chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Lymphadenopathy, Malaise, Rosacea
Clinical narrative: DIARRHEA, MALAISE, LETHARGY, WEAKNESS, FATIGUE, LOSS OF APPETITE, SWOLLEN GLANDS, ROSACEA.
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. The physician mentioned a patient who was at the time of the report in kindergarten, received a first doe of (Oka/Merck) VARIVAX (route, dose and lot # not reported) on an unspecified date 22 days before the patient turned 12 months of age. No adverse symptoms reported. No further information provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a health worker (medical assistant) refers to a patient of unknown age and gender. On 17-AUG-2008 the patient was vaccinated with the first dose of GARDASIL (lot#, dose, route not reported). On 20-AUG-2009 the patient was vaccinated with the second dose of GARDASIL  (lot#, dose, route not reported). Concomitant medications were not provided. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date in March 2014, the patient was vaccinated with the first dose of ZOSTAVAX, vial, 0.65 ml, subcutaneous (lot # and expired date were not reported) at the pharmacy. Concomitant therapy was not reported. The patient inadvertently received a second dose of ZOSTAVAX at her (the patient's) physician's office today on 03-SEP-2014. No adverse effect reported. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Blood culture negative, C-reactive protein normal, Cellulitis, Culture wound negative, Full blood count normal
Clinical narrative: Swelling, redness and warmth at site. Developed cellulitis that required ER visit.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Metabolic function test normal
Clinical narrative: Swelling, redness and warmth at site. Developed cellulitis that required ER visit.
Age: 1.8
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMRV, PNC13
Symptoms: Rash
Clinical narrative: Rash.
Age: 18.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Injected limb mobility decreased, Injection site discomfort, Injection site reaction, Injection site swelling, Pain
Clinical narrative: Swelling and red blotches spreading across left deltoid area. Increasing in size and discomfort day 1 and 2 post administration of vaccine.  Severe pain and limited mobility of affected arm. Body aches.
Age: 18.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Pain in extremity, Rash macular
Clinical narrative: Swelling and red blotches spreading across left deltoid area. Increasing in size and discomfort day 1 and 2 post administration of vaccine.  Severe pain and limited mobility of affected arm. Body aches.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Electrocardiogram normal, Fatigue, Headache, Pain
Clinical narrative: EXTREME HEADACHE, TREMORS, COLD EXTREMITIES, TROUBLE BREATHING, BODY ACHES, FATIGUE.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral coldness, Tremor
Clinical narrative: EXTREME HEADACHE, TREMORS, COLD EXTREMITIES, TROUBLE BREATHING, BODY ACHES, FATIGUE.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Pain, Swelling
Clinical narrative: Patient had excessive swelling, chills and pain after vaccine.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling/itching around injection site. Pain in distal joint.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site vesicles, Injection site warmth
Clinical narrative: This spontaneous report as received from a female consumer of unknown age refers to herself. On an unknown date the patient was vaccinated with ZOSTAVAX, vial (dose, route, lot # and expired date were not reported). Concomitant therapy was not reported. On an unknown date the patient experienced a red-hot, blistering rash at the injection site after receiving ZOSTAVAX. The outcome of adverse events was not reported. The relationship between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received fro a pharmacist refers to a 71 year old female patient with hypertension, irritable bowel syndrome, migraine headaches and drug reactions/allergies to sulfonamides. On 26-AUG-2014 the patient was vaccinated with PNEUMOVAX 23 0.5 ml in the left arm (lot # K004487 and expiry date: 21-AUG-2015) (route not reported). On 27-AUG-2014 the patient developed a large area of redness and warmth at the injection site. The area of reaction started 2 inches below the left shoulder and extended to the elbow. The patient visited an emergency room and on 27-AUG-2014 was diagnosed with an allergic reaction. She was prescribed BENADRYL, MOTRIN and ice compresses as a treatment. The outcome of an allergic reaction and a large area of redness and warmth at the injection site was unknown. Relatedness between the events and PNEUMOVAX 23 was not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site reaction
Clinical narrative: This spontaneous report as received from a healthcare worker (also reported as medical assistant) via a company representative referred to an anonymous female patient of unknown age. On an unknown date the patient was vaccinated with one injection of PNEUMOVAX 23 (Lot # J013555, expired on 02-MAY-2015) (dose and route unspecified). The patient was called into the office that after receiving the PNEUMOVAX 23 with severe injection site reactions including redness and hardness at the injection site on unknown date. The patient had sought medical attention via calling the office. The outcome of "injection site reactions including redness and hardness at the injection site" were unknown. This is one of several reports received from the same source. Additional information is not expected.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 17 year old patient of unknown gender. On 01-JUL-2014 the patient was vaccinated with a dose of improperly stored GARDASIL (lot # J009788, expiration date: 17-MAR-2016, strength, dose and route unknown), which was exposed to 31 F for one hour. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 17 year old patient of unknown gender. On 06-JUN-2014 the patient was vaccinated with a dose of improperly stored GARDASIL (lot # J009788, expiration date: 17-MAR-2016, strength, dose and route unknown), which was exposed to 31 F for one hour. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 25.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an approximately 25 year old patient of unknown gender. No relevant medical history of the patient was reported. On 31-JUL-2007 the patient was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscular, on 07-JUL-2014, the second 0.5 ml dose of GARDASIL was administered (lot number and expiration dates were not reported for the first and the second dose). On 08-SEP-2014, the patient received the third dose of GARDASIL 0.5 ml, intramuscular (lot # J008423 and expiration date: 21-JAN-2016). No concomitant medications were reported. There was no adverse effects reported. The patient did not seek any medical attention. There was no product quality complaint (PQC) involved. The outcome was unknown. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old patient of unknown gender. No concurrent conditions or medical history were provided. On 10-SEP-2014, the patient was inadvertently vaccinated with a dose of PROQUAD (merck), injection administered subcutaneously (dose, indication, lot# and expiry date unspecified). No concomitant medications were reported. No adverse effects were reported. 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 medical assistant refers to a patient of unknown age and gender. On 03-SEP-2014 the patient was vaccinated with a third dose of GARDASIL (lot # K001500 and expiry date: 06-NOV-2016, 0.5 ml, intramuscular) which had been improperly stored. No adverse effects were reported. Additional information is not expected as there was no consent to contact physician.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. It was reported that since 29-AUG-2014, unknown number of patients were administered LIQUID PEDVAX HIB (dose, route of administration, lot numbers and expiration dates were not reported) which was improperly stored. No adverse effects reported. This is one of several reports from the same source. 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 medical assistant refers to unspecified patients of unknown age and gender. It was reported that since 29-AUG-2014 unknown number of patients were administered GARDASIL (dose, route of administration, lot numbers and expiration dates were not reported) which was improperly stored. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 years old female patient. The patient's relevant medical history, relevant concomitant medications, and relevant past drug history are unknown. On 04-SEP-2014, the patient received a dose of PNEUMOVAX 23 (dose and route not reported lot # J006242) that had expired on 03-AUG-2014. It was unknown if there was relevant lab data. It was unknown if the patient sought medical attention. As of 06-SEP-2014, it was unknown if the patient was still on PNEMOVAX 23 and the outcome of receiving expired PNEUMOVAX 23 was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Information regarding medical history and drug reactions or allergies was not reported. The nurse reported that on unspecified date in approximately 2014, unspecified patients were vaccinated with  (oka/merck) VARIVAX (subcutaneous injection, 0.5 ml once, subcutaneous, strength, lot #, expiration date and anatomical location not reported), that was improperly stored at a maximum of 7.5 degrees Fahrenheit for up to 11 hours in July 2014 and August 2014. Concomitant medications were not reported. No adverse effects reported. Follow up information has been received from medical assistant on 27-AUG-2014. The medical assistant was able to provide patient identifier, lot number and expiration dates of (oka/merck) VARIVAX that was administered to a 4 year old patient on 07-AUG-2014: lot# J013067 and expiration date: 16-OCT-2015. This is one several reports received from the same source. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Information regarding medical history and drug reactions or allergies was not reported. The nurse reported that on unspecified date in approximately 2014, unspecified patients were vaccinated with (oka/merck) VARIVAX (subcutaneous injection, 0.5 ml once, subcutaneous, strength, lot #, expiration date and anatomical location not reported), that was improperly stored at a maximum of 7.5 degrees Fahrenheit for up to 11 hours in July 2014 and August 2014. Concomitant medications were not reported. No adverse effects reported. Follow up information has been received from medical assistant on 27-AUG-2014. The medical assistant was able to provide patient identifier, lot number and expiration dates of (oka/merck) VARIVAX that was administered to a 12 months old patient on 20-AUG-2014: lot# J013067 and expiration date: 16-OCT-2015. This is one several reports received from the same source. Additional information has been requested.
Age: 1.05
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Information regarding medical history and drug reactions or allergies was not reported. The nurse reported that on unspecified date in approximately 2014, unspecified patients were vaccinated with (Oka/Merck) VARIVAX (subcutaneous injection, 0.5 ml once, subcutaneous, strength, lot #, expiration and anatomical location not reported), that was improperly stored at maximum of 7.5 degrees Fahrenheit for up to 11 hours in July 2014 and August 2014. Concomitant medications were not reported. No adverse effects reported. Follow-up information has been received from medical assistant on 27-AUG-2014. The medical assistant was able to provide patient identifier, lot number and expiration dates of (Oka/Merck) VARIVAX that was administered to a 12 months old patient on 13-AUG-2014: lot# J013067 and expiration date: 16-OCT-2015. This is one several reports received from the same source. Additional information has been requested.
Age: 1.02
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Information regarding medical history and drug reactions or allergies was not reported. The nurse reported that on unspecified date in approximately 2014, unspecified patients were vaccinated with (Oka/Merck) VARIVAX (subcutaneous injection, 0.5 ml once, subcutaneous, strength, lo #, expiration date and anatomical location not reported), that was improperly stored at a maximum of 7.5 degrees Fahrenheit for up to 11 hours in July 2014 and August 2014. Concomitant medications were not reported. No adverse effects reported. Follow-up information has been received from medical assistant on 27-AUG-2014. The medical assistant was able to provide patient identifier, lot number and expiration dates of (Oka/Merck) VARIVAX that was administered to a 12 months old patient on 21-AUG-2014: lot# J014228 and expiration date: 08-NOV-2015. This is one several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Information regarding medical history and drug reactions or allergies was not reported. The nurse reported that on unspecified date in approximately 2014, unspecified patients were vaccinated with (oka/merck) VARIVAX (subcutaneous injection, 0.5 ml once, subcutaneous, strength, lot #, expiration date and anatomical location not reported), that was improperly stored at a maximum of 7.5 degrees Fahrenheit for up to 11 hours in July 2014 and August 2014. Concomitant medications were not reported. No adverse effects reported. Follow up information has been received from medical assistant on 27-AUG-2014. The medical assistant was able to provide patient identifier, lot number and expiration dates of (oka/merck) VARIVAX that was administered to a 4 years old patient on 21-AUG-2014: lot# J014228 and expiration date: 08-NOV-2015. This is one several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 15 year old patient of unknown gender. On 08-JUL-2014 the patient was vaccinated with a dose of improperly stored GARDASIL (lot # J009788, expiration date: 17-MAR-2016, strength, dose and route unknown), which was exposed to 31 F for one hour. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 15 year old patient of unknown gender. On 01-JUL-2014 the patient was vaccinated with a dose of improperly stored GARDASIL (lot # J009788, expiration date: 17-MAR-2016, strength, dose and route unknown), which was exposed to 31 F for one hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 15 year old patient of unknown gender. On 09-JUL-2014 the patient was vaccinated with a dose of improperly stored GARDASIL (lot # J009788, expiration date: 17-MAR-2016, strength, dose and route unknown). which was exposed to 31 F for one hour. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an 18 year old patient of unknown gender. On 06-JUN-2014 the patient was vaccinated with a dose of improperly stored GARDASIL (lot # J009788, expiration date: 17-MAR-2016, strength, dose and route unknown), which was exposed to 31 F for one hour. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. There was no information on pertinent medical history and drug reactions or allergies. On 07-SEP-2014, the patient was vaccinated with expired dose of PNEUMOVAX 23 INJ N/A 10 vials of 1 (Product Lot # J009827, Expiry date: 10-AUG-2014) dose .5 ml (millilitre), intramuscularly. The pharmacist reported that expired dose of PNEUMOVAX 23 was inadvertently administrated to patient. No adverse effects reported. There was no product quality complaint involved. The outcome of the event was unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient with no drug reactions or allergies. On 26-AUG-2014 the patient was vaccinated with PNEUMOVAX 23 0.5 ml in the right arm (lot # K004487 and expiry date: 21-AUG-2015) (route not reported). On 27-AUG-2014 the patient developed a large area of erythema and tenderness at the injection site of the right arm. The patient sought medical attention and was prescribed KEFLEX and unspecified antihistamines as a treatment. The outcome a large area of erythema and tenderness at the injection site of the right arm was unknown. Relatedness between the events and PNEUMOVAX 23 was not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a patient of unknown age. On 26-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot # H019038, expiration date 17-JAN-2104, does, route and frequency were unknown). The reporter stated one vial of ZOSTAVAX in the carton of ten had a different lot number than the rest. The lot number on the carton and the other nine vials was K000456, Exp 15-DEC-2014. Lot H019038, Exp 17-JAN-2014 was administered to the patient. After the patient left the pharmacy, it was noticed the vaccine was expired. No adverse effects were reported. The patient did not seek for medical attention. PQC was filed. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: This spontaneous report was received from a 52 year old female physician refers to herself. On an unknown date the physician was vaccinated with one injection of ZOSTAVAX, subcutaneous (dose, lot # unknown). On an unknown date the physician experienced a hyper reaction to ZOSTAVAX which included redness and irritation around the injection site. No treatment was given for the events. No medical attention was sought. The outcome of events was unknown. Additional information is not expected as we could not contact the physician.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Rash
Clinical narrative: Swelling, rash on upper arm. Also a rash on legs and slight rash on arms. Symptoms clearing after 1st day.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: Low grade fever for 48 hrs, fine maculopapular rash developed 2 days after vaccines; no treatment necessary.
Age: 70.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Body temperature increased, Erythema, Injection site swelling, Local swelling, Pain
Clinical narrative: Pt seen urgent care 9/6/14 had PNEUMOVAX 2d prior c/o right arm redness, temp 99.9 first day and body aches. On 9/6/14 right arm swelling gone up into right shoulder and upper arm. Pt has rash on right arm also. TX with methylprednisone 4 mg tid x 3 days and BENADRYL.
Age: 70.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Rash
Clinical narrative: Pt seen urgent care 9/6/14 had PNEUMOVAX 2d prior c/o right arm redness, temp 99.9 first day and body aches. On 9/6/14 right arm swelling gone up into right shoulder and upper arm. Pt has rash on right arm also. TX with methylprednisone 4 mg tid x 3 days and BENADRYL.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Intussusception
Clinical narrative: This case was reported by a physician and described the occurrence of intussusception in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included DTaP-IPV/HepB; GlaxoSmithKline; unknown; unknown given on 14 January 2014; Hib (non-gsk); non-GSK manufacturer; unknown; unknown given on 14 January 2014; pneumococcal vaccines (non-gsk); non-GSK manufacturer; unknown; unknown given on 14 January 2014. On 14 January 2014 at 09:36 the subject received 1st dose of ROTARIX (1 ml, oral). On 19 January 2014, 5 days after vaccination with ROTARIX, the subject experienced intussusception. The subject was hospitalised and the physician considered the event was life threatening and clinically significant (or requiring intervention). At the time of reporting the event was resolved. The vaccination course with ROTARIX was discontinued. The physician considered the event was probably related to vaccination with ROTARIX.
Age: 0.37
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Intussusception, Screaming, Surgery, Vomiting
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of intussusception in a subject of unspecified age and gender who was vaccinated with ROTARIX (GlaxoSmithKline). On 21 February 2014 the subject received a dose of ROTARIX (oral). On 25 February 2014, 4 days after vaccination with ROTARIX, the subject experienced intussusception. The subject was taken to the emergency room on 25 February 2014 and "had surgery to correct" the intussusception on 26 February 2014. No further details were available at the time of reporting. The subject was hospitalised and the physician considered the event was disabling, life threatening and clinically significant (or requiring intervention). GSK considered this case medically serious. On 26 February 2014, the event was resolved. Follow up was received from the physician on 26 February 2014. The physician reported the occurrence of intussusception in a 4-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline) as the second dose in the rotavirus series. Concurrent vaccination included Hib; manufacturer unspecified; intramuscular; unknown given on 21 February 2014; DTaP-IPV/HepB; GlaxoSmithKline; intramuscular; unknown given on 21 February 2014; pneumococcal vaccines (non-gsk); manufacturer unspecified; intramuscular; unknown given on 21 February 2014. There was no history of alcohol or tobacco use per the physician. The physician confirmed that the subject received ROTARIX on 21 February 2014. On 25 February 2014, the subject experienced intussusception, vomiting, and screaming. On 26 February 2014, the outcome of the events were unresolved. The physician reported that the subject had surgery as treatment. The physician considered the events to be serious. Follow-up received on 17 July 2014 from physician via the targeted follow-up questionnaire. As previously reported the ROTARIX vaccine was administered correctly along with concomitant vaccinations. ROTARIX was administered by a nurse at the physician's office. The subject experienced intussusception on 25 February 2014 and resolved on 27 February 2014 (previously reported as 26 February 2014). At the time of this report the subject had completed the ROTARIX vaccination series. No other information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The pharmacist reported that, on 06-SEP-2014, she inadvertently administered ZOSTAVAX, subcutaneously (dose and lot number not provided), which expired on 03-JUL-2014, to the patient. It was reported that this was supported. No adverse effects were reported. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Nickel-sized raised red area that itched and caused pain on left knee area, similar on right side of forehead but did not itch until a later date. He claims it felt similar, but less severe, than a previous case of shingles.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Blood uric acid normal, Dizziness, Exposure during pregnancy, Full blood count normal
Clinical narrative: Received vaccination the morning of August 25th, began experiencing a headache the afternoon of the 25th.  Went to bed, woke up the morning of August 26th with 10/10 headache throbbing frontal headache.  Associated symptoms include extreme photophobia, scotomas, phonophobia, dizziness, and nausea.  Headache has been constant and unrelenting in nature.  Currently on day 17 of the headache.  Was seen twice in labor and delivery triage for the pain.  Was given percocet and fioricet for pain.  Chose not to take percocet.  Fioricet decreased pain level to 3/10.  Admitted to hospital 9/09/2014 for further work up of headache.  MRI negative, all blood work negative, blood pressures normal range.  No previous history of migraines or headaches.  Unable to attend work for last 17 days due to debilitating headache and associated symptoms.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Metabolic function test normal, Nausea, Nuclear magnetic resonance imaging brain normal, Phonophobia
Clinical narrative: Received vaccination the morning of August 25th, began experiencing a headache the afternoon of the 25th.  Went to bed, woke up the morning of August 26th with 10/10 headache throbbing frontal headache.  Associated symptoms include extreme photophobia, scotomas, phonophobia, dizziness, and nausea.  Headache has been constant and unrelenting in nature.  Currently on day 17 of the headache.  Was seen twice in labor and delivery triage for the pain.  Was given percocet and fioricet for pain.  Chose not to take percocet.  Fioricet decreased pain level to 3/10.  Admitted to hospital 9/09/2014 for further work up of headache.  MRI negative, all blood work negative, blood pressures normal range.  No previous history of migraines or headaches.  Unable to attend work for last 17 days due to debilitating headache and associated symptoms.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Photophobia, Scotoma, Urine protein/creatinine ratio normal
Clinical narrative: Received vaccination the morning of August 25th, began experiencing a headache the afternoon of the 25th.  Went to bed, woke up the morning of August 26th with 10/10 headache throbbing frontal headache.  Associated symptoms include extreme photophobia, scotomas, phonophobia, dizziness, and nausea.  Headache has been constant and unrelenting in nature.  Currently on day 17 of the headache.  Was seen twice in labor and delivery triage for the pain.  Was given percocet and fioricet for pain.  Chose not to take percocet.  Fioricet decreased pain level to 3/10.  Admitted to hospital 9/09/2014 for further work up of headache.  MRI negative, all blood work negative, blood pressures normal range.  No previous history of migraines or headaches.  Unable to attend work for last 17 days due to debilitating headache and associated symptoms.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection pain and swelling at site of reaction, followed by redness and itch traveling down arm.  MD is a physician and when asked if she required further medical attention she said that it was not necessary.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Blister
Clinical narrative: DEVELOPED SMALL BLISTERS ON RIGHT AND LEFT LEGS ABOVE THE KNEE.  APPX 7 BLISTERS TOTAL AS OF 9/11/2014 BLISTERS WERE DRYING UP (PER MOTHER REPORT).
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Fatigue, Feeling hot, Hyperhidrosis, Vision blurred
Clinical narrative: Patient became sweating, warm feeling, dizziness, lightheadedness, blurry vision and this lasted up until today at the time of this report. She had to sit down and regain herself but pushed through the day of work. No treatment was provided during the event on 09/10/2014.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Fainted.
Age: 0.39
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Abnormal behaviour, Decreased appetite, Diarrhoea, Irritability, Pyrexia
Clinical narrative: Low grade fever x 2 days, vomiting and mucusy diarrhea without blood x 1 week, change in demeanor with increased fussiness x 1 week, decreased appetite x 3 days. Supportive care only.
Age: 0.39
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Vomiting
Clinical narrative: Low grade fever x 2 days, vomiting and mucusy diarrhea without blood x 1 week, change in demeanor with increased fussiness x 1 week, decreased appetite x 3 days. Supportive care only.
Age: 34.0
Sex: F
Vaccine: YF
Symptoms: Musculoskeletal chest pain
Clinical narrative: Patient reports a pain in the area under her right rib starting 9-7 and continuing till 9.10. She denies any N/V/fever or changes in bowel or urine.
Age: 65.0
Sex: F
Vaccine: TYP
Symptoms: Myalgia, Pain, Paraesthesia
Clinical narrative: Patient placed a call stated she took her first dose of the oral typhoid vaccine yesterday morning around 7:30 AM. Patient stated that later in the afternoon around 4:00 PM yesterday she experienced "excruciating pain and tingling from the waist down". Patient stated the pain was so awful that she almost went to the ER. Patient stated that on 9/03/14 she feels "muscle soreness" from the waist down. Patient stated she did not have any other side effects. Patient denied fever, vomiting, diarrhea, stomach pain, headache, SOB or rashes. Patient stated that she took ibuprofen and her muscle pain and tingling subsided.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Large area of erythema and pruritus noted to arm where MMRV was administered 2 days after vaccine was administered.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUX, MMRV
Symptoms: Injection site joint swelling, Juvenile idiopathic arthritis, Laboratory test, Musculoskeletal stiffness, Pain
Clinical narrative: JIA, knee swelling, stiff and pain still continue.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea, Flushing, Hypoaesthesia
Clinical narrative: Patient received Fluarix vaccine at 5:10 PM. She stayed seated in vaccination area for 15 minutes and did not experience any initial adverse effects. Patient left the store and came back within 1-2 minutes and stated that she was experiencing numbness of her entire left arm in which vaccine was administered. She also was experiencing tightness in her throat, facial flushing, dizziness, shortness of breath, and involuntary tears from both eyes. I, the intern who adminstered the vaccine, immediately knew she was having an anaphylactic reaction. I immediately notified the pharmacist in charge and the pharmacy technician called 911. Epipen (adult dose) was administered to the patient within a minute of identifying anaphylactic reaction. Paramedics arrived shortly after and administered IV Benadryl 25 mg and took patient to the ER.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site anaesthesia, Lacrimation increased, Throat tightness
Clinical narrative: Patient received Fluarix vaccine at 5:10 PM. She stayed seated in vaccination area for 15 minutes and did not experience any initial adverse effects. Patient left the store and came back within 1-2 minutes and stated that she was experiencing numbness of her entire left arm in which vaccine was administered. She also was experiencing tightness in her throat, facial flushing, dizziness, shortness of breath, and involuntary tears from both eyes. I, the intern who adminstered the vaccine, immediately knew she was having an anaphylactic reaction. I immediately notified the pharmacist in charge and the pharmacy technician called 911. Epipen (adult dose) was administered to the patient within a minute of identifying anaphylactic reaction. Paramedics arrived shortly after and administered IV Benadryl 25 mg and took patient to the ER.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: She presented with a painful, hot and red left outer upper arm that measured 5-6 cm of redness. There was no swelling, it was tender and warm to touch. She had normal function of her arm. No respiratory symptoms. VS BP 126/76, T 97.9, P 76, R 14, O2Sat 98%, Pain 6/10. Advised to take an antihistamine like Benadryl or Zyrtec, an anti-inflammatory and to ice the area. To return to the clinic if any further problems.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Dyspnoea, Pharyngeal oedema, Swelling face
Clinical narrative: Swelling of face and throat, difficulty breathing, dizziness and weakness.
Age: 55.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Chills, Hypotension, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Fever 103 degrees F, muscle aches, chills, hypotension, swelling and redness at site of injection.
Age: 55.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Fever 103 degrees F, muscle aches, chills, hypotension, swelling and redness at site of injection.
Age: 44.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Local swelling, Pain in extremity, Pyrexia, White blood cell count
Clinical narrative: Fever, pain and swelling on injected arm which lasted for 4 days.  MD prescribed antibiotic for possible cellulitis.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pain in extremity, Pyrexia
Clinical narrative: Fever, pain, swelling and redness on injected arm.  Patient took Ibuprofen for the pain and fever.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations
Clinical narrative: I felt my heart racing for awhile.  I read for about a half hour and then went back to sleep.
Age: 48.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Injection site pain, Mobility decreased, Neck pain, X-ray limb
Clinical narrative: 3 vccines administered on 4/3/2014. Pain in left upper arm; inability to raise arm fully. After 5/3/2014 vaccine, pain in right upper arm as well but also into shoulder and up neck.
Age: 7.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Ear pain, Nausea
Clinical narrative: Ear pain, stomach pain, nausea.
Age: 26.0
Sex: F
Vaccine: TYP
Symptoms: Facial pain, Feeling hot, Muscular weakness, Pain, Pain in extremity
Clinical narrative: Intense pain in injection arm (right arm). Pain and warmth extending to right forearm and hand and up the right side of the face. Growing pain and muscle weakness. Made worse by body movements.
Age: 26.0
Sex: F
Vaccine: TYP
Symptoms: Skin warm
Clinical narrative: Intense pain in injection arm (right arm). Pain and warmth extending to right forearm and hand and up the right side of the face. Growing pain and muscle weakness. Made worse by body movements.
Age: 30.0
Sex: F
Vaccine: FLUC3
Symptoms: Dysarthria, Dysphagia, Hypoaesthesia, Jaw disorder, Muscular weakness
Clinical narrative: Swelling of tounge, problems with jaw muscles, weakness and numbness in arms and hands and difficulty swallowing and slurred speech.
Age: 30.0
Sex: F
Vaccine: FLUC3
Symptoms: Swollen tongue
Clinical narrative: Swelling of tounge, problems with jaw muscles, weakness and numbness in arms and hands and difficulty swallowing and slurred speech.
Age: 83.0
Sex: F
Vaccine: FLUX
Symptoms: Pneumonia, Vaccination complication
Clinical narrative: This medically confirmed report (initial receipt 28-Mar-2014) concerns an 83-year-old female patient. No medical history was provided. The patient was "otherwise healthy". In Sep-2012, the patient was vaccinated with PNEUMOVAX 23, which may have been a booster dose. On an unspecified date, the patient received an unspecified influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, the patient was unable to tolerate the flu vaccine. The patient had been previously hospitalised at an unspecified facility on an unspecified dates. Outcome was reported as recovered. Reporter's comment: The health authority assessed the case as serious. The pharmacist was unsure if the patient received more than one dose of PNEUMOVAX 23 and if the patient was hospitalised after receiving a dose of PNEUMOVAX 23 before Sep-2012. The authority reported preferred term of 'pneumonia'. Case correction (02-May-2014): Ae 1 re-coded. Case correction (10-Jul-2014): AE 1 re-coded. Follow-up (01-Sep-2014)- Case upgraded to serious, patient details, new event, manufacturer information for influenza vaccine, additional suspect vaccine, vaccine administration information and clinical course.
Sex: U
Vaccine: FLU3
Symptoms: Foetal exposure during pregnancy, Pierre Robin syndrome
Clinical narrative: This report from study was reported via Pregnancy Registry (initial receipt 04-Sep-2014) and concerns a neonate patient. Concomitant medications, received via the mother in utero, included prenatal vitamins, iron, estradiol, progesterone vaginal insert, menotropin and urofollitropin. The mother's medical history included IVF (in-vitro fertilisation) treatment, in which embryo transfer took place on day 5. The mother's DOC (date of conception) was 26-May-2013 and EDC (estimated date of confinement) was 16-Feb-2014. On the 12-Nov-2013, the patient received the AFLURIA injection (batch number not reported) via the mother, intra-uterine, 1 shot 1 day. On the 06-Feb-2014, the patient was born at a gestation age of 38.6, birth weight was 3235.0 grams and was diagnosed with Pierre Robin Sequence. The patient was born a twin - the patient's twin was a healthy newborn, without malformation. Outcome was unknown. Linked to case 2014044961.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to unknown number of patients of unknown demographics. No relevant medical history of the patients was reported. On an unknown date the patients were vaccinated with ROTATEQ (strength, dose, lot number and expiration dates were not reported) orally. No concomitant medications were reported. It was reported that since 18-AUG-2014, unknown number of patients were administered with ROTATEQ which was improperly stored. This was supported. No adverse effects were reported. There was no product quality complaint involved. The outcome was unknown. This is one of several reports received from the same reporter. 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 registered nurse refers to unknown number of patients of unknown demographics. No relevant medical history of the patients was reported. On an unknown date in 2014, the patients were vaccinated with RECOMBIVAX HB (strength, dose, route of administration, lot number and expiration dates were not reported). No concomitant medications were reported. It was reported that since 18-AUG-2014, unknown number of patients were administered RECOMBIVAX HB which was improperly stored. This was supported. No adverse effects were reported. There was no product quality complaint involved. The outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 27.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 27 year old patient. On approximately 03-SEP-2014 (reported as week ago from the time of report) the patient less than 50 years was vaccinated with ZOSTAVAX lot # K007548 with expiration date: 23-AUG-2015 (also reported as K00754B) 0.65 ml, once, route of administration subcutaneous. No adverse effect reported. Patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to unknown number of patients of unknown demographics. No relevant medical history of the patients was reported. On an unknown date in 2014, the patients were vaccinated with VAQTA (strength, dose, route of administration, lot number and expiration dates were not reported). No concomitant medications were reported. It was reported that since 18-AUG-2014, unknown number of patients were administered VAQTA which was improperly stored. This was supported. No adverse effects were reported. There was no product quality complaint involved. The outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to unknown number of patients of unknown demographics. No relevant medical history of the patients was reported. On an unknown date in 2014, the patients were vaccinated with GARDASIL (strength, dose, route of administration, lot number and expiration dates were not reported). No concomitant medications were reported. It was reported that since 18-AUG-2014, unknown number of patients were administered GARDASIL which was improperly stored. This was supported. No adverse effects were reported. There was no product quality complaint involved. The outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 1.23
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 14 month old patient of unknown gender. No concurrent conditions or medical history were provided. Nurse reported that on 29-AUG-2014 (during an appointment), a patient's mother incorrectly reported to the office that the patient had never received any doses of MMR II and (Oka/Merck) VARIVAX in the past. The patient was then vaccinated with doses of MMR II and (Oka/Merck) VARIVAX injections (dose, route of administration, indication, lot# and expiry date unspecified for both) during that appointment (on 29-AUG-2014). Later it was discovered that the patient had already received dose 1 of MMR II and (Oka/Merck) VARIVAX from a different provider's office (unspecified health department) on 12-JUN-2014. No concomitant medications were reported. No symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to unknown number of patients of unknown demographics. No relevant medical history of the patients was reported. On an unknown date in 2014, the patients were vaccinated with PEDVAXHIB (strength, dose, route of administration, lot number and expiration dates were not reported). No concomitant medications were reported. It was reported that since 18-AUG-2014, unknown number of patients were administered PEDVAXHIB which was improperly stored. This was supported. No adverse effects were reported. There was no product quality complaint involved. The outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a female patient of unknown age reporting on herself. No relevant medical history of the patient was reported. On an unknown date the patients mail order pharmacy shipped RECOMBIVAX HB directly to her in order to bring it to her physicians office to be administered. The patient received the shipment, placed it in the refrigerator and then about an hour or two later drove it to her physician's office where the she was vaccinated with RECOMBIVAX HB (strength, dose, route of administration, lot number and expiry date were not reported) for prophylaxis (date unknown). No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint involved. The outcome was unknown. No further information was provided. Additional information is not expected because the reporter details were not provided.