chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: White blood cell count increased
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 16 year old male patient with asthma and no Drug Reactions/Allergies. On 21-AUG-2014 the patient was vaccinated with GARDASIL (lot#, expiration date, dose and route unspecified). No concomitant medication reported. On 21-AUG-2014, the patient experienced fainting for 30 seconds, hit his head as he fell, an abrasion and scalp hematoma, after receiving GARDASIL. The patient sought medication attention via office visit on an unspecified date. IV fluid (unspecified name, dose, frequency, and manufacturer) and ondansetron (unspecified dose, frequency and manufacturer) were given for treatment. The patient underwent Full Blood Count (CBC), metabolic panel, Comprehensive metabolic panel (CMP), Computerized tomogram (CT scan) and Electrocardiogram (EKG) without results provided. The events outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram, Electrocardiogram, Excoriation, Fall, Full blood count
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 16 year old male patient with asthma and no Drug Reactions/Allergies. On 21-AUG-2014 the patient was vaccinated with GARDASIL (lot#, expiration date, dose and route unspecified). No concomitant medication reported. On 21-AUG-2014, the patient experienced fainting for 30 seconds, hit his head as he fell, an abrasion and scalp hematoma, after receiving GARDASIL. The patient sought medication attention via office visit on an unspecified date. IV fluid (unspecified name, dose, frequency, and manufacturer) and ondansetron (unspecified dose, frequency and manufacturer) were given for treatment. The patient underwent Full Blood Count (CBC), metabolic panel, Comprehensive metabolic panel (CMP), Computerized tomogram (CT scan) and Electrocardiogram (EKG) without results provided. The events outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Haematoma, Head injury, Metabolic function test, Syncope
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 16 year old male patient with asthma and no Drug Reactions/Allergies. On 21-AUG-2014 the patient was vaccinated with GARDASIL (lot#, expiration date, dose and route unspecified). No concomitant medication reported. On 21-AUG-2014, the patient experienced fainting for 30 seconds, hit his head as he fell, an abrasion and scalp hematoma, after receiving GARDASIL. The patient sought medication attention via office visit on an unspecified date. IV fluid (unspecified name, dose, frequency, and manufacturer) and ondansetron (unspecified dose, frequency and manufacturer) were given for treatment. The patient underwent Full Blood Count (CBC), metabolic panel, Comprehensive metabolic panel (CMP), Computerized tomogram (CT scan) and Electrocardiogram (EKG) without results provided. The events outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: FLU3, PPV, TDAP, PPV
Symptoms: Axillary pain, Chest pain, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a patient of unknown age and gender. On 28-AUG-2014, the patient was inadvertently vaccinated with PNEUMOVAX 23 lot # H011780 that had expired on 16-FEB-2014 (dose and route were not reported). Concomitant therapy was not reported. No adverse effects reported. This is one of several same reporter cases. Additional information has been requested.
Sex: U
Vaccine: FLU3, PPV, TDAP, PPV
Symptoms: Injection site swelling, Painful respiration
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a patient of unknown age and gender. On 28-AUG-2014, the patient was inadvertently vaccinated with PNEUMOVAX 23 lot # H011780 that had expired on 16-FEB-2014 (dose and route were not reported). Concomitant therapy was not reported. No adverse effects reported. This is one of several same reporter cases. Additional information has been requested.
Sex: U
Vaccine: FLU3, PPV, TDAP, PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a patient of unknown age and gender. On 28-AUG-2014, the patient was inadvertently vaccinated with PNEUMOVAX 23 lot # H011780 that had expired on 16-FEB-2014 (dose and route were not reported). Concomitant therapy was not reported. No adverse effects reported. This is one of several same reporter cases. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Blindness unilateral, Depression, Headache, Multiple sclerosis
Clinical narrative: High headache, blurry vision, on 03/08/14 the headache come much more strong, lost his left eye vision, went to ER, and transferred him to another hospital by helicopter there make a several exams like a CAT scan, MRI's, Lumbar puncture, blood, and diagnose him with a MS, stays there for 4 days with a treatment for MS, after couple days the episode of MS gets worse went to a third hospital, made a lots of exams again, and stay with treatment for 5 days. In a middle of May another MS episode, and stays for 5 more days at hospital. Now he is having treatment for MS, like a injection every week, and still having a MS symptoms.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Blindness unilateral, Blood test, Computerised tomogram, Headache, Lumbar puncture
Clinical narrative: High headache, blurry vision, on 03/08/14 the headache come much more strong, lost his left eye vision, went to ER, and transferred him to another hospital by helicopter there make a several exams like a CAT scan, MRI's, Lumbar puncture, blood, and diagnose him with a MS, stays there for 4 days with a treatment for MS, after couple days the episode of MS gets worse went to a third hospital, made a lots of exams again, and stay with treatment for 5 days. In a middle of May another MS episode, and stays for 5 more days at hospital. Now he is having treatment for MS, like a injection every week, and still having a MS symptoms.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Multiple sclerosis, Nuclear magnetic resonance imaging, Vision blurred
Clinical narrative: High headache, blurry vision, on 03/08/14 the headache come much more strong, lost his left eye vision, went to ER, and transferred him to another hospital by helicopter there make a several exams like a CAT scan, MRI's, Lumbar puncture, blood, and diagnose him with a MS, stays there for 4 days with a treatment for MS, after couple days the episode of MS gets worse went to a third hospital, made a lots of exams again, and stay with treatment for 5 days. In a middle of May another MS episode, and stays for 5 more days at hospital. Now he is having treatment for MS, like a injection every week, and still having a MS symptoms.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site induration, Injection site swelling, Injection site warmth, Pain, Pruritus
Clinical narrative: Pt had a 5 cm swollen induration on right deltoid where vaccine was given. She described pain 6/10 on pain scale, itchiness, and the site was hot to the touch.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Bed rest, Chills, Fatigue, Heart rate increased
Clinical narrative: Fatigue, then joint/muscle pain followed by fever/chills night sweating at 12 AM and rapid/irregular heart rate.  Patient took aspirin, fluids, bed rest for the day.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Heart rate irregular, Myalgia, Night sweats, Pyrexia
Clinical narrative: Fatigue, then joint/muscle pain followed by fever/chills night sweating at 12 AM and rapid/irregular heart rate.  Patient took aspirin, fluids, bed rest for the day.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Swelling face
Clinical narrative: Significant right arm redness swelling from injection sight inferior to just above elbow and extending superiorly to right shoulder, also next day developed right sided facial swelling.  pt also developed fever.  Fever lasted for less than 24 hours.  Face swelling improved after less than 24 hours.  Arm swelling also improved in 24 hours.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Cough, Eyelid oedema, Urticaria, Wheezing
Clinical narrative: Wheezing, coughing, urticarial and eyelid have been swelling progressive over a 15 minute period.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Post vaccination autoinoculation, Rash pustular, Scar
Clinical narrative: Smallpox self inoculator. Sites to chin, neck, left knee and right thigh. All sites are apparently one week or older (pus filled pockets except for several that patient removed shaving, healed scars at those sites) Patient recieved smallpox vaccine this facillity on 25 August 2014 with major reaction documented on 2 September 2014.
Age: 34.0
Sex: F
Vaccine: ANTH
Symptoms: Headache, Injected limb mobility decreased, Injection site erythema, Injection site nodule, Injection site pruritus
Clinical narrative: Patient as well until 3 December 2013 when she received in her left biceps area her first AVA vaccine. States that it immediately 'stung' and subsequently developed a headache mid AM on the following day. She experiences headaches anyway secondary to TMJ and is unsure if this headache was different than those. About 3 days later she developed swelling around the injection site and at day 7 post vaccine she noted a nodular, red area at injection site with a pruritic maculopapular rash. The rash consisted of "raised pinhead bumps in an arc shape at the bottom of injection site near that elbow." She continued to have headache with muscle soreness in the injected arm. She denied similar reactions from other vaccines. The mobility of her left arm was limited -"I could hardly raise my arm"-and impacted her ability to move it in full range of motion. Due to the occurrence of her initial reaction with AVA it was recommended that her next dose be given approximately 35 days after the initial dose and that the 2nd dose be preceded by an antihistamine and ibuprofen. She took all pre-treatment 45 minutes prior to the 2nd dose that she received on 7 Jan '14. Within 24 hours following the receipt of the vaccine she reported moderate generalized myalgias/arthralgias with fatigue. Her injected arm was again very sore with redness and swelling and a pinpoint nodule at the needle entry site. She felt weak and sore and felt progressively worse throughout day 2 post vaccine and experienced an intense headache (10/10) which lasted 2 days. At 48 hours post-vaccine, she also reports chills and temp of 101.7. All symptoms resolved within 60 hours after receiving the vaccine. She received no other vaccination simultaneously.
Age: 34.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site rash, Injection site swelling, Myalgia, Rash maculo-papular
Clinical narrative: Patient as well until 3 December 2013 when she received in her left biceps area her first AVA vaccine. States that it immediately 'stung' and subsequently developed a headache mid AM on the following day. She experiences headaches anyway secondary to TMJ and is unsure if this headache was different than those. About 3 days later she developed swelling around the injection site and at day 7 post vaccine she noted a nodular, red area at injection site with a pruritic maculopapular rash. The rash consisted of "raised pinhead bumps in an arc shape at the bottom of injection site near that elbow." She continued to have headache with muscle soreness in the injected arm. She denied similar reactions from other vaccines. The mobility of her left arm was limited -"I could hardly raise my arm"-and impacted her ability to move it in full range of motion. Due to the occurrence of her initial reaction with AVA it was recommended that her next dose be given approximately 35 days after the initial dose and that the 2nd dose be preceded by an antihistamine and ibuprofen. She took all pre-treatment 45 minutes prior to the 2nd dose that she received on 7 Jan '14. Within 24 hours following the receipt of the vaccine she reported moderate generalized myalgias/arthralgias with fatigue. Her injected arm was again very sore with redness and swelling and a pinpoint nodule at the needle entry site. She felt weak and sore and felt progressively worse throughout day 2 post vaccine and experienced an intense headache (10/10) which lasted 2 days. At 48 hours post-vaccine, she also reports chills and temp of 101.7. All symptoms resolved within 60 hours after receiving the vaccine. She received no other vaccination simultaneously.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Convulsion, Pyrexia
Clinical narrative: Seizure and fever to 104- spontaneous resolution, pt discharged with Diastat.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Erythema, Heart rate increased, Hyperhidrosis, Skin warm
Clinical narrative: Difficulty breathing, fast heartbeat, starting sweating and my whole body turned red and hot.
Age: 22.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Minor rash to face, legs, buttock.  Employee was treated in Urgent Care.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Patient developed a rash on her neck.  She described it as a shingles cluster.  By Monday, she said it had dried up and was no longer itching.
Age: 81.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Painful sore left upperarm musculature extending below injection site into bicep followed by redness and swelling. Next day flu like achiness across back and upper body; followed by fever the night of 09/13/2014.  09/14/2014 fever and achiness gone but swelling, soreness in bicep remains today with skin redness in the same area but slowly diminishing.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain, Poor peripheral circulation
Clinical narrative: Pt reports that sight of injection was sore, but after a few hours started getting a bruise around injection site. Over the weekend the patient's entire arm appears to be bruised and he reports that blood is pooling at lower part of arm by the elbow. Instructed patient to visit the doctors office as soon as possible and/or go to emergency room.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC13
Symptoms: Autism, Autism spectrum disorder, Infection, Injection site rash, Irritability
Clinical narrative: Normal well baby visit. Next day my daughter developed a rash around injection site. I called her PCP but they told me it wasn't related. Even though it was the exact injection site. they said to keep an eye on it. She then fell ill with vomiting, irritability and fever the next day, continued for over a week. So we made an appointment with her doctor (on vacation) so we got the person on call. Visit is documented. Fever was 102 to 103.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC13
Symptoms: Malaise, Pyrexia, Vomiting
Clinical narrative: Normal well baby visit. Next day my daughter developed a rash around injection site. I called her PCP but they told me it wasn't related. Even though it was the exact injection site. they said to keep an eye on it. She then fell ill with vomiting, irritability and fever the next day, continued for over a week. So we made an appointment with her doctor (on vacation) so we got the person on call. Visit is documented. Fever was 102 to 103.
Age: 11.0
Sex: F
Vaccine: MEN
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Menomune vaccine ordered from website (stated on website vaccine was for all ages).  Administered and later discovered this vaccine was for ages above 55 only, unless the appropriate vaccines were not available.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Chest pain, Electrocardiogram normal
Clinical narrative: Onset of chest pain approximately 30 mins. post Flu vaccine. Pt. described pain to be 6/10 initial BP reading was 130/103. Upon administering 2 doses of ASA 81 pain and BP subsided a little bit. Followed by a brief relief and int. pain.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old male patient with no pertinent medical history and no drug reactions/allergies. On 02-SEP-2014 the patient was vaccinated with a dose of 0.65 ml of ZOSTAVAX (lot # K000996, expiration date 13-MAR-2015), subcutaneous. Concomitant therapies included VIAGRA and alprazolam. On 08-SEP-2014, the patient experienced a rash with raised areas, "like blisters" around the eyes, nose and on the cheeks after receiving ZOSTAVAX. Patient has not had any pain or itching. No lab diagnostics studies performed. The patient sought medical attention via saw pharmacist. No treatment was given. The outcome of a rash with raised areas, "like blisters" around the eyes, nose and on the cheeks was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. Patient's relevant medical history and concurrent condition was unknown. On an unknown date the patient was vaccinated with GARDASIL (dose and frequency unknown). Patients concomitant medication was unknown. On an unknown date the patient experienced change in pap smear after administration of GARDASIL. patient's diagnostic tests were unknown. The outcome of the event was unknown. The reporter considered the event to be related to GARDASIL. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Paraesthesia
Clinical narrative: This spontaneous report as received from a physician refers to an 18 year old female patient. On 28-JUL-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K004148, expiration date 10-MAY-2015) (dose unspecified), intramuscular. On 28-JUL-2014, the patient experienced redness, tingling and burning at the injection site, that radiated to the hand, after receiving PNEUMOVAX 23. The patient sought medical attention via office visit on an unspecified date. Steroids (unspecified name, dose/frequency and manufacturer) were given for treatment. The events outcome was reported as recovered/resolved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a patient of unknown age and gender. On 26-AUG-2014, the patient was inadvertently vaccinated with PNEUMOVAX 23, lot # H011780 that had expired on 16-FEB-2014 (dose and route were not reported). Concomitant therapy was not reported. No adverse effects reported. This is one of several same reporter cases. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a patient of unknown age and gender. On 19-AUG-2014, the patient was inadvertently vaccinated with PNEUMOVAX 23, lot # H011780 that had expired on 16-FEB-2014 (dose and route were not reported). Concomitant therapy was not reported. No adverse effects reported. This is one of several reporter cases. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Injection site erythema, Pallor
Clinical narrative: Erythema surrounding injection site and then on 9/13/14 erythema worsened and induration noted.  Put ice on it immediately.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillian-Barre Syndrome
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Warmth, redness and swelling at site of injection.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Warmth, redness and swelling at injection site.
Age: 59.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Back pain, Haemophilus infection, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: Client reports that she had muscle aches, fever of 101 degrees, very sore and red throat, pain in teeth on left side, lethargy, backache and reports feeling like "she has the flu". Also reports redness, swelling, and warmth at the site of the Tdap vaccine in left deltoid area.
Age: 59.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Injection site warmth, Lethargy, Myalgia, Oropharyngeal pain, Pharyngeal erythema
Clinical narrative: Client reports that she had muscle aches, fever of 101 degrees, very sore and red throat, pain in teeth on left side, lethargy, backache and reports feeling like "she has the flu". Also reports redness, swelling, and warmth at the site of the Tdap vaccine in left deltoid area.
Age: 59.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Pyrexia, Toothache
Clinical narrative: Client reports that she had muscle aches, fever of 101 degrees, very sore and red throat, pain in teeth on left side, lethargy, backache and reports feeling like "she has the flu". Also reports redness, swelling, and warmth at the site of the Tdap vaccine in left deltoid area.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Pyrexia, Rash erythematous
Clinical narrative: Huge red orange sized rash around injection site, fever
Age: 16.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Pruritus, Rash generalised, Rash maculo-papular, Skin lesion
Clinical narrative: Client presented to the Health Department on 9/15/2014 with c/o onset of rash on 9/12/2014.  Macular-papular lesions present on left arm, concentrated near exterior side of left elbow and left forearm.  2-3 lesions each on ankles, neck, left mid abdomen and upper back. C/o itching. Denies any fever, chills, fatigue, malaise, sore throat, cough or  other prodromal type symptoms.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Fatigue, Malaise, Pyrexia
Clinical narrative: Redness, swelling, warm to touch, fatigue, malaise, low grade fever. Dr diagnosed as cellulitis, gave antibiotic rx.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: Redness, swelling, warm to touch, fatigue, malaise, low grade fever. Dr diagnosed as cellulitis, gave antibiotic rx.
Age: 16.0
Sex: M
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: Varicella like rash over entire trunk (front and back)
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: Trouble Breathing / Throat Closure for about 4 hours the night of the vaccination delivered.
Age: 42.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Convulsion, Electrocardiogram, Fall, Hypopnoea, Pulse abnormal
Clinical narrative: Patient received Hepatitis B vaccine in left deltoid muscle and then Hep A vaccine in right deltoid muscle.  He appeared to be fine and walked to the waiting room to sit after the vaccines.  A few minutes after he sat, Administrative employee, noticed he was not looking well.  She asked him if he would like a juice drink and he said yes.  She got him one and took it to him, but he would not respond and was slumping in the chair.  She got behind him and held him up and called for help.  RN came to help, as did another RN.  He was assisted to the floor where he had some mild seizure activity.  He was responsive for a few seconds, then became unresponsive again. BP was 78/56.  Oxygen was placed at 10 l/min. via non-rebreather. Pulse was weak and thready, color gray, resp.24 but shallow.  As he appeared to not be coming around, an ambulance was called at 11:25. BP 82/64; at 11:27 BP 86/60. Oxygen upped to 15 l/min. by RN.  Ambulance personnel and Fire Dept. personnel on scene at 11:28. An IV was placed and an EKG ran. The client became responsive with the EMS team.  He was taken by ambulance to the hospital.
Age: 42.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Pulse pressure decreased, Skin discolouration, Unresponsive to stimuli
Clinical narrative: Patient received Hepatitis B vaccine in left deltoid muscle and then Hep A vaccine in right deltoid muscle.  He appeared to be fine and walked to the waiting room to sit after the vaccines.  A few minutes after he sat, Administrative employee, noticed he was not looking well.  She asked him if he would like a juice drink and he said yes.  She got him one and took it to him, but he would not respond and was slumping in the chair.  She got behind him and held him up and called for help.  RN came to help, as did another RN.  He was assisted to the floor where he had some mild seizure activity.  He was responsive for a few seconds, then became unresponsive again. BP was 78/56.  Oxygen was placed at 10 l/min. via non-rebreather. Pulse was weak and thready, color gray, resp.24 but shallow.  As he appeared to not be coming around, an ambulance was called at 11:25. BP 82/64; at 11:27 BP 86/60. Oxygen upped to 15 l/min. by RN.  Ambulance personnel and Fire Dept. personnel on scene at 11:28. An IV was placed and an EKG ran. The client became responsive with the EMS team.  He was taken by ambulance to the hospital.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Nausea, Pyrexia, Vomiting
Clinical narrative: Patient was having nausea that was coming and going. Injection site was sore.  On 09/10/2014 patient's mother called back stating that patient was running fever 102.5 with vomiting. Patient's mother also stated that 1st Vaccine given on 07/07/2014 patient did have severe pain in neck and arm. Patient did not report this at time of onset symptoms.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Rash, Skin warm, Tenderness
Clinical narrative: Redness, tenderness, rash, heat to touch
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Skeletal injury
Clinical narrative: Patient said his arm started to hurt and believed that the needle hit his bone. He visited his primary Dr.  Has now retained a lawyer for damages.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dysphagia, Fatigue, Incomplete course of vaccination, Infectious mononucleosis
Clinical narrative: Throwing up on 8/27/2014 & 8/28/2014,she became very weak. Cold like symptoms on September 1, 2014 that included a sore throat and Body aches. We noticed swelling of the tonsils on September 4, 2014. Went to a clinic on September 5, 2014 and was given Flonase for nasal drip but nothing else because they were testing for strep throat which was negative.  Went to Emergency  center on September 7, 2014 because she could hardly swallow and her tonsils were even more swollen with white spots on them. Was diagnosed with mononucleosis.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Nasopharyngitis, Oropharyngeal pain, Pain, Streptococcus test negative, Tonsillar hypertrophy
Clinical narrative: Throwing up on 8/27/2014 & 8/28/2014,she became very weak. Cold like symptoms on September 1, 2014 that included a sore throat and Body aches. We noticed swelling of the tonsils on September 4, 2014. Went to a clinic on September 5, 2014 and was given Flonase for nasal drip but nothing else because they were testing for strep throat which was negative.  Went to Emergency  center on September 7, 2014 because she could hardly swallow and her tonsils were even more swollen with white spots on them. Was diagnosed with mononucleosis.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Throwing up on 8/27/2014 & 8/28/2014,she became very weak. Cold like symptoms on September 1, 2014 that included a sore throat and Body aches. We noticed swelling of the tonsils on September 4, 2014. Went to a clinic on September 5, 2014 and was given Flonase for nasal drip but nothing else because they were testing for strep throat which was negative.  Went to Emergency  center on September 7, 2014 because she could hardly swallow and her tonsils were even more swollen with white spots on them. Was diagnosed with mononucleosis.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site reaction, Myalgia
Clinical narrative: Extreme muscle soreness at site of injection on upper left shoulder. The pain has lasted over one week and has not yet totally subsided. My left arm is almost immobile, but it is gradually improving.
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: a large black and blue  bruise on injection arm
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Myalgia, Pyrexia, Rhinitis
Clinical narrative: fever (100.4 F), rhinitis, fatigue, HA, myalgia first time getting quadrivalent flu vaccine, had no previous reactions with trivalent
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Abdominal pain upper, Decreased appetite, Rash
Clinical narrative: Woke up with decreased appetite and stomach ache, then developed rash on extremities.  By the following morning (9/15) she had rash all over the torso, stomach continued to bother her.  No V/D.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Middle insomnia, Pain in extremity
Clinical narrative: Arm pain radiating to fingers at times;progressing to decreased range of motion of arm. pain at times brings pt to knees and wakes her up.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Asthenia, Dizziness, Metamorphopsia, Visual impairment
Clinical narrative: Patient called the pharmacy at 5:15 pm and reported feeling extremely dizzy and weak, to the point that getting up from her couch was extremely difficult. She reported having trouble seeing and her vision being distorted. Patient was advised to seek medical attention.
Sex: U
Vaccine: FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: Case number PHEH2014US018358 is an initial spontaneous report received from a physician on 11 Sep 2014. This case refers to an unknown age and gender patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported), on an unknown date. On an unknown date after vaccination, the patient experienced anaphylactic reaction. The outcome, seriousness and causality of the event were not reported.
Age: 16.0
Sex: M
Vaccine: FLU3, HPV4, MNQ
Symptoms: Injection site anaesthesia, Muscular weakness, Swelling
Clinical narrative: (R) arm injection site numbness. (-) weakness of arm. Had mild swelling improved now. Rest of the arm no numbness.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Pyrexia, Vaccination complication, Viral infection
Clinical narrative: Prolonged fever 7 days. ER x 2. Headache viral etiology vs vaccine rxn.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness at injection site, soreness at injection site radiating down arm.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Headache, Papule, Pyrexia
Clinical narrative: This spontaneous report as received from a physician refers to a 12 year old female patient. On 03-DEC-2003 the patient was vaccinated subcutaneously in the left arm with the first dose of VARIVAX (Merck) (lot # 647241/0894N, expiration date 19-AUG-2015, dose not reported). On 18-FEB-2009 the patient was vaccinated subcutaneously with the second dose of VARIVAX (Merck) (lot # 662146/1562X, expiration date 27-OCT-2010, dose not reported). On 24-AUG-2014 (also reported as "2 days ago") the patient developed papules and vesicles. It was reported that the patient had low grade fever and headache on 25-AUG-2014 (also reported as "yesterday"). It was also reported that 11 month old sibling tested positive for varicella PCR in an approximately August 2014 (also reported as "last week"). The outcomes of the events and relatedness between the events and VARIVAX (Merck) were not reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a male patient of unknown age. On an unknown date in September 2013 the patient was vaccinated with a dose of GARDASIL (route, dose and lot # not reported). The consumer reported that it had been almost a year since the first dose and lot # not reported). The consumer reported that it had been almost a year since the first dose of GARDASIL was given to her son and she wanted to know if her son could get the second GARDASIL dose going on a year later. Additional information is not expected as the consumer did not provide any contact information.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site erythema, Injection site pruritus, Injection site warmth, Pain
Clinical narrative: Body aches within 24 hours of vaccine administration for about 48 hours. Low grade fever and chills 72 hours after administration. site wram to touch, red, and itchy.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Body aches within 24 hours of vaccine administration for about 48 hours. Low grade fever and chills 72 hours after administration. site wram to touch, red, and itchy.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (Merck) (dose, frequency, route of administration and indication were not provided). No concomitants were reported. No adverse effects reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a physician refers to a 25 year old female patient. On an unknown date in August 1999, the patient was vaccinated with RECOMBIVAX HB, dose and route not reported. Concomitant therapies included amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, ADDERALL and CELEXA and unspecified birth control. On an unknown date in August 1999, the patient experienced hives. The outcome of hives was unknown. Follow up information received from physician who stated that, the physician did not have further information concerning the RECOMBIVAX HB the patient did when she was 10 years old. Causality was not reported. This case had been linked to 1409USA000559 as same patient link. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Significan swelling and erythema of the entire upper arm where vaccines were given.
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 29-AUG-20114 the patient was vaccinated with the second dose of VAQTA (injection strength: 25/0.5(units were not reported), 0.5 ml, lot # and expiry date were not reported). which was early as first dose of VAQTA was given on 09-MAY-2014. No symptom was reported. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Irritability
Clinical narrative: Infant had severe swelling of (R) thigh- Redness and swelling. Painful to touch. Extreme fussiness.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Local swelling, Pyrexia
Clinical narrative: Huge swelling in arm and shortness of breath x 3 days, and had fever.
Age: 1.59
Sex: F
Vaccine: FLU3, HEP
Symptoms: Irritability, Off label use
Clinical narrative: Hep B Adult dose given, not pediatric HB. Irritable during same day.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Activities of daily living impaired, Erythema, Local swelling, Myalgia, Pain
Clinical narrative: Achy on waking 9/3/14. Struggled to finish round of golf. Went home - slept 12 hours. Took ALEVE. 9/4: feeling little better (am). PM: came back and showed arm: red, raised reaction 2 inches x 4 inches upper left arm. Achy, muscle sore = continued ALEVE and BENADRYL gel.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling abnormal, Local swelling, Rash, Rash erythematous
Clinical narrative: Arm was red and swollen. Red rash on face also. Also got new med on same day making her very "loopy".
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: T 101.0-104.0 treated w/ TYLENOL and MOTRIN x 6 days. Redness/swelling/induration at site.
Age: 50.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Swelling, Urticaria
Clinical narrative: Swelling and redness in vaccine area. 8/21 - received vaccine. 8/22 - swelling and welting Kw/ redness. 8/23 Si/sx include dark.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site warmth, Pruritus
Clinical narrative: Patient started experiencing itching at night along with a "lump" and heat at the administration site. She came to me 2 days later with about a 4 inch by 9 inch area of redness on the patient's back side of her upper arm. The lump is where the administration was, not in the deltoid.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The injection site became swollen, red, and hot to the touch. Pt. saw primary care physician and was given antibiotic ointment.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Body temperature increased, Injection site erythema, Injection site movement impairment, Injection site swelling, Injection site warmth
Clinical narrative: His arm blew up swollen and was red hot for a week. His body temperature rose and he could not use his arm well.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Eye movement disorder, Vomiting
Clinical narrative: Dizziness, vomiting, involuntary rapid movement side to side in both eyes.
Age: 20.0
Sex: M
Vaccine: HPV4, MNQ, PPV
Symptoms: Headache, Leukocytosis, Local swelling, Pyrexia
Clinical narrative: Fever, leukocytes, headache 1 day after the vaccinations. Local swelling at the arm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Day after vaccine broke out in generalised red bumps all over body, non itchy, sparing palms and soles. No fever, no malaise.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Borrelia test, Computerised tomogram, Diplopia, VIth nerve paralysis
Clinical narrative: Nerve 6 palsy.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Headache, Insomnia
Clinical narrative: Patient experienced weakness, headache, and insomnia.
Age: 47.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Erythema, Injection site pruritus
Clinical narrative: Red area - Lt. arm itching Tdap vaccination.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Swelling face, Wheezing
Clinical narrative: Developed facial swelling and wheezing with itching after receiving MMR booster. Pt improved with albuterol, combivent, and antihistamine. Mild flares over subsequent days.
Age: 71.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Arthritis, Headache, Inflammation, Laboratory test normal, Musculoskeletal stiffness
Clinical narrative: Within 2 hrs of shots had stiffening of neck and then severe headache and continued to get more severe. Went to Dr. on 6th day. Had X-rays to show severe arthritis. Dr thinks shots triggered inflammation in neck and headache.
Age: 71.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: X-ray abnormal
Clinical narrative: Within 2 hrs of shots had stiffening of neck and then severe headache and continued to get more severe. Went to Dr. on 6th day. Had X-rays to show severe arthritis. Dr thinks shots triggered inflammation in neck and headache.
Age: 51.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Rash followed by swelling at site of shingles shot. Patient applied anti-itch cream and advised to apply cold compresses.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Somnolence
Clinical narrative: Patient described extreme sleepiness and fatigue for 2 days following administration of the vaccine.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Anxiety, Hyperhidrosis, Insomnia, Tremor
Clinical narrative: Pt is having sweating, shakey, unable to sleep and anxiety.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Agitation, Crying, Electrocardiogram normal, Full blood count normal, Lethargy
Clinical narrative: Within 1 hr after vaccine pt. became agitated, cried for a period, became lethargic, difficult to respond. Seen by EMS, but better. After brief normal period again became lethargic. Taken to ED, initially only response to painful stimuli, but slowing returned to normal level of activity and discharged him.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Liver function test normal, Metabolic function test, Unresponsive to stimuli, Urine analysis normal
Clinical narrative: Within 1 hr after vaccine pt. became agitated, cried for a period, became lethargic, difficult to respond. Seen by EMS, but better. After brief normal period again became lethargic. Taken to ED, initially only response to painful stimuli, but slowing returned to normal level of activity and discharged him.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash erythematous, Rash generalised, Rash maculo-papular
Clinical narrative: Within 30 minutes, pt had erythematous, maculopapilar rash to 75% of his body-face, chest, arms, legs, upper back. Pt. was given oral BENADRYL. Within 20 minutes, ras was greatly decreased. No other symptoms occurred.
Age: 53.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Chest X-ray, Computerised tomogram thorax, Hypoaesthesia, Hypoaesthesia oral, Laboratory test
Clinical narrative: Took tetanus shot on May 9th 2014. On June 8th 2014 half of my face was numb Rt side. Saw PCP, referred to neurologist; two MRI's done, trigeminals were enhanced. Two lumbar punctures, a CT of chest, chest X-ray, labs done. No medical diagnosis determined. Discharged by neurologist but mouth still numb.
Age: 53.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Took tetanus shot on May 9th 2014. On June 8th 2014 half of my face was numb Rt side. Saw PCP, referred to neurologist; two MRI's done, trigeminals were enhanced. Two lumbar punctures, a CT of chest, chest X-ray, labs done. No medical diagnosis determined. Discharged by neurologist but mouth still numb.
Age: 53.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia oral, Lumbar puncture, Nuclear magnetic resonance imaging abnormal, Trigeminal nerve disorder
Clinical narrative: Took tetanus shot on May 9th 2014. On June 8th 2014 half of my face was numb Rt side. Saw PCP, referred to neurologist; two MRI's done, trigeminals were enhanced. Two lumbar punctures, a CT of chest, chest X-ray, labs done. No medical diagnosis determined. Discharged by neurologist but mouth still numb.
Age: 53.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Chest X-ray, Computerised tomogram thorax, Hypoaesthesia, Hypoaesthesia oral, Laboratory test
Clinical narrative: Patient has been experiencing numbness in the mouth and has gone through extensive testing and specialist visits. MRI showed trigeminal nerve inflammation.
Age: 53.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Patient has been experiencing numbness in the mouth and has gone through extensive testing and specialist visits. MRI showed trigeminal nerve inflammation.
Age: 53.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia oral, Lumbar puncture, Nuclear magnetic resonance imaging abnormal, Trigeminal nerve disorder
Clinical narrative: Patient has been experiencing numbness in the mouth and has gone through extensive testing and specialist visits. MRI showed trigeminal nerve inflammation.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Laboratory test, Pyrexia, Vaccination complication
Clinical narrative: 1 1/2 hours after administration patient experienced chills and spiked > 102 degree fever. Patient went to hospital due to extensive health conditions to be cautious. Numerous tests ran on the patient. Per pt. CDC MD stated must have had reaction to egg protein in the vaccine despite having previous flu vaccinations.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Body temperature increased, Injected limb mobility decreased, Injection site bruising, Injection site erythema, Injection site induration
Clinical narrative: 8/19/14 3:30 pm Mother called in, states that patient lower (L) arm (where she received VARIVAX) is slightly swollen - size of a fifty cent piece, red and itchy. Advised to put ice on the arm and if symptoms increased to contact physician immediately. 8/26/14 Mother called in regarding patient. States after she spoke with me she called the doctor. He had patient take BENADRYL. As the day progressed however, the redness increased in size to the size of a pancake, became hard in the center, had a rash, c/o pain, itchiness and couldn't move her arm. She also had a slight temp of 100 degrees. She said she attempted to call the doctor but was unable to reach him so she took patient to the ER. She was put on prednisone twice qd, and told to take BENADRYL 25mg tid. At present mom states that the arm is now just slightly swollen, no pain and looks like a bruise. She is able to move the arm. Questioned mom if child had a neomycin allergy. She states she is allergic to NEOSPORIN herself - unsure about patient. HD will complete a VAERS form.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: 8/19/14 3:30 pm Mother called in, states that patient lower (L) arm (where she received VARIVAX) is slightly swollen - size of a fifty cent piece, red and itchy. Advised to put ice on the arm and if symptoms increased to contact physician immediately. 8/26/14 Mother called in regarding patient. States after she spoke with me she called the doctor. He had patient take BENADRYL. As the day progressed however, the redness increased in size to the size of a pancake, became hard in the center, had a rash, c/o pain, itchiness and couldn't move her arm. She also had a slight temp of 100 degrees. She said she attempted to call the doctor but was unable to reach him so she took patient to the ER. She was put on prednisone twice qd, and told to take BENADRYL 25mg tid. At present mom states that the arm is now just slightly swollen, no pain and looks like a bruise. She is able to move the arm. Questioned mom if child had a neomycin allergy. She states she is allergic to NEOSPORIN herself - unsure about patient. HD will complete a VAERS form.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Abdominal discomfort, Abnormal behaviour, Asthenia, Hyperhidrosis, Pallor
Clinical narrative: After a few minutes of waiting post vaccine administration. Mom reports that pt started perspiring so mom escorted her to the water fountain for a drink, but perspiring persisted so mom altered Pedi Reception staff who in turn notified me of pt's symptom. Mom and I escorted pt to triage room. Pt was pale, weak, damp all over from sweat, very quiet, however when asked how she felt said her stomach "feels funny". I lay pt supine on exam table. Vital signs stable. Pt drank about  half-cup of water; then another half-cup of water a while later. Damp cloth applied to forehead. PCP notified. She evaluated pt and after rpt confirmed she was feeling a little better and her skin color improved, head of bed raised a bit and BP rechecked - normal range. After another 5 minutes pt sat upright and BP rechecked - again in the normal range. Medically cleared by PCP and left with instruction to contact PCP office if any further concerns or questions.