chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site inflammation, Injection site mass, Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old female patient. The patient's pertinent medical history included vertigo, acid reflux, allergy to penicillin and allergy to latex. On 10-OCT-2014, the patient was vaccinated with ZOSTAVAX (lot # K008880, expiration date: 20-SEP-2015) subcutaneous. The patient did not take any concomitant medications. On an unspecified date in October 2014, the patient experienced a reaction at the injection site. The pharmacist reported that it began as a hard little lump at the injection site which has grown into an extremely red and inflamed area covering half of back of the arm. The reporter stated that there was no rash present, only redness and swelling. On an unspecified date in October 2014, the patient also experienced headache and vomiting. There was none treatment given for adverse events and none lab diagnostics studies performed. The outcome of the events was reported as not recovered. The relatedness between the events and the vaccination with ZOSTAVAX was unknown. The patient sought medical attention by calling to pharmacy. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Vomiting
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old female patient. The patient's pertinent medical history included vertigo, acid reflux, allergy to penicillin and allergy to latex. On 10-OCT-2014, the patient was vaccinated with ZOSTAVAX (lot # K008880, expiration date: 20-SEP-2015) subcutaneous. The patient did not take any concomitant medications. On an unspecified date in October 2014, the patient experienced a reaction at the injection site. The pharmacist reported that it began as a hard little lump at the injection site which has grown into an extremely red and inflamed area covering half of back of the arm. The reporter stated that there was no rash present, only redness and swelling. On an unspecified date in October 2014, the patient also experienced headache and vomiting. There was none treatment given for adverse events and none lab diagnostics studies performed. The outcome of the events was reported as not recovered. The relatedness between the events and the vaccination with ZOSTAVAX was unknown. The patient sought medical attention by calling to pharmacy. 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 nurse refers to unspecified patients of unknown age and gender. On an unknown dates the patients were vaccinated with improperly stored doses of GARDASIL (dose, route, lot numbers and expiration dates were not provided). No adverse events reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified patients of unknown age and gender. On an unknown dates the patients were vaccinated with improperly stored doses of (Merck) VARIVAX (dose, route, lot numbers and expiration dates were not provided). No adverse events reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a multiple patients of unknown age and gender. No pertinent medical history was reported. Since 28-JUL-2014, the patients were vaccinated with PROQUAD (dose, route, lot# were not reported) after being improperly stored. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 49 year old female patient with no pertinent medical history, drug reactions or allergies. At the time of this report the patient was not pregnant. On 13-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (0.5 ml once, subcutaneous, lot number was not reported). On 13-OCT-2014 (reported as later the same day) the patient experienced redness and swelling at the injection site. None concomitant medication was reported. No treatment was given for the adverse events. None lab diagnostics studies were performed. The patient sought medical attention via speaking with the pharmacist. The outcome of redness and swelling at the injection site was reported as recovering/resolving (reported also that the patient's symptoms were starting to resolve as of today 15-OCT-2014. The relatedness between events and PNEUMOVAX 23) was not reported. Additional information has been requested.
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Blister, Haemorrhage, Pruritus
Clinical narrative: Itching/bleeding/oozing blisters.
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 16 year old patient of unknown gender. on 13-OCT-2014, the patient was inadvertently vaccinated with a dose of PROQUAD, 0.5 ml, subcutaneous (lot#, expiration date and strength not reported). No adverse effects reported. It was unspecified if the patient sought medical attention. This is one of two reports received from the same source. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 68 years old female patient. She had no drug reactions/allergies. No information on her medical history or concurrent conditions was provided. On 06-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneously, lot # K008883, expiration date 20-SEP-2015. Concomitant therapies included methotrexate (manufacturer unknown), folic acid, propranolol hydrochloride and simvastatin (manufacturer unknown). In approximately October 2014 the patient experienced cellulitis at the injection site. The patient sought medical attention via an office visit and was prescribed an unspecified antibiotic by a registered nurse. The outcome of cellulitis at the injection site was reported as not recovered/not resolved. The relatedness between use of ZOSTAVAX and the adverse event was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. On 10-OCT-2014 the patient was vaccinated with ZOSTAVAX (dosing regimen unspecified). No concomitant therapies were reported. On 11-OCT-2014, the patient experienced rash on her leg. The patient was referred to her unspecified physician for diagnosis and treatment (details unspecified). The outcome of rash on her leg is unknown. There was no product quality complaint (PQC) involved. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HEP, HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with 1 dose of ENGERIX-B (dose, route, lot # and expired date were not reported) and then at the later unspecified date, the patient was vaccinated with 1 dose of RECOMBIVAX HB (dose, route, lot # and expired date were not reported) at a different facility. Concomitant therapy was not reported. No adverse events were reported. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site urticaria, Pruritus, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient. No information on her medical history, concurrent conditions or concomitant drugs was provided. On 06-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX subcutaneously in the right upper arm, lot # K000330, expiration date 06-MAR-2015. In October 2014 (reported as "either 07-OCT-2014 or 08-OCT-2014), the patient experienced itching all the time and welts around the vaccination site, when she touched the welts it would itch. The welts and a rash were also on her right upper thigh and have gone over to her left hip area, the middle of her belly button, under the left breast, and on her back on the left side of her body. Reportedly, the patient was feeling well except for the itchiness. It was unknown if there was any laboratory data. The outcome of the adverse events was unknown at the time of the report. Relatedness between use of the ZOSTAVAX and the adverse events was unknown. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Fatigue, Headache, Herpes zoster
Clinical narrative: This spontaneous report as received from a 76 year old female consumer refers to herself. The patient's medical history included asthma and keratocones. In June 2012 the patient was vaccinated with a dose of ZOSTAVAX (dose and route not reported, lot # K000995, exp date 16-MAR-2015 (also reported as 06-MAR-2015) in her arm. Concomitant therapies included atorvastatin and levothyroxine sodium (manufacturer unknown). On 25-SEP-2014 the patient experienced: being tired, headache, nerve pain, itching, burning, big red clusters on her back, a 'full blown case' of shingles, and feeling irritated after ZOSTAVAX. She also stated that she had not been able to sleep since she developed shingles. The patient had sought medical attention. No lab diagnostics studies were performed. Treatment was given: acyclovir 400 mg and LYRICA 50 mg capsule. At the time of the report, the patient had not recovered from the events. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Irritability, Neuralgia, Pruritus
Clinical narrative: This spontaneous report as received from a 76 year old female consumer refers to herself. The patient's medical history included asthma and keratocones. In June 2012 the patient was vaccinated with a dose of ZOSTAVAX (dose and route not reported, lot # K000995, exp date 16-MAR-2015 (also reported as 06-MAR-2015) in her arm. Concomitant therapies included atorvastatin and levothyroxine sodium (manufacturer unknown). On 25-SEP-2014 the patient experienced: being tired, headache, nerve pain, itching, burning, big red clusters on her back, a 'full blown case' of shingles, and feeling irritated after ZOSTAVAX. She also stated that she had not been able to sleep since she developed shingles. The patient had sought medical attention. No lab diagnostics studies were performed. Treatment was given: acyclovir 400 mg and LYRICA 50 mg capsule. At the time of the report, the patient had not recovered from the events. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Administration site pain, Injection site erythema, Injection site swelling, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 72 year old female patient with no known drug reactions. On 07-OCT-2014 the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 (lot#, expiration date, dose not reported) intradermally instead of purified protein derivative (PPD) test. On 08-OCT-2014, the patient experienced site of administration was swollen, red and pain in her forearm around the injection site. The patient was prescribed an unspecified antibiotic for this reaction to the PNEUMOVAX 23 intradermally. The outcome of the events was reported as not recovered. The patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 25-SEP-2014 the patient was vaccinated with improperly stored VARIVAX (Merck) (dose and lot # not reported). No adverse effects reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 year old female patient. On 09-OCT-2013 the patient was vaccinated with the first dose of ZOSTAVAX (lot#, strength, dose and route unspecified). On 10-OCT-2014 the patient was inadvertently vaccinated with the second dose of ZOSTAVAX (lot#, strength, dose and route unspecified). No adverse effects reported. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 year old patient of unknown gender. On 13-OCT-2014, the patient was inadvertently vaccinated with a dose of PROQUAD (Merck), 0.5 ml, subcutaneous (lot#, expiration date and strength not reported). No adverse effects reported. It was unspecified if the patient sought medical attention. This is one of two reports received from the same source. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Blood test normal, Haematochezia, Irritability, Occult blood positive
Clinical narrative: 8/14/14 got oral ROTATEQ #2; 2d later with blood in stool; fussy.
Age: 1.32
Sex: F
Vaccine: HIBV, PNC13, VARCEL
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Fever (103 plus), facial redness, swelling
Age: 35.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Chest discomfort, Dizziness, Flushing, Nausea, Swelling face
Clinical narrative: Received IM Hep B left u arm, within 60 secs became nauseated, dizzy, chest tightness, flushing and swelling on left side of face.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Injection site reaction; red, warm to the touch with small "lump" at injection site. No treatment at time of reporting.
Age: 42.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Injection site erythema, Injection site reaction, Myalgia, Pain
Clinical narrative: Whole body achy, muscles hurt and chills - day after vaccine right upper arm w/ localized reaction of erythema, visible lesions.
Age: 42.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Skin lesion, White blood cell count increased
Clinical narrative: Whole body achy, muscles hurt and chills - day after vaccine right upper arm w/ localized reaction of erythema, visible lesions.
Age: 33.0
Sex: M
Vaccine: HEP, PPV
Symptoms: Local swelling, Urticaria
Clinical narrative: Day after receiving immunization patients arm became swollen and developed hives down the arm. Recommended BENADRYL or ZYRTEC c/o help w/hives. Cool compressed to injectoin site, TYLENOL or ibuprofen for pain.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt came in 2 days after vaccination with redness and swelling at site of injection. Instructed pt to consult with MD. Also called MD and reported incident.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling face, Trismus
Clinical narrative: Swelling to left side of face difficulty in opening jaw.
Age: 1.15
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Chicken pox like rash.
Age: 1.75
Sex: F
Vaccine: HEPA
Symptoms: Hypotonia, Pyrexia
Clinical narrative: Mild limp, toes pointing out while walking since Hep a injection in (L) thigh. Fever.
Sex: U
Vaccine: HBHEPB
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse refers to an adult patient of unknown age. On 30-SEP-2014 the patient accidentally was vaccinated with COMVAX, 1 mL, intramuscular (lot # was not reported) instead of a dose of RECOMBIVAX HB. No adverse effects were reported. This is one of several report received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a multiple patients of unknown age and gender. No pertinent medical history was reported. Since 28-JUL-2014, the patients were vaccinated with ROTATEQ suspension 2 (dose, route, lot# were not reported) after being improperly stored. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and demographics. Current conditions and medical history was not reported. On 26-SEP-2014, the patient was vaccinated with M-M-R II, lot number: H 017436, expiry date- 20_SEP-2014, 0.5 milliliter, subcutaneous for unknown indication. Concomitant medications were not reported. On 26-SEP-2014, expired dose of M-M-R II was inadvertently administered. No adverse effects reported. Product quality complaint was not reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered, Pain in extremity
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a 22 year old female patient with no drug reactions or allergies and with no medical history. The patient received two vaccinations of GARDASIL injection administered intramuscularly (strength, dose, lot# and expiry date unspecified). The patient went to her gynecologist on 02-OCT-2014 and received a dose of GARDASIL. She then went to her pediatrician on 14-OCT-2014 (reported as "yesterday"), for a physical and the pediatrician administered another dose of GARDASIL. Concomitant therapies included SINGULAIR. The patient suffered from pain in her arm after the injection (since 14-OCT-2014). She was not experiencing any other symptoms. The patient sought medical attention via calling the doctors office back. No treatment was given for the event and no laboratory test were performed. The outcome of pain in her arm was unknown. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse refers to an adult patient of unknown age. On 02-OCT-2010 the patient accidentally was vaccinated with COMVAX, 1 mL, intramuscular (lot # was not reported) instead of a dose of pediatric RECOMBIVAX HB. No adverse effects were reported. This is one of several report received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and unknown gender. No pertinent medical history, drug reactions or allergies were reported. Since 19-AUG-2014 doses of VARIVAX (Merck), which had been exposed to a supported temperature excursion, have been administered to unspecified patients on unspecified dates (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effect has been observed or reported. No concomitant therapies were reported. The outcome of the events was unknown. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Accidental overdose
Clinical narrative: This case was reported by a nurse and described the occurrence of accidental overdose in a 13-year-old male patient who received HAVRIX adult (batch number PC527, expiry date 8th June 2015). On an unknown date, the patient received HAVRIX adult. On an unknown date, an unknown time after receiving HAVRIX adult, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown. It was unknown if the reporter considered the accidental overdose to be related to HAVRIX adult.
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: This spontaneous report as received from a consumer's sister refers to a female patient of unknown age. The reporter mentioned that her sister developed reactions to other company's products (unspecified). Other pertinent medical history was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX 19400 PFU, (dose, dose number, route, anatomical location and expiration date were unspecified). No concomitant therapies were reported. On an unknown date the patient experienced chicken pox. The outcome of chicken pox was unknown. The relatedness between chicken pox and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of inappropriate age at vaccine administration in a 8-year-old patient who received KINRIX. On 25th September 2014, the patient received the 1st dose of KINRIX. On 25th September 2014, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration to be related to KINRIX. Additional details: No other AE's voiced other than the administration.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (office administrator) refers to a patient of unknown age and gender. It was reported that on 10-SEP-2013 the patient received the first dose of GARDASIL (dose 0.5 ml, lot number and expiration date not reported) intramuscular injection. On 11-NOV-2013 the patient received the second dose of GARDASIL (dose 0.5 ml, lot number and expiration date not reported) intramuscular injection. On 02-APR-2014 the patient received the third dose of GARDASIL (dose 0.5, lot number and expiration date not reported) intramuscular injection. On 15-OCT-2014, the patient received the fourth dose of GARDASIL (dose 0.5 ml, lot number and expiration date not reported) intramuscular injection. There was no concomitant medication reported. No adverse effects reported. Additional information is not expected due to no permission was given to be contacted.
Age: 0.2
Sex: U
Vaccine: DTAPIPV, IPV
Symptoms: Incorrect dose administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of overdose in a 2-month-old subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included poliomyelitis vaccine, (unspecified manufacturer, unknown route, injection site and batch number) given on an unspecified date. On an unspecified date, the subject received unspecified dose of KINRIX (unknown route and injection site) at the same time with a monovalent polio vaccine that led to overdose. Additional information received on 29 September 2014: A nurse called back and followed up with patient which is fine. There are no adverse event.
Sex: F
Vaccine: TDAP
Symptoms: Adverse event
Clinical narrative: This case was reported by a other health professional and described the occurrence of unspecified adverse event in a female patient who received BOOSTRIX. In 2010, the patient received BOOSTRIX. In 2010, less than a year after receiving BOOSTRIX, the patient experienced unspecified adverse event. On an unknown date, the outcome of the unspecified adverse event was unknown. It was not reported if the reporter considered the unspecified adverse event to be related to BOOSTRIX.
Age: 14.0
Sex: M
Vaccine: HEP
Symptoms: Expired drug administered
Clinical narrative: This case was reported by a other health professional and described the occurrence of expired vaccine used in a 14-year-old male patient who received ENGERIX B (batch number AHBVCO48BB, expiry date 8th September 2014). On an unknown date, the patient received ENGERIX B (unknown). On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced expired vaccine used. On an unknown, the outcome of the expired vaccine used was unknown. It was unknown if the reporter considered the expired vaccine used to be related to ENGERIX B.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX, subcutaneous (strength, dose and lot # were not reported). There were no concomitant medications. It was reported that the patient was administered 2 doses of ZOSTAVAX on 08-OCT-2014. Patient did not receive any treatment. She did not seek medical attention. Additional information has been requested.
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Blood calcium normal, Blood urea decreased, Diarrhoea
Clinical narrative: This 5-month-old female subject was enrolled in a study. On 30th June 2014, the subject received the 1st dose of HepB vaccine (intramuscular). On 3rd September 2014, the subject received the 2nd dose of Rotavirus vaccine (oral), the 2nd dose of PENTACEL (intramuscular) and the 2nd dose of PREVNAR 13 (intramuscular). On 3rd October 2014 14:55, 95 days after receiving HepB vaccine and 30 days after receiving Rotavirus vaccine, PENTACEL and PREVNAR 13 the subject developed moderate - grade 2 chronic diarrhea. Serious criteria included hospitalization. The outcome of chronic diarrhea was recovered/resolved on 10th October 2014. The investigator considred that there was a reasonable possibility that the chronic diarrhea may have been caused by HepB vaccine, Rotavirus vaccine, PENTACEL and PREVNAR 13. Diagnostic results (unless otherwise stated, normal values were not provided): On 3rd October 2014, Blood calcium result was 10.6 mg/dL and Blood urea result was 2 mg/dL.
Age: 48.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Local swelling, Pyrexia, Tinnitus, Vision blurred
Clinical narrative: This spontaneous report was received from a physician refers to a 48 year old male patient. Patient's concurrent conditions included aortic stenosis, asthma, heart failure, COPD (chronic obstructive pulmonary disease), hypertension, obstructive sleep apnea, restless leg syndrome, hyperlipidemia, implantable cardioverter defibrillator (icd), peripheral artery disease and heart failure. Patient's drug reactions/allergies included Novocaine, PRO AIR. On 02-OCT-2014, the patient was vaccinated with PNEUMOVAX 23 arm (dose, route and lot # were not provided) for to prevent pneumonia. Other suspect therapy included FLUZONE arm. Concomitant therapies included amiodarone (manufacturer unknown), aspirin (manufacturer unknown), carvedilol (manufacturer unknown), PLAVIX, PROZAC, lisinopril (manufacturer unknown), magnesium (manufacturer unknown), metolazone (manufacturer unknown), niacin (manufacturer unknown), PROTONIX, REQUIP, spironolactone, and torsemide. On an unspecified date in October 2014, the patient was seen in the emergency room due to arm swelling, blurred vision, "being feverish at the neck", shortness of breath and ringing of the ears after receiving PNEUMOVAX 23 and FLUZONE "at the same time in the same arm". The reporter did not give any indication the vaccines were mixed in the same syringe. On an unknown date, the patient sought medical attention. The outcome of the vision blurred, "being feverish at the neck", ringing of the ears, shortness of breath and arm swelling was reported as recovered/resolved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a other health professional and described the occurrence of drug dose administration interval too short in a 12-month-old male patient who received INFANRIX. On an unknown date, the patient received the 4th dose of INFANRIX. On an unknown date, an unknown time after receiving INFANRIX, the patient experienced drug dose administration interval too short and inappropriate age at vaccine administration. On an unknown date, the outcome of the drug dose administration interval too short and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the drug dose administration interval too short and inappropriate age at vaccine administration to be related to INFANRIX.
Age: 29.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 29 year old male patient. On an unknown date, the patient was vaccinated with PNEUMOVAX 23, (lot # K009105 and expiration date 21-JAN-2016), (dose and route not reported). On 11-OCT-2014, the patient developed an injection site reaction of redness. Additionally, the arm that had received the PNEUMOVAX 23 had developed a "big red swollen shoulder". The patient went to an urgent care clinic where a nurse practitioner diagnosed him with an infection and was prescribed an antibiotic. At the time of the report the outcome of the events was unknown. This is one of several reports received from the same reproter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hormone level abnormal
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a female friend of unknown age. Concomitant medication, medical history, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, route, lot number were not reported). On an unknown date, after received GARDASIL the patient experienced adverse reaction related to unspecified "hormonal imbalances". The patient received unspecified treatment. The outcome of hormonal imbalances was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 2 patients of unknown age and gender. On an unknown dates, the patients were vaccinated with PNEUMOVAX 23 (dose, route, lot number and expiration dates not reported). In 2014, over the past month, the patients experienced severe injection site reactions. At the time of the report the outcome of severe injection site reactions was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 3 patients of unknown age and gender. On an unknown dates, the patients were vaccinated with PNEUMOVAX 23 (dose, route, lot number and expirations dates not reported). In 2014, over the past month, the patients experienced severe injection site reactions. The injection site reactions were treated with antibiotics. At the time of the report the outcome of severe injection site reactions was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia
Clinical narrative: Patient complaint of numbness on left arm after vaccination, continues until today.
Age: 31.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, Exposure during pregnancy, Nausea
Clinical narrative: This spontaneous prospective pregnancy report as received from a 31 year old female consumer reporting herself with nauseous and morning sickness. The patient had no pertinent medical history or drug reactions/allergies. The patient became pregnant with last menstruation period of appropriate February 2014 and Estimate Delivery Date of November 2014. Initial exposure to GARDASIL was at 28 week(s) ("about 7 months"). The pregnancy outcome was unknown. On 15-SEP-2014, the patient was "about 7 months" pregnant and accidentally vaccinated with a dose of GARDASIL, 0.5 ml, (lot number not provided) intramuscular. Concomitant therapies included ZOFRAN. The patient also reported that she "for the last couple days on 15-SEP-2014, she felt more nauseous than her usual morning sickness after being administered GARDASIL". The patient also reported that her "nausea has started to get better in the last few days". The patient also provided her Date of Birth which placed her outside of the recommended indications for GARDASIL. No treatment was given for event and no lab diagnostics were performed. She just visited to the office for help. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. Since 09-OCT-2014 the patients were vaccinated with doses of VARIVAX (Merck) (lot#, expiration date, route and dose were unknown) which were exposed to a supported temperature out of range. No adverse events have been observed or reported. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Faeces discoloured, Irritability, Mucous stools
Clinical narrative: Pink/red tinged mucousy discharge in stool 1 week after rotavirus vaccine given. Increased fussiness.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Local swelling w/rash around injection site.
Age: 69.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Herpes zoster, Medication error, Neuralgia, Ophthalmic herpes zoster
Clinical narrative: This spontaneous report was received from the patient's wife refers to her husband a 69 year old male patient. The patient's medical history included prior cases of shingles occurred during 1997 and another unspecified year after that. No drug/allergies were reported. On 26-JAN-2008 the patient was vaccinated with a single 0.65 ml dose/once of ZOSTAVAX, (lot number and expiration date not reported) subcutaneous injection to treat the pain caused by shingles. Concomitant therapies included a shot of influenza virus vaccine (unspecified). On 12-OCT-2014 the patient experienced shingles rash. Reporter stated that the shingles rash stretched from the back of his neck going up over his ear, up to his face, and onto the eyelid. Reporter also stated that her husband was experiencing nerve pain. The patient sought for medical attention on an unspecified date on an unspecified date in October 2014 and unspecified prescription medication and eye drop medication were given as treatment for the events. The outcome of the events was not recovered. Additional information is not expected due to no permission to contact the physician was given.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Chest pain, Pericarditis
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 08 October 2014. A 21 year-old male subject with a past medical history reported as "No", was found to have acute idiopathic pericarditis, acute pericarditis other and non-specific myocarditis on 21 February 2014, 11 days after the subject had received the following vaccine on 10 February 2014: an injection of ACAM2000 (lot number and site of administration not reported. In addition, on 15 January 2014 he received Anthrax vaccine. (other manufacturer, lot number and site of administration not reported) and on 05 February 2014 he received Japanese Encephalitis IM, (other manufacturer, lot number and site of administration not reported). The subject also experienced other and unspecified acute myocarditis on 24 April 2014. On 21 February 2014, the Troponin I result, ECG and Echocardiogram were normal. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram normal, Myocarditis, Pericarditis, Troponin I normal
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 08 October 2014. A 21 year-old male subject with a past medical history reported as "No", was found to have acute idiopathic pericarditis, acute pericarditis other and non-specific myocarditis on 21 February 2014, 11 days after the subject had received the following vaccine on 10 February 2014: an injection of ACAM2000 (lot number and site of administration not reported. In addition, on 15 January 2014 he received Anthrax vaccine. (other manufacturer, lot number and site of administration not reported) and on 05 February 2014 he received Japanese Encephalitis IM, (other manufacturer, lot number and site of administration not reported). The subject also experienced other and unspecified acute myocarditis on 24 April 2014. On 21 February 2014, the Troponin I result, ECG and Echocardiogram were normal. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 75 year old female patient with no drug reactions or allergies. On 17-SEP-2014 the patient was vaccinated with PNEUMOVAX23  (lot # K004930, expiration date 16-MAR-2015) (dose, dose  number and route were not reported). Co suspect and concomitant therapies were not reported. Pharmacist reported patient received PNEUMOVAX23 on 17-SEP-2014 and afterwards experienced severe pain and soreness in the arm at the injection site which "bothered" the patient a lot. At the time of the report the outcome was reported as recovering. Patient sought medical attention when she called to the pharmacy. Patient did not received treatment for the adverse events. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 75 year old female patient with no drug reactions or allergies. On 17-SEP-2014 the patient was vaccinated with PNEUMOVAX23  (lot # K004930, expiration date 16-MAR-2015) (dose, dose  number and route were not reported). Co suspect and concomitant therapies were not reported. Pharmacist reported patient received PNEUMOVAX23 on 17-SEP-2014 and afterwards experienced severe pain and soreness in the arm at the injection site which "bothered" the patient a lot. At the time of the report the outcome was reported as recovering. Patient sought medical attention when she called to the pharmacy. Patient did not received treatment for the adverse events. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abasia, Headache, Pain, Vertigo, Vision blurred
Clinical narrative: Patient says that he awoke in the middle of the night and felt very lightheaded and dizzy. He was unable to get out of bed and could not walk. This lasted for around 3 days. Once he was able to get up he had trouble walking in a straight line.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abasia, Dizziness, Gait disturbance, Mobility decreased
Clinical narrative: Patient says that he awoke in the middle of the night and felt very lightheaded and dizzy. He was unable to get out of bed and could not walk. This lasted for around 3 days. Once he was able to get up he had trouble walking in a straight line.
Sex: M
Vaccine: HEP, HEP
Symptoms: Convulsion, Electrocardiogram abnormal, Erythema, Tremor, Unresponsive to stimuli
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a 6 day old male patient with none pertinent medical history and drug reactions or allergies. On 09-OCT-2014 in the afternoon (also reported as 09-SEP-2014) the patient was vaccinated with RECOMBIVAX HB (dose/frequency reported as: 1 shot, therapy route reported as: injection, lot # K006682, 17-DEC-2015). No concomitant medication was reported. On 10-OCT-2014 between 20:15 and 20:30 the patient experienced a full grand-mal tonic seizure. The patient went rigid, shook, could not breathe and foamed at the mouth for a little over a minute, then went limp, then went into another seizure, that lasted a few seconds. The reporter stated that the patient was hospitalized for at least 24 hours (in October 2014 (exact date unspecified)) where had an EEG (Electroencephalogram) that showed abnormal results. The patient had also performed unspecified tests on blood, urine, CVCs (unspecified), electrolytes and sugars (no results were provided). KEPPRA was given as a treatment for the event. The patient sought medical attention. The outcome of event was not reported. The relatedness between event and RECOMBIVAX HB was not reported. Upon internal review, event full grand-mal tonic seizure was considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: HEP, HEP
Symptoms: Blood electrolytes, Blood glucose, Blood test, Central venous catheterisation, Dyspnoea
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a 6 day old male patient with none pertinent medical history and drug reactions or allergies. On 09-OCT-2014 in the afternoon (also reported as 09-SEP-2014) the patient was vaccinated with RECOMBIVAX HB (dose/frequency reported as: 1 shot, therapy route reported as: injection, lot # K006682, 17-DEC-2015). No concomitant medication was reported. On 10-OCT-2014 between 20:15 and 20:30 the patient experienced a full grand-mal tonic seizure. The patient went rigid, shook, could not breathe and foamed at the mouth for a little over a minute, then went limp, then went into another seizure, that lasted a few seconds. The reporter stated that the patient was hospitalized for at least 24 hours (in October 2014 (exact date unspecified)) where had an EEG (Electroencephalogram) that showed abnormal results. The patient had also performed unspecified tests on blood, urine, CVCs (unspecified), electrolytes and sugars (no results were provided). KEPPRA was given as a treatment for the event. The patient sought medical attention. The outcome of event was not reported. The relatedness between event and RECOMBIVAX HB was not reported. Upon internal review, event full grand-mal tonic seizure was considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: HEP, HEP
Symptoms: Electroencephalogram abnormal, Foaming at mouth, Grand mal convulsion, Hypotonia, Muscle rigidity
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a 6 day old male patient with none pertinent medical history and drug reactions or allergies. On 09-OCT-2014 in the afternoon (also reported as 09-SEP-2014) the patient was vaccinated with RECOMBIVAX HB (dose/frequency reported as: 1 shot, therapy route reported as: injection, lot # K006682, 17-DEC-2015). No concomitant medication was reported. On 10-OCT-2014 between 20:15 and 20:30 the patient experienced a full grand-mal tonic seizure. The patient went rigid, shook, could not breathe and foamed at the mouth for a little over a minute, then went limp, then went into another seizure, that lasted a few seconds. The reporter stated that the patient was hospitalized for at least 24 hours (in October 2014 (exact date unspecified)) where had an EEG (Electroencephalogram) that showed abnormal results. The patient had also performed unspecified tests on blood, urine, CVCs (unspecified), electrolytes and sugars (no results were provided). KEPPRA was given as a treatment for the event. The patient sought medical attention. The outcome of event was not reported. The relatedness between event and RECOMBIVAX HB was not reported. Upon internal review, event full grand-mal tonic seizure was considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: HEP, HEP
Symptoms: Tonic convulsion, Tremor, Urine analysis
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a 6 day old male patient with none pertinent medical history and drug reactions or allergies. On 09-OCT-2014 in the afternoon (also reported as 09-SEP-2014) the patient was vaccinated with RECOMBIVAX HB (dose/frequency reported as: 1 shot, therapy route reported as: injection, lot # K006682, 17-DEC-2015). No concomitant medication was reported. On 10-OCT-2014 between 20:15 and 20:30 the patient experienced a full grand-mal tonic seizure. The patient went rigid, shook, could not breathe and foamed at the mouth for a little over a minute, then went limp, then went into another seizure, that lasted a few seconds. The reporter stated that the patient was hospitalized for at least 24 hours (in October 2014 (exact date unspecified)) where had an EEG (Electroencephalogram) that showed abnormal results. The patient had also performed unspecified tests on blood, urine, CVCs (unspecified), electrolytes and sugars (no results were provided). KEPPRA was given as a treatment for the event. The patient sought medical attention. The outcome of event was not reported. The relatedness between event and RECOMBIVAX HB was not reported. Upon internal review, event full grand-mal tonic seizure was considered to be medically significant. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Malaise, Vaccination site swelling
Clinical narrative: After receiving the vaccination, her arm started to swell at vaccination site.  By the evening of 10/14, her arm was very swollen from shoulder to elbow, with redness, itching, hot to the touch, and general malaise. Still swollen when she came to pharmacy to inform us of her reaction on 10/16.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Carotid sinus massage, Disorientation, Dizziness, Dyspnoea, Feeling abnormal
Clinical narrative: Tachycardia (112-120 bpm) palpitations, shortness of breath, feeling faint, slightly disoriented.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Palpitations, Sensation of pressure, Tachycardia
Clinical narrative: Tachycardia (112-120 bpm) palpitations, shortness of breath, feeling faint, slightly disoriented.