chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: H1N1 influenza, Influenza
Clinical narrative: always get the flu after the shot, once H1N1; I always get the flu after the shot; Initial information regarding this unsolicited valid non-serious social media case was received from a consumer (patient) and transmitted to Sanofi on 27-Oct-2020.  This case was linked to cases 2020SA305170, 2020SA305222, 2020SA305230, 2020SA305270, 2020SA305371, 2020SA305401, 2020SA305420, 2020SA305444, 2020SA305474, 2020SA305488, 2020SA305527, 2020SA305545, 2020SA305591, 2020SA305629, 2020SA305651 and 2020SA305230.  This case involves a patient with unknown demographics who always get the flu (influenza), once H1N1 (H1N1 influenza), after the shot of vaccine INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination, concomitant medications and family history were not provided   On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious flu (influenza) and once H1N1 (H1N1 influenza) unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was nor reported. Final diagnosis was the patient always get the flu after the shot and always get the flu after the shot, once H1N1.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported events.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: get very sick; Initial information regarding this unsolicited valid non-serious social media case was received from a consumer (patient) and transmitted to Sanofi on 31-Oct-2020.  This case involved a patient of unknown demographics who get very sick (illness), while the patient received vaccine INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination, concomitant medications and family history were not provided   On an unknown date, all the patients 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.  The patient developed a non-serious got very sick (illness), unknown latency following the administration of INFLUENZA VACCINE.   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 will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: sore arm; Initial information regarding this unsolicited valid non-serious social media case was received from a consumer (patient) and transmitted to Sanofi on 01-Nov-2020.  This case involved a patient of unknown demographics who had sore arm (pain in extremity), while the patient received vaccine INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination, concomitant medications and family history were not provided   On an unknown date, all the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sore arm (pain in extremity), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: I was sick as a dog for the next six months; Initial information received regarding an unsolicited valid non-serious case received from a consumer (patient) via Social media on 01-Nov-2020.  This case involves a patient of unknown demography who was "sick as a dog for the next six months" (illness), while patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date (reported as a number of years ago), the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number, expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, patient was "sick as a dog for the next six months" (illness) (Latency unknown) following the administration of INFLUENZA VACCINE.  Patient said must have worked though. Patient not had the flu for 35 or so years after that shot.  No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  At the time of report, 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: arm still hurts; Initial information regarding this unsolicited valid non-serious case was received from a consumer (patient) and transmitted to Sanofi on 01-Nov-2020.  This case was linked to cases 2020SA307964, 2020SA308110 and 2020SA308037 (same reporter)  This case involved a patient with unknown demographics whose arm still hurts (pain in extremity), while the patient received INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination, concomitant medications and family history were not provided.   On an unknown date in October-2020 (two weeks ago, as reported), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious arm still hurts (pain in extremity), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was not resolved for the reported event.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 24-Oct-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 flu (influenza), 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 flu (influenza) 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 influenza.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Near death experience
Clinical narrative: took the flu after taking a flu shot and almost died; Initial information was received on 05-Nov-2020 regarding an unsolicited valid non-serious case from consumer/non health care professional (patient's child) via social media.  This case involves an adult female patient of unknown age who got flu after taking flu shot and had almost died (influenza), while the she received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got flu after taking flu shot and had almost died (influenza), (unknown latency) following the administration of INFLUENZA VACCINE. The reporter reported that the doctor had told the patient not to take flu shot again. Also stated that the reporter also did not take flu shots.  Details of laboratory data were not reported.  Corrective treatment was not reported.   The event outcome was unknown at the time of report.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise, Nasopharyngitis
Clinical narrative: stayed to sick for a month with my first one and last one; Initial information received on 05-Nov-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient) via social media.  This case involved an adult patient of an unknown age and gender who reported stayed to sick for a month with my first one and last one (illness), after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date and other dosing details were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, the patient experienced stayed to sick for a month with first one and last one (illness). For seven years if the patient got a cold. The patient had to take antibiotics to get rid of just a cold.  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event was reported as unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: deathly ill; Initial information received on 05-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves adult patient (unknown demographics) who was deathly ill (illness), when received vaccine INFLUENZA VACCINE.  The patient's medical history, past 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 not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was deathly ill (illness) 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 illness.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: all four got flu.; Initial information received on 05-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves four-patients (unknown demographics) who all got flu (influenza), 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 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 all patients got flu. (influenza) (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 influenza.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Threwup for 2 days; Initial information received on 23-Nov-2020 regarding an unsolicited non-valid non-serious case from a consumer or non-healthcare professional (patient) via social media.  This case involves a patient with an unknown demographics who had threw up for 2 days (vomiting), while patient received INFLUENZA VACCINE.  The patient had medical history of cancer (Neoplasm malignant) for 2 years.  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 and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient had threw up for 2 days (vomiting), (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.   On an unknown date, the event outcome was not reported for vomiting.  There will be no information available on the lot number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Chills, Hyperhidrosis, Pain
Clinical narrative: body aches; sweats; chills; Initial information was received on 24-Oct-2017 regarding an unsolicited valid non-serious case from an other health professional.  This case involves 14 patient with unknown demographics who experienced body aches (pain), sweats (hyperhidrosis) and chills, while patient received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Patient did not have a history of egg allergy or serious medical illness.  Medical history, medical treatment, vaccination, family history and concomitant medication were not provided.  On an unknown date, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UT5949PA, expiry date not reported] via an intramuscular route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious body aches (pain), sweats (hyperhidrosis) and chills 12 hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported that, reporter started flu clinic last week and have had approximately 1% of our population have a reaction to the vaccine.  This includes severe rash (the rash was flushing with redness all over the body with itching no hives), itching, high fevers, body aches, chills and sweats within 12 hours of receiving the vaccine but reporter did not have the number of patients who had the rash. It was also reported that, 400+ vaccines to patients some had fever.   Details of laboratory data not reported.  The patients were treated with counter treatments.   On an unknown date, the patients were recovered from the reported events.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Pneumonia
Clinical narrative: patient got the flu and it turned into double pneumonia; patient got the flu and it turned into double pneumonia; Initial information received on 01-Dec-2020 regarding an unsolicited valid serious case from a consumer (patient) via social media.  This case involves a patient (unknown demography) who got the flu (influenza) and it turned into double pneumonia (pneumonia), after receiving INFLUENZA VACCINE.  The patient's past vaccinations included flu shot for about 6 years and ended up sick.  Medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On an unknown date in 2001, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date in 2001, the patient developed flu (influenza) and it turned into double pneumonia (pneumonia) (serious), (unknown latency) following the administration of INFLUENZA VACCINE. The event pneumonia was assessed as medically significant.  Patient had not taken flu shot since then. This year patient was contracted with COVID-19 (coronavirus disease) and still not taking a flu shot.  No laboratory data reported.    It was not reported if the patient received a corrective treatment.  At the time of reports, the outcome was unknown for influenza and pneumonia.  Information on the batch number to be requested for this case.; Sender's Comments: This case involves patient of unknown demographics who presented with influenza and pneumonia, after vaccination with INFLUENZA VACCINE. The patient's past vaccinations included flu shot for about 6 years and always ended up sick. The time to onset is unknown in current scenario. Moreover, patient's medical condition at the time of vaccination and lab tests were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information was received on 02-Dec-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (Patient).    This case involves a patient (age and gender unspecified) who experienced flu (influenza), when received 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) [batch 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) 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: FLUX
Symptoms: Death
Clinical narrative: patient laid down and never woke up (death NOS); Initial information received on 03-Dec-2020 regarding an unsolicited valid serious case received from a consumer or non-health care professional.  This case is linked to case 2020SA350305 (same reporter).  This case involves a 65-year-old female patient who laid down and never woke up (death), while she received INFLUENZA VACCINE.  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 died (death) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Case Detail: Product name was not provided. it was assumed that the consumer was referring to the Sanofi flu vaccine.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  It was unknown if an autopsy was done and the cause of death was not reported.  Information on the batch number was requested.; Sender's Comments: This was a poorly documented case involves 65-year-old female patient who died (death) after receiving INFLUENZA VACCINE (unknown manufacturer). Time to onset is unknown. Additional information regarding patient's relevant medical history, health condition at time of vaccination and laboratory tests, autopsy results for cause of death is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: patient laid down and never woke up (death NOS)
Sex: F
Vaccine: FLUX
Symptoms: Death
Clinical narrative: patient laid down and never woke up (death NOS); Initial information received on 03-Dec-2020 regarding an unsolicited valid serious case received from a non-health care professional or consumer via social media.  This case is linked to case 2020SA350303 (same reporter).  This case involves a 73-year-old female patient who laid down and never woke up (death), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, concomitant therapy, vaccination, past medical treatment(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 died (death) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, cause of death was not reported, it was unknown if autopsy was done.  Information on the batch number was requested; Sender's Comments: This was a poorly documented social media case involves 73-year-old female patient who died (death), after receiving INFLUENZA VACCINE. Time to onset is unknown. Additional information regarding patient's relevant medical history, health condition at time of vaccination and laboratory tests, autopsy results for cause of death is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: patient laid down and never woke up (death NOS)
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: patient still get sick; Initial information received on 06-Dec-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional (Patient) via social media.  This case involves patient (age unspecified) who experienced patient still get sick (illness), 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 developed a non-serious patient still get sick (illness) 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: RAB
Symptoms: Complement factor decreased, Viral titre
Clinical narrative: post exposure resulting in low titre levels, booster dose was administered and titres were drawn again showing below normal levels; Initial information regarding this unsolicited valid non-serious case was received from a pharmacist and transmitted to Sanofi on 01-Dec-2020.  This case involved a female patient with unknown age who received RABIES (HDC) VACCINE [IMOVAX RABIES] post exposure resulting in low titre levels, also booster dose was administered and titres were drawn again showing below normal levels (complement factor decreased).  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.   On 24-Jul-2020, the patient received a 0.1 ml of first dose of suspect RABIES (HDC) VACCINE (lot R1C713M, expiry date: 30-Apr-2021), on 27-Jul-2020 she received a 0.1 ml of second dose (lot number and expiry date not reported), on 31-Jul-2020 she also received a 0.1 ml of third dose (lot R1C715M, expiry date: 30-Apr-2021) and on 07-Aug-2020 she received a 0.1 ml of forth dose (lot R1C71, expiry date: 30-Apr-2021), via unknown route in unknown administration site as post exposure immunization.  On an unknown date, first titre was drawn and the result showed low titer levels (complement factor decreased).  On 05-Sep-2020, the patient received a 0.1 ml of first dose of suspect RABIES (HDC) VACCINE (lot: 966650, expiry date: 30-Apr-2021) via unknown route in unknown administration site as post exposure immunization.  On 04-Nov-2020, second titres were drawn and resulted on 19-Nov-2020 with below limit quantifiable Rapid Fluorescent Focus Inhibition Test (RFFIT) end point test (complement factor decreased).  Final diagnosis was complement factor decreased.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: there was no adverse reactions; improperly stored administered ROTATEQ; This spontaneous report as received from a clinical medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant drugs and drug allergies were not reported.  On an unknown date, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # was 1684163, expiration date was 26-JUN-2021, strength and dose was not reported) orally for prophylaxis (product storage error). Temperature excursion of this vaccine was 0.92 degrees Celsius to 13.36 degrees Celsius for 43 hours and 45 minutes without any previous temperature excursion. No digital data logger was involved. The reporter stated that the patient did great and no adverse reactions had been reported from the parents since the vaccine was given.
Age: 0.75
Sex: F
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 09 month old female patient administered Quadracel instead of Pentacel, no AE; 09 month old female patient administered Quadracel, no AE; Initial information received on 11-Nov-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 9 month old female patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] product administered to patient of inappropriate age and wrong product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Patient did not received concomitant and no other vaccines.   On 10-Nov-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5656AA and expiry date: 13-Sep-2021) via an unknown route in the right thigh for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong product administered (latency on same day).  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 61 year old male patient administered FLUZONE HIGH DOSE, no AE; 61 year old male patient administered 0.7 ml dose of FLUZONE HIGH DOSE, no AE; Initial information received on 11-Nov-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 61 year old male patient who received 0.7 ml INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 01-Oct-2020, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ515AA and expiry date: 30-Jun-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of overdose and actual medication error due to inappropriate age at vaccine administration (latency on same day).  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 42.0
Sex: M
Vaccine: FLUA3
Symptoms: Bursitis, Discomfort, Pain
Clinical narrative: i developed deltoid bursitis per the urgent car Dr i saw. He prescribed steroids for 5 days. pain and discomfort resumed after finishing the steroids
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Musculoskeletal stiffness, Myalgia
Clinical narrative: Headache, muscle pain, stiff and. sore at site. of injection
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Chills, fatigue, aches, headache for 2 days Sore, reddened and swollen injection site for three plus days
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain
Clinical narrative: Chills, fatigue, aches, headache for 2 days Sore, reddened and swollen injection site for three plus days
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: HEADACHE, FEVER, MUSCLE SORENESS
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: High fever (over 102 degrees), headache, muscle ache, chills
Age: 65.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Pruritus, Rash, Scratch, Urticaria
Clinical narrative: Started itching day after vaccine. Started scratching what I thought I felt was a bump. As I rubbed and scratch, started feeling more and more bumps. I was feeling that something bit me, but it's cold outside.  Daughter has dog, and thought that her dog had fleas. But dogs do not have fleas. After scratching so much they started spreading down and under the arm. When a person looked at them, they stated that they were more of welps and not bumps. Used anti meds to stop scratching. Then I had some popped up on my leg. Put meds on leg and they came on other leg. I am still having having a reaction as of this morning of 12.08.20. More spots have popped up.
Age: 11.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Blood glucose normal, Loss of consciousness, Pulse abnormal, Seizure, Tonic clonic movements
Clinical narrative: Thready pulse and found unconscious five minutes post vaccination, wrists were flexed with tonic movements, patient was incontinent with urine and had loss of consciousness for 5-6 minutes; had second seizure two minutes after the first one ended, it was brief and lasted for approximately 30 seconds.
Age: 11.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Urinary incontinence
Clinical narrative: Thready pulse and found unconscious five minutes post vaccination, wrists were flexed with tonic movements, patient was incontinent with urine and had loss of consciousness for 5-6 minutes; had second seizure two minutes after the first one ended, it was brief and lasted for approximately 30 seconds.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Fatigue, Influenza like illness, Pain, Rash
Clinical narrative: 101 temperature with severe flu like symptons - body aches, tiredness. Flu symptons disapated on the 7th  and was followed by a severe body rash that showed up on the 8th(torso, arms,, neck, mouth, throat)
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Computerised tomogram abdomen, Intussusception
Clinical narrative: intussusception
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Heart rate increased, Injection site urticaria, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: First Exaggerated PVC?s, then rapid heart beat up to 122 on my walk, then chills and then fever of 100.6, then urticaria the size of half my foot under the injection site. The pvc?s lasted a month. The fever gone by bedtime. Rapid heart rate abated the following day.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Ventricular extrasystoles
Clinical narrative: First Exaggerated PVC?s, then rapid heart beat up to 122 on my walk, then chills and then fever of 100.6, then urticaria the size of half my foot under the injection site. The pvc?s lasted a month. The fever gone by bedtime. Rapid heart rate abated the following day.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Myalgia, Tenderness, Vaccination site pain
Clinical narrative: Constant pain in area of vaccine for past 30 days. Muscle pain, tenderness and stiffness
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dry skin, Erythema, Headache, Herpes zoster
Clinical narrative: I woke up in the middle of the night after getting the vaccine, I had a severe head ache, chills, nausea, fever, sweating, vomiting, couldn't move. A day later shingles started forming on the bridge of my nose. I spoke to the pharmacist and I let him know what's going on and he really didn't know what to tell me. About a week later the shingles started to go away and a red dry patch formed. I spoke with my dermatologist and I have an appointment scheduled with him in a few weeks.
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Mobility decreased, Nausea, Pyrexia, Rash
Clinical narrative: I woke up in the middle of the night after getting the vaccine, I had a severe head ache, chills, nausea, fever, sweating, vomiting, couldn't move. A day later shingles started forming on the bridge of my nose. I spoke to the pharmacist and I let him know what's going on and he really didn't know what to tell me. About a week later the shingles started to go away and a red dry patch formed. I spoke with my dermatologist and I have an appointment scheduled with him in a few weeks.
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder, Vomiting
Clinical narrative: I woke up in the middle of the night after getting the vaccine, I had a severe head ache, chills, nausea, fever, sweating, vomiting, couldn't move. A day later shingles started forming on the bridge of my nose. I spoke to the pharmacist and I let him know what's going on and he really didn't know what to tell me. About a week later the shingles started to go away and a red dry patch formed. I spoke with my dermatologist and I have an appointment scheduled with him in a few weeks.
Age: 86.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pt experienced extreme pain and shoulder immobility in left arm starting late afternoon after receiving her immunization.
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Fatigue, Injection site pain, Insomnia, Pain, Pyrexia
Clinical narrative: Around 10PM started feeling feverish, ache throughout my body, tired, inability to rest and sleep and soreness at injection site. It's now 11:45 and still feeling the same.
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Restlessness
Clinical narrative: Around 10PM started feeling feverish, ache throughout my body, tired, inability to rest and sleep and soreness at injection site. It's now 11:45 and still feeling the same.
Age: 65.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: CSF protein increased, Electromyogram abnormal, Guillain-Barre syndrome, Magnetic resonance imaging spinal
Clinical narrative: Guillain/Barre syndrome
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dysphonia, Erythema, Feeling abnormal, Headache
Clinical narrative: Patient woke up the next day after vaccination (12/06) around 5AM not feeling good. Whole body was aching, took her temperature 99.0F at that time experienced headache. Did not eat Sunday. Stayed in bed most of the day. Yesterday (12/07), 2 days after vaccine she experienced itchy throat, noticed red blood like blisters, very dark, on her tongue and on the sides of her tongue as well. Very red worse on the left side. Her voice started getting hoarse and still is, her lips are dry. She started feeling a little better yesterday although the headache still comes and goes and she also felt lightheaded but no body pains. Feels a little better today although her throat has not improved (12/08). Has FU with her PCP on 12/10 at 3:15PM. Patient received the first dose of Shingrix in October and had no adverse events. Took the flu vaccine in September and no issues to report.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip dry, Loss of personal independence in daily activities, Oral blood blister, Pain, Sleep disorder
Clinical narrative: Patient woke up the next day after vaccination (12/06) around 5AM not feeling good. Whole body was aching, took her temperature 99.0F at that time experienced headache. Did not eat Sunday. Stayed in bed most of the day. Yesterday (12/07), 2 days after vaccine she experienced itchy throat, noticed red blood like blisters, very dark, on her tongue and on the sides of her tongue as well. Very red worse on the left side. Her voice started getting hoarse and still is, her lips are dry. She started feeling a little better yesterday although the headache still comes and goes and she also felt lightheaded but no body pains. Feels a little better today although her throat has not improved (12/08). Has FU with her PCP on 12/10 at 3:15PM. Patient received the first dose of Shingrix in October and had no adverse events. Took the flu vaccine in September and no issues to report.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Throat irritation
Clinical narrative: Patient woke up the next day after vaccination (12/06) around 5AM not feeling good. Whole body was aching, took her temperature 99.0F at that time experienced headache. Did not eat Sunday. Stayed in bed most of the day. Yesterday (12/07), 2 days after vaccine she experienced itchy throat, noticed red blood like blisters, very dark, on her tongue and on the sides of her tongue as well. Very red worse on the left side. Her voice started getting hoarse and still is, her lips are dry. She started feeling a little better yesterday although the headache still comes and goes and she also felt lightheaded but no body pains. Feels a little better today although her throat has not improved (12/08). Has FU with her PCP on 12/10 at 3:15PM. Patient received the first dose of Shingrix in October and had no adverse events. Took the flu vaccine in September and no issues to report.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Chills, feeling feverish, all-over muscle pain, fatigue, pain in arm at injection site
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Patient was an adolescent and was given an adult dose of Hep A.  No adverse reaction.
Age: 50.0
Sex: F
Vaccine: HEP, HPV9
Symptoms: Wrong product administered
Clinical narrative: We gave the wrong vaccine to a patient. lt was the Gardasil 9 vaccine and this patient is 50 years old .; This practice manager reported that a 50 year old female patient received the Gardasil 9 vaccine instead of the Hepatitis B vaccine; This spontaneous report was received from a practice manager and refers to a 50-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 30-NOV-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot# 1621934, expiration date 29-JAN-2022 (dose and route of administration were not reported). The reporter stated that the patient received the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) instead of hepatitis b vaccine (manufacturer unknown) (product administered to patient of inappropriate age and wrong product administered). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621934; expirationdate: 29-JAN-2022; deviceage and unit: 0 ; operatorofdevice: Unknown; malfunction: Unknown; deviceusage: Unknown; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: M
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: the reporter thought that she and her husband received fluzone high dose for this season, in error, the pharmacist gave them the fluzone low dose with no adverse event; Initial information regarding an unsolicited valid non-serious case received from a consumer Via call center and transmitted to Sanofi on 26-Oct-2020.  This case is linked to case 2020SA303708.  This case involves male patient of unknown age for whom it was the reported that his wife and patient received  INFLUENZA VACCINE TRIVALENT [FLUZONE HD] for this season, in error, the pharmacist gave them the INFLUENZA VACCINE TRIVALENT [FLUZONE] (product dispensing error) (dose, route, anatomical location, expiry date and lot number unknown) for prophylactic vaccination on 20-Oct-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not provided.   This is a true medication error case due to product dispensing error (latency same day).   No laboratory data was provided.  At the time of this report, no adverse event symptoms 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.  There will be no information regarding batch number for the case.
Sex: M
Vaccine: FLUX
Symptoms: Death
Clinical narrative: Killed; Initial information was received on 03-Dec-2020 regarding an unsolicited valid serious social media case from a consumer/non-health care professional.  This case involves a male patient (age unspecified) who was killed (death), while he received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was killed (death) (unknown latency) following the administration of INFLUENZA VACCINE.  This event was assessed as medically significant.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment before death.  It is unknown if an autopsy was done. The cause of death was not specified.  Information on batch number was requested for this case.; Sender's Comments: This poorly documented case from social media involves a male patient who died (NOS) after receiving INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown.  Additional information regarding medical history, condition at the time of vaccination, concomitant medications, lab /radiological investigation excluding other etiologies and detailed autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.; Reported Cause(s) of Death: killed
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 10 year-old female patient administered a Fluzone High-Dose Quadrivalent, no AE; 10 year-old female patient administered 0.7 ml dose of Fluzone High-Dose Quadrivalent, no AE; Initial information received on 11-Nov-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 10 year old female patient who received 0.7 ml INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  Medical history, medical treatment, vaccination and family history were not provided.  Patient did not received concomitant and no other vaccines.  On 11-Oct-2020, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ541AA and expiry date: 30-Jun-2021) via an intramuscular route in the left arm for prophylactic vaccination.  It was a case of overdose and actual medication error due to inappropriate age at vaccine administration (latency on same day).  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 69.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Axillary pain, Injection site pain, Musculoskeletal chest pain, Myalgia
Clinical narrative: Severe left arm pain. Placed ice packs on left arm. Took ibuprofen. Throughout the night was unable to move arm due to pain. Experienced warmth, muscle, joint aches, and swollen. Aching. Pain underneath left arm. Slight fever 99.2. Pain in ribs on left side.
Age: 69.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain, Pain in extremity, Pyrexia, Skin warm, Swelling
Clinical narrative: Severe left arm pain. Placed ice packs on left arm. Took ibuprofen. Throughout the night was unable to move arm due to pain. Experienced warmth, muscle, joint aches, and swollen. Aching. Pain underneath left arm. Slight fever 99.2. Pain in ribs on left side.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Gaze palsy, Injection site pain
Clinical narrative: Headache, Fatigue, very cold with shivers, body ache, soreness of arm at injection site.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Headache, Fatigue, very cold with shivers, body ache, soreness of arm at injection site.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema
Clinical narrative: redness and now a diagnosis of cellulitis requiring antibiotics and f/u visit tomorrow
Age: 22.0
Sex: M
Vaccine: FLU4
Symptoms: Computerised tomogram head, Dizziness, Dysarthria, Dysphemia, Electrocardiogram
Clinical narrative: Sudden onset of headache approx. 24 hours after administration, dizziness, mildly slurred speech/stuttering described by patient (not seen on exam), neck pain, eye pain. Also c/o palpitations.