chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an administrator regarding two patients of unknown age and gender. The patients' medical history, concurrent conditions, or concomitant therapies were not reported. On 10-SEP-2017 and 13-SEP-2017, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB intramuscularly (lot number reported as "N011851", expiration date: 19-DEC-2019) for prophylaxis. According to the reporter, the doses were exposed to temperatures between 9 degrees Celsius (C) to 25 C for 10 minutes. No previous temperature excursions were reported. A digital data logger was involved. No adverse effects were reported. Lot number N011851 is an invalid lot number for LIQUID PEDVAXHIB.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II lot # L032181, expiration date 25-AUG-2017, rHA albumin status (strength, dose number and route of administration were not provided) for prophylaxis. On 04-JUN-2017, the vaccines were exposed to a temperature of 47° Fahrenheit (F) during a time frame of 43 hours (hrs); on 06-JUN-2017, to 47°F for 18 hrs; 07-JUN-2017, to 47°F for 18 hrs; on 09-JUN-2017, to 47°F for 16 hrs; on 10-JUN-2017, to 47°F for 40 hrs; on 17-JUN-2017, to 47°F for 8 hrs 30 minutes (min); on 20-JUN-2017 and 22-JUN-2017, to 47°F for 18 hrs; on 23-JUN-2017, to 47°F for 19 hrs; on 26-JUN-2017, 29-JUN-2017 and 24-JUL-2017, to 47°F for 18 hrs. Total cumulative hours: 252 hrs 30 minutes. There was not previous temperature excursion, the temperature excursion was not called by a data logger. It was not reported if the administered vaccines were exposed to all temperature excursions. Adverse effects were not reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1709USA004111: US-009507513-1709USA008834: US-009507513-1709USA008836: US-009507513-1709USA008833.
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician, concerning a 2 years old female patient. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 15-SEP-2017, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, strength, dose, route of administration or anatomical location were not provided), for prophylaxis, which was considered an inappropriate age at vaccine administration. No adverse effects were reported and it was stated that the patient was doing fine. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an unknown number of patients of unknown gender and age. The patients' concurrent condition and medical history were not reported. On unknown dates, an unknown number of patients were vaccinated with improperly stored VARIVAX (dose and route unknown, lot # M046924, expiration date 28-NOV-2018) for prophylaxis. It was unknown if the sterile diluent (manufacturer unknown) used to reconstitute the vaccine was properly stored. The vaccine was improperly stored at 6 to 14 degrees Fahrenheit for 51 minutes. The vaccine also had a previous temperature excursion at 15 to 46 degrees Fahrenheit for 3 hours. The phone call was a result of the data logger. No adverse effects were reported. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1709USA000676: US-009507513-1709USA009051.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Injection site erythema, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: PATIENT EXPERIENCED EXTREME HEADACHE, MUSCLE ACHES,FEVER, WHICH LASTED 2 DAYS AND VERY RED, SORE UPPER ARM WHERE VACCINE WAS GIVEN. SHE FELT BETTER AS OF 9/18/17 BUT HER ARM WAS STILL RED IN A LARGE AREA OF HER DELTOID.
Age: 41.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Erythema, Impaired work ability, Induration, Injection site erythema
Clinical narrative: Left arm raised, red, warm to touch. Redness from shoulder to elbow. Hard bump under her skin aprox 1-1.5 inches wide by 1 inch long. Pt had body aches especially her large joints (elbows and knees). Pt was off from work for a week.
Age: 41.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Left arm raised, red, warm to touch. Redness from shoulder to elbow. Hard bump under her skin aprox 1-1.5 inches wide by 1 inch long. Pt had body aches especially her large joints (elbows and knees). Pt was off from work for a week.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Disorientation, Eye movement disorder, Glassy eyes, Headache, Hyperacusis
Clinical narrative: In late June 2017 he received a Dtap vaccine. Immediately after he started displaying sensory symptoms like covering his ears when music was on, or when a toilet flushed and covering his eyes in groups of people. Approximately 10 days after he came down with an extremely high fever and was so disoriented he didn't know where he was laying in his own bed. Crying "mommy, where am I?". Wired with eyes darting back and forth, lethargic, and couldn't follow my finger back and forth. The following days he was disoriented again and said his head hurt badly, he could hear "bells", and that it was noisy. His eyes were so glassy he didn't look like himself. He would be fine for a bit then get extremely upset because his head hurt so much. Since then he can't tolerate crowds, says that the volume has been turned up and has started rubbing his earlobes for comfort. He now seems disturbed in these situations and rubs his head, is aggravated and not himself.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Lethargy, Neurological examination abnormal, Pyrexia, Sensory disturbance
Clinical narrative: In late June 2017 he received a Dtap vaccine. Immediately after he started displaying sensory symptoms like covering his ears when music was on, or when a toilet flushed and covering his eyes in groups of people. Approximately 10 days after he came down with an extremely high fever and was so disoriented he didn't know where he was laying in his own bed. Crying "mommy, where am I?". Wired with eyes darting back and forth, lethargic, and couldn't follow my finger back and forth. The following days he was disoriented again and said his head hurt badly, he could hear "bells", and that it was noisy. His eyes were so glassy he didn't look like himself. He would be fine for a bit then get extremely upset because his head hurt so much. Since then he can't tolerate crowds, says that the volume has been turned up and has started rubbing his earlobes for comfort. He now seems disturbed in these situations and rubs his head, is aggravated and not himself.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Axillary pain, Chest pain, Cough, Dry eye, Eye irritation
Clinical narrative: Oculo-respiratory syndrome - Of note, I am the pt's spouse, and am an Allergist/Immunologist with special training in immunization medicine. I did not feel she needed a visit for these sx, but if I was not her spouse, she likely would have sought care. Patient had a little soreness in deltoid and in armpit shortly after the injection, but not out of proportion to what was expected. Within 4 hours of injection started to have nasal congestion and scratchy feeling in eyes. Within 6 hours got increased nasal sx, postnasal drip, eyes watery and slightly red. That evening had worsening sx with cough, ache in chest, redness in eyes. Overnight eyes got very gummy with crusting and dry feeling. Cough kept her awake and nose was very congested with copious thick post nasal drip. The following day had persistent sx in the AM, still felt very ill/unwell. Began to feel better that by evening and all sx were fully resolved by the 48 hour mark.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Eyelid margin crusting, Insomnia, Lacrimation increased, Malaise, Nasal congestion
Clinical narrative: Oculo-respiratory syndrome - Of note, I am the pt's spouse, and am an Allergist/Immunologist with special training in immunization medicine. I did not feel she needed a visit for these sx, but if I was not her spouse, she likely would have sought care. Patient had a little soreness in deltoid and in armpit shortly after the injection, but not out of proportion to what was expected. Within 4 hours of injection started to have nasal congestion and scratchy feeling in eyes. Within 6 hours got increased nasal sx, postnasal drip, eyes watery and slightly red. That evening had worsening sx with cough, ache in chest, redness in eyes. Overnight eyes got very gummy with crusting and dry feeling. Cough kept her awake and nose was very congested with copious thick post nasal drip. The following day had persistent sx in the AM, still felt very ill/unwell. Began to feel better that by evening and all sx were fully resolved by the 48 hour mark.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Ocular hyperaemia, Pain in extremity, Upper-airway cough syndrome
Clinical narrative: Oculo-respiratory syndrome - Of note, I am the pt's spouse, and am an Allergist/Immunologist with special training in immunization medicine. I did not feel she needed a visit for these sx, but if I was not her spouse, she likely would have sought care. Patient had a little soreness in deltoid and in armpit shortly after the injection, but not out of proportion to what was expected. Within 4 hours of injection started to have nasal congestion and scratchy feeling in eyes. Within 6 hours got increased nasal sx, postnasal drip, eyes watery and slightly red. That evening had worsening sx with cough, ache in chest, redness in eyes. Overnight eyes got very gummy with crusting and dry feeling. Cough kept her awake and nose was very congested with copious thick post nasal drip. The following day had persistent sx in the AM, still felt very ill/unwell. Began to feel better that by evening and all sx were fully resolved by the 48 hour mark.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Arm was red and swollen about 2 inches past the injection site all around. The parents were told to take BENADRYL and MOTRIN by mouth and apply ice. Called and spoke with the father on 9-19 at 4:10pm and was told she was doing better and the swelling was going down.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Condition aggravated, Seizure
Clinical narrative: Member had seizure around 1325 on September 19th. Member placed on his side and 911 was contacted. Vitals taken by Medical staff on site member was watched until paramedics arrived Member was taken to the hospital via ambulance.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: Patient came in for her PNEUMOVAX 23 vaccine. The next day the husband came in with a Rx for 2 medications for the patient from the emergency room and stated that during the night she starting having a bad reaction on her arm in the same area as where the vaccine was given. He said the arm was very swollen almost down to the elbow.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Pt was administered inactive flu vaccine on 9/18/17 lot # WT56808A exp: 6/30/17. Pt is 18.5wks pregnant at time of administration, with EDC: 2/14/18 by LMP. Pt doing well, did not have any side effects after administration. Pt will return to office in 1wk  9/25/2017 with Dr.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Nausea, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: PATIENT'S RIGHT ARM WAS SWOLLEN, RASH DEVELOPED AND WAS SORE. PATIENT ALSO REPORTED NAUSEATED AND FEVER AND A HEADACHE.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash
Clinical narrative: PATIENT'S RIGHT ARM WAS SWOLLEN, RASH DEVELOPED AND WAS SORE. PATIENT ALSO REPORTED NAUSEATED AND FEVER AND A HEADACHE.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Skin lesion
Clinical narrative: Patient experienced bi lateral raised lesions on elbows and additional raised lesions on right upper arm and left forearm. L forearm lesion measured 5"x 4".  No other signs of anaphylaxis noted.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Pruritus generalised, Urticaria
Clinical narrative: Diffuse Itching all over her body, hives, redness to her neck and face starting after she got home after receiving vaccine on 09/08/17. Symptoms progressively worse and she presented to ER 09/09/2017 early morning, per employee she was given BENADRYL in ED and sent home with prescription for EPIPEN and BENADRYL.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Dyskinesia, Grunting, Rhinorrhoea, Tic
Clinical narrative: After receiving the flu shot in December, within 4 to 5 days he developed a tic (throat/grunting). We notified our doctor's office, and within two months the tic cleared up on its own. On May 10th 2017 he received the MMR vaccine, and again within 4 to 5 days developed a tic (this time sniffing). We notified our doctor's office, and they said it was safe to continue with his next vaccine. On July 27th 2017 he received the DTaP and polio combo vaccine (KINRIX), and again within 4 to 5 days developed another tic, this time nose scrunching, along with the sniffing that never went away, and his throat/grunt returned. We are now seven weeks removed, and he still has all three tics. Obviously we cannot be sure that the vaccines caused these tics, but we have no history of tics or neurological issues in our family history. And he has shown no signs of these tics prior to these vaccines. All three times the tics showed up within 4 to 5 days of a shot.
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster
Clinical narrative: Pt developed major shingles. Redness all over entire back as serious as the sample photos that we present in the pharmacy.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Pain, Pain in extremity, Pleurisy, Streptococcus test negative
Clinical narrative: Day 1-3: Sore arm, typical of prior seasonal flu vaccines; Day 4-6 (currently on Day 6): Periodic severe throbbing pain in vaccinated arm (Ibuprofen relieves pain). Day 4 & 5: severe sore throat Day 6: Pleuritis (right lung).
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: SWELLING AND REDNESS ON UPPER LEFT ARM, VERY HOT AND RED FOR LAST 24 HRS ALL THE WAY TO THE ELBOW, CALLING DOCTOR IN THE MORNING.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Hyperhidrosis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reported swelling, pain, redness, and hot to touch at site of injection. Started to notice affect about one hour vaccine was given. She also reported having a fever--feeling hot and sweating. Patient hasn't gone to see a doctor. She was advised by pharmacist to take TYLENOL or Ibuprofen, place ice compress on area and to also take BENADRYL to help with symptoms. Patient advised that if swelling and redness begin to spread further and/or no improvement in the morning, then to head to a clinic.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Patient reported swelling, pain, redness, and hot to touch at site of injection. Started to notice affect about one hour vaccine was given. She also reported having a fever--feeling hot and sweating. Patient hasn't gone to see a doctor. She was advised by pharmacist to take TYLENOL or Ibuprofen, place ice compress on area and to also take BENADRYL to help with symptoms. Patient advised that if swelling and redness begin to spread further and/or no improvement in the morning, then to head to a clinic.
Age: 31.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Swelling throughout whole arm, redness throughout whole arm, tenderness in whole arm and armpit.
Age: 67.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Rash
Clinical narrative: Pt came to pharmacy on tuesday after receiving immunizations on sunday. Pt said her arm at injection site is swollen and itchy and hurst and pt also stated she has a rash on her legs. Pt. was informed that this is a possible reaction due to the latex allergy and was advised to go top the hospital. Pt said she was going to take benadryl to see if that helps her. I advised pt again to go to the hospital.
Age: 89.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Rash, Rash erythematous
Clinical narrative: Patient got a painful red rash in a band around the left arm. The rash was sensitive to touch pressure. No itching. Patient got chills in her back approximately 6 hours after the onset of the rash in the arm. The rash continued until Tuesday when pt's healthcare provider recommended acetaminophen and antihistamines. After taking the recommended medications, patient began to feel better. Pt was also administered FLUZONE HD in the same arm.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram, Nuclear magnetic resonance imaging, Ophthalmoplegia
Clinical narrative: Acute Intranuclear Ophthalmoplegia CN3 (R) eye - partial recovered at D4.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Pain and numbness in left arm.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Shoulder pain and radiation cross and down the arm. Severe shoulder pain.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Body temperature increased, Erythema, Induration, Oedema peripheral
Clinical narrative: Erythema, edema and induration of Lt arm. Body temperature 99.9 oral. Treated with Rest, Ice and Acetaminophen.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient received vaccine on 9/16/17. On 9/17/17 patient report a red spot at injection site. On 9/18/17 patient reported that the red spot was the size of a baseball and went to the doctor. Per patient doctor said that the spot was warm to the touch, swollen, and red. Doctor prescribed her a course of antibiotics (KEFLEX 14 day course). Outcome unknown at this time.
Age: 82.0
Sex: F
Vaccine: FLUA3
Symptoms: Hypoaesthesia, Injection site nerve damage, Injection site pain, Mobility decreased
Clinical narrative: Patient reported sharp pain at time of injection. Patient's husband came in 24 hours later to pharmacy to report that patient had difficulty moving arm, some numbness, and was experiencing significant pain all day. Patient went to hospital and was examined by physician. Patient's husband states that physician's opinion was that vaccine liquid and/or needle struck nerve and is causing the pain.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Hyperhidrosis, Pyrexia
Clinical narrative: Patient reported shortness of breath for 1 day after receiving the vaccination. Patient also woke up with a fever and kept sweating in the early morning after receiving the shot.
Age: 1.08
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Ear infection, Pyrexia
Clinical narrative: High fever over 103, then diagnosed with ear infection.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Muscle spasms, Nausea, Pyrexia
Clinical narrative: Muscle cramps, fever, dizziness, nausea experienced over the course of 3 days (from 09/15/2017 to 09/17/2017).
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Muscular weakness, Nausea, Pallor
Clinical narrative: After vaccine administration, patient reports feeling a generalized weakness to entire left arm, feeling light-headed, and being told by others that he looked pale. Onset occurred approximately 10 after vaccine administration. Shortly after that he abruptly felt very nauseous but denies any vomiting. Patient was reclined in a chair and given ice to the back of head, neck area. After approximately 25 minutes symptoms subsided.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Blister, Chills, Headache, Injection site reaction, Pyrexia
Clinical narrative: Patient experienced reaction at injection site. 10cm swelling, blister, headache, chills, and fever 104 degrees.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Patient experienced reaction at injection site. 10cm swelling, blister, headache, chills, and fever 104 degrees.
Age: 31.0
Sex: F
Vaccine: FLU4, JEV1
Symptoms: Cerebral haematoma, Computerised tomogram head abnormal, Confusional state, Foreign travel, Headache
Clinical narrative: This is a 31 y/o woman brought in by her husband for a headache followed by a gradual change in mental status. Her husband reports that she was in her usual state of health until Monday when she developed a headache after receiving an influenza and JEV (3rd) vaccinations. Her headache progressed to the point where it woke her up at 0100 on 9/19/2017 and was associated with several episodes of vomiting. Throughout the day her husband noticed a steady decline of her mental status beginning with inappropriate words and leading to frank confusion. In the ED, she is able to open her eyes to voice and follows commands intermittently but cannot respond with anything more than a word or two (inappropriate). Her husband did report recent travel where she found a leech attached to her leg that was removed by the patient. He reports that the site was cleaned and did not develop any signs of infection.
Age: 31.0
Sex: F
Vaccine: FLU4, JEV1
Symptoms: Mental status changes, Sleep disorder, Speech disorder, Vomiting
Clinical narrative: This is a 31 y/o woman brought in by her husband for a headache followed by a gradual change in mental status. Her husband reports that she was in her usual state of health until Monday when she developed a headache after receiving an influenza and JEV (3rd) vaccinations. Her headache progressed to the point where it woke her up at 0100 on 9/19/2017 and was associated with several episodes of vomiting. Throughout the day her husband noticed a steady decline of her mental status beginning with inappropriate words and leading to frank confusion. In the ED, she is able to open her eyes to voice and follows commands intermittently but cannot respond with anything more than a word or two (inappropriate). Her husband did report recent travel where she found a leech attached to her leg that was removed by the patient. He reports that the site was cleaned and did not develop any signs of infection.
Age: 1.17
Sex: M
Vaccine: MMR
Symptoms: Diet refusal, Irritability, Measles post vaccine, Pyrexia, Rash generalised
Clinical narrative: One week following the vaccine my son developed high fevers ranging from 100-103 that lasted for 5 days, spiking at night. Approximately 7 days after the MMR vaccine, in addition to the fever he developed measles rash starting in his face and then spreading over his entire body, which lasted for approximately 5 days. In addition to the high fevers and rash he was severely irritable and refused to eat solids for nearly a week, he was only consoled by nursing.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat.
Age: 31.0
Sex: F
Vaccine: FLUR3
Symptoms: Condition aggravated, Disability
Clinical narrative: Increased overall worsening of pre-existing health conditions to the point I became disabled.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Cardiovascular symptom, Chills, Dyspnoea, Myocardial necrosis marker increased
Clinical narrative: Patient reported cardiac (heart attack like) symptoms. Patient went into the local hospital and reported increased HA enzyme levels. Symptoms were reported by patient by 4 pm (chills, labored breathing, heart attack like symptoms).
Age: 17.0
Sex: F
Vaccine: HPV4, MENB, MNQ
Symptoms: Arthralgia, Headache, Neck pain, Pyrexia, Rash generalised
Clinical narrative: I got a rash on both upper thighs by the evening on the day I got the shots. Later the rash spread to my whole body, face, hands, arms, legs, back, stomach, everywhere. I also developed a slight fever the day of and it worsened the day after. I still have a fever today. I also got joint pain 2 days after the shot. My neck hurt, my left hip, both ankles, and now my elbows hurt. I've also had a slight headache on and off since I got the shots.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdomen scan, Decreased appetite, Haematochezia, Hypophagia, Intussusception
Clinical narrative: Lack of appetite 8/2/17, vomiting 8/2/17, bloody stools 8/3/17, intussusception dx 8/4/17 and surgery done. This is a 2-month old female with about a day to day and a half history of decreased po intake, not drinking or eating much at all, and having some bloody stool, since about 1 am this morning. She has also been vomiting. She has not had any fever and she has been very fussy. The child has been seen in the emergency room twice and sent back home. She is seen in the clinic at this time and is admitted to hospital for evaluation.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Surgery, Vomiting
Clinical narrative: Lack of appetite 8/2/17, vomiting 8/2/17, bloody stools 8/3/17, intussusception dx 8/4/17 and surgery done. This is a 2-month old female with about a day to day and a half history of decreased po intake, not drinking or eating much at all, and having some bloody stool, since about 1 am this morning. She has also been vomiting. She has not had any fever and she has been very fussy. The child has been seen in the emergency room twice and sent back home. She is seen in the clinic at this time and is admitted to hospital for evaluation.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Axillary pain, Pain of skin, Tenderness
Clinical narrative: Lateral tender (L) axilla pain radiating down distribution of brachial vein to distal bicep w/sore skin.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hives x 24 hrs. that developed 5 days after shots given. Tactile fever 5 days after shots (for 1 day).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I received the ZOSTAVAX vaccine on 9/8/17 and developed symptoms of Shingles on 9/12. Doctor verified diagnosis on 9/14/17.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Swelling, redness, fever, instructed pt to go to hospital.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Small outbreak of shingles on abdomen, improving.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Right arm very swollen on the side where shot was given. It got very red as well as my neck and rib cage and the side of my hip. I did run a low grade fever!
Age: 17.0
Sex: F
Vaccine: HPV9, VARCEL
Symptoms: Nausea, Pain, Pain in extremity, Throat tightness
Clinical narrative: Mother called office 09-13-2017 at 1530 stated that patient was feeling nauseas, felt like throat was closing up with pain and stinging down the (R) arm. Patient was directed to ER per nurse practitioner whom alerted ER prior to patient's arrival.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Pt says generalized achiness since getting shot.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Vaccination site vesicles
Clinical narrative: 14 days after varicella vaccine had 6 small vesicles at the vaccine site. Tx supportive care only.
Age: 74.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash, Swollen tongue
Clinical narrative: Rash - neck, arms, torso, inner thighs - swollen tongue.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Patient fainted momentarily after she received the vaccine. Patient was okay afterward. She sat in the pharmacy for few minutes before leaving. Patient suffer no injury.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Neck pain
Clinical narrative: Pt received shot on 9/6/17 went to ER with high shoulder/neck pain of left side. On 9/9/17 was issued NORCO and baclofen.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site rash, Injection site swelling, Rash, Swelling
Clinical narrative: Patient rec'd DTaP 9-9-17 and reported rash and swelling to both deltoid area on 9-14-17. This was patients first visit to our clinic.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient stated her (L) arm swelled from her shoulder to her elbow for 2 days and then had severe itching. Area was red and slightly warm to touch.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Extra dose administered
Clinical narrative: Pt given required doses of MENVEO and BEXSERO on 8/14/17. Pt was given another dose of both MENVEO and BEXSERO on 8/29/17.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site hypoaesthesia
Clinical narrative: Called clinic shortly after leaving to report numbness from HPV injection site down to elbow.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Chest X-ray normal, Chest pain, Neck pain, Oropharyngeal pain
Clinical narrative: Presented to ED on 8/23/17 for chest pain, neck pain and sore throat. Sent home with prednisone script.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Men B vaccine was given IM (R) deltoid on 9/14/17. No redness or swelling seen at injection site immediately after injection was administered. Pt returned to clinic 9/15/17 w/ c/o swelling and redness (R) arm at injection site. There was a 1 in localized area of erythema and swelling on exam. Prednisone, ATARAX and ice pack TID was advised. Pt to return to clinic for f/u in 3 days. No fever.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Many hives clustered on left side of abdomen 2 were 1 1/4 inches in size (felt very hyper) some on inner thigh, ankle right leg. About 12 total.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Face injury, Fall, Limb injury
Clinical narrative: Patient was sitting after the RN gave the shot playing his video game, the RN was in the room standing when she heard a noise and RN and father saw him fall hitting his shoulder and face on the ground. He was conscious and given water and juice and snack.  I examined him in few minutes and he was ok, vitals were stable, he was observed for 30 more minutes and discharged home in stable condition.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient had redness and swelling at injection site.
Age: 38.0
Sex: M
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Limb discomfort, Paraesthesia
Clinical narrative: Pt has tingling and numbness in arm - discomfort in fingers.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Loss of consciousness
Clinical narrative: 9/19/17 9:50 Patient received MENACTRA vaccine in right thigh. Patient rested briefly in office before leaving with mother. Mother returned to office 15 minutes later. Mother states that patient passed out in vehicle 10 minutes after getting vaccine. Patient was evaluated by ARNP.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Sunburn
Clinical narrative: Pt. reported area turned bright red w/in a few hrs of administration - like a "sunburn" - took a few doses BENADRYL and was resolved by Sunday the 17th.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left arm deltoid red, swollen and warm to touch. Complaints of some pain to site.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Warm to the touch at injection site, red, swollen (local symptoms) night of receiving vaccination.
Age: 49.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Abdominal pain, Diarrhoea, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Redness and swelling to the area w/fever abd pain and diarrhea.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: Swollen shoulder and upper arms.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Abdominal pain, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 09/15/2017 The patient's mother called the office few hours after the shots with complaints of abdominal pain. On 9/18/17 the nurse documented Rt deltoid swell up erythema and pain on the weekend size 15 cm.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Swelling
Clinical narrative: Patient had excessive swelling on left side from face to toes (shot was on left side) received shot at 9am - symptoms came at 5pm.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt received MCV4 vaccine on 9/11/17. No symptoms of reaction was seen 15 min after administration of vaccine. Pt returned to clinic on 9/13/17 w/ c/o  (L) upper arm swelling and erythema. ATARAX, PRELONE was advised and ice to site TID and return to clinic for follow up in 5 days.
Age: 1.08
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt rec. the above vaccines and PCV on 9/14/17. 5 min after administration of vaccines, (L) leg swelling and redness measuring 4 in was noted at injection site. PRELONE and ATARAX and Ice pack to site was advised. Pt returned to clinic on 9/18/17 for follow up. No redness or swelling seen at site. She was advised (mom) to return to clinic prn if return of symptoms occur.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Swollen painful red rashy area at injection site approximately 2 hrs after injection. Cold compresses and cortisone cream.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Pyrexia, Syncope
Clinical narrative: This spontaneous report has been received from a pharmacist, concerning a 60 year old male patient. The patient's concurrent condition included high blood pressure. Medical history included an ear infection 2 weeks previous. No known allergies was reported. On 05-SEP-2017, the patient was vaccinated with one dose of ZOSTAVAX subcutaneously in the arm, lot # N016185 and expiration date 31-JUL-2018, which was reconstituted with a sterile diluent (manufacturer unknown) lot number N013282 and expiration date 23-AUG-2019 for shingles prevention. Concomitant therapies included amlodipine, hydrochlorothiazide, lisinopril and metoprolol. On 06-SEP-2017, the patient experienced a mild fever and severe dizziness. The patient woke up feeling dizzy and fainted upon standing and sometimes when the patient got up too fast, he got dizzy still. The reporter did not receive any treatment for the adverse events. The outcome for the adverse events of fever, dizziness and fainted was reported as recovering. The causal relationship between the adverse events and the therapy with ZOSTAVAX was not assessed. There was no product quality complaint involved.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Fall, Pyrexia, Syncope
Clinical narrative: This spontaneous report has been received from a pharmacist, concerning a 60 year old male patient. The patient's concurrent condition included high blood pressure. Medical history included an ear infection 2 weeks previous. No known allergies was reported. On 05-SEP-2017, the patient was vaccinated with one dose of ZOSTAVAX subcutaneously in the arm, lot # N016185 and expiration date 31-JUL-2018, which was reconstituted with a sterile diluent (manufacturer unknown) lot number N013282 and expiration date 23-AUG-2019 for shingles prevention. Concomitant therapies included amlodipine, hydrochlorothiazide, lisinopril and metoprolol. On 06-SEP-2017, the patient experienced a mild fever and severe dizziness. The patient woke up feeling dizzy and fainted upon standing and sometimes when the patient got up too fast, he got dizzy still. The reporter did not receive any treatment for the adverse events. The outcome for the adverse events of fever, dizziness and fainted was reported as recovering. The causal relationship between the adverse events and the therapy with ZOSTAVAX was not assessed. There was no product quality complaint involved.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV, TDAP, FLU4, PPV, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a male patient of unknown age with blood cholesterol and allergy to penicillin. The patient's concomitant therapies included losartan potassium (manufacturer unknown) and atorvastatin. On 09-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 intramuscularly, in the left upper arm for prophylaxis, lot number N010106 and expiration date of 07-NOV-2018 (dose was not reported). Other suspect therapies included BOOSTRIX in the left upper arm, lot number 7y29z and expiration date of 17-AUG-2019 (indication, dose and route of administration were not reported) and FLUZONE in the right arm for prophylaxis, lot number UI808AB and expiration date of 28-FEB-2018 (indication, dose and route of administration were not reported). On an unspecified date in September 2017, the patient developed a red band around the left arm (erythema), the reported also stated that the area was swollen (peripheral swelling). Furthermore, the patient had taken ibuprofen (MOTRIN) which helped with the swelling. On 12-SEP-2017, the patient was seen by an unspecified physician and received unknown treatment. The outcome of peripheral swelling and erythema was reported as not resolved. Additionally, the reporter did not provided causal relationship between the event and vaccination with PNEUMOVAX 23, BOOSTRIX and FLUZONE.
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 76 year old female patient. The patient's concurrent conditions included: hypothyroid, intellectual disabilities, age related osteoporosis, seizure disorder, severe constipation and bottom's skin irritation. The patient had a drug reactions or allergies for gentamicin. The patient did not have any illnesses at time of vaccination and did not have any other vaccination within four weeks prior to the PNEUMOVAX 23. On 29-AUG-2017 at 9:00 in the morning, the patient received a second dose of PNEUMOVAX 23 lot # N001007, intramuscularly in the right arm for prophylaxis (dose and expiration date were not reported). The patient was vaccinated at private doctor's office or hospital and vaccine was purchased with private funds. Concomitant therapies included erythromycin, CITRACAL, DULCOLAX, KEPPRA, levothyroxine sodium (manufacturer unknown), CALMOSEPTINE, lovastatin (manufacturer unknown), baby wash topical cleanser, FOSAMAX and MIRALAX. On 29-AUG-2017 after noon, the patient sought medical attention and came to the office with redness, swelling, edema, warmth at injection site and low grade fever. As a treatment patient received two capsules of BENADRYL. The patient's symptoms resolved by the evening of 29-AUG-2017. The relatedness between the events and PNEUMOVAX 23 was not reported. After the vaccination the patient also received VITAMIN D3 1.000 unit tablet, orally taken every day and FLONASE 50 mcg/ actuation nasal spray suspension, for allergy relief  inhale 1 spray by intranasal route every day in each nostril.
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 76 year old female patient. The patient's concurrent conditions included: hypothyroid, intellectual disabilities, age related osteoporosis, seizure disorder, severe constipation and bottom's skin irritation. The patient had a drug reactions or allergies for gentamicin. The patient did not have any illnesses at time of vaccination and did not have any other vaccination within four weeks prior to the PNEUMOVAX 23. On 29-AUG-2017 at 9:00 in the morning, the patient received a second dose of PNEUMOVAX 23 lot # N001007, intramuscularly in the right arm for prophylaxis (dose and expiration date were not reported). The patient was vaccinated at private doctor's office or hospital and vaccine was purchased with private funds. Concomitant therapies included erythromycin, CITRACAL, DULCOLAX, KEPPRA, levothyroxine sodium (manufacturer unknown), CALMOSEPTINE, lovastatin (manufacturer unknown), baby wash topical cleanser, FOSAMAX and MIRALAX. On 29-AUG-2017 after noon, the patient sought medical attention and came to the office with redness, swelling, edema, warmth at injection site and low grade fever. As a treatment patient received two capsules of BENADRYL. The patient's symptoms resolved by the evening of 29-AUG-2017. The relatedness between the events and PNEUMOVAX 23 was not reported. After the vaccination the patient also received VITAMIN D3 1.000 unit tablet, orally taken every day and FLONASE 50 mcg/ actuation nasal spray suspension, for allergy relief  inhale 1 spray by intranasal route every day in each nostril.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Pt states that arm that PNEUMOVAX was given was in the left arm and was extremely swollen and red. Pt went to dr today who states she got cellulitus and was given an antibiotic.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Injection site haemorrhage
Clinical narrative: Patient was given the FLUAURIX QUAD 2017/2018 vaccine (0.5ml) around 10am and patient waited in store as advise to monitor if any reactions occurred. I suggested that she sit down (she is allowed to sit in our vaccine area for privacy if she wishes). Patient said she needed to shop so she went to shop and after 20 minutes of getting the vaccine she said that she was feeling a little dizzy. I tried to speak to patient as much as possible and stay with patient as she expressed her dizziness. She was sitting at the pharmacy benches after she shopped around the store and when someone started to cough in back of her she stood up and moved to another area away from the coughing patient to speak to me. I asked her about her dizziness and if she wanted me to call an ambulance for her but she said, no it wasn't that bad. Patient waited a little longer and said she felt okay to go home. She called the pharmacy 4 hours later to say that she has bled more than usual from the injection site and was wondering why. She did mention that the bleeding stopped. I informed her that there were patients that have bled more from this type of vaccine so I didn't think it was that uncommon. She wanted to know if it was the vaccine formulation or the exact reason but she was feeling okay overall just not very pleased with her flu shot experience.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Lymphadenopathy, Staphylococcal infection, Staphylococcus test positive, Surgery
Clinical narrative: Above I put 2 unknown only cause he had Hep A and Influenza but I'm not sure what types. 21 days after his shots he developed swollen lymph nodes (paranoid) and 5 weeks after had to have surgery because they became swollen so badly and developed a staph infection.
Age: 1.0
Sex: F
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 12 months old female patient. Information about concurrent condition, concomitant medication and medical history was not reported. On 17-AUG-2016, the patient was vaccinated with a dose of ROTATEQ (lot number and expiration date were not provided) orally for prophylaxis (inappropriate age at vaccine administration). No adverse effects were reported. No product quality complaint (PQC) was involved in this case.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old male patient. The patient concurrent condition included diabetes mellitus. The patient's medical history was not reported. The patient had no drug reaction/allergy. The patient had concomitant medications (name unspecified). On 17-AUG-2017, the patient was vaccinated with ZOSTAVAX, (lot # N014942 with expiration date on 06-JUL-2018 (also reported as 02-FEB-2018) subcutaneous for prophylaxis and Sterile diluent (lot# L048686 with expiration date on 20-JUN-2018) was used to reconstitute the vaccine. On 23-AUG-2017, the patient "threw out his back" and was prescribed Prednisone (manufacturer unknown), 10mg (unknown lot and expiration date), 1 tablet by mouth once daily (QD) for 10 days, as well as NORCO, 7.5mg, (unknown manufacturer, lot and expiration date), 1 tablet by mouth, QD for 10 days to "help with the pain". The outcome of the event was reported as not recovered. The causality assessment was not provided by the reporter.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a office manager responsible for vaccine storage referring to an unknown number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date(s), the patients were vaccinated with RECOMBIVAX HB 2.5/0.5 (unit not provided) (lot # L048848, 0.5 ml, once, exp. date 09-AUG-2018, data logger) for prophylaxis, following a temperature excursion of 33 to 35F for a total of 25 days. No adverse effects were reported in any patients. Temperature and time frame: 35F for 12 days and 33 to 34F for 13 days. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA002039.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unknown patients. The patients received improperly stored doses of VARIVAX (lot # M005971 and lot # M045205 with expiration date 11-NOV-2018, dose and route unknown) for prophylaxis on multiple unknown dates. Lot and expiration for properly stored sterile diluent (manufacturer unknown) was unknown by reporter. The vaccine was stored at -14 degrees Celsius to -10 degrees Celsius for 63 hours. There was no temperature excursion previously. No adverse effects were reported.
Age: 1.25
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 15 month old patient of unknown gender. On 30-AUG-2017 the patient was vaccinated with a dose of GARDASIL 9 lot # N018273, expiration date 17-JUN-2019 (route was unknown) for prophylaxis (Product use in unapproved population). No adverse effect reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse, referring to an unspecified patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 30-AUG-2017, the patient vaccinated with the improperly stored ROTATEQ (lot # M002254, expiration date of 15-NOV-2017, oral; dose and dose# unknown) for prophylaxis. No adverse effects were reported. The administered doses of vaccine was underwent the temperature excursion from 47 to 77 degrees Fahrenheit for 10 hours 30 minutes. The previous temperature excursions was reported as from 47 to 77 degrees Fahrenheit for 2 hours. Data logger was involved. No product quality complaint (PQC) was involved in this case. This is one of four reports received from the same reporter. Sender's Comments: US-009507513-1709USA009700: US-009507513-1709USA009699: US-009507513-1709USA009698.