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

Incidents per State

State Total
72,296
AK1,638
AL5,339
AR3,412
AS44
AZ13,316
CA58,147
CO11,002
CT7,824
DC1,626
DE1,670
FL36,235
FM3
GA13,429
GU82
HI2,195
IA4,332
ID2,473
IL19,261
IN22,568
KS4,284
KY6,945
LA4,714
MA13,886
MD11,901
ME2,997
MH8
MI17,865
MN11,345
MO8,919
MP30
MS2,676
MT2,147
NC15,401
ND1,273
NE2,732
NH2,859
NJ17,232
NM3,702
NV4,071
NY32,763
OH18,072
OK5,940
OR7,954
PA22,457
PR2,104
QM2
RI1,911
SC6,055
SD1,133
TN8,691
TX34,122
UT4,023
VA13,944
VI49
VT1,661
WA13,811
WI10,395
WV2,220
WY805
XB5
XL1
XV2

ID: 1555758
Sex: U
Age:
State: LA

Vax Date: 08/07/2021
Onset Date: 08/07/2021
Rec V Date: 08/14/2021
Hospital:

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Symptoms: No additional AE; Patient was administered Improperly stored GARDASIL 9; This spontaneous report was received from a registered nurse and refers a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 07-AUG-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # 1687292 was confirmed to be valid, expiration date 25-AUG-2022, (dose, route and site of administration were not reported) for prophylaxis. The administered dose was exposed to the temperature of 1.53 degrees Celsius (C) for 30 minutes. The previous temperature excursions were reported as 1.29 C for 45 minutes, 1.43 C for 45 minutes and 1.38 C for 45 minutes. No additional adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability

Other Meds: GARDASIL 9 SYRINGE (DEVICE)

Current Illness:

ID: 1555759
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
Hospital:

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Symptoms: Wasn't able to get second dose/ NOBODY had it; This case was reported by a consumer via interactive digital media and described the occurrence of product supply issue in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received about 2 years ago from the date of reporting on an unknown date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown. Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The reporter stated that, did not receive 2nd dose of Shingrix as nobody had it, which led to product supply issue. The reporter stated that, it had been almost 2 years and doctor said that could just get 2nd dose but did not need to start over.

Other Meds:

Current Illness:

ID: 1555760
Sex: U
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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Symptoms: First dose in January 2021, can i still get dose #2?; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 22nd January 2021). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter wanted to know if could still get 2nd dose of Shingrix.

Other Meds:

Current Illness:

ID: 1555761
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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Symptoms: suspected vaccination failure; My Mom had shingles; Shot was mildly painful; Covered with oozing rashes / couldn't even wear a light shirt; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and rash. On an unknown date, the outcome of the vaccination failure, shingles, pain and rash were unknown. It was unknown if the reporter considered the vaccination failure, shingles, pain and rash to be related to Shingles vaccine. Additional details provided were as follows: Age at vaccination was not reported. The reporter was the patient's daughter/son. The patient received the Shingles shot which was midly painful and experienced Shingles.The patient was covered with oozing rashes front and back and could not even wear a light shirt but put a towel in the elastic waistband of her slacks. The reporter visited the patient daily to make sure that she had at least one or two meals. Follow-up was not possible as no contact details available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1555762
Sex: F
Age:
State: AL

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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Symptoms: first dose/04-Jan-2019/not received dose two.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 4th January 2019). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. This case was linked with cases US2021168350, US2020079556, US2019096333, reported by same reporter for different patients.; Sender's Comments: US-GLAXOSMITHKLINE-US2021168350:Same reporter US-GLAXOSMITHKLINE-US2020079556:Same reporter US-GLAXOSMITHKLINE-US2019096333:Same reporter

Other Meds:

Current Illness:

ID: 1555763
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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Symptoms: first dose/3 years ago, never received the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received 3 years ago on an unknown date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were pro vided as follows: The age at vaccination was not applicable for this report. Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No vaccine details were available. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1555764
Sex: F
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
Hospital:

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Symptoms: first dose/8 months ago.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received 8 months ago from the date of reporting). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. This case was linked with case US2021168360, reported by same reporter for different patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2021168360:Same reporter

Other Meds:

Current Illness:

ID: 1555765
Sex: F
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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Symptoms: received the first dose / on 14Aug2019 and has not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 14th August 2019). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. The VAERS details were reported for 1st dose of Shingrix.

Other Meds:

Current Illness:

ID: 1555766
Sex: F
Age:
State: MO

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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Symptoms: accidentally get Shringrix in her eye; accidentally get Shringrix in her eye; This case was reported by a nurse via call center representative and described the occurrence of accidental occupational exposure to product in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced accidental occupational exposure to product and exposure via eye contact. On an unknown date, the outcome of the accidental occupational exposure to product and exposure via eye contact were unknown. Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that their colleague accidentally exposed to Shringrix in her eye, which led to accidental occupational exposure to product and exposure via eye contact. The patient used the eye wash station. The reporter enquired if there was any other recommendations. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1555767
Sex: U
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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Symptoms: First dose given 08/2019. Second dose not yet given; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received in August 2019). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The pharmacist did not wish to disclose adverse event information. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1555768
Sex: F
Age:
State: PA

Vax Date: 03/30/2019
Onset Date:
Rec V Date: 08/14/2021
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Symptoms: received the 1st dose / developed shingles 3 weeks later; rash on abdomen to her back; 1st dose of Shingrix on 30Mar2019 / is late for the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 4X733, expiry date 8th March 2020) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On 30th March 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 3 weeks after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles, rash and incomplete course of vaccination. On an unknown date, the outcome of the shingles, rash and incomplete course of vaccination were unknown. It was unknown if the reporter considered the shingles and rash to be related to Shingrix. Additional details provided were as follows: The age at vaccination for 1st dose was not provided but it could be 79 or 80 years and it was not applicable for this report. The patient received the 1st dose of Shingrix and experienced shingles 3 weeks later, no pain but rash was on abdomen to her back. The patient was late for the second dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow-up.

Other Meds:

Current Illness:

ID: 1555769
Sex: F
Age:
State:

Vax Date: 08/08/2021
Onset Date: 08/01/2021
Rec V Date: 08/14/2021
Hospital:

Vax Type:
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Symptoms: swelling at injection site; muscle pain; fever; headache; shivering; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 8th August 2021, the patient received the 1st dose of Shingrix. In August 2021, less than a week after receiving Shingrix, the patient experienced injection site swelling, muscle pain, headache, shivering and upset stomach. On an unknown date, the patient experienced fever. On an unknown date, the outcome of the injection site swelling, muscle pain, fever, headache, shivering and upset stomach were not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, muscle pain, fever, headache, shivering and upset stomach to be related to Shingrix. Additional case details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got her 1st Shingrix shot on Sunday. The patient developed swelling at injection site, muscle pain, headache, shivering, upset stomach and fever, which had not resolved. The reporter did not consent to follow-up.

Other Meds:

Current Illness:

ID: 1555770
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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Symptoms: Shingrix vaccines were placed in the freezer; This case was reported by a nurse via call center representative and described the occurrence of intercepted product storage error in an unspecified number of patients who received Herpes zoster (Shingrix) (batch number L4RD3, expiry date 8th October 2022) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted product storage error. On an unknown date, the outcome of the intercepted product storage error was unknown. Additional details were reported as follows: The age at vaccination was not applicable for this report. Nurse reported that Shingrix vaccines was exposed to a minimum temperature of minus 8.1 degree Fahrenheit since 28th July, 2021, which led to intercepted product storage error. The nurse realized they had made a mistake, and that the PI said that the vaccines should not be placed in the freezer. Vaccines was not given to patients, the health care professional wanted to know if they were still viable or not. No further details was provided at the time of the call. The reporter consented to follow up.

Other Meds:

Current Illness:

Date Died: 08/01/2021

ID: 1555771
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
Hospital: Y

Vax Type:
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Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19; This spontaneous report received from a company representative on behalf of a health care professional concerned a male patient of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date after vaccination, the patient experienced suspected covid-19 (suspected clinical vaccination failure). On an unspecified date in AUG-2021 (same week of this report), the patient was hospitalized and was intubated. The duration of hospitalization was not specified. On an unspecified date in AUG-2021 (same week of this report), the patient died of covid-19. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of suspected clinical vaccination failure and suspected covid-19 on AUG-2021. This report was serious (Death, and Hospitalization Caused / Prolonged). This case was associated with the Product Quality Complaint number 90000188817.; Sender's Comments: V0: 20210815127- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Suspected COVID-19. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210815127- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.; Reported Cause(s) of Death: COVID-19

Other Meds:

Current Illness:

ID: 1555772
Sex: U
Age:
State:

Vax Date:
Onset Date: 08/06/2021
Rec V Date: 08/14/2021
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Symptoms: TACHYCARDIA; MEDICATION ERROR; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. Concomitant medications included bnt 162 for prophylactic vaccination. On 06-AUG-2021, the patient experienced tachycardia. On 06-AUG-2021, the patient experienced medication error. On 06-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tachycardia, and fever, and the outcome of medication error was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per the standard procedure as the case is assessed as non-serious.

Other Meds: PFIZER VACCINE

Current Illness:

ID: 1555773
Sex: U
Age:
State:

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 08/14/2021
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Symptoms: COVID-19 INFECTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 29-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-JUL-2021, the patient experienced covid-19 infection. Laboratory data included: SARS-CoV-2 test (NR: not provided) positive. On 16-JUL-2021, Laboratory data included: SARS-CoV-2 test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 infection on 16-JUL-2021. This report was non-serious.; Sender's Comments: V0-Medical Assessment comment is not required as per standard procedures, as the case was assessed as non-serious.

Other Meds:

Current Illness:

ID: 1555774
Sex: M
Age:
State: IL

Vax Date:
Onset Date: 08/03/2021
Rec V Date: 08/14/2021
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Symptoms: SWEATING; SICKNESS; NOT ABLE TO DO EXERCISE FOR WEEK; ANXIETY; FEET AND TOES WERE NUMB; NUMBNESS IN CALVES; SORE ARM; NOT FEELING WELL; FEVER; This spontaneous report received from a parent concerned a 21 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient was usually very healthy and did not take any medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-AUG-2021, the patient experienced sweating. On 03-AUG-2021, the patient experienced sickness. On 03-AUG-2021, the patient experienced not able to do exercise for week. On 03-AUG-2021, the patient experienced anxiety. On 03-AUG-2021, the patient experienced feet and toes were numb. On 03-AUG-2021, the patient experienced numbness in calves. On 03-AUG-2021, the patient experienced sore arm. On 03-AUG-2021, the patient experienced not feeling well. On 03-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, and numbness in calves on 05-AUG-2021, had not recovered from sore arm, not able to do exercise for week, and feet and toes were numb, and the outcome of fever, not feeling well, sickness and anxiety was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1555775
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 06/23/2021
Rec V Date: 08/14/2021
Hospital: Y

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Symptoms: POSSIBLE MORE THAN ONE EPISODE OF BRAIN STROKE/RIGHT SIDE OF THE BODY LIKE PARALYSIS/WEIRD TYPE WALK/EXTREME DIZZINESS/BAD HEADACHE OVER TOP LEFT SIDE/UNBEARABLE HEADACHE; BLOOD PRESSURE SPIKE DIASTOLIC; BURNING PAIN SENSATION BEHIND NOSE BRIDGE; LEFT SIDED VOCAL CORD PARALYSIS/VOICE CHANGE; PAIN BEHIND LEFT EYE; ARRHYTHMIA; This spontaneous report received from a patient concerned a 60 year old male. The initial information was processed along with additional information received from the patient on 10-AUG-2021. The patient's height, and weight were not reported. The patient's past medical history included: triple bypass open heart surgery (3 years ago), and concurrent conditions included: non-alcohol user, nonsmoker, and pulmonary embolism, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of drug abuse/illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 02-JUN-2021 for prophylactic vaccination. The concomitant medications included rivaroxaban (Xarelto). The patient had no side effects after vaccination between 2-JUN-2021 and 22-JUN-2021. On 23-JUN-2021, the patient experienced burning pain sensation behind the bridge of nose and then extended into pain behind the left eye. The patient had bad headache over the top left side of the head and it was accompanied with very extreme dizziness. The patient also experienced voice change. The blood pressure had spiked up to 200 diastolic (that the patient had never experienced before and his blood pressure was usually normal). The duration of the symptoms lasted for 2 hours. On 25-JUN-2021, the patient had same symptoms and lasted for 3 to 7 hours and it was intense than before. The patient went to emergency room(ER)for the symptoms as he felt like a brain stroke or hemorrhage due to his symptoms. The patient had undergone CT (computed tomography) scan and nothing found on testing. On 26-JUN-2021 and 27-JUN-2021, the patient had same symptoms. On 28-JUN-2021, the patient had very bad symptoms and went back to the ER. The ER doctor recommended the patient to consult with ENT. On 01-JUL-2021, the patient consulted with ENT and doctor stated the patient had not experienced symptoms due to vertigo. As the doctor identified the patient had left sided vocal cords paralysis. The ENT referred the patient to neurologist. The Patient was told by the neurologist, to have CT scan with a contrast and MRI (magnetic image resonance) if nothing showed up in CT scan. On MRI it showed that patient had occlusion in left vertebral artery, and the right vertebral artery was clear. On 2-JUL-2021, the neurologist explained that it might be possible that the patient might have over more than 1 episode of brain strokes, and the machine might have not detected. The patient was also advised to maintain cholesterol level below 70. On 03-JUL-2021, the patient had experienced same symptoms. On 4-JUL-2021, the patient had severe symptoms with unbearable headache, diastolic blood pressure200-220(felt like going to explode from the inside). The patient was hospitalized upon ER doctor decision. The patient was ordered for X-ray of heart and echo of the heart and which all came out good. On 05-JUL-2021 to 06-JUL-2021, the patient had worst episode of symptoms and was transferred in the middle of night to the ICU (intensive care unit) The blood pressure was 240/113mmHg and the hospital gave medication for BP then, the patient experienced arrhythmia. At the time of reporting the patient's symptoms are not worse but the BP only goes up to 169-175. The patient had dizziness and voice changes (still get vocal cord paralysis) along with that, the patient stated 3 episodes of symptoms per day which last only for 5 minutes. The patient also stated all of his symptoms are slowly fading in terms of intensity and duration. The cardiologist told the patient that his symptoms was not related to heart. The patient consulted almost 8 to 10 doctors (internal medicine, ER doctors, neurologists, and ENT) and had 4 CT scans and 3 MRIs to look for bleeding or hemorrhage and brain stroke. The patient was referred to another hospital on January or February 2022 for consultation with radiologists. The patient has an upcoming MRI imaging to be done. The Patient reported another episode of dizziness while reporting and decided to end the call when asked if patient was okay to continue with the conversation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from burning pain sensation behind nose bridge, blood pressure spike diastolic, and pain behind left eye, had not recovered from left sided vocal cord paralysis/voice change, and possible more than one episode of brain stroke/right side of the body like paralysis/weird type walk/extreme dizziness/bad headache over top left side/unbearable headache, and the outcome of arrhythmia was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210820232-COVID-19 VACCINE AD26.COV2.S. ARRHYTHMIA, POSSIBLE MORE THAN ONE EPISODE OF BRAIN STROKE/RIGHT SIDE OF THE BODY LIKE PARALYSIS/WEIRD TYPE WALK/EXTREME DIZZINESS/BAD HEADACHE OVER TOP LEFT SIDE/UNBEARABLE HEADACHE. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY 20210820232-COVID-19 VACCINE AD26.COV2.S. BLOOD PRESSURE SPIKE DIASTOLIC, BURNING PAIN SENSATION BEHIND NOSE BRIDGE, LEFT SIDED VOCAL CORD PARALYSIS/VOICE CHANGE, . This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds: XARELTO

Current Illness: Abstains from alcohol; Non-smoker; Pulmonary embolism (2 weeks after the open heart surgery. Patient has been on Xarelto for 3 years now.)

ID: 1555776
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
Hospital:

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Symptom List:

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The reporter called to report about female who she knew was vaccinated with Janssen COVID-19 vaccine and was sick with COVID after being vaccinated (suspected clinical vaccination failure, and suspected COVID-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected COVID-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210821314- Covid-19 vaccine ad26.cov2. s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1555777
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
Hospital:

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Symptoms: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1898089, expiry: 04-AUG-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1555778
Sex: F
Age:
State: CO

Vax Date:
Onset Date: 08/11/2021
Rec V Date: 08/14/2021
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Symptoms: ADMINISTRATION OF A FILLED SYRINGE THAT WAS STORED IN REFRIGERATOR FOR 12-18 HOURS; ADMINISTRATION OF A FILLED SYRINGE THAT WAS STORED IN REFRIGERATOR FOR 12-18 HOURS; This spontaneous report received from a pharmacist concerned a 65 year old female. The patient's weight was 210 pounds, and height was 67 inches. The patient's concurrent conditions included: asthma, arthritis, alcohol user and smoker and other pre-existing medical conditions included: The patient is taking pro-air inhaler for unknown indication. The patient was previously experienced hives and skin rash when treated with ciprofloxacin for drug used for unknown indication, and drug dependence when treated with aripiprazole, colchicine, fluticasone propionate, escitalopram oxalate, naproxen, omeprazole, paracetamol and diclofenac for drug used for unknown indication, drug dependence when treated with gabapentin and oxybutynin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-AUG-2021, the patient experienced administration of a filled syringe that was stored in refrigerator for 12-18 hours. On 11-AUG-2021, the patient experienced administration of a filled syringe that was stored in refrigerator for 12-18 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of a filled syringe that was stored in refrigerator for 12-18 hours and administration of a filled syringe that was stored in refrigerator for 12-18 hours was not reported. This report was non-serious.

Other Meds:

Current Illness: Alcohol use (beer, liquor (amount varies)); Arthritis; Asthma; Smoker (4 cigarettes/day)

ID: 1555779
Sex: U
Age:
State:

Vax Date:
Onset Date: 07/30/2021
Rec V Date: 08/14/2021
Hospital:

Vax Type:
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Symptom List:

Symptoms: TERRIBLE PAIN; FEVER; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 30-JUL-2021, the patient experienced terrible pain. On 30-JUL-2021, the patient experienced fever. On 30-JUL-2021, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, fatigue and terrible pain was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1555780
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
Hospital:

Vax Type:
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Symptoms: SLEEPINESS; SORE ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced sleepiness, and sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleepiness, and sore arm. This report was non-serious.

Other Meds:

Current Illness:

ID: 1555781
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 08/11/2021
Rec V Date: 08/14/2021
Hospital:

Vax Type:
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Vax Name:
Lot:
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Symptoms: HIT LIKE A TON OF BRICKS; ACHY FEELING; SCRATCH IN THROAT; COLD CHILLS; TIREDNESS AND FATIGUE; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: UNKNOWN) dose was not reported, administered on 10-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-AUG-2021, the patient experienced hit like a ton of bricks. On 11-AUG-2021, the patient experienced achy feeling. On 11-AUG-2021, the patient experienced scratch in throat. On 11-AUG-2021, the patient experienced cold chills. On 11-AUG-2021, the patient experienced tiredness and fatigue. Laboratory data included: SARS-CoV-2 test (NR: not provided) Negative. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hit like a ton of bricks, tiredness and fatigue, achy feeling, cold chills, and scratch in throat. This report was non-serious.

Other Meds:

Current Illness:

ID: 1555782
Sex: U
Age:
State:

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 08/14/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

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Symptom List:

Symptoms: REACTIVE ARTHRITIS (SEVERE PAIN); This spontaneous report received from a patient concerned a patient of unspecified age, sex, unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: UNKNOWN) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date in JUL-2021, the patient was diagnosed with reactive arthritis. The patient is still in severe pain after three weeks. Laboratory data included: Lab test (NR: not provided) diagnosed with Reactive Arthritis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from reactive arthritis (severe pain) This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210822977-Covid-19 vaccine ad26.cov2.S-Reactive arthritis (severe pain).This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1555783
Sex: M
Age: 49
State: TX

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 08/14/2021
Hospital:

Vax Type:
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Symptoms: Experienced a little soreness in his arm after the injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Experienced a little soreness in his arm after the injection) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included High cholesterol and Diabetes. Concomitant products included EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE (SYNJARDY) for Diabetes, ROSUVASTATIN for High cholesterol, ASPIRIN [ACETYLSALICYLIC ACID]. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced INJECTION SITE PAIN (Experienced a little soreness in his arm after the injection). At the time of the report, INJECTION SITE PAIN (Experienced a little soreness in his arm after the injection) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested

Other Meds: ROSUVASTATIN; SYNJARDY; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness: Diabetes; High cholesterol

ID: 1555784
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
Hospital:

Vax Type:
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Symptom List:

Symptoms: Redness and itchiness; Redness and itchiness; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Redness and itchiness), PRURITUS (Redness and itchiness) and delayed reaction to the vaccine in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012120A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness and itchiness), PRURITUS (Redness and itchiness) and delayed reaction to the vaccine. At the time of the report, ERYTHEMA (Redness and itchiness) and PRURITUS (Redness and itchiness) delayed to the vaccine utcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.

Other Meds:

Current Illness:

ID: 1555785
Sex: F
Age: 65
State: FL

Vax Date: 02/15/2021
Onset Date: 02/15/2021
Rec V Date: 08/14/2021
Hospital:

Vax Type:
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Lab Data:

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Symptom List:

Symptoms: Nausea; Little Headache; Sore Arm; A spontaneous report was received from a (Reporter like Consumer) concerning a ? 65 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (Nausea, Little Headache and Sore Arm) list. The patient's medical history was not provided. No relevant concomitant medications were reported. On 15-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 006M20A) intramuscularly for prophylaxis of COVID-19 infection. On 15-FEB-2021, The patient experienced the events list (Nausea, Little Headache and Sore Arm). Laboratory details was not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the event(s) (Nausea, Little Headache and Sore Arm) was unknown. The reporter assessed the event(s), [Nausea, Little Headache and Sore Arm], as related to study drug.

Other Meds:

Current Illness:

ID: 1555786
Sex: F
Age: 60
State: CA

Vax Date: 01/15/2021
Onset Date: 02/12/2021
Rec V Date: 08/14/2021
Hospital:

Vax Type:
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Symptom List:

Symptoms: Body ache; Fever; Rash (on her trunk-front and back); Chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Body ache), RASH (Rash (on her trunk-front and back)) and CHILLS (Chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 030M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported). On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced PAIN (Body ache), RASH (Rash (on her trunk-front and back)) and CHILLS (Chills). At the time of the report, PAIN (Body ache), RASH (Rash (on her trunk-front and back)) and CHILLS (Chills) outcome was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. This case was linked to MOD21-033093 (E2B Linked Report).; Sender's Comments: MOD21-033093:

Other Meds:

Current Illness:

ID: 1555787
Sex: M
Age:
State: NY

Vax Date: 01/12/2021
Onset Date: 02/18/2021
Rec V Date: 08/14/2021
Hospital:

Vax Type:
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Lab Data:

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Symptom List:

Symptoms: had 0 antibodies on a test after getting 2 vaccine; A spontaneous report was received from a consumer concerning a male patient who developed had 0 antibodies on a test after getting 2 vaccine/ drug ineffective. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mrna-1273 (Batch number : 012L20A) on 12 Jan 2021. On 09 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mrna-1273 (Batch number: 012M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 12 Jan 2021, patient received first dose and on 09 Feb 2021, patient received second dose of vaccine. On 11 Feb 2021, the patient reported having no antibodies on a test after getting 2 vaccine/ drug ineffective. Treatment information was not provided. The patient received both scheduled doses of mrna-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome of the events had 0 antibodies on a test after getting 2 vaccine/ drug ineffective were not reported.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1555788
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

Allergies:

Symptom List:

Symptoms: Still getting sick with COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Still getting sick with COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Still getting sick with COVID). At the time of the report, COVID-19 (Still getting sick with COVID) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. No treatment information provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1555789
Sex: F
Age:
State: MA

Vax Date: 02/03/2021
Onset Date: 03/12/2021
Rec V Date: 08/14/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: soreness; dizziness; diarrhea; felt sick; Tired; nausea; had a robust reaction to first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), DIZZINESS (dizziness), DIARRHOEA (diarrhea), ILLNESS (felt sick) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (soreness), DIZZINESS (dizziness), DIARRHOEA (diarrhea), ILLNESS (felt sick), NAUSEA (nausea) and FATIGUE (Tired). At the time of the report, PAIN (soreness), DIZZINESS (dizziness), DIARRHOEA (diarrhea), ILLNESS (felt sick), NAUSEA (nausea) and FATIGUE (Tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication not provided. Concomitant medication not provided.

Other Meds:

Current Illness:

ID: 1555790
Sex: F
Age: 72
State: NC

Vax Date: 02/24/2021
Onset Date: 02/01/2021
Rec V Date: 08/14/2021
Hospital:

Vax Type:
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Lot:
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Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: injection site arm warm; A spontaneous report was received from a 72-years-old female patient concerning herself who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event injection site arm warm. The patient's medical history was not provided. No relevant concomitant medications were reported. On 24 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On an unknown date in Feb 2021, the patient experienced the event injection site arm warm. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event, injection site arm warm was not recovered.

Other Meds:

Current Illness:

ID: 1555791
Sex: F
Age: 81
State: CA

Vax Date: 01/20/2021
Onset Date: 02/17/2021
Rec V Date: 08/14/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: pain in the left breast; freezing cold; not hungry; sweats; Headache; swollen lymph nodes on the left side of my neck and the left side of my left breast; chills; This spontaneous case was reported by a nurse and describes the occurrence of BREAST PAIN (pain in the left breast), FEELING COLD (freezing cold), DECREASED APPETITE (not hungry), HYPERHIDROSIS (sweats) and HEADACHE (Headache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Non-Hodgkin's lymphoma in 2001 and Fusion lumbar spine in January 2021. Concurrent medical conditions included Hypothyroidism since 29-Mar-2015, Latex allergy, Drug allergy (Bacitracin), Drug allergy (Tegarderm Patch), Allergy to antibiotic (Biaxin), Drug allergy (Codeine), Drug allergy (Vicodin), Drug allergy (Elavil), Drug allergy (Ultram), Drug allergy (Morphine), Drug allergy (Fentanyl HCL), Drug allergy (Darvon), Penicillin allergy, Drug allergy (Dilantin), Allergy to antibiotic (Sulphonamide), Allergy to antibiotic (Neosporin), Allergy to antibiotic (Polysporin), Allergy to antibiotic (Erythromycin), Drug allergy (Oxycodone), Drug allergy (Omeprazole DR), Drug allergy (Oxydrolone), Drug allergy (Meperdine), Drug allergy (Phenytoin), Drug allergy (Tramadol), Drug allergy (Fluten) and Drug allergy (Levofloxacin). Concomitant products included LEVOTHYROXINE from 29-Mar-2015 to an unknown date, CLOPIDOGREL, KETOROLAC TROMETHAMINE (TORADOL), MACROGOL 3350 (RESTORALAX), LORAZEPAM (LORAZEPAN), LEVOFLOXACIN (LEVAQUIN), CIPROFLOXACIN, HYDROXYZINE, HYDROXYZINE EMBONATE (VISTARIL [HYDROXYZINE EMBONATE]), MIDAZOLAM HYDROCHLORIDE (VERSED), ONDANSETRON, LEVOFLOXACIN, KETOROLAC, FAMOTIDINE, CLINDAMYCIN, DEXAMETHASONE, MUPIROCIN, CEFIXIME (FLEXERIL [CEFIXIME]), METHYLPREDNISOLONE ACEPONATE and AZITHROMYCIN for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced BREAST PAIN (pain in the left breast), FEELING COLD (freezing cold), DECREASED APPETITE (not hungry), HYPERHIDROSIS (sweats), HEADACHE (Headache), LYMPHADENOPATHY (swollen lymph nodes on the left side of my neck and the left side of my left breast) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse drug reaction, at an unspecified dose and frequency. On 24-Feb-2021, BREAST PAIN (pain in the left breast), FEELING COLD (freezing cold), DECREASED APPETITE (not hungry), HYPERHIDROSIS (sweats), HEADACHE (Headache) and LYMPHADENOPATHY (swollen lymph nodes on the left side of my neck and the left side of my left breast) had resolved and CHILLS (chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: increased (High) Body temperature increased. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Besides Tylenol she also took hot tea, Pedialyte and plenty of water. Patient was planning to get dense mammogram scheduled on 06JAN2021. This case was linked to MOD-2021-024366 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow-up information received on 01-Jun-2021 no new information was recorded On 22-Jun-2021: Follow up received on 22-JUN-2021 contains significant information -Medical history added. Concomitant medications added. Events and outcome of event added

Other Meds: LEVOTHYROXINE; CLOPIDOGREL; TORADOL; RESTORALAX; LORAZEPAN; LEVAQUIN; CIPROFLOXACIN; HYDROXYZINE; VISTARIL [HYDROXYZINE EMBONATE]; VERSED; ONDANSETRON; LEVOFLOXACIN; KETOROLAC; FAMOTIDINE; CLINDAMYCIN; DEXAMETHASONE; MUPIROCIN; FLEXERIL [CE

Current Illness: Allergy to antibiotic (Sulphonamide); Allergy to antibiotic (Polysporin); Allergy to antibiotic (Neosporin); Allergy to antibiotic (Erythromycin); Allergy to antibiotic (Biaxin); Drug allergy (Vicodin); Drug allergy (Ultram); Drug allergy (Tramadol); Drug allergy (Tegarderm Patch); Drug allergy (Phenytoin); Drug allergy (Oxydrolone); Drug allergy (Oxycodone); Drug allergy (Omeprazole DR); Drug allergy (Morphine); Drug allergy (Meperdine); Drug allergy (Levofloxacin); Drug allergy (Fluten); Drug allergy (Fentanyl HCL); Drug allergy (Elavil); Drug allergy (Dilantin); Drug allergy (Darvon); Drug allergy (Codeine); Drug allergy (Bacitracin); Hypothyroidism; Latex allergy; Penicillin allergy

ID: 1555792
Sex: F
Age: 86
State: NC

Vax Date: 01/15/2021
Onset Date: 02/04/2021
Rec V Date: 08/14/2021
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Symptoms: tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid-19) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported). On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced COVID-19 (tested positive for Covid-19). At the time of the report, COVID-19 (tested positive for Covid-19) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1555793
Sex: F
Age:
State:

Vax Date: 02/23/2021
Onset Date:
Rec V Date: 08/14/2021
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Symptoms: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. No concomitant medication was reported. No treatment medication was reported. Action taken with mRNA-1273 in response to the events was not Applicable.

Other Meds:

Current Illness:

ID: 1555794
Sex: M
Age: 30
State: GA

Vax Date: 02/15/2021
Onset Date: 02/23/2021
Rec V Date: 08/14/2021
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Symptoms: hives; severe rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) and RASH (severe rash) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. No Medical History information was reported. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced URTICARIA (hives) and RASH (severe rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (hives) and RASH (severe rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Treatment medications included 2 IM steroids injection, oral steroids.

Other Meds:

Current Illness:

ID: 1555795
Sex: M
Age:
State: NY

Vax Date:
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Rec V Date: 08/14/2021
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Symptoms: arm hurt; "felt tired"; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt), FATIGUE ("felt tired") and CHILLS (chills) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt), FATIGUE ("felt tired") and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (arm hurt), FATIGUE ("felt tired") and CHILLS (chills) outcome was unknown. No concomitant medication and treatment information were reported.

Other Meds:

Current Illness:

ID: 1555796
Sex: F
Age:
State:

Vax Date: 01/29/2021
Onset Date:
Rec V Date: 08/14/2021
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Symptoms: left arm red; left arm itchy; vomiting two times; slit rash over her body, pink, little thing in the skin; Nausea; Chills; feverish; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 08-Feb-2021. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 08-Feb-2021. A spontaneous report was received from a consumer concerning herself, who is a 81-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events left arm red, left arm itchy, vomiting two times, slit rash over her body, pink, little thing in the skin, chills, nausea, feverish. The patient's medical history was blood pressure, also allergic to panicillin. Concomitant medications reported were blood pressure medicine. On 29 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) through unknown route in the unknown location for prophylaxis of COVID-19 infection. On an unknown date, 8 days later after first dose the patient experienced the events left arm red and itchy , color, collapse two times, slit rash over her body, pink, little thing in the skin. After taking paracetamol patient experienced chills, nausea and feverish. Treatment details included paracetamol. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events left arm red, left arm itchy, vomiting two times, slit rash over her body, pink, little thing in the skin, chills, nausea, feverish was unknown.

Other Meds:

Current Illness: Blood pressure; Penicillin allergy

ID: 1555797
Sex: F
Age: 50
State: NY

Vax Date: 01/31/2021
Onset Date: 01/31/2021
Rec V Date: 08/14/2021
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Symptoms: Arm was itchy and she started scratching it; Red; Swollen under the skin at the injection site; Swollen circle the size of a tennis ball; Tender; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 08-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tender), VACCINATION SITE PRURITUS (Arm was itchy and she started scratching it), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE SWELLING (Swollen under the skin at the injection site) and VACCINATION SITE MASS (Swollen circle the size of a tennis ball) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy. On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced TENDERNESS (Tender). On 07-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swollen under the skin at the injection site) and VACCINATION SITE MASS (Swollen circle the size of a tennis ball). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Arm was itchy and she started scratching it) and VACCINATION SITE ERYTHEMA (Red). At the time of the report, TENDERNESS (Tender), VACCINATION SITE PRURITUS (Arm was itchy and she started scratching it), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE SWELLING (Swollen under the skin at the injection site) and VACCINATION SITE MASS (Swollen circle the size of a tennis ball) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications used were not reported. No treatment information were reported.

Other Meds:

Current Illness:

ID: 1555798
Sex: F
Age: 75
State: FL

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 08/14/2021
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Symptoms: sore arm; Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (Fatigued) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O12MZ0A) for COVID-19 vaccination. No Medical History information was reported. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (Fatigued). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (Fatigued) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications includes blood pressure. treatment information includes allergy meds and vitamins.

Other Meds:

Current Illness:

ID: 1555799
Sex: F
Age:
State: OK

Vax Date: 02/03/2021
Onset Date: 02/04/2021
Rec V Date: 08/14/2021
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Symptoms: Rash spread on back and neck; Rash on her chest; Soreness; Chills; soreness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Feb-2021 and was forwarded to Moderna on 08-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on her chest), MYALGIA (Soreness), CHILLS (Chills), PAIN (soreness) and RASH (Rash spread on back and neck) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced RASH (Rash on her chest), MYALGIA (Soreness), CHILLS (Chills) and PAIN (soreness). On 05-Feb-2021, the patient experienced RASH (Rash spread on back and neck). At the time of the report, RASH (Rash on her chest), MYALGIA (Soreness), CHILLS (Chills), PAIN (soreness) and RASH (Rash spread on back and neck) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included Benadryl.

Other Meds:

Current Illness:

ID: 1555800
Sex: M
Age: 68
State: TX

Vax Date: 02/23/2021
Onset Date: 02/24/2021
Rec V Date: 08/14/2021
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Symptoms: fell shouldn't drive car; body ache; chills; maybe fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (fell shouldn't drive car), MYALGIA (body ache), CHILLS (chills) and PYREXIA (maybe fever) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. No Medical History information was reported. On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced FEELING ABNORMAL (fell shouldn't drive car), MYALGIA (body ache), CHILLS (chills) and PYREXIA (maybe fever). At the time of the report, FEELING ABNORMAL (fell shouldn't drive car), MYALGIA (body ache), CHILLS (chills) and PYREXIA (maybe fever) outcome was unknown. No concomitant medications and treatment information were reported. This case was linked to MOD-2021-024150 (Patient Link).

Other Meds:

Current Illness:

ID: 1555801
Sex: F
Age: 74
State: OH

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 08/14/2021
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Symptoms: Shortness of breath; Fatigued; Left face numbness that lasted 20 minutes/left hand numbness that last 20 minutes; Slurred speech for 20 minutes; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Left face numbness that lasted 20 minutes/left hand numbness that last 20 minutes), DYSARTHRIA (Slurred speech for 20 minutes), DYSPNOEA (Shortness of breath) and FATIGUE (Fatigued) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COVID-19 on 26-Dec-2020 and Transient ischaemic attacks. Concurrent medical conditions included Colon cancer and Diabetes. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced HYPOAESTHESIA (Left face numbness that lasted 20 minutes/left hand numbness that last 20 minutes) and DYSARTHRIA (Slurred speech for 20 minutes). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath) and FATIGUE (Fatigued). At the time of the report, HYPOAESTHESIA (Left face numbness that lasted 20 minutes/left hand numbness that last 20 minutes), DYSARTHRIA (Slurred speech for 20 minutes), DYSPNOEA (Shortness of breath) and FATIGUE (Fatigued) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. concomitant medications includes Blood thinners. No treatment information were reported.

Other Meds:

Current Illness: Colon cancer; Diabetes

ID: 1555802
Sex: F
Age: 56
State: TX

Vax Date: 03/22/2021
Onset Date:
Rec V Date: 08/14/2021
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Symptoms: Congestion; Elevated blood pressure; nausea; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congestion), HYPERTENSION (Elevated blood pressure), NAUSEA (nausea), HEADACHE (Headache) and PYREXIA (Fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (Congestion), HYPERTENSION (Elevated blood pressure), NAUSEA (nausea), HEADACHE (Headache) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, NASAL CONGESTION (Congestion), HYPERTENSION (Elevated blood pressure), NAUSEA (nausea), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure increased: elevated (High) elevated blood pressure. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication includes use of blood pressure medications (not further specified).

Other Meds:

Current Illness: Blood pressure high

ID: 1555803
Sex: F
Age: 77
State: NY

Vax Date: 02/21/2021
Onset Date: 02/22/2021
Rec V Date: 08/14/2021
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Symptom List:

Symptoms: Body aches; Itchiness at the injection site; redness on injection site; fatigue; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE ERYTHEMA (redness on injection site), FATIGUE (fatigue) and CHILLS (Chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced MYALGIA (Body aches), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE ERYTHEMA (redness on injection site), FATIGUE (fatigue), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, MYALGIA (Body aches), FATIGUE (fatigue), CHILLS (Chills) and HEADACHE (Headache) had resolved and VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE ERYTHEMA (redness on injection site) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1555804
Sex: M
Age: 41
State: MS

Vax Date: 02/21/2021
Onset Date: 02/21/2021
Rec V Date: 08/14/2021
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Symptoms: weak; problem with his jaw/muscle related; unable to open his mouth all the way; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm), ASTHENIA (weak), JAW DISORDER (problem with his jaw/muscle related) and DYSKINESIA (unable to open his mouth all the way) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. No Medical History information was reported. On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced INJECTION SITE PAIN (sore arm), ASTHENIA (weak), JAW DISORDER (problem with his jaw/muscle related) and DYSKINESIA (unable to open his mouth all the way). At the time of the report, INJECTION SITE PAIN (sore arm), ASTHENIA (weak), JAW DISORDER (problem with his jaw/muscle related) and DYSKINESIA (unable to open his mouth all the way) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications and treatment information were reported.

Other Meds:

Current Illness:

ID: 1555805
Sex: M
Age: 82
State:

Vax Date: 02/05/2021
Onset Date: 02/06/2021
Rec V Date: 08/14/2021
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Symptoms: chills; Arm sore; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 08-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and VACCINATION SITE PAIN (Arm sore) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included NAPROXEN, LEVOTHYROXINE SODIUM (SYNTHROID), NAPROXEN, DOXYLAMINE SUCCINATE (UNISOM 2), MELATONIN and ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) for an unknown indication. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced CHILLS (chills) and VACCINATION SITE PAIN (Arm sore). At the time of the report, CHILLS (chills) and VACCINATION SITE PAIN (Arm sore) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided.

Other Meds: NAPROXEN; SYNTHROID; NAPROXEN; UNISOM 2; MELATONIN; PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]

Current Illness:

ID: 1555806
Sex: U
Age:
State:

Vax Date: 02/23/2021
Onset Date:
Rec V Date: 08/14/2021
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Symptoms: mucus build-up; elevated glucose; fluctuated BP; Bad Headache; This spontaneous case was reported by a consumer and describes the occurrence of INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (mucus build-up), BLOOD GLUCOSE INCREASED (elevated glucose), BLOOD PRESSURE FLUCTUATION (fluctuated BP) and HEADACHE (Bad Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. No Medical History information was reported. On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (mucus build-up), BLOOD GLUCOSE INCREASED (elevated glucose), BLOOD PRESSURE FLUCTUATION (fluctuated BP) and HEADACHE (Bad Headache). At the time of the report, INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (mucus build-up), BLOOD GLUCOSE INCREASED (elevated glucose), BLOOD PRESSURE FLUCTUATION (fluctuated BP) and HEADACHE (Bad Headache) outcome was unknown. No concomitant medications and treatment information were reported.

Other Meds:

Current Illness:

ID: 1555807
Sex: M
Age: 71
State: FL

Vax Date: 01/27/2021
Onset Date: 01/28/2021
Rec V Date: 08/14/2021
Hospital:

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Symptom List:

Symptoms: Covid arm 1st dose-left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Covid arm 1st dose-left arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included LITHIUM CARBONATE, INSULIN GLARGINE, INSULIN ASPART (NOVOLOG), BENZTROPINE [BENZATROPINE], DOCUSATE, VITAMIN C [ASCORBIC ACID], ZINC and MELATONIN for an unknown indication. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION COMPLICATION (Covid arm 1st dose-left arm). On 30-Jan-2021, VACCINATION COMPLICATION (Covid arm 1st dose-left arm) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. The patient was prescribed an unspecified antibiotic for the adverse event. This case was linked to MOD-2021-024410 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up information received provided concomitant and treatment medications.

Other Meds: LITHIUM CARBONATE; INSULIN GLARGINE; NOVOLOG; BENZTROPINE [BENZATROPINE]; DOCUSATE; VITAMIN C [ASCORBIC ACID]; ZINC; MELATONIN

Current Illness: Type 1 diabetes mellitus

Total 2021 VAERS Injuries: 599,999

Page last modified: 03 October 2021 5:28pm