chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: This spontaneous report as received from a nurse refers to a 13 years old female patient. No medical history of concomitant conditions were reported. It was reported that the patient had no known allergies. The nurse reported that the patient received the first dose of GARDASIL on 12-JUN-2012 (lot number reported as 1016Z with an expiration date of 22-NOV-2012). The second dose was received on 17-AUG-2012 (lot number reported as 1016Z with an expiration date of 22-NOV-2012). The route of administration and anatomical location were not reported. No co-suspects or concomitant medications were reported. The patient developed fatigue with whole body pain, but mostly abdominal and back pain on 24-SEP-2012. About a week later the patient experienced a headache with worsening of the pain (whole body pain but mostly abdominal and back pain) and a burning sensation (discomfort) in the chest. Fatigue was reported as a significant disability or incapacity because the patient was unable to attend school for the last month due to fatigue. The patient was evaluated for a urinary tract infection and Rocky Mountain Spotted Fever. No results were provided. The patient had an emergency room visit in the first week of October which was pain related. No treatment information was provided and the patient did not recover from the events. The reporter relatedness for fatigue, burning sensation (discomfort) in the chest, headache, whole body pain but mostly abdominal and back pain is unknown for GARDASIL. No further information was provided. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema
Clinical narrative: Redness & erythema at injection site.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Sensory disturbance, Syncope
Clinical narrative: Fainted, light-headed, SOB for at least 24 hrs. Discussed w/ mother. Cont. to feel pulsations in arm vaccine given. No further doses will be given since response to further doses unknown.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Convulsion, Dyskinesia, Hypotonia, Lethargy, Neurological examination normal
Clinical narrative: Patient is a previously healthy 4-month-old male born via spontaneous vaginal delivery following uncomplicated pregnancy who developed stereotypic events concerning for seizure approximately 2-3 weeks ago. These events consisted of oral motor movements followed by loss of tone and lethargy and were occurring 3-4 times per day. Reassuringly however patient has a normal neurologic examination today and has not had an episode of these movements for the past week. Given his typical development and normal neurologic examination I am less concerned that this is a manifestation of a seizure disorder however these events were fairly stereotypical and performing an EEG would be a simple way to further investigate this. If his EEG has a focal abnormality, I would consider at that time further neural imaging (MRI of the brain without contrast). At this time, I am hesitant to order an MRI of the brain as I believe it would need to be performed under sedation and given that the episodes have stopped I think the clinical scenario does not merit this level of investigation at this time.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Stereotypy
Clinical narrative: Patient is a previously healthy 4-month-old male born via spontaneous vaginal delivery following uncomplicated pregnancy who developed stereotypic events concerning for seizure approximately 2-3 weeks ago. These events consisted of oral motor movements followed by loss of tone and lethargy and were occurring 3-4 times per day. Reassuringly however patient has a normal neurologic examination today and has not had an episode of these movements for the past week. Given his typical development and normal neurologic examination I am less concerned that this is a manifestation of a seizure disorder however these events were fairly stereotypical and performing an EEG would be a simple way to further investigate this. If his EEG has a focal abnormality, I would consider at that time further neural imaging (MRI of the brain without contrast). At this time, I am hesitant to order an MRI of the brain as I believe it would need to be performed under sedation and given that the episodes have stopped I think the clinical scenario does not merit this level of investigation at this time.
Age: 62.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Cellulitis, Feeling cold, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: 24 hr post vaccination felt achy, cold, freezing, erythema at ZOSTAVAX site, swelling, red rash, went to urgent care temp 103, tachycardia -> ER IV ANCEF & KEFLEX for home ER again 10/21/12 BACTRIM/ZOFRAN cellulitis diagnosed.
Age: 62.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pain, Pyrexia, Tachycardia
Clinical narrative: 24 hr post vaccination felt achy, cold, freezing, erythema at ZOSTAVAX site, swelling, red rash, went to urgent care temp 103, tachycardia -> ER IV ANCEF & KEFLEX for home ER again 10/21/12 BACTRIM/ZOFRAN cellulitis diagnosed.
Age: 71.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Chills, Migraine, Nausea, Pain, Swelling
Clinical narrative: Pt states that evening after receiving vaccines experience severe migraine headache, body aches, chills that lasted 3 days. Migraine made her nauseated.
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Nasal congestion, Pyrexia, Sleep disorder, Sneezing
Clinical narrative: Sneezing, coughing, nasal congestion, fever 98.9, disrupted sleep.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Headache, Immediate post-injection reaction, Pruritus
Clinical narrative: Immediate burning sensation for 24 hr. Then red blotch 5 inches by 1 1/2 inches with itching continuously. Headache and low grade fever. Itching and sensitivity continues. Redness beginning to fade today - 7 days post vaccination.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash erythematous, Rash macular
Clinical narrative: Immediate burning sensation for 24 hr. Then red blotch 5 inches by 1 1/2 inches with itching continuously. Headache and low grade fever. Itching and sensitivity continues. Redness beginning to fade today - 7 days post vaccination.
Age: 22.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Tdap administered to approx 8 wk pregnant pt. Adverse affects unknown. Pt found out she is pregnant day of vaccine administration. Provider ordered vaccine to be administered.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Immediate post-injection reaction, Injection site erythema
Clinical narrative: Instant - redness at injection site - rapidly increasing in size. Ice applied - TYLENOL given 15 mins - decrease in size.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain, Rash pruritic, Swelling
Clinical narrative: Initially pain, swelling, itching right breast. Progressed to itching rash - swelling right side of neck then pain in neck and right ear. Rash on right wrist - then right waist (tiny blisters in a line).
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Vomiting
Clinical narrative: 24 hours after vaccination redness, swelling, warmth at injection site - 36 hours after vaccination vomiting x 3 - mother reports no fever - (ADVIL given warm compress to leg).
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Contusion, Erythema, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Red, swollen, "bumpy", warm area where vaccines given, 10x6 cm splotchy erythema on (L) thigh with 2cm area of bruising without induration no difficulty using legs.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site warmth, Rash macular
Clinical narrative: Red, swollen, "bumpy", warm area where vaccines given, 10x6 cm splotchy erythema on (L) thigh with 2cm area of bruising without induration no difficulty using legs.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Convulsion, Petit mal epilepsy, Syncope
Clinical narrative: Patient received GARDASIL and MENACTRA vaccine, patient fainted and had two seizures. Seizure activity lasting for approx. few seconds each. Petit mal activity.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Patient developed vomiting (x4 episode with the last possibly bilious) and diarrhea with fever to 102.7 within 24 hr of receiving vaccines. Afebrile in office, with normal mental status and abdominal exam on 11/9/12.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever - 103.5 - went to ER.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 1 week after injection pt states the injection site became hard and red about the size of a silver dollar. No pain. No fever. No treatment. Pt advised to monitor. Pt returned call next day stating injection sit improving.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Discomfort, Pain
Clinical narrative: Patient experiencing needle like shooting pain which had disrupted her life since she got the shot. Pain scale 6-8 and extremely uncomfortable with any chore at home.
Age: 7.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Patient has been diagnosed with Herpes zoster.
Age: 88.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, erythema, swelling of upper arm surrounding injection site. 5 inch x5 inch.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a group of unspecified patients. The patients were vaccinated with RECOMBIVAX HB (date, route and lot number unknown). No other co-suspects were reported. No concomitant medications were reported. On unknown dates the patients received vaccine doses that were exposed to temperatures above 46 F for 45 minutes, with the highest temperature of 78 F for 15 minutes. No adverse effect reported. No treatment information was reported. Information about GARDASIL, PNEUMOVAX23, PEDVAXHIB and VAQTA that were exposed to temperatures above 46 F for 45 minutes, with the highest temperature of 78 F for 15 minutes is also reported. This is information is processed in the linked cases: 1210USA007111, 1211USA001302, 1211USA001297 and 1211USA001298. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: This spontaneous reports as received from a male patient of unknown age refers to himself. The patient was vaccinated with ZOSTAVAX (route, dose and lot # were not reported) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. The patient experienced that after receiving ZOSTAVAX his arm has turned red, swollen, and itchy. No treatment was given. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. Additional information is not expected.
Age: 0.93
Sex: M
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant a 11.5 months old patient. The patient was vaccinated with dose 1 of VARIVAX (lot # and route not reported) at 11.5 months of age. No concomitant medications were reported. No adverse symptoms were reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 years old female patient. The patient's medical history included no drug reactions/allergies. On 13-OCT-2012 the patient was vaccinated with ZOSTAVAX (vial. lot number reported as H011431, expiry date 12-SEP-2013), 0.65 ml subcutaneously (dose number not reported). No other co-suspects were reported. No concomitant medications were reported. In October 2012 (exact date not reported) the patient experienced a small rash the size of 2 half dollars at the site of injection. The patient sought medical attention by visiting the pharmacy. No treatment was given, no labs were performed. The outcome of 'small rash the size of 2 half dollars at the site of injection' is unknown. A reporter causality for 'small rash the size of 2 half dollars at the site of injection' was not provided for ZOSTAVAX. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: FLUX, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: This spontaneous reports as received from a patient's mother refers to a 12 months old female patient. She reported that her daughter had the "first doses" of M-M-R II (route and lot# unspecified), VARIVAX (Merck) (route and lot# unspecified) and a dose of influenza virus vaccine (manufacturer unspecified) (route, dose and lot# unspecified) on 15-OCT-2012. Concomitant medications included ranitidine and vitamins (unspecified). The patient's mother reported that the last night (23-OCT-2012) the patient had a fever of 101.6 degrees Fahrenheit and no other adverse reactions. The patient was treated with TYLENOL. The patient the next morning (on 24-OCT-2012) had a normal temperature of 98 degrees Fahrenheit. The patient's mother feared that the temperature might "spike back up" later on that day. At the time of the report, the patient was recovering of fever. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Pain, Pruritus, Upper extremity mass
Clinical narrative: This spontaneous report as received from a 67 years old female consumer refers to herself with breast cancer, drug allergy to unspecified amnesia drug and drug allergy to pain pills. The patient was subcutaneously vaccinated with a dose of 0.65 ml ZOSTAVAX on 13-OCT-2012. No other co-suspects were reported. Concomitant medication included unspecified thyroid medication. On 14-OCT-2012 "a day after receiving ZOSTAVAX", the patient experienced itching and redness on her injection arm. It was varying degrees of red, swollen, and with a lump. As of today, the redness has reduced from an original grapefruit-sized circle to a quarter-sized circle. She mentioned that there was some minor pain, and she treated herself with over-the-counter antihistamines. The patient had not sought medical attention and no laboratory diagnostics studies were performed. The outcome of itching on her injection arm, some minor pain, her injection arm with a lump, her injection arm swollen and redness on her injection arm, varying degrees of red was reported as recovering/resolving. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Information regarding the patient's medical history was not provided. On 15-OCT-2012 the patient was vaccinated with two doses of VAQTA (dose, route and lot number was not reported for both doses). No other co-suspects were reported. No concomitant medications were reported. The patient had received two doses of VAQTA instead of one dose of VAQTA and one dose of RECOMBIVAX. No adverse effects were reported. No treatment information was reported. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse concerning an 84 year old female patient who on 04-NOV-2012 was vaccinated with an expired dose of PNEUMOVAX 23 (lot number 9874408, expiration date October 2011) (dose and route not provided). No adverse reactions noted. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Oedema peripheral
Clinical narrative: This spontaneous report was received from a doctor in pharmacy concerning to a 65 year old female patient with thiazides allergy, sulfonylureas allergy and carbonic anhydrase inhibitors allergy. On 25-OCT-2012, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX (dose and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that about 10 days ago, in approximately 27-OCT-2012, the patient went to the emergency room (was unspecified and the pharmacist was unsure at the time of the call if the patient was ever hospitalized) complaining of a several headache, swelling and redness of the arm (believed to be injection arm). The patient went to their physician on 05-NOV-2012 and the physician reported to the pharmacist that the patient was slowly resolving. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Urticaria
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative refers to a 70-year-old female patient. On 04-NOV-2011 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # 0813AA, expiration date 17-MAR-2013) dose and route not reported. No concomitant medications were reported. On 05-NOV-2011 the patient developed a fever of 101 Fahrenheit (F). On 08-NOV-2011 the patient developed hives on an unspecified area of the body. The patient went to an unspecified walk-in clinic. The patient was given prednisone (dose and manufacturer unspecified). The patient recovered on an unspecified date. The patient sought medical attention for the events. No further information is available. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling, Malaise, Pyrexia
Clinical narrative: This spontaneous report was received from a physician regarding a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # 0491AE, expiry and route not reported). No concomitant medications were reported. On an unknown date, the patient experienced local swelling at injection site, malaise and fever. It was unspecified if the patient had sought medical attention. No treatment information was reported. The outcome of local swelling at injection site, malaise and fever was unknown. This one of several reports received from the same reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Oedema peripheral, Pruritus, Upper extremity mass
Clinical narrative: This spontaneous report as received from a 63 years old female patient with no pertinent medical history and no drug reactions/allergies, reporting on herself, who was vaccinated with a dose of ZOSTAVAX (lot# and dose not reported) subcutaneous, on her left arm, on 18-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On 18-OCT-2012 the patient experienced that "it had been about 3 inches x 2.5 inches down on arm, itchy, and swollen, hard lump, on back side of her arm where she had had a red area". The patient did not seek medical attention and no treatment was given. No lab diagnostics studies were performed. At the time of report the status of patient was unknown. The relatedness for adverse events were not reported for ZOSTAVAX. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Jaundice, Malaise
Clinical narrative: This spontaneous report as received from a nurse refers to a 62 years old male patient with thyroid disease, hypertension and diabetes. The patient was vaccinated with ZOSTAVAX (lot number, expired date, dose and injection site were not reported) (subcutaneous injection) for prevention of shingles on 29-OCT-2012. No other co-suspects were reported. Concomitant medications included: TDAP. The patient came back in the office for medical attention on 01-NOV-2012 sick where he was diagnosed having jaundice. The adverse event onset date was 29-OCT-2012. The outcome was unknown at the time of report. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to two unspecified patients of unknown age. The patients were vaccinated with doses of PNEUMOVAX 23 (dose, route, lot# not reported) on unspecified dates, from a multi-dose vial that had been exposed to an unspecified, unsupportable temperature excursion. No adverse effect reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to a patient with unspecified age, gender, pertinent medical history or drug reaction / allergies. On 29-OCT-2012, the patient was vaccinated intramuscularly with 0.5 ml dose of LIQUID PEDVAXHIB (lot number 0236Z (in verification process)and exp date 19-OCT-2012). No other co-suspects were reported. No concomitant medications were reported. On 29-OCT-2012, the patient received a dose of LIQUID PEDVAXHIB (lot number 0236Z and exp date 19-OCT-2012) and vaccine expired on 19-OCT-2012. No treatment information was reported. The patient's outcome was unknown. No adverse effect reported. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthropod bite, Neuralgia, Rash
Clinical narrative: This spontaneous report as received from a consumer refers to her 75 years old husband with no drug allergy. The reporter had been traveling and thought perhaps the rash on her husband's face was due to a bug bite. The reporter said when they got back home her husband had visited his HCP and given a dose of ZOSTAVAX (lot#, dose and route unspecified) in the second week in August 2012. Concomitant medication included ibuprofen 3 every 6 hours. It was later determined he had shingles at the time of injection. The reporter stated the rash only lasted two weeks after the vaccine was given however the patient was experiencing extreme nerve pain on approximately 11-AUG-2012 ("2nd weekend in August"). The patient was treated with gabapentin 400 mg. The outcome of extreme nerve pain was unknown. The patient had sought unspecified medical attention. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a healthcare professional refers to a 60 years old female patient. The patient was vaccinated with a dose of ZOSTAVAX (dose, route not reported, lot # reported as H012575) on 16-OCT-2012. On 17-OCT-2012 the patient experienced baseball size around injection site, red from shoulder to elbow. The patient was advised to take BENADRYL as directed and apply cold compress. It was reported that the patient did not seek medical attention. The outcome of adverse events was reported as unknown. The relatedness for baseball size around injection site and red injection site, from shoulder to elbow is unknown for ZOSTAVAX. Additional information is not expected.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 55 years old female patient with allergy to sulfa and azithromycin and no past drug history. The patient was vaccinated with expired lot # (669776/0614AA, exp. 27-SEP-2012), 0.5 ml PNEUMOVAX23, IM on 19-OCT-2012. There was no concomitant medications. Additional information has been requested.
Age: 0.23
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, Nasopharyngitis, Rhinorrhoea, Upper respiratory tract infection
Clinical narrative: This spontaneous report as received from a medical assistant refers to an 83 days old female patient with no drug or food allergies or pertinent medical history. The patient was vaccinated with a dose of 0.5 ml VARIVAX (Merck) (Lot# reported as H006538 and Exp date reported as 09-MAR-2014) and M-M-R II (Lot# 0128AE and Exp date: 10-JAN-2014) subcutaneously on 28-SEP-2012. Concomitant medications included selenium sulfide and EUCERIN creme. The medical assistant stated that the patient received M-M-R II and VARIVAX (Merck) too early on 28-SEP-2012. The patient was seen in office on 05-NOV-2012 for an upper respiratory infection, runny nose and cold. The patient presented smiling and happy. The patient did not seek medical attention. No lab diagnostics studies were performed. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 49 years old female patient with Chronic obstructive pulmonary disease (COPD), emphysema and drug allergy to sulfas. The patient's medical history included pneumonia. The patient was intramuscularly vaccinated with a dose of 0.5 ml PNEUMOVAX23 (lot number reported as 19478A, expiry date: 20-OCT-2013) on 31-OCT-2012. No other co-suspects were reported. Concomitant medications included albuterol sulfate and fexofenadine hydrochloride, ALLEGRA. On 31-OCT-2012 the patient could not lift her arm after receiving PNEUMOVAX23. The patient called the physician, who advised that she take BENADRYL (unspecified strength and amount) and alternate hot and cold compresses on the affected arm. There were no laboratory diagnostics studies performed. The outcome of could not lift her arm after receiving PNEUMOVAX23 was reported as recovering/resolving. This is one of several reports from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to a 66 years old female patient with no pertinent medical history who have drug allergy to sulfa. The patient was intramuscularly vaccinated with a dose of 0.5 ml PNEUMOVAX 23 (lot number reported as H009826, expiry date: 11-FEB-2014) on 13-AUG-2012. No other co-suspects were reported. Concomitant medications included FLEXERIL. On 13-AUG-2012 the patient developed injection site reactions after receiving a dose of PNEUMOVAX 23. The sire of injection was swollen, warm, red, and tender. The patient had sought medical attention via office visit. No laboratory diagnostics studies were performed. Steroid cream and BENADRYL were given for the adverse events. The outcome of the site of injection was swollen, the site of injection was tender, the site of injection was red and the site of injection was warm was reported as recovered/resolved on 17-AUG-2012. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 70 years old female patient with asthma, tuberculosis and no drug reactions/allergies. The patient was intramuscularly vaccinated with a dose of 0.5 ml PNEUMOVAX 23 (lot number reported as 1947A, expiry date: 20-OCT-2013) on 29-OCT-2012. No other co-suspects were reported. Concomitant medications included: hydrochlorothiazide, losartan potassium. On 29-OCT-2012 the patient could not lift her arm after receiving PNEUMOVAX 23. The patient called the physician, who advised that she take BENADRYL (unspecified strength and amount) and alternate hot and cold compresses on the affected arm. There were no laboratory diagnostics studies performed. She was recovered on 31-OCT-2012. This is one of several reports from the same source. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Insomnia, Pyrexia
Clinical narrative: This spontaneous report was received from a consumer concerning a 73 year old female patient with no pertinent medical history. Patient's current condition included iodine allergy. On 09-OCT-2012, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously in her left arm (dose, lot number unspecified). Concomitant medications included unspecified cholesterol medicine, unspecified thyroid medicine and aspirin. On 09-OCT-2012 the patient experienced fever, itching at the site of injection. She was unable to sleep after the vaccination. No treatment was provided. The consumer referred her to a physician due to itching and inquired that how long to stay away from newborns. The outcome of unable to sleep after the vaccine, itching at the site of injection and fever was unknown. The relatedness for fever, unable to sleep after the vaccine and itching at the site of injection was unknown for ZOSTAVAX. Additional information has been requested.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician assistant via company representative refers to a 73 years old patient. The patient was vaccinated with a dose of ZOSTAVAX (lot number not provided) subcutaneously on an unknown date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced shingles after receiving ZOSTAVAX. The outcome of shingles was reported as recovered. The patient saw healthcare professional (HCP) for seek medical attention. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Eye irritation, Headache, Insomnia, Sinus congestion
Clinical narrative: This spontaneous report as received from a office manager refers to a 51 years old male patient with high cholesterol, high blood pressure and no drug allergies. The patient was vaccinated with 0.5 ml PNEUMOVAX 23 (lot# was unknown) on 23-OCT-2012. Concomitant therapies included FLUVIRIN. On 23-OCT-2012 the patient experienced sinus congestion, problems sleeping, burning of eyes and headache. There was no treatment. The patient contacted the physician's office for medical attention. No lab diagnostics was performed. The outcome of sinus congestion, headache, problems sleeping and burning of eyes was reported as recovering/resolving. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Limb discomfort, Musculoskeletal stiffness
Clinical narrative: Flu shot resulted in stiffness and discomfort in arm and shoulder-received 2 months of physical therapy and finally injections - took about 1 & 1/2 years to completely heal.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Decreased appetite, Headache, Injection site erythema, Injection site pain
Clinical narrative: Fever to 101.8 x 3 days, myalgias diffuse; local increasing tenderness, redness and swelling at site, rigors, headache, anorexia.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Fever to 101.8 x 3 days, myalgias diffuse; local increasing tenderness, redness and swelling at site, rigors, headache, anorexia.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Chest pain, Pain in extremity, Rash
Clinical narrative: Soreness in arm shot was given, followed by rash and soreness to chest area.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Guillain-Barre syndrome, Headache, Vomiting
Clinical narrative: Patient complained about headache then next day stated she had diarrhea and vomiting 11/6/12 then store asst. director stated patient went to hospital 11/09/12 and patient stated she has Guillain Barre syndrome. We at the pharmacy have not confirmed from patient or hospital yet on diagnosis.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site erythema, Paraesthesia
Clinical narrative: 10/31/12 injection site redness & no recall of exact time left arm tingling. Arm tingling progressed over next few days and no relief from chiropractor. Area appears dark bruise 11/10/12. Advised to seek medical help if worse or other symptoms.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site vesicles, Injection site warmth
Clinical narrative: This morning, patient discovered that she has approx 2 inch red area around injection site, area has small blisters, warm to the touch and is hard, can feels like an egg under the skin. Patient is experiencing no pain and did not even notice the reaction until someone else pointed it out to her.  Patient said that after the immunization she was exhausted, and needed to lay down to take a nap which is unusual to her.
Age: 81.0
Sex: M
Vaccine: TDAP
Symptoms: Chills
Clinical narrative: Chills, no manually detected fever (not measured with thermometer); time course approx 5P-2AM (11/10/2012); treatment=cover w/3 blankets & robe.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Blister, Herpes zoster
Clinical narrative: Severe pain in upper back joint; broke out in Shingles blisters on 11/06/12.
Age: 52.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Back pain, Band neutrophil count increased, Blood culture negative, Injection site erythema, Injection site pain
Clinical narrative: Pain, warmth, erythema and tenderness over site of injection (lateral aspect of left deltoid), fever of 102.5, area of redness is not quite cirucular but approximately 5 to 6 inches in size around site of injection.  Also complained of severe back pain onset concurrent with fever and left deltoid pain and redness.
Age: 52.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Pyrexia, White blood cell count normal
Clinical narrative: Pain, warmth, erythema and tenderness over site of injection (lateral aspect of left deltoid), fever of 102.5, area of redness is not quite cirucular but approximately 5 to 6 inches in size around site of injection.  Also complained of severe back pain onset concurrent with fever and left deltoid pain and redness.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Discomfort, Insomnia, Mobility decreased, Musculoskeletal pain, Neck pain
Clinical narrative: Left shoulder pain and pain in neck lower left side. Mobility limited by 20%. Discomfort disrupts sleep. Taking ibuprofen with little affect.
Age: 40.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthenia, Chills, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: For 48 hours, I had alternating fever and chills, severe body aches, and sore throat. I only took ibuprofen and naproxen and after that 48 hours I was fine, although slightly weak.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Injection site rash, Malaise, Mobility decreased, Myalgia
Clinical narrative: After pneumococcal vaccine, left arm administration (IM injection): left arm soreness, painful to touch in evening after administration similar to past injections. Next morning: Severe pain, inability to raise arm laterally past 90 degrees, severe pain to touch, required ibuprofen to control pain > 48 hours after administration. Malaise, fatigue, localized muscle pain. No fevers. Rash noted >48 hours after administration approx 3 inch x 2 inch in area of injection site. At 72 hours mild pain and rash continue.  Reported because of length of pain / rash, no life-threatening side effects.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Tenderness
Clinical narrative: After pneumococcal vaccine, left arm administration (IM injection): left arm soreness, painful to touch in evening after administration similar to past injections. Next morning: Severe pain, inability to raise arm laterally past 90 degrees, severe pain to touch, required ibuprofen to control pain > 48 hours after administration. Malaise, fatigue, localized muscle pain. No fevers. Rash noted >48 hours after administration approx 3 inch x 2 inch in area of injection site. At 72 hours mild pain and rash continue.  Reported because of length of pain / rash, no life-threatening side effects.
Age: 32.0
Sex: M
Vaccine: FLUX, TDAP
Symptoms: Blood test, Discomfort, Nodule
Clinical narrative: Pea-sized nodule above collar bone on same side as shot.  Experienced discomfort. Nodules also discovered in throat after examination.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: Severe pain in pectoral muscles with radiation to back of arms and between shoulder blades, little to no relief with anti-inflammatory meds, ongoing.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Erythema, Musculoskeletal stiffness, Skin warm
Clinical narrative: Per call from patient. Whole arm hot and red. Joint pain and stiff neck (11-8-12). Patient saw doctor, but doctor did not indicate if he thought it was related to vaccine.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: 11/5/12: Vaccine administered; 11/6/12: Patient said does not feel well - chills (advised to call MD but refused); spouse came into pharmacy said 103 degree fever advised to go directly to urgent care - given tel & address 11/7: spoke to pt 4 PM - he feels much better - did not go to urgent care; fever broke 1 AM & has felt a lot better since; advised him to contact us if feels bad.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Immediate swelling around site. Decreased after 15 minutes. Called pt few hours later. He was fine.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. The patient was vaccinated with the first and second dose of GARDASIL (dose, route and lot number not provided) respectively on 28-SEP-2011 and 16-FEB-2012. No other co-suspects were reported. No concomitant medications were reported. On 23-OCT-2012 "today" the patient was to get the third dose. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site infection
Clinical narrative: Pt states that there was improper swabbing of area. Area check of arm became infected. A one-inch needle was used.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from an other health professional (C.M.A) refers to a 77 years old female patient. On 31-OCT-2012 the patient was vaccinated with ZOSTAVAX (lot # not reported). On 03-NOV-2012 the patient was at the doctor's office with a rash at the waistband. Diazepam, VALTRAX 1 gram was given. The outcome was unknown. Additional information is not expected.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Seborrhoea, Skin odour abnormal
Clinical narrative: This spontaneous report was received from a 83 years old female consumer refers to herself. The patient was vaccinated with a dose of ZOSTAVAX (dose, route, anatomical location and lot# not reported) on 22-OCT-2012. On 24-OCT-2012, reported also as within 48 hour after vaccination, the patient noticed wet, greasy, sweaty spot under left breast. When she ran her finger through it had an offensive odor. She stated that it was a really red spot halfway up her breast and down under her breast onto her chest. She stated that the red spot was now fading. She sought unspecified medical attention. No treatment was given for adverse events. At the time of the report patient's status was reported as recovering. Additional information is not expected.
Age: 29.0
Sex: M
Vaccine: FLUN3, SMALL
Symptoms: Abnormal behaviour, Dysarthria, Headache, Neurological symptom
Clinical narrative: Sudden onset of neurological status changes, slurred speech, inappropriate behavior, headaches.
Age: 61.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Malaise, Pyrexia, Respiratory tract congestion, Sinusitis
Clinical narrative: Started feeling sick; kept thinking my immune system was just kicking in.  Ended up getting chills, fever, sinusitis and congestion that lasted for three weeks.  I treated with OTC cold and flu medicine.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dyspnoea, Fatigue, Headache, Malaise
Clinical narrative: One day following vaccination: headache, malaise, general body aches and fatigue. Four days following vaccination: dry hacking cough, headaches. Nine days following vaccination: productive cough with thick yellow sputum, headaches. Eleven days following vaccination:  productive cough with thick yellow sputum, headaches and occasional shortness of breath. Thirteen days following vaccination will be tomorrow (11/12/2012) and the soonest I will be able to contact my physician for treatment of the persistent and worsening cough.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Productive cough, Sputum discoloured
Clinical narrative: One day following vaccination: headache, malaise, general body aches and fatigue. Four days following vaccination: dry hacking cough, headaches. Nine days following vaccination: productive cough with thick yellow sputum, headaches. Eleven days following vaccination:  productive cough with thick yellow sputum, headaches and occasional shortness of breath. Thirteen days following vaccination will be tomorrow (11/12/2012) and the soonest I will be able to contact my physician for treatment of the persistent and worsening cough.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Gait disturbance, Joint stiffness, Musculoskeletal stiffness, Pain
Clinical narrative: On Day 3 after the shot, experienced acute pain and stiffness in all joints and lower back--level 6 pain in both knees, both hips, and all thigh muscles--as if injury sustained.  Impaired my ability to walk.  Treated with Ibuprofen.  Days 4, 5, 6 improved slightly, but left knee and hip remained unchanged--stiff and very painful.  Attempted 20 mins. of cycling to loosen joints, without success. Day 7 relapsed; left knee and hip worsened.  Stayed home from work; lay down; continued Ibuprofen; could not find comfortable position.  Day 8 resumed work, still limping.  Three weeks later (6/23)--though still somewhat stiff and sore, attempted to mount and ride a horse.  Crippled me.  Went to PCP and received two months of physical therapy, and continue to experience residual (albeit relatively minor) effects today.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, X-ray
Clinical narrative: On Day 3 after the shot, experienced acute pain and stiffness in all joints and lower back--level 6 pain in both knees, both hips, and all thigh muscles--as if injury sustained.  Impaired my ability to walk.  Treated with Ibuprofen.  Days 4, 5, 6 improved slightly, but left knee and hip remained unchanged--stiff and very painful.  Attempted 20 mins. of cycling to loosen joints, without success. Day 7 relapsed; left knee and hip worsened.  Stayed home from work; lay down; continued Ibuprofen; could not find comfortable position.  Day 8 resumed work, still limping.  Three weeks later (6/23)--though still somewhat stiff and sore, attempted to mount and ride a horse.  Crippled me.  Went to PCP and received two months of physical therapy, and continue to experience residual (albeit relatively minor) effects today.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia oral, Pharyngeal oedema, Sensation of foreign body
Clinical narrative: Throat started to feel like something was stuck in it. By 7:30 was swelling and my tongue started to tingle. By 10:00 the underside of my tongue was the size of a golf ball and I headed to the emergency room.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Severe swelling, redness, tenderness at site and extending over entire upper arm. Very hot and hard. Ibuprofen administered 11/9/2012 8:00 PM.
Age: 45.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Bed rest, Chills, Injection site haematoma, Injection site pain, Injection site swelling
Clinical narrative: Soreness swelling and bruising at injection site, fever of 103 and chills treated with ice packs, Anaprox, and bed rest.
Age: 45.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: Soreness swelling and bruising at injection site, fever of 103 and chills treated with ice packs, Anaprox, and bed rest.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Aphonia, Body temperature increased, Fatigue, Headache, Lymphadenopathy
Clinical narrative: By four hours after receiving the high-dose flu vaccine, I started feeling extremely tired with general malaise, then within the next hour I started feeling glands swelling just under my jawbone, beginnings of a headache and sore throat.  Within the next hour I had a full-blown sore throat, lost my voice, had a low-grade temperature and was shaking, headache became more severe and there was upper sinus congestion.  I took two aspirin and two immune booster capsules (Mannatech AO), drank a hot cup of lemon juice in water and honey and went to bed.  Within 24 hours, the symtoms started to subside.  I was back to normal on the next day and was feeling fine.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Oropharyngeal pain, Sinus congestion, Tremor
Clinical narrative: By four hours after receiving the high-dose flu vaccine, I started feeling extremely tired with general malaise, then within the next hour I started feeling glands swelling just under my jawbone, beginnings of a headache and sore throat.  Within the next hour I had a full-blown sore throat, lost my voice, had a low-grade temperature and was shaking, headache became more severe and there was upper sinus congestion.  I took two aspirin and two immune booster capsules (Mannatech AO), drank a hot cup of lemon juice in water and honey and went to bed.  Within 24 hours, the symtoms started to subside.  I was back to normal on the next day and was feeling fine.
Age: 63.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Pruritus, Rash pustular, Skin warm
Clinical narrative: This spontaneous report as received from a 61 years old female patient with no drug allergy refers to herself. The patient's medical history included chicken pox. The patient had developed chicken pox twice in her life, once as a baby and once after 30 years of teaching. The patient was vaccinated with ZOSTAVAX (lot# unknown) and influenza virus vaccine (unspecified) in a different arm on 29-SEP-2012 or 30-SEP-2012. On 21-OCT-2012 the patient developed "pustules" around the left back portion of her neck. She stated that her neck felt warm at the time. She applied BENADRYL gel to the area and the warmth went away, and at this point the area looked better than it did initially to where the pustules are disappearing. The BENADRYL stopped the itching for the treatment information. There was no lab reported and the patient did not sought medical attention. The outcome of was reported as recovering. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 11/09/12 c/o tenderness (L) upper arm after flu vaccine injection on 11/07/12. Red, mild swelling, warm area of mid lateral outer arm. MOTRIN 400mg PO Q4 hours PRN moderate pain. Seen by APRN.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Haemorrhage, Headache
Clinical narrative: This spontaneous report as received from a registered nurse refers to an approximately 16 years old female patient. The patient was vaccinated with 0.5 ml GARDASIL (lot# unspecified) in approximately September 2012. No other co-suspects were reported. Concomitant medication included an unspecified meningococcal vaccine. On approximately September 2012 ("approximately 2 months ago"), within 2-3 days of the vaccination the patient experienced a headache and heavy bleeding. No treatment information was reported. The outcome of heavy bleeding and headache was unknown. The patient had sought unspecified medical attention. No lab test was performed. Additional information has been requested.