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: 1010960
Sex: F
Age:
State:

Vax Date: 12/06/2020
Onset Date:
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Her pneumonia titers were low; This spontaneous report was received from a physician who was also the patient, reporting on herself. She was approximately 46 years old and her ethnicity was reported as other. Her concurrent conditions included autoimmune antibodies to thyroid with normal thyroid values, and unspecified food and environmental allergies. Her medical history and concomitant medications were not provided. On approximately 06-DEC-2020 (reported as "a full month prior, 30 days prior"), the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unspecified date, the patient's pneumonia titers were low. The outcome of the event and the causal relationship between the event and the suspect vaccine were not reported.

Other Meds:

Current Illness: Anti-thyroid antibodies; Environmental allergy; Food allergy

ID: 1010961
Sex: U
Age:
State: OH

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: VARIVAX administered after a temperature excursion; This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown gender and age. The patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant therapies were unknown. On 28-JAN-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck)(VARIVAX) (0.5 ml, once, strength and route were not reported, lot # T024281 has been verified as valid, expiration date 15-JUL-2022) for prophylaxis. The vaccine administered experienced a temperature excursion of 7.1 degrees Fahrenheit, for a time frame of 59 hours 45 minutes. There were no previous temperature excursions. No digital data logger was involved.

Other Meds:

Current Illness:

ID: 1010962
Sex: U
Age:
State: LA

Vax Date: 01/28/2021
Onset Date:
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Proquad was stored in the refrigerator instead of freezer; No further AE; This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 28-JAN-2021, the patient was vaccinated with an incorrect storage vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T025221 with expiration date of 19-JAN-2022), 0.5 ml, for prophylaxis (route of administration was not provided); and with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, for prophylaxis (route of administration, lot# and expiration date were not provided). The vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored in the refrigerator instead of the freezer since 01-DEC-2020 with a temperature of 44F during 1506 hours and had since then been administered to patients. There was not previous temperature excursion and this was not call because of a data logger. There was not adverse event involved.

Other Meds:

Current Illness:

ID: 1010963
Sex: U
Age: 13
State: TX

Vax Date: 10/01/2017
Onset Date:
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: a patient got 1st dose of GARDASIL 9 in October 2017. Patient missed the 2nd dose.; No additional AE reported; This spontaneous report was received from a physician, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. In October 2017, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the patient missed the second dose. No additional AE reported.

Other Meds:

Current Illness:

ID: 1010964
Sex: F
Age: 63
State:

Vax Date: 07/06/2016
Onset Date: 07/06/2016
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Nasal congestion; hemorrhage from her nose; This spontaneous report was received from a 63 year old female patient who was reporting on herself. The patient's medical history included sinus infections. The patient's concomitant therapies included unspecified thyroid medicine and metformin hydrochloride(GLUCOPHAGE XR). the patient had drug reactions/allergies to scopolamine and prednisone. On 06-JUL-2016 (also reported as "about 5 years ago") the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 0.5 milliliter for prophylaxis (frequency, route of administration, anatomical location, lot number and expiration date were not provided). On the same date (also reported as "in the days following the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccine"), the patient had nasal congestion for about two years followed by a hemorrhage from her nose (epistaxis). The patient did not seek medical attention and no lab diagnostics/studies were performed. The outcome of nasal congestion was resolved on approximately 06-JUL-2018 and epistaxis was reported as resolved on an unknown date. The causality assessment was not provided.

Other Meds: thyroid; GLUCOPHAGE XR

Current Illness: Drug allergy; Drug hypersensitivity

ID: 1010965
Sex: U
Age: 1
State: NJ

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: An expired dose of the vaccine was given on 1/29/2021; This spontaneous report was received from a physician concerning a 20 month old patient of an unknown gender. There was no information regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 29-JAN-2021, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated(VAQTA) 0.5ml lot # T008149 with expiration date of 06-JAN-2021 for prophylaxis (frequency, route of administration, anatomical location, lot number and expiration date were not provided).

Other Meds:

Current Illness:

ID: 1010966
Sex: U
Age:
State: OK

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE/PQC involved; Nurse called to report expired dose of MMR II given to patient; This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 03-FEB-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported). No additional Adverse Event (AE)/Product Quality Complaint (PQC) was involved.

Other Meds:

Current Illness:

ID: 1010967
Sex: M
Age: 1
State: NY

Vax Date: 12/08/2020
Onset Date: 12/08/2020
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE reported.; A nurse reported V ARlV AX was improperly stored and administered.; This spontaneous report was received from a licensed practical nurse regarding a 1 year old male patient with 1 siblings, birth weight of 8.3 lb. Her concomitant therapies included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), hepatitis a virus vaccine inactivated(HAVRIX) and influenza virus split virion 4v vaccine inactivated (FLULAVAL). The patient's concurrent conditions and medical history were not provided. Since 12-FEB-2020, the varicella virus vaccine live (oka/merck)(VARIVAX) experienced temperature excursions with a total of 29.5h. On 08-DEC-2020, the patient was vaccinated with her first dose of this improperly stored varicella virus vaccine live (oka/merck)(VARIVAX), lot# T017686, expiration date 20-NOV-2021 subcutaneously in the left thigh, for prophylaxis, on a private doctor's office/hospital with public funds. This is one of several reports from the same reporter (US-009507513-2101USA011364).; Sender's Comments: US-009507513-2101USA011364:Original Case : 2101USA011364

Other Meds: M-M-R II; HAVRIX; FLULAVAL (influenza virus split virion 4v vaccine inactivated)

Current Illness:

ID: 1010968
Sex: F
Age: 4
State: NY

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE reported.; A nurse reported V ARlV AX was improperly stored and administered.; This spontaneous report was received from a licensed practical nurse regarding a 4 year old female patient with 1 sibling, birth weight of 8.7 lb. Her concomitant therapies included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II). Since 02-DEC-2020, the varicella virus vaccine live (oka/merck)(VARIVAX) experienced temperature excursions with a total of 29.5h. On 12-JAN-2021, the patient was vaccinated with her first dose of this improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot# T017686, expiration date 21-MAY-2022, subcutaneously in the Right Arm, for prophylaxis, on a private doctor's office/hospital with public funds. This is one of several reports from the same reporter (US-009507513-2101USA011364).; Sender's Comments: US-009507513-2101USA011364:Original Case : 2101USA011364

Other Meds: M-M-R II

Current Illness:

ID: 1010969
Sex: F
Age: 4
State: NY

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE reported.; A nurse reported V ARlV AX was improperly stored and administered.; This spontaneous report was received from a licensed practical nurse regarding a 4 year old female patient with 2 siblings, birth weight of 6.5 lb. Her concomitant therapies included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II). Since 02-DEC-2020, the varicella virus vaccine live (oka/merck)(VARIVAX) experienced temperature excursions with a total of 29.5h. On 13-JAN-2021, the patient was vaccinated with her first dose of this improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) Lot# T017682, expiration date 21-MAY-2022, subcutaneously in the left arm, for prophylaxis, on a private doctor's office/hospital with private funds. This is one of several reports from the same reporter (US-009507513-2101USA011364).; Sender's Comments: US-009507513-2101USA011364:Original Case : 2101USA011364

Other Meds: M-M-R II

Current Illness:

ID: 1010970
Sex: M
Age: 4
State: NY

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE reported.; A nurse reported V ARlV AX was improperly stored and administered.; This spontaneous report was received from the licensed practical nurseregarding a 4 year old male patient. Her concomitant therapies included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II). The patient's concurrent conditions and medical history were not provided. Since 02-DEC-2020, the varicella virus vaccine live (oka/merck)(VARIVAX) experienced temperature excursions with a total of 29.5h. On 04-JAN-2021, the patient was vaccinated with her first dose of this improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot# T017686, expiration date 21-MAY-2022, subcutaneously in the left arm, for prophylaxis, on a private doctor's office/hospital with public funds. This is one of several reports from the same reporter (US-009507513-2101USA011364).; Sender's Comments: US-009507513-2101USA011364:Original Case : 2101USA011364

Other Meds: M-M-R II

Current Illness:

ID: 1010971
Sex: F
Age: 4
State: NY

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

Lab Data:

Allergies:

Symptoms: No additional AE reported.; A nurse reported V ARlV AX was improperly stored and administered.; This spontaneous report was received from a licensed practical nurse regarding a 4 year old female patient with birth weight of 8 lb. Her concomitant therapies included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II). Since 02-DEC-2020, the varicella virus vaccine live (oka/merck)(VARIVAX) experienced temperature excursions with a total of 29.5h. On 08-JAN-2021, the patient was vaccinated with her first dose of this improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # T017682, expiration date 21-MAY-2022, subcutaneous in the left arm, for prophylaxis, on a private doctor's office/hospital with private funds. This is one of several reports from the same reporter (US-009507513-2101USA011364).; Sender's Comments: US-009507513-2101USA011364:Original Case : 2101USA011364

Other Meds: M-M-R II

Current Illness:

ID: 1010972
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Some have been sick with them; This case was reported by a pharmacist and described the occurrence of sickness in unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not applicable for this report. Pharmacist reported that some patients received the dose of Shingrix and got sick. The reporter consented to follow up. This case is 1 of the 5 cases reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2020AMR257399:same reporter_individual pt US-GLAXOSMITHKLINE-US2020AMR257416:same reporter_some patients (sick, 2nd dose) US-GLAXOSMITHKLINE-US2020256890:same reporter_individual pt US-GLAXOSMITHKLINE-US2020256891:same reporter_some patients (late)

Other Meds:

Current Illness:

ID: 1010973
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Some have been sick with them; This case was reported by a pharmacist and described the occurrence of sickness in unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not applicable for this report. Pharmacist reported that some patients received the dose of Shingrix and got sick. The reporter consented to follow up. This is 1 of the 5 cases reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2020AMR257400:same reporter_some patients (sick, 1st dose) US-GLAXOSMITHKLINE-US2020AMR257399:same reporter_individual pt US-GLAXOSMITHKLINE-US2020256890:same reporter_individual pt US-GLAXOSMITHKLINE-US2020256891:same reporter_some patients (late) US-GLAXOSMITHKLINE-US2020AMR257399:

Other Meds:

Current Illness:

ID: 1010974
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: permanent hearing loss; This case was reported by a consumer via call center representative and described the occurrence of hearing loss in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss was unknown. It was unknown if the reporter considered the hearing loss to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. After receiving dose of Shingrix, the patient experienced the incidence of permanent hearing loss. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1010975
Sex: F
Age: 69
State: CT

Vax Date: 12/03/2020
Onset Date: 12/01/2020
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: didn't sleep; headache; nausea; body ache; chills; rash came back raised up and got a little itchy; raised rash; rash may be a mild case of shingles; This case was reported by a consumer and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of rash pruritic (also experienced tingling after receiving 1st dose on 30th August 2020, refer case US2020AMR245204). On 3rd December 2020, the patient received the 2nd dose of Shingrix. On 3rd December 2020, less than a day after receiving Shingrix, the patient experienced insomnia, headache, nausea, general body pain and chills. In December 2020, the patient experienced shingles, itchy rash and raised rash. The patient was treated with valaciclovir hydrochloride (Valtrex). Rechallenge with Shingrix was positive. On 4th December 2020, the outcome of the insomnia was recovered/resolved. On 6th December 2020, the outcome of the headache, nausea, general body pain and chills were recovered/resolved. On an unknown date, the outcome of the shingles, itchy rash and raised rash were unknown. It was unknown if the reporter considered the shingles, insomnia, headache, nausea, general body pain, chills, itchy rash and raised rash to be related to Shingrix. Additional details were reported as follows: The patient did not sleep, headache, nausea, body ache chills lasted till 6th December 2020. In December 2020, less than a week after receiving Shingrix, her rash came back raised up and got a little itchy. The rash had never been oozy or blistery and Valtrex makes it decrease in intensity. In December 2020, less than a week after receiving Shingrix, her general practitioner said the rash might be a mild case of shingles, but she would scheduled for a lyme test next week from day of reporting she may see a dermatologist this friday.; Sender's Comments: US-GLAXOSMITHKLINE-US2020AMR245204:same reporter

Other Meds:

Current Illness:

ID: 1010976
Sex: M
Age:
State:

Vax Date: 01/03/2021
Onset Date: 01/04/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data: Test Date: 20210104; Test Name: Body temperature; Result Unstructured Data: (Test Result:101,Unit:degree C,Normal Low:,Normal High:); Test Date: 20210104; Test Name: Heart rate; Result Unstructured Data: (Test Result:100,Unit:/min,Normal Low:,Normal High:)

Allergies:

Symptoms: racing heart beat of 100 per minute.; experiencing a fever of 101; This case was reported by a consumer and described the occurrence of heart rate increased in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On 3rd January 2021, the patient received the 2nd dose of Shingrix. On 4th January 2021, 1 days after receiving Shingrix, the patient experienced heart rate increased and fever. On an unknown date, the outcome of the heart rate increased and fever were not recovered/not resolved. It was unknown if the reporter considered the heart rate increased and fever to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not provided. The reporter was patient's wife. The patient received 2nd dose of Shingrix, and experienced increased heart rate of 100 beats per minute and fever of about 101 degree Celsius. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1010977
Sex: F
Age: 83
State: FL

Vax Date: 01/05/2021
Onset Date: 01/01/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: received her two doses / 28 days apart, 08Dec2020 and 05Jan2021; myalgia 3 days after the 2nd dose.; This case was reported by a pharmacist and described the occurrence of myalgia in a 83-year-old female patient who received Herpes zoster (Shingrix) (batch number 3PD3E, expiry date 8th October 2022) for prophylaxis. Concomitant products included Herpes zoster (Shingrix). On 5th January 2021, the patient received the 2nd dose of Shingrix. On 5th January 2021, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. In January 2021, the patient experienced myalgia. On an unknown date, the outcome of the myalgia was not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown. It was unknown if the reporter considered the myalgia to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. 3 days after receiving 2nd dose of Shingrix, patient experienced myalgia. The patient received 2nd dose of Shingrix, less than the recommended interval , which led to shortening of vaccination schedule. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1010978
Sex: F
Age: 67
State: OH

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

Lab Data:

Allergies:

Symptoms: Sore Arm; This case was reported by a consumer and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 17th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 17th January 2021, several hours after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional information are as follows: The patient reported for herself. The patient received dose of shingrix and experienced after few hours as she began to experience a sore arm. The reporter did not had lot number or expiration date. The patient was still experiencing some soreness in her arm (unresolved). The reporter did not consented to follow up. No further information was available

Other Meds:

Current Illness:

ID: 1010979
Sex: F
Age: 50
State: PA

Vax Date: 10/09/2020
Onset Date: 10/09/2020
Rec V Date: 02/08/2021
Hospital:

Lab Data: Test Date: 202010; Test Name: CT Scan; Result Unstructured Data: (Test Result:unknown,Unit:unknown,Normal Low:,Normal High:) abscess was ruled out

Allergies:

Symptoms: It was diagnosed as cellulitis; area gradually became swollen and red; area gradually became swollen and red; right buttock area; This case was reported by a consumer and described the occurrence of injection site cellulitis in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 9th October 2020, the patient received the 1st dose of Shingrix. On 9th October 2020, several hours after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and vaccine administered at inappropriate site. On an unknown date, the patient experienced injection site cellulitis. The patient was treated with antibiotics nos. On an unknown date, the outcome of the injection site cellulitis and vaccine administered at inappropriate site were unknown and the outcome of the injection site swelling and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site cellulitis, injection site swelling and injection site erythema to be related to Shingrix. Additional details were provided as follows: The patient received the 1st dose of Shingrix on her right buttock area which led to vaccine administered at inappropriate site. Few hours later, the patient experienced area gradually became swollen and red and the swelling was the size of a softball. The patient was diagnosed with cellulitis and treated with antibiotics in emergency room visit. A CT scan was performed and an abscess was ruled out. The patient recoverd after week and half . The patient felt it was important to note that she is a natural red head and it has been proven that red heads can react strangely to medications. The reporter consented to follow up. No further information was available.

Other Meds:

Current Illness:

ID: 1010980
Sex: F
Age: 25
State: MA

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 02/08/2021
Hospital: Y

Lab Data: Test Date: 202101; Test Name: MRI; Result Unstructured Data: MRI positive for inflammation, a brain bleed and swelling.

Allergies:

Symptoms: Brain hemorrhage (inflammation, swelling); Dizziness; Difficulty with coordination; Difficulty with balance; Vision changes in left eye; Drift in left arm; Issues going through daily routine; Neurological symptoms; Was confused; Headaches; Very nauseous; A spontaneous report was received from a consumer, who was a 25-years-old, white female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, very nauseous, neurological symptoms, headaches, dizziness, difficulty with coordination, difficulty with balance, vision changes in left eye, drift in left arm, issues going through daily routine, confusion, and brain bleed. The patient's medical history, as provided by the reporter, included gluten allergy. Products known to have been used by the patient, within two weeks prior to the event, included ethinylestradiol/ ferrous fumarate/ norethindrone acetate. On 06 Jan 2021 at 10:30am, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 06 Jan 2021, after receiving the vaccine, the patient became very nauseous through 08 Jan 2021. On 09 Jan 2021, the patient started having neurological symptoms. She started having headaches, dizziness, difficulty with coordination and balance, and vision changes in the left eye (not specified). She reported that she had a "drift" in the left arm and described it as "when you try to manipulate the arm, but it does not go where you want it to go". On 11 Jan 2021, the patient still had neurological symptoms, issues moving left arm, colliding with objects all day, and issues going through daily routine. On 12 Jan 2021, the patient was seen by a neurologist and magnetic resonance imagining (MRI) was scheduled. The MRI revealed inflammation, and brain bleed and swelling. The patient was sent to the emergency room and admitted on 19 Jan 2021. Treatment for the events included calcium carbonate for nausea, ibuprofen for headaches and diphenhydramine. Action taken with mRNA-1273 in response to the events was not reported. The event, very nauseous, was considered resolved on 08 Jan 2021. The events, neurological symptoms, headaches, dizziness, difficulty with coordination, difficulty with balance, vision changes in left eye, drift in left arm and issues going through daily routine, confusion, and brain bleed were considered not resolved. Follow-up received on 23 Jan 2021 included patient details, medical history, lab tests, concomitant medications, hospitalization, and updated events.; Reporter's Comments: This case concerns a female patient, who experienced a non-serious unexpected event of dizziness, coordination abnormal, balance disorder, visual impairment, movement disorder, loss of personal independence in daily activities, and neurological symptom, and non-serious expected event of nausea, and headaches. The events of nausea occurred 1 day (same day) after first dose of mRNA-1273, lot # unknown. The event of neurological symptoms, dizziness, coordination abnormal, balance disorder, visual impairment, loss of personal independence in daily activities, and movement disorder occurred 3 days after first dose of mRNA-1273, lot # unknown. Treatment for the events included, Tums, nauseam, ibuprofen and Benadryl. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.

Other Meds:

Current Illness: Gluten sensitivity (Gluten allergy)

ID: 1010981
Sex: U
Age:
State:

Vax Date:
Onset Date: 01/19/2021
Rec V Date: 02/08/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Potential Guillain-Barre; A spontaneous report was received from a pharmacist concerning an unknown patient who received Moderna's COVID-19 vaccine and potentially developed Guillain-Barre Syndrome. 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 intramuscularly for prophylaxis of COVID-19 infection. On 19 Jan 2021, the patient is in the hospital for potential Guillain-Barre Syndrome. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, potential Guillain-Barre Syndrome, was unknown/ not reported.; Reporter's Comments: This case concerns a patient of unknown age and gender, who experienced a serious unexpected event of potential Guillain-Barre Syndrome which required hospitalization. The event occurred on an unspecified date after first dose of mRNA-1273, lot # unknown. Treatment details were not provided. 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:

Current Illness:

ID: 1010982
Sex: F
Age:
State:

Vax Date: 01/19/2021
Onset Date:
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Arrhythmias; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273), and who experienced arrhythmias. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. Prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. Patient had adverse heart reaction after receiving the vaccination. Patient has some arrhythmias and ended up in the ER two days later. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the events, adverse heart reaction and arrhythmias were not reported.; Reporter's Comments: This case concerns a female patient of unknown age with unknown medical history subject, who experienced a serious unexpected event of arrhythmia. The event occurred on unspecified time after the first dose of mRNA-1273 vaccine (but not later than 2 days after vaccination). Treatment information was reported; however, patient was sent to emergency room. Outcome of reported arrhythmia is unknown. The event was assessed as possibly related, however additional information has been requested.

Other Meds:

Current Illness:

ID: 1010983
Sex: F
Age:
State: GA

Vax Date: 01/16/2021
Onset Date: 01/01/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data: Test Date: 20210122; Test Name: Hemoglobin decreased; Test Date: 20210122; Test Name: Platelets; Test Result: 1000 {DF}

Allergies:

Symptoms: Pancytopenia; Malaise; Muscle aches; Fever; A spontaneous report was received from a physician concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pancytopenia, fever, malaise, and muscle aches. There was no medical history provided. There were no concomitant medications provided. On 16 Jan 2021, the patient received her first of two planned doses of mRNA-1273 (Batch # unknown), for prophylaxis of COVID-19 infection. On 22 Jan 2021, the patient experienced the serious event of pancytopenia. Additionally, on an unspecified date in Jan 2021, following in jection, the patient experienced the non-serious events of fever, malaise, and muscle aches. Relevant laboratory result included platelet count of 1000 and hemoglobin was decreased on 22 Jan 2021. There was no treatment information provided. Action taken with mRNA-1273 in response to the events of pancytopenia, fever, malaise, and muscle aches, was not provided. The event of pancytopenia was unknown. The outcome for the events fever, malaise, and muscle aches, was unknown at the time of this report.; Reporter's Comments: This case concerns a female patient, who experienced a serious unexpected event of pancytopenia and non-serious unexpected event of malaise, non-serious expected events of myalgia, and pyrexia. The event of pancytopenia occurred 7 days after first dose of mRNA-1273, lot # unknown. The event of myalgia and pyrexia occurred on an unspecified date after first dose of mRNA-1273, lot # unknown. Treatment was not specified. 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 events a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1010984
Sex: F
Age:
State: NJ

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Subcutaneous Injection; lump at injection site; A spontaneous report was received from a nurse concerning a 65-year old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) via subcutaneous injection and experienced lump at injection site. No relevant medical history and concomitant medications were reported. On 20-Jan-2021, prior to the onset of the events, the patient received a dose of mRNA-1273 (lot number 032L20A) subcutaneously for prophylaxis of COVID-19 infection. On 20-Jan-2021, the patient developed a lump at the injection site when vaccine was given to her subcutaneously. No treatment information was provided. Action taken with mRNA-1273 in response to the events were not reported. The event subcutaneous injection was considered to be resolved on 20-Jan-2021. The outcome of event lump at injection site was unknown.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273, lot #: 032L20A. There were no reported AEs associated with this case of incorrect route of product administration.

Other Meds:

Current Illness:

ID: 1010985
Sex: F
Age: 65
State:

Vax Date: 01/18/2021
Onset Date: 01/18/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data: Test Name: blood test; Result Unstructured Data: Normal; Test Name: chest x-ray; Result Unstructured Data: Normal; Test Name: EKG; Result Unstructured Data: Normal

Allergies:

Symptoms: Lungs congested; Trouble breathing; Trouble speaking/Trouble breathing; When she would speak she would cough hard; A spontaneous report was received from a consumer concerning a 65-year-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced trouble breathing, trouble speaking, lungs congested and when she would speak she would cough hard. The patient's medical history included back pain being treated by a pain management doctor, high blood pressure, high cholesterol, asthma and diabetes. Medications reported by the patient, within two weeks prior to the event, included albuterol inhaler. On 18 Jan 2021, in the morning, the patient received their first of two planned doses of mRNA-1273 (Lot number 028L20A) intramuscularly for prophylaxis of COVID-19 infection. On 18 Jan 2021, in the evening on the same day of vaccination, the patient went to the ER (emergency room) due to trouble breathing and speaking, lungs congested, and cough when she would speak. While in the ER she had a blood test, chest x-ray, and an EKG which all came back normal. She stated that she did not think that the symptoms were related to an environmental change. Treatment for the event included steroid and nebulizer treatment, and the symptoms resolved after treatment on the same day. Action taken with mRNA-1273 in response to the events was not provided. The outcomes of the events were resolved on 18 Jan 2021.; Reporter's Comments: This case concerns a 66-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 028L20A), and who experienced the serious unlisted event of lungs congested, and the non-serious unlisted events of trouble breathing, trouble speaking, and cough. The events occurred on the day of vaccination. Based on the current available information and temporal association between the use of the product and the onset of events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.

Other Meds:

Current Illness:

ID: 1010986
Sex: F
Age: 77
State: CA

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Bad heart rate; sore arm; A spontaneous report was received from a nurse who was also a 77-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm and bad heart rate. The patient's medical history was not provided. No concomitant medications were reported. On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection. On the same day, the patient developed a sore arm. No treatment was administered. On 10 Jan 2021, the patient experienced bad heart rate and had to go to the emergency room (ER). On 21 Jan 2021, the patient had a second visit to the ER, where she required a cardioversion for the bad heart rate. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the event, sore arm, was resolved on an unknown date. The outcome for the event, bad heart rate, was resolved on 21 Jan 2021.; Reporter's Comments: This case concerns a 77-year-old female patient, who experienced a medically significant unexpected event of Heart rate abnormal and unexpected non-serious event of Pain in extremity. The medical history is not provided. The event of Pain in extremity occurred on the same day after receiving their first of two planned doses of mRNA-1273 (Lot # 025L20A). The event of Heart rate abnormal occurred approximately five days after receiving their first of two planned doses of mRNA-1273 (Lot # 025L20A). Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1010987
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Angioedema both times, the second time was a little bit worse; A spontaneous report was received from a healthcare facility staff member concerning an unknown patient who received Moderna's COVID-19 Vaccine, and who experienced angioedema after both doses. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On unknown date, prior to the onset of the symptoms, the patient received their two planned doses of mRNA-1273 unknown batch number intramuscularly for prophylaxis of COVID-19 infection. On unknown date, the patient experienced angioedema both times after vaccination. The second time was a little bit worse and lasted for three days. Treatment for the event included prednisolone, Pepcid and Benadryl. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. The outcome of the event angioedema both times not reported.; Reporter's Comments: This case concerns a patient who received their two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted event of angioedema after both doses. Based on the current available information, including reoccurrence of event after second dose and temporal association between the use of the product and the onset of event after vaccination, a causal relationship cannot be excluded and the event of angioedema is considered possibly related to the vaccine.

Other Meds:

Current Illness:

ID: 1010988
Sex: F
Age: 50
State: WA

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Injection site had two nodules,nodules 2.5 inches then nodules became 4 inches; Injection site inflamed; Injection site raised; Lot of arm pain; Arm warm to touch; Headache; Vaccine given subcutaneously; Extreme fatigue; Joint pain; Muscle aches; Swelling at the injection site; Redness at the injection site; Red mark down the arm; A spontaneous report was received from a 50-year old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) was given subcutaneously by the pharmacist resulting in the event and also experienced redness and swelling on the injection site, headache, fatigue, joint pain, red mark down the arm, lot of arm pain, arm was warm to touch, muscle aches, injection site had 2 nodules which got really red, injection site raised and inflamed. The patient's current medical history was reported as allergic to Penicillin and Sulfa drugs. Concomitant medications were Vitamins. On 13 Jan 2021, the patient received their first dose of two planned doses of MRNA-1273 (Lot Number: 041L20A) subcutaneously for prophylaxis of COVID-19 infection. On 13th Jan 2021, the patient received the mRNA-1273 vaccine subcutaneously, which was told by another pharmacist. No treatment for the event was provided. On an unknown date, she experienced redness and swelling on the injection site, headache, fatigue, joint pain, red mark down the arm, and muscle aches. By Day 7 these symptoms subsided. Treatment for the events were Ciprofloxacin, Benadryl and ice. On 21st Jan 2021, she started to experience a lot of arm pain and arm was warm to touch. The injection site had 2 nodules, got red (a quarter of an inch). The nodules became 2.5 Inches after 8 hours which were raised and inflamed. On 23rd Jan 2021, the area became 4 inches. Treatment for the event was Ciprofloxacin, Benadryl and ice. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, Vaccine given subcutaneously was considered resolved. The outcome of the events, redness and swelling on the injection site, headache, fatigue, joint pain, red mark down the arm were recovering/resolving. The outcome of the events, lot of arm pain, arm was warm to touch, the injection site had 2 nodules, got red (a quarter of an inch), 8 hours later it was 2.5 Inches, raised and inflamed then the area became 4 inches was unknown.; Reporter's Comments: This case concerns a 50-year-old female patient with relevant medical history of allergy to Penicillin and Sulfa drugs. The patient reported Incorrect route of product administration and experienced non-serious expected events of Injection site swelling, Injection site erythema, Injection site pain, Erythema, Headache, Fatigue, Arthralgia, Myalgia, and non-serious unexpected events of Injection site warmth, Injection site nodule, Injection site inflammation, and Injection site reaction. The events of Injection site swelling, Injection site erythema, Erythema, Fatigue, Headache, Myalgia and Arthralgia occurred on an unknown date after receiving their first of two planned doses of mRNA-1273 (Lot #041L20A). The events of Injection site pain, Injection site warmth, Injection site nodule, Injection site inflammation, and Injection site reaction occurred approximately eight days after receiving their first of two planned doses of mRNA-1273 (Lot #041L20A). Treatment for the events were Ciprofloxacin, Benadryl and ice. Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine. Of note, patient's medical history of allergy to Penicillin and Sulfa drugs is considered a risk factor.

Other Meds: VITAMINS NOS

Current Illness: Allergy to antibiotic (Allergic to Sulfa drugs.); Penicillin allergy

Date Died: 01/04/2021

ID: 1010989
Sex: F
Age: 69
State: FL

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Brain aneurysm; Anaphylactic reaction; Collapsed; BP sky rocketed; Shortness of breath; A spontaneous report was received from a consumer concerning a 69-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced blood pressure skyrocketed, shortness of breath, loss of consciousness, massive anaphylactic reaction, and brain aneurysm. The patient's medical history, as provided by the reporter, included high blood pressure and arthritis. Products known to have been used by the patient, within two weeks prior to the event, included an antihypertensive. On 04 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. Twenty-two minutes later she had a massive anaphylactic reaction. She experienced shortness of breath, blood pressure skyrocketed, and loss of consciousness. She was taken to the emergency room. The patient had a brain aneurysm and never recovered. No treatment information was provided. The patient died on 04 Jan 2021. The cause of death was reported as brain aneurysm. Plans for an autopsy were not provided.; Reporter's Comments: This case concerns a 69-year-old, female patient with a medical history of hypertension, who experienced fatal, serious, unexpected events of Anaphylactic reaction, hypertension, dyspnea, loss of consciousness and brain aneurysm. The events occurred 22 minutes after the first dose of mRNA-1273 was administered. No treatment information was provided. The patient never recovered and died. The cause of death was reported as brain aneurysm. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Additional information has been requested.; Reported Cause(s) of Death: Brain aneurysm

Other Meds:

Current Illness: Arthritis; Hypertension

ID: 1010990
Sex: F
Age: 52
State: WA

Vax Date: 12/31/2020
Onset Date: 01/15/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Colitis; A spontaneous report was received from a 52-year-old, female consumer, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed colitis. The patient's medical history was not provided. Concomitant product reported included ogmentin. On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) in the right arm for prophylaxis of COVID-19 infection. The patient experienced weight loss and was unable to eat after receiving the first dose. On 15 Jan 2021, the patient reported that she started to experience lower pelvic pain and was diagnosed with colitis. On 21 Jan 2021, she had a follow up with PCP (primary care physician) and the PCP advised not to get second dose until 29 Jan 2021. On an unspecified date, she started her new antibiotic treatments. Treatment for the event included levosloxacin. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, colitis, was not reported.; Reporter's Comments: This case concerns a 52 year-old, female patient, who experienced event of colitis. The event of colitis occurred 16 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.

Other Meds: OGMENTININE

Current Illness:

ID: 1010991
Sex: F
Age:
State: IL

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

Lab Data:

Allergies:

Symptoms: A spontaneous report was received from a pharmacist concerning 43-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 number 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 43-year old, female patient who received their first of two planned doses of mRNA-1273 (lot # 026L20A), reporting Product administration error. There were no reported AEs associated with this case of Product administration error.

Other Meds:

Current Illness:

ID: 1010992
Sex: F
Age:
State: NY

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: My face started feeling very hot / feeling warm; my arms were looking mottled; first got hives under my neck on the left side and then it traveled to the tight side of my neck/ had hives on my arms legs neck chest and back; within 5 more minutes my neck was red / my face started getting red; This is a spontaneous report from a contactable Health Professional, the patient. A 63-year-old non-pregnant female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL3242), via intramuscular route in the left arm on 22Jan2021 17:00 (at the age of 63-years) as a single dose for COVID-19 immunization. Medical history included Thyroid -Hashimoto's thyroiditis, Penicillin allergy, Brussels sprouts and avocados allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine and ibuprofen (ADVIL). The patient previously took erythromycin and experienced allergy. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 22Jan2021 at 17:15, after approximately 10 minutes of receiving vaccination, the patient started feeling warm, she noticed her arms were looking mottled and she went to the nurse. She first got hives under her neck on the left side and then it traveled to the tight side of my neck. Within 5 more minutes her neck was red, and her face had started feeling very hot. Her face started getting red. The patient was taken to the emergency room and she had hives on her arms, legs, neck, chest, and back. The patient was treated for feeling very hot, arms mottled, hives, and neck and face red with intravenous (IV) Benadryl 50mg with Famotidine IV and saline solution IV. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event for feeling very hot, arms mottled, hives, and neck and face red were recovered in Jan2021; Sender's Comments: Based on the compatible time association, the contribution of suspect vaccine BNT162B2 to the events is possible . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: LEVOTHYROXINE; ADVIL [IBUPROFEN]

Current Illness:

ID: 1010993
Sex: F
Age:
State: VA

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: my lips and tongue started itching and got swollen; my lips and tongue started itching and got swollen; my lips and tongue started itching and got swollen; my lips and tongue started itching and got swollen; itching and got hives; itching and got hives; This is a spontaneous report from a contactable Nurse reported for herself. A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jan2021 16:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient was not pregnant. Medical history included Asthma, food and environmental allergies, allergy to PCN and Sulfa. Concomitant medications included montelukast sodium (SINGULAIR), bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (LEXAPRO), loratadine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first dose of BNT162B2 on an unknown date for covid-19 immunization. The patient previously took acetylsalicylic acid (ASA), levofloxacin (LEVAQUIN), codeine and azithromycin (ZITHROMAX) and experienced allergy. 8 minutes after the vaccine was given on 22Jan2021 16:08, patient started itching and got hives. She was given Benadryl. About 5 minutes after that on 22Jan2021 16:13, her lips and tongue started itching and got swollen. At that time she was given an injection of Epinephrine and transferred to the Emergency Department. The outcome of the events was recovered on an unknown date in Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: Pfizer comment: Based on the information currently available, a possible contributory role of the BNT162B2 in the reported events lip and tongue itching and got swollen cannot be excluded in this 56 years old female patient, who with medical history of allergy to food, environment and multiple medications. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: SINGULAIR; WELLBUTRIN; LEXAPRO; LORATADINE

Current Illness:

ID: 1010994
Sex: F
Age:
State: PA

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data: Test Date: 202101; Test Name: heart ultrasound; Result Unstructured Data: Test Result:Unknown results; Test Date: 202101; Test Name: EKG; Result Unstructured Data: Test Result:Unknown results; Test Date: 202101; Test Name: Pulse rate; Result Unstructured Data: Test Result:returned to normal; Test Date: 20210122; Test Name: Pulse rate; Result Unstructured Data: Test Result:152; Test Date: 20210101; Test Name: Covid-19; Test Result: Positive

Allergies:

Symptoms: Took pulse and it was 152; stumbling walking; mild dizziness/dizziness turned severe; Mild breathing problems/continued breathing issues; pressure on chest; This is a spontaneous report from a contactable Other Health Professional (patient). A 21-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK 9231), via an unspecified route of administration on 21Jan2021 16:15 at single dose in Right arm for COVID-19 immunisation. Medical history included asthma, anxiety, and depression, all from an unknown date. Concomitant medication included duloxetine, lamotrigine, buspirone hydrochloride (BUSPAR), etonogestrel (NEXPLANON), ethinylestradiol, norethisterone acetate (JUNEL) in two weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 31Dec2020 02:30 PM in Right arm at single dose for COVID -19 immunisation and was tested positive for COVID on 01Jan2021; took cefdinir and experienced drug hypersensitivity. The patient reported symptoms began 12 hours after second COVID vaccine (5am on 22Jan2021). Mild breathing problems and pressure on chest. At 7am on 22Jan2021, mild dizziness started and continued breathing issues. At 12pm (noon) dizziness turned severe, was stumbling walking. Took pulse and it was 152 on 22Jan2021, checked several times. The patient went to the ER (Emergency room) and was determined it was a reaction to the vaccine. After receiving medication and fluids, pulse returned to normal after about seven or eight hours. The events resulted in Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Covid-19 tested Positive on 01Jan2021, Pulse rate: 152 on 22Jan2021, Pulse rate returned to normal in Jan2021, heart ultrasound and EKG (Electrocardiogram) with unknown results in Jan2021. The patient received Fluids and medication as treatment. COVID was not tested post vaccination. The outcome of event Took pulse and it was 152 was recovered on an unspecified date in Jan2021. The outcome of the other events was recovering.; Sender's Comments: Based on the compatible time association and drug's safety profile, the events are possibly related to suspect vaccine BNT162B2 injection. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: DULOXETINE; LAMOTRIGINE; BUSPAR; NEXPLANON; JUNEL

Current Illness:

ID: 1010995
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: half after the shot patient was pregnant 7 months besides; flu; Initial information received on 19-Jan-2021 regarding an unsolicited valid non-serious case via social media, consumer or non-health care professional (Patient). This case involves adult female patient who experienced flu (influenza) after the INFLUENZA VACCINE [Flu shot] maternal exposure before pregnancy. Data regarding this pregnancy were received prospectively. The date of last menstrual period was not reported. The estimated due date was not reported. It was unknown if the patient had any medical history, concomitant disease or risk factor. Medical treatment, vaccination and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number not and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date in 1957, the patient developed a non-serious flu (influenza) a month and a half following the administration of INFLUENZA VACCINE. It was the case of vaccine exposure before pregnancy (maternal exposure before pregnancy) [Latency : unknown]. It was reported that, that was patients first in 1957 and last one after that and never had the flu since. Pregnancy outcome was unknown at the time of report. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. At the time of reporting, the event outcome reported as unknown for influenza. Information on the batch number was requested.

Other Meds:

Current Illness:

ID: 1010996
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Hair coming out toes took 6 months then boom; Initial information received on 24-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional. This case involves a patient (age and gender not reported) who experienced hair coming out toes took 6 months then boom (hair growth abnormal), while he/she received INFLUENZA VACCINE. Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed non-serious hair coming out toes took 6 months then boom (hair growth abnormal) (unknown latency) following the administration of INFLUENZA VACCINE. Details of laboratory data not reported. It was not reported if the patient received any corrective treatment. At the time of reporting, the event outcome reported as unknown for event. There will be no information available on batch number for this case.

Other Meds:

Current Illness:

ID: 1010997
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: patient was sick; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case from social media via consumer or non-health care professional. This case involves adult female patient who was sick (illness), while she received vaccine INFLUENZA VACCINE [Flu shot]. It was unknown if the patient had any medical history, concomitant disease or risk factor. Medical treatment, vaccination and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number not and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient was sick (illness) (non-serious) unknown latency following the administration of INFLUENZA VACCINE. It was reported that, she had the flu shot every year and she was sick every year no shot for her husband never had never would. There were no lab data/results available. It was not reported if the patient received any corrective treatment. At the time of reporting, the event outcome reported as unknown for event. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1010998
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: got the shot was never so sick patient in life; Initial information received on 18-Nov-2020 regarding an unsolicited valid non-serious case from social media. Via consumer or non-health care professional (Patient). This case involves adult patient (gender not specified) who got the INFLUENZA VACCINE [shot] was never so sick patient in life (illness). It was unknown if the patient had any medical history, concomitant disease or risk factor. Medical treatment, vaccination and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number not and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient got the shot was never so sick patient in life (illness) (non-serious) unknown latency following the administration of INFLUENZA VACCINE. There were no lab data/results available. It was not reported if the patient received any corrective treatment. At the time of reporting, the event outcome reported as unknown for event. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1010999
Sex: F
Age: 9
State: TN

Vax Date: 10/11/2020
Onset Date: 10/11/2020
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: A nine year old girl received Flublok Quadrivalent, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Global Medical Information (GMI) (Reference number- 00440411) and transmitted to Sanofi on 21-Jan-2021. This case involves a 9 years old female patient who received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot UJ455AA, expiry date: 17-Mar-2021) via intramuscular route in the right deltoid for prophylactic vaccination on 11-Oct-2020 (Product administered to patient of inappropriate age) Medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient did not receive any other concomitant vaccines. It was a case of an actual medication error due to Inappropriate age at vaccine administration (latency same day). On 11-Oct-2020, both the 9-year-old patient and her mother came into the clinic for their flu shot. It is possible that the Flublok was inadvertently given to the 9-year-old instead of to the mother, but that is not certain. It could have been a mix-up in the paperwork. Reporting nurse stated that she always double-checks for this, just before administering the flu vaccine, which is why she thinks it could just have been recorded incorrectly. At the time of report, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1011000
Sex: F
Age: 37
State: TX

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data: none

Allergies: NKA

Symptoms: head ache, nausea, fever, chills, body aches

Other Meds: Zoloft, Vitamin D3, Prenatal vitamin, Fish oil

Current Illness: none

ID: 1011001
Sex: F
Age: 54
State: OH

Vax Date: 01/12/2021
Onset Date: 01/20/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies: None

Symptoms: 9 days after vaccine was received in the left arm , there was swelling , redness , warmth and pain at the site . I took 600mg Ibuprofen every 6 hours for about 30 hours and I placed ice at the site frequently. I saw my PA next day and I was prescribed a Medrol pack , which helped resolve all those symptoms after first day of taking the medication.

Other Meds: None

Current Illness: None

ID: 1011002
Sex: F
Age: 74
State: IN

Vax Date: 02/07/2021
Onset Date: 02/08/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies: Penicillin, Sulfa

Symptoms: Fever and chills starting 12 hours after injection. Temperature 101.7 then and now 5 hours later! Unable to sleep, restlessness! Lower legs itch. Site is sore! Had been to to not take ibuprofen or Tylenol to help antibodies form! Can I take Benadryl? I had none of these adverse effects with 1st dose!

Other Meds: Lisinopril, Cardura, Diltiazem ER, Spirolactolone, Lexapro, Prilosec, Livalo, Xarelto Calcium, Vitamin D, Magnesium, Multiple Vitamins, Zinc, Fish oil, Turmeric, CBD oil. Prolia

Current Illness: Hypertension, Preserved Ejection Fraction Heart Failure, osteoporosis, HEREafter vaccination. Fever 101.7 chills. Sore site, restlessness! No adverse reactions with 1st vaccination 1/17/21

ID: 1011003
Sex: F
Age: 52
State: MN

Vax Date: 01/30/2021
Onset Date: 02/07/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies: none

Symptoms: I had some swelling and pain the first two days following the vaccine, then all was fine. On day 8 I awoke to a large (2.5 inch) hard, red, itchy, hot welt at the injection site. There is mild pain when I touch it.

Other Meds: Cymbalta, Abilify, Trazodone, Litium, Wellbutrin, Buspar Vitamin C, AREDS vitamins, Elderberry chews

Current Illness: none

ID: 1011004
Sex: F
Age: 74
State: NY

Vax Date: 01/29/2021
Onset Date: 02/06/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data: None

Allergies: Sulphur

Symptoms: Large red welt that was itchy but not anymore. Slight burning on site

Other Meds: Erythromycin 0.5%, Levothyroxine 88mcg, Myrbetriq ER 50mg, Omeprazole DR 20mg, Prolia, Restasis 0.05%, Calcium, D3 5000, Fish Oil 1200 mg, Multivitamin

Current Illness: None

ID: 1011005
Sex: F
Age: 26
State: NY

Vax Date: 02/07/2021
Onset Date: 02/08/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies: Sulfa

Symptoms: Body aches, muscle weakness around midnight Fever at 6am

Other Meds: Wellbutrin, adderall

Current Illness: N/a

ID: 1011006
Sex: F
Age: 71
State: FL

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies: Shellfish

Symptoms: Patient stated her lips and tongue feel itchy. Patient stated she is allergic to shellfish and gets anxious every time she gets a vaccine. Vital signs within normal limits. BP 128/74, HR 68, O2 sat 96%. Patient took her own Benedryl PO. Patient stated she is feeling better, and she wants to go home.

Other Meds: None

Current Illness: None

ID: 1011007
Sex: F
Age: 59
State: OH

Vax Date: 01/30/2021
Onset Date: 01/30/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies: NA

Symptoms: Pt complaint of dizziness 2 minutes after getting the vaccine. Pt the stated her vision was blurry. BP 200/130 Pt stated she was feeling better. Medic rechecked BP 247-200/130. Medic rechecked 191/119, HR 68 @ 1310 Pt advised to go to ER. Pt doesn't want to go by squad. States she will call her daughter 1332 RN still monitoring pt. Pt sitting quietly waiting on her daughter to take her to ER as advised by medic. 1337 daughter of pt arrived. Rn supervisor walked pt to meet daughter and advised daughter take her to ER ASAP and to pull over squad if worsen. Pt advised to go to ER by medics & RN due to elevated BP, blurred vision, & dizziness.

Other Meds: NA

Current Illness: NA

ID: 1011008
Sex: F
Age: 37
State:

Vax Date: 01/30/2021
Onset Date: 01/30/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies: PCN, ASA, SULFA

Symptoms: Dizziness, nausea and inability to sit up 5-minutes following injection. BP rose to 200/100 (normally 80/60). BP declined over two hours of observation. Expected sleepiness a few hours later; slept for 18-hours. Ongoing dizziness and nausea still present 7-days post vaccine.

Other Meds: None

Current Illness: NONE

ID: 1011009
Sex: F
Age: 68
State: IN

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies: Amoccoxilian (spelling?)

Symptoms: Felt like CoVid. I had CoVid about 6 months ago. Fever (104 F) Chills Total body ache

Other Meds: Verapamil Losortan Potassium Acetamin-COD #3 Escitalopram NP Thyroid Progesterone BIEST (80/20) Tumeric Vitamin B12 Vitamin C Geneva Sylvestre DHEA Magnesium Potassium Gluconate Melatonin Culturelle D3 Valerian Root

Current Illness: Gastritis

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm