chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Pain in extremity, Pyrexia, Rash
Clinical narrative: Patient reports her arm started to swell and get what looked like a rash day of vaccination.  By the next morning, patient states entire upper arm was red, HOT, swollen, and still had a rash. Patient reports additional symptoms of severe exhaustion, inability to sit up for longer than a few minutes without extreme dizziness, fever, achy and painful joints, back pain, ear pain, headache, nausea, feeling like she was going to pass out, severe arm pain. These symptoms lasted for 4 days and the most severe day was the day after the vaccines were administered.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chills, Computerised tomogram normal, Headache, Laboratory test normal
Clinical narrative: Initially only headache - then leading into horrible stomach pains, aches, chills and low grade fever. 9/15/16 Vomiting.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Initially only headache - then leading into horrible stomach pains, aches, chills and low grade fever. 9/15/16 Vomiting.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Fever & Redness around injection site.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Injection site swelling
Clinical narrative: Swelling of the arm where the shot was given, Chest Tightness, shortness of breath, trouble breathing, Went to the ER.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Pain
Clinical narrative: Patient has had ongoing soreness, "especially when I lift things" since being vaccinated.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Decreased appetite, Influenza like illness, Insomnia, Pain, Tremor
Clinical narrative: Patient says shook all over for 45 min night of sept 16 2016 also very painful when touching hips arms hair. sat in chair all night could not slepp didn't feel like eating. felt like he had the flu. 9/16 am reports getting better on its own.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Urticaria
Clinical narrative: Whelps all over body including lips. They did not give any treatment. Mom called me at 1:00pm on 9/16/2016-I informed to give Benadryl and go straight to ER.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Immediate post-injection reaction, Injection site pain, Skin warm, Swelling
Clinical narrative: Immediate soreness at injection site. Patient developed swelling and warmth within four days of receiving vaccination.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Chills, Headache, Myalgia
Clinical narrative: Chills shakes, muscle and joint aches for 5 hours then followed by nausea and overall weakness.  Then 24 hours later had a severe headache for approx. 12 hours.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Tremor
Clinical narrative: Chills shakes, muscle and joint aches for 5 hours then followed by nausea and overall weakness.  Then 24 hours later had a severe headache for approx. 12 hours.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Tremor
Clinical narrative: An hr and a half after shot experienced severe shakes. Went to ER. Had extremely high fever.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to multiple unspecified patients of unknown age and gender. Pertinent medical history, drug reactions/allergies and concomitant therapy were not reported. Between 10-AUG-2016 and 26-AUG-2016, the patients were vaccinated with improperly stored M-M-R II, lot # M004063, expiry date 25-JAN-2018, subcutaneously, 12 doses. No adverse effects were reported. The outcome of the events was unknown. Therapy with M-M-R II was continued. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: This spontaneous report as received from a nurse refers to a 69-year-old female patient with no drug reactions or allergies. No concurrent conditions or medical history were provided. On 26-MAY-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 injection administered intramuscularly (lot # M006139 with expiry date: 13-MAY-2017; strength, dose and site of administration were unspecified). Concomitant therapies included PRADAXA. On an unspecified date in 2016, the patient developed redness and pain which radiated to elbow. No laboratory tests were provided. The nurse stated that the patient was treated with BENADRYL and TYLENOL for pain. The symptoms subsided after a couple of days and patient was fine at the time of this report. The relatedness between the event and PNEUMOVAX 23 was not reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 21-JUL-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # M001200, dose, route of administration and expiration date was not reported). This is one of several reports received from the same source. Additional information has been requested.
Age: 1.75
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 21-month-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 08-APR-2016, the patient was vaccinated with an incorrectly stored dose of PROQUAD (therapy type: rHA, lot # L031601, an expiration date 18-FEB-2017, dose, dose number, anatomical location and route of administration were not provided). It was reported that the refrigerator was out of range. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 18-AUG-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II lot # L029266, therapy type was not specified (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Peripheral swelling
Clinical narrative: Swelling right arm, treated with KEFLEX.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Blood culture, Breast pain, Chills, Computerised tomogram
Clinical narrative: Major swelling and moderate pain at site of injection, light sensitivity, chills, moderate flu-like symptoms. Took Ibuprofen as needed. 9/12/2016 - Body aches, weakness in left arm, headache, moderate light sensitivity. Took Ibuprofen, consulted with person at CDC for advice. 09/13/2016 - Moderate flu-like symptoms, all major joints hurting, large painful lymph nodes in neck and armpit near injection site, painful left breast, chills, loss of appetite, lethargy, took ibuprofen and slept. 9/14/2016 - Woke up with swollen face and eyes, severe migraine like headache, took migraine medicine, moderate stiff neck upon awakening, applied ICY-HOT patch, took ibuprofen and slept in upright position, woke up around 1pm unable to turn head, unable to lift left arm, severe pain in neck, shoulder, arm, left hand, jaw pain when speaking or chewing. Went to primary doctor, sent from office to emergency room without treatment. Arrived at E.R. about 4pm, immediately isolated for suspected meningitis, administered IV fluids and pain medicine, rigorous testing including blood culture, CT-scan, xray, and spinal tap. Admitted into Hospital for evaluation and consultation with CDC. Released from Hospital on 9/15/2016 about 4pm.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Decreased appetite, Eye swelling, Headache, Influenza like illness, Injected limb mobility decreased
Clinical narrative: Major swelling and moderate pain at site of injection, light sensitivity, chills, moderate flu-like symptoms. Took Ibuprofen as needed. 9/12/2016 - Body aches, weakness in left arm, headache, moderate light sensitivity. Took Ibuprofen, consulted with person at CDC for advice. 09/13/2016 - Moderate flu-like symptoms, all major joints hurting, large painful lymph nodes in neck and armpit near injection site, painful left breast, chills, loss of appetite, lethargy, took ibuprofen and slept. 9/14/2016 - Woke up with swollen face and eyes, severe migraine like headache, took migraine medicine, moderate stiff neck upon awakening, applied ICY-HOT patch, took ibuprofen and slept in upright position, woke up around 1pm unable to turn head, unable to lift left arm, severe pain in neck, shoulder, arm, left hand, jaw pain when speaking or chewing. Went to primary doctor, sent from office to emergency room without treatment. Arrived at E.R. about 4pm, immediately isolated for suspected meningitis, administered IV fluids and pain medicine, rigorous testing including blood culture, CT-scan, xray, and spinal tap. Admitted into Hospital for evaluation and consultation with CDC. Released from Hospital on 9/15/2016 about 4pm.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Injection site swelling, Lethargy, Lumbar puncture, Lymph node pain
Clinical narrative: Major swelling and moderate pain at site of injection, light sensitivity, chills, moderate flu-like symptoms. Took Ibuprofen as needed. 9/12/2016 - Body aches, weakness in left arm, headache, moderate light sensitivity. Took Ibuprofen, consulted with person at CDC for advice. 09/13/2016 - Moderate flu-like symptoms, all major joints hurting, large painful lymph nodes in neck and armpit near injection site, painful left breast, chills, loss of appetite, lethargy, took ibuprofen and slept. 9/14/2016 - Woke up with swollen face and eyes, severe migraine like headache, took migraine medicine, moderate stiff neck upon awakening, applied ICY-HOT patch, took ibuprofen and slept in upright position, woke up around 1pm unable to turn head, unable to lift left arm, severe pain in neck, shoulder, arm, left hand, jaw pain when speaking or chewing. Went to primary doctor, sent from office to emergency room without treatment. Arrived at E.R. about 4pm, immediately isolated for suspected meningitis, administered IV fluids and pain medicine, rigorous testing including blood culture, CT-scan, xray, and spinal tap. Admitted into Hospital for evaluation and consultation with CDC. Released from Hospital on 9/15/2016 about 4pm.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Meningitis, Migraine, Mobility decreased, Muscular weakness, Musculoskeletal pain
Clinical narrative: Major swelling and moderate pain at site of injection, light sensitivity, chills, moderate flu-like symptoms. Took Ibuprofen as needed. 9/12/2016 - Body aches, weakness in left arm, headache, moderate light sensitivity. Took Ibuprofen, consulted with person at CDC for advice. 09/13/2016 - Moderate flu-like symptoms, all major joints hurting, large painful lymph nodes in neck and armpit near injection site, painful left breast, chills, loss of appetite, lethargy, took ibuprofen and slept. 9/14/2016 - Woke up with swollen face and eyes, severe migraine like headache, took migraine medicine, moderate stiff neck upon awakening, applied ICY-HOT patch, took ibuprofen and slept in upright position, woke up around 1pm unable to turn head, unable to lift left arm, severe pain in neck, shoulder, arm, left hand, jaw pain when speaking or chewing. Went to primary doctor, sent from office to emergency room without treatment. Arrived at E.R. about 4pm, immediately isolated for suspected meningitis, administered IV fluids and pain medicine, rigorous testing including blood culture, CT-scan, xray, and spinal tap. Admitted into Hospital for evaluation and consultation with CDC. Released from Hospital on 9/15/2016 about 4pm.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Musculoskeletal stiffness, Neck pain, Pain, Pain in extremity, Pain in jaw
Clinical narrative: Major swelling and moderate pain at site of injection, light sensitivity, chills, moderate flu-like symptoms. Took Ibuprofen as needed. 9/12/2016 - Body aches, weakness in left arm, headache, moderate light sensitivity. Took Ibuprofen, consulted with person at CDC for advice. 09/13/2016 - Moderate flu-like symptoms, all major joints hurting, large painful lymph nodes in neck and armpit near injection site, painful left breast, chills, loss of appetite, lethargy, took ibuprofen and slept. 9/14/2016 - Woke up with swollen face and eyes, severe migraine like headache, took migraine medicine, moderate stiff neck upon awakening, applied ICY-HOT patch, took ibuprofen and slept in upright position, woke up around 1pm unable to turn head, unable to lift left arm, severe pain in neck, shoulder, arm, left hand, jaw pain when speaking or chewing. Went to primary doctor, sent from office to emergency room without treatment. Arrived at E.R. about 4pm, immediately isolated for suspected meningitis, administered IV fluids and pain medicine, rigorous testing including blood culture, CT-scan, xray, and spinal tap. Admitted into Hospital for evaluation and consultation with CDC. Released from Hospital on 9/15/2016 about 4pm.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Patient isolation, Photophobia, Swelling face, X-ray
Clinical narrative: Major swelling and moderate pain at site of injection, light sensitivity, chills, moderate flu-like symptoms. Took Ibuprofen as needed. 9/12/2016 - Body aches, weakness in left arm, headache, moderate light sensitivity. Took Ibuprofen, consulted with person at CDC for advice. 09/13/2016 - Moderate flu-like symptoms, all major joints hurting, large painful lymph nodes in neck and armpit near injection site, painful left breast, chills, loss of appetite, lethargy, took ibuprofen and slept. 9/14/2016 - Woke up with swollen face and eyes, severe migraine like headache, took migraine medicine, moderate stiff neck upon awakening, applied ICY-HOT patch, took ibuprofen and slept in upright position, woke up around 1pm unable to turn head, unable to lift left arm, severe pain in neck, shoulder, arm, left hand, jaw pain when speaking or chewing. Went to primary doctor, sent from office to emergency room without treatment. Arrived at E.R. about 4pm, immediately isolated for suspected meningitis, administered IV fluids and pain medicine, rigorous testing including blood culture, CT-scan, xray, and spinal tap. Admitted into Hospital for evaluation and consultation with CDC. Released from Hospital on 9/15/2016 about 4pm.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash papular
Clinical narrative: Papular rash on both Legs, no fever, no pain, non itchy, no abdominal pain.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Back pain, Dyspnoea, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Pain in neck, back, and back of arm on injection site side (left).  A little trouble breathing, for a short time as well.  She said she is feeling a lot better now (9-16-2016 2:38pm EDT) and just a little bit of residual pain in the left arm, but it's going away.  I recommend she talk to her doctor as well.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea
Clinical narrative: Started having severe diarrhea (10 plus times per day) about 24 hours after vaccine.  She did not have any other symptoms.  The diarrhea lasted approximately 1 week.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Bed rest, Chills, Fatigue, Injection site pain, Musculoskeletal disorder
Clinical narrative: Severe muscle pain at injection site preventing use of arm. Followed by chills, fatigue requiring bed rest. Applied hot & cold compresses and took Advil 2x/day.  After 7 days still experiencing pain when trying to achieve full range of motion in the arm.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Severe muscle pain at injection site preventing use of arm. Followed by chills, fatigue requiring bed rest. Applied hot & cold compresses and took Advil 2x/day.  After 7 days still experiencing pain when trying to achieve full range of motion in the arm.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Feeling abnormal, Hypoaesthesia, Injection site pain
Clinical narrative: Woke up with stabbing pain in upper arm on the injection arm and her hand on the same arm felt numb. As time progressed the hand is less numb but her lower arm and elbow still feel "weird". She doesn't think she needs to go the Dr or a hospital today, but if she is still experiencing problems tomorrow she may as a precaution.
Age: 57.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site infection, Injection site pain, Injection site swelling
Clinical narrative: The patient stated that his upper right arm started to get sore and swell. He went to the ER and they said that the arm was infected. They couldn't find any other source of infection besides his injection site from his vaccine. He was started on clindamycin and they are going to keep an eye on the swelling.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Staphylococcal infection
Clinical narrative: Patient had extreme localized swelling, redness, and fever around the injection site which was later diagnosed as a Staph infection.
Age: 30.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Pyrexia, Swelling
Clinical narrative: Swelling, fever to 102, redness, pain at injection site.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pruritus, Injection site rash, Injection site urticaria
Clinical narrative: Hives rash left upper arm at injections site itching.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Mobility decreased, Pain in extremity
Clinical narrative: Arm is still sore after a few days and she is unable to lift her arm. She also noticed swelling around the injection site that is oval shaped and the size of about two quarters.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: RASH/HIVES ON NECK AND TORSO.  MOM STARTED GIVING DIPHENHYDRAMINE ON 9-15-16.
Age: 13.0
Sex: M
Vaccine: FLU4, HEP, HEPA, IPV, MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Client was to receive 9 injections. Received 5 in RUA then went to LUA. Received 3 there and then fainted.
Age: 12.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Erythema, Injection site swelling, Skin warm
Clinical narrative: Swelling, redness, warmth to touch.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Muscle spasms, Pruritus, Pyrexia
Clinical narrative: Chest spasms, fever, itchy palms, feet, inner ear.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Allergy to vaccine, Chest discomfort, Pruritus, Skin lesion, Urticaria
Clinical narrative: Chest spasms, fever, itchy palms, feet, inner ear.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Wheezing
Clinical narrative: Chest spasms, fever, itchy palms, feet, inner ear.
Age: 0.75
Sex: M
Vaccine: FLU4
Symptoms: Seizure
Clinical narrative: New onset seizure activity. No fever.
Age: 21.0
Sex: F
Vaccine: HEP, HEP, HEP, HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received an expired dose of Hep B (Recombivax) on 9/13/16. Following CDC guideline this dose was not counted and a valid vaccine was administered same day. Patient has not reported any adverse event.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Area of injection was swollen,painful, and warm. Pt. was taking Mobic and adding Advil 600mg for 3 doses.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Hypoaesthesia oral, Oedema, Pruritus
Clinical narrative: Pruritus with erythema to forehead on 9/13/16. Took BENADRYL 25 MG po x 1 at home. 9/14/16 c/o severe pruritus/increased erythema with edema to forehead. Starting to have lower lip numbness. Took another BENADRYL 25 MG po x 1 on 9/14/16. Referred to worker's comp.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Incomplete course of vaccination, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. Patients concurrent conditions, medical history and concomitant medications were not reported. On an unknown date of 2014 the patient was administered the first dose in the three dose series of GARDASIL and on 06-SEP-2016 the second dose was vaccinated with GARDASIL 9, intramuscularly (lot, expiration date, dose and route of administration was not provided). The primary reporter stated that the third dose in the series was not administered (drug dose omission). No adverse effects reported. No product quality complaint (PQC) filed. No further information was provided. Additional information has been requested.
Age: 45.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 45-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-APR-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # L035283, expiration date 15-DEC-2016 (dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of -13 degrees Celsius for 48 hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 63-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-JAN-2016, the patient was vaccinated with improperly stored of ZOSTAVAX lot # L029484, expiration date 06-NOV-2016 (dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of -13 degrees Celsius for 48 hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 04-AUG-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (lot # M010478 with expiry date on 01-SEP-2017, therapy type, dose and route of administration were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 60-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 07-MAR-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # L029484, expiration date 06-NOV-2016 (dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of -13 degrees Celsius for 48 hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 21-JUN-2016, the patient was vaccinated with improperly stored dose of PROQUAD lot # M001152, expiration date: 05-JUL-2017 (therapy type: recombinant human albumin (rHA); dose, route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 2 patients of unknown age and gender. The patients' medical history was not reported. On 13-SEP-2016, the patients were vaccinated with improperly stored doses of VARIVAX lot # L041204, expiration date 20-OCT-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Hepatic enzyme increased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 31 year old male patient. The patient had no drug reactions or allergies. He was a smoker. The patient's concurrent conditions included elevated liver enzymes. On 06-SEP-2016, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23 (lot# and expiration date were not provided), intramuscular, concomitantly on the same arm with influenza virus vaccine (unspecified). The patient had no concomitant medications. On 07-SEP-2016, the patient developed fever. On 08-SEP-2016, the patient experienced redness, swelling and tenderness at injection site. On 09-SEP-2016, the patient visited an office, where he was diagnosed with cellulitis. Lab diagnostic studies were not performed. The patient was ordered a 7 day course of KEFLEX, per pharmacist. At the time of the report, the patient was still recovering from the adverse event. The relatedness between the cellulitis and PNEUMOVAX 23 was not provided. Upon internal review, the event of cellulitis was considered to be medically significant. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 31 year old male patient. The patient had no drug reactions or allergies. He was a smoker. The patient's concurrent conditions included elevated liver enzymes. On 06-SEP-2016, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23 (lot# and expiration date were not provided), intramuscular, concomitantly on the same arm with influenza virus vaccine (unspecified). The patient had no concomitant medications. On 07-SEP-2016, the patient developed fever. On 08-SEP-2016, the patient experienced redness, swelling and tenderness at injection site. On 09-SEP-2016, the patient visited an office, where he was diagnosed with cellulitis. Lab diagnostic studies were not performed. The patient was ordered a 7 day course of KEFLEX, per pharmacist. At the time of the report, the patient was still recovering from the adverse event. The relatedness between the cellulitis and PNEUMOVAX 23 was not provided. Upon internal review, the event of cellulitis was considered to be medically significant. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient with no known drug reactions or allergies. No information regarding the patient's medical history and concurrent conditions was provided. On 24-AUG-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 injection, lot # L013428, expiration date: 03-FEB-2017, intramuscularly in the left deltoid, (dose and dose number were not provided). There were no concomitant medications reported. On 25-AUG-2016, the patient returned to the pharmacy with an "area from the injection site in the left deltoid, down to the elbow" that was "red, warm to the touch and itchy". No laboratory diagnostics studies were performed. No treatment was given for the adverse events. The patient's status since 25-AUG-2016 was unknown. The relatedness between the events and PNEUMOVAX 23 was not provided. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: FLU3, PNC13, TDAP
Symptoms: Urticaria
Clinical narrative: Hives on Left arm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Varicella
Clinical narrative: Patient seen in Hospital and diagnosed with Varicella.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Eye swelling, Rash
Clinical narrative: Pt. felt light headed at first after immunization. Monitored pt. for approximately 15 minutes. Patient insisted he was fine and left on his own volition. Called pharmacy 2 days later reporting rash on forehead, arms, and swollen eyes. Pt told to go to ER.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pruritus, Rash, Stomatitis
Clinical narrative: Rec'd shot 9-9, on 9-10 presented with complaints of swelling, itching, and redness in vaccine arm. On 9-11 she called and said it was worse with the rash spreading all around the arm and that arm was full fluid and she has mouth sores.
Sex: F
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Loss of consciousness, Seizure, Seizure like phenomena, Syncope
Clinical narrative: This is a spontaneous report from a non-contactable consumer reporting for her daughter. A female patient of unspecified age and ethnicity received first dose of TRUMENBA, via an unspecified route of administration, on an unspecified date, at 0.5 ml single. The patient's medical history and concomitant medications were not reported. Right after vaccination the patient experienced seizure and passed out. They did not really document it as if they called it like neurocardiogenic syncope as she passed out after vaccination. She lost her urine and had a seizure like episode so they took her to the hospital. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: MENB
Symptoms: Urinary incontinence
Clinical narrative: This is a spontaneous report from a non-contactable consumer reporting for her daughter. A female patient of unspecified age and ethnicity received first dose of TRUMENBA, via an unspecified route of administration, on an unspecified date, at 0.5 ml single. The patient's medical history and concomitant medications were not reported. Right after vaccination the patient experienced seizure and passed out. They did not really document it as if they called it like neurocardiogenic syncope as she passed out after vaccination. She lost her urine and had a seizure like episode so they took her to the hospital. No follow-up attempts possible. No further information expected.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site vesicles, Pain in extremity
Clinical narrative: BLISTERS NEAR INJECTION SITE; 2 CLUSTERS 1 CM FROM SITE, ONE CLUSTER 8 CM ANTERIOR TO THAT; CLUSTERS ABOUT 1 CM X 0.5 CM SIZE.  ARM A LITTLE SORE, BUT NOTHING OUT OF THE ORDINARY FOLLOWING VACCINATION.  GIRLFRIEND FIRST NOTICED BLISTERS AT 10 PM 9/15/16, BUT THEY MIGHT HAVE APPEARED EARLIER WITHOUT MY NOTICING.  NO ITCHING.  FRIDAY 9/16/2016 AT 3 PM, APPEARANCE UNCHANGED.
Age: 52.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Impaired work ability, Injection site reaction, Pain, Periarthritis
Clinical narrative: Per patient this is is due to TDAP vaccine on the right shoulder; eventhough we gave her Flu vaccine on the right shoulder. Since the vaccine patient cannot move the arm up or backward without a pulling pain.
Age: 27.0
Sex: M
Vaccine: PPV
Symptoms: Blood bicarbonate normal, Blood chloride, Blood creatinine normal, Blood glucose normal, Blood potassium normal
Clinical narrative: Per RN who reported this ADR: "Patient developed a rash after receiving the pneumonia vaccine. He was admitted this morning and is allergic to egg. We are calling the doctor to let him know that". Per RPh conversation with patient's RN on Mon 8/17/15 at 1035 AM: Patient got a dose of PNEUMOVAX 23-standard adult dose on Sunday, then broke out in a generalized rash/hives. Per RN patient is okay and is getting BENADRYL 25mg IV every 8 hours as needed for itching. MD also ordered prednisone 20mg po Q morning (8/16 2130).
Age: 27.0
Sex: M
Vaccine: PPV
Symptoms: Blood sodium normal, Blood thyroid stimulating hormone decreased, Blood urea normal, Chest X-ray normal, Food allergy
Clinical narrative: Per RN who reported this ADR: "Patient developed a rash after receiving the pneumonia vaccine. He was admitted this morning and is allergic to egg. We are calling the doctor to let him know that". Per RPh conversation with patient's RN on Mon 8/17/15 at 1035 AM: Patient got a dose of PNEUMOVAX 23-standard adult dose on Sunday, then broke out in a generalized rash/hives. Per RN patient is okay and is getting BENADRYL 25mg IV every 8 hours as needed for itching. MD also ordered prednisone 20mg po Q morning (8/16 2130).
Age: 27.0
Sex: M
Vaccine: PPV
Symptoms: Haematocrit normal, Haemoglobin normal, Platelet count normal, Rash, Rash generalised
Clinical narrative: Per RN who reported this ADR: "Patient developed a rash after receiving the pneumonia vaccine. He was admitted this morning and is allergic to egg. We are calling the doctor to let him know that". Per RPh conversation with patient's RN on Mon 8/17/15 at 1035 AM: Patient got a dose of PNEUMOVAX 23-standard adult dose on Sunday, then broke out in a generalized rash/hives. Per RN patient is okay and is getting BENADRYL 25mg IV every 8 hours as needed for itching. MD also ordered prednisone 20mg po Q morning (8/16 2130).
Age: 27.0
Sex: M
Vaccine: PPV
Symptoms: Tachycardia, Urticaria, White blood cell count normal
Clinical narrative: Per RN who reported this ADR: "Patient developed a rash after receiving the pneumonia vaccine. He was admitted this morning and is allergic to egg. We are calling the doctor to let him know that". Per RPh conversation with patient's RN on Mon 8/17/15 at 1035 AM: Patient got a dose of PNEUMOVAX 23-standard adult dose on Sunday, then broke out in a generalized rash/hives. Per RN patient is okay and is getting BENADRYL 25mg IV every 8 hours as needed for itching. MD also ordered prednisone 20mg po Q morning (8/16 2130).
Age: 67.0
Sex: M
Vaccine: FLU4, PNC
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Patient says he developed a rash about 6 inches long at the injection site and it was red, warm to the touch, and itched.
Age: 77.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Administration site inflammation, Administration site swelling, Erythema, Malaise
Clinical narrative: Large palm-sized raised and inflamed area around administration site. Felt ill on day 2. Redness still visible day 2.
Age: 73.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Erythema, Hypersensitivity, Nodule, Swelling
Clinical narrative: Patient had an allergic reaction (swelling/redness/knot formation).
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture, C-reactive protein, Chest X-ray, Culture urine, Full blood count
Clinical narrative: Pt experienced grand mal seizure at home (day of vaccination) lasting 15-25 min requiring EMS transport to hospital. VERSED intranasal given via EMS x2; seizure stopped after 2nd dose and was postictal upon ER arrival. TX with ceftriaxone x1 and NS bolus x2 in ER. TYLENOL as well given.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Generalised tonic-clonic seizure, Lumbar puncture, Metabolic function test, Postictal state, Urine analysis
Clinical narrative: Pt experienced grand mal seizure at home (day of vaccination) lasting 15-25 min requiring EMS transport to hospital. VERSED intranasal given via EMS x2; seizure stopped after 2nd dose and was postictal upon ER arrival. TX with ceftriaxone x1 and NS bolus x2 in ER. TYLENOL as well given.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash all over her upper body, arms and thighs. She did not get a fever. Rash has been present for tow days, has no gone away.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Pruritus, Pyrexia, Urticaria
Clinical narrative: Hives, redness, swollen of the arm, fever, itchy, and affected 3 inch ribbon around the arm. Around in the evening was not able to rise arm.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 18-AUG-2016, the patient was vaccinated with improperly stored dose of M-M-R II lot # L029266, therapy type was not specified (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Swelling
Clinical narrative: I vaccinated on 9/14 pm and patient presented with redness and swelling 9/16 at 330 pm.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Site redness, swelling, firm to touch, itching, approximately 5 inch diameter.
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Peripheral swelling, Rash, Rash erythematous
Clinical narrative: Patient has swelling in both hands and some red patches on his legs.  No reaction at injection site, just swelling in hands and states no new meds or changes.
Age: 53.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Vaccination site inflammation
Clinical narrative: Vaccine was administered to Patient about 3:45 PM on 09/15/2016. Patient called Pharmacy Next day with vaccine area very red and inflamed even after taking benadryl and using Ice packs.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: The patient did not report any pre-existing conditions at the time of the vaccination, on 09/16/16 at 9:15 AM. She called on 09/16/16 at 1:14 PM, stating that she was 4-5 weeks expecting and was wondering if the Varicella vaccination we had administered would impact her pregnancy.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia
Clinical narrative: Numb right side of face cheek down to under chi and lip, like after dental visit. Lasted about 45 minutes. Next day, on 9/16/2016, symptoms returned about 2:00, more left side of face and chin area involvement. Decided to look on CDC site for info on Flu vaccines. Concerned when I saw online there may be latex in the vaccine. Possible reaction ? Or something else wrong?
Age: 22.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Headache
Clinical narrative: Headache.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: No sign or symptom of distress or adverse reactions immediately after and after 20 minutes of monitoring.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope, Vomiting
Clinical narrative: Approx. 5 minutes after giving vaccine mom called out from room stating pt. had fainted. Support Staff and provider assisted, gave pt. apple juice and monitored until pt. felt ok to leave clinic. Approx. 1 hour after pt. left clinic they came back because when in parking lot pt. began to vomit and wouldn't stop.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient passed out/fainted approximately 3-5 minutes after receiving the FLUARIX QUADRIVALENT Flu vaccine. After becoming alert the patient stated that he has a history of passing out with immunizations/blood draws and should have notified me previously.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS, FLU4, VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Lip swelling, Rash pustular
Clinical narrative: She had welts on her stomach, they turned into blisters that she popped and pus came out. She also got red all over her arms, chest and face. Her lips got really big. She decided to ER 09/15/2016 at 10:45 pm where she was diagnosed with shingles.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS, FLU4, VARZOS
Symptoms: Urticaria
Clinical narrative: She had welts on her stomach, they turned into blisters that she popped and pus came out. She also got red all over her arms, chest and face. Her lips got really big. She decided to ER 09/15/2016 at 10:45 pm where she was diagnosed with shingles.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS, FLU4, VARZOS
Symptoms: Asthenia, Bone disorder, Cervical radiculopathy, Fear of death, Grip strength decreased
Clinical narrative: She had welts on her stomach, they turned into blisters that she popped and pus came out. She also got red all over her arms, chest and face. Her lips got really big. She decided to ER 09/15/2016 at 10:45 pm where she was diagnosed with shingles.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS, FLU4, VARZOS
Symptoms: Herpes zoster, Hypotonia, Insomnia, Lymphadenopathy, Malaise
Clinical narrative: She had welts on her stomach, they turned into blisters that she popped and pus came out. She also got red all over her arms, chest and face. Her lips got really big. She decided to ER 09/15/2016 at 10:45 pm where she was diagnosed with shingles.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS, FLU4, VARZOS
Symptoms: Mobility decreased, Muscle atrophy, Pain, Posture abnormal, Skin burning sensation
Clinical narrative: She had welts on her stomach, they turned into blisters that she popped and pus came out. She also got red all over her arms, chest and face. Her lips got really big. She decided to ER 09/15/2016 at 10:45 pm where she was diagnosed with shingles.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS, FLU4, VARZOS
Symptoms: Asthenia, Bone disorder, Cervical radiculopathy, Erythema, Fear
Clinical narrative: She had welts on her stomach, they turned into blisters that she popped and pus came out. She also got red all over her arms, chest and face. Her lips got really big. She decided to ER 09/15/2016 at 10:45 pm where she was diagnosed with shingles.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS, FLU4, VARZOS
Symptoms: Grip strength decreased, Hemiparesis, Herpes zoster, Hypotonia, Lymphadenopathy
Clinical narrative: She had welts on her stomach, they turned into blisters that she popped and pus came out. She also got red all over her arms, chest and face. Her lips got really big. She decided to ER 09/15/2016 at 10:45 pm where she was diagnosed with shingles.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS, FLU4, VARZOS
Symptoms: Malaise, Mobility decreased, Muscle atrophy, Pain, Posture abnormal
Clinical narrative: She had welts on her stomach, they turned into blisters that she popped and pus came out. She also got red all over her arms, chest and face. Her lips got really big. She decided to ER 09/15/2016 at 10:45 pm where she was diagnosed with shingles.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS, FLU4, VARZOS
Symptoms: Skin burning sensation, Sleep disorder, Urticaria, Viral infection
Clinical narrative: She had welts on her stomach, they turned into blisters that she popped and pus came out. She also got red all over her arms, chest and face. Her lips got really big. She decided to ER 09/15/2016 at 10:45 pm where she was diagnosed with shingles.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: RASH ON INJECTION SITE.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Large 8cm by 20 cm area of redness, induration, pain around injection site.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Area where given vaccine became hot, red, painful, and swollen.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Pt said arm hurt for 3 days then moved into his shoulder. One month out shoulder still hurts.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site pain, Injection site reaction, Injection site streaking, Injection site swelling
Clinical narrative: The patient had a Zostavax administered subcutaneously on 09/14/16. He returned the pharmacy two days later (09/16/16) with an enlarged, inflamed, and hot to the touch upper left arm. The affected area also had a rash that had red and elongated streaks and was painful to touch. He stated that he did not have any other systemic symptoms or other issues.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Rash erythematous
Clinical narrative: The patient had a Zostavax administered subcutaneously on 09/14/16. He returned the pharmacy two days later (09/16/16) with an enlarged, inflamed, and hot to the touch upper left arm. The affected area also had a rash that had red and elongated streaks and was painful to touch. He stated that he did not have any other systemic symptoms or other issues.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient describes a small red spot and redness accompanied by a warm to the touch area under where the flu shot was administered.
Age: 16.0
Sex: M
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Dyspnoea, Flushing, Pruritus, Respiratory distress, Urticaria
Clinical narrative: Patient started to have itching and shortness of breath about 20 minutes after receiving vaccinations at Clinic. Patient was brought to Emergency Room by mother; arrived in respiratory distress with shortness of breath; flushed skin and hives on upper body. IV was given, Benadryl 50mg IV given, Solumedrol 125mg IV given, Pepcid 20mg IV given.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Visual impairment
Clinical narrative: Vision changes, dizziness.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 29-AUG-2016, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L013204, expiration date 28-JAN-2017, oral (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 25 degrees Fahrenheit for 7 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction, red, warm, raised, about 6" diameter. MD diagnosis possible cellulitis.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Paraesthesia, Pharyngeal oedema, Skin warm
Clinical narrative: Ears - warm, Nasal cavity - tingling, Eyes - tingling / fuzziness, Throat - slight swelling sensation, overwhelming feeling of something not right.
Age: 43.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Dizziness, Fatigue, Nausea, Pain in extremity, Skin warm
Clinical narrative: Patient c/o feeling dizzy, sore arm, fatigue and nausea. Area warm to touch, and CV progressed to fever and swelling. Seen by MD 9-14-16 Prednisone 50mg x 5 days.
Age: 43.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Swelling
Clinical narrative: Patient c/o feeling dizzy, sore arm, fatigue and nausea. Area warm to touch, and CV progressed to fever and swelling. Seen by MD 9-14-16 Prednisone 50mg x 5 days.