chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Information has been received from a pharmacist referring to three patients of unknown age and gender. Concurrent or medical conditions were not reported. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (lot # L003188, expiration date 06-JUL-2016) (dose, strength, frequency were not reported). Secondary suspects and concomitant therapies were not reported. The pharmacist reported that upon administration of PNEUMOVAX 23 to the patients, they experienced injection site reaction described as swollen, red and raised area with blisters. No treatment was received for the events. It was reported that the patients sought medical attention by telling the pharmacist about the events. The outcome of events was not reported. The reporting pharmacist required a lot check of PNEUMOVAX 23. The events did not require intervention to prevent serious criteria, did not produce significant disability or incapacity, did not require hospitalization and were not life threatening for the patients. No product quality complaint was reported. Follow-up information has been received during phone call on 26-MAY-2015. The physician was unavailable at the time of the call. The call was transferred to the nurses' station where a voice mail was left requesting patient identification and a returned phone call. Follow-up information was received on 17-JUN-2015 from a physician's office via a registered nurse. The nurse reported that there were four patients who received a dose of PNEUMOVAX (lot # K008419, previously reported as lot # L003188 with events for three patients) and upon follow up from physician the lot number was corrected to K008409 and information was provided for four patients. This patient is a 72 year old female who on 08-APR-2015 at 12:53 PM received dose of PNEUMOVAX 23 in the left deltoid muscle. This was her first dose. There were no previous illnesses at time of vaccine administration and she had allergies to codeine, sulfa, phenobarbital, atenolol, CIPRO, cortisone, BETADINE, BENADRYL, lidocaine and ADVAIR. On approximately 09-APR-2015 the patient experienced pain, swelling, redness and heat at the injection site. It was not reported if the patient recovered. No other information was provided. The event of injection site vesicles was removed as physician did not report this reaction on questionnaire. Additional information is not expected. Narrative was updated. New cases created for 2 additional patients (MARRS # 1506USA012350, 1506USA012352, original case 1504USA09855).
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Information has been received from a pharmacist referring to three patients of unknown age and gender. Concurrent or medical conditions were not reported. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (lot # L003188, expiration date 06-JUL-2016) (dose, strength, frequency were not reported). Secondary suspects and concomitant therapies were not reported. The pharmacist reported that upon administration of PNEUMOVAX 23 to the patients, they experienced injection site reaction described as swollen, red and raised area with blisters. No treatment was received for the events. It was reported that the patients sought medical attention by telling the pharmacist about the events. The outcome of events was not reported. The reporting pharmacist required a lot check of PNEUMOVAX 23. The events did not required intervention to prevent serious criteria, did not produce significant disability or incapacity, did not required hospitalization and were not life threatening for the patients. No product quality complaint was reported. Follow-up information has been received during phone call on 26-MAY-2015. The physician was unavailable at the time of the call. The call was transferred to the nurses' station where a voice mail was left requesting patient identification and a returned phone call. Follow-up information was received on 17-JUN-2015 from a physician's office via a registered nurse. The nurse reported that there were four patients who received a dose of PNEUMOVAX (lot # K008419, previously reported as lot # L003188 with events for three patients) and upon follow up from physician the lot number was corrected to K008409 and information was provided for 3 additional patients (MARRS # 1506USA012350, 1506USA012351, 1504USA009855). This patient is a 77 year old female who on 08-APR-2015 at 11:28 AM received a dose of PNEUMOVAX 23 in the left deltoid muscle. This was her first dose. There were no previous illnesses at time of vaccine administration and she had an allergy to sulfa. On approximately 08-APR-2015 the patient experienced pain, swelling, redness, fluid and heat at the injection site. The patient recovered on an unknown date. No other information was provided. The event of injection site vesicles was removed as physician did not report this reaction on questionnaires. Additional information is not expected. Narrative was updated. New cases were created for the 3 additional patients (MARRS # 1506USA012350, 1506USA012351, 1506USA012352. Initial case 1504USA009855).
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 12-FEB-2015 the patient was received improperly stored VARIVAX (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Information has been received from a pharmacist referring to three patients of unknown age and gender. Concurrent or medical conditions were not reported. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (lot # L003188, expiration date 06-JUL-2016) (dose, strength, frequency were not reported). Secondary suspects and concomitant therapies were not reported. The pharmacist reported that upon administration of PNEUMOVAX 23 to the patients, they experienced injection site reaction described as swollen, red and raised area with blisters. No treatment was received for the events. It was reported that the patients sought medical attention by telling the pharmacist about the events. The outcome of events was not reported. The reporting pharmacist required a lot check of PNEUMOVAX 23. The events did not require intervention to prevent serious criteria, did not produce significant disability or incapacity, did not require hospitalization and were not life threatening for the patients. No product quality complaint was reported. Follow-up information has been received during phone call on 26-MAY-2015. The physician was unavailable at the time of the call. The call was transferred to the nurses' station where a voice mail was left requesting patient identification and a returned phone call. Follow-up information was received on 17-JUN-2015 from a physician's office via a registered nurse. The nurse reported that there were four patients who received a dose of PNEUMOVAX (lot # K008419, previously reported as lot # L003188 with events for three patients) and upon follow up physician the lot number was corrected to K008409 and information was provided for four patients. This is concerning a 66 year old female who on 08-APR-2015 at 2:33 PM received dose of PNEUMOVAX 23 in the left deltoid muscle. This was her first dose. There were no previous illnesses at time of vaccine administration and allergies there were none known. On 08-APR-2015 the patient experienced pain, swelling, redness and heat at the injection site. The patient recovered on an unknown date. No other information was provided. The event of injection site vesicles was removed as physician did not report this reaction on questionnaire. Additional information is not expected. Narrative was updated. New cases created for 3 additional patients (MARRS # 1506USA012350, 1506USA012351, 1506USA012352, source case 1504USA009855).
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a currently 21 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 09-APR-2012, the patient received a pediatric dose of VAQTA (lot number4 and dose were not reported) intramuscular. ON 21-MAY-2013, the patient received adult dose of VAQTA (lot number and dose were not reported) intramuscular and on 29 MAY 2015, the received pediatric dose of hepatitis a (lot number and dose were not reported) intramuscular. No adverse events were reported.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a physician via field representative refers to a female patient of unknown age. The patient's pertinent medical history was none and drug allergies were unspecified. On an unknown date in March 2014 the patient was vaccinated with a dose of GARDASIL (reported as last dose of the series). Concomitant medications were unspecified. From an unknown date (reported as since the last dose), the patient developed fever when she gets her period. The outcome of the event was unknown. The relatedness of the event with GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The reporter stated that on unspecified dates ranging from 15-JUN-2015 through 18-JUN-2015, the patients received doses that were improperly stored of RECOMBIVAX HB (strength, lot number, expiration date, dose # and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a child patient of unknown age and gender. The patient's medical history was not reported. On 04-MAY-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K026385, expiration date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Age: 20.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 20 year old patient of an unknown gender. The patient's current conditions and medical history were not reported. On 17-JUN-2015, the 20 year old patient was accidentally vaccinated with pediatric dose of VAQTA (unknown route) at a dose of 0.5 ml. Concomitant medications were not reported. No adverse effect was reported. The outcome of the event was unknown. There was no product quality complaint involved. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patients' medical history or concurrent conditions were not provided. On 22-APR-2015, the patient was vaccinated with the first dose of GARDASIL (0.5 ml, intramuscular, lot number and expiration date were not provided). Then on 17-JUN-2015, the patient was vaccinated with the second dose of GARDASIL (0.5 ml, intramuscular, lot number and expiration date were not provided). On 24-JUN-2015, the patient was vaccinated with the third dose of GARDASIL (0.5 ml, intramuscular, lot number K007828, expiration date 02-MAR-2017). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 27-MAY-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 23-JUL-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown demographics. No concurrent condition, medical history or allergy/drug reactions were reported. The nurse reported that on an unspecified date, an unspecified number of patients were administered improperly stored doses MMR II (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.27
Sex: M
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 3 month old male patient (weight 17 (units unspecified)). No concurrent condition or medical history reported. On 21-APR-2015 at 15:00 hours, the patient was vaccinated with one dose of RECOMBIVAX HB, (Lot# L001456) intramuscular (LVL) which was exposed to temperatures outside of the recommended range. On the same day, the refrigeration temperature was out of range for 30 minute (-1.8 degree Celsius). It was advised that the vaccine was not stable to be revaccinated. The patient was vaccinated at private doctor's office and the vaccine was purchased with public funds. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: A spontaneous report was received on 19JUN2015 from a pharmacist via a company representative regarding an approximately 65 year old female who received ZOSTAVAX 0.65 ml subcutaneous in JAN2015. The pharmacist reported that the patient developed cellulitis on her "entire upper arm at the injection site" (arm unspecified) "within a few days of receiving ZOSTAVAX" (unspecified as to what facility/provider gave the ZOSTAVAX). It was reported the patient sought medical attention when she "informed an unspecified pharmacist an unspecified way on an unspecified date". No further information was provided. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 16 year old male patient. The patient's pertinent medical history and concomitant medications were not reported. On unknown dates, in 2012 the patient was vaccinated with three doses of GARDASIL (lot#, expiry date, dose not reported, intramuscularly). On an unknown date in 2015, the patient was vaccinated with the 4th dose of GARDASIL (lot#, expiry date, dose not reported, intramuscularly). The patient did not seek medical attention. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 09-APR-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Age: 10.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Syncope
Clinical narrative: Patient had syncope episode within 24 hours of receiving vaccination.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Limb discomfort, Oropharyngeal pain
Clinical narrative: A spontaneous report was received on 19JUN2015 from a 57 year old female consumer (who is also a nurse), reporting about herself. The consumer/patient reported that she had received an unspecified dose of ZOSTAVAX on 18JUN2015. On the morning of 19JUN2015 she developed a sore throat, injection site pain, and injection site arm heaviness. The patient reported that she took TYLENOL "18JUN2015" for the pain. The patient planned to call her physician's office when they open (today), 19JUN2015 to make an appointment. Concomitant medication included NEXIUM for the treatment of gastroesophageal reflux disease (GERD), and SYNTHROID for the treatment of hypothyroidism. The patient reported a history of drug allergies to codeine, morphine and epinephrine. No further information was available. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On 22-JUN-2015 the patient received an expired dose of M-M-R II (lot # J006185, expiry date: 24-MAY-2015 .5 ml, subcutaneous. Concomitant medications were not reported. No symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse who refers to a patient of unknown age and/or gender. The nurse reported that a dose of M-M-R II that expired on 07-JUN-2015 was inadvertently administered to an unspecified patient on 12-JUN-2015. No adverse experiences were reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The reporter stated that on unspecified dates ranging form 15-JUN-2015 through 18-JUN-2015, the patients received doses that were improperly stored of PNEUMOVAX 23 (strength, lot number, expiration date, dose # and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Dermatitis allergic, Hypersensitivity, Rash
Clinical narrative: This spontaneous report was received from a physician, refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with an unspecified hepatitis b vaccine (Manufacturer unknown), (route, dosage, lot# and expiration date were not reported). Concomitant therapies were not reported. On an unknown date the patient experienced dermatitis allergic, reported as an allergic reaction-rash. The outcome of dermatitis allergic was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.21
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Injection site swelling, Irritability
Clinical narrative: Left leg swelling at inj site, seems more fussy.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Erythema, Laboratory test, Pain, Pyrexia
Clinical narrative: Fever 103 F, pain, swelling, redness, hot to touch, abdominal pain. Went to urgent care, examined by her PCP, labs drawn, received Tylenol for fever. PCP prescribed antibiotics if fever returns. Client reports not taking any antibiotic. Client reports site feels and looks better today.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm, Swelling
Clinical narrative: Fever 103 F, pain, swelling, redness, hot to touch, abdominal pain. Went to urgent care, examined by her PCP, labs drawn, received Tylenol for fever. PCP prescribed antibiotics if fever returns. Client reports not taking any antibiotic. Client reports site feels and looks better today.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, HEPA, PNC13
Symptoms: Wrong drug administered
Clinical narrative: Child given incorrect vaccination. Child given a Hepatitis A vaccine instead of a Hepatitis B vaccine. The error found when recording vaccines on child's immunization card. Parents notified and Hepatitis B vaccine administered to child.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling, redness, warm to the touch.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: Swollen, hard and red- warm to touch.
Age: 26.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site pain, Nuclear magnetic resonance imaging normal, Vaccination site injury
Clinical narrative: Extreme pain in shoulder which began within hours of injection (SIRVA) and continues intermittently.  MRI is negative.
Age: 1.03
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Small red raised bumps developed on the arms. Since time of onset, red raised bumps have spread to the abdomen, face, and back. No fevers. No local injection site reaction noted.
Age: 33.0
Sex: M
Vaccine: DTAP
Symptoms: Chest pain, Cough, Dyspnoea, Throat irritation
Clinical narrative: Itching of throat, difficulty breathing, chest pain, cough.
Age: 59.0
Sex: F
Vaccine: DTAP
Symptoms: Headache, Injection site joint pain, Injection site rash, Injection site swelling, Injection site vesicles
Clinical narrative: Pain to Rt. upper arm shoulder and elbow joints shot was given in the rt arm. Swelling to the whole upper arm with a developed rash approximately 7-9 cm, the rash area has developed a small blister also warm to touch. Lastly frequent headaches. I have been putting ice, hydro-cortisone cream, and taking Mobic.
Age: 59.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site warmth
Clinical narrative: Pain to Rt. upper arm shoulder and elbow joints shot was given in the rt arm. Swelling to the whole upper arm with a developed rash approximately 7-9 cm, the rash area has developed a small blister also warm to touch. Lastly frequent headaches. I have been putting ice, hydro-cortisone cream, and taking Mobic.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Dizziness, Fatigue, Injection site pain
Clinical narrative: Dizziness, Weakness, Fatigue, Soreness at injection site.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Irritability
Clinical narrative: Patient very fussy after vaccines. Fussiness continued for several hours intermittently, Mom very concerned and brought patient back in to clinic.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site reaction, Myalgia, Oedema, Oedema peripheral
Clinical narrative: Fever for 24 hours.  Treated with Tylenol.  Edema of the right arm, right chest and scapular area.  Severe myalgia in upper right arm.  Mild redness at injection sites at right arm. Presented with severe splinting to the right.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pyrexia
Clinical narrative: Fever for 24 hours.  Treated with Tylenol.  Edema of the right arm, right chest and scapular area.  Severe myalgia in upper right arm.  Mild redness at injection sites at right arm. Presented with severe splinting to the right.
Age: 5.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Redness and swelling of left upper arm at site of injections. Some blistering 2-3 days post vaccination.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture abnormal, Paraplegia
Clinical narrative: Low back pain, paraplegia - bilateral lower extremities; urine retention Guillain-Barre Syndrome, confirmed. Hospitalized 10/23/14 thru 11/1/14; PT rehab thru 01/26/15. Treatment consisted of IVIG and plasmapheresis and extensive physical therapy.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Plasmapheresis, Urinary retention
Clinical narrative: Low back pain, paraplegia - bilateral lower extremities; urine retention Guillain-Barre Syndrome, confirmed. Hospitalized 10/23/14 thru 11/1/14; PT rehab thru 01/26/15. Treatment consisted of IVIG and plasmapheresis and extensive physical therapy.
Age: 2.0
Sex: F
Vaccine: FLUN4
Symptoms: Dysphonia
Clinical narrative: Pt. received FLUMIST on 9-10-14. Has had dysphonia since.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Dyskinesia, Injection site reaction
Clinical narrative: (R) shoulder shrugging started approx 5 PM increased in freq intermittent and irregular. Gave BENADRYL at 9PM continued during sleep with decreased in freq has happened approx 2-3 times this morning.
Age: 35.0
Sex: F
Vaccine: HEPA
Symptoms: Altered visual depth perception, Dizziness, Feeling abnormal, Vertigo
Clinical narrative: This spontaneous report received from a physician, refers to a 35 year old female patient, with allergic rash to an unspecified hepatitis B vaccine There were not other pertinent medical history. On 08-JUN-2015 the patient was vaccinated with VAQTA 25/0.5 (units not reported) (dosage, route, lot # and expiration date were not reported). There were no concomitant therapies. On 09-JUN-2015, the patient experienced vertigo, feeling abnormal and dizziness, reported as "dizziness, mild vertigo problems with depth perception and felt like she was in a fog". The patient sought medical attention calling the physician, no treatment was prescribed and the patient did not recovered at the time of this report. There were not laboratories diagnostics performed.  Also was reported that the patient was scheduled for an appointment with the physician on 17-JUN-2015. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Redness, mild swelling, and pain at site of injection. Felt a hard lump at site. Symptoms resolved in 48 hours.
Age: 31.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Burning sensation, Hypoaesthesia
Clinical narrative: Pt experienced numbness in left arm with some burning sensation two weeks after getting the ADACEL vaccination, but it is getting better now. Pt advised to follow up with doctor.
Age: 62.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Viral rash
Clinical narrative: Rash c/w viral exanthem.
Age: 1.55
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left thigh started getting red/warm/swollen on 6/24/15. Seems like it was spreading. No fever.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a male patient of unknown age. Patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On 22-JUN-2015 the patient was vaccinated with second dose of GARDASIL (dose/frequency, lot #, expiry date unspecified). Concomitant medications were not reported. Reporting physician stated that the patient was administered with the first dose in the series of GARDASIL on an unspecified date in 2014 (reported as a year ago) (inappropriate schedule of drug administration). No adverse effects were reported. Additional information is not expected as the reporter did not wish further contact.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Erythema, Injection site warmth, Pain, Swelling
Clinical narrative: Localized redness, mild swelling, body aches chills and site was warm to touch. Received on 6/22/15. Redness presented 5-6 hrs after. Still present on 6/25/15. Advised home treatment/monitoring for now will T/M PRN.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Viral titre decreased
Clinical narrative: This spontaneous report was received from a licensed practical nurse, refers to a 20 year old female patient. Medical history and concurrent conditions were not reported. On 28-FEB-2015, the patient was vaccinated with the first dose of VARIVAX (Merck), (route, dosage, frequency and lot# were not reported) and on 12-MAY-2015, received the second dose of VARIVAX (Merck), (route, dosage, frequency and lot# were not reported). Concomitant therapies were not reported. On 27-MAY-2015, the patient's blood was drawn and it did not demonstrate protective titers. The outcome of varicella virus test negative was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 23-APR-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K011800, exp date 21-AUG-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 27-MAY-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K011800, exp date 21-AUG-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 13-FEB-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K005427, exp date 15-APR-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 06-MAY-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K011800, exp date 21-AUG-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 06-MAY-2015, the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K011800, exp date 21-AUG-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 06-APR-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K005427, exp date 15-APR-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 29-APR-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K011800, exp date 21-AUG-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 04-FEB-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 24-APR-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 08-APR-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 29-MAY-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 23-JUL-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 18-MAY-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 23-JUL-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 16-APR-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 23-JUL-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus
Clinical narrative: 6/5/15 lump at (L) deltoid site, 6/7/15 larger lump, 6/8/15 redness from site to elbow, itching, tiny bump to elbow, hard area around (L) arm at level of injection site. Entire (L) upper arm at affected, worse on outside of arm. Pt applied calamine 6/9/15 until resolved. Zyrtec 6/9/15 to 6/16/15. Sx resolved 6/23/15. Pt reported reaction on 6/15/15 when she was improving.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown demographics. No concurrent condition, medical history or allergy/drug reactions were reported. The nurse reported that on an unspecified date, an unspecified number of patients were administered improperly stored doses of PNEUMOVAX 23 injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from two healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 05-MAY-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K026385, expiration date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 12-MAR-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 23-FEB-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 09-MAR-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 16-FEB-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from two healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 29-JAN-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 24-MAR-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown. Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from two healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 26-MAY-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K026385, expiration date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 12-MAY-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 23-JUL-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from two healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 11-MAY-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K026385, expiration date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 19-MAR-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 13-MAY-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K026385, expiration date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 18-MAR-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K005427, exp date 15-APR-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.