chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to approximately 2-3 patients of unknown age and gender. On an unknown date (reported as int he past few years) those patients were vaccinated with PNEUMOVAX23 (dose, units, route of administration, anatomical location, lot number were not reported). On an unknown date (reported as in the past few years) those patients experienced unspecified injection site reactions after the administration of PNEUMOVAX23. The outcome of events was not reported. The relatedness between events and PNEUNMOVAX23 was not reported.  This is one of several reports from the same reporter. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Angioedema, Dysphagia, Hypoaesthesia oral, Pharyngeal hypoaesthesia, Swelling face
Clinical narrative: Angioedema and numbness of tongue, throat, dysphagia, facial swelling.
Sex: M
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, units, route of administration, anatomical location, lot number were not reported). On an unknown date (reported as recently) the patient felt really sick after receiving PNEUMOVAX 23 at his physician's office (unspecified). The outcome of events was not reported. The relatedness between event and PNEUMOVAX 23 was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.51
Sex: F
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to an 8-months old female patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the third dose of ROTATEQ (oral, batch/lot # J004875, expiration date 17-OCT-2014), on 13-JAN-2014 at 2:00 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event was also reported as 27-FEB-2014 at 10:00 AM). The reporter reported that it was decided not to revaccinate the patient. No adverse event was reported for the patient. Outcome was also reported as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Sex: F
Vaccine: HEP
Symptoms: Reaction to preservatives
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with HepB vaccine (manufacturer unknown) (dose, lot # and route of administration was not reported). On an unknown date the patient experienced an unspecified reaction to the unspecified preservative in HepB vaccine (manufacturer unknown). It was reported that RECOMBIVAX could not be ruled out. The outcome of the event was reported as recovered/resolved on unknown date. Additional information has been requested.
Age: 0.49
Sex: F
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to an 8-months old female patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the third dose of ROTATEQ (oral, batch/lot # J004875, expiration date 17-OCT-2014), on 22-JAN-2014 at 10:00 AM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event was also reported as 27-FEB-2014 at 10:00 AM). The parents of the patient were going to consult with physician and declined to repeat the dose. No adverse event was reported for the patient. Outcome was reported by the reporter as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Age: 0.34
Sex: F
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to an 5-months old female patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the second dose of ROTATEQ (oral, batch/lot # J001254, expiration date 19-SEP-2014), on 06-FEB-2014 at 2:00 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event was also reported as 27-FEB-2014 at 10:00 AM). A revaccination dose was declined. No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Age: 0.34
Sex: F
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to an 5-months old female patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the second dose of ROTATEQ (oral, batch/lot # J001254, expiration date 19-SEP-2014), on 05-FEB-2014 at 9:00 AM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event was also reported as 27-FEB-2014 at 10:00 AM). It was informed that vaccinated repeat was declined. No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Age: 59.0
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 59 year old patient of unknown gender. No medical history or concurrent conditions reported. On 27-SEP-2014, the patient was vaccinated with PNEUMOVAX 23 (dose, strength, route of administration and lot number not provided). No co-suspect or concomitant therapies were reported. The dose that the patient received had expired on 20-JUL-2014. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Malaise
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 year old female patient with hypertension and none drug reactions or allergies. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (in the arm, intramuscular, lot # K006681, expiration date: 21-OCT-2015). Concomitant medications included unspecified medication for hypertension. On 20-SEP-2014, after receiving PNEUMOVAX 23 the patient's upper arm became swollen and red at the injection site, down to her elbow and that she also felt sick after receiving PNEUMOVAX 23. None lab diagnostics studies were performed. The patient sought medical attention via calling the pharmacy. The pharmacist requested a lot check for PNEUMOMVAX 23 (lot # K006681, expiration date: 21-OCT-2015) and requested a call back regarding the results of the lot check. The outcome of events was reported as recovering. The relatedness between events and PNEUMOVAX 23 was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Flu vaccine given 9/20/14 pt called on 9/21/14 said there was red circle at site of injection and it was feverish to touch. Advise she go to clinic immediately.
Age: 0.23
Sex: F
Vaccine: DTAP, RV5
Symptoms: Diarrhoea
Clinical narrative: Diarrhea for 1 week, 3+ stools per day (normal 1 per day).
Age: 36.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Contusion, Injection site erythema, Injection site reaction, Pain, Rash macular
Clinical narrative: Morning of 9-20-2014 started being very sore. Cannot sleep on that arm,. Slightly warm to touch. Yellowish bruise near arm pit. Red blotchy patches in right arm around admin site.
Age: 36.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm, Sleep disorder
Clinical narrative: Morning of 9-20-2014 started being very sore. Cannot sleep on that arm,. Slightly warm to touch. Yellowish bruise near arm pit. Red blotchy patches in right arm around admin site.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Cyanosis, Electroencephalogram, Eye movement disorder, Full blood count
Clinical narrative: Generalized tonic-clonic seizures - approx 3 min w/20 minute recovery. - loss of consciousness - lips and jaw blue - whole body convulsions - eyes rolled back - bit sides of tongue - chipped tooth - loss of bladder control. Dates of seizures: 7/08/13 and 3/15/14. Diagnosis: Generalized seizure disorder of unknown origin.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Grand mal convulsion, Loss of consciousness, Nuclear magnetic resonance imaging, Tongue biting, Tooth fracture
Clinical narrative: Generalized tonic-clonic seizures - approx 3 min w/20 minute recovery. - loss of consciousness - lips and jaw blue - whole body convulsions - eyes rolled back - bit sides of tongue - chipped tooth - loss of bladder control. Dates of seizures: 7/08/13 and 3/15/14. Diagnosis: Generalized seizure disorder of unknown origin.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Urinary incontinence
Clinical narrative: Generalized tonic-clonic seizures - approx 3 min w/20 minute recovery. - loss of consciousness - lips and jaw blue - whole body convulsions - eyes rolled back - bit sides of tongue - chipped tooth - loss of bladder control. Dates of seizures: 7/08/13 and 3/15/14. Diagnosis: Generalized seizure disorder of unknown origin.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site infection, Injection site scab
Clinical narrative: Pt has area of infection at injection site. Scab approximately 1 cm with redness 3 cm x 5 cm. Pt sent to Dr who started pt on sulfa. Pt asked if immunizer used alcohol swab. Pt said yes.
Age: 26.0
Sex: M
Vaccine: ANTH, TYP, VARCEL
Symptoms: Burning sensation, Erythema, Hypersensitivity, Local swelling, Skin warm
Clinical narrative: Pt states it burns, swollen, red, and warm. It is approximately 3 inches in diameter.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cold sweat, Dizziness, Nausea, Pain
Clinical narrative: Cold sweats, nausea, dizziness, body aches, shivering.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Joint swelling, Pruritus generalised
Clinical narrative: Client reports swelling in ankles and all fingers. Client reports itching all over body. No rash or hives reported at this time. Client reports soreness near site of injection, but no redness or swelling.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Local swelling, Pruritus
Clinical narrative: Itching, swelling, burning in Lt. arm around 5 mins. after receiving vaccine.
Age: 52.0
Sex: F
Vaccine: DTP, PPV
Symptoms: Arthralgia, Chills, Erythema, Hyperhidrosis, Influenza like illness
Clinical narrative: Patient presents to clinic to f/u on c/o LA redness, swelling, and pain s/p PNA injection on 10/08. She reports that since receiving this vaccine she has developed flu like symptoms including sweats/chills (reported highest temp 101) joint pain, sore throat. T: 98.4 (36.9 C) P: 113 R: 18 B/P: 95/60* (sitting) Pulse Oximetry: 96% via room air Pain: 6.
Age: 52.0
Sex: F
Vaccine: DTP, PPV
Symptoms: Oropharyngeal pain, Pain, Swelling
Clinical narrative: Patient presents to clinic to f/u on c/o LA redness, swelling, and pain s/p PNA injection on 10/08. She reports that since receiving this vaccine she has developed flu like symptoms including sweats/chills (reported highest temp 101) joint pain, sore throat. T: 98.4 (36.9 C) P: 113 R: 18 B/P: 95/60* (sitting) Pulse Oximetry: 96% via room air Pain: 6.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to a patient of unknown age and gender. On 23-SEP-2014, the patient was vaccinated with an expired dose of MMR II, 0.5 ml dose, subcutaneous, lot # H017027 and expiration date 14-SEP-2014. No adverse effect reported. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Local swelling, Musculoskeletal stiffness
Clinical narrative: Pt. complained of swollen, stiff, right arm 2 days after vaccination.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was inadvertently administered a dose of PNEUMOVAX 23 (dose, route, lot number and expiration date not reported) which expired in August 2014. At the time of the report the outcome of the event was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal distension, Abdominal pain upper, Dehydration, Headache, Influenza like illness
Clinical narrative: Pt complained of flu-like symptoms including stomach ache, bloated, headache, dehydrate, stomach pains and fever.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Pt complained of flu-like symptoms including stomach ache, bloated, headache, dehydrate, stomach pains and fever.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Register Nurse refers to a female patient of 1 day old. On 27-JUN-2014 at 10:41 the patient was vaccinated with an improperly stored RECOMBIVAX HB lot # J012520, first dose, intramuscular. No adverse events were reported. Vaccine storage temperature dipped to 0-1 degree in 18 different episodes between 14-MAY-2014 and 21-JUL-2014 according to min and max temperature. They knew that when all recorded temperatures checked were within 2-8 degrees. This is one of several reports received from the same source. Additional information is not expected, all follow ups requested to complete the case were received.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The registered nurse reported a temperature excursion dated 02-AUG-2014 of 0 degrees centigrade for 8 hours affecting PEDVAXHIB. The excursion was supported. The nurse reported that PEDVAXHIB was administered post excursion (dose, routes and lot numbers not provided), (approximately in 2014). The nurse did not have access to specific patient or product information. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The registered nurse reported a temperature excursion dated 02-AUG-2014 of 0 degrees centigrade for 8 hours affecting GARDASIL. The excursion was supported. The nurse reported that GARDASIL INJ was administered post excursion (dose, routes and lot numbers not provided) (approximately in 2014). The nurse did not have access to specific patient or product information. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.35
Sex: F
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to an 6-months old female patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the second dose of ROTATEQ (oral, batch/lot # J004875, expiration date 17-OCT-2014), on 17-JAN-2014 at 4:04 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event was also reported as 27-FEB-2014 at 10:00 AM). The parents of the patient were going to consult with physician and patient was going to be revaccinated on 31-MAR-2014. No adverse event was reported for the patient. The outcome was reported by the reporter as recovered/resolved on 24-MAR-2014. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The registered nurse reported a temperature excursion dated 02-AUG-2014 of 0 degrees Centigrade for 8 hours affecting RECOMBIVAX HB. The excursion was supported. The nurse reported that RECOMBIVAX HB was administered post excursion (dose, routes and lot numbers not provided), (approximately in 2014). The nurse did not have access to specific patient or product information. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: UNK
Symptoms: Bacterial test positive
Clinical narrative: Pulmonary cocci.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Induration
Clinical narrative: Immediate quarter sized red area with induration.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: MCV-4 was given when not due.
Age: 1.07
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Erythema, Papule, Polymerase chain reaction, Rash erythematous
Clinical narrative: Child had VZV/MMR/HAV vaccines on 9/22/14. On 9/27/14 mom noted several red spots on lower back. On 9/29/14, he had developed band like distribution rash on lower bk (L2 dermatome) with erythematous papules, vesicles and crusting.
Age: 1.07
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Scab, Varicella virus test, Viral test
Clinical narrative: Child had VZV/MMR/HAV vaccines on 9/22/14. On 9/27/14 mom noted several red spots on lower back. On 9/29/14, he had developed band like distribution rash on lower bk (L2 dermatome) with erythematous papules, vesicles and crusting.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient came into the clinic to receive her 4th PENTACEL. The shot was given too early. Both the PHN; contract RN thought it was dose #2 going to dose #3. So 4 weeks would be appropriate. 6 months is the correct span. Called mom: re-scheduled 4th dose for Feb 3rd 2015.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Exfoliative rash
Clinical narrative: Patient stated she developed an elevated, raw, scaly rash under her left armpit that extends around to spine.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Pt rec ZOSTAVAX 9/27/14 approx 1 PM. 9/30/14 12:20P pt presents with swelling (about 2-3" circ). It had been larger and extended to her elbow on 9/29/14 but today seems to be receding. Advised to ice and APAP. She is sensitive to many meds including antihistamines.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Fall, Syncope
Clinical narrative: Patient fainted/fell outside after receiving flu shot. Patient has eaten since 10 am, said was feeling dizzy. Had flu shot before, no previous reaction. Paramedic was called upon approval from pt. Pt received food and water. Confirmed with patient that she probably did not eat enough on that day and felt weak this reason for fainting.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Body aches for 5 days post flu shot. Told pt to take ibuprofen/acetaminophen. Will f/u in 2 days.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Extrasystoles, Fatigue
Clinical narrative: Concern that his palpitations he developed during deployment may be related to the AVA vaccines he received. July 09 assessed as having SVT with occas PVC's. Ablation was attempted in 09 but unsuccessful since sit could not be located. He saw cardiology in Jan 2011 in which a brief history was obtained and a request for records. Next cardiology visit was in Jan 2014 in which he reported fatigue and occasional skipped beat, no chest pain, dizziness, palpitations or SOB. He admitted to smoke 1/2 ppd, drank 24 oz of coffee every am and 2-3 32 oz of tea throughout the day. He had a repeat Holter in July showed occas PVC and PAC's and he is currently requesting a repeat EP visit. Exact onset date unknown. Only that it was in July 08.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Myalgia
Clinical narrative: Muscle ache left upper arm since shot was given yesterday.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Cellulitis, we did not observe it here in the pharmacy. Pt was seen at a walk-in clinic and received clindamycin.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Influenza vaccine was administered on 9/22/14. Patient began to experience increased pain with decreased ROM to left arm within 1 hour of administration. S/s have been getting worse.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to an 7-months old patient of unknown gender, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the second dose of ROTATEQ (oral, batch/lot # J001254, expiration date 19-SEP-2014), on 10-FEB-2014 at 5:20 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event was also reported as 27-FEB-2014 at 10:00 AM). The patient was revaccinated on 28-MAR-2014 without charge. No adverse event was reported for the patient. The reporter reported the outcome as recovered on 28-MAR-2014. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Staphylococcal infection, Streptococcal infection
Clinical narrative: Patient had cellulitis upper left arm and elbow, went the Dr twice and urgent care twice and was given 2 antibiotic and penicillin shot.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Immediate post-injection reaction, Limb discomfort, Pain, Skin warm
Clinical narrative: 9/26/14 - Immediately after vaccine, heavy discomfort on (L) deltoid area. 9/27/14 - Red/hot, swollen - 3" x 6" raised area took BENADRYL 50 mg and TYLENOL. 9/28/14 -Still sore, hot, swollen - 2" x 2" area. Pain less.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: 9/26/14 - Immediately after vaccine, heavy discomfort on (L) deltoid area. 9/27/14 - Red/hot, swollen - 3" x 6" raised area took BENADRYL 50 mg and TYLENOL. 9/28/14 -Still sore, hot, swollen - 2" x 2" area. Pain less.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Bright red painful at injection site. Started about 24 hrs after injection. Patient saw her Dr. just to be sure.
Age: 0.34
Sex: F
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to an 5-months old female patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the second dose of ROTATEQ (oral, batch/lot # J001254, expiration date 19-SEP-2014), on 07-FEB-2014 at 11:00 AM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event was also reported as 27-FEB-2014 at 10:00 AM). Parent of the patient was going to discuss with physician and declined to repeat dose. No adverse event was reported for the patient. The outcome was reported by the reporter as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Evening after shot patient said was nauseous felt like vomiting.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Amenorrhoea, Eating disorder, Laboratory test normal
Clinical narrative: Started HPV series in December within one month developed amenorrhea and eating disorder, unclear if related.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unspecified date, the patient was vaccinated with RECOMBIVAX HB (dose, route and lot were not reported). On an unknown date, the patients received improperly stored RECOMBIVAX HX. No adverse symptoms reported. At the time of the report the action taken was not reported. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Follow up information was received from the registered nurse regarding 1 day old female patient who on 08-JUL-2014 at 14:46 was vaccinated with improperly stored first dose of RECOMBIVAX HB (lot # J012520, expiration date 30-JAN-2016) intramuscularly. The reporter stated that, between 14-MAY-2014 and 21-JUL-2014, vaccine storage temperature dropped to 0-1 degree in 18 different episodes, and that according to minimum and maximum, all recorded temperatures were supposed to be between 2-8 degrees. It was also reported that the patient was vaccinated with RECOMBIVAX HB on 08-JUL-2014 at 14:46 pm. No symptoms reported. This is one of several reports from the same source. Additional information is not expected because all follow up information was received.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Erythema, Pain, Pruritus, Skin warm
Clinical narrative: Pain and swelling 4 hours after injection, 7 cm red, tender, warm area extended towards elbow. Treatment: ZYRTEC morning, BENADRYL at night, warm compression and 4 time a day, Sunday itching with chills
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling, Tenderness
Clinical narrative: Pain and swelling 4 hours after injection, 7 cm red, tender, warm area extended towards elbow. Treatment: ZYRTEC morning, BENADRYL at night, warm compression and 4 time a day, Sunday itching with chills
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Parents report that after child given FLUARIX I.M. 9/8/14 had 1 night severe wheezing that night. No previous h/o wheeze.
Age: 49.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a 49 year old male patient with no pertinent medical history or drug pre-existing medical conditions. On 11-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose number and route were not reported), lot # J012679, expiration date 21-JAN-2015 (also reported as 01-FEB-2015), dose and frequency reported as 1 injection. Co-suspect and concomitant therapies were not reported. On 11-SEP-2014 his arm was swollen, painful and red. On 14-SEP-2014 patient reported the symptoms to the pharmacist. It was unknown if there was any relevant laboratory data. At the time of the report it was unknown if he would get another ZOSTAVAX and his arm continued to be swollen, painful and red. Additional information is not expected. The pharmacist did not give the consent for follow up.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The registered nurse reported a temperature excursion dated 02-AUG-2014 of 0 degrees centigrade for 8 hours affecting ROTATEQ. The excursion was supported. The nurse reported that ROTATEQ was administered post excursion, orally (dose and lot numbers not provided) (approximately in 2014). The nurse did not have access to specific patient or product information. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to an 6-months old patient of unknown gender, with no known drug allergies. As illness at time of vaccination, it was reported that the patient had mild stuffy nose. The patient was vaccinated with the third dose of ROTATEQ (oral, batch/lot # J001254, expiration date 19-SEP-2014), on 12-FEB-2014 at 11:50 AM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event was also reported as 27-FEB-2014 at 10:00 AM). The parents of the patient were going to consult with physician to repeat the dose at no charge. No adverse event was reported for the patient. Outcome was reported by the reporter as recovered. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Age: 60.0
Sex: M
Vaccine: HEPA, VARZOS
Symptoms: Differential white blood cell count, Full blood count, Metabolic function test, Urticaria, Wheezing
Clinical narrative: Received vaccines on 9-25-14. Hives and wheezing started on 9-26-14. Pt to ER on 9-27-14. 9-30-14 follow-up visit PCP. 9-27-14 meds received at ER visit: Albuterol 2.5 mg. (inhalation), SOLU-MEDROL 125 mg. IV, BENADRYL 12.5 mg. IV, PEPCID 20 mg. IVPB, Hydroxyzine HCl 1 tablet Q 6 hrs., Prednisone 2 tablets once daily.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 3 x 3 inch redness and swelling at inj site. Slightly warm to touch. Cool compress/BENADRYL Q6-8 hours PRN.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Dizziness, Headache, Pain
Clinical narrative: Pt states he experienced body aches and headache and diarrhea and backache a few hours after influenza vaccine was administered. Advised by provider to drink plenty of fluids and take TYLENOL or MOTRIN for body aches. Pt stated he did not plan to do this he will update provider with how he is feeling.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: Myalgia.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a three number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with PROQUAD (dose, and route were not reported) that were improperly stored. No adverse events were reported. This is one of several reports from the same source. 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 medical assistant refers to a unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with RECOMBIVAX HB (dose, and route were not reported) that were improperly stored. No adverse events reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt. was given Prevnar too soon
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: Symptoms started about 5 pm and included temp of 103.5 and muscle/joint aches. She took TYLENOL for high fever and later developed chills and sweating. High fever and aches were intense overnight and lessened over the next 3 days.
Age: 66.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Erythema, Feeling hot, Local swelling, Pain, Pyrexia
Clinical narrative: On 9/19/2014 MA administered 3 vaccines on patient left arm. Patient came back on 9/22 because she had a reaction to vaccines her left arm was swelling, severe pain on palpation, redness, warm for 3 days associated with fever. Symptom started after injections.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On 24-SEP-2014, the patient was vaccinated with ROTATEQ vial lot # J001254, expiry date: 19-SEP-2014 oral. Concomitant medication was not reported. The reporting nurse stated that an expired dose of ROTATEQ was administered to the patient. No adverse effects reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Hypopnoea, Loss of consciousness, Orthostatic hypotension, Pallor
Clinical narrative: Within minutes of receiving the vaccine, she became pale and diaphoretic. Asked for water, then she lost consciousness. Breathing erratic and shallow. Unresponsive. Called 911. Directed by 911 to place her in supine position. Breathing improved, but still not completely responsive. Emergency personnel arrived and assessed her. They reported she had orthostatic hypotension. Possible dehydration. She was transported to the ER.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Unresponsive to stimuli
Clinical narrative: Within minutes of receiving the vaccine, she became pale and diaphoretic. Asked for water, then she lost consciousness. Breathing erratic and shallow. Unresponsive. Called 911. Directed by 911 to place her in supine position. Breathing improved, but still not completely responsive. Emergency personnel arrived and assessed her. They reported she had orthostatic hypotension. Possible dehydration. She was transported to the ER.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to an 15-weeks old female patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the first dose of ROTATEQ (oral, batch/lot # J001254, expiration date 19-SEP-2014), on 14-FEB-2014 at 10:00 AM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event was also reported as 27-FEB-2014 at 10:00 AM). It was reported that revaccination was declined. No adverse event was reported for the patient. The outcome was reported as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Injection site pain, Injection site pruritus, Urticaria, Wheezing
Clinical narrative: Ache/pain and itch at injection site - 1am welts - later on Sat. sx started going away - but some SOB/wheezing. On Sunday - all sx resolved.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Pt states that a 2 inch diameter, circular rash has appeared around injection site that is hot, raised about 5 mm.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: Patient received flu shot on 9/24/13. On Friday 9/26/14 she was treated for cellulitis.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Myalgia
Clinical narrative: Severe myalgia in all body muscles started in (R) arm in then affected all the other muscles x 24 hours, slept most of the day then got up Sunday did ALS walk and golfed.
Age: 1.27
Sex: F
Vaccine: DTAPIPVHIB, FLU3
Symptoms: Rash, Sleep disorder, Viral test
Clinical narrative: 9/17 developed rash on left leg rash spread later to knee superiorly up leg and extended to posterior buttock over the course of 2 days. Disturbed sleep secondary to discomfort. No treatment.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Fall, Muscle spasms, Pain, Walking aid user
Clinical narrative: Flu vaccine was administered on 9/23. Pt developed severe cramping in thighs on 9/24 upon exertion. Pain and cramping caused the patient to fall. She was then taken to the physician. The patient needed help walking. MD gave TORADOL injection and prescribed FLEXERIL 10 mg 1 TID. This reduced cramping so patient was able to walk without assistance. Cramping has reoccurred with exertion. Blood work performed 9/30.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Vaccination complication
Clinical narrative: 5 minutes after the patient was administered flu shot "AFLURIA" she felt tingling sensation on both sides of her forehead. I checked her bl. pressure it was 206/110 with 85 pulse. She was rushed to her Dr who is at the same building who monitored her and told her it's from the flu shot.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Redness, swelling app 3" below injection site. Very hot, also pain starting approx 6 hr after.
Age: 40.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Extreme pain in upper right arm this morning, accompanied by slight swelling and warm to touch.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: Arm stiff with pain on raising up. Basically she says is that it is aching and painful.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: Client received HPV #2 IM.  Immediately c/o seeing spots, dizziness, diaphoretic.  Head lowered between knees; unresponsive.  Lowered to floor. Placed in supine, Trendelenburg position.  Regained consciousness in about one minute.  Wet cloth to forehead.  Crackers & fluids given.  Full recovery noted.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Visual impairment
Clinical narrative: Client received HPV #2 IM.  Immediately c/o seeing spots, dizziness, diaphoretic.  Head lowered between knees; unresponsive.  Lowered to floor. Placed in supine, Trendelenburg position.  Regained consciousness in about one minute.  Wet cloth to forehead.  Crackers & fluids given.  Full recovery noted.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red, warm 3.5 cm area adjacent to injection site.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Myalgia, Nausea
Clinical narrative: Headache, muscle aches and nausea. Treatment OTC pain relievers and rest.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Anxiety, Arthralgia, Back pain, Confusional state, Diarrhoea
Clinical narrative: Severe flu like symptoms. Body pain including headache, back, joints, etc.. 101 + degree fever. Dry heave vomit, sick to stomach. Diarrhea. Mental confusion and anxiety.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Influenza like illness, Nausea, Pain, Pyrexia
Clinical narrative: Severe flu like symptoms. Body pain including headache, back, joints, etc.. 101 + degree fever. Dry heave vomit, sick to stomach. Diarrhea. Mental confusion and anxiety.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Retching
Clinical narrative: Severe flu like symptoms. Body pain including headache, back, joints, etc.. 101 + degree fever. Dry heave vomit, sick to stomach. Diarrhea. Mental confusion and anxiety.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: Severe rash and itching over entire body except face.  Took 2 Benadryl tablets; started to subside within an hour; took 2 more Benadryl 4 hours later; completely cleared up overnight.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Feeling hot, Heart rate increased, Needle issue, Oropharyngeal pain
Clinical narrative: I have received the flu shot every year for at least the past 7 years and have never had any allergic reaction. I was feeling fine (no fever or other indication of illness) today. After the administrator inserted the needle into my arm, the needle head became separated from the syringe. The administrator pulled the syringe away, leaving the needle with the plastic syringe top still in my arm. After that the administrator removed the needle and informed me that I would have to receive a second shot because I "only got a dot" of the first injection. The administrator also informed me that this was the second time that day that the needle and plastic top had separated from the part of the syringe with the vaccine. It is unacceptable that a vaccine should be separated from the needle WHILE IN A PATIENT'S ARM. Please investigate this immediately. Within the last 20 minutes, I have felt dizzy, warm, sore throat, and increased heart beat. I am seeking additional medical treatment.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Underdose
Clinical narrative: I have received the flu shot every year for at least the past 7 years and have never had any allergic reaction. I was feeling fine (no fever or other indication of illness) today. After the administrator inserted the needle into my arm, the needle head became separated from the syringe. The administrator pulled the syringe away, leaving the needle with the plastic syringe top still in my arm. After that the administrator removed the needle and informed me that I would have to receive a second shot because I "only got a dot" of the first injection. The administrator also informed me that this was the second time that day that the needle and plastic top had separated from the part of the syringe with the vaccine. It is unacceptable that a vaccine should be separated from the needle WHILE IN A PATIENT'S ARM. Please investigate this immediately. Within the last 20 minutes, I have felt dizzy, warm, sore throat, and increased heart beat. I am seeking additional medical treatment.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 4 cm area red et warm adjacent to injection site.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPVHIB, PPV, RVX
Symptoms: Pyrexia, Vomiting
Clinical narrative: 103 Fever; Vomiting.
Age: 1.47
Sex: M
Vaccine: DTAP, HEPA, HIBV, IPV, PNC13
Symptoms: Blood culture negative, CSF test normal, Convulsion, Electroencephalogram, Nuclear magnetic resonance imaging
Clinical narrative: Seizure and fever.
Age: 1.47
Sex: M
Vaccine: DTAP, HEPA, HIBV, IPV, PNC13
Symptoms: Pyrexia
Clinical narrative: Seizure and fever.