chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse effect reported.; Nurse called to report that on two different dates a patient was administered a less than recommended dose of RECOMBIVAX; Nurse called to report that on two different dates a patient was administered a less than recommended dose of RECOMBIVAX; Information has been received from a nurse reporting on a 53-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 05-NOV-2019, the patient was vaccinated with the first dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) pediatric; on 06-DEC-2019, the patient was vaccinated with the first dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) pediatric; and on 11-JUN-2020, the patient was vaccinated with the third dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB),  after previously receiving 2 pediatric strength doses in the past, all vaccines were administered for prophylaxis (dose, route of administration, lot number and expiration date were not reported). No additional adverse effect reported.
Age: 0.17
Sex: U
Vaccine: PPV, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient experienced no symptoms; Nurse reports that on 18-JUN-2020 a 2 month old was administered a dose of PNEUMOVAX 23; This initial spontaneous report was received from a registered nurse, referring to a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies, and concomitant medications were not disclosed.  On 18-JUN-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) administered via intramuscular as prophylaxis; lot number T007790, expiration date reported as 03-DEC-2020 but upon internal validation was established as 03-DEC-2021 (strength, dose number, and anatomical vaccination site were not provided) (product administered to patient of inappropriate age). the nurse reported that the administered dose was not due to a product packaging related confusion. The patient did not experience any symptoms. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T007790; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 4 plus year old has only had 3 doses of Pentacel, no AE; Initial information received on 16-Jun-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 4 plus year old patient (age between 4 and 5 years) who had three doses of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  Medical history, medical treatment, vaccination, concomitant therapy and family history were not provided.  It is an actual medication error case due to inappropriate schedule of product administration. It was reported that the child is between 4 and 5 years of age and had 3 doses of Pentacel.  At the time of this report, no adverse event was reported.  There will be no information available on the batch number for this case  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Sex: U
Vaccine: DTAP
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction; Initial information was received on 18-Jun-2020 regarding an unsolicited valid serious case received from a physician.  This case is linked to case 2020SA159441 (same reporter).  This case involves patient of unknown demographics who experienced anaphylactic reaction, when received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided. At the time of the event, the patient had ongoing severe milk allergy.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (batch number and expiry date not reported) via unknown route and administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious anaphylactic reaction unknown latency following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant.  Case detail : Physician wanted to know why the company had not included history of anaphylaxis to milk protein in the warnings section and stated that he received a letter about the milk contents for Adacel, DIPHTHERIA TETANUS (DT), and Menactra and requests another letter with all 5 products.  Details of laboratory data were not reported.  Final diagnosis was anaphylactic reaction.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for the event of anaphylactic reaction.  Information on the batch number was requested.; Sender's Comments: This case involves patient of unknown demographics who developed serious anaphylactic reaction on an unknown latency following the vaccination with DAPTACEL vaccines. Time to onset was unknown. Patient had history of severe milk allergy. However, detail additional information of past medical treatments, concomitant therapies, past vaccination and tolerance were not reported. Based upon the reported information, the role of the vaccine cannot be assessed. Missing data needed for further assessment of the case.
Sex: U
Vaccine: RAB
Symptoms: Exposure via skin contact, Needle issue
Clinical narrative: needle cap off the the entire luer lok came off and the diluent spilled all over her / no AE; Initial information received on 18-Jun-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 51 years old patient when preparing RABIES (HDC) VACCINE [IMOVAX RABIES] (lot number R1C713M and Expiration date :30-Apr-2021)and at that time needle cap off the the entire luer lok came off and the diluent spilled all over her.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was also a case of Exposure via skin contact.  Global PTC number : 100048111 Batch number: R1C713M Expiry date: 30-Apr-2021 Investigation stats: In process  It was reported that administrator said that she pulled off the plastic cap off the diluent syringe like she always does and then secured the needle to luer Lok end and then when she pulled theneedle cap off the the entire luer lok came off and the diluent spilled all over her.  Followup information received on 18-Jun-2020 regarding an unsolicited valid non-serious case received from a nurse.  PTC details were added.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient was adminitered Daptacel vaccine at the wrong dosing intervals at age 2, 4, 6 months and 2 years /No AE; Initial information received on 19-Jun-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a two years old male patient who vaccinated with fourth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (batch number and expiry date not reported) via unknown route and administration site for prophylactic vaccination, first, second and third dose at age two, four and six months age.  The patient's medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided  It was an actual medication error case due to inappropriate schedule of vaccine administered.  At the time of reporting no adverse reactions were 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.
Age: 1.5
Sex: U
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a 18 month old patient administered to Adacel , no AE; Adacel was administered to an 18 month old patient for their 4th dose in the series instead of DTap, no AE; Initial information received on 19-Jun-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 18 months old patient who inadvertently administered DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [DTap] for fourth dose in DTAP series.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medication was not reported.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date: not reported) via an unknown route and administration site for prophylactic vaccination.  It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  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.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Crying, Product preparation error
Clinical narrative: the patient received the DTAP/Ipol liquid portion of the Pentacel and was not injected with the powdered portion of the ActHIB. The doctor reconstituted the powdered ActHIB with the 0.4% NaCl diluent and injected the patient; crying could be heard; Initial information was received on 19-Jun-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 1 year 3 months and 3 days old female patient who received the dtap/ipol liquid portion of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and was not injected with the powdered portion of the ACTHIB. Later, the doctor reconstituted the powdered ACTHIB with the 0.4% sodium chloride (NACL) diluent and injected the patient (Product preparation error) after which she cried (Crying).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. No other vaccines were given.   On 19-Jun-2020, the patient received a 0.5 ml fourth dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ261AA, expiry date 14-May-2021, Vial) via intramuscular route in the right thigh for prophylactic vaccination.  It was a case of an actual medication error due to Product preparation error (product used only partially first, then used the remaining component with another diluent).  The doctor gave the DTAP/Ipol liquid portion of the Pentacel to the patient and did not inject the powdered portion of the ActHIB. Later, the doctor reconstituted the powdered ActHIB with the 0.4% NaCl diluent and injected the patient after which she started crying on same day following the administration of PENTACEL.  No laboratory data was reported.  Final diagnosis was crying.  At the time of report, outcome of crying was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Menactra was administered to a patient, no AE; Initial information received on 19-Jun-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves patient of unknown age and gender, who was vaccinated with expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (batch number, expiration date, dose, route and site of administration was not reported for both vaccines) on an unspecified date.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder' compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: patient was only given the liquid portion (DTaP-IPV component) of Pentacel and the powdered component (ActHIB vaccine) was not given, no adverse event; Initial information was received on 19-Jun-2020 regarding an unsolicited valid non-serious case from the other healthcare professional.  This case involves a five month old female patient who was vaccinated with a 0.5 ml second dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ315AA and expiration date 03-Apr-2021) via an intramuscular route in the left thigh on 05-Jun-2020 for prophylactic vaccination.  The patient's medical history, medical treatment, vaccination and family history were not provided.  The patient's concomitant vaccinations included PNEUMOCOCCAL VACCINE and ROTAVIRUS VACCINE received on an unknown date for prophylactic vaccination.  It was an actual medication error case due to active ingredient not added to diluent (product preparation error) as the patient was only given the liquid portion (Dtap-Ipv component) of pentacel and the powdered component (ACTHIB vaccine) was not given.  No adverse event occurred following immunisation.  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: 1.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: two patients was given "diluent versus the vaccine" for Pentacel/no ae; Initial information was received on 22-Jun-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to case 2020SA162258. (same reporter)  This case involves a one year old male patient who had received "diluent versus the vaccine" for DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (product preparation error).   Medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received concomitant medication as HEPATITIS A VACCINE (HEPATITIS A).  On 19-Jun-2020, the patient received a 0.5 mL fourth dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [carton: UJ230AAA, lot UJ315AA, expiry date: 04-Apr-2021] via an intramuscular route in the right thigh for prophylactic vaccination.  It was a case of actual medication error due to Active ingredient not added to diluent.  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: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: patients was given "diluent versus the vaccine" for Pentacel/no AE; Initial information was received on 22-Jun-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to case 2020SA162245. (same reporter)  This case involves a 6 month old male patient who had received "diluent versus the vaccine" for DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (product preparation error).   Medical history, medical treatment, vaccination and family history were not provided. Concomitant medication if any, not reported.  On an unknown date, the patient received concomitant medications as PREVNAR (PNEUMOCOCCAL VACCINE CONJ 7V (CRM197)) and ROTATEQ (ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V).  On 19-Jun-2020, the patient received a 0.5 mL third dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [carton: UJ230AAA, lot UJ315AA, expiry date: 04-Apr-2021] via an intramuscular route at the right thigh for prophylactic vaccination.  It was a case of actual medication error due to Active ingredient not added to diluent.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event, Product preparation issue
Clinical narrative: only liquid portion of Pentacel was administered/no AE; Initial information was received on 22-Jun-2020 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves patient (unknown demographics) to whom only liquid portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] was administered because administrator failed to reconstitute it (batch number and expiry date not reported) unknown route in unknown administration site on an unknown date for prophylactic vaccination(product preparation issue).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to Inappropriate reconstitution technique.  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 batch number for this case.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Injection site swelling, Insomnia
Clinical narrative: Swelling at injection site followed by headache, nausea, chills, sweating, unable to sleep.  Swelling remains after two days.  Others symptoms have largely subsided.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Swelling at injection site followed by headache, nausea, chills, sweating, unable to sleep.  Swelling remains after two days.  Others symptoms have largely subsided.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Blood test, Computerised tomogram, Pneumonia, SARS-CoV-2 test, Urine analysis
Clinical narrative: Got pneumonia on June 14, 2020.  Went to ER and received antibiotics.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: X-ray
Clinical narrative: Got pneumonia on June 14, 2020.  Went to ER and received antibiotics.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Pain, Pain in extremity
Clinical narrative: "Throbbing" pain, local inflammation, general soreness in arm
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face, Swelling of eyelid
Clinical narrative: Swelling of face including eyelids 2 days following vaccination. Treatment is prednisone 5mg daily for 7 days. Outcome pending.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Rash, Swelling
Clinical narrative: rash, erythematous, and swelling
Age: 26.0
Sex: M
Vaccine: DTAP
Symptoms: Blindness transient, Headache, Pain, Photophobia, Tunnel vision
Clinical narrative: Pain,  temporary blindness,  reduced  visual fields ( tunnel vision) and headaches . Later,  after treatment and the  passage of time, sensitivity to light  and  reduced vision in both eyes.
Age: 26.0
Sex: M
Vaccine: DTAP
Symptoms: Visual field defect, Visual impairment
Clinical narrative: Pain,  temporary blindness,  reduced  visual fields ( tunnel vision) and headaches . Later,  after treatment and the  passage of time, sensitivity to light  and  reduced vision in both eyes.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Presyncope
Clinical narrative: Vasovagal response
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported.; one male patient was administered improperly stored PROQUAD; This spontaneous report has been received from a nurse concerning  a 4 year old male patient . The patient's concurrent conditions, concomitant therapies and  previous medical history were not reported.  Information was extracted from data logger.  On 16-JUN-2020, the patient was vaccinated with  one dose of improperly stored (product storage error) measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S030210, expiration date 25-MAR-2021, therapy type rHA for prophylaxis  (strength and patient route of administration were not provided). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was reconstituted with properly stored sterile diluent (DILUENT MRK INJ).  The storage temperature was reported to be in between  6°F to l 4°F, more specifically  in 11.97 °F for  a period of 10 minutes. No additional adverse effects were reported.
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 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a healthcare provider at an elementary school for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequently to inoculation with zoster vaccine live (ZOSTAVAX), the pt was treated by a healthcare provider at an urgent care unit for shingles. As a direct and and proximate result of the pt's 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 of shingles was considered to be not recovered. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
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 or about 18-NOV-2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to inoculation with zoster vaccine live (ZOSTAVAX), the pt was treated by a healthcare provider at a primary care unit for shingles. As a direct and proximate result of the 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. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Age: 71.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: Patient completed Tdap & Shingles IZ 2 days ago, noticed last night small erythema/warmth to L arm below injection site of first Shingles IZ. Site has not changed from last night. Denies pain, just some mild itching.   Vaccine from pharmacy
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Antinuclear antibody positive, Erythema, Skin warm, Swelling
Clinical narrative: redness, swelling, and warmth to right arm a few inches below where shot was given. Injection site however shows no redness, swelling or warmth.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Erythema multiforme, Full blood count, SARS-CoV-2 test
Clinical narrative: Erythema Multiforme minor 7 days after vaccination
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Discomfort, Dizziness, Erythema
Clinical narrative: Very sore shoulder Little swelling Redness...2-3? Chills Headache Very sore back across middle Rapid Heart beat in sleep Achey body Feels like I have a temperature Feel pressure behind right knee...clot? Funny sensation during night....           pin pricks all over  Dizzy
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Feeling hot, Headache, Heart rate increased, Musculoskeletal pain
Clinical narrative: Very sore shoulder Little swelling Redness...2-3? Chills Headache Very sore back across middle Rapid Heart beat in sleep Achey body Feels like I have a temperature Feel pressure behind right knee...clot? Funny sensation during night....           pin pricks all over  Dizzy
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia, Sensory disturbance, Swelling
Clinical narrative: Very sore shoulder Little swelling Redness...2-3? Chills Headache Very sore back across middle Rapid Heart beat in sleep Achey body Feels like I have a temperature Feel pressure behind right knee...clot? Funny sensation during night....           pin pricks all over  Dizzy
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: 06/21/2020 from about 7:00am to about 8:00pm Fever, muscle aches, shivering, chills, tired
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Injection site erythema, Injection site streaking, Injection site swelling
Clinical narrative: Developed redness, swelling, streaking, warmth to site of injection - spread to axillary area.  Had chills.  No fever.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Skin warm, Swelling
Clinical narrative: Developed redness, swelling, streaking, warmth to site of injection - spread to axillary area.  Had chills.  No fever.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Impaired work ability, Loss of personal independence in daily activities, Rash, Rash vesicular
Clinical narrative: Shingrix187. 4 days after the injection, I developed a rash on my forehead.  No pain. No tingling. No itching. I called the drs office and I was able to talk to the Dr on call. We did a video call. He said it didn?t look like shingles but he could not rule it out. Since I didn?t have any other shingle symptoms, I waited. It did not go away. It only got worse.  On Monday, 06/22, I went to my dermatologist who visually confirmed the rash to be shingles.  I was prescribed Valtrex to stop further spreading of the blister like rash.  It is healing but I?ve had to call in sick at work and cancel my appointments this week.
Age: 25.0
Sex: U
Vaccine: HEPA, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events; a patient was administered a properly stored but expired VAQTA; This spontaneous report was received from a medical assistant and refers to a 25-year-old patient of an unknown gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided. The report refers to one patient and one combination product.  On 04-JUN-2020, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) lot number: S001832, expiration date: 12-MAY-2020 for prophylaxis (exact dose and route of administration were not provided). The hepatitis a vaccine, inactivated (VAQTA) was properly stored but expired. No additional adverse events were provided. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S001832; expirationdate: 12-MAY-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash vesicular
Clinical narrative: painful blistering rash, which was diagnosed as herpes zoster; Information has been received from a lawyer, regarding a case in litigation, and refers to a currently approximately 83-year-old patient (pt) of an unknown gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or about 24-JUL-2011, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the pt was treated by a "provider" for painful blistering rash, which was diagnosed as herpes zoster and resulted from the pt's use of zoster vaccine live (ZOSTAVAX). The outcome of the event was not provided. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No olher adverse effects; lmproper spacing of GARDASIL-9 doses; This spontaneous report as received from a nurse refers to a 19-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  Approximately in August 2019 (reported as 10 months ago), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 19-JUN-2020, 10 months after the initial dose, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml (route of administration, lot # and expiration date were not reported) for prophylaxis. There was no adverse event reported.
Age: 11.0
Sex: M
Vaccine: HIBV, HPV9, TDAP
Symptoms: Syncope
Clinical narrative: syncope; This spontaneous report was received from an administrator via company representative and refers to an 11-year-old male patient. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On an unknown date in June 2020 (reported as last week), the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as series of adolescent vaccines (exact dose, route of administration, lot number and expiration date were not provided), with a dose of an unspecified meningococcal vaccine (manufacturer unknown) and with a dose of an  unspecified diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid vaccine (exact dose, route of administration, indication, lot number and expiration date were not provided).  On the same day, the patient had syncope. He sought medical attention and he was in doctor's office. The patient was observed but no treatment and no lab diagnostic or studies were performed.  The patient fully recovered and he went home on the same day as administration. The causality assessment was not provided.   Upon internal review, the event of syncope was determined to be medically significant.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: Lot Number N022727 is NOT valid for Gardasil 9, it is valid for GARGASIL; No adverse event; the patient was inadvertently administered a dose of Gardasil 9 that was expired; Information has been received from the nurse prescribing, concerning an 18-year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 23-JUN-2020, patient was inadvertently administered an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, dose number, and route were not provided) for prophylaxis (expired vaccine used). The reporter reported HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) Lot # N022727 with expiration date on 12-JUN-2020 which was not valid for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) but valid for Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (product lot number issue). No additional adverse event was reported.
Age: 42.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: her shoulder was turgid and red, was kind of blown up, and hard, and felt like a softball. It was a radius of about 2 inches around the injection site; her shoulder was turgid and red, was kind of blown up, and hard, and felt like a softball. It was a radius of about 2 inches around the injection site; her shoulder was turgid and red, was kind of blown up and hard, and felt like a softball. It was a radius of about 2 inches around the injection site; She noticed it was sore.  Since then it had gotten bigger and more sore; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on 22Jun2020 at single dose at left deltoid for susceptible to pneumonia based on previous hospitalizations. Medical history included obesity (she was on the low end of that due to her BMI) from 2016 to an unknown date, carrier for hemochromatosis genetically (she did not have a problem with it, she was just a carrier) from 07Sep1977, seasonal allergies, spring time and fall time (she was not on any medication and was not having any issues) start when she was 14-year-old, allergic to cats (the allergies began when she hit puberty) start also when she was around 14-year-old, hospitalized for severe pneumonia in 2016 and it was correlated to losing a pregnancy. She had Pneumonia in all 4 lobes of her lung. Her doctor told her that since she was susceptible, she should get the vaccine. There were no concomitant medications. Prior vaccinations within 4 weeks was none. She received the pneumococcal 13-val conj vac (dipht crm197 protein) vaccine on 22Jun2020 at 09:30 this morning maybe 09:45. She noticed right when she got home by 10:00-10:15. She noticed it was sore. Since then it had gotten bigger and more sore. Over the course of the day, her shoulder was turgid and red, was kind of blown up, and hard, and felt like a softball. It was a radius of about 2 inches around the injection site. She has not received any medical treatment. No AE required a visit to emergency room or physician's office. The outcome of events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in patients right arm and face per mom.
Age: 0.67
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Eye movement disorder, Full blood count, Metabolic function test, Neurological examination normal, Tremor
Clinical narrative: per mom went home that day after vaccines, was fine until suddenly went into shaking spell, per mom last 10-15 minutes of shaking and eye rolling, per mom pt was unresponsive to her and did not stop when she picked her up and even tried patting her back, per mom called squad and since had stopped by time arrived and was afebrile they didn't take her in, per mom has been fine since, has not had any similar episodes before or after event
Age: 0.67
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Unresponsive to stimuli
Clinical narrative: per mom went home that day after vaccines, was fine until suddenly went into shaking spell, per mom last 10-15 minutes of shaking and eye rolling, per mom pt was unresponsive to her and did not stop when she picked her up and even tried patting her back, per mom called squad and since had stopped by time arrived and was afebrile they didn't take her in, per mom has been fine since, has not had any similar episodes before or after event
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Red down to elbow, itchy stinging and pain
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: patient felt dizzy when walking out car. brought pt back inside, gave him cool water, candy & pedisure and layed him down took blood pressure patient layed in supine position for 30min until blood pressure was back up & feeling better. Patient was able to get up and walk around before leaving office
Sex: U
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bell's palsy; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided.  On 31-DEC-2012, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) for routine health maintenance and prevention of shingles (herpes zoster).   On an unknown date (reported as "shortly after receiving vaccine"), the patient experienced Bell's Palsy. It was reported that the patient's symptoms had resulted in physical limitations not present prior to used zoster vaccine live (ZOSTAVAX). Also, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   At the time of the report, the outcome of facial paralysis was reported as not recovered/not resolved.    Upon internal review, Bell's Palsy was considered to be an important medical event, and due to severe and permanent personal injuries was also considered disabling.  The reporter considered Bell's Palsy to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her medical history, concurrent conditions and concomitant medications were not reported. On or about 30-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, anatomical location and route of administration were not reported), as prescribed and/or administered by a pharmacist at a pharmacy, for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to vaccination, she was treated by a physician for shingles (herpes zoster). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient had and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for those injuries; significant medical and related expenses as a result of those injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome for herpes zoster was considered to be not recovered.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation on 17-JUN-2020. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On or about 23-JUN-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, anatomical location not provided) prescribed and/or administered by a pharmacist for the long-term prevention of shingles and/or zoster-related conditions. On an unspecified date, subsequently to patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a physician at a medical center for shingles. As a direct and proximate result of use of zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries; including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the reporting time, the outcome of herpes zoster was considered as not recovered. The reporters considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her medical history, concurrent conditions and concomitant medications were not reported. In 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, anatomical location and route of administration were not reported), as prescribed and/or administered by a pharmacist at a pharmacy, for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to vaccination, she was treated by a healthcare provider for shingles (herpes zoster). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient had and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for those injuries; significant medical and related expenses as a result of those injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome for herpes zoster was considered to be not recovered.