chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Information was received from a 78 year old female consumer on 07-JUN-2017 who was reporting on herself. Concomitant medications included "a very low dose of ZOLOFT" and an allergy to penicillin. No medical history was reported. On 27-OCT-2015, the patient received a dose of ZOSTAVAX (lot, expiration and dose not reported) subcutaneously and on that same day experienced "redness, fever and soreness" at  the injection site. The patient stated that "the symptoms went away after a few days". The patient then declared that "about 8 days later after getting the ZOSTAVAX vaccine, got shingles". After the patient "got shingles" she stated that "the symptoms appeared over a couple of days". The patient said "over those next couple of days" she experienced the following: her "back felt like it was on fire", "the insides of body was hot", "urine was hot", "swollen and painful glands" (unspecified type of gland), "painful joints", "weakness in legs", "had difficulty walking" and was "extremely fatigued".  During the time the patient had the shingles, she met with her primary physician (unspecified name) on the following dates: 04-NOV-21015, 05-NOV-2015, 17-NOV-2015, 25-NOV-2015, 08-DEC-2015, 16-DEC-2015,  "maybe one more time before 01-JAN-2016". When the patient had met with her physician, she was prescribed acyclovir  (manufacturer unknown) and oxycodone (manufacturer unknown) as treatment for the events. Furthermore, the patient stated that "the shingles had cleared up in February 2016." The patient then stated that she "got sick again with shingles at the end of April 2017" and she mentioned that she "had the same kind of symptoms as the first time she had shingles". She reported that she saw her primary physician on 08-MAY-2017 and 18-MAY-2017 and received acyclovir (manufacturer unknown) as treatment for her outbreak of "shingles". The patient reported that she "still has shingles but the symptoms are clearing up". No other information was reported. Additional information has been requested.
Sex: M
Vaccine: SMALL
Symptoms: Injection site reaction, Orthopoxvirus test positive, Post vaccination autoinoculation, Pyrexia, Skin lesion
Clinical narrative: Initial unsolicited report received from the literature on 09 June 2017. This case involves a 57-year-old male patient who was vaccinated with a dose of ACAM2000 (batch number: "VV04-003-A/ VV03-019-C and VV03-011-C", expiration date, dose, site and route of administration were not reported) via percutaneous route on an unknown date in January 2016. Patient had had no ocular, oral, nasal, genital lesions, immunosuppression, heart disease, or history or presence of eczema. Other medical history and concomitant medications were not reported. On 03 February 2016, 11 days post vaccination, patient had fever (38 degree Celsius) 101 degree Fahrenheit and three lesions near the inoculation site. On 04 February 2016, 12 days following the vaccination, arrived at the plasma center with numerous lesions surrounding the inoculation site and 20-30 lesions on his contralateral arm, abdomen, and back. It was reported that patient's lesions likely resulted from inadvertent autoinoculation caused by handling the area around the vaccination site during redressing. Relevant laboratory test results included DNA for both Orthopoxvirus and non-variola Orthopoxvirus detected from the patient's specimens, consistent with ACAM2000 vaccination. Patient was advised regarding proper vaccination site bandaging and hand hygiene. Outcome of the event was not reported. Upon internal review the case was considered as serious because of important medical event autoinoculation. Documents held by sender: none. Sender's Comments: Sanofi company comment dated 14-Jun-2017: Patient was vaccinated with ACAM2000 vaccine, 11 days after patient had lesion at inoculation site and fever which are expected, on 12th day patient had 20-30 lesions on his contralateral arm, abdomen, and back which might me due autoinoculation. Based on available information the role of vaccine is likely considering the culture report from the lesion.
Sex: M
Vaccine: SMALL
Symptoms: Viral test positive
Clinical narrative: Initial unsolicited report received from the literature on 09 June 2017. This case involves a 57-year-old male patient who was vaccinated with a dose of ACAM2000 (batch number: "VV04-003-A/ VV03-019-C and VV03-011-C", expiration date, dose, site and route of administration were not reported) via percutaneous route on an unknown date in January 2016. Patient had had no ocular, oral, nasal, genital lesions, immunosuppression, heart disease, or history or presence of eczema. Other medical history and concomitant medications were not reported. On 03 February 2016, 11 days post vaccination, patient had fever (38 degree Celsius) 101 degree Fahrenheit and three lesions near the inoculation site. On 04 February 2016, 12 days following the vaccination, arrived at the plasma center with numerous lesions surrounding the inoculation site and 20-30 lesions on his contralateral arm, abdomen, and back. It was reported that patient's lesions likely resulted from inadvertent autoinoculation caused by handling the area around the vaccination site during redressing. Relevant laboratory test results included DNA for both Orthopoxvirus and non-variola Orthopoxvirus detected from the patient's specimens, consistent with ACAM2000 vaccination. Patient was advised regarding proper vaccination site bandaging and hand hygiene. Outcome of the event was not reported. Upon internal review the case was considered as serious because of important medical event autoinoculation. Documents held by sender: none. Sender's Comments: Sanofi company comment dated 14-Jun-2017: Patient was vaccinated with ACAM2000 vaccine, 11 days after patient had lesion at inoculation site and fever which are expected, on 12th day patient had 20-30 lesions on his contralateral arm, abdomen, and back which might me due autoinoculation. Based on available information the role of vaccine is likely considering the culture report from the lesion.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Biopsy colon abnormal, Colitis, Endoscopy abnormal
Clinical narrative: Pt suffered endoscopy/biopsy proven colitis following influenza vaccine administration. Please see attached history from specialist.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Crying, Injected limb mobility decreased, Injection site pain, Swelling, Tenderness
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. An 86-year-old female patient received PREVNAR 13, intramuscular on 25Sep2016 at single dose for immunisation. Medical history included knee operation. The patient's concomitant medications were not reported. The patient experienced pain in arm where they gave the shot, a lot of pain/ it's really strong/ hurts really bad every day, it restricted my arm movement couldn't lift her arm and couldn't lift the cup of coffee even, swelled, keep taking the pain pills and then after that it was so severe that it made her cry, because of knee that sets off the belt when went through the security and so they sent her back through it and x-rayed she (security check) felt up her knee of course and then she felt that arm and she said that hurt, from 25Sep2016 outcome of not recovered. From the vaccination day had pain and it's really strong. In the first few months, it restricted arm movement couldn't lift arm and couldn't lift the cup of coffee even so when was in the nursing home had occupational therapy for that reason. And then when  got home. I had home healthcare and they continued the treatment of occupational therapy for several months but nothing worked. It just, it never got better. It's never improved. It's swelled after, she cried for the first two or three days with it and keep taking the pain pills and then after that it was so severe that it made her cried but it still hurts really bad every day. Took Oxycodone when  was in the nursing home and was not taking it anymore. Then took TYLENOL once in a while for this.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Computerised tomogram head, Dizziness, Head injury, Hypoaesthesia, Loss of consciousness
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a 14 year old female patient. The patient's concurrent conditions, medical history or concomitant medications were not reported. On an unspecified date, the patient was vaccinated with GARDASIL 9 (strength, dose, route of administration, lot number and expiration date were not reported) for prophylaxis. On 28-APR-2017, the patient was vaccinated intramuscularly, in the left arm, either intramuscularly in her left arm, with the second or the third dose of GARDASIL 9, with lot # M037770 (strength, dose and expiration date were not reported) for prophylaxis. The reporter stated on the same date, that while the patient was leaving the physician's office, the patient said that she felt dizzy (dizziness), then, she passed out, hit her head on the floor (head injury), and was unconscious for about 30 seconds (loss of consciousness). Subsequently, the patient was monitored in the physician's office for an unspecified amount of time,  and then, on an unspecified date, she was sent for a stat computerized tomography (CT) scan of her head, but the results were not reported. As a result of hitting her head on the floor, the patient was still experiencing headaches since an unspecified date in 2017. Also, on an unknown date in 2017, the patient experienced pain , numbness, and swelling in her left arm (pain in extremity, hypoaesthesia, and peripheral swelling, respectively). Additionally, it was reported that the Patient had been referred to a neurologist. At the time of reporting the outcome for the events dizziness, head injury, headaches, pain in extremity, hypoesthesia and swelling was not reported. Upon internal review, loss of consciousness was considered to be a medically significant event. The causal relationship between all the aforementioned events and the GARDASIL 9 was not reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Pain in extremity, Swelling
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a 14 year old female patient. The patient's concurrent conditions, medical history or concomitant medications were not reported. On an unspecified date, the patient was vaccinated with GARDASIL 9 (strength, dose, route of administration, lot number and expiration date were not reported) for prophylaxis. On 28-APR-2017, the patient was vaccinated intramuscularly, in the left arm, either intramuscularly in her left arm, with the second or the third dose of GARDASIL 9, with lot # M037770 (strength, dose and expiration date were not reported) for prophylaxis. The reporter stated on the same date, that while the patient was leaving the physician's office, the patient said that she felt dizzy (dizziness), then, she passed out, hit her head on the floor (head injury), and was unconscious for about 30 seconds (loss of consciousness). Subsequently, the patient was monitored in the physician's office for an unspecified amount of time,  and then, on an unspecified date, she was sent for a stat computerized tomography (CT) scan of her head, but the results were not reported. As a result of hitting her head on the floor, the patient was still experiencing headaches since an unspecified date in 2017. Also, on an unknown date in 2017, the patient experienced pain , numbness, and swelling in her left arm (pain in extremity, hypoaesthesia, and peripheral swelling, respectively). Additionally, it was reported that the Patient had been referred to a neurologist. At the time of reporting the outcome for the events dizziness, head injury, headaches, pain in extremity, hypoesthesia and swelling was not reported. Upon internal review, loss of consciousness was considered to be a medically significant event. The causal relationship between all the aforementioned events and the GARDASIL 9 was not reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Computerised tomogram head, Dizziness, Head injury, Headache, Hypoaesthesia
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a 14 year old female patient. The patient's concurrent conditions, medical history or concomitant medications were not reported. On an unspecified date, the patient was vaccinated with GARDASIL 9 (strength, dose, route of administration, lot number and expiration date were not reported) for prophylaxis. On 28-APR-2017, the patient was vaccinated intramuscularly, in the left arm, either intramuscularly in her left arm, with the second or the third dose of GARDASIL 9, with lot # M037770 (strength, dose and expiration date were not reported) for prophylaxis. The reporter stated on the same date, that while the patient was leaving the physician's office, the patient said that she felt dizzy (dizziness), then, she passed out, hit her head on the floor (head injury), and was unconscious for about 30 seconds (loss of consciousness). Subsequently, the patient was monitored in the physician's office for an unspecified amount of time,  and then, on an unspecified date, she was sent for a stat computerized tomography (CT) scan of her head, but the results were not reported. As a result of hitting her head on the floor, the patient was still experiencing headaches since an unspecified date in 2017. Also, on an unknown date in 2017, the patient experienced pain , numbness, and swelling in her left arm (pain in extremity, hypoaesthesia, and peripheral swelling, respectively). Additionally, it was reported that the Patient had been referred to a neurologist. At the time of reporting the outcome for the events dizziness, head injury, headaches, pain in extremity, hypoesthesia and swelling was not reported. Upon internal review, loss of consciousness was considered to be a medically significant event. The causal relationship between all the aforementioned events and the GARDASIL 9 was not reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Loss of consciousness, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a 14 year old female patient. The patient's concurrent conditions, medical history or concomitant medications were not reported. On an unspecified date, the patient was vaccinated with GARDASIL 9 (strength, dose, route of administration, lot number and expiration date were not reported) for prophylaxis. On 28-APR-2017, the patient was vaccinated intramuscularly, in the left arm, either intramuscularly in her left arm, with the second or the third dose of GARDASIL 9, with lot # M037770 (strength, dose and expiration date were not reported) for prophylaxis. The reporter stated on the same date, that while the patient was leaving the physician's office, the patient said that she felt dizzy (dizziness), then, she passed out, hit her head on the floor (head injury), and was unconscious for about 30 seconds (loss of consciousness). Subsequently, the patient was monitored in the physician's office for an unspecified amount of time,  and then, on an unspecified date, she was sent for a stat computerized tomography (CT) scan of her head, but the results were not reported. As a result of hitting her head on the floor, the patient was still experiencing headaches since an unspecified date in 2017. Also, on an unknown date in 2017, the patient experienced pain , numbness, and swelling in her left arm (pain in extremity, hypoaesthesia, and peripheral swelling, respectively). Additionally, it was reported that the Patient had been referred to a neurologist. At the time of reporting the outcome for the events dizziness, head injury, headaches, pain in extremity, hypoesthesia and swelling was not reported. Upon internal review, loss of consciousness was considered to be a medically significant event. The causal relationship between all the aforementioned events and the GARDASIL 9 was not reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Injection site pain, Rash
Clinical narrative: This is a spontaneous report from two contactable nurses. A 16-year-old female patient received on 01Jun2017 the first dose of TRUMENBA  (lot R45077, exp.date Jul2018) at single dose and the second dose of MENACTRA (lot V5460BA, exp.date 16Jan2018) both via an unspecified route in the thigh for immunization. Relevant medical history and concomitant medication were none. Several days later the patient experienced a chicken pox type rash and pustules only on her deltoids.  She had no pain, no fever, nothing else except a little pain and tenderness at the site of the injection. The patient did not receive any treatment for the events. The outcome of the events was not recovered. Nurse confirmed that patient has not taken any treatment. Nurse confirmed that there were no other medical condition or medications.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Injection site pain, Rash pustular, Rash vesicular
Clinical narrative: This is a spontaneous report from two contactable nurses. A 16-year-old female patient received on 01Jun2017 the first dose of TRUMENBA  (lot R45077, exp.date Jul2018) at single dose and the second dose of MENACTRA (lot V5460BA, exp.date 16Jan2018) both via an unspecified route in the thigh for immunization. Relevant medical history and concomitant medication were none. Several days later the patient experienced a chicken pox type rash and pustules only on her deltoids.  She had no pain, no fever, nothing else except a little pain and tenderness at the site of the injection. The patient did not receive any treatment for the events. The outcome of the events was not recovered. Nurse confirmed that patient has not taken any treatment. Nurse confirmed that there were no other medical condition or medications.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Arthralgia, Body temperature increased, Injection site pain, Laboratory test, Pyrexia
Clinical narrative: Child started complaining of not feeling well 5 hrs. after administration of TRUMENBA, next day had tmpt 102.9F and complained of muscular pain of arm and legs, hurts when walking, was given TYLENOL.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Body temperature increased, Malaise, Myalgia, Pain
Clinical narrative: Child started complaining of not feeling well 5 hrs. after administration of TRUMENBA, next day had tmpt 102.9F and complained of muscular pain of arm and legs, hurts when walking, was given TYLENOL.
Age: 11.0
Sex: M
Vaccine: HPV9, HPV9, MNQ, TDAP
Symptoms: Blood test normal, Hyperhidrosis, Hypotension, Immediate post-injection reaction, Lethargy
Clinical narrative: HPV had just been given and he started clenching his fists and shaking with eyes rolled back. Patient stable when he left. Rec'd call that pt. started vomiting advise to take to ER.
Age: 11.0
Sex: M
Vaccine: HPV9, HPV9, MNQ, TDAP
Symptoms: Nausea, Pallor, Syncope, Tonic convulsion, Vomiting
Clinical narrative: HPV had just been given and he started clenching his fists and shaking with eyes rolled back. Patient stable when he left. Rec'd call that pt. started vomiting advise to take to ER.
Age: 11.0
Sex: M
Vaccine: HPV9, HPV9, MNQ, TDAP
Symptoms: Eye movement disorder, Muscle contractions involuntary, Tremor, Vomiting
Clinical narrative: HPV had just been given and he started clenching his fists and shaking with eyes rolled back. Patient stable when he left. Rec'd call that pt. started vomiting advise to take to ER.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Back pain, Blood thyroid stimulating hormone normal, CSF test normal, Chest X-ray normal, Chills
Clinical narrative: Severe headache (worst of life), neck pain/nuchal rigidity, back pain, fever measured at 101.8°F, chills, nausea, dizziness, tachycardia to 130 bpm, diffuse myalgias. Worsening symptoms over the course of the night requiring Emergency Department evaluation in the morning, due to patient being a physician working in an emergency department. Head CT, lumbar puncture, CBC, chemistry performed.  Medication given for severe headache. Headache improved with medication. Patient continued with fever, myalgias, neck pain, back pain until 06/17/2017.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Computerised tomogram head normal, Dizziness, Full blood count normal, Headache, Laboratory test normal
Clinical narrative: Severe headache (worst of life), neck pain/nuchal rigidity, back pain, fever measured at 101.8°F, chills, nausea, dizziness, tachycardia to 130 bpm, diffuse myalgias. Worsening symptoms over the course of the night requiring Emergency Department evaluation in the morning, due to patient being a physician working in an emergency department. Head CT, lumbar puncture, CBC, chemistry performed.  Medication given for severe headache. Headache improved with medication. Patient continued with fever, myalgias, neck pain, back pain until 06/17/2017.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Myalgia, Nausea, Neck pain, Nuchal rigidity, Pyrexia
Clinical narrative: Severe headache (worst of life), neck pain/nuchal rigidity, back pain, fever measured at 101.8°F, chills, nausea, dizziness, tachycardia to 130 bpm, diffuse myalgias. Worsening symptoms over the course of the night requiring Emergency Department evaluation in the morning, due to patient being a physician working in an emergency department. Head CT, lumbar puncture, CBC, chemistry performed.  Medication given for severe headache. Headache improved with medication. Patient continued with fever, myalgias, neck pain, back pain until 06/17/2017.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Tachycardia, Thyroxine free normal
Clinical narrative: Severe headache (worst of life), neck pain/nuchal rigidity, back pain, fever measured at 101.8°F, chills, nausea, dizziness, tachycardia to 130 bpm, diffuse myalgias. Worsening symptoms over the course of the night requiring Emergency Department evaluation in the morning, due to patient being a physician working in an emergency department. Head CT, lumbar puncture, CBC, chemistry performed.  Medication given for severe headache. Headache improved with medication. Patient continued with fever, myalgias, neck pain, back pain until 06/17/2017.
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain upper, Asthenia, Dizziness, Headache, Injection site pain
Clinical narrative: My daughter received the series of rabies vaccines after a cat bite. Her side effects included headache/fever, dizziness, stomach pain, pain at the site, general malaise and weakness.
Sex: F
Vaccine: RAB
Symptoms: Malaise, Pyrexia
Clinical narrative: My daughter received the series of rabies vaccines after a cat bite. Her side effects included headache/fever, dizziness, stomach pain, pain at the site, general malaise and weakness.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the unspecified patient was vaccinated with an improperly stored dose of PROQUAD injection, by subcutaneous route, lot number M042497, expiration date: 17-APR-2018 (strength and dose were not reported) for prophylaxis. The temperature excursion with PROQUAD was in the range of 6 to 14 Fahrenheit degrees for 7 hours and 51 minutes. No previous temperature of excursion was performed. The temperature excursion was detected by a data logger. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with doses of VARIVAX injection (strength, dose, route of administration, lot number and expiration date were not reported) for prophylaxis. The temperature excursion was 0.2 Centigrade degrees for 7 hours and 14 minutes. Previous temperature excursion was 0.2 Centigrade degrees for 9 hours and 18 minutes which were detected by data logger. No adverse symptoms were reported and no product complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA005147:
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 07-JUN-2017, the patient was inadvertently vaccinated with an expired dose of GARDASIL injection, by intramuscular route, lot number M014929, expiration date: 27-MAY-2017 (strength and dose were not reported) for prophylaxis. The Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine was stored appropriately. No adverse effects were reported and not product quality complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple patients of unknown demographics. The pertinent medical history, concurrent conditions and concomitant therapies of the patients were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot# M034187, expiration date: 17-MAY-2019) (dose, route of administration and anatomical location were not provided), for prophylaxis. The vaccines underwent the temperature excursion of more than 32 Fahrenheit degrees (F) but less than 35 F for 3 hours and 20 minutes, which was detected by a data logger. No previous temperature excursions were reported. No adverse effects were reported. No Product Quality Complaint (PQC) was filed. Follow up information has been received from the medical assistant on 10-MAY-2017, reported that the temperature excursion occurred in the middle of the night when no one was present and the cause was unknown. Follow up information has been received from the medical assistant on 07-JUN-2017. The patients' identifiers, age and gender were provided. The patient was a female infant (reported as 2 & 4 months old) patient vaccinated with LIQUID PEDVAXHIB in a clinic by a clinic nurse. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA006513: US-009507513-1704USA010745: US-009507513-1705USA013407: US-009507513-1705USA013406: US-009507513-1705USA013408: US-009507513-1706USA009003: US-009507513-1706USA009002: US-009507513-1706USA009001: US-009507513-1706USA009004: US-009507513-1706USA009007: US-009507513-1706USA009006: US-009507513-1706USA009005:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via a Company representative, referring to a female patient in her late 60s, who experienced chickenpox (varicella) and singles (herpes zoster) previously on unspecified dates. The patient's concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot#, dose, frequency, and route of administration were unspecified) to prevent another episode of shingles (prophylaxis). However, after receiving the vaccine, she experienced an episode of shingles (herpes zoster) on an unspecified date in 2016 (reported as "over one year ago") Moreover, it was reported that the patient was not hospitalized; however, she sought medical attention with the reporting pharmacist. No product quality complaint was involved. At the time of the report, it was stated that the patient did not have an active case of shingles (herpes zoster). The relatedness of herpes zoster with ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant, concerning to patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 06-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # N002720 and expiration date 12-MAY-2019 (dose, frequency, route of administration were not provided) for prophylaxis. No adverse event was reported. The vaccine was stored at a temperature of 78° Fahrenheit or warmer, time frame of 26 hours; no previous temperature excursion was reported and digital data logger was not involved. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a physician assistant via a company representative referring to a 22 year old non-pregnant female patient. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were unknown by reporter. Concomitant medications included GILDESS. On 31-MAY-2017, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly, Lot # M040412 with an expiration date on 30-JUN-2019 (strength and dose were not reported) for prevention of HPV. On 02-JUN-2017, the patient had developed hives on both of her legs. The patient was advised by physician assistant to treat the hives with cool showers, compresses, Calamine lotion, unspecified antihistamine and unspecified hydrocortisone. The patient sought medical attention and she was not hospitalized. It was unknown if any laboratory study was performed. At the reporting time, the outcome of urticaria was unknown. The causality assessment between the event and vaccination with GARDASIL 9 was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in 2017, the patient was inadvertently vaccinated with a properly stored but expired dose of VARIVAX (lot # L010146 with an expiration date of 24-MAR-2017; strength, dose, route and anatomical location were not provided), for prophylaxis. It was reported that the VARIVAX was reconstituted with sterile diluent (manufacturer unknown) (lot number M031575 with expiration date of 26-MAR-2019). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPVX
Symptoms: Tourette's disorder
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to an about 17 or 18 years old female patient. The patient was a fraternal twin. There was no information about the patient's concurrent conditions, any known allergies or reaction, medical history or concomitant medications. On an unknown date, the patient was vaccinated with an unspecified dose of GARDASIL or GARDASIL 9, for prevent human papillomavirus (HPV) (dose, route of administration, lot number and expiration date were not reported).  On an unknown date, after received the vaccine, the patient experienced Tourettes (Tourette's disorder). It was unknown if the patient sought medical attention, treatment was given for the adverse event or laboratory diagnostics studies were performed. The outcome of Tourette's disorder and the causal relationship between the event and therapy with GARDASIL or GARDASIL 9 were not reported. No product quality complaint was involved. Upon internal review the event Tourette's disorder was considered to be medically significant. This is one of two reports received from the same reporter. Additional information is not expected because the reporter did not consent for further follow up.; Sender's Comments:  US-009507513-1706USA008242:
Age: 77.0
Sex: M
Vaccine: HEP
Symptoms: Ill-defined disorder, Transfusion
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 77 year old male patient. The patient did not have concurrent conditions, medical history or concomitant medications. There was no information about any patient's known allergies or reactions. On 02-JAN-2017, the patient was vaccinated with the first dose of RECOMBIVAX HB, for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 02-FEB-2017, the patient was vaccinated with the second dose of RECOMBIVAX HB, for prophylaxis (dose, route of administration, lot number and expiration date were not reported).      On an unspecified date, the patient experienced an unspecified medical condition (adverse event). Then, due to the event, the patient sought medical attention. Therefore, on approximately 02-MAR-2017 (reported as "one month after" administration of the second dose of the vaccine), "the patient was given a blood transfusion for an unspecified medical condition" (adverse event). However, it was unknown if the "unspecified medical condition" started, on an unspecified date in 2017 before or after first and second dose of RECOMBIVAX HB. The pharmacist believed that the patient might had been hospitalized on an unspecified date in 2017; however, did not have any information in regards to the hospital details. Subsequently, on 14-JUN-2017 after the patient's blood transfusion, the patient was vaccinated with the third dose of RECOMBIVAX HB lot # M023892 expiration date of 15-SEP-2017, for prophylaxis (dose and route of administration were not reported). The outcome of the unspecified medical condition (adverse event) was reported as recovered, on an unknown date in 2017. The causal relationship between the event and therapy with RECOMBIVAX HB was not reported. No product quality complaint was involved. Upon internal review the event of unspecified medical condition was considered to be medically significant since the patient received a blood transfusion. Additional information has been requested.
Sex: U
Vaccine: HIBV, MMR, PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 14-JUN-2017 from a pharmacy intern regarding an unspecified number of patients. Medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date, the unspecified patients may have received improperly stored dose of M-M-R II (lot # M035388, exp 02-AUG-2018), (dose not specified); PEDVAX HIB (lot # N00327, exp 25-OCT-2019 (dose not specified) or PNEUMOVAX 23 (lot # M047519, exp 04-AUG-2018) (dose not specified). Lot and expiration date of STERILE DILUENT for M-M-R II are unknown (it is unclear if diluent was improperly stored). No adverse effects were reported. The action taken was not applicable and the outcome of improper storage was unknown.  Temperature excursion details: Temperature: 78 degrees Fahrenheit or warmer (95 degrees Fahrenheit) Time frame: 10 days Previous temperature excursion? No Was call because of a "data logger"? no. No further details provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 02-JUN-2017, the patient was inadvertently vaccinated one expired dose of with GARDASIL lot # L035105, expiration date on 14-MAY-2017 (strength, dose number, route and anatomical location were not provided) for prophylaxis. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 15-JUN-2017, the patient was vaccinated with an expired dose of VAQTA, lot number M031695  with expiration date 28-MAY-2017 (dose, route, and anatomical location were not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: HPVX
Symptoms: Tourette's disorder
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to an about 17 or 18 years old male patient. The patient was a fraternal twin. There was no information about the patient's concurrent conditions, any known allergies or reaction, medical history or concomitant medications. On an unknown date, the patient was vaccinated with an unspecified dose of GARDASIL or GARDASIL 9, for prevent human papillomavirus (HPV) (dose, route of administration, lot number and expiration date were not reported).  On an unknown date, after received the vaccine, the patient experienced Tourette's (Tourette's disorder). It was unknown if the patient sought medical attention, treatment was given for the adverse event or laboratory diagnostics studies were performed. The outcome of Tourette's disorder and the causal relationship between the event and therapy with GARDASIL or GARDASIL 9 were not reported. No product quality complaint was involved. Upon internal review the event Tourette's disorder was considered to be medically significant. This is one of two reports received from the same reporter. Additional information is not expected because the reporter did not consent for further follow up.; Sender's Comments: US-009507513-1706USA006825:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown ages and genders. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patient were vaccinated with improperly stored doses of ZOSTAVAX (dose, route of administration, injection site, lot # and expiration date were not provided) for prophylaxis. The vaccines were administered along with improperly stored sterile diluents (dose, route of administration, injection site, lot# and expiration date were not provided). The reporter stated that the vaccines and the diluents were placed in a cooler with an icepack and transported to the physician's office. Additionally, it was reported that the vaccines were improperly stored during "10 to 30 minutes" and there were no previous temperature excursions. No data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple patients of unknown demographics. The pertinent medical history, concurrent conditions and concomitant therapies of the patients were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot# M034187, expiration date: 17-MAY-2019) (dose, route of administration and anatomical location were not provided), for prophylaxis. The vaccines underwent the temperature excursion of more than 32 Fahrenheit degrees (F) but less than 35 F for 3 hours and 20 minutes, which was detected by a data logger. No previous temperature excursions were reported. No adverse effects were reported. No Product Quality Complaint (PQC) was filed. Follow up information has been received from the medical assistant on 10-MAY-2017, reported that the temperature excursion occurred in the middle of the night when no one was present and the cause was unknown. Follow up information has been received from the medical assistant on 07-JUN-2017. The patients' identifiers, age and gender were provided. The patient was a 1 year old male patient and was vaccinated with LIQUID PEDVAXHIB in a clinic by a clinic nurse. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA006513: US-009507513-1704USA010745: US-009507513-1705USA013407: US-009507513-1705USA013406: US-009507513-1705USA013408: US-009507513-1706USA009004: US-009507513-1706USA009005: US-009507513-1706USA009006: US-009507513-1706USA009003: US-009507513-1706USA003615: US-009507513-1706USA009007: US-009507513-1706USA009002:
Age: 0.58
Sex: F
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple patients of unknown demographics. The pertinent medical history, concurrent conditions and concomitant therapies of the patients were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot# M034187, expiration date: 17-MAY-2019) (dose, route of administration and anatomical location were not provided), for prophylaxis. The vaccines underwent the temperature excursion of more than 32 Fahrenheit degrees (F) but less than 35 F for 3 hours and 20 minutes, which was detected by a data logger. No previous temperature excursions were reported. No adverse effects were reported. No Product Quality Complaint (PQC) was filed. Follow up information has been received from the medical assistant on 10-MAY-2017, reported that the temperature excursion occurred in the middle of the night when no one was present and the cause was unknown. Follow up information has been received from the medical assistant on 07-JUN-2017. The patients' identifiers, age and gender were provided. The patient was a 7 months old female patient and was vaccinated with LIQUID PEDVAXHIB in a clinic by a clinic nurse. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA006513: US-009507513-1704USA010745: US-009507513-1705USA013407: US-009507513-1705USA013406: US-009507513-1705USA013408: US-009507513-1706USA003615: US-009507513-1706USA009007: US-009507513-1706USA009001: US-009507513-1706USA009003: US-009507513-1706USA009006: US-009507513-1706USA009005: US-009507513-1706USA009004:
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple patients of unknown demographics. The pertinent medical history, concurrent conditions and concomitant therapies of the patients were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot# M034187, expiration date: 17-MAY-2019) (dose, route of administration and anatomical location were not provided), for prophylaxis. The vaccines underwent the temperature excursion of more than 32 Fahrenheit degrees (F) but less than 35 F for 3 hours and 20 minutes, which was detected by a data logger. No previous temperature excursions were reported. No adverse effects were reported. No Product Quality Complaint (PQC) was filed. Follow up information has been received from the medical assistant on 10-MAY-2017, reported that the temperature excursion occurred in the middle of the night when no one was present and the cause was unknown. Follow up information has been received from the medical assistant on 07-JUN-2017. The patients' identifiers, age and gender were provided. The patient was a 2 months old female patient and was vaccinated with LIQUID PEDVAXHIB in a clinic by a clinic nurse. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA006513: US-009507513-1704USA010745: US-009507513-1705USA013407: US-009507513-1705USA013406: US-009507513-1705USA013408: US-009507513-1706USA009004: US-009507513-1706USA009005: US-009507513-1706USA009006: US-009507513-1706USA003615: US-009507513-1706USA009001: US-009507513-1706USA009007: US-009507513-1706USA009002:
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple patients of unknown demographics. The pertinent medical history, concurrent conditions and concomitant therapies of the patients were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot# M034187, expiration date: 17-MAY-2019) (dose, route of administration and anatomical location were not provided), for prophylaxis. The vaccines underwent the temperature excursion of more than 32 Fahrenheit degrees (F) but less than 35 F for 3 hours and 20 minutes, which was detected by a data logger. No previous temperature excursions were reported. No adverse effects were reported. No Product Quality Complaint (PQC) was filed. Follow up information has been received from the medical assistant on 10-MAY-2017, reported that the temperature excursion occurred in the middle of the night when no one was present and the cause was unknown. Follow up information has been received from the medical assistant on 07-JUN-2017. The patients' identifiers, age and gender were provided. The patient was a 6 months old female patient and was vaccinated with LIQUID PEDVAXHIB)in a clinic by a clinic nurse. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA006513: US-009507513-1704USA010745: US-009507513-1705USA013407: US-009507513-1705USA013406: US-009507513-1705USA013408: US-009507513-1706USA009002: US-009507513-1706USA009007: US-009507513-1706USA009001: US-009507513-1706USA009003: US-009507513-1706USA009006: US-009507513-1706USA009005: US-009507513-1706USA003615:
Sex: F
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple patients of unknown demographics. The pertinent medical history, concurrent conditions and concomitant therapies of the patients were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot# M034187, expiration date: 17-MAY-2019) (dose, route of administration and anatomical location were not provided), for prophylaxis. The vaccines underwent the temperature excursion of more than 32 Fahrenheit degrees (F) but less than 35 F for 3 hours and 20 minutes, which was detected by a data logger. No previous temperature excursions were reported. No adverse effects were reported. No Product Quality Complaint (PQC) was filed. Follow up information has been received from the medical assistant on 10-MAY-2017, reported that the temperature excursion occurred in the middle of the night when no one was present and the cause was unknown. Follow up information has been received from the medical assistant on 07-JUN-2017. The patients' identifiers, age and gender were provided. The patient was a female infant (reported as Ë 6 months old) patient and was vaccinated with LIQUID PEDVAXHIB in a clinic by a clinic nurse. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA006513: US-009507513-1704USA010745: US-009507513-1705USA013407: US-009507513-1705USA013406: US-009507513-1705USA013408: US-009507513-1706USA009004: US-009507513-1706USA003615: US-009507513-1706USA009006: US-009507513-1706USA009003: US-009507513-1706USA009001: US-009507513-1706USA009007: US-009507513-1706USA009002: