chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was shipped on 30-Oct-2019 and delivered on 04-NOV-2019, had a shipment delay, no AE; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA308920, 2019SA308921, and 2019SA309165 (same reporter).  This case involves a 72 years old female patient who received a 0.5 mL dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ290AB, Exp. Date 09-Jun-2020) via intramuscular route in the right deltoid on 04-Nov-2019 that had a shipment delay.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to incorrect product storage.  It was reported that the vaccines were shipped 30-Oct-2019 and were delivered this morning 04-Nov-2019. She has taken care of the replacements. Before they received the email, 1 dose of Fluzone Quadrivalent and 3 doses of Fluzone High Dose had been administered to patients.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: 54-year-old female inadvertently received Fluzone HD, no AE; 54-year-old female inadvertently received Fluzone HD, no AE; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a 54 years old female patient received 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ283AB, Exp. Date 29-May-2020 via intramuscular route in the right deltoid on 01-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) 0.5 mL dose in left deltoid for Immunisation.  It was an actual medication error case due to inappropriate age at vaccine administration and overdose.  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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Sanofi stating if shipment is more than 2 days not to use ,3 doses of Fluzone High Dose had been administered to patients; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA308846, 2019SA308921, and 2019SA309165 (same reporter).  This case involves a 89 years old male patient who received a 0.5 mL dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ290AB, Exp. Date 09-Jun-2020 via intramuscular route in the left deltoid on 04-Nov-2019 that had a shipment delay.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to incorrect product storage.  It was reported that the vaccines were shipped 30-Oct-2019 and were delivered this morning 04-Nov-2019. She has taken care of the replacements. Before they received the email, 1 dose of Fluzone Quadrivalent and 3 doses of Fluzone High Dose had been administered to patients.  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.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: product was administered to patient after it was received late due to delay in shipment/no AE; shipment is more than 2 days not to use and to obtain a replacement of the products/no AE; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA308920, 2019SA309165 and 2019SA308846 (same reporter).  This case involves a 69 years old male patient who received a 0.5 mL dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ290AB, Exp. Date 09-Jun-2020) via intramuscular route in the left deltoid on 04-Nov-2019 that had a shipment delay.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient was not on any concomitant therapy.   It was an actual medication error case due to incorrect product storage and Product shipment delay.  It was reported that the vaccines were shipped 30-Oct-2019 and were delivered this morning 04-Nov-2019. She has taken care of the replacements. Before they received the email, one dose of Fluzone High Dose had been administered to this patient.  It was reported that no adverse event was experienced.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLUR4
Symptoms: Vaccination site induration
Clinical narrative: hardening of tissue below injection site; Initial information received on 02-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 57 years old male patient who experienced hardening of tissue below injection site (vaccination site induration), while he received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapies were not provided.  On 02-Nov-2019, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and Expiry date unknown) via intramuscular route in right arm.  On 02-Nov-2019, the patient developed a non-serious hardening of tissue below injection site (vaccination site induration) 2-3 hours following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was hardening of tissue below injection site.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Recovering for hardening of tissue below injection site.
Age: 17.0
Sex: M
Vaccine: FLU4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient received a dose of Flublok QIV instead of Fluzone QIV, no AE; a 17 year old patient received a dose of Flublok QIV instead of Fluzone QIV, no AE; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from other health-care professional.  This case involves a 17 years old male patient who was vaccinated with a 0.5 ml dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA1934 Exp. Date 30-Jun-2020) via intramuscular route in the right upper arm instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on 05-Nov-2019.  The patient's medical history was not reported.  Concomitant medications included MENINGOCOCCAL VACCINE (MENACTRA) for Immunisation .  It was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration.  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'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: 1.25
Sex: M
Vaccine: DTAPIPVHIB, HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patirnt suppose to administer Pentacel vaccine, only administered the DTAP/IPV portion and did not reconstitute it with ActHIB, no adverse event; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old male patient who was vaccinated with 0.5 ml  first dose of  DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] via intramuscular route in right thigh (batch number and expiration date not reported) on 15-Oct-2019. The patient received only DTAP/IPV portion of pentacel and did not reconstitute it with HIB (PRP/T) VACCINE [ACT-HIB].  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  Patient's medical history was not reported.  It was an actual medication error case due to inappropriate reconstitution technique.  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'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.  Information on the batch number was requested.
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 11 year old patient received a dose of Flublok Quadrivalent/No AE; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer (pharmacy-other).  This case is considered as non-valid as patient identifier was not reported.  This case involves a 11 years old patient (gender unknown) who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] VACCINE lot number and expiry date not reported via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to 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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Tinnitus
Clinical narrative: tinnitus; Initial information received on 07-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 34 years old male patient who experienced tinnitus(Tinnitus), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Nov-2019, the patient received a  0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE  [FLUZONE QUADRIVALENT] (lot UT6686LA expiry date: 30-jun-2020) via intramuscular route in the left arm.  On 04-Nov-2019, the patient developed a non-serious tinnitus (tinnitus), same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Other relevant tests were not reported.  Final diagnosis was tinnitus.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received a Fluzone HD on 24-Sep-2019 and on Last week, no AE; Initial information received on 07-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 68 years old male patient who received two doses of 0.5 ml of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ232AB, Exp. Date 10-Apr-2020) via intramuscular route in the left arm on 24-Sep-2019 and on last week.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to extra dose 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.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: patient did not receive the entire dose, due to the leakage, no AE; Fluzone HD was leaking during the injection at the needle site, no AE; Initial information received on 07-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 88 years old female patient received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ290AA Exp. Date 09-Jun-2020) via intramuscular route in the left deltoid on 07-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of vaccine underdose and needle leak.  It was reported that pharmacist reported "leakage" from the prefilled syringe while administering Fluzone High Dose. The patient did not receive the entire dose, due to the leakage.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Age: 61.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 61 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as left) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 58.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 58 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as left) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 64.0
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Overdose
Clinical narrative: patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 64 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as left) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUA3
Symptoms: Narcolepsy
Clinical narrative: Narcolepsy risk due to residual chicken orexin receptor protein in the vaccine DSU; This is a spontaneous case, initially received from other non-health professional on 07-Nov-2019, concerning a patient, of an unspecified age and gender.   The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient was administered Fluad (TIV) [Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose, anatomical location, route of administration, batch number and expiration date: not provided] for an unknown indication.  On an unspecified date, the patient experienced narcolepsy risk due to residual chicken orexin receptor protein in the vaccine DSU.  At the time of initial reporting, the outcome for the event of narcolepsy was not reported.  The case was assessed as serious. The reporter did not provide causality assessment to Fluad (TIV).  Company comment: The patient experienced narcolepsy (reported as narcolepsy risk due to residual chicken orexin receptor protein in the vaccine DSU) after vaccination with the suspect product Fluad (TIV). Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Sender's Comments: The patient experienced narcolepsy (reported as narcolepsy risk due to residual chicken orexin receptor protein in the vaccine DSU) after vaccination with the suspect product Fluad (TIV). Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.
Age: 2.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Rash erythematous, Rash pruritic, Skin exfoliation
Clinical narrative: red scaly rash on torso. seemed to clear up then came back & spread on torso - has become itchy.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Abdominal discomfort, Migraine, Nausea, Vomiting
Clinical narrative: On 11/14/19 @ 8.30 am (while in school) patient developed a migraine like headache & nausea and vomiting- No fever/SOB or rash- his Mother took him home, he slept and rested for the rest of the day. They did not seek medical attention.Mother called me to report this. I advised her to monitor patient and if symptoms did not improve or worsened to seek medical attention. I informed patient's Mother that I would complete a VAERS report, and explained what it was. 11/15/19  T/C to patient's mother, patient is improving, tummy still a little upset and he remained home from school today. No medical attention needed.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Blood creatine phosphokinase increased, Blood electrolytes normal, C-reactive protein normal, Catheterisation cardiac normal, Chest pain
Clinical narrative: 24 yo male who received SPV 25 MAR 19 and has a hx of syncope attributed to heat injury, who presented to ER 18 APR 2019 with acute CP of 2 hour duration starting at 22:00 17 APR 2019 (day 23). He noted stabbing midchest pain with a positional component. ER noted elevated troponin which peaked at 12.4, CK 976. CRP 0.5, discharge doc states .34 and is elevated; ESR 5, CBC WBC 14; lytes OK normal EKG Echo & cath. Examine note chest wall pain was tender to palpation. He was monitored overnight and discharged at host country facility.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram normal, Electrocardiogram normal, Full blood count, Musculoskeletal chest pain, Red blood cell sedimentation rate normal
Clinical narrative: 24 yo male who received SPV 25 MAR 19 and has a hx of syncope attributed to heat injury, who presented to ER 18 APR 2019 with acute CP of 2 hour duration starting at 22:00 17 APR 2019 (day 23). He noted stabbing midchest pain with a positional component. ER noted elevated troponin which peaked at 12.4, CK 976. CRP 0.5, discharge doc states .34 and is elevated; ESR 5, CBC WBC 14; lytes OK normal EKG Echo & cath. Examine note chest wall pain was tender to palpation. He was monitored overnight and discharged at host country facility.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Troponin increased, White blood cell count increased
Clinical narrative: 24 yo male who received SPV 25 MAR 19 and has a hx of syncope attributed to heat injury, who presented to ER 18 APR 2019 with acute CP of 2 hour duration starting at 22:00 17 APR 2019 (day 23). He noted stabbing midchest pain with a positional component. ER noted elevated troponin which peaked at 12.4, CK 976. CRP 0.5, discharge doc states .34 and is elevated; ESR 5, CBC WBC 14; lytes OK normal EKG Echo & cath. Examine note chest wall pain was tender to palpation. He was monitored overnight and discharged at host country facility.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Pt has a sore arm
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Pruritus, Pyrexia
Clinical narrative: Redness, itching, and swelling. Injection was given at approximately 1:30 p.m.; redness and swelling by 9:30 a.m. the next morning was approximately 2.25 inches in diameter.  Redness and swelling increased to 4.5 inches diameter and remained red and itchy for 5 days. Xyrtec dose was increased beginning day 2 (1 in morning, 1 at night). Redness, swelling, and itching started improving day 6 after injection. Approximately 24 hours after injection, experienced mild fever, slight headache, and fatigue, which lasted several hours but was gone by the following morning.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Redness, itching, and swelling. Injection was given at approximately 1:30 p.m.; redness and swelling by 9:30 a.m. the next morning was approximately 2.25 inches in diameter.  Redness and swelling increased to 4.5 inches diameter and remained red and itchy for 5 days. Xyrtec dose was increased beginning day 2 (1 in morning, 1 at night). Redness, swelling, and itching started improving day 6 after injection. Approximately 24 hours after injection, experienced mild fever, slight headache, and fatigue, which lasted several hours but was gone by the following morning.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Blood glucose increased, Crying, Lethargy, Lip swelling, Pain in extremity
Clinical narrative: Patient presented to clinic for 4 yr old vaccines as well as seasonal flu. Vaccines were given at 2:50 pm at 3:00 mom brought pt back into clinic pt was vomiting, and complaining on his hands hurting. When pt was brought back to room he was crying and then became lethargic. Pt was not responding to commands. Pts face started to swell including eye lids and lips
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Swelling face, Swelling of eyelid, Unresponsive to stimuli, Vomiting
Clinical narrative: Patient presented to clinic for 4 yr old vaccines as well as seasonal flu. Vaccines were given at 2:50 pm at 3:00 mom brought pt back into clinic pt was vomiting, and complaining on his hands hurting. When pt was brought back to room he was crying and then became lethargic. Pt was not responding to commands. Pts face started to swell including eye lids and lips
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Condition aggravated, Pruritus, Urticaria
Clinical narrative: Pt. received influenza vaccine at work place clinic on 11/14/19 at 3:40pm and states that by the time he got home that evening noticed he was itchy on his arms b/l and then stomach and back and thighs and when he looked noted pink small hives which persist today. Pt. came in to report his symptoms and for evaluation to clinic on 11/15/19. Hives itchy but remain stable. Self treated with Zyrtec and Benadryl which helped with itching. Denies any oral/facial swelling, difficulty breathing, SOB, CP,  wheezing, N/V, Abdominal cramping.
Age: 11.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: started w/itching initially, felt warm and red on 11-12-19 used HCT and cool compresses, on 11-12-19 redness spreading and hard and swollen.  On PE 16x13 cm erythematous warm to touch area of right upper extremity.  Treated with Cephalexin 250mg TID x 7 days and well as Benadryl po PRN.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; improperly stored vaccine administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 30-OCT-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, (lot # S015460 an expiry date 20-MAY-2021 verified to be valid) (strength, dose and route of administration were not reported) for prophylaxis. The sterile diluent used to reconstitute the vaccine was properly stored. The suspect vaccine was stored in a temperature from 6 Fahrenheit (F) to 14 F (average temperature: 7.4 F) for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site pain
Clinical narrative: Route: lntradermal; pain in her whole upper lef arm; pain at the injection site; This spontaneous report as received from a consumer, who was a friend of the patient, refers to a 75-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 30-OCT-2019 (reported as four days ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intradermally (dose, lot # and expiration date were not reported) (incorrect route of product administration) and with influenza virus vaccine inactivated (unspecified) (manufacturer unknown) intradermally (dose, lot # and expiration date were not reported) both for prophylaxis.  On an unknown date in 2019, the patient experienced pain at the injection site and in her whole upper left arm. The patient did not seek for medical treatment.   At the time of the report the patient was still in pain, the outcome of pain at the injection site and in her whole upper left arm was reported as not recovered.  The relatedness between the events and the suspect vaccines was not reported.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Myalgia, Rash, Swelling, Urticaria
Clinical narrative: The patient experienced redness, swelling and a demarcation-hive appearance (6 inches out from the elbow); The patient experienced redness, swelling and a demarcation-hive appearance (6 inches out from the elbow); the patient reported muscle soreness; The patient experienced redness, swelling and a demarcation-hive appearance (6 inches out from the elbow); This spontaneous report was received from a pharmacist regarding a 68-year-old female patient. The patient did not have any medical history, concurrent conditions, concomitant medications and drug allergies/reactions. On 05-NOV-2019, the patient was vaccinated with a pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S018405, expiration date: 23-MAR-2021 (dose number and anatomical location were unknown) intramuscularly for prophylaxis (reported as "vaccination"). On 06-NOV-2019, in the morning the patient reported muscle soreness (myalgia). In the evening of the same day, the patient experienced redness, swelling and a demarcation hive appearance (6 inches out from the elbow) (erythema, swelling and urticaria). The patient returned to the pharmacy on 06-NOV-2019 and the pharmacist instructed her to take diphenhydramine (BENADRYL) (unspecified dose). On 07-NOV-2019, the pharmacist was followed up with the patient and the rash was mildly improved (recovering) but the patient did not take the diphenhydramine (BENADRYL). The pharmacist instructed her to take diphenhydramine (BENADRYL) again. The patient sought medical attention. There were no lab diagnostics/study performed. The outcome of events erythema, swelling and myalgia was reported as not recovered at the time of report. The reporter's causality assessment was not provided. No product quality complaints (PQC) involved.  This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-1911USA003496:01393890: case #
Sex: M
Vaccine: VARZOS
Symptoms: Deafness, Herpes zoster
Clinical narrative: Hearing loss; Shingles; Information had been received on 11-NOV-2019 from a lawyer and the patient (pt), regarding a case in litigation referring a male pt of unknown age. Concurrent conditions and medical history were not provided.  In or around October 2017, the pt was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dose, route, anatomical location, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose of the prevention of shingles (herpes zoster).  Shortly after vaccination the pt suffered of shingles and hearing loss. Pt sustained severe and permanent personal injuries. Further, as tragic consequence of companies' wrongful conduct, pt suffered serious, progressive, and permanent incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  The causality between Zoster Vaccine Live (ZOSTAVAX) and the events was related. The reporters considered shingles and hearing loss to be disabling. Upon internal review hearing loss was considered as medically significant event
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Diarrhoea, Nausea, Vomiting
Clinical narrative: diarrhea; INTENSE STOMACH CRAMPING; Nausea; Vomitting; This case was reported by a nurse via patient support programs and described the occurrence of diarrhea in a 61-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included treprostinil (Tyvaso) (batch number 2101674, expiry date 30th April 2020) for pulmonary arterial hypertension and riociguat (Adempas) for an unknown indication.   Concurrent medical conditions included pulmonary arterial hypertension (had primary pulmonary arterial hypertension). Concomitant products included diltiazem.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On 31st July 2019, the patient started Tyvaso (inhaled) at an unknown dose 4 times daily. On an unknown date, the patient started Adempas at an unknown dose and frequency. On an unknown date, 2 days after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced diarrhea, stomach cramps, nausea and vomiting. The action taken with Tyvaso was unknown. Adempas was discontinued. On an unknown date, the outcome of the diarrhea, stomach cramps, nausea and vomiting were unknown.   It was unknown if the reporter considered the diarrhea, stomach cramps, nausea and vomiting to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient received dose of Flu vaccine and experienced  diarrhea, intense stomach cramps, nausea and vomiting. The patient reported that stopping Adempas, helped to relieve the issues. On 31st July 2019, the patient received Tyvaso 6mg per ml for primary pulmonary arterial hypertension by inhalation as a treatment medication. The patient received Diltiazem as a treatment medication. No further details were provided.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Dizziness, Headache, Malaise
Clinical narrative: dizzy; doesn´t feel good; she was going to throw up; diarrhea; chills / shivering; headache; nausea; This case was reported by a consumer via call center representative and described the occurrence of chills in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in July 2019, refer case US2019201110).   On 29th October 2019, the patient received the 2nd dose of Shingrix. On 29th October 2019, 8 hrs after receiving Shingrix, the patient experienced chills, headache and nausea. On an unknown date, the patient experienced dizziness, feeling unwell, vomiting and diarrhea. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the chills, headache, nausea, dizziness, feeling unwell, vomiting and diarrhea were not recovered/not resolved.   It was unknown if the reporter considered the chills, headache, nausea, dizziness, feeling unwell, vomiting and diarrhea to be related to Shingrix.  Additional details were provided as follows: On 29th October 2019, patient received dose of Shingrix at around 10 am. By 6 pm on the day of vaccination, the patient had chills, shivering, headache and nausea. By 8 pm, the patient went to bed and could not get ou of bed untill 3 pm the following day. Less than a week after vaccination, the patient had dizziness, feeling unwell and vomiting. The patient would get dizzy and felt as if was going to threw up. Several days later, the patient had diarrhea everithing she ate. Till the time of reporting, th patient still not feeling good but was able to get up and move around.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Vaccine positive rechallenge, Vomiting
Clinical narrative: dizzy; doesn´t feel good; she was going to throw up; diarrhea; chills / shivering; headache; nausea; This case was reported by a consumer via call center representative and described the occurrence of chills in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in July 2019, refer case US2019201110).   On 29th October 2019, the patient received the 2nd dose of Shingrix. On 29th October 2019, 8 hrs after receiving Shingrix, the patient experienced chills, headache and nausea. On an unknown date, the patient experienced dizziness, feeling unwell, vomiting and diarrhea. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the chills, headache, nausea, dizziness, feeling unwell, vomiting and diarrhea were not recovered/not resolved.   It was unknown if the reporter considered the chills, headache, nausea, dizziness, feeling unwell, vomiting and diarrhea to be related to Shingrix.  Additional details were provided as follows: On 29th October 2019, patient received dose of Shingrix at around 10 am. By 6 pm on the day of vaccination, the patient had chills, shivering, headache and nausea. By 8 pm, the patient went to bed and could not get ou of bed untill 3 pm the following day. Less than a week after vaccination, the patient had dizziness, feeling unwell and vomiting. The patient would get dizzy and felt as if was going to threw up. Several days later, the patient had diarrhea everithing she ate. Till the time of reporting, th patient still not feeling good but was able to get up and move around.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: redness; swelling; pain; didn´t feel well; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 31st July 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site pain and feeling abnormal. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site pain and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 66 or 67 years old. The patient received vaccine in left arm. The patient experienced pain, swelling and redness at the injection site which was huge. The patient body overall didn't felt well. These began on the same day of the injection and lasted about a week. The patient consented to follow up. For tolerance of 2nd dose refer case US2019AMR204749.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Rash / samll rash presented on the left arm at injection site down to elbow and up to the neck/ bunch of spots on arm, neck shoulder; Rash / samll rash presented on the left arm at injection site down to elbow and up to the neck/ leg, torso; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number 2AH5M, expiry date 18th May 2021) for prophylaxis.   Previously administered products included Shingrix (1st dose received on November 2018).   On 10th January 2019, the patient received the 2nd dose of Shingrix .5 ml. In April 2019, less than 4 months after receiving Shingrix, the patient experienced injection site rash and rash. The patient was treated with clobetasol propionate (Clobetasol) and prednisone. On an unknown date, the outcome of the injection site rash and rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site rash and rash to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. In April 2019, a small rash was presented on the left arm at injection site down to elbow and up to the neck.  It presented as eight or nine 1 and 2 inch circle spots.  It was treated with Clobetasol and resolved temporarily but presented again after treating. This continued in a cycle. At the end of June, early July the bunch of spots were on arm neck and expanded to the shoulder. The patient noted that these were areas that were exposed to sun. Toward middle of July the rash became more intense. The patient was treated with several cycles of prednisone. The rash would clear and then return 5 days after finishing the prednisone. The patient was on his 4th cycle of prednisone and each time it represented it was expanded to another area. It was currently on his legs and torso. The reporter consented to follow up.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Rash / samll rash presented on the left arm at injection site down to elbow and up to the neck/ bunch of spots on arm, neck shoulder; Rash / samll rash presented on the left arm at injection site down to elbow and up to the neck/ leg, torso; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number 2AH5M, expiry date 18th May 2021) for prophylaxis.   Previously administered products included Shingrix (1st dose received on November 2018).   On 10th January 2019, the patient received the 2nd dose of Shingrix .5 ml. In April 2019, less than 4 months after receiving Shingrix, the patient experienced injection site rash and rash. The patient was treated with clobetasol propionate (Clobetasol) and prednisone. On an unknown date, the outcome of the injection site rash and rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site rash and rash to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. In April 2019, a small rash was presented on the left arm at injection site down to elbow and up to the neck.  It presented as eight or nine 1 and 2 inch circle spots.  It was treated with Clobetasol and resolved temporarily but presented again after treating. This continued in a cycle. At the end of June, early July the bunch of spots were on arm neck and expanded to the shoulder. The patient noted that these were areas that were exposed to sun. Toward middle of July the rash became more intense. The patient was treated with several cycles of prednisone. The rash would clear and then return 5 days after finishing the prednisone. The patient was on his 4th cycle of prednisone and each time it represented it was expanded to another area. It was currently on his legs and torso. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Paraesthesia
Clinical narrative: Tingling in head; Modest case of shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (the patient had history of shingles twice after receiving older shingles vaccine.).   On 3rd September 2019, the patient received the 1st dose of Shingrix. On an unknown date, 28 days after receiving Shingrix, the patient experienced shingles and tingling. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the tingling was unknown.   It was unknown if the reporter considered the shingles and tingling to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left upper arm. Approximately 4 weeks later patient had a modest case of shingles that lasted approximately 8 days. The reporter mentioned first sign was tingling in her head. The reporter mentioned that both of those instances as well as this instance described as modest, not significant and no eruptions. The reporter consented to follow up.