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
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: 0918119
Sex: U
Age:
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Rec V Date: 01/04/2021
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Symptoms: Shingles; This case was reported by a consumer and described the occurrence of shingles in a 75-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (already had shingles when patient was younger). Previously administered products included FLU VACCINE. On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient reported no more vaccines for him/her as no matter what anyone says dosen't matter what GlaxoSmithKline have (flu, cold, allergies, pneumonia,etc.) they probably would say it's the Covid virus The patient haven't lived all this time with no common sense.; Sender's Comments: US-GLAXOSMITHKLINE-US2020AMR231589:same reporter

Other Meds:

Current Illness:

ID: 0918120
Sex: U
Age:
State:

Vax Date: 11/16/2020
Onset Date: 11/01/2020
Rec V Date: 01/04/2021
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Symptoms: The site of my shot is still red; The site of my shot / sore.; The site of my shot is still / itchy; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On 16th November 2020, the patient received Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site pain and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site itching were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site pain and injection site itching to be related to Shingrix. Additional details were provided as follows: The age at the vaccination was not reported. The age group was not reported but was selected as an adult as per the vaccine indication. The patient received the vaccine. The patient experienced site of shot was still red, itchy and sore.

Other Meds:

Current Illness:

ID: 0918121
Sex: U
Age:
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Rec V Date: 01/04/2021
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Symptoms: A little ache in my arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The patient said that never got sick from shots, may be a little ache in my arm for 2 days.

Other Meds:

Current Illness:

ID: 0918122
Sex: U
Age:
State:

Vax Date: 11/19/2020
Onset Date: 11/20/2020
Rec V Date: 01/04/2021
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Symptoms: i have fever today; This case was reported by a other health professional via other manufacturer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date). Concurrent medical conditions included gastrointestinal symptom nos and rheumatoid arthritis. Concomitant products included tofacitinib citrate (Xeljanz). On 19th November 2020, the patient received the 2nd dose of Shingrix. On 20th November 2020, 1 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to Shingrix. Additional details were reported as follows: The age group was not reported, but was selected adult as per vaccine indication. The age at vaccination was not reported. The patient reported that he/she had gastrointestinal symptoms before starting Xeljanz and was unchanged since previous contact (10th August 2020). The patient received 2nd dose of Shingrix and next day experienced fever. Physician awareness was not stated.

Other Meds: XELJANZ

Current Illness: Gastrointestinal symptom NOS; Rheumatoid arthritis

ID: 0918123
Sex: U
Age:
State:

Vax Date: 09/01/2020
Onset Date:
Rec V Date: 01/04/2021
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Symptoms: Tiredness; ache in upper left arm; This case was reported by a consumer and described the occurrence of tiredness in a 65-year-old patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. The patient's past medical history included chickenpox (mild case chickenpox when 12 or 13 years of age). Concurrent medical conditions included drug allergy (allergy to sulfa drugs). On 1st September 2020, the patient received the 1st dose of Influenza vaccine Quadrivalent unspecified season. On 1st September 2020, less than a day after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced tiredness and pain in arm. On an unknown date, the outcome of the tiredness and pain in arm were recovered/resolved. It was unknown if the reporter considered the tiredness and pain in arm to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were reported as follows: The patient had no allergic reactions, only known drug allergy was to sulfa drugs. The age at vaccination was not reported but it could be 64 to 65. As the patient was aged his or her temperature ranges from 97 plus to 98.4 degree F. The patient received the Flu shot in left arm and experienced tiredness with ache in upper left arm lasted 3 days, beginning in the evening of the day of shot. The patient received Prevnar 13 vaccine on 6th October 2020 in left arm and experienced same events. The patient received 1st dose of Shingrix on 16th November 2020 and had allergic reaction. On 19th November 2020, the patient confirmed that he or she never had shingles. This case has been linked with US2020AMR234476 reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2020AMR234476:same reporter

Other Meds:

Current Illness:

ID: 0918124
Sex: U
Age:
State: CA

Vax Date:
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Rec V Date: 01/04/2021
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Symptoms: nausea; vomiting; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced vomiting and nausea. On an unknown date, the outcome of the vomiting and nausea were recovered/resolved. It was unknown if the reporter considered the vomiting and nausea to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of Shingrix 10 weeks ago. The patient experienced extreme reaction nausea and vomiting for 6 hours. The patient asked expect the same reaction with the 2nd dose.

Other Meds:

Current Illness:

ID: 0918125
Sex: F
Age: 64
State: CA

Vax Date: 12/03/2020
Onset Date: 12/01/2020
Rec V Date: 01/04/2021
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Symptoms: chills; headache; fever / low grade temp; sore arm; This case was reported by a consumer via call center representative and described the occurrence of chills in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on unknown date. please refer the case US2020240919). On 3rd December 2020, the patient received the 2nd dose of Shingrix. On 3rd December 2020, less than a day after receiving Shingrix, the patient experienced chills, headache and fever. In December 2020, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the chills, headache, fever and pain in arm were unknown. It was unknown if the reporter considered the chills, headache, fever and pain in arm to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix. The patient reported headache, chills, fever, and a sore arm. The reporter did not consent to follow up.; Sender's Comments: US-GLAXOSMITHKLINE-US2020240919:same patient

Other Meds:

Current Illness:

ID: 0918126
Sex: F
Age: 53
State: NJ

Vax Date: 12/10/2020
Onset Date: 12/01/2020
Rec V Date: 01/04/2021
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Symptoms: The soreness in her left arm (at injection site); Several flu-like symptoms developed; Not able to sleep through the night; Pt stated this shot "knocked her for a loop"; Headache; Shivering / chills; Myalgia; Fatigue; Still "walking slowly"; Feels unwell / "under the weather"; Feeling hung over; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 8th or 9th October 2020, refer case US2020246456) and Flu vaccine with an associated reaction of chills (received on 8th or 9th October 2020). On 10th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). In December 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, influenza-like symptoms, difficulty sleeping, discomfort, headache, chills, myalgia, fatigue, walking difficulty, feeling unwell and hangover effect. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, chills and fatigue were not recovered/not resolved and the outcome of the influenza-like symptoms, difficulty sleeping, discomfort, walking difficulty, feeling unwell and hangover effect were unknown and the outcome of the headache and myalgia were recovering/resolving. The reporter considered the injection site pain, headache, chills, myalgia and fatigue to be related to Shingrix. It was unknown if the reporter considered the influenza-like symptoms, difficulty sleeping, discomfort, walking difficulty, feeling unwell and hangover effect to be related to Shingrix. Additional details were reported as follows: The patient stated that on the night of vaccination she did had some soreness in her left arm but no (systemic) other symptoms before bedtime, during the night however several flu-like symptoms developed and she was not able to sleep through the night because she kept waking up with symptoms. The patient stated that this 2nd dose of Shingrix knocked her for a loop. The patient had a bad headache and the headache was going away, she did not take any medication to treat the headache. She had shivering/chills, the shivering had resolved though she still feels a little chilled. She had myalgia, she says it was still going on but getting better. The patient reported she experienced fatigue. On the morning of reporting she stated she was feeling a little better now that she has eaten breakfast and had some coffee. The patient stated that she was still walking slowly because she feels unwell and under the weather and feeling hung over. At the time of this reporting, the soreness in her left arm (at injection site) was still sore to the touch. The reporter consented to follow up.; Sender's Comments: US-GLAXOSMITHKLINE-US2020246456:Same reporter. 1st dose

Other Meds:

Current Illness:

ID: 0918127
Sex: M
Age:
State: CO

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

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Symptoms: severe Shingrix vaccine reaction / hospitalized for almost three weeks; This case was reported by a consumer via call center representative and described the occurrence of hospitalization in a male 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 hospitalization (serious criteria hospitalization). On an unknown date, the outcome of the hospitalization was unknown. It was unknown if the reporter considered the hospitalization to be related to Shingrix. Additional information was provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The reporter stated that she had a complex issue, but it was a severe Shingrix vaccine reaction, patient was hospitalized for almost three weeks. The reporter was wondering what commonalities there might be with the new COVID vaccines. She was guessing other people have this big problem, so that to her it was something that need to figure out, so she don't have to have her doctor track this down. The reporter consented to follow up.; Reporter's Comments: realize we have a complex issue, but it was a severe Shingrix vaccine reaction, my husband was hospitalized for almost three weeks, (inaudible) I was wondering what commonalities there may be with the new COVID vaccines. I'm guessing other people have this big problem, so that to me is something you guys need to figure out, so I don't have to have my doctor track this down.

Other Meds:

Current Illness:

ID: 0918128
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/04/2021
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Symptoms: Seizures; This case was reported by a consumer via interactive digital media and described the occurrence of seizure in a female patient who received DTPa (DTaP vaccine) for prophylaxis. On an unknown date, the patient received DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown. The reporter considered the seizure to be related to DTaP vaccine. Additional details were provided as follows: The age at vaccination was not reported Reporter daughter reacted to DTaP, when she was a baby. Seizures abd the like. However, when reporters daughter was older, reporter went back and got her vaccinated. She didn't react that time.

Other Meds:

Current Illness:

ID: 0918129
Sex: F
Age: 59
State: SC

Vax Date: 11/04/2020
Onset Date: 11/01/2020
Rec V Date: 01/04/2021
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Symptoms: Possible shingles; reaction at the injection site / swelling; reaction at the injection site / redness; developed a H/A; started with chills; felt feverish; with shaking; rash with radiating pain; bruising at the injection site.; she felt like she had a bug bite on her lower abdomen; rash on her L lower abdomen with radiating pain; Felt bad for 2 days; This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 4th November 2020 09:30, the patient received the 1st dose of Shingrix. On 4th November 2020 18:00, 8 hrs 30 min after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced extensive swelling of vaccinated limb, injection site erythema, headache, chills, fever and tremor. In November 2020, the patient experienced injection site bruising, painful rash, shingles, feeling bad, lower abdominal pain and radiating pain. The patient was treated with valaciclovir hydrochloride (Valtrex) and paracetamol (Tylenol). On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, headache, chills, fever, tremor, painful rash, shingles and lower abdominal pain were unknown and the outcome of the injection site bruising was not recovered/not resolved and the outcome of the feeling bad and radiating pain were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site bruising, headache, chills, fever, tremor, painful rash, shingles, feeling bad, lower abdominal pain and radiating pain to be related to Shingrix. Additional details were reported as follows: The patient received the Shingrix shot around 9:30 am and around 6 pm that evening she developed a reaction at the injection site on her left arm with redness and swelling that radiated down to the middle of her arm. At 6 pm she also developed a headache then started with chills and felt feverish with shaking. She took Tylenol and felt bad for 2 days. Then it resolved. Five or 6 days later she felt like she had a bug bite on her lower abdomen but it was not itchy. She had pain with this and that evening she noticed she developed a rash on her left lower abdomen with radiating pain for 3 days. It spread to her back up towards her spine. She had bruising at the injection site at the time of reporting. Her physician put her on Valtrex which she had been on since 17th November 2020. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 0918130
Sex: M
Age: 58
State: NC

Vax Date: 11/20/2020
Onset Date: 11/01/2020
Rec V Date: 01/04/2021
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Symptoms: redness around injection site; chills/ chills; FAtigue; aching in joints; aching in joints and throughout his whole body / body aches; shakes; aching in back muscles; fever up to 101 degrees/ fever; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included paracetamol (Tylenol) and ibuprofen (Advil). On 20th November 2020, the patient received the 1st dose of Shingrix (intramuscular). In November 2020, less than a day after receiving Shingrix, the patient experienced chills, fatigue, joint pain, general body pain, tremor, muscular back pain, fever and headache. On 23rd November 2020, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema, chills, joint pain, general body pain, muscular back pain, fever and headache were not recovered/not resolved and the outcome of the fatigue and tremor were recovered/resolved. It was unknown if the reporter considered the injection site erythema, chills, fatigue, joint pain, general body pain, tremor, muscular back pain, fever and headache to be related to Shingrix. Additional details were reported as follows: The patient received the first dose of Shingrix vaccine on 20th November 2020 friday afternoon. On friday night he had chills. On 21st November 2020, saturday morning he had fatigue, aching in joints throughout his whole body, chills, shakes, aching in back muscles and fever up to 101 degree F. On 23rd November 2020, 3 days after vaccination the patient had injection site erythema. In less than a week the patient experienced headache. Patient took Tylenol and Advil on Saturday. The patient had body aches, headache, fever and chills at the time of repoting. The patient had redness around the injection site and just above or below the injection site as well. No further information was available. The reporter consented to follow up.

Other Meds: TYLENOL; ADVIL

Current Illness:

ID: 0918131
Sex: F
Age:
State: AL

Vax Date:
Onset Date: 11/01/2020
Rec V Date: 01/04/2021
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Symptoms: 7 th cranial nerve affecting the right side of her pallet; Herpes zoster on lip; has a pustule on lip; This case was reported by a nurse via call center representative and described the occurrence of herpes zoster infection neurological in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (Shingles thrice). Previously administered products included Shingles vaccine. On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). In November 2020, less than 2 months after receiving Shingrix, the patient experienced herpes zoster infection neurological (serious criteria GSK medically significant), herpes zoster and lip pustule. On an unknown date, the outcome of the herpes zoster infection neurological was unknown and the outcome of the herpes zoster and lip pustule were not recovered/not resolved. It was unknown if the reporter considered the herpes zoster infection neurological, herpes zoster and lip pustule to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The reporter was a retired nurse practitioner and stated a history of shingles on three separate occasions prior to receiving Shingrix and stated previously receiving shingles vaccine in the past. The 1st dose of Shingrix was administered approximately 2 months ago and scheduled to receive second dose of Shingrix tomorrow that would be day after date of reporting since tomorrow would make 2 months and a day since receiving the first dose of Shingrix. Approximately 4 days ago, reporter stated breaking out with shingles on her 7th cranial nerve affecting the right side of her pallet and her lip. Reporter described current outbreak as the mildest of all previous outbreaks and that it feels like outbreak wants to progress but it was not. Reporter stated that the outbreak runs across top of pallet and had a pustule on lip. Reporter had bloodwork drawn to measure IgG and IgM to determine if immune system was impaired in any way. Shingles outbreak unresolved but getting better. Reporter was comfortable forwarding lab work to Safety. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 0918132
Sex: M
Age:
State: NJ

Vax Date:
Onset Date: 11/23/2020
Rec V Date: 01/04/2021
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Symptoms: Body aches / Pain and agony; Extreme chills; Stomach ache; Shortness of breath; Nausea; It kept both of them up last night; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced general body pain, chills, stomach pain, shortness of breath, nausea and difficulty sleeping. On an unknown date, the outcome of the general body pain was recovered/resolved and the outcome of the chills, stomach pain, shortness of breath, nausea and difficulty sleeping were unknown. The reporter considered the general body pain, chills, stomach pain, shortness of breath, nausea and difficulty sleeping to be related to Shingrix. Additional details were provided as follows: The case was reported by the wife of the patient. The age at vaccination was not reported. The patient had an extreme reaction from getting the 1st dose of the Shingrix vaccine. The patient had extreme chills, body aches, stomach pain, shortness of breath, nausea, and was just in pain and agony. The reporter stated that it was so extreme that it kept both of them up last night. The reporter stated it was a rough night for the patient. The reporter also stated it had gotten better and that the patient was over it. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 0918133
Sex: F
Age: 17
State: MA

Vax Date: 06/13/2019
Onset Date:
Rec V Date: 01/04/2021
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Symptoms: had fever; extreme fatigue; was feeling very sleepy; did not feel well; This case was reported by a consumer via call center representative and described the occurrence of fever in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and GARDASIL for prophylaxis. On 13th June 2019, the patient received the 1st dose of Bexsero, Bexsero Pre-Filled Syringe Device and GARDASIL. On an unknown date, less than 3 months after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced fever, fatigue, sleepiness and feeling unwell. On an unknown date, the outcome of the fever, fatigue, sleepiness and feeling unwell were recovered/resolved. It was unknown if the reporter considered the fever, fatigue, sleepiness and feeling unwell to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The reporter was patient's mother. On 13th June 2019, the patient received the co suspect Meningococcal Vaccine by Sanofi Pasteur. The patient felt very sleepy, had fever, did not feel well and had extreme fatigue which all resolved in 2 days. The reporter did not know if it was okay to get all the three vaccines on the same day. It was unknown if the reporter considered the fever, fatigue, sleepiness and feeling unwell to be related to Gardasil and Meningococcal Vaccine The reporter did not consent to follow-up. The reporter did not want to provide her address or phone no. and also did not want to provide HCP information. This case has been linked with US2020AMR234292, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2020AMR234292:same reporter

Other Meds:

Current Illness:

ID: 0918134
Sex: F
Age:
State: TX

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

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Symptoms: spontaneous vomiting; experienced diarrhea; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 52-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vomiting and diarrhea. On an unknown date, the outcome of the vomiting and diarrhea were recovered/resolved. It was unknown if the reporter considered the vomiting and diarrhea to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she received flu vaccine 10-13 years ago and she experienced diarrhea and spontaneous vomiting which resolved in 2-3 days. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 0918135
Sex: F
Age: 69
State: MI

Vax Date: 11/05/2020
Onset Date: 11/05/2020
Rec V Date: 01/04/2021
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Allergies:

Symptom List:

Symptoms: Shingles on both inner thighs; Muscle aches; Hamstring pain; Itchiness; Rash on her wrist; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles. Previously administered products included Shingrix (1st dose received on an unknown date, there were no adverse events). On 5th November 2020, the patient received the 2nd dose of Shingrix. On 5th November 2020, 1 hr after receiving Shingrix, the patient experienced rash. On 19th November 2020, the patient experienced shingles, muscle pain, pain in thigh and pruritus. On an unknown date, the outcome of the shingles, rash, muscle pain, pain in thigh and pruritus were unknown. It was unknown if the reporter considered the shingles, rash, muscle pain, pain in thigh and pruritus to be related to Shingrix. Additional details were provided as follows: After dose 2, the patient experienced a rash on her wrist. Two weeks after the 2nd dose, the patient experienced muscle aches, hamstring pain, shingles on both inner thighs with itchiness. Patient had no further contact information available for physician phone number or address. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 0918136
Sex: M
Age:
State: CO

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: sick in bed for 1-2 days; This case was reported by a consumer via call center representative and described the occurrence of sickness in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. After receiving the 2nd dose of the Shingrix vaccine, he was sick in bed for 1 to 2 days. The reporter did not consent to follow up

Other Meds:

Current Illness:

ID: 0918137
Sex: F
Age: 70
State: MA

Vax Date: 12/01/2020
Onset Date: 12/03/2020
Rec V Date: 01/04/2021
Hospital:

Vax Type:
Manufacturer:
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Symptom List:

Symptoms: redness, swelling, and itching at the injection site; redness, swelling, and itching at the injection site; redness, swelling, and itching at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 1st December 2020, the patient received the 2nd dose of Shingrix. On 3rd December 2020, 2 days after receiving Shingrix, the patient experienced injection site itching, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site itching, injection site swelling and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the injection site itching, injection site swelling and injection site erythema to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. About 2 days after dose of Shingrix, she experienced redness, swelling, and itching at the injection site. The reporter did not consent to follow up. This case is linked to the case US2020240883, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2020240883:same reporter

Other Meds:

Current Illness:

ID: 0918138
Sex: M
Age: 68
State: MA

Vax Date: 12/01/2020
Onset Date: 12/02/2020
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: experienced arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 1st December 2020, the patient received the 2nd dose of Shingrix. On 2nd December 2020, 1 days after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were provided as follows: The case was reported by the wife of the patient. The age at vaccination was not reported. After receiving the vaccine the patient experienced arm soreness. The reporter did not consent to follow up. This case is linked to the case US2020240882, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2020240882:same reporter

Other Meds:

Current Illness:

ID: 0918139
Sex: F
Age: 85
State: FL

Vax Date: 10/01/2020
Onset Date: 11/01/2020
Rec V Date: 01/04/2021
Hospital:

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

Allergies:

Symptom List:

Symptoms: shingles in her right eye; shingles the right side of her head; pain; This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (25 years before reporting). In October 2020, the patient received the 1st dose of Shingrix. In November 2020, 2 weeks after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and eye pain. On an unknown date, the outcome of the ophthalmic herpes zoster was unknown and the outcome of the shingles and eye pain were not recovered/not resolved. It was unknown if the reporter considered the ophthalmic herpes zoster, shingles and eye pain to be related to Shingrix. Additional information was provided as follows: The patient received the first dose of the Shingrix vaccine around last week of October 2020 in her left arm and about two weeks later she started to have shingles on the right side of her head and shingles in her right eye. The patient's physician instructed for her to be seen at the hospital. At the hospital she was given some treatment. She was not admitted. The patient continued to have shingles and especially the shingles in the right eye was very painful. The patient had shingles about 25 years before reporting and then this was the second time she was having shingles which had not resolved. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 0918140
Sex: M
Age:
State:

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

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

Allergies:

Symptom List:

Symptoms: Has Bells Palsy as a result; Side of the body on which he received the Shingrix is weak; Sore arm; Felt lousy; First and only dose of Shingrix in June 2020; This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In June 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant), hemiparesis (serious criteria GSK medically significant), pain in arm, feeling bad and incomplete course of vaccination. On an unknown date, the outcome of the bell's palsy, hemiparesis, pain in arm, feeling bad and incomplete course of vaccination were unknown. It was unknown if the reporter considered the bell's palsy, hemiparesis, pain in arm and feeling bad to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. After receiving 1st dose of Shingrix, the patient had a sore arm, and feeling lousy. He did not elaborate on what feeling lousy entailed. Also, the patient's unknown side of the body on which he received the Shingrix was weak. The patient also had bells palsy as a result. Till the time of reporting, the patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. The reporter did not consent to follow-up. The patient noted that, he reported this event previously, but call center representative could not find him in the system, or his phone number. He did not wish to proceed with a safety report and did not wish to give me any demographics or further details. The patient wanted to know whether he would have a reaction to COVID 19 vaccine due to his Shingrix experienced. He was referred to his provider.

Other Meds:

Current Illness:

ID: 0918141
Sex: F
Age: 66
State: PA

Vax Date: 09/06/2019
Onset Date: 09/07/2019
Rec V Date: 01/04/2021
Hospital:

Vax Type:
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Symptom List:

Symptoms: passed out / passed out for 5 or 10 minutes; she was sweating; shivering; heart palpitations; upset stomach; felt weak for 1 whole day; This case was reported by a consumer via call center representative and described the occurrence of passed out in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 6th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 7th September 2019, 1 days after receiving Shingrix, the patient experienced upset stomach and weakness. In September 2019, the patient experienced passed out (serious criteria GSK medically significant), sweating, shivering and palpitation. On 7th September 2019, the outcome of the upset stomach and weakness were recovered/resolved. In September 2019, the outcome of the passed out, sweating, shivering and palpitation were recovered/resolved. It was unknown if the reporter considered the passed out, sweating, shivering, palpitation, upset stomach and weakness to be related to Shingrix. Additional details were provided as follows: 12 hours after receiving Shingrix, the patient was sweating, shivering, had heart palpitations, and then passed out. The patient reported, she thought she was passed out for 5 or 10 minutes both times but was not sure. The patient reported the sweating, shivering, and heart palpitations resolved after she woke up from being passed out. The patient also had an upset stomach and felt weak for 1 whole day and then these events resolved. The reporter consented to follow up. For the tolerance of 2nd dose, refer linked case US2020AMR253265.; Sender's Comments: US-GLAXOSMITHKLINE-US2020AMR253265:same patient (2nd dose)

Other Meds:

Current Illness:

ID: 0918142
Sex: U
Age:
State:

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

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

Allergies:

Symptom List:

Symptoms: Fever; chills; Based on information previously received, the following information [suspect was updated from Sanofi product NOS to influenza vaccine (unknown manufacturer) and classification was delete non-valid] has/have been amended. Initial information received on 16-Nov-2020 regarding an unsolicited valid non-serious case received from a media consumer (patient). This case involves patient (unknown demographics) who experienced fever (pyrexia) and chills, while he/she received vaccine INFLUENZA VACCINE. Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious fever (pyrexia) and chills (unknown latency) following the administration of INFLUENZA VACCINE. Details of laboratory data not reported. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome of event was not reported. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 0918143
Sex: U
Age:
State:

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

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

Allergies:

Symptom List:

Symptoms: was delirious/talked out of head; fever; slept often; Initial information regarding an unsolicited valid serious case was received from a consumer (patient) via social media on 08-Dec-2020. This case involves a patient of unknown demographics who was delirious/talked out of head (delirium), had fever (pyrexia) and slept often (hypersomnia), after receiving INFLUENZA VACCINE. The patient's medical history, past medical treatments, past vaccinations, family history and concomitant medications were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient was delirious, had talked out of head (delirium) (unknown latency) following the administration of INFLUENZA VACCINE. The event delirious was assessed as medically significant as per important medical event (IME) list. On an unknown date, the patient had fever (pyrexia) and slept often (hypersomnia),(non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported as the patient had taken vaccine during college days in 1976 and was totally out of it for 7 days. Patient list wright from not eating but never had the flu since getting that vaccine. The patient was too afraid and not taking flu shot at all. No laboratory data was reported. It was not reported if the patient received a corrective treatment. At the time of report, the outcome was unknown for the events. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 0918144
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: got the flu; Initial information was received on 14-Dec-2020 regarding an unsolicited valid non-serious media case from the non-healthcare professional. This case was linked to case 2020C015444 (same reporter). This case involved a female patient of unknown age who got the flu (Influenza), after she received INFLUENZA VACCINE. The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported. On an unknown date, the patient received a dose of suspect influenza vaccine (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination. On an unknown date, the patient developed non-serious flu (influenza), some weeks following the administration of INFLUENZA VACCINE. Details of laboratory data were not reported. It was not reported if the patient received any corrective treatment. At the time of reporting, the event outcome was unknown. There would be no information available on batch number for this case.

Other Meds:

Current Illness:

ID: 0918145
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: had a relapse was sick for weeks; took the flu shot got the flu; Initial information regarding this unsolicited valid non-serious media case was received from a consumer (patient) and transmitted to Sanofi on 17-Dec-2020. This case involved a patient with unknown demographics who got the flu (influenza), had a relapse was sick (illness), while the patient received the flu shot (INFLUENZA VACCINE). Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious flu (influenza), had a relapse was sick (illness), unknown latency following the administration of INFLUENZA VACCINE. Relevant laboratory test was not reported. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome was unknown for the reported event. There would be no information available on batch number for this case.

Other Meds:

Current Illness:

ID: 0918146
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: have not gotten the flu since not getting the shot; Initial information regarding this unsolicited valid non-serious media case was received from a consumer (patient) and transmitted to Sanofi on 17-Dec-2020. This case involves a patient with unknown demographics who had flu (Influenza), while the patient received INFLUENZA VACCINE. Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious flu (influenza), unknown latency following the administration of INFLUENZA VACCINE. It was reported that the patient had stopped taking flu shot since 15 years and since then the patient did not get the flu. Relevant laboratory test was not reported. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome was unknown for the reported event. There would be no information available on batch number for this case.

Other Meds:

Current Illness:

ID: 0918147
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: Mild soreness in the vaccination site; Initial information regarding an unsolicited valid non-serious case received from a Consumer via other (email) from on 22-Dec-2020. This case involves patient of unknown demographic detail who had mild soreness in the vaccination site (Vaccination site pain), while the patient received Influenza Vaccine. The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination. On an unknown date, the patient stated that she had one INFLUENZA VACCINE, and experienced mild soreness in the vaccination site (Vaccination site pain). It was not reported if the patient received a corrective treatment. Outcome of the event was unknown, at the time of reporting. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 0918148
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: Friends got the flu weeks after they had the flu shot; Initial information regarding an unsolicited valid non-serious case received from a consumer/Non-HCP via media on 14-Dec-2020. This case involves a patients of unknown demographic who got flu (Influenza), while the patient received Influenza Vaccine. The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination. On an unknown date, the patient stated that she had one INFLUENZA VACCINE, and had flu (Influenza). It was not reported if the patient received a corrective treatment. Outcome of the event was unknown, at the time of reporting. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 0918149
Sex: M
Age: 66
State: NY

Vax Date: 09/25/2020
Onset Date:
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: inadvertently administered the Fluzone High-Dose vaccine twice/no AE; Initial information was received on 10-Nov-2020 regarding an unsolicited valid non-serious case from a pharmacist. This case involves a 66-year-old male patient who was inadvertently administered the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] prefilled syringe twice (lot UJ535AA, expiry date not reported) (extra dose administered). Medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient received no concomitant vaccines. It was reported that the patient was inadvertently administered the Fluzone High-Dose vaccine twice, once on 25-Sep-2020 and again on 09-Nov-2020. Patient received no concomitant vaccines. Vaccines were administered at a retail pharmacy. Pharmacist reported that, so far, the patient has not reported any adverse effects related to the Fluzone High-Dose. Pharmacist had the lot number and expiration date for the second Fluzone High-Dose injection administered on 09-Nov-2020 but not for the first one administered on 25-Sep-2020. It was case of actual medication error due to extra dose administered. At the time of report, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on the lot number (of first dose) for this case.

Other Meds:

Current Illness:

ID: 0918150
Sex: F
Age:
State: MN

Vax Date: 11/10/2020
Onset Date: 11/10/2020
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: Patient of age 46 received a partial dose of Fluzon HD due to the dose leaking out around the hub at the luer lok with no AE.; Patient of age 46 received a partial dose of Fluzon HD due to the dose leaking out around the hub at the luer lok with no AE.; Patient of age 46 received a partial dose of Fluzon HD due to the dose leaking out around the hub at the luer lok with no AE.; Initial information regarding an unsolicited valid serious case was received from a Pharmacist via Agency (Reference number- 00353849) and transmitted to Sanofi on 10-Nov-2020. This case involves a 46 years old female patient who received a partial dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ517AA and expiration date: 30-Jun-2021) via unknown route at an unknown administration site for prophylactic vaccination due to the dose leaking out around the hub at the luer (product administered to patient of inappropriate age, Inappropriate dose of vaccine administered and syringe issue) on an 10-Nov-2020. Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration, Inappropriate dose of vaccine administered and syringe issue. At the time of report, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 0918151
Sex: M
Age: 4
State: MI

Vax Date: 09/09/2020
Onset Date:
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: Given ADACEL instead of DTaP; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Medical Information (Reference number-00381714) and transmitted to Sanofi on 04-Dec -2020 via call-center. This case involves a 4-years-old male patient who received a vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: U6737AA and expiry date: 07-Sep -2022) on 09-Sep-2020 via an unknown route in Left Deltoid instead of DTaP (Wrong product administered) for prophylactic vaccination. The patient's medical history, past medical treatment, vaccination and family history were not provided. The patient's concomitant medication included POLIO VACCINE INACT 3V (VERO) (IPOL [POLIO VACCINE INACT 3V (VERO)]); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE). It was an actual medication error case due to wrong vaccine administered (latency: unknown). At the time of report no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds: IPOL [POLIO VACCINE INACT 3V (VERO)]; MMR; VARICELLA VACCINE

Current Illness:

ID: 0918152
Sex: F
Age: 74
State: TX

Vax Date: 09/16/2020
Onset Date:
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: two bruises showed up a couple of days after her vaccination/bruise on her left deltoid was purplish and about the size of a quarter, was near the injections site/other bruise was on the back of her left arm; Initial information received on 09-Dec-2020 regarding an unsolicited valid non-serious case from a pharmacist in the. This case involves a 74 years old female patient for whom two bruises showed up a couple of days after her vaccination/bruise on her left deltoid was purplish and about the size of a quarter, was near the injections site/other bruise was on the back of her left arm (vaccination site bruising), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication was reported. On 16-Sep-2020, the patient received 0.7 mL once a day dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE via unknown route (lot number: 279801 and expiry date: 16-Jun-2021) for prophylactic vaccination. On an unknown date in 2020 (latency unknown), the patient stated that two bruises showed up a couple of days after her vaccination. They were still present today but fading. The bruise on her left deltoid was purplish and about the size of a quarter, was near the injections site. The other bruise was on the back of her left arm (vaccination site bruising) and about 1/5 long and 1/2 wide. No laboratory data was reported. It was not reported if the patient received a corrective treatment. At the time of report, outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 0918153
Sex: F
Age:
State: NH

Vax Date: 10/08/2020
Onset Date:
Rec V Date: 01/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: receiving FLUZONE HIGH DOSE QUADRIVALENT when patient already received Fluad vaccine with no AE; had intended on getting the pneumonia vaccine, she already had a flu vaccine with no AE; Initial information received on 10-Dec-2020 regarding an unsolicited valid non-serious case from a pharmacist. This case involves a 68 years old female patient who received fluzone high dose quadrivalent when patient already received fluad vaccine (extra dose administered) and had intended on getting the pneumonia vaccine, she already had a flu vaccine (wrong product administered), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], INFLUENZA VACCINE INACT SAG 3V [FLUAD] and PNEUMOCOCCAL VACCINE. The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication was reported. On 08-Oct-2020, the patient received suspect FLUAD (INFLUENZA VACCINE INACT SAG 3V) with an unknown dose, route, frequency, strength and formulation for prophylactic vaccination. On 12-Oct-2020, the patient received 0.7 ml to 2 ml once a day dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE via intramuscular route in right arm (lot number: UJ540AA and expiry date: 30-Jun-2021) for prophylactic vaccination. On an unknown date, the patient received PNEUMOCOCCAL VACCINE with an unknown dose, route, frequency, strength and formulation for prophylactic vaccination. On an unknown date (latency unknown), the patient received FLUZONE HIGH DOSE QUADRIVALENT when the patient already received FLUAD vaccine (extra dose administered) and pharmacist stated that the patient came in to the pharmacy and requested a Flu vaccine. She filled out the consent form and checked the influenza vaccine box. Then, after she received it, she asked the pharmacist if that was the 23 that she had received. The patient had intended on getting the pneumonia vaccine, she already had a flu vaccine in October (year unknown) (wrong product administered). This was an actual medication error due to extra dose administered and wrong vaccine administered. No laboratory data reported. At the time of reporting, no adverse event was reported to the patient. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 0918154
Sex: U
Age: 0
State: MO

Vax Date: 12/06/2020
Onset Date: 12/16/2020
Rec V Date: 01/04/2021
Hospital:

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Symptom List:

Symptoms: children received FLUBLOK QUADRIVALENT, with no adverse event; Initial information received on 17-Dec-2020 regarding an unsolicited valid non-serious case from a nurse. This case involves 7 months old patient of unknown age, who was vaccinated with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot: QFAA2056 and expiry date: 30-Jun-2021) children received flublok quadrivalent (product administered to patient of inappropriate age). The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. On 16-Dec-2020, the patient received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (Lot: QFAA2056 and expiry date: 30-Jun-2021) at a dose of 0.5 ml, via unknown route at right thigh for prophylactic vaccination. On 16-Dec-2020, (latency: unknown) children received FLQUADRIVALENT RECOMBINANT VACCINE as their second doses in their influenza vaccine series (product administered to patient of inappropriate age). Their first doses were of Flulaval on 16-Nov-2020. She asked if their entire series needs to be repeated or just the second doses. It was an actual medication error case due to Product administered to patient of inappropriate age. At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 0918155
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 01/04/2021
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Symptoms: accidentally injected a FLUZONE HIGH DOSE into an 8 year old patient with no AE; accidentally injected a FLUZONE HIGH DOSE into an 8 year old patient with no AE; accidentally injected a FLUZONE HIGH DOSE into an 8 year old patient with no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via call-center via Medical Information (Reference number- 00397824) and transmitted to Sanofi on 17-Dec-2020). This case involves a 8-year-old patient of unknown gender who had got accidentally injected a FLUZONE HIGH DOSE (wrong product administered) (product administered to patient of inappropriate age) (accidental overdose) while the patient got Influenza Quadrival A-B High Dose Hv Vaccine (FLUZONE HIGH-DOSE QUADRIVALENT) (frequency, strength, lot number and expiry date unknown) via an unknown route for prophylactic vaccination. The patient's medical history, past medical treatment, vaccination and family history were not provided. Concomitant medications were not reported. It was an actual medication error case as the patient had got ccidentally injected a influenza Quadrival A-B High Dose Hv Vaccine (latency: same day). At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 0918156
Sex: U
Age:
State: CO

Vax Date:
Onset Date:
Rec V Date: 01/04/2021
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Symptoms: 4-month-old was administered both Pentacel and ActHib at the 2-month appointment with no AE; Initial information received on 17-Dec-2020 regarding an unsolicited valid non-serious case received from a pharmacist in the United States. This case involves a 4-month-old patient patient who was vaccinated with both Pentacel and ActHib at the 2-month appointment (Product administered to patient of inappropriate age). Medical history, medical treatment, vaccination and family history were not provided. Concomitant medications were included diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (Pentacel). On an unknown date, the patient received 0.5 ml dose of suspect HAEMOPHILUS TYPE B (HIB) VACCINE (lot and expiry date unknown via an unknown route for immunization. It was a case of actual medication error as both Pentacel and ActHib at the 2-month appointment (latency on same day). At the time of report, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds: PENTACEL

Current Illness:

ID: 0918157
Sex: U
Age:
State: MO

Vax Date:
Onset Date:
Rec V Date: 01/04/2021
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Symptoms: 25 yrs ago an expired Hep A was given to a child and this was reported back then with no AE; Initial information received on 17-Dec-2020 regarding an unsolicited valid non-serious case received from a patient. This case involves a child patient who was vaccinated with an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered). Medical history, medical treatment, vaccination and family history were not provided. Concomitant medications were not reported. On an unknown date in 1995 (reported as 25 years ago), the patient received a unspecified dose of suspect HIB (PRP/T) VACCINE (lot and expiry date unknown via an unknown route in the left deltoid for prophylactic vaccination. A product complaint with HIB (PRP/T) VACCINE. When the nurse attempted to extract the medicine from the vial, the medicine was not extracted. It had only occurred with one vial of HIB (PRP/T) VACCINE (lot no UJ359AA and expiry 21-Jul-2021). It was reported that 2 different nurses tried 2 different syringes and were still was not able to extract all the liquid from the HIB (PRP/T) VACCINE vial. There was still quite a bit liquid in this vial and it would not come out. It was reported that all the medication would not draw up and the nurses tried different needles and syringes. Some liquid came out but not enough to give dose. The nurses noted that the diluent vial was checked twice to make sure it was empty and all diluent was drawn out. This happened last Friday (11-Dec-2020). It was a case of actual medication error due to expired vaccine used (latency on same day). At the time of report, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error

Other Meds:

Current Illness:

ID: 0918158
Sex: M
Age:
State: PA

Vax Date:
Onset Date: 08/22/2019
Rec V Date: 01/04/2021
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Symptoms: received his second dose, 7 months before he would have turned 16, with no adverse event; Initial information received on 18-Dec-2020 regarding an unsolicited valid non-serious case from a physician. This case involves a 15-years-old male patient who received his second dose, 7 months before he would have turned 16 (inappropriate schedule of product administration). The patient's medical history, past medical treatment(s), vaccination(s), concurrent conditions and family history were not provided. On an unknown date, the patient received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (batch number and expiry date unknown) via an unknown dose via unknown route at unknown administration site for prophylactic vaccination The pediatrician was asking whether a male patient should be re-dosed. He was given a booster vaccine in less than 4 years from the prior dose. He received his first Menactra on 19-Oct-2016, which he was 12-year-old at that time. When he came in on 22-Aug-2019 (latency unknown), he received his second dose, 7 months before he would have turned 16 (inappropriate schedule of product administration). The pediatrician asked if they should re-dose now that he was over 16. The patient Information not obtained. An attempts were made to obtain the patient information but the pediatrician was unavailable. It was an actual medication error case due to product storage error. At the time of reporting, outcome was unknown. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 0918159
Sex: F
Age: 17
State: IN

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 01/04/2021
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Symptoms: a dose of MENACTRA was inadvertently administered instead of Meningitis B with no adverse event; Initial information received on 21-Dec-2020 regarding an unsolicited valid non-serious case from a other health professional. This case involves a 17 years old female patient who received a dose of Menactra was inadvertently administered instead of Meningitis B (wrong product administered), while she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]. On 21-Dec-2020, the patient received a dose of 0.5 mL suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: U6641AB and expiry date: 30-Jul-2021) via intramuscular route in the left deltoid. Reporter stated patient had already received both (two) doses of MENACTRA, the second dose was administered 18-Jun-2020. Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. This was an actual medication error case due to the event wrong vaccine administered (latency: same day). At the time of reporting, no adverse event was reported. No laboratory data was reported. 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.

Other Meds:

Current Illness:

ID: 0918160
Sex: F
Age: 27
State: OH

Vax Date: 12/18/2020
Onset Date:
Rec V Date: 01/04/2021
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Symptoms: patient, who is pregnant, with no AE; Initial information regarding an unsolicited valid non-serious case received from a pharmacist on 21-Dec-2020. This case involves a 27 years old female patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B VACCINE in context of patient, who is pregnant, (exposure during pregnancy). Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. On 18-Dec-2020, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7081NA) via intramuscular route in the left deltoid for prophylactic vaccination. On an unknown date, (unknown latency) after initiation of INFLUENZA QUADRIVAL A-B VACCINE, the patient was pregnant (exposure during pregnancy). At the time of report, no adverse event was reported. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 0918161
Sex: U
Age:
State: IN

Vax Date:
Onset Date:
Rec V Date: 01/04/2021
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Symptoms: a 6 month old accidently received the FLUZONE HDQ with no adverse event; Initial information received on 21-Dec-2020 regarding an unsolicited valid non-serious case from a pharmacist. This case involves a 6 months old patient accidently received the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age). On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination. Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. This was an actual medication error case due to the event product administered to patient of inappropriate age (latency: unknown). At the time of reporting, no adverse event was reported. No laboratory data was reported. 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 about batch number was reported for the case.

Other Meds:

Current Illness:

ID: 0918162
Sex: F
Age:
State: WA

Vax Date: 11/24/2020
Onset Date: 11/24/2020
Rec V Date: 01/04/2021
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Symptoms: had an excursion with refrigerator problem then had another excursion and since it wasn't taken out of circulation/no AE; Initial information received on 21-Dec-2020 regarding an unsolicited valid non-serious case received from a pharmacist. This case involved an unknown age female patient who was administered IPV (VERO) [IPOL] (lot R1B252M and expiry date: 31-Mar-2021) on 24-Nov-2020 via an unknown route at an unknown administration site for prophylactic vaccination, which had an excursion due to refrigerator at the end of August then kept the vial which had another excursion then someone gave a dose from the same vial (Product storage error). Medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included NA (NA). It was an actual medication error case due to incorrect product storage (latency same day). At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds: NA

Current Illness:

ID: 0918163
Sex: F
Age: 2
State: CA

Vax Date: 12/16/2020
Onset Date: 12/22/2020
Rec V Date: 01/04/2021
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Symptoms: inadvertently received an additional dose of Fluzone quadrivalent today, with no ae; Initial information received on 22-Dec-2020 regarding an unsolicited valid non-serious case from a other health professional. This case involves a 2 years old female patient who inadvertently received an additional dose of fluzone quadrivalent today (extra dose administered), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV]. The patients past medical history, concomitant medication, medical treatment(s), vaccination(s) and family history were not provided. On 16-Dec-2020, the patient was vaccinated with 0.5 ml INFLUENZA QUADRIVAL A-B VACCINE (lot: UT7102JA; expiration date: 30-Jun-2021) via intramuscular route in the left deltoid. On 22-Dec-2020, 6 days after patient received the vaccine, patient inadvertently received an additional dose of Fluzone quadrivalent (extra dose administered). No adverse event reported at the time of reporting. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 0918164
Sex: F
Age: 22
State: UT

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 01/04/2021
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Symptoms: Daptacel was inadvertently administered instead of Adacel to a 22-year-old patient; with no AE; vaccine was given to a 22 year old and it was supposed to be for the age group 6-8 weeks; with no AE; Initial information received on 23-Dec-2020 regarding an unsolicited valid non-serious case from a other health professional. This case involves a 22 years old female patient who for whom it was reported that diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] was inadvertently administered instead of Adacel (wrong product administered) and it was supposed to be for the age group 6-8 weeks (product use issue). The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication was received. On 22-Dec-2020, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE at a dose of 0.5 ml once (lot C5624AA and expiry date: 10-Jun-2021) via intramuscular route in the left deltoid for prophylaxis vaccination instead of Adacel (wrong product administered) and it was supposed to be for the age group 6-8 weeks (product use issue). No laboratory data was provided. It was not reported if the patient received a corrective treatment. At the time of report, the outcome was not applicable for the 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 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: 0918165
Sex: M
Age: 41
State: WI

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 01/04/2021
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Symptoms: Patient received a dose of expired Fluzone Quadrivalent, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse practitioner via Medical Information (Reference number- 00405238) and transmitted to Sanofi on 23-Dec-2020. This case involves a 41 years old male patient who was administered with a 0.5 ml standard dose of expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number UT6656KA and expiry date 30-Jun-2020) once via unknown route in an unknown administration site for prophylactic vaccination on 23rd December 2020 (Expired product administered). Medical history, past medical treatment(s), vaccination(s), and family history were not provided. No other vaccine was administered concomitantly. This was an actual medication error due to expired vaccine used [latency was same day]. No laboratory data reported. At the time of reporting, no adverse event was reported. Reporter asked for appropriate follow-up after expired dose of Fluzone Quadrivalent was administered. 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. Potential PTC (product technical complaint)- No

Other Meds:

Current Illness:

ID: 0918166
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 12/23/2020
Rec V Date: 01/04/2021
Hospital:

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Symptoms: states that a male patient age 86, was injected with with Fluzone High Dose on two different occasions this year because the patient forgot that he already had a flu shot, with no ae; Initial information received on 23-Dec-2020 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 86 years old male patient for whom it was reported that a male patient age 86, was injected with fluzone high dose on two different occasions this year because the patient forgot that he already had a flu shot (overdose), while he received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. The patients medical history, concomitant medication, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date of 2020, the patient was vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Lot UJ505AA; expiration date: unknown) via unknown route in the left deltoid as prophylactic vaccination. On an unknown date of 2020, (unknown latency) after the patient was injected with fluzone high dose second time this year because the patient forgot that he already had a flu shot (overdose). No adverse event reported at the time of reporting. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 0918167
Sex: M
Age: 54
State: TX

Vax Date: 11/14/2020
Onset Date: 12/23/2020
Rec V Date: 01/04/2021
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Symptoms: a delay of over 5 weeks from the first dose, with no ae; Initial information received on 23-Dec-2020 regarding an unsolicited valid non-serious case received from a pharmacist . This case involves a 54 years old male patient who experienced a delay of over 5 weeks from the first dose (inappropriate schedule of product administration), while he received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES]. The patients medical history, concomitant medication, medical treatment(s), vaccination(s) and family history were not provided. On 14-Nov-2020, the patient was vaccinated of suspect RABIES (HDC) VACCINE (lot unknown and expiration date: unknown) via unknown route in unknown administration site for immunization. On 23-Dec-2020, 1 month 9 days after initiation of suspect, a delay of over 5 weeks from the first dose (inappropriate schedule of product administration). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 0918168
Sex: M
Age:
State:

Vax Date: 12/21/2020
Onset Date: 12/01/2020
Rec V Date: 01/04/2021
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Symptoms: had given an expired Tdap to a patient, with no ae; Initial information received on 28-Dec-2020 regarding an unsolicited valid non-serious case from a nurse. This case involves unknown age male patient who had given an expired tdap to a patient (expired product administered), while he received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. The patients medical history, concomitant medication, medical treatment(s), vaccination(s) and family history were not provided. On 21-Dec-2020, the patient was vaccinated with 0.5 ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6141AB and expiration date: 15-Dec-2020) via unknown route in the right deltoid for prophylactic vaccination. On an unknown date December-2020, (unknown latency) after initiation suspect medication, patient had given an expired tdap to a patient (expired product administered). No adverse event reported at the time of reporting. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 704,237

Page last modified: 03 October 2021 5:28pm