chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received form a physician via a company representative refers to a 14 year old female patient. On 17-JUN-2014 the patient was vaccinated with the first dose of GARDASIL (lot#, strength, dose, frequency, route unspecified). No concomitant medications were taken. The patient became dizzy five minutes after the dose was given. The physician stated that the patient did not faint. The physician stated that the patient laid down and was given ginger ale, and recovered soon after (on 17-JUN-2014. No treatment was given for AE. This is one of several reports received from the same source. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a nurse via a company representative refers to a 52 year old male patient. The patient's concurrent condition included asthma, Crohn's disease, anemia, osteopenia, malabsorption syndrome, vitamin d insufficiency, COPD (Chronic obstructive pulmonary disease), GERD (Gastrooesophageal reflux disease), nocturia, emphysema and smoking. On 12-JUN-2014 the patient was vaccinated with PNEUMOVAX 23, lot # J013345, Exp Date 11-JAN-2015, 1 single shot, intramuscular. Concomitant therapies included budesonide, SYMBICORT, SINGULAIR, ACTONEL and PROAIR. On 13-JUN-2014 the patient's left arm became swollen from the shoulder to the elbow after receiving PNEUMOVAX 23. The patient seek medical attention and received BENADRYL as a treatment for the adverse event. There were no laboratory diagnostics performed. The outcome of the event was reported as not recovered/not resolved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a nurse via a company representative refers to a patient of unknown age and gender. On unknown date the patient was vaccinated with PNEUMOVAX23 (dose, Lot# and route were not reported). On unknown date the patient's left arm became swollen from the shoulder to the elbow after receiving PNENUMOVAX23. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mother states (L) anterior thigh red and swollen, hot to touch. Dr prescribed abx for cellulitis.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Mother called to report child's left leg had large red spot around shot site "way bigger than a softball", raised and hot to touch. Complained of itching day after shot but no long bothering her. Advised to use warm compress to area QED, pain control with MOTRIN or TYLENOL and call back if not improving.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Pyrexia, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Red dots started 2 days ago in the stomach and spread to arms and face. Had fever initially. Rash is itchy.
Age: 25.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Cold sweat, Pallor, Skin warm, Syncope
Clinical narrative: Patient fainted for 5 seconds after received vaccines. Her skin was pale, moist, warm to touch. Patient recovered without receiving any treatment.
Age: 27.0
Sex: M
Vaccine: FLU3, HEPAB, MNQ, TDAP
Symptoms: Abasia, Epistaxis, Feeling abnormal, Hypoaesthesia, Pyrexia
Clinical narrative: Received T/C ct c/o fever, numbness of arm, unable to walk, nosebleed and not feeling the same since receiving vaccines on 6/4/14. Ct reports still having symtoms this date.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Nausea, Oropharyngeal discomfort
Clinical narrative: Patient received ZOSTAVAX, after 5 min reported complaints of nauseous and woozy. Kept patient under close observation for about 90 min. In that time patient complained of slight headache/throat discomfort. Upon conversation the patient noted she had not eaten anything for about 16 hours. After 45 min. patient given granola bar and felt better. Left pharmacy on her own accord 90 min after vaccine administration.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Mother called stating child woke up with rash on her left thigh. States it is red and swollen and child complains of it being itchy. Did not give antihistamine for itching. Per Dr advised mom to give BENADRYL 1 tsp every 6-8 hrs as needed and to call if not improving.
Age: 55.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Adverse events = very high fever, shivering, body ache, severe swelling and pain of injection site. Duration = severe symptom: 2 days (still swelling of site). Treatment - Dr prescribed clindamycin, ZOFRAN, FIORICET.
Age: 29.0
Sex: M
Vaccine: HEPA
Symptoms: Blister, Burning sensation, Oral discomfort
Clinical narrative: BLISTERS (NOT PAINFUL) ON HANDS. MOUTH FELT LIKE IT WAS BURNT ALL OVER.
Age: 1.11
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Medication Error wrong medication administered.  Patient was to receive Prevnar 13 and was given Pneumovax 23.  No adverse reactions noted at time of visit.
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting (4x in 12 hour timeframe) and Fever.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Glycosylated haemoglobin, Herpes zoster, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a 57 year old female patient who was pre diabetic and had codeine allergy. On 08-MAY-2014, the patient was vaccinated with ZOSTAVAX. Concomitant therapies included Metformin and unspecified blood pressure medication. On 10-MAY-2014 (also reported as approximately 2 days later), the patient experienced swelling and redness at the injection site on her arm. She contacted the physician office and was told this was a normal reaction. But within a week to 10 days later she had developed a painful and itchy rash under her right arm in the armpit. On an unknown date in 2014, she also had some red bumps on her abdomen that she thinks were unrelated as they went away quickly. On 22-MAY-2014, she went to the doctor where the nurse practitioner diagnosed her as having full blown shingles. On an unknown date in 2014, the patient experienced sore throat and body aches. The laboratory diagnostics studies included A1C blood work. Patient visited doctor to sought medical attention. Patient was treated with Tramadol Hydrochloride and Bactrim DS. As of 10-JUN-2014 (also reported as of today), the patient had the rash under her right arm which was not painful and only slightly itchy and all other symptoms were resolved. The causality assessment for the events was not provided. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pain, Rash, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report was received from a 57 year old female patient who was pre diabetic and had codeine allergy. On 08-MAY-2014, the patient was vaccinated with ZOSTAVAX. Concomitant therapies included Metformin and unspecified blood pressure medication. On 10-MAY-2014 (also reported as approximately 2 days later), the patient experienced swelling and redness at the injection site on her arm. She contacted the physician office and was told this was a normal reaction. But within a week to 10 days later she had developed a painful and itchy rash under her right arm in the armpit. On an unknown date in 2014, she also had some red bumps on her abdomen that she thinks were unrelated as they went away quickly. On 22-MAY-2014, she went to the doctor where the nurse practitioner diagnosed her as having full blown shingles. On an unknown date in 2014, the patient experienced sore throat and body aches. The laboratory diagnostics studies included A1C blood work. Patient visited doctor to sought medical attention. Patient was treated with Tramadol Hydrochloride and Bactrim DS. As of 10-JUN-2014 (also reported as of today), the patient had the rash under her right arm which was not painful and only slightly itchy and all other symptoms were resolved. The causality assessment for the events was not provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Blood glucose normal, Presyncope
Clinical narrative: Weakness, presyncope starting 12 hours after injections given, persisted into next day.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse to a patient of unknown age. On 14-JUN-2014, the patient was vaccinated with a booster dose of VARIVAX lot# H011233, expiration date 12-JUN-2014 (also reported as 06-JUN-2014), 2 days after expiration date, for unknown indication. On an unknown date in April 2003, patient was vaccinated with VARIVAX, 0.5 ml (milliliter), subcutaneous, for unknown indication. No concomitants were reported. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. No additional information provided. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 14 year old patient. The patient's medical history was not reported. On an unknown date in 2005, the patient was vaccinated with first dose of RECOMBIVAX HB. Concomitant medications were not reported. On an unknown date in 2009, the patient was vaccinated with second dose of RECOBIVAX HB. On 04-JUN-2014 the patient was vaccinated with third dose of RECOMBIVAX HB. No adverse effect reported. The outcome of inappropriate schedule of drug administration was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: This spontaneous report as received from retired nurse also reported as healthcare worker via company representative concerns a female patient in her sixties years of age who was referring to herself. Medical history was not reported. On an unspecified date in 2006, the patient was vaccinated with ZOSTAVAX (dose, units, dose number, anatomical location, route of administration, and lot number were not reported). Concomitant medications were not reported. On an unspecified date in fall 2013, the patient developed shingles. The patient developed the shingles in face and eye area. The patient received treatment from Urgent Care Facility from which she had retired. On unspecified date in 2013, the patient was also referred to optometrist as the shingles was also in the eye (area of side not specified). The reporter stated that the patient did not develop PHN (post-herpetic neuralgia) commonly associated and has since recovered (date unspecified). The patient was treated with antiviral drugs (manufacturer unspecified, dose unspecified) and Prednisone (manufacturer unspecified, dose unspecified). The patient did not seek medical attention. The outcome of the reported events was reported as recovered (date unspecified). The relatedness between provided events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Laboratory test, No therapeutic response
Clinical narrative: This spontaneous report as received from a physician refers to a 21 year old female patient. On an unknown date the patient was vaccinated with a dose of RECOMBIVAX HB (dose, route and lot number not provided). The patient was revaccinated with one dose of RECOMBIVAX HB (dose, route and lot number not provided) adult dose, on an unspecified date. The physician reported that the patient was a non responder to RECOMBIVAX HB series. The patient sought unspecified medical attention. The patient had unspecified lab work that showed "less than 5". The outcome of non responder to RECOMBIVAX series was unknown. The causal relationship was not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Local swelling
Clinical narrative: CLIENT PRESENTED TO HEALTH DEPT CLINIC ON 6/2/14 FOR IMMUNIZATIONS, PHN NOTICED SWELLING & BRUISE ON ARM. CLIENT STATED INJURY IS FROM FLU VACCINE RECEIVED ON 3/12/2014.  CLIENT STATED SHE FOLLOWED-UP WITH PHYSICIAN FROM CLINIC 1 WEEK AFTER VACCINATION. PHN OBSERVED BRUISE ON CLIENT'S LEFT ARM OF ABOUT 1-INCH IN DIAMETER AND AREA OF SWELLING 2.5 INCHES X 6 INCHES. CLIENT ALSO REPORTED AREA OF REDNESS AFTER FLU VACCINE RECIEVED, PHN DID NOT OBSERVE REDNESS ON 6/2/14.
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: Laboratory test, No therapeutic response
Clinical narrative: This spontaneous report as received from a physician refers to a 17 year old male patient. On an unknown date the patient was vaccinated with the series of RECOMBIVAX HB (dose, route and lot number not provided). The physician reported that the patient was a non responder to RECOMBIVAX HB series. The patient sought unspecified medical attention. The patient had unspecified lab work that showed "less than 5" on an unspecified date. The outcome of non responder to RECOMBIVAX series was unknown. The causal relationship was not reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patient with unknown gender and age. The reporter stated that an unknown number of patients were inadvertently administered ROTATEQ (lot#, strength, dose, frequency and route unspecified) during March 2014 and April 2014 that had been improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site vesicles
Clinical narrative: This spontaneous report as received from a nurse refers to a 23 year old female patient. Concomitant therapies included DEPO-PROVERA. Approximately on an unknown date in 2009 the patient was vaccinated with VARIVAX (Merck). Later on 09-JUN-2014 when the patient was vaccinated with VARIVAX 1350 U (Merck) lot # K004419, expiration date 31-MAR-2016, dose 0.5 ml, route subcutaneous in left arm the patient developed injection site reaction on her left arm within 30 minutes of receiving VARIVAX (Merck). The reporter also stated that the patient was experiencing slight swelling, warmth, tenderness and a 4 inch by 4 and a half inch area of redness on her left arm at the injection site. The patient had reported to the nurse that she also had a few small blisters at the injection site and low grade fever. The lot number for diluents was reported as J003177, expiration date 12/2014. The patient was administered with Tuberculin skin test (09-JUN-2014): results unknown. The patient was treated with BENDARYL, Ibuprofen, TYLENOL for the events. The outcome of injection site reaction, low grade fever, redness on her left arm at the injection site and the patient is experiencing slight swelling, warmth, tenderness was reported as not recovered/not resolved. The outcome of few small blisters at the injection site was reported as recovered/resolved on an unknown date and the outcome of other event reported is unknown. The patient sought medical attention. No product quality complaint was involved. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth, Pyrexia, Tuberculin test
Clinical narrative: This spontaneous report as received from a nurse refers to a 23 year old female patient. Concomitant therapies included DEPO-PROVERA. Approximately on an unknown date in 2009 the patient was vaccinated with VARIVAX (Merck). Later on 09-JUN-2014 when the patient was vaccinated with VARIVAX 1350 U (Merck) lot # K004419, expiration date 31-MAR-2016, dose 0.5 ml, route subcutaneous in left arm the patient developed injection site reaction on her left arm within 30 minutes of receiving VARIVAX (Merck). The reporter also stated that the patient was experiencing slight swelling, warmth, tenderness and a 4 inch by 4 and a half inch area of redness on her left arm at the injection site. The patient had reported to the nurse that she also had a few small blisters at the injection site and low grade fever. The lot number for diluents was reported as J003177, expiration date 12/2014. The patient was administered with Tuberculin skin test (09-JUN-2014): results unknown. The patient was treated with BENDARYL, Ibuprofen, TYLENOL for the events. The outcome of injection site reaction, low grade fever, redness on her left arm at the injection site and the patient is experiencing slight swelling, warmth, tenderness was reported as not recovered/not resolved. The outcome of few small blisters at the injection site was reported as recovered/resolved on an unknown date and the outcome of other event reported is unknown. The patient sought medical attention. No product quality complaint was involved. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a consumer refers to herself as a 66 year old female patient with penicillin allergy. On 29-FEB-2008, the patient was vaccinated with ZOSTAVAX (dose and frequency were not reported), subcutaneous. On an unknown date in 2011, the patient experienced first shingles outbreak. On 20-JUN-2014, 2304 days after onset of therapy, the patient experienced second shingles outbreak. The patient sought medical attention and visited the office. The patient stated that the symptoms began vague and have now become full down. The patient was treated with high dose of antiviral medications with valacyclovir HCL at that time. The patient was controlling the pain ALEVE and which on scale of 1 to 10 addresses the pain at a 3-4 level. The patient was resistant to taking narcotic pain medications due to her own personal feelings about narcotics and therefore chooses not to taken them. The outcome of second shingles outbreak was reported as not recovered/not resolved. The outcome of first shingles outbreak was unknown. 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 an unspecified number of patients of unknown age and gender. On an unknown date the multiple unspecified patients were vaccinated with GARDASIL (lot#, dose, frequency and route unspecified) that was stored improperly. No adverse effect reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unknown number of patients with unknown gender and age. The reporter stated that an unknown number of patients were inadvertently administered GARDASIL (lot#, strength, dose, frequency and route unspecified) during March 2014 and April 2014 that had been improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, Injection site pain, Screaming
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. The patient medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with GARDASIL first dose ("one single shot") (dose, frequency, route, lot number and expiration date were not provided) for the prevention of HPV. No concomitant therapies were reported. On an unknown date, the patient developed terrible pain at the injection site within 44 hours after receiving the 1st shot of GARDASL. The patient was in a such pain that she woke up in the middle of the night screaming and her mother had to help her. The patient woke up the following morning and was able to do cross country running and {Tae Kwon Do}. The mother of the patient wanted to GARDASIL vaccine washed out of the patients system and did not want her to get the 2nd and 3rd shots of GARDASIL. Vaccination with next doses of GARDASIL was discontinued. The outcome of terrible pain at the injection site was reported as recovered/resolved (date unspecified). The relatedness between the event and the therapy with GARDASIL was unknown. The patient did not seek medical attention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MEN, TDAP, VARCEL
Symptoms: Guillain-Barre syndrome, Nuclear magnetic resonance imaging
Clinical narrative: Guillain-Barre Syndrome.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown of patients of unknown patient demographics. The patients medical history and current conditions is not reported. It was reported that approximately on an unknown in 2014 (reported as between February 5, 2014 and June 9, 2014) the patient were vaccinated with LIQUID PEDVAXHIB of unknown dose and route of administration (Lot # and batch # was not reported) that had been improperly stored. No adverse effects reported. The outcome is unknown. No product quality issue was reported. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood glucose, Convulsion, Cyanosis, Febrile convulsion, Vomiting
Clinical narrative: Febrile seizure approx 14 hours after 4 mo immunization given (PENTACEL, PREVENAR and ROTATEQ) mom states she gave TYLENOL twice and Ibuprofen once last at 9pm, occurred 1 1/2-2 hr later found in bed convulsing and vomited, turned blue. Taken to ER by ambulance.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown patient demographics. The patients medical history and current conditions is not reported. It was reported that approximately on an unknown date in 2014 (reported as between 5-FEB-2014 and 9-JUN-2014) the patients were vaccinated with GARDASIL of unknown dose and route of administration (Lot # and batch # was not reported) that had been improperly stored. No adverse effects reported. The outcome is unknown. No product quality issue was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. On an unknown date in July 2012 the patient was vaccinated with the first dose of GARDASIL, (lot number and expiration date unknown) 0.5 ml, intramuscular, (anatomical location unspecified). The nurse practitioner stated that the patient was in her office on 17-JUN-2014 (reported as "this morning) but did not received the second dose of GARDASIL yet. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified numbers of patients. Pertinent medical histories were not provided. The physician reported that an unspecified number of physicians (unspecified physician names) have told him that they had some new patients came to their offices with vaccination records which showed the patients received a dose of PROQUAD (Merck) (lot#, dose and route were not provided, unspecified if the dose was dose 1 or dose 2) when they were older than 12 years of age. The ages of the patients when they had received PROQUAD (Merck) were in the age range of 13 years to 15 years of age. No symptoms reported. The outcome of the events was unknown. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperhidrosis, Nausea, Visual impairment
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 12 year old female patient. The patient pertinent medical history included scholiosis. On 19-JUN-2014, the patient was vaccinated with first dose of GARDASIL lot # J009788 (0.5 ml) intramuscular. On 19-JUN-2014, three minutes after the administration of the dose, the patient experienced black vision, nausea and sweating. The healthcare worker reported that the patient did not faint and was sitting for the injection. The reporter stated that after 20 minutes, the symptoms resolved. No further information was provided. The outcome of the events was reported as recovered. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to an unknown age and gender patient. Medical history was not reported. On 18-JUN-2014 the patient was vaccinated with ZOSTAVAX, lot# H013020 expiration date 10-SEP-2013 strength, dosage and route were not reported. No adverse effects were reported. Concomitant therapy was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. No pertinent medical history and concurrent conditions reported. On an unknown date the patient was vaccinated with MMR II, subcutaneous (dose not reported). No other concomitant therapies reported. On an unknown date the patient was tested negative for rubella. The outcome of negative for rubella was unknown. The causality of the event was unspecified. The case as been linked with the cases (same reporter link) # 1406USA008681 and 1406USA012138. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Chest X-ray normal, Electrocardiogram normal, Syncope
Clinical narrative: Syncope lasting one hour after vaccine, patient transported to ER for evaluation because syncope persisted.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Polymerase chain reaction, Rash, Varicella virus test positive
Clinical narrative: Lab confirmed herpes zoster diagnosis in an individual previously vaccinated with zoster vaccine. Painful, unilateral rash in multiple dermatomes. Seen by her PCP. Treated with valacyclovir and acyclovir. Not hospitalized, lasted less than 4 weeks.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Asthenia, Dizziness, Injection site anaesthesia, Injection site pain, Muscular weakness
Clinical narrative: Pain, weakness and numbness in arm where vaccine was given.  Lignt headed, nauseous and too weak to do anything except lay down.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Nausea
Clinical narrative: Pain, weakness and numbness in arm where vaccine was given.  Lignt headed, nauseous and too weak to do anything except lay down.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Feeling hot, Swelling, Weight bearing difficulty
Clinical narrative: Heat and swelling to the point where patient could not walk or bear weight on leg.
Age: 57.0
Sex: F
Vaccine: VARCEL
Symptoms: Arthralgia, Fatigue, Pain in extremity
Clinical narrative: Complaints of mild arm soreness and fatigue.  1 Week later 6/24/14 complained of moderate to severe joint pain shoulder/hip, and fatigue.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Pt c/o arm soreness, redness at injection site.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Cough, Injection site pain, Injection site reaction, Irritability, Nasopharyngitis
Clinical narrative: Red rash, tender on the left thigh, cold/ cough, was very hot, and has been fussy.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Red rash, tender on the left thigh, cold/ cough, was very hot, and has been fussy.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Fall, Headache, Hypotonia, Loss of consciousness
Clinical narrative: Approx 2 minutes after receiving 2 vaccinations, patient was standing next to exam table and began to complain of feeling nauseated then became limp and her body began to lower to the floor. RN and patient's mother assisted patient to the floor before any injury could occur, patient's head came into contact with the wall and a metal stand up weight scale but without causing injury to patient. Patient awoke within less than 15 seconds from intially staring to slump and was alert but was asking what happened and complained of a headache on the right side and dizziness. Pt was assisted to a supine position, a pillow placed underneath her head and her feet raised upon a stool and allowed to rest for a period of time, BP taken throughout the remainder of the time the patient was monitored. Pt recovered without further events. Sips of water given.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Nausea
Clinical narrative: Approx 2 minutes after receiving 2 vaccinations, patient was standing next to exam table and began to complain of feeling nauseated then became limp and her body began to lower to the floor. RN and patient's mother assisted patient to the floor before any injury could occur, patient's head came into contact with the wall and a metal stand up weight scale but without causing injury to patient. Patient awoke within less than 15 seconds from intially staring to slump and was alert but was asking what happened and complained of a headache on the right side and dizziness. Pt was assisted to a supine position, a pillow placed underneath her head and her feet raised upon a stool and allowed to rest for a period of time, BP taken throughout the remainder of the time the patient was monitored. Pt recovered without further events. Sips of water given.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hypoacusis, Hypotonia, Nausea
Clinical narrative: Patient received the Gardasil vaccine (#K005083) on June 25, 2014 at approximately 2:30 pm administered by a nurse. Approximately 10-15 minutes later, as her mother was completing check out formalities in the lobby, patient complained of dizziness, nausea and said she could not hear too well (as though her ears were filled with fluid). She felt limp against me so I made her sit on the floor while the nurses came to her. They took her to a room and asked her to lie down. Patient asked for water and they gave her a box of juice. They put wet towel on her forehead and a dry ice pack wrapped in ice on her chest. They also took her blood pressure. After about 10-15 minutes of lying down, patient said she felt better and returned home. She went to bed in the afternoon and
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Blood aluminium, Blood test, Nasopharyngitis, Nuclear magnetic resonance imaging, Ophthalmological examination
Clinical narrative: Head starting pulling to the left with no control of neck muscles. Cold and later after the second shot on Feb 11 broke out in hives.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Posture abnormal, Spinal X-ray, Urticaria
Clinical narrative: Head starting pulling to the left with no control of neck muscles. Cold and later after the second shot on Feb 11 broke out in hives.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Dyskinesia, Dystonia, Hypotension, Tremor
Clinical narrative: Tremoring distonic movements associated with hypotension, abnormal movements persisted after hypotension resolved. Pt was sent to hospital by ambulance.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis infected, Rash erythematous, Skin warm
Clinical narrative: Very red rash with bumps, warm to the touch, pharmacist recommended taking Benadryl.  The rash enlarged in size and became infected.  Went to Urgent Care Facility on 06/08/2014.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: This spontaneous report was received from a 45-year-old nurse practitioner (also a patient). No pertinent medical history reported. Drug allergies include Sulpha and latex allergy. The nurse reported that on an unknown date in 1970 (reported as early 70's) she was vaccinated with MMR II human serum albumin (HSA), subcutaneous (dose not reported). The nurse stated that she had titres drawn in 2002 (exact date not reported) and tested negative for mumps. On an unknown date in 2002 the nurse reported that she was given a booster dose of MMR II subcutaneous. On an unknown date in 2011 she again had titres drawn and again tested negative. There was no significant disability or incapacity. There was no hospitalization required. The event was not life-threatening. No PQC involved. The outcome of the events was unknown. The causality of the event was unspecified. The case has been linked with the cases (same reporter link) # 1406USA012141 and 1406USA012138. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. No pertinent medical history and concurrent conditions reported. On an unknown date the patient was vaccinated with M-M-R II, subcutaneous (dose not reported). No other concomitant therapies reported. On an unknown date the patient was tested negative for mumps titres. The outcome of negative for mumps was unknown. The causality of the event was unspecified. The case has been linked with the cases (same reporter link) # 1406USA008681 and 1406USA012141. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Depression, Influenza like illness, Injected limb mobility decreased, Insomnia
Clinical narrative: This case was reported by a healthcare professional (the subject) and described the occurrence of flu-like symptoms in a 47-year-old female subject who was vaccinated with Influenza vaccine unspecified (GlaxoSmithKline). No pertinent medical history. In November 2012, the subject received an unspecified dose of Influenza vaccine unspecified (intramuscular, right deltoid). Within 1 week after vaccination with Influenza vaccine unspecified, the subject experienced flu-like symptoms. After 2 weeks, the events were resolved. From January 2013, the subject developed severe right frozen shoulder that lasted until January 2014. In May 2013, she went to physical therapy and it made the pain worse, she couldn't support the therapy. In August 2013, she was treated with steroid but it was not effective. She continued the physical therapy until April 2014. Her shoulder was still not normal and it caused her great stress because she's right handed and had limited range of motion. She stated that her arm hurt so much that she could not move it and she couldn't even button her bra. The pain and tenderness was so severe that she could not sleep at night. Psychologically, the pain has been difficult and depressing. The healthcare professional considered the events were disabling. At the time of reporting, the events were unresolved. The subject considered the events were almost certainly related to vaccination with Influenza vaccine unspecified. As no additional information could be obtained, the case has been closed.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Periarthritis, Stress, Tenderness
Clinical narrative: This case was reported by a healthcare professional (the subject) and described the occurrence of flu-like symptoms in a 47-year-old female subject who was vaccinated with Influenza vaccine unspecified (GlaxoSmithKline). No pertinent medical history. In November 2012, the subject received an unspecified dose of Influenza vaccine unspecified (intramuscular, right deltoid). Within 1 week after vaccination with Influenza vaccine unspecified, the subject experienced flu-like symptoms. After 2 weeks, the events were resolved. From January 2013, the subject developed severe right frozen shoulder that lasted until January 2014. In May 2013, she went to physical therapy and it made the pain worse, she couldn't support the therapy. In August 2013, she was treated with steroid but it was not effective. She continued the physical therapy until April 2014. Her shoulder was still not normal and it caused her great stress because she's right handed and had limited range of motion. She stated that her arm hurt so much that she could not move it and she couldn't even button her bra. The pain and tenderness was so severe that she could not sleep at night. Psychologically, the pain has been difficult and depressing. The healthcare professional considered the events were disabling. At the time of reporting, the events were unresolved. The subject considered the events were almost certainly related to vaccination with Influenza vaccine unspecified. As no additional information could be obtained, the case has been closed.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 PFU (plaque forming units) 0.65 ml, subcutaneously, on the lower arm. No adverse effects reported. The outcome of the patient received a dose of ZOSTAVAX subcutaneously, on the lower arm was unknown. Additional information is not expected.
Age: 1.28
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Urticaria
Clinical narrative: 48 hours after DTaP and Hib child was seen with hives all over body. Treated with antihistamines.
Age: 65.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Local swelling, Rash, Skin warm
Clinical narrative: Swelling of left arm for over a week after administration of HAVRIX, accompanied by a rash spreading down to the elbow. Region feels warm to the touch. Patient saw doctor and was told there was no cause for concern.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Tenderness
Clinical narrative: Vaccines given 6/23/14. Developed redness and swelling at site (lt arm) that night. Tenderness on 6/24 and saw MD 6/25. Rx for KEFLEX 500mg/5ml - 5ml tid x 7d.
Age: 60.0
Sex: F
Vaccine: HIBV, HIBV
Symptoms: Dizziness, Euphoric mood, Wrong drug administered
Clinical narrative: Patient received a PEDVAXHIB in error. Pneumonia vaccine ordered. When patient was notified she said she experienced dizziness and a sense of euphoria as she was leaving the clinic. Patient returned to clinic with same symptoms shortly after getting vaccine.
Age: 60.0
Sex: F
Vaccine: HIBV, HIBV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient received a PEDVAXHIB in error. Pneumonia vaccine ordered. When patient was notified she said she experienced dizziness and a sense of euphoria as she was leaving the clinic. Patient returned to clinic with same symptoms shortly after getting vaccine.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: I reported initial complaint of severe pain/stiffness in arm. On 10/7/13 but VAERS was unable to find claim. Today 6/25/14 she reports that she has had MRI's due to loss of range of motion, physical therapy and possible surgery in the future due to flu shot.
Age: 1.25
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: *Per mom on 06/19/14, all (3) vaccine sites with redness and a little raised on (LT) thigh, took about 1 wk to resolve; (RT) thigh at 2 sites), resolved in about 1-2 days, all without tx. Denies fever or hives.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Lethargy, Pyrexia
Clinical narrative: Fatigue, lethargic, fever, joint aches (hand and elbow).
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Small raised red 12mm dia, itchy (slight), slightly diminished in depth over time but still sensitive.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Localized swelling, tenderness to left outer aspect of arm.
Age: 1.25
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse reaction. KINRIX given at 15 mos - licensed for 4-6 year old.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site reaction, Irritability, Pyrexia, Rash erythematous, Wheezing
Clinical narrative: Growing rash on both thighs, rash is bumpy, red, raised. Patient fever, fussy, some wheezing in upper lungs (breathing normally).
Age: 1.75
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site swelling
Clinical narrative: Marked swelling of right leg within 24 hrs of receiving a DPT in right thigh - treated for "presumptive cellulitis" - shot given on 6/23/14.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Aphonia, Asthenia, Dyspnoea
Clinical narrative: The day after pt received the ZOSTAVAX vaccine she developed minor SOB, no energy and lost her voice.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Erythema, Hypersensitivity
Clinical narrative: This spontaneous report as received from a consumer refers to a 69 year old female patient regarding herself. The patients current conditions included element allergies. On 17-JUN-2014 the patient was vaccinated with PNEUMOVAX 23 (one time vaccination), incorrectly for treatment of an immune deficiency (deficiency unspecified). Concomitant therapies included VYTORIN (dose and frequency unspecified) and unspecified allergy medications (manufacturers, dose and frequencies unspecified). The patient reported that she had received the vaccine four inches below the shoulder, on the back fat of her arm. The patient also reported a red mark the size of a 50 and a half cent piece. The patient also reported feeling horrific deathly allergies and the patient was also coughing consistently while on call. The patient's present status was reported as recovering/resolving. The causality of the events with PNEUMOVAX 23 was not reported. Action taken with PNEUMOVAX 23 was assessed as not applicable. The patient did not seek any medical attention. No product quality issue was reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Injection site pain, Laboratory test, Menstruation irregular, Nerve conduction studies
Clinical narrative: Severe pain in injection site, headaches, body rash, chronic arm and leg pain, ovarian cysts, menstrual irregularities.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Ovarian cyst, Pain in extremity, Rash generalised
Clinical narrative: Severe pain in injection site, headaches, body rash, chronic arm and leg pain, ovarian cysts, menstrual irregularities.
Age: 40.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Pneumonia
Clinical narrative: Case number PHHY2012US110958 is an initial spontaneous report from vaccine adverse event reporting system (VAERS reference number: 466121) on 04 Dec 2012, with a follow-up information received from Quality Assurance Department (reference number: 302313) on 24 Jun 2014. This case refers to 40-year-old male patient. The patient's medical history included allergies to iodides and penicillin and iodinated contrast media. The patient was vaccinated with FLUVIRIN (batch number: 1205001 and expiry date: 30 Jun 2013) intramuscularly and PNEUMOVAX (batch number: H009826) intramuscularly on 20 Sep 2012. Two days after the vaccination, the patient experienced pneumonia. The patient could not move the arm for about 3 days. The patient went to emergency room and was hospitalized for one day. The patient was treated with antibiotics. The outcome of the events was reported as complete recovery as of 24 Sep 2012. The causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1205001) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up information received from the Quality Assurance Department (reference number: 302313) on 24 Jun 2014: Updated batch review report.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Visual field defect, Visual impairment
Clinical narrative: Case number PHHY2013US012502 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 476295) on 08 Feb 2013, with a follow-up information received from Quality Assurance Department (reference number: 215570) on 22 Jun 2014. This report refers to a 39-year-old female patient. The patient's pre-existing conditions included migraines and black spots before migraines. She was vaccinated with FLUVIRIN (batch number: 1206401 and expiry date: 31 May 2013) intramuscularly on left arm on 27 Nov 2012. On the same day at 3:45pm, she experienced black spot in center vision 1 min after vaccination. 'Stated that she felt coming on when putting medication (vaccine) in arm' (as reported). The patient had laid down on examining table and a cool cloth was kept over her eyes. The vitals were reported as normal (heart rate: 76, respiratory rate: 16 and blood pressure: 102/78). Emergency (911) was called, after taking her into hallway, patient's black spot disappeared, but had loss of peripheral vision in the right eye and tingling sensation in right fingers. Her smile was normal and equal, hand grasps were equal. The patient was taken in an ambulance to the hospital. The patient had walked to the cart. On 29 Nov 2012, patient's vision returned to normal. The patient did stay at emergency room and went home. Outcome of the remaining events were reported as condition unchanged as of 27 Nov 2012. Seriousness and causality of the events was not reported. No further information was available. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1206401) was manufactured in accordance with the approved internal procedures and it was in compliance with cGMP requirements. Non-significant follow-up received from the quality assurance department (reference number: 215570) on 27 May 2014 and 28 May 2014: Updated QA reference number. Follow up information received from the Quality Assurance Department (reference number: 215570) on 22 Jun 2014: Updated batch review report.