VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 0922378
Sex: M
Age: 58
State: OR

Vax Date: 06/14/2020
Onset Date:
Rec V Date: 01/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: shoulder pain; feels like the muscle/tendon coming off; feels like the muscle/tendon coming off; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received in February 2020). Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season). On 14th June 2020, the patient received the 2nd dose of Shingrix. On an unknown date, between 3 and 4 months after receiving Shingrix and less than 6 months after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced shoulder pain, tendon discomfort and muscle disorder. The patient was treated with non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the shoulder pain, tendon discomfort and muscle disorder were not recovered/not resolved. The reporter considered the shoulder pain, tendon discomfort and muscle disorder to be possibly related to Shingrix. Additional details were provided as follows: The patient reported himself. The reporter stated that he has received dose 1 of Shingrix (around Feb 2020) and dose 2 of Shingrix (on 14th June 2020 as then later a flu shot. The reporter did not have the exact dates of the shots but did provide the pharmacy's phone number so that we could obtain the dates of the injections, lot number/exp date, and confirm if they were given intramuscularly. The reporter did not specified the brand name of the flu shot. The reporter stated the most recent Shingrix shot was given intramuscularly in the deltoid. He said it was given in the top left muscle of the arm but he was not sure if it was given intramuscularly or subcutaneously. The reporter informed that he felt like it went just into the skin but he was not sure. A few weeks ago (almost 2 months ago) the patient begin experiencing shoulder pain. It feels like the muscle,tendon coming off, has tried using ice and massage but it has not been helping (The left arm was the arm where he received the second Shingrix shot). This has not resolved. It had been lingering, and it had been over 30 days. The reporter said he was wondering if this was due to the Shingrix shot. The reporter consented to follow up. This case was liked with case US2020236577 reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2020236577:same reporter.

Other Meds: Influenza vaccine Quadrivalent 2020-2021 season

Current Illness:

ID: 0922379
Sex: M
Age: 77
State: OK

Vax Date: 07/01/2020
Onset Date:
Rec V Date: 01/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: suspected vaccination failure; developed Myasthenia Gravis after the second Shingrix; had shingles when he received his second vaccination / he still has shingles; is very Painful; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (had Shingles in February 2020) and shingles. Concurrent medical conditions included shingles. In July 2020, the patient received the 1st dose of Shingrix. On 24th September 2020, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix and less than 3 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), myasthenia gravis (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the myasthenia gravis, shingles and pain were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix and Shingrix. It was unknown if the reporter considered the myasthenia gravis to be related to Shingrix. Additional details were reported as follows: The patient had shingles in July 2020 when he received his first vaccination of Shingrix in his right arm and still had shingles when he received his second vaccination of Shingrix in his left arm. He stated that he still had shingles, but it occurs intermittently and was very Painful. He had been to his pharmacy, his doctor, the urgent care and the emergency room and had no relief. He developed Myasthenia Gravis after the second Shingrix dose. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting. The reporter consented to follow up.; Sender's Comments: US-GLAXOSMITHKLINE-US2020AMR242160:Same reporter

Other Meds:

Current Illness: Shingles

ID: 0922380
Sex: F
Age: 50
State: CT

Vax Date: 11/03/2020
Onset Date: 11/18/2020
Rec V Date: 01/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: spike in liver enzymes; This case was reported by a consumer via call center representative and described the occurrence of elevated liver enzymes in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 3rd November 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th November 2020, 15 days after receiving Shingrix, the patient experienced elevated liver enzymes. On an unknown date, the outcome of the elevated liver enzymes was unknown. It was unknown if the reporter considered the elevated liver enzymes to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in left arm. After receiving Shingrix, the patient's blood work showed a spike in liver enzymes. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 0922381
Sex: F
Age:
State: MS

Vax Date: 12/21/2020
Onset Date: 12/01/2020
Rec V Date: 01/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: the top of her stomach felt swollen and gassy; Diarrhea/had diarrhea that was like liquid-y water; top of her stomach had a bad burning sensation; Vomiting; she got choked on some saline and sweat ran down her face, and she had to concentrate on breathing; sore throat with a mild cough, like she needed to be clearing her throat; sore throat with a mild cough, like she needed to be clearing her throat; got a chill; food was not tasting right; arm was sore; could not raise her arm; her weight on 21Dec2020 when she got the vaccine, was 200.6, but her weight today, was 196.0 pounds; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) via an unspecified route of administration on 21Dec2020 on left upper arm at a single dose for COVID-19 prevention. Current medical history included a lung disease called asthma and allergies, diagnosed in her late 20's; Diabetes Type 2, diagnosed about 10 years ago and High Blood pressure, diagnosed when she was in her 30's. Caller also wanted to include that she did have COVID before, she had COVID in Jul2020. Current concomitant medications included salbutamol (ALBUTEROL) at 2 Puffs via inhalation, twice daily for asthma; Unspecified Blood Pressure Medication One pill, once daily by mouth in the morning; Unspecified Nasal Spray 1 spray in each nare, once daily via nasal inhalation; montelukast sodium (SINGULAIR) at 1 pill via oral, once a day for allergies; metformin at 1 pill, daily, by mouth for Diabetes Type 2. The patient stated that her place of employment did not give her the card that has the lot number on it, they said they would give it to her with her second injection. The patient did not know the dose received, just that it was the first in the series. The patient had no other vaccines on the same day as the COVID vaccine. The patient reported that her weight on 21Dec2020 when she got the vaccine, was 200.6, but her weight today, was 196.0 pounds. The patient received the vaccine on 21Dec2020, and as soon as she got the shot, her arm was sore like a flu shot. When she got the shot, she could not raise her arm past her shoulder without pain, but now she can raise her arm again. On Thursday, 24Dec2020, patient got a chill, and later that same night, food was not tasting right. On 25Dec2020, the chill continued, and she had a little bit of a sore throat with a mild cough, like she needed to be clearing her throat. On 26Dec2020 morning, the patient experienced vomiting when she woke up, and the top of her stomach had a bad burning sensation, and she had diarrhea. The patient stated that while she was vomiting, she got choked on some saline and sweat ran down her face, and she had to concentrate on breathing. But the patient stated that she vomited, had diarrhea, and the burning sensation, the whole day on Saturday. The patient stated that on 27Dec2020, it calmed down, and she did not vomit at all. The patient stated that she felt like she needed to vomit, but she did not. The patient states that on Sunday, she still had the chills a little, and the top part of her stomach was still burning. The patient took some Pepto-Bismol and that helped calm down the caller's stomach. The patient stated that she could feel the Pepto-Bismol cooling her stomach off, like it had been hot, and patient stated that the top of her stomach felt swollen and gassy. The patient stated that later Sunday night, things calmed down, but she still has the burning sensation and she did not feel like she needed to vomit anymore. This morning, patient reported that she still has some burning sensation, but now, it is coming and going like labor pains. The patient stated that she did go to the bathroom once this morning and had diarrhea that was like liquid-y water. The patient stated that during all this over the last few days, each and every time that she tried to eat, she couldn't eat much because her stomach would burn more with eating. But yesterday, the patient had some fried fish and stated that the fried fish did not burn as much as the rest of the food she tried eating. The outcome of the events vomiting and the top of her stomach felt swollen and gassy was recovered on 27Dec2020, arm was sore and could not raise her arm was recovered on 26Dec2020, chills, top of her stomach had a bad burning sensation was recovering, Diarrhea/had diarrhea that was like liquid-y water was not recovered and other events was unknown. Information about batch/lot number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Vomiting and Foreign body aspiration cannot be totally excluded. The case will be reassessed if 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: ALBUTEROL [SALBUTAMOL]; SINGULAIR;

Current Illness: Allergy (Caller was diagnosed with allergies in her late 20's.); Asthma (Caller was diagnosed with this in her late 20's.); Blood pressure high (Caller was diagnosed when she was in her 30's.); Type 2 diabetes mellitus (Caller was diagnosed about 10 years ago.)

ID: 0922382
Sex: F
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: slight elevated heart rate; was white as a ghost; itching; face also swelled; This is a spontaneous report from a contactable consumer (patient's mother). A female patient of an unspecified age received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number and Expiration Date: Not Provided), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Dec2020, the patient experienced: slight elevated heart rate, was white as a ghost, itching, face also swelled; which were all assessed as non-serious. The clinical course was reported as follows: The patient's mother stated that her daughter was a grown woman and did not know that the she was calling Pfizer. The patient's mother stated that her daughter had the COVID vaccine on a Wednesday (as reported), and the patient was kept for 15 minutes after the administration. The patient's mother stated that her daughter had a slightly elevated heart rate, and her daughter's husband said that she was white as a ghost. The patient's mother stated that her daughter also experienced itching, that did require antihistamines. The patient's mother stated that her daughter called the hospital, and they just said that they will make a note of it. The patient's mother stated that as a parent, she was slightly worried about her daughter getting the second dose; however, she was more concerned about her daughter getting COVID. The patient's mother also stated that her daughter's face also swelled after getting the vaccine, but that her daughter did not have any closing of the throat. The patient did have to go to get antihistamines. The patient's doctors did not tell the patient that she needed to pre-medicate with antihistamines next time. The patient underwent lab tests and procedures which included heart rate: slightly elevated in Dec2020. Therapeutic measures were taken as a result of itching. The clinical outcome of the events was unknown. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 0922383
Sex: F
Age:
State: LA

Vax Date: 12/22/2020
Onset Date: 12/26/2020
Rec V Date: 01/06/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: Red itchy rash at injection site; Red itchy rash at injection site; Red itchy rash at injection site; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 5730), intramuscular (left arm) on 22Dec2020 15:15 at single dose for Covid-19 immunization. The patient's medical history included Intracranial HTN (intracranial hypertension) and known allergies: PCN (Penicillin). Concomitant medication included acetazolamide sodium (DIAMOX), topiramate (TOPAMAX), and Multivitamin. The patient previously took Augmentin, tetracycline, and Ceclor and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced red itchy rash at injection site on 26Dec2020. There was no treatment received for the adverse event. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.

Other Meds: DIAMOX; TOPAMAX

Current Illness:

ID: 0922384
Sex: F
Age:
State: KS

Vax Date: 12/21/2020
Onset Date: 12/26/2020
Rec V Date: 01/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: swollen lymph node in R armpit. Tender to touch and swollen; swollen lymph node in R armpit. Tender to touch and swollen; This is a spontaneous report from a contactable healthcare professional. A 30-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number 1284), intramuscular on the right arm on 21Dec2020 at 20:30 at a single dose for Covid-19 immunization. Medical history included depression, infertility, and acid reflux. Concomitant medications included omeprazole, fluoxetine hydrochloride (PROZAC), magnesium, and melatonin. The patient previously took trazodone and experienced allergies. The patient experienced swollen lymph node in right (R) armpit, tender to touch and swollen on 26Dec2020. There was no treatment received for the events. The patient was not diagnosed with COVID-19 prior to vaccination and since vaccination has not tested for COVID-19. Outcome of the events was recovering. The reporter assessed the events as non-serious.

Other Meds: ; PROZAC; ;

Current Illness:

ID: 0922385
Sex: F
Age:
State: IA

Vax Date: 12/18/2020
Onset Date: 12/20/2020
Rec V Date: 01/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: heart rate spiked; difficult to catch breath; This is a spontaneous report from a contactable healthcare professional. A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK5730), via an unspecified route of administration in the right arm, on 18Dec2020 (at the age of 39-years-old) at a single dose for COVID-19 immunization. Medical history included Hashimoto's thyroiditis, depression, acid reflux, and COVID-19 (prior to vaccination). The patient has no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medications, within two weeks prior to vaccination, included sertraline (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), liothyronine sodium (T3), and levothyroxine sodium (T4). The patient experienced heart rate spiked and difficult to catch breath on 20Dec2020. The events were reported as non-serious. The clinical course was reported as follows: In Dec2020, the heart rate spiked to 194 when running outside and it was difficult to catch breath, so the patient ran/walked the 3 mile route. The heart rate spiked to 183 during a strength training workout and to 148 during a low impact weight training, which is unusual for the patient (as reported). The patient did not receive any treatment for the events. The clinical outcome of heart rate spiked and difficult to catch breath was recovered in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Other Meds: ; ; T3; T4

Current Illness:

ID: 0922386
Sex: F
Age:
State: PA

Vax Date: 12/28/2020
Onset Date: 12/29/2020
Rec V Date: 01/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Excruciating pain from left deltoid radiating downward to wrist; Left hip pain/Bilateral knee pain; Shivering; Headache; This is a spontaneous report from a contactable nurse. A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK5730), intramuscular in the left arm, on 28Dec2020 at 16:30 (at the age of 55-years-old) at a single dose for COVID-19 immunization. Medical history included insomnia, gastrooesophageal reflux disease (GERD), anxiety, mitral valve replacement (MVR) on an unspecified date, and COVID-19 (prior to vaccination). The patient was not pregnant at the time of vaccination. Concomitant medications, taken within two weeks prior to vaccination, included atenolol (MANUFACTURER UNKNOWN), omeprazole (PRILOSEC), sertraline hydrochloride (ZOLOFT), eszopiclone (LUNESTA), krill oil (MANUFACTURER UNKNOWN), linum usitatissimum oil (FLAXSEED OIL; MANUFACTURER UNKNOWN); ascorbic acid (VITAMIN C; MANUFACTURER UNKNOWN), and calcium (MANUFACTURER UNKNOWN). The patient previously took erythromycin (MANUFACTURER UNKNOWN) and experienced allergy, nitrofurantoin (MACRODANTIN) and experienced allergy, and loracarbef (LORABED) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced excruciating pain from left deltoid radiating downward to wrist, left hip pain/bilateral knee pain, shivering, and headache on 29Dec2020 at 07:00. The events were reported as non-serious. The excruciating pain from left deltoid radiating downward to wrist woke the patient up from her sleep. Therapeutic measures were taken as a result of the events, which included treatment with hydrocodone bitartrate, paracetamol (VICODIN) and heat application. The clinical outcome of excruciating pain from left deltoid radiating downward to wrist, left hip pain/bilateral knee pain, shivering, and headache was recovered with sequel in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Other Meds: ; PRILOSEC [OMEPRAZOLE MAGNESIUM]; ZOLOFT; LUNESTA; ; FLAXSEED OIL [LINUM USITATISSIMUM OIL]; VITAMIN C [ASCORBIC ACID];

Current Illness:

ID: 0922387
Sex: F
Age:
State: VA

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: face puffy; Tingling that started at nose and spread across cheeks and lips; This is a spontaneous report from a contactable healthcare professional. A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK5730), via an unspecified route of administration in the right arm, on 28Dec2020 at 17:30 (at the age of 34-years-old) at a single dose for COVID-19 immunization. Medical history included sulfonamides allergy. The patient was not pregnant at the time of vaccination. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks prior to vaccination, included ascorbic acid (VIT C; MANUFACTURER UNKNOWN), curcuma longa (TURMERIC), and collagen (MANUFACTURER) taken as supplement. Additional concomitant medications included unspecified multivitamin (MANUFACTURER UNKNOWN). The patient previously took azithromycin (MANUFACTURER UNKNOWN) and experienced allergy and vortioxetine hydrobromide (TRINTELLIX) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced tingling that started at nose and spread across cheeks and lips on 28Dec2020 at 18:00 and face puffy on 29Dec2020. The events were reported as non-serious. Therapeutic measures were taken as a result of tingling that started at nose and spread across cheeks and lips, which included treatment with diphenhydramine hydrochloride (BENADRYL). The clinical outcome of tingling that started at nose and spread across cheeks and lips was recovered in Dec2020 and of and face puffy was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Other Meds: VIT C; TURMERIC [CURCUMA LONGA];

Current Illness:

ID: 0922388
Sex: F
Age:
State: TX

Vax Date: 12/21/2020
Onset Date: 12/22/2020
Rec V Date: 01/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: Injection site soreness; Headache; Nausea; Body aches; stiffness in neck and shoulder area; Muscle soreness; This is a spontaneous report from a contactable nurse (patient). A 23-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), intramuscularly on 21Dec2020 at 09:00 AM on Left arm at single dose for COVID-19 immunization in hospital. The patient medical history included pre-diabetes, previous liver failure from ciprofloxacin (CIPRO) in 2019, 3 septoplasty due to recurrent sinus infections and nasal cysts in 2016 and 2017. Known allergies included Ciprofloxacin. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included Metformin, Spironolactone, Sertraline. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced injection site soreness, Headache, Nausea, body aches, muscle soreness and stiffness in neck and shoulder area on 22Dec2020 at 02:00 AM. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovered with sequel in Dec2020 (also reported as Recovered with lasting effects). The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.

Other Meds: ; ;

Current Illness:

ID: 0922389
Sex: M
Age:
State: AZ

Vax Date: 12/28/2020
Onset Date: 12/01/2020
Rec V Date: 01/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: diarrhea; This is a spontaneous report from a contactable nurse (patient's wife). A 73-year-old male patient received bnt162b2 (BNT162B2) at single dose on 28Dec2020 for Covid-19 immunisation, because he was a physician. Medical history included prostate cancer receiving radiation and having bowel issues and diarrhoea. The patient's concomitant medications were not reported. The patient experienced diarrhea in Dec2020 after receiving the vaccine. He had prostate cancer and was receiving radiation so it was normal for him to have diarrhea. The nurse state it was not a good source to confirm if diarrhea is from COVID-19 Vaccine. She has not a chance to talk to her husband about his experiences. The outcome of event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0922390
Sex: F
Age:
State: CA

Vax Date: 12/20/2020
Onset Date: 12/21/2020
Rec V Date: 01/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: Achiness; Runny nose; Sore Arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (friend of patient) reported that a female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date unknown), via an unspecified route of administration on 20Dec2020 once by injection in the left arm at single dose for COVID-19 immunization. The patient medical history included already had COVID last November (unspecified year). No concomitant medications. Reporter confirmed that she spoke with her coworker (patient) who also had a runny nose and achiness, along with a sore arm on 21Dec2020. These only lasted 1-2 days for patient. She was also scheduled to receive the second dose on 10Jan2021. Investigation Assessment was not reported. Therapeutic measures were taken as result of the events included paracetamol (TYLENOL) and dextromethorphan hydrobromide; guaifenesin; paracetamol; pseudoephedrine hydrochloride (DAYQUIL). The outcome of the events was recovered in Dec2020. Information on the lot/batch number has been requested

Other Meds:

Current Illness:

ID: 0922391
Sex: F
Age:
State: MI

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 01/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: Swelling on my face around my side of my nose and same on both sides; This is a spontaneous report from a contactable other hcp (patient). This 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose in the right arm on 29Dec2020 12:00pm for Covid-19 immunisation. Medical history included asthma, eggs chicken penicillin. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), omeprazole (PROTONIX [OMEPRAZOLE]), budesonide, formoterol fumarate (SYMBICORT). The patient stated that experienced: swelling on my face around my side of my nose and same on both sides on 29Dec2020 21:00 with outcome of unknown. No treatment required. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 post the vaccination. Information on the Batch/Lot number has been requested.

Other Meds: WELLBUTRIN; PROTONIX [OMEPRAZOLE]; SYMBICORT

Current Illness:

ID: 0922392
Sex: M
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: still not feeling well; I feel a little run down; little of bit congestion; This is a spontaneous report from a contactable Other HCP (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported he felt a little run down and little of bit congestion and asked 'if he is still not feeling well should he get the second dose'. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0922393
Sex: F
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: Initial reaction: rash on chest; muscle, joint pain; muscle, joint pain; urge to run; inability to sleep; Irritable mood; Muscle spasms; dry eyes; Dry mouth; brain fog, inability to multitask; This is a spontaneous report from a contactable nurse. A 58-years-old non-pregnant female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Lot number: EJ1685; intramuscular in left arm on 18Dec2020 at 14:45 (at the age of 58 years-old) as a single dose for COVID-19 immunization. The vaccine was given in a hospital. The patient did not receive any other vaccines in the past 4 weeks. Medical history included asthma, mitral valve prolapse and an allergy to latex. Concomitant medication included calcium (CALCIUM), metoprolol (METOPROLOL), magnesium (MG [MAGNESIUM]), ergocalciferol (VIT D). The patient previously took penicillin and experienced an allergy. The patient did not receive any other vaccines in the past 4 weeks. She did take other medications (concomitant) in the past 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. In Dec2020, at 14:45, the patient experienced rash on chest followed by muscle, joint pain, urge to run, inability to sleep, irritable mood, muscle spasms, dry eyes, dry mouth, brain fog, and an inability to multitask after 1 week following COVID-19 vaccine. The patient was not hospitalized for the events and no treatment was administered. The outcome of the events: rash on chest followed by muscle, joint pain, urge to run, inability to sleep, irritable mood, muscle spasms, dry eyes, dry mouth. brain fog, inability to multitask, was recovering. Since the vaccination, the patient had not been tested for COVID-19.

Other Meds: ; ; MG [MAGNESIUM]; VIT D

Current Illness:

ID: 0922394
Sex: F
Age:
State: MN

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/06/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: Arm sore/upper arm sore; itching surrounding vaccine site; This is a spontaneous report from a contactable nurse, the patient. A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EJ1686, via an unspecified route of administration in the right arm on 30Dec2020 at 15:00 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient's medical history included an allergy to tegaderm. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL), naproxen, zinc, methocarbamol (ROBAXIN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously took chlorhexidine and experience allergies. On 30Dec2020 at 21:30, the patient experienced arm sore/upper arm sore, itching surrounding vaccine site. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the arm sore/upper arm sore, itching surrounding vaccine site was unknown.

Other Meds: TYLENOL; ; ; ROBAXIN

Current Illness:

ID: 0922395
Sex: F
Age:
State: MI

Vax Date: 12/30/2020
Onset Date: 12/31/2020
Rec V Date: 01/06/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Arm more sore than with flu shot; Woke up very nauseous; light headed; achy; Threw up twice; This is a spontaneous report from a contactable healthcare professional (the patient). A 23-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the right arm on 30Dec2020 at 19:15 (at the age of 23-years-old) as a single dose for COVID-19 immunization. Medical history included asthma and peanut allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: montelukast sodium (SINGULAIR), fluticasone propionate/salmeterol xinafoate (ADVAIR), cetirizine hydrochloride (ZYRTEC), all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 31Dec2020 at 05:00, the patient experienced arm more sore than with flu shot, woke up very nauseous, light headed, achy, and threw up twice. No treatment was given for these events. The clinical outcome of arm more sore than with flu shot, woke up very nauseous, light headed, achy, and threw up twice was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds: SINGULAIR; ADVAIR; ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness:

ID: 0922396
Sex: F
Age:
State:

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 01/06/2021
Hospital:

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: loss of her sense of taste and smell; loss of her sense of taste and smell; This is a spontaneous report from a contactable nurse (patient herself). A 53-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Since 29Dec2020, the patient had a loss of her sense of taste and smell that was unresolved. The patient wanted to know if this was a known side effect. The patient was not recovered from the events. Information on the batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 0922397
Sex: F
Age:
State: MI

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/06/2021
Hospital:

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: Bilateral numbness and tingling on entire body; Bilateral numbness and tingling on entire body; This is a spontaneous report from a contactable nurse, the patient. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK9231) solution for injection in the left arm on 30Dec2020 at 17:30 (at the age of 34-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included multiple sclerosis. Concomitant medications included fingolimod hydrochloride (GILENYA) and vitamin D3. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 30Dec2020 at 18:00, the patient experienced bilateral numbness and tingling on entire body. It was unknown if treatment was provided for events bilateral numbness and tingling on entire body. The outcome of the events bilateral numbness and tingling on entire body was not recovered. Since the vaccination, the patient has not been tested for COVID-19.

Other Meds: GILENYA; VITAMIN D3

Current Illness:

ID: 0922398
Sex: F
Age:
State: MI

Vax Date: 12/18/2020
Onset Date: 12/29/2020
Rec V Date: 01/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: severe vertigo with headache; severe vertigo with headache; nausea; vomiting; This is a spontaneous report from a contactable health care professional nurse, the patient. A 48-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE); Lot Number: EK5730, intramuscular in the left arm on 18Dec2020 15:00 as a single dose, for COVID-19 immunization. Medical history included Ongoing Hypertension and Migraines. Concomitant medication included hydrochlorothiazide, losartan potassium (LOSARTAN/HCT) 100/25 daily. The patient had no known allergies. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 29Dec2020 06:00, the patient experienced severe vertigo with headache, nausea and vomiting. The events severe vertigo with headache, nausea and vomiting occurred on Dec 29 and Dec 30, lasted 2 days. Treatment given for severe vertigo with headache, nausea and vomiting was over the counter 'antivert/meclizine'. The clinical outcome of severe vertigo with headache, nausea and vomiting was recovered on Dec2020.

Other Meds: LOSARTAN/HCT

Current Illness: Hypertension (Hypertension, Migraines)

ID: 0922399
Sex: F
Age:
State: MS

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Headache; Low grade fever - 99.3; Shaky and jittery feeling that kept me from sleeping soundly; Shaky and jittery feeling that kept me from sleeping soundly; Shaky and jittery feeling that kept me from sleeping soundly; This is a spontaneous report from a contactable Healthcare Professional reporting for a patient. A 44-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE); Lot Number: EK5730), intramuscular in the left arm on 30Dec2020 at 09:00 as a single dose, for COVID-19 immunisation. The patient had no known medical history or allergies. Concomitant medication included rosuvastatin calcium (CRESTOR). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 30Dec2020 at 2300, the patient experienced Headache, Low grade fever - 99.3, Shaky and jittery feeling that kept me from sleeping soundly. No treatment was given for the events. The clinical outcome of Headache, Low grade fever - 99.3, Shaky and jittery feeling that kept me from sleeping soundly was recovering.

Other Meds: CRESTOR

Current Illness:

ID: 0922400
Sex: F
Age:
State:

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: couldn't lift my head off my pillow; severe pain in neck; squeezing on a nerve; had soreness in my arm; This is a spontaneous report from a contactable nurse, the patient. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 18Dec2020 (at the age of 61 years old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On 18Dec2020, the patient experienced soreness in her arm that was gone by the next day. On 23Dec2020, while driving home, she felt severe pain in neck. She almost felt like something went up in her neck and started squeezing on a nerve. It proceeded to get bad so she took muscle relaxants. Christmas day was horrible, she couldn't lift her head off her pillow. The pain came from up head, under her clavicle and down her back. Her pain started getting better, but then next morning it up started again. The only way she's able to get some sleep is to take Flexeril, 800mg of Motrin and applying moist heat. The clinical outcome of severe pain in neck, squeezing on a nerve, couldn't lift her head off her pillow was unknown, and for event had soreness in her arm was recovered on 19Dec2020. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 0922401
Sex: M
Age:
State: NY

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 01/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Productive cough; Swollen lymph nodes on neck; Severe body aches; Chills; Minor headache; This is a spontaneous report from a contactable other healthcare professional, the patient. A 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: Ek5730, via an unspecified route of administration on 29Dec2020 at 13:30 (at the age of 34 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included fibromyalgia, anxiety disorder, and allergy to amoxicillin from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included omeprazole 40mg and duloxetine 120 mg, both for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 29Dec2020 at 18:30, the patient experienced severe body aches, chills, minor headache, and swollen lymph nodes on neck. On 30Dec2020, the patient experienced productive cough. The patient did not receive treatment for the events. The clinical outcome of body aches, chills, minor headache, swollen lymph nodes on neck, and productive cough was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Other Meds: ;

Current Illness:

ID: 0922402
Sex: U
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: sick; flu; Initial information was received on 04-Jan-2021 regarding an unsolicited valid non-serious social media case from a consumer. This case involves patient (unknown demography) who was sick (illness) and had flu (influenza), while the patient received INFLUENZA VACCINE. Medical history, medical treatment(s), concomitant medications, vaccination(s) 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 was sick (illness) (unknown latency) and had flu (influenza) (few weeks) following the administration of INFLUENZA VACCINE. It was reported that, the flu shot always made the patient sick. The patient stopped taking it 11 years ago when got the flu a few weeks after getting the shot, haven't taken it since and haven't been sick since, will never take it again. Details of laboratory data were not reported. It was not reported if the patient received any corrective treatment. At the time of report, the outcome was unknown for both the events. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 0922403
Sex: U
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: was sick all winter; Initial information was received on 04-Jan-2021 regarding an unsolicited valid non-serious social media case from a consumer. This case involves patient (unknown demography) who was sick all winter (illness), while the patient received INFLUENZA VACCINE. Medical history, medical treatment(s), concomitant medications, vaccination(s) 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 was sick all winter (illness) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported that, the patient I had the flu shot two years in a row a few years back. The patient was sick all winter both times also reported that, (never again. The patient won't be vaccinated for anything ever again). Details of laboratory data were not reported. It was not reported if the patient received any corrective treatment. At the time of report, the outcome was unknown for the event. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 0922404
Sex: F
Age: 0
State: OK

Vax Date: 12/10/2020
Onset Date: 12/10/2020
Rec V Date: 01/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: patient was given the Dtap/IPV portion of PENTACEL and did not get the ActHIB part, no AE; Initial information received on 14-Dec-2020 regarding an unsolicited valid non-serious case from a physician in the united States. This case involves a 2 months old female patient who was given the first dose of dtap/ipv portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Lot number UJ336AAA and expiration date 05-Jul-2021) and did not get the ACT-HIB part, via intramuscular route in the right thigh for prophylactic vaccination on 10-Dec-2020. Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) ; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for prophylactic vaccination. It was a case of actual medication error due to inappropriate reconstitution technique (product preparation issue, same day latency). 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: HEPATITIS B VACCINE; ROTAVIRUS VACCINE; PNEUMOCOCCAL VACCINE

Current Illness:

ID: 0922405
Sex: M
Age:
State: MT

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Initial information received on 16-Dec-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional. This case involves male patient of unknown age, who had tiny red spot at the injection site (vaccination site erythema), after receiving PENTACEL. Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a fourth dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination, before he turned 3 (years / months unspecified). On an unknown date, the patient developed a non-serious tiny red spot at the injection site (vaccination site erythema) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. Case details: Patient's mother reported that QUADRACEL vaccine for her 5-year-old son who needs his 5th dose of DTAP and to satisfy his school requirements, now he needs his 5th dose of the polio vaccine, as well, because he got his 4th dose before he turned 3. On speaking with the health department where they do have vaccine but the nurse said the QUADRACEL was not approved, at least not by her, for a 5th dose. So, wanted to know, is it approved for a 5th dose of Dtap plus polio and is it safe. Question number 1. Question number 2 is: Is it possible to help her locate it somewhere closer, instead of having to go to another facility, which was a 2-hour drive away. Called every pediatrician, every family doctor, every pharmacy and she can think of in the area and everyone orders through one particular pharmacy and for some reason, on their computers are unable to order QUADRACEL whether that's due to manufacturer restrictions. She doesn't know if there's a pharmacy (unintelligible) like contract. Everyone in town seems to give KINRIX, which she doesn't want to give to her son and want to give him QUADRACEL because she know, in the past, he's tolerated PENTACEL really, really well and want to stick with what works for his body and, like, want to spend money and buy and pay for QUADRACEL vaccine and just running into a million brick walls trying to get it. So, if she could be helped, so she will be appreciative. No laboratory data reported. It was not reported if the patient received a corrective treatment. At the time of reports, the outcome was not reported for the event vaccination site erythema. There will be no information on the batch number for this case.

Other Meds:

Current Illness:

ID: 0922406
Sex: M
Age:
State: WA

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: it is not recommended to give to a two month old, with no AE; Initial information regarding an unsolicited valid non-serious case received from a other health professional on 23-Dec-2020. This case involves a 2 months old male patient for whom it was reported that it was not recommended to give to a two month old, (product administered to patient of inappropriate age), while he received quadrivalent influenza vaccine (Influenza Quadrival A-B Vaccine). The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided. Concomitant medications included diphtheria vaccine toxoid, hib vaccine conj (Tet Tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (Pentacel); Hepatitis B Vaccine and Rotavirus Vaccine. On an unknown date, the patient received an unknown dose of suspect Influenza Quadrival A-B Vaccine (lot UT7102JA) via intramuscular route in the left vastus lateralis for prophylactic vaccination, who was 2 months old (product administered to patient of inappropriate age). It was a case of potential medication error due to inappropriate age at vaccine administration. 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. There will be no information available on the batch number for this case.

Other Meds: PENTACEL; HEPATITIS B VACCIN; ROTAVIRUS VACCINE

Current Illness:

ID: 0922407
Sex: F
Age: 64
State: KY

Vax Date: 01/04/2021
Onset Date: 01/05/2021
Rec V Date: 01/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: HEADACHE FATIGUE AND CHILLS

Other Meds: atenolol 50 mg Metformin HCL 500MG

Current Illness:

ID: 0922408
Sex: M
Age: 28
State: MI

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 01/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: Pollen/seasonal allergies. None to food or medications.

Symptom List: Injection site pain

Symptoms: Arm pain, muscle aches, headache, chills. Started with arm pain a 6 hours after shot. Developed rest of symptoms overnight.

Other Meds: Propranolol 30mg qhs, vitamin D3 25 mcg qday, melatonin 1mg qhs, Zyrtec 10mg qday prn.

Current Illness: N/A

ID: 0922409
Sex: M
Age: 61
State: PA

Vax Date: 12/29/2020
Onset Date: 12/31/2020
Rec V Date: 01/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: None

Symptom List: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Headaches, severe vertigo, vomiting, tired, chills

Other Meds: Loser tan, daily vitamins

Current Illness: None

ID: 0922410
Sex: F
Age: 46
State: PA

Vax Date: 12/27/2020
Onset Date: 01/04/2021
Rec V Date: 01/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies: N/A

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: Injection site is red, swollen, warm.

Other Meds: Xeljanz 5mg x 2 daily Levothyroxine 125mcg x 1 daily

Current Illness: N/A

ID: 0922411
Sex: F
Age: 53
State: MS

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 01/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: None

Symptom List: Tremor

Symptoms: Fever 101.9 , Headache, Body aches, Chills

Other Meds: Omeprazole DR 40mg, 1 daily buPropion HCL XL 300mg, 1 daily Metoprolol Succ ER 50mg, 1 daily Methylphenidate ER 54mg, 1 daily Melatonin otc 3mg, nightly as needed Diclofenac Sod DR 75mg, only as needed Cyanocobalamin 1000mcg/ml, once every

Current Illness: None

ID: 0922412
Sex: M
Age: 51
State: FL

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 01/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Myalgias Headache Arthralgias

Other Meds:

Current Illness:

ID: 0922414
Sex: F
Age: 56
State: OH

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

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies: None

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: uncontrollable chills, headache, fatigue, body aches, nausea

Other Meds: None

Current Illness: None

ID: 0922415
Sex: M
Age: 24
State: GA

Vax Date: 01/04/2020
Onset Date: 01/04/2020
Rec V Date: 01/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: none

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: Terrible chills, body aches, fever 101.9 , HA , nausea.

Other Meds: none

Current Illness: none

ID: 0922416
Sex: F
Age: 48
State: MI

Vax Date: 12/22/2020
Onset Date: 12/25/2020
Rec V Date: 01/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: No known allergies

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Patient states arm which vaccination was given became red and sore 3 days after vaccination. It them became large, softball size, red, hot, swollen, and itchy. She states it lasted 10 days and is now resolving with bactroban ointment.

Other Meds: Unknown

Current Illness: Unknown

ID: 0922417
Sex: F
Age: 38
State:

Vax Date: 12/31/2020
Onset Date: 01/01/2021
Rec V Date: 01/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies: Kiwi

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Left arm deltoid sore at injection site, tiredness

Other Meds: Multivitams, l-lysine, thermogenic, CLA, whey protein

Current Illness: None

ID: 0922418
Sex: F
Age: 34
State: IN

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: Nausea, tachycardia and elevated blood pressure. O2 at 100%, BP at 167/114 pulse 135 patient resolved within 10 minutes

Other Meds: Patient became nauseas, elevated BP and tachycardic. O2 100%, Pulse 135 BP 167/114 Brand moderna lot 039K20A

Current Illness:

ID: 0922419
Sex: F
Age: 38
State: PR

Vax Date: 01/04/2021
Onset Date: 01/05/2021
Rec V Date: 01/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: Aspirin

Symptom List: Pain in extremity

Symptoms: pain all over the body, swelling of neck, axilla and arm, pain on left side of arm.

Other Meds: Lisinopril 10mg

Current Illness: Hypertension

ID: 0922420
Sex: M
Age: 53
State: NJ

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies: CIPRO:KEFLEX: IODINE

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: SEVERE HEADACHES LASTING A FEW HOURS AND ACUTE PAIN IN ARM WITH FROZEN SHOULDER UNABLE TO LIFT ARM

Other Meds: NONE

Current Illness: UC

ID: 0922421
Sex: F
Age: 47
State: MA

Vax Date: 12/29/2020
Onset Date: 01/06/2021
Rec V Date: 01/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: sulfa

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: Moderna COVID-19 Vaccine EUA - rash at injection site one week post-injection in left upper arm

Other Meds: levothyroxine, fish oil supplements, Calcium/magnesium supplements, vitamin E, vitamin D, vitamin C, 1x day multi vitamin, zyrtec

Current Illness: none

ID: 0922422
Sex: F
Age: 68
State: CT

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: None stated.

Other Meds: Lisinopril 10mg, zinc Vit D, Multi vit,

Current Illness:

ID: 0922423
Sex: F
Age: 25
State:

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 01/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies: NKA except seasonal

Symptom List: Vomiting

Symptoms: Right arm soreness, Stomach bug and exhaustion for 3 days after the 1st dose of the vaccination.

Other Meds: Ibuprofen, Zoloft, Trazodone, Ribloflavin, etc

Current Illness: Migraines

ID: 0922424
Sex: F
Age: 44
State: ME

Vax Date: 12/26/2020
Onset Date: 01/04/2021
Rec V Date: 01/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies: NKA

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Woke up with a golf ball sized bullseye, swollen, red, itchy, sore, and hot to the touch.

Other Meds: Tramadol, Excedrin, Flonase

Current Illness: NA

ID: 0922425
Sex: F
Age: 34
State: OH

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 01/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies: Nabumetone and Keflex

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: itching and rash

Other Meds: Levothyroxine MVI

Current Illness: No

ID: 0922426
Sex: M
Age: 67
State: AL

Vax Date: 12/16/2020
Onset Date: 12/19/2020
Rec V Date: 01/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: PCN

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Three days 1st dose of Pfizer vaccine I developed moderate headache and malaise. Six days later I developed a maculo-vesicular itchy, non painful rash on my R forehead. I visited an Immediate Care office (started valacyclovir) and I was seen the same day by a retina specialist ophthalmologist (started prednisone 60 mg/day). I'm doing much better.

Other Meds: None

Current Illness: None

ID: 0922427
Sex: F
Age: 50
State: KY

Vax Date: 12/28/2020
Onset Date: 12/29/2020
Rec V Date: 01/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies: Percodan

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: Redness, swelling, induration, painful to the touch, hot to the touch and itching. Has lasted for over 1 week since vaccine administered. Applied heat and ice. Improved some with moist heat but resumed shortly after treatment. Does not interfere with arm use at this time.

Other Meds: None

Current Illness: None

ID: 0922428
Sex: F
Age: 32
State: NY

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 01/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies: None

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: Slight arm soreness about 12 hours after injection, with severe rigors shortly thereafter. Fever to 101.8 and uncontrollable shaking/chills, and moderate to severe headache. Rigors lasted about 6 hours, headache persists.

Other Meds: Lexapro

Current Illness: None

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm