chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX
Symptoms: Malaise, SARS-CoV-2 test
Clinical narrative: patient got it and been sicker then crap for 2 weeks; Initial information received on 13-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case involves a patient who got sicker then crap for 2 weeks (illness), while she received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date,the patient received a dose  of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, patient got sicker then crap for 2 weeks (illness) (Unknown latency) following the administration of INFLUENZA VACCINE and been isolating for at least that long no call back for covid test so taking it as negative.  Relevant laboratory data was not reported.  It was not reported if the patient received any corrective treatment.  The outcome was unknown for event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient contracted the flu every time patient received a vaccination; Initial information received on 13-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case involves a patient  with unknown demographics who contracted the flu (influenza) every time patient received a INFLUENZA vaccination.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date,the patient received a dose  of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, contracted the flu (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Relevant laboratory data was not reported.  It was not reported if the patient received any corrective treatment.  The outcome was reported as unknown for event.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Very Very Very sick with flu after taking flu shot; Initial information received on 14-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer/non-hcp.  This case involves a female patient who was very very very sick with flu after (influenza), while she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination and family history of the patient were not provided. Concomitant medication was not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was very very very sick with flu (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Final diagnosis was influenza.  No relevant laboratory test was reported.  It was not reported if the patient received a corrective treatment.  The outcome was reported as unknown.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Vaccine positive rechallenge
Clinical narrative: patient gets flu shot every year, gets the flu every year too; Initial information received on 18-Nov-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves female patient of unknown age who INFLUENZA VACCINE every year, gets the flu (influenza) every year too.  The patient's past vaccinations included flu shot and gets flu every time.  Medical history, medical treatment(s), concomitant medication(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 expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was not reported for the event influenza.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal
Clinical narrative: felt absolutely miserable; Initial information received on 20-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involve patient (unknown demographics) who experienced felt absolutely miserable, when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication 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 not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious felt absolutely miserable (feeling abnormal) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for feeling abnormal.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick; Initial information received on 20-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves patient (unknown demographics) who got sick (illness), when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication 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 not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick (illness) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   The patient was treated with VITAMIN D NOS [VITAMIN D NOS (not otherwise specified)], ZINC (ZINC) and a lot of vitamins for Illness.  The event outcome was unknown for illness.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: bit of soreness in arm; Initial information received on 19-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media .  This case involves patient (unknown demographics) who experienced bit of soreness in arm (pain in extremity), when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication 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 not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious bit of soreness in arm (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for pain in extremity.   There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Burning sensation, Hypersensitivity, Lip injury, Loss of consciousness, Malaise
Clinical narrative: passed out; very sick; got a floor burn on face; must have been allergic; Initial information received on 08-Dec-2020 regarding an unsolicited valid serious case received from a consumer (patient) via social media.   This case involves a patient (unknown demographics) who passed out (loss of consciousness), got very sick (illness), also floor burn on face (burning sensation) and must have been allergic (hypersensitivity), when received INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date in 1982, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in 1982, the patient passed out (loss of consciousness) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  On an unknown date in 1982, the patient got very sick (illness), also floor burn on face (burning sensation) and must have been allergic (hypersensitivity) (unknown latency) following the administration of INFLUENZA VACCINE.  Patient had to get stitches in his lip.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for all the events.  Batch number has been requested for suspect product for this case.; Sender's Comments: This poorly documented case concerns a patient (unknown demographics) who suffered from loss of consciousness, illness, burning sensation and hypersensitivity after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset was unknown. However, patient's medical condition at the time of vaccination, lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Suture insertion
Clinical narrative: passed out; very sick; got a floor burn on face; must have been allergic; Initial information received on 08-Dec-2020 regarding an unsolicited valid serious case received from a consumer (patient) via social media.   This case involves a patient (unknown demographics) who passed out (loss of consciousness), got very sick (illness), also floor burn on face (burning sensation) and must have been allergic (hypersensitivity), when received INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date in 1982, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in 1982, the patient passed out (loss of consciousness) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  On an unknown date in 1982, the patient got very sick (illness), also floor burn on face (burning sensation) and must have been allergic (hypersensitivity) (unknown latency) following the administration of INFLUENZA VACCINE.  Patient had to get stitches in his lip.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for all the events.  Batch number has been requested for suspect product for this case.; Sender's Comments: This poorly documented case concerns a patient (unknown demographics) who suffered from loss of consciousness, illness, burning sensation and hypersensitivity after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset was unknown. However, patient's medical condition at the time of vaccination, lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick; Initial information received on 09-Dec-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional.  This case involves five patients (unknown demographics) got sick (illness), when received vaccine INFLUENZA VACCINE  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   In 1974, the patients received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patients got sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.   The patients were hospitalized for this event.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for illness.  Batch number has been requested for suspect product for this case.; Sender's Comments: This poorly documented case concerns 5 patients (unknown demographics) who suffered from illness after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset was unknown. Moreover, patient's medical condition at the time of vaccination, lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient still get the flu; Initial information was received on 11-Dec-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (patient).  This case involves patient [age and gender unspecified] who still get the flu (influenza), while patient received vaccine INFLUENZA VACCINE [Flu shot].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient still get the flu (influenza) (non-serious) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: patient was mistakenly given FLUZONE HD when she was supposed to be getting a pneumonia vaccine the same patient had already received FLUZONE HD  with no adverse event; patient was mistakenly given FLUZONE HD when she was supposed to be getting a pneumonia vaccine with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a Pharmacist via Call Center via the agency (Reference number- 00356259) and transmitted to Sanofi on 12-Nov-2020.  This case involves a 65 year old female patient was mistakenly given INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] when she was supposed to be getting a pneumonia vaccine the same patient had already received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] with no adverse event (Extra dose administered and Wrong product administered).  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   It was a actual medication error due to Extra dose administered and Wrong product administered.  On 27-Sep-2020 she also received a first dose of the INFLUENZA QUADRIVAL A-B VACCINE (batch number: unknown) via an unknown route in an unknown administration site for prophylactic vaccination.  On 11-Nov-2020, patient went to go get a Pneumonia vaccine, however the clinic was filled with patients that were getting the INFLUENZA QUADRIVAL A-B VACCINE and the person administering the vaccine did not check the consent form and patient administered the INFLUENZA QUADRIVAL A-B VACCINE prefilled syringe (batch number: UT7081KA Expiration date: 30-Jun-2021 Strength Standard via an intramuscular route in an unknown administration site) in error (Extra dose administered and Wrong product administered).  The patient has not exhibited any adverse event as a result of the Extra dose administered and Wrong product administered.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event
Clinical narrative: may have been administered the dtap-ipv portion separate from the hib portion with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Global Medical Information (GMI) (Reference number- 00356816) and transmitted to Sanofi on 12-Nov-2020.  This case involves patient with unspecified age who may have been administered with the DTaP-IPV portion separate from the HiB portion with no adverse event (product preparation issue), while patient was receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number unknown) via an unknown route in an unknown administration site for prophylactic vaccination.  The patient's medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to Inappropriate reconstitution technique.  A nurse reported a possible medication error which was described as the Dtap-Ipv portion may have been administered separate from the Hib portion. Reporter did not know if there had been a medication error with the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE or that she dont not know if the DTap-IPV portion had been administered or if a consumer was only needing a HIB portion due to being only prescribed the HIB.  At the time of this report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Age: 34.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: A patient was administered an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other care professional via Medical Information (Reference number- 00360429) and transmitted to Sanofi on 16-Nov-2020.  This case is linked to cases 2020SA325400 and 2020SA326243 (same reporter).  This case involves a 34 year old male patient who was administered a dose of 0.5 ml DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U6101AA, expiry: 23-Oct-2020) once via unknown route in unknown administration site for prophylactic vaccination on 05-Nov-2020 (Expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of an actual medication error due to Expired vaccine used (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Vaqta was given to a patient; Patient is not having any; This spontaneous report was received from a medical assistant and refers to a 32-year-old female patient. She had no pre-existing allergies, birth defects, medical conditions, or illness at time of vaccination. No information regarding her concomitant therapies was provided.  On 18-NOV-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA), lot # S032371, expiration date 24-AUG-2020, in the left deltoid, for prophylaxis (strength, dose and route of administration were not reported). The patient was not having any adverse events or symptoms but it was reported that she received a treatment (unspecified).
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: patient took a flu shot every year and was sick for days.; Initial information received on 14-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer/non-hcp.  This case involves a patient who took a flu shot every year and was sick for days (illness), while she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination and family history of the patient were not provided. Concomitant medication was not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient took a flu shot every year and was sick for days (illness), (Unknown latency) following the administration of INFLUENZA VACCINE.   Final diagnosis was illness.  No relevant laboratory test was reported.  It was not reported if the patient received a corrective treatment.  The outcome was reported as unknown.
Sex: U
Vaccine: FLUX
Symptoms: Diarrhoea, Gastrointestinal disorder, Malaise, Migraine, Pain
Clinical narrative: Totally knocked on my butt sick for a full 3 days; Migraine so bad patient couldn't see; Diarrhea; Upset digestive system; Not a place on body that didn't hurt; Initial information was received on 01-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case is linked to cases 2020SA348514 and 2020SA348515.  This case involves patient with unknown demography who was totally knocked on butt sick for a full 3 days (illness), migraine so bad patient couldn't see (migraine), diarrhea (diarrhoea), upset digestive system (dyspepsia) and not a place on body that didn't hurt (pain), while he/she received vaccine INFLUENZA VACCINE.  The patient's past vaccination(s) included INFLUENZA VACCINE taken 2 years ago and still ended up in isolation at the Hospital for the "B" strain of flu.  Medical history, past medical treatments, concomitant medication 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 expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was totally knocked on butt sick for a full 3 days (illness), migraine so bad patient couldn't see (migraine), diarrhea (diarrhoea), upset digestive system (dyspepsia) and not a place on body that didn't hurt (pain), unknown latency following the administration of INFLUENZA VACCINE.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome was unknown for all the events.  There will be no information on the batch number for this case.
Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Contusion, Dizziness, Fall, Fatigue
Clinical narrative: Patient could not get up and could not move from the waist up; bruised arm; the patient felt sick; lightheaded and dizzy; tired; Patient felt like jello, very weak; fell; peeling back the skin; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via The agency (Reference number- 00313403) and transmitted to Sanofi on 13-Oct-2020.  This case involves a 72 years old female patient who could not get up and could not move from the waist up (dyskinesia), felt like jello, very weak (asthenia), sick (illness), lightheaded/dizzy (dizziness), tired (fatigue), fell and bruised arm peeling back the skin (fall, contusion and skin exfoliation), while she received INFLUENZA VACCINE.  Patient had a history getting sick from a spider bite on her foot in Dec-2019 that caused her not to be able to be able to walk. She stated that had to use a wheelchair for long distances. At the time of event patient had ongoing Diabetes mellitus. Medical treatment, vaccination, family history and concomitant medication were not provided.  On 10-Oct-2020, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an  the left arm for prophylactic vaccination.  On 11-Oct-2020, the patient could not get up and could not move from the waist up (dyskinesia), felt like jello, very weak (asthenia), sick (illness), lightheaded/dizzy (dizziness), tired (fatigue), fell and bruised arm peeling back the skin (fall, contusion and skin exfoliation) 1 day following the administration of INFLUENZA VACCINE. Relevant laboratory test results included: X-ray - On an unknown date: The x rays were clear  Final diagnosis was peeling back the skin, fell, patient felt like jello, very weak, tired, lightheaded and dizzy, the patient felt sick, bruised arm and patient could not get up and could not move from the waist up.   The patient was prescribed a treatment of an antibiotic cream and a Vitamin D shot.  At the time of reporting event outcome was not reported.  There will be no information on the batch number to be requested for this case.
Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling abnormal, Malaise, Movement disorder, Skin exfoliation, X-ray normal
Clinical narrative: Patient could not get up and could not move from the waist up; bruised arm; the patient felt sick; lightheaded and dizzy; tired; Patient felt like jello, very weak; fell; peeling back the skin; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via The agency (Reference number- 00313403) and transmitted to Sanofi on 13-Oct-2020.  This case involves a 72 years old female patient who could not get up and could not move from the waist up (dyskinesia), felt like jello, very weak (asthenia), sick (illness), lightheaded/dizzy (dizziness), tired (fatigue), fell and bruised arm peeling back the skin (fall, contusion and skin exfoliation), while she received INFLUENZA VACCINE.  Patient had a history getting sick from a spider bite on her foot in Dec-2019 that caused her not to be able to be able to walk. She stated that had to use a wheelchair for long distances. At the time of event patient had ongoing Diabetes mellitus. Medical treatment, vaccination, family history and concomitant medication were not provided.  On 10-Oct-2020, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an  the left arm for prophylactic vaccination.  On 11-Oct-2020, the patient could not get up and could not move from the waist up (dyskinesia), felt like jello, very weak (asthenia), sick (illness), lightheaded/dizzy (dizziness), tired (fatigue), fell and bruised arm peeling back the skin (fall, contusion and skin exfoliation) 1 day following the administration of INFLUENZA VACCINE. Relevant laboratory test results included: X-ray - On an unknown date: The x rays were clear  Final diagnosis was peeling back the skin, fell, patient felt like jello, very weak, tired, lightheaded and dizzy, the patient felt sick, bruised arm and patient could not get up and could not move from the waist up.   The patient was prescribed a treatment of an antibiotic cream and a Vitamin D shot.  At the time of reporting event outcome was not reported.  There will be no information on the batch number to be requested for this case.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: administered a flu shot to a consumer twice/no AE; Initial information was received on 17-Nov-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 63-year-old male patient who was administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] twice (extra dose administered).  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On 14-Sep-2020, the patient received a first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE prefilled syringe (lot number expiry date not reported) via unknown route at an unknown administration site and on 17-Nov-2020 he received 0.5 ml of second dose of the same vaccine (extra dose administered) (latency same day) (lot UT7115NA, expiry date-30-Jun-2020) via intramuscular route in the right arm for prophylactic vaccination.  It was a case of actual medication error due to (extra dose administered).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Muscle spasms
Clinical narrative: Pain at injection site x 72 hrs, severe insomnia x 48 hrs, muscle spasms causing left ankle to freeze and prevent inversion/eversion.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Injection site induration, Oedema peripheral
Clinical narrative: nearly 48 hours after vaccines, woke with marked swelling of axillae bilaterally, more on L than R, but more induration at vaccine site on R.  No systemic symptoms.  Was given benadryl.  When examined 48 hours later, was reported as improved, but still marked axillary swelling, with palpable lymphadenopathy on L, induration of vaccine site on R.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Gaze palsy, Myalgia, Tenderness
Clinical narrative: Headache, temp 99, muscle soreness, achey tender skin
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: next day injection site became reddened, warm to touch, and swollen. mother put ice to area and gave her Tylenol which helped
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Electromyogram, Guillain-Barre syndrome, Laboratory test, Magnetic resonance imaging
Clinical narrative: Guillion Barre IVIG
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever of 101, headache and body aches.  Started 15 hours after injection.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Rash
Clinical narrative: 1 year old covered in small red dots.  Raised red bump, infected area at the site of injection.  The site of injection is painful two weeks later.  Small red dots have persistent since immunization, which was nearly two weeks ago.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Pharyngeal swelling
Clinical narrative: WOKE UP AT 1230AM AND FELT AS THOUGH MY THROAT WAS SWELLING UP. BOTHS ARMS SWOLLEN. WENT RIGHT TO LOCAL ER.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Patient is a 55 y/o female here today for pneumococcal 23 vaccine reaction. She received this vaccine yesterday early afternoon here in clinic in LEFT deltoid. She reports feeling the typical aching later on but then felt the redness and swelling "growing." She went to ER around 730 pm (we do not have this note yet). She states they gave her benadryl and instructed her to ice it and she was sent home. She denies any fever, chills, n/v, SOB, swelling of tongue/throat. She states the redness has gone down but the swelling/pain has spread further down arm towards elbow and up to her neck and over left side of chest. 1. Local reaction to pneumococcal vaccine, initial encounter   Notes: The erythema has almost completely resolved  Discussed giving a Kenalog inj today to help with the residual swelling and she would like this  She'll continue benadryl prn - cautioned about sedation  Rec'd she take Zyrtec daily as well and cont icing  I imagine this will improve over the next few days  F/u if it does not improve  PCV23 added to "allergy" list  ER precautions discussed.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Chills, Fatigue, Injection site erythema, Injection site warmth
Clinical narrative: Muscle aches, Chills, Fatigue, Fever of >102oF beginning about 16 hours after administration and continuing for about 24 hours past time of onset. Visible redness, heat, and swelling at injection site of approximately 4x8 cm beginning about 24 hours after injection, fading over the next several days.  Sore arm lasting from 4 hours post injection until 4 days post injection.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Muscle aches, Chills, Fatigue, Fever of >102oF beginning about 16 hours after administration and continuing for about 24 hours past time of onset. Visible redness, heat, and swelling at injection site of approximately 4x8 cm beginning about 24 hours after injection, fading over the next several days.  Sore arm lasting from 4 hours post injection until 4 days post injection.
Age: 61.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Osteomyelitis, Peripheral swelling
Clinical narrative: pt  states shot was given in lower left arm on 12/4/2020.. it has hurt since she was given the shot.. on sunday 12/13/20 her arm started to swell .. she states the md stated her bone was infection from the shot given too low on the arm.. she was referred to an orthopedic
Age: 61.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Joint swelling, Osteomyelitis, Peripheral swelling, Product administered at inappropriate site
Clinical narrative: pt  states shot was given in lower left arm on 12/4/2020.. it has hurt since she was given the shot.. on sunday 12/13/20 her arm started to swell .. she states the md stated her bone was infection from the shot given too low on the arm.. she was referred to an orthopedic
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site rash, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Fatigue, Fever, Redness Swelling and Heat at injection site, for 2.5 days. Went away afterwards. On the 7th day a rash developed at the injection site. The rash still exists as of today.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Electrocardiogram normal, Fall, Laboratory test normal, Skin laceration, Syncope
Clinical narrative: Pt. received vaccines in thighs and then when exiting the office had a syncopal episode and fell, getting a laceration to the chin
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Pain in extremity, Sleep disorder
Clinical narrative: PATIENT CALLED TODAY TO REPORT THAT HE IS STILL EXPERIENCING VERY PAINFUL ARM AND SHOULDER PAIN  A MONTH AND A HALF AFTER RECEIVING HIS FIRST SHOT OF SHINGRIX.  HE VISITED HIS DOCTOR A FEW WEEKS AFTER THE SHOT AND HE WAS GIVEN CORTICOSTEROID PRESCRIPTION WHICH HELPED TEMPORARILY.  LAST NIGHT WHILE HE WAS ASLEEP, EXCRUCIATING PAIN JOLTED HIM AWAKE.  HE STATED THAT HE DOES NOT HAVE ANY HEART PROBLEMS.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Magnetic resonance imaging brain abnormal, Scan with contrast abnormal, Vertigo, White matter lesion
Clinical narrative: Paroxysmal vertigo resistant to treatment
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain, Dizziness, Electrocardiogram, Full blood count, Human chorionic gonadotropin
Clinical narrative: 33 year old female presents approx 48 hours after receiving 4th rabies vaccine. Patient states has had dizziness, abd cramping, nausea, and vomiting that has progressed over the past 46 hours.  Patient recieved 1000mlNS, Pepcid 20mg IV, Zofran 4mg IV, Prednisone 60mg IV
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: Lipase, Liver function test, Metabolic function test, Nausea, Urine analysis
Clinical narrative: 33 year old female presents approx 48 hours after receiving 4th rabies vaccine. Patient states has had dizziness, abd cramping, nausea, and vomiting that has progressed over the past 46 hours.  Patient recieved 1000mlNS, Pepcid 20mg IV, Zofran 4mg IV, Prednisone 60mg IV
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: Vomiting
Clinical narrative: 33 year old female presents approx 48 hours after receiving 4th rabies vaccine. Patient states has had dizziness, abd cramping, nausea, and vomiting that has progressed over the past 46 hours.  Patient recieved 1000mlNS, Pepcid 20mg IV, Zofran 4mg IV, Prednisone 60mg IV
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Cough, Dyspnoea, Ear pain, Irritability, Pyrexia
Clinical narrative: 4 hours after the vaccine my son started becoming very irritable and  grabbing his leg where he got the shot.  By Sunday, my son had a fever of 102.2 and was coughing and showed signs of trouble breathing and grabbing his ear expressing his ear was hurting.
Sex: U
Vaccine: HEP, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Patient given a dose of RECOMBIVAX HB during a temperature excursion; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.  On 16-NOV-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB), lot # S005809 expiring on 02-NOV-2021, for prophylaxis (exact dose, frequency, route and site of administration were not reported). No adverse reactions were reported.  The hepatitis b vaccine (recombinant)(RECOMBIVAX HB) was stored at a too low temperature of 3.0 degrees Fahrenheit (F) for the time frame of 3 hours and 30 minutes.The improper storage was recorded by Digital Data Logger. It was unknown if there was any previous temperature excursion. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: S005809; expirationdate: 02-NOV-2021; 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
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Arthropathy, Cardiovascular disorder, Muscular weakness, Peripheral swelling
Clinical narrative: experienced swelling and loss of strength in the vaccinated arm after he received the vaccine for what he felt was "longer than normal"; "ever since" receiving the vaccine, he has experienced "circulation and joint problems" explaining he "couldn't do push-ups"; "ever since" receiving the vaccine, he has experienced "circulation and joint problems" explaining he "couldn't do push-ups"; experienced swelling and loss of strength in the vaccinated arm after he received the vaccine for what he felt was "longer than normal"; This spontaneous report was received from a physician, who was reporting on himself, via company representative. The patient was a 65-year-old male at the time of vaccination (currently he is 70 years old). No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date in 2015 (reported as 5 years ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter (route of administration, lot# and expiration date were not reported) for prophylaxis. After receiving the vaccine, the patient experienced swelling and loss of strength in the vaccinated arm for what he felt was "longer than normal". The patient reported that ever since receiving the vaccine, he has experienced "circulation and joint problems" explaining he "couldn't do push-ups". The outcome of the events was reported as not recovered/not resolved. The causality assessment between the events and the suspect therapy was not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE/PQCs reported; administration of Improperly Stored PROQUAD; This spontaneous report was received from a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 20-NOV-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA) (lot # T021639, expiration date 21-DEC-2021) (formulation, strength, dose, frequency and route of administration were not reported) for prophylaxis. No adverse events were reported. According to the reporter, the temperature excursion was -10 to 8 (-5.6) degrees Celsius for a time frame of 1 hour and 32 minutes without any previous temperature excursion. Digital data logger was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy; This case was reported by a physician via call center representative and described the occurrence of bell's palsy in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.  Additional details were provided as follows: Inquiry from health care professional sent via webform. The age at the vaccination was not reported. The age group was selected as an adult as per vaccine indication. The patient developed Bell's Palsy soon after vaccine with Shingrix. The reporter consented to follow up. No other details were available. This case is linked to the case US2020AMR224287, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR224287:same reporter
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient took a flu shot every year until she was 37 and had the flu numerous times each year; Initial information regarding an unsolicited valid non-serious case was received from a consumer (patients husband) via Social Media and transmitted to Sanofi on 11-Nov-2020.   This case involves an adult female patient who took a flu shot every year until she was 37 and had the flu numerous times each year (Influenza), while she received vaccine INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient took INFLUENZA VACCINE (produced by unknown manufacturer) (lot number: unknown, via an unknown route in an unknown administration site prophylactic vaccination) every year until she was 37 years old and had the flu numerous times each year (influenza). The reporter and his wife (patient) received the INFLUENZA VACCINE and the reporter suggested that the patient should skip the INFLUENZA VACCINE and she never took INFLUENZA VACCINE again and did not experience influenza again.  No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as unknown for influenza.  There will be no information regarding the batch number for the case.
Sex: U
Vaccine: FLUX
Symptoms: Emotional distress, Refusal of vaccination
Clinical narrative: had a reaction to vaccine; Initial information regarding an unsolicited valid non-serious case received from a consumer (non-health care professional) via Social Media and transmitted to Sanofi on 12-Nov-2020.  This case involves patient with an unknown age who had a reaction to vaccine (Adverse reaction), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the reporter received influenza vaccine and did not had any reaction but reporters daughter refused to take the vaccine as her friend (patient) received influenza vaccine (produced by unknown manufacturer) (lot number unknown) via an unknown route in an unknown administration site for prophylactic vaccination and had reaction due to the influenza vaccine (Adverse reaction).  No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as Unknown for Adverse reaction.  There will be no information regarding batch number for the case.
Sex: U
Vaccine: FLUX
Symptoms: Headache, Influenza, Myalgia, Pyrexia
Clinical narrative: flu; headache; muscle ache; fever; Initial information received on 17-Nov-2020 regarding an unsolicited valid non-serious case received from a social media consumer.  This case involves patient (unknown demographics) who experienced flu (influenza), headache, muscle ache (myalgia) and fever (pyrexia) while he/she received vaccine INFLUENZA VACCINE.  Past vaccination included every year INFLUENZA VACCIN and who experienced year headaches, muscle aches, fever and flu.  Medical history, medical treatment, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza), headache, muscle ache (myalgia) and fever (pyrexia) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events were not reported.  There will be no information available on the batch number for this case.