chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ, VARCEL
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Client stated she was dizzy shortly after 5th vaccine was administered IM (HPV vaccine was the last one) and then fainted. Fainting lasted less than one minute. Client started speaking and stated she could hear my voice far away and could not see anything. Oxygen applied via mask and client started gaining consciousness and eyesight slowly. After a few minutes, client fully recovered and walked out of office without assistance. Called mother today 4/2 and she stated client did not have problems after they left the office and she has been doing good today.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Fatigue, Headache, Nausea
Clinical narrative: Uncontrollable cough, some minor headaches, fatigue, itchy throat, some nausea symptom, and some difficulties taken deep breaths.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: Uncontrollable cough, some minor headaches, fatigue, itchy throat, some nausea symptom, and some difficulties taken deep breaths.
Age: 1.02
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: Low fever on 3/29. Increasingly high to 105.3 on 3/31. Urgent care visit on 3/31 followed by emergency room trip for fluids. Fever still ~104 on 4/2. Additional office visit.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Differential white blood cell count, Erythema, Feeling hot, Full blood count, Swelling
Clinical narrative: Redness, swelling, warmth that worsened over 48 hours.  Treated with ibuprofen, Tylenol, Benadryl, ice.
Age: 0.17
Sex: M
Vaccine: DTAP, RV5
Symptoms: Convulsion, Dyskinesia, Electroencephalogram, Irritability, Muscle twitching
Clinical narrative: 6 hours after adm mom noticed "twitching" and sl occ involuntary movement of extremities, fussiness. Admitted to Hosp. 4/1/14 for "convulsions" per mom.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Fatigue, Palpitations
Clinical narrative: Vaccine received 3/28/14. On 3/31/14 developed SOB, palpitations, felt tired. Rested - but felt tired all day. Then: 4/02/14 developed symptoms once again (same) that lasted approximately 1 hour.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Vaccine given 3-11-14. Mom noted redness, swelling, warmth, evening of 3-12-14. Child's arm sore. Child felt warm, but did not take temp. Subsided in 2 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and erythema on right thigh.
Age: 48.0
Sex: F
Vaccine: HEPAB, MNQ, TDAP
Symptoms: Activities of daily living impaired, Fatigue, Influenza like illness, Myalgia
Clinical narrative: Muscle pain, fatigue flu like symptoms, peaked 18 hrs, better 24 hrs. Pt had to take day off from work. Rested felt much better 2nd day.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The patient's current conditions or medical history were not reported. On 27-MAR-2014, the patient was vaccinated with a dose of VARIVAX inj 0.5 ml subcutaneous (lot number and expiration date were not provided) that was stored outside of the prescribing information. No adverse effects were reported. 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 Nurse refers to a patient of unknown demographics. The patient's current conditions or medical history were not repotted. On 26-SEP-2013, the patient was vaccinated with the first dose of VAQTA (dose, route, lot number and expiration date were not reported). On 06-MAR-2014, the patient was vaccinated with the second dose of VAQTA (dose, route, lot number and expiration date were not reported). No adverse effect were reported. Additional information is expected.
Age: 2.0
Sex: F
Vaccine: HEPA, MMRV, MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Received vaccine 3/21/14. On 3/30/14 developed fever, then on 3/31/14, develope dmild rash on torso. Rash and fever worsened 4/1/14.
Age: 2.0
Sex: F
Vaccine: HEPA, MMRV, MMRV
Symptoms: Pyrexia, Rash, Varicella
Clinical narrative: Received vaccine 3/21/14. On 3/30/14 developed fever, then on 3/31/14, develope dmild rash on torso. Rash and fever worsened 4/1/14.
Age: 1.75
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Varicella given IM instead of SC accidentally - no reaction noted.
Age: 79.0
Sex: F
Vaccine: FLUX
Symptoms: Breast pain, Herpes zoster, Injection site pain, Musculoskeletal pain, Neck pain
Clinical narrative: This spontaneous report as received from a consumer refers to his wife, a 79 year old female patient. No medical history or concurrent conditions were provided. On 03-MAY-2013, the patient was vaccinated with ZOSTAVAX (lot number, dose and route not provided), and on 03-OCT-2013, the patient was vaccinated with influenza virus vaccine (manufacturer unknown) (lot number, dose and route not provided). No concomitant therapies were reported. The reporting consumer stated that the patient received her annual influenza virus vaccine (manufacturer unknown), and that three days after receiving the flu shot, on 06-OCT-2013, the patient had pain at the injection site, which traveled into her neck, and then into her shoulder. The reporter stated that the pain was "on the same side of her body" as where ZOSTAVAX and influenza virus vaccine (manufacturer unknown) were administered. The reporter also stated that the pain then "traveled underneath her breast" on the same side. The reporter stated that an unspecified physician ruled out a number of things and the patent was diagnosed with "shingles under the skin". The patient was prescribed pain medications, which were effective, and was also prescribed gabapentin which was not effective for pain. At the time of the report, the patient had not recovered from the event. The patient sought medical attention by visiting the office. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site swelling
Clinical narrative: Localized erythema and swelling at injection site.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash, Rash pruritic
Clinical narrative: I had received a shingles vac. shot at pharmacy on March 10, 2014 and after that a rash came on the top of both hands. Very itchy, painful and ugly.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Blindness, Immediate post-injection reaction, Tinnitus
Clinical narrative: Pt. was given MENVEO in R. arm and BOOSTRIX in L. arm. Immediately after administration pt. had ringing in ears and vision lost. She sat w/ Dad for 20 mins and felt better. I recommended she go to hospital.
Sex: F
Vaccine: VARZOS
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a physician refers to herself, a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot# not reported) and the needle separated from the syringe. The physician received less than the prescribed dose of ZOSTAVAX. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. It was reported that Nurse reported that one or two doses of GARDASIL (dose and lot# not reported) which was stored at temperatures outside of the current prescribing information might have been administered to patients on unspecified dates. No adverse events were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Blood test, Computerised tomogram, Dizziness, Headache, Nausea
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a 16 year old male patient with no Pertinent Medical History and no Drug Reactions/Allergies. On 27-FEB-2014 the patient was vaccinated with his first dose of GARDASIL (dose, lot # and exp date were not reported). There was no concomitant medication. The patient experienced headache, dizziness and vomiting after receiving the first dose of GARDASIL vaccine. The symptoms started with a slight headache and became progressively worse over the next few days. On 05-MAR-2014, the patient was taken to the hospital emergency room where he was treated and released. He was not admitted to the hospital. The medical assistant stated the patient was seen in the office, on 04-MAR-2014, in regards to the reaction he had to GARDASIL. The medical assistant stated the patient had nausea, headaches, dizziness and was vomiting. Laboratory studies performed included Cat Scan and Blood Work. The hospital gave an IV of medicine to help with the pain and nausea. (Details not specified). The AE's did not improve. The outcome of events was reported as not recovered/not resolved. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Pain, Vomiting
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a 16 year old male patient with no Pertinent Medical History and no Drug Reactions/Allergies. On 27-FEB-2014 the patient was vaccinated with his first dose of GARDASIL (dose, lot # and exp date were not reported). There was no concomitant medication. The patient experienced headache, dizziness and vomiting after receiving the first dose of GARDASIL vaccine. The symptoms started with a slight headache and became progressively worse over the next few days. On 05-MAR-2014, the patient was taken to the hospital emergency room where he was treated and released. He was not admitted to the hospital. The medical assistant stated the patient was seen in the office, on 04-MAR-2014, in regards to the reaction he had to GARDASIL. The medical assistant stated the patient had nausea, headaches, dizziness and was vomiting. Laboratory studies performed included Cat Scan and Blood Work. The hospital gave an IV of medicine to help with the pain and nausea. (Details not specified). The AE's did not improve. The outcome of events was reported as not recovered/not resolved. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via company representative who reported 3 individuals (unknown gender and age) who in approximately 2014 (reported as over the past 3 months) received a dose of ZOSTAVAX (Lot #, exp date, dose and route not reported). Concomitant therapy was not reported. In approximately 2014, the patients were subsequently diagnosed, per unspecified physician, with shingles. It was unknown if the patients sought medical attention. The patient's outcome for shingles was unknown. Follow up information has been received from the pharmacist. The pharmacist stated 2 patients developed herpes zoster after ZOSTAVAX administration. This report mentioned the male patient. On 03-JAN-2013, the patient was vaccinated with ZOSTAVAX lot number: H019035, expiration date: 17-JAN-2014. This is one of the two reports from the same source. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 65 year old male patient. On 31-MAR-2014, the patient was vaccinated with a 0.5 ml single dose vial of PNEUMOVAX 23 (Lot # J010332, expiration date 14-JAN-2015) intramuscularly that was exposed to 77 F (25 degrees C) for 66 hours. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. It was reported that three doses of VAQTA (dose and lot# not reported) which was stored at temperatures outside of the current prescribing information might have been administered to patients on unspecified dates. No adverse events were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. It was reported that at least three doses of VARIVAX (Merck) which was stored at temperatures outside of the current prescribed information might have been administered to patients on unspecified dates. No adverse events were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Dyspnoea
Clinical narrative: Case number PHHY2012US099155, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 463540) web site on 01 Nov 2012 and a follow-up received from Quality Assurance Department (reference number: 209579) on 01 Apr 2014: This report refers to 62 year old female patient. The patient's medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1204521), IM into left arm on 27 Aug 2012. On 29 Aug 2012, the patient complained of lower back pain and difficulty breathing which began 2 days after the vaccine. Patient was told to go to ER if having difficulty breathing. The outcome of the event, seriousness and causality assessment was not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 1204521) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 209579) on 01 Apr 2014: Updated batch review report.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Abscess, Cellulitis, Injection site erythema, Injection site macule, Injection site warmth
Clinical narrative: Case number PHHY2013US118658, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 488378) website on 15 Oct 2013 with a follow up information received from the quality assurance department (QA reference number: 260768) on 01 Apr 2014. This report refers to a 68-year-old female patient. Her medical history included allergies to amoxicillin (causes rash), erythromycin (causes stomach ache) and Bactrim. She was a non-smoker and denied alcohol use. Her concomitant medications included Aspir low, Crestor and Centrum silver ultra-woman's vitamins. She was vaccinated with FLUVIRIN (batch number: 1204101, expiration date: 31 May 2013) in the deltoid on 05 Oct 2012. She was vaccinated with ADACEL (other manufacturer, batch number C4313AA) intramuscularly in the left arm on 26 Oct 2012. On 01 Nov 2012, she experienced rash, redness and swelling at the vaccination site and sore arm. It was reported that her arm was swollen and itchy. Redness and swelling was getting worse. She did not have any fever or systemic symptoms and she denied any pain. She visited the emergency room. Her blood pressure was 130/80, pulse was 72, and temperature was 98.9. Physical examination was normal except for skin where a 6 x 6 centimeter erythematous and warm macular lesion over the left upper arm and elbow area was noted. It was reported that there was no open wound. She was diagnosed with cellulitis and abscess. She was prescribed Keflex 500 mg one tablet three times a day for seven days and ice. The event outcome was completely recovered on an unspecified date. The seriousness and causality was not reported. Upon follow up receipt from the quality assurance department (reference number: 260768), it was concluded that the FLUVIRIN batch 1204101 was manufactured in accordance with the approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. No additional information was available. Follow up information received from the quality assurance department on 01 Apr 2014: Batch summary updated.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Local swelling, Pain in extremity, Pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Case number PHHY2013US118658, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 488378) website on 15 Oct 2013 with a follow up information received from the quality assurance department (QA reference number: 260768) on 01 Apr 2014. This report refers to a 68-year-old female patient. Her medical history included allergies to amoxicillin (causes rash), erythromycin (causes stomach ache) and Bactrim. She was a non-smoker and denied alcohol use. Her concomitant medications included Aspir low, Crestor and Centrum silver ultra-woman's vitamins. She was vaccinated with FLUVIRIN (batch number: 1204101, expiration date: 31 May 2013) in the deltoid on 05 Oct 2012. She was vaccinated with ADACEL (other manufacturer, batch number C4313AA) intramuscularly in the left arm on 26 Oct 2012. On 01 Nov 2012, she experienced rash, redness and swelling at the vaccination site and sore arm. It was reported that her arm was swollen and itchy. Redness and swelling was getting worse. She did not have any fever or systemic symptoms and she denied any pain. She visited the emergency room. Her blood pressure was 130/80, pulse was 72, and temperature was 98.9. Physical examination was normal except for skin where a 6 x 6 centimeter erythematous and warm macular lesion over the left upper arm and elbow area was noted. It was reported that there was no open wound. She was diagnosed with cellulitis and abscess. She was prescribed Keflex 500 mg one tablet three times a day for seven days and ice. The event outcome was completely recovered on an unspecified date. The seriousness and causality was not reported. Upon follow up receipt from the quality assurance department (reference number: 260768), it was concluded that the FLUVIRIN batch 1204101 was manufactured in accordance with the approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. No additional information was available. Follow up information received from the quality assurance department on 01 Apr 2014: Batch summary updated.
Age: 38.0
Sex: F
Vaccine: FLUX, HEP, TD, TYP
Symptoms: Asthenia, Fatigue, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Felt achy, took alieve and went to work. Got progressively worse, extreme fatigue, nausea and aches by 2:30pm. Injection site hot, puffy and painful. Got home, took another Aleve and slept. Felt better next day, but still achy, nauseous and injection site still hot and sore. Took alieve all day but still felt weak and now slightly flu like soreness around eyes and body weakness, nauseous and nasal congestion. Injection site still hot and sore.
Age: 38.0
Sex: F
Vaccine: FLUX, HEP, TD, TYP
Symptoms: Nasal congestion, Nausea, Pain
Clinical narrative: Felt achy, took alieve and went to work. Got progressively worse, extreme fatigue, nausea and aches by 2:30pm. Injection site hot, puffy and painful. Got home, took another Aleve and slept. Felt better next day, but still achy, nauseous and injection site still hot and sore. Took alieve all day but still felt weak and now slightly flu like soreness around eyes and body weakness, nauseous and nasal congestion. Injection site still hot and sore.
Age: 1.27
Sex: F
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site. Parents concerned enough that they made appointment.
Sex: M
Vaccine: MMR
Symptoms: Aphonia
Clinical narrative: This spontaneous report as received from a consumer reporting a unspecified son of a friend, a male patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with M-M-R II (dose, lot number, expiration date, strength and route were not reported). Co-suspect and concomitant therapies were not reported. On an unknown date the patient "stopped talking" after receiving a single dose of M-M-R II. At the time of the report the outcome was unknown. Upon internal review the event "stopped talking" was considered as Medically significant. Additional information is not expected.
Sex: M
Vaccine: HPV2
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a male patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route, and lot # not provided), and was vaccinated with the second dose of GARDASIL subsequently on an unspecified date. On an unspecified date, the patient was administered a dose of CERVARIX (dose, route, lot # not reported), instead of GARDASIL, to complete a GARDASIL series. No adverse effects were reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLUC3
Symptoms: Asthma, Condition aggravated
Clinical narrative: Case number PHEH2014US003966, is an initial spontaneous report from a pharmacist received on 24 Feb 2014 with a follow-up received on 01 Apr 2014. This report refers to a 15-year-old female patient. Her concurrent condition included asthma. Concomitant medications were not reported. She was inadvertently vaccinated with FLUCELVAX (batch number: 004011A, 006001A and expiry date: Jun 2014) at a dose of 0.5 ml intramuscularly into left deltoid on 31 Dec 2013 at 3:20 pm. On an unknown date, 10 days after vaccination, she experienced an asthma attack. Seriousness, outcome and causality of the event were not reported. Follow-up received from a pharmacist on 01 Apr 2014: New event (asthma attack), concurrent condition, site and time of vaccination updated. Date of vaccination amended.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Mobility decreased, Monoplegia, Motor dysfunction, Pain
Clinical narrative: Left arm paralysis, weakness, loss of motor control, unable to abduct arm, pain and tenderness on palpation, notable marble sized deposit in muscle belly, lasted 2 months constantly then went to intermittently.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: Left arm paralysis, weakness, loss of motor control, unable to abduct arm, pain and tenderness on palpation, notable marble sized deposit in muscle belly, lasted 2 months constantly then went to intermittently.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Erythema, swelling, pain and heat at injection site, swelling decreased overnight, but erythema spreading, started on Benadryl and Bactrim.
Age: 54.0
Sex: F
Vaccine: HEPAB
Symptoms: Burning sensation, Pruritus, Urticaria
Clinical narrative: Pt. called to report hives on arms, bilatterally. States areas are itching and burning.
Age: 23.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration
Clinical narrative: VARIVAX Vaccine was given intramuscularly not subcutaneously as directed by package insert. The vaccine manufacturer was notifed and told there should be no issues.
Age: 15.0
Sex: F
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Patient was to receive Tdap vaccine, DTaP was adminitstered instead.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Cardiac arrest, Flushing, Gallbladder operation, Headache
Clinical narrative: Ache in arms and leg muscles. 10/23/2011 Stomach pain. 10/23/20111 Headache. 10/23/2011 Runny nose. 10/23/2011 Flushed feeling in face. 10/2011 Respiratory symptoms. 10/2011 Pancreatitis 11/2011 - 03/2014 hospitalized 4 times for Pancreatitis. Each hospital stay one week to two. Gallbladder surgery 7/2013 out patient surgery Cardiac Arrest 3/22/2014 Treatment at hospital Hospital Four days Heart pacemaker and defibrillator implanted 3/24/2014
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Implantable defibrillator insertion, Myalgia, Pain in extremity, Pancreatitis, Respiratory disorder
Clinical narrative: Ache in arms and leg muscles. 10/23/2011 Stomach pain. 10/23/20111 Headache. 10/23/2011 Runny nose. 10/23/2011 Flushed feeling in face. 10/2011 Respiratory symptoms. 10/2011 Pancreatitis 11/2011 - 03/2014 hospitalized 4 times for Pancreatitis. Each hospital stay one week to two. Gallbladder surgery 7/2013 out patient surgery Cardiac Arrest 3/22/2014 Treatment at hospital Hospital Four days Heart pacemaker and defibrillator implanted 3/24/2014
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Rhinorrhoea, Surgery, Ventricular tachycardia
Clinical narrative: Ache in arms and leg muscles. 10/23/2011 Stomach pain. 10/23/20111 Headache. 10/23/2011 Runny nose. 10/23/2011 Flushed feeling in face. 10/2011 Respiratory symptoms. 10/2011 Pancreatitis 11/2011 - 03/2014 hospitalized 4 times for Pancreatitis. Each hospital stay one week to two. Gallbladder surgery 7/2013 out patient surgery Cardiac Arrest 3/22/2014 Treatment at hospital Hospital Four days Heart pacemaker and defibrillator implanted 3/24/2014
Sex: U
Vaccine: HPV4
Symptoms: Muscular weakness, Myasthenia gravis
Clinical narrative: Information has been received from a physician assistant via a company representative regarding a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose and lot number were not provided). The company representative reported that a pharmacist, had requested information on 27-JAN-2014 about myasthenia gravis and GARDASIL with no patient involved. She stated that she learned today, 01-APR-2014 from another healthcare provider, a Physician Assistant, who had learned of the adverse experience from the pharmacist, that there was a patient involved in the inquiry posed on 27-JAN-2014. She stated that the patient was newly adopted patient and there was no medical history available. She stated that the patient received a dose of GARDASIL and was seen by an unspecified neurologist for symptoms of muscle weakness (date unspecified). The patient was diagnosed with myasthenia gravis (date unspecified) and the representative stated that the physician's assistant stated that an unspecified neurologist attributed the myasthenia gravis to the GARDASIL administration. The representative stated that the physician's assistant stated that the patient recovered and has no more symptoms, on unspecified date. Upon internal review the adverse event of myasthenia gravis was considered to be medically significant. Additional information is not expected.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report has been received from a registered nurse, who reported that unspecified number of patients were administered PEDVAXHIB which underwent supported excursion in December 2013. All telephone attempts to obtain follow-up information had been unsuccessful. This case is linked to 1403USA010165, 1404USA001099, 1404USA001100, 1404USA001102. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report has been received from a registered nurse, who reported that unspecified number of patients were administered RECOMBIVAX, which underwent supported excursion in December 2013. Dose and Lot information was not provided. All telephone attempts to obtain follow-up information had been unsuccessful. This is one o several reports from same reporter and case is linked to 1403USA010165, 1404USA001101,1404USA001102, 1404USA001100. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 24-MAR-2014, the patient was vaccinated with ZOSTAVAX (dose, frequency and lot# not reported) which underwent a supported temperature excursion - was exposed to 8C for 48 hrs as well as the 1C for 72 hours on unspecified dates. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to patients with unknown age and gender. On an unknown date, patients were vaccinated with a dose of M-M-R II (dose, lot # and expiration date were not related) subcutaneously. Concomitant therapy was not reported. The nurse reported that improperly stored with M-M-R II may have been administered to unspecified patients on unspecified dates. No adverse effects reported. No patient contact details available. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report has been received from a registered nurse who reported that unspecified number of patients were administered GARDASIL which underwent supported excursion in December 2013. Dosage and lot information were not provided. All telephone attempts to obtain follow-up information had been unsuccessful. This is one of several reports from the same reporter and is linked to 1403USA010165, 1404USA001101, 1404USA001100, 1404USA001099. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an approximately 14 years old male patient. On an unknown date the patient was vaccinated with the first dose of GARDASIL (lot# unknown, dose/frequency and route unknown). No other vaccine was administered at the time GARADSIL was administered. The nurse practitioner reported that on an unspecified date "in the fall", the patient experienced an episodes of syncope after receiving his first GARDASIL. Action taken was not applicable. The outcome of the event "episode of syncope" was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unknown patients of unknown age or gender. On an unknown date the patients might have been vaccinated with ROTATEQ (dose, route and lot# not reported) with an unsupported temperature excursion. No adverse effects reported. This is one of several cases from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: This spontaneous report as received from a registered nurse via a field employee refers to a male patient of unknown age. On an unspecified date about 8 years ago approximately in 2006 the patient's wife was vaccinated with a dose of ZOSTAVAX. On an unknown date after vaccination the husband broke out with chickenpox on his head. It was unknown if the patient sought medical attention. The outcome of the adverse event was unknown. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. Patient concurrent conditions and medical history were not reported. On 25-MAR-2014 the patient was vaccinated with PNEUMOVAX lot # J014401 (Expiry: 26-NOV-2014) by intramuscular route (dose and frequency was not reported). On an unknown date in March 2014 patient experienced severe redness and swelling at the injection site where the PNEUMOVAX was injected. Patient had difficulty in lifting the arm that had received PNEUMOVAX injection. The patient visited physician (reporter also mentioned 3 patients received PNEUMOVAX from same lot# and an unspecified patient among 3 visited an unspecified emergency room). Reporter was not sure whether patient received treatment with either decadron (manufacturer unknown) or SOLU-MEDROL. The outcome of the event was reported as recovering. The reporter did not provide the causality between event and the suspect drug. Lot check was requested by reporter. Additional information has been requested. This is one of several reports from same reporter.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unknown patients of unknown age or gender. On an unknown date the patients might have been vaccinated with RECOMBIVAX HB (dose, route and lot# not reported) with an unsupported temperature excursion. No adverse effects reported. This is one of several cases from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unknown patients of unknown age or gender. On an unknown date the patients might have been vaccinated with GARDASIL (dose, route and lot# not reported) with an unsupported temperature excursion. No adverse effects reported. This is one of several cases from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unknown patients of unknown age or gender. On an unknown date the patients might have been vaccinated with VAQTA (dose, route and lot# not reported) with an unsupported temperature excursion. No adverse effects reported. This is one of several cases from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified group of patients. No demographic information was provided. It was stated that unspecified patients were vaccinated with RECOMBIVAX HB pediatric formulation that was exposed to 51F for 15 minutes. No adverse effects were reported. No further information was provided. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. Patient concurrent conditions and medical history were not reported. On 26-MAR-2014 the patient was vaccinated with PNEUMOVAX lot # J014401 (Expiry: 26-NOV-2014) (also reported as lot check was requested) by intramuscular route (dose and frequency was not reported). On an unknown date in March 2014 patient experienced severe redness and swelling at the injection site where the PNEUMOVAX was injected. Patient had difficulty in lifting the arm that had received PNEUMOVAX injection. The patient visited physician (reporter also mentioned 3 patients received PNEUMOVAX from same lot# and an unspecified patient among 3 visited an unspecified emergency room). Reporter was not sure whether patient received treatment with either DECADRON or SOLU-MEDROL. The outcome of the event was reported as recovering. The reporter did not provide the causality between event and the suspect drug. Additional information has been requested. This is one of several reports from same reporter.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 16 year old patient (gender unknown). On 31-MAR-2014 the patient was vaccinated with GARDASIL dose 2, intramuscular for vaccination (dose, lot# and injection site not reported). The patient was vaccinated with GARDASIL dose 1 at his/her nine years old (in approximately 2007). No adverse effects reported. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Lymphadenopathy
Clinical narrative: This spontaneous report as received from a female physician of unknown age, who was also the patient. On an unknown day in February 2014 (within the last month), the patient was vaccinated with a dose of ZOSTAVAX route and lot were not provided. The patient reported that she received influenza virus vaccine (manufacturer unknown) 3 weeks before receiving ZOSTAVAX (unknown date in 2014. Other suspect therapies were not provided. The physician reported that 24 hours after vaccination with ZOSTAVAX (On an unknown day in February 2014) she developed an injection site reaction and swollen lymph nodes. The physician informed that the injection site reactions was severe and described as a lot of swelling, red and warm to the touch. The physician reported that the events lasted about a week and then was recovered from these events. She received unspecified non-steroidal anti-inflammatory and an unspecified topical anti-inflammatory cream as self-treatment. Additional information is not expected.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to a male patient of unknown age. Patient's medical history and other drug allergic reactions were not reported. On 07-JUL-2013, the patient was vaccinated with first dose of GARDASIL (strength, dose units, route, lot number and frequency unknown). On 06-DEC-2013 the patient was vaccinated with second dose of GARDASIL (strength, dose units, route, lot number and frequency unknown). No adverse effect reported. The outcome of the patient received first dose of GARDASIL on 07/01/2013 and their second dose on 12/06/2013 and no adverse effect was unknown.  No further information was provided. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis to left upper arm.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unspecified demographics. On 28-MAR-2014, the patient was vaccinated with dose of PNEUMOVAX 23 injection, (lot # H018441 expiry date 28-FEB-2014), intramuscular, dose and frequency unspecified. Concomitant therapy was unspecified. No product quality complaint was involved. The outcome of received an expired PNEUMOVAX 23 was unknown. No known adverse effects. No further information provided. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody positive
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of approximately 46 years old at the time of reporting. On an unknown date the patient was vaccinated with M-M-R II. On an unknown date the patient experienced IgM drawn for Rubeola was higher than normal, at 1.29. The patient showed no signs of infection. The IgG for Rubeola was equivocal at 0.98. One month later the Rubeola IgG titer was negative while the mumps and rubella remained within normal limits. No treatment was provided. The outcome of IgM drawn for Rubeola was higher than normal, at 1.29 was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unkown age or demographics. On an unspecified date (assumed to be in 2009 based on: the patient was re-vaccinated about 5 years ago) the patient was vaccinated with PNEUMOVAX 23 dose 2. Date of first dose of PNEUMOVAX 23 was unspecified, date of re-vaccination with PNEUMOVAX 23 was unspecified. No information was provided on batch/lot number or vaccination site. No adverse event reported. No other information was provided. The outcome of the patient had been revaccinated with PNEUMOVAX 23 and no adverse event is unknown. Additional information is not expected (no consent to contact reporter).
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: Cellulitis around site of injection noticed redness developing in the area where she had vaccine the day of.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: Hot, red, tender, knot on site of injection on 4/2.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Red golf ball size bump on (R) arm.
Age: 28.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Guillain-Barre syndrome
Clinical narrative: I came down with CIDP, Guillain-Barre within 60 days of flu shot.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Fall, Syncope
Clinical narrative: Child fainted in the library from the chair to the floor.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Influenza, Lumbar puncture, Muscular weakness
Clinical narrative: I don't know if there's a link, but I got Guillain-Barre syndrome diagnosed in early March 2014. I also had a confirmed case of the flu in January, after getting the shot. Symptoms were typical GBS: numb hands, muscle weakness, etc.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Blood test, Central nervous system lesion, Diplegia, Hypoaesthesia
Clinical narrative: Began having numbness and nerve pain in right foot, progressed up right leg and began in left leg until 1/30/2014 in which I acquired bilateral paralysis of my legs and was unable to walk.  I was admitted to the hospital and diagnosed with Transverse Myelitis.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Lumbar puncture, Myelitis transverse, Neuralgia, Nuclear magnetic resonance imaging spinal abnormal, X-ray
Clinical narrative: Began having numbness and nerve pain in right foot, progressed up right leg and began in left leg until 1/30/2014 in which I acquired bilateral paralysis of my legs and was unable to walk.  I was admitted to the hospital and diagnosed with Transverse Myelitis.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Blood test, Chest X-ray abnormal, Dizziness, Headache
Clinical narrative: Immediate onset debilitating headache. Severe pain in left arm.  On 11/3 doctor gave Tramodol 50 mg. On 11/17, doctor gave same medication again.  On 1-16-14, doctor gave Amoxicillin for head congestion and asthma. On 2/2/14, was dizzy with headache.  Doctor gave Augmentin.  On 2-17-14 was given Doxycycline for dizziness, headache, congestion.  Chest x-ray.  Diagnosed with pneumonia.  On March 5, hospitalized for pneumonia and low oxygen levels.  Stayed until 3/9/14.  Released with medication.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Oxygen saturation decreased, Pain in extremity, Pneumonia, Respiratory tract congestion
Clinical narrative: Immediate onset debilitating headache. Severe pain in left arm.  On 11/3 doctor gave Tramodol 50 mg. On 11/17, doctor gave same medication again.  On 1-16-14, doctor gave Amoxicillin for head congestion and asthma. On 2/2/14, was dizzy with headache.  Doctor gave Augmentin.  On 2-17-14 was given Doxycycline for dizziness, headache, congestion.  Chest x-ray.  Diagnosed with pneumonia.  On March 5, hospitalized for pneumonia and low oxygen levels.  Stayed until 3/9/14.  Released with medication.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Sinus congestion
Clinical narrative: Immediate onset debilitating headache. Severe pain in left arm.  On 11/3 doctor gave Tramodol 50 mg. On 11/17, doctor gave same medication again.  On 1-16-14, doctor gave Amoxicillin for head congestion and asthma. On 2/2/14, was dizzy with headache.  Doctor gave Augmentin.  On 2-17-14 was given Doxycycline for dizziness, headache, congestion.  Chest x-ray.  Diagnosed with pneumonia.  On March 5, hospitalized for pneumonia and low oxygen levels.  Stayed until 3/9/14.  Released with medication.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash generalised
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. On an unknown date in March 2014 (also reported as about one to two weeks ago) the patient was vaccinated with ZOSTAVAX (dose and frequency were not reported) subcutaneous. On an unknown date in March 2014 (also reported as four days after receiving ZOSTAVAX) the patient experienced patchy rash all over her body. The patient sought medical attention and was treated with BENADRYL and MEDROL DOSEPAK. The outcome of the event was reported as not recovered. The reporter did not provide the causality between the event and the suspect drug. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representative refers to unknown number of patients of unknown demography. On an unknown date, the unknown number of patients was vaccinated with 2 and 3 dose of GARDASIL (dose and frequency were not reported) late. No adverse effects reported. No further information provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unspecified demographics. On 07-JAN-2014, the patient was vaccinated with oral ROTATEQ suspension 2, dose and frequency reported as 2 ml one dose, (lot number h015715, expiry date 15-MAR-2014). Concomitant therapy was unspecified. On 18-MAR-2014, the patient was vaccinated with expired dose of oral ROTATEQ suspension 2, (lot # h015715, expiry date 15-MAR-2014). No adverse effect reported. No product quality complaint was involved. No further information was provided. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: 3 red spots, warm to touch and sore arm.
Age: 59.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Redness, shining skin due to swelling. The swelling started out normal than continued till about the size of a grapefruit. It covered a large area of my arm, almost to my shoulder. I used ibuprofen and ice bags all night. Was a localized event.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling
Clinical narrative: Localized swelling of pt's left arm with erythema and circumference 25% larger than right arm upon exam from 4/3.
Age: 11.0
Sex: M
Vaccine: HPVX, MEN
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red circle size of a quarter around injection site that is hot. Whole upper arm swollen now with red circle the size of a baseball.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Allergy test positive, Lip swelling, Urticaria
Clinical narrative: Mom left after shot was given and within approximately 30min she saw that her son had swelling of his lips and hives on his face.  She took him to the local clinic and the PA looked at him and agreed it was a reaction and gave him Benadryl and he recovered well. Child has a peanut and egg allergy.  He was allergy tested and it was diagnosed as moderate.