chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain in extremity, Skin warm
Clinical narrative: L arm sore, as expected, thru evening of 6/14/19. Hand fell asleep when laying on left side. Stomach was queasy all the next day - ate nothing 6/15/19. Arm got much sorer from just below injection site all the way to my elbow. Left leg cramps. Arm hot to touch but didn't notice redness til Sunday 6/16/19. Daughter (PA) noticed redness - looked like cellulitis - large patch 3 inches below injection site the cellulitis-looking red elevated skin was approximately a 4 in. wide by 7 inches long patch on the left arm between elbow and top of shoulder. Ate a normal breakfast, but stayed away from coffee all day Sunday because of queasiness of stomach. I am not an wipy person - have thrown up once in the last 50 yrs from some flu bug. Felt warm but not feverish. Early Monday morning 6-17-19 had diarrhea. About 3 short bouts of that before I took 2 Imodium pills. That stopped diarrhea, but still had slightly queasy stomach for the next 4-5 days. Stool was formed, but a yellowish color like grey poupon mustard. By Friday, felt more like eating & stool turning more of a normal color. The covering physician on Monday (6-17-19) thought the redness of my arm was lightening from the pictures I had sent on Sunday. Said if my symptoms would worsen (fever, darker-red skin, etc) I could get an antibiotic from him. Nothing was prescribed that day and I left w/ a wait and see attitude. Soreness went away & feeling almost back to normal by Thurs. 6-20-19.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Pain, Skin warm
Clinical narrative: Redness, pain, hardness in the area, warm to the touch (all symptoms worsening)
Age: 71.0
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Pt presented with shingles & also on Rt orbital area of face
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Eye pruritus, Full blood count, Nodule, Oedema
Clinical narrative: fever severe rash nodules possible Kawasaki syndrome - see enclosed sheet  The patient is a 15 month old male who presents for evaluation of a rash. The onset of the rash has been sudden and has been occurring in a persistent pattern for 1 week. The course has been increasing. The rash is characterized as red. The rash was first seen on the face. It spread to the upper extremity and the lower extremity. There has been associated itching (eyes), erythema and edema, while there has been no associated pain. There has been associated fever, while there has been no alopecia, anorexia, chills, malaise, nail changes or pain. Note for "Rash": Itchy eyes started on 6/19/2019. Rash started on 6/23/2019.  Mom stated he has some "hives on his legs" 6/24/2019. Itchy eyes. No other itching noticed by mom. Fever when temp was taken at home. Mom stated "feels warm to the touch." Mom thinks possible reaction to vaccines given at previous nurse visit.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash erythematous, Red blood cell sedimentation rate increased, Skin warm, Urticaria
Clinical narrative: fever severe rash nodules possible Kawasaki syndrome - see enclosed sheet  The patient is a 15 month old male who presents for evaluation of a rash. The onset of the rash has been sudden and has been occurring in a persistent pattern for 1 week. The course has been increasing. The rash is characterized as red. The rash was first seen on the face. It spread to the upper extremity and the lower extremity. There has been associated itching (eyes), erythema and edema, while there has been no associated pain. There has been associated fever, while there has been no alopecia, anorexia, chills, malaise, nail changes or pain. Note for "Rash": Itchy eyes started on 6/19/2019. Rash started on 6/23/2019.  Mom stated he has some "hives on his legs" 6/24/2019. Itchy eyes. No other itching noticed by mom. Fever when temp was taken at home. Mom stated "feels warm to the touch." Mom thinks possible reaction to vaccines given at previous nurse visit.
Sex: M
Vaccine: HPV9
Symptoms: Head injury, Syncope
Clinical narrative: SYNCOPE; Head injury; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report was received from a regulatory authority refers to a 13 year old male patient. The patient's medically history included cast application. The concurrent conditions included wrist fracture.  On an unknown date the patient was administered with third dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength,frequency, lot number, anatomical location and expiration date  were unknown) for prophylaxis. Five minutes after the shot patient hopped off table, fainted, hit back of head (head injury and syncope). The outcome of head injury and syncope was reported as recovered.  The patient's other medications included "took hydrocodone this morning".  The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and events was not reported.  Upon internal review the event syncope was considered as medically significant.    This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act on 23-APR-2019. The patient was in office to have cast applied to his wrist which was fractured 2 days ago (No details provided). Administered with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (earlier it was captured as third dose).  Follow-up information was received from the nurse on 26-JUN-2019 regarding the 13 year old patient.  The patient went to receive cast for fractured wrist. The patient was revived immediately and was fully recovered after the events. The nurse believed that the hydrocodone was a factor in the fainting incident.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Loss of personal independence in daily activities, Myalgia, Neck pain, Pain, Quality of life decreased
Clinical narrative: patient  received Flu Shot on 1/19/19 and noticed instant pain and it then got worse over the course of the next month. Cx has pain deep into her shoulder, who was then sent to different doctors and orthopedics for x rays. Cx is still having horrible pain and needs an MRI
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: X-ray
Clinical narrative: patient  received Flu Shot on 1/19/19 and noticed instant pain and it then got worse over the course of the next month. Cx has pain deep into her shoulder, who was then sent to different doctors and orthopedics for x rays. Cx is still having horrible pain and needs an MRI
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal pain, Pain, X-ray
Clinical narrative: patient  received Flu Shot on 1/19/19 and noticed instant pain and it then got worse over the course of the next month. Cx has pain deep into her shoulder, who was then sent to different doctors and orthopedics for x rays. Cx is still having horrible pain and needs an MRI
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling at injection site; Pain at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 497D9, expiry date 11th September 2025) for prophylaxis.   On 14th June 2019, the patient received Shingrix (intramuscular). In June 2019, less than a day after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb and injection site pain. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site pain were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the arm. The reporter reported that, the patient experienced increasing swelling at injection site since vaccination. The reporter stated that, the swelling was the size of a smaller i phone.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site pain, Injection site swelling
Clinical narrative: Swelling at injection site; Pain at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 497D9, expiry date 11th September 2025) for prophylaxis.   On 14th June 2019, the patient received Shingrix (intramuscular). In June 2019, less than a day after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb and injection site pain. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site pain were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the arm. The reporter reported that, the patient experienced increasing swelling at injection site since vaccination. The reporter stated that, the swelling was the size of a smaller i phone.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 9LG54, expiry date 25th September 2021) for prophylaxis.   On 12th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 15th June 2019, 3 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient experienced shingles after receiving 2nd dose of Shingrix. Thesymptoms started 3 days after vaccination. The patient was officially daignosed with shingles on 18th June 2019.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy site unspecified abnormal, Photopsia, Polymerase chain reaction positive, Varicella virus test positive, Vitrectomy
Clinical narrative: Vitritis, left eye; presented as floaters and flashes 1 day after vaccine.  No improvement with topical steroids.  Taken for diagnostic vitreous biopsy,  which was positive for VZV PCR.  Treated with oral valacyclovir (1gram TID) x 6 weeks with full recovery.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Vitreous floaters, Vitritis
Clinical narrative: Vitritis, left eye; presented as floaters and flashes 1 day after vaccine.  No improvement with topical steroids.  Taken for diagnostic vitreous biopsy,  which was positive for VZV PCR.  Treated with oral valacyclovir (1gram TID) x 6 weeks with full recovery.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Feeling abnormal, Nausea
Clinical narrative: Patient came into the pharmacy and said that he felt fine yesterday when he received the shot. Patient came back to the pharmacy and explained that he hasn't been feeling good today. He said that he is feeling nauseous and light headed. Explained to him that some people feel under the weather when getting the shot, but I haven't heard of nauseous or light headed (the day after). Instructed him to follow up with  his physician.
Age: 21.0
Sex: F
Vaccine: TYP, YF
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive
Clinical narrative: Patient was screened prior to vaccination to include pregnancy screening, Member was notified of Positive pregnancy test 26 Jun 2019. member LMP 4 May 2019, Member and healthcare team advised of vaccination.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms.
Sex: F
Vaccine: MMR, MMRV, UNK
Symptoms: Antibody test negative, Extra dose administered, Injection site pain, Product administered to patient of inappropriate age
Clinical narrative: patient's titer for Varicella was negative; patient complained of pain at the injection site, on the left arm, after receiving M-M-R II; inadvertently received M-M-R II instead of Proquad; ptient received proquad on 07-DEC-2017; This spontaneous report was received from a Certified Medical Assistant and was refering to a 15 year old female patient. The patient's pertinent medical history included anxiety, depression, insomnia and migraines. The patient's concurrent conditions was not reported. The patient had no drug reactions or allergies.   On 07-DEC-2017, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), (strength, dose number, frequency, route and anatomical location were not reported), lot number M048201, expiration date 05-JUN-2016 (reported as "05-JUN-2018"), as required immunization (Product administered to patient of inappropriate age).    On a n unknown date (reported as "on a recent unspecified date"), the patient's titers for varicella resulted as negative, showed no immunity (antibody test negative). Then, on 29-MAY-2019, the patient presented to the physician's office to obtain required immunizations, that had not be completed at that time. Then, on that date, the patient was inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), lot # R029513, expiration date 14-OCT-2020, 0.5 milliliter, once, subcutaneous in the left arm, diluted with sterile diluent, lot number R002518, expiration date 12-DEC-2019, as required immunization, instead of the required Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live(PROQUAD) (interchange of vaccine products). On the same date, the patient complained of pain at the injection site on the left arm.      On 31-MAY-2019, the patient was seen on the physician's office and the pain at the injection site was resolved. The patient did not received any treatment for the injection site pain.   At the time of reporting, the outcome of antibody test negative was unknown. The reporter did not assessed the causal relationship between the suspect therapies and all of the events.
Sex: M
Vaccine: MMR, UNK, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Febrile Seizure; doses administered at a less than recommended time interval; This spontaneous report was received from a nurse and refers to a male patient of unknown age. The patient did not have pertinent medical history, concomitant medications and drug reactions/allergies.   On 29-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and on 06-JUN-2019 with varicella virus vaccine live (oka/merck) (VARIVAX) (dose number, doses, route of administration and anatomical site of vaccinations were not provided; lot number and expiration date were unknown by the reporter) for prophylaxis (inappropriate schedule of product administration). The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (strength, dose and route of administration were not provided; lot number and expiration date were unknown by the reporter).  On 07-JUN-2019, the patient had a febrile seizure (febrile convulsion). On the same day, the patient went to the emergency room. It was reported that the patient did not receive any treatment at the emergency room and was sent home from the emergency room on that day.     On an unknown date in June 2019, the patient recovered from febrile convulsion.  The causal assessment between febrile convulsion and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), varicella virus vaccine live (oka/merck) (VARIVAX) and sterile diluent (MERCK STERILE DILUENT) were not provided.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: was administered a 3rd dose of MMR II intramuscularly; no adverse effects; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) dose 3, intramuscular, lot # R035700 with expiration date on 09-DEC-2020, for prophylaxis (dosage schedule and anatomical location were not reported) (incorrect route of product administration). No adverse event was reported.
Age: 1.0
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Wrong vaccine administered; No adverse effect; This spontaneous report was received from a administrator concerning to a 12 month old patient. Information regarding the patient's medical history, concurrent conditions and allergies was not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S003086 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live expiration date reported as 29-JUL-2020 and upon internal validation established as 29-JUL-2020, in the left arm, for prophylaxis (strength, dose and route of administration were not reported). And in the right arm the patient was vaccinates with varicella virus vaccine live (oka/merck)(VARIVAX) lot # R027995 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck)expiration date reported as 01-OCT-2020 and upon internal validation established as 01-OCT-2020, in the left arm, for prophylaxis (strength, dose and route of administration were not reported). Administrator reported that both vaccines were reconstituted with sterile diluent, lot #S008567, expiration date 23-SEP-2021.  It was reported that the patient should have received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) instead of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (wrong product administered).  No adverse effects were reported.
Age: 4.0
Sex: M
Vaccine: MMRV, UNK
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling
Clinical narrative: his whole thigh was swollen; his whole thigh was hard; his whole thigh was hot; his whole  thigh was red; the office documented it was given subcutaneously but it was actually given intramuscularly; there was a little bit of hard knot; This spontaneous report has been received from the consumer, referring to her son, a 4 years old male patient. The patient did not have any medical history, current conditions, concomitant medications, drug reactions or allergies.  On 14-JUN-2019, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) one syringe, intramuscularly instead of subcutaneously on the top of his thigh, with lot number S000623 and expiration date on 06-JUL-2020, for prophylaxis (strength was not provided) (Incorrect route of product administration). It was also reported the sterile diluent for vaccine reconstitution, administered intramuscularly (strength, dose frequency, indication, lot number and expiration date were not reported).  In approximately June 2019, the patient initially had a little bit of a hard knot (Injection site nodule). Then, on 16-JUN-2019, when he woke up on the morning, his hole thigh was red (Erythema), hot (Feeling hot), swollen (Peripheral swelling), and hard (Induration). At beginning, his mother wondered if there was something wrong with this batch, but later she decided that her son's reaction was due to the inadvertently administration intramuscularly rather than subcutaneously. On an unknown date, the mother would take him to see the doctor. It was not reported if the patient received any treatment or if any laboratory or study were performed.  At the time of the report, the patient had not recovered from the events. The causality assessment between Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) and the aforementioned events was not reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA007443: US-009507513-1906USA007270: US-009507513-1906USA007149:
Age: 4.0
Sex: M
Vaccine: MMRV, UNK
Symptoms: Injection site warmth
Clinical narrative: his whole thigh was swollen; his whole thigh was hard; his whole thigh was hot; his whole  thigh was red; the office documented it was given subcutaneously but it was actually given intramuscularly; there was a little bit of hard knot; This spontaneous report has been received from the consumer, referring to her son, a 4 years old male patient. The patient did not have any medical history, current conditions, concomitant medications, drug reactions or allergies.  On 14-JUN-2019, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) one syringe, intramuscularly instead of subcutaneously on the top of his thigh, with lot number S000623 and expiration date on 06-JUL-2020, for prophylaxis (strength was not provided) (Incorrect route of product administration). It was also reported the sterile diluent for vaccine reconstitution, administered intramuscularly (strength, dose frequency, indication, lot number and expiration date were not reported).  In approximately June 2019, the patient initially had a little bit of a hard knot (Injection site nodule). Then, on 16-JUN-2019, when he woke up on the morning, his hole thigh was red (Erythema), hot (Feeling hot), swollen (Peripheral swelling), and hard (Induration). At beginning, his mother wondered if there was something wrong with this batch, but later she decided that her son's reaction was due to the inadvertently administration intramuscularly rather than subcutaneously. On an unknown date, the mother would take him to see the doctor. It was not reported if the patient received any treatment or if any laboratory or study were performed.  At the time of the report, the patient had not recovered from the events. The causality assessment between Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) and the aforementioned events was not reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA007443: US-009507513-1906USA007270: US-009507513-1906USA007149:
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass, Injection site pain, Local reaction
Clinical narrative: left shoulder was sore for 2 weeks; physcian diagnosed her with a localized reaction; she has a small pea-sized lump under the skin; which is mildly tender; This spontaneous report was received from a other health professional and refers to a currently 26 years old female patient. Concomitant therapies included omega-3 marine triglycerides, ethinyl estradiol, ferrous fumarate, norethindrone acetate(LOESTRIN FE), vitamin b complex, magnesium (unspecified), and zinc (unspecified). The patient did not refer historical condition, and drug reactions or allergies.      On 09-MAY-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, lot number 1602281 and expiration date 21-JUL-2021, intramuscular in the left arm (reported as shoulder), for prophylaxis (dosage schedule was not reported).      On 31-MAY-2019, the patient returned to the doctor's office, and stated that her left shoulder was sore (musculoskeletal pain)  for two weeks and that she now had a small pea-sized lump under the skin (injection site mass), which was mildly tender (injection site tenderness). Additionally, the physician diagnosed her with a localized reaction and will continue the vaccination series, according to the Prescribing Information.   The outcome of musculoskeletal pain, injection site mass, injection site tenderness and skin reaction was unknown.  At the time of the report, the causality between the aforementioned events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.
Sex: F
Vaccine: HPV4
Symptoms: Cancer in remission, Chemotherapy, Human papilloma virus test positive, Inappropriate schedule of product administration, Non-Hodgkin's lymphoma
Clinical narrative: the patient also had a positive HPV Pap Smear test; Non-Hodgkin's Lymphoma; This spontaneous report was received from a nurse practitioner and refers to a 22-year-old female patient. The patient's medical history and concurrent conditions were not provided. Historical drug included chemotherapy. The patient did not refer concomitant medications and drug reactions or allergies.         13-MAY-2008, the patient received the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) intramuscular injection, lot number 0089U, for HPV prevention (anatomical location, and expiration date were not reported).  On 18-SEP-2008, the patient received the second dose of human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (dosage schedule, route, anatomical location, lot number and expiration date were not reported).  On 05-FEB-2009, the third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection was received (inappropriate schedule of product administration)(anatomical location, lot number and expiration date were not reported).          On unspecified date in 2015, the patient developed non-hodgkin's lymphoma after completing the human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) series on  05-FEB-2009 (conflicting information, also reported as patient's concurrent condition). The patient seek for medical attention andreceived an unspecified chemotherapy on an unspecified date in 2016. The patient had been in remission (recovered) since an unspecified date in 2016 after finishing her chemotherapy.  On 22-MAY-2019, the patient had a positive human papilloma virus (HPV) Pap Smear test (human papilloma virus test positive).   At the time of the report, the outcome of human papilloma virus test positive was not provided.   The causality between the aforementioned events and human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.   Upon internal review, the event non-hodgkin's lymphoma was considered as medically significant.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: the patient also had a positive HPV Pap Smear test; Non-Hodgkin's Lymphoma; This spontaneous report was received from a nurse practitioner and refers to a 22-year-old female patient. The patient's medical history and concurrent conditions were not provided. Historical drug included chemotherapy. The patient did not refer concomitant medications and drug reactions or allergies.         13-MAY-2008, the patient received the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) intramuscular injection, lot number 0089U, for HPV prevention (anatomical location, and expiration date were not reported).  On 18-SEP-2008, the patient received the second dose of human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (dosage schedule, route, anatomical location, lot number and expiration date were not reported).  On 05-FEB-2009, the third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection was received (inappropriate schedule of product administration)(anatomical location, lot number and expiration date were not reported).          On unspecified date in 2015, the patient developed non-hodgkin's lymphoma after completing the human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) series on  05-FEB-2009 (conflicting information, also reported as patient's concurrent condition). The patient seek for medical attention andreceived an unspecified chemotherapy on an unspecified date in 2016. The patient had been in remission (recovered) since an unspecified date in 2016 after finishing her chemotherapy.  On 22-MAY-2019, the patient had a positive human papilloma virus (HPV) Pap Smear test (human papilloma virus test positive).   At the time of the report, the outcome of human papilloma virus test positive was not provided.   The causality between the aforementioned events and human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.   Upon internal review, the event non-hodgkin's lymphoma was considered as medically significant.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: No adverse effect reported.; patient was inadvertently administered a dose of PROQUAD instead of an intended dose of M-M-R II,; Both PROQUAD and VARIVAX were inadvertently administered intramuscularly; It was administered Proquad, concomitantly was administered Varivax.; have mistakenly selected Proquad from the freezer instead of M-M-R II; This spontaneous report was received from a Registered nurse refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On 20-JUN-2019, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # R021101, expiration date 20-JAN-2020, intramuscular for prophylaxis (dose was not reported), instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) as the health care worker had mistakenly selected measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) from the freezer instead of the intended Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II). Concomitantly, the patient was administered varicella virus vaccine live (oka/merck) (VARIVAX) lot number N026075, expiration date 20-SEP-2019, intramuscularly (dose was not reported). Both vaccines were reconstituted with the same lot of  sterile diluent (lot number N026075). No adverse effects were reported.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Diarrhoea, Flushing, Pyrexia, Vomiting
Clinical narrative: Fever of 103F; Flushing; loose stools; vomiting; This spontaneous report had been received from a medical assistant reporting a female patient of unknown age. There was no information about the patient's medical history, drug reactions, concomitant medications or concurrent conditions to be reported. It was stated that the patient did not have allergies.  On an unspecified date, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) and a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strengths, doses, anatomical locations, lot numbers and expiration dates not reported), both administered subcutaneously as prophylaxis.   On an unknown date after the vaccination, the patient experienced fever of 103 Fahrenheit (F) (pyrexia), flushing, loose stools (diarrhea) and vomiting. It was reported that the patient sought for medical attention as she went to see a physician. No treatment was administered for the event and it was unknown if laboratory tests or other studies were performed. At the reporting time, the patient had not recovered from the events.   The causal relationship between the suspect vaccines and the events occurred was not reported.
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Multiple patients were administered improperly stored PROQUAD. Temperature -3 C; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions/allergies, concurrent conditions and concomitant medication were not reported.      On 10-JUN-2019, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # R030805, expiration date: 22-APR-2020, albumin status: rha) (dose number, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot #, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008662: US-009507513-1906USA010327: US-009507513-1906USA010329: US-009507513-1906USA010330: US-009507513-1906USA010331: US-009507513-1906USA010326: US-009507513-1906USA010325: US-009507513-1906USA010324: US-009507513-1906USA010323: US-009507513-1906USA010328: US-009507513-1906USA008644: US-009507513-1906USA008643: US-009507513-1906USA008662:
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Patient fainted after receiving vaccine; Information has been received from a physician via a field representative referring to a female patient of unknown age. The patient's medical history, concomitant medications and drug reactions/ allergies were unknown by the reporter.  On 18-JUN-2019, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (frequency, anatomical location, route of administration, batch/ lot number and expiration date were not reported) for prevention of human papillomavirus (HPV) and the patient had nothing to eat or drink before receiving vaccine.   On the same date, the patient fainted in physician office after receiving HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). The patient had to be taken to emergency room, however it was unknown if the patient was admitted. On an unknown date in June 2019, the patient was recovered.   No product quality complaint (PQC) was involved. Information about treatment given for adverse event and lab diagnostics/ studies performed was unknown by the reporter. The patient sought medical attention.   The causality between the event and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) therapy was not provided.  Upon internal review, the event of faint was determined to be medically significant.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported.; Patient was administered improperly stored PROQUAD; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previously drug reactions, allergies, concurrent conditions and concomitant medications were not reported.      On 17-JUN-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA(PROQUAD) (lot number was S003170,expiration date was 30-JUL-2020) (strength, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (product storage error).   The measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA(PROQUAD) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger.   No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008695: US-009507513-1906USA008644: US-009507513-1906USA008643: US-009507513-1906USA008790: US-009507513-1906USA008791: US-009507513-1906USA008722: US-009507513-1906USA008903:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported.; Patient was administered improperly stored PROQUAD; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previously drug reactions, allergies, concurrent conditions and concomitant medication were not reported.      On 13-JUN-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA(PROQUAD) (lot number was S003170, expiration date was 30-JUL-2020) (strength, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (product storage error).   The measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA(PROQUAD) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger.   No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008695: US-009507513-1906USA008644: US-009507513-1906USA008643: US-009507513-1906USA008722: US-009507513-1906USA008789: US-009507513-1906USA008791: 1US-009507513-906USA008903:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported.; Patient was administered improperly stored PROQUAD; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previously drug reactions, allergies, concurrent conditions and concomitant medication were not reported.      On 13-JUN-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) (lot number was S003170, expiration date was 30-JUL-2020) (strength, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (product storage error).   The measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA(PROQUAD) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger.   No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008695: US-009507513-1906USA008644: US-009507513-1906USA008643: US-009507513-1906USA008722: US-009507513-1906USA008789: US-009507513-1906USA008790: US-009507513-1906USA008903:
Age: 31.0
Sex: F
Vaccine: MMR, UNK
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: patient received one dose of MMR II before she had found out she was pregnant; No adverse effects reported; This spontaneous prospective pregnancy report was received from a medical assistant referring to a 31 years old female patient. The patient's concurrent condition was not reported. Her medical history included migraine. Concomitant therapies included over the counter pre-natal vitamins (unspecified). There was no drug reactions/allergies.     The patient became pregnant with the last menstruation period (LMP) of 18-APR-2019 and estimated date of delivery (EDD) of 23-JAN-2020.   On 14-MAY-2019, before she had found out she was pregnant, the patient was vaccinated with 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA(M-M-R II) (lot # was R028004, expiration date was 01-OCT-2020) subcutaneous for immigration purpose (drug exposure during pregnancy, first trimester). It was reconstituted with a diluent. The initial exposure to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA(M-M-R II) was at 3 weeks. The patient sought medical attention and contacted a prenatal coordinator on 24-MAY-2019. There was no lab diagnostics/studies performed. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: The patient may have been administered a dos eof M-M-R II via the intramuscular route rather than the recommended subcutaneous route; No adverse effects were reported; This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, drug reactions, allergies and concomitant therapies were not reported.   On unknown date (reported as "couple of weeks ago"), the patient may had been administered a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, dosage, frequency, lot number and expiration date were not reported) for prophylaxis via intramuscular route rather that the recommended subcutaneous route (Incorrect route of product administration).No adverse effects were reported.
Age: 86.0
Sex: M
Vaccine: PPV
Symptoms: Aphasia, Nuclear magnetic resonance imaging brain abnormal, Tremor
Clinical narrative: shakes and had difficulty finding the right words; shakes and had difficulty finding the right words; This spontaneous report was received from a physician via company representative refers to a 86-year-old male patient. There was no information about the patient's concurrent conditions or concomitant therapies provided. The patient's medical history included stroke. On 19-JUN-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(formulation, dose, route and exact site of administration, lot # and expiration date were not reported) for prophylaxis. On the same day(also reported as one hour after vaccination), the patient experienced shakes and had difficulty finding the right words. He was taken to an unspecified hospital (also reported as hospitalization; went to hospital) however it was unknown by reporter if the patient was admitted to that hospital. In approximately June 2019 (reported as in an unspecified hospital), magnetic resonance imaging was done and it showed an old stroke. It was unknown by reporter if the patient was still at the hospital or if he was currently alive. The outcome of shakes and difficulty finding the right words and relatedness between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) were not reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects were reported; The patient received MMR II and VARIVAX via intramuscular; This spontaneous report has been received from a pharmacist concerning to a patient of unknown age and gender.   The patient's concurrent conditions, medical history, past drug reactions or allergies and concomitant medications were not reported.  On 21-JUN-2019, the patient received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live Albumin status of rHA (recombinant human albumin) (M-M-R II) injection (dose number, dose, strength and anatomical location were not provided)(lot#: R031628, expiration date: 01-NOV-2020); sterile diluent was used to reconstitute the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live Albumin status of rHA (recombinant human albumin) (M-M-R II) (lot#: S008564, expiration date: 05-AUG-2021); the patient also received varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (dose number, dose, strength and anatomical location were not provided) (lot#: S002738, expiration date: 28-JAN-2021), sterile diluent was used to reconstitute the varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot#: S012824, expiration date: 18-DEC-2021). Both vaccines were administered intramuscularly (incorrect route of product administration) as prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored dose of M-M-R II / VAQTA administered; no adverse effect reported; This spontaneous report was received from a registered nurse referred to a patient of unknown age and gender. Information regarding medical history, drug allergies or reactions and concomitant medications were not reported. On 24-JUN-2019, the patient was vaccinated with improperly stored measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) with lot # R028381 and expiry date 03-OCT-2020 via subcutaneous route for prophylaxis (dose details unknown). On 24-JUN-2019, the patient was also vaccinated with improperly stored Hepatitis A Vaccine, Inactivated (VAQTA) with lot # S002460 and expiry date 15-MAY-2020 via intramuscular route for prophylaxis (dose details unknown). Both the vaccines were stored at a temperature of above 47degree Fahrenheit within time frame of 2 hours. The digital data logger was involved. No adverse effects reported. Product quality complaint was not involved.  This is one of the several reports received from the same reporter (link case # 1906USA009882, 1906USA009902, 1906USA009914, 1906USA010076).; Sender's Comments:  US-009507513-1906USA009882: US-009507513-1906USA009902: US-009507513-1906USA010076: US-009507513-1906USA009914:01251178
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; improperly stored dose administered; This spontaneous report was received from a registered nurse referred to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications were not reported. On 24-JUN-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) with lot # S000623 and expiry date 06-JUL-2020 via subcutaneous route for prophylaxis (dose was not reported). The concomitant therapy included sterile diluent (STERILE DILUENT) which was stored appropriately. The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored at a temperature of 6 degree F (Fahrenheit) to 14 degree F for 2 hours 40 minutes and from 15 degree F to 46 degree F for 7 hours and 40 minutes. There was no previous temperature excursion reported. The digital data logger was involved. The patient did not experience any adverse effect. Product quality complaint was not involved.  This is one of the several reports received from the same reporter (link case # 1906USA009902, 1906USA009880, 1906USA009914, 1906USA010076)
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored dose of VAQTA administered; No adverse ffect; This spontaneous report was received from a registered nurse referred to a patient of unknown age and gender. The patient's historical conditions, past drugs, concomitant medications and concurrent conditions was not reported. On an unknown date the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) (lot # S002460, expiry date 15-MAY-2020) (strength, dose and frequency not reported) intramuscularly for prophylaxis. On 24-JUN-2019, the patient administered improperly stored doses of with hepatitis a vaccine, inactivated(VAQTA) which was stored at a temperature of above 47 degree F (Fahrenheit) for 2 hours. There was no previous temperature excursion reported. The digital data logger was involved. No adverse effect reported. Product quality complaint was not involved.  This is one of several reports received from the same reporter.