chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Improperly stored vaccine administered - recalled; RECOMBIVAX HB that was recalled; This spontaneous report has been received from a nurse regarding a 6-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 23-OCT-2020, the patient was vaccinated with a recalled improperly stored dose of hepatitis b vaccine (recombinant) thimerosal free (RECOMBIVAX HB) 0.5 mL, lot # T00798 for prophylaxis and expiration date 01-NOV-2022 (dose and route of administration were not reported).  This report is one from multiple reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA009762: US-009507513-2010USA009823: US-009507513-2010USA009853: US-009507513-2010USA010090: US-009507513-2010USA010095: US-009507513-2010USA010216: US-009507513-2010USA010884:
Age: 49.0
Sex: F
Vaccine: FLUR3, PNC13, PPV
Symptoms: Asthenia, Inflammation, Pain in extremity, Pyrexia
Clinical narrative: isolated inflammatory reaction; weakness; She said along with PNEUMOVAX 23 shot, she got PREVNAR 13; This spontaneous report as received from a 49-year-old female patient who reported on herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 22-OCT-2020 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in the left arm (exact dose, route of administration, lot # and expiration date were not reported), pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported; extra dose administered) and influenza virus rha 3v vaccine (baculovirus) (FLUBLOK) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported); all for prophylaxis. On the same date, she experienced pain in her arm, weakness and had a fever of 101 (units not provided). The patient sought medical attention: she called her insurance company that had 24 hour advise line and was recommended to got to the emergency room (ER). She said she was diagnosed by the ER doctor with isolated inflammatory reaction. She was prescribed with acetaminophen, hydrocodone bitartrate (NORCO) 5/325 and ondansetron 4 mg. The outcome of the events was reported as not recovered.        Causality assessment was not provided.
Age: 0.17
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: No other AE information; improperly stored vaccine administered; patient was given RECOMBIVAX HB that was recalled; Information has been received from a nurse reporting on a 10-week-old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 23-OCT-2020, the patient was vaccinated with a recalled, improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) thimerosal free, 0.5 mL, lot# T007984 has been verified to be a valid lot number, expiration date 01-NOV-2022 for prophylaxis (route of administration and anatomical location were not reported). No other AE information was given at this time.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; improperly stored vaccine administration; This spontaneous report as received from a nurse refers to patient of an unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported.   On 21-OCT-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot # 1637651 was confirmed to be valid, expiration date 09-JUN-2022 (dose reported as "1", route of administration, vaccination site were not specified) for prophylaxis. The administered dose of the vaccine underwent a temperature excursion of 62 degrees Fahrenheit for 2 hours. There were no previous temperature excursions. Digital data logger was involved. No additional adverse effect was reported. 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: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA009775:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation, concerning a patient (pt) of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2016, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the pt experienced shingles as a result from pt's zoster vaccine live (ZOSTAVAX) use and was treated by a healthcare provider for shingles. The outcome of the event was not reported. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies.
Sex: F
Vaccine: PPV
Symptoms: Headache, Inflammation, Inflammatory marker increased, Laboratory test, Leukocytosis
Clinical narrative: Febrile reaction; erythematous rash on her left arm / localized reaction to the PPSV-23 vaccine; Inappropriate age at vaccine administration; Literature Report:.  Information was received from the authors in a published literature article entitled as stated above. This case concerns to a 23 years-old female patient. The patient's concurrent and historical conditions, as well as concomitant medications were not reported.     On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) in the left deltoid (Lot #, expiration date, dosage, and route of administration were not provided) for prophylaxis.   On an unspecified date, one day after the vaccination, the patient presented with high grade fever, malaise and headache. The patient was admitted and the physical exam upon admission was unremarkable. Initial labs revealed leukocytosis with neutrophilia and elevated inflammatory markers. Full infections workup was pursued, including a lumbar puncture (LP) which was attempted but unsuccessful. While awaiting a radiologic guided LP, the patient experienced drastic clinical improvement with resolution of headache. As such, a repeat LP was deferred, and she was monitored clinically. The patient developed an erythematous rash on her left arm the day following admission. Due to higher suspicion for an inflammatory process, antimicrobial therapy was held. Over the next 48 hours the patient defervesced without anti-pyretic medications and the rash resolved spontaneously. The patient was treated supportively and returned to her baseline state of health within 72 hours.  The author considered the events to be related to the vaccination with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown).  A copy of the published article has been requested.
Sex: F
Vaccine: PPV
Symptoms: Malaise, Neutrophil count increased, Neutrophilia, Pyrexia, Rash
Clinical narrative: Febrile reaction; erythematous rash on her left arm / localized reaction to the PPSV-23 vaccine; Inappropriate age at vaccine administration; Literature Report:.  Information was received from the authors in a published literature article entitled as stated above. This case concerns to a 23 years-old female patient. The patient's concurrent and historical conditions, as well as concomitant medications were not reported.     On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) in the left deltoid (Lot #, expiration date, dosage, and route of administration were not provided) for prophylaxis.   On an unspecified date, one day after the vaccination, the patient presented with high grade fever, malaise and headache. The patient was admitted and the physical exam upon admission was unremarkable. Initial labs revealed leukocytosis with neutrophilia and elevated inflammatory markers. Full infections workup was pursued, including a lumbar puncture (LP) which was attempted but unsuccessful. While awaiting a radiologic guided LP, the patient experienced drastic clinical improvement with resolution of headache. As such, a repeat LP was deferred, and she was monitored clinically. The patient developed an erythematous rash on her left arm the day following admission. Due to higher suspicion for an inflammatory process, antimicrobial therapy was held. Over the next 48 hours the patient defervesced without anti-pyretic medications and the rash resolved spontaneously. The patient was treated supportively and returned to her baseline state of health within 72 hours.  The author considered the events to be related to the vaccination with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown).  A copy of the published article has been requested.
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous, White blood cell count increased
Clinical narrative: Febrile reaction; erythematous rash on her left arm / localized reaction to the PPSV-23 vaccine; Inappropriate age at vaccine administration; Literature Report:.  Information was received from the authors in a published literature article entitled as stated above. This case concerns to a 23 years-old female patient. The patient's concurrent and historical conditions, as well as concomitant medications were not reported.     On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) in the left deltoid (Lot #, expiration date, dosage, and route of administration were not provided) for prophylaxis.   On an unspecified date, one day after the vaccination, the patient presented with high grade fever, malaise and headache. The patient was admitted and the physical exam upon admission was unremarkable. Initial labs revealed leukocytosis with neutrophilia and elevated inflammatory markers. Full infections workup was pursued, including a lumbar puncture (LP) which was attempted but unsuccessful. While awaiting a radiologic guided LP, the patient experienced drastic clinical improvement with resolution of headache. As such, a repeat LP was deferred, and she was monitored clinically. The patient developed an erythematous rash on her left arm the day following admission. Due to higher suspicion for an inflammatory process, antimicrobial therapy was held. Over the next 48 hours the patient defervesced without anti-pyretic medications and the rash resolved spontaneously. The patient was treated supportively and returned to her baseline state of health within 72 hours.  The author considered the events to be related to the vaccination with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown).  A copy of the published article has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: one patient was administered a dose of expired ROTATEQ; This spontaneous report was received from a registered nurse referring to a 6 months old female patient. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On 23-OCT-2020, the patient was administered a dose of expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # S000961, expiration date 19-OCT-2020; strength, vaccine dosage detail and route of administration were not reported) for prophylaxis (expired product administered).
Sex: U
Vaccine: HEP, HEP
Symptoms: Product storage error
Clinical narrative: RECOMBIVAX HB administered today prior to the nurse knowing there was a temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.  On 02-NOV-2020, the patient was vaccinated with improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 0.5 ml once, therapy type: thimerosal-free, lot # S022584 with expiration date on 31-OCT-2021 (route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 12.8 degrees Celsius for 3 hours. Digital data Logger was not involved and there was no previous temperature excursions reported.   This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2011USA001271: US-009507513-2011USA001021:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On an unknown date in 2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider for shingles. As a direct and proximate result of pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered/not resolved. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: HCP called to report a temperature excursion on VAQTA, GARDASIL 9, MMR II, PNEUMOVAX 23 AND ROTATEQ. Caller states, the VAQTA was administered one time and the ROTATEQ was administered two times; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 13-OCT-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S040483, expiration date not reported, but upon internal validation established as 19-JUN-2021 (exact dose, dose number, vaccination site and route of administration were not provided) for prophylaxis. Administered dose of vaccine was exposed to an unspecified temperature excursion.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE.; patient was inadvertently and concomitantly administered PROQUAD and VARIVAX; This spontaneous report was received from a physician, referring to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 03-NOV-2020, the patient was inadvertently and concomitantly vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection (lot number T007396 which has been verified to be a valid, expiration date not reported, but upon internal validation established as 29-AUG-2021), and varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number T000344 which has been verified to be a valid, expiration date not reported, but upon internal validation established as 05-JAN-2022) (doses, vaccination schemes, frequencies, routes of administration, and anatomical sites of injection were not reported) both administered as prophylaxis (inappropriate schedule of product administration). No additional adverse events were reported in the patient. In addition, it was mentioned that the physician requested a "MIR".
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: No additional AE details were available; Administered a dose of VARIVAX on 24-SEP-2020, which had expired on 20-AUG-2020; This spontaneous report was received from a licensed practical nurse concerning a 4-year-old patient of unknown gender. The patient's concurrent conditions, medical history, historical drug and concomitant therapies were not provided.  On 24-SEP-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot # R0123735 expiration date 20-AUG-2020 for prophylaxis (route and anatomical location of administration were not provided). The vaccine was used beyond the expiry date. No additional adverse event details were reported.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes virus infection
Clinical narrative: First outbreak of herpes in "at least 7 years"; This case was reported by a nurse via call center representative and described the occurrence of herpes virus infection in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (patient had a shingles outbreak 6 weeks ago) and herpes virus infection.   On 26th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 27th October 2020, 1 days after receiving Shingrix, the patient experienced herpes virus infection. On an unknown date, the outcome of the herpes virus infection was not recovered/not resolved.   It was unknown if the reporter considered the herpes virus infection to be related to Shingrix.  Additional details were provided as follows: The patient had received Shingrix on her left arm and on the next day, she had her first outbreak of herpes in at least 7 years. The reporter consented to follow-up and also gave consent to health care professional follow-up.
Sex: M
Vaccine: FLU3, FLUA3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient received Fluad instead of Fluzone High Dose/ NO AE; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.   This case involves a male patient who received vaccines FLUAD instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (batch number, expiry date site and route of administration not reported) (wrong product administered) on an unknown date for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to wrong vaccine administered (latency: same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Cough, Dislocation of vertebra, Influenza, Intervertebral disc protrusion
Clinical narrative: Coughed so hard that dislocated my back; flu; Coughed; ruptured a disc; Initial information received on 26-Oct-2020 regarding an unsolicited valid serious case received from a consumer (patient) via social media.  This case was linked to cases 2020SA304086, 2020SA304087, 2020SA304088, 2020SA304089, 2020SA304084, 2020SA304082, 2020SA304083, 2020SA304085, 2020SA304090 and 2020SA304081 (same source).  This case involves a patient (unknown demographics) who experienced flu (influenza) and coughed (cough) so hard that it dislocated patient's back (dislocation of vertebra) and ruptured a disc (intervertebral disc protrusion), after patient received INFLUENZA VACCINE.  The patient's medical history, past 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 lot number and expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed flu (influenza) 3 days following the administration of INFLUENZA VACCINE.  On an unknown date, the patient coughed (cough) so hard that it dislocated patient's back (dislocation of vertebra) and ruptured a disc (intervertebral disc protrusion) (unknown latency) following the administration of INFLUENZA VACCINE. Event dislocation of vertebra was assessed as medically significant.  Other relevant tests not reported.  It was not reported if the patient received a corrective treatment.  It was reported that now years later patient never had the flu but still suffer from the ruptured disc. Another flu shot and patient could be paralyzed for life.  At the time of reporting, the patient had not recovered from intervertebral disc protrusion and outcome was unknown for rest of the events.  There will be no information on the batch number for this case.; Sender's Comments: This poorly documented social media case concerns a patient (unknown demographics) who experienced influenza, cough, dislocation of vertebra and intervertebral disc protrusion after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). Time to onset was compatible for flu and unknown for rest of events. Also, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, a causal role of the vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: Guillain-Barre; Paralyzed in the beginning; Initial information was received on 27-Oct-2020 regarding an unsolicited valid serious case from a consumer/non-healthcare professional via social media.  This case involves a male patient (age unspecified) who had Guillain barre (Guillain-Barre syndrome) and was paralyzed in the beginning (paralysis) after he received INFLUENZA VACCINE.  Medical history, medical treatment(s), past 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 (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (12 years ago), the patient developed a serious Guillain barre (Guillain-Barre syndrome) and was paralyzed in the beginning (paralysis) (unknown latency) following the administration of INFLUENZA VACCINE. He had to be taught again just like a baby and there was no fix for him.  These events were assessed as medically significant.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events were unknown.  The information on lot number was requested for this case.; Sender's Comments: This case concerns a male patient (age unspecified) who had Guillain-Barre syndrome after vaccination with INFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination and lab data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 5.0
Sex: F
Vaccine: DTAP, DTAPIPVHIB
Symptoms: Medication error, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: A 5 years old patient was administered pentacel instead of Daptacel, no AE; A 5 years old patient was administered pentacel, no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (Reference number- 00313454) and transmitted to Sanofi on 13-Oct-2020  This case involves a 5 years old female patient who was administered fifth dose of 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot number not reported via unknown route in unknown administration site for prophylactic vaccination instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (product administered to patient of inappropriate age and wrong 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 wrong vaccine administered and inappropriate age at vaccine administration (latency same day).  A 5-year-old patient received Pentacel and not the ordered Daptacel. The reporter did not have any more information on the patient as the vaccination took place at another clinic and wanted to know information regarding dosing for correct product.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Product complaint, Skin laceration, Syringe issue
Clinical narrative: A cut on her finger that she saw when she removed her gloves; She felt the rim crack and a piece fell on the floor; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via agency (Reference number- 00324227) and transmitted to Sanofi on 20-Oct-2020.   This case involves female patient (unknown demography) who felt the rim crack and a piece fell on the floor (syringe issue) and got a cut on her finger that she saw when she removed her gloves (limb injury), while administering a dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ512AA and expiration date: 30-Jun-2021) to the patient (unknown demography) via unknown route at an unknown administration site for prophylactic vaccination on 20-Oct-2020.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 20-Oct-2020, the pharmacist got a non-serious cut on her finger that she saw when she removed her gloves (limb injury), on same day following the administration of INFLUENZA SPLIT TRITON THIOMERSAL FREE VACCINE - CN.  Reporter reported that the syringe was fully intact prior to administering and was not difficult to push. Flange, glass rim broke during administration. There was no damage to the carton upon receipt and no product residue in the carton and no signs of damage to any other vial in the carton.  Laboratory test was not reported.  It was not reported if the pharmacist received any corrective treatment or not.  It was also the case of product technical complaint due to syringe issue (on same day).  The outcome of the event got cut on her finger that she saw when she removed her gloves was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 85.0
Sex: F
Vaccine: UNK
Symptoms: Decreased appetite, Myalgia, Nausea, Pyrexia
Clinical narrative: nausea, fever (100.4), muscle pain, no appetite.   It felt as if I had the Shingles all over again.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: NONE
Age: 69.0
Sex: U
Vaccine: VARZOS
Symptoms: Feeding disorder, Immediate post-injection reaction, Injection site pain, Mobility decreased, Pain
Clinical narrative: Immediate injection site pain, took Tylenol. Three hours later it was difficult to move arm to pain. Grew increasingly worse. Took more Tylenol. Following day was much worse to the point that I couldn't eat or move. As the days went on the pain subsided. Still sore, but feeling better. No medical attention sought.
Age: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea, Dizziness
Clinical narrative: Patient went to emergency room the evening of 11/4/20 with dizziness and diarrhea.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site pain, Skin warm, Swelling
Clinical narrative: Symptoms started with pain at the injection site on 11/5/20 then developed increased redness, warm to touch, and swelling over 12hrs. Redness, swelling and pain persisted into the next day when seen in the office
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: received the first and second dose / 2-3 years ago / has shingles / 2 weeks ago; shingles; This case was reported by a consumer and described the occurrence of vaccination failure in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (before receiving shingrix). Previously administered products included Shingrix with an associated reaction of herpes zoster (refer case US2020019124).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. In October 2020, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. Rechallenge with Shingrix was positive. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received the first and second dose of the Shingrix vaccine about 2 to 3 years before reporting. The reporter stated she had shingles on the left side about 2 weeks before reporting and was seen at the urgent care.  The patient was feeling better and it had almost cleared. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020019124:same reporter
Sex: U
Vaccine: FLUX
Symptoms: Bedridden, Malaise
Clinical narrative: in bed almost 2 weeks; sick; Initial information was received on 24-Oct-2020 regarding an unsolicited valid serious case received from a consumer (patient) via social media.  This case involves a patient (unknown demographic) who was sick and in bed almost 2 weeks (illness and bedridden), when received INFLUENZA VACCINE.  The patient's medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) (non-serious event) and was in bed almost 2 weeks (bedridden) (serious event) (Unknown latency) following the administration of INFLUENZA VACCINE.   Event bedridden was leading to disability.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.; Sender's Comments: This case concerns a patient of unknown age, who had illness and was bedridden after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset was unknown. However, exact cause for bedridden, patient's medical condition at the time of vaccination, laboratory data and investigations were not reported. Based upon the reported information the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Pain in extremity
Clinical narrative: arm so sore; Initial information was received on 30-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.   This case is linked to cases 2020SA307387, 2020SA307452, 2020SA306301, 2020SA302198, 2020SA307939, 2020SA307940, 2020SA307941, 2020SA308033 and 2020SA308034.  This case involves an unknown demographic patient who experienced arm so sore (pain in extremity), while the patient received vaccines INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE.  Medical history, concomitant medication, past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer and PNEUMOCOCCAL VACCINE not produced by Sanofi Pasteur (lot number expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious arm so sore (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE PNEUMOCOCCAL VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  Outcome of the event was unknown.  There will be no information available on the batch number for this case.
Age: 1.5
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: a patient inadvertently received two doses of Fluzone Quadrivalent three weeks apart/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via Medical Information (MI) (reference number- 00296454) and transmitted to Sanofi on 01-Oct-2020.  This case involves a 18 months old female patient who inadvertently received two doses of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] 0.5 mL prefilled syringe on 09-Sep-2020 lot number and expiry date not reported via an unknown route and site and then another dose (0.5 mL prefilled syringe, lot number: UJ427AB, expiry date: 30-Jun-2021) via an intramuscular route in the left thigh on 29-Sep-2020 three weeks later (extra dose administered) for prophylactic vaccination.  The patient's past vaccinations included FLU vaccine in 2019 with 2 doses spaced appropriately.  The patient's medical history, medical treatments and family history were not provided.  Patient received no concomitant vaccinations.  It was an actual medication error case due to extra dose administered (latency: same day).  The patient did not experience any adverse effects but she had not talked to the mother on 01-Oct-2020.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the lot number for this case.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site rash, Paraesthesia, Pruritus
Clinical narrative: Few spots; red rectangle on arm around the injection site on left arm; itchy and broke out across forehead; welts; ear was beet red, redness on chest and underneath nose and over top lip; Ear hot/ as feeling like it was on fire; tingling on ear, chest, underneath nose and over top lip; itchy on her chest and underneath her nose and over her top lip; Initial information regarding an unsolicited valid non-serious case was received from a consumer or non-health care professional via Medical Information (Reference number- 00302631) and transmitted to Sanofi on 06-Oct-2020.  This case involves a 79-years-old female patient who experienced itchy and broke out across forehead (rash pruritic), welts (urticaria), ear was beet red, redness on chest and underneath nose and over top lip (erythema), ear hot/ as feeling like it was on fire (Feeling hot), tingling on ear, chest, underneath nose and over top lip (paraesthesia) and itchy on her chest and underneath her nose and over her top lip (pruritus), few spots (rash macular) and red rectangle on arm around the injection site on left arm (vaccination site erythema), after she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 05-Oct-2020 at 9:00 AM, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number not reported via an intramuscular route in the left arm for prophylactic vaccination.  On 05-Oct-2020 at 11:00 AM, the patient developed a non-serious itchy and broke out across forehead (rash pruritic), welts (urticaria) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On 05-Oct-2020, the patient developed a non-serious ear was beet red, redness on chest and underneath nose and over top lip (erythema), ear hot/ as feeling like it was on fire (Feeling hot), tingling on ear, chest, underneath nose and over top lip (paraesthesia) and itchy on her chest and underneath her nose and over her top lip (pruritus) 4-5 hours following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  The patient developed a non-serious few spots (rash macular) and red rectangle on arm around the injection site on left arm (vaccination site erythema) unknown latency following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Laboratory details were not reported.   The patient was treated with CALAMINE, DIPHENHYDRAMINE HYDROCHLORIDE (IVAREST [CALAMINE;DIPHENHYDRAMINE HYDROCHLORIDE]), PARACETAMOL (TYLENOL) and used a cold compress.  The patient was recovering from rash pruritic, urticaria, erythema, burning sensation, paraesthesia, pruritus at the time of reporting.  The event outcome was unknown for rash macular, vaccination site erythema.  There will be no information available on the batch number for this case.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Skin warm, Urticaria
Clinical narrative: Few spots; red rectangle on arm around the injection site on left arm; itchy and broke out across forehead; welts; ear was beet red, redness on chest and underneath nose and over top lip; Ear hot/ as feeling like it was on fire; tingling on ear, chest, underneath nose and over top lip; itchy on her chest and underneath her nose and over her top lip; Initial information regarding an unsolicited valid non-serious case was received from a consumer or non-health care professional via Medical Information (Reference number- 00302631) and transmitted to Sanofi on 06-Oct-2020.  This case involves a 79-years-old female patient who experienced itchy and broke out across forehead (rash pruritic), welts (urticaria), ear was beet red, redness on chest and underneath nose and over top lip (erythema), ear hot/ as feeling like it was on fire (Feeling hot), tingling on ear, chest, underneath nose and over top lip (paraesthesia) and itchy on her chest and underneath her nose and over her top lip (pruritus), few spots (rash macular) and red rectangle on arm around the injection site on left arm (vaccination site erythema), after she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 05-Oct-2020 at 9:00 AM, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number not reported via an intramuscular route in the left arm for prophylactic vaccination.  On 05-Oct-2020 at 11:00 AM, the patient developed a non-serious itchy and broke out across forehead (rash pruritic), welts (urticaria) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On 05-Oct-2020, the patient developed a non-serious ear was beet red, redness on chest and underneath nose and over top lip (erythema), ear hot/ as feeling like it was on fire (Feeling hot), tingling on ear, chest, underneath nose and over top lip (paraesthesia) and itchy on her chest and underneath her nose and over her top lip (pruritus) 4-5 hours following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  The patient developed a non-serious few spots (rash macular) and red rectangle on arm around the injection site on left arm (vaccination site erythema) unknown latency following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Laboratory details were not reported.   The patient was treated with CALAMINE, DIPHENHYDRAMINE HYDROCHLORIDE (IVAREST [CALAMINE;DIPHENHYDRAMINE HYDROCHLORIDE]), PARACETAMOL (TYLENOL) and used a cold compress.  The patient was recovering from rash pruritic, urticaria, erythema, burning sensation, paraesthesia, pruritus at the time of reporting.  The event outcome was unknown for rash macular, vaccination site erythema.  There will be no information available on the batch number for this case.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Dizziness, Dyspnoea, Hypersensitivity, Hypoaesthesia
Clinical narrative: Immediate numbness in my left pinky and then my arm; Racing heart; Weakness; Throat constriction; Difficulty taking a deep breath; Feeling faint; Allergic reaction; This spontaneous case was received on 28-Oct-2020 from other non-health professional via Agency (reference number: SEQW20-04424) and concerned a 40-year-old, female patient.  The patient was healthy and had no medical history. The patient was not taking any concomitant medications. The patient had Flu shots for decades and never had any allergic reaction.   On 09-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for flu prophylaxis. The batch number reported was 276578.  On the same day, immediately after receiving Flucelvax QIV, the patient had an allergic reaction which included immediate numbness in his left pinky and then in arm, heart racing, weakness, throat constriction, difficulty taking a deep breath, and the patient felt faint. The patient was treated in the emergency room (ER), and he received prednisone and Benadryl (diphenhydramine hydrochloride).  On an unspecified date in Oct-2020, the patient recovered from the events. It was reported that his symptoms lasted for about nine days.  The reporter considered the events as related to Flucelvax QIV. Reporter stated that after receiving flu shot he had an allergic reaction immediately, and that he get the flu shot every season, for over a decade, and never had any allergic reactions.   The reporter assessed the events as serious due to the criterion of medically significance.  Company comment: The patient developed all events on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. The patient was healthy and had no medical history. The patient was not taking any concomitant medications. Considering all above mentioned, causal relationship for all events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).; Reporter's Comments: I received a flu shot manufactured by your company at my local pharmacy on 10/9/2020 and had an allergic reaction immediately. I'm writing because I am a dental hygienist and got the flu shot every season, for over a decade, and never had any allergic reactions.; Sender's Comments: The patient developed all events on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. The patient was healthy and had no medical history. The patient was not taking any concomitant medications. Considering all above mentioned, causal relationship for all events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).