chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: PATIENT STATES HER ARM WAS SORE THE NEXT DAY WHEN SHE WOKE UP AS SHE EXPECTED, BUT IT GOT WORSE DURING THE COURSE OF THE DAY, 2 DAYS LATER IT WAS  VERY SORE AND GOT WORSE FOR ABOUT 2 WEEKS WHEN SHE REPORTED IT TO THE PHARMACY. HAS TROUBLE LIFTING HER ARM , NO SIGN OF REDNESS, SWELLING, OR BUMP WAS NOTICED BY HER. SHE CALLED MD AND HE SAID TO ICE IT AND LET PHARMACY KNOW, DID NOT SEE HIM. SAID IT FELT BETTER AFTER TAKING MELOXICAM SHE USES FOR FIBROMYALGIA. WILL CALL IF IT DOES NOT GET BETTER SOON.
Age: 59.0
Sex: F
Vaccine: FLU4, PPV, FLU3, PNC13
Symptoms: Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: Patient received 2 different vaccines on the right arm 1 inch apart at the same time and 1 day after she developed a fever 103 F, and her injected arm has been swollen and tender to touch.
Age: 59.0
Sex: F
Vaccine: FLU4, PPV, FLU3, PNC13
Symptoms: Cellulitis, Erythema, Laboratory test abnormal, Pyrexia
Clinical narrative: Patient received 2 different vaccines on the right arm 1 inch apart at the same time and 1 day after she developed a fever 103 F, and her injected arm has been swollen and tender to touch.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Patient presented with a rash on his left forearm. He said he had taken antihistamines and it was resolving. He was instructed to go to the ER if it got worse of his breathing became affected.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Loss of consciousness, Urinary incontinence
Clinical narrative: On September parent brought child in for four year old immunization for school. Parent was holding child securely for immunization child received the first three vaccine Dtap, IPV, and HepA. Shortly after child started to pass out. I called for emergency assistance from staff members. Administered  ammonia inhaler and elevated legs child started coming around. During the episode the client urinate on self and floor. Vital signs monitored as follows 12:05 100/64 92,12:10 100/64 92,12:15 99 /65 95.12:18 114/58 95. Applied warm blanket client vital signs stable was able to drink some fluids and eat crackers. Client was later released per parent with escort.
Age: 76.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain
Clinical narrative: Patient received PNEUMOVAX 23 in his right arm and FLUZONE High Dose in his left arm. He went home and a few hours after receiving PNEUMOVAX 23 in his right deltoid, experienced severe pain when raising his right arm. He took a "scalding hot" shower and took 3 ibuprofen. At 7:30pm, he called the pharmacy back and stated he was feeling a little better after the ibuprofen but this was unlike any pain he has felt before. He stated it was not soreness, but pain when raising his arm. He does not feel pain when pushing with his arm, only raising it. He stated it is not red, hot, or swollen. He stated he will try an Epsom salt bath, massage, and ice.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Headache, Lip swelling, Pharyngeal oedema
Clinical narrative: 5 mins after administering vaccine patient reported throat swelling, lip swelling and headache. Epinephrine was immediately administered, EMS was called and patient was transported to the ER by ambulance.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pruritus
Clinical narrative: Patient reported rash at injection site on right arm (not left that was written on immunization consent form). Symptoms per patient, were itching and rash that occurred shortly after being given immunization. Informed patient that they should take diphenhydramine to deal with the itching and to see their doctor.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Differential white blood cell count, Full blood count, Pyrexia, Rash, Skin lesion
Clinical narrative: Patient received vaccine at another facility and experienced fever, Tmax 103.5 the night of the vaccine, onset of cephalocaudal rash and nonblanchable lesions 9/25/17. Rapid strep test neg, CBC with diff pending. Instructions to avoid public places, non-immunized persons or persons with immune deficiency for at least 7 days. Patient not ill appearing at time of visit. Parent instructed to notify provider, PCP, who gave vaccine of reaction.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Streptococcus test negative
Clinical narrative: Patient received vaccine at another facility and experienced fever, Tmax 103.5 the night of the vaccine, onset of cephalocaudal rash and nonblanchable lesions 9/25/17. Rapid strep test neg, CBC with diff pending. Instructions to avoid public places, non-immunized persons or persons with immune deficiency for at least 7 days. Patient not ill appearing at time of visit. Parent instructed to notify provider, PCP, who gave vaccine of reaction.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Injection site erythema, Skin warm, Vaccination site bruising, Vaccination site mass
Clinical narrative: Mild flu symptoms, warm red arm, lump and bruise lower down the arm from the vaccination site.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site warmth
Clinical narrative: Mild flu symptoms, warm red arm, lump and bruise lower down the arm from the vaccination site.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects. Was given expired vaccine. Dose repeated with this years vaccine.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects. Was given expired vaccine. Dose repeated with this years vaccine.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects. Was given expired vaccine. Dose repeated with this years vaccine.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pain in extremity, Peripheral swelling, Rash, Rash pruritic
Clinical narrative: Within hours after the shot, patient stated arm swelled from injection site down to below elbow. There was no knot at injection site. Arm hurt. There was an itchy rash on arm that went to back of shoulder and across chest. Rec. patient take Benadryl & ice area. If not better in 24 hrs or if gets worse, contact MD or go to ED.  Spoke to patient 1 week later and she says she's 90% better.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Patient states she feels pain, itchiness, warmth to the touch, and a lump underneath the site of injection. There is redness that's about 1.5 inch diameter on her right arm. Advised patient to take BENADRYL, use a cold compress, and contact her PCP.
Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: Feeling abnormal, Pain, Pain in extremity
Clinical narrative: Patient is experiencing pain and soreness in the left arm. She is unable to lift or move her left arm without soreness. Patient is also experiencing a popping feeling in the arm.  Patient has taken Ibuprofen but has not gotten relief.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Large painful swelling at injection site. Advised patient to use ice and elevation.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Cold sweat, Nausea, Paraesthesia
Clinical narrative: Pt received vaccine at 4 PM, he called the pharmacy at 5:30 PM stating that he thought he might be having a reaction to the vaccine. His head and arms were tingling, he was nauseated and felt clammy. He is a diabetic and has heart disease. He had not eaten since lunch and was unsure of his blood sugar reading or his blood pressure. His wife said she "felt it was one of his heart episodes and not related to the vaccine". He was going to go to the emergency room.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema
Clinical narrative: Patient complains of redness and erythema absent of swelling in his right bicep, but not in the immediate area of the PNEUMOVAX 23 injection site. I checked back with patient about 1.5 hours after recommending dose of diphenhydramine and acetaminophen, and was told by patient's spouse it seemed to have improved (patient had gone on to bed for the night).
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Left arm swelling, circular erythema, and pain.
Age: 24.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Pain, and soreness, redness, rash, swelling at site of PNEUMOVAX injection (left arm). Patient went to the ER the following day treated and released. Told she had a allergic reaction to the shot.
Age: 24.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Vaccination complication
Clinical narrative: Pain, and soreness, redness, rash, swelling at site of PNEUMOVAX injection (left arm). Patient went to the ER the following day treated and released. Told she had a allergic reaction to the shot.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: LEFT ARM BECAME HOT, RED SWOLLEN. HER DR PUT HER ON CEPHALEXIN 500MG CAPS 1 TID 7D ON 9/26/2017.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Chest discomfort, Chills, Dyspnoea, Fatigue
Clinical narrative: First sympton, nausea, chills, fever (just over 100°), severe muscle and joint pain, skin pain, skin rash, tightness in chest and labored breathing. Not able to sleep due to pain. Symptoms were in full swing by 9:00pm, less than 6 hours after injection. Had to endure the pain for two days, felt better by Sunday but felt like I had been through a battle. 4 days later still fatigued and feeling like I am getting sick, chills and headache.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Insomnia, Malaise, Myalgia, Nausea
Clinical narrative: First sympton, nausea, chills, fever (just over 100°), severe muscle and joint pain, skin pain, skin rash, tightness in chest and labored breathing. Not able to sleep due to pain. Symptoms were in full swing by 9:00pm, less than 6 hours after injection. Had to endure the pain for two days, felt better by Sunday but felt like I had been through a battle. 4 days later still fatigued and feeling like I am getting sick, chills and headache.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Pain of skin, Pyrexia, Rash
Clinical narrative: First sympton, nausea, chills, fever (just over 100°), severe muscle and joint pain, skin pain, skin rash, tightness in chest and labored breathing. Not able to sleep due to pain. Symptoms were in full swing by 9:00pm, less than 6 hours after injection. Had to endure the pain for two days, felt better by Sunday but felt like I had been through a battle. 4 days later still fatigued and feeling like I am getting sick, chills and headache.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Swelling
Clinical narrative: Patient states she developed rash on her left arm and experienced swelling that went down after about 3 days. She did get prescribed a MEDROL DOSE PACK to help with swelling. Says she is okay.
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Myalgia, Pruritus, Pyrexia, Skin warm
Clinical narrative: Vaccine given 4 PM 9-24-17. Myalgias on 9-25-17. Fever that evening up to 102.5. Red spot developed on L deltoid evening of 9-25-17. Large red area on L upper arm. Tender, itchy and warm area about 5 x 8 cm size.
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Tenderness
Clinical narrative: Vaccine given 4 PM 9-24-17. Myalgias on 9-25-17. Fever that evening up to 102.5. Red spot developed on L deltoid evening of 9-25-17. Large red area on L upper arm. Tender, itchy and warm area about 5 x 8 cm size.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Patient complained of pain and soreness that lasted more than a month.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB, MNQ, VARCEL
Symptoms: Dizziness, Fall, Loss of consciousness
Clinical narrative: Client fell forward after stating "I'm dizzy." She was unconscious for less than 15 seconds. Client was caught by RN and laid down in the floor against a chair. Given water and an ice pack. Mother drove client home from clinic. She called client at 1040. Client stated she was not dizzy and was fine.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site swelling, Peripheral swelling, Vomiting
Clinical narrative: Left arm and shoulder swollen. Bright red. Vomiting. Both hands were swollen.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt got ZOSTAVAX on 9/12. Called on 9/14 to let us know that injection site was red, swollen w/itchiness about size of half dollar. F/U on 9/18 and it has improved.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Several hours after vaccine. Got symptoms that lasted 2 days-aches, fever 101.5, chills. Patient took TYLENOL.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Nodule, Pruritus, Rash macular, Skin warm
Clinical narrative: Burning sensation (feels like bee sting), red blotch, nodule 1 inch, heat to touch, itching. Pt started BENADRYL 1 hr afterwards.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Bacterial test, Blood test, Chest X-ray normal, Culture urine negative, Feeling abnormal
Clinical narrative: Sweating / flu like / body aches. Felt terrible / stiff arm / stiff neck / firmness, swelling, pain at injection site. ER on 9/9/17. F/U here at 9/13/17, felt better arm still swollen. DX viral syndrome. TX with Benzonatate, Diclofenac; ZOFRAN.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Hyperhidrosis, Influenza like illness, Influenza virus test negative, Injection site induration, Injection site pain
Clinical narrative: Sweating / flu like / body aches. Felt terrible / stiff arm / stiff neck / firmness, swelling, pain at injection site. ER on 9/9/17. F/U here at 9/13/17, felt better arm still swollen. DX viral syndrome. TX with Benzonatate, Diclofenac; ZOFRAN.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Musculoskeletal stiffness, Pain, Pregnancy test negative, Protein total
Clinical narrative: Sweating / flu like / body aches. Felt terrible / stiff arm / stiff neck / firmness, swelling, pain at injection site. ER on 9/9/17. F/U here at 9/13/17, felt better arm still swollen. DX viral syndrome. TX with Benzonatate, Diclofenac; ZOFRAN.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Urine ketone body present, Viral infection, White blood cell count
Clinical narrative: Sweating / flu like / body aches. Felt terrible / stiff arm / stiff neck / firmness, swelling, pain at injection site. ER on 9/9/17. F/U here at 9/13/17, felt better arm still swollen. DX viral syndrome. TX with Benzonatate, Diclofenac; ZOFRAN.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Discomfort, Injection site mass, Injection site pain, Nuclear magnetic resonance imaging abnormal, Tenderness
Clinical narrative: Received vaccine on 8/24/17. On or around 9/10/17, pt began to develop a lump on her arm at the injection site. Lump continued to grow and became painful. Presented to Urg Care with mild tenderness, some redness, no induration. Xray showed soft tissue swelling in the deltoid area. Was advised rest and heat.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan, X-ray abnormal
Clinical narrative: Received vaccine on 8/24/17. On or around 9/10/17, pt began to develop a lump on her arm at the injection site. Lump continued to grow and became painful. Presented to Urg Care with mild tenderness, some redness, no induration. Xray showed soft tissue swelling in the deltoid area. Was advised rest and heat.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Cellulitis at site of injection area was red and hot, was rather large area.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects. Was given expired vaccine. Dose reported with this years vaccine.
Age: 69.0
Sex: U
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Nausea
Clinical narrative: Headache, nausea, redness at site of injection. Patient will call PCP.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: Pt experienced significant bruising from high dose flu vaccine. Bruising was approximately 2x6 inches on upper arm. Pt reports bruise appearing "shortly after" receiving vaccine then increasing in size over next few days.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9, PNC13
Symptoms: Rash
Clinical narrative: Rash.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Dizziness, Fatigue, Nausea, Pyrexia
Clinical narrative: Fever, nausea, decreased appetite, torso rash, fatigue, dizziness. Vaccine 11 am - symptom onset 4:30pm same day x 10 days.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Fever, nausea, decreased appetite, torso rash, fatigue, dizziness. Vaccine 11 am - symptom onset 4:30pm same day x 10 days.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ, MENB, MNQ
Symptoms: Anxiety, Computerised tomogram head normal, Electrocardiogram normal, Fall, Lip injury
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother) on 12-Aug-2017. This case involves a 16-year-old male patient who was vaccinated with intramuscular doses of MENACTRA and TRUMEMBA (manufacturer: Pfizer) (Batch number, expiration date, dose, dose in series and site of administration were not reported) on 22-Jun-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as no known allergies but the patient did not have any illness at the time of vaccination. Concomitant medications were not reported. On 22-Jun-2017, immediately after the vaccination, the patient fell off the table hitting head, shoulder, face and had a mouth laceration. He had to be seen in the emergency room (ER) and was evaluated and diagnosed as post vaccination syncope. The patient's mother reported that so wanted this to be reported so changes might be made to prevent this in the future. Laboratory investigations and corrective treatment were not reported. On an unknown date, the patient was recovered from all the events (patient's mother reported that at this time he was fully recovered without issue). List of documents held by sender: none.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ, MENB, MNQ
Symptoms: Loss of consciousness, Mouth haemorrhage, Nervousness, Pallor, Tinnitus
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother) on 12-Aug-2017. This case involves a 16-year-old male patient who was vaccinated with intramuscular doses of MENACTRA and TRUMEMBA (manufacturer: Pfizer) (Batch number, expiration date, dose, dose in series and site of administration were not reported) on 22-Jun-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as no known allergies but the patient did not have any illness at the time of vaccination. Concomitant medications were not reported. On 22-Jun-2017, immediately after the vaccination, the patient fell off the table hitting head, shoulder, face and had a mouth laceration. He had to be seen in the emergency room (ER) and was evaluated and diagnosed as post vaccination syncope. The patient's mother reported that so wanted this to be reported so changes might be made to prevent this in the future. Laboratory investigations and corrective treatment were not reported. On an unknown date, the patient was recovered from all the events (patient's mother reported that at this time he was fully recovered without issue). List of documents held by sender: none.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ, MENB, MNQ
Symptoms: Computerised tomogram head normal, Electrocardiogram normal, Head injury, Syncope, X-ray limb normal
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother) on 12-Aug-2017. This case involves a 16-year-old male patient who was vaccinated with intramuscular doses of MENACTRA and TRUMEMBA (manufacturer: Pfizer) (Batch number, expiration date, dose, dose in series and site of administration were not reported) on 22-Jun-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as no known allergies but the patient did not have any illness at the time of vaccination. Concomitant medications were not reported. On 22-Jun-2017, immediately after the vaccination, the patient fell off the table hitting head, shoulder, face and had a mouth laceration. He had to be seen in the emergency room (ER) and was evaluated and diagnosed as post vaccination syncope. The patient's mother reported that so wanted this to be reported so changes might be made to prevent this in the future. Laboratory investigations and corrective treatment were not reported. On an unknown date, the patient was recovered from all the events (patient's mother reported that at this time he was fully recovered without issue). List of documents held by sender: none.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ, MENB, MNQ
Symptoms: Face injury, Fall, Head injury, Immediate post-injection reaction, Limb injury
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother) on 12-Aug-2017. This case involves a 16-year-old male patient who was vaccinated with intramuscular doses of MENACTRA and TRUMEMBA (manufacturer: Pfizer) (Batch number, expiration date, dose, dose in series and site of administration were not reported) on 22-Jun-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as no known allergies but the patient did not have any illness at the time of vaccination. Concomitant medications were not reported. On 22-Jun-2017, immediately after the vaccination, the patient fell off the table hitting head, shoulder, face and had a mouth laceration. He had to be seen in the emergency room (ER) and was evaluated and diagnosed as post vaccination syncope. The patient's mother reported that so wanted this to be reported so changes might be made to prevent this in the future. Laboratory investigations and corrective treatment were not reported. On an unknown date, the patient was recovered from all the events (patient's mother reported that at this time he was fully recovered without issue). List of documents held by sender: none.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ, MENB, MNQ
Symptoms: Mouth injury, Syncope
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother) on 12-Aug-2017. This case involves a 16-year-old male patient who was vaccinated with intramuscular doses of MENACTRA and TRUMEMBA (manufacturer: Pfizer) (Batch number, expiration date, dose, dose in series and site of administration were not reported) on 22-Jun-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as no known allergies but the patient did not have any illness at the time of vaccination. Concomitant medications were not reported. On 22-Jun-2017, immediately after the vaccination, the patient fell off the table hitting head, shoulder, face and had a mouth laceration. He had to be seen in the emergency room (ER) and was evaluated and diagnosed as post vaccination syncope. The patient's mother reported that so wanted this to be reported so changes might be made to prevent this in the future. Laboratory investigations and corrective treatment were not reported. On an unknown date, the patient was recovered from all the events (patient's mother reported that at this time he was fully recovered without issue). List of documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness/swelling roughly 3 inches below injection site.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness/swelling roughly 3 inches below injection site.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Rash on LE that spread to truncal area.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to 19 patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates in 2017 (reported as beginning sometime in May 2017), the patients were vaccinated with improperly stored doses of ROTATEQ oral liquid, orally, lot # M034799 with expiration date on 01-FEB-2018 (dose and frequency were not reported). There were no adverse effects reported. Administered doses of the vaccine underwent temperature excursions of 31 degrees Fahrenheit or colder for 1027 hours and 32 degrees Fahrenheit to 35 degrees Fahrenheit for 587 hours. There were no previous temperature excursions. Digital data logger was not involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA005467: US-009507513-1709USA009874.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 13 years old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 16-JUN-2017, the patient was vaccinated with the first dose of GARDASIL 9 (lot # M036059, expiration date 03-JUN-2019) (dose, route of administration and anatomical location were not reported) for prophylaxis. The administered doses of vaccine was exposed to a temperature excursion between 46.8 degrees Fahrenheit (F) which lasted for a 18 hours and 59 degrees Fahrenheit (F) which lasted for 65 hours on 13-JUN-2017. There was 59F previous temperature excursion for 4 hours. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA005381: US-009507513-1707USA010591: US-009507513-1709USA012776: US-009507513-1709USA012777: US-009507513-1709USA012774: US-009507513-1709USA012722: US-009507513-1709USA012723: US-009507513-1709USA012724: US-009507513-1709USA012725: US-009507513-1709USA012726: US-009507513-1709USA012727: US-009507513-1709USA012728: US-009507513-1709USA012729: US-009507513-1709USA012730: US-009507513-1709USA012731: US-009507513-1709USA012732: US-009507513-1709USA012733.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician concerning a female patient in her 50's age with no drug reactions or allergies reported. The patient's medical history included herpes zoster. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The physician reported that patient had two more cases of shingles since receiving the vaccine, on an unknown dates. It was reported that the patient received unspecified treatment. The outcome of herpes zoster was reported as recovered.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unspecified gender and age. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On 21-SEP-2017, an improperly stored dose of ROTATEQ 2 ml, once, lot number M045544, expiration date 23-JUN-2018 (dose, route of administration and were not reported) was administered to the patient. The dose was stored in temperature 33.8 degrees Fahrenheit for 20 minutes and in temperature 35.8 degrees Fahrenheit for 2 minutes. No previous temperature excursions were reported. No adverse effects have been reported. Data logger was involved. Product quality complaint was not involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA012899: US-009507513-1709USA012898: US-009507513-1709USA012896: US-009507513-1709USA012897.
Sex: M
Vaccine: HEP, HIBV
Symptoms: HIV test positive, Laboratory test abnormal
Clinical narrative: This spontaneous report was received from a pharmacy technician, who referred to a 22-year-old male patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 11-JUL-1995 and 14-SEP-1995, the patient was vaccinated with Hepatitis B vaccine (manufacturer unknown), dose 1 and 2 respectively (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On 14-SEP-1995, the patient was also vaccinated with Haemophilus Influenzae B vaccine (manufacturer unknown) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. The pharmacy technician reported that on an unknown date, the patient had an unknown test done, which showed that his levels were insufficient. It was also reported that the patient was also Human Immunodeficiency Virus (HIV) positive since an unknown date and was treated with an unknown medication. The reporter did not clarify whether the patient was born HIV positive or whether the patient became HIV positive after receiving the vaccinations. The outcome of the reported events was unknown. No product quality complaint was involved. The relatedness between the events and the suspect therapy was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection (exact dose, lot #, expiration date and route of administration were not reported). The vaccines were reconstituted with properly stored sterile diluent (MERCK) injection. The reporter stated that the administered doses of VARIVAX were stored at the temperature between 15 degrees Fahrenheit to 46 degrees Fahrenheit for 42 minutes on an unknown date. Data logger was used to detect this temperature excursion. There was no previous temperature excursions reported. No adverse effects were reported. No product quality complaint was involved. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1709USA012904: US-009507513-1709USA012903.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager and refers to an unspecified amount of patients of unknown demographics. The patients' pertinent medical histories and drug reactions or allergies were not reported. From 01-JAN-2017 to 25-SEP-2017, the patients received an improperly stored doses of VARIVAX (lot # N012618 with expiration date at 21-APR-2018, for prophylaxis; dose, route of administration and anatomical location were not reported), reconstituted with properly stored sterile diluent (dose, lot # and expiration date were not reported). There were previous temperature excursions (unknown by reporter). The reporter did not know the ranges of temperature excursions and their time frames. Data logger was not used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012635: US-009507513-1709USA012745: US-009507513-1709USA012747: US-009507513-1709USA012744.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager and refers to an unspecified amount of patients of unknown demographics. The patients' pertinent medical histories and drug reactions or allergies were not reported. From 01-JAN-2017 to 25-SEP-2017, the patients received an improperly stored doses ZOSTAVAX (lot # M039452 with expiration date at 19-DEC-2017, for prophylaxis; dose, route of administration and anatomical location were not reported), reconstituted with properly stored sterile diluent (dose, lot # and expiration date were not reported). There were previous temperature excursions (unknown by reporter). The reporter did not know the ranges of temperature excursions and their time frames. Data logger was not used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012746: US-009507513-1709USA012745: US-009507513-1709USA012635: US-009507513-1709USA012744.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to patient of unspecified gender and age. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On 21-SEP-2017, an improperly stored dose of ROTATEQ 2 ml, once, lot number M045544, expiration date 23-JUN-2018 (dose, route of administration and were not reported) was administered to the patient. The dose was stored in temperature 33.8 degrees Fahrenheit for 20 minutes and in temperature 35.8 degrees Fahrenheit for 2 minutes. No previous temperature excursions were reported. No adverse effects have been reported. Data logger was involved. Product quality complaint was not involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA012899: US-009507513-1709USA012898: US-009507513-1709USA011805: US-009507513-1709USA012897.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unspecified gender and age. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On 21-SEP-2017, an improperly stored dose of ROTATEQ 2 ml, once, lot number M045544, expiration date 23-JUN-2018 (route of administration and anatomical location were not reported) was administered to the patient. The dose was stored in temperature 33.8 degrees Fahrenheit for 20 minutes and in temperature 35.8 degrees Fahrenheit for 2 minutes. No previous temperature excursions were reported. No adverse effects have been reported. Data logger was involved. Product quality complaint was not involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA012899: US-009507513-1709USA012898: US-009507513-1709USA012896: US-009507513-1709USA011805:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD injection (exact dose, lot #, expiration date and route of administration were not reported; albumin status unknown). The vaccines were reconstituted with properly stored sterile diluent (MERCK) injection. The reporter stated that the administered doses of PROQUAD were stored at the temperature between 15 degrees Fahrenheit to 46 degrees Fahrenheit for 42 minutes on an unknown date. Data logger was used to detect this temperature excursion. There was no previous temperature excursions reported. No adverse effects were reported. No product quality complaint was involved. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1709USA012904: US-009507513-1709USA012678.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX injection (exact dose, lot #, expiration date and route of administration were not reported). The vaccines were reconstituted with properly stored sterile diluent (MERCK) injection. The reporter stated that the administered doses of ZOSTAVAX were stored at the temperature between 15 degrees Fahrenheit to 46 degrees Fahrenheit for 42 minutes on an unknown date. Data logger was used to detect this temperature excursion. There was no previous temperature excursions reported. No adverse effects were reported. No product quality complaint was involved. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1709USA012678: US-009507513-1709USA012903.
Age: 1.42
Sex: F
Vaccine: DTAP, MMRV, PNC13
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse (LPN) and refers to a patient of unknown age and gender. Information regarding the pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On 11-AUG-2017, the patient was vaccinated with improperly stored PROQUAD, Lot # N008825 with expiry date 12-SEP-2018 (dose, route and anatomical location not reported), that was reconstituted with sterile diluent (DILUENT MRK INJ) for prophylaxis. No adverse effects were reported. The administered vaccine underwent a temperature excursion between -9 °Centigrade(C) to 8 °C for a time frame of 4 hours and 43 minutes. Previous temperature excursion was between -9 °C to 8 °C for 57 hours and 40 minutes and between -14 °C to -10 °C for 23 hours and 57 minutes. The call was not because of a data logger. No product quality compliant (PQC) was involved. The nurse stated that she decline to give patient specific data with this report. This is one of the four reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA010551: US-009507513-1708USA009081: US-009507513-1709USA012932:
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse (LPN) and refers to a patient of unknown age and gender. Information regarding the pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On 15-AUG-2017, the patient was vaccinated with improperly stored PROQUAD, Lot # N008825 with expiry date 12-SEP-2018 (dose, route and anatomical location not reported), that was reconstituted with sterile diluent (MRK INJ) for prophylaxis. No adverse effects were reported. The administered vaccine underwent a temperature excursion between -9 °Centigrade (C) to 8 °C for a time frame of 4 hours and 43 minutes. Previous temperature excursion was between -9 °C to 8 °C for 57 hours and 40 minutes and between -14 °C to -10 °C for 23 hours and 57 minutes. The call was not because of a data logger. No product quality compliant (PQC) was involved. The nurse stated that she decline to give patient specific data with this report. This is one of the four reports received from the same reporter. Sender's Comments: US-009507513-1708USA010551: US-009507513-1708USA009081: US-009507513-1709USA012931.
Age: 58.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Injection site pain, Injection site warmth, Skin warm
Clinical narrative: PT STATED THAT LATER IN EVENING OF 9/23/17 AFTER GETTING VACCINES SHE STARTED EXPERIENCING PAIN AND WARMNESS IN LEFT ARM FROM ELBOW UP TO HER SHOULDER AND DOWN HER BACK(SAME SIDE AS VACCINES) AND SIDE. SHE DIDN'T PRESENT TO PHARMACY UNTIL MONDAY 9/25 WITH COMPLAINT. SHE WAS ADVISED TO USE ICE PACKS AND IBUPROFEN AND BENADRYL AND COME BY PHARMACY ON TUESDAY TO LET US KNOW HOW SHE WAS DOING,  SHE FOLLOWED ADVISE OF ICE PACKS AND IBUPROFEN AND ALL PROBLEMS HAD RESOLVED. PT WAS HAPPY AND RELIEVED WITH OUTCOME.
Age: 0.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This pt. is a 9 day old baby who has the same last name as a 2 month old pt that was also seen on the same day - there was a slight language barrier however that parents did not ask for a interpreter. The nurse administered a 2 month set of shots the the 9 day old pt. When the error was realized the parents were asked to wait in the room and a Doctor went in to see them - there has not been in reaction noted - however this is a medication error that we felt needed to be reported.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Abdominal pain upper, Asthenia, Back pain, Fatigue, Headache
Clinical narrative: On Thursday of last wk, felt terrible stomach ache, back ache, and also the back ache went into the back of the head. The pain in stomach subsided and then the achiness in the rest of the body felt very fatigued, very weak this past weekend it was hot. At lunch on Saturday felt stomach ache very badly slept a little the stomach ache was severe TYLENOL was tried and it didn't help. Did have some nausea but never threw up. Talked to doctor on call and he recommended taking ALEVE. The ALEVE was taken for the aches and did relieve the aches eating a small amount satisfies the hunger pains but doesn't cause any touch in epigastrium. The stomach was better if had normal meal. It is getting slightly better.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Nausea, Poor quality sleep
Clinical narrative: On Thursday of last wk, felt terrible stomach ache, back ache, and also the back ache went into the back of the head. The pain in stomach subsided and then the achiness in the rest of the body felt very fatigued, very weak this past weekend it was hot. At lunch on Saturday felt stomach ache very badly slept a little the stomach ache was severe TYLENOL was tried and it didn't help. Did have some nausea but never threw up. Talked to doctor on call and he recommended taking ALEVE. The ALEVE was taken for the aches and did relieve the aches eating a small amount satisfies the hunger pains but doesn't cause any touch in epigastrium. The stomach was better if had normal meal. It is getting slightly better.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Abdominal pain upper, Asthenia, Back pain, Fatigue, Nausea
Clinical narrative: On Thursday of last wk, felt terrible stomach ache, back ache, and also the back ache went into the back of the head. The pain in stomach subsided and then the achiness in the rest of the body felt very fatigued, very weak this past weekend it was hot. At lunch on Saturday felt stomach ache very badly slept a little the stomach ache was severe TYLENOL was tried and it didn't help. Did have some nausea but never threw up. Talked to doctor on call and he recommended taking ALEVE. The ALEVE was taken for the aches and did relieve the aches eating a small amount satisfies the hunger pains but doesn't cause any touch in epigastrium. The stomach was better if had normal meal. It is getting slightly better.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pain
Clinical narrative: On Thursday of last wk, felt terrible stomach ache, back ache, and also the back ache went into the back of the head. The pain in stomach subsided and then the achiness in the rest of the body felt very fatigued, very weak this past weekend it was hot. At lunch on Saturday felt stomach ache very badly slept a little the stomach ache was severe TYLENOL was tried and it didn't help. Did have some nausea but never threw up. Talked to doctor on call and he recommended taking ALEVE. The ALEVE was taken for the aches and did relieve the aches eating a small amount satisfies the hunger pains but doesn't cause any touch in epigastrium. The stomach was better if had normal meal. It is getting slightly better.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Computerised tomogram head normal, Eye disorder, Fall, Head injury, VIth nerve paralysis
Clinical narrative: Left Lateral rectus palsy (cranial nerve 6) noticed around 7/1/17. She had a minor fall that day and later had a head CT that was normal. She was treated on 7/5 with a course of Acyclovir and Prednisolone and showed good recovery with those treatments. She improved within a few days. She has no residual disease.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood electrolytes normal, Blood potassium decreased, Blood sodium decreased
Clinical narrative: Developed fever to 103 F and vomiting approximately 5 hours after immunization. Also had faint rash in scalp. Left deltoid was sore the following day at the site of immunization. Symptoms resolved within 24 hours.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Full blood count normal, Influenza virus test negative, Injection site pain, Liver function test increased, Mononucleosis heterophile test negative
Clinical narrative: Developed fever to 103 F and vomiting approximately 5 hours after immunization. Also had faint rash in scalp. Left deltoid was sore the following day at the site of immunization. Symptoms resolved within 24 hours.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Pyrexia, Rash, Streptococcus test negative, Vomiting
Clinical narrative: Developed fever to 103 F and vomiting approximately 5 hours after immunization. Also had faint rash in scalp. Left deltoid was sore the following day at the site of immunization. Symptoms resolved within 24 hours.
Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Exposure during pregnancy, Foetal death, Ultrasound antenatal screen abnormal, Uterine dilation and evacuation, Vaginal haemorrhage
Clinical narrative: Flu shot given on 1/3/12. Requested thimerosal-free as I was 9 weeks 6 days pregnant. Estimated date of delivery was 8/1/12. I called OB from pharmacy waiting room to verify it was safe to receive vaccine as I had had a cold a few weeks prior. Verified it was safe. Prior to pharmacy employee giving the shot, again asked if it was safe. They confirmed it was. I received the vaccine. On Thursday January 5 I noted to a friend that my morning sickness had stopped and I was relieved to feel better. On Saturday January 7 I experienced spotting in my underpants. I spent the rest of the weekend in bed. Called my OB on Monday January 9 and was seen in the afternoon. Ultrasound showed the fetus had died. Went to Radiology the next day where intrauterine ultrasound confirmed fetal death. Evacuation of uterine contents occurred on Wednesday January 11.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: Immediately after delivering dose, patients arm became swollen and red, about 1" circumference around the injection site. There were no systemic signs of allergic reaction/anaphylaxis, no disorientation or difficulty breathing, or swelling  any other areas of the body that were noticeable to me. I asked her to stay in the store for 15 minutes, and swelling went down slightly, she then left with her mother to run an errand down the street, then cam back about 30 minutes later for me to check on her; again swelling was reduced to about 1/2" circumference and redness was minimal. I called again the morning of 9/27/2017- she states she is feeling slightly under the weather but that the swelling in her arm is less than it was last night.