chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient was given a second dose of Fluzone High-Dose (with no adverse event); Initial information was received on 10-Nov-2020 regarding an unsolicited valid non-serious case from a other healthcare professional.  This case involves a 66 years old male patient who received second 0.7 mL dose of influenza quadrival A-B high dose HV vaccine (Fluzone High-Dose Quadrivalent) (Extra dose administered), (lot UJ535AA/UJ468AB, expiry date: 30-Jun-2020) via an unknown route in unknown administration site for prophylactic vaccination, on an unknown date.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  It was a case of an actual medication error due to extra dose administered (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.
Sex: F
Vaccine: DTAPIPV
Symptoms: Underdose
Clinical narrative: she accidently hit the nurses arm and the medicine spilled out with no adverse event; Initial information received on 11-Nov-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 year old who accidently hit the nurses arm and the medicine spilled out, Caller states that she is unsure of how much of the vaccine the patient received. The  syringe had 0.3 or 0.4ml left in it with no adverse event ((underdose), while she received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose  dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C573AA via unknown route in unknown administration site.  On an unknown date (unknown latency) it was reported that patient accidently hit the nurses arm and the medicine spilled out, Caller states that she is unsure of how much of the vaccine the patient received. The  syringe had 0.3 or0.4ml left in it with no adverse event (underdose).  Other relevant tests included no lab data.  Final diagnosis was underdose.  An unknown corrective treatment was received.  There will be no information available on the batch number for this case
Sex: F
Vaccine: FLUR4
Symptoms: Contusion, Incorrect route of product administration
Clinical narrative: caller stated that bruising was seen on the patient's posterior part of the patient's arm.; Flublok was inadvertently administered subcutaneously vs.intramuscular; Initial information regarding an unsolicited valid non-serious case was received from a other healthcare professional via call center on 11-Nov-2020.  This case involves adult female patient who experienced bruising was seen on the patient's posterior part of the patient's arm (contusion) and flublok was inadvertently administered subcutaneously vs intramuscular (incorrect route of product administration), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.5 ml  dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE, via subcutaneous route, lot number not reported via subcutaneous route.  On an unknown date (unknown latency) after vaccination, the patient developed a non-serious caller stated that bruising on the patient's posterior part of the patient's arm (contusion) and reported flublok was inadvertently administered subcutaneously vs intramuscular (incorrect route of product administration) (intensity: not applicable).   Action taken was reported as unknown for contusion and as not applicable for incorrect route of product administration.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for contusion and as not applicable for incorrect route 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.    No further relevant information was reported.  Additional information was received on 12-Nov-2020: Action taken for the event contusion was corrected from the previous version. Corresponding fields and narrative were updated accordingly.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: given Ipol five days before her fourth birthday with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician via Medical Information (Reference number- 00356588) and transmitted to Sanofi on 12-Nov-2020.  This case involves a 4 years old female patient  (At the time of report age 12 years) who received IPV (VERO) [IPOL] five days before her fourth birthday with no adverse event (Inappropriate schedule of product administration).  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received IPV (VERO) (lot number unknown) via unknown route in unknown administration site for prophylactic vaccination five days before her fourth birthday (Inappropriate schedule of product administration).   It was a actual medication error due to inappropriate schedule of product administration.  At the time of this report, Patient was 12 years old.    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.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Unevaluable event
Clinical narrative: patient received a dose of regular FLUZONE QUADRIVALENT the patient would rather have FLUZONE HIGH DOSE instead/ no ae; Initial information regarding an unsolicited valid non-serious case was received from a Healthcare Professional (Reference number- 00357619) on 13-Nov-2020.  This case involves a 67 year old female patient received a dose of regular INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] would rather had INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] instead (wrong product administered).  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, patient received a dose of regular FLUZONE QUADRIVALENT (dosing details and expiry date were not reported) would rather the patient have FLUZONE HIGH DOSE for prophylactic vaccination.  It was an actual medication error due to Wrong vaccine administered.(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.
Age: 28.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: The patient was administered fluzone high dose quadrivalent accidentally instead of Fluarix, no AE; The patient was administered fluzone high dose quadrivalent accidentally instead of Fluarix, no AE; The patient was administered fluzone high dose quadrivalent accidentally instead of Fluarix, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional (Reference number- 00358654) and transmitted to Sanofi on 15-Nov-2020.  This case is linked to cases 2020SA324634, 2020SA324620, 2020SA324531, 2020SA324529, 2020SA324116, 2020SA323899, 2020SA323872, 2020SA323795, 2020SA323787, 2020SA323614, 2020SA323616 and 2020SA323597 (same reporter).  This case involves a 28 years old male patient who was administered 0.7 ml INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ552AA, expiry: 30-Jun-2021) once dose via intramuscular route in the left arm for prophylactic vaccination on 05-Nov-2020 instead of INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) (wrong product administered, product administered to patient of inappropriate age and accidental overdose).  Medical history, medical treatment(s), past vaccination(s), concomitant medication and family history were not provided.   It was a case of an actual medication error due to wrong vaccine administered, inappropriate age at vaccine administration and overdose accidental (latency same day).  A Pharmacist was supposed to give Fluarix, however accidentally grabbed and administered Fluzone High Dose Quadrivalent to 13 separate patients on different days. No adverse events (AE's) were noted and no treatments were administered to any of the patients.  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: M
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: patient was given an expired dose of Tenivac with no adverse event; Initial information regarding an unsolicited valid non-serious case received from a other health professional via Global Medical Information (GMI) (reference number: 00360472) on 16-Nov-2020.  This case involved a 32-year-old male patient for whom it was reported that patient was given an expired dose of tenivac (Expired product administered), while he received vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  Medical history, medical treatment, vaccination and family history of the patient were not provided. Concomitant medication was not reported.   On 13-Nov-2020, the patient received a dose (0.5 ml) of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot number U6101AA, expiration date 23-Oct-2020) via unknown route in unknown administration site for prophylactic vaccination.  On 13-Nov-2020, it was reported that patient was given an expired dose of tenivac (Expired product administered), following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  This is a case of actual medication error due to expired product administered.  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: 73.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received two flu vaccinations for this flu season with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional (Reference number- US-SANOFI-00361585) and transmitted to Sanofi on 17-Nov-2020.  This case involves a 73 year old male patient who received two flu vaccinations this season, a dose of INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiration date not reported) on 15-Sep-2020 via unknown route and unknown administration site and 0.7 ml of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number: UJ443AA, expiration date not reported) once via unknown route at left deltoid for prophylactic vaccination on 17-Nov-2020 (extra dose administered).  The patient medical history, past medical treatment, past vaccination and family history were not provided.  The patient did not receive any other vaccinations or medications concomitantly.  It was an actual medication error case due to extra dose administered (latency same day).   At the time of this report, no adverse event 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 on the batch number for INFLUENZA VACCINE.
Age: 65.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: the patient had received Fluzone High-Dose twice in a year with no AE; patient was supposed to be getting a pneumonia vaccine at the pharmacy with no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist (Reference number- US-SANOFI-00361900) and transmitted to Sanofi on 17-NOV-2020.  This case involves a 65-year-old male patient who received a dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ491AAand expiry date: 30-Jun-2021) twice in a year via an intramuscular route in an unknown administration site for prophylactic vaccination (extra dose administered), instead of PNEUMOCOCCAL VACCINE at the pharmacy (wrong product administered).  The patient medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications not reported.  It was an actual medication error case due to extra dose administered and wrong product administered (latency same day).   It was reported that patient was supposed to be getting a pneumonia vaccine at the pharmacy but received the Fluzone high dose quadrivalent vaccine twice.  At the time of this report, no adverse event 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.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: pain in her fingers wrist and hand along with swelling; pain in her fingers wrist and hand along with swelling; Initial information was received on 17-Nov-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 79-year-old female patient who experienced pain in her fingers wrist and hand along with swelling (pain in extremity and (peripheral swelling), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On 03-Oct-2020, the patient received a dose of 0.7 ml suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ479AA, 30-Jun-2021) via intramuscular route at an unknown administration site for prophylactic vaccination.  On 10-Oct-2020, the patient developed a non-serious pain in her fingers wrist and hand along with swelling (pain in extremity and (peripheral swelling) 7 days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the events.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: patient received FLUZONE QUADRIVALENT by subcutaneously or intradermally/ NO AE; Initial information regarding an unsolicited valid non-serious case received from a other healthcare professional via call-center (Reference number- 00363166) and transmitted to Sanofi on 18-Nov-2020.  This case involves patient (unknown demographics) who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number or expiry date not reported) via subcutaneously or intradermally (incorrect route of product administration) on an unknown date for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to inappropriate route of vaccination (latency: same day).  At the time of reporting, no adverse event was reported.  Reporter want to know what are the complications or adverse effect if FLUZONE QUADRIVALENT given subcutaneously or intradermally .  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.
Sex: M
Vaccine: FLU4
Symptoms: Amnesia, Lethargy, Somnolence
Clinical narrative: Short term memory loss remembering things that had occurred/been talked about the day before; Extremly lethargic; Could barely stay awake; This spontaneous case from was received on 04-Dec-2020 from other non-health professional via Agency (reference number: SEQW20-05578) and concerned a male patient of an unknown age.  The patient's medical history and concomitant medications were not reported.  On 16-Nov-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose, route of administration, anatomical location and indication: not reported). The batch number reported was P100249167.  On 17-Nov-2020, one day after receiving Afluria Quadrivalent, the patient was extremely lethargic, could barely stay awake at work and had some short-term memory loss remembering things that had occurred/been talked about the day before. These symptoms were very extreme and things the patient had never experienced before.   On an unspecified date in Nov-2020, the patient recovered from events, as the symptoms lasted roughly a week.  The reporter did not provide a causality assessment.  The event of 'short-term memory loss' was considered to be medically significant by a Physician.  Company comment: A male patient of unknown age developed amnesia, lethargy and somnolence one day after vaccination with the suspect product, Afluria Quadrivalent. Information regarding the underlying medical history and concomitant medications have not been provided. Due to plausible time relationship, causality is assessed as possible (defaults to related in the safety database for reporting purposes).; Sender's Comments: A male patient of unknown age developed amnesia, lethargy and somnolence one day after vaccination with the suspect product, Afluria Quadrivalent. Information regarding the underlying medical history and concomitant medications have not been provided. Due to plausible time relationship, causality is assessed as possible (defaults to related in the safety database for reporting purposes).
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Bladder dysfunction, Defaecation disorder, Myelitis transverse
Clinical narrative: he developed transverse myelitis had to relearn to and could not urinated or deficate only issue remaining is urination issue
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever, chills, headache - started around 2:30  and fever resolved around 10:00 pm, headache persisted until morning of 12/14/2020.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Headache, Hypersomnia, Influenza like illness, Influenza virus test negative
Clinical narrative: Went to bed fine,  became restless and couldn?t sleep. Chilled throughout body for 2 and 1/2 hours, had a headache and body aches all over. Rated 8/10. Mostly slept for three days.  Felt like I had the flu yet tested negative for Covid and flu on Thursday, Dec.3rd.  Low grade fever for three days with body aches.  Body aches and headache 10/10 on Friday, day 2.  Had a frontal headache daily through yesterday.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pain, Pyrexia, Restlessness, SARS-CoV-2 test negative
Clinical narrative: Went to bed fine,  became restless and couldn?t sleep. Chilled throughout body for 2 and 1/2 hours, had a headache and body aches all over. Rated 8/10. Mostly slept for three days.  Felt like I had the flu yet tested negative for Covid and flu on Thursday, Dec.3rd.  Low grade fever for three days with body aches.  Body aches and headache 10/10 on Friday, day 2.  Had a frontal headache daily through yesterday.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Cellulitis, Chest discomfort, Ear pain, Erythema
Clinical narrative: Pain in shoulder to neck to chin, jaw and ear on R side, extreme and uncomfortable. Went to bed painful arm to  shoulder to neck, restless. Nurse call in the morning - advised to use warm or cold compress - patient used warm compress - no relief, neck swollen tender to touch, painful. Friday 7:00 PM Advil 200 mg. Next day discomfort neck, chest, shoulder. Red area in chest appeared, warm to touch and swollen. Nurse at clinic of vaccination clinic site advised  to follow up with urgent care, possible infection.  Cheilitis skin infection diagnosis at urgent care. B 12 injection on left side same day of vaccine.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal discomfort, Neck pain, Restlessness, Swelling
Clinical narrative: Pain in shoulder to neck to chin, jaw and ear on R side, extreme and uncomfortable. Went to bed painful arm to  shoulder to neck, restless. Nurse call in the morning - advised to use warm or cold compress - patient used warm compress - no relief, neck swollen tender to touch, painful. Friday 7:00 PM Advil 200 mg. Next day discomfort neck, chest, shoulder. Red area in chest appeared, warm to touch and swollen. Nurse at clinic of vaccination clinic site advised  to follow up with urgent care, possible infection.  Cheilitis skin infection diagnosis at urgent care. B 12 injection on left side same day of vaccine.
Age: 19.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: a 19 year old patient inadvertently receiving a 1mL dose as opposed to the expected 0.5 mL dose; This spontaneous report was received from a nurse prescriber referring to a 19-year-old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On an unknown date, the patient was inadvertently vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (1 mL; strength, route, lot # and expiration date were not reported) as opposed to the expected 0.5 mL dose that was recommended in prescribing information for prophylaxis (incorrect dose administered).
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Pneumonia, Pulmonary fibrosis
Clinical narrative: patient was in the hospital with the flu and pneumonia; patient was in the hospital with the flu and pneumonia; Initial information regarding an unsolicited valid serious case received from a consumer and transmitted to Sanofi on 06-Dec-2020.  This case involves a patient with unknown demographics who experienced flu and pneumonia (Influenza and Pneumonia), while patient received INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, when patient was in the army received INFLUENZA VACCINE (produced by unknown manufacturer) (lot number unknown) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, three days later patient was in the hospital with the flu and double pneumonia (Influenza and Pneumonia) nearly died it scared patients lungs so bad and got 30 percent disability from it when patient got out.   The event Pneumonia was assessed as medically significant.   It was not reported if the patient received any corrective treatment.  Event outcome was Unknown for Influenza and Pneumonia.  There will be no information regarding batch number for the case.
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: deathly ill; Initial information regarding this unsolicited valid serious social media case received from a consumer (patient's child) and transmitted to Sanofi on 08-Dec-2020.  This case involved a male patient of unknown age who was deathly ill (illness), after he received vaccine INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination details, 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) (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, it was reported that the patient was in the hospital for two weeks being deathly ill (illness) (unknown latency) following the administration of INFLUENZA VACCINE. The patient's child reported that the doctor had said that it was due to the INFLUENZA VACCINE that the patient had received.   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.; Sender's Comments: This case concerns a male patient of unknown age who had presented with illness after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown. Moreover, patient's medical condition, concomitant medication and laboratory tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 33.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: The patient was administered fluzone high dose quadrivalent accidentally instead of Fluarix, no AE; The patient was administered fluzone high dose quadrivalent accidentally instead of Fluarix, no AE; The patient was administered fluzone high dose quadrivalent accidentally instead of Fluarix, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Medical Information (MI) (Reference number- 00358657) and transmitted to Sanofi on 15-Nov-2020.  This case is linked to cases 2020SA324634, 2020SA324620, 2020SA324531, 2020SA324307, 2020SA324116, 2020SA323899, 2020SA323872, 2020SA323795, 2020SA323787, 2020SA323616, 2020SA323614 and 2020SA323597 (same reporter).  This case involves a 33 year old female patient who was administered 0.7 ml INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ552AA, expiry: 30-Jun-2021, form: Prefilled syringe) once via intramuscular route in the left arm for prophylactic vaccination on 06-Nov-2020 instead of INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) (wrong product administered, product administered to patient of inappropriate age and accidental overdose).  Medical history, medical treatment(s), past vaccination(s), concomitant medication and family history were not provided.   It was a case of an actual medication error due to wrong vaccine administered, inappropriate age at vaccine administration and overdose accidental (latency same day).  A Pharmacist was supposed to give Fluarix, however accidentally grabbed and administered Fluzone High Dose Quadrivalent to 13 separate patients on different days. No adverse events (AE's) were noted and no treatments were administered to any of the patients.  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.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Myalgia, Nausea
Clinical narrative: Chills, fever, soreness at site, headache, nausea, muscle aches
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Chills, fever, soreness at site, headache, nausea, muscle aches
Age: 69.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Injection site rash
Clinical narrative: Patient reports the development of a rash on the back side of her right arm beginning one day after the shot. Pneumovax 23 was given in the right arm. Denies any pain or other symptoms.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: I believe I had Covid 19 mid Dec 2019, [ I was tested for flu A & B & STREP - all came back negative] but I experienced most of symptoms and it was terrible where I thought I would be admitted into hospital, - the 24 hours of Shingle reaction was like the worst of that flu, what ever it may have been.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Pharyngeal paraesthesia
Clinical narrative: Patient received her second shingrix vaccination and stated an hour and a half later, she experienced tingling in her throat and started feeling like she was having difficulty breathing. Administered EPIPEN and went to ER. She called the following day asking if the second dose was the same as the first dose (which it is) because she had no issues with the first dose she received in our pharmacy. At the time of her call, the patient was completely fine and back to normal.
Age: 12.0
Sex: F
Vaccine: FLUC4
Symptoms: Balance disorder
Clinical narrative: Within 5-10 minute of vaccine administration patient  was noted to be unsteady on feet. Patient laid down on exam table. No loss of consciousness. Ice pack applied to forehead, coat removed. Patient rested for approximately 5-10 minutes. Vital signs checked- WNL. Patient sat at edge of exam table and stated felt 100% better .Able to leave with mother ambulating normally.
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia
Clinical narrative: The injection was very high on my arm and felt like it went into my shoulder. I have had right shoulder pain since the injection. It's been almost one month and I still struggle to use my right arm. Tying my shoes, exercising, holding my baby are all difficult with my right arm. The pain is not going away.
Age: 17.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Hyperhidrosis, Visual impairment
Clinical narrative: Patient reported that he felt light headed after vaccination and his vision was spotty.  Patient notably diaphoretic.  No loss of consciousness.  Patient given ice pack for forehead and rested in chair. Fellow NP recruited for assistance. Patient's head placed between knees. After patient was feeling better for a few minutes he was able to walk to the exam room with assistance and lay down for a few minutes. Vital signs checked and WNL. Patient given apple juice.  He returned to his baseline and was dispo'd home with parent.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Erythema, Fatigue, Headache
Clinical narrative: Patient reported stomach ache, bad headache, nausea, fatigue, arm red/swollen, body aches, shivering
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Peripheral swelling
Clinical narrative: Patient reported stomach ache, bad headache, nausea, fatigue, arm red/swollen, body aches, shivering
Age: 1.08
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HEPA, HIBV, MMRV, PNC13, VARCEL
Symptoms: Wrong product administered
Clinical narrative: MMRV was administered and it should've been an MMR that was administered.
Age: 10.0
Sex: F
Vaccine: FLUC4
Symptoms: Anxiety, Feeling hot
Clinical narrative: After vaccination patient anxious and reported feeling hot. Patient laid down on bed, ice pack for forehead, no loss of consciousness. Reported feeling back to normal within a few minutes.  Vital signs checked and within normal limits. Disposition home with parent
Age: 80.0
Sex: M
Vaccine: FLUA4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient states that he had no pain for several days after vaccine but developed soreness after a few days which has lasted for months in that arm and limited range of motion.
Age: 31.0
Sex: F
Vaccine: FLU4, MMR, TDAP
Symptoms: Dizziness, Immediate post-injection reaction, Nausea, Throat irritation, Visual impairment
Clinical narrative: IMMIDIATELLY AFTER THE THIRD VACCINE GIVEN, PATIENT STARTED FEELING DIZZY, NAUSEA, & DIMINISHED VISION. SECONDS LATER STATES FEELING A WEIRD SENSATION IN HER THROAT. BP LOW 70/43. PULSE: 43 R: 20
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Pallor, Syncope
Clinical narrative: PT GOT VERY PALE AND FAINTED
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Muscle pain, headache, chills, shivering, fatigue
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Dizziness, Erythema, Fatigue, Headache
Clinical narrative: Joint pain, headache, dizziness, fatigue, injection site red, warm, painful, with quarter-sized lump.  Facial erythema on left side.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: Joint pain, headache, dizziness, fatigue, injection site red, warm, painful, with quarter-sized lump.  Facial erythema on left side.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: Patient felt dizzy after vaccine administration. Reports this happens to her often with blood draws. Patient given ice pack for forehead and cold water, she reclined in chair for approximately 10 mins. No loss of consciousness. Vital signs checked WNL and patient feeling back to normal.  Disposition home
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Joint range of motion decreased
Clinical narrative: Left shoulder pain severely restricting range of motion of left arm. Pain required NSAIDs,, with partial relief. Unable to safely drive for 5 days due to inability to use left arm. No fever or local injection site reaction. Pain has diminished but continues on Day #8.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9, PPV
Symptoms: Dizziness, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Shortly after administration 5pm, pt reported feeling dizzy/lightheaded. Had pt lie down, feet elevated. Provided ORS. Repeated BP and pulse after 10 minutes and pt reported feeling better. BP and pulse nl. Mom called 2 days later to report  that same day pt reported pain at the injection site were PPSV23 and flu were administered (LD) and dizziness, vomiting, and HA. Now improved however, redness and swelling at the site persists.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Warm, red 2" diameter local Rx 25 mg benadryl Q6hr & tylenol 100mg/5mL take 12mL Q6 hrs/call tomorrow if not improved
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: he will need to come back in January 2021 for a second dose of the vaccine; he will need to come back in January 2021 for a second dose of the vaccine; he has had no other symptoms/ adverse events; he did receive the vaccine on 10/07/2020/ was determined that he had Shingles starting 10/02/2020; Caller states he "definitely got the Merck Herpes Zoster'/ Caller states he is not sure if he got Shingrix because he was told it was the "Merck Herpes Zoster" vaccine; This spontaneous report was received from a male patient of unknown age, who refers to himself. No information regarding the patient's medical history or concomitant medications was provided. The patient's current conditions included shingles that started on 02-OCT-2020. On 07-OCT-2020, despite of shingles, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical localization, lot # and expiration date were unknown) for prophylaxis or with a dose of zoster rge vaccine (mammalian) (SHINGRIX) (dose, route of administration, anatomical localization, lot # and expiation date were not provided) for prophylaxis. The patient stated he was not sure if he got zoster rge vaccine (mammalian) (SHINGRIX) or zoster vaccine live (ZOSTAVAX), as he was told by the physician's office.  The patient reported also that two staff members at his physician's office told that he would need to come back in January 2021 for a second dose of the vaccine (inappropriate schedule of vaccine). He confirmed that besides of shingles that he already had prior to vaccination, he had no other symptoms or adverse events.
Sex: U
Vaccine: HEPA, UNK
Symptoms: Product storage error
Clinical narrative: No adverse effects; Calling to report a temperature excursion; This spontaneous report was received from a Medical Assistant, refers to a patient of unknown age and gender. Information regrading the patient's pertinent medical history, known allergies, concurrent conditions and concomitant therapies was not provided.      On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # T008697 with expiration date on 04-JUN-2021 (strength, route and dose were not provided) for prophylaxis.         On 16-NOV-2020, it was found that hepatitis a vaccine, inactivated (VAQTA), experienced a temperature excursion of 3.0F, on a time frame of 3 hours and 30 minutes. Information regrading previous excursions was not provided. Call was made due to a data logger. The reported stated that the patient had no adverse reactions.   This is one of several reports received by the same source. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008697; expirationdate: 04-JUN-2021; 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; Sender's Comments:  US-009507513-2011USA010974: US-009507513-2012USA006027:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; multiple outbreaks of herpes zoster; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 08-AUG-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) 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 patient suffered multiple outbreaks of herpes zoster and post herpetic neuralgia. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient 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, the patient 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 to be not recovered.  The events of multiple shingles outbreaks and postherpetic neuralgia were considered to be disabling.
Sex: U
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Dermatitis, Eczema
Clinical narrative: stroke; dermatitis; eczema; This spontaneous report as received from a lawyer concerning a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On 23-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).         On an unknown date, the patient experienced dermatitis, eczema and cerebrovascular accident.  The patient's symptoms had resulted in physical limitations, also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. The patient sustained severe and permanent personal injuries, he or she also suffered serious, progressive, permanent and incurable injuries.   The outcome of cerebrovascular accident, eczema and dermatitis was unknown.     The reporter considered cerebrovascular accident, eczema and dermatitis to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event of stroke was considered medically significant.
Sex: F
Vaccine: PPV
Symptoms: Vaccination site swelling
Clinical narrative: site swelling; pneumonia vaccine administered yearly; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a currently 75-year-old female patient. Her concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiry date were not provided) administered yearly by a physician for prophylaxis.  On an unknown date, the patient experienced vaccination site swelling.   The outcome of vaccination site swelling was not reported.  The reporter considered vaccination site swelling to be related to pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown).   This is one of two reports regarding the same patient.; Sender's Comments:  US-009507513-1905USA008852:
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: No adverse effects; Calling to report a temperature excursion; This spontaneous report was received from a Medical Assistant, refers to a patient of unknown age and gender. Information regrading the patient's pertinent medical history, known allergies, concurrent conditions and concomitant therapies was not provided.      On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (strength, route, dose, lot # and expiration date were not provided) for prophylaxis.         On 16-NOV-2020, it was found that hepatitis b vaccine (recombinant)(RECOMBIVAX HB), experienced a temperature excursion. The reported stated that the patient had no adverse reactions. Information regrading the temperature excursion in which the vaccine was involved was not provided.  This is one of several reports received by the same source.; Sender's Comments:  US-009507513-2011USA010974: US-009507513-2012USA002962:
Sex: U
Vaccine: FLUX
Symptoms: Malaise, Vaccine positive rechallenge
Clinical narrative: patient got deathly ill; Initial information was received on 08-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer (patient).  This case involves a patient (unknown age and gender) who got deathly ill twice (illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got deathly ill twice (illness) (Unknown latency) 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, outcome of the event was unknown.  There would be no information available on batch number for this case.