chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Malaise
Clinical narrative: This case was reported by a consumer (the subject) and described the occurrence of got sick in a 57-year-old female subject who was vaccinated with influenza vaccine (unknown manufacturer). A physician or other health care professional has not verified this report. Concurrent medications included ADVAIR diskus and VENTOLIN HFA. On an unspecified date in October 2013 the subject received a dose of influenza vaccine (unknown, left arm). In November 2013, 1 month after vaccination with influenza vaccine, the subject experienced 'got sick' and was 'coughing'. The subject was noted to have consulted her physician, details not provided. At the time of reporting the outcome of the got sick and was coughing were improved. The subject also reported that "every year get sick around Christmas after getting flu vaccine (unknown)"; no other details were provided. The outcome of the subject getting sick was unspecified.
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Influenza like illness, Injection site induration, Injection site swelling, Pain
Clinical narrative: This case was reported by a consumer (subject) and described the occurrence of arm swelling (injection site) in a female subject aged between 50 and 59 years old who was vaccinated with influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included arthritis, high blood pressure and seasonal allergy. Concurrent medications included arthritis medication, DIOVAN and allergy medication. On an unspecified date the subject received unspecified dose of influenza vaccine (unknown details). The subject described this as "last year's vaccination." At an unspecified time after vaccination, the subject experienced flu-like symptoms. The subject described these symptoms as "slight flu symptoms" "after last year's [influenza] vaccination." On 2 December 2013 at 08:30 the subject received a dose of influenza vaccine (unknown, left arm). On 2 December 2013, less than a day after vaccination with influenza vaccine, the subject experienced arm swelling (injection site), body pain, hardness injection site, flu like symptoms, fever (described as "slight fever") and feeling tired. The subject reported that her "left arm is hard and puffy, and her left arm is swelling." The subject felt that her events were disabling. The subject did not know the manufacturer of the flu vaccine. At the time of reporting, the outcome of the event of flu-like symptoms following "last year's flu vaccine" was unknown. At the time of reporting the events were improved in 4 December 2013. The subject also reported that the symptoms were worse in 3 December 2013 "but have declined in severity today (4 December 2013)."
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer (subject) and described the occurrence of arm swelling (injection site) in a female subject aged between 50 and 59 years old who was vaccinated with influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included arthritis, high blood pressure and seasonal allergy. Concurrent medications included arthritis medication, DIOVAN and allergy medication. On an unspecified date the subject received unspecified dose of influenza vaccine (unknown details). The subject described this as "last year's vaccination." At an unspecified time after vaccination, the subject experienced flu-like symptoms. The subject described these symptoms as "slight flu symptoms" "after last year's [influenza] vaccination." On 2 December 2013 at 08:30 the subject received a dose of influenza vaccine (unknown, left arm). On 2 December 2013, less than a day after vaccination with influenza vaccine, the subject experienced arm swelling (injection site), body pain, hardness injection site, flu like symptoms, fever (described as "slight fever") and feeling tired. The subject reported that her "left arm is hard and puffy, and her left arm is swelling." The subject felt that her events were disabling. The subject did not know the manufacturer of the flu vaccine. At the time of reporting, the outcome of the event of flu-like symptoms following "last year's flu vaccine" was unknown. At the time of reporting the events were improved in 4 December 2013. The subject also reported that the symptoms were worse in 3 December 2013 "but have declined in severity today (4 December 2013)."
Age: 91.0
Sex: F
Vaccine: FLUX
Symptoms: Bronchitis, Malaise, Nasopharyngitis
Clinical narrative: This case was reported by a consumer and described the occurrence of bronchitis in a currently 91-year-old female subject who was vaccinated with Influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Historic medical conditions included sick. The subject reported that with the pneumonia vaccine (non-GSK) last year [2012] that she got sick. On an unspecified date (s) the subject received dose (s) of Influenza vaccine (details unknown). Less than one year after vaccination with Influenza vaccine, the subject experienced bronchitis, sick and cold. The subject reported that she gets sick and gets a cold that turns into bronchitis with flu shots. At the time of reporting the outcome of the events was unspecified. The patient reported events with her last flu shot. See A1050442A for details.
Age: 91.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Bronchitis, Dizziness, Dyspnoea, Fatigue
Clinical narrative: This case was reported by a consumer and described the occurrence of sneezing in a 90-year-old female patient who was vaccinated with influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. The patient's past medical history included high blood pressure and sick. The patient reported that with the pneumonia vaccine (non-GSK) last year that she got sick. Concurrent medical conditions included diabetes, osteoporosis and pain. Concurrent medications included Valsartan+hydrochlorothiazide, ZOLOFT, citalopram, metformin, LASIX, clopidogrel, vitamin D, vitamin complex, CENTRUM, meloxicam and influenza vaccine. Co-suspect medication included ADVAIR. On September 2013 the patient started fluticasone propionate+salmeterol xinafoate 100/50 mcg (inhaled) at 1 puff(s) twice per day. On September 2013, the 50-year-old patient experienced wheezing. The dose of fluticasone propionate+salmeterol xinafoate was increased from ADVAIR 100/50 mcg to ADVAIR 500/50 mcg. On the ADVAIR 500/50 mcg, patient experienced unexpected benefits. At the time of reporting, the outcome of the wheezing was worse. On 08 November 2013, the patient received influenza vaccine (unknown route/dose, left arm; manufacturer unspecified). In November 2013, within 2 days of receiving the influenza unspecified, the 91-year-old patient developed sneezing and cold. At the time of reporting, the sneezing and cold were improved. Caller transferred from GSK Access program. She was seeking assistance to get back on ADVAIR medication. She used the product for about 2 months and is not able to continue to afford the medication. She noted that she had been a new person since starting the 500/50 ADVAIR. She began taking the 100/50 in September after she developed bronchitis and it became difficult to breathing. She did feel some improvement with the 100/50, however upon her return visit the Dr. noted she needed something stronger due to her wheezing. She was then placed on the 500/50 diskus at one puff a day and she feels like a new person. She is able to walk with a single cane now, from a walker, her sinuses are clearer. She was unable to afford the next diskus she has been placed on nebulizer treatments with PROFORM MIST and budesonide for her breathing. She states on these she is sleepy, has no energy, has a hard time breathing, she's worn out, she has had to go back to using a quad cane, and she is dizzy all the time. She added her blood pressure is 138/70 and her pulse is 60, so it is not due to those. She notes her sputum remains clear but alot. Caller noted she had also received a flu vaccine on 08 November 2013, of unknown manufacturer at pharmacy. She states it was in her left arm and that within a couple of days she was sneezing and then she got a cold. She is still sneezing but it has improved. The patient reported events with previous flu shots. See A1050442A for details.
Age: 91.0
Sex: F
Vaccine: FLUX
Symptoms: Nasopharyngitis, Sneezing, Somnolence, Sputum increased, Walking aid user
Clinical narrative: This case was reported by a consumer and described the occurrence of sneezing in a 90-year-old female patient who was vaccinated with influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. The patient's past medical history included high blood pressure and sick. The patient reported that with the pneumonia vaccine (non-GSK) last year that she got sick. Concurrent medical conditions included diabetes, osteoporosis and pain. Concurrent medications included Valsartan+hydrochlorothiazide, ZOLOFT, citalopram, metformin, LASIX, clopidogrel, vitamin D, vitamin complex, CENTRUM, meloxicam and influenza vaccine. Co-suspect medication included ADVAIR. On September 2013 the patient started fluticasone propionate+salmeterol xinafoate 100/50 mcg (inhaled) at 1 puff(s) twice per day. On September 2013, the 50-year-old patient experienced wheezing. The dose of fluticasone propionate+salmeterol xinafoate was increased from ADVAIR 100/50 mcg to ADVAIR 500/50 mcg. On the ADVAIR 500/50 mcg, patient experienced unexpected benefits. At the time of reporting, the outcome of the wheezing was worse. On 08 November 2013, the patient received influenza vaccine (unknown route/dose, left arm; manufacturer unspecified). In November 2013, within 2 days of receiving the influenza unspecified, the 91-year-old patient developed sneezing and cold. At the time of reporting, the sneezing and cold were improved. Caller transferred from GSK Access program. She was seeking assistance to get back on ADVAIR medication. She used the product for about 2 months and is not able to continue to afford the medication. She noted that she had been a new person since starting the 500/50 ADVAIR. She began taking the 100/50 in September after she developed bronchitis and it became difficult to breathing. She did feel some improvement with the 100/50, however upon her return visit the Dr. noted she needed something stronger due to her wheezing. She was then placed on the 500/50 diskus at one puff a day and she feels like a new person. She is able to walk with a single cane now, from a walker, her sinuses are clearer. She was unable to afford the next diskus she has been placed on nebulizer treatments with PROFORM MIST and budesonide for her breathing. She states on these she is sleepy, has no energy, has a hard time breathing, she's worn out, she has had to go back to using a quad cane, and she is dizzy all the time. She added her blood pressure is 138/70 and her pulse is 60, so it is not due to those. She notes her sputum remains clear but alot. Caller noted she had also received a flu vaccine on 08 November 2013, of unknown manufacturer at pharmacy. She states it was in her left arm and that within a couple of days she was sneezing and then she got a cold. She is still sneezing but it has improved. The patient reported events with previous flu shots. See A1050442A for details.
Age: 91.0
Sex: F
Vaccine: FLUX
Symptoms: Wheezing
Clinical narrative: This case was reported by a consumer and described the occurrence of sneezing in a 90-year-old female patient who was vaccinated with influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. The patient's past medical history included high blood pressure and sick. The patient reported that with the pneumonia vaccine (non-GSK) last year that she got sick. Concurrent medical conditions included diabetes, osteoporosis and pain. Concurrent medications included Valsartan+hydrochlorothiazide, ZOLOFT, citalopram, metformin, LASIX, clopidogrel, vitamin D, vitamin complex, CENTRUM, meloxicam and influenza vaccine. Co-suspect medication included ADVAIR. On September 2013 the patient started fluticasone propionate+salmeterol xinafoate 100/50 mcg (inhaled) at 1 puff(s) twice per day. On September 2013, the 50-year-old patient experienced wheezing. The dose of fluticasone propionate+salmeterol xinafoate was increased from ADVAIR 100/50 mcg to ADVAIR 500/50 mcg. On the ADVAIR 500/50 mcg, patient experienced unexpected benefits. At the time of reporting, the outcome of the wheezing was worse. On 08 November 2013, the patient received influenza vaccine (unknown route/dose, left arm; manufacturer unspecified). In November 2013, within 2 days of receiving the influenza unspecified, the 91-year-old patient developed sneezing and cold. At the time of reporting, the sneezing and cold were improved. Caller transferred from GSK Access program. She was seeking assistance to get back on ADVAIR medication. She used the product for about 2 months and is not able to continue to afford the medication. She noted that she had been a new person since starting the 500/50 ADVAIR. She began taking the 100/50 in September after she developed bronchitis and it became difficult to breathing. She did feel some improvement with the 100/50, however upon her return visit the Dr. noted she needed something stronger due to her wheezing. She was then placed on the 500/50 diskus at one puff a day and she feels like a new person. She is able to walk with a single cane now, from a walker, her sinuses are clearer. She was unable to afford the next diskus she has been placed on nebulizer treatments with PROFORM MIST and budesonide for her breathing. She states on these she is sleepy, has no energy, has a hard time breathing, she's worn out, she has had to go back to using a quad cane, and she is dizzy all the time. She added her blood pressure is 138/70 and her pulse is 60, so it is not due to those. She notes her sputum remains clear but alot. Caller noted she had also received a flu vaccine on 08 November 2013, of unknown manufacturer at pharmacy. She states it was in her left arm and that within a couple of days she was sneezing and then she got a cold. She is still sneezing but it has improved. The patient reported events with previous flu shots. See A1050442A for details.
Sex: U
Vaccine: FLU3
Symptoms: Condition aggravated, Psoriasis
Clinical narrative: This case was reported by a pharmacist and described the occurrence of exacerbation of psoriasis in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included psoriasis. In 2011 the subject received unspecified dose of FLUARIX (unknown details). In 2011, less than one year after vaccination with FLUARIX, the subject experienced exacerbation of psoriasis. Per the pharmacist, the subject experienced "aggravation of underlying psoriasis" and also described it as "aggravation of their full-body psoriasis subsequent to their 2011 FLUARIX dose." At the time of reporting the outcome of the event was unspecified.
Sex: F
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: This case was reported by a healthcare professional (nurse, subject) and described the occurrence of reaction to influenza vaccine in a female subject of unspecified age who was vaccinated with influenza vaccine (unspecified), GlaxoSmithKline. On an unspecified date the subject received unspecified dose of influenza vaccine (unspecified) (unknown details). At an unspecified time after vaccination with influenza vaccine (unspecified), the subject experienced reaction to influenza vaccine. No specific details were provided. The subject questioned the latex content of flu vaccine produced by GlaxoSmithKline. Per the nurse (subject), "the infection control nurse at the hospital told her mom the flu vaccine given to her was from a single dose vial" and that "the flu vaccine had 'GlaxoSmith' on it." The reporter refused to "give any information yet because she first need to find out which flu vaccine she was given." Per the reporter, "this is one of the worst things that has happened to her." At the time of reporting the outcome of the event was unspecified.
Age: 84.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Local swelling
Clinical narrative: Inside of arm above elbow, red and puffy, not hot to the touch.
Age: 55.0
Sex: F
Vaccine: TD
Symptoms: Blood creatinine normal, Blood electrolytes normal, Chest X-ray normal, Culture urine negative, Haemoglobin normal
Clinical narrative: Within 12 hours of vaccine, patient developed fever, hypotension (BP 90/50). She was treated with IV fluids and hydrocortisone due to being on chronic prednisone.
Age: 55.0
Sex: F
Vaccine: TD
Symptoms: Hypotension, Liver function test normal, Platelet count decreased, Pyrexia, White blood cell count decreased
Clinical narrative: Within 12 hours of vaccine, patient developed fever, hypotension (BP 90/50). She was treated with IV fluids and hydrocortisone due to being on chronic prednisone.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Lethargy, Nasopharyngitis, Pain, Respiratory disorder
Clinical narrative: This case was reported by a consumer (subject) and described the occurrence of cold symptoms in a 54-year-old female subject who was vaccinated with influenza vaccine (unspecified), (manufacturer unspecified). A physician or other health care professional has not verified this report. In 2009 the subject received a dose of influenza vaccine (unspecified) (unknown details). In September 2009, less than one year after vaccination with influenza vaccine (unspecified), the subject experienced cold symptoms, pain all over, respiration problem (described as "respiratory issues") and lethargy (also described as "less pep"). The subject reported that the flu vaccination "negatively affected her health from September 2009 until January 2010." At the time of reporting the events were improved; however, the subject reported an end date as January 2010. The subject reported that she had "subsequently taken FLUMIST for the last 3 years and had not experienced any issues." The subject refused to provide details regarding the facility where the vaccine was administered.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a healthcare professional (nurse and subject) and described the occurrence of flu-like symptoms in a 52-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included rheumatoid arthritis. Concurrent medications included "a biologic immunosuppressant for his rheumatoid arthritis." In 2013 the subject received a dose of FLUARIX (unknown details). In 2013, 3 to 4 days after vaccination with FLUARIX, the subject experienced flu-like symptoms. At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: This case was reported by a healthcare professional (pharmacy technician) via sales representative and described the occurrence of vaccination adverse reaction in a subject of unspecified age and gender who was vaccinated with Influenza vaccine unspecified (GlaxoSmithKline). In 2013 the subject received a dose of Influenza vaccine unspecified (unknown details). In 2013, at an unspecified time after vaccination with Influenza vaccine, the subject experienced vaccination adverse reaction. At the time of reporting the outcome of the event was unspecified.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site rash
Clinical narrative: This case was reported by a consumer (daughter of the subject) and described the occurrence of injection site cellulitis ina 64-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included chronic lymphocytic leukemia. Concurrent medications included Acyclovir, ZETIA, Simvastatin and Trazodone. On 12 September 2013 at 12:00 the subject received a dose of FLUARIX (.5 ml, unknown route, left arm). On 13 September 2013, 1 day after vaccination with FLUARIX, the subject experienced injection site cellulitis and small rash injection site. The reporter stated that the subject "developed a small rash located 5 fingers below the injection site." The subject sought medical attention. This case was assessed as medically serious by GSK. The subject was treated with Antibiotic for 10 days. At the time of reporting the events were improved.
Age: 32.0
Sex: F
Vaccine: HPV4, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Local reaction within 24 hours - redness, swelling, pain at injection site. Ice intermittently to site and po ibuprofen.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Injection site vesicles
Clinical narrative: Superficial vesicle at injection site at 24 hours after IZZ. No systemic symptoms.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Swelling, Tenderness
Clinical narrative: Shot administered 6/25/14, local redness, tenderness > redness RUE > swelling RUE day 2-3 > seen PM 6/27 decreased redness decreased swell decreased tenderness > ice and ASA.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 2 patients of unknown age and gender. The reporter stated that 2 patients received PNEUMOVAX23 (dose number, units, route of administration, anatomical location, lot number was not reported), that were exposed to 32F for 360 hours. PNEUMOVAX23 was a supported excursion with in-house stability data. No adverse symptoms reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Lacrimation increased
Clinical narrative: This spontaneous report was received from a female patient of unknown age. On 23-JUN-2014 the patient was vaccinated with ZOSTAVAX (details unspecified), frequency, one time vaccine. No concomitant therapy was reported. On 23-JUN-2014 (same day vaccination) the patient's eye started watering after lunch. No product quality complaint (PQC) was filed. The action taken was assessed as not applicable. The outcome of event and causality were not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant (C.M.A) refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The medical assistant reported that the patient was administered first dose of GARDASIL INJ, 0.5 ml, intramuscular (lot number not provided), on 24-MAY-2013, and the second dose of GARDASIL, 0.5 ml, intramuscular (lot number not provided), on 14-APR-2014, No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction, Injection site warmth, Pain, Rash erythematous
Clinical narrative: This spontaneous report was received from a physician refers to an anonymous group of patients of unknown age and gender. ON an unknown date the patients were vaccinated with PNEUMOVAX23, 1 single dose (route and lot # were not reported). On an unknown date the patients experienced red hot spots at the injection site and also experienced pain for one week long as well. They sought medical attention. They saw the doctor. The outcome of the events was reported as recovered/resolved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction, Injection site warmth, Pain, Rash erythematous
Clinical narrative: This spontaneous report was received from a physician refers to an anonymous group of patients of unknown age and gender. ON an unknown date the patients were vaccinated with PNEUMOVAX23, 1 single dose (route and lot # were not reported). On an unknown date the patients experienced red hot spots at the injection site after receiving PNEUMOVAX23. Some of the patients also experienced pain for one week long as well (captured in MARRS#1406USA012725). They sought medical attention. They saw the doctor. The outcome of the events was reported as recovered/resolved.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare student refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with an expired dose of ZOSTAVAX (strength, indication, route, lot number and expiration date not reported). The healthcare student stated that the ZOSTAVAX expired approximately in April 2014 two months ago. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 16-JUN-2014 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous. On 16-JUN-2014, the patient received ZOSTAVAX, subcutaneously in the abdomen. No adverse event was reported. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a  78 year old female patient. On an unknown date in May 2014 the patient was vaccinated with ZOSTAVAX dose 2, and dose 1 in July 2013, subcutaneously . No other concomitant therapy reported. No adverse effect reported. The outcome of the events was unknown. There was no PQC reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative refers to a 5 year old female patient. The patient's current condition and medical history are not reported. On 24-APR-2014 the patient was vaccinated with PROQUAD of unknown dose, frequency and route of administration (Lot # reported as J006163, expiry date unspecified). On 07-MAY-2014, 14 days after the onset of therapy the patient broke out in a rash after vaccination. It was reported that the patient received treatment and no product quality issue is reported. The outcome of the event rash is unknown. Causality was unspecified by the reporter. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a company representative referring on a friends unspecified 15 month old male son. The patient's current conditions or medical history were not reported. On an unknown date, the patient was vaccinated with a dose of MMR II (dose, route, lot number and expiration date not reported). Concomitant therapies included Amoxicillin. On an unspecified date, 10 days after receiving MMR II, the patient developed a rash on his face, neck and back. The patient was given Prednisolone to treat the reaction by an unspecified physician. Outcome of rash on face, neck and back was unknown at the time of the report. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unspecified age and gender. The healthcare worker reported that, on unknown date, GARDASIL (dose, frequency, route, anatomical location, lot number and exp. date were not reported) that underwent a temperature excursion has been administered to an unspecified amount of patients. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Drug dose omission, No adverse event, Product packaging quantity issue
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown and gender. On an unknown date the patient was vaccinated with PNEUMOVAX23 (injection, lot # J006921 expiry date 09-AUG-2014; dose 0.5 ml, frequency unknown). The registered nurse reported that a under filled PNEUMOVAX23 vial caused an anonymous patient to miss a dose. No adverse events were reported. PQC was filled. It was not specified by the reporter if the therapy was discontinued. The outcome of the event was unknown. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Scrotal erythema, Scrotal swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 14 month old male patient with ano history of drug reactions or allergies. On 12-MAY-2011, the patient was vaccinated with MMR II (lot # 669200/1346Z, exp date: 13-OCT-2012)(0.5ml, subcutaneously in the right arm, dose and frequency unknown). Other suspect vaccines administered to the patient on the same day (12-OCT-2011) included (Oka/Merck) VARIVAX (lot # exp date: unknown)(strength, dose, frequency and route of administration: unknown, in left arm also reported as "in a separate arm" (than MMR) and HAVRIX. No concomitant medication was reported.  On 12-MAY-2011 also reported as "that night" the patient's mother went to change his diaper and noted the patient's  scrotum area was red and swollen. The reporter stated that the patient was prescribed loratadine (manufacturer unknown) (syrup) on 12-MAY-2011. The reporter was not sure if the patient's mother gave him loratadine (manufacturer unknown) (syrup). The patient's mother sought medical attention on 12-MAY-2011 via the telephone and she ws informed by the "on-call" physician to administer BENADRYL to the patient. . No lab diagnostics studies were performed. The outcome of "the patient's scrotum area was red and swollen" was reported as recovered/resolved on 13-MAY-2011. Relatedness between "the patient's scrotum area was red and swollen" and MMR II, (Oka/Merck) VARIVAX and HAVRIX was not reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Face and mouth X-ray normal, Fall, Laceration, Medical device complication
Clinical narrative: 330pm - 6/25/14 Tdap given lt arm IM, then MCV4 rt arm IM. Pt c/o light headedness after MCV4 injection. Nurse went to raise the head of exam table when he was sitting and pt rolled forward off of table face first on floor. Initially pt was unresponsive then after several seconds was able to respond to mother. Staff called 911. Blood was noted around the mouth and chin, as patient turned self to side there was a deep gash to chin approximately 1" length, pressure applied. Pt. c/o teeth (front) hurting and feeling that his braces were broken. No other c/o head, neck or back pain. Nurses stayed with patient until the EMT's arrived which was within ten minutes of incident. EMT's assessed patient as he was lying on the floor then had pt. stand slowly with support to walk to the stretcher awaiting for him in the hall. Mother followed the ambulance in her car to the medical center at 345pm. 06/26/14 130pm TC to mom - patient received 16 stitches to chin, facial x-ray was negative, has an appointment with orthodontics on Monday 6/30/14, cap had come off of braces, c/o teeth being sore, PCP aware of situation.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Suture insertion, Toothache, Unresponsive to stimuli
Clinical narrative: 330pm - 6/25/14 Tdap given lt arm IM, then MCV4 rt arm IM. Pt c/o light headedness after MCV4 injection. Nurse went to raise the head of exam table when he was sitting and pt rolled forward off of table face first on floor. Initially pt was unresponsive then after several seconds was able to respond to mother. Staff called 911. Blood was noted around the mouth and chin, as patient turned self to side there was a deep gash to chin approximately 1" length, pressure applied. Pt. c/o teeth (front) hurting and feeling that his braces were broken. No other c/o head, neck or back pain. Nurses stayed with patient until the EMT's arrived which was within ten minutes of incident. EMT's assessed patient as he was lying on the floor then had pt. stand slowly with support to walk to the stretcher awaiting for him in the hall. Mother followed the ambulance in her car to the medical center at 345pm. 06/26/14 130pm TC to mom - patient received 16 stitches to chin, facial x-ray was negative, has an appointment with orthodontics on Monday 6/30/14, cap had come off of braces, c/o teeth being sore, PCP aware of situation.
Age: 1.23
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Fever, vomiting, small rash, started 6/22/14.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Blood creatine phosphokinase, Immediate post-injection reaction, Injection site pain, Red blood cell sedimentation rate
Clinical narrative: Had immediate pain at site of injection and general vicinity. Pain worsened in the following days. Pain never completely resolved and still has episodes of pain and achiness to the area.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever, chills, pain and swelling at injection site.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Syncope post vaccine within 10 minutes of administration.
Age: 25.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at injection site 2 months after immunization (3/20/14).
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dyspnoea, Headache, Influenza like illness, Tachycardia
Clinical narrative: Pt reported (and insisted a report be filed) - H/A - flu-like symptoms - weakness - short duration of tachycardia - SOB - UTI.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Urinary tract infection
Clinical narrative: Pt reported (and insisted a report be filed) - H/A - flu-like symptoms - weakness - short duration of tachycardia - SOB - UTI.
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Immediate post-injection reaction, Rash, Swelling
Clinical narrative: Patient was given PCV13 on left deltoid. Pt got an immediate reaction. He developed a rash and swelling. Gave BENADRYL 3.75 ml po given.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site irritation, Injection site pruritus, Injection site rash, Injection site swelling, Injection site urticaria
Clinical narrative: This spontaneous report as received from a register nurse refers to a 62 year old female patient with high blood pressure. Drug reactions/allergies included tetracycline and lidocaine. On 03-FEB-2014 the patient was vaccinated with ZOSTAVAX, (lot#, strength, dose, frequency not provided) subcutaneous for shingles prevention. Concomitant therapies included hydrochlorothiazide (manufacture unknown) (reported as HCTZ). On 05-FEB-2014 (reported as 27 hours after receiving ZOSTAVAX, the patient experienced irritation at injection site. On 05-FEB-2014 (reported as 48 hours after ZOSTAVAX injection) the patient experienced swelling and rash at injection site. On 07-FEB-2014 an unspecified Physician's Assistant saw the patient. The nurse reported that the patient experienced an 8x8 cm wheal at injection site with vesicular center and itching at site of wheal. No treatment given at that time. On 06-JUN-2014, the patient was continuing to complain of arm pain, no rash or vesicles are present at this time. Patient describes the pain in the arm that the ZOSTAVAX was administered in as "a shooting pain that goes up and down the arm in the outer aspect of the arm." Patient also stated that "if someone touches her arm firmly or she accidently hits it against something it hurts." The outcome of the event was reported as not recovered. The causality of the event and ZOSTAVAX was not provided. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site vesicles
Clinical narrative: This spontaneous report as received from a register nurse refers to a 62 year old female patient with high blood pressure. Drug reactions/allergies included tetracycline and lidocaine. On 03-FEB-2014 the patient was vaccinated with ZOSTAVAX, (lot#, strength, dose, frequency not provided) subcutaneous for shingles prevention. Concomitant therapies included hydrochlorothiazide (manufacture unknown) (reported as HCTZ). On 05-FEB-2014 (reported as 27 hours after receiving ZOSTAVAX, the patient experienced irritation at injection site. On 05-FEB-2014 (reported as 48 hours after ZOSTAVAX injection) the patient experienced swelling and rash at injection site. On 07-FEB-2014 an unspecified Physician's Assistant saw the patient. The nurse reported that the patient experienced an 8x8 cm wheal at injection site with vesicular center and itching at site of wheal. No treatment given at that time. On 06-JUN-2014, the patient was continuing to complain of arm pain, no rash or vesicles are present at this time. Patient describes the pain in the arm that the ZOSTAVAX was administered in as "a shooting pain that goes up and down the arm in the outer aspect of the arm." Patient also stated that "if someone touches her arm firmly or she accidently hits it against something it hurts." The outcome of the event was reported as not recovered. The causality of the event and ZOSTAVAX was not provided. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site vesicles, Pain, Pain in extremity, Tenderness
Clinical narrative: This spontaneous report as received from a register nurse refers to a 62 year old female patient with high blood pressure. Drug reactions/allergies included tetracycline and lidocaine. On 03-FEB-2014 the patient was vaccinated with ZOSTAVAX, (lot#, strength, dose, frequency not provided) subcutaneous for shingles prevention. Concomitant therapies included hydrochlorothiazide (manufacture unknown) (reported as HCTZ). On 05-FEB-2014 (reported as 27 hours after receiving ZOSTAVAX, the patient experienced irritation at injection site. On 05-FEB-2014 (reported as 48 hours after ZOSTAVAX injection) the patient experienced swelling and rash at injection site. On 07-FEB-2014 an unspecified Physician's Assistant saw the patient. The nurse reported that the patient experienced an 8x8 cm wheal at injection site with vesicular center and itching at site of wheal. No treatment given at that time. On 06-JUN-2014, the patient was continuing to complain of arm pain, no rash or vesicles are present at this time. Patient describes the pain in the arm that the ZOSTAVAX was administered in as "a shooting pain that goes up and down the arm in the outer aspect of the arm." Patient also stated that "if someone touches her arm firmly or she accidently hits it against something it hurts." The outcome of the event was reported as not recovered. The causality of the event and ZOSTAVAX was not provided. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: DTP
Symptoms: Diplegia, Movement disorder, Paralysis, Plasmapheresis, Tremor
Clinical narrative: HE START WITH LEGS PARALYSIS AND THEN CONTINUE COMPLETE BODY AND ARTICULATIONS PARALYSIS HE RECEIVED FAST TREATMENT IN THE HOSPITAL AND HE WAS IN THE HOSPITAL 3 MONTHS FOR RECOVERY AND 3 PLASMAPHERESIS TREATMENTS.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Chills, fever, dizziness, soreness, headache, extreme fatigue, nausea.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Chills, fever, dizziness, soreness, headache, extreme fatigue, nausea.
Age: 70.0
Sex: M
Vaccine: FLUX
Symptoms: Anti-cyclic citrullinated peptide antibody positive, Antinuclear antibody positive, Inflammatory marker increased, Rheumatoid arthritis, Rheumatoid factor positive
Clinical narrative: Rheumatoid arthritis
Age: 33.0
Sex: F
Vaccine: YF
Symptoms: Cough, Dizziness, Dry throat, Nasal congestion, Pyrexia
Clinical narrative: Dry throat, cough, nose congestion, fever, dizziness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Hyperaesthesia
Clinical narrative: Skin sensitivity on right side upper chest and upper back/shoulder blade area (same side of body). Mild burning sensation, persistent over a number of days. It has not yet gone away.
Age: 4.0
Sex: M
Vaccine: DTPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction, Injection site warmth, Rash pruritic
Clinical narrative: DEVELOPED L DELTOID AND UPPER ARM EDEMA, ERYTHEMA, WARMTH, PRURITIC RASH PROGRESSING OVER 2 DAYS, NO SYSTEMIC SYMPTOMS.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, RVX
Symptoms: Crying, Decreased eye contact, Insomnia, Unresponsive to stimuli
Clinical narrative: He stopped smiling.  He stopped cooing and babbling.  He stopped making eye contact.  He stopped responding to people, including family.  He wouldn't sleep.  He cried for hours, even though I was holding/rocking/nursing him.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Red area around injection site (1" x 2"), itchy and warm to touch.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pruritus
Clinical narrative: Headache, itching at inj site, erythema at inj site.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant via a field employee regarding a female patient in her 20's. No information about medical history, drug reactions and allergies was specified. On an unknown ate in 2006, about 8 years ago, the patient was vaccinated with GARDASIL (dose, route not reported)(medical assistant believes that "all 3 doses were given about 8 years ago"). No concomitant medications were reported. The reporter reported to the field employee, "that an adult female patient in her 20's" received an extra dose of GARDASIL), (a 4th dose on an unspecified date). No adverse effects were reported. The outcome of the event is unknown. The causality of the event was not specified by the reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients. On 10-JUN-2014, an unspecified number of patients were administered PROQUAD (lot#, expiration date, dose, route and indication not reported) that were exposed to improperly stored temperatures outside the product insert. No adverse effects reported. This is one of several reports received from the same source. Follow up has been received. A phone call was placed to physician. The phone call was transferred to the Medical Assistant. The medical assistant stated that she had no patient identifiers or specific dates of vaccination because the Merck National Service Center offered information that her vaccines were within temperature stability data and she did not need to keep that patient data for any re-vaccinations. The medical assistant had the lot numbers available (no expiration dates). The Lot Numbers - J015595 and J011330 were provided for PROQUAD. The lot # J011330 (expiry date: 13-MAR-2105) was validated for PROQUAD. This case is linked to case # 1406USA006736 and 1406USA006998 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The reporter stated that the patient was vaccinated with PEDVAXHIB (intramuscular, dose unknown) that was stored improperly on 19-JUN-2014. Pertinent medical history and concomitant medications were not reported. No adverse effects reported. The outcome of the events was unknown. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The reporter stated that the patient received GARDASIL (intramuscular, dose unknown) on 14-OCT-2013 and 27-MAR-2014 and stated the patient would like to receive a third dose now (19-JUN-2014). Pertinent medical history and concomitant medications were not reported. No adverse symptoms reported. The outcome of the events was unknown. No further information provided. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: HEPA
Symptoms: Hepatitis A virus test positive
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 54 year old female patient with no pertinent medical history. In 1998 the patient ws vaccinated with a dose of VAQTA (dose, route, indication, lot# not reported). On 25-JUN-2014, the patient had unspecified labs drawn on because the patient was going to be having an unspecified surgery on an unspecified date and the lab results showed that the patient was positive for Hepatitis A. There was no treatment given for the event. The patient did not seek medical attention. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to patients of unknown age. The patients medical history was not reported. On an unknown date the patients were vaccinated with PROQUAD which were improperly stored. No adverse effect was reported. The outcome of improperly stored PROQUD administered was unknown. This case is linked to case # 1406USA013610 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to patients of unknown age. The patients medical history was not reported. On an unknown date the patients were vaccinated with (Oka/Merck) VARIVAX which was improperly stored. No adverse effect was reported. The outcome of improperly stored (Oka/Merck) VARIVAX administered was unknown. This case if linked to case # 1406USA009790 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from nurse practitioner refers to unspecified number of patients of unknown age and gender. No information provided regarding medical history and concurrent conditions. On an unknown date three times unspecified number of patients were vaccinated with improperly stored (Oka/Merck) VARIVAX, 0.5 ml, subcutaneous. The (Oka/Merck) VARIVAX doses have been exposed to temperature as high as 38F for total of 38 hours and 45 minutes. No adverse effects reported. It was reported that this service request (SR) was opened on 01-MAY-2014 for temperature excursion inquiry only and at that time, no adverse event (AE) was identified. However, when nurse called back on 12-JUN-2014 to report third temperature excursion (second excursion reported don 07-MAY-2014 and no AE at that time), she reported that improperly stored (Oka/Merck) VARIVAX doses have been administered to patients since first two temperature excursions and therefore AE was filed on 12-JUN-2014. Additional information has been requested.