chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Allergy test, Anaphylactic reaction, Cough, Lip swelling, Oropharyngeal pain
Clinical narrative: Information has been received from a physician concerning a currently 10 year old male patient with bee sting allergy and no other pertinent medical history who on 07-AUG-2006, was vaccinated with a dose of MMR II (Lot # 653317/0211F) (dose and route not reported). There was no concomitant medication. The physician reported that on an unspecified date, after receiving the vaccination, the patient experienced anaphylactic reaction, sore throat, rash on face and vomiting. On an unspecified date, the patient went to an emergency room. Laboratory tests included allergy testing by an allergist (date and results not provided). The patient was given BENADRYL for the treatment of the events. On an unspecified date, the patient recovered. The anaphylactic reaction, sore throat, rash on face and vomiting were determined to be immediately life threatening by the physician. The patient subsequently experienced anaphylactic reaction, rash on trunk, sore throat, swollen lip and coughing after vaccination with VARIVAX (Merck), and hepatitis A vaccine (WAES#1110USA01829). A lot check has been initiated for MMR II (Lot # 653317/0211F). Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Rash, Vomiting
Clinical narrative: Information has been received from a physician concerning a currently 10 year old male patient with bee sting allergy and no other pertinent medical history who on 07-AUG-2006, was vaccinated with a dose of MMR II (Lot # 653317/0211F) (dose and route not reported). There was no concomitant medication. The physician reported that on an unspecified date, after receiving the vaccination, the patient experienced anaphylactic reaction, sore throat, rash on face and vomiting. On an unspecified date, the patient went to an emergency room. Laboratory tests included allergy testing by an allergist (date and results not provided). The patient was given BENADRYL for the treatment of the events. On an unspecified date, the patient recovered. The anaphylactic reaction, sore throat, rash on face and vomiting were determined to be immediately life threatening by the physician. The patient subsequently experienced anaphylactic reaction, rash on trunk, sore throat, swollen lip and coughing after vaccination with VARIVAX (Merck), and hepatitis A vaccine (WAES#1110USA01829). A lot check has been initiated for MMR II (Lot # 653317/0211F). Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from certified medical assistant and patient's mother concerning her currently 17 year old daughter with no known pertinent medical history, no known drug reactions/allergies and no concurrent conditions who in November 2007, was vaccinated with the first dose of GARDASIL (Lot #, dose and route not reported). There were other vaccines given concomitantly. The consumer reported that on an unspecified date, rather than night or within the next few nights of receiving the vaccine, her daughter had a seizure during sleep. The consumer's daughter was taken to the emergency room and was given IV's. The consumer reported that her daughter was seen by a neurologist who diagnosed right frontal lobe seizure. Since the patient had only one seizure, no treatment was needed. On an unspecified date, the patient was fully recovered and would not be receiving any more GARDASIL vaccinations. Upon internal review, right frontal lobe seizure was determined to be an other important medical event. This is one of several reports received from the same source. No further information is available.
Age: 54.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Chest pain, Dyspnoea, Nausea, Throat irritation
Clinical narrative: Initial case was received on 10 October 2011 from a health care professional. A 54 year-old female patient with history of a latex allergy specific to the backing on carpets (the patient "can wear latex gloves") had received on 06 October 2011 an intramuscular left deltoid injection of FLUZONE, lot number UH476AA and shortly after vaccination, experienced nausea, chest pain, SOB (shortness of breath) and her throat felt strange. The patient went to the ER (emergency room) and was treated with steroids and albuterol aerosol. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Limb discomfort, Myalgia
Clinical narrative: Initial case was received on 10 October 2011 from a health care professional. A 54 year-old female patient with history of a latex allergy specific to the backing on carpets (the patient "can wear latex gloves") had received on 06 October 2011 an intramuscular left deltoid injection of FLUZONE, lot number UH476AA and shortly after vaccination, experienced nausea, chest pain, SOB (shortness of breath) and her throat felt strange. The patient went to the ER (emergency room) and was treated with steroids and albuterol aerosol. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Initial report was received on 10 October 2011 from a health care professional. A male patient (name, age and date of birth not reported) had received FLUZONE (lot number, route, site and date of administration not reported) and an unspecified amount of time later, experienced a high fever and was hospitalized. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Fatigue, Headache, Immediate post-injection reaction, Injection site pain
Clinical narrative: Immediately hurt going in, immediate aching, got worse took ibuprofen did not help. Iced area. Pain extended to arm to shoulder blade, to back to chest. Switched to heat compresses also. Felt very uncomfortable, achy all over -> aches continued to next day. Had headache. Feels fatigue/tired since then, general malaise. Pain has subsided. In the last couple of days also has some bumpy spots on back of neck to right ear. Called pharmacist who encouraged reporting.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Musculoskeletal pain, Pain, Rash
Clinical narrative: Immediately hurt going in, immediate aching, got worse took ibuprofen did not help. Iced area. Pain extended to arm to shoulder blade, to back to chest. Switched to heat compresses also. Felt very uncomfortable, achy all over -> aches continued to next day. Had headache. Feels fatigue/tired since then, general malaise. Pain has subsided. In the last couple of days also has some bumpy spots on back of neck to right ear. Called pharmacist who encouraged reporting.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Hypoaesthesia oral, Malaise
Clinical narrative: Numb sensation L side of tongue, which progressed to numbness of lips also. Developed bad headache and malaise that lasted 8 - 10 hours.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Dyspnoea, Eye swelling
Clinical narrative: Approximately 25-30 minutes after vaccines administered, patient returned to clinic with both eyes almost swollen shut and difficulty breathing.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dizziness, Heart rate increased, Pyrexia, Respiratory rate increased
Clinical narrative: Awoke with chills and feeling feverish.  Did not check temperature.  Also felt dizzy.  Felt like breathing was rapid and rapid heartbeat for about 30 seconds.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: He was walking out of the clinic and fainted.
Age: 1.01
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, VARCEL
Symptoms: Blister, Rash, Varicella post vaccine, Vomiting
Clinical narrative: Patient taken to ER on 9/30 with vomiting and rash on face and arms.  Patient had follow up appointment on 10/3.  According to FNP patient now had vesicles on arms, legs, and back.  Provisional diagnosis of chickenpox given.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Rash
Clinical narrative: Redness, soreness and then 08/04/2011 noticed rash on trunk.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Localized reaction: pain, swelling, and erythema in the area surrounding the injection site (>4 inches in diameter surrounding injection site).  Developed during evening of the day injection was given, continued through next day, is resolving on second day following injection.  Treatment recommended: ice pack to affected area, acetaminophen, diphenhydramine.
Age: 0.79
Sex: M
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: HIVES ON LOWER BACK.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Local reaction, Pain in extremity
Clinical narrative: Localized reaction: severe pain in injected arm (to the point that arm was difficult to move), swelling, and erythema in the area surrounding the injection site.  Developed during evening of the day injection was given, continued through next day.   Treatment recommended: ice pack to affected area, acetaminophen, diphenhydramine.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dizziness, Fall, Headache, Hyperhidrosis
Clinical narrative: Walked up to toilet in bathroom, blacked out/fainted & fell bkwds into tub. Wife helped me out, and then I had nausea, extreme lightheadedness, ringing in ears, and chills/sweating for about 15 mins. Better today, as far as I can tell, except for dull headache. I jog several times per week, am pretty physically fit, so this was very unusual for me.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness, Nausea, Syncope, Tinnitus
Clinical narrative: Walked up to toilet in bathroom, blacked out/fainted & fell bkwds into tub. Wife helped me out, and then I had nausea, extreme lightheadedness, ringing in ears, and chills/sweating for about 15 mins. Better today, as far as I can tell, except for dull headache. I jog several times per week, am pretty physically fit, so this was very unusual for me.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Diarrhoea, Nausea, Pain, Pyrexia
Clinical narrative: 2 days following the administration of the flu shot this pt developed nausea, vomiting, diarrhea, body-aches, fever, and cough.  All resolved in about 1 week except the cough which has been residual for the last 2-3 wks.  Wife also developed similar symptoms a few days after the onset of the patient's symptoms began.  The patients sx were not reported to this physician until the day of this report.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: 2 days following the administration of the flu shot this pt developed nausea, vomiting, diarrhea, body-aches, fever, and cough.  All resolved in about 1 week except the cough which has been residual for the last 2-3 wks.  Wife also developed similar symptoms a few days after the onset of the patient's symptoms began.  The patients sx were not reported to this physician until the day of this report.
Age: 65.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Asthenia, Body temperature increased, Pain
Clinical narrative: When arriving home felt weak with body aches which continued into the next day of bed rest with temp reaching 103.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Abasia, Injection site rash, Injection site swelling, Pain in extremity
Clinical narrative: 10/07/11 left thigh with swelling & rash; resolved 10/10/11.  10/11/11 right leg pain & inablility to walk; resolved 10/15/11. Parents took photos.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Immune system disorder, Leukocytosis, Pyrexia
Clinical narrative: Presents with fever. She then developed squeezing head, frontal, 9/10 in severity but not associated with mental status changes, photophobia, neck stiffness. Was then seen in follow-up by Urgent Care and noted to have leukocytosis so she was given empiric antibiotics due to her immune compromised state and referred for admission.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram head, Headache, Laboratory test, Pyrexia, Vomiting
Clinical narrative: Intense headache, head pressure, vomiting, fever.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Eye pruritus, Fatigue, Lacrimation increased, Oropharyngeal pain
Clinical narrative: Rhinitis, watery and itchy eyes, sore throat, fatigue, cough.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinitis
Clinical narrative: Rhinitis, watery and itchy eyes, sore throat, fatigue, cough.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: Mother of pt present to clinic on walk in basis 10/21/2011 c/o swelling at injection site, warm to touch, and painful, mother concern about swelling to armpit area same arm as swelling Left Deltoid.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Mobility decreased, Nausea, Oedema peripheral, Pain in extremity
Clinical narrative: 6:00 pm R arm became very sore, hard to lift.  Midnight woke up with chills, very nauseated, vomited. Next morning are swollen from shoulder to elbow, red itchy rash, continued to feel nauseated. Took 4-5 days to resolve.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Rash erythematous, Rash pruritic, Vomiting
Clinical narrative: 6:00 pm R arm became very sore, hard to lift.  Midnight woke up with chills, very nauseated, vomited. Next morning are swollen from shoulder to elbow, red itchy rash, continued to feel nauseated. Took 4-5 days to resolve.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Oropharyngeal pain, Pallor, Tremor
Clinical narrative: Client was given a flu vaccination by this nurse in the left deltiod muscle at 1133 hrs.  The vaccine is Sanofi brand, Lot # UH478AB, Expires 06/30/2012.  The client went with her mom into the next room to look at the exhibits during the wait period.  They returned to the vaccination room at 1141 and reported her symptoms.  The client appeared pale.  She complained of dizziness, sore throat, and labored breathing.  This nurse had the client sit in a near by chair and instructed the client to take slow deep breaths, in the nose and out the mouth.  Nurse administered oxygen via blow by mask while this nurse assessed vital signs at 1142 hrs:  Blood Pressure 72/52, Pulse 80, Respirations 20.  At 1144 hrs. the client stated she was feeling better and her skin color was improving.  The oxygen was removed at 1149 hrs.  The client then changed chiars so this nurse could continue with giving other's their shots, but could still monitor the client.  The client stated she then felt "shakey" and her mom allowed her to eat a piece of candy.  She reported she felt better after having the candy.  Client was released at 1205 hrs.  This nurse gave the client's mom her card and cell phone number to call if there are any concerns. This nurse left a message with the mom's cell number to follow up on the client.  The client's father was at a different flu clinic the next day and stated the client had no further problems after leaving the flu clinic the day before.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray normal, Convulsion, Influenza virus test negative, Lumbar puncture normal, Pyrexia
Clinical narrative: He woke with a fever of 101.5.  Then at approx. 8:10 AM he had a seizure that lasted approx. 5 min. followed by a period of total unresponsiveness of about 20 min.  He has no history of or prior seizures.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Streptococcus test negative, Unresponsive to stimuli
Clinical narrative: He woke with a fever of 101.5.  Then at approx. 8:10 AM he had a seizure that lasted approx. 5 min. followed by a period of total unresponsiveness of about 20 min.  He has no history of or prior seizures.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Dizziness, Sensation of foreign body, Throat irritation
Clinical narrative: Client was given a flu vaccination in the left deltiod muscle by at 0924 hrs.  The flu vaccine is manufactured by Sanofi, Lot # UH486AD, Expiration 6/30/12.  Client waited in the vaccination area after receiving her shot for approximately ten minutes and returned to her work area.  Client returned to the vaccination area at 1225 hrs. and reported she started having symptoms while she was in a meeting at approximately 1205 hrs.  The nurse that gave her the vaccination was with another client, so this nurse evaluated the client.  Client reported her symptoms as a scratchy throat, cough, tight chest, and light headedness.  Vital signs were taken immediately: Blood Pressure 120/82, Pulse 60, Respirations 16.  Lung sounds were clear bilaterally, no wheezes heard.  Her skin color appeared normal with no diaphoresis noted and no redness or swelling at the injection site.  Client rested in a chair while being monitored.  Vital signs repeated at 1235 hrs.:  Blood Pressure 118/80, Pulse 60, Respirations 16.  Client reported no change of symptoms.  She was on her luch break at the time and had not eaten yet, so allowed her to go to the nearby lounge to rest and eat her lunch, but to return for further evalutation just after her break.  She returned at 1255 hrs.  Repeated vital signs:  Blood Pressure 116/80, Pulse 60, Respirations 16.  She stated still no change of symptoms, except that she stated "It feels like something is stuck in there." as she pointed to her throat.  This nurse recommended she go see her physician for further evaluation.  The client's husband accompanied her to the vaccination area and would drive her to the doctor's office.  10/20/11 This nurse called the client on her phone at 0920 hrs. to follow up, but had to leave a message.  Client returned the call and stated her doctor felt she had a reaction to the flu vaccine and prescribed her Benadryl.  She reported feeling Ok now.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site, about 1 and 1/2 inches in diameter.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Immediate post-injection reaction
Clinical narrative: Immediately after receiving flu shot her arm had point tenderness at elbow and wrist.
Age: 5.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Lymphangitis
Clinical narrative: The patient developed redness, induration, and swelling of the left thigh at the site of the polio, varicella, and influenza immunizations, increasing over 36 hours, subsequently treated with cephalexin and TMP/SMZ for suspected cellulitis and lymphangitis, and much improved by 10/21/11. Immunizations given in the right thigh posed no problems.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Blood pressure increased, Blood test normal, Dizziness, Flushing
Clinical narrative: Tingling in head, arms, hands, legs, and feet.  Fullness in head (as if it might explode!). Elevated blood pressure, stiffness/ache in neck, shoulders, and back. Flushed face. Thick feeling in throat. Puffy feeling in lips and tongue. Dizziness. Paramedics called-Benadryl administered.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Lip swelling, Musculoskeletal pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: Tingling in head, arms, hands, legs, and feet.  Fullness in head (as if it might explode!). Elevated blood pressure, stiffness/ache in neck, shoulders, and back. Flushed face. Thick feeling in throat. Puffy feeling in lips and tongue. Dizziness. Paramedics called-Benadryl administered.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Paraesthesia oral, Pharyngeal oedema
Clinical narrative: Tingling in head, arms, hands, legs, and feet.  Fullness in head (as if it might explode!). Elevated blood pressure, stiffness/ache in neck, shoulders, and back. Flushed face. Thick feeling in throat. Puffy feeling in lips and tongue. Dizziness. Paramedics called-Benadryl administered.
Age: 26.0
Sex: M
Vaccine: MMR
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Site of injection swelled up to size of tennis ball with extreme pain.  Treatment was wearing arm in sling for one week and taking daily prescription pain medication.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Skin warm, Tenderness, Urticaria
Clinical narrative: Patient experienced a headache and a warm red and swelling whelt, persisting over night into the next day. Soreness is noticed on touch. Final size about 1 inch in diameter.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injection site pain
Clinical narrative: Patient is complaining of extreme soreness at the sight of injection. That the pain has not gone away after over a month. She went to her primary care doctor, they told her it was from getting the shot way too high up on the arm near the shoulder.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Headache, Swollen tongue
Clinical narrative: Severe chills, headache, weakness and tongue swelling.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Injection site pruritus, Injection site vesicles, Rash papular, Rash pruritic
Clinical narrative: Was a bit dizzy even sitting quiet. About 3 hours later she happened to notice that her right upper arm deltoid area where she had received her influenza vaccine yesterday is now covered with small pimple like spots that are raised and itchy if touched. They are located above the injection site and up to her neck line and across top of back. Pt has taken her BP several times and the highest it was was 180/100.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Rash vesicular
Clinical narrative: Was a bit dizzy even sitting quiet. About 3 hours later she happened to notice that her right upper arm deltoid area where she had received her influenza vaccine yesterday is now covered with small pimple like spots that are raised and itchy if touched. They are located above the injection site and up to her neck line and across top of back. Pt has taken her BP several times and the highest it was was 180/100.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ
Symptoms: Headache, Hypersensitivity, Influenza like illness, Injection site erythema, Injection site pruritus
Clinical narrative: Complaint of red, swollen left deltoid, itching at site, head ache, flu-like symptoms.  Evaluated by medical provider and was told it was an "allergic reaction."  Benedryl and Advil administered (10/20) and client felt better by the next day (10/21), with still some head ache, no complaint of itching.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ
Symptoms: Injection site swelling
Clinical narrative: Complaint of red, swollen left deltoid, itching at site, head ache, flu-like symptoms.  Evaluated by medical provider and was told it was an "allergic reaction."  Benedryl and Advil administered (10/20) and client felt better by the next day (10/21), with still some head ache, no complaint of itching.
Age: 0.97
Sex: F
Vaccine: DTAPIPVHIB, FLU3, PNC13
Symptoms: Rash generalised
Clinical narrative: Full body rash.  No treatment given.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: LEFT ARM BEGAN TO TURN RED AND BECAME SWOLLEN A FEW HOURS AFTER THE INJECTIONS
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Starting right after injection, arm is painfully sore and I am unable to lift it, gets worse every day, site is swollen and growing, red, hot to the touch and sometimes very itchy and painful at the same time when I scratch it, pain radiates to my hands and fingers, sleeping is torture, I am coughing and hives around injection site, I am going to the emergency room if this does not get better by morning as it has been several days since injection with NO relief.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site swelling, Injection site urticaria, Injection site warmth, Insomnia, Mobility decreased
Clinical narrative: Starting right after injection, arm is painfully sore and I am unable to lift it, gets worse every day, site is swollen and growing, red, hot to the touch and sometimes very itchy and painful at the same time when I scratch it, pain radiates to my hands and fingers, sleeping is torture, I am coughing and hives around injection site, I am going to the emergency room if this does not get better by morning as it has been several days since injection with NO relief.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Starting right after injection, arm is painfully sore and I am unable to lift it, gets worse every day, site is swollen and growing, red, hot to the touch and sometimes very itchy and painful at the same time when I scratch it, pain radiates to my hands and fingers, sleeping is torture, I am coughing and hives around injection site, I am going to the emergency room if this does not get better by morning as it has been several days since injection with NO relief.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Bone pain, Chills, Influenza, Insomnia
Clinical narrative: Severe Flu Symptoms Chills, Aches, Pain, Hurt all over Bones Muscles, Weakness, Sleeplessness
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Pain
Clinical narrative: Severe Flu Symptoms Chills, Aches, Pain, Hurt all over Bones Muscles, Weakness, Sleeplessness
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Bronchoscopy, Platelet count decreased, Pulmonary haemorrhage, Thrombocytopenia
Clinical narrative: I got my Flu shot around 3 in the afternoon on Sept 16th, and was in our local ER bleeding from my lung that night.   Doc's at hospital (was shipped via ambulance from our local hospital) came in next day telling me my WHITE BLOOD CELL COUNT WAS LOW AND CONCERNED THEM (I highlighted in Red the first 'reaction' shown in the box below)...So for a short 'window of time' after the Flu shot (approx. 24 hours all told), these things happened. Thrombocytopenia (abnormally low platelet count, which can result in abnormal bleeding) My note:  this is what happened to me after getting Flu shot earlier in the day...I had a LOW white cell count that concerned Docs the following day!  And was bleeding from my left lung!  One of the Serious adverse events in your package insert. I definitely will never get another Flu shot of any kind for any reason.  I was NOT informed that the shot I was getting was 4 times the amount of flu bug as the regular shots...I feel like a guinea pig being used for experimentation without my knowledge or consent!  Apparently the injection set my white cells on the attack due to your products invasion, and I could not produce them fast enough, resulting in the LOW cell count, resulting in the bleeding...
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: White blood cell count decreased
Clinical narrative: I got my Flu shot around 3 in the afternoon on Sept 16th, and was in our local ER bleeding from my lung that night.   Doc's at hospital (was shipped via ambulance from our local hospital) came in next day telling me my WHITE BLOOD CELL COUNT WAS LOW AND CONCERNED THEM (I highlighted in Red the first 'reaction' shown in the box below)...So for a short 'window of time' after the Flu shot (approx. 24 hours all told), these things happened. Thrombocytopenia (abnormally low platelet count, which can result in abnormal bleeding) My note:  this is what happened to me after getting Flu shot earlier in the day...I had a LOW white cell count that concerned Docs the following day!  And was bleeding from my left lung!  One of the Serious adverse events in your package insert. I definitely will never get another Flu shot of any kind for any reason.  I was NOT informed that the shot I was getting was 4 times the amount of flu bug as the regular shots...I feel like a guinea pig being used for experimentation without my knowledge or consent!  Apparently the injection set my white cells on the attack due to your products invasion, and I could not produce them fast enough, resulting in the LOW cell count, resulting in the bleeding...
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Hypoaesthesia
Clinical narrative: 1015 c/o of stomache, numbness of hands (hands better - stomach hurts after 30 min) afebrile 110/68 - 88.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Quarter sized raised red area left deltoid area.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Burning sensation, Chest discomfort, Eye swelling, Gingival pain
Clinical narrative: 10/7/11 16:00 - Gums & lips burning, congested chest, eyes red. 16:15 Swelling face, eyes, lips & tongue. Intermittent chest discomfort, became anxious. 18:30 ED - Antihistamine, steroid - IV. Some decrease in symptoms. 10/8/11 Symptoms gone. 10/8 - 10/17 Still lethargic.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Lethargy, Lip swelling, Ocular hyperaemia, Respiratory tract congestion, Swelling face
Clinical narrative: 10/7/11 16:00 - Gums & lips burning, congested chest, eyes red. 16:15 Swelling face, eyes, lips & tongue. Intermittent chest discomfort, became anxious. 18:30 ED - Antihistamine, steroid - IV. Some decrease in symptoms. 10/8/11 Symptoms gone. 10/8 - 10/17 Still lethargic.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue
Clinical narrative: 10/7/11 16:00 - Gums & lips burning, congested chest, eyes red. 16:15 Swelling face, eyes, lips & tongue. Intermittent chest discomfort, became anxious. 18:30 ED - Antihistamine, steroid - IV. Some decrease in symptoms. 10/8/11 Symptoms gone. 10/8 - 10/17 Still lethargic.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle twitching, Paraesthesia, Sensation of heaviness
Clinical narrative: Received FLUZONE vaccine at 1100 hours 10/18/11. When needle inserted by R.N. felt muscle twitch/jump. Patient stated "It felt like a pop, like when inserting an IV & you feel vein pop". 23 gauge 1" needle used. (No blood on aspiration noted). 2-3 pm on 10/18/11 started feeling "zingers", tingling into neck, shoulder, wrist, elbow (R) arm. Arm feels heavy. Saw M.D. Given Tramadol.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Dysphagia, Pallor, Tongue disorder
Clinical narrative: 1055 AM Pt was given FLUARIX Lot AFLU611A to RDI. Went to holding area for observation. 1107 to FNP due to feeling faint, looking pale, states difficulty swallowing and questioned thick tongue. 1110 FNP gave EPIPEN. 1120 EMS transported to Hospital ER.
Age: 22.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Musculoskeletal stiffness, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Fever & chills. (L) arm swelling & stiffness and pain.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: 10/20/11 - Left upper arm started itching & was red. Area sore & painful to touch. Pt has not taken or applied any medication or lotion. (L) upper arm is warm, red (9cm x 7cm) area & tender.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Death
Clinical narrative: Baby expired around 6AM on 10-21-11 as per the grandmother's call to the office at 0900 (approx).
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Musculoskeletal pain, Neck pain
Clinical narrative: Red at site. Raised. Area the size of hand. Painful into the shoulder & neck. Pt took TYLENOL for pain.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Had redness, swelling of the skin of the area. (Rt) deltoid area low grade fever, body aches is the next day after vaccination. Symptoms persisted for 5 days.
Age: 1.57
Sex: F
Vaccine: FLU3
Symptoms: Blood culture negative, Computerised tomogram head, Computerised tomogram normal, Diarrhoea, Febrile convulsion
Clinical narrative: Nausea, vomiting, diarrhea, fever 101-102F & febrile seizure. This seems apparent that pt. had stomach virus & timing was coincidental.
Age: 1.57
Sex: F
Vaccine: FLU3
Symptoms: Gastroenteritis viral, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea, fever 101-102F & febrile seizure. This seems apparent that pt. had stomach virus & timing was coincidental.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Bronchospasm, Immediate post-injection reaction
Clinical narrative: Case number PHEH2011US06383 is an initial spontaneous report received from a nurse on 10 Oct 2011: This case refers to a 43-year-old female patient. She was vaccinated with FLUVIRIN (batch number 110402 and expiry date: Apr2012) at dose of 0.5 ml intramuscularly on 05 Oct 2011. After vaccination immediately she experienced an asthmatic attack and bronchospasms and was subsequently admitted to the emergency room. The event outcome and causality were not reported.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient developed erythema of deltoid, then the next day had swelling of the whole arm down to his hand, right arm. Visited ER on 10/07/11 and 10/09/11 pm and was admitted for iv antibiotic/steroids.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC13
Symptoms: Injection site rash
Clinical narrative: Tiny bumps, rash on thighs (anterior lateral) Left > right which was noticed 1-2 days after vaccines administered.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US01743 is an initial spontaneous report received from a nurse on 04 Aug 2011. This report refers to a patient of unknown age group and gender. This patient was given only the MenCWY liquid conjugate component of Menveo vaccine intramuscularly on an undetermined date. No other adverse reaction was reported.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Salivary hypersecretion, Vomiting
Clinical narrative: Pt reported vomiting, but having excessive salivation. Reported to work. Suggestion was to go to local ER due to the excessive salivation was a new & unknown symptom of anthrax.
Age: 1.51
Sex: F
Vaccine: FLU3
Symptoms: Febrile convulsion, Vomiting
Clinical narrative: Pt has febrile seizure 10-11 hours post INFLUENZA vaccine. Vomited 15 min prior to seizure.
Age: 45.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Abdominal pain upper, Nausea, Pyrexia, Vomiting
Clinical narrative: Pt had fever, nausea, vomiting & stomach ache morning after receiving injections.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Condition aggravated, Febrile convulsion
Clinical narrative: Pt received flu vaccine 10/18/11. Had febrile seizure 2 AM 10/19/11. Seizure lasted 45 seconds per mother, EMTs called. Evaluated, not transported to hosp. Temp 10 mins. after seizure was 100.3; fell asleep and was usual self next AM, no fever.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Redness, swelling, warmth 10 1/2cm x 8 cm.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site discomfort
Clinical narrative: Discomfort (R) deltoid. Some numbness of (R) arm. When sleeping on (R) side - started 10/8/11.
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Flushing, Paraesthesia
Clinical narrative: Flushing of his upper torso and head with tingling sensation to both arms. Resolution with BENADRYL. Similar symptoms occurred 22 hr later. No periorbital edema. SOB or hives noted.
Age: 7.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Induration, Local swelling
Clinical narrative: Pt received flu vaccine yesterday. Today (L) deltoid swollen, firm & red.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: Gave PNEUMOVAX 10/20/11 4:30PM. Patient called at 8PM - stated arm was real sore went into neck - nerves in hand tingled still had a hard time moving arm the next day.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Received vaccine 10/18/11 at 1800. Arm at injection site red, swollen & warm to touch in a.m. on 10/19/11. Redness increased & patient saw primary care physician on 10/21/11.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Redness and warm below the injection site.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Patient received vaccination 10/20/11 about 4pm. 10/21/11 525am - nausea, vomiting & headache T-97.9 P 100 BP 144/106. TYLENOL 650 mg PO given - sxs resolved no further complaints.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: Patient states she feels tired, loopy as is she has taken a BENADRYL. BP 104/60 P 64. AAOX3. Instructed to see dr. if worsens or doesn't improve.
Age: 34.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth, Local reaction
Clinical narrative: Large local reaction on left deltoid. Itchy and painful, warm and tender.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swollen red area, hot to touch at site of injection and down deltoid area.
Age: 42.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Abdominal pain, Chills, Diarrhoea, Dizziness, Feeling of body temperature change
Clinical narrative: On day of vac developed dizziness, n/v, abd pain started about 15-20 min post vac & continued at home along w/ chills, felt hot/cold (no thermometer to take temp), diarrhea w/ cramping. Some diarrhea w/ cramping next day.
Age: 42.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: On day of vac developed dizziness, n/v, abd pain started about 15-20 min post vac & continued at home along w/ chills, felt hot/cold (no thermometer to take temp), diarrhea w/ cramping. Some diarrhea w/ cramping next day.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient's friend called back said he was displaying rash starting with legs & over time spreading. He took BENADRYL, I advised to watch symptoms if worsen go straight to medical help.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Histamine intolerance, Rash, Urticaria
Clinical narrative: Rash/erythema/urticarial rxn & histamine response.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haematoma, Myalgia
Clinical narrative: Pt received vaccines for INFLUENZA in 10/14 with no complaints on 10/14. She returned to pharmacy on 10/15 displaying 1/7 dollar-size bruise on left deltoid where injection was given. No fever, swelling, edema present per patient. Bruise was deep purple and irregular. Told to use cold compresses; avoid anti-platelet medications - pharmacy to follow-up. * Pt still having muscle pain on 10/16. 10/18/11 - increased to 2.5 m circumference. 10/21/11 - decreasing down to 1.5in minimal pain.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Dysphagia, Dyspnoea
Clinical narrative: PCP called to let us know pt. came into office after developing difficulty breathing and swallowing post PNEUMOVAX vaccination. Pt. had BENADRYL and EPIPEN on her. Both were used and pt. has recovered.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Case number PHEH2011US01537 is an initial spontaneous report received from health care professional on 10 Aug 2011. This report refers to an 18 years old female patient. She was vaccinated with Menveo on 10 Aug 2011. But, Menveo administrated to the patient has undergone temperature excursion of 67 degrees F for up to 10 hours. No adverse reaction was reported.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US01503 is an initial spontaneous report received from health care professional on 12 Aug 2011. This report refers to a 20 year old female patient. She was vaccinated with Menveo intramuscularly on unspecified date. But, she received only the Men CWY liquid conjugate without reconstituting it with the Men A lyophilized powder component. No adverse reaction had occurred following this drug administration error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US01585 is an initial spontaneous report received from health care professional on 12 Aug 2011. This report refers to an 11 year old male patient. He was vaccinated with Menveo 0.5 ml intramuscularly on 12 Aug 2011. But, he received Men A Lyophilized powder component which was reconstituted with sterile water instead of Men CWY liquid conjugate. No adverse reaction had occurred following this drug administration error.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US01620 is an initial spontaneous report received from a health care professional (nurse) on 15 Aug 2011. This report refers to a 12 year old male patient. He was vaccinated with Menveo intramuscularly on 15 Aug 2011. But, he was only vaccinated with Men A powder component which was reconstituted with unknown diluent, instead of Men CYW liquid conjugate. No adverse event was reported following this drug administration error.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US01477 is a combined initial and follow-up report received from a VSS and a physician respectively on 10 Aug 2011 and 12 Aug 2011. This report refers to a 15 year old female patient. She was vaccinated with Menveo intramuscularly on 08 Aug 2011. But, the patient was vaccinated with only the Men A lyophilized powder component which was reconstituted with sterile water instead of Men CYW-135 liquid conjugate. No adverse event was reported following this drug administration error.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US01415 is an initial spontaneous report received from a nurse on 10 Aug 2011. This report refers to patient of unknown age group and gender. This patient was given only the MenA powder conjugate component of Menveo vaccine reconstituted with a water instead of MenCWY liquid conjugate component intramuscularly on an undetermined date. No other adverse reaction was reported.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US01408 is an initial spontaneous report received from health care professional 09 Aug 2011. This case refers to a boy. He was vaccinated with Menveo intramuscularly on unspecified date. But, the patient received the Menveo lyophilized powder component of Menveo reconstituting with sterile water (Men A CYW). No adverse reaction had occurred following this drug administration error.
Sex: F
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event, Underdose
Clinical narrative: Case number PHEH2011US01242 is an initial spontaneous report received from a consumer (patient's mother) on 09 Aug 2011. This report refers to a female patient of unknown age. She was vaccinated with Menveo intramuscularly on unspecified date. However, the nurse punctured the rubber cap with needle several times and finally the syringe was shy of recommended 0.5 ml (less than 0.5 ml). There was a potential underdose. No adverse event was reported following this underdose.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: Case number PHEH2011US01194 is an initial spontaneous report received from a physician on 10 Aug 2011. This report refers to an adolescent female patient. She was given on the MenCWY liquid conjugate component of Menveo vaccine intramuscularly on 04 Aug 2011. No other adverse reaction was reported.
Sex: U
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: Case number PHEH2011US01184 is an initial spontaneous report received from a health care professional on 10 Aug 2011. This report refers to a patient of unknown age group and gender. This patient was given only the MenA lyophilized powder component of Menveo vaccine intramuscularly on an unspecified date. NO other adverse reaction was reported.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US00892 is an initial spontaneous report received from a health care professional on 01 Aug 2011. This report refers to an 11 years old male patient. He was given only the CYW-135 liquid component of MENVEO intramuscularly on 29 Jul 2011. No other adverse reaction was reported.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US01618 is an initial spontaneous report received from a health care professional on 10 Aug 2011. This report refers to a male child. He was given only the MenA powder conjugate component of MENVEO (batch number: A10052/X100030 and expiry date: Jan 2013/Sep 2012) intramuscularly on an unspecified date. No other adverse reaction was reported.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US00778 is an initial spontaneous report received from a health care professional on 03 Aug 2011. This report refers to an adolescent female patient. She was given only the MenA powder conjugate component of MENVEO (batch number: unknown) reconstituted with a sterile diluent instead of MenCWY liquid conjugate component, intramuscularly on 30 Jul 2011. No other adverse reaction was reported.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US01623 is an initial spontaneous report received from a health care professional (medical assistant) on 10 Aug 2011. This report refers to an adolescent male patient. He was vaccinated with MENVEO (batch number: X100030, expiry date: Sep 2012) intramuscularly on unspecified date. But, the patient received only the Men CYW-135 liquid conjugate component which was not reconstituted with Men A lyophilized powder component. No adverse reaction was reported following this drug administration error.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case PHEH2011US00773 is an initial spontaneous report received from a consumer on 02 Aug 2011. This report refers to a patient of unknown age group and gender. This patient was given only the MenA powder conjugate component of MENVEO (batch number: 090701) reconstituted with a sterile diluent instead of MenCWY liquid conjugate component, intramuscularly on an unknown date. No other adverse reaction was reported.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US01159 is an initial spontaneous report received from a physician on 09 Aug 2011. This report refers to a 20 year old female patient. She was vaccinated with MENVEO (batch number: X10051) intramuscularly on 09 Aug 2011. But, the patient received only the Men CYW-135 liquid conjugate component which was not reconstituted with Men A lyophilized powder component. No adverse reaction was reported following this drug administration error.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US00727 is an initial spontaneous report received from a health care professional on 01 Aug 2011. This report refers to an adolescent male patient. He was given only the CYW-135 liquid component MENVEO (batch number: unknown) intramuscularly on an unspecified date. No other adverse reaction was reported.