chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.76
Sex: F
Vaccine: FLU4
Symptoms: Cough, Pyrexia, Rhinorrhoea, Urticaria, Vomiting
Clinical narrative: Mother states the day after receiving Influenza booster dose patient had hives on her back, chest, abdomen and a little on legs.  She also had a fever of 102 degrees Fahrenheit axillary.  Mom states she also vomited twice and had a cough and runny nose.  Mom states that fever lasted 5 days, she treated at home with OTC Tylenol and Benadryl.  Mom states that the Tylenol did bring the fever down.  Mom called Public Health office on 3/7/2016 after symptoms had resolved.  Mom states she called the doctor to and described symptoms because she wanted it noted in patients chart that she felt this was a reaction to the flu vaccine.  Mom states she did not take patient in to the MD to be evaluated.  Mom denies any previous vaccine reactions.
Age: 24.0
Sex: F
Vaccine: ADEN_4_7, HEPAB
Symptoms: Decreased appetite, Dizziness, Human chorionic gonadotropin positive, Nausea, Presyncope
Clinical narrative: Given the usual trainee vaccines when she arrived along with a blood draw for hCG, titers, etc.  She returned the next week (WOT 1) to receive PCN, some pills and the neg hCG results. On 29 Feb she developed nausea, dizziness (pre syncopal), anorexia and light headedness. On 4 Mar she sought care for the symptoms and was found to have a positive hCG.
Age: 5.0
Sex: F
Vaccine: MMRV, TDAP
Symptoms: Discomfort, Injection site erythema, Injection site inflammation, Injection site nodule, Injection site pruritus
Clinical narrative: Patient woke up this morning and it was noted that her R arm was red, inflamed, and hot to the touch. A "hard knot" was felt at injection site. She c/o itching at the site. No fever noted. L arm was just red at injection site but no other symptoms. Parents took patient to pediatrician's office and was told to administer Benadryl or Claritin to child along with IBUprofen for discomfort. Also to place ice on area of reaction. No other treatment was advised. Parent reports patient has complained minimally of pain and had no reaction noticed until this AM.
Age: 5.0
Sex: F
Vaccine: MMRV, TDAP
Symptoms: Injection site warmth
Clinical narrative: Patient woke up this morning and it was noted that her R arm was red, inflamed, and hot to the touch. A "hard knot" was felt at injection site. She c/o itching at the site. No fever noted. L arm was just red at injection site but no other symptoms. Parents took patient to pediatrician's office and was told to administer Benadryl or Claritin to child along with IBUprofen for discomfort. Also to place ice on area of reaction. No other treatment was advised. Parent reports patient has complained minimally of pain and had no reaction noticed until this AM.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Patients reports swelling and progressive erythema of LUE below injection site. Patient reported lack of immediate pain, and ensuing discomfort accompanied by warmth of area around site of injection. Pt reportedly returned to pharmacy 3/7/2016 and triaged by pharmacist who reported above. Patient then was sent to doctor who upon exam did not reason for reaction. Noted possibly swollen lymph nodes in upper arm by patient. Patient received prescription for Medrol Pak on 3/7/2016. I F/U'ed with patient on 3/9/2016. Patient explained & confirmed above, patient reported minor improvements in redness and pain, patient main complaint was of itching since Monday. I also vaccinated husband on same day, no reaction or event occurred. Will attempt another F/U on Friday.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Middle insomnia, Mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: Sore Arm started and now there is alot of pain and hard to move my arm certain ways.  I feel like I have lost strength in the arm and it wakes me up 3 to 4 times a night.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Blood glucose, Loss of consciousness
Clinical narrative: Pt said she had been passing out recently and hoped she didn't today, but she did, over a period of 15 minutes passed in and out 3 times, felt weak, drank some juice and relaxed, then felt better and left with her husaband.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: On 02/19/2016, patient presents to the clinic's triage with redness and swelling (measuring about 5 inches in diameter) to the upper left arm after receiving Adacel (Tdap) seven days ago (02/12/2016).  Patient denies knowing of any allergies prior to agreeing to receive Adacel (Tdap).  Patient also denies fever, chills, SOB, or itching in any other area.  All vital signs are within normal limits.  PA-C notified and advised to apply warm compresses, take OTC Benadryl as directed, and go to the nearest Emergency Room if no improvement.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis
Clinical narrative: Patient received shot 11/12/15. She then came back to the pharmacy on 3/9/16 (almost 4 months after flu shot) asking if she had gotten the shot here. She had. She wanted the date so she could tell her physician. She said since her flu shot she has had severe bursitis in her shoulder.
Age: 30.0
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Noted to have scattered tiny rashes at my arms, chest, abdomen, and back when I woke up this morning. I got the MMR and Varicella vaccines from Employee Health.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and pain to area around injection.  Dx Cellulitis at office visit on 03/07/2016.  Antibiotics given.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness swelling, pain at injection site.  Patient/provider felt injection may have been given too low on arm.
Age: 1.01
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Asthenia, Decreased appetite, Irritability, Pyrexia, Rash
Clinical narrative: Low grade fever (100.5 F) began Wednesday evening (3/2/16) and continued through Sunday evening (3/6/16).  The fever temperature increased in the middle of the night, temperatures were not recorded, but mother could feel baby's head, face, neck, and hands were much hotter during the night-time than during any other time of day. Fever reduced and was gone by late Sunday night (3/6/16).  In addition to fever, during this period baby had decreased appetite and energy, increased fussiness and clinginess. After the fever had gone, a rash appeared on Monday (3/7/16).  Light reddish/pink dots and some tiny raised bumps were found along the neck and jaw of baby. Tuesday (3/8/16) the rash was no longer on neck and jaw, but covered entire back of baby. Again, in addition to the rash, baby had decreased appetite, increased fussiness and clinginess. Wednesday (3/9/16) no rash was noticeable and appetite, energy, and regular demeanor returned.
Age: 1.26
Sex: F
Vaccine: DTAPIPV, PNC13
Symptoms: Injection site swelling
Clinical narrative: Mother noticed child's left leg swollen. Was immunized on 3/7/16.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: Itching at the site of injection, shoulder, arm, down to the left hand. Treat with OTC anti-itching cr. She stated that anti-itching cream help.
Age: 9.0
Sex: M
Vaccine: FLUN4
Symptoms: Anxiety, Tic
Clinical narrative: Abrupt onset of severe tics and severe anxiety.
Age: 11.0
Sex: F
Vaccine: HEP, HPV4, TDAPIPV
Symptoms: Alopecia, Asthenia, Dysmenorrhoea, Fatigue, Headache
Clinical narrative: Constant headaches - ongoing. Weakness and fatigue - ongoing. Hair loss - ongoing.
Age: 11.0
Sex: F
Vaccine: HEP, HPV4, TDAPIPV
Symptoms: Myalgia, Nuclear magnetic resonance imaging
Clinical narrative: Constant headaches - ongoing. Weakness and fatigue - ongoing. Hair loss - ongoing.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Moderate to severe shoulder/arm pain and limited range of motion due to pain.
Age: 91.0
Sex: M
Vaccine: FLUC3
Symptoms: Erythema, Injection site induration, Injection site warmth, Pruritus generalised, Skin reaction
Clinical narrative: I came in on January 26, 2016 and received a flu shot in my left arm. I started itching that very night after taking the flu shot all over my body. My face became very red and I have not been scratching my face. 91 y/o male patient here as a walk in, c/p he got the flu shot on Feb/26/2016 and at night he developed itching. Patient has hive, and are red, has induration in left deltoid (where the shot was given) and is warm. Patient denies: fever, chills, nausea, SOB, cough, urine problems, hematic urine. Patient taking amoxicillin too. Diphenhydramine 25 mg BID, prednisone 21 dosepak.
Age: 91.0
Sex: M
Vaccine: FLUC3
Symptoms: Urticaria
Clinical narrative: I came in on January 26, 2016 and received a flu shot in my left arm. I started itching that very night after taking the flu shot all over my body. My face became very red and I have not been scratching my face. 91 y/o male patient here as a walk in, c/p he got the flu shot on Feb/26/2016 and at night he developed itching. Patient has hive, and are red, has induration in left deltoid (where the shot was given) and is warm. Patient denies: fever, chills, nausea, SOB, cough, urine problems, hematic urine. Patient taking amoxicillin too. Diphenhydramine 25 mg BID, prednisone 21 dosepak.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: Client went out to lobby and became very dizzy and ran into the wall. Check heart, blood pressure and lungs, gave H2O and some food.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Pain in extremity, Peripheral swelling
Clinical narrative: (L) arm pain/swelling. Limited ROM.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Pain
Clinical narrative: He has complained of muscle pain in his left arm since October. Motion aggravates the pain, slightly relieved with NSAID use.
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a pharmacist referring to a male patient of unknown age. On unknown dates, the patient's wife and two children each received one dose of VARIVAX (Merck) (route, dose and lot# were unknown). The patient was unvaccinated and experienced shingles (secondary transmission) on an unknown date. The patient sought medical attention via contacting pharmacist. The outcome of the events was unknown. The causality was not reported. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Rash
Clinical narrative: Red raised rash-like bumps, swollen at site of injection - spread from legs to torso. Prednisone.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Rash, Rash erythematous
Clinical narrative: Red raised rash-like bumps, swollen at site of injection - spread from legs to torso. Prednisone.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding unspecified number of patients of unknown age and unknown gender. On an unknown date, the patients were vaccinated with VARIVAX (Merck) (Lot# L024255, expiry: 01-JUL-2017; Lot# L041204, expiry: 20-OCT-2017; Lot# L025207, expiry: 07-JUL-2017) (route, dose and strength were not reported), which were improperly stored at -12.7 degree Centigrade for 9 hours 58 minutes. No adverse effects were reported. There were no previous excursions involved and data logger was involved. This is one of the several cases from same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and a healthcare worker refers to a 4 year old female patient. The patient's concurrent conditions, medical history and concomitant therapy were not provided. On 12-NOV-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck), lot # L030586 with an expiration date on 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and a healthcare worker refers to a 4 year old female patient. The patient's concurrent conditions, medical history and concomitant therapy were not provided. On 07-DEC-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) recombinant human albumin (rHA), lot # L030586 with an expiration date on 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant, refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2016, the patients were vaccinated with VAQTA (lot # L015460, expiration date 20-JUL-2017). The vaccines were improperly stored the months of January 2016 and February 2016. No symptoms reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: DTP
Symptoms: Blood glucose normal, Dizziness, Headache, Leukocytosis, Pain
Clinical narrative: Dizziness, headache and tremor/ shakiness / body aches. Acetaminophen 650 mg once, Diphenhydramine 25 mg once.
Age: 62.0
Sex: M
Vaccine: DTP
Symptoms: Prostatic specific antigen increased, Tremor, White blood cells urine positive
Clinical narrative: Dizziness, headache and tremor/ shakiness / body aches. Acetaminophen 650 mg once, Diphenhydramine 25 mg once.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Syncope.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: I had pain, swelling, and hives that were 6-8 inches in diameter from my right elbow to my right shoulder. I took 3 OTC BENADRYL tablets over 8 to 10 hours and it subsided after 8 hours. I didn't have any other symptoms, not even itching.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Angioedema, Injection site erythema, Injection site warmth, Pain, Pyrexia
Clinical narrative: Erythematous warm circular area approx. 10 cm around injection site. Fever, angioedema and painful. Diphenhydramine 25 mg other.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored GARDASIL lot # K007828, expiration date- 02-MAR-2017, (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. Temperature was 1.0 C, Time frame was 20 minutes. There was a previous temperature excursion - 1.2 C for 20 minutes and call was because of data logger. M-M-R II was in the product tab but did not experience a temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored GARDASIL 9 lot # L019297, expiration date- 18-AUG-2017, lot no. L02015, expiration date- 16-AUG-2017, (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. Temperature was 1.0 C, Time frame was 20 minutes. There was a previous temperature excursion- 1.2 C for 20 minutes and call was because of data logger. This is one of several reports received from the same reporter. 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 regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored oral ROTATEQ lot # L013192, expiration date- 19-JAN-2017. No adverse event was reported. The outcome of the event was unknown. Temperature was 1.0 C, Time frame was 20 minutes. There was a previous temperature excursion- 1.2 C for 20 minutes and call was because of data logger. MMR II was in the product tab did not experience a temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: 3/7/15 Received Tdap, HPV, MENACTRA. Next day developed urticarial (3/8/16). By 3/9/16, urticarial much improved. Concurrent viral illness. Treated urticarial with BENADRYL.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a 15 week old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. On 25-FEB-2016, an unspecified infant was inadvertently administered the first dose of ROTATEQ (dose, frequency, lot# and expiration date was not reported), orally. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information is not expected as there is no consent to contact with the physician.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # L014458, expiration date- 11-FEB-2017, lot # L019836, expiration date- 24-MAR-2017 and lot # L017406, expiration date- 26-FEB-2017. No adverse event was reported. The outcome of the event was unknown. Temperature was 1.0 C, Time frame was 20 minutes. There was a previous temperature excursion- 1.2 C for 20 minutes and call was because of data logger. MMR II was in the product tab but did not experience a temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and a healthcare worker refers to a 5 year old female patient. The patient's concurrent conditions, medical history and concomitant therapy were not provided. On 26-JAN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) recombinant human albumin (rHA), lot # L030586 with an expiration date on 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPVX
Symptoms: Treponema test false positive
Clinical narrative: This spontaneous report as received from a patient's mother refers to a 15 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. In approximately February 2016 (also reported as about a week and a half ago), the patient was vaccinated with a third dose of unidentified Merck HPV vaccine (name and lot number not provided). On an unknown date, the patient attempted to donate blood at unknown location and was told she could not because she was showing a false positive for syphilis. The outcome of the event was unknown. The patient sought medical attention via calling the physician by phone. The relatedness between the event and the suspect therapy was not provided. Additional information is not expected, as there was no reporter contact details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding unspecified number of patients of unknown age and unknown gender. On an unknown date, the patients were vaccinated with ZOSTAVAX (lot # L035504 and expiry: 16-DEC-2016) (route, dose and strength were not reported), which was improperly stored at -12.7 degree centigrade for 9 hours and 58 minutes. No adverse effects were reported. There was no prior temperature excursions and data logger was involved. It was reported that the MMR II (Lot: L011528 expiry: 03-APR-2017, Lot: L000458 expiry: 06-JAN-2017, Lot: K005174 expiry: 10-APR-2016) appears on the product list as temperature stability questions were asked, however, no doses of improperly stored were administered to patients. This is one of the several cases form same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-MAR-2016, the patient who was indicated for ZOSTAVAX (dose, route of administration, anatomical location, lot # and expiration date were not reported) inadvertently received a dose of (Oka/Merck0 VARIVAX lot # L011083, expiration date 01-APR-2017 (0.5 ml (also reported as unspecified dose), route of administration and anatomical location were not reported). The nurse stated that the patient "was fine". No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant, refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2016, the patients were vaccinated with GARDASIL (lot # K016966, expiration date 10-MAY-2017; lot# K010215, expiration date 05-MAY-2017). The vaccines were improperly stored during the months of January 2016 and February 2016. No symptoms reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant, refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2016, the patients were vaccinated with RECOMBIVAX HB (lot# L025738, expiration date 14-AUG-2017; L027733, expiration date 13-SEP-2017). The vaccines were improperly stored during the months of January 2016 and February 2016. No symptoms reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a unspecified patients of unknown age and gender. Medical history and current conditions were not reported. On an unknown dates, since 11-DEC-2015, the patients were vaccinated with ZOSTAVAX (dose, frequency, indication, route of administration were not reported, lot # L012478 with expiration date: 10-JUL-2016). The doses of ZOSTAVAX were improperly stored (temperature: 6F for 5 minutes). Concomitant therapy was not reported. No adverse experiences have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a unspecified patients of unknown age and gender. Medical history and current conditions were not reported. On an unknown dates, since 11-DEC-2015, the patients were vaccinated with PROQUAD (Merck) (dose, frequency, indication, route of administration were not reported, lot # reported as K010211 with expiration date: 17-JAN-2016). The doses of PROQUAD (Merck) were improperly stored (temperature: 6F for 5 minutes). Concomitant therapy was not reported. No adverse experiences have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant, refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2016, the patients were vaccinated with oral ROTATEQ (lot # L013203, expiration date 28-JAN-2017; lot# L013204, expiration date 28-JAN-2017). The vaccines were improperly stored during the months of January 2016 and February 2016. No symptoms reported. This is one of several reports received from the same source. 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 nurse and refers to unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot # L025208, expiration date 07-JUL-2017; lot # L028276, expiration date 28-JUL-2017; lot # reported as L0375561, expiration date 29-SEP-2017 (dose and route of administration were not reported). Administered doses experienced the temperature excursion of 8 degrees Fahrenheit for 48 hours and 45 minutes (also reported as 8 degrees Fahrenheit for total time of 876 minutes (14.6 hours). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot # L040414, expiration date 13-APR-2017; lot # reported as L045678, expiration date 09-MAY-2017 (also reported as 19-MAY-2017); lot # reported as L046508, expiration date 17-MAY-2017; lot # L046509, expiration date 17-MAY-2017; lot # L045676, expiration date 09-MAY-2017) (dose and route of administration were not reported). Administered doses experienced the temperature excursion of 8 degrees Fahrenheit for 48 hours and 45 minutes (also reported as 8 degrees Fahrenheit for 876 minutes (14.6 hours)). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown demographics. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates beginning in December 2015, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot # L027733, expiration date: 13-SEP-2017 and lot # L033343, expiration date: 13-SEP-2017; dose and route were not provided). The vaccine was exposed to temperature of 32 degrees Fahrenheit for 30 days. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician and refers to a 12 year old female patient with attention deficit/hyperactivity disorder. On 02-SEP-2015 the patient was vaccinated with the first dose of GARDASIL 9, second dose on 03-DEC-2015. The patient received third dose of GARDASIL 9 on 25-FEB-2016, lot # L028082, 0.5 ml, intramuscular. Concomitant therapies included FOCALIN. On an unknown date in February 2016, within 12 hours of receiving the third dose, the patient developed a fever of 102 Fahrenheit. The patient received treatment with TYLENOL in the morning and ibuprofen in the afternoon but nothing had brought the fever down. The patient sought medical attention with physician on 26-FEB-2016 and received an additional TYLENOL in the clinic for her 102.6 Fahrenheit fever and her fever had still not come down. The outcome of pyrexia was reported as not recovered. The reporter did not assess the causality of the event with GARDASIL 9. 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 and refers to an unspecified number of patients of unknown demographics. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates beginning in December 2015, the patients were vaccinated with doses of improperly stored ROTATEQ orally (lot # L006184, expiration date: 13-DEC-2016, lot # L027067, expiration date: 06-APR-2017 and lot # L029617, expiration date: 19-MAY-2017; dose was not provided). The vaccine was exposed to temperature of 32 degrees Fahrenheit for 30 days. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates beginning in December 2015, the patients were vaccinated with doses of improperly stored GARDASIL (lot # K008931, expiration date: 04-MAR-2017; dose and route were not provided). The vaccine was exposed to temperature of 32 degrees Fahrenheit for 30 days. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a patient of unknown age and gender. No concurrent condition or medical history were described. On an unknown date, the patient was vaccinated with ZOSTAVAX, (dose or anatomical location were not provided) subcutaneous. Concomitant therapy was not reported. On an unknown date, the patient experienced "small shingles like rash". The patient sought for medical attention by called the physician. At the reporting time, the outcome of small shingles like rash was not informed. 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 refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. The reporter stated that improperly stored (temperature: 15.8 F and time frame: 10 hours and 75 minutes) doses of (Oka/Merck) VARIVAX (lot: L006383, expiration date: 25-FEB-2017; lot# L015048, expiration date: 29-APR-2017; lot# L019124, expiration date: 27-MAY-2017; lot# L019130, expiration date: 27-MAY-2017; lot# L023588, expiration date: 26-JUN-2017 and lot# reported as L29418, expiration date: 06-AUG-2017) (dose and route were not reported) were administered to the patients on unspecified dates. No adverse effects reported. There were no previous excursions. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Rash.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an  unspecified number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates beginning in December 2015, the patients were vaccinated with doses of improperly stored VAQTA (lot # L023232, expiration date: 25-FEB-2017 and lot # K018181, expiration date: 04-JUN-2017; dose and route were not provided). The vaccine was exposed to temperature of 32 degrees Fahrenheit for 30 days. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an other health professional (certified medical assistant) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not reported. On 25-FEB-2016, the patient was inadvertently vaccinated with an expired dose of ROTATEQ lot number K004773, expiration date 22-FEB-2016, orally (dose was not reported). No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and a healthcare worker refers to a 4 year old male patient. The patient's concurrent conditions, medical history and concomitant therapy was not provided. On 06-JAN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck), lot # L030586 with an expiration date on 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Patient's pertinent medical history, drug reactions/allergies, concomitant medications were not reported. On 12-SEP-2002, the patient was vaccinated with the first dose of VAQTA, and then on 18-AUG-2003 the patient received the second dose (strength, dose, frequency, route and lot number were not reported). Additionally, the patient received extra 4 doses on 13-FEB-2007, on 01-FEB-2008, on 12-JUN-2012 and on 09-DEC-2013. No adverse effects were reported and no product quality complaint was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On an unknown dates, the patients "may" had received unspecified doses of MMR II injection (dose, route of administration, expiration date and indication were not reported) that had been exposed to light. No adverse effects were reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: Information has been received from a nurse referring to a 56 year old female patient who had allergy to sulfa. No information regarding pertinent medical history or concomitant medication was provided. On 25-FEB-2016 the patient was vaccinated with a dose of ZOSTAVAX (subcutaneous in the left arm, dose, dose# and lot# unknown). On 26-FEB-2016 the patient experienced onset of reaction which was descripted by the patient as that her left arm began to burn starting at injection site, around the left arm, which turned into a huge long red welted up hardness knot for a good week. She also stated she developed headache and chills. The Nurse stated that she iced the site and the patient was recovering and the redness was fading. No treatment was given for the events and the patient did not seek medical attention. Additional information is not expected since there was no consent to contact physician.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Urticaria
Clinical narrative: Information has been received from a nurse referring to a 56 year old female patient who had allergy to sulfa. No information regarding pertinent medical history or concomitant medication was provided. On 25-FEB-2016 the patient was vaccinated with a dose of ZOSTAVAX (subcutaneous in the left arm, dose, dose# and lot# unknown). On 26-FEB-2016 the patient experienced onset of reaction which was descripted by the patient as that her left arm began to burn starting at injection site, around the left arm, which turned into a huge long red welted up hardness knot for a good week. She also stated she developed headache and chills. The Nurse stated that she iced the site and the patient was recovering and the redness was fading. No treatment was given for the events and the patient did not seek medical attention. Additional information is not expected since there was no consent to contact physician.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date the patient was vaccinated with improperly stored ROTATEQ (lot # L013192, expiration date: 19-JAN-2017, dose and route were not reported). Concomitant drug was not reported. The vaccine had exposed to 32.4 F temperature for 2 hours and 15 minutes without previous temperature excursion. No adverse event was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date the patient was vaccinated with improperly stored PEDVAXHIB (lot # L004738, expiration date: 10-NOV-2017, dose and route were not reported). Concomitant drug was not reported. The vaccine had exposed to 32.4 F temperature for 2 hours and 15 minutes without previous temperature excursion. No adverse event was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with doses of improperly stored PROQUAD (Merck), lot # L041627, expiration date: 20-APR-2017 (dose and route of administration were not reported). Administered doses of PROQUAD (Merck) underwent temperature excursions at 14.5 degrees Celsius for 6.58 hours. Information about the previous temperature excursions was not reported. There were no adverse effects reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has received from a physician assistant referring to a patient to unknown age and gender. On 16-FEB-2016 the patient was vaccinated with an expired dose of VAQTA (50U/1ml, lot # K010195, expired date 15-JAN-2016), 1 DF. There was no adverse event reported. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Incorrect route of drug administration, Off label use, Pruritus
Clinical narrative: Information has been received from a 58 year old female consumer referring to herself. There were drug reactions/allergies to penicillin, all antibiotics, sulfa drugs and BOTOX. The patient's pertinent medical history included blepharospasm. Sometime during the year of2006, the patient received two vaccine shots of ZOSTAVAX (dose, lot number not provided). It was also stated that it was administered through the intramuscular, which was other-than-indicated in the prescribing information (subcutaneous injection formulation administered by other route and off label use). Concomitant therapies included simvastatin (manufacturer unknown) and lorazepam. She stated that about two years later in 2008, she had an itchiness on the "her lower right side of the back towards the spine" that continued to the reporting day. The outcome of pruritus was reported as not recovered/not resolved. She talked with physician and was given clobetasol propionate for treatment. There were no diagnostics lab studies performed. The outcome of incorrect route of drug administration and off label use was unknown. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site pain, Interchange of vaccine products
Clinical narrative: This spontaneous report as received from a consumer refers to her 13 year old son. On 13-AUG-2015 the patient was vaccinated with the first dose of GARDASIL 9, intramuscularly. On an unspecified date, the patient was vaccinated with the second dose of GARDASIL 9, intramuscularly. Concomitant therapy included VYVANSE. There were no pertinent medical history and drug reactions/allergies. On an unspecified date, the patient was given GARDASIL instead of GARDASIL 9. After receiving GARDASIL, on 05-MAR-2016, the patient experienced tenderness at the injection site. No treatment was given for this adverse event. No lab diagnostics was performed. Unspecified medical attention was sought via taking with nurse in physician's office. Action taken with therapy GARDASIL 9 was reported as continued. On an unknown date in 2016, the patient recovered from tenderness at the injection site. The relationship between tenderness at the injection site and GARDASIL 9 and GARDASIL were not provided. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a 24 year old female patient. The patient was 30 weeks pregnant and had Gestational diabetes. The patient had no known drug allergies. On 23-FEB-2016 the patient was vaccinated with a 0.5 ml dose of GARDASIL 9 lot number L016428, expiration date unknown) intramuscularly in left deltoid (Drug exposure during pregnancy, third trimester.). Concomitant medication included pre-natal vitamins only. The patient's estimated LMP was 28-JUL-2015 and EDD was 03-MAY-2016 (calculated by reported gestational week). The pregnancy outcome was pending. At the time of this reporting there was no adverse effects reported. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a licensed practitioner nurse referring to a 11 year old patient. On 18-FEB-2016, the patient was vaccinated with PEDVAXHIB (lot # J013944, expiration date 13-AUG-2016, dose, route not provided) (inappropriate schedule of vaccine administered). 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 as received from a medical assistant refers to 4 unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of VARIVAX (Merck) (Lot# L034370 and expiration date 08-SEP-2017; Lot# L026410 and expiration date 15-FEB-2017) that was improperly stored. The storage temperature was Celsius degree with time frame of 94 hours. There was no previous temperature excursion. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified two patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, patients were vaccinated with two doses of improperly stored (temperature was 56 F for 2 hours, because of data logger) PNEUMOVAX 23, lot # L017265, expiry date 10-FEB-2017, (route of administration not reported). Previous temperature excursion was 68.5F for 11 hours 45 minutes. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and a healthcare worker refers to a 4 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On 06-JAN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck), lot # L030586 with an expiration date on 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown demographics. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates beginning in December 2015, the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # L043213, expiration date: 28-AUG-2017; dose and route were not provided). The vaccine was exposed to temperature of 32 degrees Fahrenheit for 30 days. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.