chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Rash erythematous, Tuberculin test negative
Clinical narrative: Red rash appeared around site of injection.  Rash was warm and painful to the touch, swollen, and blanched around its periphery.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site vesicles, Injection site warmth
Clinical narrative: Had redness and small blisters around site of (L) arm (deltoid area) warm to touch.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Haematemesis, Haematocrit normal, Haemoglobin normal, Intestinal dilatation, Leukocytosis
Clinical narrative: Moderate hematemesis - seen in ER 11/10/2013. Leukocytosis WBC 21.3 with 22 Segs, 64 L, ANC 4700, Hgb 14.2/Hct 39, Plts 215,000.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Neutrophil count, Platelet count normal, White blood cell count increased
Clinical narrative: Moderate hematemesis - seen in ER 11/10/2013. Leukocytosis WBC 21.3 with 22 Segs, 64 L, ANC 4700, Hgb 14.2/Hct 39, Plts 215,000.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Approximately 1-2 days after injection, rash developed at and around injection site with noticeable itching. Approximately 2-3 days later the rash spread to upper shoulder and back area again, itching noticed and lasted about 1 wk. No treatment sought or administered.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a consumer refers to a 76 year old male patient with paroxysmal nocturnal hemoglobinuria (PNH). On an unknown date the patient was vaccinated with PNEUMOVAX23, lot#, dose, frequency unspecified. Other suspect therapy included intravenous SOLIRIS for paroxysmal nocturnal hemoglobinuria (PNH) (dose, frequency and therapy dates were not provided). Therapy with SOLIRIS was ongoing. On an unknown date the patient experienced cellulitis after he received PNEUMOVAX23. He was subsequently hospitalized. The patient was discharged from the hospital and the cellulitis resolved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: This spontaneous report as received from a pharmacist (patient's husband) refers to a female patient (age not provided) with diabetes type II and deafness in left ear due to Meniere's disease. On approximately 25-OCT-2013 (reported as "two weeks ago") the patient was vaccinated with PNEUMOVAX23, 0.5 ml, intramuscular. Lot number was not provided. Concomitant therapies included metformin. On approximately 27-OCT-2013 (reported as "2 to 3 days after vaccination") the patient experienced hearing loss in right ear and ringing in right deaf ear. Lab diagnostics studies were not performed. Physician was called for medical attention. The patient took antihistamine and corticosteroid nasal spray to treat the events, but her hearing had not yet improved. Causality assessment was not provided. Upon internal review the event of hearing loss was determined to be medically significant. Additional information has been requested.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal X-ray, Barium double contrast, Intussusception
Clinical narrative: Intussusception - air enema.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal, Palpitations
Clinical narrative: Pt. experienced heart palpitations. Starting evening of receiving vaccine. He felt bad for several days and consulted physician. MD unsure if related to vaccine as pt. has a history of arrhythmias for that condition.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test, Mobility decreased, Musculoskeletal stiffness, Myalgia
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 31 October 2013. A 63-year-old female patient had received an intramuscular injection in the arm of FLUZONE HIGH-DOSE (lot number not reported) on 09 November 2010 and three days later began to experience very sore, very stiff muscles of legs. She was unable to get in or out of bed or a chair, it was like she "was paralyzed". The patient saw her healthcare professional numerous times over the next nine months. Treatment was BUFFERIN or TYLENOL and symptoms resolved after nine months. The patient had no illness at the time of vaccination and allergies to Tace, iodine and adhesive for Bandaids. Outcome was recovered. Documents held by sender: None.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: Vomited immediately after administration of ROTATEQ vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On 07-NOV-2013 the patient was vaccinated with ZOSTAVAX (lot # J002242, expired date 21-MAY-2014, 0.65 ml, subcutaneous). It was reported that the dose of ZOSTAVAX was administered post temperature excursion of 30F over 10 days or 240 hours. No adverse effects reported. The outcome and action taken were not provided. The patient did not seek any medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information was received from a female consumer, age unknown, regarding herself. The patient reported that on 15-OCT-2013, she went to an unspecified pharmacy and received the ZOSTAVAX (dosage and route of administration not provided). She watched the pharmacist take the ZOSTAVAX from the freezer and leave it out for about 20 minutes at room temperature. The patient questions its effectiveness. No adverse event was reported. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a 68 year old female consumer refers to herself with cancer. She once had a reaction in the back of her neck to meloxicam. On 03-OCT-2013 the patient was vaccinated with ZOSTAVAX  (dose, frequency, route, lot# and expiration date unknown). Approximately on 04-OCT-2013 the patient experienced a big, red, painful spot with radiating heat at the injection site about one day after receiving her ZOSTAVAX. The symptoms lasted approximately three to four days. No lab diagnostics studies were performed. The patient didn't seek medical attention. The events were improved on therapy and the patient was recovered from the events on an unspecified date in October 2013. No product quality complaint (PQC) was reproted. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an other unspecified source refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of improperly stored GARDASIL(lot# J003727, expiration date: 7-NOV-2015, dose and route not reported). This is one of several reports received from the same source (linked MARRS#'s: 1310USA014881, 1310USA014888, 1310USA014891, 1311USA000056, 1311USA000071, 1310USA015417, 1310USA014897, 1311USA000012, 1310USA014858, 1310USA014850, 1310USA014870, 1311USA000289, 1311USA000282, 1310USA014874, 1310USA014861, 1310USA014866, 1310USA014868, 1310USA015422, 1310USA015165, 1311USA000069, 1310USA015424, 1311USA000058, 1311USA000042, 1311USA000013, 1310USA015170, 1311USA000014, 1310USA015153, 1310USA015090, 1311USA000067, 1311USA000064, 1311USA000020, 1311USA000021, 1311USA000040, 1310USA015096, 1311USA000022, 1310USA015101, 1310USA014853, 1311USA000075, 1310USA014895, 1310USA015119, 1310USA015113, 1311USA000059, 1311USA004931, 1311USA000065, 1311USA000739. Additional information has been requested.
Age: 1.53
Sex: M
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Nasopharyngitis, Pertussis, Post-tussive vomiting
Clinical narrative: This is one case out of a cumulative total of 219 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 01 November 2013. These 219 cases represent children who received 3 or more doses of Sanofi Pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 01 November 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 2-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of DAPTACEL; lot number C3449BA received on 12 April 2011, lot number C3449AA received on 10 June 2011, lot number 12 August 2011 and lot number C4022AA received on 24 August 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms on 02 October 2013, approximately 13 months after the last dose. On 02 October 2013, the subject developed a cough and paroxysmal cough on 08 October 2013 without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 04 October 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 21 October 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 19 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.53
Sex: M
Vaccine: DTAP
Symptoms: Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 219 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 01 November 2013. These 219 cases represent children who received 3 or more doses of Sanofi Pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 01 November 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 2-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of DAPTACEL; lot number C3449BA received on 12 April 2011, lot number C3449AA received on 10 June 2011, lot number 12 August 2011 and lot number C4022AA received on 24 August 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms on 02 October 2013, approximately 13 months after the last dose. On 02 October 2013, the subject developed a cough and paroxysmal cough on 08 October 2013 without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 04 October 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 21 October 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 19 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On 07-NOV-2013 the patient was vaccinated with ZOSTAVAX (lot # J002242, expired date 21-MAY-2014, 0.65 ml, subcutaneous0. It was reported that the dose of ZOSTAVAX was administered post temperature excursion of 30F over 10 days or 240 hours. No adverse effects reported. The outcome and action taken were not provided. The patient did not seek  any medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Crying, Haemorrhoids, Herpes zoster, Musculoskeletal pain, Pruritus
Clinical narrative: This spontaneous report was received from a 77 year old female patient with penicillin, sulfa and Intravenous Pyelogram (IVP) dye allergy. Patient stated she has drug allergies to penicillin (manufacturer unspecified) which causes a rash, sulfa (manufacturer unspecified) which causes itching and a rash and IVP dye (manufacturer unspecified) which causes her whole body to swell and itch. The patient had a medical history of surgery (details unspecified) and 3 consecutive cases of shingles 10-15 years ago. On an unknown date in November 2012 (also reported as last year) the patient was vaccinated with ZOSTAVAX (dosing regimen and frequency unknown). Concomitant therapies included acetaminophen, NORCO, OXYCONTIN, LIPITOR and metformin (manufacturer unknown). On an unknown date the patient was advised to get the ZOSTAVAX vaccination to prevent getting shingles again and was told that even if she got the shingles that it would be less severe than her previous cases of shingles. On 16-OCT-2013 (also reported as 3 weeks ago from today) the patient was very upset because she stated that the pain is much more now than what she experienced from her previous cases of shingles. On an unknown date in 16-OCT-2013 (also reported as 3 weeks ago from today) the patient was having pain in her hemorrhoidal area near her buttocks and she could not stand or sit because she was in so much pain and the patient stated that she was Very upset and in so much paint that it's so bad that it made her cry. On an unknown date in 16-OCT-2013 (also reproted as 3 weeks ago from today) the patient could not sleep since she got the shingles because of the pain. Patient sought medical attention-contacted physician. The patient was treated with Acyclovir (manufacturer unknown) 400 mg, ice, powder, CALAMINE (manufacturer unknown) lotion and CLARITIN. Consumer noted that the CLARITIN was being used to help with itching but is not working (related case 1311USA003767). Consumer also stated that she can't sleep since she got the shingles because of the pain. The outcome of the events was reported as not recovered. There was no product quality issue reported. This is 1 of 2 reports regarding the same patient. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder
Clinical narrative: This spontaneous report was received from a 77 year old female patient with penicillin, sulfa and Intravenous Pyelogram (IVP) dye allergy. Patient stated she has drug allergies to penicillin (manufacturer unspecified) which causes a rash, sulfa (manufacturer unspecified) which causes itching and a rash and IVP dye (manufacturer unspecified) which causes her whole body to swell and itch. The patient had a medical history of surgery (details unspecified) and 3 consecutive cases of shingles 10-15 years ago. On an unknown date in November 2012 (also reported as last year) the patient was vaccinated with ZOSTAVAX (dosing regimen and frequency unknown). Concomitant therapies included acetaminophen, NORCO, OXYCONTIN, LIPITOR and metformin (manufacturer unknown). On an unknown date the patient was advised to get the ZOSTAVAX vaccination to prevent getting shingles again and was told that even if she got the shingles that it would be less severe than her previous cases of shingles. On 16-OCT-2013 (also reported as 3 weeks ago from today) the patient was very upset because she stated that the pain is much more now than what she experienced from her previous cases of shingles. On an unknown date in 16-OCT-2013 (also reported as 3 weeks ago from today) the patient was having pain in her hemorrhoidal area near her buttocks and she could not stand or sit because she was in so much pain and the patient stated that she was Very upset and in so much paint that it's so bad that it made her cry. On an unknown date in 16-OCT-2013 (also reproted as 3 weeks ago from today) the patient could not sleep since she got the shingles because of the pain. Patient sought medical attention-contacted physician. The patient was treated with Acyclovir (manufacturer unknown) 400 mg, ice, powder, CALAMINE (manufacturer unknown) lotion and CLARITIN. Consumer noted that the CLARITIN was being used to help with itching but is not working (related case 1311USA003767). Consumer also stated that she can't sleep since she got the shingles because of the pain. The outcome of the events was reported as not recovered. There was no product quality issue reported. This is 1 of 2 reports regarding the same patient. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Vision blurred
Clinical narrative: This spontaneous report was received from an unspecified reporter via a company representative concerning two patients of unknown age and gender. On an unknown date, the patients were vaccinated with a doses of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On an unknown date, after the vaccination, patients experienced blurry vision. The outcome of blurry vision was unknown. The relatedness for blurry vision was unknown for GARDASIL. Additional information is not expected.
Age: 88.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Blood glucose decreased, Hypoglycaemia
Clinical narrative: Initial report was received from a consumer on 30 October 2013 with additional information received on 31 October 2013. An 88-year-old female patient had received an injection in the left arm of Influenza vaccine, lot number reported as "1308101" (manufacturer and route: not reported) on 24 October 2013. The patient also uses LANTUS SOLOSTAR 40 units daily. Within 2 hours of the vaccine, the patient had an incident of "hypoglycemia with a sugar as low as 40". She felt weak when it happened. They called 911, paramedics came and treated her and brought her blood sugar back up. She did not have to go to the hospital but was taken to her HCP later that day. The patient was well now with stable blood sugars. The patient's daughter was unsure if the patient took the insulin dose twice since she was unsure how to use the insulin pen. The patient had a history of insulin dependent diabetes mellitus (IDDM) and no known drug allergies (NKDA). The outcome was recovered on unspecified date. Documents held by sender: None.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: First sign of redness, soreness, some itching occurred on Nov 1 night.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Oropharyngeal pain, Pain
Clinical narrative: Sore throat, headache, body ache.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Headache, Lymphadenopathy, Oropharyngeal pain, Wheezing
Clinical narrative: Sore throat, headache, body ache.
Age: 1.29
Sex: M
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: This is one case out of a cumulative total of 218 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 29 October 2013. These 218 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 29 October 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a four year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received three doses of PENTACEL; dose one lot number C3228AA received on 03 March 2009, dose two lot number C3280AA received on 29 April 2009 and dose three lot number C3362AA received on 14 July 2009 and one dose of DAPTACEL, lot number C3082AA on 31 March 2010 (routes and sites of administration for all doses not reported). The subject developed cold-like symptoms on 09 September 2013, approximately three years after the last dose. On 09 September 2013, the subject developed a cough without whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 05 October 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 05 October 2013 for five days. The subject was not hospitalized. At the time of final contact on 10 October 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 31 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.29
Sex: M
Vaccine: DTAP
Symptoms: Polymerase chain reaction, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 218 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 29 October 2013. These 218 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 29 October 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a four year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received three doses of PENTACEL; dose one lot number C3228AA received on 03 March 2009, dose two lot number C3280AA received on 29 April 2009 and dose three lot number C3362AA received on 14 July 2009 and one dose of DAPTACEL, lot number C3082AA on 31 March 2010 (routes and sites of administration for all doses not reported). The subject developed cold-like symptoms on 09 September 2013, approximately three years after the last dose. On 09 September 2013, the subject developed a cough without whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 05 October 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 05 October 2013 for five days. The subject was not hospitalized. At the time of final contact on 10 October 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 31 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an other unspecified source refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of improperly store GARDASIL (lot # J003727, expiration date: 07-NOV-2015, dose and route not reported). This is one of several report received from the same source (linked MARRS#s: 1310USA014881, 1310USA014883, 1310USA014888, 1311USA000056, 1311USA000071, 1310USA015417, 1310USA014897, 1311USA000012, 1310USA014858, 1310USA014850, 1310USA014870, 1311USA000289, 1311USA000282, 1310USA014874, 1310USA014861, 1310USA014866, 1310USA014868, 1310USA015422, 1310USA015165, 1311USA000069, 1310USA015424, 1311USA000058, 1311USA000042, 1311USA000013, 1310USA015170, 1311USA000014, 1310USA015153, 1310USA015090, 1311USA000067, 1311USA000064, 1311USA000020, 1311USA000021, 1311USA000040, 1310USA015096, 1311USA000022, 1310USA015101, 1310USA014853, 1311USA000075, 1310USA014895, 1310USA015119, 1310USA015113, 1311USA000059, 1311USA004931, 1311USA000065, 1311USA000739. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an other unspecified source refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of improperly stored GARDASIL (lot # J003727, expiration date: 07-NOV-2015, dose and route not reported). This is one of several reports received from the same source (linked MARRS#s: 1310USA014881, 1310USA014883, 1310USA014891, 1311USA000056, 1311USA000071, 1310USA015417, 1310USA014897, 1311USA000012, 1310USA014858, 1310USA014850, 1310USA014870, 1311USA000289, 1311USA000282, 1310USA014874, 1310USA014861, 1310USA014866, 1310USA014868, 1310USA015422, 1310USA015165, 1311USA000069, 1310USA015424, 1311USA000058, 1311USA000042, 1311USA000013, 1310USA015170, 1311USA000014, 1310USA015153, 1310USA015090, 1311USA000067, 1311USA000064, 1311USA000020, 1311USA000021, 1311USA000040, 1310USA015096, 1311USA000022, 1310USA015101, 1310USA014853, 1311USA000075, 1310USA014895, 1310USA015119, 1310USA015113, 1311USA000059, 1311USA004931, 1311USA000065, 1311USA000739). Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Information was received from a pharmacist concerning a 67 year old male patient. On 28-OCT-2013, the patient was vaccinated with ZOSTAVAX. Concomitant therapies included PROAIR, Atorvastatin, PLAVIX, terazosin hydrochloride and hydrochlorothiazide, losartan potassium. On 29-OCT-2013, the patient experienced injection redness and heat. On 30-OCT-2013 the patient had more pronounced injection site symptoms including redness, heat and a large knot at the site of injection. The patient was treated with an unspecified antihistamine. At the time of this report the patient had not recovered. Lot number J008629 is not valid. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Asthma, Condition aggravated
Clinical narrative: Initial report was received from a healthcare professional on 31 October 2013. This reporter is the same for a cluster of patients who experienced events post-vaccination with FLUZONE, lot number UH907AC, which were captured in case number 2013SA113890. An 8-year-old patient (gender not reported) had received an injection of FLUZONE, lot number UH907AC (route, site and date not reported) on or after 19 October 2013 and within 24 hours had an asthma attack and was hospitalized for three days. The patient had known history of asthma. Outcome was unknown. Documents held by sender: None.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report was received from a pharmacist concerning an approximately 60 year old female patient. The patient has no pertinent medical history and drug reactions. The pharmacist was reported that on 04-NOV-2013, the patient was vaccinated with ZOSTAVAX (lot number: J004269 and expiry date: 12-JUL-2014) 0.65 ml subcutaneously). No concomitant therapy was reported. No adverse effect was reported. The pharmacist stated that on 06-NOV-2013, the patient called and informed him that she developed a 2"3 flat red area at injection site that is a little itchy after receiving the ZOSTAVAX. The pharmacist instructed to patient over the phone to apply a cold cloth to the injection site as treatment. The patient was called to pharmacist as to sought medical attention. At the time of report the patient was not recovered from the events. The causality for the events was unknown with the ZOSTAVAX. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning an approximately a 62 year old female patient with no pertinent medical history and no drug reactions or allergies. On 04-NOV-2013, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date were reported as J004311 and 12-JUL-2014 respectively), subcutaneously. There were not concomitant medications. On 06-NOV-2013 the patient reported that she experienced redness at injection site with some swelling. The patient sought medical attention (consulted pharmacist). The patient asked what to do for treatment and was not treated for reaction till the time of report. The patient was not recovered from redness at injection site with some swelling at the time of report. The relatedness for redness at injection site with some swelling was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist via field representative refers to several patients of unknown demographics. The pharmacist reported that in approximately October 2013 (reported as over past 2-3 weeks), she had several patients vaccinated with PNEUMOVAX23 via (dosage, lot and expiry date were not reported) who had experienced serious local reactions after vaccination including swelling and redness. The reporter (pharmacist) knew of 2 patients who had these e vents (linked case 1311USA004105). The outcome of events was unknown. This is 1 of 3 reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On 08-NOV-2013, the patient was vaccinated with a dose of GARDASIL (Lot number, expiry date, dose, route and frequency were unknown). No concomitant medications were reported. On 08-NOV-2013, the patient received the GARDASIL and immediately passed out. The patient had sought medical attention (office visit) for the same. The outcome of the event passed out after administration of GARDASIL was not recovered/not resolved (also reported as it had been 20 minutes and she had not come to yet). Upon internal review, the event passed out after administration of GARDASIL was considered as medically significant. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Flushing, Laboratory test, Malaise, Pruritus
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 31 October 2013. A 49-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE, lot number UH907AB, on 28 October 2013 and 90 minutes later developed itchy palms, red flush to face and a red rash over the body. She went to the physician's office and received treatment of IV antihistamines. The symptoms were relieved after the IV, but now the patient has malaise since 28 October 2013. The patient had no illness at the time of vaccination and allergies to thimerosal, sulfa drugs, cycline drugs, KEFLEX and AVALOX. Outcome was not recovered. Documents held by sender: None.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 31 October 2013. A 49-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE, lot number UH907AB, on 28 October 2013 and 90 minutes later developed itchy palms, red flush to face and a red rash over the body. She went to the physician's office and received treatment of IV antihistamines. The symptoms were relieved after the IV, but now the patient has malaise since 28 October 2013. The patient had no illness at the time of vaccination and allergies to thimerosal, sulfa drugs, cycline drugs, KEFLEX and AVALOX. Outcome was not recovered. Documents held by sender: None.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a consumer refers to her twin sister of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, frequency, route, lot# and expiration date unknown). On an unknown date the patient experienced swelling larger than a golf ball at the injection site after she received her ZOSTAVAX vaccination. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: Information was received from a consumer concerning her 66 year old mother with allergy to unspecified antibiotic eye drop. On 21-OCT-2013, the patient was vaccinated with ZOSTAVAX. On-22-OCT-2013, 2 days after onset of therapy the patient experienced an injection site reaction which was  "little itchy" and started out 3 inches in size and then became 5 inches in size, and was in the shape of an oval. On 26-OCT-2013 it was reported the injection site reaction resolved. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site approximately 48 hours after injection. Recommended hydrocortisone cream OTC. Advised patient to call MD if symptoms continue for > 2-3 days and to call 911 if she has difficulty breathing/swallowing.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Information was received from a pharmacist concerning two patients of unknown age. On an unknown date the patients were vaccinated with ZOSTAVAX. It was reported that the patients felt "so tired" after receiving the ZOSTAVAX. No further information was provided. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to a 68 year old female patient. The patient's medical history included shingles and drug reactions/allergies to steroids. It was also reproted that the female had a medical history of thyroid (not further specified). In November 2012 the patient was vaccinated with ZOSTAVAX (1 time vaccine). Dosing information, route of administration and lot number were not provided. On 29-OCT-2013 the patient experienced shingles again on her left side of her forehead, with pain in her left eye. Lab diagnostics studies were not performed. The outcome of shingles on her left side of her forehead, with pain in her left eye was reported as not recovered/not resolved. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, frequency, route and lot number not provided). On an unknown date the patient experienced received an expired ZOSTAVAX. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injected limb mobility decreased, Local reaction, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist via field representative refers to a female patient of unknown age (1 of 2 patients known by pharmacist/several patients). The pharmacist reported that in approximately October 2013 (reported as over past 2-3 weeks), she had several patients vaccinated with PNEUMOVAX23 vial (dosage, lot and expiry date were not reported) who had experienced serious local reactions after vaccination including swelling and redness. Patients sought medical attention-had called pharmacist. The reporter (pharmacist) knew of 2 patients who had these events, including one patient who could not move her arm after the injection (disability). The outcome of events was unknown. The reporter also mentioned that her partner at the pharmacy had seen 3 or 4 patients with injection site reactions. The reporter considered the event could not move her arm after the injection as disability. This is case 2 of 3 reports received from the same reporter. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to her 70 year old mother with hypertension and unspecified thyroid condition. Her medical history included unspecified past history of cancer (in remission). The patient had no drug reactions/allergies. First week of October 2013 (on approximately 01-OCT-2013) the patient experienced shortness of breath at night time of the day she received a dose of ZOSTAVAX (lot # unspecified) (dose and route unspecified) at arm. Concomitant therapies included with unspecified thyroid medication and unspecified medication for hypertension. The patient also developed redness, pain and an area hot to the touch on her arm at the injection site after receiving ZOSTAVAX. Pharmacist reported that about a week after receiving ZOSTAVAX (in October 2013) the patient developed 14 varicella like lesions (in various areas of her body), fever and chills. Most of the lesions had dried up. Neomycin sulfate, NEOSPORIN was given to treat lesions. No lab diagnostics studies performed. At the time of report, the outcome of the events was not recovered. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an other unspecified source refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of improperly stored PNEMOVAX23 (lot # J006921, expiration date: 09-AUG-2014, dose and route not reported). This is one of several reports from the same source (linked MARRS#: 1310USA014881, 1310USA014883, 1310USA014888, 1310USA014891. 1310USA000056, 1311USA000071, 1310USA015417, 1310USA014897, 1311YSA000012, 1310USA014858, 1310USA014850, 1310USA014870, 1311USA000289, 1311USA000282, 1310USA014874, 1310USA014661, 1310USA014866, 1310USA014868, 1310USA015422, 1310USA015165, 1311USA000069, 1310USA015424, 1311USA000058, 1311USA000042, 1311USA000013, 1310USA015170, 1311USA000014, 1310USA015153, 1310USA015090, 1311USA000067, 1311USA000064. 1311USA000020, 1311USA000021, 1311USA000040, 1310USA015096, 1311USA000022, 1310USA015101, 1310USA014853, 1311USA000075, 1310USA014895, 1310USA015119, 1310USA015113, 1311USA000059, 1311USA000065, 1311USA000739. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an other unspecified source refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of improperly stored PNEMOVAX23 (lot # J006921, expiration date: 09-AUG-2014, dose and route not reported). This is one of several reports from the same source (linked MARRS#: 1310USA014883, 1310USA014888, 1310USA014891. 1310USA000056, 1311USA000071, 1310USA015417, 1310USA014897, 1311YSA000012, 1310USA014858, 1310USA014850, 1310USA014870, 1311USA000289, 1311USA000282, 1310USA014874, 1310USA014861, 1310USA014866, 1310USA014868, 1310USA015422, 1310USA015165, 1311USA000069, 1310USA015424, 1311USA000058, 1311USA000042, 1311USA000013, 1310USA015170, 1311USA000014, 1310USA015153, 1310USA015090, 1311USA000067, 1311USA000064. 1311USA000020, 1311USA000021, 1311USA000040, 1310USA015096, 1311USA000022, 1310USA015101, 1310USA014853, 1311USA000075, 1310USA014895, 1310USA015119, 1310USA015113, 1311USA000059, 1311USA004931, 1311USA000065, 1311USA000739. Additional information has been requested.
Age: 40.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information was received from a pharmacist concerning a 40 year old patient. The patient's medical history included a brain tumor. On an unknown date the patient was vaccinated with ZOSTAVAX 0.65 ml. Subcutaneous. No adverse effect has been reported. No additional information reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report was received from a healthcare worker concerning a patient of unknown age and gender. On 04-SEP-2013, the patient was vaccinated with a dose of ROTATEQ 2 ml (Lot # and expiration date not reported, oral. On 05-NOV-2013 the patient was vaccinated with a dose of ROTATEQ, oral (dose not reported) (lot # 0284AE; expiration date 25-OCT-2013). It was reported that the patient was administered and expired dose of ROTATEQ on 05-NOV-2013. At the time of the report patients outcome was unknown. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a 12 month old female patient. It was reported that on 04-NOV-2013, the patient was vaccinated with a dose of PROQUAD (lot number, expiry date, dose and route unspecified) and a dose of MMR II (lot number, expiry date, dose and route unspecified) on the same day. No concomitant therapy was reported. No adverse effects were reported. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: RV5
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report was received from an office manager concerning a 4 month old male patient. ON an unspecified date, the patient was vaccinated with the first dose of ROTATEQ, (dose, route and lot # not provided). On 04-NOV-2013, the patient was vaccinated with the second dose of ROTATEQ, 2 ml, oral (lot # 0741AE; expiration date 03-OCT-2012). Concomitant therapies included diptheria toxoid, pertussis acellular vaccine (unspecified) (+) tetanus toxoid, poliovirus vaccine inactivated (unspecified), hib conj vaccine (unspecified carrier) and PREVNAR13. It was reproted that the second dose of ROTATEQ, was expired. Patients outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received from a pharmacist who reported that during a discussion regarding ZOSTAVAX, a consumer stated that her physician mentioned to her that one of his patients had been administered ZOSTAVAX on an unspecified date and had subsequently developed "the worse case of shingles ever". No further information was provided. Additional information was requested.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Condition aggravated, Respiratory distress
Clinical narrative: Resp distress, Asthmatic episode.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to "about 4 or 5" patients of unknown age and gender. On an unspecified date the patients were vaccinated with a dose of ZOSTAVAX (lot# unspecified) (dose, route and location unspecified) respectively. The reporter stated that on an unspecified date, "about 4 or 5" patients developed shingles after receiving the ZOSTAVAX. The pharmacist informed that his case was already reported to the Food and Drug Administration (FDA). At the time of report, the outcome of the event was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram, Electrocardiogram, Hypoaesthesia
Clinical narrative: Sudden onset of numbness on right side - arm, torso, hip area - as of date of submission of this report, numbness still present.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Impaired driving ability, Injection site pain, Joint range of motion decreased, Mobility decreased
Clinical narrative: Pain at the injection site and down the arm.  Very painful and sore muscle and can not lift arm up.  It is hard for patient to drive and function normally without muscle pain.  Reported this pain on 11/10/2013.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Pain at the injection site and down the arm.  Very painful and sore muscle and can not lift arm up.  It is hard for patient to drive and function normally without muscle pain.  Reported this pain on 11/10/2013.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Eye movement disorder, Feeling cold, Muscle rigidity, Pain
Clinical narrative: Chills, ache, fainted, revived and fainted second time during which time patient stopped breathing, went rigid, turned ashen, eyes turned to side and locked in place. When patient revived, she reported feeling very cold and inability to stop shaking.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Pallor, Respiratory arrest, Syncope, Tremor
Clinical narrative: Chills, ache, fainted, revived and fainted second time during which time patient stopped breathing, went rigid, turned ashen, eyes turned to side and locked in place. When patient revived, she reported feeling very cold and inability to stop shaking.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Woke up with low grade fever, joint & muscle pain, headache, mild nausea.
Age: 28.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Dizziness, Heart rate irregular, Hyperhidrosis, Immediate post-injection reaction, Pallor
Clinical narrative: Tdap given first in Right Arm, followed immediately by flu vaccine given in LA.  Immediately upon receiving flu vaccine, patient asked, should I be feeling dizzy?  I said no and had him lay down with feet up.  He then became unresponsive, with fixed pupils, and tonic seizure primarily of left side of body, which lasted <30 seconds.  I had medical assistant call 911.   Following seizure, patient took a few more seconds to a minute before becoming responsive, although pale and diaphoretic.  He was then oriented to time, place, date, person. PEARL.   He denied shortness of breath, swelling of throat, itching or rash.  BP 122/74, pulse 60 and regular. O2 sat 97%.   Ambulance arrived in 5-10 mn.  BP at that time 107/63 pulse 60 regular.  O2 sats remained in 96%-97% range.   Patient started to feel more stable, said he was feeling better and was asked to sit up, he again began to be lightheaded, had him lay down again, repeat BP at that was 78/42, pulse 60, occasionally irregular.  Decision made to transport patient to ER.  Patient and wife confirm no history of seizures, no known history of prior vaccine reactions, and no hx of neurological disorders.  Denies illness or recent illness other than minor cold sx.   BP at time left clinic was 90/51, pulse 60, O2 sat 97%, taken by ambulance.  Follow up phone call with patient and ER on 11/12/13.  Patient was not admitted.  In ER was neurologically intact. Diagnosis given in ER was vasovagal syncope, and patient discharged home.  On 11/12/13 patient reports he has been feeling fine since, and returned to normal activities.