chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 18-JUL-2011 the patient was vaccinated with GARDASIL (lot # not reported) (intramuscularly, dose one, total daily dose not reported). It was reported that the patient would be receiving dose two of GARDASIL (lot # not reported) on the reporting day, 17-DEC-2013. The outcome was unknown. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: HEPA
Symptoms: Arthralgia, Pain, Pyrexia
Clinical narrative: Fever, joint paint all over body.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray normal, Computerised tomogram normal, Corneal abrasion, Electrocardiogram normal, Ophthalmological examination
Clinical narrative: R Facial droop, photophobia, to st ER. CT negative, diagnosed Bell's Palsy. Valtrex & Predinsone. L x2 cornea abrasion.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Photophobia, VIIth nerve paralysis
Clinical narrative: R Facial droop, photophobia, to st ER. CT negative, diagnosed Bell's Palsy. Valtrex & Predinsone. L x2 cornea abrasion.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Hyperhidrosis, Pain in extremity, Pyrexia
Clinical narrative: Fever; chills; sweats; extreme aching in legs; restlessness; pain at point of vaccination; headache; head pounding. Through the night and into the next day 10/30. Alternated between Tylenol and ibuprofen every few hours.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Restlessness, Vaccination site pain
Clinical narrative: Fever; chills; sweats; extreme aching in legs; restlessness; pain at point of vaccination; headache; head pounding. Through the night and into the next day 10/30. Alternated between Tylenol and ibuprofen every few hours.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever of 102.8.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Pain Swelling. Shot administered in left arm- severe pain to the point where arm still cannot be used or lifted 30 hours later continued pain three days not getting better.
Age: 19.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Abdominal pain upper, Blindness unilateral, Decreased appetite, Dysstasia, Fatigue
Clinical narrative: 07/19/2013 at 10:00 PM, I temporarily lost vision in my left eye. It lasted about one minute and slowly came back. 12/09/2013, found two lumps on my neck and the doctor said it was swollen lymph nodes.  The same day I began to feel very fatigued, nauseous, and loss of appetite.  I could barely hold myself up in the shower.  During the following week I had severe stomach pain, headaches and muscle aches.  I also became very drowsy and wasn't able to be normally active.  12/19/2013, I found two rock hard lumps right behind my ear.
Age: 19.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Headache, Lymphadenopathy, Mass, Myalgia, Nausea
Clinical narrative: 07/19/2013 at 10:00 PM, I temporarily lost vision in my left eye. It lasted about one minute and slowly came back. 12/09/2013, found two lumps on my neck and the doctor said it was swollen lymph nodes.  The same day I began to feel very fatigued, nauseous, and loss of appetite.  I could barely hold myself up in the shower.  During the following week I had severe stomach pain, headaches and muscle aches.  I also became very drowsy and wasn't able to be normally active.  12/19/2013, I found two rock hard lumps right behind my ear.
Age: 19.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Somnolence
Clinical narrative: 07/19/2013 at 10:00 PM, I temporarily lost vision in my left eye. It lasted about one minute and slowly came back. 12/09/2013, found two lumps on my neck and the doctor said it was swollen lymph nodes.  The same day I began to feel very fatigued, nauseous, and loss of appetite.  I could barely hold myself up in the shower.  During the following week I had severe stomach pain, headaches and muscle aches.  I also became very drowsy and wasn't able to be normally active.  12/19/2013, I found two rock hard lumps right behind my ear.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Musculoskeletal pain, Nausea, Neck pain, Pain in extremity
Clinical narrative: Severe arm, shoulder, neck pain onset followed immediately by dizziness, faintness, light-headedness and nausea. Event lasted appx 45 minutes.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Presyncope
Clinical narrative: Severe arm, shoulder, neck pain onset followed immediately by dizziness, faintness, light-headedness and nausea. Event lasted appx 45 minutes.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Patient described a lump at the site of injection along with some redness. She described redness going down over time, but not gone. She described the lump as small, boil-like, painless, and maintaining its size (not getting bigger).
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a over 60 year old female patient. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot # J004196, Expiration Date: 06-DEC-2014) injection intramuscular. Concomitant medication was unspecified by the reporter. On an unknown date, (reported as one women) who within 24 hours of the vaccination experienced the entire arm from elbow to injection site was red and they felt absolutely terrible on an unspecified date. No treatment was given. Patient sought medical attention reported as went to pharmacy. No Product quality complaint. It was unclear if patient had ever had PNEUMOVAX 23 injection before. Outcome of the reported events was unknown. Causality of the reported event was unknown (not provided). This case related to 1312USA005844 and 1312USA009850 (Same Reporter Link). Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to several women, all over 60 years old female patients. On an unknown date, the patients was vaccinated with PNEUMOVAX23 (lot # J004196, Expiration Date: 06-DEC-2014) injection intramuscular. Concomitant medication was unspecified by the reporter. It was reported that the patients experienced same type of reaction to the PNEUMOVAX23 injection. The reported that on an unknown date each patients suffered the following reaction: entire arm from elbow to injection site was red and they felt absolutely terrible on an unspecified date. No treatment was given. Patient sought medical attention and one/ more patients went to pharmacy. No Product quality complaint. It was unclear if any of the patients
Age: 46.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Arthralgia, Blood creatine phosphokinase, Full blood count, Hyperhidrosis, Metabolic function test
Clinical narrative: This spontaneous report was received from a registered nurse via physician refers to a 46 year old male patient. The patient pertinent medical history included diabetes, asthma, hyperlipidemia and hypertension. The patient also had a historical drug Simvastatin with Unspecified reaction. On 10-DEC-2013, the patient was vaccinated with PNEUMOVAX23 lot # J006921, 0.5 ml, intramuscular in the left arm. On 11-DEC-2013, 2 days after onset of therapy the patient experienced a feverish feeling, sweating and body aches. The outcome of a feverish feeling, body aches and swelling was reported as not recovered. The reporter did not provide the causality between the events and the suspect product. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Musculoskeletal chest pain, Pain, Pyrexia, Red blood cell sedimentation rate decreased, Urine analysis
Clinical narrative: This spontaneous report was received from a registered nurse via physician refers to a 46 year old male patient. The patient pertinent medical history included diabetes, asthma, hyperlipidemia and hypertension. The patient also had a historical drug Simvastatin with Unspecified reaction. On 10-DEC-2013, the patient was vaccinated with PNEUMOVAX23 lot # J006921, 0.5 ml, intramuscular in the left arm. On 11-DEC-2013, 2 days after onset of therapy the patient experienced a feverish feeling, sweating and body aches. The outcome of a feverish feeling, body aches and swelling was reported as not recovered. The reporter did not provide the causality between the events and the suspect product. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Hyperhidrosis, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a registered nurse via physician refers to a 46 year old male patient. The patient pertinent medical history included diabetes, asthma, hyperlipidemia and hypertension. The patient also had a historical drug Simvastatin with Unspecified reaction. On 10-DEC-2013, the patient was vaccinated with PNEUMOVAX23 lot # J006921, 0.5 ml, intramuscular in the left arm. On 11-DEC-2013, 2 days after onset of therapy the patient experienced a feverish feeling, sweating and body aches. The outcome of a feverish feeling, body aches and swelling was reported as not recovered. The reporter did not provide the causality between the events and the suspect product. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dysgeusia, Increased upper airway secretion, Nausea, Vertigo
Clinical narrative: After breakfast and church patient had multiple episodes of nausea and vomiting. Feelings of light headedness, dizzy, vertigo. Metallic taste and excessive phlegm in throat.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: After breakfast and church patient had multiple episodes of nausea and vomiting. Feelings of light headedness, dizzy, vertigo. Metallic taste and excessive phlegm in throat.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site swelling
Clinical narrative: Injection site swelled and over time increased in size and spread. Patient went to PCP and diagnosis of cellulitis. Patient given antibiotic and is recovering.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Infection, Injection site erythema, Injection site swelling
Clinical narrative: After receiving ZOSTAVAX on 12/20/13, the patient came in on 12/22/13 presenting with a raised, red bump where the injection site was. She went to a clinic and picked up a cephalexin prescription to treat the infection.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate increased, Injection site swelling, Pyrexia
Clinical narrative: Swelling at injection site, fever, fast heart beat, sleep.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Bacterial infection, Erythema, Inflammation, Local swelling
Clinical narrative: VERY SWOLLEN, V. INFLAMED, LEFT ARM. SAT. STILL RED AND INFLAMED FROM SHOULDER TO ELBOW. SAT - WENT TO URGENT CARE. DOCTOR SAID IT WAS A BACTERIAL INFECTION, GAVE ME AN INJECTION IN THE TUSH, PRESCRIPTION FOR 7 DAYS ANTIBIOTICS. STILL RED & SWOLLEN BETWEEN ELBOW AND SHOULDER.  Sunday: still red and swollen, but not as much as Friday. I THINK IT IS AFFECTING THE R. SIDE OF MY FACE. SUNDAY. STILL INFLAMED AND SWOLLEN.
Age: 36.0
Sex: F
Vaccine: FLUN3
Symptoms: Blindness, Blood test, Dyspnoea, Lumbar puncture, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Wheezing and difficulty breathing. 11/5/2009 - loss of vision.  MRI showed mass on optic nerve/chiasm.  Possible demyelination, but all tests are inconclusive because of location of mass.  Still have loss of vision.
Age: 36.0
Sex: F
Vaccine: FLUN3
Symptoms: Optic nerve disorder, Visual pathway disorder, Wheezing
Clinical narrative: Wheezing and difficulty breathing. 11/5/2009 - loss of vision.  MRI showed mass on optic nerve/chiasm.  Possible demyelination, but all tests are inconclusive because of location of mass.  Still have loss of vision.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Pain, Urticaria, Vomiting
Clinical narrative: Nausea, vomiting, aching, hives.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Bacterial infection, Borrelia test negative, Chest pain
Clinical narrative: Per EMR documentation: 09/27/13:  trivalent influenza virus vaccine administered. 11/7/13-11/13/13:  Patient complained of febrile illness, found to have increased LFTs. Suspected ehrlichosis, tx empirically with doxycycline x10 days (per ID 12/7/13 Lyme, ehrlichosis labs negative). 11/25/13 back pain with radiation noted, suspected sciatica. 12/2/13: more back pain. 12/7/13 numbness in hands, chest pain, weakness.  12/9/13 left foot numbness (new), 12/14/13: increased leg weakness, hand numbness. 12/16/13 admit to hospital for weakness. Patient treated with IVIG x 5 days (12/17-12/21/13). 12/22/13: discharged with dx of Guillain-Barre syndrome.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Ehrlichia test, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Laboratory test normal
Clinical narrative: Per EMR documentation: 09/27/13:  trivalent influenza virus vaccine administered. 11/7/13-11/13/13:  Patient complained of febrile illness, found to have increased LFTs. Suspected ehrlichosis, tx empirically with doxycycline x10 days (per ID 12/7/13 Lyme, ehrlichosis labs negative). 11/25/13 back pain with radiation noted, suspected sciatica. 12/2/13: more back pain. 12/7/13 numbness in hands, chest pain, weakness.  12/9/13 left foot numbness (new), 12/14/13: increased leg weakness, hand numbness. 12/16/13 admit to hospital for weakness. Patient treated with IVIG x 5 days (12/17-12/21/13). 12/22/13: discharged with dx of Guillain-Barre syndrome.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Liver function test abnormal, Muscular weakness, Pyrexia, Sciatica
Clinical narrative: Per EMR documentation: 09/27/13:  trivalent influenza virus vaccine administered. 11/7/13-11/13/13:  Patient complained of febrile illness, found to have increased LFTs. Suspected ehrlichosis, tx empirically with doxycycline x10 days (per ID 12/7/13 Lyme, ehrlichosis labs negative). 11/25/13 back pain with radiation noted, suspected sciatica. 12/2/13: more back pain. 12/7/13 numbness in hands, chest pain, weakness.  12/9/13 left foot numbness (new), 12/14/13: increased leg weakness, hand numbness. 12/16/13 admit to hospital for weakness. Patient treated with IVIG x 5 days (12/17-12/21/13). 12/22/13: discharged with dx of Guillain-Barre syndrome.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling to injection site, with redness In 12/22/2013. On 12/23/2013 increased size of swelling and more redness and soreness. Dizziness with chills but is warm. Heated cheeks and goosebumps.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Piloerection, Skin warm
Clinical narrative: Swelling to injection site, with redness In 12/22/2013. On 12/23/2013 increased size of swelling and more redness and soreness. Dizziness with chills but is warm. Heated cheeks and goosebumps.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphonia, Malaise, Somnolence
Clinical narrative: 5 days after vaccine received: malaise, falling asleep frequently in church, weak voice for about 3 hours. No treatment received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to unspecified 13 patients of unknown age and gender. This report pertains to the patient who on 10-DEC-2013 was vaccinated with VARIVAX (Merck), (lot # J003540, expiry date 25-MAR-2015) 0.5 milliliter (ml), subcutaneous. The medical assistant reported that improperly stored VARIVAX (Merck) that was exposed to unsupported temperature conditions was administered to an unspecified patient. No adverse effect reported. No further information was available. This case is linked to 1312USA007815, 1312USA009865, 1312USA009866, 1312USA009867, 1312USA009868, 1312USA009869, 1312USA009870, 1312USA009871, 1312USA009872, 1312USA009873, 1312USA009874 (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 was received from a medical assistant refers to unspecified 13 patient of unknown age and gender. This report pertains to 2 patients who on 18-JUL-2013 were vaccinated with VARIVAX, (lot # H014074, expiry date 20-JUL-2014) 0.5 milliliter (ml), subcutaneous. The medical assistant reported that improperly stored VARIVAX that was exposed to unsupported temperature conditions were administered to 2 unspecified patients. No adverse effect reported. No further information was available. This case is linked to 131USA007815, 1312USA009866, 1312USA009867, 1312USA009868, 1312USA009870, 1312USA009872, 1312USA009873, 1312USA009874, 1312USA009875, 1312USA009869 (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 was received from a medical assistant refers to unspecified 13 patients of unknown age and gender. This report pertains to the patient who on 01-JUL-2013 was vaccinated with VARIVAX (Merck), (lot # H014074, expiry date 20-JUL-2014) 0.5 milliliter (ml), subcutaneous. The medical assistant reported that improperly stored VARIVAX (Merck) that was exposed to unsupported temperature conditions was administered to an unspecified patient. No adverse effect reported. No further information was available. This case is linked to 1312USA009865, 1312USA009866, 1312USA009867, 1312USA009868, 1312USA009869, 1312USA009870, 1312USA009871, 1312USA009872, 1312USA009873, 1312USA009874, 1312USA009875 (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 was received from a medical assistant refers to unspecified 13 patient of unknown age and gender. This report pertains to the patient who on 16-AUG-2013 was vaccinated with VARIVAX, (lot # H020672, expiry date 14-NOV-2014) 0.5 milliliter (ml), subcutaneous. The medical assistant reported that improperly stared VARIVAX that was exposed to unspecified temperature conditions was administered to an unspecified patient. No adverse effect reported. No further information was available. This case is linked to 1312USA007815, 1312USA009865, 1312USA009866, 1312USA009867, 1312USA009869, 1312USA009870, 1312USA009871, 1312USA009872, 1312USA009873 1312USA009874, 1312USA009875. (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 was received from a medical assistant refers to unspecified 13 patients of unknown age and gender. This report pertains to the patient who on 06-AUG-2013 was vaccinated with VARIVAX (Merck), (lot # H020672, expiry date 14-NOV-2014) 0.5 milliliter (ml), subcutaneous. The medical assistant reported that improperly stored VARIVAX (Merck) that was exposed to unsupported temperature conditions was administered to an unspecified patient. No adverse effect reported. No further information was available. This case is linked to 1312USA007815, 1312USA009865, 1312USA009867, 1312USA009868, 1312USA009870, 1312USA009871, 1312USA009872, 1312USA009873, 1312USA009874, 1312USA009875, 1312USA009869 (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 was received from a medical assistant refers to unspecified 13 patients of unknown age and gender. This report pertains to the patient who on 08-AUG-2013 was vaccinated with VARIVAX, (lot # H020672, expiry date 14-NOV-2014) 0.5 milliliter (ml), subcutaneous. The medical assistant reported that improperly stored VARIVAX that was exposed to unsupported temperature conditions was administered to an unspecified patient. No adverse effect reported. No further information was available. This case is linked to 1312USA007815, 1312USA009865, 1312USA009866, 1312USA009868, 1312USA009870, 1312USA009871, 1312USA009872, 1312USA009873, 1312USA009874, 1312USA009875, 1312USA009869 (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 was received from a medical assistant refers to unspecified 13 patients of unknown age and gender. This report pertains to the patient who on 20-SEP-2013 was vaccinated with VARIVAX (Merck), (lot # H020672, expiry date 14-NOV-2014) 0.5 milliliter (ml), subcutaneous. The medical assistant reported that improperly stored VARIVAX (Merck) that was exposed to unsupported temperature conditions was administered to an unspecified patient. No adverse effect reported. No further information was available. This case is linked to 1312USA007815, 1312USA009865, 1312USA009866, 1312USA009867, 1312USA009868, 1312USA009869, 1312USA009871, 1312USA009872, 1312USA009873, 1312USA009874, 1312USA009875 (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 was received from a medical assistant refers to unspecified 13 patient of unknown age and gender. This report pertains to the patient who on 14-OCT-2013 was vaccinated with VARIVAX, (lot # H020672, expiry date 14-NOV-2014) 0.5 milliliter (ml), subcutaneous. The medical assitant reproted that improperly stored VARIVAX that was exxposed to unsupported temperature conditions was administered to an unspecified patient. No adverse effect reported. No further information was available. This case is linked to 1312USA007815, 1312USA009865, 1312USA009866, 1312USA009867, 1312USA009868, 1312USA009869, 1312USA009870, 1312USA009872, 1312USA009873, 1312USA009874, 1312USA009875 (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 was received from a medical assistant refers to unspecified 13 patients of unknown age and gender. This report pertains to the patient who on 01-OCT-2013 was vaccinated with VARIVAX (Merck), (lot # J003540, expiry date 25-MAR-2015) 0.5 milliliter (ml), subcutaneous. The medical assistant reported that improperly stored VARIVAX (Merck) that was exposed to unsupported temperature conditions was administered to an unspecified patient. No adverse effect reported. No further information was available. This case is linked to 1312USA007815, 1312USA009865, 1312USA009866, 1312USA009867, 1312USA009868, 1312USA009869, 1312USA009870, 1312USA009871, 1312USA009873, 1312USA009874, 1312USA009875 (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 was received from a medical assistant refers to unspecified 13 patients of unknown age and gender. This report pertains to the patient who on 13-NOV-2013 was vaccinated with VARIVAX (Merck), (lot # J003540, expiry date 25-MAR-2015) 0.5 milliliter (ml), subcutaneous. The medical assistant reported that improperly stored VARIVAX (Merck) that was exposed to unsupported temperature conditions was administered to an unspecified patient. No adverse effect reported. No further information was available. This case is linked to 1312USA007815, 1312USA009865, 1312USA009866, 1312USA009867, 1312USA009868, 1312USA009869, 1312USA009870, 1312USA009871, 1312USA009872, 1312USA009873, 1312USA009875 (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 was received from a medical assistant refers to unspecified 13 patients of unknown age and gender. This report pertains to the patient who on 23-AUG-2013 was vaccinated with VARIVAX (Merck), (lot # H020672, expiry date 14-NOV-2014) 0.5 milliliter (ml), subcutaneous. The medical assistant reported that improperly stored VARIVAX (Merck) that was exposed to unsupported temperature conditions was administered to an unspecified patient. No adverse effect reported. No further information was available. This case is linked to 1312USA007815, 1312USA009865, 1312USA009866, 1312USA009867, 1312USA009868, 1312USA009870, 1312USA009871, 1312USA009872, 1312USA009873, 1312USA009874, 1312USA009875 (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 was received from a medical assistant refers to unspecified 13 patients of unknown age and gender. This report pertains to the patient who on 04-OCT-2013 was vaccinated with VARIVAX (Merck), (lot # J003540, expiry date 25-MAR-2015) 0.5 milliliter (ml), subcutaneous. The medical assistant reported that improperly stored VARIVAX (Merck) that was exposed to unsupported temperature conditions was administered to an unspecified patient. No adverse effect reported. No further information was available. This case is linked to 1312USA007815, 1312USA009865, 1312USA009866, 1312USA009867, 1312USA009868, 1312USA009869, 1312USA009870, 1312USA009871, 1312USA009872, 1312USA009874, 1312USA009875 (Same reporter link). Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Depressed level of consciousness, Hyperhidrosis, Incoherent, Respiratory arrest, Syncope
Clinical narrative: Case number PHHY2012US111571, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 467567) web site on 04 Dec 2012, with the follow-up received from Quality Assurance Department (reference number: 210066) on 18 Dec 2013. This report refers to 51 year old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1204601, Expiry date: 31 May 2013) first, later was vaccinated with ADACEL (batch number: C4196AA) intramuscularly on 01 Oct 2012. On the same day the patient broke out in a sweat, became unalert and incoherent and appeared to have fainted after second vaccine was given. Patient did not respond to name being called and was not breathing for several seconds. Paramedics were called. Patient refused to have paramedics taken her to the hospital. Left pharmacy on her own. Vital signs, pulse, blood pressure, were taken by paramedics. The results were not reported. The outcome of the events was recovered. Seriousness and causality assessment was not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN vaccine (batch number: 1204601) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 210066) on 18 Dec 2013: Updated batch review report.
Age: 51.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Unresponsive to stimuli
Clinical narrative: Case number PHHY2012US111571, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 467567) web site on 04 Dec 2012, with the follow-up received from Quality Assurance Department (reference number: 210066) on 18 Dec 2013. This report refers to 51 year old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1204601, Expiry date: 31 May 2013) first, later was vaccinated with ADACEL (batch number: C4196AA) intramuscularly on 01 Oct 2012. On the same day the patient broke out in a sweat, became unalert and incoherent and appeared to have fainted after second vaccine was given. Patient did not respond to name being called and was not breathing for several seconds. Paramedics were called. Patient refused to have paramedics taken her to the hospital. Left pharmacy on her own. Vital signs, pulse, blood pressure, were taken by paramedics. The results were not reported. The outcome of the events was recovered. Seriousness and causality assessment was not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN vaccine (batch number: 1204601) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 210066) on 18 Dec 2013: Updated batch review report.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Disorientation, Dizziness, Pallor
Clinical narrative: Case number PHHY2012US111738 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 468094) website on 04 Dec 2012, with the follow-up received from Quality Assurance Department (reference number: 209871) on 18 Dec 2013. This report refers to an 87-year-old male patient. His medical history included high blood pressure. His concomitant medication included Amlodipine 10 mg QD. He was vaccinated with FLUVIRIN (batch number: 1204601, Expiry date: 31 May 2013) intramuscularly to left arm on 02 Oct 2012. He became extremely pale, disoriented, and dizzy approximately three to five minutes after vaccination. He appeared to be recovering, then experienced same symptoms again a few minutes later. 911 was called. Patient recovered by the time they got there. EMT checked his blood pressure and it was normal. Final outcome was reported as complete recovery. No further information about seriousness and causality was provided. Based on the investigations performed, QA department stated that, the FLUVIRIN vaccine (batch number: 1204601) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 209871) on 18 Dec 2013: Updated batch review report.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Heart rate increased, Rash
Clinical narrative: Case number PHHY2013US000901 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 470575) on 02 Jan 2013, with a follow up received from the QA department on 17 Dec 2013. This report refers to a 30-year-old female patient. The patient was vaccinated with FLUVIRIN (batch number: 1207101) intramuscularly in right arm on 18 Oct 2012. On 18 Oct 2012, after the vaccination, she experienced rash, warmth and increased heart rate. She was treated with Epipen after which she felt better. The outcome of the events was reported as complete recovery as of 19 Oct 2012. The seriousness and causality of the events was not reported. Based on the batch review, it was stated that the concerned FLUVIRIN batch number 1207101 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the QA department on 17 Dec 2013: Updated batch report.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Dysgeusia, Hypogeusia, Hypotonia
Clinical narrative: Case number PHHY2013US00586, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 470910) web site on 02 Jan 2013, with the follow-up received from Quality Assurance Department (reference number: 213658) on 18 DEC 2013. This report refers to a 31-year-old male patient. His medical history and concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 1204601, Expiry date: 31 May 2013) into left arm on 20 Oct 2012. Approximately 3-4 hours after vaccine, patient noticed a pronounced metallic taste in mouth with diminished taste. Patient also reports lack of muscle tone/control on right side of face (eye and mouth) as of this morning. The outcome of the events was condition unchanged. The seriousness and causality assessment was not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN vaccine (batch number: 1204601) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Following internal review on 21 Jan 2013 based on the information received on 02 Jan 2012, a significant case correction was done. This case was upgraded to serious "medically significant". Follow-up received from Quality Assurance Department (reference number: 213658) on 18 Dec 2013: Updated batch review report.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Balance disorder, Blood potassium abnormal, Blood pressure increased, Burning sensation
Clinical narrative: Case number PHHY2013US000738 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 471040) website on 02 Jan 2013, with the follow-up received from Quality Assurance Department (reference number: 208810) on 17 Dec 2013: This report refers to a 37-year-old female patient. Her medical history included nephrolithiasis and seasonal allergies. Concomitant medication included PRILOSEC. The patient was vaccinated with FLUVIRIN (batch number: 97850P1) intramuscularly in the left arm on 07 Oct 2009. On the same date, after vaccination the patient experienced paresthesia of feet that lasted for several days then resolved on an unknown date. On 23 Oct 2009, the patient experienced paresthesia of left foot, then bilateral feet that spread to hands and then face. The patient had difficulty in lifting the left foot. On 27 Oct 2009, the patient experienced severe shortness of breath, dyspnea, palpitations, severely elevated blood pressure and heart rate. She also had progression of her severe lower extremity weakness, upper extremity weakness, motor/neurological motor processing difficulty, orthostatic hypotension and labile blood pressure, hyperventilation, anxiety, fatigue, severe burning sensations in spine and extremities, temperature sensitivity, Raynaud phenomenon, insomnia, myalgia, slow speech, hypokalemia, abnormal balance and gait. She also developed severe sensitivity to sound and experienced cholecystitis. The patient was hospitalized and received blood pressure medications, physical therapy and massage therapy. The patient's lab data showed lumbar puncture as negative, physical tests showed delayed motor processing, MRI head was with negative findings, potassium levels showed hypokalemia and tilt table showed orthostatic hypotension. The patient visited the emergency room on an unknown date. The events seriousness was reported as permanent disability. The outcome was reported as condition unchanged. The causality of the events was not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 97850P1) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from the Quality Assurance Department (reference number: 208810) on 17 Dec 2013: Updated batch review report.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Cholecystitis, Dyspnoea, Fatigue, Gait disturbance, Heart rate increased
Clinical narrative: Case number PHHY2013US000738 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 471040) website on 02 Jan 2013, with the follow-up received from Quality Assurance Department (reference number: 208810) on 17 Dec 2013: This report refers to a 37-year-old female patient. Her medical history included nephrolithiasis and seasonal allergies. Concomitant medication included PRILOSEC. The patient was vaccinated with FLUVIRIN (batch number: 97850P1) intramuscularly in the left arm on 07 Oct 2009. On the same date, after vaccination the patient experienced paresthesia of feet that lasted for several days then resolved on an unknown date. On 23 Oct 2009, the patient experienced paresthesia of left foot, then bilateral feet that spread to hands and then face. The patient had difficulty in lifting the left foot. On 27 Oct 2009, the patient experienced severe shortness of breath, dyspnea, palpitations, severely elevated blood pressure and heart rate. She also had progression of her severe lower extremity weakness, upper extremity weakness, motor/neurological motor processing difficulty, orthostatic hypotension and labile blood pressure, hyperventilation, anxiety, fatigue, severe burning sensations in spine and extremities, temperature sensitivity, Raynaud phenomenon, insomnia, myalgia, slow speech, hypokalemia, abnormal balance and gait. She also developed severe sensitivity to sound and experienced cholecystitis. The patient was hospitalized and received blood pressure medications, physical therapy and massage therapy. The patient's lab data showed lumbar puncture as negative, physical tests showed delayed motor processing, MRI head was with negative findings, potassium levels showed hypokalemia and tilt table showed orthostatic hypotension. The patient visited the emergency room on an unknown date. The events seriousness was reported as permanent disability. The outcome was reported as condition unchanged. The causality of the events was not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 97850P1) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from the Quality Assurance Department (reference number: 208810) on 17 Dec 2013: Updated batch review report.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperacusis, Hyperventilation, Hypokalaemia, Insomnia, Labile blood pressure
Clinical narrative: Case number PHHY2013US000738 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 471040) website on 02 Jan 2013, with the follow-up received from Quality Assurance Department (reference number: 208810) on 17 Dec 2013: This report refers to a 37-year-old female patient. Her medical history included nephrolithiasis and seasonal allergies. Concomitant medication included PRILOSEC. The patient was vaccinated with FLUVIRIN (batch number: 97850P1) intramuscularly in the left arm on 07 Oct 2009. On the same date, after vaccination the patient experienced paresthesia of feet that lasted for several days then resolved on an unknown date. On 23 Oct 2009, the patient experienced paresthesia of left foot, then bilateral feet that spread to hands and then face. The patient had difficulty in lifting the left foot. On 27 Oct 2009, the patient experienced severe shortness of breath, dyspnea, palpitations, severely elevated blood pressure and heart rate. She also had progression of her severe lower extremity weakness, upper extremity weakness, motor/neurological motor processing difficulty, orthostatic hypotension and labile blood pressure, hyperventilation, anxiety, fatigue, severe burning sensations in spine and extremities, temperature sensitivity, Raynaud phenomenon, insomnia, myalgia, slow speech, hypokalemia, abnormal balance and gait. She also developed severe sensitivity to sound and experienced cholecystitis. The patient was hospitalized and received blood pressure medications, physical therapy and massage therapy. The patient's lab data showed lumbar puncture as negative, physical tests showed delayed motor processing, MRI head was with negative findings, potassium levels showed hypokalemia and tilt table showed orthostatic hypotension. The patient visited the emergency room on an unknown date. The events seriousness was reported as permanent disability. The outcome was reported as condition unchanged. The causality of the events was not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 97850P1) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from the Quality Assurance Department (reference number: 208810) on 17 Dec 2013: Updated batch review report.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Lumbar puncture normal, Mobility decreased, Motor dysfunction, Muscular weakness, Myalgia
Clinical narrative: Case number PHHY2013US000738 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 471040) website on 02 Jan 2013, with the follow-up received from Quality Assurance Department (reference number: 208810) on 17 Dec 2013: This report refers to a 37-year-old female patient. Her medical history included nephrolithiasis and seasonal allergies. Concomitant medication included PRILOSEC. The patient was vaccinated with FLUVIRIN (batch number: 97850P1) intramuscularly in the left arm on 07 Oct 2009. On the same date, after vaccination the patient experienced paresthesia of feet that lasted for several days then resolved on an unknown date. On 23 Oct 2009, the patient experienced paresthesia of left foot, then bilateral feet that spread to hands and then face. The patient had difficulty in lifting the left foot. On 27 Oct 2009, the patient experienced severe shortness of breath, dyspnea, palpitations, severely elevated blood pressure and heart rate. She also had progression of her severe lower extremity weakness, upper extremity weakness, motor/neurological motor processing difficulty, orthostatic hypotension and labile blood pressure, hyperventilation, anxiety, fatigue, severe burning sensations in spine and extremities, temperature sensitivity, Raynaud phenomenon, insomnia, myalgia, slow speech, hypokalemia, abnormal balance and gait. She also developed severe sensitivity to sound and experienced cholecystitis. The patient was hospitalized and received blood pressure medications, physical therapy and massage therapy. The patient's lab data showed lumbar puncture as negative, physical tests showed delayed motor processing, MRI head was with negative findings, potassium levels showed hypokalemia and tilt table showed orthostatic hypotension. The patient visited the emergency room on an unknown date. The events seriousness was reported as permanent disability. The outcome was reported as condition unchanged. The causality of the events was not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 97850P1) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from the Quality Assurance Department (reference number: 208810) on 17 Dec 2013: Updated batch review report.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Nervous system disorder, Nuclear magnetic resonance imaging brain normal, Orthostatic hypotension, Palpitations, Paraesthesia
Clinical narrative: Case number PHHY2013US000738 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 471040) website on 02 Jan 2013, with the follow-up received from Quality Assurance Department (reference number: 208810) on 17 Dec 2013: This report refers to a 37-year-old female patient. Her medical history included nephrolithiasis and seasonal allergies. Concomitant medication included PRILOSEC. The patient was vaccinated with FLUVIRIN (batch number: 97850P1) intramuscularly in the left arm on 07 Oct 2009. On the same date, after vaccination the patient experienced paresthesia of feet that lasted for several days then resolved on an unknown date. On 23 Oct 2009, the patient experienced paresthesia of left foot, then bilateral feet that spread to hands and then face. The patient had difficulty in lifting the left foot. On 27 Oct 2009, the patient experienced severe shortness of breath, dyspnea, palpitations, severely elevated blood pressure and heart rate. She also had progression of her severe lower extremity weakness, upper extremity weakness, motor/neurological motor processing difficulty, orthostatic hypotension and labile blood pressure, hyperventilation, anxiety, fatigue, severe burning sensations in spine and extremities, temperature sensitivity, Raynaud phenomenon, insomnia, myalgia, slow speech, hypokalemia, abnormal balance and gait. She also developed severe sensitivity to sound and experienced cholecystitis. The patient was hospitalized and received blood pressure medications, physical therapy and massage therapy. The patient's lab data showed lumbar puncture as negative, physical tests showed delayed motor processing, MRI head was with negative findings, potassium levels showed hypokalemia and tilt table showed orthostatic hypotension. The patient visited the emergency room on an unknown date. The events seriousness was reported as permanent disability. The outcome was reported as condition unchanged. The causality of the events was not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 97850P1) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from the Quality Assurance Department (reference number: 208810) on 17 Dec 2013: Updated batch review report.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Raynaud's phenomenon, Slow speech, Temperature intolerance, Tilt table test positive
Clinical narrative: Case number PHHY2013US000738 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 471040) website on 02 Jan 2013, with the follow-up received from Quality Assurance Department (reference number: 208810) on 17 Dec 2013: This report refers to a 37-year-old female patient. Her medical history included nephrolithiasis and seasonal allergies. Concomitant medication included PRILOSEC. The patient was vaccinated with FLUVIRIN (batch number: 97850P1) intramuscularly in the left arm on 07 Oct 2009. On the same date, after vaccination the patient experienced paresthesia of feet that lasted for several days then resolved on an unknown date. On 23 Oct 2009, the patient experienced paresthesia of left foot, then bilateral feet that spread to hands and then face. The patient had difficulty in lifting the left foot. On 27 Oct 2009, the patient experienced severe shortness of breath, dyspnea, palpitations, severely elevated blood pressure and heart rate. She also had progression of her severe lower extremity weakness, upper extremity weakness, motor/neurological motor processing difficulty, orthostatic hypotension and labile blood pressure, hyperventilation, anxiety, fatigue, severe burning sensations in spine and extremities, temperature sensitivity, Raynaud phenomenon, insomnia, myalgia, slow speech, hypokalemia, abnormal balance and gait. She also developed severe sensitivity to sound and experienced cholecystitis. The patient was hospitalized and received blood pressure medications, physical therapy and massage therapy. The patient's lab data showed lumbar puncture as negative, physical tests showed delayed motor processing, MRI head was with negative findings, potassium levels showed hypokalemia and tilt table showed orthostatic hypotension. The patient visited the emergency room on an unknown date. The events seriousness was reported as permanent disability. The outcome was reported as condition unchanged. The causality of the events was not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 97850P1) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from the Quality Assurance Department (reference number: 208810) on 17 Dec 2013: Updated batch review report.