chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Pain in extremity, Tenderness
Clinical narrative: Redness around arm in a area of about 9 cm long and 5 to 6 cm wide. It is tender and painful. Used BENADRYL but not helping her. Also using Ibuprofen for pain.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pain, Injected limb mobility decreased, Pain in extremity, Vaccination complication, Vision blurred
Clinical narrative: States whole arm hurt after shot. Could not move arm at all x 2 nights. Had difficulty moving, but could care for self. Blurred vision started the next day. Eye pain. After a week, eyes were still hurting, pt went to eye Dr. and Dr told her it was not pressure but probably caused by vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Patient developed rash (about fist-size) at site of injection and a bump.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site swelling, Pain in extremity
Clinical narrative: Pt experienced extreme pain in left arm shortly after receiving vaccination. Could not lift arm. Complained of swelling to "bicep" the following day, butno improvement.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Patient reports redness and inflammation at site. Reported that she reported to her doctor and was put on antibiotics.
Age: 63.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Dizziness, Headache, Pain, Swelling, Vision blurred
Clinical narrative: About 30 min following for approximately 2 hours: dizziness (resolved). One sided headache behind right eye (resolved after 1-2 days). 11/18 - presented with 2 round, raised areas about the size of a penny that are painful one over right eye the other on top of head, slight blurred vision. 11/19 - MD prescribed 7 day course of valacyclovir.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Headache, Influenza like illness, Lacrimation increased, Lymphadenopathy
Clinical narrative: Body ache, head-ache, runny eyes/nose. Excess salivation and flu-like symptoms. Sore neck, possible swollen lymph nodes, started Fri 11/22 night. Worsened sx from Sat-Sun.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain, Rhinorrhoea, Salivary hypersecretion
Clinical narrative: Body ache, head-ache, runny eyes/nose. Excess salivation and flu-like symptoms. Sore neck, possible swollen lymph nodes, started Fri 11/22 night. Worsened sx from Sat-Sun.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Vaccination site swelling
Clinical narrative: Swollen arm where vaccine was administered, she has reported cellulitis and is receiving IV antibiotics.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site inflammation
Clinical narrative: Inflammation, redness, minor bleeding at injection site.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Infertility female
Clinical narrative: This spontaneous report as received from a physician via field employee refers to a 20 year female patient. On an unknown date the patient was vaccinated with GARDASIL. The patient was reported to have experienced infertility after receiving GARDASIL. The outcome of infertility is unknown. No PQC involved. Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Injection site pain, Injection site swelling, Oedema peripheral, Pain
Clinical narrative: This spontaneous report as received from a health medical assistant refers to a male patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot # J004064; expiry date: 06-AUG-2014). On an unknown date after vaccination the patient experienced fatigue, fever and was achy. The patient also stated he had pain and swelling at the injection site which developed into edema "of the entire arm". The patient saw his unspecified primary care provider on an unspecified date regarding the reaction. Medical assistant stated "based on the report that patient was not recovered and had been out of work for 2 weeks. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a health medical assistant refers to a male patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot # J004064; expiry date: 06-AUG-2014). On an unknown date after vaccination the patient experienced fatigue, fever and was achy. The patient also stated he had pain and swelling at the injection site which developed into edema "of the entire arm". The patient saw his unspecified primary care provider on an unspecified date regarding the reaction. Medical assistant stated "based on the report that patient was not recovered and had been out of work for 2 weeks. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Erythema, Swelling
Clinical narrative: This spontaneous report as received from a nurse refers to a 71 year old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX (lot was not reported, subcutaneous). On an unknown date, the patient experienced extreme swelling, redness and discomfort. The outcome of adverse events was unknown. This is one of the reports from the same source. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a male patient of unknown age. "2 weeks ago", on approximately 30-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, route not reported) for shingles prevention. On an unknown date the patient experienced minor rash on both chest and back. The outcome of the event was reported as recovered. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse refers to her husband, a 63 year old male patient. On an unknown date in July 2013 the patient was vaccinated with ZOSTAVAX (lot # was not reported, subcutaneous) for Prevention of shingles. On an unknown date in July 2013, the patient experienced an injection-site reaction, described as "extreme swelling that covered" the majority of the upper arm, nearly to the elbow." In addition there was redness and discomfort. The reaction lasted "about a week", after which time, it subsided. The patient did not seek medical attention. This is one of the reports from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: This spontaneous report as received from a 66 year old female patient refers to herself with no medical attention and with drug reactions/allergy to Iodine. On 01-AUG-2012 the patient was administered with a dose of ZOSTAVAX (vial "one shot", strength, formulation, lot#, dose, route were unspecified) by an unspecified pharmacist "very slowly" into "the underside of her upper arm"). Concomitant therapies included DIOVAN, aspirin(manufacturer unknown) and simvastatin(manufacturer unknown). Patient reported that, "by 02-AUG-2012, "she had developed redness and warmth at the injection site. A spot on her arm was "still beet red" and "sore" a month after she received the injection. She had also been experiencing periodic "bouts" of pain in her injection arm that affect her entire upper arm "front and back" from "above the elbow to below the shoulder"(date unspecified). The bouts of pain were variable in length. She reported one recent instance (dates unspecified) which "lasted 2 days." She stated that physical activity with her injection arm, using her injection arm to carry things, and sleeping on her injection arm worsen the pain. She was told to treat the pain with TYLENOL and other unspecified "pain medications." She stated that the pain felt like it might be in the nerves and that one of the products she had tried have relieved the pain. The periodic bouts of pain were initially more severe and have generally lessened in severity over time. She was still suffering from arm pain. The patient also reported that she "fell a couple weeks ago"(2013). She first sought medical attention by calling her pharmacy on 04-SEP-2012. She also called the FDA and saw her physician "about a week ago"(11-NOV-2013). No lab diagnostics studies was performed. The outcome of arm pain was reported as not recovered. The outcome of other events were unknown. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Bronchospasm
Clinical narrative: Case number PHHY2013US069420 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 477487) website on 03 Jul 2013 and a follow up report from the QA department (QA number: 258541) received on 14 Nov 2013. This report refers to 29-year-old female patient. Her medical history included Crohn's disease and asthma and was receiving several concomitant medications (not reported). She was vaccinated with FLUVIRIN (batch number: 123102) intramuscularly into left arm on 13 Nov 2012. On the same day, she was also vaccinated with PNEUMOVAX (other manufacturer, batch number: H01096) intramuscularly into right arm and ZOSTAVAX (batch number: H012576) subcutaneously into right arm. She was immunized with the above vaccines in the early evening. On the same day, during the night, she experienced four episodes of severe bronchospasm and her physician prescribed SINGULAIR. The outcome of the event was reported as not recovered as of 10 Dec 2012. The causality and seriousness of the event were not reported. Based on the document review, it was stated that the concerned FLUVIRIN batch number (123102) was manufactured in accordance with an approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Following internal review on 04 Jul 2013 of the data received on 03 Jul 2013 following significant correction was done: The event bronchospasm was assessed as unlisted (previously assessed as listed). Follow up report from the QA department received on 14 Nov 2013: The batch review report was updated.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV, PPV, PPV
Symptoms: Dyspnoea, Muscle spasms, Skin discolouration
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 52 year old female patient. A pharmacist reported to the representative that the pharmacist's wife had an adverse experience shortly after receiving PNEUMOVAX. The patient's medical history included high blood pressure and no allergies was reported. On 09-SEP-2013, the patient was vaccinated with PNEUMOVAX23 (dose, route of administration, lot#batch# were not reported). The patient receives high blood pressure medication (unspecified) as concomitant medication. On 09-SEP-2013, the patient's face turned beet red and she experienced stopped breathing. The pharmacist called 911 and his wife was taken to the emergency room of an unspecified hospital due to the adverse events. The patient sought medical attention (went to emergency room). It was unknown by the representative if the wife was admitted to the hospital. The legal issue was involved and adverse event was sent to legal. The outcome of the event reported as recovered at the time of the report (date unspecified). Upon internal review the event stopped breathing considered to be medically significant. All the reported events were considered to be life threatening. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV, PPV, PPV
Symptoms: Erythema, Respiratory arrest
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 52 year old female patient. A pharmacist reported to the representative that the pharmacist's wife had an adverse experience shortly after receiving PNEUMOVAX. The patient's medical history included high blood pressure and no allergies was reported. On 09-SEP-2013, the patient was vaccinated with PNEUMOVAX23 (dose, route of administration, lot#batch# were not reported). The patient receives high blood pressure medication (unspecified) as concomitant medication. On 09-SEP-2013, the patient's face turned beet red and she experienced stopped breathing. The pharmacist called 911 and his wife was taken to the emergency room of an unspecified hospital due to the adverse events. The patient sought medical attention (went to emergency room). It was unknown by the representative if the wife was admitted to the hospital. The legal issue was involved and adverse event was sent to legal. The outcome of the event reported as recovered at the time of the report (date unspecified). Upon internal review the event stopped breathing considered to be medically significant. All the reported events were considered to be life threatening. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV, PPV, PPV
Symptoms: Anaphylactic shock, Choking, Dyspnoea, Erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 52 year old female patient. A pharmacist reported to the representative that the pharmacist's wife had an adverse experience shortly after receiving PNEUMOVAX. The patient's medical history included high blood pressure and no allergies was reported. On 09-SEP-2013, the patient was vaccinated with PNEUMOVAX23 (dose, route of administration, lot#batch# were not reported). The patient receives high blood pressure medication (unspecified) as concomitant medication. On 09-SEP-2013, the patient's face turned beet red and she experienced stopped breathing. The pharmacist called 911 and his wife was taken to the emergency room of an unspecified hospital due to the adverse events. The patient sought medical attention (went to emergency room). It was unknown by the representative if the wife was admitted to the hospital. The legal issue was involved and adverse event was sent to legal. The outcome of the event reported as recovered at the time of the report (date unspecified). Upon internal review the event stopped breathing considered to be medically significant. All the reported events were considered to be life threatening. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV, PPV, PPV
Symptoms: Muscle spasms, Presyncope, Respiratory arrest
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 52 year old female patient. A pharmacist reported to the representative that the pharmacist's wife had an adverse experience shortly after receiving PNEUMOVAX. The patient's medical history included high blood pressure and no allergies was reported. On 09-SEP-2013, the patient was vaccinated with PNEUMOVAX23 (dose, route of administration, lot#batch# were not reported). The patient receives high blood pressure medication (unspecified) as concomitant medication. On 09-SEP-2013, the patient's face turned beet red and she experienced stopped breathing. The pharmacist called 911 and his wife was taken to the emergency room of an unspecified hospital due to the adverse events. The patient sought medical attention (went to emergency room). It was unknown by the representative if the wife was admitted to the hospital. The legal issue was involved and adverse event was sent to legal. The outcome of the event reported as recovered at the time of the report (date unspecified). Upon internal review the event stopped breathing considered to be medically significant. All the reported events were considered to be life threatening. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Blood heavy metal test, Blood test, Computerised tomogram head, Dizziness
Clinical narrative: Seizure like activity, could not breathe, panic attacks, brain fog, severe fatigue, severe joint pain, muscle spasms, severe knee pain, twiches, uncontrollable jerking of the limbs and entire body, hearing, loss, numbness of legs and back of head. Menstrual cycle problems, hot flashes.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Drooling, Fall, Headache, Nausea, Pyrexia
Clinical narrative: Seizure like activity, could not breathe, panic attacks, brain fog, severe fatigue, severe joint pain, muscle spasms, severe knee pain, twiches, uncontrollable jerking of the limbs and entire body, hearing, loss, numbness of legs and back of head. Menstrual cycle problems, hot flashes.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Toxicologic test, Tremor, Urinary incontinence, Urine analysis
Clinical narrative: Seizure like activity, could not breathe, panic attacks, brain fog, severe fatigue, severe joint pain, muscle spasms, severe knee pain, twiches, uncontrollable jerking of the limbs and entire body, hearing, loss, numbness of legs and back of head. Menstrual cycle problems, hot flashes.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Deafness, Dyskinesia, Dyspnoea, Fatigue
Clinical narrative: Seizure like activity, could not breathe, panic attacks, brain fog, severe fatigue, severe joint pain, muscle spasms, severe knee pain, twiches, uncontrollable jerking of the limbs and entire body, hearing, loss, numbness of legs and back of head. Menstrual cycle problems, hot flashes.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Feeling abnormal, Hot flush, Hypoaesthesia, Laboratory test, Menstrual disorder
Clinical narrative: Seizure like activity, could not breathe, panic attacks, brain fog, severe fatigue, severe joint pain, muscle spasms, severe knee pain, twiches, uncontrollable jerking of the limbs and entire body, hearing, loss, numbness of legs and back of head. Menstrual cycle problems, hot flashes.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscle spasms, Muscle twitching, Panic attack, Seizure like phenomena
Clinical narrative: Seizure like activity, could not breathe, panic attacks, brain fog, severe fatigue, severe joint pain, muscle spasms, severe knee pain, twiches, uncontrollable jerking of the limbs and entire body, hearing, loss, numbness of legs and back of head. Menstrual cycle problems, hot flashes.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information was received from a registered nurse regarding a 69 year old female patient, who on 28-OCT-2013, received PNEUMOVAX23 lot # J006082, expiration date 12-APR-2014, 0.5 ml once, intramuscularly in the right deltoid as preventative. Concomitant therapies included: CLARITIN, and aspirin, anastrozole, gabapentin, hydrochlorothiazide, lovastatin, metoprolol, venlafaxine hydrochloride and verapamil (manufacturers unknown). After receiving PNEUMOVAX23, on 29-OCT-2013, the patient developed a large red area at the injection site, the deltoid of the right arm, measuring "10 x 13 centimeters" which was painful to touch. The patient was seen in the office on 29-OCT-2013 and was instructed by the physician to use a cold compress on the area. The outcome of the event was reported as not recovered. Follow-up information was received from the registered nurse who stated that the patient presented back to the office on 30-OCT-2013 and noted that the "pain in right deltoid is gone, and that the red area that was around the injection site is now more anterior on her arm and is 8.5-by-5.5 centimeters." The nurse reported that "this red area is not painful, tender, or warm to the touch." Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information was received from a registered nurse regarding a 69 year old female patient, who on 28-OCT-2013, received PNEUMOVAX23 lot # J006082, expiration date 12-APR-2014, 0.5 ml once, intramuscularly in the right deltoid as preventative. Concomitant therapies included: CLARITIN, and aspirin, anastrozole, gabapentin, hydrochlorothiazide, lovastatin, metoprolol, venlafaxine hydrochloride and verapamil (manufacturers unknown). After receiving PNEUMOVAX23, on 29-OCT-2013, the patient developed a large red area at the injection site, the deltoid of the right arm, measuring "10 x 13 centimeters" which was painful to touch. The patient was seen in the office on 29-OCT-2013 and was instructed by the physician to use a cold compress on the area. The outcome of the event was reported as not recovered. Follow-up information was received from the registered nurse who stated that the patient presented back to the office on 30-OCT-2013 and noted that the "pain in right deltoid is gone, and that the red area that was around the injection site is now more anterior on her arm and is 8.5-by-5.5 centimeters." The nurse reported that "this red area is not painful, tender, or warm to the touch." Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site mass, Injection site pain, Pain in extremity
Clinical narrative: So far event lasting one month 10/17 - 11/18. My sore upper left arm, after the flu shot, continued being sore plus got worse and worse to the point of being quite painful. Took Rx "TRAMADOL" HCL 50mg, but it didn't help. 600mg "Ibuprofen" worked better, which I'm still taking. Have had physical therapy TX for arm so far.
Age: 74.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, X-ray limb normal
Clinical narrative: So far event lasting one month 10/17 - 11/18. My sore upper left arm, after the flu shot, continued being sore plus got worse and worse to the point of being quite painful. Took Rx "TRAMADOL" HCL 50mg, but it didn't help. 600mg "Ibuprofen" worked better, which I'm still taking. Have had physical therapy TX for arm so far.
Age: 12.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Blood test normal, Idiopathic thrombocytopenic purpura, Increased tendency to bruise, Periorbital contusion, Petechiae
Clinical narrative: This spontaneous report as received from a consumer refers to her 12 year old son. The patient had no pertinent medical history and no drug reactions/allergies. On 26-DEC-2012 the patient was vaccinated with M-M-R II (lot# 0649AE, expiry date 27-MAR-2014) (dose, route not provided). No concomitant medications were reported. On 08-JAN-2013, the patient was rushed to the emergency room (and later admitted over night) due to a petechial rash all over both legs with spontaneous bruising in other areas of his body. Medical attention was sought. He was diagnosed with Idiopathic thrombocytopenic purpura (ITP) at that time and was treated with an IVIG (intravenous immune globulin) while in the hospital. At the time of the report, he still had rash and has been diagnosed with chronic ITP. Outcome of the event was reported as not recovered. On an unknown date blood work was performed (result unknown). There was no product quality complaint involved. Upon internal review, the event Idiopathic thrombocytopenic purpura was considered to be medically significant. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Platelet count decreased, Rash generalised
Clinical narrative: This spontaneous report as received from a consumer refers to her 12 year old son. The patient had no pertinent medical history and no drug reactions/allergies. On 26-DEC-2012 the patient was vaccinated with M-M-R II (lot# 0649AE, expiry date 27-MAR-2014) (dose, route not provided). No concomitant medications were reported. On 08-JAN-2013, the patient was rushed to the emergency room (and later admitted over night) due to a petechial rash all over both legs with spontaneous bruising in other areas of his body. Medical attention was sought. He was diagnosed with Idiopathic thrombocytopenic purpura (ITP) at that time and was treated with an IVIG (intravenous immune globulin) while in the hospital. At the time of the report, he still had rash and has been diagnosed with chronic ITP. Outcome of the event was reported as not recovered. On an unknown date blood work was performed (result unknown). There was no product quality complaint involved. Upon internal review, the event Idiopathic thrombocytopenic purpura was considered to be medically significant. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Blood test, Idiopathic thrombocytopenic purpura, Immunoglobulin therapy, Increased tendency to bruise, Petechiae
Clinical narrative: This spontaneous report as received from a consumer refers to her 12 year old son. The patient had no pertinent medical history and no drug reactions/allergies. On 26-DEC-2012 the patient was vaccinated with M-M-R II (lot# 0649AE, expiry date 27-MAR-2014) (dose, route not provided). No concomitant medications were reported. On 08-JAN-2013, the patient was rushed to the emergency room (and later admitted over night) due to a petechial rash all over both legs with spontaneous bruising in other areas of his body. Medical attention was sought. He was diagnosed with Idiopathic thrombocytopenic purpura (ITP) at that time and was treated with an IVIG (intravenous immune globulin) while in the hospital. At the time of the report, he still had rash and has been diagnosed with chronic ITP. Outcome of the event was reported as not recovered. On an unknown date blood work was performed (result unknown). There was no product quality complaint involved. Upon internal review, the event Idiopathic thrombocytopenic purpura was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV
Symptoms: Fatigue, Pain, Pyrexia, Swelling
Clinical narrative: This spontaneous report as received from health care worker (medical assistant) refers to a female patient of unknown age. The patient's medical history included splenectomy. On an unknown date the patient was vaccinated with PNEUMOVAX23 lot # J004064, expire date 06-AUG-2013, dose 3 (route dosage were not reported). It was reported that after the patient received her 3rd dose of PNEUMOVAX23 she experienced a fever, fatigue and achiness. The patient also stated she had pain and swelling at the injection site. The medical assistant stated the patient was admitted to an unspecified Emergency Room twice, both on unspecified dates. During one of visits to the Emergency Room, the patient was diagnosed with pneumonia by an unspecified healthcare provider and was given unspecified antibiotics. The patient sought medical attention. The outcome of pneumonia, pain and swelling at the injection site, achiness, fatigue and fever was reported as recovered/resolved. All the reported events were considered to be hospitalized. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV
Symptoms: Fatigue, Injection site pain, Injection site swelling, Pain, Pneumonia
Clinical narrative: This spontaneous report as received from health care worker (medical assistant) refers to a female patient of unknown age. The patient's medical history included splenectomy. On an unknown date the patient was vaccinated with PNEUMOVAX23 lot # J004064, expire date 06-AUG-2013, dose 3 (route dosage were not reported). It was reported that after the patient received her 3rd dose of PNEUMOVAX23 she experienced a fever, fatigue and achiness. The patient also stated she had pain and swelling at the injection site. The medical assistant stated the patient was admitted to an unspecified Emergency Room twice, both on unspecified dates. During one of visits to the Emergency Room, the patient was diagnosed with pneumonia by an unspecified healthcare provider and was given unspecified antibiotics. The patient sought medical attention. The outcome of pneumonia, pain and swelling at the injection site, achiness, fatigue and fever was reported as recovered/resolved. All the reported events were considered to be hospitalized. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from health care worker (medical assistant) refers to a female patient of unknown age. The patient's medical history included splenectomy. On an unknown date the patient was vaccinated with PNEUMOVAX23 lot # J004064, expire date 06-AUG-2013, dose 3 (route dosage were not reported). It was reported that after the patient received her 3rd dose of PNEUMOVAX23 she experienced a fever, fatigue and achiness. The patient also stated she had pain and swelling at the injection site. The medical assistant stated the patient was admitted to an unspecified Emergency Room twice, both on unspecified dates. During one of visits to the Emergency Room, the patient was diagnosed with pneumonia by an unspecified healthcare provider and was given unspecified antibiotics. The patient sought medical attention. The outcome of pneumonia, pain and swelling at the injection site, achiness, fatigue and fever was reported as recovered/resolved. All the reported events were considered to be hospitalized. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: Crying, Discomfort, Local swelling, Pain, Screaming
Clinical narrative: Large oval area of swelling on upper thigh where majority of vx were administered/ screamimg/ crying from extreme discomfort/ pain.  Attempted warm compress but infant too sensitive. Elevated legs while infant layed down, but any movement of the limb would set him off again. Swelling/pain reduced approx. 1-2 hrs after first noticed. (No vx reaction to 4 mos vx series aside from drowsiness).
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: Somnolence
Clinical narrative: Large oval area of swelling on upper thigh where majority of vx were administered/ screamimg/ crying from extreme discomfort/ pain.  Attempted warm compress but infant too sensitive. Elevated legs while infant layed down, but any movement of the limb would set him off again. Swelling/pain reduced approx. 1-2 hrs after first noticed. (No vx reaction to 4 mos vx series aside from drowsiness).
Age: 33.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Injection site cellulitis, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: This spontaneous report was received from a physician refers to a 33 year old male patient. No drug allergies were reported. The patient's medical history included appendectomy for which he was hospitalized on an unspecified date. Upon discharge from the hospital on 09-NOV-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number, expiry date and dose were not reported) in the left arm. No concomitant medications were reported. The patient returned to the hospital the next day on 10-NOV-2013 (exact time frame development was unspecified) and was admitted on same day for the injection site reaction (cellulitis, redness and warmth), headache and fever(fever of 103F). The patient was currently hospitalized (patient sought medical attention). The patient received symptomatic treatment and unspecified antibiotic were prescribed for the adverse events. No laboratory tests were performed. The outcome of the reported events was not recovered. The reporter considered the events injection site reaction (cellulitis, redness and warmth), headache and fever to be significant disability. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Pneumonia, Pulmonary fibrosis, Rheumatoid arthritis
Clinical narrative: This spontaneous report as received from a physician refers to a 72 year old female patient with asthma and no known drug reactions or allergies. In 2009, the patient was vaccinated with a dose of PNEUMOVAX23, lot # reported as 01124 (Lot number 01124 is an invalid lot number for PNEUMOVAX23 for because the patient has asthma so she was a candidate for PNEUMOVAX23 (dose, route and expiration date were not provided). In 2011, the patient was diagnosed with rheumatoid arthritis and pulmonary fibrosis. At that time, the patient was prescribed ENBREL, methotrexate and isoniazid. On 21-MAY-2013, the patient developed pneumonia and was hospitalized and given oxygen. The patient's current medications are prednisone and ACTEMRA. The patient could possibly be taking other medications but the physician was not sure. At the time of the report, the patient's status was unknown. The physician thought the pneumonia was possibly life-threatening and also it was considered to be medically significant as the patient received oxygen in the hospital. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Administered at 320 on 11/21/13 (pt had same manf. last year 9/12) went to work afterward. Experienced itching on (L) arm then body later. Noticed some hives later. Took BENADRYL decreased hives (50mg oral).
Age: 73.0
Sex: M
Vaccine: PNC13, PNC13, TDAP
Symptoms: Blister, Purpura, Rash generalised, Rash maculo-papular
Clinical narrative: This is a spontaneous report from a contactable nurse who reported for a patient. This 73-year-old male patient received PREVNAR 13 (Lot. # G95400, Expiration Date: Feb2015) intramuscularly on 29Oct2013, and DTP on an unknown date. Relevant medical history included diabetes, hypertension and atrial flutter, all since an unknown date. Relevant concomitant medication included LIPITOR at an unknown dose of frequency for an unknown indication, metformin at an unknown dose and frequency for diabetes, MULTAQ at an unknown dose and frequency for atrial flutter, and XARELTO at an unknown dose and frequency for atrial flutter; all since an unknown date. It was reported that the patient experienced generalized maculopapular hemorrhagic blistering rash all over body (more pronounced on palm of hands, soles of feet and toes) since an unknown date in Oct2013. Relevant laboratory data was none. Therapeutic measures taken in response to the event included unspecified topical antibiotics since an unknown date at an unknown dose and frequency. Clinical outcome of the event was unknown at the time of report.
Age: 73.0
Sex: M
Vaccine: PNC13, PNC13, TDAP
Symptoms: Blood blister, Dry skin, Pruritus, Rash generalised, Rash maculo-papular
Clinical narrative: This is a spontaneous report from a contactable nurse who reported for a patient. This 73-year-old male patient received PREVNAR 13 (Lot. # G95400, Expiration Date: Feb2015) intramuscularly on 29Oct2013, and DTP on an unknown date. Relevant medical history included diabetes, hypertension and atrial flutter, all since an unknown date. Relevant concomitant medication included LIPITOR at an unknown dose of frequency for an unknown indication, metformin at an unknown dose and frequency for diabetes, MULTAQ at an unknown dose and frequency for atrial flutter, and XARELTO at an unknown dose and frequency for atrial flutter; all since an unknown date. It was reported that the patient experienced generalized maculopapular hemorrhagic blistering rash all over body (more pronounced on palm of hands, soles of feet and toes) since an unknown date in Oct2013. Relevant laboratory data was none. Therapeutic measures taken in response to the event included unspecified topical antibiotics since an unknown date at an unknown dose and frequency. Clinical outcome of the event was unknown at the time of report.
Age: 73.0
Sex: M
Vaccine: PNC13, PNC13, TDAP
Symptoms: Rash vesicular, Scab, Skin lesion
Clinical narrative: This is a spontaneous report from a contactable nurse who reported for a patient. This 73-year-old male patient received PREVNAR 13 (Lot. # G95400, Expiration Date: Feb2015) intramuscularly on 29Oct2013, and DTP on an unknown date. Relevant medical history included diabetes, hypertension and atrial flutter, all since an unknown date. Relevant concomitant medication included LIPITOR at an unknown dose of frequency for an unknown indication, metformin at an unknown dose and frequency for diabetes, MULTAQ at an unknown dose and frequency for atrial flutter, and XARELTO at an unknown dose and frequency for atrial flutter; all since an unknown date. It was reported that the patient experienced generalized maculopapular hemorrhagic blistering rash all over body (more pronounced on palm of hands, soles of feet and toes) since an unknown date in Oct2013. Relevant laboratory data was none. Therapeutic measures taken in response to the event included unspecified topical antibiotics since an unknown date at an unknown dose and frequency. Clinical outcome of the event was unknown at the time of report.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Discomfort, Injection site erythema, Injection site induration
Clinical narrative: Patient developed erythema and induration around injection site of pneumonia vaccine. Mild discomfort but no fever, itch or SOB. Antihistamines as directed and ice pack x10 min prn.
Age: 90.0
Sex: M
Vaccine: FLUX, HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 90 year old male patient who was inadvertently given a dose of GARDASIL by intramuscular instead of PNEUMOVAX. This was related to a staff error and not product confusion. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Swelling
Clinical narrative: This spontaneous report as received from a physician via field representative refers to two female patients of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX vial (dose, lot and expiry date unknown). On an unknown date the patient developed rash, redness and swelling after receiving ZOSTAVAX. The outcome of events was reported as not resolved. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthma
Clinical narrative: This spontaneous report as received from a nurse refers to a 50 year old female patient with asthma. No drug reactions/allergies were reported. On 14-NOV-2013 the patient was vaccinated with a dose of ZOSTAVAX, (lot# not reported) vial 19400 PFU, 0.65 ml, subcutaneous. Concomitant therapies included glucosamine, TOPROL (reported as "toporol"), aspirin (manufacturer unknown) and MOBIC. The patient went to physician's office. On 15-NOV-2013, the patient's physician prescribed the patient prednisone (manufacturer unknown) to treat her unspecified asthma symptoms. No lab was performed. The outcome of asthma was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a pediatric patient of unknown age. On 12-JUN-2013, the patient was given the first dose of VAQTA, injection(lot#, expiration date, dose, route and indication not reported). On 12-AUG-2013, the patient was given the second dose of VAQTA, injection(lot#, expiration date, dose, route and indication not reported). No adverse effect reported. It was not reported if the patient had sought medical attention. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: This spontaneous report was received via a company representative from a 65 year old female nurse practitioner who was also the patient. On 10-OCT-2013, the patient was vaccinated with a single dose injection of ZOSTAVAX (dose and therapy route were not reported). Patient was not taking any concomitant medications. In October 2013, the patient developed a painful rash after receiving the ZOSTAVAX. It was reported that this rash was "on the trunk of her body" and she was using acyclovir for treatment. The patient also received an "unspecified steroid injection" in her neck 4 days after receiving the ZOSTAVAX. At the time of the report the patient was recovering from the painful rash. The relationship between the painful rash and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL dose 1. The time gap between first and second dose was not reported. The patient received the second dose on 31-MAY-2013 and third  on 26-JUL-2013. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Local swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age with asplenia. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (INJ 25/0.5 Y) (dose, lot and expiry date unknown). On an unknown date the patient developed severe arm swelling that looked cellulitis. The outcome of event was reported as recovered/resolved. The patient was seen in emergency room. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of zoster vaccine live (manufacturer unknown). On an unknown date the patient experienced adverse event reaction to the vaccine. It was unknown if the patient sought medical attention. The outcome of adverse reaction to the vaccine was unknown. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Nausea
Clinical narrative: Arm was red in shape of Bandaid. Patient removed Bandaid on 11/7 and came to pharmacy to show pharmacist. Patient felt a "little sick" to stomach and not sure if due to flu shot.
Sex: M
Vaccine: HPV2
Symptoms: Autoimmune disorder
Clinical narrative: This spontaneous report as received from a consumer refers to her son, a male patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, lot, expiry date unknown). On an unknown date, after vaccination (reported as and then), the patient was diagnosed with unspecified autoimmune disease. The outcome of unspecified autoimmune disease was unknown. Additional information has been requested.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Pain
Clinical narrative: This spontaneous report as received via a company representative from a pharmacist refers to unspecified number of patients. On an unknown date the patients was vaccinated with PNEUMOVAX23. Other suspect therapies included influenza vaccine (manufacturer unknown). On an unknown date the patients experienced aches and pains. The outcome of aches and pains was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report refers to a female patient of unknown age who reported regarding herself. On an unknown date the patient was vaccinated with GARDASIL dose 1 and unknown date, dose 2. Dosage details, lot number and expiry date for both doses were unknown. The patient reported that she did not receive the third shot of GARDASIL. The patient does not want to receive the third shot because she wanted to become pregnant and start a family. The patient did confirm that she was not pregnant at the time of report. No other adverse events were reported at this time. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Tongue disorder
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old female patient. None drug reactions/allergies reported. On 04-NOV-2013 the patient was vaccinated with ZOSTAVAX (lot # J006156, expire date: 30-AUG-2014, 0.65 ml, subcutaneous). Concomitant therapies included pravastatin sodium, SPIRIVA, ESTRACE (vaginal cream) and PROAIR (unspecified). On 05-NOV-2013 the patient experienced bump toward the back of her mouth on her tongue. Eventually the same area of her mouth progressed to having 7 to 8 bumps. The patient visited her physician who told her to take BENADRYL. No lab test performed. It was reported that patient's symptoms were subsiding and she only had one bump at the time of report. The relatedness between ZOSTAVAX and the event was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report has been received from a pharmacist who reported that M-M-R II (lot #, dose, strength not reported) reached 75'F for 96 hours, and was unsupported. It was not established whether the M-M-R II vaccine had been administered to any patient. Since possibility of administration which could not be ruled out this was considered as an adverse event. Additional information has been requested.
Age: 93.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 93 year old female patient. On 23-OCT-2013 the patient was vaccinated with PNEUMOVAX23 lot # J007059, exp date 31-JUL-2014, intramuscular. The pharmacist reported that the patient's arm still hurts at the injection site of PNEUMOVAX23 vaccination. Onset date was unspecified. The pharmacist had no other information about the patient's arm that still hurts at the injection site of the PNEUMOVAX23 vaccination. Outcome of the event was reported as not recovered. The patient contacted pharmacist for medical attention. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician via field representative refers to a 60 year old male patient. On 22-OCT-2012 the patient was vaccinated with ZOSTAVAX vial of lot # J005849 and expiry date 17-AUG-2014, dose and route unknown, for shingles vaccination. On same day, the patient experienced redness, itchiness, swelling and rash around the injection site after receiving ZOSTAVAX. The outcome of events was unknown The patient was given BENADRYL (dosage unspecified) and DURICEF 500mg (frequency unspecified) to treat the events. The patient had sought medical attention by seeing the physician. Additional information has been requested.
Age: 55.0
Sex: U
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 55 year old patient of unknown patient. On 07-NOV-2013 the patient was vaccinated with MMR II dose 1. The patient received the second dose on 20-NOV-2013. Dose, lot and expiry date for both doses were not reported. No adverse effects were reported. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route of administration and lot/batch expiry date were not reported). On an unknown date the patient got shingles at an unspecified time following the vaccine. The outcome of the event was unknown. Additional information has been requested.