chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Abnormal behaviour, Aggression, Anger
Clinical narrative: Unusual Angry attitude at day care, throwing things, saying 'no' to everything, hitting, not listening (2 days).
Age: 12.0
Sex: M
Vaccine: HEPA, MEN
Symptoms: Abdominal pain upper, Erythema, Nausea, Oropharyngeal pain, Skin discolouration
Clinical narrative: Had the shot Wed. Thursday he came home in tears w stomach pain, nausea, vomiting. He had been on a field trip that day so I didn't put two and two together. I administered PEPTO and ADVIL Friday he woke up w chills, sore throat and slightly nausea. Came home Friday w the mark on his arm, but it was light. By 7 pm Friday night it was huge and red and swollen. Went to ER last night and they confirmed it was a vax reaction and/or infection from needle. Steroid cream and oral antibiotic.
Age: 12.0
Sex: M
Vaccine: HEPA, MEN
Symptoms: Swelling, Vomiting
Clinical narrative: Had the shot Wed. Thursday he came home in tears w stomach pain, nausea, vomiting. He had been on a field trip that day so I didn't put two and two together. I administered PEPTO and ADVIL Friday he woke up w chills, sore throat and slightly nausea. Came home Friday w the mark on his arm, but it was light. By 7 pm Friday night it was huge and red and swollen. Went to ER last night and they confirmed it was a vax reaction and/or infection from needle. Steroid cream and oral antibiotic.
Age: 68.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Blood test, Chest pain, Electrocardiogram, Headache
Clinical narrative: Headache wouldn't go away. On 3rd day ended up in E.R. via ambulance with severe headache and chest pains.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Dizziness, Headache, Nausea, Neck pain
Clinical narrative: Severe severe headache that won't quit. Headache goes all the way down my neck. Chills, fever, dizziness, nausea.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Severe severe headache that won't quit. Headache goes all the way down my neck. Chills, fever, dizziness, nausea.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Headache, Nausea, Pain
Clinical narrative: Patient stated she felt generalized pain above the waist, nausea, headache, tired, sore joints.
Age: 85.0
Sex: F
Vaccine: TD
Symptoms: Flank pain, Injection site pain, Pyrexia
Clinical narrative: Pain in injection site (Left delt), fever, pain along L side of body.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: Muscle soreness at inner portion of upper left arm (not at injection site) with red welt like circles warm to the touch. No symptoms.
Age: 0.42
Sex: F
Vaccine: DTAP, RV1
Symptoms: Body temperature increased, Crying, Dyskinesia, Eczema, Haemorrhage
Clinical narrative: 12 hours inconsolable distressed crying. 104 Temperature. Regression of baby babbling for 3 months after. Moving hands in a rolling manner. Development of severe eczema that she would scratch open to bleed. Since treated with antibiotic and steroid for eczema. Started a probiotic and dha supplement, has significantly improved.
Age: 0.42
Sex: F
Vaccine: DTAP, RV1
Symptoms: Regressive behaviour
Clinical narrative: 12 hours inconsolable distressed crying. 104 Temperature. Regression of baby babbling for 3 months after. Moving hands in a rolling manner. Development of severe eczema that she would scratch open to bleed. Since treated with antibiotic and steroid for eczema. Started a probiotic and dha supplement, has significantly improved.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Blood test, Electroencephalogram, Immediate post-injection reaction, Pyrexia, Rash
Clinical narrative: Instant rash at doctor's office but was told he was fine. Fever spiked to 102 and he started have a seizure at 5:30 pm.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Seizure, Urine analysis
Clinical narrative: Instant rash at doctor's office but was told he was fine. Fever spiked to 102 and he started have a seizure at 5:30 pm.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Hypoaesthesia, Pain in extremity, Sleep disorder
Clinical narrative: APPROXIMATELY 1 DAY AFTER FLU VACCINE WAS ADMINISTERED, PATIENT BEGAN TO NOTICE INTERMITTENT NUMBNESS IN HER LEFT ARM, AND CONSISTANT NUMBNESS IN HER LEFT HAND. PATIENT COMPLAINS OF PAIN ALSO IN THE ARM, INCLUDING NOT BEING ABLE TO CARRY HER PURSE, OR LAY ON HER LEFT SIDE DURING SLEEP. NO TREATMENT THUS FAR, PRESENTED TO PHARMACY TO REPORT REACTION 4 DAYS AFTER RECEIVING VACCINE WITH NO RELIEF
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Fatigue, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Fever, swelling of leg, fatigue, sore.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Cardiac stress test, Chest pain, Computerised tomogram, Cough, Dizziness
Clinical narrative: Is shot is mandatory for workers for employer. I got the shot by our corporate health nurse. 20 to 30 minutes later, I was short of breath, chest pain, lightheaded and dizzy, red eyes (very blood shot), coughing. I went to the nurse that gave me the shot and she advised I go to our ER (I was in our hospital at the time at work). The nurse walked me to the ER.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Electrocardiogram, Electrocardiogram ambulatory, Fibrin D dimer, Full blood count
Clinical narrative: Is shot is mandatory for workers for employer. I got the shot by our corporate health nurse. 20 to 30 minutes later, I was short of breath, chest pain, lightheaded and dizzy, red eyes (very blood shot), coughing. I went to the nurse that gave me the shot and she advised I go to our ER (I was in our hospital at the time at work). The nurse walked me to the ER.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Metabolic function test, Ocular hyperaemia, Troponin, Ultrasound scan
Clinical narrative: Is shot is mandatory for workers for employer. I got the shot by our corporate health nurse. 20 to 30 minutes later, I was short of breath, chest pain, lightheaded and dizzy, red eyes (very blood shot), coughing. I went to the nurse that gave me the shot and she advised I go to our ER (I was in our hospital at the time at work). The nurse walked me to the ER.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Patient reported red, hot, itchy skin at reaction site. She sought care from her PCP.
Age: 7.0
Sex: M
Vaccine: IPV
Symptoms: Abnormal behaviour, Genital swelling, Joint swelling, Peripheral swelling, Pruritus genital
Clinical narrative: Tested and penis swelled and were itchy. The swelling increased knee a period of days and radiated to his thighs and stomach. Swelling abated after 4 days. Then, about 4 weeks later he began to exhibit OCD symptoms and tics.  He started needed to have doors closed, lining up books and DVDs to the edges of furniture, and began to obsessively scrunch and touch his nose.
Age: 7.0
Sex: M
Vaccine: IPV
Symptoms: Swelling, Tic
Clinical narrative: Tested and penis swelled and were itchy. The swelling increased knee a period of days and radiated to his thighs and stomach. Swelling abated after 4 days. Then, about 4 weeks later he began to exhibit OCD symptoms and tics.  He started needed to have doors closed, lining up books and DVDs to the edges of furniture, and began to obsessively scrunch and touch his nose.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Bruising at injection site, and redness of arm about 6 inches below the injection site. The patient states that the area is not painful or itching, just red.
Age: 64.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Patient got immunization on 08/24/16.  On 09/17/16 patient came into the pharmacy complaining that the injection site on his left arm still hurt especially when he raises his arm to take his shirt off.  Patient has used ice, icy hot and motrin.  At the time patient presented arm there was no swelling, brusing or infection.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site reaction, Injection site swelling, Injection site warmth, Joint stiffness
Clinical narrative: Severe muscle pain, I jumped off the needle. She reinserted same needle and added a tetanus/pertussis shot. I had had an allergy shot at 11am, 2 hours prior. I turned down shingles shot as I never had chicken pox and was vaccinated for it in 2012? I believe. In 24 hours extremely painful, now more so at 48 hours post injection. Site is hot, swollen, stiff, shoulder joint and neck are quite stiff and painful. Hydrocodone alleviates a lot.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Myalgia, Neck pain
Clinical narrative: Severe muscle pain, I jumped off the needle. She reinserted same needle and added a tetanus/pertussis shot. I had had an allergy shot at 11am, 2 hours prior. I turned down shingles shot as I never had chicken pox and was vaccinated for it in 2012? I believe. In 24 hours extremely painful, now more so at 48 hours post injection. Site is hot, swollen, stiff, shoulder joint and neck are quite stiff and painful. Hydrocodone alleviates a lot.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema
Clinical narrative: Patient came to pharmacy 9-16 to show us her arm where she received two vaccinations. PNEUMOVAX 23 and  FLUZONE HD, her arm was red from shoulder to elbow. She stated it started on 9-15 and was painful. It looks the reddness may go down past the elbow. she said it is no longer as painful as the day before she had no problem breathing or no itching. She wanted to report the reaction to us. I advised her we notify her PCP and report the adverse reaction on VAERS reporting system. I told her to take IBU for pain and if she does have itching or difficulty breathing to take beanadryl. I also advised her to speak to her PCP as well and to go to them if the condition worsens. she said that the pain was less and felt it was going away.
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right after immunization was administered, patient developed an injection site reaction. Patient experienced swelling with slight redness but no itching. Patient was given a cold pack and the swelling was reduced dramatically.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Peripheral swelling
Clinical narrative: Soreness & redness on inside of upper arm (not on deltoid area) & swelling of arm.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Injection site erythema, Injection site pain
Clinical narrative: Woke up with mild fever, chills, headache, weak, felt nauseous, where injection - redness, soreness, swelling, itching.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Woke up with mild fever, chills, headache, weak, felt nauseous, where injection - redness, soreness, swelling, itching.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, pain, extreme itching, swelling from elbow to upper arm.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching at site of injection first noticed in the shower. The redness has continued to enlarge and itching is still occurring as of Saturday 9/17/16.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Patient had large amount of swelling, redness and fluid buildup in entire right arm one day post vaccination with PNEUMOVAX; patient also received a flu shot in other arm (left arm) with no adverse reactions. Pt was referred to emergency room for treatment.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Rash
Clinical narrative: Pt presented with a reddened arm that vaccine was administered in and appeared to have a rash indicating a possible allergic response.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin burning sensation, Skin exfoliation, Skin warm
Clinical narrative: Patient's arm (shoulder to elbow) was red, swollen, hot to touch, burning, skin peeled.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Dyspnoea, Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: The patient stated that she received the influenza vaccine and 2 hours later her asthma symptoms kicked in. She had shortness of breath. The injection site was warm to the touch and red. The patient also stated that her arm was very sore. She called her on call doctor today 9/17/16 and received a medrol dose pack.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Arthralgia, Chills, Feeling hot, Flushing, Injection site erythema
Clinical narrative: Patient got chills, fever, joint paint, swollen lymph node in left armpit, flush face (like burn), her face felt very hot. Site of vaccine at PNEUMOVAX 23 was red, hot and swollen. ZOSTAVAX site was pink and lumpy. Patient might go into urgent care if get worse.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Lymphadenopathy, Pyrexia, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient got chills, fever, joint paint, swollen lymph node in left armpit, flush face (like burn), her face felt very hot. Site of vaccine at PNEUMOVAX 23 was red, hot and swollen. ZOSTAVAX site was pink and lumpy. Patient might go into urgent care if get worse.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PPV
Symptoms: Eating disorder, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Rash from scalp to feet with hives over injection site. Rash looks like thousands of red bumps. Swelling at injection site which was also red, warm to the touch, and hard. Rash is very bumpy and is over his entire body. Was told to give him BENADRYL and infant TYLENOL. He has trouble sleeping and eating.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PPV
Symptoms: Insomnia, Rash, Rash erythematous
Clinical narrative: Rash from scalp to feet with hives over injection site. Rash looks like thousands of red bumps. Swelling at injection site which was also red, warm to the touch, and hard. Rash is very bumpy and is over his entire body. Was told to give him BENADRYL and infant TYLENOL. He has trouble sleeping and eating.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Herpes zoster, Leukocytosis
Clinical narrative: Woke up the next day with shingles have had leukocytosis since then.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Intense shoulder pain.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Started getting itchy spots on myself, eventually broke out in hives all over my body.
Age: 15.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Fatigue, Headache, Pyrexia, Vomiting
Clinical narrative: 15SEP : Tiredness. 16SEP : Fever, vomiting (traces of blood), headache. 17SEP : Headache, mild fever.
Age: 15.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Haematemesis, Headache, Nausea, Pyrexia, Restlessness
Clinical narrative: 15SEP : Tiredness. 16SEP : Fever, vomiting (traces of blood), headache. 17SEP : Headache, mild fever.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Retinal deposits
Clinical narrative: This spontaneous report was received from a quality manager via field employee, refers to a female patient of unknown age. Drug reactions/allergies were unknown by the reporter. Pertinent medical history included diabetes and blood disorder. Multiple (unspecified) concomitant medication were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, injection, (lot #, expiry date, dose and frequency not reported). On an unknown date, the patient experienced shingles on her scalp after receiving ZOSTAVAX. It was not specified how long after receiving ZOSTAVAX that the patient developed shingles. The patient was still receiving unspecified treatment for a scab on her left retina. The outcome of the events was unknown. Causality assessment was not provided. It was unknown if patient sought medical attention. No product quality complaint (PQC) was involved. No further adverse event information provided. Upon internal review, scab on left retina was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse prescribed regarding a multiple patients of unknown demographics. No pertinent medical history, drug reactions or allergies and concomitant therapies were reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored with GARDASIL 9 (lot # M013636, expiration date of 15-FEB-2018) (dose and route not reported). The administered dose experienced a temperature excursion of 9.6 degrees for 19 minutes and -9.8 degrees for 33 hours. No adverse effects were reported. No PQC (product quality complaint) filed. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 1 year old patient of unknown gender. There was no information about concurrent condition and historical medication. On 09-SEP-2016, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous instead of VARIVAX. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored M-M-R II subcutaneously (lot # L040961, expiry date 19-OCT-2017, dose, strength, dose number, vaccination site not provided). No adverse effects were reported. Product quality complaint (PQC) was not involved. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # M011840, expiry date 01-FEB-2018, dose, strength, dose number, vaccination site, route not provided). The temperature excursions were reported as 1.6 c for 39 minutes on 09-AUG-2016, C for 1 hour 40 minutes on 10-AUG-2016, 1.5 C for 55 minutes on 11-AUG-2016, 1.5 C for 1 hour 7 minutes on 28-AUG-2016. No adverse effect were reported. Product quality complain (PQC) was not involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse prescriber regarding a multiple unspecified patients of unknown demographics. No pertinent medical history, drug reactions or allergies and concomitant therapies were reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored RECOMBIVAX HB (lot # M022077 and expiration date of 10-MAR-2019) (dose and route not reported). The administered dose experienced a temperature excursion of 9.6 degrees for 19 minutes and -9.8 degrees for 33 hours. No adverse effects were reported. No PQC (product quality complaint) filed. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse prescriber regarding a multiple unspecified patients of unknown demographics. No pertinent medical history, drug reactions or allergies and concomitant therapies were reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored M-M-R II (lot # L015282, expiration date of 30-APR-2019 and lot # M000768, expiration date of 05-JAN-2018) (dose and route not reported). The administered dose experienced a temperature excursion of 9.6 degrees for 19 minutes. No adverse effects were reported. No PQC (product quality complaint) filed. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse prescriber regarding a multiple unspecified patients of unknown demographics. No pertinent medical history, drug reactions or allergies and concomitant therapies were reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored VARIVAX (lot # M014908, expiration date 25-MAR-2018) (dose and route not reported). The administered dose experienced a temperature excursion of 4.9 degrees for 263 hours. No adverse effects were reported. No PQC (product quality complaint) filed. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse prescriber regarding a multiple unspecified patients of unknown demographics. No pertinent medical history, drug reactions or allergies and concomitant therapies were reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored VAQTA (lot # M022531, expiration date of 23-FEB-2018) (dose and route not reported). The administered dose experienced a temperature excursion of 9.6 degrees for 19 minutes and -9.8 degrees for 33 hours. No adverse effects were reported. No PQC (product quality complaint filed. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding 2 patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # L019836/expiration date - 24-MAR-2017, 0.5 ml. No adverse event was reported. Temperature of excursion was 25-7 C (Celsius) and time frame was 57 hours. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On 13-SEP-2016, the patients were vaccination with improperly stored PROQUAD lot # M011664/ expiration date- 08-SEP-2017. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a multiple unspecified patients of unknown demographics. No pertinent medical history, drug reactions or allergies and concomitant therapies were reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored M-M-R II (lot #M015931, expiration date 30-MAR-2018, lot # L028273, expiration date 28-JUL-2017 and lot # L039551, expiration date 07-OCT-2017) (dose and route not reported). The administered dose experienced a temperature excursion of 29 Fahrenheit for 2 hours and had previous temperature excursion of 1.5 degrees for 2 hours 50 minutes on 20-JUL-2016. No adverse effects were reported. No PQC (product quality complaint) filed. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker (Medical Assistant) refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 15-JUL-2016, the patient was vaccinated with first dose of RECOMBIVAX HB (lot # L042846, expiry date 15-SEP-2017, dose, vaccination site, route not provided). On 25-AUG-2016, the patient received second dose of RECOMBIVAX HB (lot # M007763, expiry date 15-SEP-2017, dose, vaccination site, route not provided). On 09-SEP-2016, the patient was inadvertently received third dose of RECOMBIVAX HB (lot # M007763, expiry date 15-SEP-2017, dose, vaccination site, route not provided). No adverse effects were reported. Product quality complaint (PQC) was not involved. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a multiple unspecified patients of unknown demographics. No pertinent medical history, drug reactions or allergies and concomitant therapies were reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored VARIVAX (lot # M023383, expiration date 11-MAY-2018, lot # M024681, expiration date 18-MAY-2018, lot # L043620 expiration date 02-FEB-2017, lot # M009766, expiration date 23-FEB-2018 and lot # M000756, expiration date 06-JAN-2018) (dose and route not reported). The administered dose experienced a temperature excursion of 29 Fahrenheit for 2 hours and had previous temperature excursion of 1.5 degrees for 2 hours 50 minutes on 20-JUL-2016. No adverse effects were reported. No PQC (product quality complaint) filed. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with improperly stored VARIVAX (lot # M023383, expiry date 11-MAY-2018, dose, strength, dose number, vaccination site, route not provided). No adverse effect were reported. Product quality complain (PQC) was not involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions, medical history and concomitant medications were reported. On 02-SEP-2014 the patient was vaccinated with first dose of GARDASIL, second dose on 10-NOV-2014 and third dose on 13-JAN-2015 (inappropriate schedule of drug administration) (lot number, expiration date, dose and route of administration was not reported for all). No symptoms reported. No PQC (product quality complaint) filed. Additional information has been requested.
Age: 0.92
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 11 month old patient. On 20-NOV-2014 (reported as 6 days prior to the first birthday) the patient was vaccinated with M-M-R II (Inappropriate schedule of drug administration). No adverse effect was reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Patient said flu shot site was very painful and red and hot. Swollen out 3-4 inches. Had to use hydrocortisone. Still swollen and hot on 9/17/16.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site discolouration
Clinical narrative: Redness/yellow discoloration at injection site 10 days after vaccine administered.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: -Redness, round, swollen, warm, 3-4 inches diameter on RA.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity, Respiratory tract infection
Clinical narrative: Pain at injection site that has persisted for over 2 weeks. Pt. States that soreness in left arm worsens throughout the day. Spoke to Pt. on 9/16/16 regarding congestion.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site inflammation
Clinical narrative: Baseball sized red inflammation surrounding injection site for last 2 1/2 days-pain, does not itch. Recommended use of hydrocortisone 1%-seek medical attn., if not improved in 2 days (allergic to BENADRYL).
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Inflammation
Clinical narrative: Some inflammation throughout upper arm and redness.
Age: 77.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Feeling cold, Headache, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Redness, swelling at site. Chills, whole body soreness. Headache. Missed 1/2 day of work.
Age: 80.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Patient received FLUZONE HD in left deltoid on 9/9/16. Patient began to experience redness, rash by injection site that is about 3 inches in diameter. Patient states it itches her and she is currently applying hydrocortisone cream on the site for relief.
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Local reaction, Vaccination site reaction
Clinical narrative: This spontaneous report as received from a nurse refers to a male patient of unknown age. The patient was allergic to corn. On 07-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # M011117 dose 1, intramuscular in the right arm. Other suspect therapies included MENACTRA (dose, route and frequency were not reported) which was administered on 07-JUL-2016. On an unknown date in July 2016 (reported as after 07-JUL-2016) the patient experienced localized reaction to the vaccination that involved his entire right arm. The primary reporter states the mother did not bring her son back to the office, so the primary reporter never saw the right arm reaction. The primary reporter stated the patient does have a history of an unspecified allergic reaction to corn. It was reported that the patient did not sought medical attention and did not receive any treatment for the event. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report was received from a office manager via field representative, refers to a 83 year old female patient. Patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown by the reporter. In approximately 2014 (also reported as about 2 years ago), the patient was vaccinated with ZOSTAVAX, 1 dose, subcutaneously (SQ), (lot#/expiry date unknown). The patient received ZOSTAVAX at the age of 81. Patient then developed shingles at 82 (in 2015, about a year ago) and was on pain medications afterwards. Patient was given treatment for the events. The outcome of the events was recovered. Causality assessment was not provided. Patient was seen by the physician. No product quality complain (PQC) was involved. No further adverse event information provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # M010212, expiry date 21-JAN-2019, dose, strength, dose number, vaccination site, route not provided). The temperature excursions were reported as 1.6 C for 39 minutes on 09-AUG-2016, 0.6 C for 1 hour 40 minutes on 10-AUG-2016, 1.5 C for 55 minutes on 11-AUG-2016, 1.5 C for 1 hour 7 minutes on 28-AUG-2016. No adverse effect were reported. Product quality complain (PQC) was not involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with improperly stored PEDVAXHIB (lot # L042257, expiry date 17-AUG-2018, dose, strength, dose number, vaccination site, route not provided). The temperature excursions were reported as 1.6 C for 39 minutes on 09-AUG-2016, 0.6 C for 1 hour 40 minutes on 10-AUG-2016, 1.5 C for 55 minutes on 11-AUG-2016, 1.5 C for 1 hour 7 minutes on 28-AUG-2016. No adverse effect were reported. Product quality complain (PQC) was not involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were not specified. On unspecified dates, the patients were vaccinated with improperly stored ROTATEQ (lot # M019691 with expiry date 02-NOV-2017 and lot # L026076 with expiry date 25-MAY-2017, dose, strength, dose number, vaccination site, route not provided). The temperature excursions were reported as 1.6 C for 39 minutes on 09-AUG-2016, 0.6 C for 1 hour 40 minutes on 10-AUG-2016, 1.5 C for 55 minutes on 11-AUG-2016, 1.5 C for 1 hour 7 minutes on 28-AUG-2016. No adverse effect were reported. Product quality complain (PQC) was not involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # L019835 with expiry date 23-MAR-2017 and lot # M020521 with expiry date 17-NOV-2017, dose, strength, dose number, vaccination site, route not provided). The temperature excursions were reported as 1.6 C for 39 minutes on 09-AUG-2016, 0.6 C for 1 hour and 40 minutes on 10-AUG-2016, 1.5 C for 55 minutes on 11-AUG-2016, 1.5 C for 1 hour 7 minutes on 28-AUG-2016. No adverse effect were reported. Product quality complain (PQC) was not involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with improperly stored M-M-R II (lot # L012482, expiry date 10-APR-2017, dose, strength, dose number, vaccination site, route not provided). The temperature excursions were reported as 1.6 C for 39 minutes on 09-AUG-2016, 0.6 C for 1 hour 40 minutes on 10-AUG-2016, 1.5 C for 55 minutes on 11-AUG-2016, 1.5 C for 1 hour 7 minutes on 28-AUG-2016. No adverse effect were reported. Product quality complaint(PQC) was not involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a multiple unspecified patients of unknown demographics. No pertinent medical history, drug reactions or allergies and concomitant therapies were reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored PROQUAD injection (lot # M018638, expiration date 11-OCT-2017 and lot # M017335, expiration date 05-OCT-2017) 0.5 ml (route not reported). The administered dose experienced a temperature excursion of 29 Fahrenheit for 2 hours and had previous temperature excursion of 1.5 degrees for 2 hours 50 minutes on 20-JUL-2016. No adverse effects were reported. No PQC (product quality complaint) filed. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an adult male patient in his fifties. The pertinent medical history and concurrent conditions were unknown by reported. On an unknown date, the patient was vaccinated with ZOSTAVAX lot # M001746, dose unknown, via subcutaneous route. On approximately 19-AUG-2016 (3 weeks ago) the patient developed a huge rash which spread and was hot to touch. The outcome of the events was reported as recovered on an unknown date in 2016. No further information available. No product quality complaint reported. The reporter did not assess the causality of the events with ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL (# lot K009482, expiry date 06-MAR-2017, dose, strength, dose number, vaccination site, route not provided). No adverse effect were reported. Product quality complain (PQC) was not involved. No further information was provided. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: This solicited report was received from a consumer (mother), via Market Research Agency. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On unknown date (reported as this morning), the patient was vaccinated with GARDASIL (strength, dosage schedule, route, lot number and expiration date were not reported). The reporter said that the patient mentioned that it hurts a lot and therefore she wasn't very keen on getting the shot. He said that you have to sit there for 10 minutes after to make sure you don't pass out. This scared the crap out of her (reporter). The reporter said that she had never heard of this before so why would she want to get a shot that could hurt her child (daughter). This made the reporter not want to get the shot now. The reporter kept going back and forth in her mind. Action taken was not applicable. The outcome of the event was unknown. The reporter's causality was unknown. Additional information is not expected because the reporter refused to be contacted.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On an unknown date, the patient was vaccinated with improperly stored PEDVAXHIB (lot # M001814, expiry date 15-OCT-2018, dose, strength, dose number, vaccination site, route not provided). No adverse effects were reported. Product quality complain (PQC) was not involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 38.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 38 year old patient. On an unknown date in June 2016, the patient was vaccinated with first dose of RECOMBIVAX HB. On 13-SEP-2016, the patient was in the pharmacy to receive a second dose of RECOMBIVAX HB. No adverse effect was reported. No PQC involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified Medical Assistant regarding multiple unspecified patients of unknown demographics. There was no information about concurrent condition and historical medication. On 06-SEP-2016, the patients were vaccinated with improperly stored PROQUAD lot # L033692/expiration date- 28-FEB-2017, (incorrect product storage). No adverse event was reported. No concomitant medication was reported. The outcome of event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional (medical assistant) regarding a multiple unknown patients of unknown demographics. No pertinent medical history, drug reactions or allergies and concomitant therapies were reported. On multiple unknown dates multiple unknown patients were vaccinated with improperly stored GARDASIL 9 (lot, expiry date, dose and frequency unknown by the reporter) and PEDVAXHIB (lot, expiry date, dose and frequency unknown by the reporter). The administered vaccines experienced a temperature excursion of 32.8 Fahrenheit for 20 hours and no previous temperature excursion was reported. No adverse effects reported. No product quality complaint (PQC) filed. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On an unknown date, the patient was vaccinated with improperly stored VAQTA(lot # M011116, expiry date 17-JUN-2017, dose, strength, dose number, vaccination site, route not provided). No adverse effects were reported. Product quality complain (PQC) was not involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On an unknown date, the patient was vaccinated with improperly stored PEDVAXHIB (lot # K004541, expiry date 04-DEC-2016, dose, strength, dose number, vaccination site, route not provided). No adverse effects were reported. Product quality complain (PQC) was not involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified Medical assistant regarding multiple unspecified patients of unknown demographics. There was no information about concurrent condition and historical medication. On 06-SEP-2016, the patients were vaccinated with improperly stored ZOSTAVAX lot # M019646/ expiration date-18-JUL-2017. No adverse event was reported. No concomitant medication was reported. The outcome of event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. 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 certified Medical Assistant regarding multiple unspecified patients of unknown demographics. There was no information about concurrent condition and historical medication. On 06-SEP-2016, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX lot no. M023383/expiration date- 11-MAY-2018, lot no. M019642/expiration date- 20-APR-2018, lot # L026412/expiration date- 15-JUL-2017, lot # L019126/expiration date- 27-MAY-2017, (incorrect product storage). No adverse event was reported. No concomitant medication was reported. The outcome of event was unknown. No PQC(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: F
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demography. On 25-FEB-2016, the patient was vaccinated with first dose of ZOSTAVAX. On 12-SEP-2016, the patient inadvertently received second dose of ZOSTAVAX (Lot# M024700, Expiry: 18-JUL-2017) (Extra dose administered). No adverse effects reported. No PQC involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 08-SEP-2016, the patient was inadvertently administered an expired dose of ZOSTAVAX 19400 PFU lot # L015417/expiration date 01-AUG-2016. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.