VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
46,870MODERNA
532GLAXOSMITHKLINE BIOLOGICALS
353PFIZER\BIONTECH
231MERCK & CO. INC.
221UNKNOWN MANUFACTURER
62SEQIRUS, INC.
25DYNAVAX TECHNOLOGIES CORPORATION
13EMERGENT BIOSOLUTIONS
12SANOFI PASTEUR
9NOVARTIS VACCINES AND DIAGNOSTICS
5PFIZER\WYETH
5PAXVAX
2TEVA PHARMACEUTICALS
2PROTEIN SCIENCES CORPORATION
1BERNA BIOTECH, LTD.
1INTERCELL AG
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL1,906
1,575
289
IMM209286
252
236
229
s029456178
171
UT7065MA166
155
149
145
S034636133
107
U62828AA103
100
98
P10025327596
U6737AA85
UJ446AA79
78
78
59
57
4BH3254
4F47253
52
27656352
50
PP9L548
49TM346
42
40
38
MENVEO38
4F47237
R1B252M36
34
C5763AA30
93362229
25
300057A24
UNK24
22
CW311621
18
17
15
UH894AB15
3Y7NL12
R1B743M12
EJ168611
el128410
10
10
10
9
ARBA141A9
UNK9
8
UNK8
8
1F4EB8
Unknown7
7
No batch number6
5
5
UJ090AA5
5
5
4
4
4
UNK4
JEV18K95E4
UNK3
A115A3
Z127A3
3
3333324181073
2
2
2
TAR352
1
1
1
1
1
A739081
1
1
1
1
1
037K20A68,542
EL128447,700
133

Incidents per State

State Total
15,185
CA14,096
NY7,507
TX7,196
FL6,939
IN5,527
PA4,560
IL4,179
OH4,054
AZ3,856
MI3,771
NJ3,411
MA3,278
VA3,208
NC3,114
WA3,034
GA2,864
MD2,652
MN2,534
CO2,532
WI2,457
MO2,029
OR1,943
TN1,715
CT1,693
KY1,603
OK1,226
AL1,201
KS1,162
IA1,157
SC1,106
NM1,065
UT973
AR951
LA945
NE829
NV797
ME795
MT789
NH756
ID674
AK661
WV661
PR650
MS585
HI536
RI510
VT441
SD361
ND356
DE350
DC239
WY209
GU32
AS16
VI13
MP9
MH3
FM2
QM1
XB1

ID: 1016575
Sex: F
Age: 71
State: OH

Vax Date: 11/28/2020
Onset Date: 11/29/2020
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: flushing in her face / flushed; face is visibly red; face/ feels warm; . This case was reported by a consumer and described the occurrence of facial flushing in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 28th November 2020, the patient received the 2nd dose of Shingrix. On 29th November 2020, 1 days after receiving Shingrix, the patient experienced facial flushing, red face and feeling of warmth facial. On an unknown date, the outcome of the facial flushing, red face and feeling of warmth facial were not recovered/not resolved. It was unknown if the reporter considered the facial flushing, red face and feeling of warmth facial to be related to Shingrix. Additional details were provided as follows: Patient woke up with flushing in her face also her face was visibly red and it felt warm. Patient did not have a fever or high blood pressure Patient was not sure if that was due to Shingrix or just a coincidence. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1016576
Sex: F
Age: 84
State: FL

Vax Date: 09/16/2020
Onset Date: 11/01/2020
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: had pain in both arms from the elbow to the shoulder / pain / comes and goes; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included INFLUENZA VACCINE (FLUAD) for prophylaxis. The patient's past medical history included breast operation and shingles. On 16th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 10th October 2020, the patient received FLUAD (intramuscular). In November 2020, less than 2 months after receiving Shingrix, the patient experienced pain in arm. The patient was treated with ibuprofen (Advil), paracetamol (Tylenol), trolamine salicylate (Aspercreme) and biofreeze (nos) (Biofreeze). 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 details were provided as follows: On 10th October 2020, the patient received Fluad. The beginning of November 2020 she had pain in both arms from the elbow to the shoulder. The patient reported it was not a steady pain but comes and goes. The patient had used Advil, Tylenol, Aspercreme, and Biofreeze to help treat the pain. The patient did not have lot number or expiration date information to provide. The reporter consented to follow up. It was unknown if the reporter considered the pain in arm to be related to fluad.

Other Meds:

Current Illness:

ID: 1016577
Sex: M
Age:
State: TX

Vax Date: 12/05/2020
Onset Date: 12/01/2020
Rec V Date: 02/09/2021
Hospital:

Lab Data: Test Date: 202012; Test Name: Heart rate increased; Result Unstructured Data: (Test Result:Rapid,Unit:unknown,Normal Low:,Normal High:)

Allergies:

Symptoms: headache; Rapid heart beat; Arm soreness; chills; sick; Diarrhea; This case was reported by a consumer and described the occurrence of sickness in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On 5th December 2020, the patient received the 1st dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced sickness, diarrhea, headache, chills, heartbeats increased and pain in arm. On an unknown date, the outcome of the sickness, diarrhea, chills, heartbeats increased and pain in arm were recovered/resolved and the outcome of the headache was unknown. It was unknown if the reporter considered the sickness, diarrhea, headache, chills, heartbeats increased and pain in arm to be related to Shingrix. Addditional details were reported as follows: The age at vaccination was not reported. The patient received the dose of Shingrix and experienced some arm soreness for 4 days, rapid heart beat for 1.5 days, chills, diarrhea and felt sick for 4 days. The reporter consented to follow up. Date of birth was not provided. This case has been linked with case ID US2020246524, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2020246524:same reporter

Other Meds:

Current Illness:

ID: 1016578
Sex: F
Age:
State: TX

Vax Date: 12/05/2020
Onset Date: 12/01/2020
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: headache; diarrhea; Arm soreness; This case was reported by a consumer and described the occurrence of headache in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On 5th December 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced headache, diarrhea and pain in arm. On an unknown date, the outcome of the headache, diarrhea and pain in arm were unknown. It was unknown if the reporter considered the headache, diarrhea and pain in arm to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. Husband stated that his wife received the dose of Shingrix and she experienced headache, diarrhea and arm soreness. The reporter consented to follow up.; Sender's Comments: US-GLAXOSMITHKLINE-US2020246522:same reporter

Other Meds:

Current Illness:

ID: 1016579
Sex: F
Age:
State:

Vax Date: 03/21/2020
Onset Date:
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Tiredness; malaise; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Flu shot (received shot annually). On 21st March 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, between 1 and 3 months after receiving Shingrix, the patient experienced tiredness and malaise. On an unknown date, the outcome of the tiredness and malaise were recovered/resolved. It was unknown if the reporter considered the tiredness and malaise to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported, however it could be 50 or 51 years. Shingrix vaccine was given in the patient's left arm The patient reported that she experienced malaise and tiredness after receiving the vaccine. The patient stated that these side effects only lasted for a day and a half. The patient reported not having a fever. The reporter did not consent to follow up. For tolerance after 2nd dose refer case US2020AMR253323.; Sender's Comments: US-GLAXOSMITHKLINE-US2020AMR253323:same reporter

Other Meds:

Current Illness:

ID: 1016580
Sex: F
Age: 73
State: CT

Vax Date: 01/05/2020
Onset Date: 01/05/2020
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Allergic reaction or throat tightness; Allergic reaction or throat tightness; Swollen tongue; Increased phlegm; Loss of voice; This case was reported by a consumer and described the occurrence of allergic reaction in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 5th January 2020, the patient received the 2nd dose of Shingrix. On 5th January 2020, 2 hrs after receiving Shingrix, the patient experienced allergic reaction, throat tightness, swollen tongue, phlegm and loss of voice. The patient was treated with steroids nos (Steroid (Not Specified)). On an unknown date, the outcome of the allergic reaction, throat tightness, swollen tongue, phlegm and loss of voice were recovered/resolved. It was unknown if the reporter considered the allergic reaction, throat tightness, swollen tongue, phlegm and loss of voice to be related to Shingrix. Additional details were provided as follows: The patient received the Shingrix vaccine at the pharmacy and about 2 hours later she had an allergic reaction or throat tightness, swollen tongue, increased phlegm and loss of voice. The patient did not go to emergency room, but was seen by her doctor on 6th January 2020 Monday or 7th January 2020 Tuesdays and was started on steroid and some other medication. It took a total of about 2.5 to 3 weeks for all the adverse events to resolve. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1016581
Sex: M
Age: 73
State: MS

Vax Date: 08/27/2020
Onset Date: 08/01/2020
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: low grade fever; chills; MILD nausea; stomach upset / mild stomach discomfort; This case was reported by a physician and described the occurrence of low grade fever in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 27th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, 1 day after receiving Shingrix, the patient experienced nausea and upset stomach. On 27th August 2020, the patient experienced low grade fever and chills. On 28th August 2020, the outcome of the low grade fever and chills were recovered/resolved. On an unknown date, the outcome of the nausea and upset stomach were recovered/resolved. It was unknown if the reporter considered the low grade fever, chills and nausea to be related to Shingrix. The reporter considered the upset stomach to be related to Shingrix. Additional details were provided as follows: Immunololgist reported that patient received the Shingrix and within the first 24 hours he developed a low grade fever and chills that dissipated. It was reported that low grade fever and chills started within 5-6 hours after Shingrix administration. On next day 15 to 20 hours post injection patient experienced mild nausea, stomach upset, mild stomach discomfort which was lasted for a few hours and then resolved. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1016582
Sex: F
Age: 72
State: WI

Vax Date: 10/02/2019
Onset Date:
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: sore arm; flu like symptoms; tired; achy; This case was reported by a consumer and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 2nd October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm, influenza-like symptoms, tiredness and general body pain. On an unknown date, the outcome of the pain in arm, influenza-like symptoms, tiredness and general body pain were recovered/resolved. It was unknown if the reporter considered the pain in arm, influenza-like symptoms, tiredness and general body pain to be related to Shingrix. Additional details were provided as follows: Patient received the 1st dose of Shingrix and experienced a sore arm and flu like symptoms consisting of being tired and achy. The reporter consented to follow up.; Sender's Comments: US-GLAXOSMITHKLINE-US2020AMR253321:same reporter

Other Meds:

Current Illness:

ID: 1016584
Sex: M
Age: 68
State: CA

Vax Date: 01/13/2020
Onset Date: 01/17/2020
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: mild bumps on the back of both hands / 4 or 5 bumps on each hand/ on the neck and arms; This case was reported by a consumer via call center representative and described the occurrence of raised rash in a 68-year-old male patient who received HAB (Twinrix adult) (batch number 3597P, expiry date 12th March 2022) for prophylaxis. Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 13th January 2020, the patient received the 1st dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On 17th January 2020, 4 days after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced raised rash. The patient was treated with cortisone (non-proprietary) (Cortisone Topical). On an unknown date, the outcome of the raised rash was recovered/resolved. It was unknown if the reporter considered the raised rash to be related to Twinrix adult and Twinrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were reported as follows: The patient received 1st dose of Twinrix adult and 4 days after started to notice mild bumps on the back of both hands, 4 or 5 bumps on each hand. The bumps presented on the neck and arms some time later. The patient was seen by nurse practitioner on 11th Febuary 2020 and treated with topical cortisone. For further 2nd dose of Twinrix adult, refer case ID US2020AMR253500, reporter for same reporter.

Other Meds:

Current Illness:

ID: 1016585
Sex: M
Age: 58
State: TX

Vax Date: 12/17/2020
Onset Date: 12/18/2020
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: achiness and throbbing around left shoulder and chest; Sore arm; sensitive skin around left shoulder and chest; sore joints in knees and elbows/shoulder PAIN; This case was reported by a consumer and described the occurrence of chest pain in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 17th December 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th December 2020, 1 days after receiving Shingrix, the patient experienced chest pain, pain in arm, sensitive skin and soreness of joint. On 20th December 2020, the outcome of the soreness of joint was recovered/resolved. On an unknown date, the outcome of the chest pain, pain in arm and sensitive skin were not recovered/not resolved. The reporter considered the chest pain, pain in arm, sensitive skin and soreness of joint to be related to Shingrix. Additional details were provided as follows: The patient received the first dose of Shingrix and about a day later, he began to experience a sore arm, achiness and throbbing around left shoulder and chest, sensitive skin around left shoulder and chest and sore joints in knees and elbows. The sore joints in knees and elbows lasted about 2 days. The patient reported that he was still experiencing the achiness, throbbing and sensitive skin in his left shoulder and chest area and that it actually may be worsening. No LOT number or EXP date was known. The reporter did not consent to follow up. The case has been linked with the case US2020AMR255588 reported for wife.; Sender's Comments: US-GLAXOSMITHKLINE-US2020AMR255588:same reporter

Other Meds:

Current Illness:

ID: 1016586
Sex: M
Age: 79
State: OH

Vax Date: 12/06/2020
Onset Date: 12/01/2020
Rec V Date: 02/09/2021
Hospital: Y

Lab Data: Test Date: 202012; Test Name: urine culture; Result Unstructured Data: (Test Result:positive for a UTI,Unit:unknown,Normal Low:,Normal High:); Test Date: 202012; Test Name: Urine test; Result Unstructured Data: (Test Result:negative,Unit:unknown,Normal Low:,Normal High:)

Allergies:

Symptoms: act delusional/Asking for things that are impossible; results were positive for a UTI; This case was reported by a consumer via call center representative and described the occurrence of delusion in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 6th December 2020, the patient received the 1st dose of Shingrix. In December 2020, 1 week after receiving Shingrix, the patient experienced delusion (serious criteria hospitalization). On an unknown date, the patient experienced urinary tract infection. On an unknown date, the outcome of the delusion and urinary tract infection were recovered/resolved. It was unknown if the reporter considered the delusion and urinary tract infection to be related to Shingrix. Additional details were provided as follows: The patient had the vaccine and approximately a week later he started to act delusional. The patient was asking for things that were impossible. The patient was admitted to the hospital on 16th December 2020 for 2 weeks and is in a rehap center. An urine test was performed and results were negative. A urine culture was done 3 weeks after the urinalyses and results were positive for a UTI. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1016587
Sex: U
Age:
State: IA

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

Lab Data:

Allergies:

Symptoms: 1ml dose of Moderna Vaccine was given.; A spontaneous report was received from a pharmacist concerning patients who received Moderna's COVID-19 Vaccine and received a 1 mL dose. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an undisclosed date, prior to the onset of the event, the patient received their planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. The patient received 1 mL of the Moderna COVID-19 Vaccine when the nurse did not pay attention that the dose should have been 0.5 mL. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event, patient received a 1 mL dose, was resolved.; Reporter's Comments: This case concerns a patient of unknown age and gender who received 1mL of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 instead of 0.5 mL dose. There were no reported adverse events in this case of accidental overdose.

Other Meds:

Current Illness:

ID: 1016588
Sex: F
Age:
State: ND

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Was on a blood thinner; A spontaneous report was received from a consumer who is a 89-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was on a blood thinner. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included a blood thinner. On 14 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection. On 14 Jan 2021, the patient called to report she was given the Moderna COVID-19 vaccine while on a blood thinner (name not of drug not provided). The patient stated that she did not know she wasn't supposed to get the vaccine until she read the paperwork. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, was on a blood thinner, were considered resolved on 14 Jan 2021.; Reporter's Comments: This report refers to a case of Product administration error for mRNA-1273 (Lot number: not provided). The patient was given the mRNA-1273. while on a blood thinner (name not of drug not provided). The patient stated that she did not know she wasn't supposed to get the vaccine until she read the paperwork. There were no reported AEs associated with his case of out of specification product use.

Other Meds:

Current Illness:

ID: 1016589
Sex: U
Age:
State:

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered a Moderna COVID-19 vaccine to a 16 year old; A spontaneous report was received from a healthcare facility staff member concerning a 16-years-old patient who received Moderna's COVID-19 Vaccine and experienced Moderna's COVID-19 vaccine was administered to a 16-year-old. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 31 Dec 2020, the patient received their planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection at the age of 16-years-old. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event, Moderna's COVID-19 vaccine was administered to a 16-years-old, was resolved.; Reporter's Comments: This case concerns a 16 year old patient who received their planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection. There were no reported adverse events in this case of product administered to patient of inappropriate age

Other Meds:

Current Illness:

ID: 1016590
Sex: F
Age: 77
State: FL

Vax Date: 01/26/2021
Onset Date: 01/27/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Rectal bleeding/ Bleeding from the rectum; A spontaneous report was received from a consumer concerning a 67-years-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced rectal bleeding. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Xarelto, Sotalol, Synthroid, Vitamin D, Calcium Vitamin b12, Clonazepam, Hydrocodone and Metamucil. On 26 Jan 2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 032L20R) intramuscularly in the left upper arm for prophylaxis of COVID-19 infection. On 27 Jan 2021, the patient experienced rectal bleeding. The subject informed that she got the vaccine for the first time on 26 Jan 2021 and did not tell them that she takes Xarelto. Later she experienced bleeding from her rectum while taking a bowel movement. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event rectal bleeding was not reported.; Reporter's Comments: This case concerns a 67year old female patient with medication history within two weeks prior to the event, included Xarelto, Sotalol, Synthroid, Clonazepam, Hydrocodone and Metamucil. who experienced a serious unexpected event of Rectal haemorrhage. The event occurred approximately one day after first dose of the study medication administration. Based on medication the patient is taking, Xarelto which is blood thinner, the event is assessed as unlikely related to mRNA-1273.

Other Meds: XARELTO; SOTALOL; SYNTHROID; VITAMIN D NOS; CLONAZEPAM; HYDROCODONE; METAMUCIL CITRON

Current Illness:

ID: 1016591
Sex: F
Age:
State: NM

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

Lab Data:

Allergies:

Symptoms: Vaccine that had dark grey particulate matter present had been administered to the patient.; Vaccine that had dark grey particulate matter present had been administered to the patient; A spontaneous report was received from a healthcare professional concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) where a dark grey particulate presented inside the vial, but a dose had already been administered to the patient. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unknown date, the patient received her first of two planned doses of mRNA-1273 (Lot number: 010M20A) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, patient received the vaccine which already contained dark grey particulate matter inside the vial. Treatment information was not provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the event, a dose had already been administered to the patient and a dark grey particulate presented inside the vial, was resolved.; Reporter's Comments: This report refers to a case of Product contamination physical and poor quality product administered for mRNA-1273, lot # 010M20A. There were no reported AEs associated with this case of Product contamination physical and poor quality product administered .

Other Meds:

Current Illness:

ID: 1016592
Sex: M
Age: 91
State: IL

Vax Date: 12/30/2020
Onset Date: 01/26/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data: Test Date: 20210128; Test Name: 100.0 temp; Test Result: 100.0 {DF}

Allergies:

Symptoms: Inflamed area noted to left arm that is warm to touch, tender, and lumpy; Inflamed area noted to left arm that is warm to touch, tender, and lumpy; Inflamed area noted to left arm that is warm to touch, tender, and lumpy; Inflamed area noted to left arm that is warm to touch, tender, and lumpy; 100.0 temp; Possible cellulitis; It appears that the injection was given too low that muscle may have been missed; May not have received the full dose of the Moderna vaccine; A spontaneous report was received from a nurse, concerning a 91-year-old male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced inflamed area noted to left arm that is warm to touch, tender, and lumpy, 100.0 temp, may not have received the full dose of the Moderna vaccine, it appears that the injection was given too low that muscle may have been missed, and possible cellulitis. The patient's medical history was not provided. Concomitant medications were not reported. On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Batch number: 039K208) intramuscularly in the left arm for the prophylaxis of COVID-19 infection. On 26 Jan 2021, at the time of the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly in the left deltoid for the prophylaxis of COVID-19 infection. On 26 Jan 2021, the patient may not have received the full dose of the Moderna vaccine as it appeared that the injection was given too low that muscle may have been missed. On 28 Jan 2021, the patient experienced an inflamed area to the left arm, that was warm to touch, tender, and lumpy. The patient also had fever of 100.0 Fahrenheit (F). He was being evaluated for concerns of possible cellulitis Treatment for the events included paracetamol and diphenhydramine. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome of events, inflamed area noted to left arm that is warm to touch, tender, and lumpy, 100.0 temp, may not have received the full dose of the Moderna vaccine, and possible cellulitis, were considered unknown. The events, it appears that the injection was given too low that muscle may have been missed and may not have received the full dose of the Moderna vaccine, were considered resolved on 26 Jan 2021.; Reporter's Comments: This case concerns a 91-year-old, White, male, who experienced a Product administration error, Incorrect dose administered, and non-serious unexpected event of injection site cellulitis, injection site warmth, and non-serious expected events of injection site swelling, injection site pain, and pyrexia. There were no reported AEs associated with this case of a Product administration error and incorrect dose administered. The events occurred 2 days after mRNA-1273 (Lot# 039k208). Treatment included Tylenol and Benadryl. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1016593
Sex: F
Age: 72
State: MA

Vax Date: 01/18/2021
Onset Date: 01/18/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: received another 50% more vaccine; A spontaneous report was received from a nurse concerning a 72-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt vaccine rolling down her arm. The nurse told her that in that case, their protocol was to administer another 50% dose which she received. The patient's medical history was not provided. Concomitant medications was not provided by the reporter. On 18 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number:010M20A) intramuscularly for prophylaxis of COVID-19 infection. On18 JAN 2021, patient received her first injection of Moderna vaccine and she felt the vaccine rolling down her arm. The nurse told her that in that case, their protocol was to administer another 50% dose which she received. Action taken with mRNA-1273 in response to the events was not reported. The event, vaccine rolling down her arm and received another 50%more vaccine was considered recovered/resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273. There were no reported adverse events associated with this case.

Other Meds:

Current Illness:

ID: 1016594
Sex: F
Age: 31
State: TX

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

Lab Data:

Allergies:

Symptoms: Got shocked as when she pull out the shot/injection, she wiped her arm; A spontaneous report was received from a consumer, a 31-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and "got shocked as when she pull out the shot/injection, she wiped her arm." The patient's medical history was not provided. No concomitant medications were reported. On an unknown date, the patient received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 01 Feb 2021, the patient received her second of two planned doses of mRNA-1273 (Lot number: 012M20A) intramuscularly in the arm for prophylaxis of COVID-19 infection. On 01 Feb 2021, during administration of the vaccine, the patient "got shocked as when she pull out the shot/injection, she wiped her arm". The patient was concerned whether she had received the complete dose or not. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore the action taken in response to the event was not applicable. The event, "got shocked as when she pull out the shot/injection, she wiped her arm," was considered resolved on 01 Feb 2021.; Reporter's Comments: This report refers to a case of Accidental underdose for mRNA-1273, lot # 012M20A. There were no reported AEs associated with this case of Accidental underdose.

Other Meds:

Current Illness:

ID: 1016595
Sex: M
Age: 91
State: IL

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: heat on the arm, which is warm to the touch; redness on arm; second dose administered subcutaneously; A spontaneous report was received from a health care professional (HCP) concerning a 91-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the second dose administered subcutaneously, redness on arm, and heat on the arm. The patient's medical history was not provided. Concomitant medications reported included Senna, Zoloft, Risperdal, Aspirin, Aricept, finasteride, Lasix and multivitamins. on 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K208) . On 26 Jan 2021, approximately 28 days after the first dose, the patient received the second of two planned doses of mRNA-1273 (Lot number: 012M20A) subcutaneously for prophylaxis of COVID-19 infection. The HCP stated that the patient's second dose was inadvertently administered subcutaneously. The patient experienced redness and heat on the arm, which was warm to the touch. Treatments of these events included Benadryl and Tylenol. The event, second dose administered subcutaneously was resolved. The events, redness on arm, and head on the arm were not resolved.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 and concerns a 91 year-old, male patient, who experienced the events of redness on arm, and heat on the arm. The events occurred the same day after the first and only dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.

Other Meds: SENNA LAXATIVE; ZOLOFT; RISPERDAL; ASPIRIN (E.C.); ARICEPT; FINASTERIDE; LASIX M; MULTIVITAMIN & MINERAL

Current Illness:

ID: 1016596
Sex: F
Age: 17
State: MN

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 17 year old female received Moderna vaccine; A spontaneous report was received from a nurse concerning a 17-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273). The patient's medical history was not provided. No relevant concomitant medications were reported. On 07Jan2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: 037K20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection. The patient was administered mRNA-1273 vaccine at age 17 on 07Jan2021 . No treatment information was provided. Action taken with the first dose of mRNA-1273 in response to the event was not reported. The event, a 17 year-old female patient received Moderna vaccine, was considered resolved.; Reporter's Comments: This case concerns a 17-year old female who received her first of two planned doses of mRNA-1273 (Lot number: 037K20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection. There were no reported adverse events associated with this event of product administered to patient of inappropriate age.

Other Meds:

Current Illness:

ID: 1016597
Sex: F
Age: 82
State: GA

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: expired vaccine was administered; A spontaneous report was received from a healthcare facility staff member concerning an 82-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered expired vaccine. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 29 Jan 2021, the patient received planned dose of mRNA-1273 (Lot umber: 025L20A) (it was not reported if this was dose 1 or dose 2) intramuscularly at unspecified site for prophylaxis of COVID-19 infection. On 28 Jan 2021, the vaccine vial was punctured and was set to expire at 15:30. On 29-Jan-2021, the physician accidently administered the expired vaccine to the patient. The vial was discarded after the mistake was realized. Action taken with mRNA-1273 in response to the event was not reported. The event expired vaccine was administered, was considered recovered / resolved on 29-Jan-2021.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273. There were no reported adverse events associated with this case.

Other Meds:

Current Illness:

ID: 1016598
Sex: M
Age: 29
State: NC

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vasovagal syncope; I suffered incontinence; Blood pressure dropped; A spontaneous report was received from a 29-year-old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced vasovagal syncope, blood pressure dropped, and incontinence. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included multivitamin and fish oil. On 27 Jan 2021, 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. Approximately five minutes after receiving the vaccine, the patient experienced vasovagal syncope. The patient reported his blood pressure dropped too much and he passed out for about ten seconds. He also suffered incontinence. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. On 27 Jan 2021, the outcome of the events, experienced vasovagal syncope, blood pressure dropped, and incontinence, were considered resolved.; Reporter's Comments: This case concerns 29-year-old male patient, who experienced non serious unexpected events of blood pressure decreased with vasovagal syncope and incontinence. The events occurred 5 minutes after the first dose of mRNA-1273 vaccine. No treatment was reported, and outcome of reported events was reported as resolved. All events were assessed as related to mRNA-1273 vaccine due to temporal association.

Other Meds: MULTIVITAMINS [VITAMINS NOS]; FISH OIL

Current Illness:

ID: 1016599
Sex: M
Age: 77
State:

Vax Date: 01/21/2021
Onset Date: 01/23/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Hearing loss in left ear; A spontaneous report was received from a 77-year-old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hearing loss in the left ear. The patient's medical history was not provided. No relevant concomitant medications were reported. On 21 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. On 23 Jan 2021, the patient started to experience hearing loss in the left ear. Tinny sound in left ear. Treatment for the events was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome for the event, hearing loss in the left ear, was unknown.; Reporter's Comments: This case concerns a 77 year-old, male patient, who experienced event of hearing loss in the left 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 events, a causal relationship cannot be excluded and the events are assessed as possibly related.

Other Meds:

Current Illness:

ID: 1016600
Sex: U
Age:
State: CA

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

Lab Data:

Allergies:

Symptoms: found a piece of particulate matter in one of the moderna vaccine; A spontaneous report was received from a pharmacist concerning a patient of unknown age and gender who received Moderna's COVID-19 vaccine and it was noted "a piece of particulate in one of the Moderna vaccines (poor quality vaccine administered). There were no medical history and concomitant medications reported. On 01-Feb-2021, the patient received a dose of mRNA-1273 (Batch number 042L20A) (injection site not provided) for prophylaxis of COVID-19 infection. It was not specified if it was their first or second dose. On 01-Feb-2021, the pharmacist reported their clinic found a piece of particulate matter (poor quality vaccine administered) in one of the Moderna vaccine vials. At the time of finding the particulate matter, they had administered vaccine doses to 6 patients. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The event, a piece of particulate was found in one of the Moderna vaccines (poor quality vaccine administered) was considered resolved.; Reporter's Comments: This case concerns a patient of unknown age and gender who received a dose of mRNA-1273 (Batch number 042L20A) (injection site not provided) for prophylaxis of COVID-19 infection and the clinic found a piece of particulate matter (poor quality vaccine administered) in one of the Moderna vaccine vials. It was not specified if it was their first or second dose. There were no reported adverse events in this case of poor quality vaccine administered.

Other Meds:

Current Illness:

ID: 1016601
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Patient did not receive the full amount in the syringe; A spontaneous report was received from a healthcare professional concerning a female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced the event, did not receive the full amount of dose in the syringe. The patient's medical history was not provided by the reporter. Concomitant medications were not reported. On an unspecified date, one day prior to the onset of event, the patient received their first two planned doses of mRNA-1273 (Batch number: unknown) for the prophylaxis of COVID-19 infection. The patient did not receive the full amount of dose in the syringe. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event, did not receive the full amount of dose in the syringe, was considered resolved on unspecified date.; Reporter's Comments: This case concerns a female patient of unknown age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect dose administered.

Other Meds:

Current Illness:

ID: 1016602
Sex: F
Age:
State: NC

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

Lab Data:

Allergies:

Symptoms: not all vaccine went in her arm, she states some gurgled out; A spontaneous report was received from a female patient, unknown age, who received Moderna's COVID-19 Vaccine (mRNA-1273) and not all vaccine went in her arm, she stated some gurgled out. There were no medical history or concomitant medications reported. On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient reported that, not all the vaccine went into her arm, and some of the vaccine gurgled out of arm when getting the vaccine. No treatment information was provided. Action taken with second dose of mRNA-1273 in response to the event was not reported. The outcome of the event, "not all vaccine went in her arm, she states some gurgled out" was considered resolved on 28 Jan 2021.; Reporter's Comments: This report refers to the product administration error for mRNA-1273 (Lot number: Unknown). This case concerns a female patient of unknown age, who experienced incomplete dose administration. There were no reported AEs associated with this case of incomplete dose administered.

Other Meds:

Current Illness:

ID: 1016603
Sex: U
Age:
State: PA

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

Lab Data:

Allergies:

Symptoms: There was a Moderna vaccine given to a 17 year old; A spontaneous report was received from a healthcare professional concerning a 17-years old, unknown gender patient of unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, "COVID-19 vaccine given to a 17-year-old patient". The patient's medical history was not provided. No concomitant medications were reported. On an unknown date, prior to the onset of event, the patient received their first dose of mRNA-1273 (Lot number: unknown), for prophylaxis of COVID-19 infection. It was reported that, the healthcare professional while working at a clinic last week , after doing research, she found that there was a mix up. There was a Moderna vaccine given to a 17-year-old patient on an unknown date. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event "Moderna vaccine given to a 17 year old", was considered resolved on an unknown date.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of product administered to patient of inappropriate age.

Other Meds:

Current Illness:

ID: 1016604
Sex: F
Age: 75
State: CA

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Intense itching on both arms; Both injection sites were slightly enlarged; Both injection sites were red; Both arms had become swollen; Aches and pains; Flu-like symptoms; Lost two pounds due to the nausea; Nausea; Pain in both arms; Chills; Received a half dose of the Moderna COVID19 Vaccine in both arms 30 minutes apart; A spontaneous report was received from a consumer, a 75-year-old female patient, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced received a half dose of the Moderna COVID19 Vaccine in both arms 30 minutes apart, flu-like symptoms, nausea, chills, aches and pains, pain in both arms, lost two pounds due to the nausea, both arms had become swollen, intense itching on both arms, both injection sites were red, and both injection sites were slightly enlarged. The patient's medical history included low weight and family history of vaccine problems. Concomitant product use was not provided by the reporter. On 21 Jan 2021, a day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in both arms for prophylaxis of COVID-19 infection. The patient reported that she received a half dose of the vaccine in both arms 30 minutes apart in her immunologist's office. The patient noted that she had received pediatric doses in other instances due to her low weight. On 22 Jan 2021, the patient experienced flu-like symptoms including nausea, chills, aches and pains, and pain in both arms on. The patient reported that she lost two pounds due to the nausea. On 23-JAN-2021, the patient was feeling substantially better. On 25 Jan 2021, the patient noticed that both her arms had become swollen. On 30 Jan 2021, the patient began experiencing intense itchiness on both arms and both injection sites were red and slightly enlarged. Treatment information was not provided. The Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the event, received a half dose of the Moderna COVID19 Vaccine in both arms 30 minutes apart, was considered resolved on 21 Jan 2021. The outcome of the events, flu-like symptoms, nausea, chills, aches and pains, and pain in both arms, were considered resolving. The outcome of the events, lost two pounds due to nausea, both arms had become swollen, intense itchiness on both arms, both injection sites were red, and both injection sites were slightly enlarged, were unknown.; Reporter's Comments: This spontaneous report concerns a 75-year-old female patient, with family history of vaccine problems (unspecified)who w experienced received a half dose of the Moderna COVID19 Vaccine in both arms 30 minutes apart, flu-like symptoms, nausea, chills, aches and pains, pain in both arms, lost two pounds due to the nausea, both arms had become swollen, intense itching on both arms, both injection sites were red, and both injection sites were slightly enlarged. The events of flu-like symptoms nausea, chills, aches and pains, and pain in both arms, lost two pounds due to the nausea occurred 1 day after the administration of mRNA-1273 vaccine (Lot #: unknown, expiration date: unknown) and arms had become swollen occurred 3 days after vaccine administration. The events of itchiness on both arms and both injection sites were red and slightly enlarged occurred 4 days after mRNA-1273 vaccine. Treatment provided was not reported and lost two pounds due to nausea, swollen and intense itchiness on arms, injection sites were red and slightly enlarged, were unknown. Flu-like symptoms, nausea, chills, aches and pains, and pain in both arms, were considered resolving. Based on the information provided which shows a temporal association a causal association, between the reported events and the administration of mRNA-1273 vaccine cannot be excluded. The events of received a half dose of the Moderna COVID19 Vaccine in both arms 30 minutes apart (Product administration error) is not applicable.

Other Meds:

Current Illness: Low weight

Date Died:

ID: 1016605
Sex: M
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Sepsis; A spontaneous report was received from a consumer post , concerning an approximately 55-year-old, male physician who received Moderna's COVID-19 vaccine (mRNA-1273) and developed sepsis, resulting in death. There was no medical history provided. There were no concomitant medications provided. On an unknown date (Thursday), the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. According to the post, two days after vaccine administration, the patient died of sepsis on Saturday. Action taken with mRNA-1273 in response to the event was not applicable. The event, sepsis, was considered fatal. The patient's date of death was not provided. The cause of death was reported as sepsis.; Reporter's Comments: This case concerns a 55-year-old, male subject, who experienced a serious unexpected event of Sepsis. Sepsis occurred after first dose of mRNA-1273 vaccine administration. On an unknown date, two days after vaccine administration, the patient died of sepsis. Treatment for the event was not provided. The patient's medical history was not provided. The patient is a physician. Concomitant product use was not reported. Very limited information regarding this event has been provided at this time and no definite diagnosis or autopsy report have been provided. Based on the current available information and temporal association between the use of the product and the start date of the event of Sepsis, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Sepsis

Other Meds:

Current Illness:

ID: 1016606
Sex: F
Age:
State: VA

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Rash; Vaccine first dose administered subcutaneously; A spontaneous report was received from a consumer, 34 years-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced rash and "vaccine first dose administered subcutaneously". The patient's medical history was not provided. No concomitant medications were reported. On 07 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (batch number: 026L20A), subcutaneously in the left arm for the prophylaxis of COVID-19 infection. On 07 Jan 2021, the patient received her first dose which pulled up the fat on the back of her left arm and administered the vaccine subcutaneously. On 14 Jan 2021, one week after the first dose, the patient experienced rash and went away on an unknown date in 2021. On 04 Feb 2021, the patient received the second planned dose of mRNA-1273 (batch number: 030L20A), intramuscularly for the prophylaxis of COVID-19 infection. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event rash was resolved on an unknown date in 2021 and "vaccine first dose administered subcutaneously", was considered as resolved on 07 Jan 2021.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 and concerns a 34 year-old, female patient, who experienced the event of rash. The event occurred 1 week after the first dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded and the event is assessed as possibly related.

Other Meds:

Current Illness:

ID: 1016607
Sex: U
Age:
State:

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Felt a couple or few drops running down arm/entire dose wasn't administered; A spontaneous report was received from a consumer, unknown patient of an unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273) which resulted in few drops running down arm and entire dose wasn't administered to patient. The patient's medical history was not provided. No concomitant medications were reported. On 16 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown), for prophylaxis of COVID-19 infection. On 16 Jan 2021, the patient felt a couple or few drops running down bared arm and entire dose wasn't administered. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event "few drops running down arm and entire dose wasn't administered to patient" was considered as resolved on 16 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown age and gender who received their first of two planned doses of mRNA-1273 (batch number: unknown), for prophylaxis of COVID-19 infection which resulted in few drops running down arm and entire dose wasn't administered to patient. There were no reported adverse events after the vaccine was administered in this case of incorrect dose administered and exposure via skin contact.

Other Meds:

Current Illness:

ID: 1016608
Sex: F
Age:
State: PA

Vax Date: 01/13/2021
Onset Date: 01/16/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: sudden onset lower lip angioedema- only on the right side of my lip; This is a spontaneous report from a contactable Other HCP. This other HCP reported different events for the same patient during diffferient vaccination dose. This case is referred to the second vaccine dose A 30-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EL3247 intramuscular on 13Jan2021 12:30 second dose at SINGLE DOSE for covid-19 immunisation. Facility type vaccine: Hospital . Vaccine location: right arm Medical history included asthma, eczema, hypersensitivity, anxiety and depression. Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL FE 1/20), bupropion hydrochloride (WELLBUTRIN XL), fluoxetine hydrochloride (PROZAC), rizatriptan (RIZATRIPTAN), salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), levocetirizine dihydrochloride (XYZAL), betamethasone (BETAMETHASONE). The patient previously took aspirin and experienced rash. The patient experienced flushing, palpitations and hyperhidrosis after the first dose of bnt162b2 vaccine. The patient experienced sudden onset lower lip angioedema- only on the right side of my lip on 16Jan2021 20:30 with outcome of recovered. The action taken was not applicable. Therapeutic measures were taken: benadryl inhaler self treated, consultation w/allergist and allergy testing. The reporter stated "developed sudden onset lower lip angioedema only on the right side of my lip. I took 50mg benadryl and my inhaler and monitored- I never developed itching, additional swelling, difficulty breathing or other symptoms of anaphylaxis. Swelling had resolved by morning. I had no other new exposures that have yet been identified, although I am going through a work up with an allergist."; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021073355 Same patient/ drug, different dose/AE.

Other Meds: JUNEL FE 1/20; WELLBUTRIN XL; PROZAC; RIZATRIPTAN; ALBUTEROL [SALBUTAMOL SULFATE]; FLONASE [FLUTICASONE PROPIONATE]; XYZAL; BETAMETHASONE

Current Illness:

ID: 1016609
Sex: F
Age:
State: OR

Vax Date: 01/16/2021
Onset Date: 01/17/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Profuse nose bleed/ I woke up with another profuse nose bleed. Bled very heavily for 1/2 hour; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that the 75-year-old female patient who received first dose of bnt162b2 (Covid-19, Lot#: EL3247), via an unspecified route of administration on 16Jan2021 at 05:30 PM on Right arm at single dose for covid-19 immunisation. She is not pregnant. Facility type vaccine was other. No other vaccine in four weeks. Medical history included Known allergies and pacemaker, a-fib, pulmonary embolism. Concomitant medications included apixaban (ELIQUIS), fexofenadine hydrochloride (ALLEGRA), simvastatin and escitalopram. The following day she had a profuse nose bleed. Ended up at Urgent Care. They were able to stop it after 15 min. An ENT Dr cauterized one of her nostrils. On Sunday, 24Jan, at 3:00 am, she woke up with another profuse nose bleed. Bled very heavily for 1/2 hour. Drs. are trying to find reason for this profuse bleeding. Unknown yet. The event started from 17Jan2021 02:00 PM. AE resulted in: [Emergency room/department or urgent care]. The outcome of the event was not recovered. Treatment was received included Dr.'s visit. Nose bleeding stopper. Saline drops. No covid prior vaccination. No covid tested post vaccination.

Other Meds: ELIQUIS; ALLEGRA; SIMVASTATIN; ESCITALOPRAM

Current Illness:

ID: 1016610
Sex: F
Age:
State: AL

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Syncope; passed out; This is a spontaneous report from a contactable pharmacist reported that a 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), intramuscular on the left arm on 25Jan2021 15:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received flu vaccine on an unspecified date for immunization and experienced fever. On 25Jan2021, the patient was experienced syncope and passed out. She woke up within the next couple of minutes and was monitored. The patient eaten food. The outcome of the events was unknown.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events, syncope and passed out, and the administration of COVID-19 vaccine, BNT162B2, based on the reasonable temporal association, and lacking alternative explanations. 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 RA, IEC, as appropriate.

Other Meds:

Current Illness:

ID: 1016611
Sex: M
Age:
State: AL

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 02/09/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: hives; anxious; This is a spontaneous report from a contactable other healthcare professional. A 61-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at the right leg on 25Jan2021 (lot number EN5318 and expiry date unknown) at single dose for Covid-19 immunization in a nursing home/senior living facility. Medical history included COVID prior vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. On 25Jan2021, the patient experienced hives and was anxious, the patient was taken to the hospital. The events resulted in emergency room/department or urgent care. The events caused hospitalization on 25Jan2021. The outcome of the events hives and anxious was unknown.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the urticaria and anxiety. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1016612
Sex: F
Age:
State: AL

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: trouble breathing; Patient experienced itching on legs arms and face along with hives; Patient experienced itching on legs arms and face along with hives; Headache getting severe by the minute; This is a spontaneous report from a contactable pharmacist. A 29-year-old female patient received 2nd dose of bnt162b2 (BNT162B2; lot number EN5318) on 25Jan2021 intramuscular at right arm for COVID-19 immunization. Medical history was not reported. The patient had no COVID prior to vaccination. Historical vaccine include BNT162B2 for COVID-19 immunization. The patient had no other vaccine in weeks, concomitant drugs was none. The patient experienced headache getting severe by the minute. Patient experienced itching on legs arms and face along with hives and trouble breathing. Event start date was 25Jan2021. One epinephrine was received. Patient was taken to the hospital. The events resulted in Emergency room/department or urgent care. The outcome of the events was unknown.; Sender's Comments: Based on the compatible time association and drug's safety profile, the events headache, dyspnea, urticaria and pruritus are possibly related to suspect vaccine BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1016613
Sex: F
Age:
State: NJ

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data: Test Name: blood work; Result Unstructured Data: Test Result:perfectly fine; Test Date: 20210125; Test Name: Heart rate; Result Unstructured Data: Test Result:jumped to over 150

Allergies:

Symptoms: hard time catching her breath; throat felt a little tight; her throat felt a little tight, and she found it hard to swallow; little nervous; very lightheaded; her husband told her she looked very pale; her heart rate jumped to over 150, according to her (company name) watch; she had pins and needles up and down her entire left arm; her left arm initially felt almost totally numb from her shoulder to her finger tips, and then she felt pins and needles down the entire length of her arm.; maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of bnt162b2 (Lot Number: EK4176), via an unspecified route of administration in left arm on 25Jan2021 12:50 at single dose for covid-19 immunization. Medical history included coeliac disease from Mar2013 and ongoing. There were no concomitant medications. She said initially she was OK after she received the COVID-19 Vaccine. She said after about 5 minutes in from receiving the COVID-19 Vaccine, she had a hard time catching her breath, and her throat felt a little tight, and she found it hard to swallow. She said she thought she was nuts at first, and was a little nervous for a minute. She said the staff at the vaccination center made people wait 15 minutes after receiving the COVID-19 Vaccine before being allowed to leave. She said she actually spoke to the vaccination center staff while she was waiting for the 15 minutes to go by. She said she didn't say anything to the staff because she thought she might be crazy. She said she scheduled her second COVID-19 Vaccine dose, and after the 15 minutes went by, she left. She said her husband had drove her to and from the COVID-19 Vaccine facility location. She said 5 minutes into her car trip after leaving the facility, she became very lightheaded. She said her throat began to feel tight again (saying the throat tightness was worse than what she first experienced at the convention center), and she kept trying to clear her throat. She said her husband told her she looked very pale. She said her heart rate jumped to over 150, according to her Apple watch. She said she had pins and needles up and down her entire left arm. She clarified her left arm initially felt almost completely numb from her shoulder to her finger tips. She said she thought that maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm. She clarified the numbness improved in her left arm, but she still has a pins and needle sensation down the length of her left arm. Patient asked if it is OK for her to received the second COVID-19 Vaccine based on what she experienced after the first COVID-19 Vaccine dose. Reported if she would have been driving the car after she received her first COVID-19 Vaccine dose, she would have had to pull over on the side of the road because of the side effects she was experiencing. Reported the side effects she experienced in the car after leaving the vaccination facility, resolved after a couple minutes, with the exception of the pins and needles and numbness in her left arm. She said the pins and needles, and numbness in her left arm improved, but was still present. Reported she had a well visit not too long ago, and her blood work was perfectly fine. The outcome of the events Peripheral nerve injury, Pins and needles, Numbness of upper extremities was recovering, other events was recovered on 25Jan2021.

Other Meds:

Current Illness: Celiac disease

ID: 1016614
Sex: F
Age:
State: AL

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 02/09/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: headache with hives; headache with hives; This is a spontaneous report from a contactable pharmacist. A 46-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at the right arm on 25Jan2021 (lot number EN5318 and expiry date unknown) at single dose for Covid-19 immunization in a nursing home. Medical history included latex allergy, mushrooms allergy. The patient has no covid prior vaccination. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 first dose at the right arm on unspecified date for Covid-19 immunization. The patient had no other vaccine in four weeks. On 25Jan2021, the patient experienced headache with hives and was taken to the hospital. The events resulted in emergency room/department or urgent care. The events caused hospitalization on 25Jan2021. The outcome of the events headache with hives was unknown.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of headache with hives cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1016615
Sex: F
Age:
State: OH

Vax Date: 01/21/2021
Onset Date: 01/24/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: UTI; This is a spontaneous report from a contactable consumer (patient). A 87-year-old female patient received the first dose of bnt162b2 (Lot number: EL3249), via an unspecified route of administration in left arm on 21Jan2021 09:00 at single dose for covid-19 immunization. Medical history included hypertension (HTN), atrial fibrillation, Allergies to Sulfa. Concomitant medication included diltiazem, apixaban (ELIQUIS), metoprolol, budesonide, formoterol fumarate (SYMBICORT). The patient experienced urinary tract infection (UTI) on 24Jan2021 14:00. The patient received the Antibiotics as treatment. The event resulted in Doctor or other healthcare professional office/clinic visit. The patient was no pregnant. The outcome of event was recovered on Jan 2021.

Other Meds: DILTIAZEM; ELIQUIS; METOPROLOL; SYMBICORT

Current Illness:

ID: 1016616
Sex: F
Age:
State: GA

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

Lab Data: Test Date: 20201228; Test Name: liver enzymes(ALT, AST); Result Unstructured Data: Test Result:elevated; Test Date: 20201228; Test Name: liver enzymes(ALT, AST); Result Unstructured Data: Test Result:elevated; Test Date: 20201228; Test Name: bilirubin; Result Unstructured Data: Test Result:Elevated; Test Date: 20201228; Test Name: blood pressure; Result Unstructured Data: Test Result:dropped to 70/40

Allergies:

Symptoms: syncopal episodes; Vomited 40+ times; blood pressure dropped to 70/40; Elevated bilirubin; elevated liver enzymes (ALT, AST); elevated liver enzymes (ALT, AST); This is a spontaneous report from a contactable other health professional (patient herself). A 25-year-old female patient (non-pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0142), via an unspecified route of administration on 28Dec2020 12:30 in right arm at single dose for covid-19 immunization. The patient had COVID prior vaccination. Concomitant medication in two weeks included levothyroxine sodium (SYNTHROID), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient experienced vomited 40+ times, syncopal episodes, blood pressure dropped to 70/40, elevated bilirubin, elevated liver enzymes (ALT (alanine aminotransferase), AST (aspartate aminotransferase)) on 28Dec2020 19:30. Events resulted in emergency room/department or urgent care. IV fluids were received for events. The patient was not tested COVID post vaccination. Outcome of elevated bilirubin was recovered on an unspecified date, and outcome of other events were recovering.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported syncope cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: SYNTHROID; ADDERALL

Current Illness:

ID: 1016617
Sex: M
Age:
State: NY

Vax Date: 01/22/2021
Onset Date: 01/01/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data: Test Date: 20210125; Test Name: Weight; Result Unstructured Data: Test Result:lost about 4 pounds

Allergies:

Symptoms: He almost passed out a couple times; Fever; weak; Awful shakes; Sweating; Chills; Stomach like on fire; Diarrhea; He lost about 4 pounds; has autoimmune disease, lupus; has autoimmune disease, lupus; he thinks he was almost dehydrated; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration at right arm, on 22Jan2021 14:30, at SINGLE DOSE for COVID-19 immunization. Medical history included autoimmune disease, systemic lupus erythematosus diagnosed in 2018 (over 3 years ago). Concomitant medication included baricitinib taken in a clinical trial, a study, unknown if 2 or 4mg plus placebo for lupus. On 25Jan2021, at 14:30 in the afternoon, the patient was sweating and it was awful shakes and chills, and it lasted over three hours, and on 26Jan2021 he was weak. The patient lost about 4 pounds on 25Jan2021, with all the water running out of of him. The sweating and shakes happened so suddenly and stomach felt like it was on fire on 25Jan2021. The stomach feeling like it is on fire has gone away, he almost passed out a couple times on an unspecified date, he had diarrhea on 25Jan2021, it was unbelievable. The sweats with awful shakes has gone away on 25Jan2021, but it was horrible, he has recovered with a lasting effect, he is a little weak, but he can move he had to take his dog to the beautician. Diarrhea: the is not eating (had no breakfast this morning) however it was also reported that the patient had a little slice of roast beef and blackberries not many, and he has been drinking, he thinks he was almost dehydrated in Jan2021, he drank about a quart of water so far today. On an unspecified date, the patient had fever. His doctor called the day before and said it was alright; his rheumatologist said it was ok. Outcome of the events he almost passed out a couple times, fever, chills, weak, Diarrhea, He lost about 4 pounds, he thinks he was almost dehydrated was unknown; the events sweating, awful shakes recovered on 25Jan2021 with sequalae, while Stomach like on fire recovered in 2021. Information on the lot/batch number has been requested.

Other Meds: BARICITINIB

Current Illness:

ID: 1016618
Sex: F
Age:
State: FL

Vax Date: 01/25/2021
Onset Date: 01/26/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Cellulitis in the arm; Fever; strong muscle pain; chills; headache; muscle weakness; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL1283), intramuscularly on 25Jan2021 at 10:00 AM in Left arm at single dose for COVID-19 immunization. The patient medical history included Hypothyroidism and COVID prior vaccination. No known allergies, no allergies to medications, food, or other products. The patient's concomitant medications reported as no. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Ek4176), on 07Jan2021 in Left Arm at single dose for COVID-19 immunization at age of 47-year-old. The patient experienced fever, strong muscle pain, chills, headache and muscle weakness on 26Jan2021 at 03:00 AM; Cellulitis in the arm on 27Jan2021 at 08:00 AM. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events fever, strong muscle pain, chills, headache and muscle weakness included Acetaminophen, ibuprofen; no treatment was received for the event Cellulitis in the arm. The outcome of the events was not recovered. The report was reported as non-serious for event "Cellulitis in the arm", with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1016619
Sex: F
Age:
State: VA

Vax Date: 01/23/2021
Onset Date: 01/24/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Atrial fibrillation; pleurisy (flank pain, diagnosed as pleurisy at the ER); pleurisy (flank pain, diagnosed as pleurisy at the ER); This is a spontaneous report from a contactable consumer. An 86-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: E13248, expiry date: unknown), via an unspecified route of administration on 23Jan2021 07:00 at single dose (Left arm) for COVID-19 immunization. Medical history included well managed hyperlipidemia and hypertension, arthritis, meningioma benign, Bell's palsy (onset was 2010) resolved with sequelae. Known allergies include Sulfa, Codeine, and Macrobid. The patient is not pregnant. Concomitant medication included duloxetine hydrochloride (CYMBALTA), losartan, hydrochlorothiazide (HTZ), desmopressin, fenofibrate. Facility type vaccine was reported as Doctor's office/urgent care. The patient experienced atrial fibrillation, pleurisy (flank pain, diagnosed as pleurisy at the ER) on 24Jan2021 20:00. Events resulted in Emergency room/department or urgent care. Treatment of IV pain medication (unk) was given. Patient had no covid prior vaccination, covid was not tested post vaccination. The outcome of the events was not recovered. Therapeutic measures were taken as a result of the events.

Other Meds: CYMBALTA; LOSARTAN; HTZ; DESMOPRESSIN; FENOFIBRATE

Current Illness:

ID: 1016620
Sex: F
Age:
State: AZ

Vax Date: 01/16/2021
Onset Date: 01/19/2021
Rec V Date: 02/09/2021
Hospital: Y

Lab Data: Test Name: mon screen negative; Test Result: Negative ; Test Name: covid test; Test Result: Negative ; Test Name: strep throat; Test Result: Negative ; Test Name: viral panel; Test Result: Negative

Allergies:

Symptoms: Started showing symtpoms of odynophagia (pain in swallowing) on 19Jan2021; Had ulcerative pharyngitis; clean based yellow ulcers on tonsillar beds bilaterally; This is a spontaneous report from a non-contactable consumer. A 31-year-old female patient 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 16Jan2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient started showing symptoms of odynophagia (pain in swallowing) on 19Jan2021. The patient also experienced ulcerative pharyngitis, clean based yellow ulcers on tonsillar beds bilaterally. No purulent discharge, no lymphadenopathy, no angioedema, mon screen negative, COVID screen negative, strep throat negative, viral panel negative on an unspecified date. The patient was hospitalized for 2 days due to the events. The patient received treatment for the events. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1016621
Sex: F
Age:
State: TX

Vax Date: 01/16/2021
Onset Date: 01/01/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: All my stroke symptoms returned immediately; numbness on left side of face, left hand, left foot, left chin; Weakness; pain; all her stroke symptoms returned immediately. Numbness on left side of face, left hand, left foot, left chin. Weakness and pain; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: PF EL3249), via an unspecified route of administration in arm left, on 16Jan2021 12:00 PM at single dose for COVID-19 immunisation. Medical history included massive stroke in Jul2018, left side effected; numbness on left side of face, left hand, left foot, left chin, weakness and pain from stroke 2 years ago; asthma. Patient was allergic to shrimp, lobster. Patient is not pregnant. Patient did not receive other vaccine in four weeks. Patient did not have COVID prior vaccination. Patient did not test COVID post vaccination. Concomitant medications included Losartan, Amlodipine, acetylsalicylic acid (ASPIRIN), Atorvastatin, Montelukast. Patient was previously allergic to codine, tetracycline. On an unspecified in Jan2021 (reported as 15Jan2021, pending clarification), all her stroke symptoms returned immediately. Numbness on left side of face, left hand, left foot, left chin, weakness and pain from stroke 2 years ago returned immediately and had not subsided 2 weeks later. Patient received treatment, physical therapy continued for stroke symptoms. AE resulted in doctor or other healthcare professional office/clinic visit, the reported seriousness criterion is disability. Outcome of the events was not recovered.

Other Meds: LOSARTAN; AMLODIPINE; ASPIRIN [ACETYLSALICYLIC ACID]; ATORVASTATIN; MONTELUKAST

Current Illness:

ID: 1016622
Sex: F
Age:
State: VA

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data: Test Date: 20210115; Test Name: Blood sugar; Result Unstructured Data: Test Result:90; Test Name: BP; Result Unstructured Data: Test Result:116/63; Test Date: 20210115; Test Name: BP; Result Unstructured Data: Test Result:141/93; Test Date: 20210115; Test Name: Body temperature; Result Unstructured Data: Test Result:100 degrees; Test Name: Body weight; Result Unstructured Data: Test Result:120 lbs

Allergies:

Symptoms: faint; feeling off; feel dizzy/light headed; dry mouth; hard to swallow; They took my BP upon arrival and it was 141/93; chills; low grade fever 100 degrees; This is a spontaneous report from a contactable 45-year-old female other health professional reported for herself that she received 1st dose of bnt162b2 (lot number EL8982) on 15Jan2021 08:00 AM at left arm for Covid-19 immunization. Medical history included hereditary angioedema from unknown date (last episode 2015). The patient had not received other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant drug included caffeine, paracetamol (ACETAMINOPHEN AND CAFFEINE). The patient reported that after waiting the 15 minutes, she walked to her car, and started feeling off. She thought about sitting in the hospital parking lot, but started to drive home. She started to feel dizzy, light headed, faint, dry mouth, hard to swallow so she drove herself to the fire station. They took her blood pressure (BP) upon arrival and it was 141/93 and blood sugar was 90 on 15Jan2021. She was 120 pounds and her normal BP was 116/63. The event onset time was reported as 15Jan2021 08:30 AM. Later on 15Jan2021, the patient had chills and low grade fever 100 degrees. Treatment was received for the events. The events were resolved on unknown date. Events were reported non-serious. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event syncope cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: ACETAMINOPHEN AND CAFFEINE

Current Illness:

ID: 1016623
Sex: F
Age:
State:

Vax Date: 01/07/2021
Onset Date: 01/01/2021
Rec V Date: 02/09/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: She has COPD and other health conditions and went to the hospital for a few days after getting the vaccine; This is a spontaneous report from a contactable consumer (reported for her mother-in-law). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the COVID-19 vaccine on 07Jan2021. It was reported that on Jan2021, she has chronic obstructive pulmonary disease (COPD) and other health conditions and went to the hospital for a few days after getting the vaccine. The reporter was where she can get the second dose now, she thinks the date she was supposed to get it has passed. She needed to find out where the second dose can be attained and asked for the number to the local health department for their area. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1016624
Sex: M
Age:
State:

Vax Date: 01/24/2021
Onset Date: 01/26/2021
Rec V Date: 02/09/2021
Hospital:

Lab Data:

Allergies:

Symptoms: he was bleeding profusely; fell; hurt his hand; This is a spontaneous report from a Pfizer-sponsored program. A male patient (caller's husband) of an unspecified age received BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) at single dose on 24Jan2021 for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient got his Covid vaccine on 24Jan2021 and today (26Jan2021) he fell and hurt his hand and he was bleeding profusely. They want to give him a tetanus shot, but caller was not sure if he can get it or not. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1016625
Sex: F
Age:
State: TX

Vax Date: 01/23/2021
Onset Date: 01/01/2021
Rec V Date: 02/09/2021
Hospital: Y

Lab Data: Test Date: 20210126; Test Name: body temperature; Result Unstructured Data: Test Result:fever

Allergies:

Symptoms: appendicitis/abdominal pain/fever; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on 23Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a fever on 26Jan2021. She was having abdominal pain. She went to the emergency room and found out she had appendicitis. On 29Jan2021 (reported as six days after getting vaccine), she had to have emergency surgery and have an appendectomy due to have appendicitis. She mentioned she is following up finding out statistics with CML and appendicitis. She did not regret getting the vaccine, but she wanted to make sure events were reported. Like anything leaded to a hospitalization needed to be noted regardless if it was concluded to be related to the vaccine or excluded from being related. She mentioned she wanted to find out the most accurate up to date information on how many cases of Adverse Event reactions have occurred, related to appendicitis. She wonders if there is a website where she found this information. She did not want to look on internet and find inaccurate information. The outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The reported appendicitis with symptoms of abdominal pain and fever is considered related to the administration of the COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm