chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: I called to see if vaccine will be effect and I was told no So she will need 3 more injections (this was her first); Patient received GARDASIL 9 in the tricep muscle instead of the deltoid muscle; Information has been received from a nurse practitioner referring to a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, units, lot# and expiration date unknown) intramuscularly in the triceps muscle instead of deltoid muscle (product administered at inappropriate site). No adverse effects were reported.   Follow up information has been received from the nurse practitioner on 10-JUL-2019. The patient was 17 years old female. The patient had none illness at time of vaccination, none pre-existing physician-diagnosed allergies, birth defects, medical conditions (specify) or adverse event following a prior vaccination. On 26-JUN-2019, the patient's first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# R004689 has been verified to be a valid lot number for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast), expiration date not reported, but upon internal validation established as 29-NOV-2020) was given in the left triceps muscle by a medical assistant instead of deltoid muscle where it should have been given. The nurse practitioner called to see if vaccine would be effective and was told no (drug ineffective) and so, the patient would need 3 more injection. The patient had no other adverse reaction. Prescription drug treatment for the event was not required. The outcome of drug ineffective was unknown (contradiction information: also reported as recovered). The causality assessment was no provided.
Age: 15.0
Sex: F
Vaccine: HPV2, HPV4
Symptoms: Interchange of vaccine products, No adverse event, Wrong product administered
Clinical narrative: No adverse effects; patient received CERV ARIX dose when she was 14 years of age in 2015. Patient then received GARDASIL HPV 4 when she was 15 years 6 months of age in 2016; patient received CERV ARIX dose when she was 14 years of age in 2015. Patient then received GARDASIL HPV 4 when she was 15 years 6 months of age in 2016; This spontaneous report as received from a nurse refers to a 15-year-old female patient. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  The patient received hpv rl1 16 18 vlp vaccine (baculovirus) (CERVARIX) (lot number, expiration date, dose and route of administration were not provided) when she was 14 years of age in 2015. She then received quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (lot number: M014929, expiration date: 25-MAY-2017, dose was not provided) administered intramuscularly when she was 15 years and 6 months of age in 2016 (interchange of vaccine products, wrong product administered). No adverse effects were reported.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Pyrexia
Clinical narrative: Three days later the male patient had a headache and fever (temperature unspecified).; Three days later the male patient had a headache and fever (temperature unspecified).; Information has been received from a physician and a nurse via a field representative, referring to a 15 years old male patient. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was unknown.     On 19-MAR-2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(strength, dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. The patient did not have any adverse effect after the first dose. On 03-JUL-2019, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(strength, dose, frequency, route, lot# and expiration date were unknown) for prophylaxis.         On 06-JUL-2019 (reported as three days later), the patient had a headache and fever (temperature unspecified). The male patient was leaving for vacation and was not seen by the physician but was given instructions over the phone to take ibuprofen for fever or headache. The outcome of the events was recovering. The causality assessment was not provided by the reporter.
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 05-NOV-2018, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose,  lot # R000554 with expiration date 08-JAN-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: E2B Linked Report: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 05-NOV-2018, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose,  lot # R000554 with expiration date 08-JAN-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: E2B Linked Report: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 05-NOV-2018, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose,  lot # R000554 with expiration date 08-JAN-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter ; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA0103071: US-009507513-1907USA010372: US-009507513-1907USA010373:
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 21-NOV-2018,  the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R000554 with expiration date 08-JAN-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 26-NOV-2018, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R000554 with expiration date 08-JAN-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 26-NOV-2018, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R000554 with expiration date 08-JAN-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles, Local reaction
Clinical narrative: injection site erythema; blisters around the injection site; Injection site swelling; Injection site pain; This case was reported by a physician and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema, injection site blisters, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site blisters, injection site swelling and injection site pain were unknown.   It was unknown if the reporter considered the injection site erythema, injection site blisters, injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had no previous reaction to vaccination. After vaccination with Shingrix, the patient had local reactions. The patient asked if that was an allergic reaction and if she should get 2nd dose of Shingrix or not.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Condition aggravated, Dry mouth, Dry throat, Pain in extremity, Parosmia
Clinical narrative: chemical smell; dry mouth worsened; dry throat worsened; Itching on her back; sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included dry mouth and dry throat.   On 8th April 2019, the patient received Shingrix. On 8th April 2019, less than a day after receiving Shingrix, the patient experienced smell alteration, mouth dry aggravated and dry throat. In April 2019, the patient experienced pain in arm and pruritus. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the pruritus was recovering/resolving and the outcome of the smell alteration was not recovered/not resolved and the outcome of the mouth dry aggravated and dry throat were unknown.   It was unknown if the reporter considered the pain in arm, pruritus, smell alteration, mouth dry aggravated and dry throat to be related to Shingrix.  Additional information received were as follows: The reporter received her vaccine at her local pharmacy. The lot number and expiry date was not available. The reporter reported that she received a dose of Shingrix vaccine on unknown arm. The patient experienced sore arm which lasted for a couple of days. A week later, the patient started experiencing itching on her back every morning after getting out of the shower. The patient saw her dermatologist a week later and no rash was seen by the dermatologist. The reporter reported that two weeks ago from the reporting date, the itching had started to subside. The reporter also reported that after receiving Shingrix, the patient had been experiencing a chemical smell through her sinuses when she breathes in. The chemical smell occurs when the air conditioning comes on, when it was windy or when she laid down and it had not subsided. The reporter stated that after receiving Shingrix, the patient dry mouth and dry throat had worsened slightly since her Shingrix vaccine. The reporter would be seeing her family physician in September 2019.  The caller consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pruritus
Clinical narrative: chemical smell; dry mouth worsened; dry throat worsened; Itching on her back; sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included dry mouth and dry throat.   On 8th April 2019, the patient received Shingrix. On 8th April 2019, less than a day after receiving Shingrix, the patient experienced smell alteration, mouth dry aggravated and dry throat. In April 2019, the patient experienced pain in arm and pruritus. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the pruritus was recovering/resolving and the outcome of the smell alteration was not recovered/not resolved and the outcome of the mouth dry aggravated and dry throat were unknown.   It was unknown if the reporter considered the pain in arm, pruritus, smell alteration, mouth dry aggravated and dry throat to be related to Shingrix.  Additional information received were as follows: The reporter received her vaccine at her local pharmacy. The lot number and expiry date was not available. The reporter reported that she received a dose of Shingrix vaccine on unknown arm. The patient experienced sore arm which lasted for a couple of days. A week later, the patient started experiencing itching on her back every morning after getting out of the shower. The patient saw her dermatologist a week later and no rash was seen by the dermatologist. The reporter reported that two weeks ago from the reporting date, the itching had started to subside. The reporter also reported that after receiving Shingrix, the patient had been experiencing a chemical smell through her sinuses when she breathes in. The chemical smell occurs when the air conditioning comes on, when it was windy or when she laid down and it had not subsided. The reporter stated that after receiving Shingrix, the patient dry mouth and dry throat had worsened slightly since her Shingrix vaccine. The reporter would be seeing her family physician in September 2019.  The caller consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Antinuclear antibody, Burning sensation, Dry throat, Food intolerance, Parosmia
Clinical narrative: chemical smell; dry mouth worsened; dry throat worsened; Itching on her back; sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included dry mouth and dry throat.   On 8th April 2019, the patient received Shingrix. On 8th April 2019, less than a day after receiving Shingrix, the patient experienced smell alteration, mouth dry aggravated and dry throat. In April 2019, the patient experienced pain in arm and pruritus. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the pruritus was recovering/resolving and the outcome of the smell alteration was not recovered/not resolved and the outcome of the mouth dry aggravated and dry throat were unknown.   It was unknown if the reporter considered the pain in arm, pruritus, smell alteration, mouth dry aggravated and dry throat to be related to Shingrix.  Additional information received were as follows: The reporter received her vaccine at her local pharmacy. The lot number and expiry date was not available. The reporter reported that she received a dose of Shingrix vaccine on unknown arm. The patient experienced sore arm which lasted for a couple of days. A week later, the patient started experiencing itching on her back every morning after getting out of the shower. The patient saw her dermatologist a week later and no rash was seen by the dermatologist. The reporter reported that two weeks ago from the reporting date, the itching had started to subside. The reporter also reported that after receiving Shingrix, the patient had been experiencing a chemical smell through her sinuses when she breathes in. The chemical smell occurs when the air conditioning comes on, when it was windy or when she laid down and it had not subsided. The reporter stated that after receiving Shingrix, the patient dry mouth and dry throat had worsened slightly since her Shingrix vaccine. The reporter would be seeing her family physician in September 2019.  The caller consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pruritus, Sjogren's syndrome
Clinical narrative: chemical smell; dry mouth worsened; dry throat worsened; Itching on her back; sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included dry mouth and dry throat.   On 8th April 2019, the patient received Shingrix. On 8th April 2019, less than a day after receiving Shingrix, the patient experienced smell alteration, mouth dry aggravated and dry throat. In April 2019, the patient experienced pain in arm and pruritus. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the pruritus was recovering/resolving and the outcome of the smell alteration was not recovered/not resolved and the outcome of the mouth dry aggravated and dry throat were unknown.   It was unknown if the reporter considered the pain in arm, pruritus, smell alteration, mouth dry aggravated and dry throat to be related to Shingrix.  Additional information received were as follows: The reporter received her vaccine at her local pharmacy. The lot number and expiry date was not available. The reporter reported that she received a dose of Shingrix vaccine on unknown arm. The patient experienced sore arm which lasted for a couple of days. A week later, the patient started experiencing itching on her back every morning after getting out of the shower. The patient saw her dermatologist a week later and no rash was seen by the dermatologist. The reporter reported that two weeks ago from the reporting date, the itching had started to subside. The reporter also reported that after receiving Shingrix, the patient had been experiencing a chemical smell through her sinuses when she breathes in. The chemical smell occurs when the air conditioning comes on, when it was windy or when she laid down and it had not subsided. The reporter stated that after receiving Shingrix, the patient dry mouth and dry throat had worsened slightly since her Shingrix vaccine. The reporter would be seeing her family physician in September 2019.  The caller consented to follow up.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The reporter was wife of the patient. The patient received dose of Shingrix in the left arm, 6 weeke ago from the date of reporting. The patient after vaccination still experiencing a sore arm. The reporter did not consent to follow up. This is 1 of the 3 cases reported by the same reporter. There was discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
Sex: U
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: High fevers/104 degrees F; This is a spontaneous report from a contactable unspecified HCP via Pfizer sales representative who reported similar events for 3 patients. This is the 1st of 3 reports. A patient of unknown age and gender received a single dose of meningococcal group b rlp2086 (TRUMENBA) for immunization on an unknown date in Jul2019. Medical history and concomitant medications were not reported. After vaccination, in Jul2019 the patient had high fever (104 degrees F). It was mentioned that last 3 patients they vaccinated with meningococcal group b rlp2086 from their private stock, each reported high fevers to the office. These 3 doses came from a box of 5 received in Jul2019, the week before this report. Outcome was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019303936 same reporter/drug/event, different patient;US-PFIZER INC-2019303935 same reporter/drug/event, different patient
Sex: U
Vaccine: MENB, MENB
Symptoms: Pyrexia
Clinical narrative: High fevers; This is a spontaneous report from a contactable unspecified HCP via Pfizer sales representative who reported similar events for 3 patients. This is the 3rd of 3 reports. A patient of unknown age and gender received a single dose of meningococcal group b rlp2086 (TRUMENBA) for immunization on an unknown date in Jul2019. Medical history and concomitant medications were not reported. After vaccination, in Jul2019 the patient had high fevers. It was mentioned that last 3 patients they vaccinated with meningococcal group b rlp2086 from their private stock, each reported high fevers to the office. These 3 doses came from a box of 5 received in Jul2019, the week before this report. Outcome was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019303935 same reporter/drug/event, different patient;US-PFIZER INC-2019303925 same reporter/drug/event, different patient
Sex: U
Vaccine: MENB, MENB
Symptoms: Pyrexia
Clinical narrative: high fevers; This is a spontaneous report from contactable Other-HCP via Pfizer Sales Representative. This Other-HCP reported similar events for 3 patients. This is 2nd of 3 reports.   A patient of unknown age and gender received meningococcal group b rlp2086 (TRUMENBA) at single dose on an unknown date in Jul2019 for immunization, from a private stock.  Medical history and concomitant medications were not reported.  After vaccination, in Jul2019 the patient had high fevers. The dose came from a box of 5 received in Jul2019, the week before this report. Outcome was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019303936 same reporter/drug/event, different patient;US-PFIZER INC-2019303925 same reporter/drug/event, different patient
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Full blood count normal, Pyrexia, Urine analysis normal
Clinical narrative: Baby began to run a fever the same day the vaccines were given, no other symptoms presented, fever continued to next day
Age: 85.0
Sex: M
Vaccine: PPV
Symptoms: Contusion, Pain in extremity, Peripheral swelling, Skin discolouration
Clinical narrative: left arm pain, swelling to the lower left hand and arm, and skin color change (bruising)
Age: 0.17
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Apnoea, Hyporesponsive to stimuli, Oxygen saturation decreased, Pallor
Clinical narrative: Low O2 saturations, dusky pale appearance, delayed response to stimulation, apnea
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: Pt developed rash the day after HPV vaccine and mom was sure it was from the Gardasil. To me and to the Dermatologist I consulted, it looked more like a bug bite hypersensitivity. Since that diagnosis is not certain and it occurred 24 hours after the vaccination, this is being reported. HE ALSO got Menactra  LOT # U5869AB made by Sanofi that day, It was his first Menactra
Age: 3.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: Child passed out after receiving the Hep A and P13 vaccines. The child's father was holding the child in his lap during vaccine administration.  The vaccines were given at 9:20 AM, and he passed out at 9:25 AM. The child was walking around the room after the vaccines were given. Child was standing at the desk looking at stickers, and fell backwards and hit his head on the floor.  EMS was called at 9:26 AM, and EMS arrived at 9:36 AM. The mom picked the child up and put him in her lap. The child remained conscious, and was back to normal within a couple minutes after the fall. EMS was called, but the child was not taken to the hospital. Vital signs were normal after the fall. No medicine or CPR needed. Mom was educated by EMS about signs of a concussion to monitor her child at home, and to bring to the ER if any signs of a concussion occur.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Myalgia
Clinical narrative: Muscle pain, headache. I took Acetaminophen. Pain reduced to a manageable level.
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Dry mouth, Facial pain, Flushing, Headache
Clinical narrative: Headache, fever (103), pain side of neck and face, malaise, no appetite, flushed, dry mouth.   Doctor agreed symptoms consistent with Mumps. Fever burned out within three days, and with rest and hydration he recovered.
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Malaise, Mumps, Neck pain, Pyrexia
Clinical narrative: Headache, fever (103), pain side of neck and face, malaise, no appetite, flushed, dry mouth.   Doctor agreed symptoms consistent with Mumps. Fever burned out within three days, and with rest and hydration he recovered.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: had titers drawn recently which were negative for immunity to hepatitis B; This spontaneous report was received from medical assistant and office manager referring  about 25 years old male patient. The patient's concurrent condition, concomitant medication and medical history were unknown. On an unknown date, when the patient was a child, he was vaccinated with 3 dose series of hepatitis b vaccine (recombinant)(manufacturer unknown) (reported as "unspecified hepatitis b vaccine") (strength, frequency, route of administration, lot # and expiry date unspecified) for prophylaxis while living in country. On an unknown date in 2019 (reported as "recently"), the patient, who is living in country now, had titers drawn which were negative for immunity to hepatitis B (hepatitis b antibody negative). On an unknown date in 2019 (reported as "recently"), patient was then revaccinated with a 3 dose series of hepatitis B virus vaccine rHBsAg (yeast) (ENGERIX-B). Medical assistant reported that the patient had titers drawn again recently after the revaccination series, but these were still negative for immunity to hepatitis B. It was also reported that the patient's wife is a carrier of hepatitis B antigen. Office manager then came back on the line and reported there were no second titers drawn, contrary to what the medical assistant reported. The outcome of the event was unknown. Causality assessment was not reported by the reporter.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 26-NOV-2018, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R001658 with expiration date 17-JAN-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Vaccine positive rechallenge
Clinical narrative: doses were very painful; This case was reported by a consumer via patient support programs and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on an unknown date, refer case US2019AMR122591').   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's husband via voicemail. The age at vaccination was not reported. It was reported that the Shngrix was very painful. The patient received Shingrix and experienced very painful. The patient's husband was told that it was normal, but was calling to find out why it was so painful. For the tolerance of 2nd dose, refere case US2019AMR122634.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows:  Around 24th to 28 April 2019, the patient received 1st dose of Shingrix on left deltoid. Afterwards he had only some soreness in his left deltoid where he received the injection. For tolerance after 2nd dose, refer case US2019123027.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site warmth
Clinical narrative: redness at injection site; warm at the injection site; red arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number AC79X, expiry date 17th October 2021) for prophylaxis.   On 3rd July 2019, the patient received the 1st dose of Shingrix .5 ml. In July 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site warmth and erythema of extremities. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injection site erythema, injection site warmth and erythema of extremities were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. The patient was asking about how to manage a very large red and warm patch at the administration site. The redness was about 4 inches by 3 inches wide and it started where the vaccine was administered and going down her arm. The pharmacist recommended Tylenol.