chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: On June 8, 2017 patient received her ADACEL and MENACTRA shots. She had been a healthy girl only missing 2 days of school that year. 48 hours after the shots she developed a fever (101) with sore throat and upper respiratory cold. The fever, sore throat, and cold resolved in about a week, but she still reported "not feeling well". She describes it as the feeling right before you get sick - you feel a little sick and know you aren't 100% well. She describes it as feeling 85%. She has muscle aches and twitching. She has had these symptoms for 5 months, and it all started 48 hours after the shots. We have visited out primary care physician. She ordered the attached labs, but all came back normal. After 5 months, we visited our neurologist, but only supplement recommendations were given. My daughter has not been the same since her shots. She still complains of feeling 85% with muscle aches and twitching.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Left arm redness and swelling which occurred less than 24 hrs after injection of PNEUMOVAX.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Myalgia, Nausea, Pyrexia, Retching
Clinical narrative: I had the current vaccine for the flu given at the clinic. About 10 hours later, I had the chills with body shaking. I was nauseated with gag, had muscle pain especially in the upper legs. I had an initial fever of 101 degrees that went to 103 degrees. This lasted about 4 hours. After taking Motrin, the issues subsided around midnight the day of the vaccination.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: I had the current vaccine for the flu given at the clinic. About 10 hours later, I had the chills with body shaking. I was nauseated with gag, had muscle pain especially in the upper legs. I had an initial fever of 101 degrees that went to 103 degrees. This lasted about 4 hours. After taking Motrin, the issues subsided around midnight the day of the vaccination.
Age: 0.67
Sex: M
Vaccine: HEP
Symptoms: Apnoea, Irritability
Clinical narrative: Apnea episode the night of the vaccine (had not had an episode since his adenoids were removed). The episode was approximately 30 seconds (we have a monitor that begins sounding after 20 seconds of no breathing). He fully woke and began breathing approximately 10 seconds after the alarm sounded. Additionally, he is extremely irritable the day following the shot (date of this report). He has not had irritability with any prior vaccines.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Asthenia, Bedridden, Chest discomfort, Dyspnoea
Clinical narrative: FIRST DAY I EXEPERIENCE MUSCLE SORENESS, PAIN IN JOINTS THROUGH THE FOLLOWING DAY, 10/27. I WAS UNABLE TO GET OUT OF BED DUE TO WEAKNESS, NOT TO MENTION  IT FELT AS THOUGH THERE WAS TON OF BRICKS ON MY CHEST WHERE I WAS HAVING DIFFICULTY BREATHING. I THOUGHT IT MIGHT HAVE BEEN SOMETHING I ATE THAT TOOK ALL OF THE TASTE OUT OF MOUTH. I KEPT DRINKING HOT FLUIDS HOPING MY CHEST WOULD OPEN UP. I SPOKE WITH A FRIEND THAT DAY BY PHONE AND HAD TO TAKE A BREATH WITH EACH WORD. THAT NIGHT I STARTED VOMITING, AND PERSPIRING UNCONTROLLABLE. I HAD SERVERAL MORE OCCURENCES TILL MORNING. UNABLE TO KEEP FLUIDS DOWN. I WAS BED RIDDEN FOR 4 DAYS DUE TO MY ADVERSE BREATHING. MY ASSUMPTION WAS ALLERGIES BECAUSE THE WEATHER HAD BEEN CHANGING. 10/30 I WENT OUT WITH MY HUSBAND SHOPPING BUT DID NOT HAVE THE ABILITY TO CONTINUE. I ASKED HIM IF WE HAVE LIQUID ABUTORAL BECAUSE I WAS GOING TO DO A TREATMENT. IT HELP SLIGHTLY TO EASE MY PARONOIA. DAY 10/31, MY CHEST OPENED UP. THE BODY ACHES SUBSIDED, HOWEVER I DEVELOPED A FULL BLOWN  HEAD COLD, THAT HAS NOW PASSED THROUGH TO MY LUNGS'. IF NOT BETTER I WILL SEE MY DOCTOR OR GO TO WALK IN, TO INSURE THIS DOES NOT DEVELOP INTO PNEUMONIA.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Hyperhidrosis, Malaise, Mobility decreased, Myalgia, Nasopharyngitis
Clinical narrative: FIRST DAY I EXEPERIENCE MUSCLE SORENESS, PAIN IN JOINTS THROUGH THE FOLLOWING DAY, 10/27. I WAS UNABLE TO GET OUT OF BED DUE TO WEAKNESS, NOT TO MENTION  IT FELT AS THOUGH THERE WAS TON OF BRICKS ON MY CHEST WHERE I WAS HAVING DIFFICULTY BREATHING. I THOUGHT IT MIGHT HAVE BEEN SOMETHING I ATE THAT TOOK ALL OF THE TASTE OUT OF MOUTH. I KEPT DRINKING HOT FLUIDS HOPING MY CHEST WOULD OPEN UP. I SPOKE WITH A FRIEND THAT DAY BY PHONE AND HAD TO TAKE A BREATH WITH EACH WORD. THAT NIGHT I STARTED VOMITING, AND PERSPIRING UNCONTROLLABLE. I HAD SERVERAL MORE OCCURENCES TILL MORNING. UNABLE TO KEEP FLUIDS DOWN. I WAS BED RIDDEN FOR 4 DAYS DUE TO MY ADVERSE BREATHING. MY ASSUMPTION WAS ALLERGIES BECAUSE THE WEATHER HAD BEEN CHANGING. 10/30 I WENT OUT WITH MY HUSBAND SHOPPING BUT DID NOT HAVE THE ABILITY TO CONTINUE. I ASKED HIM IF WE HAVE LIQUID ABUTORAL BECAUSE I WAS GOING TO DO A TREATMENT. IT HELP SLIGHTLY TO EASE MY PARONOIA. DAY 10/31, MY CHEST OPENED UP. THE BODY ACHES SUBSIDED, HOWEVER I DEVELOPED A FULL BLOWN  HEAD COLD, THAT HAS NOW PASSED THROUGH TO MY LUNGS'. IF NOT BETTER I WILL SEE MY DOCTOR OR GO TO WALK IN, TO INSURE THIS DOES NOT DEVELOP INTO PNEUMONIA.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: FIRST DAY I EXEPERIENCE MUSCLE SORENESS, PAIN IN JOINTS THROUGH THE FOLLOWING DAY, 10/27. I WAS UNABLE TO GET OUT OF BED DUE TO WEAKNESS, NOT TO MENTION  IT FELT AS THOUGH THERE WAS TON OF BRICKS ON MY CHEST WHERE I WAS HAVING DIFFICULTY BREATHING. I THOUGHT IT MIGHT HAVE BEEN SOMETHING I ATE THAT TOOK ALL OF THE TASTE OUT OF MOUTH. I KEPT DRINKING HOT FLUIDS HOPING MY CHEST WOULD OPEN UP. I SPOKE WITH A FRIEND THAT DAY BY PHONE AND HAD TO TAKE A BREATH WITH EACH WORD. THAT NIGHT I STARTED VOMITING, AND PERSPIRING UNCONTROLLABLE. I HAD SERVERAL MORE OCCURENCES TILL MORNING. UNABLE TO KEEP FLUIDS DOWN. I WAS BED RIDDEN FOR 4 DAYS DUE TO MY ADVERSE BREATHING. MY ASSUMPTION WAS ALLERGIES BECAUSE THE WEATHER HAD BEEN CHANGING. 10/30 I WENT OUT WITH MY HUSBAND SHOPPING BUT DID NOT HAVE THE ABILITY TO CONTINUE. I ASKED HIM IF WE HAVE LIQUID ABUTORAL BECAUSE I WAS GOING TO DO A TREATMENT. IT HELP SLIGHTLY TO EASE MY PARONOIA. DAY 10/31, MY CHEST OPENED UP. THE BODY ACHES SUBSIDED, HOWEVER I DEVELOPED A FULL BLOWN  HEAD COLD, THAT HAS NOW PASSED THROUGH TO MY LUNGS'. IF NOT BETTER I WILL SEE MY DOCTOR OR GO TO WALK IN, TO INSURE THIS DOES NOT DEVELOP INTO PNEUMONIA.
Age: 40.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Dyspnoea
Clinical narrative: Patient reported she experienced SOB, stated she took Benadryl with good effect.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Blood test normal, Borrelia test negative, Malaise, Musculoskeletal pain
Clinical narrative: Patient reported having a fever and achiness in her right shoulder on the night of receiving vaccine and it lasted until the Sunday after, which was 2 days post vaccine. Spoke to her on 10-11-17 and she said she was feeling better but she has returned to pharmacy on 11-15-17 to report she is still feeling ill and now has joint pain all over. She saw md and all tests to this point are negative and has been referred to Rheumatologist for further testing.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Patient reported having a fever and achiness in her right shoulder on the night of receiving vaccine and it lasted until the Sunday after, which was 2 days post vaccine. Spoke to her on 10-11-17 and she said she was feeling better but she has returned to pharmacy on 11-15-17 to report she is still feeling ill and now has joint pain all over. She saw md and all tests to this point are negative and has been referred to Rheumatologist for further testing.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug reactions or allergies were not provided. On 17-OCT-2017, the patient was vaccinated with expired M-M-R II (dose and route of administration not specified) lot # L039613, expiration date 08-OCT-2017 for prophylaxis. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT) lot number N021895, expiration date 29-NOV-2019. The patient experienced no adverse events. The outcome of expired product administered was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-OCT-2017, the patient was vaccinated with an expired dose of ZOSTAVAX 0.65 ml, subcutaneously, lot# M033910, expiration date17-OCT-2017 (anatomical location was not reported) for prophylaxis. The sterile diluent (manufacturer unknown) used for vaccination was not expired.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Blood immunoglobulin G decreased, Maternal exposure before pregnancy, Therapy non-responder
Clinical narrative: This spontaneous prospective pregnancy report as received from a licensed practical nurse refers to a 31 year old female patient. The patient's concurrent conditions were not provided. The patient had no drug reactions or allergies. Concomitant therapies included unspecified prenatal vitamins. On 10-JAN-2016, the patient received her first dose of M-M-R II, lot # L027431 with expiration date on 27-JUL-2017 (dose and route of administration were not reported), which was reconstituted with sterile diluent (lot # and expiration date were unknown). On an unknown date in 2017, after administration of M-M-R II, the patient became pregnant. At the time of this report (reported as "currently"), the patient was still pregnant. The pregnancy outcome was pending. The fetal outcome was unknown. The last menstrual period (LMP) date was on an unknown date in 2017 (estimated based on the fact that the patient was still pregnant). The estimated due date (EDD) was unknown. On an unknown date, after unspecified laboratory work was performed, it was discovered that the patient failed to seroconvert after administration of M-M-R II. On 17-APR-2017, a rubella titer test was performed and the result was indeterminate. In July 2017, the patient's immunoglobin G (IgG) was less than 0.90 (units not provided). No treatment was given for the event. The outcome of the event "failed to seroconvert" was not reported. The relatedness between the event "failed to seroconvert" and M-M-R II was not assessed by the reporter.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 01-NOV-2017 the patient was vaccinated with an expired dose of M-M-R II (unknown albumin status) lot # L041457 with an expiration date 22-OCT-2017, 0.5 ml, subcutaneously for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT). No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, historical condition and concomitant therapy were unknown. In approximately November 2017, the patient was vaccinated an expired dose of M-M-R II (albumin status rHA, lot # L043704, with expiration date 04-NOV-2017) (dose, dose#, route of administration were not reported) for prophylaxis, which was reconstituted with sterile diluent (manufacture unknown) (lot # N014021 with expiration date at 04-AUG-2019). M-M-R II had not gone through any temperature excursion. No adverse effects reported.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cold sweat, Loss of consciousness, Pallor, Posture abnormal
Clinical narrative: Patient given Tdap, MCV4, and HPV. After HPV patient blacked out, lean head down forward. He was able to talk after few second. He was pale and clammy. Vitals WNL recovered.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Crying, Injection site rash, Injection site swelling, Pain, Pyrexia
Clinical narrative: Per mom- legs red swollen rash at the injection sites. Crying in pain, fever, imbalance according to the mother (Telephone message).
Age: 10.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site Rt arm.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Flushing, Peripheral swelling, Rash, Salivary hypersecretion
Clinical narrative: Face flushed -10 minutes , arm swelling - 1 hr lasting two days., arm rash -5 hours -lasting two days, fatigue 5 hours - lasting two days, weak feeling -5 hours. lasting two days, mouth watering - 8th  hour- lasting 1 hour.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Oropharyngeal pain, Urticaria
Clinical narrative: Sore throat, hives, and headache. Hives started on wrists/hands but progressed up arms, feet, and top of thighs. No breathing impacts other than sore throat.
Age: 12.0
Sex: M
Vaccine: IPV
Symptoms: Drug prescribing error, No adverse event
Clinical narrative: Physician checked the wrong vaccine box to administer on the Encounter/order. She meant to check HPV. Parent was notified. Patient did not experience any side effects.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Insomnia, Pain in extremity, Tremor, Vomiting
Clinical narrative: Arm pain, chills, shaking, sleeplessness, vomiting.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Pain in extremity, X-ray
Clinical narrative: HORRIBLE PAIN IN RIGHT SHOULDER BLADE THAT RADIATES TO MY FOREARM - NOTHING ALLEVIATES THE PAIN AND HAVE BEEN TAKING 800 MG OF IBUPROFEN EVERY 6 HOURS SINCE PAIN STARTED.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chills, Confusional state, Dyspnoea, Headache
Clinical narrative: Recurrent chills, headaches, confusion and breathing difficulties. Breathing difficulties and headache improved with use of albuterol inhaler. Symptoms lasted for 2 months then resolved. This happens every year she gets vaccinated.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, Pregnancy test positive, Ultrasound antenatal screen normal
Clinical narrative: No adverse events know as of now. No symptom, signs, etc known as of now. Pt was given vaccines by another CMA and pregnancy was unknown to all parties. Pt came to office on 8/16/17 to establish care w/ Dr. Patient requested OBC but denied being sexually active - last cycle 7/28/17. Pt. was given OBC and given vaccines listed above. Pt took OBC in months September and October. Pt returned 10/25/17 for 2nd HPV vaccine. Pt returned 11/9/17 reporting positive home preg. test. Blood HCG was positive in office, pt sent for OB U/S and measured 38 weeks plus 3 days.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose increased, Electrocardiogram normal, Feeling hot, Loss of consciousness, Syncope
Clinical narrative: She had an episode of syncope about 22 hours after receiving the vaccine. She was standing in the bathroom first thing in the morning, and said she felt hot. Shortly thereafter, she passed out and her mom caught her. Her mom estimates she was unresponsive for about 30 seconds before she spontaneously awoke. She was brought to the ED, and vomited several times on arrival. She then returned to normal and was able to be discharged from the ED without intervention.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Unresponsive to stimuli, Urine analysis normal, Vomiting
Clinical narrative: She had an episode of syncope about 22 hours after receiving the vaccine. She was standing in the bathroom first thing in the morning, and said she felt hot. Shortly thereafter, she passed out and her mom caught her. Her mom estimates she was unresponsive for about 30 seconds before she spontaneously awoke. She was brought to the ED, and vomited several times on arrival. She then returned to normal and was able to be discharged from the ED without intervention.
Age: 1.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, VARCEL
Symptoms: Blister, Crying, Pyrexia, Scab, Skin lesion
Clinical narrative: Mother reports that child started to break out in lesions Nov. 3rd, one day after vaccines were given. She had them on arms, legs, hands, feet, back and buttock. Developed a fever Thursday that lasted thru Sunday. She had crying bouts that started Saturday, Nov. 4th  from approx. 9PM to 3AM that night Mother contacted her PMP and described what was going on, was advised to treat the symptoms, no respiratory distress was noted and follow up with urgent care in the AM. Child was seen at Urgent Care clinic Sunday Nov. 5th and then by Dr. on Monday Nov. 6th. Dr. diagnosed the condition as chicken pox. I spoke with Mother 11/15/2017 and she reports that patient is much better now and most of the vesicles have crusted over fine and are healed up. The few remaining are on her buttock area that is covered by a diaper and harder to heal. She is open to contact by VAERS if needed for additional information.
Age: 1.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Mother reports that child started to break out in lesions Nov. 3rd, one day after vaccines were given. She had them on arms, legs, hands, feet, back and buttock. Developed a fever Thursday that lasted thru Sunday. She had crying bouts that started Saturday, Nov. 4th  from approx. 9PM to 3AM that night Mother contacted her PMP and described what was going on, was advised to treat the symptoms, no respiratory distress was noted and follow up with urgent care in the AM. Child was seen at Urgent Care clinic Sunday Nov. 5th and then by Dr. on Monday Nov. 6th. Dr. diagnosed the condition as chicken pox. I spoke with Mother 11/15/2017 and she reports that patient is much better now and most of the vesicles have crusted over fine and are healed up. The few remaining are on her buttock area that is covered by a diaper and harder to heal. She is open to contact by VAERS if needed for additional information.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Gait inability, Mobility decreased
Clinical narrative: Patient couldn't walk or move his legs. Called pediatrician, told to monitor child. Twelve hours later the patient completely recovered.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site inflammation, Injection site pain
Clinical narrative: After injection, patient stated he experienced some burning sensation but nothing extreme. The next morning, the burning sensation had increased and he saw that the injection site was inflamed in a circular area around it about the size of a pear. The patient stated it was painful but not unbearable and no systemic symptoms. All symptoms were limited to localized side effects. On day 2, the area seemed to have improved a little but came in for a consultation with the pharmacist on staff and they chose to continue to monitor the condition. It has improved each day.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reports headache noticed on 11/15 along with generalized muscle aches and local pain, heat, swelling and redness around injection site. She treated the symptoms with Excedrin Migraine, which the headache and muscle aches have resolved. The injection site pain, heat, and redness have increased since onset. No other treatments have been tried. Affected area measures 4.5 x 5.5 cm.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia
Clinical narrative: Patient reports headache noticed on 11/15 along with generalized muscle aches and local pain, heat, swelling and redness around injection site. She treated the symptoms with Excedrin Migraine, which the headache and muscle aches have resolved. The injection site pain, heat, and redness have increased since onset. No other treatments have been tried. Affected area measures 4.5 x 5.5 cm.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain, Body temperature increased, Diarrhoea, Erythema, Injection site pruritus
Clinical narrative: Reports 102 degree temp, abd pain, N/D, arm swollen size of softball from shoulder to elbow with redness, body aches, itching at injection site; reports taking BENADRYL, applying ice, rest; improved after 24 hours.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Pain, Peripheral swelling
Clinical narrative: Reports 102 degree temp, abd pain, N/D, arm swollen size of softball from shoulder to elbow with redness, body aches, itching at injection site; reports taking BENADRYL, applying ice, rest; improved after 24 hours.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Back pain, Injection site pain
Clinical narrative: Left shoulder/upper left back area pain. I still have pain and soreness. My doctor prescribed an anti-inflammatory medication, but did not help much.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Injection site bruising, Injection site swelling, Musculoskeletal pain
Clinical narrative: I received the flu shot on the above date. I instantly noticed swellling of the area. The next morning a brusie was noted at the injection site. 2 days after I started having pain inside my shoulder. The pain was so uncomfortable i was unable to get comfortable at times. Anti inflammatory did help some. When the pain got intense i did notify my management. To this day. I do have some soreness but minimal. I have seen an improvement. My bruise is still present.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient has pain, tenderness, and swelling around injection site since the day injection was administered for the past two months. Still hurts to lie on and has been massaging the area and taking ADVIL, TYLENOL but without relief.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an adolescent patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not specified. In June 2016 (at 13 years of age), the patient was vaccinated with the first dose of GARDASIL 9 (dose, route of administration, lot number and expiration date were not provided) for prophylaxis. On 20-OCT-2017, the patient visited an office to be vaccinated with the second dose of GARDASIL 9 (dose, route of administration, lot number and expiration date were not provided) for prophylaxis. The patient did not experience any adverse events. The outcome of the event was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy intern referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. The patient's concomitant medications included sterile diluent (MERCK). On 25-OCT-2017, the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque-Forming Units, 1 dose, intramuscularly (incorrect route of drug administration), for prophylaxis (lot # and expiration date were not reported). No symptoms were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report was received from a physician referring to a 71 year old female patient. The patient had no pertinent medical history, drug reactions/allergies, nor concomitant medications. On an unspecified date in 2015, the patient was vaccinated with a dose of ZOSTAVAX, 19400 Plaque Forming Units, for prophylaxis (route of administration, lot # and expiration date were not reported). On an unknown date, the patient developed shingles lesions on the left side of the gluteus with slight pain. No treatment was given for the adverse events and no diagnostic tests were performed. The patient recovered from herpes zoster 1 and half weeks later. At the time of reporting, the outcome of pain was reported as recovered on an unspecified date. The causality assessment between herpes zoster, and pain with ZOSTAVAX was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 plaque-forming units (PFU) vial, (dose, route of administration, lot # and expiration date were not reported). On 02-NOV-2017, the patient missed a dose of ZOSTAVAX, lot # N024561 with expiration date on 05-DEC-2018, because the sterile diluent used for reconstitution was "not available". No adverse effects were reported.
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an adult female patient (exact age unknown). The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 03-NOV-2017, the patient was administered a pediatric dose of VAQTA (dose, route of administration, lot # and expiration date were not reported), instead of an intended adult dose. No adverse effects were reported.
Age: 61.0
Sex: M
Vaccine: HEP, HEPA, PPV, VARZOS
Symptoms: Erythema, Induration, Skin reaction, Type III immune complex mediated reaction
Clinical narrative: This spontaneous report was received from a physician who referred to a 61 year old male patient with diabetes and immunodeficiency. The patient did not have any known drug reactions or allergies. On 02-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 (lot# and expiration date were not reported) for immunodeficiency. Other suspect therapies also included ZOSTAVAX, hepatitis A vaccine (manufacturer unknown) and hepatitis B vaccine (manufacturer unknown) all administered on 03-NOV-2017 (lot numbers and expiration dates were not reported). On the same day (also reported as 24 hours after receiving PNEUMOVAX 23), the patient experienced a skin reaction, described as a "17 cm, erythema, circular area with induration, appeared like a Arthus reaction. The physician was not able to clarify further. The patient sought medical attention and unspecified treatment was given for the adverse event. There were no lab diagnostic studies performed. The patient was recovering from the event, at the time of the report. The relatedness between the event and all suspect therapies was not reported. Upon internal review, the event of Arthus reaction was considered to be medically significant.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Pt. given 2nd flu vaccine today was at office seeking VARIVAX. Miscommunication of scheduling and nurse/parent. 1st FLUZONE 11-2-2017.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Skin warm
Clinical narrative: Redness erythematous 5 1/2 cm x 5 1/2 cm. Warm to touch no swelling, no streaking.
Age: 79.0
Sex: F
Vaccine: FLUX
Symptoms: Chest discomfort, Chills, Fatigue, Nasopharyngitis, Pain
Clinical narrative: Cold like symptoms. Aches, chills, fatigue, heaviness of chest.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Crying, Irritability
Clinical narrative: Approximately 2.5 hours after vaccinations, infant became fussy and irritable, crying inconsolably which lasted, despite TYLENOL and other comfort measures, until he went to sleep that night. This lasted greater than 7 hours.
Age: 46.0
Sex: M
Vaccine: MNQ
Symptoms: Paraesthesia, Rash
Clinical narrative: 9:10 AM-vaccinated with MENACTRA, 9:30 AM paresthesia of left hand; resolved within minutes. 10:54 AM rash of left thumb, no pruritus, no chest pain, no SOB, no cough or wheeze; vs stable. On ALLEGRA, take BENADRYL once at home and course of steroids.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Abdominal pain upper, Amino acid level increased, Anti-thyroid antibody positive, Asthenia
Clinical narrative: In Aug 13th, patient received her HPV vaccine. 1 month later (Sept 13th)  Started with HA fatigue, stomach pain, sore throat ear pain, runny nose, no fevers. Tested for strep and was negative.  Symptoms lasted 5 days. She would come home from school, and then go right to bed for about and hour and then get up. Do her schoolwork. She continued to have some lingering fatigue. Was able to go on trip, after 3rd day of the trip she was dragging quite a bit, wanted to go back to the room.  October 3rd, developed another sore throat and belly pain. Throat Cx and CBC were normal. TSH 5. FT4 1.08 nml. Continued to have stomach and HA ear pain, lasting another couple weeks. Went back to the doctor Oct 5th. Tested for EBV and Lyme which were neg. Strep negative again. Seen by ENT, no sinus disease. October 6th she started having difficulty walking stating that the room was spinning. Developed slow movements. She didn't want to eat or drink. Continued to complain of sore throat.     Pediatrician did prescribe doxycycline for a course which did not effect symptoms. Treated with singulair and Benedryl started to improve some. She started to need to be helped up the stairs. On Oct 14th she had very difficult time getting to stand which they attributed to weakness. She was really saying why she couldn't get up. Says she felt like the room was spinning (worse with eyes closed and with turning of her head) and that her legs were very heavy. No nausea or vomiting. Seemed lethargic. Admitted to the hospital. MRI of the brain and the spine were normal. She was having difficulty standing. For the first few days of admission worked with the psychologist. She then continued to have substantial HA, abdominal pain, anorexia, extreme fatigue, dizziness. She did have an episode when she came out the shower, she seemed pale and looked like she was going to pass out. Started IVF's after that. Following this she seemed to walk a little better. Had an EMG, EEG, LP which were all normal. Overall seemed to be slowly improving was able to walk with PT and walk up stairs. Since she got home, she is eating better. Dizziness is worse in the evening. In the morning she seems to have better energy level. Now HA once every other day last 10 min -60 min back of the head. No N/V/D.  Belly pain waxes and wanes, about every other day. Fatigue is slowly improving but waxes and wanes. Out of school arranging for home school. Overall functionality: at its worse 2/10, currently 4/10.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Blood thyroid stimulating hormone normal, Borrelia test negative, Culture throat negative, Decreased appetite, Diet refusal
Clinical narrative: In Aug 13th, patient received her HPV vaccine. 1 month later (Sept 13th)  Started with HA fatigue, stomach pain, sore throat ear pain, runny nose, no fevers. Tested for strep and was negative.  Symptoms lasted 5 days. She would come home from school, and then go right to bed for about and hour and then get up. Do her schoolwork. She continued to have some lingering fatigue. Was able to go on trip, after 3rd day of the trip she was dragging quite a bit, wanted to go back to the room.  October 3rd, developed another sore throat and belly pain. Throat Cx and CBC were normal. TSH 5. FT4 1.08 nml. Continued to have stomach and HA ear pain, lasting another couple weeks. Went back to the doctor Oct 5th. Tested for EBV and Lyme which were neg. Strep negative again. Seen by ENT, no sinus disease. October 6th she started having difficulty walking stating that the room was spinning. Developed slow movements. She didn't want to eat or drink. Continued to complain of sore throat.     Pediatrician did prescribe doxycycline for a course which did not effect symptoms. Treated with singulair and Benedryl started to improve some. She started to need to be helped up the stairs. On Oct 14th she had very difficult time getting to stand which they attributed to weakness. She was really saying why she couldn't get up. Says she felt like the room was spinning (worse with eyes closed and with turning of her head) and that her legs were very heavy. No nausea or vomiting. Seemed lethargic. Admitted to the hospital. MRI of the brain and the spine were normal. She was having difficulty standing. For the first few days of admission worked with the psychologist. She then continued to have substantial HA, abdominal pain, anorexia, extreme fatigue, dizziness. She did have an episode when she came out the shower, she seemed pale and looked like she was going to pass out. Started IVF's after that. Following this she seemed to walk a little better. Had an EMG, EEG, LP which were all normal. Overall seemed to be slowly improving was able to walk with PT and walk up stairs. Since she got home, she is eating better. Dizziness is worse in the evening. In the morning she seems to have better energy level. Now HA once every other day last 10 min -60 min back of the head. No N/V/D.  Belly pain waxes and wanes, about every other day. Fatigue is slowly improving but waxes and wanes. Out of school arranging for home school. Overall functionality: at its worse 2/10, currently 4/10.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Dyskinesia, Dysstasia, Ear pain, Electroencephalogram normal
Clinical narrative: In Aug 13th, patient received her HPV vaccine. 1 month later (Sept 13th)  Started with HA fatigue, stomach pain, sore throat ear pain, runny nose, no fevers. Tested for strep and was negative.  Symptoms lasted 5 days. She would come home from school, and then go right to bed for about and hour and then get up. Do her schoolwork. She continued to have some lingering fatigue. Was able to go on trip, after 3rd day of the trip she was dragging quite a bit, wanted to go back to the room.  October 3rd, developed another sore throat and belly pain. Throat Cx and CBC were normal. TSH 5. FT4 1.08 nml. Continued to have stomach and HA ear pain, lasting another couple weeks. Went back to the doctor Oct 5th. Tested for EBV and Lyme which were neg. Strep negative again. Seen by ENT, no sinus disease. October 6th she started having difficulty walking stating that the room was spinning. Developed slow movements. She didn't want to eat or drink. Continued to complain of sore throat.     Pediatrician did prescribe doxycycline for a course which did not effect symptoms. Treated with singulair and Benedryl started to improve some. She started to need to be helped up the stairs. On Oct 14th she had very difficult time getting to stand which they attributed to weakness. She was really saying why she couldn't get up. Says she felt like the room was spinning (worse with eyes closed and with turning of her head) and that her legs were very heavy. No nausea or vomiting. Seemed lethargic. Admitted to the hospital. MRI of the brain and the spine were normal. She was having difficulty standing. For the first few days of admission worked with the psychologist. She then continued to have substantial HA, abdominal pain, anorexia, extreme fatigue, dizziness. She did have an episode when she came out the shower, she seemed pale and looked like she was going to pass out. Started IVF's after that. Following this she seemed to walk a little better. Had an EMG, EEG, LP which were all normal. Overall seemed to be slowly improving was able to walk with PT and walk up stairs. Since she got home, she is eating better. Dizziness is worse in the evening. In the morning she seems to have better energy level. Now HA once every other day last 10 min -60 min back of the head. No N/V/D.  Belly pain waxes and wanes, about every other day. Fatigue is slowly improving but waxes and wanes. Out of school arranging for home school. Overall functionality: at its worse 2/10, currently 4/10.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Electromyogram normal, Epstein-Barr virus test negative, Fatigue, Full blood count normal, Gait disturbance
Clinical narrative: In Aug 13th, patient received her HPV vaccine. 1 month later (Sept 13th)  Started with HA fatigue, stomach pain, sore throat ear pain, runny nose, no fevers. Tested for strep and was negative.  Symptoms lasted 5 days. She would come home from school, and then go right to bed for about and hour and then get up. Do her schoolwork. She continued to have some lingering fatigue. Was able to go on trip, after 3rd day of the trip she was dragging quite a bit, wanted to go back to the room.  October 3rd, developed another sore throat and belly pain. Throat Cx and CBC were normal. TSH 5. FT4 1.08 nml. Continued to have stomach and HA ear pain, lasting another couple weeks. Went back to the doctor Oct 5th. Tested for EBV and Lyme which were neg. Strep negative again. Seen by ENT, no sinus disease. October 6th she started having difficulty walking stating that the room was spinning. Developed slow movements. She didn't want to eat or drink. Continued to complain of sore throat.     Pediatrician did prescribe doxycycline for a course which did not effect symptoms. Treated with singulair and Benedryl started to improve some. She started to need to be helped up the stairs. On Oct 14th she had very difficult time getting to stand which they attributed to weakness. She was really saying why she couldn't get up. Says she felt like the room was spinning (worse with eyes closed and with turning of her head) and that her legs were very heavy. No nausea or vomiting. Seemed lethargic. Admitted to the hospital. MRI of the brain and the spine were normal. She was having difficulty standing. For the first few days of admission worked with the psychologist. She then continued to have substantial HA, abdominal pain, anorexia, extreme fatigue, dizziness. She did have an episode when she came out the shower, she seemed pale and looked like she was going to pass out. Started IVF's after that. Following this she seemed to walk a little better. Had an EMG, EEG, LP which were all normal. Overall seemed to be slowly improving was able to walk with PT and walk up stairs. Since she got home, she is eating better. Dizziness is worse in the evening. In the morning she seems to have better energy level. Now HA once every other day last 10 min -60 min back of the head. No N/V/D.  Belly pain waxes and wanes, about every other day. Fatigue is slowly improving but waxes and wanes. Out of school arranging for home school. Overall functionality: at its worse 2/10, currently 4/10.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Housebound, Inflammation, Lethargy, Limb discomfort
Clinical narrative: In Aug 13th, patient received her HPV vaccine. 1 month later (Sept 13th)  Started with HA fatigue, stomach pain, sore throat ear pain, runny nose, no fevers. Tested for strep and was negative.  Symptoms lasted 5 days. She would come home from school, and then go right to bed for about and hour and then get up. Do her schoolwork. She continued to have some lingering fatigue. Was able to go on trip, after 3rd day of the trip she was dragging quite a bit, wanted to go back to the room.  October 3rd, developed another sore throat and belly pain. Throat Cx and CBC were normal. TSH 5. FT4 1.08 nml. Continued to have stomach and HA ear pain, lasting another couple weeks. Went back to the doctor Oct 5th. Tested for EBV and Lyme which were neg. Strep negative again. Seen by ENT, no sinus disease. October 6th she started having difficulty walking stating that the room was spinning. Developed slow movements. She didn't want to eat or drink. Continued to complain of sore throat.     Pediatrician did prescribe doxycycline for a course which did not effect symptoms. Treated with singulair and Benedryl started to improve some. She started to need to be helped up the stairs. On Oct 14th she had very difficult time getting to stand which they attributed to weakness. She was really saying why she couldn't get up. Says she felt like the room was spinning (worse with eyes closed and with turning of her head) and that her legs were very heavy. No nausea or vomiting. Seemed lethargic. Admitted to the hospital. MRI of the brain and the spine were normal. She was having difficulty standing. For the first few days of admission worked with the psychologist. She then continued to have substantial HA, abdominal pain, anorexia, extreme fatigue, dizziness. She did have an episode when she came out the shower, she seemed pale and looked like she was going to pass out. Started IVF's after that. Following this she seemed to walk a little better. Had an EMG, EEG, LP which were all normal. Overall seemed to be slowly improving was able to walk with PT and walk up stairs. Since she got home, she is eating better. Dizziness is worse in the evening. In the morning she seems to have better energy level. Now HA once every other day last 10 min -60 min back of the head. No N/V/D.  Belly pain waxes and wanes, about every other day. Fatigue is slowly improving but waxes and wanes. Out of school arranging for home school. Overall functionality: at its worse 2/10, currently 4/10.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of personal independence in daily activities, Lumbar puncture normal, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal, Oropharyngeal pain
Clinical narrative: In Aug 13th, patient received her HPV vaccine. 1 month later (Sept 13th)  Started with HA fatigue, stomach pain, sore throat ear pain, runny nose, no fevers. Tested for strep and was negative.  Symptoms lasted 5 days. She would come home from school, and then go right to bed for about and hour and then get up. Do her schoolwork. She continued to have some lingering fatigue. Was able to go on trip, after 3rd day of the trip she was dragging quite a bit, wanted to go back to the room.  October 3rd, developed another sore throat and belly pain. Throat Cx and CBC were normal. TSH 5. FT4 1.08 nml. Continued to have stomach and HA ear pain, lasting another couple weeks. Went back to the doctor Oct 5th. Tested for EBV and Lyme which were neg. Strep negative again. Seen by ENT, no sinus disease. October 6th she started having difficulty walking stating that the room was spinning. Developed slow movements. She didn't want to eat or drink. Continued to complain of sore throat.     Pediatrician did prescribe doxycycline for a course which did not effect symptoms. Treated with singulair and Benedryl started to improve some. She started to need to be helped up the stairs. On Oct 14th she had very difficult time getting to stand which they attributed to weakness. She was really saying why she couldn't get up. Says she felt like the room was spinning (worse with eyes closed and with turning of her head) and that her legs were very heavy. No nausea or vomiting. Seemed lethargic. Admitted to the hospital. MRI of the brain and the spine were normal. She was having difficulty standing. For the first few days of admission worked with the psychologist. She then continued to have substantial HA, abdominal pain, anorexia, extreme fatigue, dizziness. She did have an episode when she came out the shower, she seemed pale and looked like she was going to pass out. Started IVF's after that. Following this she seemed to walk a little better. Had an EMG, EEG, LP which were all normal. Overall seemed to be slowly improving was able to walk with PT and walk up stairs. Since she got home, she is eating better. Dizziness is worse in the evening. In the morning she seems to have better energy level. Now HA once every other day last 10 min -60 min back of the head. No N/V/D.  Belly pain waxes and wanes, about every other day. Fatigue is slowly improving but waxes and wanes. Out of school arranging for home school. Overall functionality: at its worse 2/10, currently 4/10.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Pallor, Rhinorrhoea, Streptococcus test negative, Thyroxine free normal, Vertigo
Clinical narrative: In Aug 13th, patient received her HPV vaccine. 1 month later (Sept 13th)  Started with HA fatigue, stomach pain, sore throat ear pain, runny nose, no fevers. Tested for strep and was negative.  Symptoms lasted 5 days. She would come home from school, and then go right to bed for about and hour and then get up. Do her schoolwork. She continued to have some lingering fatigue. Was able to go on trip, after 3rd day of the trip she was dragging quite a bit, wanted to go back to the room.  October 3rd, developed another sore throat and belly pain. Throat Cx and CBC were normal. TSH 5. FT4 1.08 nml. Continued to have stomach and HA ear pain, lasting another couple weeks. Went back to the doctor Oct 5th. Tested for EBV and Lyme which were neg. Strep negative again. Seen by ENT, no sinus disease. October 6th she started having difficulty walking stating that the room was spinning. Developed slow movements. She didn't want to eat or drink. Continued to complain of sore throat.     Pediatrician did prescribe doxycycline for a course which did not effect symptoms. Treated with singulair and Benedryl started to improve some. She started to need to be helped up the stairs. On Oct 14th she had very difficult time getting to stand which they attributed to weakness. She was really saying why she couldn't get up. Says she felt like the room was spinning (worse with eyes closed and with turning of her head) and that her legs were very heavy. No nausea or vomiting. Seemed lethargic. Admitted to the hospital. MRI of the brain and the spine were normal. She was having difficulty standing. For the first few days of admission worked with the psychologist. She then continued to have substantial HA, abdominal pain, anorexia, extreme fatigue, dizziness. She did have an episode when she came out the shower, she seemed pale and looked like she was going to pass out. Started IVF's after that. Following this she seemed to walk a little better. Had an EMG, EEG, LP which were all normal. Overall seemed to be slowly improving was able to walk with PT and walk up stairs. Since she got home, she is eating better. Dizziness is worse in the evening. In the morning she seems to have better energy level. Now HA once every other day last 10 min -60 min back of the head. No N/V/D.  Belly pain waxes and wanes, about every other day. Fatigue is slowly improving but waxes and wanes. Out of school arranging for home school. Overall functionality: at its worse 2/10, currently 4/10.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: At time of immunization there was no visible reaction to the immunization. Patient called 7 days later to report to us that later that day and through now she has been experiencing pain, swelling, redness and itching at the site of the immunization. She just wanted to confirm that her reaction was justified from the vaccine and seek information on how to treat it. We did not treat the patient in the pharmacy at the time of the immunization as it was not necessary at that time.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain, Injection site reaction
Clinical narrative: Throbbing pain in upper left arm that worsened over time. The pain began night of injection and progressed to patient not being able to raise left arm over a period of 2 weeks. Patient went to primary care physician office for injection for bursitis at site and was ordered physical therapy. Patient has already received two weeks of physical therapy. Patient is able to raise arm now but is still experiencing pain.
Age: 21.0
Sex: F
Vaccine: FLU4, PPV, TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Fever(102.0F), redness, swelling at injection site. Stiffness and soreness localized to Rt upper deltoid.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising
Clinical narrative: PATIENT RETURNED TO THE PHARMACY 5 DAYS AFTER RECEIVING THE FLU IMMUNIZATION PRESENTING WITH A LARGE MODERATELY BLUE/YELLOW BRUISED AREA WHICH WAS APPROXIMATELY 3-4 INCHES BELOW THE SITE OF INJECTION AND TO THE LEFT OF THE INJECTION SITE. THE BRUISED AREA WAS NEVER PAINFUL TO THE PATIENT.