chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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-009507513-1706USA009005: US-009507513-1706USA003615: US-009507513-1706USA009003: US-009507513-1706USA009001: US-009507513-1706USA009007: US-009507513-1706USA009002:
Age: 0.33
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 4 months old female 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-009507513-1706USA009004: US-009507513-1706USA009005: US-009507513-1706USA009006: US-009507513-1706USA009003: US-009507513-1706USA009001: US-009507513-1706USA003615: US-009507513-1706USA009002:
Sex: F
Vaccine: YF
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: Initial unsolicited report received from a nurse on 08-Jun-2017. This case involves a 46-year-old female patient who was vaccinated with a dose of YELLOW FEVER VACCINE - US (YELLOW FEVER) (batch number: UI606AA, dose and route of administration was not reported), in the left post arm on 05-Jun-2017. The patient's medical history and concomitant medications reported as none. On 08-Jun-2017, three days following the vaccination, the patient developed itching and had a mildly red back of her arm and an indurated area of 4 by 5 is planning to watch the patient and monitor the site. The patient required ER/doctor visit. The patient's laboratory data and corrective treatment reported as none. At the time of report the patient was not recovered from the events. List of documents held by sender: none.
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial unsolicited report received from a pharmacist on 12-JUN-2017. This case involves a 67-year-old male patient who was vaccinated with a dose of INFLUENZA VACCINE (unspecified influenza vaccine) (manufacturer unknown, batch number, expiry date, route and site of administration were not reported) on an unspecified date (in the late 70's). The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient diagnosed with Guillain-Barre syndrome. Lab data was not reported. The patient received unspecified corrective treatment. On an unspecified date, the patient recovered from the event. It was reported that the patient was advised by another physician never to get a flu vaccine again. Upon internal review, the company decided to consider the event serious because of important medical event Guillain-Barre syndrome. List of documents held by sender: none.; Sender's Comments: Sanofi Company comment dated 19-Jun-2017: This case concerns 67 year old male patient who vaccinated with INFLUENZA VACCINE (unknown manufactuer) and developed Guillain-Barre syndrome. Time to onset was compatibility is unknown with role of vaccination. However in this particular case very limited information has been provided. Further information regarding etiological work up, concurrent condition at the time of vaccination, concomitant medication, and investigation results to rule out the alternative cause are needed for complete assessment of the case.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Dizziness, Fall
Clinical narrative: Administered Tdap and MENACTRA to client. After sitting for a couple of minutes client stood up by mother while sibling was receiving vaccines and became lightheaded falling to the floor. Client did not lose consciousness and immediately got up with some assistance.  Client reported that she felt fine but did complain of pain behind left ear. No redness or swelling was noted. After drinking juice client again reported she felt fine and walked out of clinic with mother accompanied by nurse.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Asthenia, Blindness, Fall
Clinical narrative: Child got up after receiving the vaccines. Walked out the door with his Dad, then fell down but was caught by the Dad. The child stated that his "vision went black and he felt some weakness but did not hit his head" on the floor. He reported he was aware and conscious the whole time. 2 RNs laid him down in a supine position and placed a rotating fan on beside him. He answered questions coherently. A pouch of juice was given to him and he drank it without difficulty. Verbalized he felt better after 15 minutes, got up, and walked out of the clinic office with a steady gait, accompanied by his parents and siblings.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Abdominal discomfort, Culture, Diet refusal, Fatigue, Lethargy
Clinical narrative: Sudden onset lethargy; patient slept remainder of the day; slept majority of the day 6/17, 6/18/, and 6/19. Very lethargic 6/20. Slight abdominal discomfort 6/17-not eating; maintaining fluid level; rapid strep test 6/18 NEGATIVE; culture-requested results 6/20, were told not available; advised too early to test for mono. Patient has remained afebrile for entire process. Patient still experiencing extreme lethargy and fatigue.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Streptococcus test negative
Clinical narrative: Sudden onset lethargy; patient slept remainder of the day; slept majority of the day 6/17, 6/18/, and 6/19. Very lethargic 6/20. Slight abdominal discomfort 6/17-not eating; maintaining fluid level; rapid strep test 6/18 NEGATIVE; culture-requested results 6/20, were told not available; advised too early to test for mono. Patient has remained afebrile for entire process. Patient still experiencing extreme lethargy and fatigue.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Myalgia, Nodule, Vomiting
Clinical narrative: Knot on left arm and armpit, right side of jaw knot, headache, muscle pain and vomiting.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Medical assistant and refers to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # M042498, expiration date 17-APR-2018; and lot # M044018, expiration date 05-JAN-2018 (dose, route of administration, and frequency were not reported), for prophylaxis. The vaccine data logger measured a temperature of 8.6 Fahrenheit (F) for a total time frame of 20 minutes. The sterile diluent used to reconstitute vaccines was properly stored.There was no previous temperature excursion. No adverse effects were reported, and a product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocarditis, Troponin I increased
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. Initial solicited report received from an investigator in a trial on 09 June 2017 and follow up information received on 12 June 2017. A 24-year-old male subject with no significant medical history reported. The subject's concomitant medication were not reported. The subject received a dose of ACAM2000 (lot number and site of administration not reported) on 15 June 2010. On 14 July 2010, 29 days after vaccination the subject was diagnosed with 429.0 non-specific myocarditis, unspecified. The lab data included 14 July 2010, the Troponin I was 02.12 ng/mL (abnormal); on 25 July 2010 electrocardiogram (ECG) was abnormal; on 05 August 2015 Echocardiogram was normal. MRI (heart), MRI (brain and spinal cord) and Lumbar puncture (spinal tap) were not performed. Treatments were not reported. The outcome of the event was not reported. Relationship to investigational product according to company: associated. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Sender's Comments: This case involves a healthy 24-year-old male who developed myocarditis non specific with favorable temporal association post vaccination with ACAM2000. Myocarditis is a listed adverse event that may occur following vaccination with live vaccinia virus smallpox vaccines. Alternative etiologies could be myocardial infarction, pulmonary edema and coronary artery vasospasm. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, myocardial biopsy, role of study vaccine can not be ruled out.
Age: 48.0
Sex: M
Vaccine: YF
Symptoms: Chills, Pyrexia
Clinical narrative: Client's fever began approx. 10:00 the following day of vaccine. Client began shivering uncontrollably and call 911. Client was taken to hospital and reported a fever of 105.3 F. Client was given medication to bring down fever at the hospital and fever was brought down to 101.0 by 3:00 AM on 06/21. Client was released from hospital shortly after 3:00 AM. Client's secretary called Health Dept approx. 10:00 AM 06/21 to report event. Travel clinic called client approx. 10:30 AM and client reported he was feeling better with no fever. Client is currently taking Ibuprofen at home but was unsure what medications he was given at the hospital.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Hives to face. Given 1 mg/kg BENADRYL orally. Hives resolved within 5 minutes.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Feeding disorder, Myalgia, Nausea
Clinical narrative: Reported at 6/21/17 at 11:15AM by patient to employee: achy, nausea, unable to eat, sore joints and muscles, chills.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Reported at 6/21/17 at 11:15AM by patient to employee: achy, nausea, unable to eat, sore joints and muscles, chills.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: I had a pneumonia vaccine injection in my right upper arm. It is extremely sore, swollen, red and painful at the injection sit all the way down my arm to elbow. I have flu like symptoms, the pain and redness keep growing. I was not told that this can occur. Will go to the emergency hospital as it is getting out of control.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Cellulitis, Discomfort, Injection site erythema, Injection site induration
Clinical narrative: I received my shingles vaccination from my pharmacist at pharmacy on Wednesday, June 14th, 2017. On Thursday, June 15, 2017, I began experiencing redness, a hard lump at the injection site and warmth on my left arm. I applied ice all day and took MOTRIN, thinking that the discomfort would subside. Instead, the rash grew larger and the lump under the skin became the size of a tangerine and by Friday morning the skin had blistered. I have been prescribed AUGMENTIN for the acute cellulitis that occurred due to this vaccination.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site mass, Rash, Skin warm, Vaccination complication
Clinical narrative: I received my shingles vaccination from my pharmacist at pharmacy on Wednesday, June 14th, 2017. On Thursday, June 15, 2017, I began experiencing redness, a hard lump at the injection site and warmth on my left arm. I applied ice all day and took MOTRIN, thinking that the discomfort would subside. Instead, the rash grew larger and the lump under the skin became the size of a tangerine and by Friday morning the skin had blistered. I have been prescribed AUGMENTIN for the acute cellulitis that occurred due to this vaccination.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: I received my shingles vaccination from my pharmacist at pharmacy on Wednesday, June 14th, 2017. On Thursday, June 15, 2017, I began experiencing redness, a hard lump at the injection site and warmth on my left arm. I applied ice all day and took MOTRIN, thinking that the discomfort would subside. Instead, the rash grew larger and the lump under the skin became the size of a tangerine and by Friday morning the skin had blistered. I have been prescribed AUGMENTIN for the acute cellulitis that occurred due to this vaccination.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site vesicles, Injection site warmth, Pain
Clinical narrative: I received my shingles vaccination from my pharmacist at pharmacy on Wednesday, June 14th, 2017. On Thursday, June 15, 2017, I began experiencing redness, a hard lump at the injection site and warmth on my left arm. I applied ice all day and took MOTRIN, thinking that the discomfort would subside. Instead, the rash grew larger and the lump under the skin became the size of a tangerine and by Friday morning the skin had blistered. I have been prescribed AUGMENTIN for the acute cellulitis that occurred due to this vaccination.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Cellulitis
Clinical narrative: I received my shingles vaccination from my pharmacist at pharmacy on Wednesday, June 14th, 2017. On Thursday, June 15, 2017, I began experiencing redness, a hard lump at the injection site and warmth on my left arm. I applied ice all day and took MOTRIN, thinking that the discomfort would subside. Instead, the rash grew larger and the lump under the skin became the size of a tangerine and by Friday morning the skin had blistered. I have been prescribed AUGMENTIN for the acute cellulitis that occurred due to this vaccination.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized erythema and swelling at injection site.
Sex: U
Vaccine: RAB
Symptoms: Appendicectomy, Appendicitis
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of appendicitis in a patient who received RABAVERT. On 3rd June 2017, the patient received the 1st dose of RABAVERT. On an unknown date, less than a week after receiving RABAVERT, the patient experienced appendicitis (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the appendicitis was unknown. It was unknown if the reporter considered the appendicitis to be related to RABAVERT. Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of RABAVERT pre-exposure prophylaxis. Prior to the second dose, the patient was hospitalized for appendicitis and did have an emergency appendectomy surgery. The patient was not expected to be available for the second dose until 15th June 2017. The healthcare professional was unable to supply the date of hospitalization or surgery or further medical history. The healthcare professional did not have access to lot number or expiration date of the administered dose or the patient details.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Ear pain, Fine motor skill dysfunction, Headache, Muscle spasms, Neck pain
Clinical narrative: The day after I received the flu shot about mid afternoon it started w/an earache that increased steadily and then spread to my whole left side head neck. Then several days later subsided. Then paralysis set in, then recovered some after six months. Pain/cramps to my head neck followed yrs. until I became aware of an adverse effect and refused the flu shot. Since then the afflictions subsided. However there is still diffuse pain and loss of dexterity in left hand at times.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Paralysis, Vaccination complication
Clinical narrative: The day after I received the flu shot about mid afternoon it started w/an earache that increased steadily and then spread to my whole left side head neck. Then several days later subsided. Then paralysis set in, then recovered some after six months. Pain/cramps to my head neck followed yrs. until I became aware of an adverse effect and refused the flu shot. Since then the afflictions subsided. However there is still diffuse pain and loss of dexterity in left hand at times.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: The patient stated swelling, redness and soreness in her upper arm from her elbow to her shoulder. She said it started between 6 and 7 pm the day of her shot. The following day, she called in to the pharmacy to tell us about the reaction. As of now, I have recommended that she go to urgent care. She is waiting for a call back from her PCP and does not want to go to the urgent care as of now.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event
Clinical narrative: No adverse health effects.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Chest X-ray, Death, Endotracheal intubation, Laboratory test, Pulse absent
Clinical narrative: Found by EMS on back in her crib.  Pt was intubated and given 6 doses of epi in route to ER.  Pt had no pulse on arrival.  Pt received a larger ET tube and bicarb.  Resucitation unsuccessful, pt expired.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Resuscitation
Clinical narrative: Found by EMS on back in her crib.  Pt was intubated and given 6 doses of epi in route to ER.  Pt had no pulse on arrival.  Pt received a larger ET tube and bicarb.  Resucitation unsuccessful, pt expired.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Viral infection, Vomiting
Clinical narrative: Child started with a fever and then developed vomiting. Highest fever was 102.5. Mother called our office on 6/14/17 and was instructed to call her family doctor for advice. Dr. thought vomiting was either a virus or was caused by the fever. No treatment other than antipyretic/analgesic. Child is doing better.
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain in arm of injection. Full Body aches.
Sex: U
Vaccine: HPV9
Symptoms: Drug dispensed to wrong patient, No adverse event
Clinical narrative: This information has been received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. The nurse stated that on 31-MAY-2017, the patient was inadvertently vaccinated with a dose of GARDASIL 9 with lot number M041213 and expiration date on 22-JUN-2019, administered for prophylaxis by an unspecified route that was supposed to be administered to the patient's sister (dose, dose number and anatomical location were not provided). There was no product quality complaint (PQC) involved. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to an unspecified number of unspecified patients of unknown age and gender. The patients' had no medical history, concurrent condition, drug and allergy history reported. Since 12-JAN-2017, an unspecified number of patients were vaccinated with improperly stored doses of VAQTA lot # M021124 expiration date  02-FEB-2018, (strength, dose were not provided) for prophylaxis. The patients concomitant medications were not reported. On an unspecified date VAQTA was exposed to a temperature excursion of 32° Fahrenheit (°F) to 35°F (31°F) during a time frame of 1 hour, with no previous temperature excursion (incorrect product storage). No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested; Sender's Comments:  US-009507513-1706USA000407:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Medical assistant and refers to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # M040138, expiration date 28-SEP-2018 (dose, route of administration, and frequency were not reported), for prophylaxis. The vaccine data logger measured a temperature of 8.6 Fahrenheit (F) for a total time frame of 20 minutes. The sterile diluent used to reconstitute vaccines was properly stored. There was no previous temperature excursion. No adverse effects were reported, and a product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Musculoskeletal stiffness, Seizure like phenomena, Staring, Unresponsive to stimuli
Clinical narrative: This spontaneous report was received from a physician referring to an 18 year old male patient. The patient had no relevant medical history and was not taking any concomitant medications. He had no known drug reactions or allergies. Concurrent conditions were not reported. On 14-JUN-2017, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly, for prophylaxis (dosage not reported; lot # N001533, expiration date 16-OCT-2019). Other suspect medications included MENACTRA, with which the patient was vaccinated on the same date. About a minute after the vaccines were administered, the patient experienced a seizure-like episode: he leaned backwards from a sitting position to being flat and exhibited upper body stiffening and he stared unresponsively. The event lasted about 10 seconds in total. The patient did not receive treatment for the event and he recovered on the same day. The reporter did not provide an assessment on the causal relationship between the event seizure like phenomena and therapy with GARDASIL 9. Upon internal review, the event seizure like phenomena was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant who reported that on an unknown date, improperly stored doses of ROTATEQ, (lot # M041768, expiry date 25-JUN-2018) had been administered to unspecified patients (incorrect product storage). The numbers of doses were unspecified. There was a previous temperature excursion for the vaccines of 47°F to 77°F for 45 minutes. Then, the vaccines had other temperature excursions of 47°F to 77°F for 4 hours. No data logger involved. No adverse effects were reported. This is one of three reports from the same reporter source, (linked to MARRS # 1706USA009318 and 1706USA009319). Additional information has been requested. Lot # M041768 is valid lot # for ROTATEQ.; Sender's Comments: US-009507513-1706USA009318: US-009507513-1706USA009319:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant who reported that on an unknown date, improperly stored doses of PNEUMOVAX 23, (lot # N003997, expiry date 20-OCT-2018) had been administered to unspecified patients. The numbers of doses were unspecified. There was a previous temperature excursion for the vaccines of 47°F to 77°F for 45 minutes. Then, the vaccines had other temperature excursions of 47°F to 77°F for 4 hours. No data logger involved. No adverse effects were reported. This is one of three reports from the same reporter source, (linked to MARRS # 1706USA008963 and 1706USA009319). Additional information has been requested. Sender's Comments: US-009507513-1706USA008963: US-009507513-1706USA009319.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant who reported that on an unknown date, improperly stored doses of PEDVAXHIB, (lot #s M036056, expiry date 18-MAY-2019 and L042258, expiry date 18-AUG-2018) had been administered to unspecified patients. The numbers of doses were unspecified. There was a previous temperature excursion for the vaccines of 47°F to 77°F for 45 minutes. Then, the vaccines had other temperature excursions of 47°F to 77°F for 4 hours. No data logger involved. No adverse effects were reported. This is one of three reports from the same reporter source, (linked to MARRS # 1706USA008963 and 1706USA009319). Additional information has been requested. Sender's Comments: US-009507513-1706USA008963: US-009507513-1706USA009318.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ, VARCEL
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: After receiving immunizations patient began feeling dizzy and passed out for approx. 60 second. After coming to, he drank some juice and remained seated for approx. 10 minutes before leaving.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Sore injection site, redness.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Influenza like illness, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Flu-like symptoms - fever, body aches/pain, nausea and vomiting for 2 days.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Indicated of headache the night after receiving the vaccine. Also reported pain at the insertion site. Today there is redness and warmer than her other arm. Employee spoke to her department coordinator and she will be sent to an occupational center for follow up. Pharmacy contract staff have their own workers compensation program.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Unable to move arm for 2 days. Triceps pain.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Redness, warmth, pain and swelling from shoulder to elbow. Currently improving with ice and ibuprofen.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Redness, pain, swelling from shoulder to elbow. Unable to move arm for a day. Pruritus developed as pain improved.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified date, the patient was vaccinated with an improperly stored dose of PROQUAD "rHA" injection (dose, frequency and route were not reported) lot # M044021 with expiration date of 01-MAY-2018, for prophylaxis. The sterile diluent (lot # and expiration date were not reported) used to reconstitute the PROQUAD was properly stored. The temperature excursion of the PROQUAD was between -9 °C and 8 °C for a time frame of 1 hour and 10 minutes. No previous temperature excursion was reported. No adverse effects were reported. Data logger was involved. Additional information has been requested. Sender's Comments: US-009507513-1706USA005174: US-009507513-1706USA005175: US-009507513-1706USA005176: US-009507513-1706USA005177: US-009507513-1706USA005178: US-009507513-1706USA005179.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified date, the patient was vaccinated with an improperly stored dose of PROQUAD "rHA" injection (dose, frequency and route were not reported) lot # M044021 with expiration date of 01-MAY-2018, for prophylaxis. The sterile diluent (lot # and expiration date were not reported) used to reconstitute the PROQUAD was properly stored. The temperature excursion of the PROQUAD was between -9 °C and 8 °C for a time frame of 1 hour and 10 minutes. No previous temperature excursion was reported. No adverse effects were reported. Data logger was involved. Additional information has been requested. Sender's Comments: US-009507513-1706USA005163: US-009507513-1706USA005175: US-009507513-1706USA005176: US-009507513-1706USA005177: US-009507513-1706USA005178: US-009507513-1706USA005179.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified date, the patient was vaccinated with an improperly stored dose of PROQUAD "rHA" injection (dose, frequency and route were not reported) lot # M044021 with expiration date of 01-MAY-2018, for prophylaxis. The sterile diluent (lot # and expiration date were not reported) used to reconstitute the PROQUAD was properly stored. The temperature excursion of the PROQUAD was between -9 °C and 8 °C for a time frame of 1 hour and 10 minutes. No previous temperature excursion was reported. No adverse effects were reported. Data logger was involved. Additional information has been requested. Sender's Comments: US-009507513-1706USA005163: US-009507513-1706USA005174: US-009507513-1706USA005176: US-009507513-1706USA005177: US-009507513-1706USA005178: US-009507513-1706USA005179.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy, concerning a two unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On 22-MAY-2017 and 23-MAY-2017, the patients were vaccinated with improperly stored doses of VARIVAX (lot number reported as M00343 with expiration date of 19-JAN-2018; strength, dose, route and anatomical location were not provided), for prophylaxis. No adverse reactions were reported. It was also reported that on unspecified dates, the administered doses experienced temperature excursions during 15 minutes, 20.5 hours and 2.25 hours, at a temperature between -14 degrees Celsius and -10 degrees Celsius, -9 degrees Celsius and 8 degrees Celsius, and 9 degrees Celsius and 25 degrees Celsius, respectively. No previous temperature excursion was reported. A data logger issue was involved. Lot number M00343 is an invalid lot number for varicella virus vaccine live (oka/merck). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates since 05-JUN-2017, the patients were vaccinated with improperly stored doses of oral ROTATEQ (dose and frequency were not reported) lot # M044396 with expiration date of 19-JUN-2018, that were reconstituted with diluent MRK (injection; lot # and expiration date were not reported), for prophylaxis. The temperature of the ROTATEQ was between 9 °C and 25 °C for a time frame of 2 hours and 2 minutes. No previous temperature excursion occurred and data logger was involved. No adverse effects were reported. This is one of four reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA004409: US-009507513-1706USA006312: US-009507513-1706USA006314:
Age: 1.75
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received 31-MAY-2017 from a medical assistant (see original case 1705USA005086) and refers to a 21 month old male patient. On 13-APR-2017, he was vaccinated with VARIVAX lot # M039615, expiration date 20-SEP-2018 which had undergone a temperature excursion between 15 to 46 degrees Fahrenheit (F) (22.3 (F)) for 1 hour and 3 minutes.  No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected because follow-up information was received. Sender's Comments: US-009507513-1705USA005093: US-009507513-1705USA005094: US-009507513-1705USA005086: US-009507513-1706USA008916: US-009507513-1706USA008917: US-009507513-1706USA008918: US-009507513-1706USA008919: US-009507513-1706USA008920: US-009507513-1706USA008921: US-009507513-1706USA008922.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received 31-MAY-2017 from a medical assistant (see original case 1705USA005086) and refers to a 13 month old female patient. On 11-APR-2017, she was vaccinated with VARIVAX lot # M039615, expiration date 20-SEP-2018 which had undergone a temperature excursion between 15 to 46 degrees Fahrenheit (F) (22.3 (F)) for 1 hour and 3 minutes. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected because follow-up information was received. Sender's Comments: US-009507513-1705USA005093: US-009507513-1705USA005094: US-009507513-1705USA005086: US-009507513-1706USA008915: US-009507513-1706USA008917: US-009507513-1706USA008918: US-009507513-1706USA008919: US-009507513-1706USA008920: US-009507513-1706USA008921: US-009507513-1706USA008922.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received 31-MAY-2017 from a medical assistant (see original case 1705USA005086) and refers to a 4 year old female patient. On 18-APR-2017, she was vaccinated with VARIVAX lot # M039615, expiration date 20-SEP-2018 which had undergone a temperature excursion between 15 to 46 degrees Fahrenheit (F) (22.3 (F)) for 1 hour and 3 minutes.  No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected because follow-up information was received.; Sender's Comments: US-009507513-1705USA005093: US-009507513-1705USA005094: US-009507513-1705USA005086: US-009507513-1706USA008915: US-009507513-1706USA008916: US-009507513-1706USA008918: US-009507513-1706USA008919: US-009507513-1706USA008920: US-009507513-1706USA008921: US-009507513-1706USA008922:
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received 31-MAY-2017 from a medical assistant (see original case 1705USA005086) and refers to a 45 month old female patient. On 13-APR-2017, she was vaccinated with VARIVAX lot # M039615, expiration date 20-SEP-2018 which had undergone a temperature excursion between 15 to 46 degrees Fahrenheit (F) (22.3 (F)) for 1 hour and 3 minutes.  No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected because follow-up information was received.; Sender's Comments: US-009507513-1705USA005093: US-009507513-1705USA005094: US-009507513-1705USA005086: US-009507513-1706USA008915: US-009507513-1706USA008916: US-009507513-1706USA008917: US-009507513-1706USA008919: US-009507513-1706USA008920: US-009507513-1706USA008921: US-009507513-1706USA008922:
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received 31-MAY-2017 from a medical assistant (see original case 1705USA005086) and refers to a 59 month old male patient. On 18-APR-2017, she was vaccinated with VARIVAX lot # M039615, expiration date 20-SEP-2018 which had undergone a temperature excursion between 15 to 46 degrees Fahrenheit (F) (22.3 (F)) for 1 hour and 3 minutes. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected because follow-up information was received. Sender's Comments: US-009507513-1705USA005093: US-009507513-1705USA005094: US-009507513-1705USA005086: US-009507513-1706USA008915: US-009507513-1706USA008916: US-009507513-1706USA008917: US-009507513-1706USA008918: US-009507513-1706USA008920: US-009507513-1706USA008921: US-009507513-1706USA008922.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received 31-MAY-2017 from a medical assistant (see original case 1705USA005086) and refers to a 24 year old female patient. On 11-APR-2017, she was vaccinated with VARIVAX lot # M041513, expiration date 11-OCT-2018, which had undergone a temperature excursion between 15 to 46 degrees Fahrenheit (F) (22.3 (F)) for 1 hour and 3 minutes. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected because follow-up information was received.; Sender's Comments: US-009507513-1705USA005093: US-009507513-1705USA005094: US-009507513-1705USA005086: US-009507513-1706USA008915: US-009507513-1706USA008916: US-009507513-1706USA008917: US-009507513-1706USA008918: US-009507513-1706USA008919: US-009507513-1706USA008921: US-009507513-1706USA008922:
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received 31-MAY-2017 from a medical assistant (see original case 1705USA005086) and refers to a 29 year old female patient. On 13-APR-2017, she was vaccinated with VARIVAX lot # M041513, expiration date 11-OCT-2018, which had undergone a temperature excursion between 15 to 46 degrees Fahrenheit (F) (22.3 (F)) for 1 hour and 3 minutes.  No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected because follow-up information was received.; Sender's Comments: US-009507513-1705USA005093: US-009507513-1705USA005094: US-009507513-1705USA005086: US-009507513-1706USA008915: US-009507513-1706USA008916: US-009507513-1706USA008917: US-009507513-1706USA008918: US-009507513-1706USA008919: US-009507513-1706USA008920: US-009507513-1706USA008922:
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received 31-MAY-2017 from a medical assistant (see original case 1705USA005086) and refers to a 32 year old female patient. On 13-APR-2017, she was vaccinated with VARIVAX lot # M041513, expiration date 11-OCT-2018, which had undergone a temperature excursion between 15 to 46 degrees Fahrenheit (F) (22.3 (F)) for 1 hour and 3 minutes. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected because follow-up information was received.; Sender's Comments: US-009507513-1705USA005093: US-009507513-1705USA005094: US-009507513-1705USA005086: US-009507513-1706USA008915: US-009507513-1706USA008916: US-009507513-1706USA008917: US-009507513-1706USA008918: US-009507513-1706USA008919: US-009507513-1706USA008920: US-009507513-1706USA008921:
Sex: F
Vaccine: HPV4
Symptoms: Growth retardation
Clinical narrative: This spontaneous report was received from the patient's aunt via a company representative, referring to her niece, a 13 year old female patient. On unknown dates, the patient was vaccinated with the 3 dose series of GARDASIL, for prophylaxis (dose, route, frequency, lot number and expiration date were not provided). On an unknown date, it was stated that the GARDASIL vaccine has stunted the patient's growth. Furthermore, it was reported that the doctor recommended hormone growth therapy to help with her height. At the time of reporting, the outcome of growth retardation was unknown. The reporter considered GARDASIL to be related with the event growth retardation. Nevertheless, it was also reported that the patient's doctor did not think that the stalling of the patient's growth was caused by GARDASIL. Upon internal review, the event growth retardation was determined to be a medically significant event. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Local reaction, Local swelling, Pain, Skin warm
Clinical narrative: This is a spontaneous report from a contactable consumer. A 74-year-old female patient of unknown race/ethnicity received PREVNAR 13 in Jun2017 (8 days before this report) at single dose for immunization. Medical history and concomitant medications were not reported. In Jun2017, the patient had a local reaction. Her shoulder is hot to the touch with swelling and pain. Outcome was not recovered.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Disorientation, Fatigue, Feeling abnormal, Headache, Somnolence
Clinical narrative: This is a spontaneous report from a contactable consumer reported for her granddaughter. A 18-year-old female patient received TRUMENBA for immunization on 14Jun2017 13:00 at 0.5ml single dose. On 09Jun2017 the patient had received MARIJUANA for migraine. On unknown date the patient also received a hepatitis B vaccine. Relevant medical history included Post concussion migraine, Ehler-Danlos genetic disorder and Wiedemann-Steiner syndrome. The patient was a premature baby. On unknown date the patient experienced extremely tired, groggy, really sleepy and slept for 3 hours, little bit loopy, little tiny bit disoriented and the patient had pain in her head which has not been higher than 2 out of 10/ 5 out of 10 when she woke up then 6 and now 7 out of 10. The outcome of all events was reported as not recovered.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Incorrect product storage, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse (pediatrics). A 4-month-old female patient receive the 1st doses of PREVNAR 13 (Lot # R66271, Expiry Date May2018) intramuscular at 0.5ml IM left vastus lateralis, PEDIARIX (GlaxoSmithKline; Lot: 9b4cd/Expiry date: 10Mar2019) via an unspecified route of administration at 1 DF, single at left vastus lateralis, rotavirus vaccine (Merck; Lot: M040267/Expiry date: 14May2018) oral at 1 DF, single, PEDVAXHIB (Merck; Lot: M046140/ Expiry date: 27Sep2019) via an unspecified route of administration at 1 DF, single at right vastus lateralis, all on 13Jun2017 in afternoon at about 3 or 4 for immunization, at physician office. The patient medical history and family medical history were none. The concomitant medications were not reported. The patient previously received PREVNAR 13 (Lot: R37129; Expiry date: Mar2018) at right vastus lateralis, PEDIARIX, ROTAVIRUS VACCINE and PEDVAXHIB, all on 11Apr2017 at 2 month of age for immunisation and experienced pyrexia. No prior Vaccinations within 4 weeks. On 13Jun2017 the patient received the product after temperature excursion: they had a temperature alarm for 30 minutes, 1.1 degrees Celsius. The nurse requested viability information. On unspecified date in 2017 she experienced mild fever with outcome of unknown. No relevant tests performed. The patient did not require a visit to Emergency room nor physician office.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Body temperature increased, Chills, Flushing, Headache
Clinical narrative: Subjective data: joint pain, flushed skin, oral temp 102 degree F, local reaction, headache, chills, ringing in her ears.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Local reaction, Tinnitus
Clinical narrative: Subjective data: joint pain, flushed skin, oral temp 102 degree F, local reaction, headache, chills, ringing in her ears.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Laboratory test, Unevaluable event
Clinical narrative: 13 days after vaccination was hospitalized for 3 months.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Erythema, Pain, Tenderness
Clinical narrative: Dizziness the next day and soreness. The following day dizziness resolved but pt noted tender red streaks.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Gave patient Tdap and varicella in R arm and Meningococcal and HPV in left arm. About one minute after shots give, patient fainted.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Feeling cold, Injection site pain, Pyrexia
Clinical narrative: Feeling cold, dizzy, muscle surrounding injection site was in pain but no swelling. Measured body temperature and got a 101.7 F underarm. Fever lasted for about 30 hours.
Age: 61.0
Sex: F
Vaccine: HEPAB
Symptoms: Loss of consciousness, Presyncope, Syncope, Urinary incontinence
Clinical narrative: Vasovagal response with syncope, loss of consciousness, and urinary incontinence.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site rash
Clinical narrative: Rash started on bilateral anterior aspect of both thighs where previously vaccinated 6/17/17, on 6/18/17 noticed bumps in addition to rash, patient introduced to applesauce evening of 6/19/17.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: AREA OF INJECTION IS RED AND HOT TO TOUCH. PT STATES IT IS VERY ITCHY.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Lateral aspect of right thigh with 4x5in irregular red rash.