chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Pupillary light reflex tests normal, Retinal exudates, Scotoma, Vision blurred, Visual acuity tests normal
Clinical narrative: Case retrieved from the literature on 04 September 2013. A 53-year-old male patient presented with a complaint of "seeing a purple haze in his right eye (00) for 3 days." Ocular history was significant for remote ptetygium excision OD. Medical history, in addition to hepatitis B and C, was significant for polysubstance abuse, for which he had recently entered rehabilitation. He was currently taking buprenorphine and naloxone. He had received an influenza vaccine (manufacturer unknown, batch number, route and site of administration not reported) 10 days before noting visual symptoms. Initial examination revealed corrected visual acuity of 20/25 -2 OD and 20/20 OS. Results of pupillary reactions, confrontational visual field, color vision, and intraocular pressure were all within normal limits. An unremarkable anterior segment examination and quiet vitreous were noted. Fundus examination in right eye revealed multiple white lesions at the level of outer retina/RPE with a granular foveal appearance. Fluorescein angiography (FA) revealed early multiple punctate hyperfluorescent spots with late taining, which also involved the optic nerve head. Initial Humphrey 30-2 visual field was of low reliability, but follow-up testing revealed residual enlargement of the blind spot with a paracentral scotoma, which improved over. A diagnosis of MEWDS was made and the patient was followed with serial examinations. At the 1-month visit, the patient noted improvement in symptoms. Fundus lesions resolved and vision recovered to 20/20.
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Visual field tests normal
Clinical narrative: Case retrieved from the literature on 04 September 2013. A 53-year-old male patient presented with a complaint of "seeing a purple haze in his right eye (00) for 3 days." Ocular history was significant for remote ptetygium excision OD. Medical history, in addition to hepatitis B and C, was significant for polysubstance abuse, for which he had recently entered rehabilitation. He was currently taking buprenorphine and naloxone. He had received an influenza vaccine (manufacturer unknown, batch number, route and site of administration not reported) 10 days before noting visual symptoms. Initial examination revealed corrected visual acuity of 20/25 -2 OD and 20/20 OS. Results of pupillary reactions, confrontational visual field, color vision, and intraocular pressure were all within normal limits. An unremarkable anterior segment examination and quiet vitreous were noted. Fundus examination in right eye revealed multiple white lesions at the level of outer retina/RPE with a granular foveal appearance. Fluorescein angiography (FA) revealed early multiple punctate hyperfluorescent spots with late taining, which also involved the optic nerve head. Initial Humphrey 30-2 visual field was of low reliability, but follow-up testing revealed residual enlargement of the blind spot with a paracentral scotoma, which improved over. A diagnosis of MEWDS was made and the patient was followed with serial examinations. At the 1-month visit, the patient noted improvement in symptoms. Fundus lesions resolved and vision recovered to 20/20.
Sex: U
Vaccine: FLUX, TDAP
Symptoms: Foetal exposure during pregnancy, Foetal growth restriction
Clinical narrative: Initial report was received on 03 September 2013 from a health care professional. An unknown infant (end of pregnancy date reported as 05 November 2012) had received during mother's pregnancy Tdap and Influenza vaccine (manufacturers, lot numbers, routes and dates of administration not reported) and an unspecified amount of time later was found to have IUGR (Intrauterine growth restriction). The mother had a history of asthma and concomitant medications included albuterol and pantoprazole. No further information was available at the time of the report. The infants outcome was not reported. This case linked mother case 2012-08665. Documents held by sender: none.
Age: 58.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Allergy to vaccine, Cough, Dyspnoea, Pain, Scleral hyperaemia
Clinical narrative: Initial report was received on 03 September 2013 from a consumer who is also the patient. An adult female with a history of mild environmental allergies had received on an unspecified date in August 2013 an intramuscular influenza vaccine (lot number and site of administration not reported) and more than hour after vaccination developed a tickle in her throat which caused her to cough. The coughing became worse and caused difficulty breathing. The patient reported her sclera became reddened and she reported generalized body aches. The patient was evaluated and treated in the emergency room (treatments were not reported). The patient was diagnosed with an allergic reaction to the vaccine. No further information was available at the time of the report. The patient's outcome was recovered on an unspecified date. Documents held by sender: none.
Age: 58.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Throat irritation
Clinical narrative: Initial report was received on 03 September 2013 from a consumer who is also the patient. An adult female with a history of mild environmental allergies had received on an unspecified date in August 2013 an intramuscular influenza vaccine (lot number and site of administration not reported) and more than hour after vaccination developed a tickle in her throat which caused her to cough. The coughing became worse and caused difficulty breathing. The patient reported her sclera became reddened and she reported generalized body aches. The patient was evaluated and treated in the emergency room (treatments were not reported). The patient was diagnosed with an allergic reaction to the vaccine. No further information was available at the time of the report. The patient's outcome was recovered on an unspecified date. Documents held by sender: none.
Age: 58.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial report was received on 03 September 2013 from a consumer who is also the patient. An adult female with a history of mild environmental allergies had received on an unspecified date in August 2013 an intramuscular influenza vaccine (lot number and site of administration not reported) and more than hour after vaccination developed a tickle in her throat which caused her to cough. The coughing became worse and caused difficulty breathing. The patient reported her sclera became reddened and she reported generalized body aches. The patient was evaluated and treated in the emergency room (treatments were not reported). The patient was diagnosed with an allergic reaction to the vaccine. No further information was available at the time of the report. The patient's outcome was recovered on an unspecified date. Documents held by sender: none.
Sex: M
Vaccine: MEN
Symptoms: Syncope
Clinical narrative: Case received from a consumer who is the patient's mother on 05 September 2013: A male patient (age not reported), medical history and concomitant medication were unknown, had received a dose of Meningococcal vaccine from unknown manufacturer (Lot number, route and anatomical site of administration were not reported) on an unspecified date. On an unspecified date after vaccination, the patient fainted and was taken to the emergency room. Laboratory details and corrective medication was not reported. The patient's outcome was unknown.
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Initial report was received from a healthcare professional on 04 September 2013. A female patient (age and date of birth not reported) had received an injection of FLUZONE (Sanofi Pasteur, lot number, route and site not reported) in 2012 and an unspecified amount of time later experienced arm pain. At the time of the report, the patient was still complaining of arm pain and underwent physical therapy. Outcome was not recovered. Documents held by sender: None.
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Defect conduction intraventricular, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Electrocardiogram repolarisation abnormality, Fatigue
Clinical narrative: This study case was received from the investigator in a trial on 04 September 2013. A male subject had received the following vaccinations on 20 August 2013: ACAM2000 (lot number, route and site not reported), Typhoid (Manufacturer Unknown, lot number, route and site not reported), and Anthrax (Other Manufacturer, lot number, route and site not reported). Nine days later, on 29 August 2013, the subject was found to have an elevated Troponin level. From labwork from 29 August 2013, the troponin level was 0.67 ng/ml. The subject also experienced fatigue starting on 21 August 2013 and stopping 29 August 2013. The fatigue was considered possibly related to vaccine. The subject did not take any medications for treatment. The subject had an EKG on 03 September 2013 and it was described by reporter as "normal". On the EKG it noted, "Sinus bradycardia with occasional supraventricular premature complexes, non-specific intraventricular conduction delay, ST elevation consistent with epicardial injury, pericarditis, or early repolarization, abnormal EKG" with a notation written, "artifact." On 29 August 2013, the patient felt good and denied any trouble breathing, chest discomfort, chest pain, pressure, palpitations, shortness of breath, dizziness, and dry cough without cold symptoms. Subject circled "0" on the scale. Subject stated that one month prior to smallpox vaccine he experienced an episode of syncope. No further information was expected to become available except a follow-up redraw. The subject's outcome was not recovered. According to the Investigator, the event of elevated troponin was considered an important event and possibly related. Per the Investigator, this represents a case of potential myopericarditis and was referred to the ACAM2000 Myopericarditis Adjudication Committee for assessment. Documents held by sender: None.
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Heart injury, Pericarditis, Sinus bradycardia, Supraventricular extrasystoles, Troponin increased
Clinical narrative: This study case was received from the investigator in a trial on 04 September 2013. A male subject had received the following vaccinations on 20 August 2013: ACAM2000 (lot number, route and site not reported), Typhoid (Manufacturer Unknown, lot number, route and site not reported), and Anthrax (Other Manufacturer, lot number, route and site not reported). Nine days later, on 29 August 2013, the subject was found to have an elevated Troponin level. From labwork from 29 August 2013, the troponin level was 0.67 ng/ml. The subject also experienced fatigue starting on 21 August 2013 and stopping 29 August 2013. The fatigue was considered possibly related to vaccine. The subject did not take any medications for treatment. The subject had an EKG on 03 September 2013 and it was described by reporter as "normal". On the EKG it noted, "Sinus bradycardia with occasional supraventricular premature complexes, non-specific intraventricular conduction delay, ST elevation consistent with epicardial injury, pericarditis, or early repolarization, abnormal EKG" with a notation written, "artifact." On 29 August 2013, the patient felt good and denied any trouble breathing, chest discomfort, chest pain, pressure, palpitations, shortness of breath, dizziness, and dry cough without cold symptoms. Subject circled "0" on the scale. Subject stated that one month prior to smallpox vaccine he experienced an episode of syncope. No further information was expected to become available except a follow-up redraw. The subject's outcome was not recovered. According to the Investigator, the event of elevated troponin was considered an important event and possibly related. Per the Investigator, this represents a case of potential myopericarditis and was referred to the ACAM2000 Myopericarditis Adjudication Committee for assessment. Documents held by sender: None.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Death
Clinical narrative: Past away. 12-4-2011.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 10-SEP-2013, the patient was vaccinated with PNEUMOVAX23 (lot 3 J001180, expiry; 18-AUG-214) which was exposed to a temperature excursion that was not supported (75F for 56 hours). It was unknown if this was the first or second dose of PNEUMOVAX23 that this patient has been administered. No adverse effect reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 72 year old female patient. On an unknown ate, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, subcutaneously for prevention of shingles. No concomitant medications were reported. Approximately on 29-AUG-2013 (reported as about one and half weeks ago), the patient developed cellulitis after being administered ZOSTAVAX. The patient sought medical attention-visited an unspecified emergency room, on an unspecified date and was treated with antibiotics (unspecified names, dosages/frequencies, and manufacturers). It was confirmed that it was unknown whether the patient was admitted to the hospital for cellulitis. There were no demographics provided for the emergency room. The outcome of cellulitis was reports as recovering. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a pharmacist refers to unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with a dose of ZOSTAVAX (lot#, expiry, route not reported). On unspecified dated, the patients experienced injections site reactions following vaccination with ZOSTAVAX in the past. The outcome of injection site reactions was unknown. This is one of 2 reports received from the same reporter. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old female patient with allergy to sulfa and no pertinent medical history. On 13-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot# J002241, Expiration date 21-MAY-2014) (dose and route not reported). Concomitant therapies included cyclobenzaprine hydrochloride, atorvastatin and levothyroxine sodium (manufacturer unknown). On 19-AUG-2013 the patient experienced one inch in diameter red, itchy rash that was hard underneath. The patient sought medical attention  contacted pharmacist. There was no treatment given for adverse event. No lab diagnostics were performed. The outcome of event was reported as not recovered/not resolved. Relationship of the one inch in diameter red, itchy rash that was hard underneath to the ZOSTAVAX was not reported by the pharmacist at the time of report. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse refers to a 19 year old unknown gender patient. On 30-AUG-2013 the patient was mistakenly vaccinated with a dose of PNEUMOVAX23 (lot# H014561, expiration date: 21-MAR-2014), route and dose unspecified instead of MENACTRA. No adverse effects reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Hyperhidrosis, Local swelling, Nausea, Tremor
Clinical narrative: Per phone conversation with mother symptoms started 9-11-13 at 2:30-3:00 PM. Over the next 24 hours her daughter had projectile vomiting, shaking, sweating, chills. "Tylenol didn't seem to help." Mother states she was unable to take temp. due to vomiting and nausea. With first phone call on 9-12-13 it was recommended that mother take child to PCP for evaluation. Mother also stated child had a baseball size swelling on her right arm. Fol. up call on 9-13-13 found that mother considered child fully recovered with arm swelling gone. She had not taken child to MD. She stated she had called them and was told not to bring her in as "there was nothing they could do".
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting projectile
Clinical narrative: Per phone conversation with mother symptoms started 9-11-13 at 2:30-3:00 PM. Over the next 24 hours her daughter had projectile vomiting, shaking, sweating, chills. "Tylenol didn't seem to help." Mother states she was unable to take temp. due to vomiting and nausea. With first phone call on 9-12-13 it was recommended that mother take child to PCP for evaluation. Mother also stated child had a baseball size swelling on her right arm. Fol. up call on 9-13-13 found that mother considered child fully recovered with arm swelling gone. She had not taken child to MD. She stated she had called them and was told not to bring her in as "there was nothing they could do".
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning an approximately 12 year old female patient with asthma, environmental and food allergies, shellfish allergy, tree nuts allergy and peanuts allergy. On 05-SEP-2013, the patient was vaccinated with the first dose of 0.5 milliliter (ml) of GARDASIL (lot number and expiry date were reported as UH898AA and 30-JUN-2014 respectively), intramuscularly. Concomitant therapy included ADVAIR. On 05-SEP-2013, the patient developed widespread hives 2 hours after administration of the first dose of GARDASIL. The patient sought medical attention (office visit). She was treated by her unspecified primary care provider with unspecified antihistamines and topical cream. No lab tests were performed. At the time of the report, the event was not resolved. The reporter stated that the GARDASIL series would not be continued. The relatedness for widespread hives was unknown for GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. Information on medical history was not reported. It was reported that the patient received GARDASIL injection (lot # not reported) 0.5 ml, intramuscularly series as followed: first dose was administered on 28-OCT-2009, second on 12-JUN-2013 and third on 23-AUG-2013. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a child of unknown age. On 06-AUG-2013 the patient was vaccinated with COMVAX (route, dose, Lot # and expiration date were not provided). The patient was vaccinated with improperly stored vaccine. The patient experienced no adverse effects. It was reported that revaccination will be scheduled. This case is linked by same reported to case # 1308USA014806 of a child who received improperly stored GARDASIL vaccine and case # 1309USA006536 of a child who received improperly stored ROTATEQ vaccine. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
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 received ZOSTAVAX vial 19400 PFU (lot number, expiry date, route and dose were not reported) instead of VARIVAX. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age and gender. On 09-SEP-2013, the patient was vaccinated with a dose of MMR II (Lot number, expiry date, route and dose were not reported). Approximately on an unknown date in September 2013, the patient experienced unspecified rash. The outcome of unspecified rash was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Hypoaesthesia, Sensory disturbance
Clinical narrative: This spontaneous report as received from a pharmacist of unknown age regarding herself. Approximately on 20-AUG-2013 (reported as about 3 weeks ago), after reconstituting ZOSTAVAX (Lot number, and expiry date was not reported) she withdrew the syringe too early and got ZOSTAVAX on her hands (Topical). The effects did not show up for 5-7 days. Approximately on 27-AUG-2013 (reported as since 14 days), the patient experienced on the ring finger and pinky finger a feeling of it being frost bitten and numb. The patient was still experiencing these effects. The outcome of the event experiencing on the ring finger and pinky finger a feeling of it being frost bitten and numb was reported as not recovered/not resolved. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 6 month old patient. The nurse practitioner reported that the patient received dose 1 of ROTARIX at 2 months of age and dose 2 of ROTARIX at 4 months of age. Dosing information, route of administration and lot numbers were not provided. At 6 months of age the patient inadvertently received dose 1 of ROTATEQ. Dosing information, route of administration and lot number were not provided. No symptoms were reported. No other details. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 77 year old male patient. On 25-AUG-213 the patient was vaccinated with ZOSTAVAX 19400 PFU lot 3 J002692, 0.65 ml, subcutaneous in the upper left arm. The patient was seen at an unspecified physician's office at an unspecified date. The physician had advised the patient to be seen by the pharmacist. The pharmacist reported that on 28-AUG-2013 the patient had a really red area about 1 ½ inches in diameter on upper left arm, which looked like zoster itself in color but not raised, inside of a 5 inch in diameter lighter pink area, and the affected area looked like a bulls eye, was extremely sore and the patient could not lay on it. The outcome of the event is unknown. This case is linked by same reporter link to case # 1309USA006520 on a female patient who experienced redness and inflammation at the ZOSTAVAX administration site, on an unspecified date in 2013. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date in 2013 the patient was vaccinated with ZOSTAVAX, dosing information was not reported. On an unknown date in 2013 the patient experienced inflammation and redness at the administration site. The outcome of inflammation at the administration site and redness at the administration site is unknown. This case is lined by same reporter link to case #1308USA014147 on a 77 year old male who on 28-AUG-2013 had a really red area on his upper left arm after ZOSTAVAX vaccination. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 57 year old female patient. There were no drug allergies or reactions. On 10-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous in the right arm. Concomitant therapies included PRADAXA. On 11-SEP-2013, the patient developed 3 inch area of erythema, soreness and swelling at the injection site. Treatment rendered for the events were BENADRYL and ZYRTEC. There were  no laboratory diagnostics performed. The outcome of the events were reported as not recovered. The patient did not seek medical attention. Additional information is not expected.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Rash
Clinical narrative: This spontaneous report has been received from a 78 year old female patient concerning herself without any drug reactions/allergies. The patient's medical history included asthma. On 16-OCT-2012 the patient was vaccinated with a sing injection of 0.65 ml ZOSTAVAX (lot number unspecified) subcutaneous at a local pharmacy. There was no concomitant medications. The patient stated she had broken out in a rash on her back that looked like "prickly heat". The rash began forming on 31-AUG-2013. The patient said she felt jabbing pains in the area of her back where the rash was. The outcome of the events was not recovered/not resolved. The patient had not yet contacted her doctor but planned to do so. 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 nurse refers to a child of unknown age. On 18-JUN-2013 the patient was vaccinated with ROTATEQ (route, dose, Lot # and expiration date were not provided). The patient was vaccinated with improperly stored vaccine. The patient experienced no adverse effects. It was reported that revaccination will be scheduled. This case is linked by same reporter to case # 1309USA006535 of a child who received improperly stored COMVAX vaccine and case # 1308USA014806 of a child who received improperly stored GARDASIL vaccine. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Gait disturbance, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a 65 year old female patient regarding herself. Medical history and drug allergies were reported as none. On 04-SEP-2013, the patient was vaccinated with a standard dose (0.65 ml) of ZOSTAVAX, subcutaneously. On 06-SEP-2013, the patient experienced redness at the injection site with the center of the area becoming very hard, swollen, and hot to the touch in about a 1.5 inch diameter. The patient also had developed stiffness in her knee joints to the point that she couldn't extend the leg easily or without pain and it had become hard to walk. The stiffness had spread to the muscles in her calf and has continued to spread below that calf area. Patient received treatment with ADVIL. Patient sought medical attention-talked to the doctor. No laboratory tests were performed. The outcome of the events were reported as not recovered. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Joint range of motion decreased, Joint stiffness, Musculoskeletal stiffness, Pain
Clinical narrative: This spontaneous report was received from a 65 year old female patient regarding herself. Medical history and drug allergies were reported as none. On 04-SEP-2013, the patient was vaccinated with a standard dose (0.65 ml) of ZOSTAVAX, subcutaneously. On 06-SEP-2013, the patient experienced redness at the injection site with the center of the area becoming very hard, swollen, and hot to the touch in about a 1.5 inch diameter. The patient also had developed stiffness in her knee joints to the point that she couldn't extend the leg easily or without pain and it had become hard to walk. The stiffness had spread to the muscles in her calf and has continued to spread below that calf area. Patient received treatment with ADVIL. Patient sought medical attention-talked to the doctor. No laboratory tests were performed. The outcome of the events were reported as not recovered. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abasia, Arthralgia, Erythema, Induration, Myalgia
Clinical narrative: This spontaneous report was received from a 65 year old female patient regarding herself. Medical history and drug allergies were reported as none. On 04-SEP-2013, the patient was vaccinated with a standard dose (0.65 ml) of ZOSTAVAX, subcutaneously. On 06-SEP-2013, the patient experienced redness at the injection site with the center of the area becoming very hard, swollen, and hot to the touch in about a 1.5 inch diameter. The patient also had developed stiffness in her knee joints to the point that she couldn't extend the leg easily or without pain and it had become hard to walk. The stiffness had spread to the muscles in her calf and has continued to spread below that calf area. Patient received treatment with ADVIL. Patient sought medical attention-talked to the doctor. No laboratory tests were performed. The outcome of the events were reported as not recovered. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin lesion, Swelling
Clinical narrative: This spontaneous report was received from a 65 year old female patient regarding herself. Medical history and drug allergies were reported as none. On 04-SEP-2013, the patient was vaccinated with a standard dose (0.65 ml) of ZOSTAVAX, subcutaneously. On 06-SEP-2013, the patient experienced redness at the injection site with the center of the area becoming very hard, swollen, and hot to the touch in about a 1.5 inch diameter. The patient also had developed stiffness in her knee joints to the point that she couldn't extend the leg easily or without pain and it had become hard to walk. The stiffness had spread to the muscles in her calf and has continued to spread below that calf area. Patient received treatment with ADVIL. Patient sought medical attention-talked to the doctor. No laboratory tests were performed. The outcome of the events were reported as not recovered. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Skin lesion
Clinical narrative: This spontaneous report was received from a medical assistant concerning an approximately 59 year old female patient with no drug reactions/allergies. Current conditions of the patient included asthma and osteoporosis. The medical history of the patient included shingles on forehead on 11-JUN-2013. On 06-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date were reported as J002241 and 21-MAy-2014 respectively), subcutaneously in the right arm. Concomitant therapies included ADVAIR, ACTONEL, and VAGIFEM. On 09-SEP-2013, the patient was diagnosed with lesions at the injection site of the right upper arm. The patient sought medical attention (office visit). It was unspecified if any treatment was provided. No lab tests were performed. The chart dictation for the office visit was pending. The patient was not recovered from the event. The relatedness for the event was unknown for ZOSTAVAX. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare student (also reported as Pharm D) refers to a patient of unknown age and gender. The reporter stated that on 28-AUG-2013 the patient was vaccinated with expired PNEUMOVAX23 lot # 1489AA, expiration date: 12-MAY-2013 (dose and route not reported). No adverse events were reported. The patient's outcome was unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. The patient had no drug allergies. On 21-AUG-2013 the patient was vaccinated with ZOSTAVAX lot # J002869, 0.65 ml, administered subcutaneously. It was not reported if the patient took any concomitant or co-suspected medications. The pharmacist noted that, on 22-AUG-2013, the patient experienced an injection site reaction after receiving ZOSTAVAX on 21-AUG-2013. The patient noted on 22-AUG-2013 that the injection site was red, swollen and warm to the touch. The patient called the pharmacist on 23-AUG-2013, to report the previous day's findings and to also report that she was now experiencing tingling from the unspecified injection site down to her fingers. The pharmacist instructed the patient to call her physician, to have her arm evaluated. The adverse events did not resolve. A causality assessment was not provided. The action taken with ZOSTAVAX was not applicable. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Malaise, Vomiting
Clinical narrative: Vaccines given on 9/5/13 around 3:30 PM. Pt. awoke 8AM 9/6/13 not feeling well and started vomiting later. Injection sites clear of swelling, bruising, heat, and drainage.
Age: 1.08
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Rash pustular
Clinical narrative: Pt. had a small pustule form 10 days after VARIVAX given at vaccination of VARIVAX site no other symptom pt.'s mother was advised to use anti-itch cream.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site cellulitis, Injection site rash
Clinical narrative: Rash/cellulitis on L thigh-treated with Keflex.
Age: 51.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Red inflammation at injection site over 5 days post injection. BENADRYL ineffective, patient saw MD got prednisone day 5 which worked.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal stiffness, Poor quality sleep, Walking aid user
Clinical narrative: Pt received vaccine on 9-13-2013 at approx. 5 PM. He awoke at about 2 AM 9-14-13 and was completely stiff. He got up every hour all night and couldn't move. His wife had to assist him to the restroom with a walker. Patient slowing recovered at approx 11 AM on 9-14-13 but didn't feel completely normal until 4 PM on 9-14-2013. Patient stated he never felt better on 9-16-13 at approx 10:45 AM when he spoke with pharmacist. His wife contacted his MD on 9/16/13 at 9:45 AM. His doctor said he didn't need to be seen since he felt fine. Pharmacist notified of incident at approx 9 AM on 9-16-2013.
Age: 12.0
Sex: F
Vaccine: DTAP, MNQ, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Patient received Infanrix DTap intended for ages 6 wks-7yrs instead of Tdap.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug
Clinical narrative: This report, as received from a physician via a field representative, regards an unspecified number of patients (no demographic details were provided). No medical history was reported. It was reported that a healthcare clinic stored PROQUAD (Merck) for three weeks in the refrigerator instead of in the freezer. An unspecified number of anonymous patients may have received the improperly stored PROQUAD (Merck), but whether any patients received it was not confirmed. No further information was provided. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Muscle spasms, Pain, Swelling
Clinical narrative: Given flu vaccine R deltoid. Immediate spasm of deltoid, swelling and pain. No anaphylaxis.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Pain in extremity
Clinical narrative: Arm sore on Sat/Sun of with massive bruise and Monday just bruising soreness gone. Pt will follow-up with MD on Tuesday.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Blood test normal, CSF test normal, Computerised tomogram, Computerised tomogram head, Diplegia
Clinical narrative: Paralysis of right arm and both legs, onset 9/5/13 after minor tumble. MRI spine revealed edema/myelitis C2-C7, 9/6/13, MRI normalized 9/12/13 after high dose steroids.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Fall, Monoplegia, Myelitis, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal abnormal
Clinical narrative: Paralysis of right arm and both legs, onset 9/5/13 after minor tumble. MRI spine revealed edema/myelitis C2-C7, 9/6/13, MRI normalized 9/12/13 after high dose steroids.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Oedema
Clinical narrative: Paralysis of right arm and both legs, onset 9/5/13 after minor tumble. MRI spine revealed edema/myelitis C2-C7, 9/6/13, MRI normalized 9/12/13 after high dose steroids.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Local swelling, Pain in extremity, Skin warm
Clinical narrative: Called Dr (on call MD) on 9/14/13. C/O temp 102, L arm swollen, warm and sore - referred to another med center was started on Keflex and prednisone.
Age: 56.0
Sex: M
Vaccine: TTOX
Symptoms: Asthenia, Biopsy, Chronic inflammatory demyelinating polyradiculoneuropathy, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: 5/21 (date of vaccine) patient complaining of leg aches over next few months he complained of leg numbness also (7/26/12) nerve test ordered showed severe peripheral neuropathy. Patient started to have weakness that progressed. He eventually was diagnosed with CIDP.
Age: 56.0
Sex: M
Vaccine: TTOX
Symptoms: Nerve conduction studies, Neuropathy peripheral, Pain in extremity
Clinical narrative: 5/21 (date of vaccine) patient complaining of leg aches over next few months he complained of leg numbness also (7/26/12) nerve test ordered showed severe peripheral neuropathy. Patient started to have weakness that progressed. He eventually was diagnosed with CIDP.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV, PPV, PPV
Symptoms: Dyspnoea, Muscle spasms, Skin discolouration
Clinical narrative: Gave Pneumovax flu shot (1st). Within minutes Pt reported difficulty breathing and started to change color. Administered 2x 0.2 mg Epipen on upper left thigh after calling 911. Pt normalized but had low back muscle spasm. Paramedics arrived.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV, PPV, PPV
Symptoms: Erythema, Respiratory arrest
Clinical narrative: Gave Pneumovax flu shot (1st). Within minutes Pt reported difficulty breathing and started to change color. Administered 2x 0.2 mg Epipen on upper left thigh after calling 911. Pt normalized but had low back muscle spasm. Paramedics arrived.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV, PPV, PPV
Symptoms: Anaphylactic shock, Choking, Dyspnoea, Erythema, Injection site pain
Clinical narrative: Gave Pneumovax flu shot (1st). Within minutes Pt reported difficulty breathing and started to change color. Administered 2x 0.2 mg Epipen on upper left thigh after calling 911. Pt normalized but had low back muscle spasm. Paramedics arrived.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV, PPV, PPV
Symptoms: Muscle spasms, Presyncope, Respiratory arrest
Clinical narrative: Gave Pneumovax flu shot (1st). Within minutes Pt reported difficulty breathing and started to change color. Administered 2x 0.2 mg Epipen on upper left thigh after calling 911. Pt normalized but had low back muscle spasm. Paramedics arrived.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Terrible aching in arm, traveling down the body.
Age: 35.0
Sex: U
Vaccine: TDAP
Symptoms: Headache, Lymphadenopathy, Mass, Swelling, Ultrasound scan abnormal
Clinical narrative: Saturday evening noticed lump on clavicular area, more swollen Sunday, ultrasound showed four large lymph nodes on R side. Headache starting Monday, lasted till Thursday, continues swelling in clavicular area.
Age: 1.28
Sex: F
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Vaccine given 9/10, 9/10 pt noted to have pink area on deltoid. Pt noted to have pink faint 3.5 x 2 inches on deltoid surrounding injection site. Varicella site not affected.
Age: 61.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Hypersensitivity, Pruritus
Clinical narrative: Pt had allergic reaction to Zostavax shot. Described as whole arm being red and itchiing, spreading upwards to neck.
Age: 20.0
Sex: M
Vaccine: PPV, TD
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Within 5 minutes of receiving Td vaccine patient with numbness/tingling of fingers followed by several days of prickling sensation to thumb, then continued numbness. 5 days later minimal thumb pain. Pt seeing neurologist.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Body temperature increased, Disorientation, Dizziness, Electrocardiogram
Clinical narrative: Dizzy/disoriented, joint pain, sharp pain in lungs, headaches. Went to emergency room due to temp of 101.5 degrees F and pulse 121. Received IV fluids and MOTRIN.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Painful respiration
Clinical narrative: Dizzy/disoriented, joint pain, sharp pain in lungs, headaches. Went to emergency room due to temp of 101.5 degrees F and pulse 121. Received IV fluids and MOTRIN.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Nuclear magnetic resonance imaging, Periarthritis
Clinical narrative: Several weeks post vaccine L shoulder pain inject. site. Spread to shoulder upper arm (pain). Restricted shoulder movement/increased pain. Primary care Dr. sent me to PT, MRI, surgeon; diagnosed adhesive capsulitis. Surgery 6/5/12. PT 6/13-9/13. Improved, still pain with some shoulder restriction. PT says several women in for therapy after flu vaccine. Same vaccine 2011: exercises per primary care dr - most pain gone, most restriction gone by 2/12. Advised no flu shot arm.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Surgery
Clinical narrative: Several weeks post vaccine L shoulder pain inject. site. Spread to shoulder upper arm (pain). Restricted shoulder movement/increased pain. Primary care Dr. sent me to PT, MRI, surgeon; diagnosed adhesive capsulitis. Surgery 6/5/12. PT 6/13-9/13. Improved, still pain with some shoulder restriction. PT says several women in for therapy after flu vaccine. Same vaccine 2011: exercises per primary care dr - most pain gone, most restriction gone by 2/12. Advised no flu shot arm.
Age: 79.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Hyperhidrosis, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever, sweats, redness, swelling around site for 2 days. Visible redness today.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor, Presyncope
Clinical narrative: Pt had left the clinic after meningococcal vaccination and went to the local store 2 blocks from the clinic.  The father states while they were in the store the pt become pale, sweaty and passed out.  The father brought the pt back to the clinic where he was noted to be alert, pale sweaty.  He was placed in a treatment room, placed in Trendelenburg position and monitored.  His color improved, sweating improved, he was more interactive.  Vital signs and oxygen saturation was normal.
Age: 2.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Large red and swollen area with bruising on right arm.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: REDNESS, WARMTH AT INJECTION SITE.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Mobility decreased, Muscle tightness, Musculoskeletal pain, Pain in extremity
Clinical narrative: Vaccine arm achey: day 2-3 days 'under the weather' feeling: day 4 neck, bilateral shoulder, bilateral chest -muscle tightness and pain. Could hardly lift arms up: day 5 vomiting AM, started to feel better noon time day 5.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Vaccine arm achey: day 2-3 days 'under the weather' feeling: day 4 neck, bilateral shoulder, bilateral chest -muscle tightness and pain. Could hardly lift arms up: day 5 vomiting AM, started to feel better noon time day 5.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Dizziness, Dyspnoea, Flatulence
Clinical narrative: Chills, shivering, headache, gassy stomach.  Later  - 2 AM awoke with  rapid heart beat, difficulty breathing and dizziness upon arising.  Following day temperature of 100.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Heart rate increased
Clinical narrative: Chills, shivering, headache, gassy stomach.  Later  - 2 AM awoke with  rapid heart beat, difficulty breathing and dizziness upon arising.  Following day temperature of 100.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Patient reports symptoms occurred within 24 hours of receiving the vaccine. She noticed when she woke up the next day that she had small blisters across her nose. Once they popped open, the blisters felt like lumps or knots. The blisters then popped into open sores. She has been applying Neosporin topically to her nose once every other day. Today she has purchased Eucerin ointment and will be applying it to her nose topically to prevent it from drying.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Burning sensation, Diarrhoea, Headache, Hypoaesthesia
Clinical narrative: Symptoms onset 5-10 minutes after admin. burning in back, joint pain, burning/tingling all over body randomly. Nausea, severe headache, diarrhea injection site hot/red, numbness in left leg, symptoms worsen when laying down.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Nausea, Paraesthesia
Clinical narrative: Symptoms onset 5-10 minutes after admin. burning in back, joint pain, burning/tingling all over body randomly. Nausea, severe headache, diarrhea injection site hot/red, numbness in left leg, symptoms worsen when laying down.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pain radiating down left arm.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: SORENESS, ACHY, CAN NOT LIFT UP LEFT ARM, EXTREME PAIN.
Age: 10.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Fever (100) and severe swelling at the injection side-raised swelling covering half of the upper arm and hot to the touch-deep red in color.  Applied ice 09/10/2013 and 09/11/2013  Returned to the MC Pediatrics clinic for evaluation and to report reaction-swelling resolved 09/13/2013.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Vertigo
Clinical narrative: Extreme vertigo for two days.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose increased
Clinical narrative: Pt had increased blood glucose and could not relate the increase to anything else.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Injection site pain, Lymphoedema
Clinical narrative: Severe lymphedema on left side - Armpit, neck, and clavicle area. Site of injection very tender, painful, and hard.
Age: 77.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: Right upper arm erythema, edema, induration and tenderness. Cool compresses and Tylenol prn indicated on 9/16/13, by PCP.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Electroencephalogram, Epilepsy, Grand mal convulsion, Laboratory test
Clinical narrative: Grand mal seizures. No hx of seizures in family or patient.  Patient diagnosed w/epilepsy with no know cause.
Age: 22.0
Sex: M
Vaccine: FLUN4
Symptoms: Headache, Nausea, Oropharyngeal pain
Clinical narrative: Girlfriend to patient who received the nasal flu vaccine showed multiple signs of virus including headache, sore throat, and nausea after interacting with patient.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Diffuse pruritic rash all over body. Symptoms persisting despite home use of Benadryl x 5 days.