chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: FLU3, HEPA, HPV4, TDAP
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Tactile fever with swelling and redness at injection site.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: PATIENT PRESENTED WITH A WARM, RED 4 INCH DIAMETER RED SPOT. REFERRED PATIENT TO HER PHYSICIAN WHO PRESCRIBED ANTIBIOTICS.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Atonic seizures, Blood test normal, Computerised tomogram head normal, Convulsion, Electroencephalogram abnormal
Clinical narrative: On the way out of the doctor's office the patient had an unprovoked fall in the lobby of the office (did not trip), followed by 2 more unprovoked falls at home later that night. The next day had a generalized afebrile seizure and was seen at our Urgent Care office. Remained well there and had a normal exam. Released, and later that night had another generalized seizure at home. Was then brought to ED and admitted for a full evaluation. CT and MRI of head normal. Bloodwork normal. EEG very abnormal. Had a few more seizures at the hospital. Diagnosed to have grand mal and atonic seizures. Was started on Keppra which controlled seizures successfully, and discharged home with Neurology follow up.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Grand mal convulsion, Nuclear magnetic resonance imaging brain normal
Clinical narrative: On the way out of the doctor's office the patient had an unprovoked fall in the lobby of the office (did not trip), followed by 2 more unprovoked falls at home later that night. The next day had a generalized afebrile seizure and was seen at our Urgent Care office. Remained well there and had a normal exam. Released, and later that night had another generalized seizure at home. Was then brought to ED and admitted for a full evaluation. CT and MRI of head normal. Bloodwork normal. EEG very abnormal. Had a few more seizures at the hospital. Diagnosed to have grand mal and atonic seizures. Was started on Keppra which controlled seizures successfully, and discharged home with Neurology follow up.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Increased pain at injection site Friday night but full onset only discovered 10/13 in the am.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Blew up & fire engine read from site to elbow & around.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood pressure increased, Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Began to have slight redness at injection site the evening of the injection.  By the next morning stated it was red, swollen and warm.  Pt. went to class and showed nursing instructor who circled the area. At the end of the day the area had doubled.  Pt went to the ER that evening.  She stated her BP was elevated and was running a fever. The Doctor measured the site at 7.5cm x 10.5 cm.  They placed her on Bactrim and told her it was a cellulitis. Since then, now some 15 hours later, patient states it has doubled in size again, and remains warm to the touch and painful.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Began to have slight redness at injection site the evening of the injection.  By the next morning stated it was red, swollen and warm.  Pt. went to class and showed nursing instructor who circled the area. At the end of the day the area had doubled.  Pt went to the ER that evening.  She stated her BP was elevated and was running a fever. The Doctor measured the site at 7.5cm x 10.5 cm.  They placed her on Bactrim and told her it was a cellulitis. Since then, now some 15 hours later, patient states it has doubled in size again, and remains warm to the touch and painful.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Fatigue, Headache, Nausea, Pain
Clinical narrative: Difficulty breathing, soreness, nausea, headache, fever, and fatigue.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Difficulty breathing, soreness, nausea, headache, fever, and fatigue.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Bursa injury, Drug administered at inappropriate site, Tendon rupture, X-ray
Clinical narrative: Flu shot given in shoulder joint. Ruptured bursa and probably tendons. Required physical therapy and appt. upcoming with orthopedic surgeon.
Age: 37.0
Sex: F
Vaccine: FLUC3
Symptoms: Throat tightness
Clinical narrative: Pt started feeling tightening in throat after getting flu shot (FLUCELVAX) 5-10 min asked pt if she felt she needed epinephrine she said not. Requested she stay longer for observation. Started feeling worse gave epinephrine 0.3 mg called 911. Paramedics took her to hospital. Pt was released after couple of hours.
Age: 28.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient reported intense pain in muscle surrounding right arm injection site. Pain was getting worse overnight, she had difficulty raising arm above chest level, and might not be able to go to work. FLUVIRIN given in other arm but that arm was fine. PNEUMOVAX arm was the problem.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Pt has received flu shots annually for years. This year's shot, FLUVIRIN, hurt much more and she had tingling and numbness down the arm that received the shot - left deltoid.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood calcium normal, Blood creatinine normal, Blood culture positive, Blood glucose increased, Blood potassium normal
Clinical narrative: 10/12/13: 2200h: screaming with discomfort. 10/13/13: 0230h: 100.9 degree F fever. 0830h: increased BG (135), decreased BP (96/40), increased HR (110-115 BPM), pallor, given TYLENOL 650mg by mouth (daily med four times daily), temperature 102 degrees F on arrival at hospital with raised site on left deltoid that was red and warm to touch, 8-10 cm in total area and positive induration. Hospital diagnosis - 16:05 (10/13/13) - SIRS.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood pressure decreased, Blood sodium normal, Blood urea increased, Discomfort, Heart rate increased
Clinical narrative: 10/12/13: 2200h: screaming with discomfort. 10/13/13: 0230h: 100.9 degree F fever. 0830h: increased BG (135), decreased BP (96/40), increased HR (110-115 BPM), pallor, given TYLENOL 650mg by mouth (daily med four times daily), temperature 102 degrees F on arrival at hospital with raised site on left deltoid that was red and warm to touch, 8-10 cm in total area and positive induration. Hospital diagnosis - 16:05 (10/13/13) - SIRS.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pallor
Clinical narrative: 10/12/13: 2200h: screaming with discomfort. 10/13/13: 0230h: 100.9 degree F fever. 0830h: increased BG (135), decreased BP (96/40), increased HR (110-115 BPM), pallor, given TYLENOL 650mg by mouth (daily med four times daily), temperature 102 degrees F on arrival at hospital with raised site on left deltoid that was red and warm to touch, 8-10 cm in total area and positive induration. Hospital diagnosis - 16:05 (10/13/13) - SIRS.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Screaming, Staphylococcus test positive, Systemic inflammatory response syndrome, White blood cell count increased
Clinical narrative: 10/12/13: 2200h: screaming with discomfort. 10/13/13: 0230h: 100.9 degree F fever. 0830h: increased BG (135), decreased BP (96/40), increased HR (110-115 BPM), pallor, given TYLENOL 650mg by mouth (daily med four times daily), temperature 102 degrees F on arrival at hospital with raised site on left deltoid that was red and warm to touch, 8-10 cm in total area and positive induration. Hospital diagnosis - 16:05 (10/13/13) - SIRS.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient experienced hives the day after getting flu shot.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Dizziness, Headache, Myalgia, Nausea
Clinical narrative: This spontaneous report was received from an approximately 78 year old male patient regarding himself. There were no pertinent medical histories and no drug reactions or allergies. On 27-AUG-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). Concomitant therapies included metoprolol, hydrochlorothiazide, alendronate sodium / cholecalciferol tablets (reported as alendronate) and aspirin. On an unknown date in September 2013 (reported as first week of September), the patient experienced lightheadedness, nausea and headache after the vaccination. The patient was also experiencing muscle ache and joint pain. The patient sought medical attention (called doctor). No lab tests were performed. The treating physician prescribed methylprednisolone. The patient stated that he was prescribed 4 milligrams (mg) oral tablets taken as a dose pack over the course of 5 days. The patient then stated that this medication was manufactured by other company. The patient was refusing to administer this medication due to the adverse events that were reported in the product information (PI) of this specific medication. Approximately on an unknown date in 2013, the patient recovered from lightheadedness, headache and nausea as the symptoms went away. The patient improved slowly from muscle ache and joint pain (also reported as not recovered). The patient enquired about how long his joint/muscle pain side-effect from ZOSTAVAX would last. It was reported that there was no exact duration period stated in the PI. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Dizziness, Headache, Muscle spasms, Musculoskeletal pain
Clinical narrative: This spontaneous report was received from an approximately 78 year old male patient regarding himself. There were no pertinent medical histories and no drug reactions or allergies. On 27-AUG-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). Concomitant therapies included metoprolol, hydrochlorothiazide, alendronate sodium / cholecalciferol tablets (reported as alendronate) and aspirin. On an unknown date in September 2013 (reported as first week of September), the patient experienced lightheadedness, nausea and headache after the vaccination. The patient was also experiencing muscle ache and joint pain. The patient sought medical attention (called doctor). No lab tests were performed. The treating physician prescribed methylprednisolone. The patient stated that he was prescribed 4 milligrams (mg) oral tablets taken as a dose pack over the course of 5 days. The patient then stated that this medication was manufactured by other company. The patient was refusing to administer this medication due to the adverse events that were reported in the product information (PI) of this specific medication. Approximately on an unknown date in 2013, the patient recovered from lightheadedness, headache and nausea as the symptoms went away. The patient improved slowly from muscle ache and joint pain (also reported as not recovered). The patient enquired about how long his joint/muscle pain side-effect from ZOSTAVAX would last. It was reported that there was no exact duration period stated in the PI. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Neck pain, Oropharyngeal pain, Pain
Clinical narrative: This spontaneous report was received from an approximately 78 year old male patient regarding himself. There were no pertinent medical histories and no drug reactions or allergies. On 27-AUG-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). Concomitant therapies included metoprolol, hydrochlorothiazide, alendronate sodium / cholecalciferol tablets (reported as alendronate) and aspirin. On an unknown date in September 2013 (reported as first week of September), the patient experienced lightheadedness, nausea and headache after the vaccination. The patient was also experiencing muscle ache and joint pain. The patient sought medical attention (called doctor). No lab tests were performed. The treating physician prescribed methylprednisolone. The patient stated that he was prescribed 4 milligrams (mg) oral tablets taken as a dose pack over the course of 5 days. The patient then stated that this medication was manufactured by other company. The patient was refusing to administer this medication due to the adverse events that were reported in the product information (PI) of this specific medication. Approximately on an unknown date in 2013, the patient recovered from lightheadedness, headache and nausea as the symptoms went away. The patient improved slowly from muscle ache and joint pain (also reported as not recovered). The patient enquired about how long his joint/muscle pain side-effect from ZOSTAVAX would last. It was reported that there was no exact duration period stated in the PI. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site swelling
Clinical narrative: Gave client flu vaccine as a part of the school flu project. Mom works at school. Approximately 30 minutes after administering vaccine mom brought client back to nurse arm swollen at vaccination site. About the size of a lemon. Applied ice pack and gave BENADRYL 12.5 mg. No further problems reported.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to a female patient of unknown age. The patient's concurrent condition included diabetes. The patient "in her 20s had had 5 doses of MMR II (lot # not provided) as required for medical school, all on unspecified dates. There was no concomitant medication reported. The Nurse practitioner reported that an unspecified primary care provider tested the patient for titers after each dose of MMR II, all on unspecified dates. The patient had always tested negative for titers after vaccination with MMR II. Titers were taken on unspecified dates. Patient's outcome was unknown. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Pain
Clinical narrative: Erythema, noted in left arm area with warmth approx 2 inches, itchy per grandparent. No drainage noted, pain.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphonia
Clinical narrative: Developed hoarseness in evening 10/16 next day. No other symptom. Improved on 10/16.
Age: 0.36
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Abdominal X-ray, Intussusception, Therapeutic procedure, Ultrasound abdomen
Clinical narrative: Intussusception 7 weeks 5 days after ROTATEQ #2. Intussusception successfully reduced in radiology.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Headache, Pain
Clinical narrative: Chills, body aches, headache, coughing.
Age: 53.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Pain, Rash, Skin sensitisation
Clinical narrative: Sensitive skin on left side of torso, front and back. Barely noticeable at first, but it got progressively worse. Within a day, I noticed a small rash and increasing pain. On the morning of the third day, 11/17/13, I went to see my doctor.
Age: 53.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Herpes zoster, Paraesthesia
Clinical narrative: Sensitive skin on left side of torso, front and back. Barely noticeable at first, but it got progressively worse. Within a day, I noticed a small rash and increasing pain. On the morning of the third day, 11/17/13, I went to see my doctor.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Pharyngitis, Pharyngitis streptococcal
Clinical narrative: Rash and hot and swollen injection site. On 8/25/13 developed severe strep throat, on 08/28/13 developed rt upper lobe pneumonia, then on 09/5 treated for sinus and on the 9/25 for another sinus then on 10/15/13 pharyngitis and sinus.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Pneumonia, Rash generalised, Sinus disorder
Clinical narrative: Rash and hot and swollen injection site. On 8/25/13 developed severe strep throat, on 08/28/13 developed rt upper lobe pneumonia, then on 09/5 treated for sinus and on the 9/25 for another sinus then on 10/15/13 pharyngitis and sinus.
Age: 7.0
Sex: F
Vaccine: HEP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Very red and swollen at vaccine location. This lasted for a week. Applied both heat and cold compresses.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site induration, Injection site pain, Injection site paraesthesia, Local swelling, Neck pain
Clinical narrative: Tingling, induration & tenderness in left deltoid at injection site. Complains of pain and swelling in entire arm and neck area.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Tingling, induration & tenderness in left deltoid at injection site. Complains of pain and swelling in entire arm and neck area.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Local swelling, Neck pain
Clinical narrative: Right side of neck and collarbone area very sore and swollen per employee.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Local area of injection in L deltoid reddened and warm to the touch. Child denied discomfort. Mother denies swelling.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site bruising, Injection site pain, Injection site swelling, Pain
Clinical narrative: Patient felt pain during injection that she thought was unusual for the vaccination but was unsure since it had been a year since she was last vaccinated. Significant pain started in evening of 10/15, within 6 hours of injection. Noticed significant swelling in the morning on 10/16. Sought care in urgent care clinic on 10/17 at 12pm. Pain in left shoulder is severe and the left should is swollen. Patient is unable to abduct due to pain. There is no numbness or weakness in the left arm, no warmth or redness in the left arm, and no drainage from the injection site. She did bump her left arm while getting out of her car during the past weekend on 10/13 or 10/14 and her anterior left upper arm has a small quarter sized bruise on it from that injury. She denied having any pain prior to 10/15. Xray negative for fracture or fluid collection. Patient's cellulitis is being treated with Keflex, Benadryl for any itching, and ibuprofen for pain.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, X-ray normal
Clinical narrative: Patient felt pain during injection that she thought was unusual for the vaccination but was unsure since it had been a year since she was last vaccinated. Significant pain started in evening of 10/15, within 6 hours of injection. Noticed significant swelling in the morning on 10/16. Sought care in urgent care clinic on 10/17 at 12pm. Pain in left shoulder is severe and the left should is swollen. Patient is unable to abduct due to pain. There is no numbness or weakness in the left arm, no warmth or redness in the left arm, and no drainage from the injection site. She did bump her left arm while getting out of her car during the past weekend on 10/13 or 10/14 and her anterior left upper arm has a small quarter sized bruise on it from that injury. She denied having any pain prior to 10/15. Xray negative for fracture or fluid collection. Patient's cellulitis is being treated with Keflex, Benadryl for any itching, and ibuprofen for pain.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Flushing, Paraesthesia, Paraesthesia oral
Clinical narrative: RECEIVED THE INFLUENZA VACCINE AT 11:30AM, FELT WARM AND FLUSH FACE AT 1300. AT 1330 MILD TINGLING ON THE BACK OF TONGUE AND THROAT. DENIES PROBLEM BREATHING OR SWALLOWING OR ANY OTHER ISSUES. TEMP 97.7 AT 14:30PM.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Incorrect route of drug administration, Musculoskeletal pain, Pain, Skin reaction, Tendonitis
Clinical narrative: Pain/soreness in right shoulder which worsened with lifting/movement of right shoulder better with rest. Examination consistent with tendinitis most likely due to localized reaction of shot which was administered in an inappropriate location (not in deltoid rather given up high on the deltoid in line but posterior to the AC joint).
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Vertigo
Clinical narrative: Vertigo, significant for 3 hours theen graduallly improved.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Cough, Decreased appetite, Dyspnoea, Oropharyngeal pain, Pain
Clinical narrative: Child woke with high fever 103.1 complained of body aches.  Day of 10/10/13 cough started, nasal drainage, sore throat, fever continued. 10/11-10/14 Wheezing, cough, vomiting, continued fever between 101.0 to 103.2 No appetite, sore throat, continued wheezing, shortness of breath.  Child taken to hospital 10/17/13.  Was instructed side effects can last 5 - 10 days after Flumist was administered.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Pyrexia, Rhinorrhoea, Vomiting, Wheezing
Clinical narrative: Child woke with high fever 103.1 complained of body aches.  Day of 10/10/13 cough started, nasal drainage, sore throat, fever continued. 10/11-10/14 Wheezing, cough, vomiting, continued fever between 101.0 to 103.2 No appetite, sore throat, continued wheezing, shortness of breath.  Child taken to hospital 10/17/13.  Was instructed side effects can last 5 - 10 days after Flumist was administered.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back pain, Chest pain, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Nausea, vomiting, pain at injection site spreading to entire arm, chest, and back, redness at and around injection site, warmth and swelling at injection site.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Nausea, Pain in extremity, Vomiting
Clinical narrative: Nausea, vomiting, pain at injection site spreading to entire arm, chest, and back, redness at and around injection site, warmth and swelling at injection site.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site on left deltoid.
Age: 21.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Loss of consciousness, Vertigo
Clinical narrative: Dizziness described as lightheadedness initially but then progressed to "room spinning" sensation.  Sat for few minutes, they was helped to lie down due to severe dizziness and lost consciousness for about 30 seconds.  Smelling salts used to successfully rouse the patient.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Arthralgia, Chest pain, Chills, Diarrhoea
Clinical narrative: 4-5 weeks of worsening symptoms of adverse reaction, including: blackout at time of injection, fatigue, light-headedness, headaches, cold chills, night sweats, diahrrea, achey muscles, insomnia, nausea, muscle fasciculations, weakness in arms, legs, and hands, vomiting, chest pains, anxiety, racing heartbeat, pain in joints, back, neck, legs, and head (temples, eyes, forehead), pain at injections site.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Headache, Immediate post-injection reaction, Insomnia
Clinical narrative: 4-5 weeks of worsening symptoms of adverse reaction, including: blackout at time of injection, fatigue, light-headedness, headaches, cold chills, night sweats, diahrrea, achey muscles, insomnia, nausea, muscle fasciculations, weakness in arms, legs, and hands, vomiting, chest pains, anxiety, racing heartbeat, pain in joints, back, neck, legs, and head (temples, eyes, forehead), pain at injections site.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Muscle contractions involuntary, Muscular weakness, Myalgia, Nausea
Clinical narrative: 4-5 weeks of worsening symptoms of adverse reaction, including: blackout at time of injection, fatigue, light-headedness, headaches, cold chills, night sweats, diahrrea, achey muscles, insomnia, nausea, muscle fasciculations, weakness in arms, legs, and hands, vomiting, chest pains, anxiety, racing heartbeat, pain in joints, back, neck, legs, and head (temples, eyes, forehead), pain at injections site.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Night sweats, Pain, Palpitations, Vomiting
Clinical narrative: 4-5 weeks of worsening symptoms of adverse reaction, including: blackout at time of injection, fatigue, light-headedness, headaches, cold chills, night sweats, diahrrea, achey muscles, insomnia, nausea, muscle fasciculations, weakness in arms, legs, and hands, vomiting, chest pains, anxiety, racing heartbeat, pain in joints, back, neck, legs, and head (temples, eyes, forehead), pain at injections site.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Myalgia
Clinical narrative: Severe headache and muscle aches.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia, Tachycardia
Clinical narrative: Sudden fever up to 102.5 by 12:00pm, uncontrollable shivering, body aches, tachycardia.  Treatment:  Tylenol, fluids, overnight hospital stay.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: Patient called stating she started getting chills and got a fever a few hours after receiving the vaccine. The next day she also had a fever ranging from 100-103.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Local swelling, Pruritus, Urticaria
Clinical narrative: Itchy, then welt, the swelling of whole upper arm shoulder area.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Burning sensation, Hyperaesthesia, Pain, Pruritus
Clinical narrative: Woke up from a nap with burning/itching/sensitivity in hands "like pain from shingles" about 20 minutes later started experiencing stomach upset. Within an hour began feeling achy and feverish. At 8:45 PM got up to get ready for bed and noticed a rash similar to that experienced in bacterium reaction on arms and chest.  Took diphenhydramine at 9PM and left for emergency room at 9:30.  Arrived at the ER at 10:15 and was in a bed by 11. Given additional dose of diphenhydramine at unknown time and released at 3:00 after observation.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Rash
Clinical narrative: Woke up from a nap with burning/itching/sensitivity in hands "like pain from shingles" about 20 minutes later started experiencing stomach upset. Within an hour began feeling achy and feverish. At 8:45 PM got up to get ready for bed and noticed a rash similar to that experienced in bacterium reaction on arms and chest.  Took diphenhydramine at 9PM and left for emergency room at 9:30.  Arrived at the ER at 10:15 and was in a bed by 11. Given additional dose of diphenhydramine at unknown time and released at 3:00 after observation.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Musculoskeletal stiffness, Nasopharyngitis, Rhinorrhoea
Clinical narrative: Stiff neck across the top of the shoulders to the base of the skull.  Very red (2 inches long and 1/2 inch wide at injection site). Then on 10/17/13 got a really bad runny nose and a cold.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Ear, nose and throat examination normal, Nausea, Vertigo
Clinical narrative: Extreme vertigo and nausea.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Feeling cold, Headache, Pain, Pyrexia
Clinical narrative: FEVER, SHAKING, ACHING ALL OVER, DIZZY, HEADACHE, COULD NOT WARM BODY UP,
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Tremor
Clinical narrative: FEVER, SHAKING, ACHING ALL OVER, DIZZY, HEADACHE, COULD NOT WARM BODY UP,
Age: 24.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Asthma, Chest discomfort, Chills, Dyspnoea
Clinical narrative: Fever first day with asthma symptoms second day I got chills tightness in chest, headache, weak, difficulty breathing.
Age: 24.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Pyrexia
Clinical narrative: Fever first day with asthma symptoms second day I got chills tightness in chest, headache, weak, difficulty breathing.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Pruritus, Rash, Urticaria
Clinical narrative: Broke out in hives. First felt itching under arms. Removed shirt and witness rash going across entire back, under arms, up neck and abdominal region. Called nurse on call who recommended urgent care it the mention of swollen feeling in throat. Got to urgent care at 11:00 PM.  Administered 10 mg Dexamethasone Na Phospate 1 Mg 10 mg Intramuscular. Prescribed prednisone 20 mg tablet 3 a day for 3 days.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Coagulation test normal, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: When the nurse gave me the shot she said the needle was dull and had to give me a second shot. She told me that none of the medicine went into my arm the first time. Then I started having pain and numbness in left leg with tingling in the toes about a week after the shot. Went to ER to check for blood clot. Did not have clot and was given pain medicine. Told to go to my doctor is pain continued. My pain did continue and I went to my family doctor. He gave me steroids and hydrocodone for pain. While the pain is better, the numbness continues.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Chills, Dizziness, Influenza like illness, Injection site urticaria
Clinical narrative: 30 minutes after vacine was given. I became severely nausated and vomited. Dizzy. Within the first hour to second hour I experienced moderate weakness and chills. By the 6th hour I had hives on the upper part of the arm that I recieved the shot in. The following day, I way just extremely weak and had mild flu-like symptoms. They had resolved by the 3rd day. I took 600mg og Motrin at the first signs of symptoms. 50mg of Benadryl with the hives. I never experienced any shortness of breath or cardiac issues.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Nausea, Vomiting
Clinical narrative: 30 minutes after vacine was given. I became severely nausated and vomited. Dizzy. Within the first hour to second hour I experienced moderate weakness and chills. By the 6th hour I had hives on the upper part of the arm that I recieved the shot in. The following day, I way just extremely weak and had mild flu-like symptoms. They had resolved by the 3rd day. I took 600mg og Motrin at the first signs of symptoms. 50mg of Benadryl with the hives. I never experienced any shortness of breath or cardiac issues.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Painful rash along R arm dx as herpes zoster.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Erythema, Feeling abnormal, Feeling hot
Clinical narrative: Within minutes I had headache that felt like tight rubberband around temples and circumfernce of my head. Back of my neck ached and felt stiff. My face is flush and feels hot. Both my cheeks are red all day. My chest has funny tight feeling and I have heart pallpatations all day. I also felt dizzy.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Headache, Musculoskeletal stiffness, Neck pain, Palpitations
Clinical narrative: Within minutes I had headache that felt like tight rubberband around temples and circumfernce of my head. Back of my neck ached and felt stiff. My face is flush and feels hot. Both my cheeks are red all day. My chest has funny tight feeling and I have heart pallpatations all day. I also felt dizzy.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Palpitations
Clinical narrative: This is a spontaneous report received from a consumer (via a specialty pharmacy, additional information from a physician) that described a 53 year old female patient (race not specified) who commenced LETAIRIS 10 mg once daily on 25 March 2009 for idiopathic pulmonary hypertension. Co-suspect medication included influenza vaccine. Concomitant medications reported were TYVASO and ADCIRCA. Medical history was not reported. The patient was hospitalized on 20 September 2013 for severe palpitations (onset date not reported). The patient reported that she thought the palpitations were a reaction to a flu shot. The patient was discharged on 22 September 2013. Ambrisentan was continued. At the time of this report, the outcome of palpitations was reported as unknown. On 11 October 2013, in response to query, the patient's physician confirmed the event of palpitations. The physician assessed the event as not related to ambrisentan. The initial report was received on 26 September 2013.
Sex: M
Vaccine: FLU4
Symptoms: VIIth nerve paralysis
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of bell's palsy in an adult male subject aged less than 65 years who was vaccinated with FLUARIX (GlaxoSmithKline). On 3 October 2013 the subject received a dose of FLUARIX (unknown details). On 8 October 2013, 5 days after vaccination with FLUARIX, the subject experienced bell's palsy. The subject "was seen by the physician on 8 October 2013 and diagnosed with Bell's palsy." The reporter did not know when the symptoms started or have any subject specific details at the time of reporting. The subject was vaccinated at an off site health fair on 3 October 2013 and the reporter "thinks the patient was less than 65 years old as another group was vaccinating older adults." This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unknown.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphagia, Dyspnoea, Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a consumer (subject) and described the occurrence of arm swelling (injection site) in a 65-year-old female subject who was vaccinated with FLULAVAL TETRA (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to morphine, codeine allergy, high blood sugar, high cholesterol and sulfa allergy. Concurrent medications included Anti-cholesterol medication, Metformin and Vitamins. On 7 October 2013 at 14:30 the subject received 1st dose of FLULAVAL TETRA (unknown details, left arm). On 7 October 2013, hours after vaccination with FLULAVAL TETRA, the subject experienced arm swelling (injection site), red area at injection site, injection site discoloration, difficulty breathing and swallowing problems. The subject described a "bright red and purple grapefruit sized area on left arm" within a few hours after vaccination with FLULAVAL TETRA. The subject also stated that the "arm swelled up to size of a grapefruit". The subject was treated with Unknown injection at the doctor's office and continues to take BENADRYL. At the time of reporting, the outcome of the events of arm swelling (injection site), red area at injection site, and injection site discoloration were improved and ongoing. At the time of reporting, the event of difficulty breathing had resolved within a few hours of onset. The outcome of swallowing problems was unknown.
Age: 29.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Local swelling, Pyrexia
Clinical narrative: Patient given 2 vaccines on 10-14-113, started that night with left arm redness, fever 102 left arm red raised area. Started erythromycin and cetirizine for treatment of cellulitis.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Fall, Loss of consciousness, Peripheral coldness
Clinical narrative: Received shot/flu within 5 minutes felt blanked out, happened twice - felt dizzy -> lied on floor -> tachycardia -> extremities cold -> near syncope extreme called 911 -> had rigors -> went to ER.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Presyncope, Tachycardia
Clinical narrative: Received shot/flu within 5 minutes felt blanked out, happened twice - felt dizzy -> lied on floor -> tachycardia -> extremities cold -> near syncope extreme called 911 -> had rigors -> went to ER.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Immediate post-injection reaction, Injection site pain, Nausea
Clinical narrative: Pt had fever, chills, prickly skin, very fatigued, after vaccine. Immediately with injection pt. felt pain then 7pm whole arm hurt. Pt. reported feeling achy and nauseous.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Pt had fever, chills, prickly skin, very fatigued, after vaccine. Immediately with injection pt. felt pain then 7pm whole arm hurt. Pt. reported feeling achy and nauseous.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Skin discolouration
Clinical narrative: Donor received shot on 9/17/13 to right arm. Later that night arm was numb and both armpits turned black. Arm stayed numb for 2-3 days.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt came in with redness and burning at the injection site. Size was about the size of a tennis ball.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient started with normal arm soreness after injection. She states in the last 4-5 days her discomfort has increased and she has pain with movement. She has no trouble while just sitting. She experienced no redness or her arm did not swell at all.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site reaction, Rash erythematous
Clinical narrative: Patient reported seeing bruising and "silver dollar" size red rash to left of injection site. About 1 week post shot. Symptoms lasted approx 1 week and have since subsided. No treatment was needed.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: Mild itching at site of injection.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Feeling hot, Pallor
Clinical narrative: Pale color, cold sweats but hot.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Vaccination site bruising
Clinical narrative: Pt went home, slept for approx 4-5 hours, woke up with chills which lasted approx. 2 hours. Area of vaccine also bruised.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Erythema, Eyelid oedema, Wheezing
Clinical narrative: 10-15 min after FLUZONE IM bilat periorbital erythema with eyelid swelling, severe cough/wheeze, treated with epinephrine 0.15, ZYRTEC, Albuterol nebulizer, ORAPRED 15 mg in office and continued x 2 days, PATADAY eye drops and continued ZYRTEC x 2 days.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Local swelling, Mobility decreased, Pain in extremity
Clinical narrative: Patient says she has swollen arms and sore arms. She says she can't left up her arms.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, warm (temperature), itching approx. 7 inch swollen area of injection.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ear pain, Herpes zoster oticus, Hypoaesthesia, Pain in jaw
Clinical narrative: None stated.
Age: 69.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Feeling hot, Pain, Pruritus
Clinical narrative: Redness, itching, pain, warm, spreading. Pain got worse each day-went to visit her PCP 10/14/13.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Local swelling
Clinical narrative: Patient returned to pharmacy on 10/17/13 at 12PM and indicated that she had swelling on the arm and a headache that had not gone away as of this time. Patient referred to PCP if swelling worsens or headache does not subside.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Pain in jaw, Swelling
Clinical narrative: Pt said she had jaw pain on the same side as the shot. She said it feels more like a lymph node issue, jaw was extremely swollen. No fever, no redness, no rash. Took Ibuprofen and swelling went down. Pt stated this occurred 24 hours after shot. Advised Pt to see MD.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Local reaction at injection site. Upper right arm is swollen, hot and itching. Pt took 1/2 tab of 10 mg loratadine and itching stopped. Dr said that it is just local reaction and suggested to take BENADRYL tablet and to use ice pack to cool down.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Local swelling, Lymphadenopathy, Oropharyngeal pain, Rash
Clinical narrative: After injection (flu) - arm swelled some and rash appeared - (slight red, raised rash). Throat sore and became sweaty and glands on neck swelled. Took vitals and had pt sit down and relax for a while. Felt better.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: After injection (flu) - arm swelled some and rash appeared - (slight red, raised rash). Throat sore and became sweaty and glands on neck swelled. Took vitals and had pt sit down and relax for a while. Felt better.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient stated that pain in the areas surrounding the vaccine site started on Mon., Oct. 14; 2 days following vaccination. The pain radiates to her elbow and her shoulder. The vaccine site itself is not painful. There is no redness or swelling at the site. Advised an ER or MD visit.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Musculoskeletal pain, Pain, Swelling
Clinical narrative: Large, red,  raised rectangular area. Developed next am, following vaccine. Painful and lasted x 7 days. Even pain into shoulder area. Had completely resolved after 1 week.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Eyelid oedema, Throat irritation
Clinical narrative: Vaccine around noon. Symptoms at 5-6 pm, raw throat, mild SOB, edema of eyelids. CLARITIN 10 mg at home. 25 mg BENADRYL at clinic. 4 mg dexamethasone/40mg KENALOG IM at clinic at 8 pm at 8:30 pm symptoms improved.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: 8 days post GARDASIL vaccine, patient had a seizure. Sibling had similar reaction to GARDASIL vaccine in the past.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, FLUN4
Symptoms: Erythema, Induration, Swelling
Clinical narrative: (L) deltoid -> DTaP-IPV. Within 48 hours: swelling/erythema/small induration.
Age: 19.0
Sex: M
Vaccine: HEP, MNQ, VARCEL
Symptoms: Headache, Injection site erythema, Injection site pain, Oropharyngeal pain, Pyrexia
Clinical narrative: C/O sore throat with a few days of red bumps to forehead side of abdomen that are slightly itchy. Also c/o mild headache. Pt. also stated he had a fever, but none noted at visit. Also had faint redness and tenderness to L deltoid area.
Age: 19.0
Sex: M
Vaccine: HEP, MNQ, VARCEL
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: C/O sore throat with a few days of red bumps to forehead side of abdomen that are slightly itchy. Also c/o mild headache. Pt. also stated he had a fever, but none noted at visit. Also had faint redness and tenderness to L deltoid area.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Asthma, Condition aggravated
Clinical narrative: Child received FLUMIST in flu clinic getting at school parents had marked FLUMIST as desired vaccine child had a 5 day steroid treatment 6 weeks ago for URI. Recently 2 hours after vaccination and Dx with asthma. Follow up phone call 24 hours after vaccine shows no side effects to FLUMIST.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain, Vaccination site pain
Clinical narrative: Patient says muscle hurts at vacc site. Also her scapula hurts. Hurts to raise her arm. Left arm.
Age: 50.0
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Patient reported hot, red rash at injection site. She f/u w/ provider and was prescribed 10 days of antibiotics (KEFLEX).
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Fatigue, Induration, Pruritus, Respiratory tract infection
Clinical narrative: Pt presented/stated big hard red spot of L/arm; hot to touch; itchy. Pt said felt very fatigue; felt like had respiratory and sinus infection all at the same time. After further discussion stated she felt sniffy when she came in perhaps she was starting to get sick when she came in.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Sinusitis, Skin warm
Clinical narrative: Pt presented/stated big hard red spot of L/arm; hot to touch; itchy. Pt said felt very fatigue; felt like had respiratory and sinus infection all at the same time. After further discussion stated she felt sniffy when she came in perhaps she was starting to get sick when she came in.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Injected limb mobility decreased, Injection site pain, Joint effusion, Synovitis, Ultrasound scan abnormal
Clinical narrative: Phone call from mom 10/10/13, stating pt. began with left leg pain and unable to bear weight since 10/9/13 evening sent to ER 10/10/13 pt diagnosed "transient synovitis of left hip" given ibuprofen. Phone call to parent 10/11/13 pt improved less pain and increased mobility and able to bear weight. Vaccines given 10/1/13.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Weight bearing difficulty
Clinical narrative: Phone call from mom 10/10/13, stating pt. began with left leg pain and unable to bear weight since 10/9/13 evening sent to ER 10/10/13 pt diagnosed "transient synovitis of left hip" given ibuprofen. Phone call to parent 10/11/13 pt improved less pain and increased mobility and able to bear weight. Vaccines given 10/1/13.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Ear pain, Feeling hot, Hypersensitivity, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a physician who is a 67-year-old female patient. Current conditions included chronic sinusitis and history of endometrial cancer. On 24-SEP-2013 the patient was vaccinated with a dose of 0.5 milliliter (ml) PNEUMOVAX23 (lot#, expiration date not reported) intramuscularly in the right arm. Concomitant therapies included FLUVIRIN administered on the same date in the left arm. The physician reported that she developed redness and pain at the injection site on 25-SEP-2013. The patient also developed right ear pain and nasal congestion. On 27-SEP-2013, the physician experienced a warm sensation at the nape of her neck after walking for exercise. The sensation resolved after she drank sugar water. Later that evening, she developed welts on the right and left scapula area, which resolved with the use of BENADRYL and unspecified cortisone cream topically. On 30-SEP-2013, the patient developed a circular welt on her mid-back. On 01-OCT-2013, she developed welts under both axilla. These welts also responded to BENADRYL and cortisone cream. The evening of 02-OCT-2013, the patient developed a large welt on her left forearm which she treated with BENADRYL and topical cortisone cream. The physician stated she was evaluated on 03-OCT-2013 by her unspecified healthcare provider who diagnosed an unspecified allergic reaction. It was suggested that the patient eliminated medications and foods one at a time in an attempt to determine the cause of her allergic reaction. Laboratory diagnostic studies were not performed for the events. The patient sought medical attention for the events (office visit). The events were resolving at the time of this report. Causality was not reported. This is one of the reports from the same reporter. Additional information is not expected.