeutic phlebotomy to reduce the iron in the blood; very rare bacterial infection called Arupense from an unknown; he has a slight case of asthma but mentioned that it was related to living on the coast with the mold and moisture and also has a little wheezing. Concomitant medications included ethambutol, montelukast, pravastatin, amlodipine; hydrochlorothiazide, lisinopril; colecalciferol (VITAMIN D), acetylsalicylic acid (ASPIRIN (E.C.) and rifampin for infection and blood pressure medications. Patient had the first dose of the vaccine yesterday 13Jan2021. He has no discomfort, but at the site where the shot was administered, he has some red streaks running from the site up to his neck and shoulder. It was very small. It looks like if he took a ball point pin and drew some lines. However, the patient's wife said it was bigger than a ball point pen. It was jagged lines. The one at the injection site itself, the injection site swelling was about the size of a dime, a red area. He only discovered the red streaks about an hour ago on 14Jan2021, so there has not been no radical change. Patient has concerns; he wanted to know if he should seek medical advice. "Is it just a rash?", he asked. His doctor doesn't know about this yet. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.

Other Meds: ETHAMBUTOL; MONTELUKAST; PRAVASTATIN; AMLODIPINE; HYDROCHLOROTHIAZIDE;LISINOPRIL; VITAMIN D [COLECALCIFEROL]; ASPIRIN (E.C.); RIFAMPIN

Current Illness:

ID: 0990367
Sex: M
Age:
State: AL

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

Lab Data: Test Name: blood work; Result Unstructured Data: Test Result:Unknown results; Test Name: Temperature; Result Unstructured Data: Test Result:low grade fever; Test Date: 20210113; Test Name: Covid19 test; Test Result: Negative

Allergies:

Symptoms: been in contact with someone who is Covid-19 positive; Chest tightness; Low grade fever; Vomiting; Cough; has been sick since getting the vaccine; tired and fatigue; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received his second dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration left arm on 11Jan2021 at a single dose for front line worker (covid-19 immunization). Medical history included ongoing HIV since 2015. There were no concomitant medications. The patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for front line worker (covid-19 immunization). The patient reported that he received his second dose of the Pfizer-BioNTech Covid-19 Vaccine last Monday (11Jan2021) between 8:00 am and 8:30 am, and since then he has been sick and has been experiencing some side effects. He mentioned that he has been in contact with someone who is Covid-19 positive on an unspecified date. He works at the front desk registration in a hospital. He has been tired and fatigued, has had a low-grade fever, vomiting, headache, cough and chest tightness. He added that on Monday evening (11Jan2021), he became tired and fatigued. He had an on and off fever on Tuesday (12Jan2021). He started vomiting while coughing on 12Jan2021. He went to the doctor last night (13Jan2021) and he said he got tested for Covid-19 on 13Jan2021, but the results came out negative. The physician said that it would. However, his physician said that it was too early to tell if he has been infected since he has just been exposed last Monday. Normally, they like to have a 5 day turn around for a true reading. He said his physician told him he just needed to quarantine. He mentioned that his chest feels tight when he coughs on 13Jan2021. When he had to take deep breaths while the doctor was listening to him breath his chest was tight. He had blood work drawn at the doctor's office, but he does not have any results to provide. The patient wanted to know what he needs to do about this. He was inquiring if there any recommendations. He is probably negative because he is symptomatic. His employer said it may be a reaction from the shot. The outcome of the events sickness and exposure to COVID-19 were unknown, as for the event vomiting was recovered on 12Jan2021 while the outcome of the other events was not recovered. ? The following information on the batch/lot number has been requested.

Other Meds:

Current Illness: HIV infection (Verbatim: HIV)

ID: 0990368
Sex: F
Age:
State: LA

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

Lab Data: Test Name: diastolic; Result Unstructured Data: Test Result:normal; Test Date: 202008; Test Name: Covid test; Test Result: Negative

Allergies:

Symptoms: swollen lips; tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening; tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening; tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening; chills and shaking; chills and shaking; red dot on the inside of her throat; she took the Benadryl thinking it was an allergic reaction; swelling on left side where the nodule was removed; burning sensation in her left arm; ear pain; nausea; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on Left deltoid (upper left arm) on 13Jan2021 14:00 at single dose to prevent COVID. Medical history included sulfa drug reaction, high blood pressure diagnosed in 1970s or 1980s (States she was in the hospital in the 70s or 80s. She has high blood pressure which has been difficult to control, she is seeing a cardiologist and he is content with her blood pressure readings, her diastolic is normal), incontinence, thyroid nodule surgery a year ago (2020), thyroid nodule, ten operations in the last 3 years, tightening in her neck repeatedly since her thyroid nodule surgery, scratchy throat problems since a week prior to getting the vaccine (from Jan2021) and post nasal drip and she has had that for years and when they operated nothing worked. The patient's concomitant medications were not reported. The patient previously took cipro where she could not breathe. She does not have lot, ndc or expiration date to provide for any of the medications mentioned that she had a reaction to. She took the Asiatic flu shot in 1958 (as reported), she had a reaction and high fever, weak and pale. This occurred when she was 19 years old. She took the Pfizer covid 19 shot last Wednesday. She stated that it could be her but she got a few of the reported side effects. What she found most important was that she had swollen lips that started about an hour after receiving the vaccine. Last night (13Jan2021) she got the chills and was shaking during the night. She had mild chills in the last few days, during the night she was shaking from the chills but it may have been cold at night, reporting the chills have subsided but she can feel it a little bit. In Jan2021, she felt a burning sensation in her left arm which lasted about two minutes. She got a piercing earache in her left ear for about two minutes and then it went away. She experienced nausea within two minutes, but she ate the ginger candy she had in her purse and her nausea went away. She could have something else too since she has a red dot on the inside of her throat. She did not see it was red before last night (13Jan2021). She took Benadryl on Wednesday afternoon after she called the doctor's office, she took the Benadryl thinking it was an allergic reaction, her swollen lips seemed like it was improved but now it was minor. She has had the tightening in her neck repeatedly since her thyroid nodule surgery but she felt the tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening, it is sort of still ongoing but states it has sort of improved. Patient also mentioned swelling on left side where the nodule was removed. She was asking if she should get the second dose. She has an appointment for her second dose. She has never had much problems till she was 80. Her husband tested negative for covid and she tested negative in Aug2020 prior to one of her surgeries. Patient stated that she is 83 but she is biologically younger. She felt pretty good normally. The events did not require emergency room visit or physician office visit. No prior vaccinations (within 4 weeks). The outcome of the events burning sensation in her left arm, ear pain and nausea was recovered in Jan2021; Swollen lips, tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening, chills was recovering; and unknown for the other events. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 0990369
Sex: F
Age:
State: CA

Vax Date: 01/12/2021
Onset Date: 01/13/2021
Rec V Date: 02/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Painful Lymphadenopathy in the vaccinated arm and same side of the neck; This is a spontaneous report from a contactable physician (patient). A 37-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3246) intramuscular in the left arm on 12Jan2021 07:15 AM at a single dose as Covid vaccine. The patient had no medical history. She has no known allergies. Concomitant medications were not reported. The patient had her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EJ1685) intramuscular in the left arm on 22Dec2020 12:45 AM as Covid vaccine. She had no other vaccine in four weeks. She experienced painful lymphadenopathy in the vaccinated arm and same side of the neck that started 24hrs post vaccine on 13Jan2021 07:15 AM. Treatment was not received for the event. She has no Covid prior to vaccination. She did not have Covid tested post vaccination. The outcome of the event was recovering.

Other Meds:

Current Illness:

ID: 0990370
Sex: F
Age:
State: KY

Vax Date: 01/11/2021
Onset Date: 01/13/2021
Rec V Date: 02/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: I had a bowel movement and lots of blood; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EJI686), via an unspecified route of administration in the right arm on 11Jan2021 at 12:45 as a single dose for COVID-19 immunization. Medical history included arthritis and migraines. The patient had no other vaccines within four weeks and did not have COVID prior to the vaccination. Concomitant medications (reported as other medications in two weeks) included fexofenadine hydrochloride (ALLEGRA) and paracetamol (TYLENOL). On 13Jan2021 at 12:00 AM, the patient had a bowel movement and lots of blood and also on 15Jan2021, she had a bowel movement with blood. The patient was not treated for the event. The patient had not tested positive for COVID post vaccination. Outcome of the event was not recovered.

Other Meds: ALLEGRA; TYLENOL

Current Illness:

ID: 0990371
Sex: F
Age:
State: NC

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

Lab Data:

Allergies:

Symptoms: Acute asthma attack; This is a spontaneous report from a contactable pharmacist. A 46-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), intramuscular in the left arm on 15Jan2021 07:45 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced acute asthma attack on 15Jan2021 08:00. This adverse event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of acute asthma attack and included treatment with albuterol inhaler. Outcome of the event was recovering.

Other Meds:

Current Illness:

ID: 0990372
Sex: M
Age:
State: NY

Vax Date: 12/30/2020
Onset Date: 01/12/2021
Rec V Date: 02/01/2021
Hospital:

Lab Data: Test Date: 20210112; Test Name: Covid; Test Result: Positive ; Test Date: 20210114; Test Name: Covid; Test Result: Negative

Allergies:

Symptoms: tested positive for covid on 12Jan, is asymptomatic, and tested negative after two days; tested positive for covid on 12Jan, is asymptomatic, and tested negative after two days; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the COVID vaccine on 30Dec2020 and was supposed to take the next dose on 20Jan2021. However he tested positive for COVID on 12Jan2021 and was asymptomatic, and tested negative after two days on 14Jan2021. He wanted to know if he can take the second dose even if he tested positive. The outcome of the event was recovered on 14Jan2021. Information on the lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 0990373
Sex: F
Age:
State: AZ

Vax Date: 12/30/2020
Onset Date: 01/04/2021
Rec V Date: 02/01/2021
Hospital:

Lab Data: Test Date: 20210104; Test Name: COVID test; Test Result: Positive ; Test Date: 20210104; Test Name: Nasal swab; Test Result: Positive

Allergies:

Symptoms: I received the first dose of the Pfizer vaccine on 30Dec2020 and got covid on 04Jan2021 via positive nasal swab test; I received the first dose of the Pfizer vaccine on 30Dec2020 and got covid on 04Jan2021 via positive nasal swab test; This is a spontaneous report from a from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (Lot number and Expiration date not provided), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. The patient had her first dose of COVID vaccine on 30Dec2020. She had a positive COVID test via Nasal swab test on 04Jan2021. She will be off of quarantine on 18Jan2021. For some reason her second dose of COVID Vaccine is not scheduled until 29Jan2021. She asked if she is COVID positive when should she get that next dose; and also the second dose scheduled her out 30 days which is a long time which she was questioning that as well. The outcome of the events was unknown. Information on Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 0990374
Sex: F
Age:
State: FL

Vax Date: 01/12/2021
Onset Date: 01/15/2021
Rec V Date: 02/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Not feeling great; Slight headache; Breathing is heavier; Below her breast line is a tightness she can't really describe; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: SL3246), via an unspecified route of administration in right arm, on 12Jan2021 at 10:45, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took varicella zoster vaccine (SHINGLES VACCINE) for immunization and had a little reaction but just the normal things. On Tuesday morning, the patient got the COVID-19 shot and was fine. This morning (15Jan2021), the patient was not feeling great, has a slight headache, her breathing is heavier, and below her breast line is a tightness she can't really describe. The patient asked if these were a side effect of the COVID-19 vaccine and wondering if this is normal. As a treatment for the events, the patient took paracetamol (TYLENOL). The patient asked if she can or should get a test, a COVID-19 test. It has been so many days since having the vaccine, 4 days later, she is wondering if she might have COVID-19. The patient isn't sure and is just asking a question. It is confirmed that she has not had a test or tested positive for COVID-19. The outcome of "Not feeling great" was unknown. The patient had not recovered from the remaining events.

Other Meds:

Current Illness:

ID: 0990375
Sex: F
Age:
State:

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

Lab Data: Test Name: SARs-Cov-2; Test Result: Positive

Allergies:

Symptoms: received first dose of vaccine and then tested positive for SARs-Cov-2; received first dose of vaccine and then tested positive for SARs-Cov-2; This is a spontaneous report from a contactable healthcare professional (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were 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 received first dose of vaccine and then tested positive for SARs-Cov-2 on an unspecified date. The patient was asking about the efficacy. Outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be completely excluded for reported events.

Other Meds:

Current Illness:

ID: 0990376
Sex: F
Age:
State:

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

Lab Data: Test Name: covid test; Test Result: Positive

Allergies:

Symptoms: got tested and tested positive; got tested and tested positive; lethargic; This is a spontaneous report from non-contactable consumer. This consumer reported similar events for two patients (husband and wife). This is the first of two reports (for the wife). A 72-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on 04Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, reported as two days after, the patient was lethargic. A week ago on an unspecified date, reported as past Monday, she had no cough, no fever, received azithromycin, got tested and tested positive. She wanted to know if they can receive the second dose and the timing of the second dose of vaccine. The patient underwent laboratory tests and procedures which included SARS-CoV-2 test: positive on an unspecified date. Outcome of the events was unknown. No follow-up attempts are possible. Information about the lot/batch cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021046180 same drug/event, different patient

Other Meds:

Current Illness:

ID: 0990377
Sex: F
Age:
State: TX

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

Lab Data: Test Date: 20210114; Test Name: heart rate; Result Unstructured Data: Test Result:150

Allergies:

Symptoms: heart rate increased to 150; nausea; headache; jittery; coldness; lightheaded; weakness; legs felt light; fever last night (very hot and thirsty); very hot; thirsty; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first dose of the COVID vaccine yesterday on 14Jan2021 and after 1 or 2 minutes of receiving it, her heart rate increased to 150, she felt nausea, headache, jittery, coldness, lightheaded, weakness, legs felt light , fever last night (very hot and thirsty) and today she does not feel 100%. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 0990378
Sex: F
Age:
State:

Vax Date: 01/04/2021
Onset Date: 01/12/2021
Rec V Date: 02/01/2021
Hospital:

Lab Data: Test Date: 20210112; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Comments: PCR test.; Test Date: 20210112; Test Name: SARS-CoV-2 Rapid diagnostic test; Test Result: Positive ; Comments: Rapid test; Test Date: 20210112; Test Name: SARS-CoV-2 Rapid diagnostic test; Test Result: Positive ; Comments: Rapid test

Allergies:

Symptoms: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable other healthcare professional (patient). This female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On 11Jan2021, the patient started developing symptoms such as loss of smell and, on 12Jan2021, she tested positive for COVID from 2 rapid tests and a PCR test. The outcome of the events was unknown. The information on Lot/Batch number has been requested.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (7 days in this case). However, a causal relationship between event "positive COVID-19 test with symptoms" (coded to Drug ineffective / COVID-19) and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded.

Other Meds:

Current Illness:

ID: 0990379
Sex: F
Age:
State: NY

Vax Date: 12/23/2020
Onset Date: 01/11/2021
Rec V Date: 02/01/2021
Hospital:

Lab Data: Test Date: 20210111; Test Name: COVID RNA test nasopharyngeal swab; Test Result: Positive

Allergies:

Symptoms: second vaccine was scheduled supposedly on 13Jan2021 but was rescheduled to 19Jan2021; supposedly on 13Jan2021 but was rescheduled to 19Jan2021; received the first dose on 23Dec2020 and tested positive for COVID RNA test nasopharyngeal swab; received the first dose on 23Dec2020 and tested positive for COVID RNA test nasopharyngeal swab; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program, IBCC (Inbound Call Center for HCPs). A 53-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; strength: 30 mcg, lot number: EK9231) via an unspecified route of administration in the left deltoid on 23Dec2020 at 0.3mL, single dose for covid-19 immunisation. There were no medical history and no concomitant medications. The patient received the first dose on 23Dec2020 and tested positive for COVID RNA test nasopharyngeal swab on 11Jan2021. The outcome of the event was not recovered. Her second vaccine was scheduled supposedly on 13Jan2021 but was rescheduled to 19Jan2021 because they didn't allow her to go to the hospital while she was positive. She wanted to know if this was recommended. She just wanted some advice on getting the second vaccine, and how does it affect efficacy because she didn't get it on day 21.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 23Dec2020, and tested positive for COVID RNA test nasopharyngeal swab on 11Jan2021. No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.

Other Meds:

Current Illness:

ID: 0990380
Sex: F
Age:
State: MI

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

Lab Data:

Allergies:

Symptoms: experienced allergic reactions; her eyes got red; Her eye lids were red; Her eye lids were red, swollen, and puffy.; Her eye lids were red, swollen, and puffy.; cheeks were bright red; This is a spontaneous report from a contactable nurse (patient) reported that a 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), via an unspecified route of administration on the left arm on 14Jan2021 14:00 at a single dose for Covid-19 immunization. Medical history included that the patient was diabetic and hypertensive; both were ongoing. Concomitant medications included atenolol taken from 14Jan2021 for blood pressure high; pioglitazone hydrochloride (ACTOS) and ongoing metformin both were taken from an unspecified date for diabetes; ongoing montelukast sodium (SINGULAIR) for history of food and drug allergies and ongoing chlorothiazide for diuretic. It was reported that she had the first dose of the covid vaccine on 14Jan2021 and experienced allergic reactions after she left the facility; they were not life threatening but were not pleasant. She realized how bad it was after she got in the car, removed her mask, and looked at her face. She was concerned about getting the second dose. She even took Benadryl 1 hour before getting the shot and still had a reaction. She clarified her allergic reaction to be as her eyes got red. Her eye lids were red, swollen, and puffy. It looked bad. When she got in the car took her mask of her cheeks were bright red. She sat in the ER parking lot for an hour waiting for it to resolve. It resolved after like an hour and half. After it resolved and went away she went back home. She stated that this allergic reaction is anxiety producing. She gets anxious because she knew what could happen. The outcome of the events was recovered on 14Jan2021.

Other Meds: ATENOLOL; ACTOS; METFORMIN; SINGULAIR; CHLOROTHIAZIDE

Current Illness: Diabetic; Hypertensive

ID: 0990381
Sex: F
Age:
State:

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

Lab Data: Test Name: tested positive for Covid 19; Test Result: Positive

Allergies:

Symptoms: tested positive for Covid 19; tested positive for Covid 19; lethargic; cough; arm hurt; This is a spontaneous report from a non-contactable consumer. 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 04Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter tested positive for COVID 19 this past Wednesday after receiving the first shot on 04Jan2021. She is due for her second shot on 25Jan2021 and is wondering if she can take the second dose if it is already past her quarantine time? The night of receiving her first shot (04Jan2021), her arm hurt that night and went away the following day. She felt a little lethargic and it had gone away. She then wounded up with a cough, went into a walk-in clinic to check the chest and everything was normal. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on an unspecified date. The outcome of the events arm hurt was recovered on 05Jan2021, lethargic was recovered on an unspecified date, while of the rest was unknown. No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.

Other Meds:

Current Illness:

ID: 0990382
Sex: F
Age:
State: KY

Vax Date: 01/06/2021
Onset Date: 01/14/2021
Rec V Date: 02/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: pleural effusion; This is a spontaneous report from a contactable health care professional (patient). A 39-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL 0142) in the hospital via an unspecified route of administration on 06Jan2021 at 11:15 AM at a single dose on the right arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included escitalopram oxalate (LEXAPRO), calcium carbonate, magnesium carbonate, magnesium trisilicate (TUMS) and ibuprofen (manufacturer unknown) which was given 8 hours before (as reported). The patient previously took morphine and experienced allergies. The patient did not have COVID-19 prior to vaccination. The patient reported that she ended up on the ER on the day of the report diagnosed with a pleural effusion which was reported to have started on 14Jan2021 at 08:00 AM. The doctors are unsure whether it could be related to the vaccine, but she was only 39 years old and have never had something like this happen before. The patient was given azithromycin as treatment for the event. The patient had not recovered from the event. The patient had not been tested for COVID-19 post vaccination.

Other Meds: LEXAPRO; TUMS [CALCIUM CARBONATE;MAGNESIUM CARBONATE;MAGNESIUM TRISILICATE]; IBUPROFEN

Current Illness:

ID: 0990383
Sex: F
Age:
State:

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

Lab Data: Test Name: COVID-19; Result Unstructured Data: Test Result:diagnosed with a COVID-19 infection; Comments: 2 days after the second dose of the Pfizer's COVID-19 vaccine.

Allergies:

Symptoms: diagnosed with a COVID-19 infection 2 days after the second dose of the Pfizer's COVID-19 vaccine.; diagnosed with a COVID-19 infection 2 days after the second dose of the Pfizer's COVID-19 vaccine.; This is a spontaneous report from a contactable consumer. A 91-year-old female patient received their second 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, their first dose, via an unspecified route of administration on an unspecified date; both at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was diagnosed with a COVID-19 infection 2 days after the second dose of the Pfizer's COVID-19 vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: diagnosed with a covid-19 infection on an unspecified date (2 days after the second dose of the Pfizer's COVID-19 vaccine). The reporter inquired if the patient could be administrated with a monoclonal antibody infusion for the management of mild COVID-19 symptoms. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0990384
Sex: F
Age:
State: CO

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

Lab Data:

Allergies:

Symptoms: body aches; bad arm and armpit pain.; bad arm and armpit pain/leg pain; cough; neck pain; headache; a little swelling; throat dry at night; joint pain/ankle pain; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 08Jan2021 14:00 at a single dose for COVID-19 immunization. The patient medical history was none. Patient's concomitant medications were not reported. The patient previously took cortisone. It was reported that the patient got the vaccine on 08Jan2021 and started having the headaches right after. Still has some pain in the forehead and temples area. Has had neck pain, overall body aches, joint pain, pain in ankles and legs that still happens with getting up and down from sitting position. Overall pain is improved but still there, still has pain in ankles and legs. Got the shot in the left upper arm and having real bad armpit pain and a little swelling there. It has gotten a little better, but mostly hurts when moving and laying down. Has had a cough since she got the vaccine, it's mostly a dry cough and not really wet and mostly in the morning. She drinks a lot of fluids throughout the day and still has a little cough off and on. During the night her throat is really dry and which causes more coughing which she did not have before the vaccine. They are mostly concerned with the cough and the stuff when read online about the side effects that last about 2-3 days, but these have been since she got the vaccine. They know this is also know and not much known about it or what is normal yet, but they want to know if she could get the second vaccine, would it be okay. It was stated that the seriousness of the events is in the middle of not serious and medically significant. She is worried about the cough since it is ongoing, when reads online the side effects are listed as 2 or 3 days and her side effects have been going on since she got the vaccine which is worrisome. The outcome of the events cough and throat dry was not recovered, event pain was recovering, while the outcome of the rest of the events was unknown. Information on the Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0990385
Sex: F
Age:
State:

Vax Date: 12/28/2020
Onset Date: 01/04/2021
Rec V Date: 02/01/2021
Hospital:

Lab Data: Test Date: 20210104; Test Name: Covid-19; Result Unstructured Data: Test Result:postive

Allergies:

Symptoms: she tested positive for Covid-19; she tested positive for Covid-19; This is a spontaneous report from a non-contactable nurse (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 28Dec2020 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient said she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine last 28Dec2020, but on 04Jan2021, she tested positive for Covid-19. She said she has been quarantined since and was asymptomatic. Patient said she was due to receive the 2nd dose on the 18th of January and wants to know if that was okay. Outcome of the event was unknown. No follow up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The patient received the single dose of BNT162B2 on 28Dec2020, and was diagnosed with COVID-19 on 04JAN2021. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. The company considers that the COVID-19 infection is more pre-existing infection prior to vaccine use, and unrelated to BNT162B2.

Other Meds:

Current Illness:

ID: 0990387
Sex: F
Age:
State: CA

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

Lab Data: Test Date: 20210114; Test Name: fever; Result Unstructured Data: Test Result:101.6; Comments: yesterday at 101.6 degrees; Test Date: 20210114; Test Name: fever; Result Unstructured Data: Test Result:98.2; Comments: got down to 98.2 degrees; Test Date: 20210115; Test Name: fever; Result Unstructured Data: Test Result:99.8; Comments: She took temperature at 6am today and it was 99.8; Test Date: 20210115; Test Name: fever; Result Unstructured Data: Test Result:99.2; Comments: by 7am it was down to 99.2; Test Name: Covid test; Test Result: Negative ; Comments: Mentions she was tested on Monday for Covid and told if she didn't get a call she was fine and she didn't hear anything./covid test on Monday and was negative; Test Date: 20210114; Test Name: Covid test; Test Result: Positive ; Comments: she had testing again yesterday. She is awaiting results./Yesterday she received the first dose and then tested positive later in the day

Allergies:

Symptoms: tested positive later in the day; tested positive later in the day; exposed to someone with covid virus; headaches in the back of head and ears; heaviness, it seems like pressure; Fever/101.6; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration, administered to the left deltoid, on 14Jan2021 between 2:30-2:45pm (14:30-14:45) at single dose for COVID-19 immunisation. It was offered at her worksite. The patient's medical history included ongoing Baker's cyst right knee. The patient had no family history. Concomitant medication included celecoxib (CELEBREX) from May2020 for Baker's cyst. The patient had no additional vaccines administered on the same date of the BNT162B2. The patient previously took flu shot and she got sick (in the 1980's or 1990's). The patient had no prior vaccinations that were within 4 weeks prior to the first administration date of BNT162B2. The patient, a Senior facility HCP, took a covid test on Monday and was negative. Yesterday (14Jan2021), she received the first dose and then tested positive later in the day. She wanted to know if she can get the next dose at the appropriate time or if she has to wait 90 days. On 14Jan2021, the patient experienced headaches in the back of head and ears, heaviness, it seems like pressure, fever, and exposed to someone with covid virus. It was reported that the patient was debating on getting the Pfizer BioNTech Covid vaccine and so she finally decided to get it yesterday (14Jan2021). Two hours after getting it and getting home, her head started to hurt and fever, which she thought that was typical. That night the fever broke and it started again this morning (15Jan2021). She works at a senior facility and had to ask for an extended medical leave. She was tested yesterday for Covid that morning and had the vaccine in the afternoon. She was exposed to someone with the virus. She knows there are 2 shots and now she has had the one. She wanted to know if it's safe to get the second one since someone said she may need to wait 90 days since being exposed. She still has the headaches in the back of head and ears, heaviness, it seems like pressure. The fever has been under 100, it's been about 99 and the highest it got was yesterday at 101.6 degrees. By the time she went to bed last night it got down to 98.2 degrees. She has alternated Advil and Tylenol. She took temperature at 6am today (15Jan2021) and it was 99.8 and so she took a couple of Advil to help and by 7am it was down to 99.2. So, it's staying in the 99.2-99.3 range. The patient did not receive any other vaccines the same day or 4 weeks prior. The patient mentioned when getting the her very first flu shot, which she was hesitant about getting, she did get sick, but it wasn't immediately after. Since then she has been fine. She thinks this was in the 1980's or 1990's. She mentioned that this is a new vaccine and there is not a lot of information out there. She wanted to know if she will get immunity right away. She mentioned she was tested on Monday for Covid and told if she didn't get a call she was fine and she didn't hear anything. Then was told yesterday she was exposed to someone with Covid and so she had testing again yesterday. She is awaiting results (pending clarification). No further details provided. She was diagnosed around Memorial Day last year for right knee baker's cyst and given celecoxib. She went through physical therapy and has full range of motion, but cyst still there and tender. She may see a rheumatologist. She just finished her 30 days of celecoxib and didn't see any difference. It was reported that the events did not require a visit to emergency room nor physician office. The outcome of the event " tested positive later in the day" was unknown while the outcome of the events headaches in the back of head and ears, heaviness, it seems like pressure, fever, and exposed to someone with covid virus was not recovered.; Sender's Comments: The reported tested positive on the same day that the patient received first dose of COVID 19 vaccine, BNT162B2, is considered unlikely related to the suspect. Of note, the patient exposed to someone with the virus.

Other Meds: CELEBREX

Current Illness: Baker's cyst (Additional Information for Other Conditions: Right knee)

ID: 0990388
Sex: F
Age:
State: CA

Vax Date: 12/28/2020
Onset Date: 01/09/2021
Rec V Date: 02/01/2021
Hospital:

Lab Data: Test Date: 20210112; Test Name: covid; Test Result: Positive ; Comments: she is positive for covid

Allergies:

Symptoms: began having symptoms on 09Jan2021 and she had a positive test on 12Jan2021; began having symptoms on 09Jan2021 and she had a positive test on 12Jan2021; This is a spontaneous report from a contactable nurse (patient) reported that a 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on the left arm on 28Dec2020 16:00 at a single dose for safety for herself working with COVID patients. The patient's medical history and concomitant medications were reported as none. The patient asked how she should proceed with her second vaccine dose now that she is positive for covid. The patient received the first dose of the vaccine on 28Dec2020. She was looking for recommendations of what to do about the second dose. She began having symptoms on 09Jan2021 and she had a positive test on 12Jan2021. The outcome of the events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported positive test/having symptoms based on the known safety profile. However the short duration since the vaccine first dose is given it is unlikely patient would have fully developed immunity.

Other Meds:

Current Illness:

ID: 0990389
Sex: F
Age:
State: LA

Vax Date: 12/21/2020
Onset Date: 12/22/2020
Rec V Date: 02/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: the redness came back but it was itchy, hot to touch, and hard; the redness came back but it was itchy, hot to touch, and hard; With my first vaccine I had redness to the site the day after injection; It was probably about a quarter to half dollar in size and was red and inflamed; This is a spontaneous report from a contactable nurse (patient) reported that a 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on the right arm on 21Dec2020 17:15 at a single dose for Covid-19 immunization. Medical history included attention deficit hyperactivity disorder (ADD), eczema, and psoriasis; all from an unknown date. Patient was not pregnant. Concomitant medications included vitamin b complex, ergocalciferol (VIT D), and birth control. It was reported that with patient's first vaccine, the patient had redness to the site the day after injection (22Dec2020). It was probably about a quarter to half dollar in size and was red and inflamed but went away and faded as the week went on. Then about a week after that vaccine (reported as '27Dec2020 19:00'), the redness came back but it was itchy, hot to touch, and hard. Over the next day or so it grew quite large. The patient visited a physician, and was placed on an oral antibiotic and it slowly began to fade and go away. The outcome of the events was recovered.

Other Meds: VIT B COMPLEX; VIT D

Current Illness:

ID: 0990390
Sex: M
Age:
State: NC

Vax Date: 01/12/2021
Onset Date: 01/14/2021
Rec V Date: 02/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: rash on his right arm and right leg; it is like little red bumps that kind of itch; This is a spontaneous report from a contactable consumer (patient). A 23-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot no: EK9231, via an unspecified route of administration in left arm (top of shoulder) on 12Jan2021 at a single dose for Covid-19 immunization. The patient had no relevant medical history, stated that he is perfeclty healthy. There were no concomitant medications. There were no prior vaccination within 4 weeks.The patient received the first dose of the Covid 19 vaccine on 12Jan2021. It was administered in his left arm; however, he has developed a rash on his right arm and right leg. It's kind of large but it is not oozing or anything. The patient wanted to know if this is a normal side effect. He wanted to know if this a serious allergic reaction. He stated that he got the first dose Tuesday and he is beginning to have, he does not know if it is a mild allergic reaction or just a symptom but he has a rash on his right arm right around the elbow and one his leg it is like little red bumps that kind of itch. In his paperwork it is saying one symptoms that could be severe allergic reaction is a rash all over the body so he is wondering if this is a mild reaction of some sort and also if there are any other cases like this. He first noticed the rash on his arm yesterday (14Jan2021) after he took a shower he looked on his arm and seen a trail going down and today he noticed one on his leg. He noticed the area on his arm yesterday and today he noticed the area on his leg. He says they are little red bumps that itch. He does not know if it was kind of wet but there was a little trail going down and its itchy, it is only the 2 spots that he has noticed are really bad. He says is has persisted he thinks it has remained about the same, he definitely won't say they have gotten worse, they may have swelled up a little bit, he is trying not to scratch but he has scratched a little bit so that is probably why it has swollen up a little bit. The patient has not taken anything for the events; other than using lotion, he was putting lotion on when he first noticed it. The patient had not recovered from the events.

Other Meds:

Current Illness:

ID: 0990391
Sex: F
Age:
State: WA

Vax Date: 01/13/2021
Onset Date: 01/14/2021
Rec V Date: 02/01/2021
Hospital:

Lab Data:

Allergies:

Symptoms: malaise/ feeling of severe unwell; migraine; neck pain; heart racing; blurry vision; muscle spasms; muscle pain; nausea; dizziness; swollen entire left arm injection arm; joint pain; kidney pain; unable to think clearly; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on 13Jan2021 12:00 PM at a single dose on left arm for COVID-19 immunization. The patient medical history was not reported. No known allergies. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 23Dec2020, 05:00 PM at a single dose on left arm for COVID-19 immunization and experienced cold frostbite like hands and feet, dizziness when warmed up too quickly, racing heart rate, trouble finding words, with extreme fatigue, nausea, achiness at joints, and swollen lymph nodes. The patient experienced malaise, feeling of severe unwell, migraine and neck pain, heart racing, blurry vision, muscle spasms, muscle pain, nausea, dizziness swollen entire left arm injection arm, joint pain, kidney pain, unable to think clearly on 14Jan2021. AE resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of muscle pain and nausea. The outcome of the events was recovering. The patient was not pregnant. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not tested for COVID post vaccination.

Other Meds:

Current Illness:

ID: 0990392
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: hive rash on her body; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no history of allergies. The patient reported on unspecified date, six days after receiving a dose of the covid vaccine, she developed hive rash on her body requiring steroids to treat. Outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0990393
Sex: F
Age:
State: UT

Vax Date: 12/30/2020
Onset Date: 01/04/2021
Rec V Date: 02/01/2021
Hospital:

Lab Data: Test Date: 20210104; Test Name: low-grade fever; Result Unstructured Data: Test Result:between 99-100

Allergies:

Symptoms: have limited use in my L hand; numbness down the L side of my body into my L foot; experiencing a major flare-up of my condition; low-grade fever (between 99-100); severe muscle & joint pain; severe muscle & joint pain; existing nerve impingement affecting the left (L) side of my body & both sides of my face; decreased concentration & executive functioning; GI upset; anticipated some inflammation response to the vaccine; feel sick; This is a spontaneous report from a contactable other-HCP (patient). A 41-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 30Dec2020 at 18:00 at single dose in right arm for covid-19 immunization. Medical history included Ehlers-Danlos syndrome hypermobility type, IgA deficiency, cervical radiculopathy, spondylosis of cervical region, chronic hypertension, fibromyalgia, androgenic alopecia, seasonal allergies, and known allergies: gold, nickel. The patient's concomitant medications were not reported. The patient previously took prednisone and experienced allergies. The patient reported that she anticipated some inflammation response to the vaccine from 04Jan2021. Briefly, she started to feel sick around 04Jan2021, by 10Jan2021 was experiencing a major flare-up of her condition requiring additional medication and time off from work. She had had a low-grade fever (between 99-100) from 04Jan2021 for 7 days, severe muscle and joint pain from 04Jan2021. She had existing nerve impingement affecting the left (L) side of her body and both sides of her face from 04Jan2021. Beginning 12Jan2021 she had limited use in her L hand, numbness down the L side of her body into her L foot. This was most likely due to significantly increased levels of inflammation as a result of the vaccine. She had also had GI upset, decreased concentration & executive functioning from 04Jan2021. It was unknown if the patient received treatment for the events. The outcome of the events was not resolved. The events resulted in doctor or other healthcare professional office/clinic visit.

Other Meds:

Current Illness:

ID: 0990394
Sex: F
Age:
State:

Vax Date: 01/07/2021
Onset Date: 01/13/2021
Rec V Date: 02/01/2021
Hospital:

Lab Data: Test Date: 20210113; Test Name: COVID-19; Result Unstructured Data: Test Result:tested positive

Allergies:

Symptoms: Caller received her first shot of the COVID vaccine on 07Jan2021 however tested positive on the 13Jan2021; Caller received her first shot of the COVID vaccine on 07Jan2021 however tested positive on the 13Jan2021; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received her first shot of the COVID vaccine on 07Jan2021 however tested positive on the 13Jan2021. Scheduled for her second dose on 27Jan2021. She asked that will it help or harm to get the second dose of the COVID vaccine with her history of a COVID positive test? She would like to know if she should get her second dose of the COVID vaccine after testing positive for the COVID infection, or not. Events outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 0990395
Sex: M
Age:
State:

Vax Date: 12/26/2020
Onset Date: 01/14/2021
Rec V Date: 02/01/2021
Hospital:

Lab Data: Test Date: 20210114; Test Name: Covid; Test Result: Positive ; Comments: was exposed to Covid on 09Jan2021, experienced symptoms on 12Jan2021, and tested positive on 14Jan2021

Allergies:

Symptoms: tested positive on 14Jan2021; tested positive on 14Jan2021; This is a spontaneous report from a contactable nurse (Patient's wife). A male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 26Dec2020 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She states that her husband, who is also an RN, got first dose of the vaccine on 26Dec2020, was exposed to Covid on 09Jan2021, experienced symptoms on 12Jan2021, and tested positive on 14Jan2021. She wants to know if he can still get the 2nd dose which he was originally scheduled to receive on 16Jan2021. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm