chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Blindness, Blood pressure increased, Dyspnoea, Eye movement disorder, Heart rate increased
Clinical narrative: After administration, patient stood up, and started walking away. Got 3 steps away, told mom that he couldn't see.  Pharmacist immediately helped mom get patient over to bench.  Quickly patient's coloring turned pallor, breathing abruptly slowed.  Very shallow and difficulty breathing.  Eyes rolled back in head. Sweat through entire shirt. Pharmacist used EpiPen JR to right thigh (Lot number4GN349, Exp 12/15). Called 911. Over the next 10 min, breathing returned, vision returned, ability to talk returned. Paramedics came and walked next to patient and mom.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Hyperhidrosis, Hypopnoea, Pallor, Respiratory rate decreased
Clinical narrative: After administration, patient stood up, and started walking away. Got 3 steps away, told mom that he couldn't see.  Pharmacist immediately helped mom get patient over to bench.  Quickly patient's coloring turned pallor, breathing abruptly slowed.  Very shallow and difficulty breathing.  Eyes rolled back in head. Sweat through entire shirt. Pharmacist used EpiPen JR to right thigh (Lot number4GN349, Exp 12/15). Called 911. Over the next 10 min, breathing returned, vision returned, ability to talk returned. Paramedics came and walked next to patient and mom.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Asthma, Condition aggravated, Erythema, Inflammation, Injection site pruritus
Clinical narrative: ITCH AT INJECTION SITE. REDNESS. THEN HIVES. HIVES SPREAD ABOUT ACROSS ARM TO APPROX 4X5 PATCH. INCREASED INFLAMMATION & REDNESS ACCOMPANIED WITH TIGHTNESS AND L ARM PAIN OVER THE NEXT COUPLE HOURS. ASTHMATIC SYMPTOMS BEGAN, EG WHEEZING. REACHED OUT TO MD VIA EMAIL. THEN WENT TO ER WITHIN ANOTHER HOUR AT MD'S INSTRUCTIONS.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Skin tightness, Urticaria, Wheezing
Clinical narrative: ITCH AT INJECTION SITE. REDNESS. THEN HIVES. HIVES SPREAD ABOUT ACROSS ARM TO APPROX 4X5 PATCH. INCREASED INFLAMMATION & REDNESS ACCOMPANIED WITH TIGHTNESS AND L ARM PAIN OVER THE NEXT COUPLE HOURS. ASTHMATIC SYMPTOMS BEGAN, EG WHEEZING. REACHED OUT TO MD VIA EMAIL. THEN WENT TO ER WITHIN ANOTHER HOUR AT MD'S INSTRUCTIONS.
Age: 32.0
Sex: U
Vaccine: PPV
Symptoms: Disability, Mental retardation
Clinical narrative: This spontaneous report was received from a pharmacist via another company regarding a 32-year-old patient of unknown gender. Current conditions included patient was wheelchair user. Medical history was not reported. On an unknown date in 2009, the patient was vaccinated with PNEUMOVAX 23 (dosing details, route and indication unknown). No concomitant medications were reported. On an unknown date, the patient was reported to be handicapped (disability), suffered from mental retardation and was in a wheelchair. The pharmacist reported that the doctor wanted to administer PREVNAR 13 at the time of reporting (reported as now). The response received was that it was not indicated but recommended by the advisory committee for immunocompromised patients. The outcome of the events handicapped (disability) and mental retardation was unknown. The causality assessment for the events with regards to PNEUMOVAX 23 was unknown. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Hyperhidrosis, Malaise, Systemic lupus erythematosus, Vertigo
Clinical narrative: Received FLUZONE HD about 11 AM on 10/31/14 about 2 PM patient became very ill suddenly with diaphoresis, vomiting, diarrhea, and vertigo. Patient has lupus as well.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Received FLUZONE HD about 11 AM on 10/31/14 about 2 PM patient became very ill suddenly with diaphoresis, vomiting, diarrhea, and vertigo. Patient has lupus as well.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Patient reports she continues to have localized pain in left arm at administration site since receiving immunization on 10/3/14.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: Patient developed rash and itching on trunk of body and arms the day following immunization. She applied ice and took diphenhydramine by mouth. Symptoms had resolved by 11/9/14 (3 days after vaccination).
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Pyrexia, Rash generalised, Rash maculo-papular
Clinical narrative: Patient developed high fever 104.3 and diffuse fever 3 days after administration. Patient has no history of egg allergy. He previously received injection of flu vaccine. His rash extended over entire body, which spread rapidly after 3 days. Rash was maculopapular, and became confluent over trunk. Pruritic.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Hepatic enzyme increased
Clinical narrative: This spontaneous report was received from a 54 year old female (nurse) reporting on herself. No information about medical history, concurrent conditions was reported. On 23-OCT-2014 the patient was vaccinated with ZOSTAVAX (194000 plaque forming units (PFU) lot#, dose, frequency, route not reported). No concomitant medications were reported. On an unknown date in approximately 2014 the patient developed elevated liver enzymes that were 2-3 times the upper limit of normal after receiving ZOSTAVAX. On an unknown date in approximately 2014 a blood work was done. The patient sought medical attention. There was no product quality complaint. No intervention was done. The outcome of the event was reported as not recovered. The causality of the event was not specified by the reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 11 patients of unknown age and gender. On an unknown date the patient was vaccinated with M-M-R II (route, dose, lot number was unknown). On an unknown date 11 patients were inadvertently administered M-M-R which was improperly stored. No adverse effects reported. No product quality complaint was involved. The outcome of the events was unknown. This case is linked to MARRS# 1411USA003396 and 1411USA003397 with the same reporter link. Additional information is not expected.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to 11 patients of unknown age and gender. On an unknown date 11 patients were inadvertently vaccinated with PEDVAXHIB (dose, route and lot number was unknown) which had been improperly stored. No adverse effects were reported. The outcome of the events was unknown. This case is linked to MARRS # 1410USA007761 and 1411USA003396 with the same reporter link. Additional information is not expected.
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 11 patients of unknown age and gender. On an unknown date 11 patients were inadvertently vaccinated with GARDASIL (dose, lot number and route was unknown) which was improperly stored. No adverse effects were reported. The outcome of the events was unknown. This case is linked to MARRS# 1410USA007761 and 1411USA003397 with the same reporter link. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of unspecified patients (unknown age and gender). On unknown dates these patients received doses of PROQUAD (lot#, dose, route not reported) that were exposed to temperatures outside of the proper storage range. Concomitant medications were not provided. No adverse effect was reported. This is one of two reports received from the same reporter (other MARRS# 1411USA003487). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of unspecified patients (unknown age and gender). On unknown dates these patients received doses of VARIVAX (Merck) (lot#, dose, route not reported) that were exposed to temperatures outside of the proper storage range. Concomitant medications were not provided. No adverse effect was reported. This is one of two reports received from the same reporter (MARRS# 1411USA003420), Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 13 year old male patient. On 30-OCT-2014 the patient was vaccinated with second dose of VAQTA (lot# reported as 010AE, expiration date 24-OCT-2014) 0.5 ml, intramuscularly which was expired. The first dose of VAQTA was administered in August 2013. No adverse effects noted to patient. The patient did not seek medical attention. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old male patient with high blood pressure, high cholesterol, diabetes and no drug reactions/allergies. On 22-OCT-2014, the patient was vaccinated with ZOSTAVAX (lot # K009199, expiration date 27-SEP-2015), (dose and frequency not provided) subcutaneous. Concomitant therapies included metformin, hydrochlorothiazide (HCTZ) (manufacturer unknown), VICTOZA, CRESTOR, LEVEMIT and lisinopril (manufacturer unknown). On 23-OCT-2014, the patient developed soreness and redness at the ZOSTAVAX injection site. On 24-OCT-2014 the patient developed shingles on the head. On 24-OCT-2014, the patient started acyclovir (manufacturer unspecified) therapy. No lab diagnostics studies were performed. The patient went to see a physician. The patient was recovering. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. The register nurse reported that the patient was inadvertently administered PROQUAD and VARIVAX (Merck) concomitantly on 12-SEP-2014 (reported as today). No adverse effect reported. Additional information is not expected.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Grip strength decreased, Hypoaesthesia, Infection, Swelling
Clinical narrative: Swelling of edema in forehand. Patient indicated that his right hand is getting numb and he is not able to use his hand grab things and do his normal activities.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, heat, and some swelling around the injection site. Also reports of tenderness.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Nodule, Pain in extremity, Skin warm
Clinical narrative: The day after the shot, I had a palm-sized area with arm toward the inside, hot, red and very sore, also a hot quarter sized knot next to my underarm. Both very sore and hot. Began BENADRYL as per Rph on Friday afternoon. Both areas dissapated a small knot remained.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Malaise, Rash
Clinical narrative: Vaccine administered on 11/7/14 at 4:25 p. Patient stayed in store for 15 min, but not reaction. Went home and noticed rash on face around 7 pm that night, felt malaised, shortness of breath that continued through next two days. Treated with hydrocortisone cream and BENADRYL. Rash still present, but improved.
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Injection site cellulitis, Skin warm, Swelling
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. Approximately on 13-AUG-2014 the patient was vaccinated with PNEUMOVAX 23. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. On 13-AUG-2014, the patient experienced cellulitis after being vaccinated with PNEUMOVAX 23. The representative explained that the nurse made it seem as if the patient received the vaccine on 13-AUG-2014 and experienced the AE shortly afterwards on the same day, however this was not specifically confirmed during the call. The outcome of cellulitis was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. Approximately on 13-AUG-2014 the patient was vaccinated with PNEUMOVAX 23. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. On 13-AUG-2014, the patient experienced cellulitis after being vaccinated with PNEUMOVAX 23. The representative explained that the nurse made it seem as if the patient received the vaccine on 13-AUG-2014 and experienced the AE shortly afterwards on the same day, however this was not specifically confirmed during the call. The outcome of cellulitis was unknown. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased
Clinical narrative: Unable to move left arm in any direction greater than 20 degrees - 30 degrees. Significant pain in any direction. Need to manually lift arm greater than 20 degrees - 30 degrees. No fever, swelling, warmth at site; bruising at site, initially. Now (10/17) light bruising and warmth below injection site and laterally on deltoid. Saw orthopedic MD. Rx for MOBIC qd, PT 2x/wk x 4-6 wk. 1 mo. follow up.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site bruising, Injection site swelling, Injection site warmth
Clinical narrative: Unable to move left arm in any direction greater than 20 degrees - 30 degrees. Significant pain in any direction. Need to manually lift arm greater than 20 degrees - 30 degrees. No fever, swelling, warmth at site; bruising at site, initially. Now (10/17) light bruising and warmth below injection site and laterally on deltoid. Saw orthopedic MD. Rx for MOBIC qd, PT 2x/wk x 4-6 wk. 1 mo. follow up.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Unable to move left arm in any direction greater than 20 degrees - 30 degrees. Significant pain in any direction. Need to manually lift arm greater than 20 degrees - 30 degrees. No fever, swelling, warmth at site; bruising at site, initially. Now (10/17) light bruising and warmth below injection site and laterally on deltoid. Saw orthopedic MD. Rx for MOBIC qd, PT 2x/wk x 4-6 wk. 1 mo. follow up.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Ear pain, Influenza like illness, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Very sore arm w/hives on lg. area at site of shot. Hot shot in evening and next day had symptoms of: fatigue, headache, chills, extreme body aches and earache. Lasted 48 hrs. but sore arm for (1) week.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Chills, Ear pain, Fatigue, Headache, Injection site urticaria
Clinical narrative: Very sore arm w/hives on lg. area at site of shot. Hot shot in evening and next day had symptoms of: fatigue, headache, chills, extreme body aches and earache. Lasted 48 hrs. but sore arm for (1) week.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: Very sore arm w/hives on lg. area at site of shot. Hot shot in evening and next day had symptoms of: fatigue, headache, chills, extreme body aches and earache. Lasted 48 hrs. but sore arm for (1) week.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Back pain, Musculoskeletal pain, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: Muscle ache, joint ache radiating from shoulder to neck and lower back.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Back pain, Myalgia, Neck pain
Clinical narrative: Muscle ache, joint ache radiating from shoulder to neck and lower back.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lupus-like syndrome
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route of administration and lot # were not reported). On an unknown date the patient experienced lupus like symptoms. The pharmacist did not provide any further clarification about the symptoms. She sought unspecified medical attention on unknown date. The patient had not been diagnosed with Lupus at the time of the report. The outcome of the event was reported as recovered/resolved on unknown date. Upon internal review the event of experienced lupus like symptoms was determined to be medically significant. Follow up information has been received via telephone call on 05-NOV-2014 from pharmacist. The pharmacist stated that currently 59 years old female patient was asking if ZOSTAVAX and markers of lupus were related or if it was just coincidental. The patient told the pharmacist that her physician stated that she had markers of lupus, not diagnostic, and the patients Antinuclear antibody (ANA) was elevated. The pharmacist also stated that the patient was still experiencing symptoms to date (previously reported as recovered by the same pharmacist in the previous version). This case has been downgraded, since the events was changed from Systemic lupus erythematosus to Lupus-like syndrome that was not considered as a medical significant event. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Antinuclear antibody increased, Lupus-like syndrome
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route of administration and lot # were not reported). On an unknown date the patient experienced lupus like symptoms. The pharmacist did not provide any further clarification about the symptoms. She sought unspecified medical attention on unknown date. The patient had not been diagnosed with Lupus at the time of the report. The outcome of the event was reported as recovered/resolved on unknown date. Upon internal review the event of experienced lupus like symptoms was determined to be medically significant. Follow up information has been received via telephone call on 05-NOV-2014 from pharmacist. The pharmacist stated that currently 59 years old female patient was asking if ZOSTAVAX and markers of lupus were related or if it was just coincidental. The patient told the pharmacist that her physician stated that she had markers of lupus, not diagnostic, and the patients Antinuclear antibody (ANA) was elevated. The pharmacist also stated that the patient was still experiencing symptoms to date (previously reported as recovered by the same pharmacist in the previous version). This case has been downgraded, since the events was changed from Systemic lupus erythematosus to Lupus-like syndrome that was not considered as a medical significant event. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Facial pain, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Severe pain, redness and swelling of my upper arm that spread through out the night down my arm, into my hand, up into my left shoulder, neck and into my face.  I took 3 Benadryl and ibuprofen.  My doctor told me to stay home, not be alone, use my Epi-Pen if needed and to continue monitoring the situation.  Even today, Sunday, my upper left arm is still tender to the touch.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Neck pain, Pain in extremity, Peripheral swelling, Swelling face
Clinical narrative: Severe pain, redness and swelling of my upper arm that spread through out the night down my arm, into my hand, up into my left shoulder, neck and into my face.  I took 3 Benadryl and ibuprofen.  My doctor told me to stay home, not be alone, use my Epi-Pen if needed and to continue monitoring the situation.  Even today, Sunday, my upper left arm is still tender to the touch.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Severe pain, redness and swelling of my upper arm that spread through out the night down my arm, into my hand, up into my left shoulder, neck and into my face.  I took 3 Benadryl and ibuprofen.  My doctor told me to stay home, not be alone, use my Epi-Pen if needed and to continue monitoring the situation.  Even today, Sunday, my upper left arm is still tender to the touch.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Shoulder pain where injected with motion limitation.  Hopefully it will go away. May seek doctor if it does not go away.
Age: 36.0
Sex: F
Vaccine: TYP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Confirmation of unplanned pregnancy once month following administration of Vivotif.  She reportedly dosed the Vivotif during the week of conception.  No adverse effects noted to date.  No pregnancy complications to date.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Gait disturbance, Heart rate increased, Insomnia, Middle insomnia
Clinical narrative: Rapid pulse of 100; weakness in legs, trouble walking; up 3x during night to urinate; trouble sleeping; mind foggy next morning.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Muscular weakness, Nocturia
Clinical narrative: Rapid pulse of 100; weakness in legs, trouble walking; up 3x during night to urinate; trouble sleeping; mind foggy next morning.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Circular redness around injection site, continued to grow large for 7 days.  Patient returned to clinic for observation.  Reddened area now 6X9 CM.  Not hot to touch.  Patient says it itches.  Pt instructed to apply cortizone cream to site and follow up on Monday 11/10/14.  Call PT today, she states redness around injection site is almost gone.  Much relief with cortizone cream.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Full blood count normal, Headache, Laboratory test normal, Lumbar puncture normal
Clinical narrative: SEVERE HEADACHE, VERTIGO, NAUSEA.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Nuclear magnetic resonance imaging normal, Vertigo
Clinical narrative: SEVERE HEADACHE, VERTIGO, NAUSEA.
Age: 34.0
Sex: M
Vaccine: MMR
Symptoms: Blindness, Disorientation, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Caused black out of vision and immediate loss of consciousness followed by disorientation upon waking.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling
Clinical narrative: Red swollen arm and red feet.
Age: 37.0
Sex: F
Vaccine: FLUC3
Symptoms: Hypoaesthesia, Movement disorder, Rotator cuff syndrome, Sleep disorder, Weight bearing difficulty
Clinical narrative: Experiencing severe pain in upper rotator cuff area and shoulder. Pain radiating down arm and creating numbness in arm and hand. Unable to move arm in certain directions or bear any weight. Unable to sleep through the night because of pain and no comfortable position. Was seen in Urgent Care and told to try heat, ice, 600-800mg Ibuprofen, Hydrocodone for pain control, none of which is helping. Schedule to seen pain management specialist on 11/11/14.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Blood creatine phosphokinase MB, Chest X-ray, Convulsion, Full blood count, Influenza virus test
Clinical narrative: Fever 104, seizure >10min, Respiratory Distress. O2 SATS in 70's.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Laboratory test, Metabolic function test, Pyrexia, Respiratory distress, Streptococcus test
Clinical narrative: Fever 104, seizure >10min, Respiratory Distress. O2 SATS in 70's.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Urine analysis
Clinical narrative: Fever 104, seizure >10min, Respiratory Distress. O2 SATS in 70's.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Culture, Full blood count, Injection site erythema, Injection site induration
Clinical narrative: Redness that grew in size rapidly, hot, and hard to touch from shoulder to elbow. Went to ER was diagnosised with cellulitis and treated with IV antibiotics and went home with oral antibiotics.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site warmth
Clinical narrative: Redness that grew in size rapidly, hot, and hard to touch from shoulder to elbow. Went to ER was diagnosised with cellulitis and treated with IV antibiotics and went home with oral antibiotics.
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot# were not reported). The reporter reported patient developed chickenpox after receiving ZOSTAVAX. The patient "was in the (unspecified) hospital in January (2014) and she had developed chickenpox." The pharmacist did not clarify when the patient received the dose of ZOSTAVAX or why the patient was in the hospital. She states that the patient's medical record states that the "chickenpox was from the vaccine." The pharmacist did not know if any tests were performed to confirm whether or not the causative agent was from ZOSTAVAX or another type. She indicated that the patient had since recovered from her chickenpox.
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Facial pain, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Initial report received from a healthcare professional (pharmacist) on 31 October 2014. A 75-year-old female patient, with no reported past medical history and no known allergies, received on 22 September 2014 a left deltoid injection of FLUZONE HD (lot number U5017BA). The day of vaccination, she experienced an aching pain in her left arm which has since that time moved to the left side of her face. She reported that she was unable to move or use the arm at all. She had been seen in the emergency room, in an urgent care facility, by her family physician and by a specialist. She did not provide the reporter with any additional details about diagnostic testing or treatment. She did not receive prior dose of FLUZONE HD. At the time of the report, the events were ongoing. Documents held by sender: None.
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Facial pain, Hypoaesthesia, Pain in extremity
Clinical narrative: Initial report received from a healthcare professional (pharmacist) on 31 October 2014. A 75-year-old female patient, with no reported past medical history and no known allergies, received on 22 September 2014 a left deltoid injection of FLUZONE HD (lot number U5017BA). The day of vaccination, she experienced an aching pain in her left arm which has since that time moved to the left side of her face. She reported that she was unable to move or use the arm at all. She had been seen in the emergency room, in an urgent care facility, by her family physician and by a specialist. She did not provide the reporter with any additional details about diagnostic testing or treatment. She did not receive prior dose of FLUZONE HD. At the time of the report, the events were ongoing. Documents held by sender: None.
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Facial pain, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Left arm is aching and left side of face is numb/hurting. Seen multiple physicians with no diagnosis.
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Facial pain, Hypoaesthesia, Pain in extremity
Clinical narrative: Left arm is aching and left side of face is numb/hurting. Seen multiple physicians with no diagnosis.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Dysphonia, Dyspnoea, Injection site pain
Clinical narrative: Started sore throat and very hoarse within about 20 minutes after injection.  By the following morning I had shortness of breath upon walking to bathroom, soreness at injection site, paleness, weakness, and a feeling of light headedness. Since the symptoms were fairly severe I called my provider clinic and they advised that I was probably having some type of reaction to the vaccine and to rest take ibuprofen drink fluids and to go to the ER if my breathing worsened or my throat felt like it was going to close up. My symptoms lasted from Thursday PM 11/06/2014 until Sunday AM 11/09/2014.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Oropharyngeal pain, Pallor, Vaccination complication
Clinical narrative: Started sore throat and very hoarse within about 20 minutes after injection.  By the following morning I had shortness of breath upon walking to bathroom, soreness at injection site, paleness, weakness, and a feeling of light headedness. Since the symptoms were fairly severe I called my provider clinic and they advised that I was probably having some type of reaction to the vaccine and to rest take ibuprofen drink fluids and to go to the ER if my breathing worsened or my throat felt like it was going to close up. My symptoms lasted from Thursday PM 11/06/2014 until Sunday AM 11/09/2014.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chills, Diarrhoea, Feeling cold, Headache
Clinical narrative: Extremely cold, headache, nausea and vomiting, diarrhea, weakness all through the night, took temp several times was in 96 range, chills, called Urgent Care but did not seek treatment, symptoms continued to Monday and then felt weakness and had loose stools for a week ending 11/10/14.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Vomiting
Clinical narrative: Extremely cold, headache, nausea and vomiting, diarrhea, weakness all through the night, took temp several times was in 96 range, chills, called Urgent Care but did not seek treatment, symptoms continued to Monday and then felt weakness and had loose stools for a week ending 11/10/14.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Headache, Nausea, Pain
Clinical narrative: Fever, chills, headache, body aches, weakness, nausea. Took Nyquil, Ibuprofen. Did not help. Illness lasted through the 7th & into the 8th. Felt much better 1st part of the 8th. Then bad headache again. Still have headache and today is 11/10/2014.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Fever, chills, headache, body aches, weakness, nausea. Took Nyquil, Ibuprofen. Did not help. Illness lasted through the 7th & into the 8th. Felt much better 1st part of the 8th. Then bad headache again. Still have headache and today is 11/10/2014.
Age: 16.0
Sex: M
Vaccine: FLUN4, HPV4, MNQ
Symptoms: Balance disorder, Blood chloride decreased, CSF glucose normal, CSF protein increased, CSF white blood cell count negative
Clinical narrative: Numbness of toes on 10/28/14, on 11/03/2014, weakness of legs and arms, 11/04/2014, balance and coordination off and tingling of finger tips and jaw pain.
Age: 16.0
Sex: M
Vaccine: FLUN4, HPV4, MNQ
Symptoms: Computerised tomogram head normal, Coordination abnormal, Hypoaesthesia, Muscular weakness, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Numbness of toes on 10/28/14, on 11/03/2014, weakness of legs and arms, 11/04/2014, balance and coordination off and tingling of finger tips and jaw pain.
Age: 16.0
Sex: M
Vaccine: FLUN4, HPV4, MNQ
Symptoms: Pain in jaw, Paraesthesia, Red blood cells CSF positive
Clinical narrative: Numbness of toes on 10/28/14, on 11/03/2014, weakness of legs and arms, 11/04/2014, balance and coordination off and tingling of finger tips and jaw pain.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Patient briefly fainted (while seated) a few minutes after receiving vaccine. Patient immediately recovered and stated he was fine. He responded well to all questions and was coherent.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Welts around waistband of pants and on backs of both arms. They were itchy, raised, but not red. Applied spray his wife had used for shingles (helps itching). Lasted a couple of hours. Went away and came back the next day on legs and back. Resolved and returned again this morning.
Age: 74.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Eye swelling, Oropharyngeal pain, Pharyngeal oedema, Sinusitis
Clinical narrative: Swelling of eyes, face, throat, sore throat, cough, swollen sinus.  Took Benadryl, next day needed ER.
Age: 74.0
Sex: F
Vaccine: FLUX
Symptoms: Swelling face
Clinical narrative: Swelling of eyes, face, throat, sore throat, cough, swollen sinus.  Took Benadryl, next day needed ER.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Extreme chills for first couple of hours, body aches, headache, and after I went to bed, high fever of 101.3 until the fever broke.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Cerebellar ataxia, Electroencephalogram, Lumbar puncture, Nuclear magnetic resonance imaging brain
Clinical narrative: Cerebellum ataxia. Paroxysmal spells. Physical therapy.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Seizure like phenomena
Clinical narrative: Cerebellum ataxia. Paroxysmal spells. Physical therapy.
Age: 0.35
Sex: F
Vaccine: DTAP, HIBV, RV5
Symptoms: Enema administration, Haematochezia, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Patient received second dose of ROTATEQ on 11/4/14 at primary care MD office. Presented to Hospital on 11/8/14 with bloody stool and was transferred to another Hospital on 11/9/14. Intussusception was confirmed on sonogram and patient underwent air enema x 2.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea
Clinical narrative: Approximately 30-45 minutes after receiving Flu vaccine patient began to experience difficulty breathing. Patient taken by EMS to emergency room. Received epinephrine in squad and received epinephrine and steroids in emergency room.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Blood culture negative, C-reactive protein normal, Chest X-ray normal, Culture urine negative, Decreased appetite
Clinical narrative: Initial report was received on 07 October 2014 from a health care professional. A two month-old patient (date of birth not reported) had received PENTACEL (lot number, route, site and date of administration not reported) and later that evening, developed a fever of approximately 103 degrees. The patient was taken to the ER (emergency room) and was admitted. No further information was available at the time of the report. Outcome was not reported. Follow-up information was received from a health care professional on 03 November 2014. The patient was a 2-month old male infant, with no relevant medical history. The patient did not experience adverse events following vaccination in the past. He received an intramuscular right thigh injection of PENTACEL (lot number C4540AA) on 01 October 2014 and one day post-vaccination, on 02 October 2014, presented to the emergency room with a fever. No vomiting, diarrhea, cough, or rash was noted; the patient's sibling, however, was ill and was noted to have mouth sores. The patient was admitted to the pediatric unit to rule out sepsis, and underwent testing including complete blood count, c-reactive protein, blood cultures, urine cultures, urinalysis, and chest x-ray; all results were normal. The fever continued on 03 October 2014 (102.6 degrees), and the patient was fussy but consolable, with improving appetite. On 04 October 2014 he was afebrile, and was discharged home with instructions to follow-up with his physician in two days. The final diagnosis was fever post-vaccination, possible viral syndrome. The events recovered on an unspecified date. Documents held by sender: Physician notes from hospital.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Full blood count normal, Irritability, Pyrexia, Stomatitis, Urine analysis normal
Clinical narrative: Initial report was received on 07 October 2014 from a health care professional. A two month-old patient (date of birth not reported) had received PENTACEL (lot number, route, site and date of administration not reported) and later that evening, developed a fever of approximately 103 degrees. The patient was taken to the ER (emergency room) and was admitted. No further information was available at the time of the report. Outcome was not reported. Follow-up information was received from a health care professional on 03 November 2014. The patient was a 2-month old male infant, with no relevant medical history. The patient did not experience adverse events following vaccination in the past. He received an intramuscular right thigh injection of PENTACEL (lot number C4540AA) on 01 October 2014 and one day post-vaccination, on 02 October 2014, presented to the emergency room with a fever. No vomiting, diarrhea, cough, or rash was noted; the patient's sibling, however, was ill and was noted to have mouth sores. The patient was admitted to the pediatric unit to rule out sepsis, and underwent testing including complete blood count, c-reactive protein, blood cultures, urine cultures, urinalysis, and chest x-ray; all results were normal. The fever continued on 03 October 2014 (102.6 degrees), and the patient was fussy but consolable, with improving appetite. On 04 October 2014 he was afebrile, and was discharged home with instructions to follow-up with his physician in two days. The final diagnosis was fever post-vaccination, possible viral syndrome. The events recovered on an unspecified date. Documents held by sender: Physician notes from hospital.
Age: 9.0
Sex: F
Vaccine: FLUX
Symptoms: Acute disseminated encephalomyelitis, Aphasia, Bedridden, Movement disorder, Paralysis
Clinical narrative: Initial case received on 02 November 2014 from a consumer who is the parent, via a news source on the internet. The following is verbatim from the report: "A woman says her daughter became paralyzed after getting a routine flu shot. (The mother) says her child was happy and healthy until getting the flu shot just before the Thanksgiving Day holiday last year. Three days later, however, her daughter could not move or talk, (the mother) said. The child is now a bedridden 10-year-old diagnosed with a rare viral infection of the brain called Acute Disseminated Encephalomyelitis, or ADEM. (The mother) believed what happened is directly tied to the flu shot. "The doctors won't confirm it or deny it," the mother told the news source Sunday. "Her father and I are certain, due to all of our research, that this was what caused (the patient's) condition. She was a happy, healthy, running and playing 9-year-old then this happened." (The mother) added: "There was no underlying condition. I mean so many tests at the hospital to try and find something else that could have caused it and they could not find anything." Patient's father has to carry her to get around. "It can just appear out of the blue or after maybe a surgical procedure," (A physician) told the news media. (The physician) is a physician at a hospital where he is director of infectious diseases. He told the station Friday a flu shot can cause the illness, but he does not recommend not getting the flu shot. "If I get the flu I'm more likely to get ADEM than from the flu vaccine," (The physician) said, adding that recovery is possible. (The mother) said parents need to educate themselves about the flu vaccine. "Be informed and make an informed decision with you doctor's guidance," she said. The patient outcome is unknown. Documents held by sender: None.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Injected limb mobility decreased, Pain, Periarthritis, X-ray
Clinical narrative: Pain at time of injection, which increased over time. It became so bad, I could not move shoulder. I went to my Dr. 5 wks after injection because pain was not getting better.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature, Pain
Clinical narrative: PATIENT CALLED OUR OFFICE RECEIVED VACCINE ON 11-6-2014, PNEUMONIA 23 HAS DEVELOPED A TEMPERATURE AND BODY ACHES. ADVISED FOLLOW UP WITH PCP FOR FURTHER INSTRUCTIONS, PATIENT WILL TAKE TYLENOL AND OBSERVE AND CONTACT URGENT CARE IF NEEDED.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Awoke with severe chills, low grade fever (100.1), muscle aches and headache at 1:00 AM. Took two Tylenol every 4-6 hours for the following 10 hours. Symptoms did not disappear until 11/09/2014.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Heart rate increased, Hypoaesthesia, Muscular weakness, Nausea
Clinical narrative: Nausea, limb weakness, ringing in ears, facial numbness, chills, rapid heart beat.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Tinnitus
Clinical narrative: Nausea, limb weakness, ringing in ears, facial numbness, chills, rapid heart beat.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Campylobacter test positive, Diarrhoea, Hyperhidrosis, Lymphadenitis
Clinical narrative: Patient received the Flu vaccine on 9/27/14. On 9/30/14 he developed a fever (101.3) and N w/o V, diarrhea, diaphoresis and abd. cramping. By Thursday, temp increased to 102.8. On 10/3/14 he was admitted to the Hospital until 10/6/14. Thought to be related to Flu vaccine due to egg connection.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Pyrexia
Clinical narrative: Patient received the Flu vaccine on 9/27/14. On 9/30/14 he developed a fever (101.3) and N w/o V, diarrhea, diaphoresis and abd. cramping. By Thursday, temp increased to 102.8. On 10/3/14 he was admitted to the Hospital until 10/6/14. Thought to be related to Flu vaccine due to egg connection.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Anxiety, Central auditory processing disorder, Decreased eye contact, Diarrhoea, Disturbance in attention
Clinical narrative: Loss of eye contact, social withdrawal, jerking of the body, repetitive movements, restlessness, hyperactivity, unable to concentrate, auditory processing issues, sensory dysfunction, high anxiety, loose stool/bowel disturbances.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Dyskinesia, Functional gastrointestinal disorder, Psychomotor hyperactivity, Restlessness, Sensory disturbance
Clinical narrative: Loss of eye contact, social withdrawal, jerking of the body, repetitive movements, restlessness, hyperactivity, unable to concentrate, auditory processing issues, sensory dysfunction, high anxiety, loose stool/bowel disturbances.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Social avoidant behaviour, Stereotypy
Clinical narrative: Loss of eye contact, social withdrawal, jerking of the body, repetitive movements, restlessness, hyperactivity, unable to concentrate, auditory processing issues, sensory dysfunction, high anxiety, loose stool/bowel disturbances.
Sex: M
Vaccine: MMR
Symptoms: Catatonia, Convulsion, Vomiting
Clinical narrative: This spontaneous unconfirmed report refers to a male patient, currently 24 years old, with autism. On an unknown date the patient was vaccinated with M-M-R II (therapy type, route of administration, lot number and expiration date were not reported). On an unknown date (reported as "eight months before he was given the M-M-R II") the patient experienced convulsions, rolling on the floor, freezing in a catatonic state and vomiting. It was reported that the patient's mother embarked upon an odyssey of often costly remedies and responses, ranging from wrapping electrical equipment in the patient's room with tin foil, through cranial osteopathy, reflexology, oxygen chamber sessions for six hours at a time and dosing him with handfuls of pills. The range of biomedical interventions being supplied to the patient included a probiotic, six vitamin supplements, four mineral supplements, five trace elements, fatty acids, amino acids, enzymes and a range of homeopathic remedies. The outcome of convulsions, rolling on the floor, vomiting and freezing in a catatonic state was not reported. The relatedness between the adverse events and M-M-R II was not reported. Additional information is not expected, because no contact information has been provided. This is one of several reports from the same source.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 48 year old female patient. The patient had no pertinent medical history or drug allergies/reactions. On 29-OCT-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (injection, lot# K007262, expiry date unspecified, dose and route were not provided) in the arm. Concomitant medications were not provided. "The next day", on 30-OCT-2014, the patient experienced fever, nausea, vomiting, soreness and swelling at the injection site. The pharmacist reported that "3 days after" administration, on 01-NOV-2014, the injection arm "got red hot to the touch" and was very inflamed therefore the patient was taken to a hospital and admitted due to myositis of the injection arm and leukocytosis (unspecified white blood cell count (WBC) levels, onset date unspecified, in approximately 2014). The pharmacist reported that the patient was treated with an unspecified intravenous (I. V.) antibiotic and was released on an unspecified date (in approximately November 2014). The pharmacist required lot check for PNEUMOVAX 23 (lot# K007262, expiry date unspecified) to determine if myositis had occurred with other patients who had received doses from this lot#. The outcome of the events was reported as recovering. The reporter considered the events to be significant disability or incapacity. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Leukocytosis, Myositis, Nausea, Pyrexia, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 48 year old female patient. The patient had no pertinent medical history or drug allergies/reactions. On 29-OCT-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (injection, lot# K007262, expiry date unspecified, dose and route were not provided) in the arm. Concomitant medications were not provided. "The next day", on 30-OCT-2014, the patient experienced fever, nausea, vomiting, soreness and swelling at the injection site. The pharmacist reported that "3 days after" administration, on 01-NOV-2014, the injection arm "got red hot to the touch" and was very inflamed therefore the patient was taken to a hospital and admitted due to myositis of the injection arm and leukocytosis (unspecified white blood cell count (WBC) levels, onset date unspecified, in approximately 2014). The pharmacist reported that the patient was treated with an unspecified intravenous (I. V.) antibiotic and was released on an unspecified date (in approximately November 2014). The pharmacist required lot check for PNEUMOVAX 23 (lot# K007262, expiry date unspecified) to determine if myositis had occurred with other patients who had received doses from this lot#. The outcome of the events was reported as recovering. The reporter considered the events to be significant disability or incapacity. Additional information has been requested.