chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: This is a 72 yrs old male comes to clinic complaining of redness and swelling on the left arm for the past few days after Injection. Patient came to clinic for Physical exam. He got Pneumonia, Tdap and Zoster vaccine on the right deltoid area. Next day, he noticed mild swelling. Yesterday, he noticed redness and mild pain. He comes to clinic for medical recommendation. He denies skin rash, no SOB, no difficult to breath Start Benadryl Allergy Tablet, 25 MG, 1 tablet as needed, Orally, every 8 hrs, 5 day(s), 15 Tablet, Refills 0 ;  Start Naproxen Tablet, 375 MG, 1 tablet with food or milk as needed, Orally, every 12 hrs, 10 day(s), 20 Tablet, Refills 0. Notes: Immune response material was printed.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Gastric disorder, Malaise, Pruritus, Skin exfoliation
Clinical narrative: On Friday 12/1/17 patient received FLUZONE HD in her right arm. Patient had never had a history of reaction to a flu shot. The patient and her daughter called on 12/19/17 to let us know that she had a reaction to the shot that was described as followed. By Sunday 12/3 she was not feeling well/stomach issues. On Monday her face was red, by Tuesday her face was swollen/red/peeling. She went to her doctor in town on 12/6/17 who did not think it was related to the flu shot. He thought she just had a skin infection, wrote BACTRIM DS. On Friday 12/8/17 the swelling redness was worse, itching, flaking, spread from her face to her ears. She went to the ER where the doctor there thought it was a reaction to the flu shot and prescribed her MEDROL dose pack and Hydroxyzine. She has since finished that course of therapy and her symptoms have basically resolved by now. This is all according to the conversation I had with her daughter on 12/20/17 2:00p. The daughter wanted to make sure we were aware of the situation, and I informed her that we would let her PCP know of the occurrence. She was pleased by this. Patient's PCP was notified by myself to representative 12/20/17 2:13p to describe that she had reaction to the flu shot given.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face, Vaccination complication
Clinical narrative: On Friday 12/1/17 patient received FLUZONE HD in her right arm. Patient had never had a history of reaction to a flu shot. The patient and her daughter called on 12/19/17 to let us know that she had a reaction to the shot that was described as followed. By Sunday 12/3 she was not feeling well/stomach issues. On Monday her face was red, by Tuesday her face was swollen/red/peeling. She went to her doctor in town on 12/6/17 who did not think it was related to the flu shot. He thought she just had a skin infection, wrote BACTRIM DS. On Friday 12/8/17 the swelling redness was worse, itching, flaking, spread from her face to her ears. She went to the ER where the doctor there thought it was a reaction to the flu shot and prescribed her MEDROL dose pack and Hydroxyzine. She has since finished that course of therapy and her symptoms have basically resolved by now. This is all according to the conversation I had with her daughter on 12/20/17 2:00p. The daughter wanted to make sure we were aware of the situation, and I informed her that we would let her PCP know of the occurrence. She was pleased by this. Patient's PCP was notified by myself to representative 12/20/17 2:13p to describe that she had reaction to the flu shot given.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Patient had syncope event approximately 10 minutes after receiving HPV vaccine.
Age: 47.0
Sex: F
Vaccine: HEPA
Symptoms: Pain in extremity
Clinical narrative: Pt. c/o pain in right arm 3 weeks after admin.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Rash
Clinical narrative: Rash on shoulders, back, stomach, feet, hands.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin tightness, Skin warm
Clinical narrative: Swollen/tightness to left arm with redness and warmth.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discharge, Injection site erythema, Injection site vesicles, Injection site warmth
Clinical narrative: Left Deltoid/Upper arm red and warm to touch. Blistering with oozing.
Age: 51.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Noticed swelling, redness, and warm area where injection was given this morning (12/20) while taking a shower. The swollen area is hard under the skin. The affected area has gotten bigger throughout the day. Patient denies any itching or shortness of breath.
Age: 21.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: On 12-18-2017 during prenatal follow up office visit patient was administered a second dose of Flu at Gestational age of 35 weeks and 2 days and EDD 01/20/2018. First dose was administered on 10/21/2017. Patient has been notified and is scheduled for follow up on 12-28-2017. Awaiting on Glaxo Smith Kline Medical advisor to call back with recommendations for patient.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Chest pain, Dizziness, Dyspnoea, Immediate post-injection reaction, Injection site swelling
Clinical narrative: Immediate swelling at injection site, severe itching, tachycardia, difficulty breathing, chest pain, lightheaded.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Tachycardia
Clinical narrative: Immediate swelling at injection site, severe itching, tachycardia, difficulty breathing, chest pain, lightheaded.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Back pain, Erythema, Mobility decreased, Neck pain, Pain
Clinical narrative: A FEW HOURS AFTER THE INJECTION, DEVELOPED TREMENDOUS PAIN, PROGRESSED TO REDNESS, WARMTH, SWELLING- UNABLE TO RAISE ARM ABOVE SHOULDER. NO PARETHESIAS. NO LOSS OF HAND OR FINGER CONTROL. PAIN RADIATED TO BACK AND NECK AND LEG. JAW PAIN WAS WORSE (CHRONIC CONDITION). 2ND DAY- LESS REDNESS AND SWELLING, FROM PASSIVE MOVEMENT.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Pain in jaw, Skin warm, Swelling
Clinical narrative: A FEW HOURS AFTER THE INJECTION, DEVELOPED TREMENDOUS PAIN, PROGRESSED TO REDNESS, WARMTH, SWELLING- UNABLE TO RAISE ARM ABOVE SHOULDER. NO PARETHESIAS. NO LOSS OF HAND OR FINGER CONTROL. PAIN RADIATED TO BACK AND NECK AND LEG. JAW PAIN WAS WORSE (CHRONIC CONDITION). 2ND DAY- LESS REDNESS AND SWELLING, FROM PASSIVE MOVEMENT.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling face
Clinical narrative: The patient called and reported swelling in the left cheek. She took BENADRYL and the swelling went down.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Patient came into the pharmacy to let us know that she developed cellulitis and was treated with antibiotics, and that she just wanted to let us know. She states she is find now.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Discomfort, Loss of control of legs, Pain in extremity, Paraesthesia
Clinical narrative: Pt reported having painful tingling/tight pressure in legs about 3 weeks after having the vaccine administered. Pt then stated he experienced a loss of control of leg movement. Pt contacted the pharmacy on 12/20/17 from hospital to report the event. Pt stated that medical doctors have not given a diagnosis yet but have ruled out Guillain-Barre Syndrome.
Age: 33.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site inflammation, Pain, Pyrexia, Rash
Clinical narrative: 7 days later patient still experiencing fever, pain, rash, inflammation at injection site.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: PATIENT STATES THAT HER ARM IS SWELLING UP STARTING TO TRAVEL TOWARD ELBOW.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Concussion, Fall, Head injury, Headache, Lip injury
Clinical narrative: 2:15 pm son awakens at nap time complaining of headache, tells preschool teacher. Standing in line for afternoon snack, he becomes pale and faints. Hitting his head nose and lip on ground of classroom. After coming conscious he vomits twice. Completely sheet white, skin, lips. Preschool calls 911 and myself. I arrive at preschool and ride with patient in ambulance to ER. We admit through ER and he is ruled with a reaction to immunizations, a head injury/concussion from falling. Discharged same night, no further diagnostics.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Loss of consciousness, Nasal injury, Pallor, Syncope, Vaccination complication
Clinical narrative: 2:15 pm son awakens at nap time complaining of headache, tells preschool teacher. Standing in line for afternoon snack, he becomes pale and faints. Hitting his head nose and lip on ground of classroom. After coming conscious he vomits twice. Completely sheet white, skin, lips. Preschool calls 911 and myself. I arrive at preschool and ride with patient in ambulance to ER. We admit through ER and he is ruled with a reaction to immunizations, a head injury/concussion from falling. Discharged same night, no further diagnostics.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: 2:15 pm son awakens at nap time complaining of headache, tells preschool teacher. Standing in line for afternoon snack, he becomes pale and faints. Hitting his head nose and lip on ground of classroom. After coming conscious he vomits twice. Completely sheet white, skin, lips. Preschool calls 911 and myself. I arrive at preschool and ride with patient in ambulance to ER. We admit through ER and he is ruled with a reaction to immunizations, a head injury/concussion from falling. Discharged same night, no further diagnostics.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Dizziness, Pallor
Clinical narrative: Pt. felt light headed and dizzy. Upon observation, she was pale and forehead was clammy.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Burning sensation, Paraesthesia
Clinical narrative: Patient experienced back pain, burning and tingling in the back and spine.
Age: 29.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 29-year-old male patient who received FLUARIX QUADRIVALENT (batch number N933S, expiry date 30th June 2018). Concomitant products included FLUARIX QUADRIVALENT. On 11th December 2017, the patient received the 2nd dose of FLUARIX QUADRIVALENT. On 11th December 2017, unknown after receiving FLUARIX QUADRIVALENT, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional details were received as follows: On 18th September 2017, the patient received a dose of FLUARIX. The patient received another dose on the day of reporting, which led to extra dose administered.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Headache, Influenza A virus test, Influenza B virus test, Laboratory test, Nuclear magnetic resonance imaging
Clinical narrative: After receiving the vaccines he had a rash on left arm and started w/severe headache went to the hospital and was admitted after Dr's tried to relieve headache w/TORADOL morphine. They also tested for meningitis.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Rash, X-ray
Clinical narrative: After receiving the vaccines he had a rash on left arm and started w/severe headache went to the hospital and was admitted after Dr's tried to relieve headache w/TORADOL morphine. They also tested for meningitis.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Blood electrolytes, Body temperature increased, Breath holding, Chest X-ray, Fatigue
Clinical narrative: Became overly tired. Had cluster of brief stiffening, shaking, breath holding lasting 2-3 seconds, pause x 3-5 minutes, recur. Lasted approximately 20 minutes. Seen in ER. Temp 101. Resolved. No other signs of illness. May have been seizure, may have been fussy baby.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Full blood count, Musculoskeletal stiffness, Tremor, Urine analysis normal
Clinical narrative: Became overly tired. Had cluster of brief stiffening, shaking, breath holding lasting 2-3 seconds, pause x 3-5 minutes, recur. Lasted approximately 20 minutes. Seen in ER. Temp 101. Resolved. No other signs of illness. May have been seizure, may have been fussy baby.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Injection site nodule, Injection site reaction, Pain in extremity, Rash pruritic
Clinical narrative: Pt seen in office on 12/15/17 for complaint of bilateral arm soreness and "knots" under skin where injections were given. Pt developed a rash on her left arm under injection site that itches. Dx: Faint erythema.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Injection site erythema
Clinical narrative: Redness around injection site.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Malaise, Pyrexia, Tenderness
Clinical narrative: Erythema, tender, malaise, fever.
Age: 36.0
Sex: F
Vaccine: HEP, MMR, VARCEL, HEP, MMR, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous report was received from a nurse, referring to a 36 year old female patient. The patient did not have any medical history, concomitant medications or concurrent conditions. The patient's drug allergies included aspirin (information captured in MARRS # 1712USA010320). On 20-OCT-2017, the patient was vaccinated with M-M-R II subcutaneously in the right arm, lot # N004433, expiration date 07-FEB-2019, for prophylaxis (strength, dose and frequency were not reported), VARIVAX subcutaneously in the left arm,  lot # N008828, expiration date 16-MAR-2019, for prophylaxis (strength, dose and frequency were not reported) and (unspecified) (HEPATITIS B) lot # B34CM, intramuscularly in the left deltoid, for prophylaxis (strength, dose and frequency were not reported). On 30-OCT-2017, (reported as "had vaccines 10 days before pregnancy test") previously reported as 18-NOV-2017; conflicting information, the patient had a confirmed positive pregnancy blood test. It was unknown how far along pregnant the patient was. No adverse effects were reported. The patient did not receive any treatment. At the time of reporting, the outcome of exposure during pregnancy was unknown. Additionally, the causality assessment between exposure during pregnancy and M-M-R II, VARIVAX and hepatitis B virus vaccine (unspecified) (HEPATITIS B) was not provided. This is one of several reports received from  the same patient.; Sender's Comments: US-009507513-1712USA010320:
Age: 36.0
Sex: F
Vaccine: HEP, MMR, VARCEL, HEP, MMR, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous report was received from a nurse, referring to a 36 year old female patient. The patient did not have any medical history, concomitant medications or concurrent conditions. The patient's drug allergies included aspirin (information captured in MARRS # 1712USA010320). On 20-OCT-2017, the patient was vaccinated with M-M-R II subcutaneously in the right arm, lot # N004433, expiration date 07-FEB-2019, for prophylaxis (strength, dose and frequency were not reported), VARIVAX subcutaneously in the left arm,  lot # N008828, expiration date 16-MAR-2019, for prophylaxis (strength, dose and frequency were not reported) and (unspecified) (HEPATITIS B) lot # B34CM, intramuscularly in the left deltoid, for prophylaxis (strength, dose and frequency were not reported). On 30-OCT-2017, (reported as "had vaccines 10 days before pregnancy test") previously reported as 18-NOV-2017; conflicting information, the patient had a confirmed positive pregnancy blood test. It was unknown how far along pregnant the patient was. No adverse effects were reported. The patient did not receive any treatment. At the time of reporting, the outcome of exposure during pregnancy was unknown. Additionally, the causality assessment between exposure during pregnancy and M-M-R II, VARIVAX and hepatitis B virus vaccine (unspecified) (HEPATITIS B) was not provided. This is one of several reports received from  the same patient.; Sender's Comments: US-009507513-1712USA010320:
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse, and refers to a 14 year old female patient. No information about the patient's medical history, concurrent conditions and concomitant medications was provided. On 08-NOV-2017, the patient was vaccinated with the second dose of GARDASIL intramuscular in the left deltoid (lot # N017697 with an expiration date in 21-JAN-2020), for prophylaxis (dose and strength were not provided). On 29-NOV-2017, the patient's mother contacted the reporter and stated that the patient was pregnant at the time of the vaccination. The patient became pregnant on an unspecified date, the last menstrual period (LMP) and estimated delivery date (EDD) were not known. At the time of reporting, the pregnancy outcome was pending.
Sex: F
Vaccine: FLU4, HPV9, FLU4, HPV9
Symptoms: Computerised tomogram head normal, Contusion, Epistaxis, Laceration, Suture insertion
Clinical narrative: This initial spontaneous report was received from a pediatrician and refers to a 16 year, 8 month old female patient. Concurrent conditions included anxiety issues. Medical history included anorexia. She had no history of drug reactions/allergies. Concomitant medications included ZOLOFT. In August 2017, the patient received her first dose of GARDASIL 9 intramuscularly for the prevention of human papilloma virus (HPV) at the reporting physician's office. She received her second dose on 09-OCT-2017 at the office. Lot # was not provided. The patient received FLUZONE during the same visit. The patient was monitored in the office for 15 minutes after receiving the second dose of GARDASIL 9 and after leaving the office, she passed out. The patient returned to the physician's office where she was seen and steri strips were applied to her chin. She was then seen in the Emergency Room (ER) on the same day, where she received two stitches in her chin. CT scan of the head and facial bones were normal. The patient was then seen by a dentist on an unspecified day for a chipped tooth. The physician stated the adverse event was reported to VAERS. The pt's present status was unknown by the physician (although presumed she recovered from passing out). The physician reported the family has not returned his calls and he has not seen the patient since 09-OCT-2017. The physician also reported he was contacted by a lawyer, requesting the patient's medical records. The physician did not provide causality assessment. Additional information has been requested.
Sex: F
Vaccine: FLU4, HPV9, FLU4, HPV9
Symptoms: Syncope, Tooth fracture
Clinical narrative: This initial spontaneous report was received from a pediatrician and refers to a 16 year, 8 month old female patient. Concurrent conditions included anxiety issues. Medical history included anorexia. She had no history of drug reactions/allergies. Concomitant medications included ZOLOFT. In August 2017, the patient received her first dose of GARDASIL 9 intramuscularly for the prevention of human papilloma virus (HPV) at the reporting physician's office. She received her second dose on 09-OCT-2017 at the office. Lot # was not provided. The patient received FLUZONE during the same visit. The patient was monitored in the office for 15 minutes after receiving the second dose of GARDASIL 9 and after leaving the office, she passed out. The patient returned to the physician's office where she was seen and steri strips were applied to her chin. She was then seen in the Emergency Room (ER) on the same day, where she received two stitches in her chin. CT scan of the head and facial bones were normal. The patient was then seen by a dentist on an unspecified day for a chipped tooth. The physician stated the adverse event was reported to VAERS. The pt's present status was unknown by the physician (although presumed she recovered from passing out). The physician reported the family has not returned his calls and he has not seen the patient since 09-OCT-2017. The physician also reported he was contacted by a lawyer, requesting the patient's medical records. The physician did not provide causality assessment. Additional information has been requested.
Sex: F
Vaccine: FLU4, HPV9, FLU4, HPV9
Symptoms: Computerised tomogram head normal, Loss of consciousness, Suture insertion, Tooth fracture
Clinical narrative: This initial spontaneous report was received from a pediatrician and refers to a 16 year, 8 month old female patient. Concurrent conditions included anxiety issues. Medical history included anorexia. She had no history of drug reactions/allergies. Concomitant medications included ZOLOFT. In August 2017, the patient received her first dose of GARDASIL 9 intramuscularly for the prevention of human papilloma virus (HPV) at the reporting physician's office. She received her second dose on 09-OCT-2017 at the office. Lot # was not provided. The patient received FLUZONE during the same visit. The patient was monitored in the office for 15 minutes after receiving the second dose of GARDASIL 9 and after leaving the office, she passed out. The patient returned to the physician's office where she was seen and steri strips were applied to her chin. She was then seen in the Emergency Room (ER) on the same day, where she received two stitches in her chin. CT scan of the head and facial bones were normal. The patient was then seen by a dentist on an unspecified day for a chipped tooth. The physician stated the adverse event was reported to VAERS. The pt's present status was unknown by the physician (although presumed she recovered from passing out). The physician reported the family has not returned his calls and he has not seen the patient since 09-OCT-2017. The physician also reported he was contacted by a lawyer, requesting the patient's medical records. The physician did not provide causality assessment. Additional information has been requested.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Decreased activity, Decreased appetite, Diet refusal, Erythema, Irritability
Clinical narrative: 12/14 around 3 after napping my 1 year old woke up a high fever 102 and cheeks tomato red.  The rest of the day he refused to eat or nurse. Day 2 fever and red cheeks still refused food, would nurse and have bottle. He refused to be put down, unlike his usual active self. Day 3 fever goes to 101.7 rash on cheeks lighten a little. Day 4 no fever. Rash on cheeks and now body, little appetite and clingy. Day 5-7 mirror day 4.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash generalised
Clinical narrative: 12/14 around 3 after napping my 1 year old woke up a high fever 102 and cheeks tomato red.  The rest of the day he refused to eat or nurse. Day 2 fever and red cheeks still refused food, would nurse and have bottle. He refused to be put down, unlike his usual active self. Day 3 fever goes to 101.7 rash on cheeks lighten a little. Day 4 no fever. Rash on cheeks and now body, little appetite and clingy. Day 5-7 mirror day 4.
Age: 81.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a 81 year old male patient. Information regarding the patient's medical history, drug reactions or allergies and concurrent conditions was not reported. Concomitant therapies included FLUVIRIN. On 21-NOV-2017, the patient was vaccinated in the left arm with an expired dose of VARIVAX first dose, lot # L035127 (also reported as L025127) and expiration date 14-SEP-2017 (strength and route were not provided) for prophylaxis. The patient did not have any illness at the time of vaccination.  The reporter stated that after administered the vaccine, she realized it was expired by a couple of months. She called the manufacturer and was told the vaccine's potency was still the same. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a 19 year old patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient was vaccinated with VAQTA pediatric intramuscular (dose, frequency and anatomical location, were unknown) with lot # N005796 and expiration date 26-MAY-2018 for prophylaxis. No adverse effects reported.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 13 year old male patient with no concomitant medication, no pertinent medical history and no drug allergies. On 08-NOV-2017, the patient was vaccinated with a dose of GARDASIL 9 lot # M032650 with expiration date of 31-MAR-2019, intramuscularly, for prophylaxis.  Other suspect therapies included MENACTRA and ADACEL administered on the same date. On 27-NOV-2017, the patient experienced injection site pain with a knot under the skin and no redness, no swelling and no warmth to touch, she was afebrile and treatment of ice and ibuprofen (unspecified manufacturer) was performed on 27-NOV-2017 which provided some relief "but the knot under the skin still remained."  It was reported that the patient did not have significant disability, did not need hospitalization and the events were not life threatening events. The outcome of injection site nodule and injection site pain was reported as not recovered/not resolved. The causality between injection site nodule and injection site pain with the suspect therapy was not reported.
Sex: U
Vaccine: MMR
Symptoms: Extra dose 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 concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not provided. On 06-DEC-2017, the patient was vaccinated with double dose (1.0 ml) of M-M-R II, subcutaneously (lot number and expiration date were not provided) for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT) used to reconstitute the vaccine. The patient experienced no adverse events. The outcome of incorrect dose administered was unknown.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant and refers to a patient of unknown age. No information regarding the patient's medical history and concurrent conditions was provided. On 09-NOV-2017, the patient was vaccinated with a dose of VARIVAX injection (dose, route of administration, lot number and expiration date were not reported) and subsequently, 27 days later, on 06-DEC-2017, with a 0.5 ml dose of M-M-R II subcutaneous injection, lot # N013867 with expiration date on 04-MAY-2019. The dose of M-M-R II was reconstituted with sterile diluent (MERCK STERILE DILUENT). No adverse effects were reported.
Age: 38.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Injection site reaction, Muscular weakness
Clinical narrative: This non-valid spontaneous report as received from a pharmacy intern refers to a patient of unknown age. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not provided. On 05-DEC-2017, the patient was vaccinated with PNEUMOVAX23 intramuscular injection in a deltoid muscle (dose and expiration date were not provided) lot # N003993 for prophylaxis. On an unknown date in December 2017, the patient began to experience shoulder pain. The outcome of the event was unknown. The relatedness between PNEUMOVAX23 and the event was not provided. Follow-up information has been received from a physician on 19-DEC-2017. This report refers to a 38 years old female patient. The patient's concomitant therapies included azathioprine, AMITRIPTILYNE and topiramate. The patient received PNEUMOVAX23 vaccine to her left deltoid on 05-DEC-2017. The patient's concomitant therapies included azathioprine, AMITRIPTILYNE and topiramate. With in few hours, she experienced pain and weakness to the left shoulder and had difficulty raising her left arm more than 20-30 degrees and went to the urgent care. They noted that the injection appeared high on her shoulder and suspected it may have entered the sub acromial space. They placed a sling and gave her a prescription for hydrocodeine. The physician saw her for follow-up on 07-DEC-2017 and she couldn't abduct the arm past 20-30 degrees. She contacted the physician again on 10-DEC-2017 and was not improving. She was now scheduled for EMG (electromyography) (on 10-JAN-2018) to rule out motor nerve palsy, possibly an axilla nerve dysfunction. The outcome and causality of the event pain and weakness to the left shoulder were unknown. The event pain and weakness to the left shoulder was considered to be serious due to disability.
Age: 38.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Musculoskeletal pain
Clinical narrative: This non-valid spontaneous report as received from a pharmacy intern refers to a patient of unknown age. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not provided. On 05-DEC-2017, the patient was vaccinated with PNEUMOVAX23 intramuscular injection in a deltoid muscle (dose and expiration date were not provided) lot # N003993 for prophylaxis. On an unknown date in December 2017, the patient began to experience shoulder pain. The outcome of the event was unknown. The relatedness between PNEUMOVAX23 and the event was not provided. Follow-up information has been received from a physician on 19-DEC-2017. This report refers to a 38 years old female patient. The patient's concomitant therapies included azathioprine, AMITRIPTILYNE and topiramate. The patient received PNEUMOVAX23 vaccine to her left deltoid on 05-DEC-2017. The patient's concomitant therapies included azathioprine, AMITRIPTILYNE and topiramate. With in few hours, she experienced pain and weakness to the left shoulder and had difficulty raising her left arm more than 20-30 degrees and went to the urgent care. They noted that the injection appeared high on her shoulder and suspected it may have entered the sub acromial space. They placed a sling and gave her a prescription for hydrocodeine. The physician saw her for follow-up on 07-DEC-2017 and she couldn't abduct the arm past 20-30 degrees. She contacted the physician again on 10-DEC-2017 and was not improving. She was now scheduled for EMG (electromyography) (on 10-JAN-2018) to rule out motor nerve palsy, possibly an axilla nerve dysfunction. The outcome and causality of the event pain and weakness to the left shoulder were unknown. The event pain and weakness to the left shoulder was considered to be serious due to disability.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history, drug reactions and allergies were not provided. On 08-MAY-2017, the patient was vaccinated with a first dose of GARDASIL 9 (strength, dose, frequency, route of administration, lot# and expiration date were not reported). On 14-NOV-2017, the patient was vaccinated with the second dose of GARDASIL 9 (strength, dose, frequency, route of administration, lot# and expiration date were not reported. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse via a company representative referring to a 62 year old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 14-DEC-2017, the patient was vaccinated with an expired dose of ZOSTAVAX lot # M037654, expiration date on 29-NOV-2017, subcutaneous (strength and  dose number were not provided). Concomitant therapies included sterile diluent(manufacturer unknown). No adverse events reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD subcutaneously, lot # N020615, expiration date 22-JAN-2019, albumin status rHA; and lot # N010246, expiration date 25-SEP-2018; (dose and albumin status were not reported) for prophylaxis; administered along with a properly stored sterile diluent, subcutaneously, lot # L028663, expiration date 29-MAR-2018 (dose was not reported) for prophylaxis. It was reported that the vaccine was exposed to temperature of -9 degrees Celsius to 8 degrees Celsius, for a time frame of 4 hours and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received form the same reporter (MARRS # 1712USA008050, 1712USA008779, 1712USA008780, 1712USA008781, 1712USA008782, 1712USA008784, 1712USA008785, 1712USA008786, 1712USA008787.). Sender's Comments: US-009507513-1712USA008050.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD subcutaneously, lot # N020615, expiration date 22-JAN-2019, albumin status rHA; and lot # N010246, expiration date 25-SEP-2018; (dose was not reported) for prophylaxis; administered along with a properly stored sterile diluent, subcutaneously, lot # L028663, expiration date 29-MAR-2018 (dose was not reported) for prophylaxis. It was reported that the vaccine was exposed to temperature of -9 degrees Celsius to 8 degrees Celsius, for a time frame of 4 hours and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received form the same reporter (MARRS # 1712USA008050, 1712USA008779, 1712USA008780, 1712USA008781, 1712USA008782, 1712USA008783, 1712USA008785, 1712USA008786, 1712USA008787.). Sender's Comments: US-009507513-1712USA008050.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD subcutaneously, lot # N020615, expiration date 22-JAN-2019, albumin status rHA; and lot # N010246, expiration date 25-SEP-2018; (dose was not reported) for prophylaxis; administered along with a properly stored sterile diluent, subcutaneously, lot # L028663, expiration date 29-MAR-2018 (dose was not reported) for prophylaxis. It was reported that the vaccine was exposed to temperature of -9 degrees Celsius to 8 degrees Celsius, for a time frame of 4 hours and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received form the same reporter (MARRS # 1712USA008050, 1712USA008779, 1712USA008780, 1712USA008781, 1712USA008782, 1712USA008783, 1712USA008784, 1712USA008786, 1712USA008787.). Sender's Comments: US-009507513-1712USA008050.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD subcutaneously, lot # N020615, expiration date 22-JAN-2019, albumin status rHA; and lot # N010246, expiration date 25-SEP-2018; (dose was not reported) for prophylaxis; administered along with a properly stored sterile diluent, subcutaneously, lot # L028663, expiration date 29-MAR-2018 (dose was not reported) for prophylaxis. It was reported that the vaccine was exposed to temperature of -9 degrees Celsius to 8 degrees Celsius, for a time frame of 4 hours and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received form the same reporter (MARRS # 1712USA008050, 1712USA008779, 1712USA008780, 1712USA008781, 1712USA008782, 1712USA008783, 1712USA008784, 1712USA008785, 1712USA008787.). Sender's Comments: US-009507513-1712USA008050.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD subcutaneously, lot # N020615, expiration date 22-JAN-2019, albumin status rHA; and lot # N010246, expiration date 25-SEP-2018; (dose was not reported) for prophylaxis; administered along with a properly stored sterile diluent, subcutaneously, lot # L028663, expiration date 29-MAR-2018 (dose was not reported) for prophylaxis. It was reported that the vaccine was exposed to temperature of -9 degrees Celsius to 8 degrees Celsius, for a time frame of 4 hours and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received form the same reporter (MARRS # 1712USA008050, 1712USA008779, 1712USA008780, 1712USA008781, 1712USA008782, 1712USA008783, 1712USA008784, 1712USA008785, 1712USA008786.). Sender's Comments: US-009507513-1712USA008050.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On 12-DEC-2017, the patient was vaccinated with a properly stored but expired dose of ZOSTAVAX 19400 plaque-forming unit (PFU), lot number M037653, expiration date 29-NOV-2017 (dose number, dose, frequency and administration route were not reported), for prophylaxis. Concomitant therapies included a sterile diluent. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On an unknown date, the patient was inadvertently vaccinated with a pediatric dose of VAQTA (strength, dose number, dose, frequency, administration route, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-DEC-2017, the patient was vaccinated with an expiry dose of PNEUMOVAX 23 expiration date 12-NOV-2017 (strength, dose, route and lot number were not reported) for prophylaxis. No adverse effects reported.
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a second dose of LIQUID PEDVAXHIB (lot # N008080 with expiration date of 02-DEC-2019; strength, dose, route and anatomical location were not provided), for prophylaxis, 6 weeks after receiving the first dose. No adverse effects reported.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Started with constant pain in left arm around 5 pm the evening of the vaccine. Swelling from injection sight of Left deltoid that radiated down arm to right above the elbow. Currently 2 days later, redness has radiated down the left side of the arm past elbow. Client reports pain is better this am. Encouraged client to apply cool compresses and can use anti-itch cream to area if itching occurs. Can take acetaminophen for pain if needed.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Skin discolouration
Clinical narrative: Skin: Positive for color change (rt arm site of vaccine 3 cm big raised red hot to touch area, nl  limitation in ROM). Afebrile. Warm compresses, TYLENOL for pain prn.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Erythema, Pyrexia, Swelling
Clinical narrative: Patient has redness and swelling below the injection site, not on or around. Patient stated that he also experience chills and fever the night of the vaccine and continues to experience this. Suggested that the patient contact physician or immediate care facility if no physician. Can also take tylenol for the fever and use a cool compress for left arm.
Age: 0.67
Sex: M
Vaccine: HEP, HEPA, PNC13
Symptoms: Irritability, Lethargy, Rash
Clinical narrative: Day of vaccine patient was very fussy for remainder of the day. Next day mom noticed rash on buttocks and some lethargy. Second day after vaccine rash started to spread to back and face. Mom has used BENADRYL for the rash and states it has helped some. Nystatin cream was being used prior to vaccine on patient but not in the areas that the rash has developed at. Seen today for the rash, does not look like eczema or any viral rash. Mom notified provider and myself during examination that she is highly allergic to DTaP and had an anaphylaxis reaction to DTaP as a child.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Left cheek numbness for 10 hours.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV4, MNQ, TDAP
Symptoms: Fall, Syncope
Clinical narrative: Patient was given 4 vaccines. Went to go get up to go to waiting room to wait 20 minutes ->patient fell back up against wall while sitting on exam table and fainted. Patient stayed in room, cool compress on head, blood pressure taken x2, pulsox x2, sent home.
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a Nurse Practitioner and refers to a female patient of unknown age. The patient was believed to reside in a nursing home. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (dose, route of administration, lot number and expiration date were not reported). On an unknown date, the patient experienced an unspecified injection site reaction and contacted the nurse practitioner on 02-DEC-2017 to seek medical attention. The patient recovered from the event by 05-DEC-2017. The relatedness between the event and PNEUMOVAX 23 was not reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to a 18-year-old patient. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection (dose and route of administration were not reported) lot # N013276 with expiration date on 21-JAN-2020. The vaccine underwent a temperature excursion of 0.1 degrees Celsius for 6 hours. Digital data logger was involved in the recording of the excursion. Unspecified previous excursions were reported. No adverse events were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1712USA001308.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to a 19-year-old patient. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection (dose and route of administration were not reported) lot # N013276 with expiration date on 21-JAN-2020. The vaccine underwent a temperature excursion of 0.1 degrees Celsius for 6 hours. Digital data logger was involved in the recording of the excursion. Unspecified previous excursions were reported. No adverse events were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1712USA001308.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to a 16-year-old patient. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection (dose and route of administration were not reported) lot # N013276 with expiration date on 21-JAN-2020. The vaccine underwent a temperature excursion of 0.1 degrees Celsius for 6 hours. Digital data logger was involved in the recording of the excursion. Unspecified previous excursions were reported. No adverse events were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1712USA001308.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to a 14-year-old patient. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection (dose and route of administration were not reported) lot # N013276 with expiration date on 21-JAN-2020. The vaccine underwent a temperature excursion of 0.1 degrees Celsius for 6 hours. Digital data logger was involved in the recording of the excursion. Unspecified previous excursions were reported. No adverse events were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1712USA001308.
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient reported lower arm pain on 12/20/17 and stated its from her flu shot on 8/21/17. She stated lower dull arm pain. Dull pain, consistent, always there -no redness, no swelling.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Hospital volunteer received flu shot from employee health department. She reported the development of a "red itchy rash" all over her body. She stated that she took a dose of oral BENADRYL for treatment. She did not receive any medical treatment.