chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Decreased appetite, Fatigue, Insomnia, Pain
Clinical narrative: Sudden onset of aches, fever and chills at indicated time resulting in sleeplessness. Moderate to high amount of fatigue and some loss of appetite. Symptoms subsided Sunday evening (9/21/2014). Took Ibuprofen to control the fever and body aches.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Sudden onset of aches, fever and chills at indicated time resulting in sleeplessness. Moderate to high amount of fatigue and some loss of appetite. Symptoms subsided Sunday evening (9/21/2014). Took Ibuprofen to control the fever and body aches.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Blister, Erythema, Herpes zoster, Pain in extremity, Vision blurred
Clinical narrative: Left leg shin and inside calf pain. Took shoe and sock off at doctor office and a cluster of red blisters. Then Sunday 9/21/14 onset blurred vision. 9/25/14 repeat doctor visit confirmed I had shingles.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling at site of injection and warm to the touch. Cephalexin was prescribed.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema
Clinical narrative: Patient received Fluzone hd and Pneumovax. Patient came in 4 days after receiving vaccination with redness on his upper arm. The affected area was not around the injection site.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Patient was administered expired vaccine (dated April 2014). No adverse reactions were experienced. Manufacturer was contacted immediately and confirmed vaccine was safe and efficacious despite being out of date.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Ear swelling, Eye swelling, Fatigue, Local swelling, Pyrexia
Clinical narrative: The symptoms began about 4pm and rapidly worsened over the next few hours. We were in the ER by 12am. Hives; Swelling of ears, feet, and around eyes; High fever; fatigue. ER doctor prescribed Prednisone, Benadryl, and Tylenol. Follow up with Primary Doctor the day following ER visit resulted in no further testing or treatment options given.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Urticaria
Clinical narrative: The symptoms began about 4pm and rapidly worsened over the next few hours. We were in the ER by 12am. Hives; Swelling of ears, feet, and around eyes; High fever; fatigue. ER doctor prescribed Prednisone, Benadryl, and Tylenol. Follow up with Primary Doctor the day following ER visit resulted in no further testing or treatment options given.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Dyspnoea, Feeling abnormal, Respiratory distress
Clinical narrative: Patient received (FLUZONE HD) vaccination. After approximately 30 seconds patient stated was not feeling good. Patient was clammy and was having trouble breathing. Immediately called 911. Patient never lost consciousness, but was evidently in respiratory distress. Patient's breathing recovered, paramedic arrived.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Hyperhidrosis, Syncope
Clinical narrative: Flu-vaccine given at 3:30 pm, at 8:30 pm suddenly became chilled, dizzy, sweating and had syncope - taken to urgent care, then hospital.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Blood test, Body temperature increased, Chills, Retching
Clinical narrative: Pt received vaccine on 9-5-14; within 24 hrs pt developed shaking, chills, dry heaves, a 101 degrees temperature, and stomach pains and went to emergency room.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor, X-ray
Clinical narrative: Pt received vaccine on 9-5-14; within 24 hrs pt developed shaking, chills, dry heaves, a 101 degrees temperature, and stomach pains and went to emergency room.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Pt in clinic for lab draw today. Pt explained to lab tech that she had had a PNEUMOVAX vaccine 3 days prior. Pt states her right arm is swollen, red and hot to touch. Complains of arm being tender around to the armpit. MD in to see pt area measured 10cm wide 9 cm top to bottom. Area marked and pt advised to observe area for increased redness and swelling. Will call clinic Monday to advise if area improving will go to ER if fever over 100.5, chills, increased pain. or increased swelling and redness will take TYLENOL for current pain. Pt repeated instructions back to MD and had her questions answered.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Infection, Staphylococcus test positive
Clinical narrative: Pt developed herpes zoster and a secondary infection. +
Age: 62.0
Sex: F
Vaccine: FLU3, PPV, TDAP, VARZOS
Symptoms: Arthralgia, Musculoskeletal pain
Clinical narrative: Pt. complains of soreness and pain in her shoulder and elbow joints. Contacted PCP.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse refers to an approximately 29 year old female patient. There was no information on pertinent medical history and drug reactions or allergies. On 12-SEP-2014, the patient was vaccinated with M-M-R II (reported as M-M-R II VACCINE VIAL (SDV, MDV OR ADDITIIVE (EA)), product lot # K002527, Expiry date: 18-FEB-2016, dose not reported, subcutaneously . After she received the M-M-R II vaccine she informed the physician that she was 16 weeks pregnant. The date of last menstrual period (LMP) was approximately 22-MAY-2014 (it was reported that the patient  was 16 weeks pregnant at the time of report on 12-SEP-2014). The expected date of delivery could be approximately around 26-FEB-2015. The exposure to M-M-R II was at 16 week(s) of pregnancy (third trimester). The pregnancy outcome was unknown. The fetal outcome was unknown. No known adverse effects was reported. There was no information on laboratory diagnostics studies performed. There was no intervention done to prevent the seriousness criteria. There was no product quality complaint involved. The outcome of the event was unknown (the patient present status reported as no known adverse effects). Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain
Clinical narrative: This spontaneous report as received from a 60 year old male patient refers to himself. On 07-AUG-2014 the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, route, lot #, expiration date and frequency were unknown) in the upper left arm.  On an unknown date in August 2014 (post ZOSTAVAX) the patient experienced red circle at the injection site and pain. It was reported that the adverse event was not improved. The outcome of pain and red circle at the injection site was reported as recovered/resolved on an unknown date in August 2014.  This is one of several reports from the same reporter. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. No current condition was reported. No historical medication was reported. Approximately in 2014, the patient was vaccinated with VAQTA lot # J005713, expiration date 25-OCT-2015 (dose, strength and route was not reported). No concomitant medication was reported. Nurse stated that an unspecified number of patients received (unspecified doses in series) VAQTA that was stored at 47F for 120 hours. Nurse also reported that temperature issue occurred on 29-JUN-2014 through 03-JUL-2014 so doses administered somewhere after 04-JUL-2014 and 23-SEP-2014. No adverse event was reported. The outcome of VAQTA stored at 47F for 120 hours was unknown. This is one of the several reports. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a other reporter, as part of marketing research program titled as "HCC Tracker ZOSTAVAX" conducted by MSW Research regarding a 51 year old female patient. There was no information on medical history. On unknown date the patient was vaccinated with ZOSTAVAX (dose, frequency, route, product lot #, expiry date not reported). There was no information on concomitant therapy reported. On an unknown date the patient reported that its a live virus, very dangerous for me. There was no information on diagnostic tests carried out to diagnose adverse event. The outcome of the event and causality was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Chills, Pyrexia
Clinical narrative: This spontaneous report as received from a physician refers to 2 patients of unknown age. Patient's medical history and concurrent condition was not reported. On 19-SEP-2014 the patient's were vaccinated with PNEUMOVAX23 prefilled syringe (dose and frequency unknown). Patient's concomitant medication was not reported. On an unknown date the patient experienced fever and chills. When doctor used the first 2 out of a 10 pack box, both patients broke out in fever and chills. The doctor does not want to use the other eight. The outcome of the event was unknown. Reporter's causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. No current condition was reported. No historical medication was reported. Approximately in 2014, the patient was vaccinated with ROTATEQ lot number reported J005713, expiration date 25-OCT-2015 (dose, strength and route was not reported). No concomitant medication was reported. Nurse stated that an unspecified number of patients received (unspecified doses in series) ROTATEQ that was stored at 47F for 120 hours. Nurse also reported that temperature issue occurred on 29-JUN-2014 through 03-JUL-2014 so doses administered somewhere after 04-JUL-2014 and 23-SEP-2014. No adverse event was reported. The outcome of ROTATEQ stored at 47F for 120 hours was unknown. This is one of the several reports. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Eructation, Malaise, Nausea, Pulse abnormal, Vertigo
Clinical narrative: This spontaneous report as received from a 67 year old female patient refers to her. On 10-SEP-2014 the patient was vaccinated with ZOSTAVAX, 1 injection (dosage information unknown) at a pharmacy by an unknown pharmacist. Concomitant therapies included DIVANIL reported as DIVAN. On 10-SEP-2014, the patient experienced nausea and belching after vaccination. The following day, on 11-SEP-2014, the patient's head was spinning. On 12-SEP-2014, the patient was still feeling ill and her pulse was also fluctuating. The outcome and casualty of the events were unknown. The patient sought medical attention by calling her physician for medical advice.  A product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an infant patient (age reported as 41 or 43 weeks) of unknown gender. On 12-SEP-2014, the patient, older than 32 weeks of age, was vaccinated with third dose of ROTATEQ 2ml, oral (lot number and expiration date were not provided). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 18-SEP-2014 the patient was vaccinated with an expired dose of PNEUMOVAX23 (dose not reported, lot #0491AE, expired date: 15-SEP-2013). No adverse effects. The patient did not seek any medical attention. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 25 year old female patient. On an unspecified day in February of 2014 the patient was vaccinated with a dose of PNEUNOVAX23 (lot # H018441, expiration date: 28-FEB-2014), dose, frequency, route were unknown. On an unknown date in 2014 the patient experienced swelling at the injection site and a fever. The outcome of the events was reported as recovered/resolved on an unknown date in 2014. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Carpal tunnel syndrome, Hypoaesthesia, Neuropathy peripheral, Paraesthesia
Clinical narrative: This spontaneous report as received from a nurse refers to a 56 year old female patient. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose, route not reported). Concomitant therapies included LYRICA. The nurse reported that the patient complained of neuropathy in her feet and hands. The patient stated she had numbness and tingling in her extremities on unspecified dates in January 2014. The patient visited an unspecified Urgent Care facility on an unspecified date. The urgent care facility prescribed and EMG (Electromyography) and a nerve conduction study on the patient.  The patient was referred to an unspecified neurologist. The patient visited the unspecified neurologist on an unspecified date. The patient was diagnosed with carpal tunnel syndrome. The patient was operated on for carpal tunnel syndrome on na unspecified day in March 2014. The patient stated that she was still experiencing neuropathy in her hands and feet. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist and refers to a 61 year old female patient with none drug reactions or allergies. On 15-SEP-2014 the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous, lot # K008079, expiration date: 03-SEP-2014). Concomitant therapies included pravastatin, ACIPHEX, PROPRANOLOL ER, SINGULAIR, PROAIR, piroxicam and estrogens,  PREMARIN. On 16-SEP-2014, the patient experienced an injection site reaction of redness, pain, itching and swelling. The area was not to the touch. There was no treatment given for the adverse events.  None lab diagnostics studies were performed. The patient sought medical attention via visiting the pharmacy. The outcome of events was reported as not recovered. The relatedness between events and ZOSTAVAX was not reported.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On 23-SEP-2014 the patient was vaccinated with an expired dose of PNEUMOVAX23 (dose and route were not reported, lot # J007060, expiration date 28-AUG-2014). No adverse effects were reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site nodule
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative and refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous, lot # K003599, expiration date: 13-MAR-2015). On an unknown date the patient experienced a bright red area around the injection site and knot at the injection site. The patient was diagnosed (date unspecified) with cellulitis. The patient sought medical attention (unspecified0. The outcome of event was not reported. The reporter considered event to be related to ZOSTAVAX (reported as adverse experiences related to this lot). The reporter wanted a lot check on #K003599. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative and refers to 2 patients of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous, lot # K003599, expiration date: 13-MAR-2015). On an unknown date these patients experienced a little redness at the injection site. The patient was diagnosed (date unspecified) with cellulitis.  The outcome of event was not reported. The reporter considered event to be related to ZOSTAVAX (reported as adverse experiences related to this lot). The reporter wanted a lot check on #K003599. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The pharmacist reported that in approximately August 2014, reported as in the last three to four weeks, she inadvertently administered a second dose of PENUMOVAX23 intramuscularly, (dose not reported), lot # H015749, which expired on 08-JUN-2014, to the patient. This was supported. The first dose was administered three years ago, in 2011. There were no adverse effects reported. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a 62 year old male patient reporting on himself. On 09-SEP-2014 the patient was vaccinated with 1 single shot of ZOSTAVAX, subcutaneous (dose, lot number and expiration date not reported). On 09-SEP-2014, over the span of 2-4 hours after receiving ZOSTAVAX, the patient experienced injection site swelling, redness, and warmth on his left arm that were becoming more and more apparent. No treatment was given for the adverse events. The patient did not seek medical attention and none lab test was performed. At the tine of the report the outcome of the events was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 2 patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX, 0.5ml, subcutaneous (lot number and expiration date not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 23-SEP-2014 the patient was vaccinated with an expired dose of (Oka/Merck) VARIVAX (0.5 ml, subcutaneously, lot # H015870, expiration date: 22-AUG-2014). No adverse experience reported. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a child patient (reported as less than 2 years of age) of unknown gender. On 17-SEP-2014, the patient was inadvertently vaccinated with PNEUMOVAX23 0.5 ml, intramuscular (lot number and expiration date were not reported) instead of PREVNAR13. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding three patients of unknown age and gender. The patients demographics were not reported. The reporter stated that on an unknown date, the three patients was vaccinated with (Oka/Merck) VARIVAX (strength, dose, frequency, dose number, route, product lot #, expiry date not reported) that was improperly stored. No adverse effects reported. There was no product quality complaint involved. The outcome of the events was unknown. Additional information has been requested.
Age: 47.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse and refers to a 47 year old patient of unknown gender. On 08-SEP-2014 the patient was vaccinated with a third dose of RECOMBIVAX HB injection, 10/1.0 mcg/ml,, dose: 1 ml lot # J008505, expiration date: 07-FEB-2016, 1 ml, intramuscular (anatomical location and lot number were not reported) which was improperly stored. The reporter stated that it was the patient's third dose in the series. No adverse effects reported. The reporter also stated that GARDASIL and PNEUMOVAX23 were improperly stored but they were not administered to any patients. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 14-AUG-2014 the patient was vaccinated with a dose of PROQUAD (Merck) (lot # K008579, expiration date 13-DEC-2015) (dose and route were unknown) which was improperly stored. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 14-SEP-2014 the patient was vaccinated with ZOSTAVAX (lot # J011338, expiry date: 19-DEC-2014, subcutaneous, dose unknown. Pertinent medical history and concomitant medications were unspecified by reporter. On 14-SEP-2014, the patient developed a "golf ball sized" red bump at the injection site after receiving the ZOSTAVAX. No treatment was provided for the event. The outcome of the events was reported as not recovered/not resolved. The causality was unknown. No further information provided. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Insomnia, Pruritus
Clinical narrative: This spontaneous report was received from a 68 year old female patient with glaucoma, Graves' disease and vitiligo reporting on herself. The patient was experiencing recurrent itchiness (reported as that "come and went") on back, neck and chest in the past. The patient had no reactions or allergies to the drugs. On 16-JUL-2014 the patient was vaccinated with ZOSTAVAX (dose, frequency and lot #: not provided). Concomitant therapies included levothyroxine sodium (manufacture unknown), temazepam (manufacturer unknown), alendronate sodium (manufacturer unknown and timolol maleate (manufacturer unknown).  On 16-JUL-2014 reported as "right after she received" ZOSTAVAX, she remembered that in the past (date unspecified) she had experienced the itchiness started. The patient reported that the symptoms of itchiness on back, neck and chest that came and went, recently got worse and she was unable to sleep if she did not use CORTIZONE 10 PLUS cream nightly to relive the itchiness. No laboratory test was performed. The patient did not seek medical attention. The outcome of itchiness gotten worse was not reported. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 5 and a half year old female patient. On 23-SEP-2014 the physician stated that the patient received inadvertently GARDASIL dose 1, intramuscular (lot# and exp date was not reported). Not adverse event reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that on unspecified dates, an unspecified number of doses of GARDASIL (intramuscular injection, dose number, route, batch and lot #, expiration date not reported, could have been administered to an unspecified amount of patients. No adverse evens reported. Further information was not provided. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a license practical nurse and refers to a patient of unknown age and gender. The reporter stated that the patient was in the office (on 25-SEP-2014) to receive GARDASIL injection (0.5 ml, intramuscular, anatomical location, lot number were not reported) as the second dose in the vaccination schedule. The patient received the first dose of CERVARIX (reported as CEVARIX) on 18-JUN-2013. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (healthcare worker) refers to a patient of unknown age and gender. It was reported that the patient received doses of GARDASIL on 25-SEP-2013 and 18-SEP-2014 (dose, route and lot numbers not reported). No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that on unspecified dates, an unspecified number of doses of RECOMBIVAX HB (intramuscular injection, dose number, route, batch and lot #, expiration date not reported, could have been administered to an unspecified amount of patients. No adverse events reported. Further information was not provided. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that on unspecified dates, an unspecified number of doses of VAQTA (Intramuscular injection, dose number, batch and lot #, expiration date not reported could have been administered to an unspecified amount of patients. No adverse events reported. Further information was not provided. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that on unspecified dates, an unspecified number of doses of COMVAX (intramuscular injection, dose number, route, batch and lot #, expiration date not reported) could have been administered to an unspecified amount of patients. No adverse events reported. Further information was not provided. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an infant patient (age reported as 41 and 43 weeks) of unknown gender. On 12-SEP-2014, the patient, older than 32 weeks of age, was vaccinated with third dose of ROTATEQ 2 ml, oral (lot number and expiration date were not provided). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: ANTH, HEP
Symptoms: Allodynia, Facial pain, Headache, Motor dysfunction, Neck pain
Clinical narrative: 28 y/o female with pain (L) hand, arm, neck w/ more recently face (L) and head (L). Paresthesia and allodynia 5th and 4th fingers, web space index thumb w/ palmar surface. Normal motor/reflex but more recent mild motor decreased (L) compared to (R) intrinsic muscle, wrist flex/ext normal CN nerves.
Age: 26.0
Sex: F
Vaccine: ANTH, HEP
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: 28 y/o female with pain (L) hand, arm, neck w/ more recently face (L) and head (L). Paresthesia and allodynia 5th and 4th fingers, web space index thumb w/ palmar surface. Normal motor/reflex but more recent mild motor decreased (L) compared to (R) intrinsic muscle, wrist flex/ext normal CN nerves.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Cellulitis, Erythema, Pyrexia, Rash
Clinical narrative: Rash, redness and fever started the next day. Diagnosed as cellulitis.
Age: 72.0
Sex: U
Vaccine: FLU3
Symptoms: Dyspnoea, Insomnia, Pain, Pain in extremity
Clinical narrative: Pain, sore arm, hard to breathe, could not sleep.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Erythema, Odynophagia, Skin warm, Swollen tongue
Clinical narrative: I received the high dose flu shot at 3PM on 9/10/14. Three hours later my tongue swelled on the left side. Pain and difficulty swallowing. Injection arm was red and warm to touch. I was put on prednisone and BENADRYL.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Fatigue, Headache
Clinical narrative: Patient received vaccine about 9:30 am on 9/18/2014. By afternoon she developed chills, headache, 102 degrees temp and a general run-down feeling. Temperature resolved after taking 1000 mg TYLENOL about 730 pm.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Excessive eye blinking, Staring, Tremor
Clinical narrative: Mom states that on 9-13-14 patient was laying down his eyes started blinking quickly and he brought his fist up to his face and was shaking them. He then briefly stared into space for about 3 sec.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Asthenia, Urticaria, Vomiting
Clinical narrative: Vomited twice at 7pm day of injections. Decreased energy level. Following morning 9/16 awoke with hives covering most of body. (R) thigh has largest hive. 9/17 hives worsening. BENADRYL being given every 4hrs. ZYRTEC initiated 9/16.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Rash erythematous
Clinical narrative: Rash on arms and legs - red raised bumps, per staff at Dr. office.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling
Clinical narrative: Arm swollen.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist (also reported as a non-health care professional) refers to a 58 year old male patient. The pharmacist did not know any additional information including patient's medical history, concomitant medications, and past drug history. On 13-SEP-2014 the patient was vaccinated with an expired dose of PNEUMOVAX23 lot # J009827 and expiration date 10-AUG-2014, dose: 0.5 ml, intramuscular. At the time of the report the outcome of the event was unknown. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dysphagia, Dyspnoea, Hypoaesthesia, Nausea
Clinical narrative: 9/24/14 2:30 pm sx: dizziness, difficulty breathing and swallowing, felt like "throat was closing", nausea, numbness in both hands (Lt worse than Rt); no hives/rash, no audible wheezing. TX: O2, 1.5L face mask, BENADRYL 25mg IM, Rt delt at 2:30 pm. EPIPEN 0.3 mg, IM (left thigh) at 2:53 pm. 3:05 pm to ER, via ambulance.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: 9/24/14 2:30 pm sx: dizziness, difficulty breathing and swallowing, felt like "throat was closing", nausea, numbness in both hands (Lt worse than Rt); no hives/rash, no audible wheezing. TX: O2, 1.5L face mask, BENADRYL 25mg IM, Rt delt at 2:30 pm. EPIPEN 0.3 mg, IM (left thigh) at 2:53 pm. 3:05 pm to ER, via ambulance.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a male patient of 0 day old. On 18-JUL-2014, the patient was vaccinated with an improperly stored RECOMBIVAX HB lot number J012520, exp date: 30-JAN-2016, intramuscular at 10:41 am, first dose, (dose was not reported). No adverse symptoms reported. It was reported that the vaccine storage temp dipped to 0-1 degree for 18 different episodes between May 14 and July 21 according to minimum/maximum. It was not possible to identify how long the temps were down. All recorded temps, before midday and after midday were the normal within 2-8 degrees.  The vaccine was removed once problem was identified and has been used after 21-JUL-2014. This is one of several reports from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Pyrexia
Clinical narrative: Crying for 3 or more hours. Fever (101).
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Swelling 3" x 4" around site of injection within 4 hours.
Age: 38.0
Sex: M
Vaccine: PNC13
Symptoms: Dermatitis, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Patient received PREVNAR vaccine (PCV13) on 4/9/14. On 4/12/14, he developed a raised itchy reddish rash all over his body. He sought care from the ED on 4/23/14. In the ED, patient reported use of a new soap starting on 4/11/14. Per ED doctor note, diagnosis was dermatitis- most likely reaction to new soap. Patient was instructed to stop new soap and was given prednisone 40mg x7 days and cetirizine 10mg PRN x20 days. Although rash was likely caused by new soap, there remains a possibility that PREVNAR could be the causative agent. Patient reported feeling a lot better during telephone follow-up on 4/24/14. Patient received PNEUMOVAX (PPSV23) on 5/7/14. As of 5/10/14, no reported signs of allergic reaction to vaccine, decreasing the likelihood patient had reaction to PCV13 vaccine.
Age: 72.0
Sex: M
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Hives from head to feet 2 days after vaccination, no problems with Td vaccination in 2001. Flu shot an outside facility was given to the pt sometime in 9/2013, exact date unknown per notes.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site urticaria, Injection site warmth
Clinical narrative: Urticaria, pruritus and redness, warmth, pain at site of injection, area got larger.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, MMRV, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever up to 103.
Age: 67.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Cellulitis, Injection site bruising, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female patient. On 16-SEP-2014 the patient was vaccinated with PNEUMOVAX23 (lot # K007773, expiry date: 01-MAY-2015, 0.5 ml intramuscular. Pertinent medical history and concomitant medications were unspecified by reporter. The reporter stated that the patient had developed bruising at the injection site that has spread to the "inside of the elbow" after receiving PNEUMOVAX23. The patient was also experienced injection site itches which were "real bad". The patient visited pharmacy on 18-SEP-2014 and informed pharmacist of the symptoms  and then "two hours later" went to an unspecified clinic and received a prescription of an unspecified antibiotic and was diagnosed with cellulitis on an unknown date in September 2014. The outcome of cellulitis was reported as not recovered/not resolved. The causality was unknown. No further information was provided. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Erythema, Musculoskeletal pain, Pain in extremity, Pruritus, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female patient. On 16-SEP-2014 the patient was vaccinated with PNEUMOVAX23 (lot # K007773, expiry date: 01-MAY-2015, 0.5 ml intramuscular. Pertinent medical history and concomitant medications were unspecified by reporter. The reporter stated that the patient had developed bruising at the injection site that has spread to the "inside of the elbow" after receiving PNEUMOVAX23. The patient was also experienced injection site itches which were "real bad". The patient visited pharmacy on 18-SEP-2014 and informed pharmacist of the symptoms  and then "two hours later" went to an unspecified clinic and received a prescription of an unspecified antibiotic and was diagnosed with cellulitis on an unknown date in September 2014. The outcome of cellulitis was reported as not recovered/not resolved. The causality was unknown. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. On 18-SEP-2014 the patient was vaccinated with PNEUMOVAX23 (lot # not reported, expiration date: 10-AUG-2014) 0.5 ml. Dose supported. No adverse experience was reported. Outcome of the event was not reported. No product quality complaint PQC was reported. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 9/23/14 Fever 100.6 degrees F, chills, right arm soreness, no redness, no SOB, no swelling, no warmth. 9/24/14 Chills, fever, injection site painful and warm to touch, fatigue, redness. Treatment on 9/24 labs, Amoxicillin.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: 9/23/14 Fever 100.6 degrees F, chills, right arm soreness, no redness, no SOB, no swelling, no warmth. 9/24/14 Chills, fever, injection site painful and warm to touch, fatigue, redness. Treatment on 9/24 labs, Amoxicillin.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Hypoaesthesia, Pharyngeal oedema
Clinical narrative: 10:45 AM Sudden onset 5 min after receiving Trivalent vaccine in (L) arm. Felt numbness on (R) side of face and arm. Very anxious. Denies any SOB, swelling of throat, no hives. 11 AM Advised to physician today.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Shot administered at 10:00 am, hives noticed at 6:00 pm, took 2 BENADRYL capsules orally Wednesday evening, saw CNP at Clinic on Thurs at 11:30 am, was prescribed course of prednisone. Took prednisone and BENADRYL orally, used neosporin eczema lotion on affected areas (forearms, upper arms, legs, trunk, chest). Hives lasted 6 days.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blister, Cellulitis, Erythema, Pyrexia, Rash
Clinical narrative: Rash, redness and fever started the next day and blister. Diagnosed as cellulitis.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. On 19-SEP-2014 the patient was inadvertently administered with (Oka/Merck) VARIVAX (lot # H011724, expiration date: 12-JUN-2014) dose and frequency unknown, subcutaneously. This was supported. No adverse effects were reported. Outcome of the event was not reported. No produce quality complaint (PQC) was reported. Causality assessment was not provided. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse refers to a currently 1 year old patient. The patient had already received 3 doses of RECOMBIVAX HB sometime in the past (unspecified dates). On an unknown date in 2014 (also reported as recently administered) the patient inadvertently received a fourth dose of RECOMBIVAX HB 5 mcg/0.5 ml. The patient was supposed to received an unspecified hepatitis A (manufacturer unknown) but instead received RECOMBIVAX HB. No symptoms reported Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLUN4
Symptoms: Back pain, Borrelia test negative, Complement factor C3, Complement factor C4, Complement factor normal
Clinical narrative: Patient presented with swollen joints and rash 7 days after receiving FLUMIST. She had low grade fever. She had back pain. General malaise/fatigue. We treated her with BENADRYL and prednisone.
Age: 14.0
Sex: F
Vaccine: FLUN4
Symptoms: Fatigue, Full blood count normal, Joint swelling, Malaise, Metabolic function test normal
Clinical narrative: Patient presented with swollen joints and rash 7 days after receiving FLUMIST. She had low grade fever. She had back pain. General malaise/fatigue. We treated her with BENADRYL and prednisone.
Age: 14.0
Sex: F
Vaccine: FLUN4
Symptoms: Pyrexia, Rash, Red blood cell sedimentation rate normal, Streptococcus test negative
Clinical narrative: Patient presented with swollen joints and rash 7 days after receiving FLUMIST. She had low grade fever. She had back pain. General malaise/fatigue. We treated her with BENADRYL and prednisone.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Local swelling, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient came back next day with slightly swollen left arm. She states she is having pain that radiates from her shoulder all the way down to her elbow. Hasn't tried anything for pain yet. Advised patient to contact her PCP and go to ER is symptoms worsen.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Pruritus, Urticaria
Clinical narrative: Hives: chest, neck, side of face, abdomen - burning and itchy - (primary physician - recommended BENADRYL HCl-25mg every 4 hrs.). 9/22/2014 - Hives still present and several new ones.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain, Post herpetic neuralgia, Pyrexia, Respiratory tract congestion
Clinical narrative: Red spot at area of injection. Fever, chest congestion. He appears increase of pain from post herpetic neuralgia.
Age: 32.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Large red, warm to touch area surrounding the injection site. Ice applied and BENADRYL cream, advised to use BENADRYL po that night.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Fatigue, Headache, Oropharyngeal pain, Pain
Clinical narrative: Fever, headache, tiredness, body aches, sore throat, cough.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever, headache, tiredness, body aches, sore throat, cough.
Age: 38.0
Sex: F
Vaccine: FLUC3
Symptoms: Arthralgia, Erythema, Injection site erythema, Injection site induration, Pain
Clinical narrative: Vaccinated 3:45 pm 9/19/14. Noticed pain and swelling and redness within 2 hrs. Joint pain, fever, swells that evening. Took ALEVE. Seen on 9/22/14 reports decreased sensation (R) arm throughout, full strength, 3 cm induration and erythema at site. Tx CLARITIN, f/u 3 days.
Age: 38.0
Sex: F
Vaccine: FLUC3
Symptoms: Pyrexia, Sensory disturbance, Swelling
Clinical narrative: Vaccinated 3:45 pm 9/19/14. Noticed pain and swelling and redness within 2 hrs. Joint pain, fever, swells that evening. Took ALEVE. Seen on 9/22/14 reports decreased sensation (R) arm throughout, full strength, 3 cm induration and erythema at site. Tx CLARITIN, f/u 3 days.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Headache, Herpes zoster, Pruritus
Clinical narrative: Headaches, itching then progressive eruption of shingles within 3 to 4 days. Positive Dx of shingles by family dr.
Age: 4.0
Sex: F
Vaccine: MMR, MMRV
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a currently 18 years old female patient. On 20-APR-1997, the patient was vaccinated with a first dose of M-M-R II dose 0.5 ml, subcutaneous, (lot number and expiration date not reported). On 17-FEB-2000 the patient was vaccinated with a second dose of M-M-R II, 0.5 ml, subcutaneous (lot number and expiration date not reported). On an unknown date, reported as recently the patient had negative titers for mumps, measles and rubella. The patient was recommended to receive another dose of M-M-R II. The patient sought medical attention. Titers laboratories were performed. No treatment was given for the events. At the time of the report the outcome of the events was unknown. The patient subsequently was inadvertently vaccinated with PROQUAD (Merck) instead of M-M-R II (MARRS 1409USA013852). Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR, MMRV
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a currently 18 years old female patient. On 20-APR-1997, the patient was vaccinated with a first dose of M-M-R II dose 0.5 ml, subcutaneous, (lot number and expiration date not reported). On 17-FEB-2000 the patient was vaccinated with a second dose of M-M-R II, 0.5 ml, subcutaneous (lot number and expiration date not reported). On an unknown date, reported as recently the patient had negative titers for mumps, measles and rubella. The patient was recommended to receive another dose of M-M-R II. The patient sought medical attention. Titers laboratories were performed. No treatment was given for the events. At the time of the report the outcome of the events was unknown. The patient subsequently was inadvertently vaccinated with PROQUAD (Merck) instead of M-M-R II (MARRS 1409USA013852). Additional information has been requested.
Sex: F
Vaccine: MMR, MMRV
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a currently 18 years old female patient. The patient had a history of negative titers for mumps, measles and rubella while on prior therapy with 2 doses of M-M-R II (1409USA008946). On an unknown date, reported as "recently", the patient was inadvertently vaccinated with PROQUAD (strength, dose, route, lot number and expiration date not reported) after the college recommended to receive another dose of M-M-R II. The patient sought medical attention. No adverse symptoms reported with the PROQUAD administration. Additional information has been requested.
Sex: F
Vaccine: MMR, MMRV
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a currently 18 years old female patient. The patient had a history of negative titers for mumps, measles and rubella while on prior therapy with 2 doses of M-M-R II (1409USA008946). On an unknown date, reported as "recently", the patient was inadvertently vaccinated with PROQUAD (strength, dose, route, lot number and expiration date not reported) after the college recommended to receive another dose of M-M-R II. The patient sought medical attention. No adverse symptoms reported with the PROQUAD administration. Additional information has been requested.