VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer

Incidents per State

State Total
92,076
AK1,880
AL6,345
AR4,151
AS46
AZ14,991
CA66,887
CO12,550
CT8,943
DC1,795
DE2,009
FL42,724
FM4
GA17,031
GU124
HI2,580
IA4,919
ID2,892
IL22,128
IN24,197
KS5,047
KY9,111
LA5,500
MA15,718
MD13,434
ME3,351
MH8
MI20,971
MN13,585
MO10,747
MP30
MS3,198
MT2,477
NC18,051
ND1,501
NE3,109
NH3,218
NJ20,216
NM4,218
NV4,728
NY37,667
OH20,793
OK6,692
OR9,244
PA25,607
PR2,588
QM2
RI2,163
SC7,261
SD1,282
TN10,445
TX39,890
UT4,618
VA15,980
VI67
VT1,830
WA16,071
WI12,042
WV2,571
WY926
XB5
XL1
XV2

ID: 1401948
Sex: M
Age:
State: NY

Vax Date: 05/15/2021
Onset Date: 05/01/2021
Rec V Date: 06/16/2021
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Symptoms: Inappropriate age at vaccine administration; fever at 100.2F; Pain in arm; headache; nausea; This is a spontaneous report from a contactable consumer or other non HCP. A 13-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0167) intramuscular, administered in Arm Left on 15May2021 17:00 (at the age of 13-years-old) as 1st dose, single dose for covid-19 immunisation at store. The patient had no other medical history and no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On an unspecified date of May2021, the patient experienced pain in arm, headache, nausea, fever at 100.2F. The patient did not received treatment for the adverse event. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1401949
Sex: F
Age:
State: NY

Vax Date: 05/15/2021
Onset Date: 05/16/2021
Rec V Date: 06/16/2021
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Symptoms: I have chill first then body ache but its mild; I have chill first then body ache but its mild; This is a spontaneous report from a contactable healthcare professional (patient). This 38-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 15May2021 at 10:15 (at the age of 38-years-old) as a single dose for COVID-19 immunization. Medical history included allergies to certain type of antibiotic medicines. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included metronidazole from an unknown date for an unknown indication. The patient previously received dose 1 of BNT162B2 (lot number EW0164) on 24Apr2021 at 10:15 as a single dose in the left arm for COVID-19 immunization. On 16May2021 at 13:00 the patient had chill first then body ache but it was mild. The patient did not receive any treatment for the events. The outcomes of chill and body ache were recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.

Other Meds: METRONIDAZOLE

Current Illness:

ID: 1401950
Sex: F
Age:
State: FL

Vax Date: 04/03/2021
Onset Date: 05/05/2021
Rec V Date: 06/16/2021
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Symptoms: sweaty hands; bad dull headache in middle of brain; Gas bloating; Drop in blood sugar; acne on my cheeks; period was late; injection site hurt; Little red zits with no heads; mild nose bleeds started in right nostril; my period is late and i have weird cramping; This is a spontaneous report from a contactable consumer (patient). This 37- year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 03Apr2021 at 12:00 (as reported) as a single dose in the right arm for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included magnesium, calcium, vitamin D3, and probiotics from unknown dates for unspecified indications and omega 3 from an unknown date to two weeks prior to the second shot for an unknown indication. The patient did not have any known allergies. The patient previously received dose 1 of BNT162B2 on 03Apr2021 at 12:00 (as reported) as a single dose in the left arm for COVID-19 immunization. On 05May2021 at 09:00 (as reported), the patient experienced first day very bad dull headache in middle of brain, second day sweaty hands. She also experienced drop in blood sugar, and gas bloating. She was due to get her menstrual cycle 13May2021 or a day or two prior in schedule. A few days after the second dose she had acne on her cheeks, little red zits with no heads. She never had those before. Two weeks after the second dose her injection site hurt similar to the second day or that second dose. It was her right arm this time where she got the second dose. It was on and off for 3 to 4 days. She had mild nose bleeds that started in the right nostril mainly in the morning. She had done nothing different including no changes to the environment. It lasted about a week. Now (on an unspecified date) her period was late and she had weird cramping. She was not sexually active; no risk of pregnancy. The patient did not receive any treatment for the events. The outcomes of headache, sweaty hands, drop in blood sugar, gas bloating, acne, zits, injection site hurt, nose bleeds, period was late, and cramping were recovering with lasting effects. It was also reported that since the vaccination the patient had not been tested for COVID-19.

Other Meds: MAGNESIUM; CALCIUM; VITAMIN D3

Current Illness:

ID: 1401951
Sex: F
Age:
State: WA

Vax Date: 05/14/2021
Onset Date: 05/16/2021
Rec V Date: 06/16/2021
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Symptoms: Skin rash and ankles and hands; This is a spontaneous report from a contactable consumer (patient). This 20-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 14May2021 at 16:00 (at the age of 20-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included hypothyroid. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) and "BCP." The patient did not have any known allergies. On 16May2021 at 10:00 the patient experienced skin rash on ankles and hands. The event was reported as non-serious. The patient was not hospitalized for the event. The patient did not receive any treatment for the event. The outcome of skin rash was recovering. It was also reported that since the vaccination the patient was not tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: SYNTHROID

Current Illness:

ID: 1401952
Sex: F
Age:
State:

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Onset Date:
Rec V Date: 06/16/2021
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Symptoms: like a metal taste; rash on my arms; don't feel great after; headaches; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced like a metal taste, rash on my arms, don't feel great after and headaches. It was reported that the patient got vaccination (unspecified vaccine) and has like a metal taste and didn't know if it was a side effect from the vaccination. It was also reported that the patient developed a rash on her arms; one arm cleared up but the other one has just a light rash. She didn't feel real great after the vaccination last week and got headaches at least once a week. The outcome of the event rash on her arms was recovering while the outcome of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1401953
Sex: U
Age:
State:

Vax Date: 05/14/2021
Onset Date: 05/14/2021
Rec V Date: 06/16/2021
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Symptoms: I am having like muscle spasm at my back, on my right back; my back is just killing me my lower right back; I am so much in pain right now; This is a spontaneous report from a contactable consumer(patient). A patient of an unspecified age and gender received BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown, solution for injection; Batch/Lot Number and expiration date were not reported), via unspecified route of administration on 14May2021 as second dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown) on 23Apr2021 as the first dose, single for COVID-19 immunisation. On 14May2021, after waiting for a little bit after the shot, the patient experienced having like muscle spasm at back, on right back, felt that "my back is just killing me my lower right back" and was in so much pain (reported as right now). The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1401954
Sex: F
Age:
State:

Vax Date: 05/14/2021
Onset Date: 05/14/2021
Rec V Date: 06/16/2021
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Symptoms: got chills; fever; headache; This is a spontaneous report from a contactable consumer. A 13-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 14May2021 (Batch/Lot number was not reported) as first dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 14May2021 at night, patient got chills, fever, and headache. The patient's mother gave her 1 Tylenol. By 1:30 am, her fever was 103, her mother gave her two Tylenol and fever went to 100. At 7:30 am, 15May2021, her fever was back to 103 and her mother gave her two Tylenol again, fever went back to 100. At 3:25 am on 16May2021, fever was 103.5. Her mother gave her two Tylenol and went back to 100. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1401955
Sex: F
Age:
State: WA

Vax Date: 05/08/2021
Onset Date: 05/14/2021
Rec V Date: 06/16/2021
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Symptoms: On 14May2021 had tingling in right forearm, then throughout the days it travelled/ on 22May2021, bumps appeared on her right hand and arm/ a test and results on 25May2021 was shingles; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 08May2021 13:30 (at the age of 35 years old) (Lot Number: EW0162) as first dose, single dose for COVID-19 immunisation. Medical history included type 2 diabetes from an unknown date and unknown if ongoing. The patient did not have COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included glipizide, metformin, insulin glargine (BASAGLAR) and Vitamins; all taken for unspecified indication, start and stop date were not reported. Six days after 1st dose (14May2021), patient had tingling in right forearm, then throughout the days it travelled. In the morning of 22May2021, bumps appeared on her right hand and arm. On 24May2021, doctor did a test and results on 25May2021 was shingles. Tingling was random but happened throughout body on both sides. Patient was given antiviral meds (valacyclovir). The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did got tested for COVID post vaccination. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: GLIPIZIDE; METFORMIN; BASAGLAR

Current Illness:

ID: 1401956
Sex: F
Age:
State: CA

Vax Date: 03/26/2021
Onset Date:
Rec V Date: 06/16/2021
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Symptoms: Ulcer pain since I got the shot; Cant walk anymore, the pain is in my legs, in my feet, in my arms, I cant walk anymore; the pain is in my legs, in my feet, in my arms/fingers hurt; I had diarrhea and I had to throw up; I had diarrhea and I had to throw up; back hurts; all my bones are hurting; This is a spontaneous report from a contactable consumer (patient). This 86-year-old female patient received 1st dose of BNT162B2 (lot# ER8732) at the age of 86 years old, on 26Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant drug were not reported. Patient experienced Ulcer pain since got the shot. Cant walk anymore, the pain is in her legs, in her feet, in her arms (if take a pain killer it do not work). She cannot drive car nor go no places. Also Diarrhea, Had to throw up. Since I got this shot the first day I got, for 4 days I had diarrhea and I had to throw up, well I have never seen this in my life because when I throw it up it was (not clear), it was like two. Now I got this shot on 03/26 and now I am in ulcer pain, I cant walk, all my bones are hurting, I cant drive my car anymore, I cant go no place. I am 86 years old and all by myself. I dont know what to do I am in pain. My leg hurts I hardly can walk, my back hurts, my arms hurt, my fingers hurt. I dont know what I have to do. I am 86 years old and I live by myself and I dont know what to do. The first shot I got was on (03/36) and I had no problem with this one, but the second one I got is killing me (refer to AER#2021630678)." Outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1401957
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
Hospital: Y

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Symptoms: diarrhea; This is a spontaneous report from a contactable consumer. An adult male patient received COVID vaccine (unspecified trade name), dose 1 via an unspecified route of administration, administered in Arm Right on 08Aug2020 14:30(as reported, pending clarify) (Lot Number: AIN09876R4) as 1ST DOSE, SINGLE DOSE for covid-19 immunization. Facility type vaccine was Doctor office/urgent care. Medical history included hypertension, diabetes and food contains nuts allergy. Patient had covid prior vaccination. Concomitant medication included ibuprofen (ADVIL) taken for an unspecified indication. The patient experienced diarrhea from 09Aug2020 08:10(as reported) with outcome of recovered. The patient was hospitalized for diarrhea for 2 days.

Other Meds: ADVIL [IBUPROFEN]

Current Illness:

ID: 1401958
Sex: F
Age:
State: TX

Vax Date: 05/19/2021
Onset Date: 05/01/2021
Rec V Date: 06/16/2021
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Symptoms: Having an allergy issue; I felt kind of low energy; face its warm; Benadryl because it raise my heart rate; pain in the arm; Had pain in arm where I got the shot; shoulder joint hurting; Itching under under the arms, legs, in my pant, my back, in my bra, my face and my head; My feet close to ankle had some red small spots look like size of a pin head on my both lower legs; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old female patient received first dose of bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Formulation: Solution for injection, lot number: EW0175 and expiration date: unknown), via an unspecified route of administration in left arm on 19May2021 as a single dose for COVID-19 immunisation, diphenhydramine hydrochloride (BENADRYL), via an unspecified route of administration from an unspecified date for an unspecified indication. Medical history included seasonal allergy and concomitant medications were not reported. It was mentioned no other products were taken by the patient. On an unspecified date the patient experienced side effects when she took the first dose vaccine. The patient did not realize, perhaps that it could be she thought that she was just having an allergy issue. The patient had the first dose of vaccine on 19May2021 and the early in the week she kept itching under the arms, the legs and especially in face it is warm (not clarified), where in her pant, her back and in her bra and even on her face and her head on an unknown date in May2021. At first she thought maybe got bitten up by some mosquito and just itching. Last night when she was taking shower and applying some lotion on leg because she didn't get bitten up by mosquito but her feet close to my ankle when she looked down at her ankle had some red spots look like size of a pin head on both lower legs on an unspecified date. It wasn't raised up like anything. It was just red small spot all on both lower legs, so she did not know the only thing different she did was take that vaccine because she was using the same soap and using the same detergent. She didn't eat anything different, so she was itching and could not take Benadryl because it raised her heart rate, so she had been taking Allegra (treatment for event), so it's not taken away the itching but it still happens as not as much as if she didn't take it. Consumer further stated at first she had pain in the arm, shoulder, she noticed by the next day that shoulder joint was hurting and she didn't do anything like lift anything heavy, she felt kind of like low energy that she noticed. When probed for event start date, consumer stated, it was after (first dose) vaccine, the next morning my arm was paining on my shoulder joint that arm where I got the shot. I noticed by next morning (20May2021). The action taken in response to the events for for diphenhydramine hydrochloride was unknown. Therapeutic measures were taken as a result of having an allergy issue, itching, my feet had some red small spots. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1401959
Sex: F
Age:
State: TN

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
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Symptoms: Cold; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. A 52-years-old female patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EP77534) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, after vaccination the patient experienced cold. Patient stated that she scheduled this morning at 10:20 to receive her second dose. However, she had a cold. So, she wanted to know what happens next. She need number to reschedule her 2nd dose. Outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1401960
Sex: F
Age: 44
State:

Vax Date: 04/26/2021
Onset Date: 05/01/2021
Rec V Date: 06/16/2021
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Symptoms: body aches (pain); Initial information received on 29-May-2021 regarding an unsolicited valid non-serious case from a consumer from a patient support program via Regulatory Authority, (Manufacturer Report Number- UNT-2021-009583). This case involves a 44 years old female patient (68 kg) who experienced body aches (pain), after receiving INFLUENZA VACCINE and while treated with TREPROSTINIL SODIUM [REMODULIN]. It was unknown if the patient had any additional medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication included SILDENAFIL CITRATE. On 26-Apr-2021, the patient started taking REMODULIN (TREPROSTINIL SODIUM, 2.5 mg/ml, batch number and expiration date not reported) via subcutaneous for Pulmonary arterial hypertension. The current dose was reported as 0.00125 ?g/kg, continuous via subcutaneous (SQ) route. On 22-May-2021, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination. In May-2021, the patient developed a non-serious body aches (pain), within few days following the dose intake of TREPROSTINIL SODIUM and in the same month following the administration of INFLUENZA VACCINE. It was unknown if the patient experienced any additional symptoms/events. No laboratory data reported. Action taken with SQ (subcutaneous) Remodulin was not reported for the event of pain. It was not reported if the patient received a corrective treatment. At time of reporting, the outcome was unknown for the event pain. The reporter did not provide causality for the event of pain. There will no information on the batch number for this case.

Other Meds: SILDENAFIL CITRATE

Current Illness:

ID: 1401961
Sex: M
Age: 35
State:

Vax Date: 05/24/2021
Onset Date:
Rec V Date: 06/16/2021
Hospital:

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Symptoms: Adacel was prepared on Friday and administered on Monday by another medical assistant, but the patient changed their mind with no adverse event; Initial information received on 27-May-2021 regarding an unsolicited valid non-serious case received from other health care professional. This case involves a 35-year old male patient who got DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] was prepared on Friday and administered on Monday by another medical assistant, but the patient changed their mind with no adverse event (product use issue) [lot number: UH949AA and expiration date: 18-Nov-2022] via intramuscular route in the left deltoid unknown route in unknown administration site for prophylactic vaccination. It was unknown if the patient had any medical history, concomitant disease or risk factor, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was an actual medication error due to product use issue (latency: unknown). It was reported that he said that a needle was attached to the syringe and that they placed the syringe with the needle attached in the refrigerator. At the time of report, no adverse event was reported. It was unknown if there were lab data/results available. Disclaimer: 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 regarding batch number in this case.

Other Meds:

Current Illness:

ID: 1401962
Sex: F
Age: 0
State: OH

Vax Date: 06/04/2021
Onset Date: 06/04/2021
Rec V Date: 06/16/2021
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Symptoms: wrong vaccine Adacel (Tdap) was administered to an infant, with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Agency (Reference number- 00630973) and transmitted to Sanofi on 07-Jun-2021. This case involves a 6 months old female patient who was administered with a 0.5 mL dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6900AA and expiry date was not reported) via unknown route at an unknown administration site (product administered to patient of inappropriate age) for prophylactic vaccination on 04-Jun-2021. The patient's medical history, past medical treatments, past vaccinations and family history 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) and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation. The reporter needed to know what she needs to do from here? She states that she administered the wrong vaccine (adacel) to an infant on Friday. what do we need to do? Is there anything to watch out for?" It was an actual medication error case due to inappropriate age at vaccine administration (latency: same day). At the time of reporting, the patient experienced no adverse event. 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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1401963
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
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Symptoms: The patient received first dose at 10 years & 8 months and the second dose at 14 years & 3 months with no AE.; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Agency (Reference number- 00631041) and transmitted to Sanofi on 07-Jun-2021. This case involves a 16 years old female patient who received first dose at 10 years and 8 months and the second dose at 14 years and 3 months of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination (inappropriate schedule of product administration) on an unknown date. The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided. The reporter stated that patient is currently 16 years old and asked does patient need a booster? It was an actual medication error case due to inappropriate schedule of vaccine administered (latency: same day). At the time of reporting, the patient experienced no adverse event. 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 the 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 on the batch number for this case.

Other Meds:

Current Illness:

ID: 1401964
Sex: F
Age: 28
State: MI

Vax Date: 06/07/2021
Onset Date: 06/07/2021
Rec V Date: 06/16/2021
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Symptoms: A patient received a partial dose with no AE; entire hub of the syringe came off/ there was a leakage with no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional (nurse) via Agency (Reference number- 00631232) and transmitted to Sanofi on 07-Jun-2021. This case involves a 28 years old female patient who received an one mL dose (partial received) of suspect RABIES (HDC) VACCINE [IMOVAX RABIES] (lot T1B492M and expiry date: 07-Dec-2021) via intramuscular route in right deltoid (underdose) for prophylactic vaccination on 07-Jun-2021, as entire hub of the syringe came off and there was a leakage while administrating (syringe issue). The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided. The nurse reports confirmed the product was not mishandled. The nurse added that they are not comfortable billing the consumer with the vaccine and was asking about how to process a reimbursement request. It was an actual medication error case due vaccine underdose (latency: same day). It was also a case of syringe leak as when reporter was mixing the medication, when she flipped the vial, the entire hub of the syringe came off. They were able to put it back in and administered the vaccine but there was a leakage. The consumer is estimated to have received half the dose. At the time of reporting, the patient experienced no adverse event. 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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1401965
Sex: F
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
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Symptoms: Relapse of bipolar depression; Aches and pains; Ringing in her ears; Joint pain / Burning pains in her small joints; Myalgia; This literature case was received on 07-Jun-2021 and concerned a 49-year-old, female patient. The patient's concurrent conditions included well controlled bipolar depression and comorbid attention-deficit / hyperactivity disorder. The patient's concomitant medications included buspirone, lurasidone, oxcarbazepine and trazodone, all for bipolar depression and lisdexamfetamine for comorbid attention-deficit / hyperactivity disorder. On an unspecified date, two weeks earlier, the patient's depression was in full remission and she had scored 0 on the 9-item Patient Health Questionnaire (PHQ-9). On an unknown date, a week before coming to clinic, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration, indication and anatomical location: not reported). The batch number was not reported. On the same day, within a couple of hours after receiving influenza virus vaccine polyvalent, the patient started feeling depressed and became tearful. These symptoms were followed a couple of days later with aches and pains, which escalated over the subsequent days. She complained of joint pain, burning pains in her small joints and myalgia, and rated her pain as 6/10. On an unspecified date, two weeks after her clinic visit, the patient returned to the clinic for an urgent, unscheduled visit due to escalating depression, which was rated as 18/27 on the PHQ-9 (a score of 15-19 was considered moderately severe). The patient also noticed ringing in her ears for the previous two days. On the assumption that patient's relapse of depression was related to an immune response, physicians agreed to a trial of celecoxib at dose of 200 mg twice a day and she was asked to return in a week if her condition did not improve. On an unknown date, the patient started treatment with celecoxib for relapse of bipolar depression. On an unknown date, the patient's depression resolved when treated with celecoxib. On an unknown date, eight weeks later, the patient returned to clinic for a previously scheduled appointment and reported having experienced a dramatic response to celecoxib. Her depression had remitted rapidly, and she scored 0/27 on the PHQ-9. The patient reported an additional benefit of improved interpersonal interactions. The outcome of 'pain', joint pain and myalgia was not reported. The author assessed the event of bipolar depression as related to influenza virus vaccine polyvalent, while the causality for other events was not provided. Physicians discussed the possibility that patient's depression might be a reaction to the flu vaccine. On the assumption that her relapse of depression was related to an immune response they agreed to a trial of celecoxib. Should bipolar patients experience vaccination-induced relapse of depression, adding celecoxib to their treatment regimen could be helpful. The event of bipolar depression was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department. Company comment: A 49-year-old, female patient with medical history of well controlled bipolar depression and comorbid attention-deficit / hyperactivity disorder was vaccinated with influenza virus vaccine polyvalent. On the same day, within a couple of hours after receiving influenza virus vaccine polyvalent, the patient started feeling depressed and became tearful. These symptoms were followed a couple of days later with aches and pains, which escalated over the subsequent days. She complained of joint pain, burning pains in her small joints and myalgia. On an unspecified date, two weeks after her clinic visit, the patient returned to the clinic for an urgent, unscheduled visit due to escalating depression. The patient also noticed ringing in her ears. On the assumption that patient's relapse of depression was related to an immune response, physicians agreed to a trial of celecoxib at dose of 200 mg twice a day. The patient's concomitant medications included buspirone, lurasidone, oxcarbazepine and trazodone. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for all events.; Reporter's Comments: Physicians discussed the possibility that patient's depression might be a reaction to the flu vaccine. On the assumption that her relapse of depression was related to an immune response they agreed to a trial of celecoxib. Should bipolar patients experience vaccination-induced relapse of depression, adding celecoxib to their treatment regimen could be helpful.; Sender's Comments: A 49-year-old, female patient with medical history of well controlled bipolar depression and comorbid attention-deficit / hyperactivity disorder was vaccinated with influenza virus vaccine polyvalent. On the same day, within a couple of hours after receiving influenza virus vaccine polyvalent, the patient started feeling depressed and became tearful. These symptoms were followed a couple of days later with aches and pains, which escalated over the subsequent days. She complained of joint pain, burning pains in her small joints and myalgia. On an unspecified date, two weeks after her clinic visit, the patient returned to the clinic for an urgent, unscheduled visit due to escalating depression. The patient also noticed ringing in her ears. On the assumption that patient's relapse of depression was related to an immune response, physicians agreed to a trial of celecoxib at dose of 200 mg twice a day. The patient's concomitant medications included buspirone, lurasidone, oxcarbazepine and trazodone. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for all events.

Other Meds: Buspirone; Lurasidone; Oxcarbazepine; Trazodone; Lisdexamfetamine

Current Illness: Attention deficit/hyperactivity disorder; Bipolar depression (History of bipolar depression, well controlled on her regimen of medications.)

ID: 1401967
Sex: F
Age: 43
State: IN

Vax Date: 06/10/2021
Onset Date: 06/10/2021
Rec V Date: 06/16/2021
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Allergies: penecillin

Symptom List:

Symptoms: Immediate strong soreness at injection site; sore enough that I spoke to the nurse doing the 15-minute watch. She told me to monitor it and that soreness was a common result. My arm was sore but I also have some tingling and numbness in my left arm and hands. It is uncomfortable and worrying but does not seem to affect my activities at this point. That being said it has worsened over the period between now and the injection. My only side effect from the first injection was soreness the day after the injection, which subsided within two days with no lasting effects.

Other Meds: lamotrigine 300 mg/daily welbutrin 300 mg/daily levothyroxine 88 mcg daily metan-X 1 tablet daily metformin 500 mg daily baby aspirin 88 mg daily fish oil vitamin E 400 units daily vitamin D 4000 units daily

Current Illness: none

ID: 1401968
Sex: M
Age: 35
State: MD

Vax Date: 05/06/2021
Onset Date: 05/06/2021
Rec V Date: 06/16/2021
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Allergies: N/A

Symptom List:

Symptoms: Last May 6, 2021, I recieved my 1st dose of MODERNA vaccine. For the last 5 days I don't feel any side effects on my body. But on the 6th day after my vaccination, I started to feel anxiety, insomnia, brain fog followed by depression, panic attack and rapid heart palpitation and it lasted for 3 weeks. Until now, there are times that I can still feel the rapid heart palpitation.

Other Meds: Sundown Multivitamin Plus24HR Immune Support

Current Illness: No

ID: 1401969
Sex: M
Age: 60
State: MA

Vax Date: 04/29/2021
Onset Date: 05/22/2021
Rec V Date: 06/16/2021
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Symptoms: Tinnitus

Other Meds: Alphagan, low dose asprin

Current Illness:

ID: 1401970
Sex: F
Age: 39
State: MD

Vax Date: 05/19/2021
Onset Date: 05/22/2021
Rec V Date: 06/16/2021
Hospital:

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Lab Data:

Allergies: Penicillin and latex

Symptom List:

Symptoms: May 22nd felt like I was going to have a heart attack. Pain started in chest more throughout the next few days. May 26 went to health clinic. Was told to go to hospital. Had ekgs. One abnormal...was sent home with no treatment. Was called but hospital nurse to come back in the next day to check for heart inflammation as she had recently read about the reverse effects with moderna. Had more ekgs done and never had a test for inflammation and got sent home. May 30th had headaches, muscle aches, sore throat at night and cough. Still having chest pain. Started getting a rash on my left side of my face. May 31st, vomited and felt sick most of the day. June 1st noon. Took a bath and got extremely dizzy and fatigued so I layed down. Didn't wake up till 7pm. June 2nd, had an appt with regular dr. Asked for a test to check for inflammation. Was told to take aleve 2 times a day.. Found out I'm allergic to it.. Had an echo done next morning. Was told test results were normal. May 11th till present day, June 16th, I am struggling with breathing and still have chest pain. Given no treatment.

Other Meds: None

Current Illness: Mental health

Date Died: 05/27/2021

ID: 1401971
Sex: F
Age: 62
State: SC

Vax Date: 04/19/2021
Onset Date: 04/24/2021
Rec V Date: 06/16/2021
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Allergies: none

Symptom List:

Symptoms: Few days after receiving the vaccine around 4/25, my mother complained to me that she was feeling very weak and tired, she was unable to hold anything down. She also had a rash. She became weaker and weaker so suddenly and unable to even drink protein drinks. She finally went to the ER on 5/4 because she could barely walk, unable to eat anything and was short of breath. They diagnosed her with pneumonia and a possible lung mass. She was diagnosed simultaneously 10 days later with small cell lung cancer however she had no symptoms prior. She received first dose chemo on 5/20/21 and had a reaction to the chemo that the doctor stated was very rare. They then had to try a different type of chemo for second dose 2 days later. She progressively got worse suddenly after chemo dose #3 and was in renal failure the day following chemo completion. She died on 5/27/2021. Her primary death diagnosis was sepsis, pneumonia and small cell lung cancer. I am reporting this for my mother because the vaccine has not been tested on cancer or chemo patients. It can and should not be regarded as coincidental. It needs to be tracked in case there are future reports regarding cancer patients.

Other Meds: none

Current Illness: umbilical hernia / hiatal hernia

ID: 1401972
Sex: F
Age: 17
State:

Vax Date: 06/12/2021
Onset Date: 06/12/2021
Rec V Date: 06/16/2021
Hospital: Y

Vax Type:
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Lab Data:

Allergies: NKDA

Symptom List:

Symptoms: PT with chest pain and SOB since the day of vaccination; this was the 2nd COVID vaccine. First dose 22May2021 with no reactions.

Other Meds: NONE

Current Illness: NONE

ID: 1401973
Sex: F
Age: 59
State: MD

Vax Date: 06/14/2021
Onset Date: 06/14/2021
Rec V Date: 06/16/2021
Hospital:

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Lab Data:

Allergies: Penicillin

Symptom List:

Symptoms: 101 fever Body aches Tiredness

Other Meds:

Current Illness:

ID: 1401974
Sex: M
Age: 21
State: PR

Vax Date: 04/29/2021
Onset Date: 05/05/2021
Rec V Date: 06/16/2021
Hospital:

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Lab Data:

Allergies: None

Symptom List:

Symptoms: Extreme weakness, myalgia, pain in body, headache, fever, chills, high blood pressure lasted for approximately 2 weeks.

Other Meds: None

Current Illness: None

ID: 1401993
Sex: U
Age:
State: AL

Vax Date: 06/26/2018
Onset Date: 05/17/2021
Rec V Date: 06/16/2021
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Symptoms: No further information is available; a patient inadvertently received the second dose of PNEUMOVAX23; This spontaneous report was received from an office manager, referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not provided. On 26-JUN-2018, the patient was given the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route, lot # and expiration date were unknown) for prophylaxis. On 17-MAY-2021, the patient inadvertently received the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (1 dose, lot # T033369 and expiration date 26-MAY-2022; strength and route were unknown) for prophylaxis (inappropriate schedule of product administration). No pqc. No further information was available. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T033369; expirationdate: 26-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent

Other Meds: PNEUMOVAX 23 SYRINGE

Current Illness:

ID: 1401994
Sex: U
Age:
State: MO

Vax Date: 05/19/2021
Onset Date: 05/19/2021
Rec V Date: 06/16/2021
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Symptoms: No additional adverse events reported; an expired dose of VAQTA was administered today; This spontaneous report was received from a temp stability agent (medical assistant) referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not provided. On 19-MAY-2021 (reported as today), an expired dose of hepatitis a vaccine, inactivated (VAQTA) (1 dose, lot # T014590 and expiration date 15-APR-2021; strength and route were unknown) was administered for prophylaxis (expired product administered). The reporter reported that product was properly stored up through administration. The reporter did not report any signs/symptoms. No further information provided. No additional adverse events reported. No product quality complaint. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T014590; expirationdate: 15-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent

Other Meds:

Current Illness:

ID: 1401996
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
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Symptoms: Suspected vaccination failure; got a severe case of the shingles!; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the consumer for herself or himself. The age at vaccination was not reported. The patient developed severe case of shingles after receiving Shingles vaccination. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation test were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1401997
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
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Symptoms: Suspected vaccination failure; Shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (Family History) (patient cousin had a shingles). On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The case was reported by the cousin of the patient. The age at vaccination was not reported. The patient developed shingles after receiving Shingles vaccination. The reporter stated that, the patient had them just as bad as reporter did. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation test were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1401998
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
Hospital:

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Symptoms: Felt a little sick for a couple of days; This case was reported by a consumer via media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles Vaccine (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved. It was unknown if the reporter considered the sickness to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The reporter stated that he/she received vaccine and felt a little sick for a couple of days. No other information was reported.

Other Meds:

Current Illness:

ID: 1401999
Sex: U
Age:
State: WI

Vax Date: 06/11/2021
Onset Date: 06/11/2021
Rec V Date: 06/16/2021
Hospital:

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Symptoms: administered an expired pediatric dose of Engerix-B / expired on 06/3/2021; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B pediatric) (batch number unknown, expiry date 3rd June 2021) for prophylaxis. Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis. On 11th June 2021, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 11th June 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were reported as follows: The age at vaccination was not reported. On 11th June 2021, patient received Engerix B pediatric which was expired on 3rd June 2021. The reporter asked if the vaccine should be repeated or not. The Healthcare professional was not confortable giving any detail. The reporter did not consented to follow up.

Other Meds:

Current Illness:

ID: 1402000
Sex: U
Age:
State: MD

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
Hospital:

Vax Type:
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Symptom List:

Symptoms: Two patient / late for the second dose / first dose / on December 2019; 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 with an associated reaction of no adverse event (1st dose of Shingrix received in December 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 the 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient's identifiers, LOT number and expiration date was not provided for the first dose. The reporter did not consented to follow up. This is 1 of the 2 cases reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR129763: reporter. Patient #2 of 2.

Other Meds:

Current Illness:

ID: 1402001
Sex: M
Age:
State: OH

Vax Date: 06/02/2021
Onset Date: 06/02/2021
Rec V Date: 06/16/2021
Hospital:

Vax Type:
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Symptoms: receive an expired dose of Menveo; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA260A, expiry date 31st March 2021) for prophylaxis. On 2nd June 2021, the patient received Menveo (intramuscular). On 2nd June 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional case details were reported as follows: The age at vaccination was not reported. The patient inadvertently received an expired dose of Menveo in the left deltoid. As per sales data sheet reported batch number was changed from AMAA260A to AMVA260A. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1402002
Sex: M
Age:
State: VA

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 06/16/2021
Hospital:

Vax Type:
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Symptoms: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; MILD PAIN IN SITE OF INJECTION; This spontaneous report received from a consumer concerned a 69 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 09-JUN-2021) 1 total dose was not reported, administered on 01-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. The patient did 2 antibodies tests and they were negative. On 28-MAY-2021 his result came out negative. The second test was done on 04-JUN-2021 and test came out negative(confirmed immunological vaccine failure). He took the vaccine, he did not have any side effects. He only had mild pain in the site of injection went away the same day after 4 hours. Laboratory data included: SARS-CoV-2 antibody test (NR: not provided) Negative. On 04-JUN-2021, Laboratory data included: SARS-CoV-2 antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild pain in site of injection on 01-APR-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210616495-covid-19 vaccine ad26.cov2. s -confirmed immunological vaccine failure. 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: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1402003
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
Hospital:

Vax Type:
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Allergies:

Symptom List:

Symptoms: OVERDOSE; PRODUCT ADMINISTRATION ERROR; NOT OBVIOUS LABELING ON VIAL; This spontaneous report received from a health care professional 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, and batch number were not reported) dose, start therapy date were 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. On an unspecified date, the subject experienced overdose, product administration error, and not obvious labeling on vial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the overdose, product administration error and not obvious labeling on vial was not reported. This report was non-serious. This report was associated with product quality complaint 90000182226. The suspected product quality complaint has been confirmed to be pqv management approval - confirmed no pqc was identified within the reported complaint reported. complaint is approved for void. based on the PQC evaluation/investigation performed.

Other Meds:

Current Illness:

ID: 1402004
Sex: F
Age:
State: OH

Vax Date:
Onset Date: 06/09/2021
Rec V Date: 06/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: ADMINISTRATION ERROR OF A VACCINE DOSE FROM A PUNCTURED VIAL THAT WAS LEFT 3 HOURS AT ROOM TEMPERATURE; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist 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: 201A21A expiry: 23/JUN/2021) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced administration error of a vaccine dose from a punctured vial that was left 3 hours at room temperature. On 09-JUN-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error of a vaccine dose from a punctured vial that was left 3 hours at room temperature and out of specification product use was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1402005
Sex: M
Age:
State: GA

Vax Date:
Onset Date: 03/22/2021
Rec V Date: 06/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: DIZZINESS; MUSCLE ACHES; SWELLING IN THE NECK AND SHOULDER AREA; UNUSUAL TASTE IN THE MOUTH; UPSET STOMACH; This spontaneous report received from a patient concerned a 69 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced swelling in the neck and shoulder area. On 22-MAR-2021, the subject experienced unusual taste in the mouth. On 22-MAR-2021, the subject experienced upset stomach. On 22-MAR-2021, the subject experienced muscle aches. On 24-MAR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in the neck and shoulder area, muscle aches, unusual taste in the mouth, upset stomach, and dizziness. This report was non-serious.

Other Meds:

Current Illness:

Date Died:

ID: 1402006
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: DEATH; This spontaneous report received from a consumer via a company representative 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, expiry: Not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient died. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died due to unknown cause. This report was serious (Death).; Sender's Comments: V0; 20210626664- COVID-19 VACCINE AD26.COV2.S-Death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness:

ID: 1402007
Sex: M
Age:
State: WI

Vax Date:
Onset Date: 06/02/2021
Rec V Date: 06/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a health care professional concerned a 69-year-old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no information on medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 14-MAY-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 02-JUN-2021, the patient had a negative antibody test (coded as suspected immunological vaccine failure). Laboratory data included: SARS-CoV-2 ELISA test (NR: not provided) as negative. The test was an IgG Elisa-Spike. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210626695 -Covid-19 vaccine ad26.cov2.s- suspected immunological vaccine failure. 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: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1402008
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: SEIZING; PASSED OUT; LIGHTHEADED; URINATED; VOMITED; NAUSEATED; This spontaneous report received from a consumer concerned a male 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: 1821286, expiry: UNKNOWN) dose was not reported, administered on 12-JUN-2021, around 12:30 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, after vaccination, patient waited around 30 minutes in store before heading home in a car driven by his father. After ten minutes, in the car, patient's father noticed that patient had slumped over after saying he felt lightheaded and passed out. Patient started seizing for about 30 seconds, urinated on himself and finally came to asking where he was. Then within five minutes, patient got nauseated and vomited. Once patient vomited, he started feeling better. He was able to shower with assistance once home and is now lying down feeling lightheaded and nauseated. Patient's parents continued monitor him for the next several hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from seizing, passed out, urinated, and vomited, and had not recovered from lightheaded, and nauseated. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210627035-COVID-19 VACCINE AD26.COV2.S- seizing, passed out. This events is considered unassessable. The events 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 events.

Other Meds:

Current Illness:

ID: 1402009
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: SEVERE PAIN; DEBILIATING CHRONIC BACK PAIN; This spontaneous report received from a patient via a company representative 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, start therapy date were 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. On an unspecified date, the subject experienced severe pain, and debiliating chronic back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe pain and debiliating chronic back pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20210627096.

Other Meds:

Current Illness:

ID: 1402010
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: PERSISTENT RANDOM QUICK SHARP PAIN IN CHEST; BLURRED VISION; HEADACHE; 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 12-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced persistent random quick sharp pain in chest, blurred vision, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from persistent random quick sharp pain in chest, headache, and blurred vision. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.

Other Meds:

Current Illness:

ID: 1402011
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: FELT LIKE CRAP THE NEXT DAY; CHILLS; ALL JOINTS HURT; FEVER; 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: Unk) 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, the subject experienced felt bad the next day, chills, all joints hurt, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome felt bad the next day, chills, all joints hurt and fever was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1402012
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: BODY ACHES; This spontaneous report received from a patient 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, start therapy date were not reported for prophylactic vaccination. The batch number was not provided and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of body aches was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1402013
Sex: M
Age:
State: MA

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 06/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: JAW PAIN; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight was 201 pounds, and height was 194 centimeters. The patient's concurrent conditions included alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 05-AUG-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced jaw pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from jaw pain. This report was non-serious. This case, from the same reporter is linked to 20210626627.

Other Meds:

Current Illness: Alcoholic (1 beer per week); Non-smoker

Date Died:

ID: 1402014
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: DEATH; This spontaneous report received from a consumer via a company representative concerned an adult male. Additional live follow up was received on 14-JUN-2021. 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) one total dose, start therapy date were 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. On an unspecified date, the patient was died. The cause of death was not reported. It was unknown whether the autopsy was done or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210629311- covid-19 vaccine ad26.cov2.s-death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness:

ID: 1402015
Sex: U
Age:
State: NV

Vax Date:
Onset Date: 06/11/2021
Rec V Date: 06/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: POOR QUALITY VACCINE ADMINISTERED; INCORRECT STORAGE OF PRODUCT (VIAL WAS PUNCTURED AT 07:51, AND DOSE WAS GIVEN AT 14:50); This spontaneous report received from a health care professional 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 expiry: 05-AUG-2021) dose was not reported, administered on 11-JUN-2021 14:50 for prophylactic vaccination. No concomitant medications were reported. On 11-JUN-2021, the subject experienced poor quality vaccine administered. On 11-JUN-2021, the subject experienced incorrect storage of product (vial was punctured at 07:51, and dose was given at 14:50). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the poor quality vaccine administered and incorrect storage of product (vial was punctured at 07:51, and dose was given at 14:50) was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1402016
Sex: M
Age: 18
State: FL

Vax Date: 06/14/2021
Onset Date: 06/15/2021
Rec V Date: 06/16/2021
Hospital:

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

Lab Data:

Allergies: None

Symptom List:

Symptoms: Upon waking up the next day after the vaccine I experienced out of the ordinary fatigue and arm soreness. This progressed into a rather severe migraine. As of today, 06/16/2021 at 6:30am I woke up with dizziness and lightheadedness which is again out of the ordinary for me and I believe is attributed to the vaccine.

Other Meds: None

Current Illness: None

ID: 1402017
Sex: F
Age: 41
State: PA

Vax Date: 01/11/2021
Onset Date: 01/25/2021
Rec V Date: 06/16/2021
Hospital:

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

Lab Data:

Allergies: No Known Allergies

Symptom List:

Symptoms: Headache Congestion or running nose Cough

Other Meds: betamethasone, augmented, (DIPROLENE AF) 0.05 % cream cannabidioL (EPIDIOLEX) 100 mg/mL oral solution cholecalciferol, vitamin D3, 125 mcg (5,000 unit) tablet clindamycin-benzoyl peroxide (DUAC) gel ezetimibe (ZETIA) 10 mg tablet famotidine

Current Illness: None

Total 2021 VAERS Injuries: 704,237

Page last modified: 03 October 2021 5:28pm