chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nasal congestion, Urticaria
Clinical narrative: This spontaneous report was received from a physician who is a 67-year-old female patient. Current conditions included chronic sinusitis and history of endometrial cancer. On 24-SEP-2013 the patient was vaccinated with a dose of 0.5 milliliter (ml) PNEUMOVAX23 (lot#, expiration date not reported) intramuscularly in the right arm. Concomitant therapies included FLUVIRIN administered on the same date in the left arm. The physician reported that she developed redness and pain at the injection site on 25-SEP-2013. The patient also developed right ear pain and nasal congestion. On 27-SEP-2013, the physician experienced a warm sensation at the nape of her neck after walking for exercise. The sensation resolved after she drank sugar water. Later that evening, she developed welts on the right and left scapula area, which resolved with the use of BENADRYL and unspecified cortisone cream topically. On 30-SEP-2013, the patient developed a circular welt on her mid-back. On 01-OCT-2013, she developed welts under both axilla. These welts also responded to BENADRYL and cortisone cream. The evening of 02-OCT-2013, the patient developed a large welt on her left forearm which she treated with BENADRYL and topical cortisone cream. The physician stated she was evaluated on 03-OCT-2013 by her unspecified healthcare provider who diagnosed an unspecified allergic reaction. It was suggested that the patient eliminated medications and foods one at a time in an attempt to determine the cause of her allergic reaction. Laboratory diagnostic studies were not performed for the events. The patient sought medical attention for the events (office visit). The events were resolving at the time of this report. Causality was not reported. This is one of the reports from the same reporter. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram, Headache, Malaise, Metamorphopsia, Sinus headache
Clinical narrative: Patient received vaccine on Monday Sept 23, did not feel well the next day (Sept 24). On September 27 developed headache on left side of head, sinus and teeth aching. Some visual distortion. Saw physician on October 1, 2 and 3 eye doctor on Oct 2, and had emergency visit for CT scan on Oct 3.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Toothache
Clinical narrative: Patient received vaccine on Monday Sept 23, did not feel well the next day (Sept 24). On September 27 developed headache on left side of head, sinus and teeth aching. Some visual distortion. Saw physician on October 1, 2 and 3 eye doctor on Oct 2, and had emergency visit for CT scan on Oct 3.
Age: 57.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Cough, Ocular hyperaemia, Rhinorrhoea, Throat tightness
Clinical narrative: 2:30 started coughing then runny nose blood shot eyes 5:00 pm got worse. Throat became constricted around 3 pm.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Muscle spasms, Muscle twitching, Muscular weakness
Clinical narrative: Pain immediately when vaccination was given. Pain down the arm to the elbow and through to the hand for at least a week. Continued weakness along with muscle spasms throughout the entire arm. Shoulder is still sore. Still twitching in places on entire arm.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pain immediately when vaccination was given. Pain down the arm to the elbow and through to the hand for at least a week. Continued weakness along with muscle spasms throughout the entire arm. Shoulder is still sore. Still twitching in places on entire arm.
Age: 71.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Malaise
Clinical narrative: My partner and I were getting our FLUZONE HD this past Saturday October 12-2013. After a few hours we became extremely sick with all the symptoms describe as side effects. For older people (that we are) 74 and 71 weight just a little above 150 pounds, that dosage was much too strong.
Age: 71.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: My partner and I were getting our FLUZONE HD this past Saturday October 12-2013. After a few hours we became extremely sick with all the symptoms describe as side effects. For older people (that we are) 74 and 71 weight just a little above 150 pounds, that dosage was much too strong.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: 48 hours after receiving vaccine, patient developed rashes from head to toe.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Rash macular
Clinical narrative: No reaction after vaccination. However, about 2 days later, developed a bright red blotch on my upper arm just above my elbow crease (left arm). I happened to be visiting a doctor (for another reason) on Oct. 4 and he said it looked as though there was bleeding under the skin. Red blotch eventually faded away.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Flushing, Headache, Hypoaesthesia, Pain
Clinical narrative: Left check of face red and flush, slightly numb, slight tingling. Left ear red/flushed. Numbness extended to left eye. C/O slight headache, dull pain. BENADRYL 25 mg po given.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Left check of face red and flush, slightly numb, slight tingling. Left ear red/flushed. Numbness extended to left eye. C/O slight headache, dull pain. BENADRYL 25 mg po given.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Dyspnoea, Eye discharge, Pharyngeal oedema
Clinical narrative: I suddenly had a tight chest with cough. My throat felt smaller, wheezing, labored breathing, took immediate BENADRYL 50mg - at 6:45 noticeable change in breathing and cough subsided then experienced pus like d/c from eyes and throat and facial swelling that continued for 48 hrs.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face, Throat tightness, Wheezing
Clinical narrative: I suddenly had a tight chest with cough. My throat felt smaller, wheezing, labored breathing, took immediate BENADRYL 50mg - at 6:45 noticeable change in breathing and cough subsided then experienced pus like d/c from eyes and throat and facial swelling that continued for 48 hrs.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Blood potassium decreased, Heart rate irregular, Hypotonia, Miosis, Pulse pressure decreased
Clinical narrative: Patient received HIGH DOSE flu shot and about 2-5 min later slumped over in wheelchair, vomited x 2, weak and irregular pulse, decreased respirations, pupils constricted bilaterally. Granddaughter reports patient has hx of seizures. Began to respond in approx 2 min. Transported to hospital by EMS. Returned home that evening.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory rate decreased, Vomiting
Clinical narrative: Patient received HIGH DOSE flu shot and about 2-5 min later slumped over in wheelchair, vomited x 2, weak and irregular pulse, decreased respirations, pupils constricted bilaterally. Granddaughter reports patient has hx of seizures. Began to respond in approx 2 min. Transported to hospital by EMS. Returned home that evening.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Strong headache since Tuesday October 15th and today is the 17-Oct the pain continues.
Age: 15.0
Sex: M
Vaccine: FLUN4, HPV4, HPV4
Symptoms: Convulsion, Seizure like phenomena
Clinical narrative: 10/16/2013 mild seizures within 3 days of Vx. 5 minutes after patient received shot he started having seizure like activity that lasted 45 seconds. Patient was seen by Dr., fully recovered and left an hour later.
Age: 15.0
Sex: M
Vaccine: FLUN4, HPV4, HPV4
Symptoms: Agitation, Immediate post-injection reaction, Incoherent, Pallor, Seizure like phenomena
Clinical narrative: 10/16/2013 mild seizures within 3 days of Vx. 5 minutes after patient received shot he started having seizure like activity that lasted 45 seconds. Patient was seen by Dr., fully recovered and left an hour later.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Blister, Injection site reaction, Local reaction, Myalgia, Pain
Clinical narrative: Local reaction at site of vaccine. "Bubbles", splotchy red rash, sore arm muscles, body aches for approximately 5 days after vaccination.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Local reaction at site of vaccine. "Bubbles", splotchy red rash, sore arm muscles, body aches for approximately 5 days after vaccination.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles, Paraesthesia, Pruritus
Clinical narrative: I received the ZOSTAVAX vaccine at pharmacy on Friday, December 21, 2012 in the back of my left upper arm. I now have a half-dollar size blister on the back of my left shoulder. I am also starting to have tingling itchiness around my left waist.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, pain, redness and heat at injection site. Also generalized achy ness. On exam, indurated warm 8 x 6 cm area L deltoid.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Swelling, pain, redness and heat at injection site. Also generalized achy ness. On exam, indurated warm 8 x 6 cm area L deltoid.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Erythema at site of injection. Treatment Drugs Used: Methylprednisolone; Diphenhydramine Dose: 25 Units: MG Freq: TID Route: PO.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient called on 10/12/13 reporting swelling/redness/warmth at site. After she came into our location she had a double area of redness - 2 inch dark red with given lighter red area that was better as of 10/14/13.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Inflammation, Rash
Clinical narrative: Redness, rash, inflammation of arm.
Age: 0.93
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 11 month old patient. On 25-SEP-2013, the patient was vaccinated with a dose of VARIVAX and a dose of MMR II, lot#, dose, frequency and route for both vaccines were unspecified, before 12 months of age. No symptoms reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Hypoaesthesia, Nervous system disorder, Paraesthesia
Clinical narrative: This spontaneous report as received from a female patient of approximately 64 years regarding herself. The patient has no drug reactions or allergies. The patient's medical history included shingles in 2011. The patient reported that, ever since her previous cases of shingles in 2011, she has been experiencing nerve tingling and numbness in her left leg at the location where she had shingles, which is "from the buttocks to the thigh: on the left side of her body. Patient's current conditions also included shoulder pain. On 03-JUL-2012, the patient was vaccinated with one shot (1 DF) ZOSTAVAX (Lot number, expiry date, route and dose were not reported) injections. Concomitant therapies included tramadol hydrochloride for shoulder pain. Approximately on an unknown date in 2013, within the past 2 months the tingling and numbness worsened "within the past 2 months" and now also includes the toes on the left side. She described this sensation by stating that her "nerves have been getting crazy". The patient sought medical attention (spoke with the physician). Lab Diagnostic Studies Performed was none. No treatment was given. The outcome of all the reported events was not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age (gender not reported). On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (route and lot not provided). On an unknown date, the patient experienced localized redness at the injections site. The outcome of localized redness at the injections site was reported as recovered (reported as it went away, date unspecified). The patient sought medical attention (office visit). Relatedness between the patient's event and ZOSTAVAX was not provided. This is one of several reports from the same source (MARRS # 1310USA007001). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age (gender not reported). On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX for immunization (route and lot not provided). On an unknown date, the patient experienced shingles (mild case). The outcome of shingles was reported as recovered (date unspecified). The patient sought medical attention (office visit). Relatedness between the patient's event and ZOSTAVAX was not provided. This is one of several reports from the same source (MARRS # 1310USA007717). Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On approximately 19-SEP-2013, reported as "a week ago" the patient was vaccinated with a dose of ZOSTAVAX (lot number reported as J0004268, expiration date: 12-JUL-2014, dose and route not reported). On an unspecified date in September 2013, after receiving ZOSTAVAX the patient developed rash. On an unknown date in September 2013 the rash subsided and the patient recovered fully with no issue. This is one of two reports received from the same source (related MARRS # 1309USA013337, concerns the patient female friend who also developed rash after the same lot of ZOSTAVAX). Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient with sulfa allergy and no pertinent medical history. On approximately 19-SEP-2013, reported as "a week ago", the patient was vaccinated with a dose of ZOSTAVAX (lot number reported as J0004268, expiration date: 12-JUL-2014, dose, and route not reported). Concomitant therapies included vitamins (unspecified) and OMEGA-3. On approximately 19-SEP-2013, just after receiving ZOSTAVAX, the patient developed red dots around injection site. The patient described those red dots as oval in shape. It was reported that those went away in about a week (recovery date: approximately 25-SEP-2013). However the patient called the pharmacy again on 26-SEP-2013 and stated that she had then developed little bigger rash around same area and this bigger rash was overlapping the area where previous rash (red dots) were present and it was oval shape and red. No treatment was given for the patient and no lab diagnostic studies were performed. At the time of the report the patient did not recover from the little bigger red rash overlapping the area where previous rash (red dots) were present. This is one of two reports received from the same source (related MARRS # 1310USA006077, concerns the patient male friend who also developed rash after the same lot of ZOSTAVAX. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a nurse refers to a 65 year old male patient who is also a physician. On 26-SEP-2013 the patient was vaccinated with single standard dose of PNEUMOVAX23 (lot # reported as H022280) subcutaneous in the right arm. Concomitant therapies included influenza virus vaccine (unspecified) administered on 26-SEP-2013 in the left arm. On 26-SEP-2013, the patient developed redness and warmth in a 2" diameter sized area at the PNEUMOVAX23 injection site that later turned into a hard golf ball sized reaction under the skin that was hard and very tender. The hardness and tenderness went away after about 5 days on approximately 01-OCT-2013. On 26-SEP-2013, the patient also developed chills that lasted for 5 days, but did not develop a fever. The patient did not seek medical attention. The outcome of all the events was reported as recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. In August 2013 the patient was vaccinated with a dose of ZOSTAVAX dose, route and lot # not reported (also reported that patient might have received ZOSTAVAX. On an unknown date the patient experienced lightheadedness. The outcome of lightheadedness was unknown. The relatedness between ZOSTAVAX and lightheadedness was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, route and dose were not reported) vial. On an unknown date, the patient experienced injection site reaction of redness and bumps. Varicella-like rash was not present. Patient sought medical attention (went to see the pharmacist). No treatment was given. On an unknown date, the event of injection site reaction of redness and bumps was recovered/resolved without treatment. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient. On 12-OCT-2013 the patient was vaccinated with ZOSTAVAX VIAL 19400 PFU (lot # J004266, exp date 12-JUL-2014) 0.65 ml (dose # unknown), subcutaneous for immunization. Concomitant therapies included SINGULAIR. Pharmacist reported that patient came back to pharmacy today (15-OCT-2013) and reported that she developed swelling, about size of a lemon, redness and itching around injection site (onset date reported as 15-OCT-2013). There were no treatment informations and no labs performed. The patient sought medical attention by spoke to pharmacist. The outcome was reported as not recovered/not resolved. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 74 year old female patient with chronic obstructive pulmonary disease (COPD), hypertension and hypothyroidism. The patient's medical history included unspecified reaction to CIPRO, unspecified reaction to Macrolide and unspecified reaction to Ketolide. The patient's history drug included CIPRO, Macrolide and Ketolide. On 05-OCT-2013 the patient was vaccinated with ZOSTAVAX (lot # unknown), 0.65 ml, once subcutaneous as recommended. Concomitant therapies included budesonide, SYMBICORT, SYNTHROID, lisinopril (manufacture unknown) and NEXIUM. Pharmacist reported that after a patient received ZOSTAVAX she developed shingles. The patient reported that "3 days after" received ZOSTAVAX, in approximately 08-OCT-2013, she developed a "headache; her head hurt and was sore to the touch". The patient saw her unspecified primary care provider on 11-OCT-2013 who diagnosed her with shingles. The unspecified primary care provider prescribed Acyclovir and Prednisone. The patient reported to the pharmacist that there was "no actual outbreak or visible rash, the shingles was intercranial". The outcome of intercranial shingles was reported as not recovered/not resolved. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Skin warm, Tenderness
Clinical narrative: This spontaneous report as received from a pharmacist and a health care student refers to a 60 year old male patient with no drug allergies. Patient's pertinent medical history was none. On 04-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J002865, expiry date was 07-JUN-2014) 0.65 milliliter (ml), subcutaneously. Approximately on an unknown date in 2013 (reported as in the last 4 weeks) the patient also received influenza virus vaccine (manufacturer unknown) (Lot number, expiry date, route and dose were not reported). No concomitant medications were reported. Approximately on an unknown date in October 2013, the patient's arm was red, swollen, had hyperthermia/heat and was tender. Patient sought medical attention (saw the pharmacist). No lab diagnostic studies were performed. Patient had received no treatment as yet. The pharmacist inquired regarding the route of vaccine administration that it was not correspondent with proper administration guidelines. The vaccine was directed to be given subcutaneous and the pharmacist asked if the shot should be given in the deltoid area where one would give an IM (intramuscular). The outcome of the event arm was red, swollen, had hyperthermia/heat and was tender was unknown. A similar reaction with ZOSTAVAX was reported for the same lot number (MARRS #1310USA003246). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Burning sensation
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to unspecified patients of unknown ages and genders. ON an unknown date the patients were vaccinated with GARDASIL (route, dose, lot#, expiration date unknown). On an unknown date the patients felt a "burning sensation" while they were receiving GARDASIL. Action taken with therapy and the outcome of the event were unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 24.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 24 year old patient. The reporter reported the unspecified patient "was administered the first dose in the GARDASIL vaccination series in 2008 and was administered the second dose of GARDASIL on an unspecified date. The third dose of GARDASIL would be administered at some point in 2013". No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 24-AUG-2013 the patient was vaccinated with ZOSTAVAX (route, dose and lot number unknown) dose 1. No other suspect therapy or concomitant medication was reported. On an unspecified date in August 2013 (reported as a couple days after the patient received ZOSTAVAX) the patient experienced stinging and tingling on her back. One week later the patient experienced the same tingling and stinging on her back. patient was concerned as she had shingles, previously (date unknown). No treatment information was reported. The outcome of shingles was reported as recovered/resolved. The outcome of stinging and tingling on her back is unknown. The reporters relatedness of stinging and tingling on her back and shingles to ZOSTAVAX is unknown. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Hives - entire body - rx; benadryl Q4H - took for 2 days.
Sex: U
Vaccine: HEP, HEPA, HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed practical Nurse refers to an unspecified number of patients. On an unknown date the patients were vaccinated with RECOMBIVAX HB (dose, route and lot were not provided). Other suspect therapies included VAQTA (dose, route and lot were not provided) and PEDVAXHIB (dose, route and lot were not provided). On an unspecified date, the vaccines were exposed to 31 F for 15 hours and also 33 F for 4 days, which is an excursion that is unsupported by in-house stability data. No adverse events symptoms were reported. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a medical assistant, refers to a female patient of currently 50 years old with amoxicillin allergy. The patient had no pertinent medical history. Medical assistant reported that the patient with an unknown vaccination history for measles, mumps, and rubella had negative titers for measles, mumps, and rubella when she was tested. Concomitant medications were not reported. The outcome of negative titers for measles, mumps, and rubella was not reported. No treatment was given for negative titers for measles, mumps, and rubella. Patient sought medical attention: Office visit. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, indication, route and lot were not reported) froma different pharmacy. On an unknown date, the patient expereienced rash on her arm. The outcome of rash on her arm was unknown. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: HPV4
Symptoms: Local swelling, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a 23 year old male patient with a sulfa allergy and no other pertinent medical history. On an unspecified date in July 2012 the patient was vaccinated with GARDASIL dose 1 in series. There was no concomitant medication. On that unspecified date in July 2012 the patient noted swelling and rash on his forearm of the unspecified arm injected with GARDASIL. The patient sought medical attention and notified his unspecified physician who prescribed BENADRYL to manage the symptoms of the reaction. No lab diagnostic tests were performed. The patient recovered on an unspecified date. The casual relationship was not reported. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old male patient, with no medical history, drug reactions or allergies. The pharmacist reported that the wife of the patient stated that her husband on 17-SEP-2013, was vaccinated with a dose of 0.65 ml ZOSTAVAX vial 19400 PFU lot # J000444; expiration date 11-APR-2014, subcutaneous in the left arm. Concomitant medication was unspecified by the reporter. On 20-SEP-2013, 4 days after onset of therapy the patient experienced redness, soreness and lump the shape and size of an egg at his left arm injection site. Treatment, lab diagnostic and if the patient sought medical attention were unspecified by the reporter. The outcome of redness, soreness and a lump the shape and size of an egg at his left arm injection site were reported as not recovered/not resolved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Nodule
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a male patient of unknown age, who on an unknown date, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. The registered pharmacist reported that on an unspecified date the patient had a nodule, location was unspecified. At the time of the report, the patient's outcome for the adverse event was unknown. The relatedness for the adverse event was unknown for ZOSTAVAX. 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 pharmacist refers to a patient of unknown age and gender. ON an unknown date the patient was vaccinated with GARDASIL 120 Y (dose, route and lot number were not reported). Concomitant medications were not reported. Pharmacist reported that the patient received a first dose of GARDASIL on an unspecified date "several years ago" and wanted to receive the second dose the day of the report, on 09-OCT-2013. No adverse symptoms were reported. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Urticaria
Clinical narrative: This spontaneous report as received from a registered nurse concerning a patient of unknown gender, over 60 years old, who in September 2013 was vaccinated with a dose of ZOSTAVAX 0.65 ml, intradermally in the anterior forearm of the deltoid region. No other co-suspects were reported. No concomitant medications were reported. The registered nurse reported that on an unspecified date, the patient experienced huge painful wheal. At the time of the report, the patient's outcome for the adverse event was unknown. The relatedness for the adverse event was unknown for ZOSTAVAX. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Maternal exposure before pregnancy, Measles antibody negative
Clinical narrative: This spontaneous prospective pregnancy report as received from an approximately 27 year old female nurse practitioner refers to herself. The patient had no medical history and no known drug reactions or allergies. In either 2005 or 2006, the patient was vaccinated with the first dose of M-M-R II, (route, lot # and expiration date were not provided). In May 2013 and on 27-AUG-2013, the patient was vaccinated with the second and third doses of M-M-R II, 0.5 ml, subcutaneous  (lot # and expiration date were not provided). There were no concomitant medications. The patient reported that the reason she received the M-M-R II was due to her titers showed no immunity to measles. The patient stated that her titers were drawn on an unspecified date before her dose in May 2013 as well as again on an unspecified date before her dose on 27-AUG-2013. The patient became pregnant after receiving the second dose of M-M-R II, at the time of report, she was 4.5 weeks pregnant. On approximately 19-AUG-2013, the patient has her last menstrual period. No treatment was given to the patient. The patient did not seek medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a 48 year old female patient with history of tuberculosis reporting on herself. On 23-SEP-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J000436, exp. date: 10-APR-2014) 0.65 ml one shot (route and site of administration were not reported). No concomitant medication was involved. On 23-SEP-2013, after receiving ZOSTAVAX, she developed extreme swelling around the injection site. She stated that this swelling extended from her elbow to her armpit and wrapped around her arm as well. She also stated that it ws "hard as a rock and painful". The patient sought medical attention via seeing a physician on 26-SEP-2013. The physician recommended that the patient took CLARITIN for treatment. The physician also suggested that the patient rub hydrocortisone cream (unspecified  manufacturer, dose and frequency) on the affected area. Of her present status, the patient stated that she was "uncomfortable and ornery". During the course of the call, the patient stated that BENADRYL (unspecified, dose and frequency) made her legs jump (date unspecified). No lab diagnostics studies were performed. The outcome of adverse events was not reported. The relatedness between therapy with ZOSTAVAX and adverse events was not reported. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Adverse drug reaction, Discomfort, Dyskinesia, Injection site induration, Injection site pain
Clinical narrative: This spontaneous report was received from a 48 year old female patient with history of tuberculosis reporting on herself. On 23-SEP-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J000436, exp. date: 10-APR-2014) 0.65 ml one shot (route and site of administration were not reported). No concomitant medication was involved. On 23-SEP-2013, after receiving ZOSTAVAX, she developed extreme swelling around the injection site. She stated that this swelling extended from her elbow to her armpit and wrapped around her arm as well. She also stated that it ws "hard as a rock and painful". The patient sought medical attention via seeing a physician on 26-SEP-2013. The physician recommended that the patient took CLARITIN for treatment. The physician also suggested that the patient rub hydrocortisone cream (unspecified  manufacturer, dose and frequency) on the affected area. Of her present status, the patient stated that she was "uncomfortable and ornery". During the course of the call, the patient stated that BENADRYL (unspecified, dose and frequency) made her legs jump (date unspecified). No lab diagnostics studies were performed. The outcome of adverse events was not reported. The relatedness between therapy with ZOSTAVAX and adverse events was not reported. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Irritability
Clinical narrative: This spontaneous report was received from a 48 year old female patient with history of tuberculosis reporting on herself. On 23-SEP-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J000436, exp. date: 10-APR-2014) 0.65 ml one shot (route and site of administration were not reported). No concomitant medication was involved. On 23-SEP-2013, after receiving ZOSTAVAX, she developed extreme swelling around the injection site. She stated that this swelling extended from her elbow to her armpit and wrapped around her arm as well. She also stated that it ws "hard as a rock and painful". The patient sought medical attention via seeing a physician on 26-SEP-2013. The physician recommended that the patient took CLARITIN for treatment. The physician also suggested that the patient rub hydrocortisone cream (unspecified  manufacturer, dose and frequency) on the affected area. Of her present status, the patient stated that she was "uncomfortable and ornery". During the course of the call, the patient stated that BENADRYL (unspecified, dose and frequency) made her legs jump (date unspecified). No lab diagnostics studies were performed. The outcome of adverse events was not reported. The relatedness between therapy with ZOSTAVAX and adverse events was not reported. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Enema administration, Grunting, Haematochezia, Haematocrit decreased, Haemoglobin normal
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included DTaP-HepB-IPV; GlaxoSmithKline; unknown; unknown given on 30 September 2013; Hib (non-gsk); non-GSK manufacturer; unknown; unknown given on 30 September 2013; pneumococcal vaccines (non-gsk); non-GSK manufacturer; unknown; unknown given on 30 September 2013. On 30 September 2013 the subject received 2nd dose of ROTARIX (1 ml, oral). On 7 October 2013, 7 days after vaccination with ROTARIX, the subject experienced intussusception. The nurse reported that the subject sought medical attention at "the emergency room, was admitted for surgery and discharged the following day." The subject was hospitalised and the healthcare professional considered the event was clinically significant (or requiring intervention). At the time of reporting the outcome of the event was unspecified.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Intussusception, Platelet count normal, Ultrasound abdomen abnormal, Urinary system X-ray, Vomiting
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included DTaP-HepB-IPV; GlaxoSmithKline; unknown; unknown given on 30 September 2013; Hib (non-gsk); non-GSK manufacturer; unknown; unknown given on 30 September 2013; pneumococcal vaccines (non-gsk); non-GSK manufacturer; unknown; unknown given on 30 September 2013. On 30 September 2013 the subject received 2nd dose of ROTARIX (1 ml, oral). On 7 October 2013, 7 days after vaccination with ROTARIX, the subject experienced intussusception. The nurse reported that the subject sought medical attention at "the emergency room, was admitted for surgery and discharged the following day." The subject was hospitalised and the healthcare professional considered the event was clinically significant (or requiring intervention). At the time of reporting the outcome of the event was unspecified.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: White blood cell count normal
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included DTaP-HepB-IPV; GlaxoSmithKline; unknown; unknown given on 30 September 2013; Hib (non-gsk); non-GSK manufacturer; unknown; unknown given on 30 September 2013; pneumococcal vaccines (non-gsk); non-GSK manufacturer; unknown; unknown given on 30 September 2013. On 30 September 2013 the subject received 2nd dose of ROTARIX (1 ml, oral). On 7 October 2013, 7 days after vaccination with ROTARIX, the subject experienced intussusception. The nurse reported that the subject sought medical attention at "the emergency room, was admitted for surgery and discharged the following day." The subject was hospitalised and the healthcare professional considered the event was clinically significant (or requiring intervention). At the time of reporting the outcome of the event was unspecified.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Intussusception, Surgery
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included DTaP-HepB-IPV; GlaxoSmithKline; unknown; unknown given on 30 September 2013; Hib (non-gsk); non-GSK manufacturer; unknown; unknown given on 30 September 2013; pneumococcal vaccines (non-gsk); non-GSK manufacturer; unknown; unknown given on 30 September 2013. On 30 September 2013 the subject received 2nd dose of ROTARIX (1 ml, oral). On 7 October 2013, 7 days after vaccination with ROTARIX, the subject experienced intussusception. The nurse reported that the subject sought medical attention at "the emergency room, was admitted for surgery and discharged the following day." The subject was hospitalised and the healthcare professional considered the event was clinically significant (or requiring intervention). At the time of reporting the outcome of the event was unspecified.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, CSF protein increased, CSF white blood cell count negative, Eyelid function disorder, Guillain-Barre syndrome
Clinical narrative: Paresthesias in the hands B/L.  After 4 days she develops some low back pain and weakness in the legs with prolonged standing, walking > 100 yards, and climbing stairs.  On Oct 10, 2013 she developed left facial droop and difficulty closing the left eyelid. On Oct 14, 2013 a lumbar puncture confirmed the diagnosis of Guillain Barre.  On Oct 14 she started IVIG 23g daily x 5 days.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Immunoglobulin therapy, Lumbar puncture abnormal, Muscular weakness, Paraesthesia, VIIth nerve paralysis
Clinical narrative: Paresthesias in the hands B/L.  After 4 days she develops some low back pain and weakness in the legs with prolonged standing, walking > 100 yards, and climbing stairs.  On Oct 10, 2013 she developed left facial droop and difficulty closing the left eyelid. On Oct 14, 2013 a lumbar puncture confirmed the diagnosis of Guillain Barre.  On Oct 14 she started IVIG 23g daily x 5 days.
Age: 38.0
Sex: M
Vaccine: ANTH, FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient given Anthrax #9 vaccination out of cycle--due in Jan 2014, given Oct 18 2013.
Age: 34.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Ear pain, Lymphadenopathy, Palpitations, Speech disorder, Swollen tongue
Clinical narrative: 5 minutes after I started seeing floating lights. Then at around 9:00PM I started shaking uncontrollably, and couldn't talk. My heart was racing.  So my wife took me to the ER. Now I've been having enlarged lymph nodes, my tounge was swollen, my ears hurt.
Age: 34.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Tremor, Vaccination complication, Vitreous floaters
Clinical narrative: 5 minutes after I started seeing floating lights. Then at around 9:00PM I started shaking uncontrollably, and couldn't talk. My heart was racing.  So my wife took me to the ER. Now I've been having enlarged lymph nodes, my tounge was swollen, my ears hurt.
Age: 34.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Anxiety, Dysphemia, Full blood count, Headache, Hypoaesthesia
Clinical narrative: 5 minutes after I started seeing floating lights. Then at around 9:00PM I started shaking uncontrollably, and couldn't talk. My heart was racing.  So my wife took me to the ER. Now I've been having enlarged lymph nodes, my tounge was swollen, my ears hurt.
Age: 34.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Metabolic function test, Muscle tightness, Speech disorder, Tearfulness, Tremor
Clinical narrative: 5 minutes after I started seeing floating lights. Then at around 9:00PM I started shaking uncontrollably, and couldn't talk. My heart was racing.  So my wife took me to the ER. Now I've been having enlarged lymph nodes, my tounge was swollen, my ears hurt.
Age: 34.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Vaccination complication, Vitreous floaters
Clinical narrative: 5 minutes after I started seeing floating lights. Then at around 9:00PM I started shaking uncontrollably, and couldn't talk. My heart was racing.  So my wife took me to the ER. Now I've been having enlarged lymph nodes, my tounge was swollen, my ears hurt.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Erythema, Local swelling, Myalgia
Clinical narrative: Swelling and redness of right arm. Muscle pain.
Age: 31.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Headache, Middle insomnia, Mobility decreased, Neck pain, Pain
Clinical narrative: Patient claimed that he woke up at 1:30 am in excruciating pain. He stated that he had a shooting pain running up from his arm to his neck and head. He also claimed to have limited ability to move his arm. Pt went back to his normal activities. No doctor visit was needed. Pt is OK. per wife.
Age: 31.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Patient claimed that he woke up at 1:30 am in excruciating pain. He stated that he had a shooting pain running up from his arm to his neck and head. He also claimed to have limited ability to move his arm. Pt went back to his normal activities. No doctor visit was needed. Pt is OK. per wife.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus generalised
Clinical narrative: Vaccine administered 1030 am itching started at 1800 all over body. Started applying CALADRYL cream to affected area.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling hot, Hypersensitivity, Injection site hypersensitivity, Injection site warmth
Clinical narrative: Hypersensitivity and heat radiating from injection site on (L) shoulder through pectoral region and on the (L) upper back area.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX concomitantly with a dose of influenza virus vaccine (unknown if AFLURIA). About 1 month ago, in approximately September 2013, the patient developed Guillain-Barre Syndrome. The patient was admitted to an unspecified hospital. The patient's outcome was unknown. The causal relationship was not provided. Upon internal review, Guillain-Barre Syndrome was considered medically significant. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Feeling hot
Clinical narrative: Localized area of redness and warmth > 11-12cm in size; (L) thigh.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Injection site reaction, Lip swelling, Local swelling, Swelling face
Clinical narrative: Swollen lips, face, arm and hands. Large reaction at the shot site. Shortness of breath by hour 9.
Age: 22.0
Sex: M
Vaccine: FLU3, HPV4, PPV
Symptoms: Axillary pain, Body temperature increased, Chills, Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain at area of injection, chills, night sweats. Came to clinic to be seen at 9:30 AM. Now is having difficulty lifting right arm. Reports pain and localized deltoid (R) area and armpit.
Age: 22.0
Sex: M
Vaccine: FLU3, HPV4, PPV
Symptoms: Night sweats
Clinical narrative: Pain at area of injection, chills, night sweats. Came to clinic to be seen at 9:30 AM. Now is having difficulty lifting right arm. Reports pain and localized deltoid (R) area and armpit.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Eye pruritus, Headache, Hot flush, Musculoskeletal stiffness
Clinical narrative: Headache, eye pain, itchy eye, stiff neck, severe hot flashes.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Electrocardiogram, Laboratory test, Palpitations
Clinical narrative: Heart palpitations starting in the AM and lasting through the evening.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Headache, Nasal congestion, Pain, Pyrexia
Clinical narrative: Started with head ache moved to stomach ache and pains. Next moved to uncontrollable shakes about 11:30 PM got a 99.5 fever at 1:00AM stuffy noise and allover body ache. No treatment.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Started with head ache moved to stomach ache and pains. Next moved to uncontrollable shakes about 11:30 PM got a 99.5 fever at 1:00AM stuffy noise and allover body ache. No treatment.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Body aches, headache, high fever.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Reaction at injection site- erythema and swelling and warmth- 13 cm, moderate pain.
Age: 0.65
Sex: F
Vaccine: FLUX
Symptoms: Lethargy, Pyrexia, Vomiting
Clinical narrative: The baby displayed significant lethargy and about an hour later vomited an unusually large amount. At that time she had a fever of 101 degrees F. She slept and nursed on and off for the next few hours. The fever appeared to have dissipated by 3am on 10/18/2013.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Fatigue, Hepatic enzyme increased
Clinical narrative: 10/9/13 AM - myalgia. 10/10/13 myalgia, malaise, fatigue. 10/10/13 PM - fever & jaundice. 10/15/13 - to MD; labs drawn.