chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Pyrexia, Stool analysis normal, Varicella virus test negative, Vomiting
Clinical narrative: Patient received above vaccinations on 11/12/2020. Symptoms of fever began 11/21/2020. Emesis began overnight 11/22-11/23. Went to Emergency department for evaluation where partial septic workup done and empiric therapy with Ceftriaxone begun. Child noted to be lethargic, diminished sensorium and not improving; on 11/24, underwent lumbar puncture. Results demonstrated CSF WBC of 551, consistent with meningoencephalitis; Cultures in blood, urine and  CSF (including enteroviral panel, VZV) all negative. Chest X-ray, stool studies also negative.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Patient reported having the following adverse events for 2 weeks after vaccine administration:  Pain in arm from shoulder to elbow Problems with moving arm Rash, swelling and itching in area  Skin peeling in area  After the reaction she spoke to her PCP over the phone, Dr. and he recommended ice at area and Acetaminophen by mouth.  Patient reported having still after the two weeks a mild pain in arm administration site and a little of itching of the arm. She came on 11/30 to report adverse event.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Skin exfoliation
Clinical narrative: Patient reported having the following adverse events for 2 weeks after vaccine administration:  Pain in arm from shoulder to elbow Problems with moving arm Rash, swelling and itching in area  Skin peeling in area  After the reaction she spoke to her PCP over the phone, Dr. and he recommended ice at area and Acetaminophen by mouth.  Patient reported having still after the two weeks a mild pain in arm administration site and a little of itching of the arm. She came on 11/30 to report adverse event.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Viral rash
Clinical narrative: Severe viral rash on chest, arms and legs. Very itchy.  I have photos.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine, Immune thrombocytopenia, Petechiae, Platelet count decreased
Clinical narrative: On March 19 I called my Primary because I had petechiae all over my legs, thighs and inside my mouth behind my lips.  My doctor told me to urgently go to the Hospital.  I went to Hospital and they transported me by ambulance to Hospital, where their Hematologist Department was located.  The vaccine depleted my platelets.  When I got to the hospital  I only had 1 or 1,000.
Age: 78.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered
Clinical narrative: No adverse events thus far. Patient received Component 1 (MenCYW) of the vaccine but did not receive Component 2 (MenA)
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Joint swelling, Swelling
Clinical narrative: swelling and redness started appx 2 hours after vaccine, swelling continued for 2 days spreading to neck and wrist, oral steroids were given to child
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: The route of flu vaccine was given incorrectly
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Nervous system disorder
Clinical narrative: Every nerve on fire. All over body.  Lasted at extreme level for 24 hours and lingered for days.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic, Swelling, Swelling face
Clinical narrative: Patient reports a red, itchy rash along  with swelling along her neck and left jawline.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient fainted in the bathroom 15 minutes after vaccine was administered.  Her mom was right there and caught her, no injury was done.  She sat at the pharmacy for 20 additional minutes and was able to walk out of store and felt fine after she rested.
Age: 12.0
Sex: F
Vaccine: DTAP, FLU4
Symptoms: Blindness, CSF test, Eye pain, Full blood count, Magnetic resonance imaging
Clinical narrative: onset of right eye pain  approx 4 weeks later. then given flu vaccine. symptoms continued.  progressive eye pain vision loss.  delay in diagnosis. diagnosed with right optic neuritis and hospitalized in October 2018. full workup for auto immune disorders. treated with IV steroids. vision recovered.
Age: 12.0
Sex: F
Vaccine: DTAP, FLU4
Symptoms: Optic neuritis
Clinical narrative: onset of right eye pain  approx 4 weeks later. then given flu vaccine. symptoms continued.  progressive eye pain vision loss.  delay in diagnosis. diagnosed with right optic neuritis and hospitalized in October 2018. full workup for auto immune disorders. treated with IV steroids. vision recovered.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient received her flu shot on 9/15/2020 and called me today to say that her arm/shoulder has been hurting her since her vaccine.
Age: 16.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Contusion, Fall, Limb injury, Loss of consciousness, Seizure
Clinical narrative: Noted in patient's visit summary, after administration of the vaccines, patient was witnessed by his mother and the MA to "Seize" while sitting up on patient bed, and then collapsed off bed to the floor. He was reported to hit his left shoulder and head on the ground. He then regained consciousness. Pt states that he just remembers getting the injection and then waking up on the floor. No post-ictal period. no confusion. Bruise noted on left parietal scalp, no laceration. Glucose checked in clinic and is within normal limits. patient was given juice, water, and crackers. He was observed for 45 minutes before discharge. mother was counseled about strict ED precautions.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Vaccination site mass, Vaccination site swelling
Clinical narrative: Swollen mass on left arm where vaccine was given from possible broken blood vessel
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Gaze palsy, Hypotonia, Muscle twitching, Postictal state, Posture abnormal
Clinical narrative: Patient with vasovagal response after administration of vaccine. Appeared to be seizure-like in nature: limp and eyes rolled back. Head flopped back and he had significant twitching about 1 minute after vaccine administered. Out of it/motions lasted for about 30 seconds and then post-itical (lasted several hours). Patient felt this way until 11/29/20. As of 11/30/20, back to his normal self.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Presyncope, Seizure like phenomena
Clinical narrative: Patient with vasovagal response after administration of vaccine. Appeared to be seizure-like in nature: limp and eyes rolled back. Head flopped back and he had significant twitching about 1 minute after vaccine administered. Out of it/motions lasted for about 30 seconds and then post-itical (lasted several hours). Patient felt this way until 11/29/20. As of 11/30/20, back to his normal self.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Vaccine error- third dose given
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Pt was administered Fluzone that was affected by refrigerator  excursion this morning. Excursion lasted   for 7 minutes. with   cooler  temperature.   Called Sanofi Pasteur and recommended repeat influenza vaccine in the next 28 days. Pt notified and will come in next week for repeat Flu vaccine. Per pt no  side effect. Per pt doing well no fever, no SOB, chest pain and numbness.
Age: 23.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 1.5 inch by 1.5 inch area of erythema and tenderness to area of injection
Age: 29.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Patient fainted immediately following administration. Unconscious approximately 10 seconds from onset. Immediate recovery. Patient stated he has history of syncope following injection with similar outcomes. No further issues following recovery.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain upper, Back pain, Hyperventilation, Moaning
Clinical narrative: Within 5 minutes of vaccine administration patient was signaling for attention. She was hyperventilating and moaning but was able to speak and describe her symptoms. She complained of cramps in her stomach that spread to her back in the kidney area. We tried to get management but they didn't respond. I referred to the clinical binder which dictated an ambulance was appropriate for this reaction. We asked patient if she would like an ambulance and she responded in the affirmative. Ambulance arrived in minutes and they took patient away. Her husband by her side was already calling for help. In about an hour and a half later the patient's husband returned with an insurance question and reported to us that the patient was doing fine and the hospital found nothing wrong with her. He said they plan on keeping her for an hour for observation but she just had an initial bad reaction to vaccine but was fine by the time she arrived at the hospital.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Flank pain, Oedema, Swelling
Clinical narrative: Pain in side below my armpit to the left outer edge of my breast stretching to beginning edge of my back.  Swelling with fluid swishing around.
Age: 44.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Pt called pharmacy several days after receiving vaccines and said her arm was sore. I told her that is normal but to if getting worse can make an appt with her pcp and also gave her home self care instructions. Pt called today and said that pain was still intense in arm and limited range of motion in shoulder. She claims we administered vaccine too low on the arm and that that caused her shoulder injury, I explained it would normally have to be given too high to cause shoulder injury and instructed her to make an appt with pcp and again gave self home care treatment rec.
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Pruritus, Rash
Clinical narrative: Rash (flat), itching and still experiencing this today
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cough, Dyspnoea, Fatigue, Pleurisy
Clinical narrative: Severe chills within 1 hour aches shortness of breathe, coughing ,exhaustion, painful breathing  these severe conditions are still prevelant after ten days.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: He experiences no pain but when lifting weights or using shoulders to exercise, his arm the shot was given in becomes too weak to continue and he has to stop
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Syncope
Clinical narrative: UPON WALKING OUT OF THE FRONT DOOR OF THE STORE, THE PATIENT FAINTED.  HER DAD SAYS THAT HE CAUGHT HER.   THE DAD AND PATIENT SAYS THAT SHE DID NOT HIT HER HEAD.  PATIENT CAME BACK TO PHARMACY LOBBY AND SAT FOR A WHILE.  PATIENT RESPONDED NO TO QUESTIONS OF FEELING LIGHT HEADED, NAUSEA, COLD SKIN SWEATING,  IRREGULAR HEART BEAT, CHEST PAIN, BLURRED VISION, CONFUSION, LIMB WEAKNESS AND CONVULSIONS.  A POLICE OFFICER RESPONDED TO A CALL THAT SOMEONE PLACED UPON SEEING HER FALL OUTSIDE.  THE POLICE OFFICER ASKED THE DAD IF SHE WOULD LIKED TO BE CHECKED OUT BY THE EMT'S ARRIVING.  DAD SAID YES.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Shooting pains in lower back and legs. Unable to move or stand.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Vaccine received 11/13 on 11/14 developed rash on chest, abdomen, neck, shoulders, arms.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Guillain-Barre syndrome
Clinical narrative: This patient said that her doctor thinks she may have gotten Guillain-Barre Syndrome after receiving her flu shot. She said that her flu shot was 3 weeks prior to her symptoms.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: tingling & numbness in Right side of face lasting throughout the day. Subsided by end of day. Shingrix in IM right Deltoid.
Age: 32.0
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 56.0
Sex: F
Vaccine: TD
Symptoms: Injection site discomfort, Injection site erythema
Clinical narrative: Redness and discomfort to site
Age: 59.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Dizziness, Ear discomfort, Effusion, Vertigo, Vomiting
Clinical narrative: Flu vaccine 9/30/20 On Oct, 16, 2020 developed fullness in ears & filling of fluid in Ears x 2 days (-) fever (-) pain, developed vertigo & dizziness Oct, 17, 2020 continued on Oct 18th with vomiting so went to ER. CT scan Negative given nausea meds meclizine, ondansetron & valium Symptoms subsided will follow up with her ENT
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Lip swelling, Swelling face
Clinical narrative: In the middle of the night after immunization, patients left side of face and lips began to swell. Patient presented to ARNP. She prescribed H1 & H2 blockers after determining no angioedema no difficulty breathing no tongue swelling. Followed up again 11/30/20 and was started on prednisone as well. Swelling was not subsiding
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Pyrexia
Clinical narrative: itching, pain, redness and fever at the injection site
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives on arm between elbow & shoulder
Age: 1.0
Sex: F
Vaccine: FLUR4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: inadvertently administered Flublok Quadrivalent vaccine to 12 months old patient /no AE; Initial information was received on 22-Oct-2020 regarding an unsolicited valid non-serious case from a other health professional via call center .  This case is linked to case 2020SA301262, 2020SA301272, 2020SA301276, 2020SA301284, 2020SA301290, 2020SA301304 and 2020SA301312 (same reporter).  This case involves a 12-months-old female patient who was inadvertently administered a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] prefilled syringe (lot QFAA2051, expiry date- 30-Jun-2021) via an unknown route in the left thigh for prophylactic vaccination on 22-Oct-2020 (product administered to patient of inappropriate age).  Medical history, concomitant medications, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration (latency on the 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 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.
Age: 14.0
Sex: M
Vaccine: FLUR4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Inadvertently administered Flublok Quadrivalent vaccine to 14-years-old patient/ No AE; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via Regulatory Agency (Reference number- 00328380) and transmitted to Sanofi on 22-Oct-2020.  This case is linked to cases 2020SA301262, 2020SA301312, 2020SA301272, 2020SA301304, 2020SA301293, 2020SA301276 and 2020SA301290 (same reporter).  This case involves a 14-years-old male patient who was inadvertently administered a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] prefilled syringe (lot number: QFAA2051, expiry date- 30-Jun-2021) via intramuscular route in left deltoid for prophylactic vaccination on 22-Oct-2020 (product administered to patient of inappropriate age).  Medical history, concomitant medications, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration (latency on the 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 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.
Age: 16.0
Sex: M
Vaccine: FLUR4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Inadvertently administered Flublok Quadrivalent vaccine to 16-years-old patient/ No AE; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via Regulatory Agency (Reference number- 00328380) and transmitted to Sanofi on 22-Oct-2020.  This case is linked to cases 2020SA301262, 2020SA301312, 2020SA301272, 2020SA301304, 2020SA301293, 2020SA301276 and 2020SA301284 (same reporter).  This case involves a 16-years-old male patient who was inadvertently administered a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] prefilled syringe (lot QFAA2051, expiry date- 30-Jun-2021) via intramuscular route in left deltoid for prophylactic vaccination on 22-Oct-2020 (product administered to patient of inappropriate age).  Medical history, concomitant medications, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration (latency on the 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 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.
Age: 4.0
Sex: U
Vaccine: FLUR4
Symptoms: Medication error, Product administered to patient of inappropriate age
Clinical narrative: Inadvertently administered Flublok Quadrivalent vaccine to 4-years-old patient/ no AE; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via Regulatory Agency (Reference number- 00328380) and transmitted to Sanofi on 22-Oct-2020.  This case is linked to case 2020SA301262, 2020SA301304, 2020SA301293, 2020SA301312, 2020SA301272, 2020SA301284 and 2020SA301290 (same reporter).  This case involves a four-years-old patient who was inadvertently administered a 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] prefilled syringe (lot QFAA2051, expiry date- 30-Jun-2021) via intramuscular route in the right vastus lateralis for prophylactic vaccination on 22-Oct-2020 (product administered to patient of inappropriate age).  Medical history, concomitant medications, medical treatments, vaccinations and family history were not provided.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency on the 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 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.
Age: 12.0
Sex: M
Vaccine: FLUR4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: inadvertently administered Flublok Quadrivalent vaccine to 12 year old patient/ no AE; Initial information was received on 22-Oct-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to case 2020SA301262, 2020SA301304, 2020SA301293, 2020SA301272, 2020SA301276, 2020SA301284 and 2020SA301290 (same reporter).  This case involves a 12-years-old male patient who was inadvertently administered a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] prefilled syringe (lot QFAA2051, expiry date- 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination on 22-Oct-2020 (product administered to patient of inappropriate age).  Medical history, concomitant medications, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration (latency on the 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 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.
Sex: M
Vaccine: FLUR4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patients who are under age 18 and received Flublok with no adverse event; Initial information received on 02-Nov-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to cases 2020SA309245, 2020SA309231 and 2020SA309247.  This case involves a 16 year old male patient who received influenza quadrivalent recombinant vaccine [Flublok QIV] (product administered to patient of inappropriate age) (batch number: QFAA2032 and expiration date: 30-Jun-2021) at a dose of 0.5 ml once 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 available regarding batch number in this case.
Age: 16.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Tuberculin test
Clinical narrative: Patients who are under age 18 and received Flublok with no adverse event; Initial information regarding this unsolicited valid non-serious case via Global Medical Information (GMI) (reference number: 00341795) was received from a other health care professional and transmitted to Sanofi 02-Nov-2020.  This case is linked to cases 2020SA309231, 2020SA309246 and 2020SA309247 (same reporter).  This case involved 16 years old female patient who received a dose of 0.5 mL of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA2032, expiry date 30-Jun-2021), on 29-Sep-2020, via unknown route in the left deltoid for prophylactic vaccination (Product administered to patient of inappropriate age) .   No other vaccines were administered.  Relevant medical history, past medical treatment, vaccination details and family history were not provided.  No adverse event was reported at the time of reporting.  The patient also had a purified protein derivative (PPD) skin test placed on 29-Sep-2020.  It was a case of actual medical error due to inappropriate age at vaccine administration (latency same day).  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 batch number for this case.
Age: 15.0
Sex: F
Vaccine: FLUR4
Symptoms: Medication error, Product administered to patient of inappropriate age
Clinical narrative: Patients who are under age 18 and received Flublok with no adverse event; Initial information regarding this unsolicited valid non-serious case via Company (reference number: 00341795) was received from a other health care professional and transmitted to Sanofi 02-Nov-2020.  This case is linked to cases 2020SA309231, 2020SA309246 and 2020SA309245 (same reporter).  This case involved 15 years old female patient who received a dose of 0.5 mL of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA2032, expiry date 30-Jun-2021), on 29-Sep-2020, via unknown route in the left deltoid for prophylactic vaccination (Product administered to patient of inappropriate age) .   No other vaccines were administered.  Relevant medical history, past medical treatment, vaccination details and family history were not provided.  No adverse event was reported at the time of reporting.  It was a case of actual medical error due to inappropriate age at vaccine 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.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Hepatitis B surface antigen negative, Inappropriate schedule of product administration
Clinical narrative: titers negative hepatitis B antibodies/ aproximately 25 or so cases with age range 6 to 19 did not sercoconvert; First Vacc. Date /Second Vacc. Date /Third Vacc. Date; This spontaneous report was received from a nurse prescriber on 29-OCT-2020 referring to 16-year-old female patient, her race/ethnicity was reported. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  The patient was vaccinated with three doses of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) unknown thimerosal status (dose, route of administration, anatomical location, strength, lot number and expiration date were not provided) for prophylaxis on 24-OCT-2004, 29-DEC-2004 and 03-JUN-2005(Inappropriate schedule of vaccination).  On an unknow date, hepatitis B surface antigen test result showed that the patient did not seroconvert. On 27-AUG-2020, the Anti-HBs Titer test was performed, the reported result was 0.0 (unit was not provided). The outcome of the event was not reported.  The reporter did not provide a causal assessment between hepatitis b vaccine (recombinant) (RECOMBIVAX HB) and the lack of seroconvertion.  This is one of several reports received from the same reporter; Sender's Comments:  US-009507513-2009USA002116:
Sex: F
Vaccine: VARZOS
Symptoms: Cardiovascular disorder, Chest pain, Hypoaesthesia oral, Paraesthesia, Rash vesicular
Clinical narrative: cardiovascular event; varicella type rash; This spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. Information regarding current condition, historical condition or concomitant medication was not provided. On or around 06-SEP-2012, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose number, strength, route, batch/lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered chest pain, hand, and foot paresthesia's along with perioral numbness and was diagnosed with a cardiovascular event. The pt also suffered a varicella type rash shortly after receiving the zoster vaccine live (ZOSTAVAX) vaccine. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not presented prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered as not recovered. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX),    The events of cardiovascular event and varicella type rash were considered as disabling.
Age: 63.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Dizziness, Syncope
Clinical narrative: I like felt i was going to black out. Got extremely hot. Weak could'nt speak.  Sweating .extremely dizzy.  Felt this way for 3 days. Called the pharmacy and community nurse hotline
Age: 63.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Asthenia, Dizziness, Feeling hot, Hyperhidrosis, Loss of consciousness
Clinical narrative: I like felt i was going to black out. Got extremely hot. Weak could'nt speak.  Sweating .extremely dizzy.  Felt this way for 3 days. Called the pharmacy and community nurse hotline
Age: 63.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Speech disorder
Clinical narrative: I like felt i was going to black out. Got extremely hot. Weak could'nt speak.  Sweating .extremely dizzy.  Felt this way for 3 days. Called the pharmacy and community nurse hotline
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AEs; temperature excursion on GARDASIL 9/ temperature above 47F; This spontaneous report as received from a medical assistance, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 02-NOV-2020 (reported as today), the patient was vaccinated with an improperly storage dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1637648 with expiration date 19-JUN-2022 (dose, frequency, route and anatomical location were not provided) for prophylaxis. No additional adverse events reported.  The vaccine was stored at a temperature of above 47 Fahrenheit degrees, time frame of 1 hour and with not previous temperature excursion. Digital Data logger was not involved. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637648; expirationdate: 19-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AEs; temperature excursion on GARDASIL 9/ temperature above 47 F; This spontaneous report as received from a medical assistance, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 02-NOV-2020 (reported as today), the patient was vaccinated with an improperly storage dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # S033308 with expiration date 08-APR-2022 (dose, frequency, route and anatomical location were not provided) for prophylaxis. No additional adverse events reported.  The vaccine was stored at a temperature of above 47 Fahrenheit degrees, time frame of 1 hour and with not previous temperature excursion. Digital Data logger was not involved. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S033308; expirationdate: 08-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored product administered; No additional AE reported; This spontaneous report was received from a physician  and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 17-NOV-2020,  the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD) Lot # T025506, expiration date 23-JAN-2022, 0.5 milliliter for prophylaxis (route of administration not reported).     The improperly stored dose of the suspect vaccine experienced a temperature excursion of 22.8 degree fahrenheit (°F) for 13 hours and 25 minutes with a previous temperature excursion of 17.4 °F for 31 minutes and 30 seconds.  The call was made due to a digital data logger. No adverse symptoms were reported.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired VAQTA was administered to a patient; This spontaneous report was received from the physician's office manager, concerning a 2 year old patient of unknown gender. There was no information regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies.  On 19-NOV-2020, the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) 0.5ml lot # S010727 with expiration date of 26-JUL-2020, for prophylaxis (frequency, route of administration and anatomical location were not provided). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S010727; expirationdate: 26-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: was given on the top of the thigh in the vastus lateralis area instead of the side of the thigh; administered IM instead of SC; no adverse event; This spontaneous report was received from a nurse referring to a 7-year-old patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   On 19-NOV-2020, the patient was vaccinated with a dose of 0.5 milliliter of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T016000, expiration date 08-MAY-2022 for prophylaxis. The vaccine was given inadvertently in the top of the thigh of the patient. It was given with a 5/8-inch needle but was given on the top of the thigh in the vastus lateralis area instead of the side of the thigh. It was given with a subcutaneous needle, but in the wrong place. No other adverse event reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: no adverse effects; administered IM instead of SC; This spontaneous report was received from a pharmacist referring to a patient of unknown age. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   On 17-NOV-2020, the patient was vaccinated with a dose varicella virus vaccine live (oka/merck)(VARIVAX) lot # S002084, expiration date 21-JAN-2021 for prophylaxis (strength, dose, frequency were not reported). The vaccine was inadvertently administered intramuscularly rather than subcutaneously to the patient. No adverse effects reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. In 2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, anatomical location and route of administration were not provided ), as prescribed and/or administered by a pharmacist at pharmacy, for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to vaccination, the patient was treated by a healthcare provider at clinic/hospital for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was not provided.
Sex: U
Vaccine: RV5
Symptoms: Gastroenteritis rotavirus, Infection via vaccinee, Rotavirus infection
Clinical narrative: Immunocompromised patient developed rotavirus after an infant sibling received Rotateq; Immunocompromised patient developed rotavirus after an infant sibling received Rotateq; This spontaneous report was received from a physician via company representative and refers to a pediatric immunocompromised patient of unknown age and gender. The patient was participating in the program. The patient's medical history included allogenic stem cell transplantation.     On an unknown date, when the patient was approximately 4-8 weeks post an allogenic stem cell transplant his or her infant sibling received a dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), orally (dose, lot # and expiration date were not reported) for prophylaxis (case # 2011USA016850).         On an unknown date, the patient developed rotavirus (gastroenteritis rotavirus and Infection via vaccinee) and was hospitalized. On unknown date, the patient recovered from gastroenteritis rotavirus and Infection via vaccinee.  The patient's family was counseled prior to the infant sibling receiving the vaccination that it was not advisable due to the risk of the immunocompromised patient developing rotavirus. The family went ahead with vaccination of the sibling infant vaccination despite recommendations.  At the time of the report, the relationship between gastroenteritis rotavirus, Infection via vaccinee and rotavirus vaccine, live, oral, pentavalent(ROTATEQ) was not reported.  Upon internal Review, gastroenteritis rotavirus was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation of a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  In 2014, the patient the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (dose, route of administration, lot number and expiration date were not reported).  Subsequently to the patient zoster vaccine live (ZOSTAVAX)inoculation, on an unknown date, the patient was treated for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was unknown. The causal assessment was related.
Sex: M
Vaccine: HPV9
Symptoms: Product administered at inappropriate site
Clinical narrative: Gardasil 9 was administered to a patient intramuscularly at the ventrogluteal site.; No additional AE/PQC filed.; This spontaneous report was received from a nurse referring to a male patient of unknown age. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.     On an unknown date in June 2020, the patient received his first dose, on August 2020, his second dose and on unknown date on mid-November 2020, his third dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) at a dose of 0.5 milliliter for prophylaxis, intramuscular at the ventrogluteal site (product administered at inappropriate site) (strength, lot number and expiration date were not reported). No additional adverse event/PQC filed
Sex: U
Vaccine: TDAP
Symptoms: Allergy to vaccine, Attention deficit hyperactivity disorder, Drug hypersensitivity, Epilepsy, Generalised tonic-clonic seizure
Clinical narrative: Epilepsy; Seizures; ADHD; Allergic to the Pertussis portion; This case was reported by a consumer via interactive digital media and described the occurrence of epilepsy in a infant patient who received DTPa (DTPa vaccine) for prophylaxis.   Previously administered products included DTPa vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of DTPa vaccine. On an unknown date, less than a year after receiving DTPa vaccine, the patient experienced epilepsy (serious criteria GSK medically significant), grand mal seizure (serious criteria GSK medically significant), attention deficit hyperactivity disorder and drug allergy. On an unknown date, the outcome of the epilepsy, grand mal seizure, attention deficit hyperactivity disorder and drug allergy were unknown.   It was unknown if the reporter considered the epilepsy, grand mal seizure, attention deficit hyperactivity disorder and drug allergy to be related to DTPa vaccine.  Additional details were reported as follows:  The age at vaccination was not reported. The patient stated that he/she received vaccine 3 times at 1st year of life. The patient experienced epilepsy with grand mal seizure, Attention deficit hyperactivity disorder. The patient stated that he/he heard Tdap was much safer than the DPT shot from old time.The patient was allergic to the Pertussis portion.  The patient still willing to do what he/she must for his/her children though. For tolerance of 1st and 3rd dose refer case US2020AMR228374 and US2020AMR228497 respectively.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR228374:1st dose, same reporter US-GLAXOSMITHKLINE-US2020AMR228497:3rd dose, same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: extreme exhaustion; This case was reported by a consumer via interactive digital media and described the occurrence of exhaustion in a adult 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 exhaustion. On an unknown date, the outcome of the exhaustion was recovered/resolved.   It was unknown if the reporter considered the exhaustion to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. After received the 2nd dose of Shingrix the patient experienced extreme exhaustion which lasted almost 2 days. The patient asked was this part of the side effects.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: fever; muscle aches; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th November 2020, the patient received Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced fever and myalgia. On an unknown date, the outcome of the fever and myalgia were not recovered/not resolved.   It was unknown if the reporter considered the fever and myalgia to be related to Shingrix.  Additional details were provided as follows: The reporter was wife of the patient. The age at vaccination was not reported. The patient experienced fever and muscle aches. The reporter asked how long did this last