chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 08-MAY-2019,  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 # R024906 with expiration date 30-AUG-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-009507513-1907USA010323: 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-009507513-1907USA010366: 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 15-MAY-2019,  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 # R024906 with expiration date 30-AUG-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-009507513-1907USA010323: 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-009507513-1907USA010367: 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 20-MAY-2019, 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 # R024906 with expiration date 30-AUG-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-009507513-1907USA010323: 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-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No adverse effect; Patient was vaccinated with improperly stored dose of VAQTA; This spontaneous report was received from a vaccine administrator referring a patient of unknown gender and age. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not provided.  On 09-JUL-2019, the patient was vaccinated for prophylaxis with improperly stored dose of Hepatitis A Vaccine, Inactivated (VAQTA) (lot number: S002460 and expiration date: 15-MAY-2020; lot number: R034340 and expiration date: 23-NOV-2019, dosage schedule, route and anatomical location were not reported) (lot number R023606 is an invalid lot number for Hepatitis A Vaccine, Inactivated (VAQTA)).  The temperature was 49.3 degrees fahrenheit (F) for a time frame of 4 hours and 30 minutes, without a previous temperature excursion and was call because a digital data logger. No further information was available.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Emotional distress, Herpes zoster, Injury, Pain
Clinical narrative: Herpes zoster; This spontaneous report as received from a lawyer regarding a case in litigation refers to a female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On approximately 23-OCT-2013, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  As a direct result of zoster vaccine live (ZOSTAVAX), on an unknown date shortly after vaccination, the pt experienced abdominal pain and was diagnosed with herpes zoster (shingles). As a direct result of the zoster vaccine live (ZOSTAVAX), the pt suffered mental and emotional distress resulting in physical limitations and the seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the event was considered to be not recovered.      Herpes zoster (shingles) was considered to be disabling.
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; a female patient was administered properly stored M-M-R II instead of VARIVAX; This spontaneous report was received from a practice manager regarding a 22-year-old female patient. There was no information reported regarding the patient's pertinent medical history, concurrent conditions, concomitant medications and drug allergies/reactions.  On 20-JUN-2019, the patient was administered a properly stored dose of M-M-R II (lot number R024907 and expiration date 30-AUG-2020; dose, route and anatomical site were not provided) for prophylaxis instead of varicella virus vaccine live (Oka/Merck) (VARIVAX). Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was reconstituted with a properly stored sterile diluent (lot number and expiration date were unknown by the reporter). No adverse effect reported.
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: A sore, raised lump/localized swelling ocurred near the injection site that lasted for 2 1/2 to 3 weeks; A sore, raised lump/localized swelling ocurred near the injection site that lasted for 2 1/2 to 3 weeks; A sore, raised lump/localized swelling ocurred near the injection site that lasted for 2 1/2 to 3 weeks; Information has been received from a nurse practitioner, concerning a female patient of unknown age. The patient's medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) intramuscularly (anatomical location, lot number and expiration date were not provided) for prophylaxis (reported as vaccination).  Subsequently on an unknown date, a sore, raised, lump localized swelling occurred near the injection site (injection site swelling/injection site lump/injection site pain) that lasted for 2 1/2 to 3 weeks. The outcome of the abovementioned adverse events were unknown at the time of this report.  The causal relationship between the abovementioned adverse events and the therapy with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.
Age: 26.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects; The patient received first dose of GARDASIL 9 at the age of 26 years old in August 2018 and the second dose on February 2019; The patient received first dose of GARDASIL 9 at the age of 26 years old in August 2018 and the second dose on February 2019; This spontaneous report was received from a 26 years old patient of unknown gender referring on himself/herself. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not provided.  On an unspecified day in August 2018, the patient was vaccinated for prophylaxis with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (route, anatomical location, lot number and expiration date were not reported). On an unspecified day in February 2019, the patient was vaccinated for prophylaxis with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (route, anatomical location, lot number and expiration date were not reported) (inappropriate schedule of vaccine administered and circumstance or information capable of leading to medication error). No adverse effects were reported. No further information was available.
Age: 0.67
Sex: M
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The doctor inadvertently gave a dose to an 8 month old who never had any dose before this.; This spontaneous report as received from an office manager concerning to an 8-month-old male patient.      The patient's concurrent conditions, medical history, previous drug reactions, allergies and concomitant therapies were not provided.  On 12-JUL-2019, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (strength, dose and frequency were not reported), lot # R021650 and expiration date 27-MAY-2020, for prophylaxis. The patient had never received a rotavirus vaccine, live, oral, pentavalent (ROTATEQ) before this dose. The patient's mother was made aware that if she noticed diarrhea or vomitng, to take the child to the emergency room.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, Pregnancy test urine positive, Prenatal care
Clinical narrative: A patient was administered a dose of GARDASIL 9 when she was about 3 to 4 months pregnant; This spontaneous prospective pregnancy report was received from a medical assistant , concerning a 15 years-old female. The patient had no pertinent medical history, drug allergies, previously drug reactions or concomitant medications. The estimated last menstrual period was approximately on 02-MAR-2019 and on approximately 16-MAR-2019 (reported as 20 weeks ) the patient became pregnant.  On 13-JUN-2019, the patient was vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot number: R020949 with expiration date: 04-MAY-2021) (route of administration and anatomical location were not reported) for prophylaxis, when she was about 3 to 4 months pregnant (vaccine exposure during pregnancy). On 05-JUL-2019, the patient returned to the office to refill her unspecified birth control pills and an unspecified urine pregnancy test was performed which was positive. The patient received prenatal care. The due date would be on 07-DEC-2019. The patient had not recovered from the vaccine exposure during pregnancy.   The causal relationship between the vaccine exposure during pregnancy and the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive
Clinical narrative: A patient was administered a dose of GARDASIL 9 when she was about 3 to 4 months pregnant; This spontaneous prospective pregnancy report was received from a medical assistant , concerning a 15 years-old female. The patient had no pertinent medical history, drug allergies, previously drug reactions or concomitant medications. The estimated last menstrual period was approximately on 02-MAR-2019 and on approximately 16-MAR-2019 (reported as 20 weeks ) the patient became pregnant.  On 13-JUN-2019, the patient was vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot number: R020949 with expiration date: 04-MAY-2021) (route of administration and anatomical location were not reported) for prophylaxis, when she was about 3 to 4 months pregnant (vaccine exposure during pregnancy). On 05-JUL-2019, the patient returned to the office to refill her unspecified birth control pills and an unspecified urine pregnancy test was performed which was positive. The patient received prenatal care. The due date would be on 07-DEC-2019. The patient had not recovered from the vaccine exposure during pregnancy.   The causal relationship between the vaccine exposure during pregnancy and the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.
Sex: M
Vaccine: MMRV, UNK
Symptoms: Varicella post vaccine
Clinical narrative: the one unspecified 1 year old patient went to the physician office on 16-JUL-2019, and was diagnosed with "chicken pox"; This spontaneous report has been received from a nurse via a company representative, concerning a 1 year old male patient.      The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 11-JUL-2019, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (frequency, anatomical location, lot number and expiration date were not reported) as routine 12 month vaccination (prophylaxis).  Other suspect therapies included sterile diluent (MERCK STERILE DILUENT), which was used to reconstitute the vaccine (dose, frequency, route, lot number and expiration date were not reported).  On 16-JUL-2019, the patient went to the physicians office and he was diagnosed with chicken pox (varicella). The nurse stated that "it was unclear as the cause of the chicken pox as the child had been around other children and it may be that the child was exposed to the chicken pox from other children or possibly from receiving the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) vaccine. Therefore, the patient received "standard treatment" for the event. At the reporting time, he was stable, however he had not recovered from the event. In addition, no other adverse effect was reported.   The causal relationship between varicella, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and other suspect therapy: sterile diluent (MERCK STERILE DILUENT), was not reported.
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: fainted after administration; This spontaneous report has been received from a physician referring to a male patient of unknown age. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      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) (lot #, expiration date, dose details were unknown) intramuscularly for "prevention of human papillomavirus (HPV) diseases."  On an unknown date the patient experienced "fainted after administration" (syncope). Treatment was not given. The patient sought medical attention.  The outcome of syncope was reported as recovered. The causality between syncope and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, fainted after administration was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 74 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 21-NOV-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 73 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 12-OCT-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Rubella antibody negative
Clinical narrative: No adverse effects reported; rubella was "less than 25.0"; This spontaneous report has been received from an office staff referring to a child patient of unknown  gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided.   On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis.            On 16-JUL-2019, the results from recent titers showed that the rubella was less than 25.0. No adverse effects reported. The outcome of the event was unknown.  The causality between the event and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient was administered an improperly stored varivax; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions, historical drugs and drug reactions/ allergies were not reported. On 11-JUL-2019 the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # S000132 and expiry date 02-JAN-2021 (dose, frequency and route of administration not reported) for prophylaxis. Concomitant therapies included sterile diluent which was used to reconstitute the varicella virus vaccine live (oka/merck) (VARIVAX) was stored properly. The storage temperature and time frame was reported as 15 degree Fahrenheit to 46 degree Fahrenheit (29.1 degree Fahrenheit) for 3 hours. There was no previous temperature excursion. No adverse effect was observed. Digital data logger was not involved. No Product Quality Complaint (PQC) was present.
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: aching; Injection site redness and sweling; Injection site redness and sweling; fever; Chill's; This spontaneous report as received from a physician referring to a 74 year old male patient. The patient's concurrent conditions, medical history and concomitant medications were not provided. The patient had no known allergies.  On 17-JUL-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, strength and frequency were not provided) intramuscularly for "prophylactic precaution".  Lot No. S004548 has been verified to be a valid lot number for pneumococcal vaccine, polyvalent, expiration date reported as 12-AUG-2020, but upon internal validation established as the same date.  On 17-JUL-2019, the patient called to report having "injection site redness and swelling, and fever, chills, and aching (pain)". The medical assistant has requested a Lot Check. The medical assistant wanted a response quickly and reported that they would not administer any more doses of the vaccine from that Lot, until they receive a response. The outcome of pain and injection site swelling, injection site erythema was unknown. The outcome of pyrexia and chills was reported as not resolved. No laboratories were performed, and it was unknown if treatment was given for the events.  The causal relationship between the events and the vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: itchy red rash; itchy red rash; Injection site red; Injection site swollen; injection site tender to touch; This case was reported by a consumer and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th July 2019, the patient received the 1st dose of Shingrix. On 13th July 2019, 3 days after receiving Shingrix, the patient experienced itchy rash and red rash. In July 2019, the patient experienced injection site erythema, injection site swelling and injection site tenderness. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site tenderness, itchy rash and red rash were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site tenderness, itchy rash and red rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Shingrix in the unknown arm. The patient's injection site became red, swollen and very tender to the touch. On 13th July 2019 in the morning, the patient woke with a localized rash in antecubital area of arm where the patient was vaccinated. It was itchy and red. No other symptoms were reported. The patient inquired, do he need to be concerned and still need to take second injection.
Sex: U
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: itchy red rash; itchy red rash; Injection site red; Injection site swollen; injection site tender to touch; This case was reported by a consumer and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th July 2019, the patient received the 1st dose of Shingrix. On 13th July 2019, 3 days after receiving Shingrix, the patient experienced itchy rash and red rash. In July 2019, the patient experienced injection site erythema, injection site swelling and injection site tenderness. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site tenderness, itchy rash and red rash were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site tenderness, itchy rash and red rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Shingrix in the unknown arm. The patient's injection site became red, swollen and very tender to the touch. On 13th July 2019 in the morning, the patient woke with a localized rash in antecubital area of arm where the patient was vaccinated. It was itchy and red. No other symptoms were reported. The patient inquired, do he need to be concerned and still need to take second injection.
Sex: F
Vaccine: FLUX
Symptoms: Injection site nerve damage, Pain in extremity
Clinical narrative: pain in arm; Injection site nerve damage; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in an unspecified number of patients who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patients received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced pain in arm and injection site nerve damage. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the injection site nerve damage was unknown.   It was unknown if the reporter considered the pain in arm and injection site nerve damage to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that, she knew few people had the same problem and would never get that shot again. The patient got Flu vaccine in October and reported that the arm still hurts. The patient reported that they told her that they hit a nerve. This case has been linked to US2019AMR073097, reported by the same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes simplex, Herpes simplex test positive, Postural orthostatic tachycardia syndrome, Product supply issue
Clinical narrative: Product supply issue; postural orthostatic tachycardia; positive HSV-1 IgG; This case was reported by a consumer via call center representative and described the occurrence of postural orthostatic tachycardia syndrome in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cold sores. Concurrent medical conditions included postural orthostatic tachycardia syndrome.   On 5th December 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In May 2019, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced postural orthostatic tachycardia syndrome and herpes simplex type i. On an unknown date, the patient experienced product supply issue. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the postural orthostatic tachycardia syndrome, herpes simplex type i and product supply issue were unknown.   It was unknown if the reporter considered the postural orthostatic tachycardia syndrome and herpes simplex type i to be related to Shingrix.  Additional details were provided as follows: Prior to her first dose, on Thanksgiving, the patient experienced an episode of postural orthostatic tachycardia syndrome. She states this was evoked by a viral event. In May 2019, the patient had another event of this and was IgG positive for Herpes simplex virus 1. The patient noted she was not sure if this was something she had been aware of before, but noted she did have a history of cold sores. The patient was not sure if these events were related to the first injection, as she had had the events before. The patient was placed on valacyclovir in May 2019 for these events.  The patient had not received her 2nd dose of Shingrix yet due to unavailability. The patient called to see if she needed to stop the valacyclovir before getting her second dose.  The patient had been out of the country for 5 weeks, but had been contacted to say her second dose of Shingrix was now available at the pharmacy. The patient consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain, Pain in extremity
Clinical narrative: pain; Hurts; Feel sick; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) (batch number FG2D4, expiry date 19th September 2021) for prophylaxis.   On 10th June 2019, the patient received Shingrix. On 11th June 2019, 1 days after receiving Shingrix, the patient experienced pain in arm. In June 2019, the patient experienced pain and sickness. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the pain and sickness were unknown.   It was unknown if the reporter considered the pain in arm, pain and sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingrix vaccine on an unknown arm. The patient experienced pain in arm, felt sick and hurt after receiving  a dose of Shingrix.
Age: 1.5
Sex: U
Vaccine: DTAP, TDAP
Symptoms: Wrong product administered
Clinical narrative: inadvertently given Adacel instead of Daptacel; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 months old patient who experienced inadvertently given DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [Daptacel] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided.   On 12-Jul-2019, the patient received a 0.5 ml  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  it was case of actual medication error due to wrong vaccine administered  It was not reported if the patient experience any adverse reaction after the injection.   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  List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: expired menactra vaccine was given to a patient; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old male patient who received an expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [Menactra] lot U5948AB expiry date: 03-Jul-2019 via unknown route in the left deltoid on 12-Jul-2019 .  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Immunisation.  It was actual medication error due to expired vaccine used.  It was not reported if the patient experience any adverse reaction after the injection.   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.  List of documents held by sender- none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: nurse gave 1 children only the Dtap-IPV part of the Pentacel vaccine, ActHIB vials were not given; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked with 2019SA195802.   This case involves 1 child patients of unknown demographics who was vaccinated with a dose only the Dtap-IPV part of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ123AAA and Exp. Date 29-Sep-2020) ACT-HIB part was not given via unknown route in unknown administration site on an unknown date.   The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate reconstitution technique.  (DTap-IPV- lot number U6397AA and Exp. Date 09/29/2020 and ActHIB UJ123AA and Exp. Date 09/29/2020)  It was unknown whether the patient experienced any adverse event post vaccination.  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.  List of documents held by sender: none.
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: exposed to temperatures below 32 degrees F. Vaccines; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked 2019SA192700 and 2019SA192699 (same reporter)  This case involves a 12 months old male patient who received dose of vaccine HIB (PRP/T) VACCINE lot UI969AAB (Expiry date 04-Apr-2020) via intramuscular route in unknown administration site. On 28-Jun-2019.  It is an actual medication error due to incorrect product storage.   It was reported that received vaccines that were previously exposed to temperatures below 32 degrees F.  At the time of reporting, no adverse reaction 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.  List of documents held by sender: none.
Sex: M
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: patients has received Menactra that was previously exposed to temperatures below 32 degrees F.; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a Nurse.  This case is linked to cases 2019SA192699 and 2019SA192698 (same reporter).  This case involves male patient (age not reported) who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6219BA and 16-Jun-2020) via unknown route in unknown administration site that was exposed to temperatures below 32 degrees F, 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 case due to incorrect product storage.  It was unknown whether patient experienced any adverse reaction.  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.  List of documents held by sender: none.
Sex: M
Vaccine: TTOX
Symptoms: Incorrect route of product administration, Wrong product administered
Clinical narrative: Tubersol 1 ml in his left deltoid today IM; Tubersol 1 ml in his left deltoid today IM; individual that injected the pediatric patient meant to give the patient a Tetanus vaccine; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 9 years old male patient who received TUBERCULIN TEST [TUBERSOL] instead of TETANUS TOXOID and reported that Tubersol 1 ml in his left deltoid today IM and individual that injected the pediatric patient meant to give the patient a Tetanus vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); POLIO VACCINE INACT 3V (VERO) (IPOL [POLIO VACCINE INACT 3V (VERO)]); and HEPATITIS B VACCINE (HEPATITIS B [HEPATITIS B VACCINE]).  On 12-Jul-2019, the patient started taking TUBERSOL (TUBERCULIN TEST) 1 mL (lot - C5569AA, 08-Apr-2021) for Tuberculin test.  It was a case of actual medication error due to vaccine overdose, inappropriate route of vaccination and wrong vaccine administered.  It was not reported if any adverse event occurred or not.  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.  List of documents held by sender: none.
Sex: M
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: MENACTRA was scheduled to be delivered on 5/31/19, but they did not get the vaccine until 6/4/19 and when they opened ice packs were in the container but it was not frozen.; Initial information received on 09-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked with This case is linked to cases 2019SA193300, 2019SA193301, 2019SA193307, 2019SA193303, 2019SA193304, 2019SA193305, 2019SA193306 and 2019SA158240 (same reporter).  This case involves 12 years old male patient with who was vaccinated with 0.5 ml first primary dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6365AA and expiry date was not reported) via intramuscular route in the arm NOS, on 30-May-2019.  The patient's past medical history, medical treatment(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage. It was reported that MENACTRA was scheduled to be delivered on 31-May-2019. Caller stated they did not get the vaccine until 04-Jun-2019. Caller stated when they opened ice packs were in the container but it was not frozen. It was stored incorrectly from 31-May-2019 to 09-Jun-2019.  It was unknown if any adverse event occurred.  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.   List of document held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, Product preparation issue
Clinical narrative: baby only received the Pentacel diluent and not the Pentacel powder; Initial information received on 16-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient who received dose of Pentacel diluent and not the Pentacel powder from DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (PENTACEL) (lot number and Expiry date unknown) via unknown route in unknown administration site.  The patients' medical history and concomitant medications were not reported.   It was a case of actual medication error due to inappropriate reconstitution technique. (it was reported that baby only received the Pentacel diluent and not the Pentacel powder)  It was unknown whether any adverse event occurred..  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.  Documents held by sender: none